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Liver and Intestine Distribution Using Distance from Donor Hospital

Proposal Overview

Status: Board Approved

Sponsoring Committee: Liver & Intestinal Organ Transplantation

Strategic Goal 2: Provide equity in access to transplants

Comments

Anonymous | 10/8/2018

While I strongly support a fixed distance, a 150 mile circle is not in the best interest of any patient when half of the proposed circle is covered by the Gulf of Mexico, and any largely populated areas are outside of 150 miles.  While the proposal does take into account MELD scores over 32, patients with MELD scores 15-31 are severely disadvantaged. The current proposal suggests that a donor liver be allocated to a recipient with a MELD score of 15 (inside 150 miles) before a recipient with a MELD score of 30 (outside 150 miles). South Texas (mainly Houston area) has more patients listed than all other areas combined, and they have the highest number of deaths on the waiting list. Creating a 150 mile circle around one of the largest areas with the sickest patients will further increase the death rate of the patients.

Anonymous | 10/8/2018

Please keep in my Houston serves a very large population and half of our nautical miles are in the Gulf of Mexico. You would be condemning a lot of Houstonians to death.

Michael Volk | 10/8/2018

I agree with the committee that the Broader 2-circle model best balances equity, utility, and feasibility. I would favor a slightly lower MELD threshold than 32, since in many areas of the country patients are transplanted before this threshold, and because the inflection point on the mortality curve is around 25-30.

Anonymous | 10/9/2018

Caring for waitlist patients within the Houston and surrounding South Texas areas, I feel as though the broader 2-circle framework leaves our patients at a disadvantage.  Not only is half the circle encompassed by the Gulf of Mexico, but does not include the areas from which we obtain many of our grafts currently, leaving our patients at a deficit for organs, therefore increasing waitlist deaths and MELD scores at time of transplant which lead to poorer outcomes. Also, in fairness to all listed patients, no matter geographical region, I believe the MELD sharing threshold should start at 29.

Anonymous | 10/9/2018

This public comment document is pretty hard to understand - it's pretty wordy and is confusing for the lay public to read, It was hard for me, and I'm in transplant! But just looking at the summary, to me  - I always liked the different 'districts' which were actually designed to fix inequity. BUT given these two circle options, Looks like the 'Acuity circle model' is predicted to do more to fix geographic inequality Looks like the 'Broader circle model' (BTW I'm not entirely  sure why it's called a broader circle when a large portion of the allocation from MELD 15-31 is limited to a pretty small circle, so I would call this the Smaller circle model) does something to the inequity (but certainly less than the other proposal ) and the only advantage I see of this one is the % flying that's predicted to happen - BUT...  1) I only pushed OPPOSE the 'broader' circle button  instead of the STRONGLY OPPOSE button because I think if you fixed the MELD scores before it goes out to a bigger circle right away in the SMALLER 2 circle, then it might work (but then again, then it just looks more like the 'Acuity Circles ') The ischemic times and transport distances don't seem to change all that much in any of these optons. How come, and isn't it the former that really makes a difference in liver outcomes that we care about? And also, just because an organ gets offered to a center that's further away, that doesn't mean that center has to accept that offer. Look what happened after Share 35 - acceptance rates actually went down for that group of patients (I think because transplant centers got more offers, and maybe thought they could wait for a better one for their really sick patients) I understand that the mathematical modelling doesn't try to account for or tries to predict changes in behavior (yes, really hard to do, but not impossible, given the experience with other policy changes) after the policy gets put in place, so can anyone really say we know how many of these organs will actually fly??? Sure doesn't sound like it!??  and that to me is the only advantage that the SMALLER circle proposal MIGHT provide. otherwise, that proposal doesn't offer any thing better than the 'AC model' . Anyway, I know some people are saying its going to cost more, but what about all the Money we spend right now keeping really sick patients alive in the ICU while they wait forever in some parts of the country for a liver? if we cut down on that time. the health care system actually SAVES a ton of money. Also,haven't we been trying to fix this for the past 20 or 30 years? Why don't we just actually fix it once and for all?? JUST looking over what the Final Rule that governs organ allocation policy SHALL BE BASED ON SOUND MEDICAL JUDGMENT I am not sure how a proposal that would give an offer to a patient with a MELD of 15 that is a little bit closer (say 140 miles) preferentially and BEFORE  a much sicker patient with a MELD of 31, say just outside the circle,( say  160 miles) would be based on 'sound medical judgement'. This sounds like UNSOUND MEDICAL JUDGMENT and way too much local priority and interests to me.  Also, in the survey why did UNOS limit  the choices of MELD 'sharing' threshold limited down to 29??? I think 25 would be much better to get the livers to patients who need them so if I were really giving feedback, I would have selected the button for 25 or even 22 The Final Rule also says ORGAN ALLOCATION POLICY SHALL NOT BE BASED ON THE CANDIDATES PLACE OF RESIDENCY OR PLACE OF LISTING, except to the extent required by the other statements  Right now if you go onto the SRTR website and use that liver waitlist calculator that is available, it becomes obvious that the primary determinant of whether you get a liver or not IS IN FACT THE CANDIDATES PLACE OF RESIDENCY/LISTING - so we are not living up to the final rule. So we need to just fix this. Why haven't we done anything in the last decade to fix this?? Of course, I know the real answer is politics and people out for their own cause and MONEY. Also, if you look at how the heart allocation policy is written, it looks like they go from the DSA (which they will also have to get rid of, according to the edict from on high) then they offer out the organs to sickest patients at 500 miles from the get go, then eventually  go out to 1000, 1500, and 2000 mile circles. Why are the circles for liver so much smaller??? after all, livers can tolerate ischemia cold time much better than hearts can!?!?! So if we really want to try to fix inequality (and that's the real question - do people  really want to fix it or just say you're 'trying to fix it', ), the ACUITY CIRCLES seems like the better way to go than the SMALLER circle proposal. [and again, I really didn't get why we didn't just go with the 4 or 8 districts in the first place a few years back. seems like this might have been better all the way around (including the flying piece) - I remember the public comments last time or the time before and a lot of folks wrote in that livers should just stay where they are found, but that's not based on sound medical judgment either or helping as many really sick patients as you can or distributing broadly - its not like these organs actually BELONG to any person or center or any area, they are donated into the system to help the people most in need - and that's not what we are doing. We should do the thing that fixes this problem the best.   P.S.  -------------------------------  AS for the questions specifically asked in the beginning of this section: I don't have any comment/opinon  on Hawaii. For SLK, I believe the kidney should be mandated to follow liver offer for sickest patients (in my opinion MELD >=29 or whatever the MELD the wider distribution  goes out to ) because it really is disingenous to offer tthe liver and not the kidney with it to someone who really needs a kidney too. A center cant really accept a liver  without the kidney if a person really needs a kidney.  But  on a related subject, what happens when there are three multiorgan kidney recips?? need clarity here....So you need to clarify heart/kidney, lung/kidney and liver/kidney and who gets priority as well as all the organ combos like heart/liver lung/liver and liver alone candidates and who gets the liver  based on how sick they are - lots of stuff that is gray right now. I don't have an opinion about intestine

Michael Lucey | 10/9/2018

Julie, can you address the effect on  'turn down' of offered organs of the four models?

Anonymous | 10/9/2018

Patients and Families Engaged Partners (PFEP) group represents the parent and pediatric advocacy voice of SPLIT. Like SPLIT, we also applaud the efforts of UNOS to address the concerns related to children on the liver transplant wait list, and to actively engage all stakeholders in regards to organ distributions. It is our understanding that the ad-hoc geography committee has used the December 2017 Board- approved '5 Principles of Geographic Distribution' to identify and distribute 3 geographic frameworks for review for public comment. In support of SPLIT, we also agree that the continuous framework seems to allow the most flexibility to allow and account for pediatric needs. As parents, we are particularly concerned for the pediatric donor livers that are being allocated. Previously published work has shown, and we have personally seen within our liver community, the numerous amount of children that died on the liver-wait list. What is even more concerning is that more than 1600 adults were transplanted with livers that came from pediatric donors while these children passed away still on the wait list. It is our understanding that due to the prioritization of local adults over critically ill children on the wait list nationally, a number of adults, the majority whom are not critically ill, are transplanted with livers from pediatric donors without ever being offered to a child. To watch your child suffer is one of the most painful things we as parents have to go through. Organ donation gives our children who have terminal illnesses a chance and the hope to grow up, to make memories with their families, and to teach others about the good things that come from organ donation. When that hope or offer never comes, it is excruciatingly painful to watch your child continue to suffer, and eventually become too ill to transplant. Our children are fighters, some of the strongest humans I have ever had the pleasure of knowing, but they can only fight so much in an unfair battle before they loose. These children deserve the chance to live life, and if the option is taken away from them due to an unfair or inequitable organ allocation system, they will get that chance.  A fair and equitable organ allocation system must 1) distribute pediatric organs as broadly as possible and reduce disparity across the country and 2) be transparent and readily explainable to the public. In agreement with SPLIT, as parents we believe that the broader sharing of organs benefits children. There is still some lingering concern that all three frameworks presented are designed to apply to adult wait list populations. We urge you to see that special consideration must be given to pediatric wait list patients in order to assure equity and access to transplantation for our children. For example, whatever framework is chosen, there should be a separate set of rules or considerations given for the pediatric community. We hope that you hear our concerns and consider them when creating a framework. Lastly, we urge you to think of the children and save them.

Robert Cannon | 10/9/2018

I am strongly opposed to both the broader 2-circle and acuity models that the liver and intestine committee is currently proposing. The main reason for my opposition is that these proposaIs will actually result in less transplants performed overall. According to the modeling data released by the committee, the Broader 2 circle model would result in between 32 and 35 fewer liver transplants nationwide. While this is a small fraction of the total number of liver transplants performed nationally each year, each transplant missed out on represents a priceless human life that is potentially needlessly lost. Furthermore, the majority of current DSAs (32 or 33 depending on the MELD threshold used in the 2 circle model) would see fewer transplants. The distribution of which areas of the country gain and lose transplants is also highly skewed. Essentially every DSA in the Southeast will see fewer liver transplants, which is particularly concerning when you consider that many of these programs serve traditionally disadvantaged populations that already face difficult access to healthcare. The 'winners' in the proposed systems are New York (which has one of the worst performing OPO in the country), New England, and Minnesota. More important than partisan arguments over which areas of the country will gain and which will lose, though, is the fact that I strongly believe we should never support any changes which are expected to decrease the number of transplants. Our primary goal should always be to save MORE lives through transplantation, not LESS. I agree that DSA boundaries are arbitrary and eventually need to be done away with. But we should not let threats from lawyers force us into rushing into a flawed policy that will result in fewer lives saved by transplant.

Kimberly Hoagwood | 10/10/2018

I support the Hawaii variance, but believe the same variance rule should be applied to Puerto Rico. To fail to do so violates the principle of equity. The reasoning offered on the webinar did not follow the principles of justice and equity that drive other deliberations from the transplant and UNOS community.

Anonymous | 10/10/2018

We are strongly opposed to anything less than a 250 mile circle because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston. Implementing a 150 mile circle around S. Texas will deprive patients from the organs in Lubbock, El Paso, and Forth Worth to which we currently have access.

Paula Criel | 10/10/2018

If these guidelines had been in place, my 32 year old daughter would not be alive today nor the mother of a beautiful 6 year old daughter. I am strongly support a broader circle. The city of Houston loses half it circumference to the Gulf of Mexico.

David Victor | 10/10/2018

I supported the largest circles available to support as many patients to be allocated for each organ

Scott Lindberg | 10/10/2018

I feel strongly that any changes in allocation should maintain or broaden organ sharing so as to reduce the regional variance in MELD at transplant. While it may work well in the north east, the B2C model would result in a dramatic reduction in sharing of organs in the west. My present OPO is more than 600 statute miles across. Our region 4 sharing brings livers from more than 600 miles routinely. The B2C model will clearly reduce the number of Donors available to patients in the Houston area. The modeling clearly demonstrates that this restricted distribution will perpetuate the regional disparities in access to transplant.

Robinette Carson | 10/11/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance.  WHY was a 150/250 mile circle proposed?  Is saving money on airplanes used to deliver procured organs more important than saving lives

Debra Russell | 10/11/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance.  WHY was a 150/250 mile circle proposed? Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant.

Larry Simmons | 10/11/2018

It would break my heart to have a member of my family on the waiting list with this proposal. 150miles is not appropriate for Texas. We would need at least 250 miles preferably more.

Anonymous | 10/11/2018

This current proposal of allocating livers to candidates within 150, 250, or 500 nautical miles (nm) of donor hospitals before offering them nationally to allow for efficient placement of donor organs and to avoid organ wastage is too limiting given the geographic parameters of the Gulf Coast/Houston area. In the Gulf Coast/Houston area, half of any proposed circle used for organ distribution area will be negated by the presence of the Gulf of Mexico on our southern border, and will limit their access to liver donors.While this is a problem for many regions of the country, a notable difference in Texas is that there are no large population centers for quite a distance inland from where the majority of all Texas listed patients are located. The other population centers in the state of Texas are all located at a distance of over 150 miles. Houston and South Texas patients represent the largest population of patients on the waiting list for liver transplantation in the State of Texas and have the highest waitlist mortality rate. For our patients, a circle of distribution of less than 250 miles for patients with a MELD of less than 32 means erecting a barrier for organ allocation that does not currently exist and is likely to limit their opportunities based on geography.    Currently Gulf Coast/Houston region receives organs from the state of Texas and parts of Oklahoma as part of the 35 Share rule which gives a broader sharing of donor livers to patients with MELD scores of 35 and over. This rule would no longer exist and as noted below there are no largely populated cities within our 150 circle. For MELD scores between 15-31, Gulf Coast/Houston patients would not receive donor offers outside of 150 miles until they were offered in the sequence noted above.  For example, if a Houston patient with a MELD score of 30 was listed for liver transplant, and a donor from Dallas became available, the proposed allocation would allocate the liver to a recipient with a MELD score of 15, living within 150 miles from Dallas, before the Houston patient was eligible for the liver.  Therefore the patients in the Gulf Coast/Houston area are at a significant disadvantage as San Antonio is 171nm from Houston, Dallas is 208nm from Houston, Fort Worth is 233nm from Houston, Lubbock is 462nm from Houston, El Paso is 647nm from Houston, and Oklahoma City is 360nm from Houston. The 150nm circle is too limiting and should be increased to a minimum of 250nm. In summary: • We recommend larger sizes of fixed distances • We recommend 29 as the sharing threshold • We strongly oppose the broader 2-Circle We support Acuity 250+500 • UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than saving lives? • We are strongly opposed to anything less than a 250 mile circle because of the Gulf of Mexico, and lack of populated cities less than 150 miles from Houston. • Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which we currently have access. We stand to lose approximately 130 livers a year for potential transplant within the Houston region. • Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant. • Houston and South Texas represent the largest population of patients waiting for transplants. • The average MELD score at time of transplant in Houston is over 30 which is higher than the national average. • UNOS previously proposed a 250/500 circle for lung allocation, so why are the same rules not applied to the liver allocation?

Anonymous | 10/11/2018

My husband just received his liver transplant 2 months ago, his MELD was 32. I honestly did not think he would make it to transplant. He was having to have blood transfusions every 2 weeks, he was very unstable when it came to his HGB. We live in Southeast Texas. If you do the Border 2-Circle that is entirely to small for this area, as we get organs from the Dallas-Fort Worth area, and even further into Oklahoma. MELD of 32 is too high for most patients as at that score they are very sick, and may not even live through transplant. The MELD needs to lowered to 29. As the patient gets sicker from the Cirrhosis, they tend to bleed more, if the MELD score would be lowered to 29 there would be less transfusions that the patient would have to go through.

Living Legacy Foundation of Maryland | 10/11/2018

I am in support of eliminating DSA as an element of liver allocation, and broadening the sharing of donated organs. I am however concerned with some of the assumptions of what is to be gained from the proposed policies being considered. I do not see definitive evidence in the modeling that this will transplant more patients, rather it seems to be transplanting 'different' patients in greater areas of geography.  This may be the intent of the policy, in that great variability in MELD at the time of transplant and waitlist mortality should be addressed, but this would be best accomplished with variable areas of allocation circles in different parts of the country. This policy could have little to no effect on allocation in some DSA's, while in our local example the paradigm shifts from 80%+ of locally recovered livers being transplanted into local recipients, to a proposed model of 20% (or less) locally transplanted. If this were a matter of just broader sharing, that might be acceptable. Instead, the two local centers in our area are projected to do MORE transplants in the new model. So 80% of our donors are sent out, the local volumes are satisfied with organs being sent from outside OPOs. I'm trying to understand the wisdom in this...more flying (pilot shortage), more cost (substantial), more risk of discard and/or out of sequence allocation, and greater manpower required for the OPO to manage the change in practice. Ideally, in time we will find ways to minimize some of this impact (local recoveries and transport of organs to the transplant center in lieu of sending local teams on distant recoveries). This will take time. I am hopeful that some consideration will be given to the financial and operational impact to OPOs in geographically condensed areas of our country. This policy proposal is dramatically more impactful for some programs than others, please consider all perspectives.

University of Arkansas | 10/11/2018

We are concerned by the models prediction that over 90% of organs in our DSA will be flown. This will significantly stress our transplant program at multiple points and seems like an unreasonable expectation.

Ted Criel | 10/11/2018

At 23 years of age, my daughter's liver died due to years of medication for her Junior Rheumatoid Arthritis. Her liver was procured from a  greater distance than 250 miles. She would not be alive today nor would I have a beautiful 6 year old grand daughter. Texas is a huge state and many people in the Houston area will die because livers will not be procured with this new distance. This would not be good for the Houston area.

Anonymous | 10/11/2018

I volunteer with the OPO and work at a transplant hospital. I believe that the citizens of Houston will be harmed and will not have finished access to livers if any proposal other than 250+ is invoked. I do not understand how people can oppose these larger circles now that livers can safely travel that distance. Thank you for considering the larger circles.

Anonymous | 10/12/2018

Had this proposed bill been in effect a few years ago our niece would not have been able to get her transplant. DO NOT pass this bill!

Paula Criel | 10/12/2018

I understand that there needs to be a fair and equitable process for the procurement of liver organs; however, a broad paintbrush stoke across the United States does not help the state of Texas that is geographically compromised or any other state for that matter facing barriers.  Exceptions and provisions need to be put in place for those states that will be most affected if the procurement guidelines change.  In this case, the city of Houston would drastically be affected if the 150 miles circumference goes into effect especially since half of that area is lost to the Gulf of Mexico.  Texas also has one of the highest rates of liver disease in the United States and many of these people who need transplants would be severely limited if the guidelines change.   My daughter, Laura would not be alive today if the proposed guidelines were in place.  At 23, her liver failed due to the residual effects of Junior Rheumatoid Arthritis.  Today, 10 years later, Laura and her 6-year-old daughter, Beka are doing well and enjoying a beautiful life together. I totally support a concentric circle of at least 250 miles for patients with a MELD <35 and 700 miles for those with MELD >35. If we are striving for fairness and equity, then let's take everything into consideration and make decisions that will benefit all.

University of Kansas Health System | 10/12/2018

Circles are arbitrary, I would support the states model It makes sense. It incentivizes us to increase donors. It follows the flow for patients, centers, support systems and insurance.

Anonymous | 10/12/2018

Hospitals in Texas take on cases that NO other hospital in the country are willing to take on. If the new proposal is put in place patients like my husband, that had no choice but to get a transplant in Houston would not have received his life saving transplant. He could not be listed in multiple regions because no other hospital would take his case on. The Texas Medical center is fairly isolated within the population centers of Texas and would be unfairly impacted by these changes.

Marie Proznick | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Enrique Sirias | 10/12/2018

Thank you for this opportunity to make our point of view relevant.

Barnes-Jewish Hospital | 10/12/2018

We oppose broader sharing that ignores other regulatory mandates such as cost, waste, access etc. We oppose any allocation change that increases organ waste.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the impact of your decision on the survival of the patients I care for -- patients who would be disadvantaged by the proposals offered here -- it is important that the Organ Procurement & Transplantation Network FIRST take the time to conduct a thorough analysis of population-based frameworks. I believe all of these patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Houston Methodist Hospital | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/12/2018

Wrong to limit distance in recipient most patients will die due to this or get sicker waiting.

Anonymous | 10/12/2018

I ask OPTN to not make a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my institutions patients, who would be disadvantaged by the proposals offered here, it is imperative that the OPTN take the time to conduct a thorough analysis of population-based frameworks. All patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Mary BoitanoNelson | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of our patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily. We have many patients who die waiting already; we do not want to increase this percentage. Thanks.

Anonymous | 10/12/2018

I respectfully request that you refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Considering the direct impact of your decision on patient survival, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

MOCH | 10/12/2018

In order to meet the timeline stipulated in the HRSA letter, MOCH would support the broader 2-circle scenario with MELD sharing threshold of 35 as this scenario comes closest to the Board approved proposal from 12/2017 in terms of the key metrics listed. Having said that, we have the following comments: 1) The 6 month report following the change in lung allocation suggests increased discard rate and decreased utilization rate when DSA was removed from the distribution policy. And although the magnitude of the financial impact is not included in the report, the increase in regional and national transplants likely increased the organ acquisition costs for lung transplant centers. It would be helpful to know how the OPTN plans to address these issues with the lung policy and ultimately liver policy if similar changes are seen after implementation.    2) There is limited data provided about the impact of the proposed scenarios on socioeconomic inequities. Although the data suggests no impact at a national level, because all of the proposals lead to some areas of the country seeing increases in the number of transplants and other areas of the country having decreases, being able to evaluate socioeconomic stratifications a regional level would be helpful.

Anonymous | 10/12/2018

Please help! It's a matter of life and death to large rural areas.

Anonymous | 10/12/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily

Mid America Transplant | 10/13/2018

Support Hawaii variance as written

Christina D | 10/13/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily

Iowa Donor Network | 10/13/2018

The acuity 250+500 proposal is complex and will be difficult to explain to the general public. For this reason, I am supporting the broader 2-Circle proposal. I can support the Hawaii variance and the SLC threshold and Intestine proposals as proposed.

Anonymous | 10/14/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily

Laura Criel | 10/14/2018

My life has been forever changed because of my liver transplants. If it weren't for these transplants I would not be here or have my beautiful daughter Rebeka. This new procurement proposal would have prevented me from obtaining my second liver transplant.

Anonymous | 10/14/2018

I am a liver transplant recipient and there should not be any restriction on distance on way a donor liver comes from the only restriction should be a time line if the liver could be transported in a time to be transplanted. I would hate to see some one die because an organ was 1 mile out of bounds. I understand there is a waiting list all across the country be a organ may be right for one person and not another. Do away with any boundaries.

Jonathan Gentry | 10/15/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.    - Jonathan Gentry, BSN, RN

Emory University Hospital | 10/15/2018

Our transplant center abstains from a vote in support of any of the above listed options. We do so on the grounds that the large circle models forecast a massive withdrawal of life-saving organs from areas with higher disease burden and waitlist mortality, and the less-severe option is still equally predicated on flawed logic and a breach of obligations to sound medical judgment, best use of organs, efficiency and promotion of access in the Final Rule. We further dispute the statement on page 31 of this proposal that the '[i]n considering patient access, the OPTN has interpreted these requirements to apply to patients who are registered for organ transplantation - as opposed to all patients with end stage organ failure, who may or may not be registered for organ transplantation. This is consistent with the OPTN's authority under NOTA to focus on organ transplantation as opposed to broader access to healthcare.' Final Rule point 121.8.5 specifically uses the word 'patient' rather than 'candidate' when speaking to a requirement of policies to promote access to transplantation. As a contractor to the federal government, UNOS's obligation is clear - the promotion of health among Americans through transplant. The greater transplant community is composed of clinicians who share this obligation - sound medical judgment and a responsibility to use a limited supply of organs to maximize health among Americans. To do otherwise betrays medical obligations recognized from the original of Hippocrates to the Geneva Physician's Oath adopted after World War II - even UNOS mission statement ('for the benefit of patients.') It is out of the question to accept the position as written in this document.

Scott Hannover | 10/16/2018

I am submitting my comments via email. I am an individual, general public, family member of a potential transplant recipient. I strongly oppose both models. I am from New York.

As a family member of a patient who died in New York while waiting for a transplant that never came, I am NOT in favor of these proposals. While the easy answer would be for me to say that my loved one needed an organ no matter what (which they did), the benefit of time and prayer has allowed me to take a larger view on the issue. If sharing were to be done on a larger scale, then wouldn’t someone else in my previous situation experience a loss of a loved one because a single organ was transported to New York rather than staying in their community? Why should someone else experience a death of their loved one for the same reason? How are we to value lives? Is one life more valuable or more important than another?

On careful review of these proposals, as well as information that is well known in the state of New York, I simply cannot support larger scale sharing based on the following reasons:

1)   None of these proposals address organ donation. My state of New York has some of the worst donation rates in the country. I’m not sure I understand because New Yorkers are known for our generosity. I have seen several newspaper reports and other documents that show how poor the organ banks in New York perform. In good conscious, how could I possibly support taking an organ from another community and harming another human being because the New York organ bank performs so poorly? There should be culpability and accountability in holding each organ bank for any given community responsible for identifying donors. Not addressing these concerns transfers a death from one community to another.

2)   These proposals seem hastily created. On review of previous proposals and history of liver allocation, I found that a different proposal was passed by UNOS last year around this time. Then it seems that a law firm in NYC filed a lawsuit, which resulted in government interference and UNOS scrapping an agreed upon proposal. How in the world did data so quickly be analyzed when it took years to reach the initial proposal passed last year?

3)   While I am unfamiliar with healthcare policy and medical decision making, it seems that changing healthcare policy based on the threat of litigation is hazardous. Lawyers and administrators making decisions as to the best use of a scarce resource, rather than experts in the field, is unacceptable. And an organization (UNOS) responsible for creating, directing and implementing the best policy should not be fearful of litigation, nor should they respond to such childish attempts at subverting previously agreed upon proposals.

4)   Looking at other data provided, it seems that there will be a considerable amount of flying for all transplant centers throughout the country. Who will be responsible for the costs of increased flying? I assume the cost will be passed to the patient and family? That doesn’t seem fair to further financially burden the patient in their time of their desperation. And are there even enough pilots and airplanes available to go on these flyouts throughout the country?

5)   Finally, looking at waitlist mortality counts in the “DSA-level data tables”, I simply do not comprehend how waitlist mortality DECREASES for many of the areas negatively impacted by a net efflux of organs to other areas. Is this some sort of mathematics that defies logic? It simply cannot be possible. If any given area does 30% fewer transplant than before, how in the world does that same area have a DECREASE in waitlist mortality?!?! This type of mathematics may make an interesting graduate level thesis paper, but could not possibly be defended for confirmation of degree. So, provided that simple mathematics still holds true, and that waitlist mortality CANNOT DECREASE when more organs leave a given area, then I am left to question the validity of all of the data analysis.

In summary, I feel that supporting these proposals for larger scale sharing is morally bankrupt. It values one life over another, and does nothing to help improve organ donation, is inappropriately and poorly constructed “policy proposals” in response to litigation by foolish individuals. Additionally, the data analysis seems to be factually incorrect. It seems stunning to me that an analysis like this would even pass through a supposed group of experts in UNOS committees, and leads me to question the actual expertise of anyone on those committees. If policy proposals like this go through, I simply feels terrible for families and patients in other communities to have to go through what I have gone through.

Scripps Green Hospital | 10/15/2018

No changes to the Hawaii proposal, SLK or intestine proposals.    I do not favor the B2C32 proposal, it is not consistent with the final rule.   Favor either AC proposals:  500 most acceptable.    B2C 29 only if -   1. 1st level of sharing is for 29-40 and  2. sharing circle of 250 nm is bigger (out to 500 nm), and   3. If sharing goes down to smaller circle of 150 nm, then make the lower MELD limit higher to 20, so it only stays within 150 nm mile circle for 20-28.

Erin Wells | 10/15/2018

While I agree that additional population based modeling would be helpful, I am in support of the B2C model given the time constraints in place for a decision to be made. I would like to see the initial MELD sharing threshold decreased from 32 to 29 and also consider splitting 15-28, perhaps a 20-28 2nd pass then 15-19 3rd pass. I support SLK priority and hope it will match a lower initial MELD sharing threshold. I support continuing the variance for Hawaii and believe it should be extended to Puerto Rico.

Ronald Reagan UCLA Medical Center | 10/15/2018

Ronald Reagan UCLA Medical Center supports broader sharing through the adoption of acuity circles at 300 and 600 nm (Scenario 4) which, based on modeling, would result in a modest reduction in Median MELD/PELD at transplant in our DSA but would most positively impact Southern California waitlist mortality rates and the predicted number of waitlist deaths.   Per the latest LSAM release, our DSA (CAOP), has the highest median MELD/PELD at transplant in the country at 35.3. Californians comprise 12.1% of the U.S. population but account for 18.5% of all U.S. liver waitlist deaths.In 2017 alone, 223 Californians died on the liver waitlist and countless others had to be delisted because they became too ill or unstable to undergo a lifesaving transplant. NOTA requires a 'nationwide distribution of organs equitably among transplant patients'. We agree that the current system of distributing livers and intestines based on DSA boundaries is unfair and not in the spirit of NOTA as written.  Donation service area boundaries are arbitrary, DSAs vary greatly in size, and this size has no relationship whatsoever to population, geography, and most importantly, the medical need of those awaiting liver transplant. Patients without the means to travel to lower MELD/PELD DSAs for transplant continue to be disadvantaged under this current 'local first' allocation system.  Our center supports the elimination of arbitrary and inequitable boundaries and the broader allocation of livers through the use of acuity circles as an important first step in addressing MELD/PELD disparities by DSA and region. Regarding Hawaii and its unique geographic isolation, we would encourage the Board to consider a larger radius that includes the Western United States so these donor livers might also be shared in a broader, fair and equitable manner.

Anonymous | 10/15/2018

I strongly favor AC since comply with final rule over B2C proposal.  I strongly favor AC 300/600.  If  B2C. Choosen then insist on: first distribution must be 500, share at MELD 29 and allow offer to go out at MELD <20 not 15.

University of California, San Francisco | 10/15/2018

Strongly favor AC - it complies with the final rule much more than an B2C proposal.     Any proposal that gives preference to a patient of a MELD of 15 over a slightly more distant and sicker patient with MELD of 31 cannot be based on sound medical judgement. Does not distribute over a large an area as feasible.       1) if B2C is chosen, 250 mile circle is TOO SMALL (500 nm at least)  2) if B2C is chosen, should distribute down to 29 (preferably 25) 29-40 at 500 nm (not 250 nm)  3) if B2C is chosen, should go out to a larger circle down to 20 NOT 15 in other words 150 nm for candidates 20-28, NOT >15

Primary Childrens Hospital | 10/15/2018

Pediatric allocation of pediatric liver donors is a significant improvement and will hopefully direct these organs efficiently to children so that they will be transplanted in a timely way

Anonymous | 10/15/2018

The Acuity proposal is the only fair option at the moment.  We need to have this approved immediately in order to save more lives.  New Yorkers in particular are forced to endure sickness while their MELD scores rise when others in different states with lower scores are getting their organs instead.  This IS a life and death situation and the idea that the states with lower scores cannot accept that the system is unfair is mind blowing, selfish and unethical.

University of California, Los Angeles | 10/15/2018

The UCLA liver transplant program favors 300-600 nm organ sharing schema based on acquity as the most suitable of the proposed models.

Anonymous | 10/15/2018

We propose a phased in approach where we start with B2C-32 and allow for the effects to equilibrate nationally with a simultaneous push to focus on donor OPO performance. We find it interesting that we continue to have these discussions with only one sided solutions. We think most of the OPOs in this country with concentrated efforts can improve their performance and volumes which will help address some of these organ geographic issues. Such efforts could possibly mitigate the need for extreme broader sharing which leads to increasing organ travel and costs. (The AC model forces a higher median national MELD which = increased cost/transplant and requires increased travel of organs which also = increased cost/transplant) In a health care environment focused on a commodity market and value based care we feel this is not an insignificant piece of the issue at hand and that we have some responsibility towards good financial stewardship within our community. After changing the allocation AND addressing OPO performance we can then revisit whether there is further need for increased national sharing and by how much (B2C-29 or B2C-25 for example). Asking the whole country to fix NY and CA problems with a increase in median national MELD and increased transportation costs without asking the OPOs to respond in kind is a one sided argument. Additional data collection will also confirm if we are on the right track as center behaviors adapt to national allocation change. As with many things the real solution is typically found to be somewhere in the middle. In sum, we support a stepwise approach to liberalizing broader national sharing. Thank you.

Richard Gilroy | 10/15/2018

The policy does not significantly change the median MELD at transplant for patients within the current region 5 irrespective of circle size. please consider consultation with Industrial Engineers and following sound Industrial Engineering Principals.

Anonymous  | 10/16/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Tami Houston | 10/16/2018

As a liver transplant patient I favor a wider distribution because it results in the lowest deaths of patients on the list.  It is heartbreaking to me to think that someone with a low Meld Score(not as sick). Would be transplanted before a dying high Meld score patient just because they live 250 miles apart.  Please take your time in making your decision and consider all the ramifications of your actions.  This outcome is near and dear to my 'LIVER'.  Thank you. 

Anonymous  | 10/16/2018

The current liver distribution policy based on donation service areas (DSAs) violates the National Organ Transplant Act (NOTA), which requires a 'nationwide distribution of organs equitably among transplant patients.'   • Under the current allocation system, median allocation MELD/PELD at transplant varies by almost 10 points between the highest and lowest MELD/PELD regions and centers.  • Despite California's liver 2,510 wait list candidates comprising 18.3% of all liver waitlist candidates in the U.S., Californians made up only 7.6% of all liver transplants performed last year.  • Californians make up 12.1% of the U.S. population, but 18.5% of all U.S. liver waitlist deaths. In 2017, 223 Californians died on the liver waitlist and countless others had to be delisted because they became medically unsuitable for transplant after long wait times.  • In the most recent modeling data provided by the SRTR, Metropolitan Los Angeles (CAOP donation service area, or DSA) had the highest median MELD/PELD at transplant in the entire United States: 35.3.  • Patients without the means to travel to centers in states with shorter wait times are badly disadvantaged and may die waiting or become too sick to ever undergo a liver transplant.  • Donation service area boundaries are arbitrary, DSAs vary greatly in size, and this size has no relationship whatsoever to population, geography, and most importantly, the medical need of those awaiting liver transplant.  • UCLA supports the elimination of arbitrary and inequitable boundaries and the broader allocation of livers.  • Of the four liver/intestine allocation proposals currently under consideration, UCLA strongly supports the adoption of the broadest possible sharing through the implementation of acuity circles (300+600 as first choice) and (250+500 as second choice), which in Southern California would result in the largest reduction in median MELD/PELD at transplant and would provide much needed relief to Californians awaiting liver transplantation.

Raymond Lynch | 10/16/2018

I urge the board to reject all of the options in this proposal, as are both too terrible to adopt and not terrible enough to satisfy special interests groups manipulating this debate. From the national and regional webinars, it is clear that while the acuity circle models better satisfy the stated goal of equalizing MELD, the B2C proposals are included in the hope of skirting criticisms about equity and efficiency while still mollifying the plaintiffs in a suit paid for in part by the Greater New York Hospital Association (GNYHA). We have been given vague assurances - with no data - that sharing at a MELD of 29 vs. 32 or 35 may somehow turn B2C into an acceptable compromise for all groups. Based on the statements on the GNYHA-supported lobbying group CODE's website, however, this is not likely to happen. The irony of UNOS's actions is that in the effort to avoid a legal challenge, they have cobbled together a mashup of MELD scores and mileages that are actually 'arbitrary and capricious' as claimed in the lawsuit.    The harsh truth is that we are not proving ourselves worthy of the custody of a limited resource, the memories of donors, or the trust of patients. The proof of that is on page 31 of this proposal: 'In considering patient access, the OPTN has interpreted these requirements to apply to patients who are registered for organ transplantation - as opposed to all patients with end stage organ failure, who may or may not be registered for organ transplantation. This is consistent with the OPTN's authority under NOTA to focus on organ transplantation as opposed to broader access to healthcare.' The old argument used to be that the 'need is greatest on the coasts.' Myself and others have shown that this is incorrect both from a waitlist mortality sense and more broadly from where the burden of liver disease is in the country. The UNOS answer has been to move the goalposts of equity. Within the waitlist, this has been accomplished by counting the number of Medicaid patients affected, even though state differences in Medicaid coverage make it more a measure of access than disparity.     Now UNOS seeks to totally absolve itself of responsibility to sick Americans. In doing so, it abandons any pretense of equity, and makes a mockery of its own Mission Statement ('Our mission is to advance organ availability and transplantation by uniting and supporting our communities for the benefit of patients through education, technology and policy development.') and Vision ('Our vision is to promote long, healthy and productive lives for persons with organ failure by promoting maximized organ supply, effective and safe care, and equitable organ allocation and access to transplantation.') The Final Rule clearly distinguishes between patients and candidates in the statement 'promote patient access to transplantation' (42 CFR 121.8.5). This isn't surprising, as federal law is there for the benefit and protection of all Americans. This summer, the UNOS board voted to endorse the statement that 'organs are a national resource' - how can that be reconciled with a members-only attitude toward access? The creeping moral subjectivity of policies that selectively benefit the affluent and fortunate while hiding the damage to marginalized groups behind flimsy excuses is abhorrent. We in transplant may not be charged with 'fixing' social inequities in this country, but that is not a pretext for grossly worsening them and then refusing to acknowledge our role.    UNOS leadership have pushed a narrative that we are running to stay ahead of a legal challenge. In this atmosphere, we have come to accept as necessary the idea of increased costs, risks, and logistical burden for a net reduction in the number of transplants. The commitment of clinicians to caring for the sick regardless of their means is not expendable, however, and we need to strongly question the motives and fitness of those who would pretend to see it as such. The legal challenge is just that - a challenge - and we should meet it with policies that are ethically sound.

Gift of Hope Organ & Tissue Donor Network | 10/16/2018

Approve the Hawaii variance; SLK thresholds, and the proposal for the intestine.

Children's Hospital of Wisconsin | 10/16/2018

- For the Acuity 250 + 500, recommend decreasing to MELD =/> 35 (instead of 37) since 2-week waitlist mortality for MELD =/> 35 is high based on UNOS data that served as the basis of Region 35 Share!   -Broader 2 -circle- does not support providing access

Pam Gillette | 10/16/2018

MY CONCERN IS THAT THIS NEW SHARING CONCEPT WILL DISADVANTAGE CITIZENS WHO RESIDE IN LOWER SOCIO-ECONOMIC AREAS OF THE COUNTRY.  TRANSPLANTATION IS ALREADY A FINANCIAL BURDEN ON THIS UNIQUE POPULATION.

Gift of Hope | 10/16/2018

We support the other provisions of the proposal as written (pediatric allocation, variances, etc.)  There will not be a cost impact to Gift of Hope based on these changes. We do expect a slightly positive revenue impact from an increase in utilization of marginal livers given the addition of some aggressive transplant programs to our primary distribution (150 miles) area.   In general, we support the proposal as written by the Liver Committee for the following reasons:  1) the alternative of allowing HRSA or Congress to write allocation policy has a high potential to be detrimental to both transplant and donation. A protracted public fight over allocation with inevitable negative press would hurt the image of the transplant community and could result in a loss of confidence in the system and thus a decrease in donation. Families want their loved one's gifts to be used to benefit sick patients, no matter their location. Perceived fairness and respect for the Gift is critically important to maintain.  2) Circles make logical sense in terms of an allocation area. We need to look past the perceived individual impacts on our own specific situation and do what is best for all patients and the transplant community as a whole. Any change will impact some participants negatively. One way to look at this is that anyone being negatively affected now has been the beneficiary of an unfair system for 25 years. Maintaining an illogic and unfair system because it benefits a certain program or area specifically is short sighted.  3) The impacts of these changes are temporary. We know from other allocation policy changes (Share 35, Lung circles) that impacts tend to mitigate over time. Export rates for livers from our DSA dropped slowly after an initial increase with the implementation of share 35. Additionally, if there are dire consequences, UNOS has demonstrated that changes can be made quickly should they be needed.   4) Surgeon/Program practice will continue to be the single largest driver of disparity in median MELD at transplant. Programs that are aggressive, transplant low MELD patients, and use marginal livers will continue to have lower MELD at transplant than programs whose practices are more conservative. A better metric to measure the need for different allocation policies needs to be developed that accounts for this factor. As long as programs have very different practices, there will never be even Median MELD scores at transplant.

Julie Heimbach | 10/16/2018

I prefer the Acuity model of the broader 2 circle model because of the increased benefit on disparity and waitlist mortality but I do support both ideas and am happy to see both models are moving in the direction of reducing disparity

Froedtert Hospital | 10/16/2018

 - For the Acuity 250 + 500, recommend decreasing to MELD =/> 35 (instead of 37) since 2-week waitlist mortality for MELD =/> 35 is high based on UNOS data that served as the basis of Region 35 Share! -Broader 2 -circle- does not support providing access of high city patients (except status 1) to liver organs as it limits the circle to ONLY 250 nautical miles. Will likely result in higher waitlist mortality. If the intestine patients have access to organs within 500 nautical miles, I don't see any reason why we can not advocate 500 nautical miles for liver patients.  - Strongly support proposal for adolescent and pediatric donors.  - Variance for split liver to allow splitting transplant center to keep both partial liver grafts to maximize organ (partial liver grafts) utilization and optimize patient outcomes (for logistic and technical reasons).  -Hawaii variance: support.  -SLK threshold: will support MELD 35 within 500 nautical miles based on UNOS data that supported Region MELD 35 share.

Avera McKennan Hospital and University Health Center | 10/16/2018

We are opposed to the Hawaii variance as it relates to Puerto Rico and Puerto Rico is not geographically isolated and organs are routinely shipped without difficulty to other parts of the US both to and from the island.  We feel the thresholds for SLK and intestine should be high to balance benefit for single organ recipients and recommend 32 or higher for sharing.

University of Minnesota Medical Center | 10/16/2018

It is important to emphasize that these efforts to change liver allocation, which now have been going on for more than six years, were supposed to primarily address the geographic disparity in access of wait-listed patients to livers. However, in order to address geographic disparity, the discussion has to focus on what's best for PATIENTS not what is best for transplant centers. Too much effort has gone into attempting to preserve the status quo, which is generally perceived by many as best for centers as opposed to really doing what's best for patients and that is to attempt to give every waitlisted patient in this country an equal access to a liver.    The current B2C proposal, which has been put forth by the OPTN Liver and Intestine committee doesn't go nearly far enough to accomplish a decrease in geographic disparity across the country. It produces a modest decrease in the variance in the median MELD at transplant, which is the primary metric of geographic disparity that has been used by the committee to date. In particular, one should focus on the SRTR modeling data in patients without a MELD exception. These are the patients that account for the vast majority of the existing geographic disparity in access to organs. In that specific group, B2C does very little to address the marked geographic disparity that exists in access to organs. In addition, if one focuses on the 'heat maps' that were generated by the SRTR, one can see that with B2C there are still significant differences in the median MELD at transplant across the country that do not exist with acuity circles.     Far too much importance has been placed on transportation metrics in this discussion. It is important to emphasize that the SRTR transportation model is fairly crude. More importantly, we don't understand why there's been no discussion as to the fact that the transplant community certainly has the ability to mitigate a very modest increase in transportation time or the miles the organ travels. The transplant community can be quite ingenious in reducing transportation costs.    The liver transplant community can do much better than the B2C model to address important geographic disparities that exist in access to organs across the country. 

Kirk Houston | 10/16/2018

I am a transplant patient's husband and was the primary care giver post-transplant.  My spouses' liver failure was acute with no warning and she required a transplant in 1-2 days after determining a transplant was required to save her life.  Limiting access to livers for a large population could have been detrimental to her chances for survival.  Allowing transplants for patients that are less ill and not using MELD thresholds could have been detrimental if the regional maps were redrawn.    I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework.  Given the direct impact of your decision on the survival of patients, who would be disadvantaged by the proposals offered here, it is imperative that the OP&TN take the time to conduct a thorough analysis of population-based frameworks.  Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.     Thank you for your understanding.

University of Minnesota Medical Center | 10/16/2018

There needs to be discernment of allocation impact and geographic disparity of the poor. If geography is detrimental to access, it should be factored. Insufficient modeling to determine equitable allocation.

Joseph Hillenburg | 10/16/2018

I think that population-based circles would be superior, but in lieu of that (and in the interest of time), AK, HI, and PR all warrant variances. Continuous Distribution (whether 'great circle' or based upon transport time) should be examined as a long-term solution.

Yale New Haven Health System | 10/17/2018

Support the 250nm circle for median MELD at transplant. Fully support the AC model as the best next step to successfully share more broadly. We must realize that we will all have to change the way we recover and transport livers for the future. We feel that if B2C is chosen, that using a sharing threshold that is 29 is superior to 32. We would support keeping PR in the model without variance and allow HI to have a variance. In general we support the principle to create a large enough boundary to accomplish the safest care to those patients with the greatest need for transplant.

John Goss | 10/17/2018

As we discuss the allocation of a resource as scarce and as important as a cadaveric liver allograft 2 points must be kept in mind. First and foremost, we must develop a system that allows all patients the possibility of receiving a liver allograft offer. The opportunity to receive a liver offer is paramount in this discussion because without the offer the patient has no chance of transplantation. Second, we are only having these discussions because there is an ongoing shortage of liver allografts and all of us, not just the OPOs, are responsible for working toward improving organ donation, organ usage, and transplant rates.    Therefore, using the modeling data that we have been provided, if the the Acuity Circles were to be put into place in Region 4 they would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the waitlist mortality rate while only increasing the cold ischemia time by approximately 10 minutes. In addition the Acuity Circles would continue to build upon the tremendous level of sharing that is already present in Region 4. We have for years been able to care for the sickest adult and pediatric patients first and have a very supportive and collaborative mentality between the transplant centers. Conversely, if B2C 32 were to be put into place in Region 4 it would be a large step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. From a health care providers point of view it is just not acceptable to allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.    Additionally, the circles used for organ allocation must be larger in a state like Texas because of population density. One small circle does not fit the entire US and must be considered so that all patients have an equal opportunity to receive a liver allograft offer.    Finally, we must spend more time/resources studying, identifying best practices and then supporting the OPOs. There are very large geographic variations in liver allograft procurement rates and this then leads to variations in transplantation.      Thank you

Anonymous | 10/17/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

UMass Memorial Medical Center | 10/17/2018

Distance is only one component of total cold ischemia time. With inefficient centers and bad practices it is possible to waste organs from donors within the transplant center. Time to travel has an impact on graft out come not distance from the hospital. 3 to 4 hours of air travel  time is acceptable,  placing total ischemia time within acceptable 8 to 12 hours. 3 to 4 hours of air travel will provide a range in excess of 750 to 1000 miles.  Efficient program will have the hepatectomy part of the transplant completed by the time the organ arrives in the operating room. 2 hours from xclamp to loading the organ in the plane, 4 hours of air travel time, one hour traveling from airport to the OR, one hour of implantation to reperfusion will lead to 8 hours of cold ischemia time.   emphasis on the small circle size and associating it to concerns for cost and organ wastage is a falsehood.  if the purpose is to keep the status quo and keep the organs local, say it so. if there is a true desire to make change, the acuity circles need to be based on 500+1000 miles to achieve a meaningful impact. In this survey I choose between worse and bad options, the good option is what I suggested and is not there for consideration.

LifeGift | 10/17/2018

I am writing on behalf of LifeGift (TXGC), the OPO that serves the areas of Houston, Fort Worth and West Texas and more broadly in this new paradigm, the areas of Region 4 and ultimately the entire country. LifeGift is commenting as we recently did in support of broader distribution of organs and in particular, broader sharing of donated livers. We first want to express our immense gratitude and respect for donors and donor families whose generosity makes this entire topic possible to begin with. Our principles are as follows:    1) We believe in broader distribution and a patients first philosophy. Patient care and stewardship for the donor and donated organs are what we call dual advocacy, one of our 3 strategic anchors as an organization.  2) Our primary responsibility is to increase donation and the availability of organs for transplant, and equally to do all we can to increase utilization in whatever model is present.  3) A tighter distribution circle (150 nms) used in any allocation algorithm is more restrictive than is currently in place. MELD threshold should be 29, or at least as low as 32.  4) Fixed distance circles should be larger (broader sharing is best for all).  5) Strongly support Acuity 250+500. Modeling data shows that across all categories patients benefit with minimal changes to cold ischemic time.  6) Strongly oppose Broader 2 Circle (because it currently include the 150 nm circle in the allocation sequence)  7) And finally, numerous arguments are being put forth, erroneously in our opinion, that assert (without any supporting data) that these changes will extend liver CIT possibly resulting in loss of organs. However, on average, models show the extension of CIT may be only 10 mins if anything. OPOs and transplant centers will need to adjust the way we recover and ship organs or transport donors in adapting to larger system changes. We are confident that we as a system will all find ways to adjust to cost challenges. It is not practical to think the way we do things now will have to be the way we do things in the future.  Thank you for the opportunity to comment.

Anonymous | 10/17/2018

Saving money on airplanes does not save lives!. There is a lack of populated cities less than 150 miles from Houston and implementing a 150 mile circle around South Texas will deprive patients from organs from cities like El Paso and Fort Worth which we currently have access to. I have been fortunate that as of yet, I have not needed a liver transplant as I have been taking care of myselt with doctors guidance. I AM on our transplant list and would appreciate you considering my feedback. Thank-you.

Anonymous | 10/18/2018

Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which we currently have access to. We stand to lose approximately 130 donor livers a year within the Houston region.

Kentucky Organ Donor Affiliates (KODA) | 10/18/2018

KODA is open to increased sharing to benefit patients on the waiting list but any accepted change should be cautious not to significantly disadvantage other groups. We are concerned that the proposed options will significantly limit access in areas with smaller waiting lists such as the rural midwest and southeast US. If up to 70% of organs recovered in our service area, and similar statistics in surrounding areas, are expected to be exported, it is likely that local transplant programs will be forced to consolidate and/or close.What happens to the patients that must travel hours to get to local programs? Will they be forced to decide if they can travel out of state to get the care they need?

Gerard Marinaccio | 10/18/2018

As a transplant recipient from NYC I had to wait until I developed liver cancer before I became a serious candidate for a liver transplant.  While I had a successful transplant I was almost  ineligible for the surgery due to the fact that I was deathly ill.  I think that broadening the distance circle would make for a more even playing field for all transplant candidates in this country and make it possible for a person living in larger cities like New York to not have to either wait so long for a transplant or not get one at all. It will also make it unnecessary for a candidate to up-root themselves and their families and relocate to an area of the country where transplants happen quicker at a lower MELD.  It is unfair to ask a person to leave their homes when they are so ill for both the psychological and financial burdens that this option presents.

Phoebe Kmeck | 10/18/2018

HRSA expressed to OPTN in July that the implementing of Final Rule and NOTA would require OPTN to increase the equitable distribution of organ to transplant patient nationwide. Today, DSA's break this requirement, to just remove them would still go against NOTA and would just trade in one faulty system with another. The residency of a patient cannot be the basis if they receive a liver donation--aka live--unless it's required by NOTA's rare exceptions. The Final Rule is a very feasible way to ensure organs are distributed over a broad geographic area. Although the majority of transplant centers seem to prefer the unfair and illegal status quo, HRSA's letter articulates that a consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule. The B2C model is no based on a geographical design, and so disobeys NOTA resulting in HRSA's need to intervene if it is adopted by OPTN. Regarding the MEL cut-off, any restriction above 15 flies in the face of NOTA and the Final Rule. The Acuity Model, although it has it's problems, it's foundation focuses on the PATIENT'S need, and is in line with NOTA, and the only foreseeable road to achieving the goals of NOTA and the Final Rule.

Desiree Colon | 10/18/2018

Ensuring an equitable organ allocation system that prioritizes the acuity of patient need is ethical and fair and should be the gold standard for policy implementation. The Acuity Model will establish the necessary foundation to meet this goal.  While there is still work to done, this option benefits the entire transplant community and can accommodate the future goals of NOTA and the Final Rule.

Virginia Commonwealth University | 10/18/2018

any of the proposals put forth severely disadvantage the most vulnerable populations: patients who are economically and socially disadvantaged, who cannot travel, or whose access to health care and transplantation services is markedly reduced because of their rural locations.    the OPTN should not adopt any of these solutions: they are win-lose. The OPTN should strive to increase the performance of the underperforming OPO's to increase the number of available organs for transplantation for the entire country, and not pit one region of the country (affluent, metropolitan) against another (poor, minority, rural).

Anonymous | 10/18/2018

The first violates NOTA and is inconsistent with a fair and equitable distribution/access to all. The Acuity option enlarges the geographical area to 250 and provides better and fairer services and access to those in need.

Methodist University Hospital | 10/18/2018

I applaud the work of the liver /intestine committee for coming up with this proposal.  Finally, we have a common sense solution that equalizes access for all patients and removes the limitations imposed by DSAs and Regions.  The models cannot predict behavior, so we all now have the opportunity to compete for donor organs for our patients. I favor greater sharing and lowering the threshold to no higher than 32 and think 29 is even better.

Atrium Health | 10/18/2018

We do not think the current proposal is in complete compliance with final rule due to inefficiencies.  In addition, there is not a significant enough improvement in outcomes or access to justify this change.  (Again, not compliant with final rule)    The model further disadvantages lower socioeconomic groups, which is not acceptable.    Broader sharing predicts more organ wasting.  This is also not acceptable.    We do support the idea of sharing between regions.

Anonymous | 10/18/2018

pls go with Acuity !

Medical University of South Carolina | 10/18/2018

On behalf of MUSC, representing liver failure patients in South Carolina, we strongly oppose these efforts that modeling predicts a significant efflux of donor organs from our state with a high burden of liver disease and high waitlist mortality.

Rochester Methodist Hospital (Mayo Clinic) | 10/18/2018

Recommend thresholds of 29 for B2C and Acuity

Anonymous | 10/18/2018

I support LiveOnNY's position on these questions.  As HRSA's July 31, 2018, letter to OPTN makes clear, the National Organ Transplant Act (NOTA) and implementing Final Rule require OPTN to establish a 'nationwide distribution of organs equitably among transplant patients.'  While the existing regions and DSAs clearly violate this requirement, simply removing them and replacing them with a scheme that yields a similar result still violates NOTA. Where transplant patients live cannot be the basis for liver allocation unless specifically 'required' by NOTA's narrow exceptions.  The Final Rule requires distribution of organs 'over as broad a geographic area as feasible.'  While many transplant centers prefer the inequitable and unlawful status quo, HRSA's letter makes very clear that 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule.'  Because it is founded in a geographic construct, the B2C model clearly contravenes NOTA and will necessitate HRSA intervention if adopted by OPTN.  With regard to the MELD cut-off, we believe that any restriction above 15 is unwarranted and contradictory to NOTA and the Final Rule.  The Acuity model, while imperfect, is oriented in patient need, likely complies with NOTA, and is a firm foundation for achieving the goals of NOTA and the Final Rule.

Duke University | 10/18/2018

We generally support the idea of the sickest patients being transplanted first.  We also recognize that a high proportion of transplants occur across the country due to exceptions, leading to inflation of MELD scores in many regions such that these patients actually have lower mortality than those with similar lab MELD.  We therefore recommend eliminating  any MELD escalation for exceptions leaving all of them at Median MELD-3.  If any MELD escalator remains our center feels strongly that the exceptions be capped at 31 in order to avoid continued elevation of MELDs across the country and to remove them from the sharing described here so that  the patients with the highest mortality are the ones that benefit from the broadest sharing.  We support the Hawaii proposal. and approve the sharing of kidney in SLK down to 32 as part of this proposal.

Mid-South Transplant Foundation | 10/18/2018

TNMS is in favor of the Broader 2-Circle sharing at MELD 32.  We appreciate that this model reduces the variance in MMaT, incorporates more patients with higher mortality risk, improves mortality rates and keeps the percent of organs flown to a more management level.  This model also represent positive changes without complete disruption of the current system.     We oppose the accuity models for several reasons.  The percentage of organs flown under these models has the potential to completely disrupt the allocation of livers.  Under the current system, OPOs and transplant centers have difficulty, at times, securing air transportation. There is no question this problem would be extinuated with a 20% increase in the number of livers being flown around the county.  The cost of the increased number of flights would also have a negative impact on OPOs and transplant centers, and could actual prove detrimental to some transplant programs.  The increased flights would also create staffing issues at OPOs and transplant centers who fly to recover organs.  Even if transplant programs began recovering for other programs , the air transportation is still needed for transport of the liver.    Reviewing the acuity models and the impact on DSA areas is also very concerning as some DSA will see drastic changes in the number of transplants and in mortality rates.  While we support broader sharing and transplanting those with higher MELD scores, we are against any changes that create the level of disruption we believe will be created by the acuity models such as:  1)  increased costs for flights,  2) the need for staffing adjustments (layouts or need to hire more staff), 3) potential closure of transplant centers which will reduce assess to transplants for more rural populations and 4) increased time, costs and staffing for allocation as OPOs work to coordinator more out of town recovery teams and arrange for additional transportation needs.    We strongly support the Broader 2-Circle model as it offer immense improvements in the allocation system, yet does not completely disrupt the current processes and systems at OPOs and transplant centers around the country.

Anonymous | 10/18/2018

How is UNOS able to choose a model that makes it harder for certain patients to get a liver just based on where they live? I thought the new rule was supposed to increase the availability for organs? Houston and South Texas represent the largest population of patients waiting for transplants. We are strongly opposed to anything less than a 250 mile circle because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston.  Furthermore, UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance.  WHY was a 150/250 mile circle even proposed? Is saving money on airplanes used to deliver procured organs more important than saving lives? Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplants which is quite nauseating knowing that Houston and South Texas represent the largest population of patients waiting for transplants. Also, UNOS previously proposed a 250/500 circle for lung allocation, so why are the same rules not applied to the liver allocation? Lasty, the proposed 150/250 circle will hurt Texas, California and Florida...WHY would UNOS choose a model that hurts patients in MULTIPLE regions?? I appreciate the opportunity to voice my concern on this devastating proposal.

University of Kentucky | 10/18/2018

The University of Kentucky cannot support either proposal. Both proposals will results in significant harm to the citizens of the Commonwealth of Kentucky. We will support consideration of a state based model of allocation, or re-institution of the previously approved proposal in December, 2017.

Anonymous | 10/19/2018

The decision to use the 2-circle method appeared to be largely financial.  Medical professionals may have to put a price on human life.  I do not and will not.  I strongly believe we should be going with what will save the most lives. We tell potential donors that there is a national list.  As long as geography is part of the equation, that is not true.    I was asked about Meld scores.  I checked 32, but I really have no opinion.  My transplant is over 20 years old.  Meld scores were just being considered and I have no idea what mine was.  The only thing I know is that I was status 1B and was second in line for the liver I got.  The person who was first was too sick to withstand surgery and passed away while I was recovering.

Anonymous | 10/19/2018

I strongly support the Acuity model to help save the lives of the sickest patients first.

The Coalition for Organ Distribution Equity (CODE) | 10/19/2018

The Coalition for Organ Distribution Equity (CODE) appreciates the opportunity to comment on this proposal. Patients in need have waited far too long for reforms that will bring equity to liver allocation and comply with Federal law.     Given UNOS's estimate in 2014 that approximately 500 lives could be saved by such reforms in the following years, we cannot countenance calculating how many people have died as a result of the interminable, often petty debate regarding the OPTN's clear moral and legal responsibility to fix this broken system immediately.     As HRSA's July 31, 2018, letter to OPTN makes clear, the National Organ Transplant Act (NOTA) and implementing Final Rule require OPTN to establish a 'nationwide distribution of organs equitably among transplant patients.' While the existing regions and DSAs clearly violate this requirement, simply removing them and replacing them with a scheme that yields a similar result still violates NOTA. Where transplant patients live cannot be the basis for liver allocation unless specifically *required* by NOTA's narrow exceptions.    The Final Rule requires distribution of organs 'over as broad a geographic area as feasible.' While many transplant centers prefer the inequitable and unlawful status quo, HRSA's letter makes very clear that 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule.' In other words, the OPTN Executive Committee can no longer defer adoption of meaningful, NOTA-compliant reforms due to the blatantly self-interested objections of its members.    With regard to the specific proposals presented here, because it is founded in a geographic construct with arbitrary geographic and MELD cut-off limitations, the B2C model clearly contravenes NOTA and will necessitate HRSA (or judicial) intervention if adopted by OPTN. Similarly, any MELD cut-off above 15 is unwarranted and contradictory to NOTA and the Final Rule. There is no legal or substantive rationale for confining the fairness otherwise instituted in the system to a subset of patients.     The Acuity model is oriented in patient need with reasonable geographic limitations and therefore likely complies with NOTA. More importantly, it will drive considerable improvements in the equity of the liver allocation system and save lives. Modest increases in easily managed travel, which likely won't materialize to the degree modeled, cannot legally be cited as a rationale for not adopting this approach.      Again, we wish to thank the OPTN for offering this opportunity for public comment. We remain hopeful that you will do right by your charge and the thousands of patients who deserve equitable treatment under the law.

Anonymous | 10/19/2018

If you truly want into from the public, you should make this far less cumbersome. This format is not user friendly, reaches very few people, and appears to be designed to discourage input. There are many places distribution needs to improve. This is a very narrow scope as well.

Beaumont Royal Oak | 10/19/2018

Disadvantages centers adjacent to national borders and bodies of water

William Beaumont Hospital | 10/19/2018

centers on international borders or large unpopulated areas (great lakes, oceans) are disadvantaged by area-directed allocation.

Shekhar Kubal | 10/19/2018

I appreciate the efforts from the liver intestine committee with modelling of the proposed solutions to geographic disparity. The Variance in Median Allocation MELD/PELD at Transplant with Broader 2-Circle MELD 35 is modelled to be 6.74 versus 6.54 with Broader 2-Circle MELD 32, which is insignificant. I wonder how liver intestine committee has voted for the B2C32 model without the supporting data from their model. In my opinion, particularly without supporting data, it would be a big mistake to use B2C32 model over B2C35. It may be more prudent to adopt B2C35 and then assess its impact and then move to B2C32 if necessary.

Anonymous | 10/19/2018

We actually do not support any of these. The mandate was to eliminate DSA. This extends far beyond in terms of redistribution, which was not previously supported by us or the majority of the country. The optimal choice should have been to redesign the recently accepted allocation proposal with a suitable replacement for DSA and region. We would accept B2C with threshold of 35 preferably over the others, but none of these seem suitable.

Seth Warshaw | 10/19/2018

As noted in HRSA's July 2018 letter, OPTN must establish a system that distributes all organs equitably. It is essential that OPTN complies with this letter, as they are currently disadvantaging patients in certain localities and in violation of NOTA. OPTN's reforms to the organ allocation system MUST go beyond just removing the existing regions and DSAs, as simply replacing these phrases will yield a result that is extremely similar to the status quo. To rectify America's flawed organ allocation system, OPTN's implementation of the Final Rule must establish a system that distributes organs as widely and as far as they can feasibly be transported. Per HRSA's letter, it is not necessary that OPTN reaches a consensus to implement a system that aligns organ allocation with NOTA.     The Broader 2 Circle model is rooted in geographic constructs, and is both unsatisfactory and in violation of NOTA. If OPTN adopts this model, HRSA will have to intervene. Additionally, any restriction of the transportation of livers for patients with a MELD score above 15 is both unwarranted and in violation of NOTA.     The Acuity model would be a step in the right direction because it is oriented in patient need, not geography, and likely complies with NOTA. This model, if implemented, would be a strong start in achieving the goals outlined in NOTA. 

Gift of Life Michigan | 10/19/2018

I do believe discard data should be a factor for consideration, at least monitoring the impact once the new scheme is in place.  How exception points are managed will be the biggest challenge of the proposal and cause the greatest misuse of the new allocation model.

Indiana Donor Network | 10/19/2018

We strongly believe that it does not matter how we vote as the decision likely has already been made.  Such was the case when the majority of the regions voted against the last proposal and it got approved by the UNOS Board in December anyway.    While many transplant centers are going to be affected by this policy change, OPOs will be spending significantly more time allocating organs and trying to make flight arrangements in a time where allocation already takes much longer than it used to (not modeled) and when there is such a large pilot shortage.  Costs are going to sore through the roof and it will be interesting to see how payors react to this increased cost.  Not to mention how families react to waiting much longer.    These policies changes are not going to increase organ usage but instead just change where organs get transplanted and who dies waiting.  Unfortunately, this has divided our transplant community even more when we should be working together to find solutions to transplant more organs.  Certainly there are OPOs who can perform better.  This is no different than transplant centers who can also perform better.  However, as OPOs try to push more and transplant centers try to pull more, both end up being penalized for performance or outcomes.  This makes it hard to want to push boundaries.

Ascension St. John Hospital | 10/19/2018

Potential recipients in more rural areas are being unfairly penalized due to using the transplant center address rather than their own.  Additionally, states surrounded by water or foreign countries are also unfairly impacted by a concentric circle model.

Henry Ford Hospital | 10/19/2018

Our center has generally viewed these proposals as resource intensive and without significant positive impact on organ donation and organ availability (the main issue limiting transplants) or transplant rates. We oppose changes that do not increase transplant rates and organ donation or match re-allocation changes with improved access to transplantation.  In addition, one cannot decipher impact on organ discards when we historically know that wider sharing and travel will likely increase discards. We feel the proposals were rushed to meet deadlines and are not in line with deliberate and iterative modeling.     The State of Michigan (a CON State) is deeply concerned with the needs of its patients from the west side of the state who can only reach centers in southeast Michigan (instead of driving over 500+ miles around the lake) while organs can fly across the lake to coastal programs in Illinois and Wisconsin, driven by a formula utilizing nautical miles. Michigan asks for any model implemented to not penalize people in the west side of the State for its geography which is unlike any other that we know of.  Proximity of transplant center to a donor hospital in Michigan, while seemingly logical, sends patients and organs from the same community (west Michigan) in opposite directions due to location of hospitals determined by history and CON rules. This issue cannot be ignored and should not be addressed post facto.    The pressure to remove DSA borders needs to be matched with resources to evaluate modeling beyond just circles that take into consideration other models (State with sharing algorithms), population density, care standardization, aberrant geography, socio-economics, access to transplantation, and local community engagement in organ donation.      Exception points need to be capped further, below 31; especially early in the rollout of the model.    Unintended consequences: 1- Besides what has been stated by others, there will be scenarios when livers are shipped, recipient is not suitable, and due to timing the organ is placed locally off the match run sequence. This is a quality metric to be tracked. This penalizes next in line patients. 2- Totally ignored is the added human burden created by logistics and added calls, travel and fatigue. Burnout is an issue in our business. We are not attracting enough folks to train in transplantation surgery and now we are yet gain guaranteeing more travel, risk and fatigue. This is not eliminated by local teams until this aspect is indeed developed and designed to serve the needs of the community. 3- Disengagement of local communities if local mortality rises in their communities. 4- Added costs. 5- We have encountered problems getting pilots or planes when our centers got busy with flights; a pilot could not fly back recently due to exceeded hours.     Thank you for considering our comments.

Anonymous | 10/19/2018

Anything less than a 250 nm circle is strongly negated by the Gulf of Mexico in our area and in other regions across the country. For our patients, the impact is even more significant as there are no large population centers near the coast and for quite a distance inland from where are listed patients are located.  The results an unfair distribution of organs to centers such as ourselves, and others with similar geographic challenges. For this reason I strongly oppose the Broader 2 Circle proposal and support Acuity250+500.

Patricia Ault | 10/19/2018

Potential recipients in more rural areas are being unfairly penalized due to using the transplant center address rather than their own.  Additionally, states surrounded by water or foreign countries are also unfairly impacted by a concentric circle model.

Carolyn Parsons | 10/20/2018

May 1, 2014, I received my new liver. I had already spent about a month in the hospital because of liver failure. I had a feeding tube inserted because I was not able to eat. When I received my call for a new liver, I was in ICU. I was given at least three months to live. If the rules UNOS is planning to implement were in effect then, I would most likely not be writing this note. My doctors at CHI St. Luke's saved my life. Please reconsider your plans to making these changes. Many lives are at stake.

Angie LeVier | 10/20/2018

My dad is on the list to be a transplant recipient and I pray, for his grandchildren's sake, these restrictions are not put into place to hurt his already slim chances of getting a liver before it's too late! My children are far too young to not be given the chance to know and love their grandfather. I was robbed of this chance with my grandfather because of this same disease that my dad is fighting so I know first hand how it feels and how it affects you for the rest of your life. Putting more restrictions on liver transplants and the qualifying recipients will only negatively impact not only their lives but the lives of all their families and loved ones. Please consider this and all those that would be negatively affected by this horrible thought of a plan.

Rachel Beltran | 10/20/2018

As a transplant professional who has invested the majority of my career caring for those with end-stage liver disease, of course I understand the intention to provide the gift of life to as many recipients as possible. However, both of these models miss the mark. Forced to choose from these latest proposals, the B2C model with a sharing MELD threshold of 35 is the lesser of the proverbial two evils. However, in all of these schemes, OPTN has proposed solutions that seemingly create greater disparity in major parts of the country to only advantage a key few. Both models set up the nation for more organ waste, higher healthcare costs for potential recipients, and a greater risk to our surgeons and other medical team members who will face more difficult travel for procurements.  Final Rule does cite that allocation '...shall not be based on the candidate's place of residence, or place of listing, except to the extent required by paragraphs (a)(1)-(5) ...', but these all require policies to be 'based on sound medical judgement', 'designed to avoid wasting organs', and to 'promote efficient management of organ placement'.  Modeling actually demonstrates this type of sharing will actually decrease the total number of transplants nationwide. It appears both Acuity models actually predict about 60 less total transplants per year nationally.     Furthermore, transplant is a resource that should be maintained in the communities these donors serve. The Acuity model truly creates disparity at smaller programs, or those which serve a more rural population -many of whom already lack options for their care due to distance, disadvantage, or state coverage limitations.  In fact, the Acuity model decreases the transplant rate in some Midwestern communities by nearly half.     Lastly, after visiting and revisiting allocation policies over the last several years, OPTN disappoints again, by not offering further solution to the greater problem of promoting and increasing organ donation - an effort that would truly have the greatest impact on our ability to reduce death on the waitlist and increase the opportunity for transplantation.

Anonymous | 10/21/2018

If it saves a life what difference how far we have to go to save a life

Anonymous | 10/21/2018

I am strongly opposed to anything less than 250 mile radius due to the proximity to the Gulf of Mexica and the lack of large cities within 150 of Houston!

Anonymous | 10/21/2018

Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant.  How is UNOS able to choose a model that makes it harder for certain patients to get a liver just based on where they live? I thought the new rule was supposed to increase the availability for organs?

Anonymous | 10/21/2018

I applaud the work being done to more fairly allocate livers to those in need.  My son had a liver transplant 2 years ago at Westchester Medical Center in NY.  As he got sicker and his MELD score climbed to 39, it was a very anxiety ridden time as we waited for a call.  Investigating the statistics we found that patients in other parts of the country we're receiving transplants with MELD scores of 32+, while in our area, patients weren't getting livers until their scores were 38+.  We began the process to register at the Mayo Clinic in Florida to improve his chances of getting a liver.  Fortunately, we would have had the funds to be able to temporarily relocate to Florida, but not everyone patient and family is able to do so, so the current system is definitely flawed.  I am not sure that the Acuity Model proposed is ideal, but I believe it is an improvement and could evolve to be a more fair and equitable model.

Anonymous | 10/21/2018

I strongly oppose anything less than a 250 mile circle because of the lack of populated cities less than 150 miles from Houston.

Anonymous | 10/21/2018

As I understand it, the National Organ Transplant Act (NOTA) and implementing Final Rule require OPTN to establish a 'nationwide distribution of organs equitably among transplant patients.'  While the existing regions and DSAs clearly violate this requirement, simply removing them and replacing them with a scheme that yields a similar result still violates NOTA. Where transplant patients live cannot be the basis for liver allocation unless specifically 'required' by NOTA's narrow exceptions. The Final Rule requires distribution of organs 'over as broad a geographic area as feasible.' While many transplant centers prefer the inequitable and unlawful status quo, HRSA's letter makes very clear that 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule.' Because it is founded in a geographic construct, the B2C model clearly contravenes NOTA and will necessitate HRSA intervention if adopted by OPTN. With regard to the MELD cut-off, we believe that any restriction above 15 is unwarranted and contradictory to NOTA and the Final Rule. The Acuity model, while imperfect, is oriented in patient need, likely complies with NOTA, and is a firm foundation for achieving the goals of NOTA and the Final Rule.

Anonymous | 10/22/2018

I urge the Organ Procurement and Transplantation Network to refrain from making a policy decision on liver distribution until it has a modeled a population based framework.  The proposals offered here are a disadvantage to the survival of patients.

Patricia Lawney | 10/22/2018

We are strongly opposed to anything less than 250 mile circle because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston...Imposing a 150 mile circle will increase the wait time for transplants and increase the death rates even more while waiting for transplant, how do I know this, my husband is on the list and been waiting for some time now. The average MELD score at this time for a transplant patient in Houston is over 30 which is higher than the national average. This means the needs for organs is much greater than in many other cities...New Orleans, Louisiana MELD score is 25 !!!!  UNOS previously proposed a 250/500 circle for lung allocation, so WHY can't the same rules apply the liver allocation???? Houston and South Texas represent the LARGEST population of patients waiting for transplants!!!  Why would UNOS want to choose a model that makes it even harder for certain patients to get a liver based on where we live????  We stand to lose approximately 130 donor livers a year within the Houston Region and that could mean the death of my husband who's been waiting patiently...Please hear our plea on this issue!!!!

Robert Goodman | 10/22/2018

First, I recommend that the Hawaii variance stay in place. Second, as a patient (heart recipient), I favor the Acuity approach without consideration to the likelihood of increased travel related expenses, which could be substantial. My favoring of this approach comes however with a caveat - I would urge a very pro-active effort to ensure that those costs were kept at a minimum and, further, that those costs become reimbursable with minimal incremental out-of pocket expense to patients. As a member of the Board of Directors of OPTN/UNOS with many years of healthcare administration, finance and business experience, I would likely favor the Broader 2-Circle approach in the absence of any additional information to make me think differently.

NJ Sharing Network | 10/22/2018

As an OPO, our organization appreciates the need to develop liver allocation policy that meets the requirements of the Final Rule. Clearly the modeling is based on historical practice patterns and it is hoped that liver utilization will increase through changes in acceptance patterns. The key to these changes is that they must result in a decrease in discarded organs and an increase in the number of patients transplanted. We are optimistic that the policy will be monitored closely by UNOS and policy changes will be recommended that may be needed to make the liver-distribution policy more effective. Finally, I am confident that our OPO will be able to manage any changes in logistics as we have done with previous changes in organ allocation policies.

Mary Hill | 10/22/2018

After reading the information and reviewing the comments listed. It seems that this change is not something I would support. It is not supported by the medical and transplant specialists and I would respectfully request that you listen to them when looking at this plan change. As a recent liver/kidney recipient I think it would be detrimental to many people to make the changes proposed. Maybe what is really needed is education about transplants in the areas that need it instead of changing a system that clearly saves lives.

Mark Ghobrial | 10/22/2018

Many reasons indicate that the AC 250+500 is far more better for patients: 1. UNOS data indicates that nationally, the AC 250+500 has the LOWEST MORTALITY for patients, and it only increases the preservation time by 10 min. 2. The model proposed by the liver and intestinal committee B2C 150+500 provides no advantage over the current allocation system. One wonders how can UNOS defend this position. The current desire to change the allocation model was based on a law suit demanding wider allocation policies and a circle of 1000 nm. In response, the liver and intestinal committee comes up with a proposal that is WORSE, or at least EQUIVALENT, to the current allocation. How could anybody defend this position? 3. The current proposal of the B2C is based on a hypothetical increase in flying by 5%. However, we all know that behavior changes. Are we sacrificing lives for 5% extra hypothetical advantage? That will change with time. Additionally, when the MELD first came, it was attacked based on the hypothetical fear of transplanting very sick patients and outcomes would get worse. However, outcomes did not get worse. On the contrary, outcomes improved and more lives were saved. Similarly, share 35 was attacked saying that futile transplants will be done, survival will get worse and cost will increase. In fact, survival and wait-list mortality got better and we all adjusted to the hypothetical increase in cost. 4. In an attempt to resolve the geographical disparity, the DSAs were removed and circles were done. However, there is no one size fits all. A circle of 150 on the East Coast will have a high population density and may achieve wider sharing. However, a 150 circle in Texas, the second largest state in the country, would restrict sharing since the population densities are separated by longer distances that exceed 150-250 miles. For example, >35 MELD patients have access to the whole state of TX and Oklahoma, an area exceeding 700 miles. With the B2C proposal this shrinks the access to 250 miles. Similarly, patients with MELD<35 will have reduced access to organs. For all these reasons we strongly support the AC 250+500. We strongly oppose the B2C 150+250. We appeal to the UNOS board to adopt the wider sharing that saves more lives.

PAHM | 10/22/2018

Not withstanding the importance of equal access to Transplant regardless of geographic location, our institution has serious concerns with each of the proposals for wider sharing mostly given our location in a densely populated vicinity. These proposals will entail a massive increase in Donor Net calls, significantly more fly outs, and risks of importing marginal organs. The personal focus on the increased calls and travel, additional hires, and other costs will be detrimental to our hospital and our patients. We are also worried about the OPO capacity to implement these policies, to find available planes for transportation and to minimize organ wastage. We would prefer to see a policy for patients in our vicinity for MELDs below 35 to share within a 90 mile radius.

Anonymous | 10/22/2018

The proposed criteria changes will make it less fair for patients in cities like Houston and Seattle, due to the lack of other large donor cities within the small radius circles being considered. These changes will be terminal for many of us.

Anonymous | 10/22/2018

This proposal is not going to lead to more Liver transplants, so there is little benefit to implementing it. If you have a proposal to increase the number of Liver transplants, let's hear it! Most of the areas of the US that have low donation rates indicate a bigger issue- dismal OPO performance. They need to do a better job of educating their respective populations about the importance of donation and how it saves lives... like mine!  Thankfully I live in Kansas City where we have a fantastic OPO and Transplant Hospitals!

Jim Gleason | 10/22/2018

While it may not be possible to pinpoint the 'right' numbers for this proposal, it is a start and I know that results will be closely monitored against the desired outcomes and adjusted accordingly with new numbers to achieve those goals if the original ones here don't do as intended.

Paul Gaglio | 10/22/2018

I strongly believe that the current proposal, supported by the Liver-Intestine committee will dramatically improve access to organs for the patients who are most in need, specifically, patients with the highest MELD scores. The disparity in wait times based on where the patient lives will be dramatically improved, and will facilitate a more equitable organ distribution system.

Anonymous | 10/22/2018

There are regions in the US that have lower thresholds that others. People who suffer from liver disease are often too sick, too poor, or have other reasons (i.e. family responsibilities, etc.) that restrict their ability to travel to regions with lower thresholds. Many individuals are stuck waiting longer for a liver (based on MELD policy in their home region). By the time their MELD score is high enough to get a liver transplant, they are too sick to undergo surgery or have a successful outcome. This is not just unfair, it's flat out discrimination. While I understand the need to determine eligibility, relying on an antiquated scoring system that yields a number is not enough. People are human, just numbers that should be filed neatly in categories. We need a uniform national system that does spares death. Anything less is simply murder. Feel free to call it something else to dismiss the blame if you'd like, but there is no excuse for needless, avoidable death. The power to change the system is in your hands. Please save lives.

Anonymous | 10/22/2018

Fixed distance circles should take into consideration population density. For example, 150nm encompasses a much larger population size on the east coast as it does the Midwest. Circles may be much larger in the Midwest than on the East coast.

OPTN/UNOS Patient Affairs Committee | 10/22/2018

The OPTN/UNOS Patient Affairs Committee thanks the Liver & Intestinal Organ Committee for the opportunity to provide feedback on their proposal to eliminate DSA and Region from liver distribution. Unanimously, the PAC wholeheartedly supports a proposal that facilitates broader distribution of not just livers, but all organs, and thus minimizes the significance of geography in allocation. Although there was still some residual confusion about the use of concentric circles in light of the 3 frameworks recently out for public comment; a majority understood the constraints within which the Liver Committee had to make rapid changes. The PAC supports a solution that:

• Prioritizes the sickest candidates first

• Promotes utilization and mitigates discards

• Does not prolong the allocation process

• Considers recipient/graft outcomes

The PAC was evenly split regarding whether the Broader 2 Circle (B2C) or the Acuity-based Model was the better solution. Those favoring the B2C tended to also work in the transplant or OPO profession, or had other fiduciary experience, so were sensitized to cost concerns.  This cohort felt this model balances equity in access and prioritizing the most urgent patients first while optimizing successful organ transplants, avoiding organ wastage and mitigating costs. These members emphasized concerns other transplant professionals have cited pertaining to cost increases. Members acknowledged that although beyond the OPTN’s purview, reimbursement should be addressed with all payers, not just by CMS to justify and document that patients, even sicker ones receiving transplants sooner than those under the current allocation system, can return to healthier lifestyles and ultimately reduce their cost of care over an extended period of time.  A few members felt the OPTN should broach this subject with third-party payers. However, the average patient has no knowledge of the fiscal impact these changes will have to programs (or OPOs), or the downstream financial effects. The PAC did acknowledge that if the cost increases were so significant that they caused a transplant program closure, this could impact access. In terms of circle size, the PAC continues to seek a firm recognition that the variable of concern is really time, not distance. Should this system be adopted, some members supported a MELD threshold of 29, based upon increased mortality risk of the other options. Other members supported a higher threshold, such as 32, which is what the OPTN Board of Directors approved in December 2017.

Those who supported the acuity model felt this system would provide a more equitable distribution of livers based upon Median MELD at Transplant (MMaT) and Waitlist Mortality Rates.  From a patient perspective, and all things being equal, the PAC felt this model was more equitable and in line with the Final Rule. Ideally, neither cost nor geography would disadvantage candidates. They also debated whether outcomes would be better (transplanting sicker patients earlier, before they are too sick to be transplanted or die on the waiting list) or potentially negatively impacted (from the effects of potentially longer ischemic times, or transplanting sicker candidates).

There was mixed support for extending the Closed Variance for Allocation of Blood Type O Deceased Donor Livers in Hawaii to Puerto Rico (PR). Those who favored applying the variance to PR felt it was reasonable as the geographic challenges for these non-contiguous states were likely similar. In addition, there was some support for further extending a variance to Alaska and other areas in which there is not a transplant hospital w/in the 500 nautical mile circle (perhaps extending the allocation area to a slightly larger area, e.g. an additional 100 or 200 nautical miles). However, some members felt that PR was not in the same position as Hawaii, and was not at as much of a disadvantage. Others proposed revisiting this question as part of the post-implementation monitoring.

While not directly related to the proposal decision requested, the PAC emphasized education, not only for the transplant community, but particularly for the general public and patients. As the OPTN modifies the geographic distribution for the other organ systems, a proactive messaging strategy would be helpful to ensure public trust in the organ allocation system, promoting equity and fairness, and encouraging donation.

Finally, and not specific to this proposal, the PAC continues to encourage all OPTN committees to write policy proposals at a level an average candidate or recipient would understand. This is essential to more patients submitting feedback. A 79-page proposal written in “professional speak” intimidates and discourages members of the general public from commenting on these policy proposals. If the entire proposal cannot be written in plain language, we would advocate for an accompanying “layman’s abstract” or summary.

PAC members asked the following questions, which were answered to the satisfaction of the group:

• Q: Most living donor recipients do not receive their transplant based on their MELD or PELD score, because they are often recipients of directed donations, where the donor names the recipient rather than the recipient being allocated following a match run. The Liver Committee is proposing excluding these donors’ from the calculation of MMaT and MPaT because the scores at transplant for these recipients tend to be outliers. Why?
A: These are being excluded as these candidates are typically transplanted at a lower MMaT, and may disadvantage other patients if they were included in the system that calculates MMat and MPaT.
• Q: How exactly will the B2C vs Acuity model improve mortality rates on waitlists?
A: The expected survival on the waitlist was calculated to have improved under these model because patients who would have been too sick to be transplant, or were at highest risk to die while waiting, will be transplanted.
• Q: How will split livers be allocated?
A: Exactly as they are today.
• Q: What timeframe did the modelling cover?
A: The modelling included transplants conducted over a year’s time.
• Q: If the pediatric list is exhausted nationally, then would the offer come back to adult allocation and start over?
A: Yes, the offers will be extended to adult candidates after pediatric candidates, as is done today.
• Q: If travel is restricted due to weather-related events, is there a contingency distribution model in place so discards do not occur due to weather related incidents? Would the organ then be allocated within a non-fly area 150 miles?
A: There is not. Usually this is not an issue; it is rare that procurement teams can’t get an organ to a potential recipient. Sometimes the patient can’t travel. Teams typically have a robust back-up plan so organs do not go to waste.
• Q: What is the time table for implementation?
A: The National Liver Review Board is expected to be implemented in the first quarter of 2019, and the allocation changes will take effect after that.

Samuel T. Sloan III | 10/22/2018

1. The community is asked what MELD sharing threshold they recommend. 29
2. The community is asked whether the sizes of the fixed distance circles should be larger, smaller, or remain the same. Larger
3. The community is asked whether they prefer the broader 2-circle model (this is the model preferred by the committee), or the acuity circles model. Strongly Opposed!
4. Members are asked to comment on both the immediate and long term budgetary impact of resources that may be required if this proposal is approved. This information assists the Board in considering the proposal and its impact on the community. Strongly Support

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based  framework. Given the direct impact of your decision on the survival of all patients, who would be disadvantaged by the proposals offered, it is imperative that the Organ Procurement & Transplantation Network take time to conduct a thorough analysis of population-based frameworks. We have friends, family and associates who are very near and dear to our hearts that would be directly impacted. We implore you to take this into consideration. Patients deserve a policy that is fair and one that will not limit organ access and increase wait times unnecessarily.

Sincerely,
Samuel T Sloan III

Patricia A. Sloan | 10/22/2018

1. The community is asked what MELD sharing threshold they recommend. 29
2. The community is asked whether the sizes of the fixed distance circles should be larger, smaller, or remain the same. Larger
3. The community is asked whether they prefer the broader 2-circle model (this is the model preferred by the committee), or the acuity circles model. Strongly Opposed!
4. Members are asked to comment on both the immediate and long term budgetary impact of resources that may be required if this proposal is approved. This information assists the Board in considering the proposal and its impact on the community. Strongly Support

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based  framework. Given the direct impact of your decision on the survival of all patients, who would be disadvantaged by the proposals offered, it is imperative that the Organ Procurement & Transplantation Network take time to conduct a thorough analysis of population-based frameworks. We have friends, family and associates who are very near and dear to our hearts that would be directly impacted. We implore you to take this into consideration. Patients deserve a policy that is fair and one that will not limit organ access and increase wait times unnecessarily.

Kindest Regards,
Patricia A. Sloan III

OPTN/UNOS Minority Affairs Committee | 10/22/2018

On October 15, 2018 the Minority Affairs Committee (MAC) heard a presentation on the Liver Committee’s proposed changes to geographic liver allocation. The MAC thanks the Liver Committee for its work on the proposal. The following questions were asked by MAC members and answered by the Liver Committee chair.

• Question: Does the SRTR modeling upon which the proposal is based show an impact on minority populations?
o Answer: No, the modeling generally did not show positive or negative impact on minority populations compared to the current system. While ethnicity and gender were neutral compared to the current system, there was a slightly positive impact on pediatric liver candidates.

• Question: Could the proposed changes lead to livers being shipped significant distances before the liver surgeon assesses the organ, increasing discard rates?
o Answer: It is standard for liver surgeons to travel to procure the organs now, or use the local center that they have a relationship with to do so; therefore the surgeons would know at the time of procurement the liver quality and discard rates shouldn’t be impacted.

• Question: What will be the impact with SLK?
o Answer: 250 nm (the size being considered by the Liver Committee) is smaller than most regions, although it would be a moving circle based on donor hospital. There is no indication there would be broader sharing of kidneys with SLK than what it is at the current time but the Committee will monitor closely.

• Question: Will the Liver Committee carefully consider rural, gender, race and other minority and socioeconomic populations in the post-implementation monitoring plan?
o Answer: Yes, consideration of these populations is critical and will be included in the post-implementation monitoring plan.

• Question: Did the Liver Committee consider the impact on waitlist mortality and costs?
o Answer: Yes – waitlist mortality for both the B2C and acuity circles would be slightly better than the current system and the 2017 Board approved option. Although assessing impact on costs can be difficult, the modeling did look at flying rates and there was an increase which indicates a potential increase in costs.

Anonymous | 10/23/2018

To arbitrarily change the existing criteria for donors and transplantation patients using only a distance from donor hospital circumference method, may produce unimagined inequities at its best and strikes as compass gerrymandering at its worst. Surely the data exist to study all donors and patients and facilities in a large area e.g. Texas and Oklahoma statewide, over a series of timeframes 1, 5, 10 years or longer. Some examples of factors could include: Facility statistics, i.e. numbers of patients transplanted over different timeframes, meld scores, survival rates over multiple timeframes, number of patients on waiting list, number of dedicated transplant teams and projected growth rates etc. Donor hospital distances to all suitable facilities, condition of organ and suitable patient matches. Emerging technology that may significantly increase the life cycle of the donated organ, thereby decreasing the significance of using donor hospital distance as the independent variable. Many of these and other factors could be modeled using Neural Networks/Artificial Intelligence to learn more about the data and how to maximize the greatest positive patient outcomes and keep the best Hospitals and research facilities in business. There are unlimited ways to view the data and a series of negotiated or agreed upon more global criteria can be given different weights to obtain the best outcomes for all stakeholders. A more robust data driven system as a component to decision making would have the benefit of being adjustable over time to account for new data and trends and new variables that may not be predictable.

Carolyn Warkentin | 10/23/2018

I am a concerned citizen that feels patients deserve a policy that is fair, will not limit access or increase wait times unnecessarily. Broader sharing is predicted to increase organ waste, increase traveling & flying costs all in direct opposition to final rule 121.8  It appears organs will move out of socioeconomically disadvantaged areas & into states having a waiting list mortality 3 to 5 times higher. Because I live in a state with low population, rural socioeconomically challenged ,excellent small transplant center with high rate of successful transplants  I fear this change could affect availability & create high costs  This could also affect our successful local organ donations. I hope this proposal is voted down or at least restudied using most recent patient data. Thank you

Anonymous | 10/23/2018

We support the B2C model. An organ recovery in which I was heavily involved in this past month highlighted a concern of mine regarding reallocation of imperfect livers. The more ischemic time added due to travel, even if it's just a half an hour, creates an immensely more challenging reallocation process. Compound this with the fact that the further distance the liver travels in one direction, the further it will likely travel to reach the back up. Everyone on this board that actually allocates organs knows the incredible number of often unpredictable challenges that have to be navigated on nearly every case to help facilitate donation.  Having a 'firm backup' will remain a guessing game to us on the allocation end as long as they aren't treated exactly as primary offers. Until this occurs, added time will remain the enemy of the maximization of imperfect liver utilization.

Region 3 | 10/23/2018

Region 3 Vote (13 of 45 voting members submitted a vote online):

• Broader 2-circle distribution: 0 strongly support, 4 support, 3 abstain/neutral, 4 oppose, 2 strongly oppose
• MELD sharing threshold recommendation: 6 for MELD of 35, 3 for MELD 32, 4 abstain
• Size of fixed distance circles recommendation: 7 for remain the same, 2 for smaller, 4 abstain
• Acuity circles: 0 strongly support, 1 support, 2 abstain/neutral, 3 oppose, 7 strongly oppose

While some members noted that it is important for the region to provide feedback and be involved in picking a policy that addresses the legal matters at hand, there were other members who shared the following concerns:

Flying increases in all regions but only some areas of the country will gain with this proposal.  Some areas will be flying more, but they will increase the number of livers.  However, members believe that region 3 will be flying more but will be losing livers.  There will be no larger improvements for the overall system - flying will increase, logistics will become more challenging and burdensome, volume of overall livers transplanted will decrease.  Region 3 will do less, but at a higher cost.  Members also believe that the SRTR modeling uses older data to assess the “current” state of liver allocation and may affect the comparisons made to the modeled options in terms of the counts of waitlist deaths, waitlist mortality rates, and transplant volume.

There is concern that any of these proposals will jeopardize access for poor and minority patients.  Opening the door to fixed circles and lowering the sharing MELD will worsen disparity for these groups and still does not help certain areas of the country such as California.  There is a sense that the legal matters have created arbitrary time constraints and more information is needed.  Costs need to be better examined before moving forward.  Members felt that % flying is a surrogate of cost (mostly due to jet fuel), but there are other increased costs to consider as well.  Putting the cost into dollars increased vs transplant gained or dollars increased vs MELD variance decreased would be more meaningful when evaluating the value of the proposal.  Members would still like to see the state distribution idea modeled and considered before adopting a final policy.

Other feedback:

One member commented that they would prefer a sharing threshold of 29.  This would increase access for sicker patients registered at transplant centers that are in cities on the coast and areas with higher population density.

One member commented that Puerto Rico is only a 2.5 hour flight and its distance from the mainland does not justify a variance.

There was a suggestion to prioritize re-transplants differently because they have a higher mortality rate.

Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 3 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Region 11 | 10/23/2018

Region 11 Vote (14 of 37 voting members submitted a vote online):

• Broader 2-circle distribution: 3 strongly support, 1 support, 3 abstain/neutral, 2 oppose, 5 strongly oppose
• MELD sharing threshold recommendation: 4 for MELD of 35, 1 for MELD of 34, 4 for MELD 32, 1 for MELD of 30, 4 abstain
• Size of fixed distance circles recommendation: 7 for remain the same, 6 for smaller, 1 abstain
• Acuity circles: 1 strongly support, 1 support, 4 abstain/neutral, 0 oppose, 8 strongly oppose

One member commented that the Final Rule has multiple principles, not just geography. This member also stated this is a disruptive change and asked how mortality and burden of disease are being considered in this proposal.  He stated that this could potentially exacerbate the health of populations with disparities and that all patients with liver disease, not just the listed patients, should be considered. Another member agreed and added that the states with the lowest instances of liver disease (based on CDC data) stand to gain the most from this proposal and that every center in region 11 will do less transplants and they have the highest level of liver disease.

Another member commented that sharing livers between regions is the best thing about this proposal and distribution between borders is a good thing. He also expressed concern about the inefficiency of distance and increased flight times not being compliant with the Final Rule and is surprised about the staggering increases and associated costs. He recommended adjusting the distance and MELD thresholds to prevent “average livers” crisscrossing in the air.

One member shared that with the changes to exception points as a result of the NLRB, it is difficult to predict what scores will be for exception patients. This is especially true of pediatric patients, since PELD scores are higher than MELD scores, and most pediatric patients are transplanted with PELDs greater than 30. For this reason, a higher cap on exception scores should be considered to give more of a buffer and make sure these pediatric patients can get an exception score that will help them get offers.

There is concern that one of the drivers in variance in median MELD is the prevalence of exception patients and high exception scores in certain areas. Why didn’t the committee use laboratory MELD (and exclude exceptions) for the MMaT calculation?

Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 11 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

OPTN/UNOS Pancreas Transplantation Committee | 10/23/2018

On October 10th, 2018 the Pancreas Committee reviewed the Liver Committee’s proposal to change geographic allocation. The Pancreas Committee thanks the Liver Committee for its efforts and for the opportunity to comment on its proposal. The following questions were asked by Pancreas Committee members and answered by the Liver Committee analyst:

• How were the percentages of organs flown calculated?
o The SRTR based the LSAM estimate on distance, specifically, on the distance at which driving would switch to flying. There will be variation based on differences in population density in the country.

• Will the changes result in a significant change in SLK transplants?
o There is not estimated to be a significant change in SLK transplants. The same qualifications will exist to be considered for an SLK transplant; it will not change the order in which an organ is offered according to geographic distribution.

• What will be the effect on small liver programs – could some shut down because they do fewer transplants?
o There will be variation in how individual programs respond to the changes; some program volume may increase while other programs may see volume shrink. It is important to note that the modeling cannot account for changes in behavior that may result from changes in allocation.

Mammoth Hospital | 10/24/2018

Brian Shepard
Chief Executive Officer
United Network for Organ Sharing 700 North 4th Street
Richmond, VA 23218

Via email: publiccomment@unos. org

Dear Mr. Shepard and Members of the OPTN:

On behalf of our patients and community, Mammoth Hospital is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The  committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Sincerely
Gary Myers, PT, MA, OCS
Chief Executive Officer
Mammoth Hospital

Anonymous | 10/23/2018

I believe the acuity model will provide significant improved access for the sickest patients, who are ultimately, who we are trying to help as physicians.

Florida Hospital Transplant Institute | 10/23/2018

We support the SLK threshold and the Hawaii variance.

Monica NelsonKone | 10/23/2018

I support the Liver and Intestine Distribution Using Distance from Donor Hospital proposal as it will make a huge distance in a densely populated region like ours. I can remember patients with MELDS over 30 who suffered and sometimes lost their lives waiting for organs that never came. This new policy will make a great difference in Status 1 patients who wait for days in our region for an offer as well. I strongly support the proposal for a new model based on distance as either choice will make a huge difference in the lives of our patients.

Anonymous | 10/23/2018

The most important factor in any new proposal is to abandon the arbitrary DSA borders and make organs available to those with lab MELDs (not exception points) that portend high short-term mortality. Once that is done, the size of the circles/regions can be adjusted as the system matures much as we have changed the HCC points. Broader distribution  should not be linked to or contingent upon work to improve OPO performance, replacing low performing OPOs, removing disincentives for the use of ECD organs, and instituting a National Liver Review Board to prevent overuse or inappropriate use of exception points. These efforts should be concurrent.  However, exception points will continue to be used (and needed) in high MELD regions until we establish equal access to organs and decrease lab MELD at transplant across the US.

PALV | 10/24/2018

Circles that ignore population density are inefficient and unfair. For less densely populated areas (consider the state of CO), the largest circle is almost identical to the DSA, hence the proposals do nothing to improve candidates limited ability to access donors beyond their OPO. Inversely, on the east coast, the fixed distance circles encompass a blizzard of candidates, transplant centers and OPO's, generating confusion and inefficiency. High MELD candidates will be deluged with offers. The relative position on the match run for the ultimate recipient will fall and as a consequence, many more wasted offers, phone calls, and traveling donor teams will result. The mathematics for variable circles to encompass a population--whether a proportion of the total or a number--for the general population or for the waiting list candidate population is simple and not complicated as the proposal claims. The random choice of 250 or 500 nm is just that--random, and could be readily replaced with a circle to accomodate a FAIR proportion of the wait list population.

Anonymous | 10/24/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/24/2018

I urge the Organ Procurement & Transplantation Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 10/24/2018

My sister-in-law was a fortunate recipient. The 2-circle model could have resulted in her not having access to the liver she had to have to survive. Most of our family lives in the Houston area. Please provide a policy that is population based and does not create a disadvantage to those living near a coastline.

Martha Tankersley | 10/24/2018

I echo so many of the comments already submitted. I simply cannot get behind any proposal that does not include measures to increase donation and increase transplant rates. The current proposal(s) are predicted to increase organ wastage, logistical complexity, and travel for organ recovery. Further, we continually hear (and read) that modeling demonstrates that organs will shift out of the most socioeconomically disadvantaged areas despite higher waitlist mortality rates in those same areas. The entire process feels forced and rushed, without due consideration for alternative options, such as the state based allocation, the modeling of which suggests fewer discards, less movement of organs away from areas of greatest WL mortality, and less exacerbation of existing disparities for poor, minority, and rural candidates. It is simply irresponsible to push through acuity circle models without additional discussion and evaluation of this reasonable alternative.

Anonymous | 10/24/2018

The transplant community is now being forced to revisit how best to reduce random geographic boundaries as a determining factor in a candidates access to transplantation because we were previously and recently unable to overcome our own political divides in order to accomplish our mission as a community. The modeling data presented, which compares the current allocation to the 2017 Board Approved, Acuity circles (250/500 and 300/600) and Broader 2-circle (MELD 32 and 35) clearly shows a modeling advantage to the larger Acuity circle scenario, with the lowest variance in median allocation MELD and the lowest waitlist mortality rate at the expense of a trivial amount of additional travel time, distance traveled and percent of organs flown. Coming from Region 5, where flying livers from donor to recipient hospitals is a standard condition of liver allocation by virtue of the size of the region, these perceived 'disadvantages' of the larger Acuity circle model should be considered minimal with regard to organ acceptance, transplant outcome, and theoretical risk of organ discards, especially when compared to the overall advantage provided to all waitlisted patients. Models utilizing smaller circles will actually disadvantage some patients over even the current allocation model and they simply replace one random geographic boundary (DSA border) with another (small circle). If the goal of this allocation redesign and the charge placed upon us by HRSA is to minimize variation in patient access to transplant and to maximize patient survival, I find it hard for UNOS and the transplant community to justify choosing any model that knowingly accepts a higher waitlist mortality rate and wider variation in MELD across regions when compared to another viable option (i.e. B2C v. Acuity 300/600). To accept less is to put our individual center/local needs over those of the nation's patient community as a whole. In doing so, we would not only appear hypocritical as a community of healthcare providers, but would risk having our choice being rejected by HRSA and we would risk having another system imposed upon us.

Kerry Mourning | 10/24/2018

The new proposal would put too many Texans at a disadvantage, causing an incredible spike in preventable deaths.

OPTN/UNOS Transplant Coordinators Committee | 10/24/2018

The OPTN/UNOS Transplant Coordinator Committee (TCC) thanks the Liver & Intestinal Organ Committee for the opportunity to provide feedback on their proposal to eliminate DSA and Region from liver distribution. The TCC reviewed the proposal and provided the following feedback, based on the questions the Liver Committee posed.

a. What MELD sharing threshold does the Committee recommend?
The TCC supports a MELD threshold of 29-31. On average, with a few exceptions, most programs are transplanting candidates with a MELD of around 29 or lower. Although this would mean more candidates would be in the catchment area, the group felt this would be more equitable.

b. Whether the sizes of the fixed distance circles should be larger, smaller, or remain the same.
The TCC did not explicitly respond to this question.

c. Whether the Committee prefers the broader 2-circle model or the acuity circles model.
The TCC supports the acuity model. The travel time increase seems acceptable in light of the impact on waitlist mortality. In other words, it appears many more lives would be saved with a marginal increase in travel time.

d. Do you support expanding Policy 9.11.B: Closed Variance for Allocation of Blood Type O Deceased Donor Livers in Hawaii to apply to Puerto Rico as well?
The TCC supports expanding the variance to Hawaii, as it stands that Puerto Rico likely faces similar challenges.

The TCC noted that as organ recovery centers proliferate, allocation based off of those locations will have to be addressed.

SHARP Chula Vista Medical Center | 10/24/2018

Brian Shepard - Chief Executive Officer
United Network for Organ Sharing 700 North 4th Street
Richmond, VA 23218

Via email: publiccomment@unos.org

Dear Mr. Shepard and Members of the OPTN:

Sharp Chula Vista Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. We have a keen interest in ensuring that all Californians receive the care they need, especially the increasing number of patients with liver disease who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.

The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Sincerely,
Pablo Velez, PhD, RN
CEO and Senior Vice President

SHARP Grossmont Hospital | 10/24/2018

Brian Shepard
Chief Executive Officer
United Network for Organ Sharing 700 North 4th Street
Richmond, VA 23218

Via email: publiccomment@unos.org

Dear Mr. Shepard and Members of the OPTN:

Sharp Grossmont Hospital is pleased to submit comments on the Organ Procurement and Transplant Network ' s (OPTN) Liver and Intestinal Organ Transplantation Committee' s work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. As the largest provider of care in the East County of San Diego, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity . Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Sincerely,
Scott Evan s, PharmD, MHA
Senior Vice President and CEO

Region 8 | 10/25/2018

Region 8 Vote (5 of 31 voting members submitted a vote online):

• Broader 2-circle distribution: 2 strongly support, 3 support, 0 abstain/neutral, 0 oppose, 0 strongly oppose
• MELD sharing threshold recommendation: 4 for MELD of 35, 1 for MELD 32
• Size of fixed distance circles recommendation: 4 for remain the same, 1 for smaller
• Acuity circles: 0 strongly support, 0 support, 2 abstain/neutral, 1 oppose, 2 strongly oppose

Members are concerned about the increased amount of flying predicted with any of the SRTR models and the impact on cold ischemia time, discard rates, transplant rate, and costs. Members also believe that the SRTR modeling is not using the most up-to-date data. Additionally, there was a request to provide the modeling data on socioeconomics at a regional level to better understand impact and additional analysis is needed to know how this will impact rural areas. The timeline for addressing the legal matters is compressed and more analysis/information may be needed.

Members do not support lowering the MELD sharing threshold to 29 in the broader 2-circle model. There was some support for increasing the MELD sharing threshold from the proposed 32 to 35. It was noted that some city programs, like Denver, in region 8 are not going to be within even 500 nautical miles. There was also a comment that a state first distribution should be an option for consideration.

Members continue to voice concerns about access to care and access to the waiting list. Mortality on the waiting list still needs to be better addressed. Members urged UNOS and the OPTN to consider all aspects of the Final Rule and not just those that relate to geography.

Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 8 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Memorial Hermann | 10/25/2018

We would favor a simple allocation system which allows the best access for the sickest patients - as they gain the most with transplantation over this who are less sick, circles of 500 plus miles with MELD threshold of 25, this is a system that patients and their families can understand and is simple and gives patients at least an opportunity for organ offer, the other variables that affect transplantation are to difficult to control for such as transplant center behavior for organ acceptance and transplantation. We also need to eliminate the 'MELD escalator' as this great disadvantages the patients who are at the highest risk for death on the waiting list - mean or median MELD score (biological) within region patient listed might be appropriate

Methodist Specialty and Transplant Hospital | 10/25/2018

The Liver Transplant Program at Methodist Specialty and Transplant Hospital (TXHS) commends the committee for attempting to address disparities in liver organ allocation. Our program supports the proposal for Broader 2-Circle sharing at MELD 32 using the proposed 150/250/500 nautical mile radii, although the proposal is far from ideal in that the proposed solution will increase the cost and complexity of transplant, particularly through increased procurement expense. In the future, given enough time to pursue further research, the committee should consider exploring population-density-based allocation as a more equitable solution. Our program supports expanding Policy 9.11.B to apply to Puerto Rico.

Anonymous | 10/25/2018

The average distance traveled as well as the number of organs that would require air transportation would increase drastically. The modeling predicts significant increases in transportation costs (up to a 50% increase over current costs) as well as increases in cold ischemic times which damage organs.

Richard Hollis | 10/25/2018

We are on the coast; half of our circle is water

Anonymous | 10/25/2018

The average distance traveled as well as the number of organs that would require air transportation would increase drastically. The modeling predicts significant increases in transportation costs (up to a 50% increase over current costs) as well as increases in cold ischemic times which damage organs.1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/25/2018

The present proposal does not adequately account for smaller national centers in conjunction with catchment areas from a wait-list perspective when considering rural versus urban. Smaller programs will be decimated as a result, only compounding the allocation and transplant process further.

Anonymous | 10/25/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Anonymous | 10/25/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/25/2018

Organs will be moved away from low income areas to benefit wealthier states with more advantage for their populations- this will impact my state and families that need livers in SC 

Daniel Stanton | 10/25/2018

As a transplant professional for nearly 2 decades, I respectfully submit my comments on the proposals for liver allocation changes.  While I am in support of more broad distribution for livers, I strongly oppose each of these specific proposals.  These proposals have significant detrimental impacts that far outweigh the potential benefits of broader sharing of organs.  A great majority of transplant programs and professionals have publicly shared these concerns during Regional UNOS meetings.  I would hope that liver organ allocation changes would take into account the recommendations and concerns of the transplant professional community as a whole. 1) The total number of liver transplants completed nationally will decline under each of these proposals.  As the transplant community struggles to help the growing number of patients in need of liver transplant each day, it is inconceivable to consider changing allocation in a manner that would further reduce the number of patients whose lives would be saved through liver transplant?  2) The % of livers that would be transported via air flight will increase significantly (some modeling show a 50% increase from current state). This will undoubtedly increase cold ischemic time (harmful to organ), as well as distance and flight times (drastically increasing costs by as much as 50%).  3) Under each of the proposed changes, deaths within 1 year of liver transplant are expected to increase.  As incredible efforts have been made by the entire transplant community to improve the outcomes of our collective patients, it is incredulous to consider taking steps backward as it comes to the overall health and outcomes of all patients?  4) The predicted models show significant additional decline in access to transplant for regions of the country that serve higher proportions of socioeconomically disadvantaged patients.  Again, at a time when many efforts are being made to provide greater equability to underserved populations, this is certainly a step in the wrong direction. Again, as a transplant professional, I am completely supportive of broader distribution of livers.  However, I cannot in good conscience, support any recommended allocation change that reduces the number of liver transplants performed, increases costs significantly, is detrimental to the post transplant survival of liver transplant recipients, and further disadvantages underserved populations. These proposals have far too many serious adverse effects to consider placing into practice, and I therefore strongly oppose them.  Additional research is necessary in order to develop an improved allocation system for this life saving treatment option.

MUSC TRANSPLANT SERVICES | 10/25/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts. These proposals will cause imminent death to our patients and surrounding population. 

Anonymous | 10/25/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

University of Texas Medical Branch Galveston | 10/25/2018

For SLK we would prefer a lower MELD at 29 or less.

Anonymous | 10/25/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Clements University Hospital | 10/25/2018

support Hawaii variance

Anonymous | 10/25/2018

Changing the current system will result in more deaths and more waste.

Anonymous | 10/25/2018

As you are well aware, this issue is complicated by the variability in geography, population density, and disease distribution across the country. While clearly the Committee must chose an allocation model that is fair and equitable to all potential recipients, we believe that patients from Houston and South Texas have specific vulnerabilities regarding some of the options being considered for allocation. This letter focuses on the concentric circle model of allocation, as it is our understanding that this option is the one most likely to be implemented until the UNOS Geography Committee completes its deliberations.  First, it is important to note that we are in full support of the continuous effort of the Committee to achieve a fair solution for the problem of geographic disparity in transplantation. We also are, at this time, in support of the concept of concentric circles of distribution for liver organs in a manner similar to that applied to other extra renal organs. However, our patients are especially concerned that half of any proposed circle used for organ distribution area will be negated by the presence of the Gulf of Mexico on our southern border and will limit their access to donors. While this is a problem for many regions of the country, a notable difference in Texas is that there are no large population centers for quite a distance inland from where the majority of all Texas listed patients are located. The other population centers in the state of Texas are all located at a distance of over 150 miles. Houston and South Texas patients represent the largest population of patients on the waiting list for liver transplantation in the State of Texas and have a high pre-transplant waitlist mortality rate and a high rate of removal for becoming 'too sick to transplant'. Thus, to our patients, a circle of distribution of less than 250 miles for patients with a MELD of less than 35 means erecting a barrier for organ allocation that does not currently exist and is likely to limit their opportunities based on geography.  As of today, our patients in Houston are served by LifeGift which has coverage in 3 different corners of the State including the Houston area, the Lubbock area (northern portion of the State), and the Fort Worth area (middle of the State), both of which are separated from Houston (southern portion of the State) by 532 miles (462 nm) and 269 (233 nm), respectively. Additionally sicker patients from our area (i.e., with a MELD >35) get access through Share 35 to donors from Oklahoma (414 miles or 360 nm), El Paso (745 miles or 647nm), and the entire state of Texas. This enhanced access to livers within the current Donation Service Area ('DSA') that has a 500 mile radius together with regional Share 35 region with a diameter of over 750 miles allows our patients a minimally acceptable transplant access area. Our patients would be severely harmed by any consideration of a smaller circle for the distribution after dissolving the DSAs and regions as units of distribution. A 150 mile circle around the Houston area would exclude access to donors from the Fort Worth and Lubbock regions which currently provide our patients with a significant number of livers equivalent to 324 in the last 2.5 years or approximately 130 livers per year. Thus, imposing a 150nm mile circle for patients with a MELD <35 and a 250nm mile radius for patients with MELD>35, rather than the current sharing across all the State of Texas and Oklahoma, would significantly shrink our patients' access to livers and would impose a new form of circular DSA that uses geography to limit access of our patients to life saving treatment. Houston and South Texas patients are already being transplanted at high acuity and exhibit higher wait list mortality then patients in Dallas, San Antonio, and Oklahoma. Moreover, restricting Share 35 to a 250 mile circle would effectively cut the current area from which the sickest of the sick are receiving livers under the current system since the current Share 35 includes the entire States of Texas and Oklahoma. Clearly this could have a serious and indefensible negative impact on patient mortality.  Enacting a concentric circle of distribution smaller than 250 miles for patients with a MELD<35 and 700 miles for those with a MELD >35 will create a geographic barrier that is no different than the concerns with the current DSA and OPTN Region schemes and would be contradictory to the OPTN Final Rule of December 4, 2017 '(OPTN Final Rule') and 42 C.F.R. 121.8. As stated in the OPTN/UNOS Public Comment Proposal 'a circle drawn too small could improperly prioritize local organ offers and fail to balance all of the requirements of the OPTN Final Rule'. 1 Houston and the South Texas region are prime examples of the effects of such an outcome.  Despite the potential arguments that may be used to rationalize the smaller geographical circles, including balancing the need to drive versus fly, the fact is that despite identical considerations the UNOS Board of Directors imposed the 250 mile radius as a boundary for lung distribution and UNOS has successfully implemented this policy with uniform acceptance by transplant centers and patients across the country. Anything short of that standard would be hard to justify or defend. Indeed, smaller circles run contrary to the directive set forth in HRSA's July 31, 2018 letter to UNOS which states that ''[a]llocation policies shall be designed to achieve equitable allocation of organs among patients consistent with [42 CFR 121.8(a)]' through several articulated performance goals, include '[d]istributing organs over as broad a geographic area as feasible under [42 CFR 121.8(a)(1)-(5)]'.'2  In addition, establishing circles within this geographic range will meet the four Principles of Geographic Distribution adopted by OPTN/UNOS. Specifically, these are that geographic constraints must:  1. Reduce inherent differences in the ratio of donor supply and demand across the country;  2. Reduce travel time expected to have a clinically significant effect on ischemic time and organ quality;  3. Increase organ utilization and prevent organ wastage; and  4. Increase efficiencies of donation and transplant system resources.  We acknowledge the difficulties of creating an allocation system across a wide variation of  geography and population density in a country as the large as the United States. However, we  believe that a reasonable and fair solution is the concentric circles of at least 250 miles for patients  with a MELD <35 and 700 miles for those with MELD >35. This distribution is rational, meets the  criteria required by HRSA and applicable regulations and guidance, does not create a  geographical barrier for most centers and patients, and has proven to be workable with lungs.  We appreciate the opportunity to bring our concerns on behalf of Houston and South Texas  patients to the Committee and we look forward to the Committee reaching a solution that achieves  the goals of reorganization needed to maintain an equitable and fair system for transplantation.

TXHI | 10/25/2018

Acuity Circles will decrease MELD Variance and decrease waitlist mortality

TXTC | 10/25/2018

Acuity 250+500 will decrease MELD variance at transplant and will decrease waitlist mortality.

Medical University of South Carolina | 10/25/2018

The vulnerable populations in South Carolina will suffer under this system. South Carolinians have different challenges to care than in the northeast and many people in this state will die under this system.

Anonymous | 10/25/2018

I was very lucky, I got my transplant in the city where I lived in a short time. Unfortunately, so many people are on the waiting list for a long time. To make it more equitable, organs should be available in a wider geographical distance than it is now. People who live in urban areas are at a disadvantage because many people need organs and fewer are available. 

Stacy Stewart | 10/25/2018

The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/25/2018

Please do not limit the number of organs to South Carolina.

Anonymous | 10/25/2018

While pediatric liver transplant numbers are much smaller, it would be helpful to have modeling data on peds liver transplant volumes on a DSA basis under all of the proposals.

Michael E Debakey VA Med Center | 10/25/2018

Strongly support acuity circle because it decreases MELd variation at transplant, decreases waitlist mortality and does not increase cold ischemia time. A 150 mile in Texas is smaller than our current DSA

MUSC | 10/25/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts.  3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

LifeShare Transplant Donor Services of Oklahoma | 10/25/2018

We support keeping the Hawaii variance and the proposed handling of pediatrics, SLK, and intestine.

TXMC | 10/25/2018

Hawaii should have a variance

Kandice Fogle | 10/25/2018

I live in Katy, TX, a Houston suburb. In 2008, I was diagnosed with primary liver cancer. I had a liver re-section and high fraction radiation; but, my cancer returned within six months. My only hope for survival was a liver transplant. I was on IV chemotherapy from 2009 until October 2011. My MELD score was low; but, only because I had a billiary drain. The truth is that I was dying. My donor was in north Texas. Since his area was allocated to the Houston region, I was blessed to be the recipient of his liver. Seven years later, I am alive and well, cancer free and the proud single mom of two beautiful daughters.

Anonymous | 10/25/2018

No model is perfect and each would need to be analyzed and modified after evaluation of performance. At this juncture, I support the acuity model as it appears to do the most to address disparity which is the goal. However, the broader 2 circle model is a step in the right direction and would at least move the process forward. Over time, I hope that population density will be incorporated in the model.  I do not share the fear of motivation. Though a legal claim may have accelerated the change, this discussion is over a decade old.

Marshall Medical Center | 10/25/2018

Via email: publiccomment@unos.org

Dear Mr. Shepard and Members of the OPTN:

On behalf of our patients and community, Marshall Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change . While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriat e organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.

The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocat es. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Sincerely, James Whipple, Chief Executive Officer

Marshall Medical Center

Anonymous | 10/26/2018

 1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. 

Anonymous | 10/26/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. South Carolina needs these organs!

Anonymous | 10/26/2018

I strongly oppose the new UNOS proposal for liver donation. While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/26/2018

Please consider looking at a state-based distribution framework. State-based allocation has many advantages:  •States form the best boundaries to allow OPTN/UNOS policy to comply with the law.  •Individual states are well recognized as units of socioeconomic status and overall quality of health care.  •State-level differences in Medicaid have profound effects on access to transplant for socioeconomically disadvantaged patients.  •States are primarily responsible for setting up donor registries and promoting donor awareness. Brain death is determined by state law, and the Uniform Anatomical Gift Act is enacted at the state level.  •States are recognized as a community unit and represent common interests and relationships across the political, social, and financial spectrum.  While this policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Kelsie Davis | 10/26/2018

I oppose the new UNOS proposal because it is predicted to redirect donor livers away from South Carolina, increasing cost and adding complexity to the transplant process.

Anonymous | 10/26/2018

while the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Northwell Health | 10/26/2018

There is no other disease process whereby geographic location represents an absolute factor in determining access to treatment. No matter where a cancer patient lives, they can have the expectation of access to chemotherapy. No matter where a diabetic patient lives, they can expect to have access to insulin. We know liver allografts are a scarce resource, but we have a tough time understanding why a sick liver disease patient in a certain geographic location cannot expect the same access to care as someone in a different location. The goal of the current transplant system is to prioritize transplantation for the sickest patients first.   If that is the case, then adoption of the acuity circle model is paramount. While this model decreases MELD variance most dramatically, most importantly it decreases the LAB MELD variance (whereas the B2C model does not change the lab MELD variance significantly, the acuity circle model does). Again, since our goal is to eliminate disparity and transplant the sickest first, the AC model is the only one that accomplishes this goal. Further, it should be noted that the median transport time is essentially the same between B2C and AC. The distance traveled is slightly more, however this is a minor trade off for improved access to care.  Flying behavior is very difficulty to analyze and depends on traffic patterns and population density. Differences in flying should not be considered.

Montefiore Medical Center | 10/26/2018

Montefiore Einstein Center for Transplant supports broadest possible sharing of livers. The SRTR analysis clearly shows that Acuity Circle 250/500 reduces variability in median meld at transplant as well as wait list mortality compared to the UNOS LI committee B2C proposal, which still creates an arbitrary 150m circle. The UNOS data presented today shows an alarming disparity in MMAT for nonexception patients, which is only marginally helped by MMAT. In our view, the incremental 0.2h change in flight time is not relevant in the context of patient survival. We strongly support an Acuity Circle model

Westchester Medical Center | 10/26/2018

Setting thresholds will not benefit a broader collection of patients, so we support NO MELD score sharing threshold, rather than 29. The Hawaii variance seems appropriate, but we would NOT recommend extending a similar variance to Puerto Rico. The SLK thresholds and intestine proposals seem appropriate.

Children's Hospital of Wisconsin | 10/26/2018

Children's Hospital of Wisconsin strongly supports the pediatric and adolescent donor allocation provisions included in the liver and intestine distribution proposal. This represents a significant improvement in allocation policy for pediatric wait list candidates and will hopefully result in more timely pediatric/adolescent transplants. We agree with UNOS' Pediatric Transplantation Committee's assessment that the current system disadvantages pediatric candidates and does not appropriately prioritize access for this population to suitable liver donors. We appreciate the Committee's recognition of the importance of prioritizing pediatric and adolescent's candidates for pediatric/adolescent liver donors and urge the Committee to maintain the provisions in the proposed allocation system intended to improve transplant rates for children.

Medical University of South Carolina | 10/26/2018

Broader sharing will lead to organ waste, increase in logistical maneuverability and have a dramatic increase in flight costs among other rising costs. Predictions show that the net effect will allow organs to me moved out of socioeconomically under served and rural areas such as South Carolina to more affluent areas, notably to New England. The proposed models do not consider the limitations of MELD in predicting wait list death in rural versus urban populations.  South Carolina has a 3 to 5 times higher wait list mortality rate than New York and Massachusetts who stand to import the most livers in the proposals. The proposals also do not consider overall burden of disease in a population. The incidence of liver failure is much higher in SC than in NY and MA creating a disproportionate number of organs leaving SC for NY and MA. The models also do not protect centers that serve regions with poor health care access. Instead, states with the best access including the Medicaid expansion states and the highest wait list rates will benefit most from the proposals at the expense of the residents of states with diminished access to quality care. These proposals also do not evaluate variation on Organ Procurement Organization (OPO) performance metrics. The proposals will simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. These proposals will have a significant, detrimental and devastating effect on liver transplant patients in our state.

University of Rochester Med Center | 10/26/2018

We don't believe that there should be a MELD sharing threshold. We believe that broader sharing and reducing MELD disparity should be the focus of the distribution model chosen by the Board.  As a member of Region 9 we have shared livers across DSA boundaries for more than twenty years regardless of MELD.  Our Region and our hospital believe that organs are a national resource that should be shared as broadly as possible. If we select the Acuity Model we will be meeting the spirit of the final rule and therefore we support the acuity model with the largest circles.

Anonymous | 10/26/2018

I fully support the broadest possible share with the lowest (or no) MELD threshold. The B2C models will actually narrow the share in many areas of the country and I am strongly opposed.

New York Presbyterian /Weill Cornell | 10/26/2018

NYNY strongly supports broader sharing and in light of that view the Acuity model. While we do not believe that there should be a MELD threshold, we favor 29 over other choices.

Georgia Brogdon | 10/26/2018

Each of these proposals will delay timely care for the patients in the South Carolina region suffering with Kidney and Liver failure. These changes will cause wastage of organs, significantly increase the costs and flying time to get organs to patients and add a huge administrative logistical burden. It appears these new rules will take much needed organs away from our more socioeconomically disadvantaged black patients in South Carolina and give the organs to the much more affluent white patients in the north east. Why in the world would that make sense?

Rhonda Burk | 10/26/2018

A few years ago I was diagnosed with Stage 4 Liver Cirrhosis due to NASH with severe scarring. I work at MUSC Health and have an excellent team of doctors and clinical staff monitoring my status; however, there are no guarantees that my liver function will remain as it is now, especially as time progresses. The UNOS proposal to redirect livers away from areas like SC, by implementing a new geographic, scares me tremendously. While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process. Leadership here at MUSC is proposing the following course of action, which I strongly support and pray will be taken into consideration: We strongly oppose this threat to the health of South Carolina liver transplant patients. Instead, we propose a state-based distribution framework. State-based allocation has many advantages:  • States form the best boundaries to allow OPTN/UNOS policy to comply with the law.  • Individual states are well recognized as units of socioeconomic status and overall quality of health care.  • State-level differences in Medicaid have profound effects on access to transplant for socioeconomically disadvantaged patients.  • States are primarily responsible for setting up donor registries and promoting donor awareness. Brain death is determined by state law, and the Uniform Anatomical Gift Act is enacted at the state level.  • States are recognized as a community unit and represent common interests and relationships across the political, social, and financial spectrum.  Thank you for your time, and honest review, and consideration of these urgent matters.

Jang Moon | 10/26/2018

Any organ is a national resource and needs to be shared in fair fashion nationwide. The only valuable marker for the fairness is how sick the patient is. Individual transplant center may have own limit for travel distance based on practice pattern but it should not be limited by rule or law.

Rafael Khaim | 10/26/2018

Strongly supporting the acuity model as every unfortunate sick individual deserves a right to live. Patient centered care we all preach starts with properly allocating to the sickest, neediest population not geographically fortunate candidate.

Leona Kim | 10/26/2018

I believe that within the parameters of the proposals put forward, the Acuity Circle with NO threshold is the model that will provide compliance with the Final Rule. This model encompasses the basic principles of donated organs as a national resource, the sickest patient with the greatest risk of dying having priority over a less sick patient with a less risk of dying, and if there are two equally sick patients, the organ should go to the patient closer to the donor source. In making decisions about distribution fairness, we need to focus on equity for the waitlisted patients. This is not about finding equity among transplant physicians or transplant centers.  Where one lives, or where a transplant center is located should not determine life or death for a waitlisted patient with end stage organ disease.

Anonymous | 10/26/2018

acuity will help more ppl based on need

Anonymous | 10/26/2018

The policy discriminates against rural, low-income, and minority patients in regions across the country. This proposal will increase the likelihood of these patients dying while waiting for transplant and lead to increased cost.

Dianne LaPointeRudow | 10/26/2018

I support the Acuity Model to distribute Livers in the Unites States. Livers are a national resource and distribution should be broader than B2C allows and should be need based. In fact, the acuity model is more consistent with the Final Rule because it is based more upon need. B2C model is based primarily upon geography. Additionally a Meld threshold of 32 is voting for really no change at all from our current system. I am concerned that we would have a MELD threshold at all. MELD is a disease severity index and already stratifies patients based upon need. If the Board feels there, must be a MELD threshold then it should be low. WE also should not lump MELD 15-31 in such a small 150mi circle (especially for programs out West). Data shown at regional meetings demonstrate a wide degree of difference in mortality  between those scores. Our community must take this opportunity to make meaningful change not put a Band-Aid on a broken system and hope for change over time so that we can serve the patients who need the liver transplants the most.   Any small or graduated change will just result in more deaths on the waiting list. We need to help entire country - only the Acuity model starts to do so.

Anonymous | 10/26/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/26/2018

Ultimately I favor the Acuity model as it based more upon need for the sickest patients with less respect to location. I think this is the more fair way to address distribution of valuable liver resources.

Medical University of South Carolina | 10/26/2018

I have a couple of concerns surrounding the broader sharing models. The particular patients that I help serve and are concerned about are the residents of South Carolina. Our incidence of liver failure is much higher than New York and Massachusetts, yet the latter two will benefit the most from the proposals. Inherent in this is the fact the It disproportionately harms areas that are socioeconomically challenged while increasing aid to the more affluent areas. Thank you for considering these serious issues as you make a decision.

Dawn Lewis | 10/26/2018

It would be awful to change this to 150 miles! It's not appropriate for the Houston areas. We need at least 250 miles if not more! A lot more people will die if they change it to 150 miles! Please don't.

Anonymous | 10/26/2018

Few issues with this possible policy 1. The model has nothing to do with the OPO performance. It is known that NYC has the WORSE OPO in the US and all this proposal dose is re-distribute organs from areas of good OPOs to areas with bad OPOs. I think this lawsuit (like in Lung as well) would have been avoided if the NYC OPO was better. the real fix is to completely close the NYC opo and start anew 2. This new proposed model will really only assist the richer people of New York/Massachusetts/NE region at the expense of the poorer people in the South (SC, NC, GA, etc). This is robbing the poor of their opportunity to get a transplant so that the rich people in NE can get it. 3. There will be more flights with increased costs and accidents 4. This proposal doe snot consider the burden of liver disease in a population. SC has a much higher incidence of liver failure than NY or other NE states, and this will take livers from SC and place them in those people. This is an outrage. Rob the poor for the rich. 5. The circle does nothing for centers close to the coast. There are no livers in the ocean so those centers are put at a disadvantage.

Anonymous | 10/26/2018

UNOS analysis shows that 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver pocured organs more important than saving lives? Why are you trying to fix something that isn't broke.....just improve with lower MELD score and distance circles. Walk in a persons shoes that is on a transplant list.....do you know that anxiety you are already adding to their mental state?

Anonymous | 10/26/2018

An organ should go to the sickest person in the country who needs it despite the distance.

Anonymous | 10/26/2018

The approved model should simply be based on NEED. The acuity model seems to align more with an available liver being allocated to the sickest recipient despite their location.

Anonymous | 10/26/2018

While population based redistribution seems reasonable, it disproportionally harms rural and low-income areas like much of SC.

North Shore Univ. Hosp. | 10/26/2018

We should make 29 our threshold, because this is the approximate inflection point for patient survival.

Anonymous | 10/26/2018

The proposed small circles for distribution, creates an alternative system that ( in our state)  has significant disadvantages to patients in the Houston and coastal areas of Texas. the B2C model increases the deaths on waiting list, which will disproportionately affect the area with the largest wait list. Acuity models decrease Meld Variation, decrease weight list mortality , and in our area have an insignificant influence on percent flying or distance between donor and recipient. The B2C model does its harm by bisecting our current organ procurement area and separating the largest numbers of listed patients from The donor cities of Lubbock , El Paso and Fort Worth which currently produce over 130 livers annually to south Texas patients. this forced redistribution can not stand scrutiny considering the functional allocation of lungs that uses a larger circle of distribution. Our patients would be severely harmed by any consideration of a smaller circle for the distribution after dissolving the DSAs and regions as units of distribution. A 150 mile circle around the Houston area would exclude access to donors from the Fort Worth and Lubbock regions which currently provide our patients with a significant number of livers equivalent to 324 in the last 2.5 years or approximately 130 livers per year .Thus, imposing a 150nm mile circle for patients with a MELD <35 and a 250nm mile radius for patients with MELD>35, rather than the current sharing across all the State of Texas and Oklahoma, would significantly shrink our patients' access to livers and would impose a new form of circular DSA that uses geography to limit access of our patients to life saving treatment. Houston and South Texas patients are already being transplanted at high acuity and exhibit higher wait list mortality then patients in Dallas, San Antonio, and Oklahoma. Moreover, restricting Share 35 to a 250 mile circle would effectively cut the current area from which the sickest of the sick are receiving livers under the current system since the current Share 35 includes the entire States of Texas and Oklahoma. Clearly this could have a serious and indefensible negative impact on patient mortality.

MUSC | 10/26/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Jen Young | 10/26/2018

I think that some of your restrictions on living donor transplant  is outrageous. My mother has hcc and was listed on UNOS transplant list  5 months ago. She's not sick right now , her meld score is low so she's not eligible for a deceased donor. I am willing and able to be a living donor, underwent all testing required. They are telling me I am unable to donate because it would leave me with 29% of my left lobe and that's a federal guideline that I can't be left with less than 30%. 1% is mandating that I'm not eligible shouldn't that be my decision to make when you are putting percentages on people's lives! So many more people could be saved if the restrictions were more tangible and if people had a broader range of area to get an organ. I live in Massachusetts and am now considering moving to another state in order for my mom to get a liver and where the hospital is not a part of UNOS , how can you put that kind of price tag on a human life!,

Gene Im | 10/26/2018

As a transplant hepatologist in Region 9, I support the Acuity 250+500 model as it most closely adheres to the OPTN Final Rule. For me, this ultimate goal allows for successfully navigating the arguments and alternatives put forth by opponents to broader sharing of our national resource.

Anonymous | 10/26/2018

This letter is to formally oppose these new proposals for Liver and Intestine Distribution Using Distance from the Donor Hospital. Two proposals have been set forth: The Acuity Circle and Broader 2 Circles. (B2C)  Both models are supposed to be in line with the committees proposed framework of fixed distances from the donor hospital and use 150, 250 and 500  nautical miles from the donor hospital as units of allocation.  As the director of the Liver Transplant Program at Queens Medical Center in Hawaii, I am quite sure that these schemes would worsen attempts for Hawaii to share organs with any of the other contiguous 48 states.  If we have a sick, status 1 patient, there will be no hopes to import an organ from the mainland unless there is there is the mathematical improbability that there is no patient waiting with MELD >15 on the entire West Coast of that blood type. There are liver transplant centers at least every 500 miles along the West Coast that will have a patient with MELD >15 of every blood type and size at any time of the day.  It is unclear how 'National' distribution of a liver after 500 miles will be prioritized, but if distance is still the issue, Hawaii will lose any chance, every time. Ultimately this means that if you live in Hawaii and you have fulminant liver failure, primary non-function or have the  very high MELD score, that you would simply die because there is no opportunity to get a mainland organ to save you. With regards to the issue of exporting of livers, this will also be confusing for Hawaii. Because we are a relatively small program, we will sometimes have donor livers of blood type AB or B but only very low MELD score patients waiting. These organs should go to the sicker patients on the mainland and in the past, we have been perfectly willing to share such organs. With the Acuity Circle Adult Donor Allocation Sequence, if Hawaii has no patient with MELD 15, these livers would go to Classification 15 or higher which is National.  Now it is unclear once they go National Status 1 what the priority will be. Will the closest place have the priority? If it gets to Nation with MELD at least 15, will the MELD score or the distance have the priority?  There will be so many people waiting across the US with this category. There will be exponentially increased phone calling for organ offers and all of these centers will need to figure out the distance and logistics of getting an organ from Hawaii to wherever they are in the US. We currently share these livers with the programs in Region 6. This basically means that we are sharing with programs in Seattle and Portland. Our donation coordinators are well versed in the flight schedules, airlines and ground transport and are highly efficient at scheduling the donor cases to minimize ischemic times to these programs. We have worked very well with these centers and there is coordinated sharing of organs between these centers. It will be mass chaos if we have the potential to share organs across the country. Liver transplant centers typically do not indicate a limit of distance for their parameters or they will put 5000 miles and then deal with it when the offers actually come in. So what will be the scheme to numerically order all of these offers? I would also envision other problems in our current Region 6. Donors in Alaska have been typically used by the centers in Seattle and Portland and these centers have had many years of utilizing these organs efficiently in terms of logistics.  However with the 2 proposed schemes, these centers are beyond 500 miles. Basically, all liver offers from Alaska will be National shares. The logistics of getting these organs procured and allocated will be difficult if this is to go out to the rest of the nation. Again, the current scheme does not indicate the priority for such organs. We can only anticipate many more organ offers, phone calls, and added transport time, longer ischemic times, confusing logistics and increased cost with both of these proposals. There will also be downstream effects of organs missing flights, getting lost in the airport and ultimately livers discarded. These events have happened before when we have transported organs and they will only worsen if we add many different centers into the sharing scheme. While these proposals are intended to take away disparities in geography, the allocation scheme is clear for the first 500 miles, but after this, it will be a free-for-all approach and previously developed, well established efficient mechanisms of organ sharing will degenerate into a disorganized, uncontrolled and costly attempt to appease the goal of 'geography'.  For Hawaii, this proposal is a death sentence for the most ill.

Anonymous | 10/26/2018

distance should not be the criteria!  Livers can travel

OHSU | 10/26/2018

Need to address other geographic variances beyond Hawaii.  Would propose that Alaska have a variance or should be considered within 500nm of the west coast.

Anonymous | 10/26/2018

I'm concerned about the logistics and increased flying involved with these models. We don't really know how many flights we are making now. The model estimates are based on assumptions not actual flights. I think it makes sense to start with the least sharing and see how that goes before widening the circles and decreasing the meld scores. I think an unfortunate by product of this approach is to disrupt the relations ship between the local transplant centers and local opo. I feel like the coiin project was productive and I think it may be harder to take on those projects with more players involved.

Anonymous | 10/26/2018

In order for a candidate to receive a liver, two things are required: 1) A liver has to be offered, and 2) the offer has to be accepted. Any changes to liver allocation policy impact #1 above, but transplant centers retain the ability to accept or decline each liver offer. Currently, according to the SRTR PSRs, there is wide program-level disparity in   observed-to-expected liver offer acceptance rates, ranging from < 50% of expected to > 200% of expected. One strategy to mitigate the potential negative impact of any policy change will be to adapt to the new policy by changing center-level practices to increase observed-to-expected liver offer acceptance.

Anonymous | 10/26/2018

Would like a variance for Organs in Alaska

Anonymous | 10/26/2018

Alaska should be considered separately.

University of Washington | 10/26/2018

The bookend questions of this issue of allocation has been how many liver grafts will be lost and how is this going to impact mortality (and too sick to transplant) on the waitlist. Clearly this will be significant and dramatic for some regions.  Other downstream effects of these models should be thought through, such as:  -Pediatric donor allocation and splitting.  -Cost  -Logistics of increased travel

Anonymous | 10/26/2018

It is unclear how 'National' distribution of a liver over 500 miles away will be prioritized and if distance is an issue, there is no opportunity for very sick patients in Hawaii to get a mainland organ. Additionally, exporting organs from Hawaii to other areas in the US is complicated. I strongly support a variance for Hawaii.

Swedish Medical Center | 10/26/2018

We support the B2C model in general but with the caveat that the unique situation of Alaska be considered in any final model. Differences in population density, which uniquely affect Region 6, should be considered in any future proposal. For now, a variance that includes Alaska could ameliorate the paradoxical affect of reduced organ sharing that will occur in Region 6 as a result of the current proposals.

New York Center for Liver Transplantation | 10/26/2018

NYCLT strongly supports the Acuity Circles model and opposes B2C. Acuity Circles is modeled to have the greatest impact in reducing disparity in Median MELD at Transplant (MMaT) across geographic areas, with a negligible increase in organ transport time of less than ¼ hour. B2C will, in fact, narrow the distribution of livers in NYS for patients with a MELD score of 31 and less. It appears the share will narrow in a similar fashion for patients in 13 (20+%) of the DSAs in the country under the B2C model. Organs should be distributed based on medical urgency, particularly for patients at MELD scores where mortality risk increases. To that point, NYCLT supports a model without sharing thresholds or at most a sharing threshold of 29.

Thomas Schiano | 10/26/2018

Livers are a precious and national resource so their allocation and prioritization should be need-based. My opinion is that the currently proposed acuity model is more consistent with the Final Rule than the Broader 2-Circle model, and is targeted more to the populace's general need. Its time to try and move to a different model as well as away from the traditionally constructed geographic models.

Anonymous | 10/26/2018

We support the Hawaii variance so as not to further disadvantage patients who do not reside on the continental U.S.

Anonymous | 10/26/2018

This proposal does not take into consideration a number of items: 1. Waitlist mortality is not appropriately being measured and only looks at death on waitlist not those that are removed from list. In addition that is looking at how things are today and not how waitlist mortality will be affected long term 2. This proposal is unrealistic in a region with large geographical distances 3. This proposal is increase travel, cost, potentially decreasing overall number of transplants to benefit very little and a large expense 4. The impact on rural underserved population has not been modeled and the disparity for this population is underrepresented

Baylor College of Medicine | 10/26/2018

The acuity models provide decrease waitlist morality and MELD variation.

Anonymous | 10/26/2018

Accountability and maximizing organ donors from California, Texas and New York would provide us with more actual liver transplants than ill-conceived organ allocation policies. Stand up and do the right things for the right reasons and we will move the field of transplantation forward rather than changing policies due to fear of litigation. Hawaii should receive a variance.

Willscott Naugler | 10/26/2018

I add my voice to the many others in saying that making policy in reaction to lawsuits further increases the divisiveness of this process and gives the biggest voice to those who have resources to bring such suits to fruition--not to the patients needing our help and guidance. Because of the rapidity of this response (to a lawsuit), we have again reverted to focusing solely on the metric of median allocation MELD, ignoring the concerns of over half the country who clearly see significant problems with this metric. All thoughts of doing anything to increase organ donation have been thrown out the window with the policy. All thoughts about variations in access to health care have been thrown out the window with this policy. We are making a policy which sends more of our most precious resource to areas with the most resources already. Instead of evening up the playing field, we are further disadvantaging the already disadvantaged.

OHSU | 10/26/2018

1) If our nation of transplant and procurement work force focused on increasing donation by 10% across our nation, the organ availability and ability to serve the sickest liver transplant candidates, as well as the underserved populations, in addition to accomplishing the mission mandated by the 'final rule' would be better served as opposed to the current proposed strategies that are inane, not well tested and politically as well as legally driven. 2) A law suit should never serve as a medium to make a drastic and critical change in policy that will result in increased cost, shift organs from areas that have great OPO performance to those that have poor OPO performance at the expense of increasing waitlist mortality in areas that meet the metric of great OPO performance. In so doing one punishes the local and regional efforts and altruism to serve those that are not as effective, hard working nor engaged in the mission. 3) Has UNOS analyzed how and why transplant surgeons will be willing to spend their day, sans numeration, embarking on distant procurements that may result in an empty basket of organs, due to discards in the presence of long cold ischemia times and potential wastage of organs that would be sent to centers at a large distance? 4) wayward political motives (for eg a law suit from parties that serve only to gain at others' expense) should never lead long-term national policies that affect a large or small (for that matter) populations of non-political constituencies. Ethical principles should be upheld at all costs. 5) The states such as Alaska, Idaho, Puerto Rico, etc who have a substantial organ pool would best utilize these organs by placement in transplant centers that are in the closest proximity, to avoid orang wastage, cost and other logistical challenges - has UNOS even thought about these issues? we need to continue on a goal to optimize organ availability by matching the best chance at realizing the greatest outcomes in transplant recipients. 6) The national approach to organ allocation needs to be transparent, not rushed, optimize best life benefit, realize the need for equity in access to care for this very ill population, despite their wealth, location of residence and any political pressures. allocation of a scarce resource should never be driven by political or legal motives, but instead, altruism, ethical principles and truthful motivations. 7) to reiterate -- access to care, serving those that are in need, particularly those of lower socioeconomic class, and those in areas with high motivation to contribute to the organ pool should have focused attention. 8) we should not have a 'shift on the deck chairs of the titanic' mentality, but instead FOCUS on increasing ORGAN DONATION! THIS IS SO SIMPLE, EVIDENT, LESS COSTLY, AND MORE CONDUCIVE TO A DEMOCRATIC APPROACH IN A NATION WHERE EQUAL ACCESS TO ANY RESOURCE TO SAVE A LIFE SHOULD BE DEALT WITH ON AN EQUAL AND ETHICAL BASIS.

Region 10 | 10/26/2018

Region 10 Vote (16 of 34 voting members submitted a vote online):

• Broader 2-circle distribution: 6 strongly support, 7 support, 2 abstain/neutral, 0 oppose, 1 strongly oppose
• MELD sharing threshold recommendation: 1 for MELD of 30, 6 for MELD 32, 1 for MELD 33, 1 for MELD 34, 7 for MELD 35, 0 abstain
• Size of fixed distance circles recommendation: 8 for remain the same, 8 for smaller, 0 abstain
• Acuity circles: 0 strongly support, 1 support, 2 abstain/neutral, 2 oppose, 10 strongly oppose

Members in the region had concerns about geographic barriers and calculating distance from donor hospital from the transplant hospital and not place of candidate residence. Candidates who live in the western part of Michigan could potentially miss liver offers since they are listed at a transplant center in southeastern Michigan and that would increase the distance from a donor hospital on the other western side of Lake Michigan. They would also like to see that population density is considered by the committee before selecting one of the proposed models.

The comment was made that any changes made to liver allocation should be done in an iterative fashion since more changes will surely come with time. It would be sensible to make a more conservative change at this time, especially with changes in NLRB starting as well. The lawsuit has asked for DSA and region to be removed from liver allocation, and that should be the focus of any changes made to liver allocation. The group favored the B2C model and in general, favored 35 over 32 since the modeling showed minimal differences in the outcomes measured. There was concern over why 32 was favored by Liver and Intestinal Committee over 35 and how 29 will be advocated without any modeling.

There is concern that mortality rates will rise in the first year due to the volume of exception candidates. Many exception scores will be higher than the sharing threshold decided on for the new allocation system, so patients with MELD scores will be disadvantage compared to exception patients. Region 10 has roughly 10% of exception cases so will not be able to take advantage of this exception backlog.

Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 10 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Sharp Health Care | 10/26/2018

Brian Shepard, Chief Executive Officer, United Network for Organ Sharing, 700 North 4th Street Richmond, VA 23218

Via email: publiccomment@unos.org

Sharp Health Care, which operates four acute care hospitals and partners with the University of California, San Diego on liver transplant, is pleased to submit comments on the Organ Procurement and Transplant Network' s {OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. As the largest provider of care in the San Diego region, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model' s inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Michael W. Murphy, President & CEO

Daniel L. Gross, Executive Vice President, Hospital Operations

Adventist Health-Rideout Health | 10/26/2018

Brian Shepard, Chief Executive Officer, United Network for Organ Sharing, 700 North 4th Street Richmond, VA 23218

Via email: publiccomment@unos.org

Dear Mr. Shepard and Members of the OPTN:

On behalf of our patients and community, Adventist Health and Rideout is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee ' s work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle mod el.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most important ly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.

The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Richard L. Rawson

President

Prabhakar Baliga | 10/26/2018

I am writing this comment as a transplant surgeon who has practiced in SC since 1992. I have been actively involved with the OPTN as a past Board member. I have studied and been continuously funded for my research in racial disparities. I am specifically against the proposed changes in terms of circles or MELD thresholds for the reasons below. In my opinion, there should be well defined metrics to ensure such a disruptive change is justified and that the community at large can gain. There should be tangible, agreed upon, uniform thresholds for allocation policy change such as lives saved, health care value, efficiency improvements, etc. The policy should fit all tenants of the Final Rule and not be discriminatory to any specific population. The data and definitions should not be controversial but have broad consensus. Unfortunately, I find none of these principles addressed.

The leadership could not justify the rush to this new proposal prior to testing a recently approved proposal barely a few months ago. This reminds of a repeated rush to various unproven diets to treat obesity, in this case a morbidly obese waiting list. It seems acceptable to have a NY diet to keep Southeastern transplant programs lean, or as we were told repeatedly by the leadership, if it increases death from a higher burden of disease, it is not a consideration. This lack of alignment between the decision making and UNOS’s vision and mission as the OPTN is most disturbing. (Per the CDC, the death rate from liver disease in SC is 12.4 vs 6.9 in NY (CY 2016); Waitlist Mortality at NYU and NYCP are 6.8 and 5.5 respectively vs 23 / 100 years in SC). Every model I have seen suggests NY will gain 30% and SC which has the highest burden of disease will decrease 17-23%. Please help me understand the disparity we are trying to “fix”. It is alarming to me that the LSAM modeling on death on the waiting list shown in UNOS webinars did not include the drop off from “too sick” to transplant patients. The analysis utilized for HCC allocation was different : The incidence of waitlist deaths (including deaths occurring within 90 days after waitlist removal) was calculated similarly. Heimbach JK, Hirose R, Stock PG, Schladt DP, Xiong H, Liu J et al. Delayed Hepatocellular Carcinoma MELD Exception Score Improves Disparity in Access to Liver Transplant in the US. Hepatology (Baltimore, Md) 2015;61(5):1643-1650.

As has been pointed out many times the MELD scores with exception points continue to skew any analysis. Why are the simplest and most straight forward metrics manipulated? These types of lack of diligence on such significant impactful policies only fosters further lack of public trust. We cannot play with patient lives based on such broad lack of metrics, definition and opacity in threshold for changes.

It is again shocking to me that we are comfortable focusing on allocation policies that will advantage regions with the poorest performing OPO. This sends a strong message to our communities to de-emphasize local donation since there is minimal advantage to the local community. Interestingly, there is no analysis or focus on organ donation. How many lives will be saved and transplants performed if the poor performing OPOs in these areas are brought up to national standards? Why isn’t this a strategic priority for the OPTN? Why isn’t this part of a comparison to a variable in allocation? Is this analysis too difficult to perform? Is it not true that the NY OPO was decertified by CMS, so in return it sees a reward in the creation of an allocation system that brings them 30% more livers? How is this justifiable and what is the message of accountability and support that is perceived by the rest of the community?

DSA, state lines, and regions all have operational and logistic value of delivery of health care, finance, transportation, etc. It is difficult to trust an analysis showing that this broader sharing will be more efficient in improving utilization and have minimal effect on travel or costs. Disrupting these logistics for no net sum gain challenges simple common sense. There is no better way to rub salt into the wounds of a local community with high donation rates than by only allowing the marginal organs to stay in that community.

Under the shadow of the Final Rule we seem to be morally and ethically comfortable with an interpretation and a narrow focus on geographic equity of the waiting list, ignoring all other major principles such as the safety of the underserved and minority populations as was intended in the legislation. This current proposal violates so many principles, it feels like a ship that has lost its captain, its rudder and the main sail.

Hopefully, the OPTN and UNOS leadership can seek true partnership with the broad transplant community (in lieu of their current narrow partnership) to promote strategic initiatives and innovative ideas resulting in more patients successfully transplanted. These policies are archaic and failed strategies that are being repeatedly rehashed … a colossal waste of resources with no net gain, that is highly disruptive and divisive. Why is it so difficult for such a highly intellectual, innovative group to approach the goal with a different strategy? Please show me True Grit in the time of crisis.

Anonymous | 10/27/2018

while the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

James Day | 10/27/2018

As I see it there are two issues. First the Meld score should be in a 25-29 range. After evaluating all higher Meld scores for a match in the region, a match for the lower should be done. The healthier the receiver the better the odds of acceptance and recovery. Second, using the 250 mile circles allows those areas who have done the job of educating the population about organ donation to help the people in that area first. The best use of time and $$$ would be to have areas with a low donation start educating the people. The heart of the nation has done this job and now the east and west are wanting to benefit without doing the education component. To help those who are waiting without receiving an organ, due to lack of donors, can be impacted by education of people.

Anonymous | 10/27/2018

Implementing a 150 mile circle around South Texas will reprieve patients from the organs in Lubbock, El Paso, Forth Worth, and other cities in Texas and Oklahoma to which we currently have access to. We stand to lose approximately 130 donor lovers a year within the Houston region. Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rested while waiting for transplant. Houston and South Texas represent the largest population of patients waiting for transplants. I strongly opposed to anything less than a 250 mile circle because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston.

Angela Gilmore | 10/27/2018

Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rate while waiting for transplant. -A transplant RN, and I have a good friend waiting for a liver.

Anonymous | 10/27/2018

How is UNOS able to choose a model that makes it harder for certain patients to get a liver just based on where they live? I thought the new rule was supposed to increase the availability for organs?

Leah Hutson | 10/27/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. The 150/250 mile circle proposed is signaling to families that saving money on logistics is more important than saving lives. I am sure that working with any of the companies used to transport the organs could solve this issue. We are strongly opposed to anything less than a 250 mile circle because of Houstons close proximity to the Gulf of Mexico and the lack of populated cities less than 150 miles from Houston. Implementing a 150 mile circle around South Texas only will deprive patients from the organs in Lubbock, El Paso, and Fort Worth. This would cut us off from approximately 130 donor livers a year that the Houston area desperately needs. This in turn will increase the wait list and the death rate of patients waiting for donor livers to be transplanted. This is especially important to note because Houston and South Texas represent the largest population of patients waiting for transplants. Imposing the 150 mile circle will most certainly lead to and increase of deaths due to this. The average MELD score at the time of transplant in Houston is over 30. This is higher than the national average. That in hard data shows that Houston needs organs more than any other area nationwide! To impose a 150 mile circle will mean sending the sickest patients straight to their deaths.

Region 5 | 10/27/2018

Region 5 Vote (16 of 45 voting members submitted a vote online):

• Broader 2-circle distribution: 3 strongly support, 4 support, 2 abstain/neutral, 2 oppose, 5 strongly oppose

• MELD sharing threshold recommendation: 2 for MELD of 35, 6 for MELD 32, 8 for MELD 29, 0 abstain

• Size of fixed distance circles recommendation: 6 for remain the same, 0 for smaller, 9 for larger, 1 abstain

• Acuity circles: 6 strongly support, 4 support, 3 abstain/neutral, 2 oppose, 1 strongly oppose

One member commented that we should consider Acuity 300/600 since it has the most significant reduction of MELD/PELD at transplant.

Multiple members expressed they would have liked to have seen more modeling data including the impact of lowering the MELD threshold to 29 on the percent of transplants that would require flying, and the overall data for MELD thresholds lower than 32, with specific mention of 29 and 25.

One person asked who would absorb the increased transportation costs associated with larger nautical mile distances.

A member recommended phased approach with B2C-32 for 1 year and then B2C-29 phased in to allow for modeling and observation of behavior and modification of policy.

Multiple members voiced support for lower MELD thresholds including 29 (with 250/500nm), 25, and 24.

One member voiced that they feel that centers that do not share as much are underrepresented on the liver committee and that this proposal is not representative of them.

Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 5 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Anonymous | 10/28/2018

I support the Acuity 250+500 model to improve access to organs for those patients that need them most urgently.

Anonymous | 10/28/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/28/2018

We are highly opposed to anything less than a 250 mi. circle because of the Gulf of Mexico and the lack of populated cities less than 150 mi. from Houston. The proposed 150/250 circle will benefit areas on the East Coast like NYC, but hurt places like Texas, California, and Florida. Why would UNOS choose a model that hurts patients in multiple regions?

Sandy Florman | 10/28/2018

There is currently no ideal solution and the amount of data has been dizzying - the system should primarily be based upon medical need, not geography. Last December's policy and the B2C proposals were not designed to prioritize need. Acuity is based upon need, gives priority locally, and is more consistent with the spirit of equitable sharing. There are additional ways we could mitigate the ancillary concerns related to organs travelling, OPO logistics and center behaviors. Change should be meaningful, otherwise it is only change for the sake of change, which is not progress. We should embrace this opportunity to change and not settle for the status quo.

Jana Elliott | 10/28/2018

The new proposal does not help improve health equity in our state.

Anonymous | 10/28/2018

The circle puts MUSC receiving livers from the ocean! The circle model is unfair to MUSC!

Transplant Support Organization | 10/28/2018

The guiding principle is that sickest patients should be 'treated' first. And the corollary to this is that the less sick you are, the better your chances of long-term life and vitality. If people aren't so sick, the overall costs to the medical system prior to transplant will be less. AND if patients recover and re-enter their pre-illness work-a-day lives, society is the beneficiary. These facts are as true for liver transplantation as for any medical condition that is being treated on a regular basis. The issue of liver distribution and transplantation has occupied the professional community for almost two decades now. And the conclusion has always been the same: there is disparity in the distribution system for the sickest patients. And far too often UNOS has allowed this issue to move forward without the resolution that is required. Registration rates are a red herring, travel costs are a red herring, distance traveled to transport the organ from donor hospital to waiting list patient is a red herring. So the Liver and Intestine Committee and UNOS have an opportunity right now to fix this problem and begin the national healing process in the transplantation community. What are the salient points in making your decision? They are the mortality rate at each point of MELD and the variance in transplantation among MELD scores; i.e., how many more people die the higher their MELD score and how geography affects a patient's access to a liver transplant. You only need to consider these two factors and make your decision accordingly to find your way to this national action. And you will have met the requirements of eliminating geographic disparity and providing access to medical treatment for liver disease. In that light, Transplant Support Organization (TSO) is in favor of the 300/600 Acuity Circle with no MELD threshold. TSO is a patient-centered support group located in metropolitan New York City with several hundred names on our mailing lists. TSO has actively supported the cause for fair distribution of livers for several years now.

Lora Flowers | 10/28/2018

Yeah the policy is best to correct geographic differences, These disparities are artificial and the designers have refused to acknowledge the real difficulties and limitations facing the low-income rural and minority communities such as mine. Additionally this program does nothing to actually increased organ donation and may in fact in and reduce it in areas that are currently under performing. Finally the program will increase, and increased difficulty with patients and their families houses

Anonymous | 10/28/2018

Yeah the policy is best to correct geographic differences, These disparities are artificial and the designers have refused to acknowledge the real difficulties and limitations facing the low-income rural and minority communities such as mine. Additionally this program does nothing to actually increased organ donation and may in fact in and reduce it in areas that are currently under performing. Finally the program will increase costs and increase difficulty with patients and their families during the transplant process. Thankfully my uncle has received his liver transplant, but I worry he would have died if this program was enacted during his transplant.

Jean Flowwrs | 10/28/2018

Yeah the policy is best to correct geographic differences, These disparities are artificial and the designers have refused to acknowledge the real difficulties and limitations facing the low-income rural and minority communities such as mine. Additionally this program does nothing to actually increased organ donation and may in fact in and reduce it in areas that are currently under performing. Finally the program will increase costs and increase difficulty with patients and their families during the transplant process. Thankfully my uncle has received his liver transplant, but I worry he would have died if this program was enacted during his transplant.

Jeffrey Graham | 10/28/2018

Based upon the choices offered, I am in support of an Acuity Circle with 300/600 nautical miles and a MELD of 29. However, I do not believe that this goes far enough. I think that the primary reason for the proposal being offered is to bring UNOS into compliance with the portion of the Final Rule regarding allocation 'shall not be based on the candidate's place of residence or place of listing, except to the extent required'. While it is imperative to be in compliance, shouldn't the key focus be to save as many lives as possible? The 2017 Board approved proposal projected reducing the waitlist mortality count to 1386 from 1455 (supporting evidence slide as part of webinars). The current proposal offers replacing DSA's and Regions with the Broader 2 Circle approach. The waitlist mortality counts being considered, using this approach, are projected to be 1433 for a MELD of 35 and 1423 for a MELD of 32. Both of these are closer to the current allocation than what was approved last year and appear to be taking a step backward from the 2017 approved proposal. It is all well and good that the proposal is in compliance, but what about the lives being lost? Looking at the Acuity Circles it is evident that the lower the MELD threshold the more lives saved. So why have a MELD threshold at all? The same holds true for considering increasing the size of the circles. I understand that there are many other considerations, such as transport distance/time, % organs flown, additional costs, the disparity that certain cities in coastal areas may experience, etc. But these do not preclude the potential saving of more than 100 lives per year using the Acuity Circle model. As the recipient of a liver (22 years ago) I am looking at this purely from the patient perspective. Over that time I have sadly seen many liver candidates I knew deteriorate and eventually die for lack of a liver. When I was in business we always took the approach of 'okay we know what the problem is, what is the solution'? That holds true here as well. It is time for the UNITED Network for Organ Sharing to consider thinking out of the box and come up with solutions for the various obstacles that are preventing us from having an allocation system that is not only equitable for all patients, regardless of where they are, but that also saves as many lives as possible.

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/28/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process. Read the full proposal here: https://buff.ly/2JgZtFO

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Paige Ulcak | 10/28/2018

When 50% of the geographic region is made up of the ocean, it's going to decrease availability of organs to small, coastal regions. Focus should be made on increasing donations, not taking the donations away from areas.

Dawn Channer | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Cynthia Plasters | 10/28/2018

Please don't change the way organs are designated. It is unrealistic to expect our state to get them from the ocean.

Colin Purcell | 10/28/2018

I oppose both proposals.   Broader sharing will move livers out of areas like KY with higher waitlist mortality to states already much lower and increase costs incurred in the process of movement.   The data presented doesn't make sense in how it correlates fewer deaths while receiving less transplants.

Larry Lauersdorf | 10/28/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Clint Bowling | 10/28/2018

This is taking organs away from people in areas of economic hardship and in direct violation of final rule 121.8. I STRONGLY OPPOSE

Mike Smith | 10/28/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/28/2018

I strongly oppose both proposals

Anonymous | 10/28/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Robin Tomblin | 10/29/2018

Taking livers from rural areas is wrong....more people from these seas.wil! did awaiting for a transplant.....as a liver transplant survivor I would have died without having available oogan....it is morally wrong to take our livers and give them to  area with a large population who have access to a bountfulnumber organs

Anonymous | 10/29/2018

I strongly oppose both proposals. Broader sharing attempts to help patients in other geographical regions, but it will harm patients of disadvantaged socioeconomic status leading to higher mortality rates and longer wait times to donation. This is a violation of the Final Rule 121.4.  Broader sharing will also increase organ wasting as well as flying, travel times, and overall costs for the organ(s), which is a violation of Final Rule 121.8.  Broader sharing would attempt to help those areas and locations with low donation rates and hurt those with high donation rates. This does not fix the problem, but only spreads the problem out. If you want to fix the problem of low donation rates in different areas, fix the program by better training healthcare staff on discussion of organ donation with families.  Fix the culture of organ donation in areas of low donation, rather than steal organs from deserving individuals.

Anonymous | 10/29/2018

I strongly oppose both proposals

Anonymous | 10/29/2018

Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.

Annette Rebel | 10/29/2018

The apply the ethical principles on organ distribution (justice) - organs should be allocated by disease severity and distance. Therefore  i strongly oppose the new rules

Anonymous | 10/29/2018

I strongly OPPOSE both proposals.. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8 . The data presented in the models does not make sense. Despite significant number of livers leaving Kentucky, the waitlist mortality decreases.

Seth Karp | 10/29/2018

This is a deeply flawed proposal produced by a deeply flawed process marred by lack of clarity on the goals, misunderstanding of the law, and extreme conflict of interest.      1) UNOS has been unresponsive to the Final Rule mandate that organ policy 'shall seek to achieve the best use of donated organs' (121.8.2).  Without an outcome measure this is simply impossible.    2) UNOS has grossly misinterpreted the mandate that organ allocation 'promote patient access to transplantation' (121.8.5), and enact 'Policies that reduce inequities resulting from socioeconomic status, including... Reform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities (121.4.3.iv).  This clearly is not limited to patients on the waiting list but all patients.  UNOS efforts in promoting access to transplantation in underserved areas have not been consistent with the final rule mandate.  3) Even if we accept the UNOS definition that allocation policy should only refer to listed patients, how does the current policy deal with the currency higher waiting list mortality in the South versus New York and Minnesota?  The answer is it will make it worse.    4) The policy will decrease transplants due to increasing discards which is in direct opposition to the final rule provision to avoid wasting organs (121.8.5).  5) There remain major concerns around committee memberships, blacklisting, and lack of transparency around committee assignment.    6) Perhaps the most distressing aspect of the is process is UNOS own data around our country's organ donation potential and how this entire process has diverted resources away from increasing the organ supply to benefit all patients.      We need to get together again like we did in Miami 18 months ago in a meeting led by Stuart Sweet and put together a reasonable approach to this problem that recognizes the importance of the language of the entire instructions of the final rule and not the single line chosen by attorneys and lobbyists.    We need to consider real alternative that we have published including increasing minimum MELD for sharing, directed sharing, and state-based policies. 

Anonymous | 10/29/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Randy Trent  | 10/29/2018

Strongly oppose.

Tim Brendle  | 10/29/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts

Janice Galloway  | 10/29/2018

Since UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance, I do not agree with a 150/250 mile circle that is being proposed. A life is more valuable than the money that will is projected to be saved on airplanes used to deliver organs to recipients.    I STRONGLY oppose anything less than 250 mile circle because of the Gulf of Mexico and the lack of populated cities less than 150 miles from Houston.  Imposing this radius will greatly reduce the available donated livers.    Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Pas, and Fort Worth, which are currently available.  South Texas stands to lose approximately 130 donor livers/year within the Houston region.    Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplantation.    Houston and South Texas represent the largest population of patients waiting for transplants.    The average MELD score at time of transplant in Houston is over 30, which is higher than the national average, which means the need for organs is greater than in many other areas.    UNOS previously proposed a 250/500 circle for lung allocation, so the same rules should be applied for liver allocation.    The proposed 150/250 circle will benefit areas on the East Coast like New York, but will hurt places like Texas, California, and Florida.  Why would UNOS choose a model that hurts multiple regions?  Could a  model be put in place that takes into consideration the region?    UNOS should not choose a model that makes it harder for certain patients to receive a liver,merely based on where they live.      Any new rules implemented should increase the availability for organs in all regions, rather than decrease the availability.

University of Kentucky | 10/29/2018

I strongly oppose both proposals. These proposals will move livers away from rural and socioeconomically disadvantaged people, who live in KY and other states with large rural populations. KY has a higher waitlist mortality than states like NY and the mortality will increase if livers are taken away from our citizens. I have been told that this is a violation of Final Rule 121.4.  I have read it and it says you are supposed to reduce socioeconomic disadvantages, not add to them! Any changes in organ distribution must protect all citizens but should not exclude the poor and underserved populations in rural areas. The Transplant Centers that serve these populations must also be protected or these people will have no recourse.  As it is, we serve a large number of people from WV because they do not have a Liver Transplant program in their state. What will happen to them? They cannot afford to go to a big center, miles away from their home, for services. People who live in rural areas have been discriminated against in many ways over the years. Now UNOS wants to continue this practice. Changes in allocation will increase the mortality rate for liver disease and deaths on the waiting list will increase since there will be no hope and no treatment available.  Does that matter you any of you?  IT SHOULD.

Halley White | 10/29/2018

I strongly oppose both proposals. The people of Kentucky have lives that hold as much value as those in California and New York.

Anonymous | 10/29/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

James Fleming  | 10/29/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   Additionally, the proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals, despite a lower average MELD. These patients have poor access to healthcare, and these proposals will make it worse. OPTN is tasked with equitable organ allocation, and patients should not be denied organs because of their socioeconomic status or region of the country. While it is unfortunate that enough organs are not becoming available in the Northeast, I would suggest evaluating the variation in OPO performance. This is an inside job, and should not take organs from a sparingly populated region of the country to a densely populated region of the country. The number of organs available should be tightly tied to population, and any time that is not true, the real answer is to determine why it is not and rectify the situation, not take organs from regions that have spent considerable time and resources into maximizing their donor availability and OPO performance.  Finally, being a coastal transplant center, 50% of our donor area is the ocean, further limiting the organs available to our patients, as we are the only liver transplant center in the state.

Laura Ford | 10/29/2018

As a liver transplant social worker in Region 9, I strongly support the Acuity model. The most acute patients should have the greatest chance at receiving a liver, and not be limited by their geography. This is the fairest model.

John Entwistle | 10/29/2018

While this proposal is better than the current system in respecting the Final Rule, this increases equality more than equity. Patients in rural areas (or geographically isolated) will still have a smaller donor pool available to them than those in more densely populated areas. A population-based series of circles would honor equity better. A  potential recipients would have the same access to available organs. To counter the issue with long travel times (for example a patient in a geographically isolated area who has a population circle of 700 miles), priority points can be given for donors that are less than a given distance (say 500 miles, which is close to the value where a high percent of all livers are transplanted) from the recipient hospital to minimize the chance of disadvantaging these geographically isolated recipients even further.

Anonymous | 10/29/2018

Livers are a national resource.  Mothers, fathers, loved ones should not have to die simply because they do not have the resources to travel for a transplant.  Where one lives should not determine if they live or die.  Distribution of organs should be based on need. The sickest individuals should be cared for first.  I strongly support Acuity. It is the right thing for all families.

Kelcie Venden | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest. It's already hard enough on candidates and their loved ones to experience this horrible situation. Why would UNOS purposefully add to that pain by making this experience THAT much more difficult and heartbreaking? It's so disheartening and completely disgusting. It's the counter to what this organization's purpose is.

Anonymous | 10/29/2018

I strongly OPPOSE both proposals. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8.

Ramon Rodriguez| 10/29/2018

This proposed circle will cost lives, it is imperative that this be changed to a broader circle.

Nancy Hannon | 10/29/2018

I am a transplant patient.  Considering Houston Methodist's expertise and strong commitment to serve sicker patients that other centers reject, UNOS'  decision to drastically restrict the available organs is wrong and foolish.  Please reconsider.

Helen Carr| 10/29/2018

Oppose anything smaller than a 250 nmi circle.  Support the acuity 250+500  Sharing MELD threshold should be lowered to 29

Anonymous | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Kaitlyn Scott  | 10/29/2018

For patients in South Texas, anything less than a 150 mile circle is not in the best interest of the patients.  Consider larger circles, minimum of 250 nmi, lower MELD threshold to 29.

Anonymous  | 10/29/2018

We need nationwide distribution of organs equitably among transplant patients, where transplant patients live cannot be the basis for liver allocation. Distribution of organs over as broad a geographic area as feasible and can happen now with new technologies.  The Acuity model, while imperfect, is oriented in patient needs first.  In NYC where I received my liver transplant, I had to wait until I was at a 37 MELD to even be considered.  We need a better system.

Anonymous  | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest

Anonymous  | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Ed Carr  | 10/29/2018

This is very important to patients in South Texas, please reconsider proposal.  Consider minimum 250 nmile circle and a lower MELD sharing threshold to 29.

Susan Lerner  | 10/29/2018

bigger circles are better - the sickest should take priority -

Kelley Cantu  | 10/29/2018

Proposal for South Texas should be a minimum 250 mile radius for patients.  MELD sharing threshold should be lowered to 29.  South Texas has the highest number of patients waiting and the highest waitlist mortality.  A 150 mile restriction will increase deaths for patients waiting.

Baylor University Medical Center, BSW Health  | 10/29/2018

To whom it may interest:  Liver allocation should be based on what is best for the community and not being self-serving as we have seen in several comments made on the UNOS web site.   It must respect to people, donor families, communities, OPO's, hospitals what works diligently to increase organ donation. it must also take into consideration logistics and cost (monetary and operational/functional) of organ allocation. The health care financials are seriously stretched in the US already. there must also be sufficient number of aircraft and pilots to fly organs and teams around.   ever since i proposed concentric circles as the principal of liver allocation, I have heard comments about ' we poor ones living on the coasts with half of the circle is plain water, we would be suffering' - those who made such comments clearly have not fundamental understanding of history - humans have ever since the beginning of civilization settled along the sea and water ways. just take a look at a photo from space of our country during night and you will see the massive amount of light along the coasts, the great lakes and any major waterway. Programs situated along our coasts will NOT suffer. On the contrary.  Another problem is listing practices - some programs that complain, list patients seemingly with minimal work up with very high MELD scores. And those patients seems to be sitting there forever - a MELD over 35 still not transplanted after 90 days??? Just go in on the SRTR web site and it is obvious for anyone to see. The same centers do not seem to be aggressively using sub-optimal donors, older donors and DCD. You can find that a transplant center across the street or other side of town, does not show any of these behaviors. UNOS must implement oversight of listing practices for any wider sharing to be accepted.   I believe we should use the 150 miles proximity circle with 5 proximity points for recipients within. An outer circle of 400 miles. This will protect the areas where serious work to produce donors are protected, keep the logistics simple and financially sound and having the donor gifts benefit their home communities which i think is very important in spite of UNOS statements to the contrary.  It is completely unacceptable for some programs to see an increase of 30-40-50 % while receiving organs from other parts of the country who are working to make organ donations happen. And the windfall programs are often the ones in OPO's that are poorly productive.  Finally, the OPO's must be held accountable for their productivity. The transplants centers have been so ever siince UNOS was put in place. How come that several programs in the country have increased the number of donors 50-75-100->100 % over the last few years. While the complaining programs for the most part works with OPS that have not seen any improvement......  OPO's that do not meet productivity standards should loose their contract and be replaced by new OPO's that do. It is time for CMS and HHS to focus on this issue. If all OPO's in the US showed the same productivity we would not have this debate to begin with. And use a production figure that the OPO's can not manipulate as they are currently doing. Asking the OPO's to produce haw many eligible donors it had last year is like asking our tax payers to fill out their 1099 themselves - not much tax would be paid in the US. Us data routinely reported by hospitals such as number of ICU deaths per year within a OPO.   We need to bring this discussion down to essentials and stop attempts for Land Grabbing = Donor Grabbing by self serving institutions. We must be honest and consider what is practical.    Goran Klintmalm MD PhD  Chief and Chairman, Baylor Simmons Transplant Institute  Dallas Texas

Stela McMillan| 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Robin Sutliffe  | 10/29/2018

1. I strongly OPPOSE both proposals.   2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.   3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8   4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.   5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted

Anonymous  | 10/29/2018

The Acuity model more fairly distributes organs.  The Broader 2-circle violated NOTA law and should not be implemented.  Any MELD restriction above 15 is unfair and again Final Rule and NOTA.

Ron Shapiro| 10/29/2018

The Acuity proposal seems to be more of a 'sickest first' proposal, and this seems to be the best approach for liver transplant candidates. This has been the historic approach (at least from when I started in the field over 30 years ago), and has the potential to save the lives of the sickest patients.

Jonathan Fisher| 10/29/2018

As a transplant surgeon, I appreciate the difficulties in designing allocation models for organ distribution. Having served on several UNOS committees in the past, I also appreciate the time, effort, and commitment that has gone into developing new models for liver allocation. After careful review of the current proposals and as a transplant surgeon practicing in southern California, I feel the Acuity Circle Model is by far the best proposal currently being put forth. The current 58 DSA model has produced significant disparities in wait times nationwide. The wait times in parts of the country like Southern California are unacceptable while the times are so much shorter in other regions of the U.S. I see a disproportionate share of patients dying while waiting for a liver transplant as well as patients who have to become much sicker and suffer far worse sequellae of liver disease before they can receive a transplant simply because of where they live. Patients can travel to regions with shorting waiting times and list at additional transplant centers but this gives an unfair advantage to those who can afford it over those who cannot. I feel this situation shows we have much to do to work toward satisfying the Final Rule mandate of distributing organs over as broad a geographic area as feasible and in order of decreasing medical urgency. The Acuity Circle Model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Practicing in a region bordered with an ocean to the west and a national border to the south, I believe we need to extend the range of sharing as widely as possible. The minimal cost of flying more organs around can be saved transplanting a patient sooner. I urge you to please vote to adopt the Acuity Circle model for liver allocation.

Anonymous| 10/29/2018

strongly support both the acuity model for 250 miles and the lowest MELD score of 29

Roberto Hernandez| 10/29/2018

I believe that livers are a national resource, and any change to distribution should prioritize need for transplant. Acuity Circles has the greatest impact in reducing disparity in Median lab MELD at Transplant (MMaT) across the country. Additionally, there is little predicted change in cold ischemia times and it is difficult to assess how this will impact resource utilization with unknown changes in center behavior, and potential benefits in pre-transplant health care costs. The B2C model is not designed to transplant sickest first - it maintains geography as the primary driver for transplant and increases MMaT over the board approved model. As a center in an area of low population density that travels >150 nautical miles for the majority of our organs, our patients' access to transplant would be further limited with the B2C model, exacerbating our waitlist mortality.

Anonymous| 10/29/2018

I believe that we need to work to achieve greater equality for patients awaiting liver transplant. In the information I have reviewed the acuity circles appear to to a better job at reducing the MELD disparity. I think it will also be important to study the results and be able to make adjustments in order to ensure, to the best of our ability, that patients across the country have equal access to a chance at life.

Richard Flowerree | 10/29/2018

I strongly urge the adoption of the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many without the transplants we need

Anonymous | 10/29/2018

Hello Mr. Shepard and Members of the O.P.T.N., Liver allocation is currently unfair. Patients in some parts of the country, such as California, have to wait much longer and get much sicker before they can receive a liver transplant. Transplant for California Med-I-Cal patients is a deathbed last hope, not a planned procedure. California patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. A sicker recipient recovers slower and has greater chance of complications. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. People like me on Med-I-Cal cannot travel out of state for medical care. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will improve the quality of life for some patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. As a resident of California and someone with liver disease, this matter is of particular concern to me. It is unfair that I am at a disadvantage merely due to geographic location. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need.

CHI Baylor St.Luke's Medical Center | 10/29/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Anonymous | 10/29/2018

It's not Kentucky's fault that other places in the can't get their organ donations up. Do not punish Kentucky for their lack of success. Kentuckians are just as worthy.

Wanda Nicks | 10/29/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Harry Kanda | 10/29/2018

My brother-in-law is on the liver transplant list at Scripts in San Diego, CA. We know that liver allocations are currently unfair and that California has a harder time receiving donor livers. Please support the Acuity Circle model to improve the allocation procedure for implants. This is of concern to those of us who live in California and have loved ones on a liver transplant list. Thank you, Elizabeth Kaminaka, Arroyo Grande, CA.

UC San Diego Health | 10/29/2018

As one of the 13 liver transplant centers in California, we have a keen interest in ensuring that those in our service area receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. However, based on the current modeling for our area, we do not see a meaningful change in the median MELD at transplant for any of the proposed models. We do not support the proposed Broad Circle 2 model as the 150 nm sharing for MELD scores less than 32 will actually decrease organ availability for our patients from the current share 35 distribution model. We would support the Acuity Circles with 300 and 600 nautical miles distance to give patients the most access to livers access, despite fierce competition from other large nearby metropolitan areas. The national modeling shows that the variance between MELD scores decreases the most with this model, with modest increases in travel time and distance compared to the broad circle model. If the broad circle model is considered, we would support a MELD of 29 instead of a MELD of 32, and consider either increasing the nautical miles to 250 or MELD to 20 for the second circle. We believe that adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Kathleen Hall | 10/29/2018

My family's experience is that the liver allocation is currently unfair. My husband had to wait almost a year and many other patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. Because my husband had to wait so long he suffered more complications from his liver disease and could have very possibly died before he could get a liver transplant. I understand that patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait even though others may be much sicker than these. This gives an unfair advantage to those who can afford it over those who cannot. There should be broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. My husband and I are residents of California he was someone who suffered with liver disease, who has received a transplant, this matter is of particular concern to me.

John Vierling | 10/29/2018

I strongly favor implementation of acuity circles to serve the needs of all UNOS-listed patients in Region 4 for three key reasons. First, it would decrease the variability of MELD scores among potential recipients, achieving a new level of fairness in organ allocation. Second, it would increase the transplantation rate in Region 4 by increasing the number of livers procured for transplantation. Third, it would decrease the rate of mortality among candidates on the waiting list. All these positive outcomes are achievable with only a minor increase of 10 minutes in the cold ischemia time. In contrast, implementation of B2C 32 would harm patients on the waiting list in Region 4 because liver allocation would be determined by arbitrary circles and geographic boundaries. B2C 32 will disadvantage patients in Region 4 because a circle with a 150 radius is actually smaller than our current DSAs. It is unconscionable to consider implementing a system that would allow a liver offer to go to a patient with a MELD of 15 in Region 4 instead of to a patient with a MELD of 31 because of arbitrary geographic boundaries.

Thao Galvan | 10/29/2018

Using the modeling data that we have been provided, if the the Acuity Circles were to be put into place in Region 4 they would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the waitlist mortality rate while only increasing the cold ischemia time by approximately 10 minutes. In addition the Acuity Circles would continue to build upon the tremendous level of sharing that is already present in Region 4. We have for years been able to care for the sickest adult and pediatric patients first and have a very supportive and collaborative culture between the transplant centers. Conversely, if B2C 32 were to be put into place in Region 4 it would be a large step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers--totally antithetical to NOTA. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it--again, contradictory to NOTA. From a health care providers point of view it is just not acceptable to allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary. Additionally, the circles used for organ allocation must be larger in a state like Texas because of population density. One small circle does not fit the entire US and must be considered so that all patients have an equal opportunity to receive a liver allograft offer. We must spend more time/resources studying, identifying best practices and then supporting the OPOs. There are very large geographic variations in liver allograft procurement rates and this then leads to variations in transplantation.

Marie LaBlanc | 10/29/2018

My husband is a liver transplant recipient who received his transplant in Houston in 2015 after being turned down in Lafayette, LA. Houston saved his life. Creating 150 miles radius around Houston is not good for any patient.

Laura Durant | 10/29/2018

I am a liver transplant patient from Houston and know my liver came from Dallas. If the 150 mile radius happens, other patients may not be as fortunate as I was to have received a transplant.

Tom Durant | 10/29/2018

Persons in need of a donor organs should not have restrictions less than 250 miles. The sicker patients should get transplants.

Mark Orloff | 10/29/2018

The primary goal should be to reduce MELD disparity at transplant and ensure equal access to transplant irrespective of geography.

Gerald E. Baldwin | 10/29/2018

Aloha, For the past 23 years, my wife has been in slow decline from her autoimmune liver disease. As a resident of Hawaii, she has few options for transplant, the only cure. Hawaii has one, small transplant center that is not covered by our insurer. We've had to seek treatment on the mainland. She is currently listed for transplant at Scripps Green Hospital in La Jolla California. Unfortunately, in our more than two-decade journey we've discovered the unfairness in allocating livers across the United States. People are much sicker on the west coast before they qualify for transplant. Outcomes are poorer. Thus, those with resources travel to the southeast, where livers are transplanted in greater numbers. I've looked at proposals for change. I believe that the Acuity Circle model levels the field and provides the fairest way to allocate this precious resource. Best regards, Gerald E. Baldwin Hilo HI

Anonymous | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Anonymous | 10/29/2018

I strongly support as broad of sharing as possible. Many patients are dying in many areas due to need of organs, and broad sharing will help make the organ allocation more fair. I also strongly support as low of a MELD as possible for MELD sharing threshold. In addition, I oppose the proposed MELD exceptions of 'Median MELD at Transplant'. This will result in large numbers of exception patients sitting at one particular MELD score, which will prevent any patients below that MELD getting transplants. For instance, of MMaT is 29 in a particular area, then patients in that area will not be transplanted below that MELD with a medical MELD. Similarly, a different area may have MMaT of 22, which means that patients with medical MELDs in that area will have access to organs at a different MELD than the area with the HIGHER MMaT. This will in actuality continue to support the disparities of allocation MELDs in different areas.

Donor Network West | 10/29/2018

Donor Network West supports the 'acuity circles' model of liver distribution, based on the concept of distributing livers geographically to the sickest patient. The 'acuity circles' model has been demonstrated in the modeling to reduce mortality on the wait list by 1% (one patient per hundred), and to 'even out' the median MELD at transplant most fairly. We observe that patients in our area wait the longest and have the highest median MELD scores at transplant, and advocate reducing this disparity as much as possible. The 'acuity circles' accomplish this more equitably than the 'Broader 2 circles' model. We acknowledge that the acuity circles model comes with an increase in travel time of about 15 minutes and an increased distance of about 100 miles per liver, and that many more livers would travel by air rather than ground. Given this, we support a critical analysis of the OPO and center workflow and process of distributing livers that takes into account cost and team safety. The current model of 'sending a recovery team' by plane for increased distances does not seem sustainable with broader distribution. We advocate for 'local recovery' when possible and optimization of travel times.  To reduce disparity in acuity of illness, we support the acuity circles model.

Elizabeth Steadman| 10/29/2018

Organs should stay in the geographical location if there is a need for the organ and a transplant program.

Karen Dilbeck | 10/29/2018

My father was the 51st recipient of a liver at the MUSC.  I believe that was back in 1993.  Therefore, I have no idea what a MELD score is, nor what my father's was.  However, I do know that he received a LOCAL liver due to someone else's loss in the state of SC where he resided at the time.  My father was truly given the gift of LIFE...to be exact, SEVEN more years of life.  If that wasn't cool enough, my father-in-law (who resided in Atlanta, GA at the time) also was the recipient of a liver transplant (at Emory University) in 1996.  He was provided with EIGHTEEN additional years on this planet.  BOTH men received LOCAL livers while be attended to by their local doctors in their local hospitals.  The mere thoughts of sharing would have likely demeaned both my father and father-in-law to mere numbers on a page and not the patients of doctors who knew their names and their cases, thus helping to determine them as good candidates for the local livers that they received.  Aren't relationships of value?  Of course, the obvious answer is YES....if had not been YES back in 1993 and 1996, then my husband and I would not have had the joy have having both of our fathers, nor would their grandchildren have had their grandfathers.  Please, numbers are not the key.  Local doctors MUST have a say!  Local families need this!

Anonymous | 10/29/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Sherri Ranta | 10/29/2018

Don't punish people who need transplants because they don't live in a high density urban setting-especially when the donor also lives in a not urban setting.

Leslie Layman | 10/29/2018

Dear  OPTN, I believe the rules for allocating livers are currently unfair. Patients in California have to wait longer and get sicker before they can get a liver transplant.      Patients who have to wait longer often have to choose between temporarily moving to another state or suffering more complications from their liver disease and even dying before they can get a liver transplant.      Patients with a lot of money can get on lists in other states and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it.      We were told that if we go to a state that didn't have motorcycle laws the wait would be much shorter. That penalizes residents of California who have enacted laws that save many lives.      I support the proposals to allow broader sharing of livers and reduce the geographic disparities.      I believe the Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant.      I am a resident of California whose family member had liver disease and received a transplant, so this is of particular importance to me.    I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need.         Sincerely/Yours/Respectfully/etc.    Your Name

Anonymous | 10/29/2018

The committee should consider combining some the the regions rather than expanding the DSA. There are areas that are served at the maximum based on waitlist and donor numbers. This will likely just redistribute the overall shortage creating a more broad disparity rather than a concentrated disparity.

Myron Schwartz | 10/29/2018

The problem that underlies the mandate to change the allocation system is the disparity from location to location in waiting time. The Acuity 250+500 model goes a long way towards eliminating waiting time disparity; the B2C model, by contrast, does far less.

Anonymous | 10/29/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions like mine. The proposal does nothing to increase organ donation, and may actually decrease it. In addition to increasing costs this proposal will also add complexity to an already complex process. The patients needing transplants need barriers removed not created.

Tomoaki Kato | 10/29/2018

First of all I truly appreciate HHS secretary's since response and the Liver Intestine Committee's hard work to get this proposal up in a short period of time. I believe in broader sharing and equity. Opportunity for organ transplant should be as equal as possible regardless of where you live. In that sense, the Acuity Circle model best addresses the disparity. The B2C model may still be better than current DSA based model, but in some areas, it is less broader than the current model and would not fully address the disparity.   I also understand the argument that current disparity is not solely due to allocation system, but on OPO performance/willingness to donate in local area.  While all of us have to continue to work hard on increasing organ donation by raising awareness, patients who happen to live in the area should not be penalized by the poor performance of the OPO.

Anonymous | 10/29/2018

DSA first then move to 150/250/500 nautical miles. Eliminate regions entirely.   Also mandate allocation length process. OPO must allocate liver at least to sequence so and so

Anonymous | 10/29/2018

I feel a recipient in the area of the donor creates a more rapid transfer. The larger number of transplants done at a location equals more positive outcomes.

Hope Finley| 10/29/2018

Acuity Circles in Region 4 makes sense. They would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the waitlist mortality rate while only increasing the cold ischemia time by approximately 10 minutes. In addition the Acuity Circles would continue to build upon the tremendous level of sharing that is already present in Region 4. We have for years been able to care for the sickest adult and pediatric patients first and have a very supportive and collaborative mentality between the transplant centers. Conversely, if B2C 32 were to be put into place in Region 4 it would be a large step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. From a health care providers point of view it is just not acceptable to allow a patient with a MELD of 15

Anonymous | 10/29/2018

If I were able to be a donor candidate, I would stipulate that my organs would be given to people in my immediate area first if I they were a match. Only when there was no match locally and only then could my organs be shipped out to the regional area.

Anonymous | 10/29/2018

I feel the donor organ should remain local. If they expand the area less people are going to be willing to donate knowing they are not helping anyone locally. I have a son that needs a liver and it is wrong for him to be denied one while a possible match is being sent to west or east coast. They need to have a mission to recruit more donors on the coasts.

Anonymous | 10/29/2018

It is long past the time for regionalism......it is a type of tribalism.  Transplants should go for the sickest and neediest...regardless of the area.  People would actually want to save a local life over a life of someone who's needs are greater but might be further away?    Make sure to vote for legislation for more medical funds going to the ability to 'grow' organs to supplement human donors.  Make sure people sign up to be donors on their drivers licenses.  But also make sure those that have the greatest need are top of the lists for organ donations regardless of area.

Anonymous | 10/29/2018

Instead of penalizing areas that donate more, emphasis should be placed on informing and educating the East and West coasts. I will personally not be a donor if this is approved and will do my best to discourage others. I am an RN with a masters degree in nursing. Our huge population centers are on the coasts so why punish the midwest because the coasts are not willing to help their communities. Is this a power grab by the elitists on the coasts to disrespect the 'fly over ' states and take advantage of their generosity? I am personally appalled that this is even   Being considered.

Sally | 10/29/2018

As a member of the general public, a concerned citizen and an organ donor card holder, I wish to express that regionally donated organs should stay regional. Arbitrary 'circles' that break the defined regional state guidelines (that match insurance individual state boundaries, coincidentally) defy logic and fairness. Allowing local citizens to die while our region remains benevolent, by comparison, in donations not only defies logic, it smacks of usery. Frankly, I find the notion so revolting that I may consider changing my donation if common sense on this matter is ignored. At the very least, it will be impossible to encourage anyone to donate without a counterproductive caveat. And those conversations do occur in my life. I believe, passionately, in organ donorship but this conversation reminds me of science-fiction/horror literature and film whose subject matter is the diabolic results of weak, corrupt or merely niave but misguided decision-makers choosing the least path of resistance under pressure.    Not knowing nor, frankly, wishing to immerse myself in your various abbreviations and terminologies, still possibly clicking a radial button that supports anything other than what I've outlined above, I'll leave it to you provide that data.  I appreciate being informed of this situation and will be watching for the outcome.    Be well.

Anonymous | 10/29/2018

I am not a donor because I want my organs to support needs locally and you don't guarantee me that right to know they will go to a local recipient if one exists.

Malay Shah, MD, FACS | 10/30/2018

I am opposed to all proposals. My lengthier and formal comments will be forthcoming, but I would like to raise significant concerns I have about the data that has been released by UNOS on behalf of the SRTR to the public.

Waitlist mortality statistics as presented in these proposals are not factual. Typically, waitlist mortality is calculated to include patients who die on the waitlist AND those removed for being “too sick for transplant”. By including both groups in waitlist mortality, true mortality rates can be determined (and center specific waitlist removal practices can be leveled).

Unbeknownst to everyone, when these models were calculated, SRTR did NOT include patients who were removed for being “too sick for transplant”. Why this was done is unknown, but this raises major concerns about the entire process and accuracy of the data being given to physicians, patients and donor families. Why waitlist mortality was calculated in this way is in stark contrast to the way it is calculated in every other way. How else can a model predict 1-2 more deaths in a given area despite 30-40 FEWER transplants? It is an impossibility, and the exclusion of those who died after being removed from the waitlist can explain it.

This very fact of inaccurate waitlist mortality data arguably invalidates all proposed models, as well as all other proposals released/considered by UNOS that used such data. Were data in a peer-reviewed manuscript found to contain inaccurate data, the article would be retracted immediately with a statement from the Board of Editors. The community should ask if it is appropriate to consider a similar action plan in this situation. Our community, donor families and, most importantly, our patients, deserve the best.

Malay Shah, MD, FACS

Cedars-Sinai | 10/29/2018

Thomas M. Priselac, President and CEO

October 23, 2018

Brian Shepard, Chief Executive Officer, United Network for Organ Sharing, 700 North 4th Street Richmond, VA 23218

Via email: publiccomment@unos.org

Dear Mr. Shepard and Members of the OPTN:

On behalf of our patients and community, Cedars-Sinai is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model.

Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change.

As one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.

The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.

The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.

Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Sincerely, Thomas M. Priselac

Anonymous | 10/30/2018

As the wife of a transplant patient and a resident of California, I watched my husband get extremely ill many times before he received his liver transplant. I feel that the Acuity Circle model is the fairest, with a preference for a 300-600 model.  I personally know another patient that was able to move out of state to receive their transplant much sooner.  We did not have the means to do so.  It hardly seems fair that my husband had to wait longer and get much sicker before he got his transplant, just because we do not have the financial resources to move out of state.  His life is no less valuable just because we are rooted in California.

Anonymous | 10/29/2018

Currently I am a donor to support my community but if you are shipping my organs to someone outside my community I don't want to donate.  I want to help my neighbors not sacrifice them to send my help to areas with higher populations & lower donation rates.

Beth Allman| 10/30/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Teresa Bolen | 10/30/2018

Why can't an organ exchange be an option? For example this area is in receipt of a new liver that is not a match for a local recipient. We actually are in need of a heart. Another region has the organ we need and vice versa. Make a trade. Don't let people die because the new liver can be stored for later use.

Anonymous | 10/30/2018

As a patient who almost died waiting for a liver I would like to point out that patients in California have some of the longest waiting times in the United States.  Please give people a better chance.  I strongly believe that the Acuity Circle Model best serves to most fairly allocate livers.

Anonymous | 10/30/2018

1. UNOS analysis shows that the 250/500 mile circle provided the lowest mortatlity rate and the lowest variance. This should continue to go forth no matter the cost of saving on airplane transportation, etc.    2. While the proposed 150/250 mile circle will benefit areas on the East Coast like New York, it will drastically hurt places like Texas, California, and Florida where population is spread out. In Houston, where I reside, the Gulf of Mexico is within several hundred miles of the metro area which is why I am strongly opposed to anything less than a 250 mile circle. Implementing a 150 mile circle around South Texas will deprive patients form the organs in Lubbock, El Paso, and Fort Worth which patients currently have access to. This amounts to approximately 130 donor livers/year within the Houston region. Additionally, the average MELD score at time of transplant in Houston is 30+ which is greater than the national average indidcating the organ need being greater than the nation.

Robert Piedimonte | 10/30/2018

Communities need to step up to take care of their neighbors. People move to locations based on schools, outreach, and other compatible reasons. When there are large cities and mass populations on both the east and west coast, those areas need to be made aware of the needs to take care of one another in their region. Taking away from an area that gives to give it to an area that doesn't which has more population and gives less will cause people to pull back once again.

Anonymous | 10/30/2018

250/500 was recently proposed by UNOS for lung allocation, I strongly believe the same should be applied for liver allocation.    The proposed 150/250 mile circle will drastically hurt places like Texas, California, and Florida where population is spread out.     In Houston, where I reside, the Gulf of Mexico is within several hundred miles of the metro area which is why I am strongly opposed to anything less than a 250 mile circle. The average MELD score at time of transplant in Houston is 30+ which is greater than the national average indicating the organ need being greater than the nation.    Implementing a 150 mile circle around South Texas will deprive patients form the organs in Lubbock, El Paso, and Fort Worth which patients currently have access to. This amounts to approximately 130 donor livers/year within the Houston region.

Anonymous | 10/30/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/30/2018

The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.

Anonymous | 10/30/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.

Anonymous | 10/30/2018

I am in favor of broad sharing, however, I OPPOSE the proposals as written.    The current proposals are not in line with the final rule.  There is no effort made to address efficiency or allocation efforts that will increase transplants.  In fact my concern is that this will DECREASE numbers of transplants.      1. I agree that the allocation system should have some overlapping circle/overlapping boundaries to allow organs to move freely based on need.  2. I think efforts should be made to try to distribute organs to those that are sickest (in my opinion MELD 29).  3. However, I think MORE effort should be made to otherwise keep organs local at lower MELDS.  There is no need to tax the system when at the lower MELDS there is not the disparity.  4. If we are going to a broad sharing model, the regional review board should allocate the SAME MELD across the country.  The 'median MELD' concept only perpetuates disparity.  Why is one patient different based on geography?  (Sounds like a violation of final rule).  5. Organs fly for less than 150 miles.  When the 150 mile circle was picked, it was based on 'flying threshold'.  I think this concept is wrong.  You should model again with 75.  I suspect you will be surprised.      We can do better than this as a community.  I agree with sharing.  I agree with equality and equity.    I think we missed on this one.    Thank you to the UNOS Liver-Intestine committee for your volunteer work and efforts.

Anonymous | 10/30/2018

I support the Acuity Circle Model but find the proposed 150/250 mile circle far too restrictive for areas like Houston.  It would be more sensible to use the 250/500 or 300/600 circles for coastal cities that lose half of the circle to the Gulf of Mexico. If the 150/250 model works for most of the country, a variance should be created for Houston.

Anonymous | 10/30/2018

I strongly oppose this threat to the health of South Carolina liver transplant patients. Instead, I propose a state-based distribution framework.  We are an active transplant facility with very sick patients, many of whom are children.  Please don't take this away from us.

Anonymous | 10/30/2018

Houston, TX is one of the largest cities in the US and by definition will have more patients in need of a transplant.  To diminish the availability of organs to this significant population of people is in my view, a major disservice to major segment of people in need of a liver transplant.

Houston Methodist Hospital | 10/30/2018

MELD sharing threshold should be decreased to 29  We recommend larger fixed distances   We strongly oppose broader 2-Circle,   We strongly support Acuity 250 + 500. 

Anonymous | 10/30/2018

The pediatric considerations I think truly optimize this population.  80% of children on the pediatric liver wait list are transplanted with livers that come from donors under 18 years of age. Current allocation policy prioritizes adults locally over critically ill children nationally, leading to some adults being transplanted with livers from pediatric donors before that organ is ever offered to a child. The changes proposed will offer organs from pediatric donors first to children and adults at status 1A within a 500 nautical mile radius, and then to children adults at status 1A listed nationally and before being offered to adults listed with MELD/PELD status. LSAM modeling shows that this will translate into increased number of transplants for pediatric patients.  Where I am torn is that I know most of our organs in the current region, which is 11, for peds anyway at my center come from about 550 miles away, just short of the 500 NM radius.  I can keep studying the models, which were very thoughtfully done, but knowing our location and region, there are an extreme few donor hospitals that are within that 500NM to donate to us.  Rural areas typically don't have centers that donate. I just don't see any models done looking at that, and I am hoping that was considered.

Anonymous | 10/30/2018

People in the midwest take time to educate our children on the importanceof organ donation. My son's health class did a unit on this. People on the coasts need a public education campaign to increase donors, not take from other states who educate better. Organs travelling long distances may not be as healthy due to the delay and then an organ was wasted.

Jon Cooper | 10/30/2018

I applaud HRSA for taking action to make the country's organ distribution system legal. Substantial change is needed to bring distribution policy into compliance with the National Organ Transplant Act and its associated regulations. Medical need, not geography, should guide organ distribution policy. The Broader 2-Circle (B2C) proposal continues the practice of prioritizing geography over acuity and therefore I oppose it. The B2C proposal would continue to give priority to patients with lower MELD scores who happen to live closer to the donor hospital than those with greater medical need. Livers are a national resource and distribution should be broader than the B2C proposal allows, and should be based on need. Therefore, I support and ask UNOS to adopt the Acuity Circles (AC) framework. The AC framework could meaningfully impact the lives of many patients who are on waitlists.

William Richter | 10/30/2018

I have no additional feedback

Frank Kalb | 10/30/2018

* UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than saving lives? * We are strongly opposed to anything less than 250 mile circle because of the Gulf of Mexico limiting half the usable area, and lack of populated cities less than 150 miles from Houston. * Implementing a 150 mile circle around South Texas will deprive patients from organs in the Lubbock, El Paso, and Fort Worth to which we currently have access to. We stand to lose approximately 130 donor livers a year within the Houston region. *Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant. * Houston and South Texas represent the largest population of patients waiting for transplants. *The average MELD score at the time of transplant in Houston is over 30 which is higher than the national average, which means the need for organs is greater than in many other states. * UNOS previously proposed a 250/500 circle for lung allocation, so why are the same rules not applied to the liver allocation? * The proposed 150/250 circle will benefit areas on the East Coast like New York, but will hurt places like Texas, California, and Florida. Why would UNOS choose a model that hurts patients in multiple regions? * How is UNOS able to choose a model that make it harder for certain patients to get a liver just based on where they live? I thought the new rule was supposed to increase the availability for organs?

Anonymous | 10/30/2018

Organs should be distributed based on medical urgency, not geography. The Montefiore Einstein Center for Transplantation is one of the most active and successful programs in the country. Our liver transplant program is very aggressive about utilizing available organs, performing live donor liver transplants, donor after cardiac death (DCD) transplants, and offering Hepatitis C virus (HCV) infected organs to naïve recipients.      Despite our efforts, many of our listed patients are unable to receive life-saving transplantation in a timely fashion and die on the waiting list or become too sick to transplant and are delisted. Many others suffer significant declines in functional status and medical condition while waiting for organs, leading to prolonged and complicated recovery post-transplant. The goal of any new model should be to eliminate geographic disparities in Median Meld at Transplant (MMaT). This goal aligns with HRSA's July 31, 2018 letter to OPTN which reiterates that the National Organ Transplant Act (NOTA) requires OPTN to establish a 'nationwide distribution of organs equitably among transplant patients.' With that in mind, Montefiore strongly supports the Acuity Circles model.  Acuity Circles has the greatest impact on reducing disparity in MMAT across geographic areas, with a negligible difference in organ transport time of less than ¼ hour. Montefiore strongly opposes the B2C model as it is not designed to transplant sickest first and because it maintains geography as the primary driver for transplant, putting it in violation of the NOTA. B2C will only exacerbate the existing geographic disparity in New York State, narrowing the distribution of livers for patients with a MELD score of 31 and less. We do not support any MELD sharing threshold. Any restriction above 15 is unwarranted and contradicts NOTA and the Final Rule.

Anonymous | 10/30/2018

After review of your data and charts, it appears that the broader circle acuity model reduces waitlist mortality better than any other option. To adopt the smaller two circle model would equal death for many patients across the country, not just in areas like Houston. I strongly oppose the B2C model, especially with smaller circles and a higher MELD score. This model does not serve transplant recipients or donor families. The acuity model with 250 and 500nm circles is the only proposed model that increases access to available organs for patients with the highest need. I believe it is a disservice to the donor families to not make sure the organs go to those who need them most.

Anonymous | 10/30/2018

Why should the Midwest who has done an excellent job of educating the public about organ donation, be required to send their harvested organs to the east and west coasts who have not done such a great job.

Anonymous | 10/30/2018

I applaud HRSA for taking action to make the country's organ distribution system legal. Substantial change is needed to bring distribution policy into compliance with the National Organ Transplant Act and its associated regulations. Medical need, not geography, should guide organ distribution policy. The Broader 2-Circle (B2C) proposal continues the practice of prioritizing geography over acuity and therefore I oppose it. The B2C proposal would continue to give priority to patients with lower MELD scores who happen to live closer to the donor hospital than those with greater medical need. Livers are a national resource and distribution should be broader than the B2C proposal allows, and should be based on need. Therefore, I support and ask UNOS to adopt the Acuity Circles (AC) framework. The AC framework could meaningfully impact the lives of many patients who are on waitlists.

Mark Russo | 10/30/2018

I do not support the current redistribution policy nor the way it is being rushed to implementation. While the current system for distribution could be improved, it should not be at the expense of rural or under served populations. Nor should any proposal compromise sound science and be rushed through from the threat of a lawsuit. The redistribution proposal will adversely affect rural and vulnerable populations and those that experience challenges to access healthcare. We need to come together as a transplant community to thoughtfully develop a policy that finds balance between patients that live in metropolitan as well as rural areas. I appreciate all UNOS and the OPTN have done over the years for the transplant community and the current difficult position, but hope that a proposal is developed that benefits as many patients as possible.

Anonymous | 10/30/2018

People that are in the donor list expect the organs to stay local. We are going to have a decrease in donors if they know they are not staying local. The east and west coast need to be more proactive in recruiting donors for their area.

Anonymous | 10/30/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Deidra Johnson | 10/30/2018

It shouldn't be harder to get a second chance of life. Changing ways so it does put more stress on a already sick individual and does no one around that person any good. We should be keeping people alive and changing things so it gets worse, how is that a benefit? Being a family member of a liver recipient going on 13 extra years is incredible. I hope more recipients could experience that amount of extra living. Waiting lists should be shorter not longer. Boost more on the getting people to sign up/donate side rather than trying to change a well balanced regional map already.

Anonymous | 10/30/2018

People that are in the donor list expect the organs to stay local. We are going to have a decrease in donors if they know they are not staying local. The east and west coast need to be more proactive in recruiting donors for their area.

Anonymous | 10/30/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Medical University of South Carolina | 10/30/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/30/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/30/2018

I support the acuity model for 250 miles and the lowest MELD score of 29.

Anonymous | 10/30/2018

Based on my review the acuity 250+500 model provides transplant opportunity for the sickest and I feel it is fair and equitable thus far.

Medical University of South Carolina | 10/30/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  -Models predict that the net effect of the allocation proposal will move organs out of socioeconomically

Helina Selassie | 10/30/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care.  Instead, states with the best health care, including Medicaid expansion states, and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of the states with diminished access to healthcare.

Jeffrey Loveless | 10/30/2018

I am in San Diego,  I had a transplant in May 2010 . At the time I had hep c . My donor was from Montana.  I would have probably died had I not had the hep c which expanded my opportunity for donors . I was lucky , some of the patients that I met were at deaths door awaiting a donor from their geographic donor pool . It is only common sense to expand the base of available donors . Please save these people and let them have the same success that I have had since being saved .

Wendy Gomez | 10/30/2018

We applaud HRSA for finally taking action to make the country's organ distribution system legal.  We urge OPTN to adopt the acuity model as it will save more lives and get livers to those that need them most.  Our family member, Wilnelia Cruz recently died from liver disease.  She was one of the plaintiffs in the legal action that forced OPTN to review its liver distribution policy.  She was on the liver transplant list for nearly two years and had a MELD score that could have gotten her transplanted in many places in the United States.  Wilnelia was the unfortunate victim of a system that wrongly prioritized geography and we look forward to the system being fixed so all people have equal access to life saving organ transplants.

Gary Amelio | 10/30/2018

I respectfully ask that you adopt the Acuity Circle model for liver allocation. Liver allocation procedures are currently unfair to patients in some parts of the country who must wait longer and are sicker than those in other parts of the country. For example, I am advised that  I must wait longer in my current home area of southern California than some other areas of the country. I used to live in Pittsburgh on the east coast and my former home hospital actually advertises for liver transplants out in this TV market. Patients like me have to wait longer and have a greater chance of suffering more complications or dying before getting a transplant in my home area. I understand that OPTN has been working on different proposals to allow broader sharing of livers and reducing geographic disparities. The Acuity Circle model will improve the process of providing the most efficient use of limited resources and prevent discrimination against patients who reside in certain parts of the country. As a resident of southern California this matter is of particular concern. Thank you for the consideration.

Anonymous | 10/30/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts.  The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Ronald Young | 10/30/2018

I received a liver transplant 3 years ago. However I had waited years to get my transplant. During that waiting time I suffered with everyday complications. Constantly in and out of the emergency room!  Feeling and thinking I was going to die. The Organ Procurement and Transplant Network (OPTN) needs to change the disparities in allocating of organs and to reduce the geographic differences. As a resident of California and who has had a liver transplant this is of great concern to me. I have read over the Liver and Intestine Distribution using Distance from Donor Hospital. I would like for to consider and adopt the Acuity Circle Model for liver allocation.  This would be the fair and equitable those awaiting transplant. Thanks for your time.  Ron Young

Anonymous | 10/30/2018

The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

John Eaton | 10/30/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Anonymous | 10/30/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Anonymous | 10/30/2018

Distribution should be need based, we must help those who need livers the most since they are so scarce.

Robert Roth | 10/30/2018

I suggest UNOS consider the following considerations. The general population of a given area must be the most relevant factor in this discussion. Half a circle means nothing if the half circle equals ten full circles in the middle of the country. Moreover, UNOS needs to exam the statistics on a per capita basis of gross population to the number of donors generated by a given OPO. This ratio should dictate everything! If your OPO is subpar at obtaining donations, then a given area must press the OPO to simply be better at their job. If not, get a new OPO or allow for competitive OPO organizations in a given region. The answer to organ allocation should NEVER be to become a leach on an OPO or multiple OPOs that are successfully meeting their respective numbers. I firmly believe UNOS needs to be very careful with this matter concerning public appearances and/or correctness. I'm certain many individuals will reconsider their personal interests in donating organs if the primary recipients are not within their respective communities. Moreover, if a dynamic shift occurs in allocation resulting in fewer organs available in less dense areas of the USA, the middle of the USA, many of these states will seek to enact legislation to prevent such a distribution process. Endless lawsuits and no one wins beyond the lawyers. Lastly, an endless number of publications define cold time to be one of the most significant factors in achieving a successful transplant. Why would UNOS seek to jeopardize this key consideration by purposefully extending cold times and potentially decreasing the overall success rate of liver transplantation? A subsequent failure for all parties involved in the process!

Scripps Health | 10/30/2018

 October 29, 2018,  Brian Shepard, Chief Executive Officer, United Network for Org an Sharing, 700 North 4th Street  Richmon d, VA 23218.     Dear M r. Shepard:    I am writing today on behalf of Scripps Health. We are a nationally ranked, nonprofit, integrated health care delivery system with nearly 15,000 employees. Scripps has served the communities of San Diego, California for more than 125 years. Scripps established San Diego's first liver transplant program in 1990. Today, the transplant team at Scripps performs lifesaving liver transplants for people in Southern California and beyond. Our program has performed more than 750 transplant procedures at a rate of approximately 35 transplants per year . We have more than 70 patients on our waiting list, currently. Scripps is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to reduce the persistent geographic and economic disparities in access to liver transplantation. Scripps appreciates the committee's decade -long effort to implement the National Organ Transplant Act (NOTA) and its accompanying final rule to establish a 'nationwide distribution of organs equitably among transplant patients.'; Scripps Health supports a clinically appropriate, fair and equitable distribution of life-saving organs and strongly supports the Acuity Circle Model. Current liver allocation policies fall far short of meeting the final rule's mandate to ensure that the allocation of organs for transplantation 'shall not be based on the candidates' place of residence or place of listing.'ii Decades of discussion, deliberation and debate have yielded only modest progress, while many Americans - especially many Californians - wait in vain for access to this life-saving intervention . Unfortunately, the current liver allocation methodology's reliance on sharing organs within the current 58 local donation service areas (DSAs) is responsible for the disparities experienced across the country in liver transplantation, necessitating urgent change. Disparities in Access to Liver Transplants  Despite NOTA's enactment 32 years ago, requiring organ procurement organizations to allocate organs 'equitably among transplant patients according to established medical criteria,' liver allocation in the United States has been anything but equitable. Long after the final rule mandated that access to organs 'shall not be based on the candidate's place of residence or place of listing,'iii dramatic disparities remain -  a fact that even opponents of liver allocation reforms grudgingly acknowledge.    Listings for liver transplant currently vary 14-fold, while deaths due to liver disease vary 19-fold across  the current 11 United Network for Organ Sharing (UNOS) transplantation regions_ivv, c omparable  patients ' chances of receiving a transplant within 90 days range from 18 percent to 86 percent, depending on where they live or list.vi    A liver transplant recipient's likelihood of dying within a defined period of time if they do not receive a liver transplant is quantified using a risk-assessment metric known as the Model for End-Stage Liver Disease (MELD); scores range from six to 40. The higher the MELD score, the greater the risk of death. For candidates with MELD scores between 21 and 34, the probability of transplant within 90 days varies widely across organ procurement organizations (OPOs), ranging from under 30 percent in some regions to more than 90 percent elsewhere.';; Not surprisingly, both pre- and post-transplant mortality rates tend to be higher in regions where patients wait longer. For candidates from different regions, studies have found a three-fold variation in death rates of waiting list candidates, a 20-fold variation in transplant rates and 10-point differences in MELD score at the time of transplant.Viii A study of more than 100,000 patients on the liver transplant waiting list between May 8, 2003, and April 17, 2011, found that one-year mortality rates ranged from 34 percent to 60 percent across regions Y  These disparities particularly impact Californians , who face some of the most daunting barriers to liver transplantation. The median MELD score for Californians awaiting transplant is 33; for Southern Californians, it is 38 . At Scripps, the median MELD score is 31.5. Compare this to the national average of 24 - meaning, of course, that some regions have even lower average MELD scores. California transplants 27 liver patients per 100 patient years of waitlist time, versus the national average of 42 patients per 100 patient years of waitlist time. Some regions even transplant 228 patients, or nearly 10 times as many, over that same waitlist time! In short - compared to people in other parts of the county, Californians wait longer, receive transplants only when they are considerably sicker, and die at substantially higher rates while awaiting a transplant.  Scripps Health Agrees, Current Liver Allocation Policy Favors the Wealthy  At Scripps, a major concern is that the majority of our patients do not have the fiances to travel across the country to other centers for their transplant. The current allocation methodology incentivizes unintended consequences that further exacerbate inequities. For example, patients requiring liver transplants may register themselves at two or more transplant centers, a practice that reduces transplant wait time by increasing the chances of receiving a liver from a transplant center that has a shorter wait list and higher transplant rate. While this practice reduces average wait times by several months,xi it requires candidates to travel to appointments at multiple centers and to make themselves available immediately for transplant if an organ becomes available. This requires financial resources that many potential recipients simply do not have. As a result, candidates in the highest socio-economic status quartile are 70 percent more likely to travel to a non-local DSA than candidates in the lowest quartile .Xii Of all adult liver transplant candidates, only  2.3 percent listed themselves in more than one region between January 1, 2005, and December 31, 2011; these candidates were disproportionately male, white, non-diabetic, college educated and privately insured.x iii Further, recipients listed at multiple transplant centers who received a transplant outside of their area had significantly higher median incomes compared to patients who died  on the  waitlist -$84,946 versus $55,250.x vi A recent study reviewed the rate of multiple listing by candidates  waiting heart, lung, liver and kidney transplants and noted, among other things, that 6 percent of the 103,332 individuals awaiting a liver transplant were on more than one DSA list -  a cohort of patients  who were found to be wealthier and better insured than the singly listed candidates .vx Thus, not only  does the current methodology disadvantage potential recipients based on the accident of their geography, it demonstrates the impact of wealth on the ability to obtain necessary medical intervent ions.  Scripps Health Supports the Acuity Circle Model for Liver Allocation  The Acuity Circle (AC) model will improve quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing residency from dictating access to transplantation. The primary criticism of the AC is that travel time for organs will increase. However, adequately addressing the current gross disparities in organ distribution will inevitably mean more travel. Certainly, more travel will add to the initial cost of organ distribution - but the analysis included in this proposal does not account for the considerable savings gained by reducing the cost of caring for very sick patients with a high MELD score. Those savings could be realized by reducing the number of days a patient waiting for liver transplant has to stay in the intensive care unit, which far outweighs the cost of transportation. Further, a transplant center's financial benefit or loss should not be a consideration when developing the most fair and equitable policy for patients .  The AC scenario best achieves the goal of broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC scenario.Xvi  Scripps Health Supports a Lower M ELD Threshold for Broader Circle Distribution  The goal of removing the limitations of the DSAs can only be met if the sickest patients have the quickest access to compatible organs. The Broader 2-Circle (B2C) scenario recommended by the committee does not meet the standards promoted by NOTA, the final rule or the July 31 HRSA letter .xvii Further, the  MELD score bands must be narrow to ensure that the current disparities are addressed thoroughly.  Ideally, to most effectively reduce mortality rates, the MELD sharing threshold should be set at 25. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. HRSA correctly called for urgent action in its July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Scripps Health appreciates your consideration of this critical matter. Sincerely, Chris D. Van Gorder, FACHE, President and Chief Executive Officer

Susan | 10/30/2018

I strongly OPPOSE both proposals. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/30/2018

I strongly OPPOSE both proposals. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky) to states like New York, which have the lowest waitlist mortality. This is in violation of the Final Rule 121.4. Broader Sharing will lead to increased organ wastage, increased flying, and costs, which are all in violation of Final Rule 121.8. The data presented appears unclear. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths. This does not appear clear to me and causes me to question data provided. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural, and distribution scheme should have data that is properly vetted.

Boies Schiller Flexner, LLP | 10/30/2018

October 29, 2018,    Via Email:  Ms. Elizabeth Miller, J.D. UNOS,  Elizabeth.Miller@unos.org,  Public Comment Coordinator United Network for Organ Sharing, 700 North 4th Street,  Richmond, VA 23218,  publiccomment@.un os.org.    Re: Public Comment  OPTN/UNOS Liver and Intestine Transplantation Committee (' Committee') Liver and Intestine Distribution Using Distance from Donor Hospital Proposal.  Dear Ms. Miller:  The letter is being submitted in connection with the public comment for the Committee' s October 8, 2018 proposal titled Liver and Intestine Distribution Using Distance from Donor Hospital (' Proposal ' ). This public comment is being submitted on behalf of Plaintiffs in the pending action Cruz et. al. v. US. Dept. of Health and Human Serv. et. al. (SDNY l 8-CV- 06371-AT). As explained below, we oppose the Broader 2-Circle (B2C) framework because it violates NOTA and the Final Rule.  By contrast, the Acuity Circles (AC) framework set forth in the proposal, if properly implemented, can lead to meaningful change and bring OPTN policy into compliance with the law.  1. The OPTN's mandate, as set forth in NOTA and the Final Rule, is to develop a nationwide organ distribution system that allocates organs over as broad a geographic area as feasible in order of decreasing medical urgency. Geographic constraint has no role in a nationwide system except to the extent required to avoid the wasting of organs.  2. The B2C framework continues to prioritize candidates by geography instead of medical priority. B2C is a local-first distribution system that makes mere cosmetic changes to the current policy, which HHS made clear is inconsistent with the law. Under the B2C framework, a patient  with a MELD  score of 16 that  is 140 miles from  the donor hospital   is given  priority  over  a  patient  with  a MELD  score  of  31 who is only 15 miles further.  BOIES SC HILLER FLEXNER LLP,  333  Main Street. Armonk. NY. 10 5 0 4 I (t) 914 74 9 8 2 0 0 I (f ) 9 14 749   8 3 0 0 I www .bsfll p.com         B2C is particularly troubling given that the band of MELD 15 to 32 includes more than 40% of active waitlist candidates.  3. The purported broader sharing of 250nm for MELD 32 and above is also too small. Lungs share, in the first instance, to a range of 250nm yet they have a preservation time that is half of livers. The Committee has not presented any legitimate evidence to justify a sharing of 250nm instead of 500nm.    4. OPTN has long recognized variance in median MELD at transplant as the primary disparity metric. The current variance for patients with lab MELD scores (i.e., no exceptions) is a shocking 21 MELD points.  The AC 300+600 framework would reduce the variance by over 60% while the B2C frameworks would only reduce it  by approximately 30%.  5. The AC framework will have over 100 fewer waitlist deaths than the B2C framework. The goal of organ transplantation is to save lives. The AC framework saves more lives. Indeed, SRTR modeling shows the B2C framework is even worse than the December 2017 revised policy, which HHS found to be imp roper, as B2C would result in dozens of additional waitlist deaths. 6. The Committee appears to justify its recommendation for the local-first B2C framework by focusing on metrics that are either not meaningful or unreliable. In this regard we make the following observations:  • Transplant Count. The Committee focuses on transplant count while at the same time recognizing that transplant count data is not reliable because it 'does not account for changes in member behavior.'  Moreover, while focusing on transplant count it largely ignores the modeling that shows more than 100 less waitlist death  under  the  AC framework. An  optimized  system  that  saves  more lives with fewer transplants is preferable  to a system  that  does  more  transplants but results in more waitlist deaths . • Transport Metrics: The fact that donor livers travel farther under the B2C or AC framework is both expected and the goal of a nationwide distribution system. It means the system is working as it should and that livers are getting to those who need them most urgently on a nationwide basis. • Median Transport Time: The Committee recognizes that median transport time is relevant to considering the cold ischemia time of transplanted organs.  In this regard the data shows that, under the AC framework, a mere 6 to 12  minutes of  additional transport time can result in substantially lower median MELD at transplant and over 100 fewer waitlist deaths. This once again shows how a nationwide system - instead of the current local-first system - can and would save additional lives without a substantial increase in travel time.  7. Percent of Organs Flown: To support its recommendation, the Committee relies heavily on the purported increase in percent of organs flown as a proxy for increased cost. As an initial matter, neither NOTA nor the Final Rule provides for geographic limitations due to an increase in organs flown or increased cost. The Final Rule does provide for a system that promotes the efficient management of organ placement.  An organ distribution system is efficient when it gets organs to those who need them most and reduces waitlist deaths. Moreover, the metric of percent of organs flown is unreliable as it fails to account for changes in transplant center behavior and acceptance practice.  As noted by the Committee Chair, 'travel impact will not be as significant' and travel metrics are the 'hardest to be certain about.' The Committee rejects the benefits of the AC framework with increased benefits based on 'remarkably robust' data in favor of data that is unreliable, untested and likely wrong.  The misleading nature of this data is further underscored by the Committee's conclusion that 'increases in the need to flights could lead to an increase in organ offers that were unable to be accepted because flights or pilots were not available.'  Respectfully, there is no basis to conclude that there will not be sufficient flights or pilots to transport organs let alone to recommend an arbitrary geographic limitation based on this superficial analysis. Additionally, even if there are insufficient flights (for which there is no real evidence), the result will not be wasted organs but a change in transportation or acceptance practices. There is no basis for the Committee to assume that transplant professionals will act irrationally. As suggested by the Committee Chair, transplant professionals and practices will adapt to any new policy and travel impact will likely not be as significant as suggested.  8. Increased Cost: The Committee' s suggestion that an increase in organs flown ' represents a significant jump in costs of transportation for a transplant, and increased costs make the process less efficient' is incorrect. Even assuming that more organs do fly, that does not necessarily equate to greater cost. The very research relied upon by the Committee makes clear that any economic assessment of organ allocation policy must look at the overall costs and savings attributable to a policy - not simply one data input. That same study concludes that the increased cost of sharing organs is more than offset by lower overall medical costs. Alternatively stated, nationwide sharing of organs (as mandated by NOTA) saves money and saves lives and one cannot myopically look at only one cost metric.  The Committee relies heavily on the increase in percentage of organs flown  but  never actually quantifies what that additional cost may be, who  will  bear that cost or how that  cost may be mitigated or shared. Surprisingly, the Proposal also ignores the 2015 SRTR analysis , which modeled 28 different distribution scenarios and found that the 'projected differences in overall cost for transport and patient  care  among  the 28 scenarios  tested  were small' with 'only about a 2% difference between the most expensive and least expensive   options '   before accounting  for  additional  cost   reductions   resulting  from changes in acceptance behaviors. That same analysis showed  that  even  focusing  on just  the increased transport cost metric (which  would  be  economically  irrational),  the additional transport cost of the AC framework would be less than 1% of the overall transplant cost per year and that this cost would be more than offset by cost savings from having patients transplanted earlier - let alone the numerous lives that  would  be saved under the AC  framework.  Finally, the Committee's recommendation, reasoning and lack of unanimity suggests the Committee is not of one mind in its proposal.  This  concern  is  heightened  by  the  fact  that Committee's composition is weighted in favor of  Regions  that  are  benefited  by  the  local- first  system, have below average median MELD at transplant  and  have  fewer  waitlist candidates.  For example, Regions 1, 2, 4, 5, 7, and 9  have  over  68%  of  the  nation's  waitlist candidates  but  have less than 50% of the  Committee  votes.  Similarly,  Region 8, has nearly  20% of the Committee votes but only 6% of the waitlist candidates and transplants. While the lopsided and provincial composition of the Committee may explain the difficulty in formulating a new policy, it does  not justify a policy that is inconsistent with the Final Rule or one that does not make meaningful change to the  current,  illegal  distribution framework. As HHS noted in its July 31 directive , 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final  rule. '    Motty Shulman

Anonymous | 10/30/2018

I strongly OPPOSE both proposals.

Anonymous | 10/30/2018

Specifically, I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall.  It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/30/2018

Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality.

Anonymous | 10/30/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8  4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results.  5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/30/2018

Specifically, I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally

Anonymous | 10/30/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Houston Methodist Transplant Center | 10/30/2018

Texas is a large land mass state but has only small pockets of large population centers. These large population centers are well over 150 miles from one another (range is 171-647 miles from Houston). By restricting the local allocation of donor livers to a circle of less than 250 nmi, there is a high likelihood that sick patients with higher melds will be disadvantaged and that organs will go to waste as the volume of patients waiting in our region (TXGC) is 2 1/2 - 3 times as large as the other regions in Texas. This would be a disservice to the candidates who are waiting as well as to the OPO's that will have to manage this. I strongly urge you to reconsider this decision to change the organ distribution area.

Yolanda Murray | 10/30/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Patricia Watson | 10/30/2018

I strongly oppose both proposals.  Broader sharing means moving potential organs out of socioeconomically disadvantaged areas (away from my community), places with a higher waitlist mortality and putting them in areas with a lower waitlist mortality. It increases cost of organ transportation as well as cold time. I don't believe this serves the goals of the transplant mission and from what I have read it violates UNOS rules.  Please do not approve this model!

Claudette Campbell | 10/30/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

University of Texas Medical Branch Galveston | 10/30/2018

The model we support is the AC 250+500 model with a sharing MELD 29. As mentioned during the recent Region 4 update, modeling data demonstrates a lower mortality with a minimal increase in transportation time of 10 minutes with this model. Additionally, it is important to note that few transplant centers are as isolated on the gulf coast than our transplant center. As such, we would advocate that UNOS develop a comprehensive population based model that equalizes access to donors. One suggestion we have is to target clusters of transplant centers that are within 50 nautical miles of each other across the country. Those clusters will then draw from the same population of donors at 250/500 from the center of that cluster. Coverage areas would vary across the country but would be equitable from a donor perspective. When one looks at modeling, our transplant center loses out on a significant donor population along the I35 corridor in central Texas in addition to a significant donor population in the Dallas/Ft. Worth area. These areas are included in the Houston coverage area however. This will most definitely result in a donor pool discrepancy and decreased organ sharing despite our close proximity to the Houston Medical Center. We support any model that decreases mortality and increases access to save more lives.

Andrew Civitello | 10/30/2018

If the the Acuity Circles were to be put into place in Region 4 they would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the waitlist mortality rate while only slightly increasing cold ischemia time. However, if B2C 32 were to be put into place in Region 4 it would be a huge step backwards, allowing geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact increases it. It is simply not acceptable to allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.  Thank you

Baylor St. Luke's Medical Center | 10/30/2018

If acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes. If B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Anonymous | 10/30/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall.  It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/30/2018

I support B2C

Houston Methodist Hospital, JC Walter Jr Transplant Center | 10/30/2018

Commenting here for the benefit of our transplant pts and advocating on their behalf.

Anonymous | 10/30/2018

B2C is a good compromise given the organ shortage. Until more organs are available, there will be patients that lose no matter what model is implemented. It makes sense to prioritize by MELD, keeping in mind small # differences do not have clinical significance. But let's not forget distance can matter in vulnerable livers at highest risk of cold ischemic injury (older donors or DCD). These should stay locally-what's the point of sending them away if ischemic injury will give poorer results? Thank you.

Anonymous | 10/30/2018

Dear Mr. Shepard/Members of the OPTN, This is to urge you to vote for and adopt the Acuity Circle Model for liver allocation. Of the various models the Committee has considered the Acuity Circle Model prioritizes the most efficient placement among candidates and allows candidates who are further away to have increased and more timely access to livers. Liver allocation is currently unfair. Patients in California have to wait much longer to receive a liver transplant. Please reduce the geographic disparities and vote to adopt the Acuity Circle Model which will provide the best and most efficient use of limited liver resources. Thank you.

Anonymous | 10/30/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall.  It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/30/2018

Most importantly, It does not increase the total number of transplants that will happen in the country. That is what solutions that are proposed should actually be concentrating on. With Healthcare costs rising fast, flying more and longer will only exacerbate the already high costs. This also does not seem to consider the risk of times in transport to the more sensitive organs.  There are areas with extremely low donor enrollments and conversions that need to be fixed and done immediately. We need to have improvement to the procurement organizations & facilities. This just seems to be aiming at a target that will increase the problems that healthcare already faces.

Anonymous | 10/30/2018

I support the B2C 35 model

Anonymous | 10/30/2018

High performing OPOs that serve lower socioeconomic demographics should not have their patients suffer to serve lower performing OPOs. The higher costs of transplants, the increased waste of organs just makes no sense.

Jessica Schnable | 10/30/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.  The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many states than New York or Massachusetts, yet organs will flow out of these states and organs will flow into New York and Massachusetts. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, many states have 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts

Anonymous | 10/30/2018

Specifically, I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Joseph Odin | 10/30/2018

We should adopt the Salvation Army's slogan 'Doing the Most Good'. Sharing organs as widely as possible based on patient need, not geography, qualifies as doing the most good.

Studies in Pediatric Liver Transplantation | 10/30/2018

Studies in Pediatric Liver Transplantation (SPLIT) represents the majority of pediatric liver transplant centers in the United States. SPLIT has repeatedly advocated for the rights and lives of children on the liver transplant wait list. The members of SPLIT commend the efforts of the OPTN/UNOS Liver Committee to prioritize children on the liver wait list for deceased donor pediatric livers. 80% of children on the pediatric liver wait list are transplanted with livers that come from donors under 18 years of age. Current allocation policy prioritizes adults locally over critically ill children nationally, leading to some adults being transplanted with livers from pediatric donors before that organ is ever offered to a child. The changes proposed in the most recent Public Comment Proposal 'Liver and Intestine Distribution Using Distance from Donor Hospital' will offer organs from pediatric donors first to children and adults at status 1A/1B within a 500 nautical mile radius, then to children and adults at status 1A/1B listed nationally, and then to all children listed nationally before being offered to any adults listed with a MELD score. LSAM modeling shows that this will translate into an increased number of transplants for pediatric patients. Pediatric centers as a whole typically travel further for livers, so the increased distance travelled seen in the modeling is less relevant to our patients. We believe it is appropriate as proposed not to place a cap on PELD exception scores, given recent evidence showing that the PELD score underestimates risk of mortality for children in comparison to the MELD score for adults. SPLIT urges the UNOS Board to consider the fate of children on the liver wait list when evaluating this proposal. Executive Council of SPLIT, Vicky Ng, MD; Beau Kelly, MD; Simon Horslen, MBCHB; George Mazariegos, MD; SPLIT Advocacy Chair, Evelyn Hsu, MD

Anonymous | 10/30/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care including Medicaid expansion states and the highest waiting list rates will benefit the most from these proposals at the expense of the residents of states with diminished access to healthcare.

Anonymous | 10/30/2018

The OPTN was given a mandate to improve equity and put a lot of work into revising the existing system in a manner based on evidence, and balancing the elimination of arbitrary geographical advantages/disadvantages vs. excessive increase in costs and storage times with minimal increase in 'fairness'.  Liver availability is multifactorial, and is dependent on center/surgeon practices as much as geography and allocation algorithms.  I know, I have done many transplants using organs declined by all centers from the regions claiming that the system disadvantages their patients. I favor the B2C option as it improves equity and preserves total transplants done without an extraordinary increase in proportion of organs requiring charter air transport.  Also, any such changes should be subject to ongoing review and adjustment, obviating the rationale for drastic changes in a single step.

Zakiyah Kadry | 10/30/2018

As a transplant professional I am very concerned by the push to quickly proceed with major changes in our liver allocation policies based on legal interventions.  I think this sets a very poor precedent as we are not setting policies in a step wise scientifically studied fashion. Medical best practices are driven by prospective and supporting data.  Transplant seems to be at this point the only specialty that is making decisions based on unproven statistical modeling proposals.  There is a huge difference between looking at numbers and statistical analysis, versus affecting patient lives who have to live or survive by these policies. In my opinion, we have to get it right the first time and the heart of the issue is the geographic disparity in the organ donation rates across the country.  In the presentations by the liver committee, waiting list deaths are described as being reduced by the broader sharing proposals:  acuity models and broader 2 circles.  The reality however is that we are actually describing a redistribution of waiting list mortality based on re-allocation proposals for a limited resource.  Those areas of the country who had better access to organs due to excellent donation rates and strong OPO performance are going to see higher wait list deaths, a lower ability to access organs and absolutely no positive reinforcement for their efforts in improving organ donation rates.  In fact the neither the liver or geographic committee is taking action to improve overall liver organ donation or OPO performance.  Additionally, if policies are being made based on legal action by one group, it is predictable that we will be following a slippery slope:  after all, what would prevent newly disenfranchised populations negatively impacted by the new polices to proceed in the same fashion?  This sets a bad precedent for our community and our specialty.  In terms of the proposals put forward by the liver committee, I also have the following concerns:    a. I do not think we should have wider sharing for lower MELD scores.  I am not for the acuity circles or for the concentric circle sharing, however, if I had to decide on a MELD score for sharing with the concentric circles, I would set the limit at a MELD of 35.  The reason for this relates to MELD exceptions.  A decision was made to propose broader sharing based on allocation MELD and not calculated MELD.  This means that MELD exceptions will be added to the mix.  MELD exceptions will be set by the median MELD of a transplant center.  Many of the hospitals in New York State have traditionally been liberal with MELD exceptions and have set them much higher than other institutions.  A lower MELD limit for sharing will lead to a higher proportion of organs being transported long distances for less sick patients with MELD exceptions.    b. I believe median MELD for MELD exceptions should not be based on the median MELD at transplant centers but rather median MELD of area of organ distribution. This will avoid the center disparities within the same area of distribution, whatever the final nautical mile allocation distance that is decided upon.  c. The previous proposal of maintaining DCD and 70 year old liver organs locally was better than the current proposals.  It would allow centers to utilize these organs more efficiently with a minimum of cold ischemia time.  Wide distributions over 150 to 500 nautical miles will place a huge burden on OPOs who are trying to place these organs expeditiously and this increased allocation distance will increase their work with centers to place them.  The longer distances and cold ischemia times will also promote greater discard rates of these organs.  d. I am also concerned that there will be not only a higher discard rate of organs due to longer travel distances involved, but there could also be a higher proportion of organs being utilized outside the allocation system (as open offers) given the distances involved with back up patients being too far to accept an organ that cannot ultimately be used at the primary center.  I think if we proceed with any of these proposals, this data will need to be carefully tracked to see how many organs are transplanted as allocated.  Finally, I am very concerned at the way these policy proposals are being pushed quickly forward without taking into account the concerns voiced by so many in the transplant community.  We need to be more balanced and thoughtful in these decisions that are going to impact patient lives so significantly.  I am also very perplexed as to why organ donation and OPO performance are not being examined in more detail?  Geographic disparity in organ donation and limited numbers of liver organs are after all at the root of these redistribution proposals and heated discussions.  Why are we not addressing the issue of geographic disparity in organ donation first before proceeding with an analysis and drastic change in our allocation policies...

Anonymous | 10/30/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/30/2018

 Dear Mr. Shepard / Members of the OPTN, Liver allocation is currently unfair. Patients in California have to wait much longer and get much sicker before they can receive a liver transplant. This was painfully true in my husbands case. My husband never fully recovered after transplant. He continued to suffer with blood Clots in his lungs, heart attach etc. and having waited so long to get a liver, the damage from ammonia to his brain while waiting on the list in California never really cleared after surgery. Those with money can 'pay to play' by buying their way on to shorter wait lists in different states The Acuity Circle model will improve the possibility of a liver transplant recipient successfully enduring the wait and preventing a possible tragic final outcome.. My experience as my husband's care giver watching him go through such a long period of illness before transplant because of the way California allocation currently works was devastating and unnecessary for my husband and for me. I know that there is a better way to serve those with lever disease awaiting transplant. We must do better. Please vote to adopt the Acuity Circle model for liver allocation. The current broken system ended my husbands life prematurely and has left me a widow.. Sincerely,

Amy Scarpitta | 10/30/2018

I think that organs should be available to recipients who live in the community in which it was donated. Also, increasing the distance that organs travel before transplant will decrease a patient's chance of survival.

Tyler Tunic | 10/30/2018

UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than the lives being saved? Anything less than a 250 mile circle is STRONGLY opposed because of the Gulf of Mexico and lack of populated cities less than 150 miles from Houston, TX. Implementing a 150 mile circle around South Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which Houston Methodist patients currently have access to. Houston Methodist would stand to lose approximately 130 donor livers a year. Imposing the 150 mile circle will increase wait time for transplantation and ultimately increase the death rates while waiting for that transplant. Houston and South Texas represent the LARGEST population of patients waiting for transplants. The average MELD score at time of transplantation in Houston is OVER 30 which is higher than the national average, which means the need for organs is far greater here than in many other areas. The 150/250 circle will benefit areas on the East Coast like New York but hurts Texas, California, and Florida. Why would UNOS choose a model that hurts multiple regions? Especially in an area where the need is greatest.

Beatrice Borrego | 10/30/2018

The liver allocation seems to be unfair, in particular in the State of California. Due to the large number of people who are donor recipients in our State, we are asked to wait much longer and have a much higher Meld score in order to receive a liver. I have had cirrhosis for the last six years, and because of the wait, I now am in need of a kidney as well. I have been on the waiting list for a liver and kidney for almost three years now and am losing hope. My numbers are so low on my kidneys that I now need dialysis. I know that the Organ Procurement and Transplant Network Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will certainly improve the quality of life for most patients producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. As a resident of California and someone who needs and liver and a kidney transplant, this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver and kidney allocation. Failing to do so is severely unfair and leaves many of us to suffer in pain, facing death. Please, please think this over very carefully and think of all those patients you would be helping, including myself. Thank you in advance, Beatrice Borrego

Anonymous | 10/30/2018

The acuity circles will likely change from the current state to where 75% of livers from Louisiana will be exported outside of Louisiana and the region.

Karim | 10/30/2018

I strongly oppose both proposals. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural.

Anonymous | 10/30/2018

I strongly OPPOSE both proposals. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality

Anonymous | 10/30/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many states than New York or Massachusetts, yet organs will flow out of these states and organs will flow into New York and Massachusetts.  Also, the proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Macy Godman | 10/30/2018

Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8

Jim Wetzel | 10/30/2018

I am disappointed with both of the proposals being considered.  My wife recently passed away without being able to get a liver transplant.  I don't believe either of this proposals adequately address the requirements that they should NOT be based on place of residence , etc.  Having a small circle is in direct violation of that requirement.  I am also very aware of what happens to a person as their MELD score goes up.  I support a lower MELD score of 29 or even lower if possible.  We should be enabling patients to be transplanted as early as possible so they have the best outcomes.  It seems that much of the analysis was cost driven instead of patient and mortality driven.  Saving your spouse is more important than a plane ticket.  With all of the technology and brilliance in this space, I don't understand why population based analysis was not done.  This seems like a hasty move to go forward without it.   Lastly, go Hawaii.  Sounds like that is the place to be for an O blood type. I don't understand why Puerto Rico would not be allowed the same policy.

Eric Fickessen | 10/30/2018

I am strongly against the change to the Broader 2-Circle. This would penalize pre-transplant liver patients in the greater Houston area limiting their access to viable organs. Much of this proposed circle is in the Gulf of Mexico which is is simply unfair to this region. The MELD score also needs to be lowered to 29. My wife had numerous liver-related underlying issues which which masked how truly sick she was, though her MELD score alone did not reach the the necessary score. I believe the Acuity 250+500 is the fairest way to go.

Anonymous | 10/30/2018

* UNOS analysis shows that the 250/500 mile circle provided the lowest mortality rate and the lowest variance. WHY was a 150/250 mile circle proposed? Is saving money on airplanes used to deliver procured organs more important than saving lives? * We are strongly opposed to anything less than 250 mile circle because of the Gulf of Mexico limiting half the usable area, and lack of populated cities less than 150 miles from Houston. * Implementing a 150 mile circle around South Texas will deprive patients from organs in the Lubbock, El Paso, and Fort Worth to which we currently have access to. We stand to lose approximately 130 donor livers a year within the Houston region. *Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant. * Houston and South Texas represent the largest population of patients waiting for transplants. *The average MELD score at the time of transplant in Houston is over 30 which is higher than the national average, which means the need for organs is greater than in many other states. * UNOS previously proposed a 250/500 circle for lung allocation, so why are the same rules not applied to the liver allocation? * The proposed 150/250 circle will benefit areas on the East Coast like New York, but will hurt places like Texas, California, and Florida. Why would UNOS choose a model that hurts patients in multiple regions? * How is UNOS able to choose a model that make it harder for certain patients to get a liver just based on where they live? I thought the new rule was supposed to increase the availability for organs?

Malay Shah | 10/30/2018

I had previously constructed a very different public comment based on specific topics, data, etc. Fortunately, there are many smarter colleagues of mine that can more eloquently talk about those things. I have decided to provide a public comment from my heart, driven by passion and emotion.  I STRONGLY OPPOSE BOTH PROPOSALS. I find it both amusing and concerning that supporters of broader sharing constantly state that opponents of broader sharing are self-serving, as well as driven by greed and finances. I am unable to contain myself at the hypocrisy of those statements. When I look at the supporters of broader sharing, the vast majority of these individuals/groups:   1. Come from largely urban and metropolitan parts of the country.  2. Represent patients who are well resourced, with excellent access to healthcare and transplant benefits.  3. Stand to gain everything by broader sharing, taking livers away from other communities, while leaving a broad swath of the population of the country at risk of increased death from liver disease.   Therefore, the suggestion that opponents of broader sharing (people like myself) are greedy and selfish are unfounded and those types of statements need to be dropped from the conversation.  There has been no greater disappointment in my career to date than to witness what is going on in transplantation throughout this country. And despite me only being an attending surgeon since 2011, I have been involved in transplant since 1994, so my viewpoints come from a long-standing experience in many different capacities in the last 20+ years. I remember giving a plenary session talk at the ASTP in 1998 comparing Sandimmune and Neoral. I remember doing retrospective analysis of outcomes of OKT3 and mALG induction therapy. Not once do I remember such a lack of collegiality and vitriol in the entire transplant community towards each other.  To the UNOS Board of Directors: I ask you, what is someone like me supposed to think when witnessing and participating in a process like this? Where the greed and selfishness of a few has resulted litigation and detrimental policy 'development'. Where the optics appear to suggest that the leadership structure of an organization that should represent the entire transplant community is slanted towards certain well-resources areas of the country? Where the voices of the many are not heard? Where the rights of patients in rural and socioeconomically deprived areas are not considered? Where modelling is done that demonstrates significant organs leaving a given area, but simultaneously shows a decrease in waitlist mortality in that same area? And then to find out that SRTR has calculated waitlist mortality in a way not consistent with the accepted methodology? To find out that patients who were removed from the waitlist for 'being too sick for transplant' were EXCLUDED from the waitlist mortality calculations, which is in stark contrast to how waitlist mortality is typically assessed (which includes those who died on the list AND those who died after being removed from the list). And then to find out that no one on the LI committee was even notified of this variance/deviation? And to find out that the data was not even vetted by the experts? What is the action plan for re-analyzing the data, considering that waitlist mortality statistics were not calculated using the accepted methodology? Are there plans to remove the current proposals until the data is re-examined? What am I to tell my patients, who die at lower MELD scores than folks on the coasts, what to expect when their life saving liver is not coming? Am I to tell them that some person on the east coast got their liver because they were supposedly sicker?  To the UNOS Board of Directors: I put my 10 year old son through a simple mathematics exercise about 4 people, 2 in KY and 2 in NY, waiting for a liver. 2 people in KY got a liver, 1 in NY. I asked what happened and he told me that the other person in NY died. I then asked him if 2 people in NY got a transplant because 1 liver left KY, what happened to the other person in KY? He quickly said that the other person in KY died. I realize that my son is quite good in math, but this math isn't hard for him. He didn't even begin to think that the other person KY somehow lived despite not receiving a transplant. So I ask, how is it that a 10 year old knows that in a zero-sum game, someone has to die, but the expert data analysts think that somehow waitlist mortality decreases?  To the UNOS Board of Directors: as a community, how are we to respond and progress in a satisfactory manner when harsh terminology and verbiage is used? There have been a few supporters of broader sharing (certainly just a handful of people and not the majority) that have used terms such as 'Confederate' and 'tribalism' to describe opponents of broader sharing. And at national meetings, there has been individuals referring to the hard work of those opposed to broader sharing as 'Fake News'. These types of terms and verbiage have no place in the conversation and should certainly not be championed. We should not be resorting to political and media terminology, nor insults, to demean one side or the other.    People can say what they want about me. They can say that I'm brash. That I'm not sophisticated. That I'm not a scientist. That I'm prone to drama and conspiracy theories. And at the end of everything everyone wants to think of me as, they had better add that I'm a patient care advocate, I'm passionate, I'm a good surgeon, I'm a good doctor, I'm principled, I'm a family man, and I'm a role model. I will not allow my patients to suffer injustices due to greed. I will not allow for the generosity of our organ donors and their families in Kentucky and West Virginia to not help local patients while only helping those residing in communities that have poor donation. I will not allow for rural and socioeconomically disadvantaged patients in Kentucky, West Virginia, and many other states like mine, to pay the ultimate price. These are great people here. They have every right to live as anyone else in the country.  On my deathbed, if I am still considered all those things and have fought the good fight, I will consider my life a success. And my kids will always know that their father was principled, did what was right, and was not hesitant to speak his mind & fight for the path of righteousness. And the citizens of the Commonwealth of Kentucky and surrounding areas will know that there was a man who stood up for their right to live.

Cathy Godwin | 10/30/2018

Dear Mr. Shepard / Members of the OPTN, My husband and I support the Acuity Circle Model of liver allocation. My husband is awaiting a liver transplant at Stanford Hospital in California. His MELD is 34, and he is VERY sick. The sicker he gets, the more I worry about whether he can even survive a liver transplant operation. I don't want to lose my best friend. Meanwhile, people in other parts of the country are transplanted at much lower MELDs... 18, 24, etc. I know this because I am a member of a Facebook support group that is for liver transplant caregivers. I see people join the support group, get transplanted in other parts of the country, and carry on with life. Meanwhile my husband is dying. Some people move from California to other regions of the country to get transplanted at a lower MELD. This is not an option for us. We are poor. Our insurance is Medicare/Medicaid. We cannot afford travel expenses and the extremely high co-payments associated with an out-of-state transplant. There has got to be a more equitable way to allocate organs. People in California are dying and in dire need of donor organs while people in other states get transplanted early and do not have to endure the life threatening complications of liver failure while waiting for their MELD to rise to 36, 38, 40.... who knows. Please vote to adopt the Acuity Circle Model of liver allocation, so that some of us in California can have a fighting chance at a second chance in life. Thank you. Respectfully, Catherine Godwin and Robert Flynn Santa Cruz, CA 95060

Beth Israel Medical Center; Brigham and Women's Hospital; Children's Hospital Boston; Lahey Medical Center; LifeChoice Donor Services; Massachusetts General Hospital; New England Organ Bank; University of Massachusetts Memorial Medical Center; Yale New Haven Hospital | 10/30/2018

The undersigned 6 Directors of liver transplant programs in Region 1, in conjunction with the leadership of the New England Donor Services on behalf of the two OPOs in Region 1 and the Regional Councilor for Region 1, have reviewed the liver allocation proposal put forth by the LI Committee (LIC) as well as the other options that were under consideration. We appreciate the efforts of the LIC as well as the mandate by HRSA to eliminate DSA and Region as arbitrary boundaries in allocation and to develop a liver policy that is based on medical priority and distributes livers over as broad a geographic area as feasible consistent with the Final Rule. Our unanimous position is that the key principles to guide distribution of livers requires application of the broadest possible boundary to achieve equitable access to liver transplant for listed candidates who have the greatest acuity. In review of the policy proposals under current consideration, we feel the acuity based distribution is most compatible with these priorities and have a number of concerns about the B2C 32 proposal put forth by the LIC, detailed below. 1. The proposal does not properly align with the principles of geography or with the final rule mandate to share over as broad a distance as possible. - If livers for Status I patients and pediatric patients can be successfully shared with a 500 mi radius, it is unclear what rationale the LIC is relying on that requires excluding livers from being shared at this distance for other acutely ill patients. - Similarly, lungs and hearts are successfully shared over a minimum of 250 and 500 respectively, (each with circles expanding to 1000, 1500, 2000, 2500 and >2500). Hearts and lungs have less tolerance to cold ischemia than livers; if heart and lungs can be shared at these distances, livers can certainly be shared at these distances without negative clinical implications. We do not believe the LIC has adequately addressed what distinguishes livers from these other organs that requires distribution over shorter distances. We believe the Final Rule requires the LIC to make such a finding to support its current proposal. - The primary justification put forth by the LIC limiting broader sharing is the anticipated increase in the number of organ recoveries requiring flights for transport and the associated costs. Again, we note that many transplant centers and OPOs have accepted a high need for air transportation in regard to the broader distribution of other organs. Some DSAs and Regions already fly for more than 70% of their liver recoveries and are able to make that work from an operational and cost perspective. Accordingly, the LIC's position that 60% is acceptable but 70% is not is unsupported by experience and insufficient to conclude constricted distribution is required on that basis. Moreover, we strongly believe that changes to the system will precipitate changes in system behavior including how organs are procured and how transportation is arranged. Estimates of future cost increases based on current practices are speculative and unlikely to be valid predictors because future behaviors will change when the system changes. Cost analyses also need to consider that transplanting fewer high MELD patients with broader sharing will yield a net saving in post-transplant costs. Finally, the LIC misconstrues the legal responsibilities under the Final Rule when it states it seeks to 'balance' considerations of 'efficiency, access and avoiding wastage.' The Final Rule doesn't provide for a balancing - it prohibits basing distribution on a candidate's place of listing except as 'required' by these other factors. See 42 CFR 121(a)(8). Based on these facts, we do not believe the LIC has sufficiently articulated justification for why the distribution of livers must be restricted as proposed resulting in less sharing (117 vs 183.5 to 211 median miles), higher disparity in median MELD at transplant (6.54 vs 4.33 to 4.07) and a higher wait list death rate (.95 vs .87 to .85) compared to the two AC models considered by the LIC as other possible liver policy reforms and on the UNOS/OPTN Regional Webinar. See National Webinar to Review Liver Proposal, October 9, 2018. The burden is on the LIC and ultimately the OPTN Board to justify how any proposed liver distribution policy shares as broadly as feasible and is not based on a candidate's place of listing or residence except to the extent required by these factors. 2. The LIC proposal may be subject to the same challenge that previously initiated legal action and HRSA directive. The proposed share level is so high at 32, that it leaves open the possibility that a patient with a MELD of 31 and 50% 3-month mortality risk could not receive a liver offer that is instead offered to a patient with a MELD of 15 and < 10% 3-month mortality risk if these two candidates are listed in centers only 1 mile apart (e.g. 151 miles vs 150 miles from the donor hospital). A lower initial sharing threshold and/or and additional levels of sharing are needed such as those in the AC model to avoid this unacceptable result. 3. The 500-mile sharing only for Status 1 is not supported by the data and should instead be based on recipient mortality risk. Published data suggest that patients with a MELD of 36 to 40, experience a similar mortality risk as Status 1 patients and that patients with a MELD >40 experience twice the mortality risk (Sharma, Hepatology 2012). There is no rationale to treat them differently in a distribution model that seeks to ensure - consistent with the mandates of the Final Rule - equitable access based on medical priority for similarly situated candidates. See 42 CFR 121.8(b). If MELD 36-40+ were also distributed at 500 mi, the published data would support the next distribution level to lower than 32. Accordingly, we support an initial distribution level of >35 MELD at 500 miles and the next level at 25 MELD at 250 miles as the initial distribution then increasing to 500 mi. 4. The current LIC proposal is heavily weighted toward local allocation of livers and does not share over as broad an area as feasible. Since the majority of transplants occur at MELD less than 32 (median MELD at transplant nationally is 29), setting MELD 32 as the share threshold drastically minimizes broader sharing of livers without sufficient justification. In conjunction with an initial distribution of only 150 miles for patients with a MELD of 15-31 (the majority of transplants), the proposal put forth by the LIC is heavily and inappropriately weighted toward local distribution rather than distribution of livers over as broad an area as feasible as is required by the Final Rule and the HRSA directive. We note that Region 1 includes four states with no liver program; Maine, New Hampshire, Rhode Island and Vermont. Patients from these states travel significant distances for liver transplantation. Currently in MA, for example, there are over 200 candidates (>50% with public insurance) listed for liver that are from these under-served states. Equitable access to liver transplantation based on medical urgency and not place of listing, for these patients and all patients awaiting liver transplantation, requires broader sharing. Signed (in alphabetical order), Mohamed Akoad, MD - Lahey Medical Center; Adel Bozorgzadeh, MD- University of Massachusetts Memorial Medical Center; Francis Delmonico, MD - New England Donor Services (New England Organ Bank and LifeChoice Donor Services); Robert Fisher, MD - Beth Israel Deaconess Medical Center; Alexandra Glazier, JD MPH - New England Donor Services (New England Organ Bank and LifeChoice Donor Services); Heung Bae Kim, MD - Children's Hospital Boston; James Markmann, MD, PhD - Massachusetts General Hospital; David Mulligan, MD - Yale New Haven Hospital; Stefan Tullius, MD PhD - Region 1 Councilor, Brigham and Women's Hospital

John Seal | 10/30/2018

Specifically, I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall.  It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/30/2018

In the Midwest we work hard at getting people to donate. We are giving people and we want to take care of our own. We had a lot of people travel to our area to be listed. When we approach families about donation, they want to help people locally. Places like NJ and NY don't honor first person.

Anonymous | 10/31/2018

I do not see how this will increase the number of transplants performed or lives being saved. My community is strong and our local hospitals and OPO work diligently to reach all community members and share the importance of organ donation. It is through their tireless efforts that we have such a high donor rate. These organizations worked to get us there. If the current allocation method is changed this would damage what our area has worked so hard to build. How will the grafts hold up when they are flying these distances? If this model was in place two years ago I would probably still be on the wait list.

William Bryce | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. I am a California resident who underwent a successful double transplant (liver and kidney) three years ago to the day. My family saw to it I received the very best of medical care. However, even with the ultimate of care being given to me my life was in extreme jeopardy. I was placed on transplant waiting lists which were extremely unpredictable as well as unfair. I went through numerous false alarms of my receiving new organs. I would be at home asleep in the middle of the night and the phone would ring telling me of organs that were waiting for my arrival to the hospital for surgery. These calls would come at 2-3-4 a.m. My family would rush me to the hospital anticipating immediate surgery only to be disappointed once again. Upon arrival to the hosp I would go through total preparation for major surgery but to no avail. This meant all medical staff were summoned to the OR to perform immediate surgery. All for nothing. The medical staff decided to keep me in the hospital after I had a severe falling accident because of my worsening health. There were way too many false alarms that occured because of my potential much needed organs. I was always on the secondary organ waiting list and never the primary list. Every professional person who worked in the organ transplant dept in Scripps Hospital Torrey Pines did every thing possible to save my life. I have nothing but the utmost respect and adoration for these wonderful professional people. They saved my life along with thousands of others in the same situation. So many of these people, including myself, could have been taken better care of in a more expedient method had there been greater accessibility to the much needed organs. Therefore I am pleading with you to vote in the Acuity Circle model to benefit and do the most good for the most patients in this country. NOBODY HAS THE RIGHT TO CHOOSE WHO IS TO LIVE AND WHO IS TO DIE. This Acuity Circle model simply helps to make life a bit more even for those who have no say so. Sincerely, William J Bryce ( liver and kidney recipient )

Anonymous | 10/31/2018

I appreciate OPTN's recognition of the fact that the donation service areas (DSAs) and OPTN regions applied under current distribution policy 'are not good proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations,' and applaud the agency's efforts to find a solution. However, the proposed model of concentric geographic circles has all the same flaws of the current system in place. To achieve the goal of 'nationwide distribution of organs equitably among transplant patients' as required by regulation, liver allocation cannot be based on geographic location. Allocation should instead be based on patient need, such as the system reflected in the Acuity model. Geographic distribution creates a fatal access issue for many patients, and such impacts often fall disproportionately on vulnerable, low-income communities of limited means.

Oschner Medical Center | 10/31/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

I strongly OPPOSE both proposals. I can't understand WHY you continue to want to pull organs from socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky) to states like New York, which have the LOWEST waitlist mortality.

Hender Rojas | 10/31/2018

1. I strongly OPPOSE both proposals. 2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. 3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8 4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results. 5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/31/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations . Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/31/2018

1. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts 2.The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, many states have 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 3.The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many states than New York or Massachusetts, yet organs will flow out of these states and organs will flow into New York and Massachusetts. 4.The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 5.The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.

Anonymous | 10/31/2018

I strongly oppose both proposals as it moves organs out of socioeconomically disadvantaged areas with higher waitlist mortality to states which have lowest waitlist mortality. Patients in our region will be significantly and negatively impacted.

Anonymous | 10/31/2018

I strongly oppose both proposals. I work with a patient population that has low economic status and many travel long distances to obtain care from our transplant center. That being said, I also have a very close friend that is in need of a liver transplant and has been advised by his hepatologist to go to a transplant center that is hours away from our home due to waiting times. He has been advised that the other center is in a larger city and has more donors, allowing them to transplant faster. He has not been advised that this other center has improved outcomes or superior care, simply that he can be transplanted faster. For the past several years, he and his family have incurred large healthcare bills and travel costs being transferred from a local hospital in here KY to another transplant center in another state due to waiting times. This proposal is suggesting moving further organs from our center, which further disadvantages not only my friend, but our patient's as a whole. My friend is lucky enough that he has insurance and a good job that allow him to choose to go to a center that is further away (rather than the one that is literally down the road) to have improved access to organs, however the large majority of our population in KY and WV do not have this option. Again I strongly oppose both proposals. Final Rule 121.4 is in violation with these proposals, as livers would move from socioeconomically disadvantaged areas with higher waitlist mortality. These proposals are also in violation of Final Rule 121.8, as they will they will increase flying/costs and ultimately could lead to increase in organ wastage. I urge the committee to take another look at the data that has been presented. I cannot fathom how moving organs away from an area can decrease wait list deaths. As with my friend, at the recommendation of his doctors, those with economic ability are being instructed to travel further to have improved access to organs to improve his chances of survival. Any change in distribution of livers needs to take in to consideration that they must protect the rights of the disadvantaged population and rural populations. Again, I strongly oppose both proposals on a professional and personal level. We need to focus on improving deceased donation. It makes since that there would be larger need in larger cities, however the same logic should yield that in the same population with a well-functioning OPO, there should be more access to deceased donors as well. I plead that you please consider this prior to moving forward with this proposal. The focus should be on improving the number of deceased donor liver transplants in our country, not simply moving the current donors from one population of underserved/disadvantaged patients to another population of patients. There is no one patient life that is more valuable than the next.

Anonymous | 10/31/2018

I strongly oppose a broader 2 circle model. For Houston, half of any proposed circle used for organ distribution area will be negated by the presence of the Gulf of Mexico on our southern border. While this is a problem for many regions of the country, a notable difference in Texas is that there are no large population centers for quite a distance inland from where the majority of all Texas listed patients are located.

Tammie Benzinger | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, many states have 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many states than New York or Massachusetts, yet organs will flow out of these states and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

I am against taking livers or any organs from Kentucky (and many states like Kentucky) and siphon them to areas of the country that have poor donation rates and fewer deaths on the wait list.

Jeffrey Meador | 10/31/2018

I oppose both proposals. We should not further disadvantage areas that are already socioeconomically disadvantaged areas with higher waitlist mortality.

Anonymous | 10/31/2018

The Broader 2-Circle model seems to be a better compromise model for a majority of transplant centers. It prioritizes patients with higher MELD scores, and would decrease cold ischemia times due to distribution of organs to centers closer to donor hospitals.

Nigel Girgrah | 10/31/2018

I strongly support the B2C 35 model as it reflects the hard work and compromise agreed upon by our community in the fall of 2017. It prioritizes patients with highest MELD scores at risk of dying without transplant services while keeping livers most in need of short cold ischemia time (marginal and DCD livers) local. It also reduces unnecessary flights for livers to recipients with clinically insignificant differences in MELD scores.

Anonymous | 10/31/2018

I strongly oppose anything less than a 250 mile circle because of the Gulf of Mexico, and lack of populated cities less than 150 miles from Houston

Anonymous | 10/31/2018

My husband and 2 of my friends family need transplants. We need to keep the possibility of all getting a transplant as fast and easy as possible !!!

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, many states have 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many states than New York or Massachusetts, yet organs will flow out of these states and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

Specifically, I support the B2C 35 model becuase it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELD'S, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

While the policy is supposed to correct 'geographic differences', these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently underperforming. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/31/2018

Specifically, I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

I support the B2c 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally

Anonymous | 10/31/2018

I strongly support the B2C35 model. We have agreed to this last year at this time. I strongly support giving livers the highest melds. I don't believing in flying livers around for slightly different melds. It just doesn't make sense and frankly I am suprised this is even being considered. Isn't anyone worried about cold ischemic times? You would really consider flying DCD livers like this? The data does not support this change.

Anonymous | 10/31/2018

I have friends who have received a gift of life from a donor family. What a gift indeed! This girl has vibrancy and a good life where once she was sick most of the time. It is critical that we have viable organs (time to transplant) within the area the organ is procured. This circle concept does not make sense to me in regards to good patient outcomes. It will make family support (which is VERY important to patient well-being) more challenging. Shouldn't the target be best possible patient outcome and care of the donated organ? If more organs are unusable because they are traveling further - this is not acceptable! Is the root cause that we need more donors in areas of the country outside of the Midwest??? If more donors are needed - shouldn't education to the potential donors be the key priority for states with lower donor rates? Shouldn't donor education and organ donor awareness be the primary mission of UNOS??? Thank you for your consideration.

Carolinas Medical Center | 10/31/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

New England Donor Services | 10/31/2018

There are a number of duplicative posted public comments that appear to be copied and pasted (21 at last count) that specifically target Massachusetts and state 'these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.' As the OPOs responsible for donation in MA and the other five states in New England, we are compelled to respond publicly to this damaging and false statement. The fact is that the primary OPO serving MA, New England Organ Bank (NEOB), has consistently ranked above the mean under the OPO performance metrics for years according to publicly available data and is a recognized national leader in Donation after Cardiac Death (DCD) donation rates by both percent and number of donors annually. NEOB's rate of donation increased significantly over the past 5 years in organ donors (34%) and importantly in organs transplanted from local donors (43%); fifty percent higher than the national growth rate during that same time period. LifeChoice Donor Services, the smaller OPO serving western MA and the Hartford CT area affiliated with NEOB under the umbrella of New England Donor Services in 2017 resulting in the largest percent increase in the number of organs transplanted from local doors (65%) of any DSA in the country that year. The growth for both OPOs continues as we will have coordinated over 1,000 organ transplants from local donors in 2018 by the end of this week. Every OPO has the opportunity to improve and we take that responsibility very seriously; the critical urgency of the mission to increase availability of organs for transplantation drives our work. It is unhelpful to donation efforts everywhere and particularly discouraging to the OPO teams here in MA to have to spend time defending its performance against false and misinformed public statements. Ultimately, it distracts from the allocation issue which should be focused on best serving patients awaiting liver transplantation regardless of where they live. We support the Acuity Model as the most patient-focused way to distribute livers based on medical urgency and not place of listing and have submitted a detailed comment together with 6 Liver Programs in the region.

Jill Chadwick | 10/31/2018

The only solution to an organ shortage is organ donation. The problem and solution is that simple, although it takes hard work to achieve results. A KCTV5 report puts the current attempt by UNOS to fly organs around into better perspective and explains what is happening in simple terms. I invite you to watch. https://www.kctv5.com/news/doctors-warn-rules-for-liver-allocation-could-change-once-again/article_40014a74-dba8-11e8-8310-17a3e269d9c2.html As a communications and media relations specialist who has been covering this story for the past several years ... it is discouraging to see the persistent efforts by UNOS to divert organs from areas where they are needed the most and where the community is engaged in donation ... and give those life-saving gifts to transplant programs that refuse to focus on donation and refuse to engage their communities. I think much more study and work should be done before drastically moving organs around ... it will hurt our program and patients as well as other under-served areas. How is that fair? How does that follow the Final Rule?

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. Furthermore, many of the centers that are for broader sharing will see a quick uptick in available livers. Do they have the staff and resources to accommodate this? If not, it goes back to organ wastage and more importantly, patient safety.

David Levi | 10/31/2018

The current UNOS proposals disregard the principles of the Final Rule, and if implemented would be terribly inefficient, expensive, result in more livers discarded, and would not save more lives.  The last proposal, approved by UNOS last year, was sound; it was never implemented. Now the process has become highly politicized and less transparent. I strongly oppose this proposal for a multitude of reasons well documented and eloquently stated by many transplant professionals.

Anonymous | 10/31/2018

1. Each of the proposals for broader sharing will increase organ waste, logistical complexity, and costs.  2. Models predict that the net effect of the proposal will move organs out of socioeconomically disadvantaged areas to affluent areas of the country.  3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs urban populations. Many states have higher waiting list mortality than the states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population.  The incidence of liver failure is much higher in many states where organs will flow out of.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care.

Tabitha Ottiwell | 10/31/2018

While the policy is supposed to correct 'geographic differences,' these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in regions such as ours. In addition, the proposal does nothing to increase organ donation, and may actually decrease it in areas that are currently under performing. Finally, the proposal will increase costs and add greatly to the complexity of the transplant process.

Anonymous | 10/31/2018

I believe the solution to organ disparity is improving OPO's across the nation to be more effective. Sharing across the county will only increase cold ischemic times as well as increase cost, and create a disparity for rural areas. Transplanting at higher MELDS and increasing the cold time on organs, can only negatively effect outcomes across the nation.

Julie Ginter | 10/31/2018

Please consider the current healthcare climate, and the multitude of state-to-state insurance models that impact patient's coverage. Based on this, the only patient-centered model is a state based model that follows established geographic (and insurance-based) borders and provides insurance coverage requirements that allow sharing with border states lacking transplant programs. Any random geographic circles put undue burden on the financial, physical and emotional condition of already-stressed patients and families. It is well-established that patient outcomes are significantly improved with the support of family and friends. Forcing patients to leave the support of their network will negatively impact transplants, discounting the gift of the organ donor.

Anonymous | 10/31/2018

1. I strongly OPPOSE both proposals. 2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. 3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8 4. The data presented in the models does not make sense. Despite significant number of liver leaving Kentucky, the waitlist mortality decreases. Fewer liver transplants, yet FEWER deaths?!?! This does not make sense and calls into question the data results. 5. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 10/31/2018

This proposal would have a tremendous negative impact on our patient population, primarily in North and South Carolina. South Carolina has one of the highest incidences of Liver failure in the country and 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not consider the overall burden of liver disease in this population nor the limitations of MELD in predicting waiting list death in rural vs. urban populations. This allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina. In addition to patient disadvantage, there would be a significant stress on the health care system, we would see flights more than double and therefore see increased logistical complexity and cost. In addition, states with the broadly available health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Norma Flores | 10/31/2018

Acuity circles were implemented in Region 4, it would decrease the MELD variation at transplant, increase the transplant rate, increase the number of livers procured for transplantation, and decrease the wait list mortality rate while increasing the cold ischemia time by only 10 minutes.   B2C 32 were to be put into place in Region 4, it would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would and would not receive liver offers. Region 4 is geographically quite large and a 150 mile circle is smaller than the current DSAs. Therefore, B2C does not decrease the effect of geography but in fact enhances it. We can not allow a patient with a MELD of 15 to receive a liver offer while a patient with a MELD of 31 does not because of a geographic boundary.

Richard Benzinger | 10/31/2018

I work in St. Louis, which has a highly-efficient OPO whose region includes a large medically underserved, rural population in a non-Medicaid-expansion state. To my understanding, the modeling of these proposals' effects suggests a net redistribution from poor, relatively underserved areas toward more affluent, densely-populated areas, most dramatically NY and MA. The relative availability of organs in my state is small compensation for its relatively poor health care and high burden of disease (presumably including narcotic overdoses). It feels inequitable to have these organs removed. What's more, I imagine that the logistic and financial burden of this much additional flying would be significant. (Also, why do hepatologists, surgeons, and psychiatrists get their own check boxes, but not us anesthesiologists?)

Gregory Conner | 10/31/2018

Patients, as well as smaller transplant centers, in the Southeast Region will be negatively impacted by the proposed changes.  If these proposals are implemented, then the net effect will move organs out of less affluent areas of the country to more affluent areas of the country. Our region in the southeast consists of a higher percentage of residents who are socioeconomically disadvantaged when compared to the areas in the northeast.  Just this week, an article came out that documented the closing of more rural hospitals. This is more notable in states that did not expand Medicaid. Of concern is that the proposal does not have protections for transplant centers that serve these regions. Have you considered the limitations of MELD in predicting waiting list death in rural versus urban populations. The focus needs to include improving the 'underperforming OPO's' in the areas they serve. Your proposed model does not look at the variation in OPO performance. We are moving organs from the better performing OPO's to an area of lower OPO performance. The proposed changes will discriminate against our patients who live in a socio-economically disadvantaged area and only benefit those living in more affluent areas.

Anonymous | 10/31/2018

Speaking as a potential doner ... With all due respect for your organization, as your function in the medical biome is life critical, I just want to say that I will not be listed as a doner as long as organs which have good candidates in the midwest are instead sent to the coasts. If you have a participation issue in those areas, then your best solution is to work on increasing the participation in those areas, not harvesting them from other parts of the country. The preference should be the closest best match to maximize the success rate, as intuitively the longer the organ waits the lower the success rate. It is disappointing that the focus appears to be to advantage a preferred group rather than maximize lives saved. Just as likely I expect there is serious money involved, some of which I bet find it's way into influential pockets. This is one more step towards a society wherein the rich get medical care and everyone else get nothing. You write your rules to benefit them instead of the needy, and I will keep my organs, thank you.

Roshan Shrestha | 10/31/2018

Broader sharing will increase flying distance, cost, allocate organs out of socioeconomically disadvantaged areas, wait list death increased from rural areas, do not improve the activities of poor performing OPO instead just redistribute organs from better OPO performance areas.

Anonymous | 10/31/2018

1. I strongly OPPOSE both proposals.  2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4.  3. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations (like the University of Kentucky). Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted

Dennese Flowers | 10/31/2018

I am strong support of the Acuity Circle Model! Liver allocation is currently unfair! Patients are suffering more complications, even dying, from their liver disease due to the all too common fact that scioeconomically they are at a disadvantage. Too many patients don't have the financial means to make the extended drive or fly to other parts of the country for the shorter wait list times and greater transplant opportunities. Where a person lives or does not live should not be the advantage or unfair disadvantage to being transplanted- these boarders should be removed and broadened for all patients in need of a liver transplant. True organ transpalnt equality should be blind to a patient's financial ability to live as full and healthy life as possible.

Leigh Darby | 10/31/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.

K Gerber | 10/31/2018

Proposed broad sharing models do not have protections for transplant centers that serve regions with poor health care access. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. As a Social Worker in a poorer state with limited resources/access to care, this would negatively affect my patients and lead to poorer outcomes, more difficult placements, and increased needs post-op that often go unanswered.

Anonymous | 10/31/2018

I feel the proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care access. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of sates with diminished access to healthcare.  Also, the proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flown out of South Carolina and organs will be flown into New York and Massachusetts.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

I am STRONGLY opposed to this change. Organs donated locally will be shipped out from the local area. I see this as a discouragement to organ donation. When people start to hear that the organs from their town went to New York or California, they will be less likely to donate. This also seems to penalize high performing OPO's and not ask that lower performing OPO's elevate their standards. This will have a negative impact on patients needing liver transplants that are not on the coast. It sends a strong message that only the people on the coast matter and if you are in the middle of the country, your only purpose is to serve the people on either coast.tise & educate the community, if they understand number of donors will go up.  They can NOT rely on the mid-west for organs.

Sandra Couch | 10/31/2018

BOTH costal areas NEED to advertise & educate the community, if they understand number of donors will go up. They can NOT rely on the mid-west for organs.

Anonymous | 10/31/2018

The changes to broader sharing that have been proposed, while good in theory, do not take into account many patient fairness and equality factors. It would unfairly result in redistributing organs to regions that already have better healthcare and out of socioeconomically disadvantaged areas. Patients in regions with poor health care access are missing out on needed protections. There are also many limitations to predicting waitlist death using MELD and there are rural and urban populations factors that need to be considered.

Anonymous | 10/31/2018

I oppose any change to the current liver allocation. I understand the request of the proposed change is to help the sickest patients get quicker access to livers. However, while benefiting those patients in larger populated areas, you are punishing those that live in smaller populated areas. Many of the patients listed for liver transplant in our state have limited financial and social resources. They would not be able to travel outside of our state to access transplant due to insurance, finances and/or inability of support persons to travel with the patient. Our state/OPO has worked very hard to increase the number of residents to register to be donors. Many residents of our state choose to be donors to help their 'neighbor'/fellow state resident. I am certain that if this proposal is passed, some of our state's residents will cancel their donor registration knowing their organs will most likely not benefit their 'neighbor'. The donor registry numbers are low in states such as New York. Why is our state having to fill their gap? Maybe HRSA needs to require their OPO(s) to work harder to get more residents to register for donation. The proposed policy change will also increase costs due to travel logistics. This cost increase will have to be passed on to the insurance carrier and eventually the patient. The increased travel will also impact organ viability/increase cold time. What is being gained when it will certainly increase the number of livers being discarded. Please carefully consider how this proposal will NOT be a win/win - some will win, but others will lose, especially those that live in less populated areas. Thank you.

Anonymous | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, The current system for liver allocation is unfair. Patients in certain parts of the country have to wait much longer and get much sicker before they are able to receive a liver transplant. As a California resident and someone who donated part of his liver, this matter is of particular concern to me. Patients who have to wait longer are much more likely of suffering more complications from their liver disease and dying before they can get their life saving liver transplant. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. I am aware the OPTN Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. Please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many patients without the life saving transplants they need.

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts

Anonymous | 10/31/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts

Anonymous | 10/31/2018

These proposals put rural and economically challenged populations at a disadvantage in allocation. The allocations should stay regional

Raymond Rubin | 10/31/2018

There they go again. I remain adamantly opposed to these and any other untested, unprincipled proposals that pick and choose which part of the Final Rule needs to be followed. These again completely ignore the inequities in access to transplant centers and sub-specialty care in socially and economically disadvantaged, more rural areas of the country. For these areas, including much of the South, they would result in a double whammy of not only increased transplant wait list mortality but also restricted access to livers donated in their own communities. How can we justify to potential donors in our communities that their organs will be suctioned up to New York since New York's donation rate is the worst in the country and their OPO's contract won't be renewed in 2 months? Compound this by the predictable increased organ wastage, logistical nightmares of transporting these organs greater distances, and the complete absence of evidence-based justification for these proposals and one has to vote NO! These haphazard proposals are being slapped together without regard to predictable consequences of their ill-conceived design.

Anonymous | 10/31/2018

As a person who lives in the 'flyover' region of the Midwest, I find it offensive that my GIFT of organ donation would be preferentially sent elsewhere. I am an organ donor because it is something I do for my community. People already have to travel many miles to get to a transplant center in this region- heaven only knows where they would have to go if you start sending organs further afield. Your focus needs to be on getting more donors on the coasts. In my opinion, this seems like it will only flow in one direction- away from us and to the larger cities. I thought organs have a limited viability outside the human body- is this really what's best for all patients or just what works best for the places that can't seem to get enough donors?

Selma Ishag | 10/31/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Missouri to affluent areas of the country, most notably New England states including New York and Massachusetts

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

Each of the proposals for broader sharing increases organ waste, makes getting organs more complex and unreasonably increases costs.

Michael Ault | 10/31/2018

As a person currently awaiting a transplant I can't imagine lowering the distance for donors. Currently overall the donor volume is down this year further limiting the available organs. Unos Analysis shows 250/500 mile circle providing below his mortality rate and the lowest variance. Why was a 150/250 circle proposed?. I am strongly opposed to anything less than a 250 mile circle because of the Gulf of Mexico and lack of populated cities less than 150 miles miles from houston. Implementing and 150 miles circle around south Texas will deprive patients from the organs Lubbock, El Paso, and fort wotht. We stand to lose approximately 130 livers per year in the houston region.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

David Reed | 10/31/2018

My wife has been listed for transplant for over 10 years. We are blessed that she has been managing her disease, but if/when she needs a transplant, I am very concerned that Houston could be put at a disadvantage if the Broader 2 Circle is approved.

Rebecca Thomasson | 10/31/2018

Being the mother of a recent liver transplant patient, having a transplant hospital within a 3 hour drive is life-saving. We are in Region 8 being a recipient at KU Medical Center. We waited 7 months on a match. In that time frame my daughter got sicker and sicker waiting for a liver. Organs donated in our area MUST stay in our area for the people who live here. People want their selfless donations to stay in our area for the people in our area. It is a crime to send them to other areas 500+ miles away. Please do not expand the sharing of organs. My daughter was listed at KU and Nebraska, we had to be at Nebraska within 6 hours when called, almost impossible. Perimeters do not need t to be expanded, people would not have access to transplant hospitals near our area. It's a crime to expand sharing!

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. This has tremendous impact on the liver patients we serve.

Emily Brown | 10/31/2018

Predictions show that the allocation proposal will move organs out of socioeconomically disadvantaged areas to more affluent areas of the country, creating an even greater disparity in health care.

Anonymous | 10/31/2018

The proposed changes would significantly decrease liver transplants in our region. Our low income, rural patients will not get an opportunity at a new life. Organs should be allocated to areas of higher incidence of liver failure. People needing transplants are depending on fair allocation!

Anonymous | 10/31/2018

The proposed models will shift organs from socioeconomically disadvantaged parts of the country to more affluent parts of the country while increasing organ wasting and increasing costs.

Bryan Wood | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity and dramatically increase flying and costs.

Atrium Health/ Carolinas Medical Center | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. This has tremendous impact on the liver patients we serve. Please give us a brief moment of your time, and submit your comments online.

American Society of Transplantation | 10/31/2018

The AST strongly supports initiatives to improve equity in access to organ transplantation. The AST understands that there are unique considerations specific to liver allocation and has endeavored to obtain a broad understanding of these issues. While we appreciate the effort and challenges in advancing a policy to address the complex issue of geographic disparity on a short time-line, we provide the following comments that reflect the feedback we have received from our members: Any proposed allocation policy to decrease disparity that involves broader sharing of organs must consider potential negative effects, feasibility and unintended consequences. These considerations include prolonged ischemic times of marginal livers that may negatively impact outcomes, potential increases in organ discard rates, increased travel for organs and recovery teams leading to increased cost, and increased potential risk to organ recovery teams. These two competing sides of the equation require reasonable balance and compromise. While appreciating the rationale for the current proposal at hand, the Society recognizes that many important aspects of the proposal’s effects have not been adequately studied- particularly with regard to the impact on the safety, health, and quality of life of transplant processionals who will by default be working harder and longer, and will be taking more risk with any broader sharing policies. These considerations are heightened given the reality of the current opioid crisis, which has already challenged the system’s ability to provide safe organ donation services in some regions. Additionally, the Society feels this current proposal misses an opportunity to increase transplantation by development of specific strategies to increase organ donation by improving OPO performance which many of our members deem to be at least as important as changing the liver distribution framework. Finally, the Society recognizes that any proposal based on simulation methods is unable to truly predict transplant center behavior with regard to organ acceptance rates and therefore may lead to fewer liver transplants being performed. Our responses to specific questions posed by the Liver Committee: 1. The community is asked whether they prefer the Broader 2-Circle model or the Acuity circles model. Despite support for the Acuity 250/500 model due to its greater improvement in the variance of the median MELD at Transplant, the predicted significant increases in percentage of organs flown makes the Acuity model unacceptable. The potential for longer ischemic times to negatively impact transplant outcomes and increase organ discards and costs, as well as the increased risks due to flying for the procurement team outweigh any predicted benefit. In addition, the cost burden on small to medium sized programs as compared to larger programs will have potential negative impact on access to transplant for those served by the smaller volume programs. 2. The community is asked what MELD sharing threshold they recommend. The AST liver community has expressed support for a sharing threshold of MELD 35 over MELD 32 given that there are minimal differences in the metrics reported in the SRTR modeling between the B2C 32 and B2C 35, including waitlist mortality. The advantage of B2C 35 over B2C 32 would be the small decrease in travel which will translate to shorter ischemic times, less cost, less risks to transplant personnel, and more efficiency in organ allocation. It should be noted that the AST pediatric community feels that a sharing threshold of 32 would be acceptable. 3. The community is asked whether the sizes of the fixed distance circles should be larger, smaller, or remain the same. The AST pediatric community ranks the order of simulated SRTR models as 250, 500, and then 150nm. 4. Members are asked to comment on both the immediate and long term budgetary impact of resources that may be required if this proposal is approved. This information assists the Board in considering the proposal and its impact on the community The B2C 32 allocation is predicted to result in a 10% increase in organs flown compared to current practice. This change will result in significant short and long-term budgetary impacts which include but are not limited to; the actual costs of flying, the longer person hours spent in procurement, the increased hospital costs that may be a consequence of negative liver transplant outcomes related to increased ischemic time. Not quantifiable but of no less importance are the increased risks to the safety and lives of the procurement teams. Again less quantifiable in terms of costs are the potential increase in organ discards due to the longer travel distances and ischemic times. 5. Should the variance to relating to the treatment of O donor livers in Hawaii be extended to Puerto Rico? AST agrees with the proposal to extend the variance proposed for Hawaii to Puerto Rico in light of the geographic and ethnic similarities; but given the risk that such a variance would potentially disadvantage higher MELD candidates in the continental US, a clear plan for post implementation monitoring of such should be included in the policy. The AST Pediatric community has additional feedback regarding the proposal: • Broader liver sharing may have the unintended consequence of disincentivizing/discouraging in-situ donor liver splitting which may lead to decreasing organ access for the < 1year old candidate who presently has the highest waitlist mortality. We suggest the policy include clear commitment to monitoring the effect this policy has on age-stratified pediatric transplant rates and wait list mortality. Additionally, we suggest that consideration of additional priority be given to centers/adult recipients who are willing to split the appropriate organ with a list of suitable pediatric recipients • We suggest that the current modeling which looks at the pediatric candidates as a group, again is inadequate to determine the effect of the B2C model on pediatric liver candidates stratified by age. We are particularly concerned that children who are 12-17 years old (considered for their MELD priority score) actually benefit from this policy change at a rate that is commensurate with adults given the combination of constraints that prioritize MELD scores >31 and cap MELD exceptions at 31. Over 30% of children are transplanted with exception points. If additional, age-stratified modeling confirms that the 12-17 yr candidates do not proportionately benefit or are disadvantaged, we suggest additional priority points be added for this age group. • Although the proposal justifies in great detail the premise that donated livers are a national rather than local resource, we would contend that this premise overlooks the fact that many local and state organ donation initiatives are supported at the state level. Although the modeling of B2C may point to improved organ utilization, the modeling does not account for the fact that the behavior that leads to authorization for organ donation is based on local efforts of hospitals and the communities that they serve. Many OPO’s leverage statistics of local and state waitlisted patients in need of transplantation as a mechanism to assure donor families that their gift will benefit their community. The hypothesis that dissolution of DSA’s will improve organ utilization will only be true if organ donation rates do not ultimately decline from decreased donation authorization.

Charles Ince | 10/31/2018

My wife of 40 years was diagnosed with hepatocellular carcinoma of the liver in 2011 and received a liver Transplant in 2012, approximately 10 months after her diagnosis. Approximately 2 years later, she was diagnosed with metastasized liver cancer in her lung which later spread to her new liver and other places in both lungs. She died in 2017. Although I am grateful for the extra 5 years I had with her, I am angry she had to wait for so long to receive her transplant which was directly responsible for her death. Had she received her transplant sooner before the cancer had spread, not only would she have lived, but a perfectly good liver would not have been good for only 5 years, but would have lasted for a lifetime. Although my wife was 62 when she passed, she was in excellent health otherwise and had many more good years left to share with me. I know this has got to have happened many times before with transplants to much younger recipients who had even more years to live. California has one of the longest waiting periods in the nation. That does not bode well for people in my wife's situation. I think that patients with cancer should be given higher priority so that a good liver is utilized to its full potential as it could have been if she had received the transplant sooner. I do not know what proposal is best, but for those of you who can look at my wife's story, our location, and any other pertinent information, I urge you to pick one that will result in earlier transplants to cancer patients, and even out the waiting period time disparity between regions. From what I can ascertain from my own research, southern California, like other areas bordered on two sides (the Pacific Ocean to the west and Mexico to the south) by areas where there are no transplant donors is obviously penalized because of its location. This needs to be addressed. Of the options presented, I would think the acute circle model would be the best option. However, I urge you to consider my wife's story and give higher consideration to those with cancer so that transplantation is accomplished before it is too late and a liver is not utilized to its full potential.

Anonymous | 10/31/2018

Keep it simple, don't waste money on flying organs all over the country that can be used quickly and efficiently in their own regions. Organ recipients should not be given preferential treatment just because they live in high metropolitan areas. Our patients suffer longer on the list, rarely have MELD exception, and are sicker at time of transplant in the south. If new guidelines are instituted, it will decrease organ quality, lower success rates and cause the poor/rural patients to suffer. THIS IS BAD FOR EVERYONE EXCEPT NEW YORK AND MASSACHUSETTS.

Carolinas Medical Center | 10/31/2018

This proposal will increase the amount of organs we cannot use for transplant, and dramatically increase flying and costs. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, New York and Massachusetts These broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. It also does not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. With this broader sharing models there are no protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare- this could mean poor post-op care and maintenance of required medications and lab follow-up. These models also do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

John Renz | 10/31/2018

I am opposed to B 2-C. With so much talent within the transplant community and the data capability of the SRTR, I believe a system that fundamentally relies only upon MELD and distance is a disappointment. For decades we have been aware of this problem and only through recent events has there been a sustained push to change allocation within a fixed timetable. While many regard B2-C as a compromise, the two most often comments I have heard to support it are: 1) 'It's easy to explain' and 2) air transportation/safety issues. Let's begin with 'It's easy to explain.' Each day Americans interact with their cellphone via a variety of sophisticated algorithms to achieve banking, purchase items, and a variety of other activities of daily living. Most have no understanding of how their information are being used by algorithms and, despite repeated instances where their privacy may have been violated, cellphone usage has not substantially changed. My point is if the end result (better organ distribution equity, lower wait-list mortality, higher utilization) is transparent and deemed valuable to society, I believe people will accept (and indeed expect our well-educated community) the use of sophisticated, data-driven allocation schemes. Few care how Amazon is able to make the package arrive faster, they are just happy it arrived faster. Air transportation/safety. Concerns over safety and air transportation are an often cited reason to support B 2-C. Air transportation/safety are items of fundamental importance which have been largely unaddressed by the transplant community and UNOS despite multiple accidents and incidents. If we continue to approach transportation as we have always done, then any of the solutions will present the same dilemma, just on a different scale. I believe we need to fundamentally re-evaluate how we approach transportation, both clinically and logistically. While the transport of an abdominal team may occasionally be necessary, the use of local talent, coordinated through the OPO would be a breakthrough. Concerns over quality and data dissemination can largely be addressed through available technology. If we clinically move away from our decades-old methods of organ recovery, we open vast new opportunities for air transport that have revolutionized personal transportation in the past decade. Single engine turbine aircraft are often as fast and even safer than the older technology aircraft that are typical for team transport. Their cost is often less than half what we pay for twin-engine aircraft with far greater availability. The incremental increases in travel distance and amount of travel involved in more sophisticated allocation schemes could easily be achieved at a lower per mile cost if we, as a community, were prepared to fundamentally address travel in cooperation with our OPO colleagues. When FEDEX and UPS could no longer accomodate Amazon's logistic needs, they created their own airline. As a community, we must be mission driven and pursue that mission with relentless passion, just like Amazon. The Acuity model is an elegant attempt to integrate multiple factors that could seamlessly be re-evaluated and updated to generate algorithms that are clearly designed to generate outcomes consistent with the public's expectation of us as stewards of a precious resource. We should not be timid in integrating technology and the power of the SRTR in designing transparent, interactive allocation schemes while re-thinking age-old practices that do not promote our mission to society. Sadly, B 2-C does neither while barely attempting to clear a very low bar.

Anonymous | 10/31/2018

1. Seems to me proposals for broader sharing will increase organ wastage, increase the complexity, and dramatically increase flying and costs to both care teams and patients. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts, where there is already healthcare disparity. 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals, furthering the gap. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts at a disparate rate. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. That's not value-based care.

Anonymous | 10/31/2018

I think that this allocation proposal would have the effect of taking organs away from areas that are poorer and have higher occurrence of liver disease.

Vanessa Humphreville | 10/31/2018

Major concerns with the current proposals: 1. increase in organ waste 2. Longer cold ischemia times and therefore declining outcomes. Inability to use more marginal organs due to longer cold times. 3. Higher MELD at transplant and more deaths on our waitlist 4. Disadvantaging our lower socioeconomic population (Cleveland area) 5. The proposed model does not take into account variations in OPO performance and does encourage improvement 6. Increased cost of transplant due to the need for air travel. Also the increased risk to the transplant teams that will need to travel further for organs.

TGH | 10/31/2018

The coastal programs as well as transplant centers in less demographically dense areas are at a disadvantage with the concentric circle models. If regulated to the concentric circle model, we would propose smaller distances of 150+300

Hope Colyer | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance

Anonymous | 10/31/2018

I am not a clinician and cannot comment on MELD scores or other clinical matters. However, I retired from an OPO in finance and currently work PRN status on reimbursement related transplant projects for a transplant hospital. I read the proposal but did not find any discussion of donation rate differences across the country. The local OPO has very good donation rates; however, that did not occur by accident, nor can it be explained away because of the culture of the area. The OPO worked hard to increase donation rates in our area. You should compare donation rates across the country and other OPOs should be held to some donation rate standards. Perhaps best practices should be adopted to increase donation rates in other areas, such as in the high population areas and on the two coasts. Another comment I have is that this proposal appears to disadvantage rural patients. Kansas is 400 miles from one end to the other. Several hospitals in rural Kansas are part of our Health System. Consideration should be given to patients from these hospital since many have relatives and a support system in the Kansas City area. Finally, this proposal appears to increase the cost of a liver transplant and may result in an increase in discarded organs.

Bethany Lane | 10/31/2018

It seems like the results of this proposal might lead to wasting of more organs and make things more complicated.

Anonymous | 10/31/2018

I have concerns about the complex logistics and costs that would result from expanding the distance circle. I also feel that the proposed broad sharing needs to consider the overall burden of liver disease in the given population when allocating liver organs. Areas with poor performance OPO's need to address the OPO and fix the issue, rather than redistributing organs from the better performing OPOs.

Anonymous | 10/31/2018

The proposed liver sharing model will disproportionately disadvantage lower socioeconomic areas and funnel available livers for transplant to affluent geographic areas which are already advantaged. This will further worsen healthcare disparities in the liver disease population. In addition, differences of OPO performance/quality will translate to OPOs that function well losing available organs to OPOs that function less productively.

Anonymous | 10/31/2018

I believe that each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. As a liver transplant coordinator these proposed changes would greatly increase the hours that it takes to coordinate liver getting to where it needs to go, therefore increasing cold time making the possibility of the liver functioning to decrease, therefore making the patient at a higher risk of having non functioning liver. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. So OPOs that works hard getting Donors are not getting the benefits of their hard work and instead the OPOs that are not producing and getting donors are reaping the benefits of someone else hard work. This has tremendous impact on the liver patients we serve .

Lei Yu | 10/31/2018

I oppose both proposals because of concerns outlined below. This is a very difficult project. 1. Did the models consider variations of MELD at transplant within the same donor service area or region (Croome et al. and Abt et al. Editorial 2018)? Are the plaintiff and Health and Human Services Department aware that such variations exist? 2. Age groups were modeled as adults vs. pediatrics. Do we have data on the proposals' effect on different adult age groups? I suspect the waitlist mortality will rise overall among older candidates with decompensated cirrhosis because they often become too sick before reaching a competitive MELD. 3. For all the reasons outlined in the public comments against these proposals, do we anticipate, and have a plan for, potential lawsuits following implementation of these plans? For example, broader sharing might disadvantage older candidates' access to liver transplantation. 4. Broader sharing naturally will involve more center competition. This leads to more reliance on objective measure of disease severity. The price of reducing geographic disparity, as shown by the models, is an overall higher MELD at transplant. If these proposals pass, the patients in the majority of the country will have to be sicker to receive a transplant. While this seems 'fair,' the chance of death increases at the same time as the chance of being transplanted. I would not want that as a patient no matter where I live. I wonder whether the committee came across sharing models which will result in a LOWER average MELD at transplant for the entire country. The current proposals penalize regions that are doing well. A more ideal policy should reduce not only the geographic variance of MELD at transplant, but also the absolute MELD at transplant for all regions.

Anonymous | 10/31/2018

Boarder sharing will increase the cost of organ procurement ie: flying costs, organs will go to more affluent areas, it will increase organ wastage and it does not take into consideration the socioeconomically disadvantaged areas.

Anonymous | 10/31/2018

I am strongly opposed to the proposed broader sharing models that do not consider the limitations of MELD alone in predicting death while on the waiting list in rural vs. urban populations. For example, Ohio has a higher waiting list mortality than New York or Massachusetts, the two states that will import the highest number of livers in these proposals. This will be a huge disincentive for organ donation, given that a 'local resource' is being shipped out to other parts of the country. The fact that the high waiting times and waiting list mortality seen in NY is due to significantly lower-than-average rates of organ donation. It behooves UNOS to address the issues at hand re: poor OPO performance - rather than the extreme reactionary proposals that have been presented, which will disadvantage patients with end-stage liver disease across the country. New York has one of the worst-performing OPO's in the country - yet UNOS seeks to reward this by simply ignoring these issues and simply redirecting organs from across the country to New York. Organ procurement organizations with best-practice models and high donation rates are going to be directed to now move those organs (from the local communities) to New York, Massachusetts and Minnesota. This does not serve patients with end-stage liver disease well. These models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as Michigan, Indiana, Kentucky, Missouri and Ohio to more affluent areas of the country, notably New York and Minnesota. This does not adhere to the principles laid out in the Final Rule.

Sandra Galanakis | 10/31/2018

Should not lump MELD 15-31 in such a small 150mi circle (especially for programs out West. Bigger circles better - sickest should be taken care of first. No rationale reason heart and lung can distribute further than liver

Lisa Willis | 10/31/2018

I strongly oppose the proposals because models predict that the net effect will move organs out of socioeconomically disadvantaged areas such as northeast Ohio and therefore do not protect ALL patients, especially those will limited access to healthcare and little or no ability leave home for a better chance for a life-saving transplant.

Brad Beckstrom | 10/31/2018

No surprise that Acuity is associated with more travel - it is designed to help more people over a broader area (based upon their need

Rosemary Cross | 10/31/2018

I am concerned that Georgia organs, which our OPO does an excellent job with our area's donation rates, are going to be sent elsewhere or wasted in transit to areas that should instead work on increasing their area donation rates.

Kambiz Kosari | 10/31/2018

As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Debbie | 10/31/2018

Mr. Shepard/Members of OPTN, I strongly urge you to vote for the Acuity Circle Model being purposed. My husband received a liver transplant and is alive today because of that transplant. However, the wait time nearly killed him. With each passing day, he became increasingly more ill from complications due to the liver disease to the point that he might not survive the surgery. But for him, it came at the last hour and he was saved. The patient in ICU next to my husband who also was waiting for a liver transplant, was not so fortunate, he died 2 days after my husband's surgery. We live in California and could not financially relocate to another state to acquire an organ where the organs for transplant were more readily available. Our only option was to stay here and WAIT. I appreciate that it is recognized that the current system is not equitable but the only one that is, is the Acuity Circle Model. I am counting on you to cast your vote for it. All lives matter, Debbie

Anonymous | 10/31/2018

Simply put, allocation of donor organs should be based on the MELD Score. The sickest patients deserve access to those organs, regardless of their geographic location. Makes no sense that a patient in Dallas with a MELD of 21 would receive Donor offers before someone in Houston with a MELD of 31.

Nicholas Nissen | 10/31/2018

As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars -Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need t hem. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.

Bryan Sauter | 10/31/2018

To whom it may concern, I requesting the adoption of the Acuity Circle model for liver allocation as this is a fairer based model for many regions of the country that have extensive weight times, thus worsening patient conditions. Certain patients have exploded the current system and go to different regions of the country from where they currently live, and obtain higher placement, displacing those within that region. This is often based on patient's income and their ability to financially move to another region. The Acuity Circle model would end this abuse and level the field for all pending transplant patients. Thank you for your consideration Bryan Sauter, PA-C

Dolly Khatwani | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, I am currently on a wait list for Liver Transplants. Our Doctors at Scripps have brought this situation to our attention. 1. Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. 5. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6. As a resident of California and someone with liver disease this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely, Dolly Khatwani

Todd Brennan | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 10/24/2018 Dear Mr. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Todd V. Brennan, MD, MS Director, Pancreatic Transplantation Surgeon Liver and Kidney Transplantation Comprehensive Transplant Center

Motty Shulman | 10/31/2018

Ms. Elizabeth Miller, J.D. UNOS Elizabeth.Miller@unos.org; Public Comment Coordinator; United Network for Organ Sharing, 700 North 4th Street Richmond, VA 23218; publiccomment@unos.org; Re: Public Comment, OPTN/UNOS Liver and Intestine Transplantation Committee ('Committee') Liver and Intestine Distribution Using Distance from Donor Hospital Proposal; Dear Ms. Miller: The letter is being submitted in connection with the public comment for the Committee's October 8, 2018 proposal titled Liver and Intestine Distribution Using Distance from Donor Hospital ('Proposal'). This public comment is being submitted on behalf of Plaintiffs in the pending action Cruz et. al. v. U.S. Dept. of Health and Human Serv. et. al. (SDNY 18-CV-06371-AT). As explained below, we oppose the Broader 2-Circle (B2C) framework because it violates NOTA and the Final Rule. By contrast, the Acuity Circles (AC) framework set forth in the proposal, if properly implemented, can lead to meaningful change and bring OPTN policy into compliance with the law. 1. The OPTN's mandate, as set forth in NOTA and the Final Rule, is to develop a nationwide organ distribution system that allocates organs over as broad a geographic area as feasible in order of decreasing medical urgency. Geographic constraint has no role in a nationwide system except to the extent required to avoid the wasting of organs. 2. The B2C framework continues to prioritize candidates by geography instead of medical priority. B2C is a local-first distribution system that makes mere cosmetic changes to the current policy, which HHS made clear is inconsistent with the law. Under the B2C framework, a patient with a MELD score of 16 that is 140 miles from the donor hospital is given priority over a patient with a MELD score of 31 who is only 15 miles further. B2C is particularly troubling given that the band of MELD 15 to 32 includes more than 40% of active waitlist candidates. 3. The purported broader sharing of 250nm for MELD 32 and above is also too small. Lungs share, in the first instance, to a range of 250nm yet they have a preservation time that is half of livers. The Committee has not presented any legitimate evidence to justify a sharing of 250nm instead of 500nm. 4. OPTN has long recognized variance in median MELD at transplant as the primary disparity metric. The current variance for patients with lab MELD scores (i.e., no exceptions) is a shocking 21 MELD points. The AC 300+600 framework would reduce the variance by over 60% while the B2C frameworks would only reduce it by approximately 30%. 5. The AC framework will have over 100 fewer waitlist deaths than the B2C framework. The goal of organ transplantation is to save lives. The AC framework saves more lives. Indeed, SRTR modeling shows the B2C framework is even worse than the December 2017 revised policy, which HHS found to be improper, as B2C would result in dozens of additional waitlist deaths. 6. The Committee appears to justify its recommendation for the local-first B2C framework by focusing on metrics that are either not meaningful or unreliable. In this regard we make the following observations: • Transplant Count. The Committee focuses on transplant count while at the same time recognizing that transplant count data is not reliable because it 'does not account for changes in member behavior.' Moreover, while focusing on transplant count it largely ignores the modeling that shows more than 100 less waitlist death under the AC framework. An optimized system that saves more lives with fewer transplants is preferable to a system that does more transplants but results in more waitlist deaths. • Transport Metrics: The fact that donor livers travel farther under the B2C or AC framework is both expected and the goal of a nationwide distribution system. It means the system is working as it should and that livers are getting to those who need them most urgently on a nationwide basis. • Median Transport Time: The Committee recognizes that median transport time is relevant to considering the cold ischemia time of transplanted organs. In this regard, the data shows that, under the AC framework, a mere 6 to 12 minutes of additional transport time can result in substantially lower median MELD at transplant and over 100 fewer waitlist deaths. This once again shows how a nationwide system - instead of the current local-first system - can and would save additional lives without a substantial increase in travel time. 7. Percent of Organs Flown: To support its recommendation, the Committee relies heavily on the purported increase in percent of organs flown as a proxy for increased cost. As an initial matter, neither NOTA nor the Final Rule provides for geographic limitations due to an increase in organs flown or increased cost. The Final Rule does provide for a system that promotes the efficient management of organ placement. An organ distribution system is efficient when it gets organs to those who need them most and reduces waitlist deaths. Moreover, the metric of percent of organs flown is unreliable as it fails to account for changes in transplant center behavior and acceptance practice. As noted by the Committee Chair, 'travel impact will not be as significant' and travel metrics are the 'hardest to be certain about.' The Committee rejects the benefits of the AC framework with increased benefits based on 'remarkably robust' data in favor of data that is unreliable, untested and likely wrong. The misleading nature of this data is further underscored by the Committee's conclusion that 'increases in the need to flights could lead to an increase in organ offers that were unable to be accepted because flights or pilots were not available.' Respectfully, there is no basis to conclude that there will not be sufficient flights or pilots to transport organs let alone to recommend an arbitrary geographic limitation based on this superficial analysis. Additionally, even if there are insufficient flights (for which there is no real evidence), the result will not be wasted organs but a change in transportation or acceptance practices. There is no basis for the Committee to assume that transplant professionals will act irrationally. As suggested by the Committee Chair, transplant professionals and practices will adapt to any new policy and travel impact will likely not be as significant as suggested. 8. Increased Cost: The Committee's suggestion that an increase in organs flown 'represents a significant jump in costs of transportation for a transplant, and increased costs make the process less efficient' is incorrect. Even assuming that more organs do fly, that does not necessarily equate to greater cost. The very research relied upon by the Committee makes clear that any economic assessment of organ allocation policy must look at the overall costs and savings attributable to a policy - not simply one data input. That same study concludes that the increased cost of sharing organs is more than offset by lower overall medical costs. Alternatively stated, nationwide sharing of organs (as mandated by NOTA) saves money and saves lives and one cannot myopically look at only one cost metric. The Committee relies heavily on the increase in percentage of organs flown but never actually quantifies what that additional cost may be, who will bear that cost or how that cost may be mitigated or shared. Surprisingly, the Proposal also ignores the 2015 SRTR analysis, which modeled 28 different distribution scenarios and found that the 'projected differences in overall cost for transport and patient care among the 28 scenarios tested were small' with 'only about a 2% difference between the most expensive and least expensive options' before accounting for additional cost reductions resulting from changes in acceptance behaviors. That same analysis showed that even focusing on just the increased transport cost metric (which would be economically irrational), the additional transport cost of the AC framework would be less than 1% of the overall transplant cost per year and that this cost would be more than offset by cost savings from having patients transplanted earlier - let alone the numerous lives that would be saved under the AC framework. Finally, the Committee's recommendation, reasoning and lack of unanimity suggests the Committee is not of one mind in its proposal. This concern is heightened by the fact that Committee's composition is weighted in favor of Regions that are benefited by the local-first system, have below average median MELD at transplant and have fewer waitlist candidates. For example, Regions 1, 2, 4, 5, 7, and 9 have over 68% of the nation's waitlist candidates but have less than 50% of the Committee votes. Similarly, Region 8, has nearly 20% of the Committee votes but only 6% of the waitlist candidates and transplants. While the lopsided and provincial composition of the Committee may explain the difficulty in formulating a new policy, it does not justify a policy that is inconsistent with the Final Rule or one that does not make meaningful change to the current, illegal distribution framework. As HHS noted in its July 31 directive, 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule.' cc: Dr. Julie K. Heimbach, Chair, Liver & Intestinal Organ Transplantation; Heimbach.Julie@mayo.edu

Sarah Zien | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, I am requesting that you implement the Acuity Circle Model, in order to help as many patients as possible to avoid the many complications that can arise while waiting for an organ transplant. I was diagnosed with autoimmune hepatitis and cirrhosis as an otherwise healthy and active 8th grader living in southern California. I was lucky enough to survive into my late 30's before my liver started to fail. I was put on the waiting list and remained there 14 years with a low MELD score that was not commensurate with my level of illness. During those years, I became septic twice, I had a mesenteric arterial clot, and I had a near fatal reaction to Rifampin, which I took only after the many other drugs for itching failed to help me. I had large esophageal varices and a bloated belly due to ascites; I lived in fear of a variceal bleed and infection from peritonitis every day of my life for 14 years. I consider myself lucky that I finally received a liver just shy of my 52nd birthday, and I am thriving and extremely grateful today at 54. I promised myself that I would do everything possible to make this journey easier for other patients waiting for an organ transplant. Thank you for your consideration. Sincerely, Sarah Zien

Mazen Noureddin | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 10/24/2018 Dear Mr. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant hepatologists, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Mlt1 Mazen Noureddin, MD, MHSc Liver Transplantation and Gastroenterology Cedars-Sinai Fatty Liver Program (CS-FLP) Comprehensive Transplant Center

Rebecca Mills | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, I am writing this letter to you today in support of the Acuity Circle model for liver allocation. 1. My husband, luckily, received a liver transplant but it was during his final days. He was very sick. Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2. He was in ICU for 13 days vs. 1 or 2. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3. I was looking at flying him to another part of the country so he would receive a transplant sooner. I couldn't sit and watch him die as he waiting for a liver, but others who could not afford it, possibly had to do just that. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. Even in Los Angeles vs. San Diego, there is a disparity. 5. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6. As a resident of California and have someone who has received a transplant this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely/Yours/Respectfully/etc. Rebecca Sue Mills

Richard Fouhy | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, I received a liver transplant in June of 2006 after waiting on the transplant list for six and one half years. My MELD score always seemed to hover around 17 to 24 and was not high enough to qualify for a transplant until my liver failed. Living in Southern California it was very difficult to qualify for transplant and my wife and I looked into traveling to other states that had lower transplant MELD scores because of my health degradation. I volunteer at a liver transplant group to help those going through the process realize that there is life after transplant. Unfortunately several individuals have passed while waiting on the list for transplant. I would really like to see more of a fairness to the allocation process for areas like mine and I feel that the Acuity Circle Model is the most appropriate way to allocate organs for transplant. I urge you to adopt the Acuity Circle Model for liver allocation. I feel that the current method and others proposed will continue to be unfair for many of us and leaves us without the transplants we need. Thank you for your time and understanding, Richard Fouhy

Robert Ashmore | 10/31/2018

Acuity Circle Model is the most equitable choice for Organ Sharing ! Hi, my name is Robert Ashmore, I am a California Liver Transplant Recipient in 2016 I survived liver cancer by liver transplant at Scripps Green Hospital. My tumors were at the the upper size limit and after 2 Tace Procedures to stabilize the tumors, the wait for the correct liver match was stressful ! I feel the Acuity Circle Model is the Best And Most Realistically Responsible Method to save lives for all persons awaiting transplant! Please select the Acuity Circle Model as your choice for the most equitable Sharing of Vital Organs. Thank you for your time. Questions, contact me? Robert Ashmore

Vinay Sundaram | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 10/ 24/ 2018 Dear Mr. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change . My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule' s requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant hepatologists, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocatio n, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Vinay Sundaram, MD, MsC Assistant Medical Director, Liver Transplantation Department of Gastroenterology and Hepatology Comprehensive Transplant Center

Stephen Dean | 10/31/2018

1. Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. 5. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6. As a resident of California and someone (with liver disease or who has someone close to me with liver disease, who has received a transplant or has someone close to me who has received a liver transplant) this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely/Yours/Respectfully/etc. STEPHEN R DEAN,DOUBLE ORGAN TRANSPLANT RECIPIENT

Nick Tibaldi | 10/31/2018

Dear Mr. Shepard, I am a practicing gastroenterologist in Las Vegas, Nevada. As Nevada does not have a center for liver transplant, most of our patients receive specialty care and liver transplant in Southern California. It is through my liver transplant hepatology colleagues that I became aware of current and ongoing discussions regarding liver distribution for transplant. Upon reviewing some of the discussion, I would like to voice my support for the Acuity Circle Model. I believe this application policy will result in the most fair allocation of organs across United States and best serve our patients in Las Vegas. Thank you for considering my thoughts. Sincerely, Nick Tibaldi Nicholas A. Tibaldi, M.D. Chief, Gastroenterology Southwest Medical Associates Office

Anonymous | 10/31/2018

If these allocation changes happen, I will likely not be a donor. I know overall losing donors will hurt all recipients, but it's the only leverage I have so I will use it.

Andrew Klein | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218; 10/24/2018; Dear Mr. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nat ionwide , necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocat es. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 lett er to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, /4 Andrew Klein, MD, MBA, FACS; Director, Comprehensive Transplant Center Esther and Mark Schulman Chair of Surgery and Transplant Medicine; Professor and Vice Chair, Department of Surgery

Sutter Medical Center | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos. org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Medical Center, Sacramento is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely Dave Cheney, CEO Sutter Medical Center, Sacramento

Walid Ayoub | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218; 10/24/2018; Dear M r. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant hepatologists, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Walid S. Ayoub, MD Interim Medical Director, Liver Transplant Department of Gastroenterology and Hepatology Comprehensive Transplant Center

Barbara King | 10/31/2018

We need to help entire country - only Acuity model starts to do so.

Tsuyoshi Todo | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 10/ 24/ 2018 Dear Mr. Shepard and Members of the OPTN: As a physician who is intimately involved in the care of patients with severe liver disease, I would like to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. I strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. My hospital, Cedars-Sinai Medical Center, is one of the 13 liver transplant centers in California. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration , the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Tsuyoshi Todo, MD Surgeon, Liver and Kidney Transplantation Comprehensive Transplant Center

Anonymous | 10/31/2018

this will increase organ wastage,flying and costs, logistics doesn't look at the limitations of MELD

Anonymous | 10/31/2018

This just appears to add cost to a model that isn't broken. B2C would work. I am strongly in favor of increasing donations as a task force for the highly populated areas that have such low donation rates and do not fix the problem at the local level. A rework to the OPOs and donor enlistments is in urgent need.

Leah Cochran | 10/31/2018

Concerned these changes for broader sharing will increase organ wastage and increase costs. Notably, very concerned about how this will effect moving organs out of lower income areas and those serving lower socioeconomics groups.

Kindred Hospital San Francisco Bay Area | 10/31/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Kindred Hospital San Francisco Bay Area is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Varsha Chauhan CEO, Kindred San Francisco Bay Area 2800 Benedict Drive San Leandro, CA 94577

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as Ohio to affluent areas of the country, most notably New England states including New York and Massachusetts and Minnesota 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, Ohio has a higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care or an impoverished population ( like Cleveland). Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. New York has the worst OPO in the Country and we have one of the best.

Region 4 | 10/31/2018

Region 4 Vote ( 17/44 voting members submitted a vote online): • Broader 2-circle distribution: 4 strongly support, 3 support, 1abstain/neutral, 1 oppose, 8 strongly oppose • MELD sharing threshold recommendation: 8 for MELD of 29, 1 for MELD 33, 4 for MELD 32, 4 for MELD 35 • Size of fixed distance circles recommendation: 5 for remain the same, 2 for smaller, 9 for larger, • Acuity circles: 7 strongly support, 2 support, 3 abstain/neutral, 2 oppose, 3 strongly oppose Comments: Those attending the webinar were engaged and provided thoughtful feedback. Some members commented that in Texas they are already flying 60-70% of the time to get livers and have a much larger distribution area than what is in the proposed policy. There was concern that the proposed model would disadvantage patients at centers near the coast where much of the circle will be over water. There was also concern that the B2C model would result in an increase in waiting list mortality in Texas. Some on the webinar commented that any proposal should have very large circles (500 plus nm), and the sharing for MELD down to 25 to affect mortality for sick people and to increase access. There was some support for the acuity models and for lowering the threshold for the B2C model to 25-26 because the mortality curve increases around that level. There was concern that transplanting candidates with higher MELDs would increase costs more than additional flying. There was feedback that based on the data, centers in Texas and Oklahoma will have an increase in transplants under the B2C model. There was concern that increasing the MELD threshold or reducing the circle size would limit access for patients at the VA hospitals since there are a very few across the country and veterans have to travel to one of these centers to get a transplant. There was a comment that the modeling does not reflect disparity between supply and demand. This is influenced by OPO performance, center acceptance practices and activity of living donor programs. Centers need to consider maximizing resources and capabilities. Increasing the size of the circle is not the answer given the cost associated with flying. A cost analysis is needed to understand how changes will effect transplant centers. Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 4 outside the regional webinar is also available on the public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Marwan Kazimi | 10/31/2018

As a transplant surgeon who was trained in the Northeast, has worked in the Midwest and now the Southeast, and has colleagues all over the map, I've closely observed this march towards re-allocation with wonder, disenchantment, and distaste. We all understand that political forces and legal maneuvers are attempting to cover up OPO under-performance, transplant center greed, and socioeconomic inequalities that should never be gerrymandered to affect access to medical care, especially transplantation. To embrace a new allocation model in this forced fashion, with flawed models and statistics used as 'evidence,' fully knowing it will result in higher medical costs and more lost lives, not to mention a disproportionately negative outcome for those from underserved populations, is antithetical to the altruism that attracts generations to Transplant to begin with. Idealism and justice apparently have no place in the hyper-competitive marketplaces that are driving these legal maneuvers and advocating an era of, essentially, Transplant Colonialism. But logic, objective data, and consensus should certainly trump political action, financial influence, and legal threats. Otherwise we are no more moral or ethical as physicians and Transplant professionals than the lobbyists and highly paid lawyers that have been enlisted to force this issue.

Anonymous | 10/31/2018

The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas to more affluent areas of the country, most notably New England states including New York and Massachusetts.

Anonymous | 10/31/2018

These proposals will increase organ wastage and increase costs

Anonymous | 10/31/2018

Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas to more affluent areas of the country, most notably New England states including New York and Massachusetts.

Scott Iverson | 10/31/2018

My spouse unexpectedly had a health complication in April 2016 which now requires him to have a liver transplant. It is going on 3 years and he was recently diagnosed with PH as well. So now it is even more critical that he have a transplant as soon as possible. Living in California has made it very difficult since the liver allocation is unfair. In addition, needing to wait for a patient to have a MELD score in the high twenties or thirties is unfair as well. Why do patients have to become 'more' sick before they can receive a transplant? Patients who have to wait longer have a greater chance of suffering more complications, as my spouse is experiencing, and even dying before they can get a liver transplant. As a spouse and caregiver, this process is quite the emotional roller coaster. Having to wait months on end to know if/when we will be called that a liver is available is not fun and we feel restricted from living our lives. Perhaps everyone involved with this process needs to imagine what it would be like to be in the shoes of a patient needing a transplant or as a caregiver. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Respectfully, Scott Iverson (Caregiver/Spouse)

Malay Shah | 10/31/2018

As a follow-up to New England Donor Services comments regarding duplicative posts, I would also like to point out that the Coalition for Organ Distribution Equity (CODE) is similarly encouraging a copy/paste directive to supporters of broader sharing (http://www.transplantequity.org/optn-proposal.html). I continue to oppose both proposals.

Lon Eskind | 10/31/2018

As an organ donor, transplant surgeon and Director of a Liver Transplant Program, any rushed proposal that increases organ wastage in a non-starter. I oppose what is being put forward for the reasons already beautifully outlined in comments against. Go back to the drawing board with each region well represented and hash out a better plan based on the best science available. I'm embarrassed for UNOS and the Transplant Community that we are rushing this and its obvious to everyone involved. This is an opportunity to slow down, make incremental changes toward a goal of 'getting it right' for both our donor families and patients burdened with liver disease. Make small vetted changes, study the outcome and make adjustments accordingly (just like the QAPI projects UNOS make the Transplant Centers do). For example, we should go back to what we all agreed on last year, implement it and let it play out for a couple of years, study the effect and make changes as necessary. Don't let the courts decide. That's a lose-lose for all of us.

Anonymous | 10/31/2018

I am of the opinion that either of these proposals may inadvertently increase organ discards and will increase travel time and costs. The models do not address disparities between Organ Procurement Organization performances and how their territories are served. It is possible that more organs will leave Region 3, leaving patients listed with transplant centers in this area with less access to transplants.

Anonymous | 10/31/2018

The proposal does not take in to account the necessary time and communication needed to transport organs long distance and the number or organs that are disposed of after being transported over a long distance. The proposal does not take in to account the number of people who die waiting for liver in rural areas as apposed to those in more populated areas. Liver failure is also higher in many rural areas than in heavy populated areas. The proposal will allocate organs to areas of denser population but ignore those rural areas where liver failure and mortality on wait list is higher. There will be increase in organ waste and increase in the time and complexity needed to transport organs great distances. Several hospitals in rural areas have been forced to close due to unintended consequences of changes in healthcare delivery and reimbursement. I fear that this will could be the outcome for transplant centers who are located in less populated / denser populated areas. The proposal will adversely impact our patients, patient care and our transplant center. Please consider a proposal that will provide excellent health care to all patients not just those in large metropolitan areas with large transplant centers .

Lena Curry | 10/31/2018

. Broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. Broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. Broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. Broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. Proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Lyndell Doiley | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

It seems like your taking from poor and giving to the rich!! If the mortality rate is lower in NY, why do they need more?

Bradley Korn | 10/31/2018

Low (or no) MELD threshold. MELD is a disease severity index and already stratifies patients based upon need.

Tucky Rodrigue | 10/31/2018

Dear Mr. Shepard/Members of the OPTN Because of the unfair allocation of livers, we considered moving out of California to save my son's life. However this turned out to be impossible for us. So for two years, then months, then weeks, to days I watched him slowly die. With just a handful of hours left (even the staff didn't expect him to last to the next day) a liver was available, by the grace of God. But that's only part of the story. His doctor Frenette had to fight for him to be accepted by submitting photos and statements because he didn't fit the 'usual' requirements. As an elderly widowed mother I am deeply grateful. Yes, I have believed the current system of allocation is greatly unfair. The Acuity Circle model would be a much needed improvement. I plead with you to please adopt the Acuity Circle model. Tucky Rodrigue

Anonymous | 10/31/2018

Livers are a national resource and distribution should be more broad than B2C allows and should be need based. The Acuity model is more consistent with the Final Rule and is based more upon need. B2C model is based mostly upon geography.

Amy Kennett | 10/31/2018

As a transplant professional I understand the intention to provide the gift of live to as many recipients as possible. However, both models miss the mark. Both models predict more organ waste, higher healthcare costs, and greater risk for surgeons and medical teams due to increased travel. This is unacceptable, especially when the models predict less total transplants per year nationally. The Acuity model truly creates disparity at smaller programs, or those which serve a more rural population -many of whom already lack options for their care due to distance, disadvantage, or state coverage limitations. Lastly, after visiting and revisiting allocation policies over the last several years, OPTN disappoints again, by not offering further solution to the greater problem of promoting and increasing organ donation. The most efficient way to solve the problem of MELD variance at transplant is to educate the public on the importance of organ donation.

Anonymous | 10/31/2018

The broader sharing models do not take into account the overall burden of liver disease in a region. The incidence of liver failure is much higher in South than the Northeast. So there is no reason to have organs funnel from the South where the burden is higher to the Northeast. The proposed models seem to discriminate against centers that serve regions that have poorer access to healthcare. It seems that the Northeast or the more affluent areas would be the major beneficiaries of the new models.

Kevin Stump | 10/31/2018

To Whom It May Concern, I have been involved in organ donation and transplantation since 1986 and this proposed is one of the most disturbing policy proposals that I have seen in my career. I am against this policy because: • Broader sharing is predicted to increase organ wastage which many feel is in direct opposition to final rule 121.8 • Broader sharing is predicted to increase logistical complexity which many feel is in direct opposition to final rule 121.8 • Broader sharing is predicted to dramatically increase flying and costs which many feel is in direct opposition to final rule 121.8 • Models predict organs will move out of socioeconomically disadvantaged areas which many feel is in direct opposition to the final rule 121.4. This is particularly egregious in moving organs out of places like South Carolina into NY despite SC having a waiting list mortality 3-5X higher • The process has been rushed and is continually being changed to get a result to answer a lawsuit. A law firm should not be able to set organ allocation policy • UNOS has decided in a non-transparent manner that they are only interested in patients on the waiting list which many feel is inconsistent with NOTA and the Final Rule In past years I have voted in UNOS regional meeting for policies because they: • Protected poor and rural populations • Took into consideration the transplants centers that serve regions with poor healthcare • Account for increased wait list mortality among populations who are poor and rural and are concentrated in certain areas of the country • Not add incremental cost for no advantage • Recognize the limitations of MELD in predicting waiting list death • Consider overall burden of liver disease in a population. In closing, I strongly believe that we will see a decrease in organ donation when we make such drastic changes to allocation of any organ such as is being considered for liver. Sincerely, Kevin Stump, BS, BSN, RN, CPTC President / CEO Mississippi Organ Recovery Agency

Hospital Espanol Auxilio Mutuo | 10/31/2018

The UNOS proposal is trying to redirect donor livers flow away from areas that are successful at obtaining them by implementing new geographic boundaries based on distance. While the policy is supposed to correct 'geographic differences', these disparities are artificial, and the designers have refused to consider the real difficulties faced by rural, low-income, and minority patients in many regions that will see a flow of organs away from where they are obtained. In addition, the proposal does not include policies to increase organ donation and may actually decrease it in areas that are currently successful when the population discovers the donation does not benefit the locals. Such effect could have been produced in our Island after implementation of the Share 35 policy had we been more vocal. Recent and dramatic experience has proved how difficult it is to obtain relief due to isolation. Access to health care in Puerto Rico has been deteriorating from early in the century, with a financial crisis that started before than in USA and plummeted after hurricane Maria hit us a year ago. Based on population we should have been receiving many more referrals than the actual numbers indicate due largely to a self-selection process based on lack of access to many in our population. The diaspora created by the financial crisis has affected more than half a million of the younger and better prepared among them and leaving behind the elder and sicker. The reduction in the medical pool with many professionals leaving also is making the situation more difficult. Medicare reimbursement is 40% lower to the lowest reimbursed State. Puerto Rico has been a huge contributor of donor livers to the transplant community in Continental USA since the 90's, but there had not been a liver transplant center in Puerto Rico until 2012. The feasibility study for creating the Auxilio Centro de Trasplante counted on the only variable in which we are rich, the resource of a large amount of liver donors historically produced locally. We have been self-sufficient limiting importing organs to high risk patients included in share 35 and Status 1 basically due to the lack of financial strength. The allocation policy prior to share 35 benefitted us as we could use most of the excellent locally-derived quality donor livers and is reflected in our 87% overall survival of those transplanted at the program's inception. However, Share 35 diverted most of the good quality donor livers towards strong institutions in the Region 3 and affected greatly our outcomes in the same manner those centers in Region 3 would have been affected if the prior allocation proposal (4-8 districts) had succeeded. The new proposals finally benefit Puerto Rico as they acknowledge how far we actually are from the closest DSA, Miami, and help us reach the point of sustainability conceding us most organs produced based in distance. But that is not the concept we want to implement. During the six years since starting the program we have needed to import 1-3 livers every year for Status 1 or high MELD cases. Unfortunately Share 35 did not help our patients at highest risk (those with MELDs of 25-35), that died in high numbers while good quality organs were bypassing them to help 'sicker' patients in the continent. Our proposal for Puerto Rico would be to create a 'super ring' of 1050 nm that would include South and Central Florida, in which we could share organs protecting our locals' high risk in a variance that would add 15 MELD points to our patients with 25 or higher MELD points. We would still export 50% of livers while keeping open the possibility to import in the few cases necessary yearly. If there is no agreement regarding this option we should then favor the 250-500 nm radius that would make be first selection for every donor, knowing that, nevertheless, 50% of donors would then go to National listing. Regarding the Hawaii variance with B recipients drawing O donors, we support the idea of applying it to Puerto Rico. Our B blood type population is 9% which means 3-4 cases a year. In the same way we lost patients with MELDs 25-35, we have lost B patients for lack of donors as they occur so rarely. It should not affect the net donor flow to the continent to keep O donors in those rare occasions for our B recipients. Juan del Rio, MD Surgical Director, Liver Transplant Program Clinical Director, Centro de Trasplante Hospital Español Auxilio Mutuo

Anonymous | 10/31/2018

I am opposed to both models. These will disadvantage patients in my region, many of who come from rural/underserved populations. Regions with lower donor rates will be rewarded. Expediting a change in redistribution policy due to the threat of a lawsuit is not the preferred approach.

Piedmont Atlanta Hospital | 10/31/2018

I strongly believe that each of these proposals for broader sharing will result in an increase in organ waste, as well as an increase in costs associated with organ transplants. In addition, the proposed broader sharing models don't take into consideration the burden of liver disease in a specific population. For example, the incidence of liver disease is more prevalent in South Carolina than New York or Massachusetts, but under the proposed broader sharing model, organs will flow out of South Carolina into New York and Massachusetts. I am totally against this!!

Timothy Fransioli | 10/31/2018

I know that nothing is simple in this life.... but, these measures seem only to make a complicated effort work against those who are most in need

Anonymous | 10/31/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, Liver allocation is currently unfair. Patients in some parts of the country, like me, have to wait much longer, and get much sicker, before they can receive a liver transplant. As a resident of California, and someone who received a transplant, this matter is of particular interest to me. I was within a few weeks of dying before I got my transplant. This has drawn out my recovery because so many of my key systems suffered: mental abilities, orthopaedics, gastrointestinal issues. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot (like me). The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need.

Katie Dokus | 10/31/2018

Livers are a national resource that should be allocated first to those in greatest need. The proposed model that comes closest to fulfilling this idea with greatest reduction in median lab MELD at transplant is the acuity without sharing thresholds, at the greatest distance feasible. Though the modeling shows little change in our center's high median MELD at transplant, I believe the acuity model is a strong step towards more equitable distribution. Due to their distance from other centers, I support the Hawaii variance.

Brian Martin | 10/31/2018

Why are you proposing to steal potential liver organs from someone dying in need of a life saving transplant to give to someone else in the same condition? Is one life worth more in California than Ohio? Why are you not helping Donate Life and other organizations to spread the word about saying YES to becoming an organ donor or fighting for the leglsiation for the 'opt out' program like other countries employ? The problem of there not being enough organs for everyone is NOT solved by stealing from one in need to give to another in need it is solved by increasing the amount of donors. As a organ recipient I am pleading with you to help us promote organ donation through schools, BMV's, and other outreaches. If everyone said YES to being an organ donor the problem of not enough organs goes away. Right?

Harrison Pollinger | 10/31/2018

The current models being proposed by UNOS for liver redistribution are ALL fundamentally flawed. They all reduce the number of transplants and increase organ wastage. They misrepresent the truth regarding waitlist mortality, and claim that shifting organs from one region to another will not adversely affect the region that loses those donor organs. These models continue to propagate the myth that waitlist mortality is greater in New York when compared to the Southeast. This is not true. MELD exception points muddy the truth regarding the severity of illness in the Northeast. This has been shown time and time again, yet it barely gets acknowledged by UNOS and the centers that will benefit from these redistribution shifts. The true geographic disparity lies solely with the poorly performing OPO's in New York. Despite what is at stake, they cannot seem to 'right the ship' when it comes to increasing donation rates. I applaud the team at NYU. The have decided to tackle this problem with comprehensive, strategic, thoughtful and grass roots efforts that have had real impact. Rather than the complain and blame game, NYU has single handedly increased organ donor awareness and donation rates in a very short period of time. We need more transplant centers and OPO's to follow their lead. It will make a real difference, not simply shift organs around and huge costs without net benefit. The only solution that will truly satisfy all of HRSA's entire mission, is a STATE based model that would replace DSA's. This model supports trust between donor families and the communities in which they live. It creates 'buy in' between the transplant center, OPO and community to increase organ donation. The data supports the fact that a state based model decreases organ discards, cost and excessive cold times and travel. A State model accomplishes all of this while still complying with the Final Rule. Thank you for your consideration. All of the redistribution models put forth by UNOS grossly under estimate the adverse impact they will have on the socioeconomically challenged populations living in the Southeastern United States. Most sincerely, Harrison Pollinger DO, FACS Program Director Piedmont Transplant Institute Atlanta, Georgia

Amy Friedman | 10/31/2018

Removing, or at least ameliorating, the disparity in patient access to deceased donor livers based on geographic location must be accomplished both to meet the requirements of NOTA and because it is the right thing to do. While it is easy (and common) to blame OPOs with low consent and/or donation rates, the etiologies are highly complex. Patients must not be made the scapegoats. Those OPOs that abstain from pursuing very marginal organs should also be held accountable for not doing so. For example, the oldest liver (from a 93 year old donor) was recovered and successfully transplanted in New York while many OPOs would not even consider using such an organ. As first recommended by the Institute of Medicine years ago, it is time to move from a culture of blame to a culture of improvement. While we work earnestly to improve donation in the areas with the lowest consent rates let's equalize the pursuit of marginal donors and abstain from penalizing patients. Abolishing the DSA and implementing broader sharing is important, fair, and overdue.

Anonymous | 10/31/2018

Dear Mr. Shepard / Members of the OPTN, For the past two years we have been supporting a beloved member of our family with our prayers and expressions of encouragement and love, while he has struggled with a debilitating liver disease. He lives in California and at last is a candidate for a liver transplant. He has suffered through a number of other illnesses related to his diseased liver. He has been exploring a number of options for receiving a transplant in other states because of the uncertainty of a timely donation in California. He and his spouse should not have to make life changing decisions about finances and relocation in order to accelerate a liver transplant. We have read and agree with the comments set forth and would recommend that the Acuity Circle model be adopted. Sincerely, Curt and Kathy Iverson Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. As a resident of California and someone (with liver disease or who has someone close to me with liver disease, who has received a transplant or has someone close to me who has received a liver transplant) this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need.

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas to more affluent areas of the country, most notably New England states including New York and Massachusetts. 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care access. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care access. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Baylor St. Luke's Medical Center | 10/31/2018

The Acuity Circle Allocation model is consistent with our philosophy of ensuring that the sickest patient(s) receive the liver offer. Due to our geographic location in Houston, the B2C allocation model has a tighter distribution and is more restrictive than using the current DSA allocation system. A large portion of the circle encompasses the Gulf of Mexico, therefore the B2C model has the potential to allow a patient with a low MELD (as low as 15) to receive a liver offer while a patient with a MELD of 30 or 31 is passed over due to the impact of a geographic location.

Malay Shah | 10/31/2018

This comment is in response to a post made by Boies Schiller Flexner, LLP. By their own statements, BSF is the law firm representing the Plaintiffs in Cruz et al vs. US Department of Health and Human Services (SDNY 8-CV-06371-AT). Their statement is lengthy and has been submitted on behalf of the Plaintiffs. I would like to point out one particular statement they have made: 'An optimized system that saves more lives with fewer transplants is preferable to a system that does more transplants but results in more waitlist deaths.' I am having a significant problem understanding the statement made in this context. This statement is concerning because this does not compute with the laws of logic. How can more lives be saved nationally by doing fewer transplants? Considering the location of the Plaintiffs in New York, California and Massachusetts, the statement would be more accurate had it been written as such: 'An optimized system that saves more lives in NY, CA, and MA, with fewer transplants performed NATIONALLY, is preferable to a system that does more transplant NATIONALLY but results in more waitlist deaths in NY, CA and MA. To the UNOS Board of Directors: is this a question of the best practices and best policies on a national basis and for the greater good? Or is this for the greater good of certain geographic areas of the country at the expense of remainder of the nation? The Final Rule 121.8(a)(5) (Allocation of Organs, Policy Development) states that any policy development 'shall be designed to avoid wasting organs'. Both proposals lead to a decrease in liver transplants and increased organ discard rates (increased wastage), and should be considered non-starters. It also seems to be highly questionable as to whether additional lives will be saved from either proposal. Outside of the simple mathematics of lives and liver transplants in a zero-sum 'game', we must again ask the question the waitlist mortality data. SRTR has indicated that they did not calculate waitlist mortality based on accepted methodology. By not including patients removed for being 'too sick for transplant' in calculations, SRTR has abandoned their typical data analysis methods used to calculate waitlist mortality for publicly released data. I wonder what true waitlist mortality data would look like had the standardized methodology been used? And it begs the question about how waitlist mortality was calculated in previous models, including the model passed last year.

CHI Baylor St. Luke's Medical Center | 10/31/2018

Implementing a geographic boundary of 150 mile circle, in Region 4, would cause a great disparity in the availability of organs for the transplant centers in Region 4. With this in mind, B2C 32 would be a huge step backwards and would allow arbitrary circles and geographic boundaries to determine which patients would receive liver offers.. Region 4 is quite large and the implementation of acuity circles would better serve the patient population. By implementing acuity circles in Region 4, there would be a decrease in MELD variation at transplant, an increase in the rate of transplant and the number of livers procured for transplantation, a decrease in the waitlist mortality rate, all while only increasing the cold ischemic time by 10 minutes. A geographic region does not justify a patient with a MELD of 15 being transplanted before a patient with a MELD of 31.

Anonymous | 10/31/2018

It looks like this will take organs out of areas that are poor and provide them to areas that are more affluent. SC has 3-5x higher waiting list mortality than NY and Mass who would benefit from these proposals.

Anonymous | 10/31/2018

Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.

Anonymous | 10/31/2018

Nautical miles make much more sense than the regional method. Variances for Hawaii and Alaska must be considered.

Anonymous | 10/31/2018

I believe the livers that become available in the Texas Oklahoma region should go to recipients within that region. Bypassing individuals in this region to send organs to other states does a disservice to recipients on the waiting list. Texas is such a vast state that limiting the area in which one can be eligible for a liver transplant will cause many possible recipients to wait longer or not receive the livers that they require to lead normal lives.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care or an impoverished population (like Cleveland). Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.

Michael E. DeBakey VA Medical Center Liver Transplant Program | 10/31/2018

The liver transplantation program at the Michael E. DeBakey Veterans Affairs Medical Center strongly opposes the broader 2-circle proposal for liver allocation. Veterans are disproportionately plagued with hepatitis C and hepatocellular carcinoma. Access to liver transplantation is provided through the VA system to all eligible veterans regardless of their financial resources at one of six sites in the United States. Of those centers, ours is one of three free-standing programs. Patients are referred to us from across the country. Looking historically at our recipients with chronic liver disease transplanted at MELD scores less than 32, distance between donor and recipient hospitals was greater than 500 nautical miles in 10% of patients, between 250-500 miles in 5% of patients, and between 150-250 miles in 37% of patients. Further, our program geographically exists near the gulf coast and is in close proximity to several other large transplant programs. By limiting access to donor offers by very short distances from donor hospitals, the broader 2-circle proposal as currently written would disenfranchise a considerable number of veterans on our list awaiting transplant. We believe broader sharing will provide a more equal playing field for our waitlisted patients. Of those plans under consideration, we believe the acuity model at 300 and 600 nautical miles best accomplishes this goal.

Anonymous | 10/31/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 10/31/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 10/31/2018

I have signed my drivers license as a donor as have many others in the Midwest. I understand that in other regions fewer people are willing to be donors. The public in those regions need more information and education so they also become willing to be donors. Please do not take the organs from our region to fill gaps far from here. I support keeping the donor areas the same size or making them smaller. Work and give locally. Thank you

Anonymous | 10/31/2018

The proposed broader sharing models do not consider the overall burden of liver disease in a population.

Anonymous | 10/31/2018

I support the Broader 2-Circle organ distribution model because this will allow for more in state acquired organs to remain within LA. This model will also allow for shorter cold ischemic time of DCD organs, supporting better recipient outcomes and organ function.

Gazi Zibari | 10/31/2018

I am a transplant surgeon and have been practicing since 1993 at JCM Regional Transplant Ctr, WKHS. As a young Transplant Surgeon, I attended many SEOPF and UNOS regional meetings with my mentor Dr John C McDonald. I was very impressed with openness of UNOS and the way their members were permitted to discuss all proposals and they voted very freely and democratically. Unfortunately, lately UNOS leadership has been forcing certain unjust polices about organ allocation down her members throats. At times, I feel this must be a nightmare, as if I am back in Middle East where there is no democracy exists! More importantly, UNOS need not to waist so much time, energy and resources to airlift so many organs from one coast to other. UNOS, CMS and Transplant Community should get united and focus on how to go about to increase number of organ donors. Very sadly, each of these proposals for broader sharing will not only increase organ wastage and increase logistical complexity, but also, it will dramatically increase flying, costs and put transplant organ recovery team's life at risk by flying far distances. Additionally, it predicts that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as rural Louisiana to affluent areas of the country, most notably in North East. Also, The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states like Louisiana with diminished access to healthcare. More importantly, the proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. Respectfully, Gazi B Zibari, MD, FACS Director, JCM Regional Transplant Ctr WKHS Shreveport, Loisiana

Jon Hundley | 10/31/2018

I am writing to oppose the proposed models for liver redistribution and to endorse a state-based model to replace DSAs.  I do so with a heavy heart, knowing that this request for public comment is merely a formality as UNOS leadership has positioned these fixed-distance options as the only viable solution.  This decision by UNOS will lead to outrage in areas that are already plagued by poverty, poor access to healthcare, and significantly higher levels of liver disease.  That outrage will lead to many more lawsuits and negative media which will undoubtedly hurt the public's faith in our system and lead to widespread decreases in organ donation.  In the end, we will all lose.     At a transplant meeting in Colorado this Spring, a New York transplant physician stood up in the general session and quoted the per capita dollar amount that New York contributes to Medicare compared to how much New York uses and compared it to the same in South Carolina: New York is much wealthier and contributes far more than it receives; the inverse is true for South Carolina.  He concluded with this audacious statement: 'South Carolina owes New York livers'.  Even those present who supported broader liver allocation were sickened by this comment.  How could you possibly justify transporting livers from one state to another simply because one state is poor and the other rich?  And yet, that is exactly what broader 'sharing' does.    Liver failure patients from affluent states have better access to all aspects of quality healthcare, a higher chance of being listed for a liver transplant, and much better survival at a given MELD score than a similar patient in a poor state.  That last point is perhaps the most critical in this entire debate, and one that has been ignored by UNOS leadership.   A patient living in rural South Carolina with a MELD score of 20-25 has a much higher risk of death than a patient with a MELD score of 26-30 living in Manhattan.  Prior to any implementation of broader sharing, it would be immoral for the UNOS board to close their eyes to this truth.  The MELD score must be replaced by a scoring system that actually predicts the individual patient's risk of death.  Shipping even one liver from rural South Carolina to a patient in Manhattan with a MELD score of 29 instead of the rural patient in South Carolina with a MELD of 23 would be unconscionable (not to mention the Manhattan patient with a MELD exception score of 29 for pruritus).     A simple solution to acquiesce to HRSA's demand that DSAs be removed is the state-based model proposed by Dr. Lynch in the Region 3 meeting.  This model received 87% support but was not discussed in other regions.  The model that was passed in December 2017, after years of debate, could be easily tweaked to change 'DSA' to 'state'.  This model would decrease liver discards, decrease cost, preserve the sacred trust between donor families and their communities, and most importantly avoid the unfair allocation of organs based on MELD scores whose mortalities shift as state lines are crossed.     As previously stated, my primary opposition to the proposed model is that crossing state lines with the current MELD score system discriminates against those living in poor, underserved areas.  There are many other reasons to oppose these models:    1. These models reduce the number of transplants.     2. These models increase organ wastage.    3. These models will greatly increase cost which will, in the long run, lead to patient deaths as smaller transplant centers will have to close.  For historical context, look at the tremendous improvement in care of Mississippi residents when a liver transplant center opened there.    4. As others have pointed out, the SRTR modeling makes no sense.  How can so many DSAs lose huge numbers of organs without increase in their waitlist mortality?      5. Livers will flow from areas with high performing OPOs to areas with low performing OPOs.  This will be most evident in the Northeast: from 1/1/18 through 9/30/18, Gift of Life (Philadelphia) generated 144.9 organs transplanted per million people in their DSA while NY Organ Donation Network generated less than half that number (69.1) and New England Organ Bank only 83.1.       6. These models lead to livers flooding into the region with the lowest waitlist mortality in the country.  Even to the most uninitiated observer, this is ridiculous.      7. The argument that equalizing median allocation MELD at transplant across the country should be paramount is tremendously flawed.  First, we all agree that New York's high MELD scores are driven significantly by Region 9's aberrant practice of granting non-traditional exception scores.  Second, center specific behavior plays a huge roll in this.  Dr. Kroome said it best in a recent issue of Liver Transplantation: 'If the only motivation for a patient to migrate was to seek a center with lower MELD scores at transplant, a taxi cab to the other side of Manhattan is likely a cheaper option than an out-of-state plane ticket'.  Any problem that would be solved in three years by replacing less progressive liver surgeons with more progressive ones can't be called a problem of 'geographic disparity'.

Anonymous | 11/01/2018

We should not have to share with a bigger population. That just puts our local patients at a lower risk of getting an organ and that could be the end for them. We should keep it the same.

Anonymous | 11/01/2018

My father in law received a liver transplant several years ago in NY. In understanding how the MELD allocation works, I think this proposal will be very sad for patients in many areas of the United States. I live in the Southern part of Texas and think 150miles is too small of a radius of this area as it cuts out many populated donor areas that bring organs to patients in this area now. A minimum of 250nmi should be considered.

Virginia Garza | 11/01/2018

As a recent transplant recipient from South Texas, I had to be very sick before receiving my transplant. Patients in this area need access to more organs than a 150 mile radius offers or they will not survive.

Rene Garza | 11/01/2018

As the spouse of a liver transplant recipient, we do not feel restricting the Houston area to a 150 mile radius is a reasonable proposal given the golf of Mexico is included in half of the radius. Patients in this area already wait for liver transplants until their MELD score is over 30 which means patients are very sick. A minimum of 250 miles should be considered.

Linda Devries | 11/01/2018

As a family member and caregiver to a liver transplant recipient, a 150 mile radius around the Houston area is not acceptable for patients. A MELD score of 32 is too high for patients to be transplanted.

Gary Devries | 11/01/2018

As a liver transplant recipient from the Houston area, this proposal does not benefit our area at all. Please consider a 250 mile radius instead of a 150 mile radius.

University of Washington | 11/01/2018

The B2C proposal more closely approximates the 150 mile circle proposal approved by the Board, yet overturned by Lawyers threatening litigation based on their interpretation of one factor of the Final Rule. The Acuity Circles of 250+500 are unacceptable since the resultant flow of large quantities of liver grafts will adversely affect our community and increase deaths on the waitlist; interestingly, the SRTR has found a way to show otherwise. Our mission as physicians and surgeons remains what motivated us to care for patients, patients we 'see' everyday. These patients are located within communities, in cities, and regions that form a safety net for them based on the hospitals, care providers, payers, and in our specialty organ donors; all of these factors which, it would seem, the Lawyers, the Geography Committee, and UNOS would try to negate. Here are more concerns, succinctly: -I am concerned with how the present process reflects a governance struggling with their mission, -The models and data are poorly studied, except for the obvious benefit to specific areas of the nation. -Negating waitlist deaths (so poorly done) only enhancing the emphasis on allocation MELD as the only factor of importance, a MELD with exceptions which does not accurately reflect medical urgency. Only the Lab MELD does. -Organ donation and transplantation saves lives; only the Lab MELD can measure this impact. MELD by exception has been an impossible concept to give up, prompting the concept of a National Liver Review Board which has not been tested.

Robert Watson | 11/01/2018

Hello Unos, I also sent an email. My understanding is that the availability of livers to those who need them is determined more by geography than by need.If true, this unfairly puts those with a higher need at a higher risk for complications or death while they wait. Further, those with more financial resources can travel to where the wait list is short and therefore better position themselves. Again, not based on need. However, I understand there are different allocation models being looked at and I hope that means more of a level playing field going forward. I've heard the Acuity Circle Model accomplishes needed improvements and hope that is under consideration. I have liver disease and working on qualification for a transplant here in California. Without access my quality of life will continue to decline and then I will die. Therefore, clearly an issue near and dear to me. Thanks very much and I appreciate my voice being heard. Best Regards, Robert Watson

Bella Gonzalez | 11/01/2018

As a family member of a transplant recipient, this proposal does not benefit patients in South Texas. Patients are transplanted with high MELD scores in this region and this proposal will restrict the number of donor organs for patients who need transplants.

Gregory Reich | 11/01/2018

As a liver recipient from the Houston area, this proposal will limit the number of livers offered to our area. Patients will wait longer for organs. A 250 mile radius should be considered.

Anonymous | 11/01/2018

For over five years I have had the pleasure of knowing and becoming great friends with my coworker. A couple years ago his husband became ill and is now in need of a transplant. I have watched the pain he has gone through with multiple hospital visits and the constant unknown of what is going to happen next. They deserve the opportunity to have access to a larger network. This will give those we love and care about hope. I urge you to please vote to adopt the Acuity Circle Model for liver allocation.

Anonymous | 11/01/2018

This seems more costly and could cause more organ wasting.

Anonymous | 11/01/2018

I have a great deal of concern for the broadening of sharing as I feel that this will ultimately result in increases in flying of organs, which will increase cost of transport, as well as more organ waste and the added complexity of logistics. Additionally, these models do not appear to take into consideration that MELD is limited in predicting waiting list death in rural vs. urban populations.

Anonymous | 11/01/2018

Promoting organ donation is the most common sense way to increase the opportunity for transplantation equity.

Anonymous | 11/01/2018

Broader sharing will increase organ wastage, logistical complexity and flying costs,. The net effective of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas. Broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs urban populations. Broader sharing models do not consider the overall burden of liver disease in a population. Sharing models do not have protections for transplant centers that serve regions with poor health care. States with the best health care and the highest waiting list rates will benefit the most from these proposals at the expense of the residents of states with diminished access to healthcare. The proposed models do not evaluate variation in OPO performance.

Anonymous | 11/01/2018

1. I strongly OPPOSE both proposals. 2. Broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality (like Kentucky and many other states) to states like New York, which have the LOWEST waitlist mortality. This is in violation of the Final Rule 121.4. 3. Broader Sharing will lead to increased organ wastage, increased flying and costs, all in violation of Final Rule 121.8

Anonymous | 11/01/2018

Models predict that the effect of the allocation proposed will move organs out of socioeconomically disadvantaged areas to more affluent ones; this is the reasoning for the recommendations and opposition expressed above.

Charles Smoot | 11/01/2018

Dear Mr. Brian Shepherd, I am writing as a primary physician in California treating many people for active Hepatitis C as well as many patients with cirrhosis and end-stage-liver-disease from a variety of causes. The sickest patients need access to liver transplants most quickly. Currently it is not fair that some parts of the country have to wait longer and be sicker to qualify for a liver transplant, as those waiting longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. Even more egregious is that some patients with financial means get on different waitlists in different parts of the country - not only giving them an unfair advantage compared to those who cannot afford it but also 'clogging up' waitlists with people who are already on a waitlist somewhere else. I feel that the Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. I urge your vote to please adopt this model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely, Bart Smoot, MD San Diego, CA

Indiana University Health; The University of Kansas Health System; Vanderbilt University Medical Center; Washington University in St. Louis/Barnes-Jewish Hospital Transplant Center | 11/01/2018

Comment Regarding OPTN's Public Comment Proposal Liver and Intestine Distribution Using Distance from Donor Hospital (the 'Proposal') October 30, 2018 Indiana University Health, The University of Kansas Health System, Vanderbilt University Medical Center, and Washington University in St. Louis/Barnes-Jewish Hospital Transplant Center (collectively referred to in this comment as the 'Centers') strongly oppose the Proposal because it fails to comply with the requirements of the National Organ Transplant Act ('NOTA') and the Final Rule governing the operation of the OPTN (63 Fed. Reg. 16,296 (Apr. 2, 1998), codified at 42 C.F.R. Part 121), as promulgated by the Health Resources and Services Administration ('HRSA'). I. BACKGROUND For several years, the liver transplant community discussed and debated the best way to allocate the scarce resource of donated livers. During this debate, many raised concerns regarding the differences in performance of regional Organ Procurement Organizations ('OPOs'), which resulted in fewer organs being available in low-performing OPO regions as compared to other regions. Some members of the community urged the OPTN to focus on broader sharing of organs as a national resource, while others argued for improved OPO performance and expressed concerns regarding increased transportation of organs leading to increased wastage and a decreased number of overall transplants. Finally, in December 2017, after protracted deliberations among transplant experts as well as input from the general public, the OPTN Board of Directors approved a policy that most members of the community agreed was a reasonable compromise. Now less than a year later-before the approved policy has even taken effect-there is a rush to change the very allocation model that was the result of so many years of hard work. As the Proposal explains, the policy revision's limited timeline was established in the immediate aftermath of a so-called 'Critical Comment,' as described in 42 C.F.R. § 121.4(d), which challenged the use of DSAs in liver allocation.(1) In response to this comment, HRSA directed the OPTN 'to adopt a liver allocation policy that eliminates the use of DSAs and OPTN Regions and that is compliant with the OPTN Final Rule' (Proposal at 5-6) (emphasis added). HRSA further directed the OPTN to approve a revised liver allocation policy by its December 2018 Board meeting (Proposal at 6). The Centers appreciate the criticisms against DSAs, but the appropriate solution is not to hastily cobble together an allocation policy that itself fails to comply with the Final Rule. The Centers are gravely disappointed that all of the simulated allocation models are projected to decrease the total number of liver transplants performed in the United States. The Proposal purports to respond to HRSA's direction to eliminate the use of DSAs and Regions in the allocation model, but rather than being tailored to address this issue, the Proposal focuses disproportionately on reducing variances in median MELD at transplant, a severely flawed metric that the OPTN uses 'to assess whether transplant candidates have equal access to transplant' (Proposal at 19). At best, the Proposal modestly furthers its stated goals while simultaneously laying the groundwork for continued litigation from both the current plaintiffs as well as additional claimants who could fairly argue that the proposal, if accepted as policy, is arbitrary and capricious. II. THE CENTERS ARE UNABLE TO SUPPORT THE PROPOSAL BECAUSE ALL OF THE PROPOSED ALLOCATION MODELS ARE LEGALLY UNTENABLE. The Centers are unable to support any of the models described in the Proposal because the OPTN has failed to follow the Final Rule, which requires that an allocation policy be designed to avoid wasting organs, promote the efficient management of organ placement, and promote patient access to transplantation. Instead, the OPTN has been driven by reducing regional variances in median MELD at transplant, which is an inherently flawed metric that does not assist the OPTN in complying with the Final Rule. A. Each scenario modeled for the Proposal reduces the number of transplants, increases organ wastage, and delays donor surgeries. Under the Final Rule, allocation policies must, among other things, 'seek to achieve the best use of donated organs' and 'be designed to avoid wasting organs.' According to the SRTR modeling,(2) all proposed scenarios reduce the average transplant count nationally, which flagrantly contravenes the stated goals of UNOS, the regulatory requirements, and HRSA's direction that the OPTN adopt a policy that is compliant with the Final Rule. The OPTN states that the Committee 'could not support an allocation plan that would be very likely to decrease the number of organs transplanted' (Proposal at 8), and yet, the proposed policy itself is expected to decrease the number of transplants from 6651 to 6616, or possibly even fewer if the MELD sharing score is dropped to 29, a proposal that was not even modeled and that the SRTR does not plan to model prior to the OPTN's Board of Directors meeting in December 2018.(3) With over 13,000 patients waiting for a liver transplant, the Centers cannot support a Proposal that is expected to decrease the number of those patients who will receive a transplant.(4) The Proposal's recommended model (Scenario 6 in the SRTR Analysis) increases the percent of organs flown from 50.7% to 60.8% and increases the median transport distance from 88.5 miles to 117.1 miles, when compared to the current policy. Increased travel, particularly air travel, will increase organ wastage and thus is contrary to the Final Rule's requirement that allocation policies avoid wasting organs and promote the efficient management of organ placement. 42 C.F.R. § 121.8(a)(5). Marginal organs are less likely to be accepted and transplanted when cold ischemic times are prolonged due to longer travel distances. As travel increases, more programs will be required to rely on unaffiliated teams to procure organs, which could negatively affect clinical outcomes. Allocation modeling does not have the ability to predict discards (Proposal at 8) and thus cannot precisely predict how an increase in travel will affect transplant counts, but part of the predicted decrease number in organ transplants is an anticipated increase in discards. Greater travel also increases risks on the procurement teams that must travel to remote locations in small aircraft, often in the middle of the night, regardless of weather conditions. A 2009 study reported that 27 members of procurement teams had died in procurement air travel in recent history and estimated that the risk of fatality while traveling on an organ procurement flight was 1000 times higher than traveling on a scheduled commercial flight.(5) Another factor not modeled or considered by the Proposal is the effect a policy change may have on donor families. After the change to the lung allocation policy, transplant centers reported delays in procurement surgeries of up to several days while waiting for each individual candidate's care team to make a decision to accept or decline the organ offer. Previously, when there was some local coordination by the OPO, such delays were reduced or eliminated. With broader sharing, there is less coordination in organ offers, which could result in excruciating delays for families who have already made a difficult decision to say goodbye to a loved one. Some families may even decide to forego organ donation entirely rather than wait for an acceptance of the organ. Obviously the transplant community must treat donor families with great care and respect, and any revised policy should be monitored for its effects on donors as well as recipients. Of the scenarios that were modeled, the Centers regard the broader 2-circle model with the sharing threshold at 35 (labeled as 'Scenario 5' in the SRTR modeling) as the least harmful and least disruptive to the allocation model that was approved by the OPTN Board of Directors in December 2017. Although the Centers believe that Scenario 5 is the least objectionable, the Centers are unable to support any of the Proposal's models in light of the OPTN's failure to comply with the Final Rule's requirements. B. The Proposal fails to properly consider socioeconomic inequities, and the OPTN's overly narrow interpretation of 'patient access' is inconsistent with legislative and regulatory intent. The Proposal recognizes that an agency's rulemaking is arbitrary and capricious if the agency 'entirely fail[s] to consider an important aspect of the problem' (Proposal at 3; see Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). Yet the Proposal itself fails to consider a critically important aspect of liver allocation and the OPTN's obligations under the Final Rule-reducing socioeconomic inequities and promoting patient access to transplantation. 1. The Proposal addresses socioeconomic inequities only of those individuals already on the waitlist and incorrectly states that the OPTN does not have a responsibility to promote patient access to transplantation for all patients with end stage organ failure. Under the Final Rule, the OPTN Board of Directors is responsible for developing policies that further the OPTN's mission, including 'policies that reduce inequities resulting from socioeconomic status.' 42 C.F.R. § 121.4(a)(3). Such policies must include the '[r]eform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities.' 42 C.F.R. § 121.4(a)(3)(iv) (emphasis added). In addition, under Section 121.8, the OPTN Board of Directors is instructed to design organ allocation policies 'to promote patient access to transplantation.' Therefore, when developing allocation policies for any organ (not just liver), the law requires the OPTN (i) to consider how the organ allocation policy will affect those who are socioeconomically disadvantaged, (ii) to reform the allocation policy in a way that reduces socioeconomic inequities, and (iii) to design the allocation policy in a way that will advance patient access to transplants. The Proposal acknowledges that under the Final Rule, 'the OPTN shall develop allocation policies that 'promote patient access.'' (Proposal at 31). Yet the Proposal then expresses the OPTN's incomprehensibly narrow interpretation of 'patient' by stating: '[T]he OPTN has interpreted these requirements to apply to patients who are registered for organ transplantation - as opposed to all patients with end stage organ failure, who may or may not be registered for organ transplantation.' Following this narrow interpretation, the proposed liver allocation policy has not been designed to promote 'patient' access to transplantation, but rather has considered access to transplant only for those candidates already on the waiting list. This interpretation is wholly inconsistent with the plain language and intent of the Final Rule.(6) As quoted above, the Final Rule states that the OPTN shall design allocation policies 'to promote patient access to transplantation.' 42 C.F.R. § 121.8(a)(5). The term 'patient' is not defined by the regulation, but a 'transplant candidate' is defined as 'an individual who has been identified as medically suited to benefit from an organ transplant and has been placed on the waiting list by the individual's transplant program.' 42 C.F.R. § 121.2 (emphasis added). If the Final Rule intended 'patient access' to be limited to those already on the waitlist, it would have used the word 'candidate' instead of 'patient.' In fact, HRSA used the word 'candidate' later in the same rule-in paragraph (a)(8), the text sets forth that allocation polices '[s]hall not be based on the candidate's place of residence, or place of listing, except to the extent required by paragraphs (a)(1)-(5) of this section.' According to legal canons of construction, when different words are used in the same statute or rule, a different meaning is conveyed by each word.(7) Therefore, under paragraph (a)(5), the OPTN is instructed to design allocation policies that promote all patients' access to transplantation (not just access for those on the waiting list). Under paragraph (a)(8), allocation policies should not be based on the candidate's place of residence, except as otherwise required by the rule, including to the extent such geographic considerations might be apposite to promote patient access to transplantation. Moreover, the legislative and regulatory history make clear that the government intended the OPTN to develop policies that consider socioeconomic factors affecting access to the waitlist, not just candidates' access to organs once waitlisted. For example, when describing Section 121.4(a)(3) in the preamble guidance published with the Final Rule, HRSA stated that a provision was added to the rule in response to issues raised at a public hearing. This new provision was to require that 'the OPTN modify or issue policies to reduce inequities resulting from socioeconomic status to help patients in need of a transplant be listed and obtain transplants.' 63 Fed. Reg. 16,296, 16,309 (Apr. 2, 1998). Shortly after this guidance and the Final Rule were released, Congress intervened and suspended the rule's implementation until October 21, 1999 because of concerns from the transplant community as well as the general public.(8) During hearings on the matter, legislators and witnesses expressed concerns about the so-called 'green screen,' which was a term used to describe the inability of low-socioeconomic status individuals to access the waiting list, particularly for extra-renal transplantation that was not necessarily covered by Medicare.(9) As part of the public debate, Congress asked the Institute of Medicine ('IOM') to conduct a study on the potential impact of the Final Rule.(10) Among other things, Congress asked the IOM to examine 'access to transplantation services for low-income populations and racial and ethnic minority groups' (IOM Report at 3). In its report, the IOM expressly considered both access to the waiting list as well as access to organs once candidates were waitlisted. Under the heading 'Factors Affecting Access,' the IOM begins by referring to '[f]actors that might influence waiting list entry' (IOM Report 41). According to the report, once a patient was placed on the waiting list, socioeconomic status had little influence on whether a patient received a transplant. Rather, the 'primary barrier' in access to transplantation 'for poor people as a group was gaining access to the waiting list.' Id. More specifically, the IOM explained that '[l]ower access by African Americans to kidney transplantation is well documented. Much of the disparity appears to be due to the fact that African Americans are not placed on waiting lists as quickly, or in the same proportion, as their white counterparts' (IOM Report at 40). For liver transplants, the IOM reported 'that African Americans enter the list and receive liver transplants when they are sicker, relative to other racial groups.' Id. The Report concluded that 'initial access to health care and to referrals for transplant evaluation is an important impediment for African Americans with liver disease.' After reviewing the IOM Report, at the end of the Congressionally-imposed suspension of the Final Rule, HRSA released an amendment to the Final Rule, which included the language at issue here from Section 121.8(a)(5) requiring that allocation policies 'promote patient access to transplantation.' In promulgating the amendment, HRSA stated that it 'relied heavily on the guidance in the IOM report.' 64 Fed. Reg. at 56,650. The rulemaking also explains that paragraph (a)(5) was added specifically in response to 'an issue Congress asked the IOM to address.' Id. at 56,656. Congress had significant concerns about the ability of low-income populations and ethnic minority groups to have access to transplantation services. In supporting implementation of the amended Final Rule, Congress directed the OPTN and HRSA to carefully weigh the impact of socioeconomic factors in accessing transplantation services, including access to the waitlist. It is inconsistent with the intent of NOTA and the Final Rule for the OPTN to ignore the disparities in access to health care for end-stage organ failure, including access to the waitlist, when developing organ allocation policies. Because the OPTN has entirely failed to consider an aspect of the problem that Congress deemed vital and is required to be considered under the Final Rule, the Centers believe the Proposal to be legally untenable and thus not worthy of support. 2. The law requires the OPTN to develop policies that reduce socioeconomic inequities, but the Proposal considers only candidates' socioeconomic characteristics, and even then ignores data in the SRTR Analysis that indicates candidates in lower-socioeconomic status, higher-risk communities will suffer under the Proposal's recommended allocation model. Perhaps because of the OPTN's narrow interpretation of 'patient access to transplantation,' the Proposal takes a similarly narrow approach to its consideration of socioeconomic inequities in assessing the allocation models. For example, the only substantive discussion of socioeconomic inequities in the Proposal describes the Cumulative Community Risk Score ('CCRS') analysis as seeking 'to determine the effect on candidates living in counties with differing socioeconomic characteristics' Id. (emphasis added). Like the OPTN's interpretation of patient access, this approach is also inconsistent with the Final Rule. As explained above, both the legislative and regulatory history demonstrate Congress's intent for the OPTN to consider socioeconomic inequities for patients accessing the waitlist, not just for those who are listed as transplant candidates. Although the Proposal briefly addresses the OPTN's narrow view of socioeconomic considerations, the Proposal fails to even hint at how the proposed policy reduces socioeconomic inequities, as required by the Final Rule. See 42 C.F.R. § 121.4(a)(3) (requiring the Board of Directors to develop policies 'that reduce inequities resulting from socioeconomic status'). Moreover, the Proposal ignores significant detrimental effects demonstrated in the SRTR modeling that the proposed scenarios have on high-risk CCRS communities. Of course, as the Proposal points out, not every transplant candidate, recipient, or patient who lives in a high-risk community is a 'high-risk' individual. But that limitation alone does not provide reason to ignore the impact an allocation policy would have on a higher risk community. If the OPTN had properly considered the CCRS data from the SRTR models, it would have noted that, when compared to the December 2017 Board approved policy, all of the modeled allocation scenarios show an increase in transplant rates for the lowest risk CCRS communities and a decrease in transplant rates for the highest risk communities (SRTR Analysis at 287). This decrease was especially significant in the Acuity Circle models. There are similarly concerning effects in looking at post-transplant mortality, where the SRTR Analysis shows the proposed models have little effect on post-transplant mortality in low-risk CCRS communities, but an increase in post-transplant mortality rates for the highest risk CCRS communities (SRTR Analysis at 311). Such data suggests that the Proposal not only fails to reduce socioeconomic inequities, as required by law, but the Proposal actually appears to increase socioeconomic inequities regarding access to transplantation, even if 'access' is limited to the OPTN's unlawfully narrow scope and considers the effects only on those individuals who are on the waiting list. These defects are further illuminated by analyzing the models from a regional perspective. Notably, the states with the highest mean of CCRS risk scores (i.e., the states with the greatest number of high-risk communities) are in Regions that will have transplant counts reduced by the Proposal. Based on modeling from kidney research, Region 3 and Region 11 have some of the highest average CCRS risk scores;(11) yet, the transplant rates and transplant counts for both of these Regions decrease under the proposed models (SRTR Analysis at 50, 58, 61, 69). By contrast, transplant rates and counts for Regions 1 and 9 increase, and on average, these Regions have the lowest CCRS risk scores (SRTR Analysis 48, 56, 59, 67). Professional analyses outside of the SRTR Analysis also describe the challenges that lower socioeconomic communities face and the relevant considerations for organ allocation policy development. One study found that end-stage liver disease patients living in communities with higher CCRS scores had a significant increase in overall mortality risk and that higher CCRS scores were statistically correlated with lower waitlist survival.(12) Moreover, regions that are typically viewed as having 'excess' organs to share with other regions that have a higher median MELD at transplant in fact have waitlist mortality rates nearly twofold higher than those regions that stand to benefit from broader sharing.(13) Among the general population in high-risk CCRS communities, the death rate from end-stage liver disease is almost twice that of communities in the lowest risk tier, but fewer candidates are listed in high-risk CCRS communities for each person dying from liver disease, suggesting an inequity in access to the waitlist. Other studies have shown that lower socioeconomic status patients with hepatocellular carcinoma have delayed access to the waitlist.(14) If the OPTN were seriously to consider the cumulative effect of allocation policies on socioeconomic inequities, as required by 42 C.F.R. § 121.4, and to promote patient access to all stages of transplant services, as required by Section 121.8, it may reasonably conclude that organ allocation policies could lawfully consider a candidate's place of residence, as such residence relates to access to care and socioeconomic inequities.(15) In Section 121.8(a)(8), the Final Rule expressly permits consideration of a transplant candidate's place of residence to the extent necessary to, among other things, achieve the best use of donated organs and promote patient access to transplantation. Seeking to achieve these goals and reduce socioeconomic disparities, a lawful and equitable liver allocation policy could result in a greater number of organs being made available in states with higher waitlist mortality rates and lower overall access to quality health care. The 'best use' of a liver donated in a socioeconomically depressed region may reasonably allocate that liver to another patient in that region, even if such a patient has a slightly lower MELD score than another patient in a socioeconomically advantaged region. Yet contrary to its legal obligations, the OPTN has entirely failed to consider how these socioeconomic inequities should affect liver and other organ allocation policies. C. Median MELD at transplant is a flawed metric to assess the severity of a patient's illness and the geographic equity of a liver allocation policy. As noted above, in addition to removing DSAs and Regions from the allocation policy, the Proposal's stated primary goal is to 'reduce the variance in geographic disparities to access' (Proposal at 7). The OPTN states that it intends to accomplish this goal by reducing the geographic variance in median allocation MELD at transplant or 'MMaT' (Proposal at 19). Ironically, the OPTN relies on variances in MMaT across DSAs to conclude that livers are allocated unfairly based on a candidate's place of residence.(16) In so doing, the Proposal is intellectually inconsistent. On the one hand, the OPTN states that DSAs may not be considered when forming allocation policies; but, on the other hand, the OPTN relies on those exact same geographic boundaries to measure MMaT 'disparities.' For example, in describing the current 'disparities,' the Proposal notes that the nation's lowest MMaT was 20 in the Indianapolis area DSA while the highest MMaT was 39 in the Los Angeles area DSA (Proposal at 4) (citing New York plaintiff's attorney Motty Shulman, Letter to Sec. Alex Azar, May 30, 2018). If it is inappropriate to use DSAs or Regions in allocation policymaking, then it must also be inappropriate to use the MMaT of a DSA or Region in any such policymaking. The OPTN appears to assume that a lower MMaT in one region means that healthier patients in that region are unfairly being transplanted while sicker patients who happen to live in another part of the country remain on the waitlist. But this assumption ignores fundamental realities of liver transplantation. First, a truly equitable system must consider non-clinical risk factors for death, which research has shown may explain more variation in outcomes than many factors considered clinically relevant.(17) MELD was intended to reflect the patient's severity of illness and likelihood of mortality, but if, as discussed above, mortality risk is actually affected by some combination of severity of illness and socioeconomic factors, including the ability to access quality health care, then an infrastructure designed to reduce the variance in median MELD at transplant is addressing only half of the problem. A policy that achieves 'the best use of donated organs' must take into consideration the reality that non-clinical factors also affect a patient's mortality risk. Second, an overemphasis on MMaT as the primary metric indicative of geographic equality ignores the reality that surgical practices are a significant factor in MMaT variances. Not all donated organs are of equal quality, and in addition to basic donor-recipient matching considerations, some transplant programs are willing to use higher risk (or marginal) organs. Transplant programs that are more aggressive usually use such marginal livers in lower MELD patients because it is thought that those marginal organs may be successfully transplanted to healthier recipients who can better tolerate a poor initial function of the liver graft.(18) Programs that are successfully able to use these marginal organs may have a lower MMaT than those programs that use higher quality organs on sicker patients, but this does not necessarily mean that there is an unfair allocation of the organs. The OPTN acknowledges the likelihood of marginal organs affecting MMaT but only in the context of organs that are accepted from donor hospitals more than 500nm away. The Proposal recommends that these organs be excluded from MMaT calculations because they are likely 'more aggressive transplants' and 'including them in the MMaT calculation could potentially serve as a disincentive to use [] these organs' (Proposal at 24). The OPTN recognizes that marginal organs are more likely to be used for lower MELD patients, which could unfairly affect MMaT, but the OPTN limits its analysis to organs accepted from more than 500nm. The Proposal does not take into consideration that certain transplant centers may be effectively using such marginal organs locally, which could also affect MMaT. Finally, MELD scores do not definitively capture the medical urgency of the patient receiving the transplant. A patient with a MELD at transplant of 32 is not necessarily sicker or at a greater risk of dying than a patient with a MELD at transplant of 28. One well-known factor affecting regional variation in MMaT is the difference in regional approval rates for symptom-based exceptions, which, if granted, increase the recipient's MELD score at transplant. These exceptions are not given to equally sick patients equally across the country. Research has demonstrated 'that there are clear regional differences in [exception] award practices irrespective of organ availability,' and Region 9 (New York and western Vermont) has a statistically significant higher rate of exception approvals when compared to other Regions.(19) The OPTN has acknowledged that exception approvals vary by Region, with some Regions approving as few as 75.8% of exception requests and other Regions approving 93.5% of requests made during the same time period.(20) To try to correct these variances, the OPTN has recommended a National Liver Review Board to promote consistent, evidence-based review of exception requests and award of exception points. However, even while recognizing the flaws inherent in MMaT, the OPTN still relies on it as a metric to indicate that organs are being allocated unfairly. The OPTN has failed to consider that once exception points are standardized, the MMaT variances may be significantly reduced, even without any change to the allocation policy. It is improper to make a fundamental change in policy based on a premise of inequality that is grounded in a flawed metric, which once corrected may reveal there was no such inequity. Some commenters during this public comment period have claimed that even without exception points, the lab or 'calculated' MELD score variance is significant. But when reviewing the calculated MELD for all deceased-donor transplant recipients, OPTN data shows that the range of calculated MMaT scores is roughly equivalent across Regions, with the vast majority of the country having a median calculated MMaT between 20 and 24. New York and New England (Regions 1 and 9) have the lowest median calculated MMaT between 15 and 19, while California and western states (Region 5) have the highest range from 25 to 29. Ultimately, MELD and MMaT are intended to be metrics to understand mortality risk, but these metrics have not served to achieve their goals. For example, the waitlist mortality in South Carolina is five times higher than the waitlist mortality in New York and Massachusetts, even though allocation MMaT is higher in New York and Massachusetts.(21) The OPTN has acknowledged this fact in its annual data report, noting that '[w]aitlist mortality rates varied substantially by geography.' The report goes on to explain that '[m]ortality did not mirror transplant rates, suggesting that waitlist outcomes were determined by factors other than simply organ availability, including referral and waitlist registration practices and possibly pretransplant patient management and quality of care.'(22) And yet, the OPTN continues to try to equalize MMaT variances across DSAs and the availability of organs across DSAs, without regard to waitlist mortality rates across DSAs. III. CONCLUSION As set forth above, the Centers have grave concerns about the Proposal and policy development process. None of the proposed models complies with the law and any policy development process must include proper consideration of socioeconomic inequities and access to transplantation, including the waiting list, for all end-stage liver disease patients. Even Scenario 5, which would have the least harmful impact on current transplantation services, suffers from the same fundamental legal and regulatory flaws as the other scenarios modeled for the Proposal. The Centers urge the OPTN to withdraw the Proposal and issue new models for consideration that take an incremental approach and focus solely on removing DSAs and Regions while otherwise maintaining the policy as approved in December 2017. To the extent additional policy revisions are necessary, the OPTN must assess how future proposals reduce socioeconomic inequities and promote patient access to transplantation. Regardless of what policy is ultimately adopted, the Centers support a phased approach to implementation with pre-designated metrics reviewed regularly to determine if the policy is having a detrimental effect on lower socioeconomic patients, access to care, organ wastage, and the volume of transplants.

(1) See Proposal at 3. (The critical comment, filed by plaintiff’s attorney Motty Shulman, was subsequently followed by litigation in New York.) As an example of the improperly accelerated timeline, the Proposal’s public comment period ends on November 1, and the Liver and Intestine Committee meets on November 2 to vote to make a policy recommendation to the OPTN Board of Directors. It is difficult to fathom how the Committee members will have fully absorbed and considered all public comments less than 24 hours after the public comment period closes.

(2) Scientific Registry of Transplant Recipients, SRTR LI_2018_01, Sept. 24, 2018, https://optn.transplant.hrsa.gov/media/2640/li2018_01_analysis-report_20180924.pdf [hereinafter “SRTR Analysis”].

(3) The Proposal notes that the Committee considered a broader 2-circle sharing threshold of 29 even though such a threshold was not modeled (Proposal at 11). Despite not knowing the predicted outcomes of this threshold, some Committee members “preferred a sharing threshold of 29” (Proposal at 12). The Centers do not understand how Committee members could support a proposal without being provided a model to understand the impact of the change. Likewise, it is improper to ask for public comment on this possibility without providing even a simulated model of the anticipated effects.

(4) Some public comments have noted that even though there will be fewer transplants performed under the Acuity Circle model, the SRTR Analysis predicts that there will be fewer waitlist mortalities. Such commenters then conclude that the Acuity Circle framework must be a more efficient system because it reduces deaths while performing fewer transplants. But this conclusion defies logic. Individuals with end-stage liver failure will die without a transplant. If fewer people are being transplanted, then more people will ultimately die; it is simply a matter of time. The SRTR modeling assumes that every person with the same basic demographics and MELD score has roughly an equivalent mortality risk, but transplant center data demonstrates the opposite: in fact, individuals from rural and socioeconomically disadvantaged areas have higher waitlist mortality, as explained later in this comment. Moreover, the SRTR Analysis does not take into account individuals removed from the waitlist because they become too sick to transplant. In short, a reduced waitlist mortality count in the SRTR Analysis does not mean that fewer people will die from end-stage liver failure under the Acuity Circle model.

(5) M. Englesbe & R. Merion, The Riskiest Job in Medicine: Transplant Surgeons and Organ Procurement Travel, 9 AM. J. TRANSPLANTATION 2406 (2009).

(6) Notably, this interpretation is even inconsistent with UNOS’s own vision statement, which reads: “Our vision is to promote long, healthy and productive lives for persons with organ failure by promoting maximized organ supply, effective and safe care, and equitable organ allocation and access to transplantation.” The vision for “promoting . . . access to transplantation” is for “persons with organ failure,” not just waitlisted candidates.

(7) See, e.g., Russello v. United States, 464 U.S. 16, 23 (1983); Race Tires Am. Inc. v. Hoosier Racing Tire Corp., 674 F.3d 158 (3d Cir. 2012); SEC v. McCarthy, 322 F.3d 650 (9th Cir. 2003); Russell v. Law Enforcement Assistance Admin., 637 F.2d 354, 356 (5th Cir. 1981).

(8) 112 Stat. 2681, 359-360, Pub. L. No. 105-277, § 213.

(9) See Joint Hearing Before the House of Representatives Subcommittee on Health and Environment of the Committee on Commerce and the Senate Committee on Labor and Human Resources, 105th Cong., 2nd Sess., June 18, 1998.

(10) INST. OF MED., ORGAN PROCUREMENT AND TRANSPLANTATION: ASSESSING CURRENT POLICIES AND THE POTENTIAL IMPACT OF THE DHHS FINAL RULE 3 (1999), available at https://www.ncbi.nlm.nih.gov/books/NBK224647/pdf/Bookshelf_NBK224647.pdf [hereinafter “IOM Report”].

(11) J. Schold et al., The Association of Community Health Indicators with Outcomes for Kidney Transplant Recipients in the United States, 147 ARCH. SURGERY 520, 525 Fig. 3 (2012).

(12) K. Ross et al., Sociodemographic Determinants of Waitlist and Posttransplant Survival Among End-Stage Liver Disease Patients, 17 AM. J. TRANSPLANTATION 2879, 2882 (2017).

(13) Id. at 2879.

(14) O. Hyder et al., Referral Patterns and Treatment Choices for Patients with Hepatocellular Carcinoma: A United States Population-Based Study, 217 J. AM. COLLEGE. SURGEONS 896 (2013).

(15) See K. Ladin, G. Zhang, & D.W. Hanto, Geographic Disparities in Liver Availability: Accidents of Geography, or Consequence of Poor Social Policy, 17 AM. J. TRANSPLANTATION 2277 (2017).

(16) See Proposal at 7, 19. The Proposal does not always clearly explain that the “variance” in MMaT is based on DSAs, but according to the SRTR Analysis, the first metric assessed was “[v]ariance in median MELD/PELD at transplant by DSA” (SRTR Analysis at 4) (emphasis added).

(17) See Schold, supra note 11 at 524.

(18) See L. McCormack et al., Rescue Policy for Discarded Liver Grafts: A Single-Centre Experience of Transplanting Livers ‘That Nobody Wants,’ 12 HPB 523 (2010).

(19) C. Argo, et al., Regional Variability in Symptom-Based MELD Exceptions: A Response to Organ Shortage?, 11 AM. J. TRANSPLANTATION 2353, 2358 (2011).

(20) OPTN/UNOS Liver and Intestinal Organ Transplantation Committee, Liver Review Board Guidance Documents, at 2, https://optn.transplant.hrsa.gov/media/2175/liver_boardreport_guidance_201706.pdf.

(21) David A. Gerber, Prabhakar Baliga, & Seth J. Karp, Allocation of Donor Livers for Transplantation: A Contemporary Struggle, JAMA Surgery (June 20, 2018), https://jamanetwork.com/journals/jamasurgery/article-abstract/2685267.

(22) W.R. Kim et al., OPTN/SRTR 2016 Annual Data Report: Liver (Jan. 2, 2018), https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.14559. Notably, the regional variances in waitlist mortality are not addressed in the Proposal.

Danielle Fuchs | 11/01/2018

This will hurt patients that already have issues with access to healthcare.

MUSC | 11/01/2018

 Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Patti Rusk | 11/01/2018

Dear Mr. Shepard / Members of the OPTN, My husband is a liver recipient from Scripps Green Hospital in LaJolla, CA. He should have died. We all knew it then, we know it today. I was told to 'tell him goodbye' on several occasions. The ICU staff refer/red to him as 'the 2012 Miracle', because he was. He is nearly seven years post-tx and is defying all odds. Other than the ultimate gift from his donor, his survival has everything to do with the dedicated medical staff at Scripps Green and Kaiser Permanente. Without their willingness to collaborate and their determination that he survive, I would be a widow. Since his transplant, I have been very involved with online and local in-person support for transplant caregivers. The stories shared are heartbreaking and infuriating. It isn't just an issue of money, or lack thereof, it is an issue of fairness in the allocation of organs. Currently, a person is able to be transplanted with a MELD as low as 19 in many areas. A MELD of 19 is a person who typically is able to function on a fairly 'normal' basis. They are often no subject to multiple painful and risky paracentesis procedures. Further, the higher the MELD, the more likely the events of potentially life-threatening bouts of Hepatic Encephalopathy. We were lucky. We were insured. He defied all odds. He became critically ill in a relatively short time (just over a year from initial diagnosis). His MELD went from 19 to 42 in a month. He was functioning when we were called and told that his kidneys were failing, based on Potassium levels. That was March, 2012. He was in the ICU for three months. Everything that could go wrong, did go wrong. He was on continuous dialysis; facing the possibility of a kidney transplant as well. He stopped clotting. He bled from every needle site and from his femoral artery after an angiogram. His hospital stay was nearly six months. Our hospital bill (including additional hospitalizations as a direct result of his transplant) are now in excess of $2MM. We have paid about $3K out-of-pocket in the last 7 years. Our options at the time were to choose a hospital nearby, thankfully we did. OR choose to move from California to Mayo Jacksonville. It would have ultimately required that we move to a Residence Inn for more than a year. Had we been living most of the other regions of the country, he would have been listed and likely transplanted before he became critically ill. It is unconscionable that a family is forced to choose to leave local support in order to receive life-saving treatment, based solely on geography. No system is perfect. The current system is seriously flawed. We had a few options, as a result of the policies of our insurer. This is the exception and not the rule. The better option is most assuredly the Acuity Circle Model. It has the potential to save lives, save families, save money. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely/Yours/Respectfully/etc. Patricia Walker Rusk

Anonymous | 11/01/2018

Imposing a 150 mile radius will increase the wait time for transplantation, thus increase the death rate of those waiting on transplant.

Sharp Memorial Hospital | 11/01/2018

October 23, 2018 Brian Shepard Chief Executive Officer, United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: Sharp Memorial Hospital, which partners with the University of California, San Diego on liver transplant, is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. As the largest provider of care in the San Diego region, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Tim Smith CEO and Senior Vice President Sharp Memorial Hospital 7901 Frost St. San Diego, CA 92123

Lance Stein | 11/01/2018

This proprosal, like all proposals to date do not account for increased cost and organ discard rates. This proprosal will only lead to organs being taken from more impoverished states to wealthier states with lower mortality rates further increasing geographic disparities rather than closing any gaps. Any acceptable proposal need to ensure US pre transplant and post transplant survival rates are approximated as closely as possible without reducing organ access to any locality. This proprosal does not do that. In fact, in certain areas, this proprosal will likely increase the death rate. People will die. That is shameful. Read the details closely. Choose wisely. History does not forgive.

Deborah Falanga | 11/01/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Sharp Coronado Hospital | 11/01/2018

October 24, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: Sharp Chula Vista Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. We have a keen interest in ensuring that all Californians receive the care they need, especially the increasing number of patients with liver disease who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Susan Stone Senior Vice President and CEO

Sharp Chula Vista Medical Center | 11/01/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: Sharp Chula Vista Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. We have a keen interest in ensuring that all Californians receive the care they need, especially the increasing number of patients with liver disease who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries, but know that there are not enough organs for all who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Pablo Velez, PhD, RN CEO and Senior Vice President

Anonymous | 11/01/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Donna Walrath | 11/01/2018

My story is a happy one. 41/2 years ago my son rec'd a liver transplant, and we have the transplant team at Scripps to thank, especially Dr Frenette and her diligent, hard working team. Heartfelt prayers and thanks for the donor and family facing an impossible situation. From the time my son was diagnosed until he had his surgery, it was 6 months. And believe me, with his rapid deterioration, it was not a moment too soon. My prayer, hope, wish is for all those in need of liver transplants to be gifted with this incredibly generous offering as soon as possible. My heart hurts for those families who face the hardest decision when a loved one cannot recover, but yet make the decision to contribute to the lives of others, and in so doing, their loved one lives on. There are no words to express thanks adequately. Let's make it so that those waiting for transplants are considered fairly with an eye to severity of need, rather than where they live. Thanks for the opportunity to speak. Donna Walrath

Paul Pockros | 11/01/2018

October 30,2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 1.Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2.Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3.Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4.The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. 5.The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6.As a physician in California and someone who cares for patients with liver disease this matter is of particular concern to me. 7.I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. With regards- Paul J. Pockros, MD Director of Liver Disease Center, Scripps Clinic Director of Clinical Research, Scripps Translational Science Institute

Greater New York Hospital Association | 11/01/2018

October Twenty-Nine 2018 Via Email Ms. Elizabeth Miller, J.D. United Network for Organ Sharing Elizabeth.Miller@unos.org Public Comment Coordinator United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 publiccomment@unos.org Re: Proposal for Liver and Intestine Distribution Using Distance from Donor Hospital Dear Ms. Miller: On behalf of our New York State members, Greater New York Hospital Association (GNYHA) is grateful for the opportunity to comment on the Organ Procurement and Transplantation Network/United Network for Organ Sharing (UNOS) Liver and Intestine Transplantation Committee's (Committee) October 8, 2018 proposal, Liver and Intestine Distribution Using Distance from Donor Hospital. Our members include several transplant centers and many more hospitals and health systems that care for patients who are adversely impacted by the current unlawful and inequitable liver distribution policy. GNYHA has been at the forefront of the struggle for organ distribution equity for many years and is supporting a legal challenge to the current policy, Cruz et. al. v. U.S. Dept. of Health and Human Serv. et. al. (SDNY 18-CV-06371-AT). We are proud to stand behind the plaintiffs, who are from New York, California, and Massachusetts, and who have courageously lent their precious time and voices to this effort, and all patients who, like the plaintiffs, are severely disfavored under the current system solely because of where they happen to live and their lack of financial resources. Medical need, not geography, must be the guiding principle in any organ distribution policy. Reducing the variance in median model for end-stage liver disease (MELD) score at transplant across the US should be the goal. The Broader 2-Circle (B2C) proposal continues the practice of prioritizing geography over acuity and is thus unlawful. We strongly oppose the B2C proposal and instead urge UNOS to adopt the Acuity Circles (AC) framework, which at least offers the promise of meaningful improvement. Substantial change is necessary to bring the distribution policy into compliance with the National Organ Transplant Act and its associated regulations. B2C does not offer such change; it differs from the status quo on semantics alone, substituting distance for donor service area. There is no legitimate reason to adopt such an ineffectual policy. Livers have a preservation time that is double that of lungs, yet the proposed 250 nautical mile sharing circle is inexplicably limited to patients at MELD 32 and above, leaving out a substantial number of very sick patients. Tinkering with the MELD sharing thresholds cannot salvage the wrongheaded B2C proposal, which Scientific Registry of Transplant Recipients modeling suggests could be even worse for patient mortality than the December 2017 revised liver distribution policy that it is intended to replace. A better approach is the AC framework. Assuming it was properly implemented, it could meaningfully impact the lives of many patients who are on waitlists in New York and even California, a state whose residents suffer from the longest wait times despite its impressive organ donation rates. The Acuity 300+600 framework would reduce variance in median MELD at transplant by nearly 60% over the current framework. Most importantly by far, this framework would result in over 100 fewer patients dying while waiting for livers compared to the current or B2C frameworks. The Committee offers no reasoned, evidence-based justification for declining to support a proposal that could save so many lives. Finally, the Committee's work and its resulting proposal highlight a structural problem that is at the heart of its inability to bring the liver distribution policy into compliance for so many years. The Committee's composition is unrelated to regional population and weighted in favor of regions that benefit from the status quo. The Committee's structure should be realigned to give more voice to those regions that have the most waitlisted candidates. Only then will the claim of 'consensus' be meaningful. Thank you for considering our comments. Sincerely, Kenneth E. Raske President

Sutter Delta Medical Center | 11/01/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Delta Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Jim Schuessler CEO

Anonymous | 11/01/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia locally

Melissa McGraw | 11/01/2018

How many transplant coordinators are on this committee? If even one serves it is well known that the length of time between donor death and in-room donor time is not hours, it is often days. This length of time of release of body to funeral home will increase the farther the procurement teams are traveling. Our system is not perfect now but we must consider donor families too if we want to continue to encourage donation. Further, while the hours it takes to coordinate a transplant is already significant IF a plane is available, IF the donor hospital has an OR room, IF there is a procuring surgeon there or if we need to send a team?, IF the airport is open (yes, this is a valid and true current matter at small airports), IF the weather is suitable, IF the pilot will overshoot flight time (or do we have to call in another pilot? and how long will that take once all the organs have been placed), IF the donor OR time starts on time, IF the biopsy is read swiftly. My point is that all these things take place with today's model of allocation. None of the things I've listed can be 100% promised with exact certainty. This is not a robotic transfer of organs to the most sick. There are so many more variables involved. I believe we can improve our current allocation system (and that we should all be involved with doing so) but I do not agree with the proposed changes as outlined here.

Katie Pahner | 11/01/2018

The proposed liver allocation system takes away livers from patients who need them the most. Where transplant patients live cannot be the basis for liver allocation unless specifically 'required' by NOTA's narrow exceptions. The Acuity model is a firm foundation for achieving the goals of NOTA and the Final Rule.

Sutter Roseville Medical Center | 11/01/2018

October 30, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Roseville Medical Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Brian Alexander Chief Executive Officer

Anonymous | 11/01/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Louis Larmeu | 11/01/2018

The changes proposed are going to siphon organs from smaller centers to larger metropolitan based transplant centers. This will negatively impact patients in rural areas and limit their access to transplant services. It will shift organs to high population and higher income areas to the detriment of those who have less resources and are probably limited financially to traveling to access transplant services further away from their local areas.

Teresa Shafer | 11/01/2018

I am opposed to both proposals for the two fatal flaws that have marred every proposal put forward by UNOS for the past two years: 1) the absence of a hard requirement to increase the number of livers donated and (2) the failure to hold local DSA's and transplant centers accountable for and dependent on their own productivity to transplant patients, increase organ donation, and increase utilization of ECD grafts (particularly DCD). The rate limiting problem to providing life-saving organs to patients in need has always been a shortage of transplantable organs. Unfortunately, rather than addressing this critical and, to date, intractable problem, the transplantation community is choosing to nibble around the edges of the system by focusing on allocation. Without a laser focus on donation, changes in allocation can only serve to privilege some patients and transplant centers by disadvantaging others. Some have stated 'OPO performance' is not the cause or solution to the current discussion about the shortage of livers and a not conceded viewpoint on disparity in MELD scores / receiving a liver transplant between various parts of the country. However, there are significant differences in the performance of OPOs and DSAs. Increasing organ donation through increased DSA performance is the only viable, ethical and net-forward-energy solution to a shortage of livers in any part of the country because more organs mean more transplants and more lives saved. Producing increases in organ donation is done every year by numerous OPO/DSAs. At the end of the day, having an organ to transplant is all that matters. It is what donation and transplant professionals within our communities work for - 'every organ, every time' to say at the end of the day, month, year, - 'this is how many lives we saved'. Donors and organs are what OPO CEOs report to Boards of Directors. They don't say to the Board that performance doesn't matter when they recover 25, 35, 50, etc., more livers than in the previous year. They say, 'look how many lives we saved!' That sounds an awful lot like 'performance matters'. What we measure usually gets paid attention to, and what we pay attention to, usually gets better. We are in it for the numbers; numbers save lives. Therefore, UNOS proposals need to focus on performance. Any proposals for liver allocation based on a zero-sum game, which are the reality of recent UNOS proposals, are not meant to cure the ills by recovering more livers but rather to spread the misery of the organ shortage between everyone, as if there is any region that has excess livers. Indeed, the current proposal merely rearranges the pieces on the chess board. As long as organ recovery performance and organ utilization are ignored in UNOS proposals, our community will continue to be divided in zero sum fashion and never address the central issue, the shortage of organs. DSA performance does matter and providing more livers for patients within and outside the recovery DSA is the critical and all-important step in curing the ills of transplantation medicine. This strategy would focus on saving more lives of patients everywhere rather than on moving organs from one DSA to another. Rates are not transplantable, organs are. We have a silver lining in this cloud if we make the right choice. The right choice is on choosing the laser focus on donation, not allocation. The number 1 and 2 efforts to perform more liver transplants are increasing donation and utilization of livers. The list below shows that with simply increasing performance to the national average in 2017, 799 more liver transplants could be performed nationwide. The current proposals do not increase the number of liver transplants. There is even no hesitation in UNOS plainly stating that zero sum game is the starting point and that donation is not involved. In fact, you can see it in numerous comments from NY, MA and CA on this public comment website. If the 31 OPOs performing below the national average increased to the national average, an additional 799 transplants (10% increase) would be performed nationwide. Even more significantly, if OPODSAs improved their performance to the top quartile of where 14 other OPO/DSAs already perform, then an additional 1838 liver transplants would be performed nationally, a 24% increase. The OPO/DSAs listed below are ranked by the number of liver transplants short of the national average and that could be performed with OPO/DSA improvement in recovery & utilization. If OPO/DSAs falling below the national average improved to reach simply the national average, tehn 799 more liver transplants would have performed nationally in 2017. Fully 35% of the total those 799 livers (282 of the 799) come from DSAs involved in the lawsuit to vastly broaden organ sharing (NY, MA, CA), with the bulk of those being from Boston, Los Angeles and New York City. OPO/DSAs PERFORMING UNDER NATIONAL AVERAGE, RANK ORDERED BY ADDITIONAL LIVER TRANSPLANTS THAT COULD BE PERFORMED WITH OPO/DSA PERFORMANCE IMPROVEMENT TO NATIONAL AVERAGE, 2017: Total U.S. - 799 liver transplants fewer than if all OPOs performed at national average MA - Boston ( MAOB) - 78 CA - Los Angeles (CAOP) - 52 NY - New York City (NYRT) - 47 Iowa ( IAOP) - 47 Oregon (ORUO) - 43 Michigan (MIOP) - 43 Arkansas (AROR) - 42 Kentucky (KYDA) - 39 NY - Rochester (NYFL) - 36 NC - Durham (NCNC) - 32 Washington (WALC) - 32 Virginia (VATB) - 31 NY - Albany (NYAP) - 31 FL - Miami (FLMP) - 30 Colorado (CORS) - 27 New Jersey (NJTO) - 26 PA Pittsburgh (PATF) - 25 Minnesota (MNOP) - 24 CA - San Francisco (CADN) - 23 Puerto Rico (PRLL) - 23 Connecticut (CTOP) - 17 NY - Buffalo (NYWN) - 13 Hawaii (HIOP) - -12 OH -Maumee (OHLC) - 9 TX - San Antonio (TXSA) - 9 New Mexico (NMOP) - 9 FL - Tampa (FLWC) - 7 Alabama (ALOB) - 5 Mississippi (MSOP) - 4 OH - Cleveland (OHLB) - 3 FL - Gainesville (FLUF) - 2 * Based on Liver Transplants by Recovery DSA per total deaths; donor and death data obtained from SRTR OSR reports. **The number to the right of the OPO indicates the number of Liver Transplants by Recovery DSA that are below the national average.) Rejecting zero sum game and embracing increasing donation and saving more lives will require accountability of OPO/DSAs to perform and will be is achieved through solid operations, leadership and relationship leveraging. The inherent nuances of making that mojo work require an intact system and boundary with no absentee stakeholders. Undeniably, it is easy to slip into the glass-half-empty group think, but the common sense and principled approach is to focus all our energy on increasing organ donation and utilization. Thank you for the opportunity to provide public comment. Teresa J. Shafer, RN, MSN, CPTC Liver Transplant Alliance

Edward Mathney | 11/01/2018

As a transplant anesthesiologist in New York City, we see some extremely sick patients for liver transplant who have been waiting on the transplant list sometimes for years getting sicker. We routinely transplant patients with MELD scores 35+. The acuity model for organ distribution would greatly benefit some of these patients by allowing them to receive organs earlier in their disease process, which I believe would greatly improve outcomes as they will be better able to recover from these massive operations. The need in large population centers such as ours is tremendous and only the acuity model would allow the sickest patients to have a fair shot at receiving an organ before they are deemed too sick for transplant.

Sutter Valley Hospitals dba Memorial Medical Center | 11/01/2018

October 29, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Valley Hospitals dba Memorial Medical Center (MMC) is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the thirteen liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Gino Patrizio, JD, MHA Chief Executive Officer

Anonymous | 11/01/2018

I support the broader 2-circle model because it is most like the policy compromise agreed to by our community last fall. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 11/01/2018

The proposed model doesn't consider patient population and the overall burden it puts on them. It doesn't protect transplant centers in areas where the access to healthcare is poor. It doesn't seems right to me that states with better healthcare will benefit. ALL patient's need liver transplants and those with better healthcare shouldn't be places above those with lower health care. To send organs to area that are more affluent seems very biased and prejudiced. Plus the proposed models want to reallocate organs to areas with a better organ procurement organization performance. The models don't take into account the limitations of MELD scores the waiting in city vs. rural areas. In all honesty, the border sharing proposals will cause more organs to be wastes, increase travel costs and complexity. Please do not to let these proposals pass.

Anonymous | 11/01/2018

I strongly OPPOSE both proposals. I think that broader sharing will move livers out of socioeconomically disadvantaged areas with higher waitlist mortality to states like New York, which have the LOWEST waitlist mortality. Any distribution scheme must protect the poor, underserved and rural populations. It must protect transplant centers that serve these same patient populations. Distribution schemes must account for increased waitlist mortality among populations who are poor and rural. And distribution scheme should have data that is properly vetted.

Anonymous | 11/01/2018

The new sharing models that are being proposed do not have protections for transplant centers that are located in regions with limited health care access. States with the best health care and the highest waiting list times, will benefit the most from these proposals, at the detriment of the residents in states with less access to healthcare.

Anonymous | 11/01/2018

I support the B2C 35 model because it is most like the policy compromise agreed upon within our community. It prioritizes those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Shelley Camardelle | 11/01/2018

The acuity circles will change from the current state where 75% of livers from LA are used in LA to only 25% being used in LA and the rest sent away.

Anonymous | 11/01/2018

I think the focus needs to be on educating more folks in the low donor regions. The communities and states have invested in the strong need for donors through education and health fairs. I am an organ donor, I would much rather my donated organs stay within my community/region, if not needed, then take the risk of organ discard and fly my organs to a person in need. It sickens me that we are even considering the chances of organ discard. IF I was a person in need of an organ, and I realized that an organ was flown out to someone in another region, and that organ was a discard, that would be very upsetting. Think about it, your had the 470 million dollar lottery ticket, but someone stole it from you. How devastating! Donor organs are not commodities, they are a gift. Efforts to increase organ donation locally and regionally should be the priority to preserve the bond between communities, patients and healthcare providers. We urge UNOS and its committees to shift the focus away from policies that increase transplant costs, organ discards rates and ultimately reduce the number of lifesaving transplants performed. We urge UNOS to focus on educations and organ donation awareness which is the only solution for all transplant programs to grow programs and save more lives.

Sheryl Monteer | 11/01/2018

I can't help but feel that people in the Midwest who are so giving with their life organs are being taken advantage of with these proposals. If it is true that the East and West coast does not donate as much then focus on the donation programs in those areas. Don't take life giving support from those who were generous enough to give it because others are selfish. In my lifetime there are 4 people who, if your proposal were in effect, I might not have gotten to know because the organ they needed would have been gone to one of the coasts. In fact there is a very real possibility that a life saving Liver transplant may be in my future. I have a rare blood type and other issues that will automatically make it harder for me to be matched from the on-set. But if the ONE organ I may need is sent overland I will not have that opportunity myself. Spend money and time to educate the peoples in the regions who are NOT giving before taking from those that are.

Anonymous | 11/01/2018

Lets not be flying livers around the country on minimal MELD differences. Lets keep hi risk livers ie DCD, HCV, PHS, steatotic - local so we can have hi utilization.

American Society of Transplant Surgeons | 11/01/2018

The American Society of Transplant Surgeons (ASTS) appreciates the effort of the OPTN/UNOS Liver and Intestine Transplantation Committee in response to the HHS Secretary's directive on designing an allocation system that removes the DSA as a unit of organ distribution. ASTS supports the goal to build a system structured on a population based model that can be adjusted incrementally to minimize unintended consequences and to fit the needs of the community. This will also allow assessment of other ongoing system changes, including implementation of the National Liver Review Board (NLRB). We recommend the committee reference the framework for organ allocation and work done previously on liver distribution. ASTS also encourages additional study on the impact of distribution circles on listed patient survival, transplantation rates, and the impact of transplant Meld, increased travel on success rates and associated costs. While there are no easy answers, we are grateful for the opportunity to share in designing a new process focused on the common good.

Stephen Jackson | 11/01/2018

Under new proposal and changes, I would be dead today

Starzl Transplantation Institute, Pittsburgh | 11/01/2018

As has been shown in numerous previous attempts at modelling liver sharing, the only thing that will help to rectify the current and long-known-about geographic disparity is sharing over broader areas. This is why the previous proposals of reducing the number of regions from eleven to four or eight showed better gains in organ-sharing equity than these concentric-circle proposals. The current proposed solutions confine the majority of organ sharing to areas that are SMALLER than most of our current regions. The largest proposed circles, at 500 or 600 miles, are considered only for status 1 recipients, a very small fraction of liver transplants performed in this country. Most sharing would occur in the smaller circles. Even the 300-mile radius produces a sharing area that is smaller than 6 of the 11 current regions. Of course, every transplant center is looking at how these proposals would affect their own transplant volume. With concentric circles that do not broaden sharing but instead make it more narrow, is it no wonder that even centers within the same current region have different opinions about these proposals? Ultimately, the Final Rule is law. The law says we must 'distribute organs over as broad a geographic area as possible.' These proposals don't accomplish that. So we only have two options, either we come up with a plan that is in accordance with the law, or congress rewrites the law. Given that these proposals were prompted by a lawsuit that has been long overdue, I doubt that a close look at the limitations of these plans will go unchallenged by the plaintiffs and I suspect that HRSA will be forced once-and-for-all to take the lead on coming up with a true plan that deals with inequities in organ sharing rather than continuing to wait for a consensus among programs, all of whom are looking out for their own interests.

Anonymous | 11/01/2018

We need to support the idea of sharing more broadly than BC2 allows for -- and thus start helping the sickest patients.

Richard Utchell | 11/01/2018

As someone that cared for a person needing a liver and the time we had to wait for the transplant (and we are grateful that we got one).  In looking at the proposed options we would think the 'Acuity Circle Model' would be fair.  Please support the Acuity Circle model.    Thank you,    Richard J Utchell  Rancho Mirage, California

Anonymous | 11/01/2018

I support the B2C 35 model because it is most like the policy compromise agreed to by our community last fall.  It priorities those with the highest lab MELDs, it avoids flying for clinically insignificant differences in MELD score and it keeps those livers most at risk to cold ischemia (DCD and over 70 donor livers) locally.

Anonymous | 11/01/2018

I oppose any change in liver allocation until the disparity in OPO performance is mitigated.  This exercise in creating allocation changes is acceptable, but the other factors that contribute must be weighted and factored into the solution.

National Organization of Transplant Professionals (NATCO) | 11/01/2018

In general, NATCO supports the proposal by the Liver Committee. We believe that allowing HRSA or Congress to write allocation policy will prove to be detrimental to both transplant and donation. We appreciate the efforts the committee has taken to meet an extremely accelerated timeframe for developing a new policy. We recognize that there is no solution that will please everyone, and we hope that all organizations will work hard to overcome any individual negative impact that may result from the policy that is ultimately implemented. NATCO agrees that circles make logical sense for the basis of an allocation area. We appreciate the analysis that went into arriving at the size of the circles. In light of the data provided in the proposal, we agree with the use of 150nm, 250nm, and 500nm circles. NATCO is, however, concerned that the committee did not pursue the concept of population adjusted circles on the basis that developing those models would be more complex. Accounting for population density might alleviate some of the concerns we are hearing about geographic inequities that will result from utilizing a pure nautical mile model. NATCO is pleased to see that the committee considered the effects on the pediatric population. We agree with the recommendation to only use larger circles for pediatric donors. Based on the results of the SRTR report which modeled different scenarios, NATCO supports the Broader 2 Circle distribution with MELD of 35. This appears to be the model that has the least negative impact overall. Regardless of what model is chosen, ongoing assessment will need to be done to assure fair and equitable distribution of organs. We thank the committee for the work done to present this proposal. Donna Dickt Executive Director PO Box 711233 Oak Hill, VA 20171 703-483-9817

Devin Eckhoff | 11/01/2018

The efforts for broader sharing do not take into account all the metrics that are important to people with advanced liver disease. Looking at only wait listed patients disregard the overall burden of liver disease in a given community. States that have large population of large proportion of poor  rural patients will suffer. Additionally many of these centers serving these states will loose significant volume and potentially drop below the threshold where it would;ld be not economically feasible to keep some of these centers open. Thereby putting a greater burden on these patients for access as they may have to travel further for transplant services. The very patient population that can least afford this burden and in many of these areas there are no public transportation available.        Secondly I feel a great sense of loss for not  only are patients but the transplant community. we have chosen to focus on narrow interest and dividing a pie that is too small already and changing the zip code of patients deaths. We have lost a great opportunity for the OPOs and transplant community to come together and focus on organ donation. Expanding the criteria for organ donors, getting patients that are the suffer the unfortuante ravages of the opioid epidemic to be organ donors. Educating the public at large about the benefits of organ donation and perhaps tackling the issue of presumed consent. The tremendous good will in the public at large has been fettered  away.

Leonardo Seoane | 11/01/2018

I support the Broader 2C 35 model because it prioritizes those with the highest MELDs, it avoids flying for clincially insignificant differences in MELD score, and it keeps most at risk to cold ischemia (DCD and over 70 donors) locally.

OCHSNER CLINIC FOUNDATION | 11/01/2018

the new allocation is hurting programs  the old way of receiving transplants should be put back in place

LifeLink of Georgia | 11/01/2018

LifeLink of Georgia appreciates the opportunity from the OPTN and UNOS to be able to make public comments related to proposed changes in liver allocation and certainly acknowledges all of the efforts of the Liver and Intestinal Committee.      In Georgia, we have a long history of sustained and collaborative relationships with all of our local transplant centers and believe that those efforts over the years have led to reproducible increases in donation, and subsequently, increased organs for transplant.  We are also immensely grateful to all of our donor families, whose generosity and thoughtfulness, allows this topic to exist in the first place.  We ultimately have a responsibility to our donors and their families, to be the best stewards possible of their precious gifts, and at the same time, also recognize the need to re-model and align allocation practices.      Additionally, we strongly support exploration into the state-based distribution model as presented at the UNOS Region 3 meeting.  This framework received 87.5% of Region 3's votes and multiple iterations of a state-based distribution framework are possible and deserve to be considered and/or modeled for comparison.  States form the only truly non-arbitrary methodology for allocating organs and are well recognized as the standard units of measurement with respect to socioeconomic status, in addition to overall quality and access to health care.  We respectfully request that the Liver and Intestinal Committee carefully consider this option.       Finally, we also strongly support inclusion of Puerto Rico into the ABO variance with Hawaii.

Association of Organ Procurement Organizations (AOPO) | 11/01/2018

The Association of Organ Procurement Organizations (AOPO) supports the efforts of UNOS to align liver allocation policy with the Final Rule consistent with the directive from HHS to eliminate DSA and Region as units of distribution and to reduce inequity in access to liver transplantation and maximize the utilization of donated organs. We applaud the Liver and Intestine Transplantation Committee for providing this proposal for comment under a very short time-frame. The Committee utilized modeling from the SRTR to look at the impact of two allocation proposals that are designed to minimize the impact of a candidate's place of residence or listing on liver allocation and reduce the number of deaths on the wait-list. We recognize that this modeling utilized historical data regarding practice patterns. Therefore, we believe the Committee is looking to provide an incremental change to the allocation policy that meets the Final Rule and maximizes the utilization of recovered livers. Subsequent to this change, OPTN should recognize that OPOs will face operational challenges in managing this new policy, be affected differently across the country and we as the OPO community expect OPTN will remain open to modifications to address these issues. Listed below are concerns that should be addressed in the future once the new policy has been enacted and some suggested actions that OPTN should be addressing concurrently with the implementation of this new policy: There may be a substantial fiscal impact on many OPOs and transplant programs, and we must be intentional in minimizing the additional expenses while adopting this change. We are concerned that the risk of out of sequence allocation will increase. As more livers travel, and the distances traveled to arrive at transplant centers increase, any potential recipient complications, or other post acceptance declines will make sequential reallocation more challenging. Organ wastage due to increases in CIT should be tracked closely and quick action taken if organs are being lost. While OPOs are committed to following the allocation list, there is higher likelihood these types of issues will increase. OPOs will be diligent in managing these challenges with a focus on maximizing liver utilization to best serve patients, but it is imperative that the OPTN quickly develop and adopt an effective expedited placement policy to help reduce organ wastage. It is also critical that along with revising liver allocation policy, that the OPTN take significant steps to improve DonorNet to increase transparency so that all OPOs know which donors are occurring, and which transplant programs on the match run have already accepted organs from other donors, so that plans for adequate back-up can be made. To increase the effectiveness of the new allocation policy, and recognizing the confined window of time that the allocation process must take place in, additional enhancements should be made to better screen transplant candidates off the match run, enhancements that are tailored to a transplant center's acceptance patterns and criteria for individual candidates. The OPTN should also develop clear definitions for 'acceptance' and 'back-up' so that all transplant programs and OPOs are clear on the expectations and parameters. AOPO supports the recommendations for pediatric allocation, with continuing the allocation for Hawaii, and for extending a similar allocation variance for Puerto Rico. AOPO recognizes that an OPO's first-and-foremost responsibility is to be the best steward possible of a gifted organ to serve donors, donor families and patients in need of transplantation. We believe that ultimately the system should have as its end-goal the saving of more lives and greater utilization of available organs.

Anonymous | 11/01/2018

Dear Mr. Shepard/Members of the OPTN,     I am writing you to address my concern over the Liver Allocation.  I feel that Liver allocation is unfair the way it is currently.  Patients in certain parts of the country are having to wait much longer and have to be much sicker before they can receive a liver transplant.  By having to wait longer the patients could die or have a greater chance of complications from their Liver disease.  I had my liver disease for 22 years and the last 3 years my health started failing.  I was retaining fluid, very fatigued and had a hard time enjoying life.  While much lower in other states, I had to wait until my meld score was 36 before I was able to receive my liver. By the time I was in the right range for my meld score, I was very sick.  I was very fortunate to receive the liver when I did.   If I hadn't received a new liver when I did I would not be here today.  By waiting for my Meld score to be in the right range, my kidneys have taken a hit and now I'm concerned about them.    I know that patients with financial means can get on wait lists in different parts of the country and fly to where there is a shorter wait, but not all of us are that fortunate.  By changing to the Acuity Circle Model, patients would have a better chance of receiving a liver transplant.   I feel that the Acuity Circle model will improve the quality of life for most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant.    As a resident of California and someone who has received a liver transplant, this matter is of particular concern to me.  I urge you to please vote to adopt the Acuity Circle model for liver allocation.  Failing to do so is not fair and leaves many of us without the transplants we need.

Stepahnie Gonzalez | 11/01/2018

As a caregiver to a liver recipient, we oppose anything less than a 250 mile radius around the Houston area because it will cause patients to wait longer for donor organs.

Linda Hines | 11/01/2018

As a transplant recipient, I oppose anything less than a 250 radius around the Houston area. Patients already wait longer than other regions before receiving liver transplants.  The proposal only will make this problem worse.

Anonymous | 11/01/2018

Increasing the circle radius will prove to be a problem logistically. Smaller centers, where patients have lesser access to transplant are likely to suffer. In addition - as per projections - there will be more flying of organs (and recovery teams) - which raises the question of safety of our teams. In addition this will result in a substantial increase in the cost of recover. In a system where health care costs are continuing to rise in general, I dont think the system will able to sustain the increase in these costs of procurements in the long run.

Chris Gonzalez | 11/01/2018

As a family member of a transplant recipient, I oppose a 150 mile radius as it resticts organs from patients in South Texas.  They already wait too long to receive transplants.

Avera McKennan Hospital and University Health Center | 11/01/2018

Given the time constraints imposed the committee has done an excellent job in providing alternatives that eliminate DSA and regional elements of liver allocation.  As a transplant center serving an entirely rural population we have concerns that selecting any circle size without considering the population will potentially worsen current allocation inequities and strongly support further review of a variable distribution area based on population.  Also, the change created to prioritize pediatric recipients above all adult recipients for pediatric donors is likewise arbitrary and not based on medical need.  This modification would allow a liver from a 17 yo donor to be procured for a much healthier child while a local MELD 40 in the ICU would not be allowed access to this deceased donor organ.  Under this scenario deceased donor livers are allocated based on arbitrary ages rather than medical urgency.  To prioritize a potential recipient under 18 over a 19 yo recipient who is at much greater risk to die without a transplant is purely arbitrary.

Houston Methodist | 11/01/2018

Changing this model to broader 2-circle would put many patients in severe detriment.

A Yough | 11/01/2018

As a transplant recipient, I feel a 150mile radius around South Texas is not in the best interest of the patients.  Patients wait too long to be transplanted here and this will only make the problem worse. Please consider something no less than 250 miles.

Eric Gibney | 11/01/2018

I am concerned about logistics, complexity and cost for what will inevitably lead to organ wastage and fewer transplants.     I am also concerned about calculated vs allocated MELD, and the number of organs that will flow to patients who have exception points granted due to regional practice. I am concerned that 'national liver review boards' will be slow to be implemented and will not address previously listed patients.

Bridget Frady | 11/01/2018

I support the B2C 35 model because it prioritizes those with the highest lab MELD's and also keep those livers most at risk to cold ischemia locally

Herbert Pardes | 11/01/2018

I appreciate the Liver and Intestinal Organ Transplantation Committee's proposal to reform the liver allocation system and offer my strong support for the Acuity Circles model. This model has the lowest mortality for patients and shows the greatest improvement in the variance of median MELD at transplant. Eliminating the arbitrary and disparate boundaries of the donation service areas is an important stride to create greater opportunity for the sickest patients to access transplants. In finalizing the proposal, the Committee should adopt the wider sharing proposal. As the Committee notes, the current system results in inconsistent application for candidates in different geographic locales. Federal law and regulations - notwithstanding our own sense of fairness - require that the nationwide liver allocation policy should distribute organs to the most medically urgent candidates and not be based on a candidate's place of residence or place of listing, except where specified in statute. Disease severity, as demonstrated by the MELD or PELD score, should be the primary basis for allocation. The new models begin to correct longstanding inequity in the liver distribution process to the benefit of those patients most in need of a transplant. In New York, only one out of every nine patients waiting for a liver transplant lives long enough to receive one; these changes can begin to correct that wrong.

Virginia Beach Friends School | 11/01/2018

Dear Liver Committee,   We would first like to say thank you for this opportunity to be a part of the liver allocation policy. We are a Medical Ethics class at the Virginia Beach Friends School and we are currently learning about scarce life saving resources. We have been talking a lot about this topic and we are excited to share with you our ideas and recommendations. Our recommendations will we based on what we think is the fairest option for all people involved.  Our understanding of fairness as it is applied to ethics is that fairness is sharing benefits, resources, and risks equitably. This concept of fairness is a major consideration for deciding when to allocate scarce life-saving resources and we will be using it to make our recommendation.   We recommend that the circles should be made larger. We think this would be the fairest option considering all of the information provided. This is due to certain areas not being properly accounted for as they are not within the circles. Therefore, the people who are not within these circles would be unable to obtain a liver. We are aware that a larger circle would result in more hospitals needing to transport organs by flight and realize this would be more costly. However, we believe that the lower waiting time and higher chance of matches would be more important than the costs, and allow everyone to have an equal chance of obtaining a liver. It would be most fair to those awaiting donations if we were to make these circles larger since more people would be able to obtain these organs as well as because larger circles would account for the areas that are not currently within them, giving these people a fair and equal chance of obtaining these organs.  One example we have is that there are some places in Texas where most of nautical miles are actually in the Gulf of Mexico when the circle is drawn. Therefore smaller circles would place Texans at a disadvantage because there would be less of a possibility for organs to be transplanted in their area. To make this policy the fairest to all people involved, we think the larger circles would be the best policy.     Thank you for your consideration,   VBFS Senior and Sophomore

Bonnie Yough | 11/01/2018

As a family member of a liver transplant recipient, please give this region a break. it's already hard enought to wait for organs now. A 150 mile radius only makes patients wait longer and get sicker.

John Carr | 11/01/2018

As a transplant recipient in the South Texas area, please reconsider the 150 mile radius proposal. Patients in this area wait too long for organs and patients are transplanted at a high MELD already compared to other regions. Nothing less than a 250 mile radius should be considered.

Louis Galish | 11/01/2018

As a transplant patient, I feel that a 150 mile radius for patients in Texas is harmful to patients. Patients wait too long for organs in this area and are very sick at time of transplant. Nothing less than a 250 mile radius should be considered.

Scott Biggins | 11/01/2018

I applaud the OPTN/UNOS and transplant community's efforts to address the geographic disparity in access to liver transplant in a manner that is fully compliant with the final rule. The AC and B2C models were created and analyzed in an expedited manner at the request of HRSA. Unfortunately, this accelerated timeline has impaired the typical iterative optimization of prior models and resulted in two models that have some significant flaws. One notable flaw in both of the fixed distance circles models is the failure to incorporate population density.     The two fixed distance circle models do a disservice to the sparsely populated areas of the west, southwest and northwest where geographic distances between population centers and across current DSAs and regions are vastly different that in other areas of the US. This is the most evident in Region 6 and in particular the WALC DSA which includes parts of Montana, Idaho, all of Washington and all of Alaska. For example, in 2015, NYRT DSA had 3019 people per square mile whereas WALC DSA had overall population density of 11 people per square mile. That is, the NYRT DSA has a 274-fold increase in population density compared to the WALC DSA.  For coastal areas, only 50% of a fixed distance circle is available as a donor population. For the transplant centers in WALC DSA, located in the extreme northwest of the continental US-bordered by Pacific Ocean on to the West and international border with Canada to the North, a fixed distance circle amounts to 25% of a circle around a donor hospital. Under the current liver distribution system, the WALC DSA due to the low population density, shares organs over 808,360 square miles. In the proposed models, with the conversion of DSA to 250 miles radius (196,250 square miles for a full circle or 49,062 for 25% of a circle) around the donor hospital, the functional distribution unit within WALC DSA would be dramatically reduced---from 808,360 square miles to about 49,062 square miles.     Under either of the proposed fixed distance circle models, the functional distribution unit for WALC would shrink to only 6% the size of the current distribution area. A 'Broader Sharing' model that shares less broadly just does not make sense. A system that incorporates population density and unique geographic features of the US is imperative. There are at least two potential solutions for this challenge: 1) Use population based circles or 2) adapt geographic variances for areas of extreme variation in density population or non-contiguous areas with large geographic distances. If one of the fixed distance circle models is going to move forward, a simple variance for deceased donor originating from Alaska would mitigate the negative impact on access to liver transplantation for patients living in the current WALC service area.      There is precedence for geographic variance for non-contiguous areas in the US. There are three non-contiguous areas of the US: Alaska, Hawaii and Puerto Rico.  A policy variance already exist for Hawaii.  A similar variance is being considered for Puerto Rico. Unlike Hawaii and Puerto Rico, there is no liver transplant program in Alaska and the vast majority of patients needing liver transplant residing in Alaska rely on the liver transplant programs serving WALC.     Any revision to deceased donor liver distribution policy must not reduce the existing geographic sharing in the Pacific Northwest. Doing so would reduce access for an already underserved population.     I propose the following simple geographic variance:   Deceased donor liver grafts procured in the state of Alaska will be distributed in the local (250nm) distribution unit then in regional (500 nm) distribution unit of the operational center of WALC OPO.

Rob Teaster | 11/01/2018

As a transplant professional and Virginia Commonwealth Citizen, I cannot with a clear conscience support a change in allocation methodology that will result in fewer transplants for Virginians and increase their likelihood of death while on the waitlist.  This is especially true when all of the proposed allocation models move organs from the Southeast to the Northeastern United States.  Here is an example to put this paradox into perspective; the CDC reports there is a death rate of 9.2% attributed to Liver Disease in Virginia compared to a 6.9% death rate in New York.  However, the proposed allocation models will decrease the number of liver transplants in Virginia by 38% and increase the number of transplants in New York by 48%.  I cannot support any of the proposed allocation changes as they stand today.

Anonymous | 11/01/2018

I also agree with many of the comments already submitted. It seems irresponsible to support any proposal that does not include measures to increase donation and increase transplant rates. The main reason for the need for reallocation is due to low donation rates in certain areas in relation to specific OPOs. The current proposals are anticipated to increase organ wastage, logistical complexity, and travel for organ recovery. Furthermore, we repeatedly hear and read that these proposals will transfer organs out of the most socioeconomically disadvantaged areas despite higher waitlist mortality rates in those same areas. I believe that alternative options, such as the state based allocation, would result in fewer discards, less movement of organs away from areas of greatest WL mortality, and less exacerbation of existing disparities for poor, minority, and rural candidates. Efforts should truly be made to increase donation in areas of shortage rather than take life-sustaining opportunities from patients in areas of greatest donation but also with the greatest socioeconomic disadvantages. Our patients should not be punished because other areas are not successfully increasing their donations. It is simply irresponsible and immoral in my opinion to push through with this allocation process without additional discussion and evaluation of reasonable and just alternatives.

Johnny Dorsett | 11/01/2018

As a liver transplant recipient, I oppose a 150 mile radius. The MELD share threshold should be lowered to at least 29. This proposal is a disadvantage to Texas since the Gulf of Mexico is part of South Texas.

Gloria Barrientos | 11/01/2018

As the spouse of a transplant recipient, we live in Texas and oppose a 150 mile radius. I would recommend a minimum of 250 mile radius due to the presence of the Gulf of Mexico in South Texas.  Patients already wait too long for transplants in this area.

George Loss | 11/01/2018

I write this letter in opposition to the liver redistribution proposals currently under consideration for the following reasons:    1. First, the process was hijacked.  Creating a policy that will affect thousands of lives under a 4 month timeline and without our usual safeguards is reckless and unwise.    After years of deliberation and two national fora, the Liver and Intestine Committee passed a compromise proposal last fall based on agreed upon guiding principles of I) share most broadly for those most likely to die waiting, that is, those with the highest laboratory MELD scores, II) do not place recovery at teams at risk flying great distances for clinically insignificant differences in MELD scores, III) give local priority to those organs least tolerant of prolonged cold ischemia times (DCD and over age 70 donor livers), IV) minimize flying (a surrogate for a cost burden that will be carried almost exclusively by transplant centers), V) variance in MMAT is recognized as one, but not the only, metric of disparity and VI) any policy compromise approved is to be studied and modeled for effects on disadvantaged populations. Our proposal was passed by the BOD last November.  During BOD deliberations, the potential of a court challenge was discussed.  It was stated then that unlike lung, the liver policy did not rely only on DSA as a unit of distribution and its compliance with the final rule could be defended.  When a lawsuit was threatened by the Boies law firm of New York arguing that the newly passed policy was out of compliance with the Final Rule, an emergency meeting of the Liver and Intestine Committee was called by HRSA and the UNOS Board Exec Committee.  The Liver and Intestine Committee conferred and overwhelmingly voted to recommend that HRSA and UNOS fight the lawsuit.  We believed the new policy was nuanced and compliant with the Final Rule as a whole.  Our recommendation was not followed and we were asked to scrap the compromise policy and create a new policy excluding both DSA and Region as units of organ distribution.  ...And with a deadline for committee approval of November 2. Creating policy under duress is unwise.    2. These policies do not increase liver transplant numbers and the dramatic variability in liver utilization and OPO performance, most evident on the West Coast and in NYC, are not addressed.    For example, where I live, a brain dead donor (DBD) resulted in a liver transplant 97% of the time (data from SRTR web site for most recent time interval: 1/1/16-12/31/17). In the Largest City on the West Coast, a liver transplant resulted from a DBD 72% of the time.  Where I live, a donation after cardiac death (DCD) donor resulted in a liver transplant 81% of the time.  In the Largest City on the West Coast, a liver transplant resulted from a DCD donor only 22% of the time.  Where I live, if our liver utilization was as expected rather than statistically significantly better than expected, 22 fewer transplants would have been performed.  If that West Coast City performed just as expected, that is, just average, rather than statistically significantly lower than expected, they would have performed 92 more liver transplants. And if they utilized livers just 10% better than average, they would have transplanted 163 additional livers. A new draconian liver distribution plan will not fix the problem described above and in fact will reward that large West Coast City for utilizing livers poorly.    Another example: Columbia University's liver transplant program is one of the best in the country. Columbia transplants livers at a rate higher than expected, their waiting list mortality rate is lower than expected and their offer acceptance rate is higher than expected, especially for hard-to-place livers which this program is 76% more likely to accept than the average US liver program.  Their overall one year recipient survival rate is better than expected (but not statistically significantly better). In comparison, a 2nd Large NYC Liver Program, located on the same island as Columbia and thus with access to the exact same livers, transplants livers at a rate lower than expected, their waiting list mortality is higher than expected and their offer acceptance rate is lower than expected, especially for hard-to-place livers which this program is 71% less likely to accept than the average US liver program. This 2nd Large NYC Liver Program's one year recipient survival rate is lower than expected (but not statistically significantly lower). A new draconian liver distribution plan will not help this 2nd Large NYC Liver Program improve its performance to level of Columbia located across town and in fact will reward them for performing less well.      Without a doubt, we need wider sharing of livers, especially for those most at risk for dying while waiting, that is, those with the highest laboratory MELD scores.  But using variance in MMAT as the only metric of disparity is misleading.  The variance in the MMAT between Columbia and the 2nd Large NYC Liver Program, two programs on the same island with access to the exact same livers, is higher than the variance in MMAT between Columbia and my center in Louisiana.  A new draconian liver distribution plan will not fix this.      Finally, members of the transplant community and the UNOS Liver and Intestine Committee worked diligently and submitted a compromise proposal based on guiding principles which was passed by the UNOS Board of Directors last November. A lawsuit was filed, the policy was scrapped and we created 2 new proposals. After modeling,  the committee voted to recommend that the B2C model be sent out for public comment.  That vote was overridden and we were told that officials at HRSA favored sending both models out for public comment.     Policy is being dictated to the liver and intestine committee.  Ultimately the UNOS BOD is charged with creating policy.  But what we are doing now is a sham, a shame, sneaky, undemocratic, reckless and just plain wrong.

Anonymous | 11/01/2018

1. Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs. 2. Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts 3. The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals. 4. The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts. 5. The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare. 6. The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance. Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.

Anonymous | 11/01/2018

I am concerned that broader sharing will increase organ wastage.  The proposed sharing model does not consider the overall burden of liver disease in a population as well as the transplant centers that serve regions with poor health care.  This has tremendous impact on the patients that are served in this region.

OPTN/UNOS Operations and Safety Committee | 11/01/2018

The Operations and Safety Committee discussed this proposal and offers the following responses:  • The Committee supports the proposed size of the fixed distance circles.  • The Committee supports the expansion of the Hawaii variance to Puerto Rico in order to mitigate the negative impact on candidates in Puerto Rico. The Committee agreed that variance would not change in the new allocation policies.  • The Committee agreed there will be an increase in travel for liver allocations, which will impact costs for OPO and transplant centers. The Committee has acknowledged there is a current regional shortage of pilots and planes nationally, which may increase stress on procurement and organ transport logistics. The Committee acknowledges there is regional variability and propose further evaluation and data collection to help ensure that the safety of organ placement is as transparent and efficient as possible.

Jacqueline Smith | 11/01/2018

The Southeast Region has worked extremely hard to streamline a system that works best in our geographic area. If it's working don't break it. It would make sense for the regions that are struggling to mimic and adopt our processes. Let them be responsible for the change that they want to see without causing disruption to a system that is clearly soaring. Please don't cause conflict and/or pain to so many patients that are already suffering.

Anonymous | 11/01/2018

The proposed models don't evaluate variation in organ procurement organization they simply redistribute organs from better areas of opo to lower areas of opo performance.

Anonymous | 11/01/2018

This proposal will only increase difficulty of the transplant process as well as potentially lead to waste of organs and over time increase of costs.

Gary Mills | 11/01/2018

Since we don't get any donors from the Gulf of Mexico, I am opposed to the 150 mile radius for Texas. Houston has more patients waiting for livers than other areas, so restricting donors to a 150 mile circle is not reasonable.

Anonymous | 11/01/2018

Saving lives and creating a more equitable allocation policy are the two fundamental morals that should guide this discussion and decision.    The Scientific Registry of Transplant Recipients (SRTR) provided an analysis of the effects of each proposal.  It is clear that only the acuity-based circles will significantly reduce the number of patients who will die while waiting for a donor liver.  Acuity-based circles will also give patients the most fair chance, regardless of where they live, by reducing the national variance in median MELD.      From the SRTR report:    Waitlist Mortality Count (national)   1,455 lives lost: Current  1,433 lives lost: Broader 2-Circle MELD 35  1,423 lives lost: Broader 2-Circle MELD 32  1,386 lives lost: Board approved  1,341 lives lost: Acuity-based 250/500  1,318 lives lost: Acuity-based 300/600    Variance in Median Allocation MELD (national)   9.97: Current  7.41: Board approved  6.74: Broader 2-Circle MELD 35  6.54: Broader 2-Circle MELD 32  4.33: Acuity-based 250/500  4.07: Acuity-based 300/600    Other metrics discussed are not materially significant.  An increase in travel percentage, travel time, and distance reflect additional costs.  However, the cost of a patient remaining in an ICU for weeks or months far outweighs the cost of transporting a liver for an additional half hour.  Livers are more resilient than lungs, which use the 250 nm model.  Furthermore, over 60% of organs are already being flown in my region because of the size of my state.      Waitlist mortality is a direct metric of lives that will be saved or lost.  MELD variation is a direct metric of geographic equity.  Acuity-based circles are the only proposal that has a positive effect on both.  I hope that OPTN will make the right decision for patients across the nation and choose the only fair model: an acuity-based circle.

Anonymous | 11/01/2018

My husband is a liver recipiet from the Houston area.  He would have died if we did not have access to donors outside of Houston.  Please keep donors available form a bigger circle, at least 250 mile radius.

Piedmont Healthcare | 11/01/2018

The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. It also reduce the numbers of transplant, and the models increase organ waste.

Anonymous | 11/01/2018

As a transplant anesthesiologist, I feel that rior to significantly changing the current allocation model, which works well, to a model which will result in more organs being flown to other centers for transplant, Efforts should be focused on increasing organ donation rates which will help ALL programs.  Whether this be by an 'opt-out' model as used in many foreign countries, or something else.

Kathy Allen | 11/01/2018

My husband received a liver transplant in Houston and he would not be alive if we had the proposed circle to receive donors from.  I oppose a 150 mile radius, I support a circle of 250 miles or larger.  The MELD threshold needs to be lowered to 29.

University of Iowa Health Care | 11/01/2018

University of Iowa Health Care urges the Board to reject all of the options provided as none will satisfy the needs of those patients residing in the majority of the country nor those patients who reside on the coasts.      The fact is this latest proposal seems like a rushed attempt to appease the plaintiffs in a suit paid for in part by the Greater New York Hospital Association (GNYHA) and those they represent.     UNOS' priority should be to honor the donors and to allocate these limited resources in a way that utilizes the best available data. UNOS has a responsibility to sick Americans. As theFinal Rule clearly distinguishes between patients and candidates in the statement 'promote patient access to transplantation' (42 CFR 121.8.5), we believe this federal law is there for the benefit and protection of all Americans regardless of their economic position.

LifeLink of Puerto Rico | 11/01/2018

PUBLIC COMMENT ON LIVER ALLOCATION POLICY  Enclosed please find organizational comment from LIFELINK OF PUERTO RICO    LifeLink of Puerto Rico appreciates the opportunity from the OPTN and UNOS to be able to make public comments related to proposed changes in liver allocation and certainly acknowledges all of the efforts of the Liver and Intestinal Committee to put forward a proposal.     We support the ABO variance for Puerto Rico.  Sick patients, who are listed for transplant on the island will not have access to organs because we are outside of the 250/500 circles.  All of the local patients listed for transplant are a minority population, and the lack of access to import organs is an unfair burden for this population.        We believe Puerto Rico's situation is unique.  We are located 1,000 miles from the nearest mainland transplant center and donor hospitals.  Puerto Rico has a long history of generously sharing organs to the closer mainland centers, in the most recent 3 years (2015-2017), a total of 427 organs recovered by LifeLink of Puerto Rico were transplanted at centers on the mainland U.S, 129 of those organs being livers.  LifeLink of Puerto Rico anticipates we will continue to export organs under this new proposal and offers our support for the proposal, and we request consideration for the following suggestions:    • Create a 1,100 nautical mile sharing circle for organ allocation off the island.  Under the current proposal, all transplant centers in the U.S. are more than 500 miles from all of our donor hospitals, so our list will have the entire country.  From a practical standpoint, this is not efficient for allocation.  • Create a 1,100 nautical mile import access circle for high MELD patients on the island, to provide some equity balance/safety net.  Patients listed for transplant in Puerto Rico face many barriers to access care, including language, transportation, and social  and financial support, and as a result many present much later in the disease progression continuum.   Many of these patients are very ill at initial presentation for listing, and face real barriers for continued care in the community.  The island is still struggling with basic power supply more than a year after the hurricane, exposing these patients to even greater vulnerability.

University Hospitals Cleveland Medical Center | 11/01/2018

Each of the proposals for broader sharing will increase logistical complexity and costs due to a dramatic increase in air transportation of organs.  These issues will in turn lead to an increase in organ wastage and ultimately a failure to provide access to transplantation to patients in need.  Additionally, these proposed models do not take into account the variation in OPO performance.  An area such as ours with a high performing OPO will lose a significant number of organs to areas with much lower performing OPOs.  Redistributing the organs in this way does not solve the problems of the under-performing OPOs.  The models also fail to take into consideration the limitations of MELD in predicting waiting list death.  Organs from Ohio will be diverted away from patients with a higher waitlist mortality.  This poses a significant disadvantage to our patient population.

Julie Corkrean | 11/01/2018

In reviewing the current proposal and comments, there are many concerns about added costs for travel.  We currently travel to the North and West Texas areas for many of our organs because these areas are in our DSA.  I believe the added cost of travel is far less than the cost of caring for sick patients with high MELD scores.  The average MELD at the time of transplant in Houston is at, or above, 30.  Patients who receive transplants at lower MELD scores require fewer days in the hospital, and fewer days in ICU.  Overall, transplanting patients who are less sick, saves more money than the cost of traveling for donor organs.  If you try to save money on flights/organ transport, you are going to transplant sicker patients which will cost more money, and may even cost patients their lives.  While I support the effort of creating acuity circles and finding a balance for organ allocation, posing a 150 mile radius around Houston is not a reasonable proposal. Depending on the donor location, your proposal would allow patients with MELD scores of 15 to receive organs before patients with MELD scores of 31 based on their location (i.e. a patient whose MELD score is 15 and 120 miles from the donor hospital would get transplanted before a patient whose MELD score is 31 and 160 miles away).  Limiting patients in the 15-31 MELD range to a 150 mile radius means we lose access to donor hospitals that we currently have access to, and we will not gain any additional populated areas that produce high volumes of donors.  The 150 miles around Houston is automatically reduced due to presence of the Gulf of Mexico.  Outside of Houston, the only populated area within 150 miles is Austin.  This proposal jeopordizes all patients in the 15-31 MELD range.  Please look at the data!  Houston has more patients waiting for transplants than most other Texas cities combined.  Reducing the organ pool for this area has no benefit for patients.

Sutter Medical Center, Sacramento | 11/01/2018

Brian Shepard  Chief Executive Officer  United Network for Organ Sharing  700 North 4th Street  Richmond, VA 23218      Dear Mr. Shepard and Members of the OPTN:    On behalf of our patients and community, Sutter Medical Center, Sacramento is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers.  We strongly support the Acuity Circle model.    Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change.   While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.      The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.  The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.     Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.      Sincerely,  Dave Cheney, CEO  Sutter Medical Center, Sacramento

Kenneth Chavin MD PhD| 11/01/2018

I want to open with my strong objection and complete rejection of all proposals put forth for liver allocation.  I have been involved in transplant for over 25 years, having practiced in Philadelphia, PA, Baltimore, MD, Charleston, SC and now Cleveland, OH.  Throughout this time, transplant has been the most exciting and innovative specialty.   It was founded by pioneers who saw the greater good for their patients and donors.  The field has always used the best scientific thought and collaboration to achieve the maximum utility with organs.  However, this has not been the case with the liver allocation discussion.  The current decision process has been rushed while only utilizing old data with a few driving the message.  Contrary voices are being ridiculed or ostracized.  Much of the greatness of transplant is being tarnished by the behavior of a few.  The threat of legal action that benefits one side while affecting many on the other is just not in the spirt of our great specialty.  I am heart broken by such behavior.  The historic relative transparency of the process is all but gone.  Agendas continue to be pushed.  The current proposal just shifts organs from one place to another in an attempt to be compliant with the final rule while ignoring many other aspects of the final rule.  No matter how one divides a scarce resource someone who didn't get the organ dies.  The playing field is not level as there are so many different practices in different areas of the country.  Until we as a community standardize practices and exceptions, true comparison can't legitimately be made.  The National review board needs to be in place and functioning to reset the country at an acceptable standard.  We then need to reassess the inequities and address them.  The solution to this is not to accept the status quo for organ donation but improve that and all are better served. One cannot have parts of the country want organs flown to them while they a have the worst performing OPO's in the country.  We need to stop take a step back not let political pressures, news feeds and lawsuits dictate a rush to a bad decision.  We need to approach this with the best scientific rigor, active participation as professionals and not have special interests and law suits dictate the best for our patients both those we will transplant and the ones we don't have an organ for an thus will die.       Kenneth D. Chavin, MD, PhD FACS  James A. Schulak, MD Endowed Director of the UH Transplant Institute  Division Chief, Transplant and Hepatobiliary Surgery  University Hospitals Cleveland Medical Center  Professor and Vice Chair of Research  Department of Surgery  Case Western Reserve University School of Medicine   11100 Euclid Avenue  Cleveland, OH  44106-5047  Phone: 216-844-2858   Fax: 216-844-5398

OPTN/UNOS Ethics Committee | 11/01/2018

The Ethics Committee reviewed the Liver Committee's proposal during the October 29 in-person meeting in Chicago, IL. The Ethics Committee appreciates the opportunity to comment, and the work that the Liver Committee has done in preparing this proposal. The Ethics Committee's comments centered on the difficulty of fully considering the implications of the Liver Committee's proposal given the limited time and lack of adequate justifications for their recommendation. Some suggested that cost and efficiency considerations do not supersede the importance of equity in changing geographic allocation.      A couple of concerns were raised:    1. Inadequate ethical justification for proposed changes: The Committee was concerned that it could not adequately evaluate the Liver Committee's recommendations because the rationales for the two options (B2C, and acuity) were not provided in relation to other options. In particular, the differences between the B2C and acuity circle options were not adequately explained, nor was the justification for preferring B2C to acuity. The Liver Committee should clearly identify the rationale for selecting one option over another, as well as the relative impact of each considered option on equity and utility.     2. Concern for harming underserved, vulnerable populations: Many theories of distributive justice suggest that while a single policy cannot rectify existing inequalities, a policy ought not to exacerbate inequalities. The accelerated timeline under which the Liver Committee was required to make changes to liver geographic allocation might have unintended consequences for vulnerable populations because the analyses may not have considered all potential outcomes. In particular, members expressed concern that rural patients could be adversely affected, and the Liver Committee should consider the potential impact to these and other patients when developing their recommendations. Efforts must be made to ensure that the perspectives of historically underrepresented groups and the vulnerable be included in allocation policies.  The Liver Committee should also assess the projected impact of their recommendation on the potential closure of transplant programs serving rural areas and underserved populations.     The Liver Committee should better explain the implications of supporting one solution over another. Ethics Committee members indicated that cost and efficiency should not drive a solution characterized by greater efficiency, and less equity. Ensuring equity means giving patients reasonable likelihood to access transplantation regardless of their geographic location.

North American Society for Pediatric Gastroentology, Hepatology and Nutrition | 11/01/2018

November 1, 2018        Yolanda Becker, MD  President  Board of Directors  Organ Procurement and Transplantation Network  United Network for Organ Sharing  PO Box 2484  Richmond, Virginia 23218    Re: Liver and Intestine Distribution Using Distance from Donor Hospital    Dear Dr. Becker:    Members of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) on behalf of the patients we serve, welcome the opportunity to comment on the proposal developed by the Organ Procurement and Transplantation Network's Liver and Intestinal Transplantation Committee that would modify liver, liver-intestine, intestine, and liver-kidney allocation policies.     NASPGHAN is comprised of more than 2,000 pediatric gastroenterologists in 46 states, the District of Columbia, Puerto Rico, Mexico and 8 provinces in Canada. The mission of NASPGHAN is to advance understanding of normal development, physiology and pathophysiology of diseases of the gastrointestinal tract and liver in children, improve quality of care by fostering the dissemination of this knowledge through scientific meetings, professional and public education, and policy development, and serve as an effective voice for members and the profession.     The changes proposed would required that livers from pediatric donors first to be offered to children and then adults at status 1A within a 500 nautical mile (nm) radius.  Subsequently, pediatric liver transplantation candidates (< 18 years of age) will be prioritized - first regionally and then nationally - for a pediatric donor liver.  NASPGHAN generally believes that organ transplantation should not be based on geography, but rather on medical priority, with particular prioritization of pediatric patients. Current allocation policy prioritizes adults locally over critically ill children nationally, leading to some adults being transplanted with livers from pediatric donors before that organ is offered to a child. NASPGHAN, therefore, strongly supports the Committee's proposal to change the pediatric allocation sequences so all of the pediatric candidates on the match will appear before adult candidates for pediatric liver donors.     Because there are a relatively small number of pediatric donors, the transplant rates for pediatric patients should increase - though modestly. Further, because there are fewer liver transplants within the pediatric population, and, consequently, greater travel time for donor livers and organ procurement teams, we do not believe there will be a significant increase in costs or decrease in efficiency to pediatric centers. Lastly, we believe it is appropriate as proposed not to place a cap on Pediatric End-Stage Liver Disease (PELD) exception scores, as the PELD score is known to underestimate mortality (in comparison to Model for End-Stage Liver Disease scores in adults).    NASPGHAN appreciates consideration of its views on the proposed liver distribution policy. Should you have any questions or wish to engage with NASPGHAN leaders further on this this important topic, please contact Camille Bonta, NASPGHAN policy advisor at (202) 320-3658 or cbonta@summithealthconsulting.com.    Sincerely,      Karen Murray, MD  President  North American Society of Pediatric Gastroenterology Hepatology and Nutrition

OPTN Region 1 | 11/01/2018

Region 1 Vote (9 of 21 voting members submitted a vote online): • Broader 2-circle distribution: 0 strongly support, 3 support, 0 abstain/neutral, 3 oppose, 3 strongly oppose • MELD sharing threshold recommendation: 1 for MELD 34, 1 for MELD 32, 6 for MELD 29, 1 abstain • Size of fixed distance circles recommendation: 1 for remain the same, 0 for smaller, 7 for larger, 1 abstain • Acuity circles: 6 strongly support, 2 support, 0 abstain/neutral, 1 oppose, 0 strongly oppose Regional Comments: Many on the call supported broader sharing and did not think either model presented by the committee would make significant changes to the current system. Of the two models presented, there was support for the Acuity Circle model as the best next step to successfully share more broadly. Those in favor of the acuity model are aware that there will need to be changes in the way the community procures and transports organs. There is no way to predict the change in cost, cold ischemic time or discards because there is no way to predict changes in behavior. If Broader Sharing 2 Circle is chosen, the most support voiced was for using a sharing threshold of 29. Those on the call supported allowing Hawaii to keep their variance, but did not see a need to expand the variance to include Puerto Rico. Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 1 outside the regional webinar is also available on the public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Anonymous | 11/01/2018

I am in support of the B2C 35 model which best reflects the policy compromise agreed to by this community last year. This model will prioritize individuals with the highest lab MELDs while avoiding flying for clinically insignificant differences in MELDs. It also keeps the livers which are most at risk to cold ischemia local (ie DCD and over 70 donor livers).

OPTN Region 2 | 11/01/2018

Region 2 Vote (16 of 58 voting members submitted a vote online):   • Broader 2-circle distribution: 4 strongly support, 4 support, 2 abstain/neutral, 2 oppose, 4 strongly oppose  • MELD sharing threshold recommendation: 1 for MELD of 29, 1 for MELD 30, 5 for MELD 32, 8 for MELD 35, 1 abstain  • Size of fixed distance circles recommendation: 5 for remain the same, 7 for smaller, 4 for larger, 0 abstain  • Acuity circles: 0 strongly support, 5 support, 3 abstain/neutral, 4 oppose, 4 strongly oppose  Comments: There is a concern about population density in relation to the size of sharing circles.  With such high population density in the northeast, did the committee consider available resources such as hospital staff and the number airplanes?  Smaller sharing circles would make more sense in areas of high population density.    There was a comment that in regards to pediatric patients, B2C seems to be the most favorable for that group.  Another commenter stated that the B2C model seems to be favorable to patients on the wait list while keeping costs down at the same time.

OPTN Region 10 | 11/01/2018

Region 10 Vote (16 of 34 voting members submitted a vote online):   • Broader 2-circle distribution: 6 strongly support, 7 support, 2 abstain/neutral, 0 oppose, 1 strongly oppose  • MELD sharing threshold recommendation: 1 for MELD of 30, 6 for MELD 32, 1 for MELD 33, 8 for MELD 35, 0 abstain  • Size of fixed distance circles recommendation: 8 for remain the same, 8 for smaller, 0 abstain  • Acuity circles: 0 strongly support, 1 support, 2 abstain/neutral, 2 oppose, 10 strongly oppose  Comments: Members in the region had concerns about geographic barriers and calculating distance from donor hospital from the transplant hospital and not place of candidate residence.  Candidates who live in the western part of Michigan could potentially miss liver offers since they are listed at a transplant center in southeastern Michigan and that would increase the distance from a donor hospital on the other western side of Lake Michigan.  They would also like to see that population density is considered by the committee before selecting one of the proposed models.  The comment was made that any changes made to liver allocation should be done in an iterative fashion since more changes will surely come with time.  It would be sensible to make a more conservative change at this time, especially with changes in NLRB starting as well.  The lawsuit has asked for DSA and region to be removed from liver allocation, and that should be the focus of any changes made to liver allocation. The group favored the B2C model and in general, favored 35 over 32 since the modeling showed minimal differences in the outcomes measured.  There was concern over why 32 was favored by Liver and Intestinal Committee over 35 and how 29 will be advocated without any modeling.  There is concern that mortality rates will rise in the first year due to the volume of exception candidates.  Many exception scores will be higher than the sharing threshold decided on for the new allocation system, so patients with MELD scores will be disadvantage compared to exception patients.  Region 10 has roughly 10% of exception cases so will not be able to take advantage of this exception backlog.

Anonymous | 11/01/2018

The proposed broader sharing models do not have protections for transplant centers that serve regions with poor access to health care or an increased risk of waitlist mortality.  These models will also have deleterious effects on organ wastage, due to increased travel and CIT.  The negative impacts these models pose to our patients are inconsistent with the overall mission of the field of transplantation.

Anonymous | 11/01/2018

The proposed liver allocation changes are disheartening to say the least.  This has been a rushed process that not allowed for time to consider all the ramifications of the proposed changes. The agenda of some should not become the rule for all.  These changes will have a negative impact on the transplant population that we serve as a transplant center.  We are in a high preforming OPO but a competitive transplant market, our patients will suffer as a result of these changes.

OPTN Region 9 | 11/01/2018

Region 9 Vote (15 of 28 voting members submitted a vote online): • Broader 2-circle distribution: 0 strongly support, 2 support, 2 abstain/neutral, 1 oppose, 10 strongly oppose • MELD sharing threshold recommendation: 12 for MELD of 29, 1 for MELD 30, 0 for MELD 32, 1 for MELD 35 • Size of fixed distance circles recommendation: 0 for remain the same, 0 for smaller, 15 for larger, 0 abstain • Acuity circles: 13 strongly support, 2 support, 0 abstain/neutral, 0 oppose, 0 strongly oppose Comments: Those who attended the call were engaged and provided thoughtful feedback. There was overall support from those on the call for the acuity model and broader sharing. Many agreed that the acuity model minimizes geography and emphasizes acuity of illness. Some commented that based on the SRTR analysis, the acuity model decreases waitlist mortality and reflects a more efficient way of allocating livers and is the most fair nationally. There was some support for not having any MELD thresholds for sharing since MELD stratifies patient at risk. In addition, data shows that MELD scores in the mid-20's have increased mortality on the waiting list. The lower the threshold, the more equity for patients. There were comments that Region 9 has long tradition of believing in broad sharing and that livers should go to patients with highest severity scores and has regional sharing of livers this way for many years. Although not in the modelling, there will likely be substantial behavioral changes regarding utilization of organs as a result of changes in policy. Some members commented that while there is increased cost to travel, cost savings by transplanting sicker patients earlier outweighs expense of travel. There won't be people sitting in ICUs with very high MELDs which takes a lot of resources. There was a comment that MELD scores guide us to the sickest patients; there is no other situation in healthcare where geography directs access to therapy for your disease (e.g. chemo or insulin for diabetics). Transport time and how many organs are flown depends on factors such as traffic and time of day. There is no way to accurately predict this. There was feedback that 150 mile circle will restrict sharing in NY and many areas of the country. 150 mile sharing circle is smaller than about 20% of current DSA and is too restrictive. There was feedback that the community needs to step back and focus on basic principles of equity. Organs are a national resource - two people, equally as sick, should have equal access to get a transplant. There needs to be equity among transplant patients who really need organs and not among transplant hospitals and physicians. If you are sick, you should have access to these organs regardless of location.

OPTN Region 6 | 11/01/2018

Region 6 Vote (23 of 80 voting members submitted a vote online).  Comments are still draft, waiting for the councillor to approve.  • Broader 2-circle distribution: 17 strongly support, 5 support, 0 abstain/neutral, 1 oppose, 0 strongly oppose  • MELD sharing threshold recommendation: 2 for MELD of 29, 3 for MELD 32, 18 for MELD 35  • Size of fixed distance circles recommendation: 21 for remain the same, 1 for smaller, 1 for larger  • Acuity circles: 1 strongly support, 2 support, 1 abstain/neutral, 4 oppose, 15 strongly oppose  Comments: The region expressed great concern over the lack of consideration for Alaskan donors.  Since any donor in Alaska will be more than 500 nautical miles from a transplant center, those livers will go straight to national sharing.  That is not an efficient means for liver allocation due to the distance to ship the organ and the increased cold ischemic time.  One member proposed that transplant centers in the Pacific Northwest be included in a 500 nautical mile circle around the donor hospital in Alaska; that way those offers would not go straight to national offers and hopefully prevent unnecessary organ discards.   It was noted that in the B2C model it is concerning that there are sharp cliffs when it comes to allocation.  A patient with a MELD of 16 that is 145 nautical miles from a donor will get a liver offer before a patient with a MELD of 31 that is 155 nautical miles from the donor.  A comment was made that the region will see an increase in the number of organs exported and they are concerned that waitlist mortality rates will increase because of that.  It was also noted that the amount of flying will increase, adding an exorbitant amount to a transplant program's costs.  With the increase in flying will there be enough planes?

Anonymous | 11/01/2018

It is too bad it takes a lawsuit to move UNOS towards change. The Final Rule is very clear about organ allocation -'it shall not be based on the candidate's place of residence or place of listing, except to the extent required'. There is no mention of using the least expensive method of allocating organs or to establish an arbitrary 'boundary' to allocate organs. Shouldn't UNOS be creating a policy that saves the most lives possible?? While the Acuity Circle model comes the closest, is there a better solution?? Probably - but it seems to be challenging for committee folks and the Board to be creative, think outside the box. Can you imagine how awesome it would be to create policy that saved as many lives as possible, to not have the politics (don't take organs away from 'my center) and for EVERYONE involved in organ donation/transplantation to believe that all donated organs are a national resources given to save as many lives as possible.

California Hospital Association | 11/01/2018

October 22, 2018    Brian Shepard  Chief Executive Officer  United Network for Organ Sharing 700 North 4th Street  Richmond, VA 23218 Dear Mr. Shepard:  On behalf of our more than 400 member hospitals and health systems - including 13 liver transplant centers - the California Hospital Association (CHA) is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to reduce the persistent geographic and economic disparities in access to liver transplantation.  CHA appreciates the committee's decade‐long effort to implement the National Organ Transplant Act (NOTA) and its accompanying final rule to establish a 'nationwide distribution of organs equitably among transplant patients.'i CHA supports a clinically appropriate, fair and equitable distribution of life‐saving organs and strongly supports the Acuity Circle Model.    Current liver allocation policies fall far short of meeting the final rule's mandate to ensure that the allocation of organs for transplantation 'shall not be based on the candidates' place of residence or place of listing.'ii Decades of discussion, deliberation and debate have yielded only modest progress, while many Americans - especially many Californians - wait in vain for access to this life‐saving intervention. Unfortunately, the current liver allocation methodology's reliance on sharing organs within the current 58 local donation service areas (DSAs) is responsible for the disparities experienced across the country in liver transplantation, necessitating urgent change.    CHA's Interest in Liver Allocation Policies  Thirteen of our member hospitals are transplant centers, and they are among the highest quality liver transplant centers in the nation. California transplant facilities transplanted 728 livers between January 1, 2014, and June 30, 2015. Of those transplants, 647 came from deceased donors and were received by 493 adults and 154 children. The remaining 81 liver transplants came from living donors and were received by 68 adults and 13 children.iii CHA supports policies that will make it possible for more Californians awaiting liver transplants to receive them.    However, our interest in this issue transcends the unique concerns of the hospitals and medical centers performing liver transplants. Hospitals from all parts of California care for patients with liver disease that may require a liver transplant, and these hospitals are every bit as concerned about access to liver transplantation as are the transplant centers. Indeed, 104 California hospitals are among a select group nationwide recognized by the Department of Health and Human Services for reaching notable achievement in promoting enrollment in state organ donor registries. These providers participated in the national Workplace Partnership for Life Hospital Campaign, which is sponsored by the Health      Resources and Services Administration (HRSA) and seeks to mobilize the nation's hospitals to increase the number of registered potential organ, eye and tissue donors.    California hospitals share a common goal - that every Californian has equitable access to affordable, safe, high‐quality, medically necessary health care. It is an objective that we believe must be shared by all stakeholders, including individuals, employers, health care providers, payers and government. When Californians - or any other Americans - are deprived of the opportunity to receive a life‐saving liver transplant simply due to their birthplace or current address, 'equitable access' to quality health care is denied.    Disparities in Access to Liver Transplants  Despite NOTA's enactment 32 years ago, requiring organ procurement organizations to allocate organs 'equitably among transplant patients according to established medical criteria,' liver allocation in the United States has been anything but equitable. Long after the final rule mandated that access to organs 'shall not be based on the candidate's place of residence or place of listing,'iv dramatic disparities remain - a fact that even opponents of liver allocation reforms grudgingly acknowledge.    Listings for liver transplant currently vary 14‐fold, while deaths due to liver disease vary 19‐fold across the current 11 United Network for Organ Sharing (UNOS) transplantation regions.v,vi Comparable patients' chances of receiving a transplant within 90 days range from 18 percent to 86 percent, depending on where they live or list.vii    A liver transplant recipient's likelihood of dying within a defined period of time if they do not receive a liver transplant is quantified using a risk‐assessment metric known as the Model for End‐Stage Liver Disease (MELD); scores range from six to 40. The higher the MELD score, the greater the risk of death. For candidates with MELD scores between 21 and 34, the probability of transplant within 90 days varies widely across organ procurement organizations (OPOs), ranging from under 30 percent in some regions to more than 90 percent elsewhere.viii Not surprisingly, both pre‐ and post‐transplant mortality rates tend to be higher in regions where patients wait longer. For candidates from different regions, studies have found a three‐fold variation in death rates of waiting list candidates, a 20‐fold variation in transplant rates and 10‐point differences in MELD score at the time of transplant.ix A study of more than 100,000 patients on the liver transplant waiting list between May 8, 2003, and April 17, 2011, found that one‐year mortality rates ranged from 34 percent to 60 percent across regions.x    These disparities particularly impact Californians, who face some of the most daunting barriers to liver transplantation. The median MELD score for Californians awaiting transplant is 33; for Southern Californians, it is 38. Compare this to the national average of 24 - meaning, of course, that some regions have even lower average MELD scores. California transplants 27 liver patients per 100 patient years of waitlist time, versus the national average of 42 patients per 100 patient years of waitlist time. Some regions even transplant 228 patients, or nearly 10 times as many, over that same waitlist time.xi In short - compared to people in other parts of the county, Californians wait longer, receive transplants only when they are considerably sicker, and die at substantially higher rates while awaiting a transplant.       Why Californians Face Barriers to Liver Transplantation  The reasons for California's uniquely disadvantaged position are complex and largely demographic. The state suffers from one of the highest rates of liver disease in the United States: 12 per 100,000 Californians have liver disease, compared to a national average of seven per 100,000.xii At the same time, California has one of the lowest death rates in the United States: 6.2/1,000, versus a national average of 8.2/1,000. While a lower death rate may otherwise be a celebrated statistic, it diminishes the potential supply of transplanted livers; instead of having a pool of potential donors that matches the national rate of 71 potential donors per 1 million population, California's donor pool is only 31 potential donors per million. In addition, eligible donor authorization rates vary nationally by race and ethnicity, with lower rates of donor authorization typically occurring among African‐Americans, Hispanics and Asians, exacerbating organ donation shortages in a state as diverse as California.xiii    Although critics of liver allocation reform loudly proclaim otherwise, the cause of the disparity in access to liver transplantation for Californians has nothing to do with OPO performance. A national study showed that, even if every OPO had a 100 percent liver donor authorization rate, significant geographic imbalances in supply and demand would remain, due largely to the demographic and epidemiological factors referenced above. The analysis found 'no evidence to support the assertion that the liver allocation system transfers livers from better performing OPOs to poorer performing OPOs,' and concluded that disparities in access were, instead, 'strongly related to differences in demand' for liver transplantation.xiv    In fact, California's OPOs are consistently ranked among the top performing OPOs in the nation. In 2015, three of the four operated with higher‐than‐expected donation rates, compared to national mean donation rates, and the fourth performed essentially at the national mean.xv Ironically, many of the OPOs in regions that experience the easiest access to liver transplantation perform more poorly than their California counterparts. California's hospitals are committed to improving organ donations, but increasing donations will always be insufficient if the distribution model remains so flawed.    Current Liver Allocation Policy Favors the Wealthy  The current allocation methodology incentivizes unintended consequences that further exacerbate inequities. For example, patients requiring liver transplants may register themselves at two or more transplant centers, a practice that reduces transplant wait time by increasing the chances of receiving a liver from a transplant center that has a shorter wait list and higher transplant rate. While this practice reduces average wait times by several months,xvi it requires candidates to travel to appointments at multiple centers and to make themselves available immediately for transplant if an organ becomes available. This requires financial resources that many potential recipients simply do not have.    As a result, candidates in the highest socio‐economic status quartile are 70 percent more likely to travel to a non‐local DSA than candidates in the lowest quartile.xvii Of all adult liver transplant candidates, only  2.3 percent listed themselves in more than one region between January 1, 2005, and December 31, 2011; these candidates were disproportionately male, white, non‐diabetic, college educated and privately insured. xviii Further, recipients listed at multiple transplant centers who received a transplant outside of their area had significantly higher median incomes compared to patients who died on the waitlist -$84,946 versus $55,250. xix A recent study reviewed the rate of multiple listing by candidates waiting heart, lung, liver and kidney transplants and noted, among other things, that 6 percent of the 103,332 individuals awaiting a liver transplant were on more than one DSA list - a cohort of patients       who were found to be wealthier and better insured than the singly listed candidates.xx Thus, not only does the current methodology disadvantage potential recipients based on the accident of their geography, it demonstrates the impact of wealth on the ability to obtain necessary medical interventions.    California Hospitals Support the Acuity Circle Model for Liver Allocation  The Acuity Circle (AC) model will improve quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing residency from dictating access to transplantation.    The primary criticism of the AC is that travel time for organs will increase. However, adequately addressing the current gross disparities in organ distribution will inevitably mean more travel. Certainly, more travel will add to the initial cost of organ distribution - but the analysis included in this proposal does not account for the considerable savings gained by reducing the cost of caring for very sick patients with a high MELD score. Those savings could be realized by reducing the number of days a patient waiting for liver transplant has to stay in the intensive care unit, which far outweighs the cost of transportation. Further, a transplant center's financial benefit or loss should not be a consideration when developing the most fair and equitable policy for patients.    The AC scenario best achieves the goal of broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC scenario.xxi    California Hospitals Support a Lower MELD Threshold for Broader Circle Distribution  The goal of removing the limitations of the DSAs can only be met if the sickest patients have the quickest access to compatible organs. The Broader 2‐Circle (B2C) scenario recommended by the committee does not meet the standards promoted by NOTA, the final rule or the July 31 HRSA letter.xxii Further, the MELD score bands must be narrow to ensure that the current disparities are addressed thoroughly.  Ideally, to most effectively reduce mortality rates, the MELD sharing threshold should be set at 25.    The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. HRSA correctly called for urgent action in its July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.    If you wish to discuss further or need more information, please do not hesitate to contact me at aorourke@calhospital.org or (202) 488‐4494.    Sincerely,    Anne O'Rourke  Senior Vice President, Federal Relations  CC: Health Resources and Services Administration Members of the California Congressional Delegation

Keri Lunsford | 11/01/2018

Despite over 15,000 patients currently awaiting transplant, only ~5500 LTs are performed annually. With the shortage of available organs, recipient selection is critical, and candidate illness severity is significantly increasing.  Based on the ethical principles of justice, this provision directs that organ allocation 'shall be designed and implemented: To allocate organs among candidates in order of decreasing medical urgency status and shall not be based on the candidate's place of residence or place of listing.  There has been significant recent criticism of current organ allocation policies with regards to currently implemented arbitrary geographic boundaries in place, resulting in the current movement to redesign the organ allocation system.  As such, two proposals have been submitted for comment.     My major concern with all of the proposals submitted for comment is that the data which has been presented relies heavily on the current allocation MELD of patients previously undergoing liver transplant.  Given that changes to the MELD exception score are proposed to occur concurrently with the proposed changes to the allocation score, the modeling with which we have been presented does not accurately demonstrate regional MELD distribution and therefore cannot accurately model the medical need of patients within specific regions of the country.  There is considerable variation in the allocation and laboratory MELD of patients undergoing transplants within each region and even within each center in a given region.  For example, within Region 4, median allocation MELD in 2017 was 30 while the median biologic MELD was 22.  Center variation was significant, however, with median biologic MELD of transplanted patients ranging from 14 to 30.  Similarly, within Region 9, Median list MELD at transplant was 33 and biologic MELD was 21, with median center biologic MELD ranging from 12.5 to 29.5.     With regards to the B2C and acuity circles proposals, my concerns are that this policy will not achieve the goals of decreasing reliance on the patient's geographic location.  Our country varies significantly in regard to the population density of specific areas.  Within Texas, the current geographic area for liver allocation is actually larger for each DSA than the area allowed by the concentric circles that are proposed.  In the provided modeling, the B2C model will do little to alter the waiting list mortality among those sickest in need of transplant.  Some improvement will be made with the concentric circles model.      Thus, my support is for the concentric circle model with a lower sharing threshold of 29 in order to maximize the potential of a sick patient receiving a life-saving liver transplant and to minimize the impact of geography on the availability of organs to that patient.

Teresa Shafer | 11/01/2018

I submitted a public comment earlier today speaking to the critical need to improve donation and utilization to address the shortage of livers for transplantation across the country, in every DSA. I want to add to that comment by encouraging the recovery and transplantation of livers from expanded donors, particularly DCD donors. It is unfortunate that the website cannot accommodate table(s), because simple graphs depict show most clearly the regions of the country who are performing above average and, where we should be focused, in the top quartile. I have always appreciated having colleagues and comparable organizations against to benchmark in order to improve my own organization's performance. None the less, sans graphs, I will show below the OPOs in the nation who are leading in DCD donation. The best way to measure such leadership is by performance based on an independently verifiable denominator solid denominator that takes into account the pool of potential donors, in this case, the number of total deaths in the DSA service area. That information was obtained on the SRTR website in the OSR reports, using DCD donors and total deaths as reported by the SRTR. The larger the OPO in terms of deaths, of course, the more donors that can be recovered. DCD PERFORMANCE - TOP QUARTILE NATIONALLY (DCD donors per total deaths) The leading/ top performing OPOs in the nation for DCD donation are: 1. Oklahoma (OKOP) - 17.9 DCD/10K total deaths 2. Arizona (AZOB) - 16.2 3. Utah (UTOP) - 15.2 4. WI - Madison (WIUW) - 13.4 5. Nevada (NVLV) - 13.4 6. Washington (WALC) - 11.1 7. PA - Philadelphia (PADV) - 11.0 8. TX - Houston (TXLG) - 10.5 9. Colorado (CORS) - 10.5 10. Nebraska (NEOR)- 10.3 11. FL - Orlando (FLFH) - 10.3 12. Michigan (MIOP) - 10.1 13. Illinois (ILIP) - 9.3 14. Kansas (MWOB) - 9.3 15. CA -San Diego (CASD) - 8.9 DCD donors per million population can also be calculated and the list varies on slightly. Oklahoma and Arizona remain the top #1 and #2 OPO/DSA performers, whether DCD per total deaths of DCDs per million population is used. Thank you for the opportunity to comment. Teresa Shafer, RN, MSN, CPTC Liver Transplant Alliance

OPTN/UNOS Organ Procurement Organization Committee | 11/01/2018

The OPO Committee discussed this proposal and offers the following responses: • The Committee supports the proposed size of the fixed distance circles. The Committee acknowledged that there are differences in populations across the country, but for simplicity it is best to keep the distances the same until further evaluation of population density can be completed. • The Committee supports the broader 2-circle model and recommend that the Liver Committee continue to evaluate this model based on the data. • The Committee supports the expansion of the Hawaii variance to Puerto Rico in order to mitigate the negative impact on candidates in Puerto Rico with the proposed change from regions to fixed distance circles in organ allocation. • The Committee agreed that there will be a budgetary impact for both the OPTN and OPO community. The Committee agreed that upgrades to DonorNet® are needed as broader distribution models are evaluated and implemented. This will help ensure that organ placement is transparent and efficient and could potentially provide important data for future efforts. The Committee also agreed that OPOs will have an increase in costs related to data collection, transportation, and logistical issues such as coordinating OR times.

LifeLink of Florida | 11/01/2018

LifeLink of Florida appreciates the opportunity to provide comment on the liver allocation proposal, and recognizes the efforts of the liver committee in bringing a proposal forward. We have a long history of collaborative relationships with our local transplant programs. We believe our joint and collaborative efforts have strengthened our community's resolve and commitment to donation, leading to more lives saved through transplantation. We take our responsibility to be good stewards of the gift our donors have entrusted to us and at the same time, recognize the need to re-model and align organ allocation. At the UNOS Region 3 meeting, there was discussion of a statewide distribution framework as the first level of sharing. States are a non-arbitrary boundary, are consistent with ability to access care for many types of funding including Medicaid, and in most cases would provide for a broader level of sharing than the current proposals. We believe this approach should be modeled and given consideration. Additionally, we support the inclusion of Puerto Rico in the ABO variance with Hawaii. Thank you, Liz Lehr, R.N., M.H.A. Senior Vice President/Executive Director

University of California, Los Angeles | 11/01/2018

November 1, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of the patients, physicians, and staff of UCLA Health's four teaching hospitals and over 170 outpatient medical practices, we are pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. UCLA Health strongly supports the Acuity Circle (AC) model and urges that it be implemented with the broadest possible sharing radius. UCLA Health is home to the largest solid organ transplant center in the country, including one of the world's leading liver transplantation programs. Over the past 30 years, we've performed more than 6,350 liver transplants for infants, children and adults (including more than 290 transplants since the beginning of 2017). Our experts are responsible for developing some of today's leading techniques and are spearheading research efforts to improve care, expand donor pools, and better manage and treat advanced liver disease. Unfortunately, the current liver allocation methodology significantly undermines our efforts and requires urgent change. In 2017, our state had 18.3% of all liver waitlist candidates, but Californians made up only 7.6% of all liver transplants performed. Californians make up 12.1% of the U.S. population, but 18.5% of all U.S. liver waitlist deaths. In 2017, 223 Californians died on the liver waitlist and countless others had to be delisted because they became medically unsuitable for transplant after long wait times. This disparity is exacerbated by the current allocation system's use of Donation Service Areas (DSA) with arbitrary boundaries that vary greatly in size, and have no relationship to population, geography, or (most importantly) the medical need of those awaiting liver transplant. As a result, the DSA that includes the Los Angeles metropolitan area has the highest median MELD/PELD at transplant in the entire United States: 35.3. UCLA Health supports the elimination of these arbitrary and inequitable boundaries and strongly urges UNOS to adopt the broadest possible sharing through the implementation of the Acuity Circle Model, which, in Southern California, would result in the largest reduction in median MELD/PELD at transplant and would provide much needed relief to Californians awaiting liver transplantation. UNOS letter from UCLA pg 2 The AC model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC best effectuates the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC model best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. In short, adopting the Acuity Circle model, with the largest possible sharing radius, will save lives and result in better outcomes for more patients than any proposal currently under consideration. Sincerely, John Mazziotta, MD, PhD, Vice Chancellor, UCLA Health Sciences, CEO, UCLA Health Johnese Spisso, MPA, President, UCLA Health, CEO, UCLA Hospitals

Robert Brickman | 11/01/2018

Dear Mr. Shepard/members of the OPTN, I am writing to support change of organ allocation to the Circle Acuity Model. There are regions of the country currently where the wait for a liver is much longer than in other regions. This is unfair and results in more severe illness, and increased frequency of death based on region. Wealthier patients can fly to shorter wait regions; also resulting in a lack of fairness. The Circle Acuity Model would mitigate these problems and I enthusiastically support this change. As a former liver transplant patient in the New York City area, my wait was greater than it would have been elsewhere. Thank you for allowing my input. Sincerely, Robert Brickman Palm Springs, California

Sutter Amador Hospital | 11/01/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Medical Center, Sacramento is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Anne Platt, FACHE CEO

New York Center for Liver Transplantation | 11/01/2018

October 29, 2018 Julie Heimbach, MD, Chair UNOS Liver Intestine Committee 700 North 4th street Richmond, VA 23219 RE: Changes to Liver Distribution Dear Dr. Heimbach: The New York Center for Liver Transplantation (NYCLT) has long advocated for changes in liver distribution policy to benefit all geographically disadvantaged patients and we have worked with HRSA, the OPTN and UNOS to do so. We appreciate the efforts of the UNOS Liver and Intestine Committee to review the proposed models, but it is the unanimous decision of NYCLT to support the Acuity Circles model as a means to reduce geographic disparity leading to unequal access to transplants. Acuity Circles has the greatest impact in reducing disparity in Median MELD at Transplant (MMaT) across geographic areas, with a negligible difference of less than 15 minutes in organ transport time. We have significant concerns about the Broad 2 Circle (B2C) proposal that was put forward by the Liver Intestine Committee, which includes many constraints intended to reduce the likelihood of meaningful benefits of policy changes. These constraints include a sharing circle of only 150 nautical miles around the donor hospital for patients with MELDs 31 or lower, which is insufficient to significantly impact disparities and is inconsistent with other organ distribution policies: heart distribution is now based on 500 nautical miles and lung distribution was recently modified to 250 nautical miles. B2C will, in fact, narrow the distribution of livers in NYS for patients with a MELD score of 31 and less. It appears the share will narrow in a similar fashion for patients in 13 of the DSAs (20+%) in the country under the B2C model. Given that mortality increases substantially over MELD 29, NYCLT cannot support the proposed MELD threshold of 32. With the elimination of DSA, there is no need for a MELD threshold at all. While NYCLT can and has supported many versions of reform proposals over the past several years, we have been consistent that any change should make significant strides toward the goal of reducing variance in MMaT. Lack of meaningful change risks the public trust in our policy development process. Thank you for the opportunity to comment. Samantha DeLair New York Center for Liver Transplantation Cc: NYCLT Board of Directo

Lloyd Norman | 11/01/2018

As a caregiver to a transplant recipient in Texas, the current threshold causes patients to get too sick before transplant. Please reconsider expanding the 150 mile radius to at least 250 miles.

FAIR Foundation | 11/01/2018

Dear Mr. Shepard / Members of the OPTN: Please vote to adopt the Acuity Circle model for liver allocation. Our patients we serve here in California wait way too long for a transplant. They are so sick by the time they finally get a transplant, their recovery time is longer and their outcomes less certain. It is utterly absurd that patients have to travel across the country co-listing at several transplant centers just to get a transplant before they become too ill to get transplanted - and that option is only available to the patients with the financial and family support to do so leaving other patients to wait even longer for a transplant. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. -- Cathy Teal Executive Director FAIR Foundation

Timothy Schmitt | 11/01/2018

I do not agree with any of the proposals. I am strongly opposed to circles as they are arbitrary and have no logical explanation.    As an organ donor in the United States I'm disappointed with UNOS and members of the transplant community.  Some have lost sight of the foundation of transplant and assume the organ is a commodity.  The American medical Association code of ethics, source for the claim that organs are a nation resource,  is based on the point of view of the physician treating the patient. This is a narrow minded, one-sided view of transplantation, disregarding where organs come from. Their statement that organs should be considered a national resource is a major oversight.  First of all organs are a gift not a resource or a commodity.  Clearly stated in the uniform anatomical gift act, donation is an 'opt in', a system that honors the free choice of an individual to donate. Furthermore the decision to be a donor is a highly personal decision of great generosity that deserves the highest respect from the law.  Organs treated as a commodity, increased discards, higher waitlist death and dismantling the relationships of community/OPO/centers have does not respect donors.     As a donor I would prefer my gift to help out my neighbor or my community.  I would be disappointed in a system that would allow my organs to go far away when I have people in my area that need them.  I am very disappointed to know that the area that has filed law suit has the lowest donation rates in the country and instead of focusing on the foundation would rather take gifts from other areas.  Lastly UNOS's claim that their measure of disparity is based solely on those candidates on the list fails to consider the disparities of end organ disease in the United States.  Disparity is access to care and death while waiting not MELD.    All this time and money should be spent on education, public policy and donation awareness to improve donation rates across the country.  Helping not only liver, but all organs.   Some studies suggest we could have an increase of 1000 or more donors a year.   Focusing on donation is the key to success.    Timothy M Schmitt MD FACS  Professor of Surgery  Director  University of Kansas Health System  Center for Transplantation

Rachel McHenry | 11/01/2018

Dear Mr. Shepard / Members of OPTN, I am a liver transplant recipient, having received my liver a year and a half ago. I feel truly blessed for this life-giving event. I have seen through our liver transplant support group many people who are very sick waiting for their opportunity at a new liver. Many of them are far more ill than those of us who had liver cancer and with the current evaluation process are still waiting. Sadly, some of these patients do not live to have a transplant opportunity. I urge you to reconsider your liver transplant evaluation process and make it fairer to patients who have other forms of acute liver disease or cannot afford to travel to another part of the country to take advantage of a shorter transplant list. Please consider adopting the Liver Acuity Model as it appears to address both severity and geographical considerations in a fairer manner. Thank you in advance for your consideration Rachel McHenry

Anonymous | 11/01/2018

This is very important to me as I reside in California and received a liver transplant in May, 2014. When I was at my sickest with liver disease I was placed on the transplant list but actively explored the possibility of traveling to my home state of Mississippi because I was told I might receive a liver sooner there. Even if I could have afforded to do it, realistically that would not have been an option for me as I became too sick to travel. I pray that the Acuity Circle Model will be adopted to ensure a more fair way for California patients to receive their much needed liver transplant. Thank you.

Julia Helman | 11/01/2018

Dear Mr. Shepard and Members of the OPTN, I am in favor of adopting the Acuity Circle Model for liver transplant allocation going forward. -Failure to do this leaves many patients without transplants they desperately need. Current liver allocation requires patients in certain parts of the United States to wait longer and therefore get sicker before they receive organ transplantation. -When patients have to wait longer for transplant there is a higher chance of incurring more complications and poor outcomes; they even die before getting a transplant with the current method of organ allocation. -There is an unfair advantage to patients with financial means to get onto waitlists in areas with shorter wait times. This is an advantage to ill persons who can afford transportation over those who cannot, regardless of their acuity. I urge you to vote to adopt the Acuity circle model for liver allocation, as failing to do so leaves many of our patients without the transplants they desperately need. Thank you. Respectfully, Julia Helman

Sutter Davis Hospital | 11/01/2018

Dear Mr. Shepard and Members of the OPTN:    On behalf of our patients and community, Sutter Davis Hospital is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity  Circle model.    Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent  change.  While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.    The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC-far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.    The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.    Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.    Rachael McKinney, CEO Sutter Davis Hospital

Sean Kumer | 11/01/2018

I am opposed to each of these proposals for broader sharing as they will violate every tenet of the Final Rule for the sake of geography and not address mortality and patient access issues. The new allocation models will increase organ discards, increase transportation, and increase cost in an environment when healthcare costs are astronomical. These models have demonstrated that most organs will move out of socioeconomically disadvantaged and rural areas to more affluent areas of the country with better access to healthcare. A patient living in New York City with a higher MELD score than someone in rural America actually has a lower mortality because of their proximity to multiple transplant centers. Relying primarily upon median MELD at transplant is flawed. First, the MELD exceptions are far from standardized as of yet and should be prior to pursuing any allocation changes. Furthermore, MELD does not predict waiting list mortality. Many of the areas and regions that will be exporting more livers with these allocation models have a higher wait list mortality than New York or Massachusetts-- the 2 states that will import the most livers in these proposals. These proposals also do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many other regions than in New York or Massachusetts. Furthermore, these proposals address allocation only when donation has not been addressed. The relationship between transplant centers and OPO's cannot be overstated. These models will push for more organs to flow into New York when their OPO has the worst record of procuring donors for them. These proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. Additionally, many of these same transplant centers do a poor job in expanding the donor pool by not routinely accepting older donors and DCD. As a community, we have spent much time on obtaining a compromise nationally which was to go into effect this year. Because of a contingent, these models are being hastily assembled with unclear effects to our patients' lives. Donors, and those people that they save, deserve better than this. The Final Rule was enacted to protect the smaller OPO's from being overrun by those areas with larger populations. As a result, the smaller population OPO's frankly became more efficient and outperform the larger population OPO's who relied on shear volume and became inefficient. Unfortunately, these larger population OPO's and transplant centers are using their inadequacies as an excuse to punish those who have worked hard to improve donation rates as well as donor conversion rates. For these reasons, I cannot support any of these models. Sean C. Kumer, MD PhD FACS Vice President, Operative Services Surgical Director, Liver Transplantation University of Kansas Health System

Sutter Health Novato Community Hospital | 11/01/2018

Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Davis Hospital is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC-far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sherrie Hickman, Administrator, Novato Community Hospital

Walt Dwyer | 11/01/2018

Dear Mr. Shepard / Members of the OPTN, I urge you to please vote to adopt the Acuity Circle model for liver allocation because as a 2009 recipient I realize first hand how unfair the current system is. Thanking you in advance, Former Mayor city of Big Bear Lake, Walt Dwyer

Linda Emery | 11/01/2018

Dear Mr. Shepard/Members of the OPTN, I would like to address the unfair organ allocation and scoring for liver patients. My husband and I live in Southern California where it is nearly impossible to receive a transplant, especially a liver/kidney transplant. On December 20, 2013 my husband was diagnosed as being in liver failure. He had encephalopathy, ascites fluid, and muscle wasting. He decompensated rapidly and was admitted to the hospital. He developed hepatorenal syndrome, his kidneys completely failed causing him to need now need a kidney transplant as well as a liver transplant. Unfortunately, his MELD score did not reflect how gravely ill he was. His MELD score was in the mid to high 20's. He was bed bound, inpatient status, for seven months when we were told by his transplant team that he would not survive to transplant here in California and that his best chance for survival would be to go to a center that transplants at a lower MELD score. . After extensive research, we found that Ochsner Hospital in New Orleans, La. was transplanting at a lower MELD and that there were only a few people with his specifics that would be ahead of him on their transplant list. At this point my husband would have to be transported by air ambulance which was not covered by insurance. Fortunately, we were financially able to afford the $21,000.00 cash for this charter. We flew to New Orleans where he was admitted to Ochsner Transplant Center. The following week, after undergoing all of the screening, he was accepted to their transplant program and listed there. One month later, after many severe complications, he received his life saving double transplants. Had we not been in a financial situation to make this move my husband would not have survived. After seeing the Proposal Overview for the Liver and Intestine Distribution, as well as reviews by doctors, it seems that the Acuity Circle Model would be best to fairly allocate livers for transplant. I urge you to vote and adopt this model. Respectfully, Jerry and Linda Emery

Stanford Health Care | 11/01/2018

Dear Mr.  Shepard and Members of the OPTN:    On behalf of our patients and community, Stanford Health Care, one of 13 liver transplant centers in California is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates prompting Health Resources and Services Administration, the agency that oversees organ allocation to call for urgent action in a July 31 letter to UNOS. Of the two proposals presented by UNOS, we support the Acuity Circle (AC) model. The AC model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity as compared to the Broader 2-Circle (B2C) model.    However, Stanford Health Care strongly supports an allocation model based on sound medical principles that provides for the widest sharing possible for the sickest patients, unrestricted by artificial geographic boundaries.    Californians Face Significant Barriers to Liver Transplant  Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change and Californians face some of the most daunting barriers to liver transplantation. The MELD score was developed as an objective measure for risk of death in chronic liver disease. It (or rather MELD-Na derived from it) remains the best measure available to stratify risk of patients awaiting liver transplant. The median MELD score for Californians awaiting transplant is 33; for Southern Californians, it is 38. Compare this to the national average of 24 - meaning, of course, that some regions have even lower average MELD scores. California transplants 27 liver patients per 100 patient years of waitlist time, versus the national average of 42 patients per 100 patient years of waitlist time. Some regions even transplant 228 patients, or nearly 10 times as many, over that same waitlist time. (OPTN/SRTR Annual Data Report: Liver at http://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/03_liver_13.pdf .) In short - compared                 to people in other parts of the county, Californians wait longer, receive transplants only when they are considerably sicker, and die at substantially higher rates while awaiting a transplant.    The reasons for California's uniquely disadvantaged position are complex and largely demographic. The state suffers from one of the highest rates of liver disease in the United States: 12 per 100,000 Californians have liver disease, compared to a national average of seven per 100,000 (CDC Mone citation). At the same time, California has one of the lowest death rates in the United States: 6.2/1,000, versus a national average of 8.2/1,000. While a lower death rate may otherwise be a celebrated statistic,  it diminishes the potential supply of transplanted livers; instead of having a pool of potential donors that matches the  national rate of 71 potential donors per 1 million population, California's donor pool is only 31 potential donors per million. In addition, eligible donor authorization rates vary nationally by race and ethnicity, with lower rates of donor authorization typically occurring among African-Americans, Hispanics and Asians, exacerbating organ donation shortages in a state as diverse as California (UNOS OPTN OPO Quarterly Auth Rate Report 2013-05/2016 Mone citation).    Although critics of liver allocation reform loudly proclaim otherwise, the cause of the disparity in access to liver transplantation for Californians has nothing to do with OPO performance.  A national study showed that, even if every OPO had a 100 percent liver donor authorization rate, significant geographic imbalances in supply and demand would remain, due largely to the demographic and epidemiological factors referenced above.    In fact, California's OPOs are consistently ranked among the top performing OPOs in the nation. In 2015, three of the four operated with higher-than-expected donation rates, compared to national mean donation rates, and the fourth performed essentially at the national mean.  Ironically, many of the OPOs   in regions that experience the easiest access to liver transplantation perform more poorly than their California counterparts.    The Use of Proximity Circles in Allocation should be based on 'Sound Medical Principles'  The use of proximity circles in allocation policy must be based on 'sound medical principles.' Distance cut-offs should be based on the potential damage (cold ischemia time) or discard of an organ, and to a lesser degree on the costs entailed in organ transport. Gentry et al. showed that variation in transport time accounts for only 15% of the variation in cold time. Heart allocation utilizes zones, the smallest of which is 500 nm. In most cases a liver should easily be able to travel as far as a heart without increased risk of graft loss due to cold ischemia time. Proximity circles of 250 and 150 nautical miles thus seem arbitrary, with little basis in 'sound medical judgment.' Furthermore, the difference between 150 and 250 nm is unlikely to alter the mode of transport (most centers will fly if the distance is> 100 miles).    It seems as though travel time and cost have driven the conversation more than medical urgency of extremely ill patients who are likely to die within a relatively short time frame without a transplant. The discard of organs has not been shown to increase with wider sharing of hearts and lungs. Marginal organs that are not likely to tolerate longer ischemia times should be selected out by center behavior. Few centers will likely add 4 hours of flight time to a DCD, fatty liver or older donor. Likewise, marginal or futile transplants are unlikely to increase as centers with poor results will be at risk of probation or loss of accreditation by UNOS/CMS, as well as loss of contracting by carriers.    MELD Score and Mortality  The threshold for sharing organs is too restrictive. Status 1A and status 1B patients are well served by nation-wide   sharing.  These patients can be secondarily stratified by distance to reduce unnecessary     travel. The 90-day mortality risk by MELD score is shown in the Public Comment Proposal p. 15 Figure 3, (https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf). Starting at MELD 12, each one point increase in MELD score increases mortality  by at least 1%, rising to as high as a 6% difference in mortality for each M ELD point at MELD scores between 30 and 35. Thus a MELD score of 30 carries a 44% higher risk of mort alit y than a MELD of 15. A MELD of 25 has 20% higher mortality than MELD 15. It is hard to provide medical justification for allocating a liver to a low MELD patient at such a disparate risk of death compared to higher MELD score patients. What remains is to determine what an acceptable difference in risk is such that allocation follows principles of sound medical judgment and is compliant with the final rule.    The Acuity Circle model while not  perfect  offers sick patients  a better  chance of receiving  a liver,  meets  the final rule's requirements and achieves  broad,  equitable  organ  distribution  as  compared  to  the Broader  2-Circle model.    However, Stanford Health Care strongly supports an allocation model based on sound medical principles that provides for the widest sharing possible for the sickest patients, unrestricted by artificial geographic boundaries.    Sincerely,    David Entwistle President and CEO Stanford Health Care

Arvin Segismar | 11/01/2018

Dear Mr. Shepard / Members of the OPTN, 1. Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. 5. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6. As a resident of California and someone (with liver disease or who has someone close to me with liver disease, who has received a transplant or has someone close to me who has received a liver transplant) this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely/Yours/Respectfully/etc. Arvin Segismar

Sutter Maternity & Surgery Center of Santa Cruz | 11/01/2018

Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Maternity & Surgery Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Trina White, Chief Administrative Officer

OPTN/UNOS OPO Committee | 11/01/2018

The OPO Committee discussed this proposal and offers the following responses:  • The Committee supports the proposed size of the fixed distance circles. The Committee acknowledged that there are differences in populations across the country, but for simplicity it is best to keep the distances the same until further evaluation of population density can be completed.  • The Committee supports the broader 2-circle model and recommend that the Liver Committee continue to evaluate this model based on the data.   • The Committee supports the expansion of the Hawaii variance to Puerto Rico in order to mitigate the negative impact on candidates in Puerto Rico with the proposed change from regions to fixed distance circles in organ allocation.   • The Committee agreed that there will be a budgetary impact for both the OPTN and OPO community. The Committee agreed that upgrades to DonorNet® are needed as broader distribution models are evaluated and implemented. This will help ensure that organ placement is transparent and efficient and could potentially provide important data for future efforts. The Committee also agreed that OPOs will have an increase in costs related to data collection, transportation, and logistical issues such as coordinating OR times.

LifeLink of Florida | 11/01/2018

LifeLink of Florida appreciates the opportunity to provide comment on the liver allocation proposal, and recognizes the efforts of the liver committee in bringing a proposal forward.  We have a long history of collaborative relationships with our local transplant programs.  We believe our joint and collaborative efforts have strengthened our community's resolve and commitment to donation, leading to more lives saved through transplantation.  We take our responsibility to be good stewards of the gift our donors have entrusted to us and at the same time, recognize the need to re-model and align organ allocation.    At the UNOS Region 3 meeting, there was discussion of a statewide distribution framework as the first level of sharing.  States are a non-arbitrary boundary, are consistent with ability to access care for many types of funding including Medicaid, and in most cases would provide for a broader level of sharing than the current proposals.  We believe this approach should be modeled and given consideration. Additionally, we support the inclusion of Puerto Rico in the ABO variance with Hawaii. Thank you,  Liz Lehr, R.N., M.H.A.  Senior Vice President/Executive Director

University of California, Los Angeles | 11/01/2018

Dear Mr. Shepard and Members of the OPTN:    On behalf of the patients, physicians, and staff of UCLA Health's four teaching hospitals and over 170 outpatient medical practices, we are pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. UCLA Health strongly supports the Acuity Circle (AC) model and urges that it be implemented with the broadest possible sharing radius.    UCLA Health is home to the largest solid organ transplant center in the country, including one of the world's leading liver transplantation programs. Over the past 30 years, we've performed more than 6,350 liver transplants for infants, children and adults (including more than 290 transplants since the beginning of 2017). Our experts are responsible for developing some of today's leading techniques and are spearheading research efforts to improve care, expand donor pools, and better manage and treat advanced liver disease.  Unfortunately, the current liver allocation methodology significantly undermines our efforts and requires urgent change. In 2017, our state had 18.3% of all liver waitlist candidates, but Californians made up only 7.6% of all liver transplants performed.  Californians make up 12.1% of the U.S. population, but 18.5% of all U.S. liver waitlist deaths. In 2017, 223 Californians died on the liver waitlist and countless others had to be delisted because they became medically unsuitable for transplant after long wait times.    This disparity is exacerbated by the current allocation system's use of Donation Service Areas (DSA) with arbitrary boundaries that vary greatly in size, and have no relationship to population, geography, or (most importantly) the medical need of those awaiting liver transplant. As a result, the DSA that includes the Los Angeles metropolitan area has the highest median MELD/PELD at transplant in the entire United States: 35.3. UCLA Health supports the elimination of these arbitrary and inequitable boundaries and strongly urges UNOS to adopt the broadest possible sharing through the implementation of the Acuity Circle Model, which, in Southern California, would result in the largest reduction in median MELD/PELD at transplant and would provide much needed relief to Californians awaiting liver transplantation.     UNOS letter from UCLA pg 2      The AC model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC best effectuates the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation.    The AC model best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.    The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.    In short, adopting the Acuity Circle model, with the largest possible sharing radius, will save lives and result in better outcomes for more patients than any proposal currently under consideration.    Sincerely,  John Mazziotta, MD, PhD, Vice Chancellor, UCLA Health Sciences, CEO, UCLA Health  Johnese Spisso, MPA, President, UCLA Health, CEO, UCLA Hospitals

Robert Brickman | 11/01/2018

Dear Mr. Shepard/members of the OPTN, I am writing to support change of organ allocation to the Circle Acuity Model.  There are regions of the country currently where the wait for a liver is much longer than in other regions.  This is unfair and results in more severe illness, and increased frequency of death based on region.  Wealthier patients can fly to shorter wait regions; also resulting in a lack of fairness.  The Circle Acuity Model would mitigate these problems and I enthusiastically support this change.  As a former liver transplant patient in the New York City area, my wait was greater than it would have been elsewhere.    Thank you for allowing my input.    Sincerely,    Robert Brickman  Palm Springs, California

Sutter Amador Hospital | 11/01/2018

Brian Shepard  Chief Executive Officer  United Network for Organ Sharing  700 North 4th Street  Richmond, VA 23218      Dear Mr. Shepard and Members of the OPTN:    On behalf of our patients and community, Sutter Medical Center, Sacramento is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers.  We strongly support the Acuity Circle model.    Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change.   While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them.      The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model.  The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS.     Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need.      Sincerely,  Anne Platt, FACHE  CEO

New York Center for Liver Transplantation | 11/01/2018

Dear Dr. Heimbach:    The New York Center for Liver Transplantation (NYCLT) has long advocated for changes in liver distribution policy to benefit all geographically disadvantaged patients and we have worked with HRSA, the OPTN and UNOS to do so.  We appreciate the efforts of the UNOS Liver and Intestine Committee to review the proposed models, but it is the unanimous decision of NYCLT to support the Acuity Circles model as a means to reduce geographic disparity leading to unequal access to transplants. Acuity Circles has the greatest impact in reducing disparity in Median MELD at Transplant (MMaT) across geographic areas, with a negligible difference of less than 15 minutes in organ transport time.    We have significant concerns about the Broad 2 Circle (B2C) proposal that was put forward by the Liver Intestine Committee, which includes many constraints intended to reduce the likelihood of meaningful benefits of policy changes. These constraints include a sharing circle of only 150 nautical miles around the donor hospital for patients with MELDs 31 or lower, which is insufficient to significantly impact disparities and is inconsistent with other organ distribution policies: heart distribution is now based on 500 nautical miles and lung distribution was recently modified to 250 nautical miles. B2C will, in fact, narrow the distribution of livers in NYS for patients with a MELD score of 31 and less. It appears the share will narrow in a similar fashion for patients in 13 of the DSAs (20+%) in the country under the B2C model. Given that mortality increases substantially over MELD 29, NYCLT cannot support the proposed MELD threshold of 32. With the elimination of DSA, there is no need for a MELD threshold at all.    While NYCLT can and has supported many versions of reform proposals over the past several years, we have been consistent that any change should make significant strides toward the goal of reducing variance in MMaT.  Lack of meaningful change risks the public trust in our policy development process.    Thank you for the opportunity to comment.    Samantha DeLair  New York Center for Liver Transplantation Cc: NYCLT Board of Directors

NY and CA Attorneys General | 11/01/2018

Dear Mr. Azar and Ms. Miller: The Attorneys General of New York and California submit these comments to oppose the U.S. Department of Health and Human Services' Organ Procurement and Transplantation Network's ('OPTN') October 8, 2018 Liver and Intestine Distribution Using Distance from Donor Hospital Proposal ('Proposal'). As State Attorneys General, we are dedicated to promoting the health and well-being of the residents of our states. Instead of the Proposal, we write to express our support for a distribution system in accordance with the U.S. Department of Health and Human Services' ('HHS') July 31, 2018 directive to the OPTN Board of Directors to 'adopt a liver allocation policy that eliminates the use of [donation service areas] and OPTN Regions and that is compliant with the' HHS final rule affecting the OPTN, 42 C.F.R. § 121.8(a) ('OPTN Final Rule').1 On October 08, 2018, the OPTN Liver and Intestine Transplantation Committee issued a Proposal that fails to comply with HHS's directive and violates the OPTN Final Rule. The Proposal purports to eliminate the use of donor service areas and consideration of 'region in liver, liver-intestine, intestine, and liver-kidney allocation policies,' and it 'allocate[s] livers to candidates within 150, 250, or 500 nautical miles (nm) of donor hospitals before offering them nationally to allow for efficient placement of donor organs and to avoid organ wastage.'2 This proposal would result in inequities in certain states, including California and New York, for patients needing transplants due to the favoring of certain geographic locations. For this reason alone, HHS must reject the Proposal because it violates the OPTN Final Rule by disparately treating certain patients based on where they live and is in contravention of federal law. The National Organ Transplant Act requires that organs be equitably distributed among transplant patients. See 42 U.S.C. § 274 et seq. However, OPTN's current policy relies on geographic donor service areas and has created vast disparities for patients, particularly in our states. As the New York Office of the Attorney General explained in a December 1, 2017 letter to HHS (attached), critically ill New Yorkers have been disadvantaged by the current policy, which allows for inequitable allocation of donated livers. The new Proposal is insufficient to address these disparities. At present, states with lower proportions of donors relative to liver disease patients suffer from longer wait times than states with more organ donors. California and New York have both made policy priorities of better health and wellness and, as a result, have lower death rates than the national average. Unfortunately, this success limits the supply of organs for transplant in our states.3 This fact is not alleviated by the geographic barriers that remain in the Proposal. For example, despite its below-average overall mortality rate, California's mortality rate from chronic liver disease exceeds the national average.4 In the most recent annual report on liver transplants, patients in Los Angeles were the sickest in the country by the time they received a donor transplant.5 This is in spite of the fact that organ procurement organizations in California are highly rated.6 Further, a study has confirmed that there is no correlation between high-performing organ procurement organizations and better transplant rates, contradicting an argument made by some who urge the adoption of the current Proposal.7 The OPTN simply cannot justify its current reliance on arbitrary geographic regions of any kind as such reliance fails to comply with the OPTN Final Rule and the National Organ Transplant Act. In contrast to the Proposal, the OPTN Final Rule explicitly limits OPTN's ability to rely on a candidate's place of residence or listing in determining its cadaveric organ allocation policies. See 42 C.F.R. § 121.8(a). As such, a revised methodology should eliminate geographic barriers to access that have caused the residents of our states to grow sicker and die while awaiting transplants. We fully support Secretary Azar's use of his legal authority to require OPTN to adopt a fair liver allocation policy that is consistent with the National Organ Transplant Act and the OPTN Final Rule (42 C.F.R. § 121.4(d)). The current Proposal does not follow the Secretary's directive and should therefore be rejected. Sincerely, Barbara D. Underwood New York Attorney General Xavier Becerra California Attorney General 1 The Final Rule requires the OPTN Board of Directors to 'develop ... policies for the equitable allocation of cadaveric organs' which 'shall' (1) 'be based on sound medical judgment'; (2) 'seek to achieve the best use of donated organs'; (3) 'preserve the ability of a transplant program to decline an offer of an organ or not to use the organ for the potential recipient in accordance with § 121.7(b)(4)(d) and (e)'; (4) 'be specific for each organ type or combination of organ types to be transplanted into a transplant candidate'; and (5) 'be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement.' 42 C.F.R. § 121.8(a)(1)-(5). The Final Rule further requires that the 'equitable allocation' of organs 'shall not be based on the candidate's place of residence or place of listing except to the extent required by paragraphs (a)(1)-(5) of this section.' 42 C.F.R. § 121.8(a)(8). 2 Proposal at Executive Summary. 3 In 2016, California's death rate from all causes was 668.1 per 100,000 population; New York's was 781.7 per 100,000 population; the national rate was 849.3 per 100,000 population. CDC, 'Deaths: Final Data for 2016,' National Vital Statistics Reports, Volume 68 No. 5, July 26, 2018. Available at https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_05.pdf. 4 In 2016 California's death rate from chronic liver disease/cirrhosis was 12.2 per 100,000 population; the national rate was 10.7 per 100,000 population. CDC, 'Chronic Liver Disease/Cirrhosis Mortality by State,' January 11, 2018. Available at https://www.cdc.gov/nchs/pressroom/sosmap/liver_disease_mortality/liver_disease.htm. 5 Los Angeles's median model for end-stage liver disease (MELD) score of 39 was the highest in the country in 2016. Kim, et al., 'OPTN/SRTR 2016 Annual Data Report: Liver,' American Journal of Transplantation, January 2018. Available at https://onlinelibrary.wiley.com/doi/10.1111/ajt.14559. 6 Rates of liver donation at California's four organ procurement organizations (OPOs) in 2018 were at or above expected levels. Scientific Registry of Transplant Recipients, OPO-Specific Reports for Donor Network West in San Ramon, CA; Lifesharing in San Diego, CA; OneLegacy in Los Angeles, CA; and Sierra Donor Services in Sacramento, CA, Table C2. August 2018. Available at https://www.srtr.org/reports-tools/opo-specific-reports/. 7 Gentry et al., 'Liver sharing and organ procurement organization performance,' Liver Transplantation 21(3), March 2015. Available at https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/lt.24074. RE: OPTN Enhancing Liver Distribution Proposal Dear Mr. Hargan and Dr. Becker: As Attorney General of the State of New York, I am deeply committed to protecting the health and safety of New Yorkers. I write to you today to express deep concerns about inequities faced by critically ill New Yorkers, who have been disadvantaged by the current policies governing liver transplants. The National Organ Transplant Act requires that organs be equitably distributed among transplant patients. See 42 U.S.C. § 274 et seq. Through this letter, I ask that the U.S. Department of Health and Human Services ('Secretary' or 'HHS') direct the Board of Directors of the United Network for Organ Sharing ('UNOS'), the private, non-profit corporation that operates the Organ Procurement and Transplantation Network ('OPTN'), to (i) immediately reject a proposed policy relating to allocation of donated livers that continues to favor a patient's geography over medical need ('Proposed Policy'), and (ii) direct the OPTN to develop a new policy that complies with the law and ensures that the sickest patients receive priority. Since 1999, UNOS has been directed by federal law to increase equity in liver distribution, and to ensure that patients requiring transplants are not disadvantaged by where they live. While in the ensuing 18 years, UNOS has made some minor changes in the allocation process, gaping disparities persist. After four years of review and debate, UNOS is poised next week to adopt a Proposed Policy that will produce only trivial improvements in the current situation that will not better the chances for New Yorkers, and which are likely to remain in place for years to come. New Yorkers demand a more equitable policy. This year, more than 1,700 New Yorkers will need a liver transplant, yet only 350 will receive one. Over 200 of those waiting will die or will become too sick for transplantation. Over 1,100 will remain on the waiting list. Because New York has relatively few available livers for organ transplantation, patients with sufficient means will be able to travel to communities with more available organs, thereby benefiting from significantly shorter waiting periods. This opportunity, however, is not an option for the vast majority of New Yorkers in need. Those insured by Medicaid, without health insurance, or with limited resources have no alternatives. Meanwhile, patients in other states who are not yet experiencing a medical crisis will receive transplants -- well before much sicker New Yorkers -- simply because of their geographic proximity to donated organs. I am encouraged by the Secretary's recent decision, announced just last week, to conduct an emergency review of the OPTN's lung allocation policy in response to an action commenced by a New York resident in need of a lung transplant. See Holman v. United States Department of Health and Human Services, 17-cv-09041. The OPTN was directed to conduct an emergency review of its lung allocation policy, and within days, the OPTN approved a new policy for determining transplant eligibility that allowed for greater access to transplants for those in most medical need. Patients in need of liver transplants should have the same access. The Secretary has the legal authority, and the moral responsibility, to prevent the OPTN from adopting a regressive policy, and to require a fairer allocation system that complies with the law. As such, it is my hope that the Secretary will exercise his legislative authority and order the OPTN to develop and adopt liver allocation policies that are fair and equitable. Arbitrary geographical boundaries should not determine whether a patient lives or dies. Thank you for your consideration and attention to this important issue. Sincerely, Eric T. Schneiderman New York Attorney

John Hines | 11/01/2018

I am writing in reference to the deceased donor organ allocation policy. As a patient awaiting liver transplantation, I understand the need of the Committee to achieve a fair solution for the problem of geographic disparity in transplantation. However, I am especially concerned that half of any proposed radius used for organ distribution will be negated by the presence of the Gulf of Mexico on our southern border which will limit access to donors that could offer patients, like myself, a lifesaving transplant. According to public data, Houston and South Texas patients represent the largest population of patients waiting for liver transplantation as well as having the highest waiting list mortality in the state of Texas.    Today, patients in Houston are served by LifeGift which recovers organs from different corners of the State including Houston, Lubbock, and Fort Worth which are within a 500 mile circle from Houston. Additionally, sicker patients from our area get access to donor organs through Share 35 from Oklahoma, El Paso, and the entire state of Texas. This enhanced access to livers allows patients in the Houston area a chance to be transplanted at a MELD score similar to the national average. The average MELD score at time of transplant in Houston is currently over 30, which is higher than the national average.    Implementing a 150 mile circle around the Houston area would deprive patients from organs from Lubbock, El  Paso, Fort Worth, and Oklahoma without adding any areas. This will take approximately 130 livers per year from an area with the highest number of patients awaiting liver transplantation. The UNOS Board of Directors imposed the 250 mile radius as a boundary for lung distribution and UNOS successfully implemented this policy with uniform acceptance by transplant centers and patients across the country. Anything short of that outcome would be hard to justify or defend for liver allocation    I am firmly against a 150 mile circle, but  would support a 250  mile circle.  I appreciate  the  opportunity to  voice my concerns and look forward to  the  Committee  reaching a  solution  that  achieves  an  equitable  and fair system for  transplantation.    Sincerely,   John Hines

FAIR Foundation | 11/01/2018

Dear Mr. Shepard / Members of the OPTN: Please vote to adopt the Acuity Circle model for liver allocation. Our patients we serve here in California wait way too long for a transplant. They are so sick by the time they finally get a transplant, their recovery time is longer and their outcomes less certain. It is utterly absurd that patients have to travel across the country co-listing at several transplant centers just to get a transplant before they become too ill to get transplanted - and that option is only available to the patients with the financial and family support to do so leaving other patients to wait even longer for a transplant. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. -- Cathy Teal Executive Director FAIR Foundation

Timothy Schmitt | 11/01/2018

I do not agree with any of the proposals. I am strongly opposed to circles as they are arbitrary and have no logical explanation. As an organ donor in the United States I'm disappointed with UNOS and members of the transplant community. Some have lost sight of the foundation of transplant and assume the organ is a commodity. The American medical Association code of ethics, source for the claim that organs are a nation resource, is based on the point of view of the physician treating the patient. This is a narrow minded, one-sided view of transplantation, disregarding where organs come from. Their statement that organs should be considered a national resource is a major oversight. First of all organs are a gift not a resource or a commodity. Clearly stated in the uniform anatomical gift act, donation is an 'opt in', a system that honors the free choice of an individual to donate. Furthermore the decision to be a donor is a highly personal decision of great generosity that deserves the highest respect from the law. Organs treated as a commodity, increased discards, higher waitlist death and dismantling the relationships of community/OPO/centers have does not respect donors. As a donor I would prefer my gift to help out my neighbor or my community. I would be disappointed in a system that would allow my organs to go far away when I have people in my area that need them. I am very disappointed to know that the area that has filed law suit has the lowest donation rates in the country and instead of focusing on the foundation would rather take gifts from other areas. Lastly UNOS's claim that their measure of disparity is based solely on those candidates on the list fails to consider the disparities of end organ disease in the United States. Disparity is access to care and death while waiting not MELD. All this time and money should be spent on education, public policy and donation awareness to improve donation rates across the country. Helping not only liver, but all organs. Some studies suggest we could have an increase of 1000 or more donors a year. Focusing on donation is the key to success. Timothy M Schmitt MD FACS Professor of Surgery Director University of Kansas Health System Center for Transplantation

Rachel McHenry | 11/01/2018

Dear Mr. Shepard / Members of OPTN, I am a liver transplant recipient, having received my liver a year and a half ago. I feel truly blessed for this life-giving event. I have seen through our liver transplant support group many people who are very sick waiting for their opportunity at a new liver. Many of them are far more ill than those of us who had liver cancer and with the current evaluation process are still waiting. Sadly, some of these patients do not live to have a transplant opportunity. I urge you to reconsider your liver transplant evaluation process and make it fairer to patients who have other forms of acute liver disease or cannot afford to travel to another part of the country to take advantage of a shorter transplant list. Please consider adopting the Liver Acuity Model as it appears to address both severity and geographical considerations in a fairer manner. Thank you in advance for your consideration Rachel McHenry

Anonymous | 11/01/2018

This is very important to me as I reside in California and received a liver transplant in May, 2014. When I was at my sickest with liver disease I was placed on the transplant list but actively explored the possibility of traveling to my home state of Mississippi because I was told I might receive a liver sooner there. Even if I could have afforded to do it, realistically that would not have been an option for me as I became too sick to travel. I pray that the Acuity Circle Model will be adopted to ensure a more fair way for California patients to receive their much needed liver transplant. Thank you.

Julia Helman | 11/01/2018

Dear Mr. Shepard and Members of the OPTN, I am in favor of adopting the Acuity Circle Model for liver transplant allocation going forward. -Failure to do this leaves many patients without transplants they desperately need. Current liver allocation requires patients in certain parts of the United States to wait longer and therefore get sicker before they receive organ transplantation. -When patients have to wait longer for transplant there is a higher chance of incurring more complications and poor outcomes; they even die before getting a transplant with the current method of organ allocation. -There is an unfair advantage to patients with financial means to get onto waitlists in areas with shorter wait times. This is an advantage to ill persons who can afford transportation over those who cannot, regardless of their acuity. I urge you to vote to adopt the Acuity circle model for liver allocation, as failing to do so leaves many of our patients without the transplants they desperately need. Thank you. Respectfully, Julia Helman

Sutter Davis Hospital | 11/01/2018

Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Davis Hospital is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC-far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Rachael McKinney, CEO Sutter Davis Hospital

Sean Kumer | 11/01/2018

I am opposed to each of these proposals for broader sharing as they will violate every tenet of the Final Rule for the sake of geography and not address mortality and patient access issues. The new allocation models will increase organ discards, increase transportation, and increase cost in an environment when healthcare costs are astronomical. These models have demonstrated that most organs will move out of socioeconomically disadvantaged and rural areas to more affluent areas of the country with better access to healthcare. A patient living in New York City with a higher MELD score than someone in rural America actually has a lower mortality because of their proximity to multiple transplant centers. Relying primarily upon median MELD at transplant is flawed. First, the MELD exceptions are far from standardized as of yet and should be prior to pursuing any allocation changes. Furthermore, MELD does not predict waiting list mortality. Many of the areas and regions that will be exporting more livers with these allocation models have a higher wait list mortality than New York or Massachusetts-- the 2 states that will import the most livers in these proposals. These proposals also do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in many other regions than in New York or Massachusetts. Furthermore, these proposals address allocation only when donation has not been addressed. The relationship between transplant centers and OPO's cannot be overstated. These models will push for more organs to flow into New York when their OPO has the worst record of procuring donors for them. These proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance. Additionally, many of these same transplant centers do a poor job in expanding the donor pool by not routinely accepting older donors and DCD. As a community, we have spent much time on obtaining a compromise nationally which was to go into effect this year. Because of a contingent, these models are being hastily assembled with unclear effects to our patients' lives. Donors, and those people that they save, deserve better than this. The Final Rule was enacted to protect the smaller OPO's from being overrun by those areas with larger populations. As a result, the smaller population OPO's frankly became more efficient and outperform the larger population OPO's who relied on shear volume and became inefficient. Unfortunately, these larger population OPO's and transplant centers are using their inadequacies as an excuse to punish those who have worked hard to improve donation rates as well as donor conversion rates. For these reasons, I cannot support any of these models. Sean C. Kumer, MD PhD FACS Vice President, Operative Services Surgical Director, Liver Transplantation University of Kansas Health System

Sutter Health Novato Community Hospital | 11/01/2018

Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Davis Hospital is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC-far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sherrie Hickman, Administrator, Novato Community Hospital

Walt Dwyer | 11/01/2018

Dear Mr. Shepard / Members of the OPTN, I urge you to please vote to adopt the Acuity Circle model for liver allocation because as a 2009 recipient I realize first hand how unfair the current system is. Thanking you in advance, Former Mayor city of Big Bear Lake, Walt Dwyer

Linda Emry | 11/01/2018

Dear Mr. Shepard/Members of the OPTN, I would like to address the unfair organ allocation and scoring for liver patients. My husband and I live in Southern California where it is nearly impossible to receive a transplant, especially a liver/kidney transplant. On December 20, 2013 my husband was diagnosed as being in liver failure. He had encephalopathy, ascites fluid, and muscle wasting. He decompensated rapidly and was admitted to the hospital. He developed hepatorenal syndrome, his kidneys completely failed causing him to need now need a kidney transplant as well as a liver transplant. Unfortunately, his MELD score did not reflect how gravely ill he was. His MELD score was in the mid to high 20's. He was bed bound, inpatient status, for seven months when we were told by his transplant team that he would not survive to transplant here in California and that his best chance for survival would be to go to a center that transplants at a lower MELD score. . After extensive research, we found that Ochsner Hospital in New Orleans, La. was transplanting at a lower MELD and that there were only a few people with his specifics that would be ahead of him on their transplant list. At this point my husband would have to be transported by air ambulance which was not covered by insurance. Fortunately, we were financially able to afford the $21,000.00 cash for this charter. We flew to New Orleans where he was admitted to Ochsner Transplant Center. The following week, after undergoing all of the screening, he was accepted to their transplant program and listed there. One month later, after many severe complications, he received his life saving double transplants. Had we not been in a financial situation to make this move my husband would not have survived. After seeing the Proposal Overview for the Liver and Intestine Distribution, as well as reviews by doctors, it seems that the Acuity Circle Model would be best to fairly allocate livers for transplant. I urge you to vote and adopt this model. Respectfully, Jerry and Linda Emery

Stanford Health Care | 11/01/2018

October 31, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Via email: publiccomment@unos.org Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Stanford Health Care, one of 13 liver transplant centers in California is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates prompting Health Resources and Services Administration, the agency that oversees organ allocation to call for urgent action in a July 31 letter to UNOS. Of the two proposals presented by UNOS, we support the Acuity Circle (AC) model. The AC model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity as compared to the Broader 2-Circle (B2C) model. However, Stanford Health Care strongly supports an allocation model based on sound medical principles that provides for the widest sharing possible for the sickest patients, unrestricted by artificial geographic boundaries. Californians Face Significant Barriers to Liver Transplant Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change and Californians face some of the most daunting barriers to liver transplantation. The MELD score was developed as an objective measure for risk of death in chronic liver disease. It (or rather MELD-Na derived from it) remains the best measure available to stratify risk of patients awaiting liver transplant. The median MELD score for Californians awaiting transplant is 33; for Southern Californians, it is 38. Compare this to the national average of 24 - meaning, of course, that some regions have even lower average MELD scores. California transplants 27 liver patients per 100 patient years of waitlist time, versus the national average of 42 patients per 100 patient years of waitlist time. Some regions even transplant 228 patients, or nearly 10 times as many, over that same waitlist time. (OPTN/SRTR Annual Data Report: Liver at http://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/03_liver_13.pdf .) In short - compared to people in other parts of the county, Californians wait longer, receive transplants only when they are considerably sicker, and die at substantially higher rates while awaiting a transplant. The reasons for California's uniquely disadvantaged position are complex and largely demographic. The state suffers from one of the highest rates of liver disease in the United States: 12 per 100,000 Californians have liver disease, compared to a national average of seven per 100,000 (CDC Mone citation). At the same time, California has one of the lowest death rates in the United States: 6.2/1,000, versus a national average of 8.2/1,000. While a lower death rate may otherwise be a celebrated statistic, it diminishes the potential supply of transplanted livers; instead of having a pool of potential donors that matches the national rate of 71 potential donors per 1 million population, California's donor pool is only 31 potential donors per million. In addition, eligible donor authorization rates vary nationally by race and ethnicity, with lower rates of donor authorization typically occurring among African-Americans, Hispanics and Asians, exacerbating organ donation shortages in a state as diverse as California (UNOS OPTN OPO Quarterly Auth Rate Report 2013-05/2016 Mone citation). Although critics of liver allocation reform loudly proclaim otherwise, the cause of the disparity in access to liver transplantation for Californians has nothing to do with OPO performance. A national study showed that, even if every OPO had a 100 percent liver donor authorization rate, significant geographic imbalances in supply and demand would remain, due largely to the demographic and epidemiological factors referenced above. In fact, California's OPOs are consistently ranked among the top performing OPOs in the nation. In 2015, three of the four operated with higher-than-expected donation rates, compared to national mean donation rates, and the fourth performed essentially at the national mean. Ironically, many of the OPOs in regions that experience the easiest access to liver transplantation perform more poorly than their California counterparts. The Use of Proximity Circles in Allocation should be based on 'Sound Medical Principles' The use of proximity circles in allocation policy must be based on 'sound medical principles.' Distance cut-offs should be based on the potential damage (cold ischemia time) or discard of an organ, and to a lesser degree on the costs entailed in organ transport. Gentry et al. showed that variation in transport time accounts for only 15% of the variation in cold time. Heart allocation utilizes zones, the smallest of which is 500 nm. In most cases a liver should easily be able to travel as far as a heart without increased risk of graft loss due to cold ischemia time. Proximity circles of 250 and 150 nautical miles thus seem arbitrary, with little basis in 'sound medical judgment.' Furthermore, the difference between 150 and 250 nm is unlikely to alter the mode of transport (most centers will fly if the distance is> 100 miles). It seems as though travel time and cost have driven the conversation more than medical urgency of extremely ill patients who are likely to die within a relatively short time frame without a transplant. The discard of organs has not been shown to increase with wider sharing of hearts and lungs. Marginal organs that are not likely to tolerate longer ischemia times should be selected out by center behavior. Few centers will likely add 4 hours of flight time to a DCD, fatty liver or older donor. Likewise, marginal or futile transplants are unlikely to increase as centers with poor results will be at risk of probation or loss of accreditation by UNOS/CMS, as well as loss of contracting by carriers. MELD Score and Mortality The threshold for sharing organs is too restrictive. Status 1A and status 1B patients are well served by nation-wide sharing. These patients can be secondarily stratified by distance to reduce unnecessary travel. The 90-day mortality risk by MELD score is shown in the Public Comment Proposal p. 15 Figure 3, (https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf). Starting at MELD 12, each one point increase in MELD score increases mortality by at least 1%, rising to as high as a 6% difference in mortality for each M ELD point at MELD scores between 30 and 35. Thus a MELD score of 30 carries a 44% higher risk of mort alit y than a MELD of 15. A MELD of 25 has 20% higher mortality than MELD 15. It is hard to provide medical justification for allocating a liver to a low MELD patient at such a disparate risk of death compared to higher MELD score patients. What remains is to determine what an acceptable difference in risk is such that allocation follows principles of sound medical judgment and is compliant with the final rule. The Acuity Circle model while not perfect offers sick patients a better chance of receiving a liver, meets the final rule's requirements and achieves broad, equitable organ distribution as compared to the Broader 2-Circle model. However, Stanford Health Care strongly supports an allocation model based on sound medical principles that provides for the widest sharing possible for the sickest patients, unrestricted by artificial geographic boundaries. Sincerely, David Entwistle President and CEO Stanford Health Care

Arvin Segismar | 11/01/2018

Dear Mr. Shepard / Members of the OPTN, 1. Liver allocation is currently unfair. Patients in some parts of the country have to wait much longer and get much sicker before they can receive a liver transplant. 2. Patients who have to wait longer have a greater chance of suffering more complications from their liver disease and even dying before they can get a liver transplant. 3. Patients with the financial means can get on waitlists in different parts of the country and fly to where there is a shorter wait. This gives an unfair advantage to those who can afford it over those who cannot. 4. The Organ Procurement and Transplant Network (OPTN) Liver and Intestine Organ Transplantation Committee has been working on different proposals to allow broader sharing of livers and reduce the geographic disparities. 5. The Acuity Circle model will improve the quality of life for the most patients, producing the best and most efficient use of this limited resource and preventing where someone lives from dictating access to transplant. 6. As a resident of California and someone (with liver disease or who has someone close to me with liver disease, who has received a transplant or has someone close to me who has received a liver transplant) this matter is of particular concern to me. I urge you to please vote to adopt the Acuity Circle model for liver allocation. Failing to do so is not fair and leaves many of us without the transplants we need. Sincerely/Yours/Respectfully/etc. Arvin Segismar

Sutter Maternity & Surgery Center of Santa Cruz | 11/01/2018

Dear Mr. Shepard and Members of the OPTN: On behalf of our patients and community, Sutter Maternity & Surgery Center is pleased to submit comments on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's work to establish a medically based, equitable distribution model for organ sharing, particularly livers. We strongly support the Acuity Circle model. Unfortunately, the current liver allocation methodology that uses 58 local donation service areas (DSAs) is responsible for significant disparities in liver transplantation nationwide, necessitating urgent change. While we are not one of the 13 liver transplant centers in California, we have a keen interest in ensuring that all Californians receive the care they need. We care for an increasing number of patients with liver disease and are concerned for our patients, who - due to long wait times resulting from the current distribution model's inequities - are only becoming sicker. We have worked diligently with our patients to encourage participation in organ donation registries but know that there are not enough organs to care for all those who need them. The Acuity Circle (AC) model will improve the quality of life for the greatest number of patients by allowing broader, clinically appropriate organ sharing and vastly reducing the current geographic disparity. Most importantly, the AC - far more than any other scenario - meets the final rule's requirements of being based on sound medical judgement, being the best and most efficient use of organs as a national resource, and preventing geographic residency from dictating access to transplantation. The AC scenario best achieves broad, equitable organ distribution and will ensure that the needs of the nation's sickest patients are met, regardless of geographic boundaries. The committee's research and data show that the greatest number of lives will be saved using the AC model. The debate over the liver allocation process has consumed an entire generation of liver transplant surgeons, providers and patient advocates. In fact, the Health Resources and Services Administration, the agency that oversees organ allocation, called for urgent action in a July 31 letter to UNOS. Adopting the Acuity Circle model to reform liver allocation policies is necessary and significant; failing to do so will leave many Americans without the transplants they need. Sincerely, Trina White, Chief Administrative Officer

OPTN/UNOS Patient Affairs Committee | 11/01/2018

The OPTN/UNOS Patient Affairs Committee thanks the Liver & Intestinal Organ Committee for the opportunity to provide feedback on their proposal to eliminate DSA and Region from liver distribution. Unanimously, the PAC wholeheartedly supports a proposal that facilitates broader distribution of not just livers, but all organs, and thus minimizes the significance of geography in allocation. Although there was still some residual confusion about the use of concentric circles in light of the 3 frameworks recently out for public comment; a majority understood the constraints within which the Liver Committee had to make rapid changes. The PAC supports a solution that: • Prioritizes the sickest candidates first • Promotes utilization and mitigates discards • Does not prolong the allocation process • Considers recipient/graft outcomes The PAC was evenly split regarding whether the Broader 2 Circle (B2C) or the Acuity-based Model was the better solution. Those favoring the B2C tended to also work in the transplant or OPO profession, or had other fiduciary experience, so were sensitized to cost concerns. This cohort felt this model balances equity in access and prioritizing the most urgent patients first while optimizing successful organ transplants, avoiding organ wastage and mitigating costs. These members emphasized concerns other transplant professionals have cited pertaining to cost increases. Members acknowledged that although beyond the OPTN's purview, reimbursement should be addressed with all payers, not just by CMS to justify and document that patients, even sicker ones receiving transplants sooner than those under the current allocation system, can return to healthier lifestyles and ultimately reduce their cost of care over an extended period of time. A few members felt the OPTN should broach this subject with third-party payers. However, the average patient has no knowledge of the fiscal impact these changes will have to programs (or OPOs), or the downstream financial effects. The PAC did acknowledge that if the cost increases were so significant that they caused a transplant program closure, this could impact access. In terms of circle size, the PAC continues to seek a firm recognition that the variable of concern is really time, not distance. Should this system be adopted, some members supported a MELD threshold of 29, based upon increased mortality risk of the other options. Other members supported a higher threshold, such as 32, which is what the OPTN Board of Directors approved in December 2017. Those who supported the acuity model felt this system would provide a more equitable distribution of livers based upon Median MELD at Transplant (MMaT) and Waitlist Mortality Rates. From a patient perspective, and all things being equal, the PAC felt this model was more equitable and in line with the Final Rule. Ideally, neither cost nor geography would disadvantage candidates. They also debated whether outcomes would be better (transplanting sicker patients earlier, before they are too sick to be transplanted or die on the waiting list) or potentially negatively impacted (from the effects of potentially longer ischemic times, or transplanting sicker candidates). There was mixed support for extending the Closed Variance for Allocation of Blood Type O Deceased Donor Livers in Hawaii to Puerto Rico (PR). Those who favored applying the variance to PR felt it was reasonable as the geographic challenges for these non-contiguous states were likely similar. In addition, there was some support for further extending a variance to Alaska and other areas in which there is not a transplant hospital w/in the 500 nautical mile circle (perhaps extending the allocation area to a slightly larger area, e.g. an additional 100 or 200 nautical miles). However, some members felt that PR was not in the same position as Hawaii, and was not at as much of a disadvantage. Others proposed revisiting this question as part of the post-implementation monitoring. While not directly related to the proposal decision requested, the PAC emphasized education, not only for the transplant community, but particularly for the general public and patients. As the OPTN modifies the geographic distribution for the other organ systems, a proactive messaging strategy would be helpful to ensure public trust in the organ allocation system, promoting equity and fairness, and encouraging donation. Finally, and not specific to this proposal, the PAC continues to encourage all OPTN committees to write policy proposals at a level an average candidate or recipient would understand. This is essential to more patients submitting feedback. A 79-page proposal written in 'professional speak' intimidates and discourages members of the general public from commenting on these policy proposals. If the entire proposal cannot be written in plain language, we would advocate for an accompanying 'layman's abstract' or summary. PAC members asked the following questions, which were answered to the satisfaction of the group: • Q: Most living donor recipients do not receive their transplant based on their MELD or PELD score, because they are often recipients of directed donations, where the donor names the recipient rather than the recipient being allocated following a match run. The Liver Committee is proposing excluding these donors' from the calculation of MMaT and MPaT because the scores at transplant for these recipients tend to be outliers. Why? A: These are being excluded as these candidates are typically transplanted at a lower MMaT, and may disadvantage other patients if they were included in the system that calculates MMat and MPaT. • Q: How exactly will the B2C vs Acuity model improve mortality rates on waitlists? A: The expected survival on the waitlist was calculated to have improved under these model because patients who would have been too sick to be transplant, or were at highest risk to die while waiting, will be transplanted. • Q: How will split livers be allocated? A: Exactly as they are today. • Q: What timeframe did the modelling cover? A: The modelling included transplants conducted over a year's time. • Q: If the pediatric list is exhausted nationally, then would the offer come back to adult allocation and start over? A: Yes, the offers will be extended to adult candidates after pediatric candidates, as is done today. • Q: If travel is restricted due to weather-related events, is there a contingency distribution model in place so discards do not occur due to weather related incidents? Would the organ then be allocated within a non-fly area 150 miles? A: There is not. Usually this is not an issue; it is rare that procurement teams can't get an organ to a potential recipient. Sometimes the patient can't travel. Teams typically have a robust back-up plan so organs do not go to waste. • Q: What is the time table for implementation? A: The National Liver Review Board is expected to be implemented in the first quarter of 2019, and the allocation changes will take effect after that.

University of California Health System | 11/01/2018

October 31, 2018 Brian Shepard Chief Executive Officer United Network for Organ Sharing 700 North 4th Street Richmond, VA 23218 Dear Mr. Shepard: The University of California Health system, referred to as 'UC Health,' appreciates this opportunity to comment on the Organ Procurement and Transplant Network's (OPTN) Liver and Intestinal Organ Transplantation Committee's ('Committee') proposals to address current geographic and socio-economic disparities in the current methodology for allocating donated livers. UC Health is comprised of five nationally ranked academic medical centers located in Davis, Irvine, Los Angeles, San Diego, and San Francisco. Three of our medical centers- UCLA Health, UC San Diego Health, and UCSF Health- are among the 13 liver transplant centers in California. These three medical centers perform a great share of California's liver transplants. As safety net providers, UC Health's medical centers treat a disproportionate share of vulnerable patients. Many of our liver transplant candidates are disadvantaged by current liver allocation policy, as the prioritization given to Donation Services Areas (DSAs) and arbitrarily drawn UNOS regions results in these candidates not timely receiving liver transplants. Also, many of our candidates for liver transplants cannot afford to travel to other DSAs for their transplants. We commend the work the Committee has done to promote more equitable liver transplantation. Much of this work has been informed by the expertise of UCSF Health's Dr. Ryutaro Hirose, a former Chair of the Committee. UC Health supports a clinically appropriate, equitable liver allocation policy that will ensure the 'sickest patients get their liver transplants the quickest.' We believe the Committee's proposed Acuity Circle (AC) model will result in a more clinically appropriate and fair distribution of donated livers. UC Health urges the Committee to recommend implementation of the AC model. Current means of allocating livers for transplantation fall far short of meeting the National Organ Transplant Act's (NOTA) final rule mandate to ensure that the allocation of organs for transplantation 'shall not be based on the candidates' place of residence or place of listing.'i Today, too many sick Californians must wait for prolonged periods of time to receive a donated liver. The current allocation methodology's insistence on sharing livers within the current 58 local DSAs perpetuates disparities experienced across the country in liver transplantation. UC Health's Interest in Equitable Liver Distribution Each of UC Health's public academic medical centers shares a public mission to provide high level patient care to every patient regardless of their ability to pay and their circumstances. We believe that every American should be able to access to affordable, safe, high-quality, medically necessary health care. Liver transplant candidates should be able to timely access a liver transplant. When Californians - or any other Americans -cannot receive a life-saving liver transplant simply due to their current place of residence, equitable access to healthcare is denied, and healthcare disparities result. Disparity in Access to Liver Transplants Three UC Health medical centers are liver transplant centers, and they rank among the country's highest recognized liver transplant centers. In 2017, UC Health's transplant facilities transplanted 372 livers.1 Of those transplants, 342 came from deceased donors and were received by 322 adults and 20 children. The remaining 30 liver transplants came from living donors and were received by 29 adults and 1 child. UC Health strongly believes in federal allocation policies that will facilitate more Californians receiving timely liver transplants. Californians remain at a significant disadvantage trying to get liver transplants. The likelihood that a liver transplant recipient will die within a defined period of time if he or she does not receive a liver transplant can be measured using a risk assessment metric known as the Model for End-Stage Liver Disease (MELD) score. The higher the MELD score, the greater a patient's risk of death. The median MELD score for Californians awaiting a liver transplant is 33. Among Southern Californians, the median MELD score is outrageously high at 38, exceeding what is considered a high MELD score. Nationally, the average MELD score is 24. For liver transplant candidates with MELD scores between 21 and 34, there is a great variance in the probability that these candidates will get a liver transplant within 90 days on the basis of the regions in which the candidates reside. The state of California transplants 27 liver patients per 100 patient years of waitlist time. Compare this to the national average of 42 patients per 100 patient years of waitlist time. For candidates from different regions, studies have found a three-fold variation in death rates of waiting list candidates, a 20-fold variation in transplant rates and 10-point differences in MELD score at the time of transplant.ii When compared with other liver transplant candidates across the country, Californians wait longer and only receive liver transplants when they are much sicker. The prolonged period of time Californian liver transplant candidates await receipt of a liver results in too many Californians dying before they can receive a liver transplant. Californians Face Demographic Barriers to Liver Transplantation The challenges facing Californians in need of liver transplants can be explained in part by demographics in addition to geography. California suffers one of the highest rates of liver disease in the United States: 12 per 100,000 Californians have liver disease as compared to a national average of seven per 100,000.iii At the same time, California has one of the lowest death rates in the United States: 6.2/1,000, versus a national average of 8.2/1,000. California's lower 1 In 2017, UCLA Health had 149 liver transplants; UC San Diego Health had 35 liver transplants; and UCSF Health had 188 liver transplants. death rate reduces the potential supply of transplanted livers. Rather than having a pool of potential donors that matches the national rate of 71 potential donors per 1 million population, California's donor pool is only 31 potential donors per million. Moreover, donor authorization rates vary nationally by race and ethnicity. Lower rates of donor authorization typically occur among African-Americans, Hispanics and Asians, thereby exacerbating organ donation shortages in a state as diverse as California.iv Studies show that Organ Procurement Organizations' (OPO) performance has little to do with Californians' access to liver transplantation. A national study demonstrated that, even if every OPO had a 100 percent liver donor authorization rate, significant geographic imbalances in supply and demand would remain, due largely to the demographic and epidemiological factors referenced above. The study's analysis found 'no evidence to support the assertion that the liver allocation system transfers livers from better performing OPOs to poorer performing OPOs,' and concluded that disparities in access were, instead, 'strongly related to differences in demand' for liver transplantation.v In fact, California's OPOs are consistently ranked among the top performing OPOs in the nation. In 2015, three of the four OPOs operated with higher-than-expected donation rates, compared to national mean donation rates, and the fourth performed essentially at the national mean.vi Ironically, many of the OPOs in regions that experience the easiest access to liver transplantation perform more poorly than their California counterparts. California's hospitals are committed to improving organ donations. However, increasing organ donations will always be insufficient if the distribution model remains so flawed. Current Allocation Policy Benefits the Affluent The current liver allocation methodology exacerbates inequity in health care access. For example, patients requiring liver transplants may register themselves at two or more transplant centers. Registration at multiple transplant centers can reduce transplant wait time by increasing the patients' chances of receiving a liver from a transplant center that has a shorter wait list and higher transplant rate. While this practice can reduce liver transplant candidates' wait times by several months, it requires candidates to travel to appointments at multiple centers and to make themselves available immediately for transplant if an organ becomes available. This requires financial resources that many potential recipients simply do not have. Many California patients are unable to afford flying to multiple transplant centers and make themselves immediately available for a transplant, should a liver become available. Consequently, the most affluent liver transplant candidates are 70 percent more likely to travel to a non-local DSA than candidates in the lowest quartile.vii Of all adult liver transplant candidates, only 2.3 percent listed themselves in more than one region between January 1, 2005, and December 31, 2011; these candidates were disproportionately male, white, non-diabetic, college educated and privately insured. viii Further, recipients listed at multiple transplant centers who received a transplant outside of their area had significantly higher median incomes compared to patients who died on the waitlist -$84,946 versus $55,250. ix A recent study reviewed the rate of multiple listing by candidates waiting heart, lung, liver and kidney transplants and noted, among other things, that 6 percent of the 103,332 individuals awaiting a liver transplant were on more than one DSA list - a cohort of patients who were found to be wealthier and better insured than the singly listed candidates.x Thus, not only does the current methodology disadvantage potential recipients based on the accident of their geography, it demonstrates the impact of wealth on the ability to obtain necessary medical interventions. California Hospitals Support the Acuity Circle Model for Liver Allocation UC Health believes the AC model will assist the most California liver transplant candidates. If implemented, the AC model would permit the greatest number of Californians, as well as liver transplant candidates across the country, generally, by granting the sickest patients timely access to a broader geographic area of donor hospitals. Far more than any other proposed model, the AC model meets the NOTA final rule's requirements of being based on sound medical judgment, being the best and most efficient use of organs as a national resource, and preventing a candidate's place of residency from dictating his or her access to liver transplantation. The most common critique of the AC model is that travel time for organs will increase. However, to appropriately remedy the inequity inherent to OPTN's existing methodology for liver transplantation, candidates in some parts of the country will experience increased travel time for organs. Under the current methodology, Californians must wait longer than liver transplant candidates in other states. A benefit of the AC model is that California patients will not have to wait so many more weeks than patients in other states, mostly falling within regions characterized by a greater supply of organs for transplantation and fewer patients with high MELD scores, to receive liver transplantation. Additionally, there are benefits in the long-run for addressing the current inequity by providing more movement of donated organs. While more travel will add to the initial costs of organ distribution, there will be considerable savings realized by reducing the cost of caring for patients with very high MELD scores. Savings could be realized by reducing the number of days a patient waiting for liver transplant has to remain hospitalized in an intensive care unit (ICU). ICU care greatly exceeds the cost of transporting organs. Lastly, a transplant center's pecuniary gain or loss should not be a factor for consideration when evaluating the most medically appropriate and equitable organ distribution policy for patients. The AC model will ensure the sickest patients have the broadest area from which to timely receive a liver transplant. Our liver transplant surgeons think the AC model will promote more equitable organ distribution not just for Californians who are currently grossly disadvantaged by a methodology that focuses on a candidate's place of residence using DSAs and arbitrarily drawn regions over his/her medical need, but for candidates across the country with high MELD scores needing a timely liver transplant who currently experience way higher than average wait times for transplantation as a result of the OPTN region in which they live. The Committee's research and data evidence that the greatest number of lives will be saved implementing the AC model.xi UC Health Supports a Lower MELD Threshold for Broader 2-Circle Model UC Health expresses great concern that the Broader 2-Circle (B2C) model recommended by the Committee does not meet the standards promoted by NOTA, the final rule implementing NOTA, or the Health Resources and Services Administration's (HRSA) July 31 letter.xii The MELD score bands in the B2C model are not narrow enough to ensure that current allocation disparities are addressed. UC Health thinks that to effectively reduce mortality rates, the MELD sharing threshold should be set at 25. We believe that the proposed B2C model MELD sharing threshold of 32 is way too high. Putting into effect a MELD sharing threshold of 32 would not remedy existing inequities. In fact, implementing the B2C model with a MELD sharing threshold of 32 would mean Californians must continue to get a lot sicker than persons in other parts of the country just to access a liver transplant. If the B2C model were to be implemented, our liver surgeons think the MELD sharing threshold would need to be at least 29 to address current inequities in liver allocation. Conclusion UC Health supports HRSA's direction to the OPTN to devise a liver allocation policy that will be equitable and prioritize patients' medical needs. We believe that of the two models proposed by the Committee, the AC model ensures the sickest patients will receive timely liver transplants. We urge the Committee to recommend to HRSA putting into effect the AC model. Failing to implement the AC model will result in too many Americans, including many Californians, continuing to not receive the timely liver transplants they need. Please refer any questions about our response to the Committee's proposal to Julie A. Clements, JD, MPP, Director of Health and Clinical Affairs, within the University of California system's Office of Federal Governmental Relations at (202)-974-6309/Julie.Clements@ucdc.edu. Sincerely, Executive Vice President i See 42 CFR 12 l.8(a)(8). ii Yeh H, Smoot E, Schoenfeld DA, Markmann JF. Geographic Inequity in Access to Livers for Transplantation. Transplantation. 2011;91(4):479-486. iii CDC (Mone citation). iv UNOS OPTN OPO Quarterly Auth Rate Report 2013-05/2016 (Mone citation). v Gentry et al. Liver sharing and organ procurement organization performance. Liver Transplantation 21(3) 2015. vi Scientific Registry of Transplant Resources, Observed vs. Expected Donation Rates for 2015 (Mone). vii Dzebisashvili et al. Following the Organ Supply: Assessing the Benefit of Inter-DSA Travel in Liver Transplantation. Transplantation, 95(2), 361-371. January 2013. viiiParsia A. Vagefi, MD, FACS correspondence email, Sandy Feng, MD, PhD, Jennifer L. Dodge, MPH, James F. Markmann, MD, PhD, FACS, John P. Roberts, Multiple Listings as a Reflection of Geographic Disparity in Liver Transplantation. Journal of the American College of Surgeons. September 2014, Volume 219, Issue 3, Pages 496- 504. ix Schwartz A, Schiano T, Kim-Schluger L, Florman S. Geographic disparity: the dilemma of lower socioeconomic status, multiple listing, and death on the liver transplant waiting list. Clinical Transplantation Volume 28, Issue 10, pages 1075-1079, October 2014. x Cha, A. E., 'Inequality in U.S. organ transplants: Researchers detail how the wealthy game the system,' Washington Post, November 12, 2015. xi See Table 4 at https://optn.transplant.hrsa.gov/media/2687/20181008_liver_publiccomment.pdf xii See https://optn.transplant.hrsa.gov/media/2583/hrsa_to_optn_organ_allocation_20180731.pdf

Boies Schiller Flexner LLP | 11/01/2018

Dear Ms. Miller: This supplemental comment is being submitted on behalf of Plaintiffs in the pending action Cruz et. al. v. US. Dept. of Health and Human Serv. et. al. (SDNY l 8-CV-06371-AT) in response to the October 30, 2018 comment of Indiana University Health, The University of Kansas Health System, Vanderbilt University Medical Center and Washington University in St. Louis/Barnes-Jewish Hospital Transplant Center (the 'Centers'). In a July 6, 2018 letter, the Centers offered their support of OPTN policymaking and lauded the Committee's efforts as one that 'has engaged experts and the public to develop a policy that reflects all factors required under the law, including socioeconomic considerations.' Recognizing that HHS and HRSA are now committed to real change in liver allocation, the Centers have done a complete about-face and now argue that all the Committee's proposals are illegal and inconsistent with the Final Rule. The Centers' comment recycles a hodgepodge of old arguments that were long ago rejected by Congress and the OPTN, unsupported claims that have been proven inaccurate and larger issues in healthcare policy that are misplaced in this forum. Simply stated, the Centers' Comment advocates for more institutional paralysis that would keep in place an admittedly illegal and inequitable policy and sacrifice good on the altar of perfection. Three decades ago, Congress made clear that organ distribution should be done on a nationwide basis. OPTN's job is to effectuate that Congressional mandate, which has been BOIES SCHILLER FLEXNER LLP 333 Main Str ee t. Arm onk. NY 10504 I (t) 914 749 8 200 I (f) 914 749 8 300 I www.bsfllp.co m BSF stymied for years by an effort to develop a consensus between those that believe in local-first distribution and those that believe in nationwide distribution. Unfortunately, as HRSA has recognized, this decade's long process has made clear 'that achieving consensus for a new liver allocation policy may not be possible' but that 'consensus is not required under the OPTN final rule.' In considering the various public comments, including that of the Centers, it is important to remember that this debate is not whether we should have a local-first or nationwide distribution framework. That issue was decided by Congress over thirty years ago and the OPTN is required by law to effectuate that Congressional dictate. The Centers now take the position that all of the frameworks are illegal and the OPTN should effectively continue its current, illegal policy. As the Committee recognized, this 'do nothing' approach risks 'having these decisions made by the legislature, the judiciary , or our colleagues in HHS.' We believe the OPTN and transplant community is best served by instituting a legal and appropriate policy even if it is not perfect. We agree with the Centers that the proposed Broader 2-Circle (B2C) framework violates the Final Rule. We recommend the Acuity Circles (AC) framework with the broadest possible sharing as set forth in the Committee ' s proposal, which, if properly implemented, can lead to meaningful change, save hundreds of lives in coming years and bring OPTN policy into compliance with the law. Yours truly, Motty Schulman cc: Dr. Julie K. Heimbach Chair, Liver & Intestinal Organ Transplantation

Malay Shah | 11/01/2018

I am opposed to all proposals. My lengthier and formal comments will be forthcoming, but I would like to raise significant concerns I have about the data that has been released by UNOS on behalf of the SRTR to the public. Waitlist mortality statistics as presented in these proposals are not factual. Typically, waitlist mortality is calculated to include patients who die on the waitlist AND those removed for being 'too sick for transplant'. By including both groups in waitlist mortality, true mortality rates can be determined (and center specific waitlist removal practices can be leveled). Unbeknownst to everyone, when these models were calculated, SRTR did NOT include patients who were removed for being 'too sick for transplant'. Why this was done is unknown, but this raises major concerns about the entire process and accuracy of the data being given to physicians, patients and donor families. Why waitlist mortality was calculated in this way is in stark contrast to the way it is calculated in every other way. How else can a model predict 1-2 more deaths in a given area despite 30-40 FEWER transplants? It is an impossibility, and the exclusion of those who died after being removed from the waitlist can explain it. This very fact of inaccurate waitlist mortality data arguably invalidates all proposed models, as well as all other proposals released/considered by UNOS that used such data. Were data in a peer-reviewed manuscript found to contain inaccurate data, the article would be retracted immediately with a statement from the Board of Editors. The community should ask if it is appropriate to consider a similar action plan in this situation. Our community, donor families and, most importantly, our patients, deserve the best. Malay Shah, MD, FACS; Associate Professor of Surgery;Surgical Director, Liver Transplant Program; University of Kentucky Transplant Center

OPTN/UNOS Pediatric Organ Transplantation Committee | 11/01/2018

The Pediatric Transplantation Committee reviewed the proposal during a conference call on October 17, 2018. The Committee understands the impetus of this proposal is to ensure liver distribution policies are in compliance with the OPTN Final Rule. As a result, the development timeline was short and opportunities for collaboration existed only in real-time. The Committee is very appreciative of the early and ongoing collaboration with the Liver Committee over the last several weeks.

It is routine practice for pediatric liver transplant teams to travel these distances and more to recover livers from deceased organ donors. The Committee supports wide sharing of deceased donor livers over either 500 or 600 nautical miles (nm). The Committee would support an allocation distance for livers from pediatric deceased donors up to 1,000 nm.

As many members of the Liver Committee are aware, the complexities of liver disease and the potential for precipitous decompensation in pediatric liver transplant candidates differ widely from adult liver transplant candidates. As a result, the Model for End-State Liver Disease (MELD) or Pediatric End-Stage Liver Disease (PELD) scores may not accurately reflect their severity of disease or risk of dying on the waiting list. Exception scores are often required to accurately reflect pediatric liver candidates’ morbidity or mortality risk. The Committee fully supports the concept in the proposal of no cap on MELD or PELD exception scores for pediatric liver transplant candidates.

Regarding the request for feedback on the two questions below:
• What is your opinion of this proposal of broader 2-circle sharing at 32 threshold? Do you prefer one of the other models, such as the acuity based model?

o The acuity model appears to result in greater gains in transplant count for pediatric liver transplant candidates. Broader sharing benefits pediatric candidates and will likely lead to increased utilization as well (e.g.: transplanting two small pediatric liver candidates with one larger donor organ).

What is your opinion of the MELD/PELD sharing threshold? Is 32 appropriate, or would you prefer 29? Or 35?

o A lower MELD/PELD sharing threshold would have the potential for broader sharing to candidates waiting for a liver transplant. This will serve to benefit pediatric liver transplant candidates

Though the development time line for this proposal was short, the Committee would like the opportunity to critically examine a further breakdown of transplant outcomes and waitlist mortality for both the Acuity Circle and B2C models across pediatric age ranges and candidate diagnoses. This additional breakdown would aid Committee members’ understanding to the appearance of slightly increased waiting list mortality for pediatric liver candidates under either model, despite the expected increased transplant rates and lower median MELD or PELD score at the time of transplant.

After a final proposal is approved by the Board and implemented, the Committee would be very interested in regular post-implementation updates examining transplant counts, waitlist mortality, and waitlist removals for pediatric liver transplant candidates and recipients by candidate age, status or score, and diagnosis.

The Committee appreciates the opportunity to provide feedback on this impactful proposal.

Louisiana Organ Procurement Agency (LOPA) | 11/01/2018

In ideal situations, if finance/safety weren't an issue with longer flights, then broader sharing would be preferred.  However, having worked in allocation for nearly 20 years, I have many concerns with logistical issues that have not been addressed with the larger circle/broader sharing model.  First, the larger the circle, the more offers that are made simultaneously to the same patient on the match run.  Theoretically, this should be a benefit, however, in actuality it often clogs the allocation system as more time is spent on deciding between offers.  Wasted time is the enemy of maximizing organ yield.  Second, when marginal livers are allocated with little time between the OR and destination, reallocation is usually possibe.  The greater the time between OR and center, the less chance for reallocation, as time is also the enemy.

Alexandra Glazier | 11/01/2018

There are a number of duplicative posted public comments that specifically target Massachusetts stating 'these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.' As the OPOs responsible for donation in MA and the other five states in New England, we are compelled to respond publicly to his damaging and false statement. The fact is that the primary OPO serving MA, New England Organ Bank (NEOB), has consistently ranked above the mean under the OPO performance metrics for years according to publicly available data and is a recognized national leader in Donation after Cardiac Death (DCD) donation rates by both percent and number of donors annually. NEOB's rate of donation increased significantly over the past 5 years in organ donors (34%) and most importantly in organs transplanted from local donors (43%); fifty percent higher than the national average. LifeChoice Donor Services, the smaller OPO serving western MA and the Hartford CT area affiliated with NEOB under the umbrella of New England Donor Services in 2017 resulting in the largest percent increase in the number of organs transplanted from local doors (69%) of any DSA in the country that year. The growth for both OPOs continues as we will have coordinated over 1,000 organ transplants in 2018 by the end of this week. Every OPO has the opportunity to improve and we take that responsibility very seriously; the critical urgency of the mission to increase availability of organs for transplantation drives our work. It is unhelpful to donation efforts in New England and discouraging to the OPO teams here in MA to have to spend time defending its performance against untrue and misinformed public statements. And ultimately, it distracts from the allocation issue which should be focused on best serving patients awaiting liver transplantation regardless of where they live. We support the Acuity Model as the most patient-focused way to distribute livers based on medical urgency and not place of listing and have submitted a detailed comment together with 6 Liver Programs in the region. Alexandra K. Glazier, Esq. President & CEO New England Donor Services - an affiliation of New England Organ Bank and LifeChoice 60 First Ave Waltham, MA 02451

Region 7 | 11/01/2018

Region 7 Vote (11 of 34 voting members submitted a vote online):   • Broader 2-circle distribution: 2 strongly support, 4 support, 1 abstain/neutral, 2 oppose, 2 strongly oppose  • MELD sharing threshold recommendation: 3 for MELD 29,  5  for MELD 32,  3 for MELD 35  • Size of fixed distance circles recommendation: 6 for remain the same, 4  for larger, 1 abstain  • Acuity circles: 3 strongly support, 2 support, 3 abstain/neutral, 1 oppose, 2  strongly oppose     An OPO member commented that:  They understand there is a need for change before intervention comes from entities outside the transplant community such as Congress.  Outside intervention would negatively affect the transplant community in general and especially donation.  There was support expressed for the circle model which makes logical sense given the time constraints.  It was noted that the changes to lung allocation caused a big shift in the export of lungs in the beginning, but now seems to be reaching an equilibrium in their area and noted that there is certainly benefit to transplanting patients who are sicker.  Whichever solution is settled on for liver will be monitored and there will be data collected that can assess for unintended consequences such as traveling too much with too little benefit.  The measure of median MELD is driven by several factors, but surgeon/transplant program preferences in organ acceptance can certainly drive this measure.  Broader sharing could level out this factor by encouraging more conservative centers to become more aggressive and centers that are already aggressive due to lack of organ offers to receive more offers and reduce some of their risk.     One member noted that they preferred the acuity circles model.  For the broader 2-circle distribution, this member thought that the MELD 32 may not be the right sharing threshold.  Additionally, for the sickest patients, access should not be limited to 250 nautical miles.     Members like the policy's modeled effects on pediatrics and adolescents and believe it is an advancement for this population.     One member commented that Hawaii and Puerto Rico both warrant variances.     Note: The feedback above was obtained from the comments expressed during the regional follow-up webinar. Additional written feedback provided by member institutions within Region 7 outside the regional webinar is also available on this public comment page. The feedback is published by the name of the organization and in the order it was submitted. The date submitted may or may not correlate with the date of the regional follow-up webinar.

Anonymous | 11/01/2018

Limiting the donor distance would not be beneficial for Texans, specifically, those in Houston. It is strongly recommended that a population based model be considered and implemented. Hundreds of Houston transplant patients die each year waiting for their liver transplant. Therefore, reducing the distance would cause longer wait times and more deaths each year unnecessarily.

Anonymous | 11/01/2018

A population-based framework would give a better reference for areas such as Houston who contend with large areas of the Gulf of Mexico within their fixed-distance circles. Given the direct impact of your decision on the survival of my patients, who would be disadvantaged by the proposals offered here, it is imperative that the Organ Procurement & Transplantation Network take the time to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Anonymous | 11/01/2018

I urge the OPO Network to refrain from making a policy decision on liver distribution until it has modeled a population-based framework. The impact of your decision will affect many patients, who would be disadvantaged by the proposals offered here.  It is imperative that time is taken to conduct a thorough analysis of population-based frameworks. Patients deserve a policy that is fair and will not limit organ access and increase wait times unnecessarily.

Carlton Young | 11/01/2018

While I understand that wider sharing appears like a great idea, has anyone honestly, without political or regional motivation, looked at the impact on the regions that would become net exporters of livers? Have regions such as New York worked on their overall OPO performance? Are their donor rates commensurate with their population and disease burden? I hope the data has been scrutinized in this manner. Also, by increasing the distance of sharing, that will increase costs for flying all over the place to procure organs. Expecting a distant center to trust a local center, unless they know they surgeons, to remove a liver will be rare. This could cause an increase in PNF. I sincerely hope that the UNOS Board and the Liver CMT have looked at all of these issues. This should NOT be a political issue or a financial issue. The ONLY motivation to change policy is that it will increase the number of lives saved with maximizing organ utilization. If these two principles are not met and the proposal passes, the SHAME on UNOS and the governing board.

Anonymous | 11/01/2018

Houston Texas is 3 largest city in USA. Also largest number of persons with liver disease in the South. Decreasing area of allocation would be detrimental hazard!

Anonymous | 11/01/2018

I would recommend lowering the higher end MELD from 32 to 29. I would also recommend changing the lower end MELD from 15 to 20.

Anonymous | 11/01/2018

Our transplant center supports the Acuity Circle (AC) model as it performs the best in simulation to reduce the variance in MELD allocation scores at the time of transplant and also most positively improves waitlist mortality. The increase in travel time, distance, and % of organs flown is only modest for the significant gains in reduced MELD variance and improvement in waitlist mortality. We are opposed to the Broader 2-Circle model as proposed, because in larger geographic regions it would actually result in more limited sharing than we are currently doing with our regional share 35 policy.

Ochsner Foundation Hospital (LAOF) | 11/01/2018

prefer we do our best to have the policy look like the policy passed by the board.  We need to minimize flying.  Also, there is a groundswell of support to look at the state-based 'neighborhood' model submitted by Ray Lynch.

University of Mississippi | 11/01/2018

Of the models presented, the B2C model is most acceptable and close to the model for which the transplant community has already compromised and agreed upon.  Our center recommends that the sharing threshold be 35 and that larger circles not be used until we know what unintended consequences will come of this model.  The higher threshold of sharing still decreases the median meld at transplant variability, but has the least increased cost and thus is most likely to protect poor populations.  It serves the sickest listed patients and has the fewest wasted organs.    The major weakness of this change is that it will not increase transplantation in the USA, and is likely to decrease the number slightly.  However, the cost of transplant will increase significantly.  Increased flying will increase the cost of liver transplant in the USA somewhere between 50M and 100M+ dollars per year for the same number of transplants.  Given the variance in MELD at transplant will decrease a clinically insignificant 5 points with the most aggressive of these models, it is simply irresponsible to increase our healthcare costs to that degree in our country.      The plan fails to examine the effect on poor and at risk populations.  Increasing costs and stress on centers, will hurt rural communities before they ever have an opportunity to get on the liver waitlist.  A disproportionate number of these at risk patients have Medicaid for coverage and the increased costs of transplant can't be sustained by the Medicaid system....further putting these patients at risk.    Our center does support a variance for Puerto Rico similar to that for Hawaii in order to protect those populations.

Billy Wynne | 11/01/2018

As a primarily geography-oriented proposal that maintains existing disparities, the Broader 2-Circle approach violates the National Organ Transplant Act (NOTA) and will not bring meaningful relief to patients currently unable to access livers simply because of where they live. Similarly, any MELD cut-off above 15 is unnecessary, inequitable, and unlawful. I am deeply disappointed that, after extensive deliberation, this is the primary proposal OPTN has unveiled. On its face, this policy does not comply with the requirements outlined very clearly in HRSA's letter to you on July 31.     As outlined in that letter, NOTA requires organs to be distributed equitably on a nationwide basis, with only narrow geographic considerations taken into account if they are *required* by the limited exceptions enumerated in the implementing regulations. Simply removing DSAs and regions and instituting another policy that yields about the same result still violates the law.      The Acuity 250+500 model does promote broader sharing and meaningfully reduces existing disparities in liver access. It is oriented in patient need with reasonable geographic limitations and, thus, likely complies with NOTA. It's a strong step forward and will save lives.    It's worth noting that, despite the fact that many stakeholders will never accept meaningful reforms, HRSA's letter to OPTN makes very clear 'consensus is not required under the OPTN final rule and should not be a barrier to adopting a liver allocation policy that complies with the OPTN final rule.' If necessary, the OPTN Executive Committee must step in to ensure its legal obligations - not to mention the needs of hundreds of patients currently waiting for a life-saving organ - are met.

University of Alabama Birmingham | 11/01/2018

The state based allocation proposed by Lynch at the last Region Three meeting had a lot of attractive features. I wish that  UNOS would have studied this further. I am concerned that patients from  lower social economic status in the South  will suffer under greater sharing in an effort to decrease geographic disparity,  that is to some effect an artifact of the granting MELD exception points.

Lucile Salter Packard Children's Hospital at Stanford | 11/01/2018

Wider sharing for all MELD scores is better for all patients for access to transplant.

Anonymous | 11/01/2018

When you have the opportunity to save lives and you know people are in desperate need of a transplant I don't understand why you would even entertain the idea of making it harder for patients to receive the organs they need to survive. This absolutely doesn't make any sense to me.  I ask one question of the Committee making this decision. If you or your family member would you support making it harder to get the transplant they need to survive? It is our responsibility to support the process of transplant patients getting the organs they need to live....not to make it harder.

Banner University Medical Center-Tucson | 11/01/2018

The B 2C proposals appear to have a more favorable modeling. I think that it would be good to pick an option that would not drastically increase the amount of flying that would occur. One issue that was not discussed very much is the problem of discards--especially of those organs that are turned down by the initial accepting center in the donor OR. It may be that increasing the distance that we need to go for organ recovery will increase that turndown rate due to increased travel (ischemic) time as well as the variable of a local team recovering the liver and having to relay its acceptability to another surgeon.

Mississippi Organ Recovery Agency | 11/01/2018

Of the models presented, the B2C model is most acceptable and close to the model for which the transplant community has already compromised and agreed upon.  Our OPO recommends that the sharing threshold be 35 and that larger circles not be used until we know what unintended consequences will come of this model.  The higher threshold of sharing still decreases the median meld at transplant variability, but has the least increased cost and thus is most likely to protect poor populations.  It serves the sickest listed patients and has the fewest wasted organs.    The major weakness of this change is that it will not increase transplantation in the USA, and is likely to decrease the number slightly.  However, the cost of transplant will increase significantly.  Increased flying will increase the cost of liver transplant in the USA somewhere between 50M and 100M+ dollars per year for the same number of transplants.  Given the variance in MELD at transplant will decrease a clinically insignificant 5 points with the most aggressive of these models, it is simply irresponsible to increase our healthcare costs to that degree in our country.      The plan fails to examine the effect on poor and at risk populations.  Increasing costs and stress on transplant centers, will hurt rural communities before they ever have an opportunity to get on the liver waitlist.  A disproportionate number of these at risk patients have Medicaid for coverage and the increased costs of transplant can't be sustained by the Medicaid system....further putting these patients at risk.    Our OPO does support a variance for Puerto Rico similar to that for Hawaii in order to protect those populations.

Anonymous | 11/01/2018

Hawaii remain the same. No variance on Puerto Rico.

Carolina Donor Services | 11/01/2018

We are concerned about the health care disparity in the south east and the impact of the projected increase of exportation of livers on our population.

Tim Taber | 11/01/2018

Meld share of 35 - most reasonable.

Patricia Ault | 11/01/2018

1) We are strongly to any thing less than a 250 mile circle because of the gulf of Mexico, and lack of populated cities less than 150 miles from Houston.  2)Implementing a 150 mile circle around south Texas will deprive patients from the organs in Lubbock, El Paso, and Fort Worth to which we currently have access to. We stand to lose approximately 130 donor livers a year within the Houston region.   3)Imposing a 150 mile circle will increase the wait time for transplantation and increase the death rates while waiting for transplant.   4) Houston and South Texas represent the largest population of patients waiting for transplants.   5) The average MELD score at time of transplant in Houston is over 30 which is higher than the national average, which means the need for organs is greater than in many other areas.   6)the proposed 150/250 circle will benefit areas on the East Coast like New York, but will hurt places like Teas, California, and florida. Why would UNOS choose a model that hurts patients in multiple regions?  7. The policy proposal has the sound of the 'smack in the face'  that the Affordable Care Act of March 23, 2010. An example of 'it is good enough for the masses, but not good enough for Congress members.

Anonymous | 11/01/2018

I oppose both the acuity circle and the broader 2-circle models. Both these proposals would move organs out of socioeconomically disadvantaged regions like Ohio to the affluent areas in New York and Massachusetts, from the regions with higher wait-list mortality to regions with lower wait-list mortality and from better performing OPOs to poorer performing OPOs. Furthermore, the circles are not based on population but just distance from the hospital. That to me goes against equitable distribution of organs. The sharing circle should be smaller (125 miles) especially for more populated areas like New York and Massachusetts.

Anonymous | 11/01/2018

1.      Each of these proposals for broader sharing will increase organ wastage, increase logistical complexity, and dramatically increase flying and costs.  2.      Models predict that the net effect of the allocation proposal will move organs out of socioeconomically disadvantaged areas such as South Carolina to affluent areas of the country, most notably New England states including New York and Massachusetts   3.      The proposed broader sharing models do not consider the limitations of MELD in predicting waiting list death in rural vs. urban populations. For example, South Carolina has 3-5x higher waiting list mortality than New York or Massachusetts, the 2 states that will import the most livers in these proposals.  4.      The proposed broader sharing models do not consider the overall burden of liver disease in a population. The incidence of liver failure is much higher in South Carolina than New York or Massachusetts, yet organs will flow out of South Carolina and organs will flow into New York and Massachusetts.  5.      The proposed broader sharing models do not have protections for transplant centers that serve regions with poor health care. Instead, states with the best health care (including Medicaid expansion states) and the highest waiting list rates, will benefit the most from these proposals, at the expense of the residents of states with diminished access to healthcare.  6.      The proposed models do not evaluate variation in Organ Procurement Organization (OPO) performance.  Instead, these proposals simply re-distribute organs from areas of better OPO performance to areas of lower OPO performance.