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Guidance on effective practices in broader distribution

Proposal Overview

Status: Implemented

Sponsoring Committee: Operations and Safety Committee

Strategic Goal: Promote the efficient management of the OPTN

View the Board report and guidance (PDF - 727 K; 6/2019)

Read the proposal and guidance (PDF; 1/2019)

Contact: Robert Hunter

Executive summary

The OPTN/UNOS Operations and Safety Committee created a guidance document to provide effective practices as well as operational and process recommendations. The intent of this guidance is to help OPTN members adapt to policy changes that address the broader distribution of organs. These allocation changes impact all members in the organ donation and transplantation community and will require operational changes to increase the efficiency of organ allocation, donor and recipient matching, transportation logistics, and organ recovery.

The guidance document is intended to serve as a resource for OPTN members. The scope and content should reflect collaboration between OPOs, transplant hospitals, and histocompatibility labs, taking into consideration their needs and best practices.

Feedback requested

The Operations and Safety Committee is requesting feedback on collecting additional data on the “mode of transportation” for organs. This will help provide data for future broader distribution discussions.

  • Does the transplant community support additional data collection necessary for OPTN Committees to evaluate the logistical impact of broader distribution? For example, collecting information on the “mode of transportation” used to transport organs.

Comments

Jay Blum | 01/27/2019

A nationwide distribution network would allow for an equal opportunity for all patients to potentially receive a transplant. Nationwide distribution will eliminate the vast difference in wait times currently experienced in different regions. A nationwide distribution should reduce the wait times for some regions and raise others but create a national wait time average more in tune with today's transportation logistics.

Anonymous | 02/08/2019

The Ad Hoc Disease Transmission Advisory Committee (DTAC) values the opportunity to comment on public proposals and, in general, commends efforts to enhance broader organ sharing. DTAC reviews potential donor-derived disease transmission events reported to the OPTN. A number of potential donor-derived transmission events reported are seasonal and geographically associated. As new broader sharing policies are implemented, transplant programs will need to review the OPO’s seasonal and geographic endemic infection screening practices and develop protocols accordingly. Recognition of disease in donors can be challenging. To minimize the risk of disease transmission a proportion of OPOs have instituted seasonal and geographic screening practices. For example, screening for West Nile Virus (WNV) is usually performed during the mosquito seasons. On the other hand, OPO’s with a high proportion of foreign-born donors have chosen to selectively screen for Strongyloides and Chagas infection based on epidemiological risk factors. If broader sharing is achieved, and recipient centers find themselves dealing with more distant OPOs, they will need to familiarize themselves with geographically restricted infections not normally encountered. DTAC is supportive of the proposal, as written, provided that resources are taken during implementation to ensure centers are educated regarding new tests and new conditions they may be exposed to through broader organ sharing.

Anonymous | 02/08/2019

Region 7 vote-1-strongly support, 6 support, 2 abstain, 3 oppose Members opposed to this document agreed that the finance sections that address billing between OPOs and surgeons as well as fair market value are outside of the purview of the OPTN.

Anonymous | 02/21/2019

Region 5 Vote: 2 strongly support, 12 support, 2 abstain, 7 oppose, 3 strongly oppose Members opposed to this document agreed that the finance sections that address billing between OPOs and surgeons as well as fair market value are outside of the purview of the OPTN. One member stated that region 5 has had broader sharing for a long time and already has these systems in place.

Anonymous | 02/21/2019

Region 2 Vote: 4 strongly support, 9 support, 2 neutral/abstain, 4 oppose, 5 strongly oppose There was great concern voiced over the inclusion of information pertaining to surgeon fees or OPO costs and fees. OPOs are strictly regulated by CMS and these discussions do not fall under the purview of the OPTN. Any discussion over fair market value should be with AOPO. Even though this is only a guidance document, it sets a bad precedence since often times these guidance documents lead to future policies. Members asked that these aspects of the guidance document be removed. As broader distribution becomes practice, it is imperative for OPOs and transplant centers to work together to help keep the allocation process efficient and timely. As OPOs and transplant centers outside of their DSA start collaborating more frequently, they need to work at building relationships and communicate.

Anonymous | 02/26/2019

Region 8 vote: 0 strongly support, 6 support, 8 neutral/abstain, 3 oppose, 3 strongly oppose As OPTN guidance can be a precursor for policy requirement(s), comments were shared from the OPO community that select content in the draft guidance was inappropriate for this type of paper. Specifically, sections addressing Organ Procurement Related Billing (lines 292-327), and Organ Procurement Malpractice Considerations (lines 338-353) were outside the purview of the OPTN. Further, content pertaining to Establishing Fair Market Value for Organ Procurement Activity (lines 329-336) would be challenging to assess and establish.

Region 10 | 02/28/2019

Region 10 Vote: 3 strongly support, 6 support, 1 neutral/abstain, 4 oppose, 4 strongly oppose; One member expressed that organ discards are under-represented in the guidance document because it does not take into consideration the number of organs that are intended to be recovered, but are ultimately not recovered. More data needs to be collected in terms of when a host center recovers their own organs and assessing when a center flies to a recovery when they could have driven. The OPOs in the region voiced concerns over the financial aspects of the guidance document, saying that is outside the purview of the OPTN. The committee lacks representation from someone who has done OPO finances, and without such representation, the committee should not make those suggestions.

Anonymous | 03/14/2019

The Organ Procurement Organization (OPO) Committee voted in support of the guidance document contingent on recommended changes to the sections addressing billing and financial issues. OPO Committee Vote: 3 Strongly Support, 6 Support, 1 Oppose

Anonymous | 03/14/2019

Region 4 vote-2-strongly support, 13 support, 0 abstain, 5 oppose, 0 strongly oppose Comments: A member commented that the use of the term “fair market value” is poor terminology and that he would like to stay away from the idea of pricing human life. Understanding costs is useful, but different wording would be better received by the community.

Association of Organ Procurement Organizations (AOPO) | 03/18/2019

AOPO opposes as written, specifically in opposition to the language regarding billing and FMV as noted in bullet 8 below. • Broader sharing has increased current organ allocation time with recent changes. To minimize the potential negative impact on organ donation from hospital perceptions and strain on donor families, these suggested strategies should be considered: 1. Employ effective communication between OPOs and transplant centers to maximize efficient allocation and acceptance of organs. 2. UNOS Policies pertaining to the time limitation for organ offer evaluation should be adhered to and enforced in order to reduce unnecessary delays in the organ donation process. 3. Transplant programs are encouraged to monitor their active waitlist and utilize realistic donor acceptance parameters to reduce unnecessary offers that slow the allocation process. • OPOs and transplant programs must put systems in place to adapt to broader sharing, most notably regarding air transportation solutions and a reduction in the use of air transport unless deemed necessary. • OPOs should be working in partnership with transplant centers beyond those in their designated service areas to build relationships. An important component to support broader sharing is the ability for member organizations to communicate and hold each other accountable for desirable outcomes. • Histocompatibility strategies for sharing donor specimen to perform crossmatches, including utilizing virtual crossmatches should be utilized to eliminate testing incompatible specimens with known antibodies to donor antigens. • OPOs and transplant centers should work collaboratively to schedule donor organ recoveries to not disadvantage candidates on the match run by setting OR times that prevent a distant candidate’s opportunity for transplantation. • Transplant centers should seek to rely on colleagues in neighboring DSAs to perform recoveries on their behalf to reduce unnecessary travel of recovery teams. • Transplant centers should be expected to increase the number of local recoveries they perform without the benefit of receiving organs recovered in those cases. The section regarding malpractice insurance seems misplaced in this guidance document. The need for medical malpractice coverage is not new or different under broader sharing arrangements. OPOs and surgeons should ensure appropriate liability insurance coverage for professional organ recovery services. Moreover, this section misunderstands the potential liability that exists. The primary legal risk that could materialize from organ procurement is potential liability from the transplant recipient not the donor family. This could occur if intraoperative findings (or lack thereof) related to medical suitability or surgical procurement technique negatively impacted outcome. AOPO suggests this section be revised accordingly. • AOPO objects to the sections regarding billing and FMV and recommends that they be removed. Because the OPTN/UNOS does not have any authority over the financial aspects of organ recovery, this section does not belong in an OPTN/UNOS guidance document. There are legal considerations under NOTA as to what OPOs can charge and be reimbursed for related to organ recovery services and OPOs are strictly regulated by CMS as it relates to kidney acquisition costs. The sharing of organ acquisition charges (OACs) and surgeon fees or attempts to bring consistency across the OPOs are subject to anti-trust review. AOPO recognizes there is a range in how these costs and charges are currently handled and that the financial impact of this variability with broader sharing will be important to consider but that discussion should take place outside of the OPTN/UNOS Operations and Safety Committee and not in this guidance document. • With the exception of kidney transplant, in the vast majority of cases accepting transplant center teams travel to the host OPO to perform organ recovery. On an ad hoc basis, centers may agree to a local team recovering the organ on their behalf, although the practice is not widespread. Broader organ sharing calls for an exploration of a systematic process to reduce surgeon and recovery team travel by using a local recovery team. Such a system of regional organ recovery teams has been implemented in the United Kingdom and should be studied by the OPTN.

Anonymous | 03/19/2019

To Whom it May Concern, On behalf of the American Nephrology Nurses Association (ANNA), thank you for allowing us the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Public Comment Proposals 01/22/19- 03/22/19. Our comments for several of the current policy proposals are as follows: OPTN Standards for Public Comment 01/22/19 – 03/22/19 Guidance on effective practices in broader distribution: ANNA supports (need more data collection).

American Society of Transplantation | 03/19/2019

The American Society of Transplantation is supportive of the proposal in concept, but offers the following comments for consideration: • There is no specific language distinguishing the unique practice challenges related to pediatric organ recovery in a broader distribution scheme. • The guidance document does not appear to be consistent with the current OPTN policies in effect; -Specifically, in the Histocompatibility Considerations section, the guidance document suggests that OPOs and HLA labs should rely more on virtual crossmatch data. In addition, the guidance document refers the reader to OPTN Policy 4.6. OPTN Policy 4.6 states that “Laboratories performing histocompatibility testing for kidney transplants or multi-organ transplants in which a kidney is to be transplanted must perform a final crossmatch and report the results to the Transplant Program before transplant.” Subsequently, under General Crossmatching Requirements, it refers to a physical crossmatch and not a virtual crossmatch. -A virtual crossmatch is not a physical crossmatch. Therefore, the guidance document appears to be at odds with the current Policy 4.6 as it relates to kidney transplantation. This guidance document should be reviewed by the Histocompatibility Committee and perhaps consideration should be made to modify OPTN Policy 4.6 to allow for Virtual Crossmatch in some patients. Given the important role of organ preservation technologies in broader sharing and the increasing availability of these approaches to facilitate sharing across longer distances, the proposal could include: 1. Introduction of a framework for discussion of technologies that extend acceptable ischemic times: In the section ‘Building Relationships to Optimize Operations’ (see line 9) language could be added to promote communication about the adoption of preservation technologies. a. When not already in place, OPOs and transplant centers should implement organized frameworks to evaluate and consider the adoption of new technologies and products, including technologies to enhance organ recovery, assessment, and preservation. Opportunities should be given for OPOs and transplant centers to share experiences with new technology adoption and best practices to create the most effective, efficient, and satisfactory processes to evaluate new technologies. b. Broader information sharing and collaboration between transplant centers, OPOs, device researchers, manufacturers, and other stakeholders relating to experiences with preservation protocols being utilized. c. Early communication of anticipated use of preservation technology in the organ evaluation and offer process. As fewer organ recoveries will be tied to local DSA teams, relevant information must be shared to improve efficiency and assist in planning for multi-organ team recoveries in particular. Testing and implementation of new preservation devices have, historically, relied heavily on local partnerships. Broader sharing necessitates broader conversations. d. Improved data reporting on preservation devices which will be critical to analyze performance and develop predictive assessments. Key factors could include: make and model of device, preserved time, perfusate/solutions used, and key clinical metrics (e.g. expected cross-clamp time, DCD, PaO2/FiO2 ratio < 300 mmHg, Active Pneumonia, Organ contusion/Lacerations, Heart LV Septal Wall Thickness more than 13 mm (LVH), Down time, Fatty Liver, Drug use, others), and collection of more granular post-transplant clinical outcomes (e.g. primary graft dysfunction, graft and patient survival over time, etc.). Information about specific requirements of each device related to organ recovery should also be made available in a standardized format. e. Development of a database of perfused organs to offer the potential for data-driven decisions at the time of offer – not only for the individual organ, which would have information gathered during perfusion (e.g. liver ALT and AST levels), but for the eventual adoption of preservation technologies and assessing the strengths and limitations of each device. f. Gap analysis for process improvement with periodic review of cases where clinical and logistical challenges may have prohibited the broader distribution of organs and where organ preservation technologies may have enabled successful recovery and transplant. Support for research: Wherever possible, organ procurement and transplant entities should support research that can facilitate effective organ sharing across broader distances. Examples include basic, translational, and/or clinical research related to organ preservation, as well as assessment for transplant suitability, donor-recipient matching, and OPO and transplant center decisionmaking under time and distance constraints.

Anonymous | 03/20/2019

We commend the OPTN for seeking new ideas to improve the allocation and distribution of deceased donor organs. The purpose of this memo is to stimulate productive discussions and accelerate changes needed to facilitate more life-saving transplants. This memo reflects input from the National Kidney Registry (NKR) and our constituents; and is offered in response to the OPTN’s request for feedback from the NKR related to the following concept papers: o Eliminating the use of DSA and regions from kidney and pancreas distribution o Guidance on effective practices in broader distribution The NKR is the largest paired exchange program in the world and has facilitated over 3,200 transplants since its inception in 2007. The NKR facilitates transplants for the most difficult cases including incompatible donor-recipient pairs, high cPRA patients, patients with more time on dialysis, etc. These transplants demonstrate a 34% lower death censored graft failure rate at seven years compared to all U.S. living donor transplants. The NKR graft survival advantage is statistically significant at 3, 5- and 7- years post-transplant. Approximately 80% of NKR facilitated transplants involve the shipment of a kidney on a commercial airline, charter flight or ground courier. The NKR has never lost a kidney or discarded a kidney due to a logistics problem or the accumulation of cold ischemic time (CIT). In 2019, the NKR expects to facilitate over 700 KPD transplants, complete over 35,000 online living kidney donor registrations and provide life and disability insurance for over 1,000 living donors. The issues under review in the above concept papers are core to the operational success of the NKR. Because NKR draws its experience from facilitating only kidney transplants, our recommendations are not necessarily intended for, but may be applicable to, other organ systems. We believe the solutions to the problems outlined in the concept papers require a broader view of the issues, so we have provided recommendations that go beyond the initial parameters of the concept papers. Benefits Changes to the OPTN system have the potential to achieve the following objectives:  Increase the number of transplants: The number of transplants can be increased by utilizing thousands of deceased donor kidneys that are currently being discarded.  Improve equity and access to transplants: Equity and access to transplants can be improved by ensuring that the majority of waitlisted patients, regardless of where they live, experience similar wait times for a deceased donor kidney. Also, simplifying the organ allocation process so that it is easier to understand will improve the perception of equity and fairness.  Improve waitlisted patients’ and transplant recipients’ outcomes: Reducing wait times and facilitating more transplants through the utilization of kidneys that are currently discarded will improve the outcomes for waitlisted patients and transplant recipients. Improved donor-recipient matching, and less CIT will drive better graft and patient survival rates, thus improving outcomes.  Promote transplant recipient safety: Transplant recipient safety will be promoted by reducing wait times and facilitating more transplants through the utilization of kidneys that are currently being discarded.  Better serve the most vulnerable populations: The most vulnerable populations will be better served by improving the accuracy of the cPRA calculation and enhancing the precision of the points awarded to hyper-sensitized patients. Approximately 1,000 100% cPRA patients – who are essentially stuck on the wait list – will have a better opportunity for a transplant.  Improve OPTN efficiency: By utilizing kidneys that are currently being discarded, each additional deceased donor kidney transplant will save Medicare and private health insurance providers approximately $500,000 per transplant (present value). Better donor-recipient matching, and less CIT will also reduce graft failure rates and save on dialysis related costs.  Reduce Healthcare Costs: If 2,000+ additional kidney transplants per year can be facilitated, Medicare and private health insurance providers will save approximately $1 billion annually. If kidney discards can be reduced, and facilitate more transplants, the savings will more than offset the costs to improve the deceased donor kidney match offer & logistics process. The OPTN should be reimbursed by Medicare and the private health insurance providers for facilitating more transplants. One approach that would better align the financial interests of the parties would be to replace the current OPTN registration fee with a higher transplant success fee. Recommendations We recommend that the OPTN streamline its decision-making process to better support faster decision making and implementation. Vesting more decision-making authority in senior OPTN leadership and reducing the size of the board are a few strategies that may help facilitate a more streamlined decision-making process. We recommend that the OPTN move from the current sequential match offer process to a batch match offer process. This will speed up the kidney offer/acceptance process, reduce cold ischemic time and reduce organ discards. The batch match offer process should execute in three tiers with three hours allotted for each tier. If there are no potential match offers in a tier, the system would immediately skip to the next tier and make the next batch match offer. The first two tiers would complete in a total of six hours allowing the final batch offers to go out with only six hours of match offer related CIT. The final batch of match offers would go out nationally and allow for the placement of organs which are currently being discarded. The following is an outline of the three-tier batch match offer approach. Tier-1: Special Situation Offers o Offer timing 0 – 3 hours o Target: 1%-5% of transplants facilitated in tier-1 offers o Offers would target approximately 0 – 5 potential matches o National in scope: no geographic limits o Target examples: 99.99%+ cPRA patients, great donor-recipient matches, etc. o The patient with the highest points, that accepts, receives the offer o No patient wait time limitations on tier-1 offers Tier-2: Local Offers o Offer timing 3 – 6 hours o Target: 70%-80% of transplants facilitated in tier-2 offers o Offers would target approximately 0 – 20 potential matches o Ground moves only: 400 miles radius from donor recovery hospital  The 400-mile limit equates to about an 8-hour max drive time  The 400-mile limit avoids air moves that are riskier and less reliable  The 400-mile limit could be reduced or increased but should be standardized nationally based on the logical limits (drive time) of ground moves o The patient with the highest points, that accepts, receives the offer o Only offered to patient with, for example, > 4 year wait time o Max points allocated to patients with, for example, > 5 year wait time o The above conditions will stabilize the entire system around a 4-5 year wait time o The wait time range (4-5 years) could gradually be narrowed (e.g. 4.3 – 4.6 years) o A narrower wait time range would allow centers/patients to better prepare for offers and would eliminate the current incentive for patients to multi-list Tier-3: Clearing Offers o Offer timing 6 – 9 hours o Target: 20%-30% of transplants facilitated in tier-3 offers o These are the kidneys that are currently being discarded o Waive CMS outcome related penalties for tier 3 transplants o Reduce the SAC fee to 50% to offset extended hospital stay costs, etc. o The first center/patient to accept the kidney, receives the offer o National in scope: no geographic limits o No wait time limitations Transplant centers would be encouraged to maximize utilization of donor preferences to filter out match offers that will not be accepted, thus reducing the number of match offers requiring responses, improving the overall efficiency of the system. Center match offer declines and non-response rates would be tallied and published to provide transparency for patients. Non-responses and declines should be minimized. Batch Match Offer Examples: Scenario 1: Two patients are offered matches in the first batch offer and both centers/patients accept the offers. Patient 1 has a cPRA of 99.990% and is an ‘A’ blood type (odds of match = 1 in 10,000). Patient 2 has a cPRA of 99.990% and is a ‘O’ blood type (odds of match = 1 in 10,000). Since patient 2 will be drawing from a smaller donor pool and has a higher cPRA, they will accrue more points (see section on Calculated Panel Reactive Antibodies) and receive the match offer. Scenario 2: The centers caring for the two patients in scenario 1 either decline or do not respond. After three hours, the first match offers are closed out and a second batch match offer is sent to 18 patients within 400 miles of the donor center. All of these patients have been on the wait list for some minimum amount of time (e.g. 4 years). After three hours, 4 offers have been accepted, 8 offers have been declined and 6 offers have not received a response. Out of the 4 offers that have been accepted, the patient with the highest points receives the offer. Scenario 3: All of the offers in scenario 1 & 2 have either been declined or have not received a response. After three hours the tier 2 match offers are closed out and a third batch match offer is sent to 45 patients that are biologically compatible, preference compatible and have opted into tier 3 offers. After 45 minutes, a center accepts one of the offers and the remaining 44 offers are closed. Eliminate Provisional Acceptances The batch match offer process requires the elimination of the ‘provisional’ acceptance which is always problematic in time sensitive processes. If an offer is accepted, the kidney must go to the intended recipient. If the kidney does not go to the intended recipient and the center is above a cutoff threshold for this kind of situation (e.g. > 5% kidneys not going to intended recipient), the recipient center would pay an out of compliance fee (e.g. $20,000). This will encourage centers to only accept offers for kidneys that are actually acceptable for patients that are available for surgery. When kidneys are frequently given to backup patients because the intended recipient fails the cross match, is not ready for surgery, etc. it undermines fairness and trust in the system. The rate of kidneys not going to intended recipients should be published to support transparency for patients. The elimination the ‘provisional’ acceptance also requires all information related to the kidney to be online before the offer is made. If this information is not available or is inaccurate when the offer is made, the procuring OPO should pay the out of compliance fee. When certain critical information cannot be made available before the match offer goes out, this should be noted in the match offer and should automatically generate a root cause and correct action plan request. Revise Calculated Panel Reactive Antibodies The OPTN needs to change the current cPRA calculation to a ‘brute force’ calculation so that the cPRA is precise and can better serve hyper sensitized patients. The brute force calculation will better reflect changes in the donor pool composition and accurately differentiate between a 99.990% cPRA patient and a 99.999% cPRA patient, the later which is ten times as hard to match as the former. The current OPTN kidney point allocation rounds a 99.51% cPRA patient up to a 100% cPRA. This point allocation needs to be enhanced to differentiate between patients with very high cPRAs (e.g. 99.9%, 99.99%, 99.999%, etc.) and point assignments must also be adjusted to reflect the expected donor pool volume for a given patient blood type. For example, a 99.99% ‘O’ blood type patient is twice as hard to match as a 99.99% ‘A’ blood type patient. Currently, the OPTN kidney cPRA point allocation ignores the patient blood type and rounds to the nearest percent (e.g. 98%, 99%, 100%). This approach is far too imprecise to equitably serve the thousands of hyper sensitized patients on the wait list. We recommend enhancing the point allocation for highly sensitized patients by basing it upon the patient’s expected wait time. This approach would use the more precise brute force cPRA and the expected blood compatible donor pool (e.g. projected based on the past 2-3 years) to calculate the expected wait time for each patient. This approach has helped the NKR consistently match and transplant hyper sensitized patients with cPRAs up to 99.7% on a living donor pool of only 700 donors per year. Based on the NKR experience and the larger deceased donor pool, we would expect the OPTN to consistently match and transplant patients with cPRAs up to 99.997% if the point allocation for highly sensitized patients was enhanced. The following are expected wait time calculation examples:  If a patient has a 99.99% cPRA (match odds = 1 in 10,000), is an ‘A’ blood type and the donor pool will provide approximately 12,000 blood compatible donors/year; this patient’s expected wait time would be approximately 1 year (10,000/12,000). Minimal points needed to find a match.  If a patient has a 99.999% cPRA (match odds = 1 in 100,000), is an ‘A’ blood type and the donor pool will provide approximately 14,000 blood compatible donors/ year; this patient’s expected wait time would be approximately 8 years (100,000/12,000). Maximum points needed to find a match.  If a patient has a 99.999% cPRA (match odds = 1 in 100,000), is an ‘O’ blood type and the donor pool will provide approximately 6,000 blood compatible donors/ year; this patient’s expected wait time would be approximately 17 years (100,000/6,000). Maximum points needed to find a match. Because many transplant centers cannot perform accurate virtual cross matching, which is critical for matching highly sensitized patients in a time sensitive environment, the OPTN should designate high cPRA centers of excellence. Any patient with a cPRA greater than the high cPRA cutoff (e.g. 98%) should be referred to one of these high cPRA centers of excellence so that the highly sensitized patients have an opportunity to receive a well-matched deceased donor transplant. As a point of reference, there are over 6,000 wait list patients with a cPRA of over 98% and approximately 1,000 patients with a cPRA of 100%. Improve Logistics The logistics required to support an effective batch match offer process should include the following key components: o RCCAP Process: Any match offer or logistics failure should automatically generate a request for a Root Cause and Corrective Plan (RCCAP) from the organization responsible for the failure. For example, if a kidney did not get transplanted into the intended recipient, a RCCAP should be completed by either the transplant center or the OPO. A Pareto analysis should be performed on the RCCAPs monthly to initiate solutions for recurring problems that can be systematically corrected. The Pareto analysis should be published to support transparency. o GPS Tracking: Utilize smart phone GPS technology for all shipped organs. Integrate GPS tracking with ‘fail-safe’ systems to ensure positive confirmation of all inflight organ moves (e.g. wheels-up and kidney on plane, plane landed and kidney on the move, etc.). o Logistics Monitoring: Implement real-time logistics failure reporting systems that are integrated with the GPS smart phone technology and the national courier vendors. Examples of these real-time integrated monitoring systems include the NKR’s swap tracker and move tracker. o OPO Efficiency: There are currently 58 Organ Procurement Organizations operating individual geographic monopolies in the United States. The lack of competition in any market allows for poorly performing organizations to stay in business and underserve their markets. This is true for the OPO market as it is for all markets. To foster competition and systematically close poorly performing OPOs, a process should be created whereby the lowest performing OPOs (e.g. 2-5 per year) are merged into the strongest bordering OPOs. This would also allow OPOs to leverage economies of scale which are significant in the OPO industry. o National Couriers: The OPTN, working in partnership with the OPOs, should contract with 2-4 national organ couriers to move all organs beyond the local OPO donor service areas with an option to provide services within donor service areas. These courier vendors should be positioned to back each other up. The best performing courier vendor(s) should receive the largest portion of the business so that competition is fostered and top performance is systematically rewarded. The courier contracts should include clear service standards and penalties. o Avoid Connector Flights: When shipping organs via commercial air, connector flight moves should be replaced with charter or charter/commercial hybrid moves whenever possible. If there is no other option, connector flight moves should always utilize an onboard courier to mitigate the extreme risk inherent in this mode of transport. o Charter Flights: The national courier vendors should manage the acquisition of charter flights to concentrate purchasing power across all OPOs. Generally, prop charters should be used for shorter distances (e.g. under 1000 miles) and jet charters should be used for longer distances (e.g. over 1000 miles). Charter/commercial hybrid moves are generally the fastest and most cost-effective method of moving a kidney more than the maximum driving distance (e.g. 400 miles). The NKR has not experienced problems with a shortage of charter flights or pilots. o Organ Containers: The OPTN, working in partnership with the OPOs, should develop & deploy a standardized kidney shipping container that supports a standardized kidney pump, built-in signage and a compartment for holding a standardized GPS smart phone. The advantages of pumping a deceased donor kidney is well documented. These standardized kidney containers should be purchased in volume (including a national maintenance contract) and seamlessly shared across all OPOs. o Lost or Damaged Organs: The OPTN should provide a quarterly report on all organs lost in transit of damaged (e.g. kidney frozen in flight, kidney ended up in wrong city, etc.). A RCCAP should be completed for every lost or damaged kidney keeping in mind that each kidney has the potential to save someone’s life and also save Medicare and the private insurance companies approximately $500,000. Enhance Donor-Recipient Matching The current OPTN point allocation for donor-recipient matching is based on A, B, DR antigen miss-matches. This point allocation approach to donor-recipient matching is dated and should be upgraded to reflect the latest science for evaluating the quality of the donor-recipient matches (e.g. Living Donor KPI, specific antigen mismatch risk for de novo antibody, epitope matching, etc.). This is an opportunity for collaborative research to find the best approach for improving long term graft survival through better donor-recipient matching. Conclusion Thank you for requesting feedback from the National Kidney Registry on these important concept papers. Please let us know if you have any questions or if we can be of any additional service to the OPTN on these important matters.

NJ Sharing Network | 03/20/2019

NJ Sharing Network objects to the sections regarding billing and FMV and recommends that they be removed. Because the OPTN/UNOS does not have any authority over the financial aspects of organ recovery, this section does not belong in an OPTN/UNOS guidance document. There are legal considerations under NOTA as to what OPOs can charge and be reimbursed for related to organ recovery services and OPOs are strictly regulated by CMS as it relates to kidney acquisition costs. The sharing of organ acquisition charges (OACs) and surgeon fees or attempts to bring consistency across the OPOs are subject to anti-trust review. NJ Sharing Network recognizes there is a range in how these costs and charges are currently handled and that the financial impact of this variability with broader sharing will be important to consider but that discussion should take place outside of the OPTN/UNOS Operations and Safety Committee and not in this guidance document.

American Society of Transplant Surgeons | 03/21/2019

The American Society of Transplant Surgeons (ASTS) appreciates the opportunity to comment on the proposed guidance document. ASTS notes some incongruence between the document’s stated goals and practices and that of the OPTN’s ability to operationalize its guidance. This can leave transplant centers in an ambiguous position. For example, the document states transplant centers should identify surgeons in nearby regions they trust to recover organs. For this to work, transplant centers need: a formalized system outlining expectations from partnering centers and a communication system that functions in real time and ideally includes video monitoring. The ASTS also supports the development of regional systems to provide feedback on organ quality, procurement injury, and other concerns. When OPOs and organ transplant centers were aligned this was done in medical advisory boards. Broader distribution requires more structured communication. When organ procurement teams are needed, it is imperative for the OPTN to define appropriate standards for travel, safety, and insurance involving air and ground transport. ASTS has been assiduously working with community stakeholders and industry to develop more definitive guidelines. Organ recovery remains the most dangerous job in medicine and this cannot be solved primarily through the use of recovery surgeons. As surgeons are going to be increasingly asked to recovery for other centers, there needs to be a standardized system to ensure medical professionals are adequately insured during this crucial work. Better communication and coordination are essential for a broader distribution system to succeed. Transplant centers need data on proposed time and contact information to discuss offer details. Ideally, donor net would incorporate a two-way communication. The proposed indicators in Donor Net (e.g. follow donor) and not adequate. Furthermore, the community would also be better served if the guidance document were to spell out the circumstances under which OPOs can withdraw offers if a transplant hospital cannot agree on the start time for procurement. What time frames are reasonable? This should be a measure of last resort and should not be done without the involvement of the medical director of the OPO. We also note with concern the documents HLA testing guidelines for highly sensitized patients. Virtual crossmatching may rule out donors, is often insufficient to move a patient to transplant, and can lead to increasing organ discards. It is still imperative that donor blood be sent ahead for highly sensitized patients. Finally, organ procurement surgeon billing and fair market value is not the purview of the OPTN. The ASTS opposes national rate setting. We should allow the individual transplant programs and their OPOs to develop appropriate arrangements. The ASTS agrees with the document in that malpractice coverage for an unrecognized injury at the time of recovery leading to a recipient’s poor outcome needs to be clarified, but respectfully, not by the OPTN. This needs to be addressed at the OPO level.

Anonymous | 03/21/2019

The Committee is concerned about the need for additional air travel and the lack of modeling for potential increased associated travel costs. There is data that shows an increase in transportation costs since the change in lung allocation. There is concern that there will be increased costs to the system as we broaden sharing. The committee also expressed concern about delays in organ recovery due to the fact that organs may be more likely to be allocated to multiple centers which will require increased time to accommodate additional flights and teams. As our community looks at expanding our boundaries of organ allocation we need to openly share data in order to identify changes in cost, efficiency and timing and other required resources.

Anonymous | 03/21/2019

The Liver and Intestinal Organ Transplantation Committee (the Liver Committee) commends the Operations and Safety Committee for their work in creating this guidance document and thanks them for presenting the proposal. Similar to the concerns raised at regional meetings, the Liver Committee felt that the guidance document’s discussion of finance does not fall under the purview of the OPTN. Additionally, the Liver Committee felt that the discussion of fair market value for procurement services touches on issues that are DSA-specific so it would be difficult to establish a national standard. Both of these topics would be best addressed in a different arena. The Liver Committee appreciates the Operations and Safety Committee’s willingness to adjust the guidance document in light of these concerns.

National Kidney Foundation | 03/21/2019

The National Kidney Foundation believes any replacement of the current distribution system should be designed to improve equality, efficiency and transparency in organ allocation. Most recently African Americans have seen an increase in transplantation that has been attributed to the current kidney allocation policy that was updated in 2014. Any future modification in organ distribution policy must also enhance access to transplantation for minority populations and those with low socioeconomic status as these groups have not historically had equal access to transplants. In addition, with any proposal implemented, we believe it is critical to monitor rates in organ donation, organ recovery and discarded organs as a result of the change in allocation policy.

Anonymous | 03/22/2019

Region 1 vote-5-strongly support, 9 support, 0 abstain, 0 oppose, 0 strongly oppose Comments: Members of Region 1 support the guidance document on Effective Practices in Broader Distribution, but there were some concerns raised regarding the sections of the document pertaining to OPO related billing, establishing fair market value (FMV) for organ procurement activity, and organ procurement malpractice coverage considerations. The region requests that the Committee remove these sections as they are beyond the purview of UNOS guidance. The Committee requested feedback from members of Region 1 on the collection of additional data to evaluate the logistical impact of broader distribution. There was no opposition to this request.

Carolina Donor Services | 03/22/2019

Carolina Donor Services (CDS) applauds the efforts of the Operations and Safety Committee to recommend efficient practices that will drive efficiency in broader distribution. The success of guidance recommendations in our interdependent network depends greatly on uniform adoption of practices to achieve efficiencies. Uniform practice will not be achieved without implementation of applicable policies that drive toward the same efficiencies in allocation, procurement, and transplantation. It is the recommendation of CDS that UNOS/OPTN prioritize a review of policy and UNet optimization to implement changes that also drive increased efficiency in practice. (For example, the histocompatibility recommendation regarding virtual crossmatching appears to be in conflict with the current OPTN kidney policy.) • Sections in the guidance document that relate to organ procurement billing and malpractice are not under the purview of the OPTN and do not belong in this document. • CDS supports the Committee’s inquiry regarding collecting data on the “mode of transportation” for organs. This should be collected efficiently through a programming change to DonorNet.

Anonymous | 03/22/2019

5 strongly support, 11 support, 4 abstain It was suggested by a member that all of the finance information should be removed from the document, as this information can be presented in a different forum.

Terri Jarman | 03/22/2019

Redistricting organ distribution is not in the best interest of our patients. Increasing the cold time increases the chance of post-op complications. The probability of decreasing the number of transplants per year is inexcusable when the number on the waitlist far outweigh the transplanted. Instead, encourage other regions with a higher wait time to do what is necessary to decrease their wait time and utilize their local donated organs. Model off of those with shorter wait time if needed. Why "shuffle chairs on the Titanic"??

Anonymous | 03/22/2019

12 strongly support, 11 support, 0 abstain, 2 oppose, 7 strongly oppose

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) opposes this guidance as too focused on financial concerns for transplant programs without sufficient consideration of issues related to histocompatibility testing. Specifically, this proposed guidance encourages transplant programs to rely further on “virtual crossmatching”. While ASHI supports the utility of virtual crossmatching, the CLIA section of CMS has yet to rule on whether virtual crossmatching meets the requirement to have the results of a pre-transplant crossmatch for renal and tandem transplants that include a kidney (42CFR §493.1278 (f)(2)).

Anonymous | 03/22/2019

12 strongly support, 12 support, 0 abstain, 0 oppose, 1 strongly oppose Comments: The region concurred that the community needs more than recommendations, need standards; something with more teeth. There was no comment regarding data collection. The presenter noted the Committee was aware of the community’s opposition regarding inclusion of sections addressing Organ Procurement Related Billing (lines 292-327), and Organ Procurement Malpractice Considerations (lines 338-353) were outside the purview of the OPTN. Further, content pertaining to Establishing Fair Market Value for Organ Procurement Activity (lines 329-336) would be challenging to assess and establish. The vote was informed by the region’s assumption that the above sections would be removed from the final proposal.

Anonymous | 03/22/2019

The Transplant Coordinators Committee reviewed the proposal during a meeting on February 19, 2019. Members supported this proposal and expressed guidance was very well written from both the OPO and transplant program perspectives. Members verbalized: • The need for future data analyses to examine impact of broader sharing across different geographic areas of the U.S. • Concern over the impact of extended organ sharing distances on scheduling OR times, the potential for cross clamp delays, and aircraft/aircrew availability. • The potential for telemedicine use (e.g.: digital video) in cases when a transplant hospital is relying on another recovery team. As broader organ sharing becomes a daily reality in organ donation and transplantation, the Committee strongly encourages enhancements to OPTN IT systems to promote patient safety. This would include real-time notifications through DonorNetSM of updated donor test results (e.g.: final culture and sensitivity results), a “sign off” by transplant staff that these updates donor test results were received and reviewed, and closed-loop communication back to the host OPO that any updated donor test results were received and reviewed. Such enhancements would directly contribute to enhancing patient safety, mitigating the risk of breakdowns conveying critical information, and the potential for untoward events. The Committee stands ready to lead such an initiative in close collaboration with the Operations and Safety Committee. The Committee appreciates the opportunity to provide feedback to Operations and Safety Committee.

New England Donor Services | 03/22/2019

NEDS appreciates the proposed guidance and is focused on the operational changes OPOs and Transplant programs must make to effectively support broader distribution. 1. Efficient allocation and effective communications between OPOs and transplant centers is particularly essential in a system of broader distribution which has already resulted in organ allocation taking more time with potential negative impact on donor hospitals and strain on donor families. Accordingly, the time limitation for organ offer evaluation should be adhered to and enforced through UNOS review and performance improvement processes or policy reform if indicated. 2. OPOs and transplant programs should agree on transportation protocols to adapt to broader distribution. This should include for example limitations on the use of air transport when ground transport is reasonable in order to increase availability of aircraft for those travel distances where air transport is the only suitable solution. 3. Histocompatibility strategies and the sharing of donor specimen for cross-matching should be performed in an efficient way, utilizing virtual crossmatch to eliminate the sharing of specimen when a candidate is incompatible and has antibody to the donor antigens. 4. We strongly agree that transplant programs perform recoveries on behalf of other programs to reduce unnecessary travel of recovery teams and to reduce "gaming" the allocation system by refusing to recover for more distant teams with a higher offer. 5. OPOs should work collaboratively to schedule donor organ recoveries to not disadvantage candidates on the match run by setting OR times that may impede a distant candidate’s opportunity for transplantation. 6. The section in the guidance regarding billing, FMV of organ recovery services and malpractice coverage are out of place and should be removed.The OPTN does not have any purview over the billing process, OPO costs or reimbursement (CMS sets the kidney recovery fee for example) and malpractice insurance considerations are unrelated to broader distribution. 7. While guidance is helpful it cannot be enforced.Therefore the performance of the allocation system under broader distribution policies must be actively and closely monitored to inform future policy reform as indicated to maximize efficiency and reduce the potential for lifesaving organs to be wasted.

S Little | 03/23/2019

Although I agree with many comments regarding the concern for increased costs as we broaden the current system, I overall feel the benefits outweigh the cons in this proposal. I do believe the billing system would need to be reconfigured, but that is not within the scope of UNOS. In modifying organ allocation policy, I would encourage additional discussion and consideration of those of a lower socioeconomic status, minority populations, and other disadvantaged populations, as enhancing their access to transplantation should be a key focus.

William Freeman | 03/23/2019

This Guidance focuses on the mechanics of broader distribution of organs, as is appropriate. The need for efficiency in the mechanics of distribution due to the changed policy and practices required by broader distribution is clear. This Guidance relies on the actual experiences and recommendations of transplant people “in the field,” and thus is certain to be quite valuable. My Comment is not narrowly about this proposed Guidance. Rather, it is about the disparities of equity _before_ being put on the official waitlist. Organ allocation and distribution by definition deals with people already on the waitlist. The new allocation and distribution system is intended to increase equity _for those on the waitlist_. The new system does not address inequities of getting on the waitlist. Many studies of organ-specific of waitlists indicate that certain populations are disadvantaged and experience major disparities in achieving that critically important step. “Going upstream” even further, many of those populations also have disparities in the quality and convenience of care both before and after being waitlisted, and thus some people may become too sick with other, comorbid, conditions to be transplanted. The populations most at risk for disparity in getting and staying on the waitlist—i.e., the “pre-allocation” phases—are often “minority” populations due to their non-European ancestry, and also have “lower” social-educational-and-economic statuses. Some rural populations face double disadvantages of relative poverty along with less available health care located at longer distances. These “pre-waitlist” disparities violate the vision expressed by NOTA of a national transplantation system that is equitable for all. The vision of the great majority of donors and recipients—of deceased donors who had signed to be an organ donor, of deceased donor families, of living donors, of recipients, and of recipient families—is that giving and receiving the national lifesource of transplanted organs should be equitable for all. These inequities and disparities in the pre-waitlist phases are under much less control by transplant programs and OPTN/UNOS than are “post-waitlist” inequities and disparities. Nevertheless, I believe that transplant programs and OPTN/UNOS can and should play an important role in _helping to reduce_ the pre-waitlist disparities and inequities. That role is to foster and promote collaborative, multi-disciplinary and multi-organizational, national and local programs with both existing and new programs. This Public Comment therefore asks the OPTN/UNOS Operations and Safety Committee to bring this recommendation to the OPTN/UNOS Executive Committee to initiate a formal effort to reduce pre-waitlist disparities by the collaboration of OPTN/UNOS with other relevant organizations and people.

Joseph Hillenburg | 03/23/2019

I concur with the comments from the American Society of Transplantation regarding pediatric recovery. Otherwise I am supportive of this white paper.

Anonymous | 03/26/2019

Vote: 0 strongly support, 16 support, 2 abstain, 0 oppose, 0 strongly oppose