Skip to main content

Liver and Intestine Distribution Using Distance from Donor Hospital

Proposal Overview

Status: Public Comment

Sponsoring Committee: Liver & Intestinal Organ Transplantation

Strategic Goal 2: Provide equity in access to transplants

Read the full proposal. (PDF - 1.6 M; 10/2018)

Listen to a recorded webinar that explains the proposal. Exit Disclaimer  

Resources

Executive summary

The United States Secretary of Health and Human Services (HHS) received critical comments regarding compliance with the National Organ Transplant Act (NOTA) and associated regulations under the OPTN Final Rule with respect to the geographic units used in liver distribution. As of July 2018, HHS and the OPTN are named defendants in a lawsuit regarding this issue.

The OPTN Final Rule sets requirements for allocation polices developed by the OPTN, including sound medical judgement, best use of organs, ability for transplant hospitals to decide whether to accept an organ offer, avoiding wasting organs, and promoting efficiency. The Final Rule also includes a requirement that policies “shall not be based on the candidate’s place of residence or place of listing, except to the extent required” by the other requirements of the Final Rule listed above.

The liver organ distribution policies currently use donation service areas (DSAs) and OPTN regions as geographic units. These are not good proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs and regions result in an inconsistent application for all candidates. This presents a potential conflict with the Final Rule.

In response to a directive from the HHS Secretary, the Liver and Intestinal Transplantation Committee (Committee) worked to develop a proposal that does not include DSA or region in liver allocation or in scoring liver candidate exceptions. The Board also committed to considering such a proposal in December 2018.

This proposal, developed at that direction, eliminates the use of DSA and region in liver, liver-intestine, intestine, and liver-kidney allocation policies. This proposal would allocate 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. (Referred to as the “broader 2-circle” framework.) Livers would be allocated to status 1A and 1B candidates within 500nm first. Candidates with a Model for End-Stage Liver Disease (MELD) score of at least 32 would then be offered livers if they were within 250nm of the donor hospital. Then livers would be offered to candidates with a MELD of 15-31, first within 150nm, then within 250nm, then within 500nm. After that, livers would be offered to status 1A and 1B candidates and candidates with MELD or PELD scores of at least 15 across the nation.

Additionally, the broader 2-circle proposal replaces median MELD at transplant (MMaT) in the DSA or region in the calculation of exception scores with the MMaT within a 250 nm circle around the transplant hospital for patients that are at least 12 years old, and with the median Pediatric End-Stage Liver Disease (PELD) at transplant in the nation for patients less than 12 years old. It also recommends changes to existing liver allocation variances, provides additional priority for pediatric candidates when there is a pediatric donor, clarifies treatment of blood type B candidates when the donor is blood type O, simplifies allocation of livers for other methods of hepatic support and MELD <6, and clarifies other references to local, DSA, and region.

Specific feedback requested

  1. The community is asked what MELD sharing threshold they recommend.
  2. The community is asked whether the sizes of the fixed distance circles should be larger, smaller, or remain the same.
  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.
  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

Contact: Elizabeth Miller


Please use this form to provide your feedback. Your comments relating to the proposal will be displayed in the comment section below (within 24 hours).

No other identifying information will be displayed unless you choose to display your name with the comment. You can also submit a comment anonymously. You may also submit comments by email, fax or mail.

IMPORTANT RULES ABOUT COMMENTING

To maintain a respectful dialogue, please review the OPTN Standards for Public Comment and also follow the guidelines below that were adapted from the HHS Comment Policy. Comments that violate these rules will not be published.

  • Stay focused. All viewpoints are welcome but comments should remain relevant to the specific proposal being addressed.
  • Be respectful. Personal attacks, profanity, and aggressive behavior are prohibited. Instigating arguments in a disrespectful way is also prohibited.
  • No spam. Repeated posting of identical or very similar content in a counter-productive manner is prohibited — this includes posts aggressively promoting services or products.

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 

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.

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.

Oscar Vazquez | 10/18/2018

Hawaii remain the same. No variance on Puerto Rico.