By James W. Lytle and Abe Sutton
Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.
While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.
Background on the proposed rule
The goal of the regulation is to improve the performance of OPOs, which have been the subject of recent exposés and editorials focusing on concerns such as bloated administrative costs, drastically disparate rates of obtaining donations from potential donors, and even instances of organs getting lost in transit.
The New York Times recently editorialized that “an astounding lack of accountability and oversight in the nation’s creaking, monopolistic organ transplant system is allowing hundreds of thousands of potential organ donations to fall through the cracks.”
Referencing the 33 Americans who die every day awaiting a transplant, a Washington Post editorial this summer noted that “Much of this death and waiting is unnecessary, because the organs would be available if those responsible for collecting and transporting organs did a better job. It is past time the government demanded it of them.”
Attempts by the federal government to utilize existing regulatory standards to decertify some OPOs whose performance was particularly deficient have, thus far, been unsuccessful. Both Democratic and Republican members of Congress have demanded reform.
The purpose of the regulation, first proposed in December, 2019, was to improve the performance of OPOs as one means to reduce the yawning gap between those who await transplants and those who actually receive them.
The proposed regulation would, among other provisions, establish new objective measures for evaluating OPO performance, including a “donation rate” (measured by calculating the percentage that actual donors comprise of the “donor potential,” which equals the total deaths of people under 75 in the region with a cause of death, as evidenced on the death certificate, that doesn’t rule out organ donation — and a “transplantation rate” [i.e., the number of organs actually transplanted as a percentage of the above-referenced “donor potential”]).
The recertification of OPOs every four-years would be contingent upon falling within a confidence interval of the donation and transplantation rates of the top quartile of OPOs, and OPOs would be subject to annual reviews to chart their progress and identify improvement areas.
Reactions to the proposed rule
Virtually no one disputes the need for improvement within the organ donation, procurement, and transplant system in the United States, and the regulation was generally praised by entities within the organ donor advocacy community and transplant professional associations.
A number of concerns over the impact of the proposed regulation were, however, raised by the Association of Organ Procurement Organizations (AOPO) and many of its members (the target of these new requirements). Among other things, the AOPO contended:
- The donation rate inappropriately relies on often inaccurate or incomplete death certificates;
- The donation rate should also include so-called “zero organ donors” (i.e., patients who were identified as potential donors and had their organs removed, but whose organ or organs were ultimately not transplanted);
- Outcome measures should be risk-adjusted to reflect the age, cause of death, and gender of the potential donors; and
- The enforcement of the new standards should be implemented more gradually, oversight should consider mitigating factors, and the decertification process should avoid destabilizing the organ procurement system.
In response to some of the advocacy in favor of the regulation, AOPO was less diplomatic and more direct, characterizing the proposed regulation as “radical changes proposed by the Trump Administration that will dismantle the U.S. organ donation system.”
Changes from the proposed rule
The final rule made a number of changes in response to comments.
Most significantly, it clarified that no decertifications would occur under the new measures until the 2026 recertification cycle. Advocates had hoped to see the measures implemented for the 2022 cycle, or alternatively that CMS would delay the 2022 cycle to 2024, at which point the measures would then apply. Expressing a desire to move slowly due to the uncertain effects of COVID-19 on organ donation and the transplantation system, CMS opted to first apply the measures in 2026.
OPOs also persuaded CMS to update the donor potential calculation to rely on a lower figure by only including individuals with a cause of death that is consistent with organ donation. This replaced the initial proposed calculation based on causes of death that were not an absolute contraindication to organ donation. The new definition did not significantly impact OPO performance rankings.
The final rule further explained how contracts for OPOs that are not performing within a confidence interval of the top quartile of OPOs will be evaluated, responding to concerns about instability. Organizations that perform within a confidence interval of the top 50% of OPOs would be allowed to compete to retain their contracts, though other bidders would also be welcome. Those OPOs that fall outside the specified range would not be recertified and would be unable to compete for their contracts. Only those OPOs that are within a confidence interval of the top quartile of OPOs would not face competition to renew their contracts.
In addition, the final rule adjusted how waiver hospitals would be treated, added an extraordinary circumstances exception, and adjusted the measure for the Hawaii OPO due to unique geographic limitations.
Reactions to the final rule
Advocates have reacted warmly to the final rule. Although there has been some concern expressed over the more gradual implementation of the new requirements. Greg Segal, co-founder of the advocacy group Organize, described the final rule to the Washington Post as “the first real hope that waiting list patients have had in a long time.” Rep. Katie Porter took to Twitter to celebrate the final rule, writing that the changes “will save thousands of lives.” John Arnold of Arnold Ventures referred to the final rule as “a great outcome.”
The reaction from the OPOs required to comply with the regulation has been more mixed. Diane Brockmeier, CEO of Mid-America Transplant, an OPO, kept her focus on patients, describing the regulation to the Washington Post as “a before-and-after moment” and praising how the final rule will “ensure that the best among us continue to earn the privilege and responsibility of serving patients.” Dr. David Mulligan, who leads a government contractor known as the United Network for Organ Sharing, criticized CMS for not offering “a plan for what happens if organ procurement organizations do not step forward” and predicted the “regulations will bring chaos.”
Future reform opportunities
How the OPO oversight regulations translate into enhanced access to transplants will be seen over time, as these new accountability measures are applied and reported over the next several years.
CMS can build on the progress made in this regulation by aligning reimbursement incentives with the new measures adopted in this regulation. The current cost-based reimbursement approach, through which OPOs are paid through transplant centers, does not sufficiently promote efficiency or align OPO incentives to maximize the number of transplants. Encouraging the merger or consolidation of OPOs should also be part of the transplant strategy: even OPO leaders acknowledge that a reimagined transplant system would have far fewer than 58 OPOs.
Improving OPO performance is not the only step that might be taken to improve the transplant system in the U.S. Transplant centers, donor hospitals, dialysis facilities, and organ donor registries are all part of the complex transplant system, and all can play their part in enhancing access to organ transplantation. More might be done to encourage living donation, and steps should be taken to eliminate persistent racial, ethnic and economic barriers to transplantation. The federal law governing organ transplantation was enacted in 1984, and the uniform state law governing anatomical gifts hasn’t been updated since 2006.
Additionally, the need for a centralized team within the United States Department of Health & Human Services (HHS) to pursue continual improvement in our organ and transplantation system has become apparent. These issues were overlooked for too long before the signing of the Advancing American Kidney Health executive order. HHS should establish a centralized Office of Organ Policy, with authority over the organ and transplant issues currently distributed between CMS and the Health Resources and Services Administration, which could help ensure that these regulations are simply the first steps toward improving the U.S. organ transplant system.