WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today joined a coalition of Congressional leaders to commend the Biden Administration for finalizing a rule to reform the organ procurement system in the United States and encourage the administration to explore additional ways to accelerate the accountability of organ procurement organizations (OPOs).

“This Final Rule marks a critical first step toward ensuring greater accountability of all 57 OPOs in the United States,” the members wrote. “Since 2015, an average of more than 12,000 people have died each year while waiting for a transplant or were removed from the waiting list due to becoming too sick to undergo transplantation. According to data from the Department of Health and Human Services the changes made by the Final Rule will address systemic problems and have the potential to save more than 7,000 lives every year.”

The Final Rule takes long overdue steps to hold OPOs accountable, which marks critical progress towards improving the organ transplant system. The Government Accountability Office (GAO) found that the rule would “increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures” and increase competition for control of open organ donation service areas.

In its current form, the Final Rule would not provide for the decertification of failing OPOs until calendar year 2026.

In February 2020, Sen. Moran spoke on the Senate floor to raise concerns with the Department of Health and Human Services’ policy for national liver allocations that would make it more difficult for people in rural states to receive liver donations.

The full letter can be found HERE and below.

Dear Secretary Becerra and Administrator Brooks-LaSure:

We write today to applaud the Administration for proceeding with the Centers for Medicare & Medicaid Services’ (CMS) final rule entitled “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations” (“Final Rule”)  and to ask CMS to explore additional ways to accelerate the accountability of organ procurement organizations (OPOs). The COVID-19 pandemic is exacerbating the need for organs now and creating an urgent health equity issue, as communities of color are disproportionately impacted by the failures of the current organ donation system and the effects of COVID-19.

Reforming the U.S. transplant system is a bipartisan issue and we commend the Department for its recent implementation of this rule. Its enactment is the culmination of years of work by the Trump and Biden Administrations, with bipartisan support from both chambers of Congress, representing an unprecedented bipartisan effort.  The Final Rule takes long overdue steps to hold OPOs accountable, which marks critical progress towards improving the organ transplant system. However, in its current form, the Final Rule would not provide for the decertification of failing OPOs until calendar year 2026, even though CMS has published data since 2019 on which OPOs are underperforming, and quantified that thousands of lives are at stake each year.  We are concerned about this protracted timeline for enforcement of the Final rule, because the COVID-19 pandemic is exacerbating the need for transplants now. Therefore, we encourage CMS to consider ways to hold OPOs accountable during this interim timeframe. It is critical that with lives at stake and disproportionate impacts on communities of color, OPOs not be allowed to continue to fail until 2026.

In November 2020, a bipartisan group of Congressional offices endorsed CMS’s issuance of this rule, noting that its implementation could help save thousands of lives each year. In March of this year, a number of us also wrote a letter in strong support of this rule when its implementation was temporarily delayed in accordance with the Biden Administration’s “Regulatory Freeze Pending Review” (86 FR 7814).   At that time, we urged the Administration to proceed with the Final rule, citing the importance of reforming the standards to which OPOs are held accountable. On March 30, 2021, CMS enacted the Final rule, an action applauded by our offices.

This Final Rule marks a critical first step toward ensuring greater accountability of all 57 OPOs in the United States. Since 2015, an average of more than 12,000 people have died each year while waiting for a transplant or were removed from the waiting list due to becoming too sick to undergo transplantation.  According to data from the Department of Health and Human Services (HHS) the changes made by the Final Rule will address systemic problems and have the potential to save more than 7,000 lives every year.  GAO found that the revisions in the Final rule would “increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures” and increase competition for control of open organ donation service areas. Reforming these standards to which OPOs are held was an important first step in improving the organ transplant system, though failure cannot be allowed to continue given the human cost of unaccountable and underperforming OPOs. As Ben Jealous, past president of the NAACP, wrote in favor of urgent enforcement of OPO decertifications, “If we understand the problem and know the solution, to withhold its implementation is cruel and senseless.”

The need to act has only increased over the last 18 months. Some experts project a dramatic increase in the demand for transplants as a result of the COVID-19 pandemic because the virus can cause organ failure in survivors, particularly damage to the kidneys. Furthermore, transplants that were once a rarity, double lung transplants, are now becoming frequent transplant surgeries because COVID-19 survivors are often left with “destroyed” lungs, needing a new pair to survive. As the demand for more organs and the need for advanced transplants continues to evolve, the transplant system must be improved to meet the needs of all patients.

Furthermore, as we noted in our previous letter, these reforms have urgent health equity implications. The failures of the current organ donation system disproportionately hurt patients of color. Communities of color are much more likely to need lifesaving organ transplants, yet research shows that as a result of differential OPO performance and treatment of Black patients, they are much less likely to receive them than clinically similar white patients. As mentioned above, experts project a dramatically increased need for transplants as a result of COVID-19, which is likely to compound the disparities already experienced by minority populations. The reforms implemented in the Final Rule have important implications for improving health equity and should be considered an urgent step as the Administration continues to respond to COVID-19.

In light of this urgent need, we are concerned about the protracted timeline for enforcement of the OPO rule, which currently does not allow for the decertification of failing OPOs until calendar year 2026. The enforcement of this rule is imperative and COVID-19 makes its implementation that much more critical. We thank the administration for moving forward with this rule, and ask you to consider additional ways to accelerate its impact to put patients’ interests first, saves lives and reduce racial health disparities. Thank you for your attention to this important matter.

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