Policy development:
A fact-based assessment

1. The Markup

HRSA, UNOS, and advocates for the policy shift said that a lawsuit brought by patients in New York against Health and Human Services, the OPTN, and UNOS was the driving force behind the policy change, according to emails included in litigation filed in Georgia. A court, however, has never ruled on whether donation service areas are unlawful. Please explain why the lawsuit was a driving force.

UNOS

Regardless of what might have been stated or by whom, the New York lawsuit should not be interpreted as a “driving force.” That would ignore decades of history in which the federal government has demanded donation service areas no longer be used to determine organ allocation and during which the OPTN sought to address geographic disparities in transplantation. Instead, the lawsuit serves as an example of why that change needed to be made.

There have been consistent efforts over the years to eliminate geography as a barrier to patients receiving transplants beginning with the 1986 Task Force Report on Organ Transplantation that was required by the National Organ Transplant Act of 1984 (NOTA).

For example, the OPTN Final Rule, effective March 16, 2000, explicitly requires that organ allocation policies be designed to achieve equitable allocation of organs among patients and must, among other goals, distribute organs over as broad a geographic area as feasible and in order of decreasing medical urgency.

Additionally, in August 2010, the Advisory Committee on Organ Transplantation (ACOT) – having been formed to provide advice and recommendations to the Secretary of HHS on proposed Organ Procurement and Transplantation Network (OPTN) policies – recommended that the Secretary take steps to ensure the OPTN develops evidence-based organ allocation policies, which are not determined by arbitrary administrative boundaries such as OPO service areas, OPTN regions and state boundaries.

In 2012, the OPTN Board of Directors approved a resolution stating that the existing geographic disparity in allocation of organs for transplant was unacceptably high and directed the organ-specific committees to address these disparities. Over the next few years, the OPTN released concept papers and held national forums to discuss how to address geographic disparities.

More recently, and in response to criticisms of the OPTN’s December 2017 “compromise” liver allocation policy, on July 31, 2018, the Administrator of the Health Resources and Services Administration (HRSA) wrote that “the OPTN has not justified and cannot justify the use of donation service areas (DSAs) and OPTN regions in the current liver allocation policy and the revised liver allocation policy approved by the OPTN Board of Directors (OPTN Board) on December 4, 2017, under the HHS Final Rule affecting the OPTN.”

The OPTN continues to explore further avenues to increase the number of lives saved through organ transplants as equitably as possible. This week, the OPTN is transitioning lung allocation policy – the first organ – into the new continuous distribution framework. This new system will provide even more equity and efficiency in organ allocation. Continuous distribution is the next phase in a long arc of efforts to improve organ allocation. The kidney, pancreas, heart and liver committees are moving forward to this new generation of allocation.

2. The Markup

Based on my reporting, HHS’ decision to do away with DSAs was a direct effect of UNOS/OPTN not defending DSAs when prompted following the critical comment the 2018 lawsuit patients filed, rather than an independent decision taken by HHS.

UNOS

The OPTN defended DSAs and Regions as units of liver allocation in a response – submitted to HHS – to the December 2018 lawsuit (Cruz v. HHS, SDNY, Case No. 18-cv-6371 (AT)) and the related “critical comment” pursuant to 42 CFR 121.4(d), which challenged the OPTN’s Board’s adoption of its December 2017 liver allocation policy.

Specifically, in its June 25, 2018, response to HRSA, the OPTN asserted that maintaining minimal reliance on DSAs in its new liver policy was compliant with the OPTN Final Rule. The OPTN’s response noted: “the [December 2017] Liver Policy does not utilize DSA as the primary unit of distribution but rather distributes livers first to the most medically urgent candidates (Status 1A, 1B and candidates with a calculated MELD/PELD of at least 32) anywhere within 150 nautical miles of the donor hospital regardless of whether those candidates are in the same DSA or OPTN Region as the donor. In addition, livers are offered to candidates anywhere in the same OPTN Region as the donor. Accordingly, the revised Liver Policy does not rely on the DSA as the primary distribution unit.”

The OPTN distinguished the 2017 liver policy from the lung allocation policy in which “DSA was the exclusive primary unit of lung distribution …. At that time, the OPTN concluded that the exclusive reliance on DSA for lung distribution constituted an ‘over reliance’ on DSA and that a policy that does not depend on DSA as the primary unit of allocation of lungs is more consistent with the Final Rule than a policy that shares first exclusively within the DSA.”

Finally, in that same letter, the OPTN cautioned against eliminating DSA as a unit of liver distribution without careful modeling. After HRSA considered the OPTN’s response, HRSA concluded that the continued use of DSAs and Regions as units of organ allocation could not be justified under the federal regulation. On July 31, 2018, HRSA directed the OPTN Board of Directors to remove DSAs and Regions from all organ allocation policies. Available at Callahan et al v. HHS et al, USDC N. Dist. Ga., Case No. 1:19CV-1783-AT, ECF-1-08).

3. The Markup

What signals or documents show that this policy would have changed at this speed without the lung lawsuit (2017) and liver lawsuit (2018)?

UNOS

We cannot speculate on what may have happened if not for a series of other developments. We would note that as early as November 2012, the OPTN Board of Directors resolved that existing geographic disparity in allocation of organs was unacceptably high. The Board further directed organ-specific committees to develop measures to assess fairness in organ allocation and develop policies to decrease geographic variation.

4. The Markup

The lawsuit appears to have been funded by the Greater New York Hospital Association, whose board of governors voted to allow the organization to “support and coordinate” the lawsuit. It paid Boies Schiller Flexner, which represented the plaintiffs, $200,000 in 2018. Was this the total cost for legal fees or did UNOS also help pay for the lawsuit?

UNOS

UNOS had nothing to do with the filing of this lawsuit. It was, in fact, named as a defendant. UNOS has no insight into the plaintiffs’ cost to bring its lawsuit.

5. The Markup

Members of the Coalition for Organ Distribution Equity (CODE), recruited at least four of the six patients named as plaintiffs in the lawsuit, according to patient interviews. And the remaining plaintiffs were being treated at hospitals that were members of CODE. In an email The Markup obtained, a lobbyist registered to CODE thanked Tom Mone, then-CEO of OneLegacy, for recruiting a California patient.

UNOS

UNOS is not a member of that organization and cannot speak for it.

6. The Markup

All but one of the plaintiffs for that lawsuit received transplants under the previous policy. The other died before she could receive a transplant. Was the information that the named plaintiffs had already received transplants ever shared with UNOS, Health and Human Services, or the Centers for Medicare and Medicaid Services? If this information was shared, when and how?

UNOS

Per HIPAA, UNOS cannot comment on individual patient status or treatment.

7. The Markup

While the 2018 lawsuit filed in New York said wait times for patients in New York, California and Massachusetts stretched on for years, an analysis of waitlist records by The Post and the Markup shows that the median wait in those states is less than a year, including the year the lawsuit was filed. Please provide comment.

UNOS

Please provide your analysis methodology. We can provide informed comment with an understanding of the following:

• What time cohort did you use?
• Did you only include patients who received a transplant, or in conjunction with those either still waiting or removed from the waiting list at the end of the period?
• Did you stratify by the medical urgency score of the candidates/recipients?
• If so, did you use their initial medical urgency score at listing, or at the time of removal or transplant?

These variables are all necessary to create an accurate analysis and for us to provide meaningful commentary.

Per the two-year policy monitoring report, the overall probability of transplant at 90-, 180-, and 365-days was higher post-policy compared to pre-policy (figure 15, page 32). The probability of removal from the waiting list due to a patient death/being too sick at these time points was lower post-policy compared to pre-policy.

Overall, at one year after listing, a patient would have ~56 percent chance of receiving a liver transplant before the liver AC policy, and that probability increased to ~60 percent after the policy was implemented. The probability of transplant is highly dependent on MELD or PELD score or status.

As would be expected, when one looks at national data through urgency categories and examines the probability of transplant over time, the most urgent candidates are transplanted more quickly, while less urgent candidates may wait longer.

Post-policy probabilities were higher in all urgency categories compared to pre-policy at all time points within one year.

Unsurprisingly, these trends held true for the states you referenced: New York, California and Massachusetts.

8. The Markup

The Greater New York Hospital Association, LiveOnNY, and OneLegacy formed a lobbying group called the Coalition for Organ Distribution Equity (CODE) in 2015 to “make the system equal.” At its peak, it had 15 organizations, mainly hospitals, in New York, California, and Massachusetts. This organization worked to organize the lawsuit and lobby members of Congress for a bill for wider organ sharing, according to our reporting.

UNOS

UNOS is not a member of nor does UNOS speak for the Greater New York Hospital Association, LiveOnNY, or OneLegacy, and we direct you to those organizations for their respective positions.

9. The Markup

In 2018, then-Rep. Eliot Engel (D-NY) and 27 cosponsors introduced federal legislation called “Fairness in Liver Allocation.” All but one of the co-sponsors came from California, New York and Massachusetts. It came after Engel sent a letter to congressional colleagues “at GNYHA’s request” to colleagues in Congress, a letter that gained 81 signatures. GNYHA donated $51,800 in 2018 to six of the co-sponsors. He had a “direct line” to Montefiore Medical Center, which was a member of CODE. This occurred after a compromise policy for broader sharing was already approved by UNOS’ board.

UNOS

The “compromise policy” was approved by the OPTN Board in December 2017; not the UNOS Board. Only the OPTN Board of Directors can approve organ allocation policies for the OPTN.

Relative to the compromise policy, we will restate that HRSA rejected it because HRSA concluded that the OPTN Final Rule required the OPTN to eliminate donation service areas and OPTN regions as units of organ allocation.

10. The Markup

The 2018 lawsuit brought by liver patients in New York was modeled on a similar lawsuit filed the year prior in New York – a woman named Miriam Holman was suing to require broader sharing for lungs. The judge in the case said it wasn’t the judge’s place to order a system-wide change since the existing policy was equally applied to all patients. Still, Health and Human Services volunteered to have OPTN/UNOS review the allocation policy. Why did the agency volunteer to do that?

UNOS

UNOS does not speak for the U.S. Department of Health and Human Services (HHS), and we direct you to the agency for its position and a response to your question.

For background, we can provide the following publicly available information about the Holman lawsuit, which is an excellent example of why the federal government sought to remove the arbitrary distinction of geography from determining organ allocation:

The plaintiff, Ms. Holman, who at the time was a lung transplant candidate, challenged the existing organ allocation system under which a pair of lungs from a donor in Fort Lee, NJ, (a three-mile drive from her transplant hospital across the Hudson River) would first be offered to all suitable lung candidates in the donation service area (DSA) encompassing Northern and Central New Jersey, even if those patients were less medically urgent candidates than she was.

Under the DSA-based lung allocation system, if a lung became available from a donor located a few miles away from the plaintiff in New Jersey or Connecticut, then all suitable candidates in that donor’s DSA were prioritized to receive the lungs first. This would be the case regardless of whether those candidates had lower lung allocation scores (LAS) than the plaintiff. The LAS helps determine priority in allocating donated lungs for transplant, with higher scores indicating that a patient is in greater need of a transplant.

There is no medical basis to offer an available lung to a similarly situated candidate with a lower lung allocation score (LAS) who is geographically farther away, and such an organ allocation system unjustifiably overemphasizes the candidate’s place of residence or place of listing – contrary to federal regulation.

11. The Markup

In response to the Health and Human Services request that UNOS/OPTN examine the policy, the OPTN thoracic committee recommended against such a change on short notice because there wouldn’t be enough time for adequate modeling. UNOS and HHS changed the policy, anyway, broadening sharing for lungs. Why did UNOS and HHS change the policy over the committee’s objections?

UNOS

At that time, the OPTN Thoracic Committee had already agreed that “broader distribution of adult donor lungs is a priority that is supported by relevant literature on the subject.” It had submitted this as a new committee project twice prior to the Holman lawsuit. Per a November 2017 memo from the Thoracic Committee, “[t]he Committee concluded that there is value in exploring the removal of the DSA as a unit of allocation, but is reluctant to recommend doing so without adequate analysis on the impact of such a change. ”

To accommodate this, the Committee requested and received SRTR modeling. Once the OPTN Executive Committee approved the emergency policy change, the Thoracic Committee had several months to review it and make recommendations before the Board adopted a permanent policy. During that time period, the SRTR produced a report on its impact (LU2017_02 – see page 33).

12. The Markup

UNOS created the “Ad Hoc Committee on Geography” to determine if broader sharing should be extended to other organs. UNOS’ then-CEO Brian Shepard first proposed the idea, and Alexandra Glazier took credit in an email for having helped come up with the idea. When did Glazier and Shepard first discuss the committee? What role did Glazier play in its creation?

UNOS

The OPTN ad hoc committee was formed to assess the recent changes in organ distribution and determine principles for a consistent framework to apply to all organ types. It wasn’t formed to “determine if broader sharing should be extended to other organs.”

We are not able to pinpoint when Alexandra Glazier and Brian Shepard first discussed the committee among themselves and with OPTN leadership. However, the nearly 40-year history of overwhelming national sentiment that donation service areas should not be a factor in determining organ allocation is well documented, and the Ad Hoc Committee on Geography was one facet of a long process leading to passage of organ allocation policies that complied with federal law. Alexandra Glazier and Brian Shepard were two individuals among hundreds of volunteers and community stakeholders who contributed, over the years, to ensuring the OPTN liver policy finally came to fruition; hundreds more continue to work tirelessly to promote transplantation for all Americans and ensure equitable policies continue to evolve.

To emphasize our point, we include here the HHS Secretary’s Advisory Committee on Organ Transplantation (ACOT)’s unanimous recommendation in 2010 to address the issue of eliminating geographic inequity and released the following directive:

“The Advisory Committee on Organ Transplantation (ACOT) met on August 19–20, 2010, in Bethesda, MD, and unanimously agreed on the following recommendation:”

“Recommendation 51: The ACOT recommends that the Secretary take steps to ensure the OPTN develops evidence-based allocation policies which are not determined by arbitrary administrative boundaries such as OPO service areas, OPTN regions and state boundaries.”

“Background: At the August 20, 2010, ACOT meeting, review of liver and kidney transplant allocation statistics in the U.S. once again demonstrates persistent geographic disparities in patient access to transplantation. ACOT believes that the current status does not comply with the intent of the Organ Procurement and Transplantation Network (OPTN) Final Rule. ACOT acknowledges that the OPTN has made efforts to revise the liver allocation policy to achieve broader geographic distribution of deceased donor livers with the goal of reducing mortality on the waitlist and equalizing access to transplantation for individuals most urgently in need of transplantation. The OPTN must seek to minimize inequities due to arbitrary geographic barriers to distribution.”

13. The Markup

Alexandra Glazier, who had publicly advocated for broader sharing, was on the geography committee. It was led by a previous colleague of hers, Kevin O’Connor. And Lewis Teperman, who was quoted as a spokesperson for CODE, which advocated for broader sharing, was also on the committee. The committee ultimately proposed a framework that recommended broader sharing for all organs. Why were these particular members chosen for the committee? What was the criteria for choosing the committee members? Who made the choices for the committee criteria and selection?

UNOS

Leaving aside the fact that sharing organs as broadly as medically possible with the sickest patients is not only ethical but required by law, the Ad Hoc Geography Committee was formed to determine principles of incorporating geographic distance into allocation for a transparent, consistent framework to apply to all organ types. It wasn’t formed to decide if organs should be distributed more broadly. Therefore, regardless of members’ opinions on the subject of broader sharing, this Committee was focused specifically on developing principles for a distribution framework.

Specifically, the OPTN Final Rule at section 121.8, states:

• (b) Allocation performance goals. Allocation policies shall be designed to achieve equitable allocation of organs among patients consistent with paragraph (a) of this section through the following performance goals:

• (3): Distributing organs over as broad a geographic area as feasible under paragraphs (a)(1)-(5) of this section, and in order of decreasing medical urgency;

As for the criteria for choosing members of the geography committee and all OPTN committees, several were considered, such as ensuring that fair representation was present in terms of subject matter expertise and member roles from existing OPTN Committee leadership. Ultimately, the OPTN Board President (who is elected by the OPTN membership) approved the creation of the committee and its membership.

The Ad Hoc Geography Committee carried out its duties per its charge:

• Establish defined guiding principles for the use of geographic constraints in organ allocation
• Review and recommend frameworks/models for incorporating geographic principles into allocation policies
• Identify uniform concepts for organ specific allocation policies in light of the requirements of the OPTN Final Rule

The OPTN Board overwhelmingly approved these recommendations.

14. The Markup

The policy has brought more organs to LiveOnNY’s and OneLegacy’s donation areas, two organ procurement organizations that are currently ranked in the lowest performance tier by CMS – tier 3 – for their low donor numbers. LiveOnNY was twice threatened with decertification within the last decade. Critics say that it is unfair to change a policy that benefits organizations that have not been up to par.

UNOS

Nationwide organ allocation policies are not designed nor are they intended to benefit or harm any particular state, geographic area, or organization. Allocation policies are designed solely to increase the number of lives saved through organ transplants as equitably as possible, per the OPTN Final Rule. To do otherwise would be contrary to the law, but more importantly would also endanger patients based on where they reside.

Furthermore, the geographic distribution of livers to transplant hospitals that are located within a particular organ procurement organization’s (OPO) donation service area (DSA) is unrelated to the measurement of OPO performance. Conflating the two is a misinterpretation of how the system works.

OPO performance is primarily measured by each OPO’s donor numbers within its DSA; and is not impacted by the number of transplants performed by transplant hospitals within their DSA boundaries.

15. The Markup

Could you clarify if you mean that an OPO’s performance at procuring organs shouldn’t affect its patients locally?

UNOS

Removing arbitrary geographic boundaries (such as OPO boundaries) increases patients’ ability to access organs from anywhere in the country and increases every OPO’s ability to allocate organs to the most appropriate medically suitable candidate – regardless of location. So, in fact, the new allocation policies for all organs will likely benefit OPOs’ performance, giving them more opportunities to place the organs they recover with the patients best suited to them. OPO success is measured by the number of organs an OPO recovers within its DSA and successfully places for transplant, regardless of where the transplants themselves take place. OPOs are not measured by the number of transplants that take place within their DSAs.

16. The Markup

How does UNOS react to reports of LiveOnNY’s performance?

UNOS

The OPTN has limited oversight of OPOs and we will not comment on the performance of individual OPTN members. Primary oversight of OPOs rests with CMS and LiveOnNY’s history with CMS is well-documented.

17. The Markup

In an email that is part of the public record in a 2019 Georgia court filing, Alexandra Glazier, who advocated for broader sharing, called people living in states with long transplant waiting lists “dumb fucks” in an email to UNOS’ then-CEO Brian Shepard. If you would like to add context or explain that statement, please do.

UNOS

Ms. Glazier has acknowledged that her choice of words in that private email were unfortunate and has clarified she was referring to surgeons in states with shorter wait times for liver transplant who were nonetheless advocating for “local” distribution of organs. A cursory reading of the full statement and the entire email chain clearly shows an OPO leader extremely frustrated by efforts to manipulate organ allocation to mask larger issues of access to healthcare in states that do a poor job of providing health insurance coverage to disadvantaged populations.

A fair and unbiased reading of this exchange clearly indicates that it is focused on access to healthcare, which varies widely by state — patient access to be waitlisted for organ transplantation is no exception.

The email exchange is part of unsealed filings with the U.S. District Court for the Northern District of Georgia in Callahan v. U.S. Dept. of Health and Human Serv. Et al., Case No. 1:19-CV-1783-AT.

While we do not speak for Ms. Glazier, it appears plainly that her primary point is stated in her draft letter to a peer reviewed journal within the email string: “Utilizing organ allocation as a tool to address social inequities, as serious and significant as they are, is not only ethically inappropriate and bad public policy, but also contrary to federal law.”

18. The Markup

UNOS and HHS declined to follow the suggestion of a committee of liver experts who recommended two other more moderate plans – the B2C plan, as well as the 2017 plan that sought to widen initial distribution to 150 nautical miles around a hospital. The latter plan took five years to develop and was passed by UNOS’ board in December 2017. Why did UNOS reject one of which took five years to develop and was signed off on by UNOS’ board in December 2017?

UNOS

To be clear, the OPTN Board of Directors – not HHS or UNOS – is charged by law with approving OPTN allocation policies.

Importantly, the approved but not implemented December 2017 liver policy included the use of donation service areas (DSAs) and OPTN regions as units of allocation. Prior to implementation, HRSA determined that DSAs could not be justified as units of allocation for organs and directed the OPTN not to implement the December 2017 policy. Instead, per the OPTN Final Rule, HRSA directed the OPTN to develop a new policy proposal that did not incorporate DSAs as a unit of distribution for the OPTN Board to approve in 2018. The OPTN complied with that direction.

In response, throughout the summer and fall of 2018, the OPTN Liver Committee developed two liver allocation proposals: the Acuity Circles proposal, and the Broader 2 Circles (B2C) Proposal. Following a comment period where both proposals were offered for public comments, the Liver Committee narrowly (by two votes) recommended its Broader 2 Circle (B2C) proposal for the OPTN Board of Directors to consider. After reviewing both the B2C and Acuity Circles allocation models, the OPTN Board of Directors overwhelmingly approved the Acuity Circles proposal in a vote of 30-7.

The suggestion that the 42 members of the OPTN Board of Directors must “rubber-stamp” a proposal that the Liver Committee narrowly approved by 2 votes appears to adopt the narrative advanced by the plaintiffs in the Callahan litigation, but reflects neither the law nor sound governance.

19. The Markup

In a June 2018 email included in the 2018 Georgia lawsuit, former UNOS CEO Brian Shepard wrote to Sue Dunn, Yolanda Becker, Stuart Sweet, Alexandra Glazier, and Maryl Johnson about the liver committee moving toward a broader sharing policy. The committee members “didn’t complain about lawyers and judges (much),” he said, but one committee member “hit every talking point. Almost like he was coached.” Sweet said that was because of “the detailed email I sent him and the follow-up conversation we had,” which “probably falls in the ‘coaching’ category.” Becker, who was president of the OPTN at the time, said “Good job coach!!” in response. Please explain why current and former board members were “coaching” the liver committee toward broader sharing. Is it UNOS/OPTN policy for current and former board members to impress upon committee members a particular point of view during policymaking? Please provide the email that Sweet sent to Will Chapman, who he “coached.” Please provide a response to these emails.

UNOS

OPTN leadership is always ready, willing and able to help Board or Committee volunteers in their development of policy when requested. The background information or suggested responses to likely questions are always provided upon request. This may include information on subject matter (law, regulation, data, etc.) not familiar to the volunteer, or recommendations on information to bring up in the course of a complex discussion.

As to your specific question, OPTN leadership was steeped in knowledge about the OPTN Final Rule and OPTN’s directives from HHS to create a more equitable allocation system that was driven by patient need and not by geography. That Stuart Sweet was able to provide a detailed email about the policy and that Yolanda Becker would jokingly say, “Good job coach!” is in no way unusual.

20. The Markup

In February 2022, OPTN Region 3 called for a vote of no confidence for UNOS’ then-CEO Brian Shepard and for Alexandra Glazier to be removed from her position after the email above and others were released. Shepard said at the meeting that the Georgia judge had read all of the emails and “ruled the policy could take effect.” The OPTN board voted that Shepard and others followed the policymaking process and that neither Glazier nor others “had improper motives or influence in the collective process.” How did the OPTN board determine these conclusions? What, if any, impact did this have on Shepard’s September 2022 departure?

UNOS

The UNOS Board of Directors considered materials provided by a few members from Region 3 and overwhelmingly determined that Ms. Glazier and Mr. Shepard appropriately supported the OPTN and compliance with the OPTN Final Rule.

This had no impact on Brian Shepard’s departure from the organization.