Section V: CMS Requested Comments

The following addresses the areas where CMS requested comments on the Final Rule.

Performance Accountability

True performance accountability requires measuring the right organizations on the right outcomes. CMS currently tiers OPOs based in part on transplant results they do not control, while HRSA continues to overlook significant and well-documented disparities in how transplant centers accept and use available organs. Holding OPOs accountable for outcomes outside their authority, while failing to hold transplant centers accountable for outcomes within theirs, is not accountability. It is a misdirection, and it has consequences: inaccurate rankings, erosion of public trust, and federal litigation that now threatens to remove CMS's oversight authority entirely.

What is needed is not a punitive or adversarial approach. Instead, federal oversight should encourage collaboration, innovation, and shared accountability. CMS should measure outcomes that matter, reward real gains, and give organizations the tools to improve. As SID&T Advisory Board members have written, the rule should set clear standards based on proven steps: growing donor designation, improving organ recovery, strengthening OPO and transplant hospital teamwork, and ensuring fast and safe organ transportation. These steps are evidence-based, teachable, and trackable. They drive improvement rather than punishment and respect real differences among communities and hospitals.

Unsound Medical Practices and Media Misinformation

CMS proposes adding "unsound medical practices" as a basis for urgent decertification without providing a formal definition of the term. Using undefined language as the trigger for one of the most consequential regulatory actions available to CMS is neither fair nor legally sound. Before this provision moves forward, CMS must define the term with precision and establish clear, evidence-based criteria for its application.

This matters especially now, because a wave of sensationalized media coverage has promoted the false narrative that OPOs remove organs before patients have died. That claim is factually wrong and legally impossible under current federal law. The Uniform Anatomical Gift Act, adopted by all fifty states and the District of Columbia, explicitly prohibits OPOs from any involvement in the declaration of death or in any medical treatment of a patient. OPO recovery teams do not touch a donor until a hospital physician has independently declared death. A mandatory waiting period follows that declaration. If a physician's declaration is premature, OPO personnel can identify and report it, as has occurred, but they cannot cause it to be premature, and OPOs have no authority over the transfer of a living patient to the operating room.

Organ transplantation leaders writing in Undark (Jedediah Lewis, Hedi Aguiar, And Adam Schiavi, “Misinformation About the End of Life Is Harming Organ Donation,” Undark, October 23, 2025, https://undark.org/2025/10/23/opinion-misinformation-organ-donation/) stated that the media coverage has confused fundamental issues, noting that the alleged errors would have occurred regardless of whether the patient was a registered donor, because they involved physician decisions about withdrawing life-sustaining treatment, not the organ donation process itself.

The consequences of this misinformation are measurable. Thousands of Americans removed themselves from donor registries in 2025, directly harming patients who depend on the system. HHS and CMS have a responsibility to correct the public record, not remain silent while false narratives erode decades of public trust.

SID&T applauds HHS's requirement that OPOs appoint patient safety officers to monitor and conduct real-time root cause analyses of safety events. That is a meaningful step. But safeguards have always been central to this system. The priorities must remain safety and science, not sensationalism.

When an OPO receives a 2 a.m. call from a hospital about a potential donor, the OPO team is looking out for patients, exploring every viable way to turn tragedy into a lifesaving gift. That is the reality of what OPOs do. Federal oversight should reflect that same spirit: one of collaboration, trust, and a shared commitment to saving lives. The current sensationalist and inaccurate media narrative, met with silence from CMS, has undermined that spirit and damaged the public trust that underpins the entire system.

Requirements for Certification

What CMS describes as administrative refinements to OPO certification requirements are, in substance, a significant reinterpretation of statutory authority. CMS has reassessed its historical reading of the OPO Certification Act of 2000 and now concludes that nothing in the Public Health Service Act limits the Secretary to recertifying only pre-2000 OPOs. CMS grounds this position in statutory text, legislative history, and recent Supreme Court precedent.

SID&T does not oppose competition or innovation. But this reinterpretation deserves serious scrutiny. Opening the door to new OPO certification while the existing metric cannot accurately evaluate the performance of current OPOs is premature at best and dangerous at worst. Certifying new entrants into a system governed by a flawed and legally contested oversight framework does not enhance competition. It compounds an already unstable situation.

CMS frames this proposal as a response to concerns about market consolidation. That framing sidesteps the more fundamental question: if the current metric cannot reliably measure who is performing well and who is not, on what basis would CMS evaluate any new OPO, or justify displacing an existing one?

Any pathway to new OPO certification must be built on a scientifically sound and legally defensible performance framework. That framework does not yet exist.

CMS should also establish a second path to compliance through national accreditation by independent experts, modeled on how hospitals are reviewed today. CMS already uses independent professional survey and accrediting bodies for hospital oversight. The same tools can and should be applied to organ procurement organizations. This would create meaningful accountability without forcing every region into the same regulatory mold, and it would align OPO oversight with the professional standards model that has served hospital oversight well for decades.

Appeal Rights

CMS proposes revisions that would distinguish non-renewal of an OPO agreement from decertification, limit the appeal rights of Tier 2 OPOs that lose competitions, and adjust notice requirements across the tiered recertification system. SID&T urges CMS to carefully reconsider these proposals, as they raise serious legal and procedural concerns that go beyond administrative refinement.

The foundation of this concern is straightforward. CMS has long maintained an ambiguous characterization of its relationship with OPOs, describing them as neither traditional providers nor suppliers. But the operational reality is unambiguous. CMS requires OPOs to submit cost reports, subjects them to adjudication of kidney reimbursement rates, and mandates specific overhead allocation to kidney recovery costs. These are the defining characteristics of a provider relationship, not a supplier relationship.

Suppliers operate under fee-for-service contractual arrangements and do not require cost reports. CMS routinely extends full appeal rights to providers under its agreements and regulations. To strip those rights from Tier 2 OPOs that lose a competition is to treat them as suppliers while continuing to impose provider-level obligations on them. That is legally inconsistent and fundamentally unfair.

There is no basis in federal law or regulation for this conversion. If CMS intends to eliminate appeal rights for Tier 2 OPOs, it must first relinquish the cost report requirement and all associated provider-level obligations. It cannot maintain the burdens of a provider relationship while removing its protections.

Allocation Out of Sequence

The United States leads the world in organ donation and transplantation by nearly every measure. Yet it also has the highest rate of recovered organ non-use in the developed world. Nearly 10,000 transplantable organs went unused last year. Understanding why requires context that the current federal oversight framework has failed to provide.

The rise in recovered organ non-use must be understood in its proper context. It is in significant part a response to the dramatic expansion of the donor pool, as OPOs now recover organs from older and more medically complex donors, and as donation after circulatory death has risen to surpass brain death as the primary pathway to donation. These are organs that would never have been recovered a decade ago. The system is succeeding in procurement in ways previously impossible.

The challenge now is to ensure that transplant centers are equipped, incentivized, and accountable for effectively using these more complex organs. Non-use in this context is not a failure of the donation system. It is a consequence of its success, and it demands a different kind of response than the one currently being pursued.

The current debate over Allocation Out of Sequence frames the issue as a choice between equity and utility. That framing is false and counterproductive. Equity and utility are not competing values in organ allocation. They are complementary goals that a well-designed system should pursue simultaneously. HHS, CMS, HRSA, OPTN, OPOs, and transplant centers must operate as a unified system with aligned metrics and shared accountability, not as competing interests pulling in opposite directions.

OPTN has asserted that allocating outside its defined match run does not reduce organ non-use and that higher rates of allocation out of sequence correlate with higher non-use rates. SID&T disputes this conclusion. No peer-reviewed study or randomized trial supports it. The assertion appears to rationalize a system that consistently underperforms on utilization while deflecting scrutiny from the transplant center practices that are a primary driver of organ non-use.

The Accelerated Kidney Placement program illustrates this failure clearly. Acceleration was introduced only after organs had already been declined by multiple transplant programs locally and regionally. By that point in the process, meaningful improvement in utilization was unlikely. The intervention came too late, and the removal of the functional Donor Service Area structure created new barriers to placing hard-to-use organs, ironically worsening the equity outcomes the program was designed to improve.

The deeper problem is the transplant center's behavior and incentive structure. Transplant centers are currently evaluated primarily on one-year survival rates, which creates a rational but system-damaging incentive to decline marginal organs rather than accept them. The Scientific Registry of Transplant Recipients documents wide performance variation among transplant centers, yet that variation receives far less regulatory scrutiny than OPO performance. This misalignment between what is measured on the donation side and on the transplant side is at the heart of the non-use problem. Metrics must work together, not in opposition.

Our donation and transplant system was established in 1984. It has not fully adapted to more than 40 years of medical advancement that now allow OPOs to recover far more challenging yet viable organs than were possible in earlier decades.

The true challenge belongs to transplant centers, which must develop the capacity, transparency, and accountability to use these organs effectively. Hard-to-place organs that can and do save lives every day must be directed toward centers most likely to use them. That has never been adequately incorporated into allocation policy, and it must be now.

HRSA has gone so far as to suppress taxpayer-funded independent research that challenges its allocation conclusions. That is not an oversight. It is the suppression of the science on which oversight depends, and it is precisely the kind of transparency failure that makes system-wide alignment impossible.

Outright censorship took place at the 2024 American Transplant Conference in Philadelphia. The Scientific Registry of Transplant Recipients (SRTR), under federal contract to provide statistical and analytical support for the development of US organ and transplant policy, was scheduled to present two peer-reviewed papers. The abstracts for those papers were attached to the digital agenda for the meeting, which all participants received and downloaded.

https://sidandt.org/news/vital-news-updates/hrsa-continues-its-heavy-hand-of-censorship?rq=censorship

The papers were entitled “Are the New CMS Performance Tiers Biased against Larger OPOs?” and “Reducing Bias against Larger Organ Procurement Organizations in Performance Evaluations,” both authored by G. Lyden et al. The first paper used 100,000 statistical simulations to prove that “the CMS evaluation system as currently defined is biased against larger OPOs, with smaller OPOs having a higher probability of being automatically recertified or being able to compete for renewal of their contracts.” The second paper proposed a solution to the identified statistical bias: An “alternative tiering system” based on Observed-to-Expected rate ratios. This study ran 30,000 simulations to conclude that O-to-E method removed the bias while continuing “to detect underperforming OPOs.”

Just hours before the planned presentations, HRSA cancelled them and removed both papers from the agenda. Dr. Suma Nair, HRSA’s Associate Administrator for the Health Systems Bureau, explained to attendees that the decision was made because “We want to refrain from publicly questioning the Final Rule.” The episode is discussed in depth in The American Journal of Transplantation in its January 2025 issue (Jesse D. Schold, Timothy L. Pruett, Elizabeth A. Pomfret, Ty B. Dunn, “The Dangerous Precedent Of Censoring Scientific Dissemination,” AJT, January 2025 https://www.amjtransplant.org/article/S1600-6135(24)00555-0/fulltext).

What is called for is better alignment, increased transparency, and best-practice communication between OPOs and transplant centers. A dynamic allocation model that incorporates transplant center behavior and organ non-use patterns is essential. When the donation side and the transplant side are measured by metrics that work together toward shared goals, equity and utility both improve. That is the standard federal oversight should aim for.

Appeals of Adverse Actions

The decision to limit appeal rights for OPOs facing decertification cannot be separated from a more fundamental question: if the metric driving those decertifications is scientifically unsound, stripping appeal rights does not protect the system. It protects the metric.

A January 2026 study published in Transplantation by Dr. James R. Rodrigue and colleagues adds to a growing body of peer-reviewed evidence demonstrating that the CMS OPO performance metric is fundamentally flawed. Most critically, the research shows that the CMS metric measures demographics, not performance, penalizing OPOs based on the communities they serve rather than the quality of their work.

The Metric Penalizes the Wrong Communities

Rodrigue and colleagues also found that OPOs serving racially and ethnically diverse populations are far more likely to be placed in lower performance tiers, not because of poor performance, but because CMS relies on unadjusted death certificate data that ignores social determinants of health. Communities already facing the greatest barriers to healthcare access are therefore at the greatest risk of losing their local donation infrastructure. This is precisely the outcome the Congressionally mandated NASEM report warned against, calling for system-wide aligned metrics rather than isolated punishment of OPOs serving underserved populations.

High-Performing OPOs Will Be Misclassified

The Rodrigue study confirms what multiple prior studies have shown. The CMS Final Rule misclassified capable, high-performing OPOs as failing because it relies on data that does not accurately identify true donor potential, does not account for hospital referral patterns or structural inequities, and confuses data limitations with organizational failure. Organizations with strong hospital relationships, effective donor family support, and solid donation outcomes are at risk of decertification, not because of what they have done, but because of where they operate and who they serve.

Disruption Without a Plan

CMS has offered no guidance for how donation services will be maintained if OPOs are shut down across large geographic regions. There is no plan for continuity of donor family support, no strategy for maintaining hospital relationships built over decades, and no framework for preventing donation slowdowns or organ loss during transitions. The current rule sets the stage for disputes, appeals, and court fights rather than steady progress, and it punishes differences without distinguishing harmful variation from healthy adaptation to local needs.

Abrupt decertification without a transition strategy does not strengthen the system. It destabilizes it at precisely the moment when donor families and transplant candidates need it most.

Bad Data Yields Bad Results

OPO performance should be evaluated using clinically meaningful measures such as ventilated hospital deaths and organ yield, not raw death certificate data that was never designed to identify eligible donors. The gold standard, Actual Donors divided by Hospital-Referred Donor Potential, is now technically feasible and verifiable. CMS has no scientific justification for continuing to rely on a proxy measure that 23 independent peer-reviewed studies have found to be inaccurate, unstable, and inequitable.

Using the wrong data produces the wrong results. And in organ donation, the wrong results cost lives.

SID&T supports reform grounded in science, transparency, and best practices. The full body of peer-reviewed research and the recommendations of the Congressionally mandated NASEM report point clearly toward a better path. Real reform measures performance accurately, accounts for community context, supports organizations in improving, and protects patients and donor families who depend on a stable, trustworthy system.

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