U.S. Senator Todd Young (R-Ind.) Tuesday joined a coalition of congressional leaders from the Senate Committee on Finance and the House Committee on Oversight and Reform to commend the finalizing of a rule to reform the organ procurement system in the United States. The rule was on hold following a freeze of regulatory actions and agency-wide review as part of the transition process. The letter also encouraged the Biden administration to explore additional ways to accelerate the accountability of organ procurement organizations (OPOs). The letter was sent to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure.
Senator Young has been working to reform the nation’s organ donation system dating back to his time in the U.S. House of Representatives when his friend, Marine Dave ‘Gunny’ McFarland from Jeffersonville, Indiana, died because his heart transplant never came. In July 2019, Senator Young introduced his legislation to bring greater oversight to OPOs and penned an op-ed outlining the need to act. In December 2019 during the Trump Administration, HHS announced proposed rules to adopt performance measures similar to Senator Young’s bill. Senator Young also sent letters to the HHS Office of Inspector General and to HHS Secretary Alex Azar seeking a comprehensive examination of the adequacy of the organ procurement and transplantation system in the United States. In November 2020, the HHS announced it finalized a proposed rule modeled after legislation introduced by Senator Young to bring greater accountability to the nation’s organ donation system and deliver more lifesaving organs to patients.
“This Final Rule marks a critical first step toward ensuring greater accountability of all 57 OPOs in the United States,” the members wrote. However, “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.”
The Final Rule takes long overdue steps to hold OPOs accountable, which marks critical progress towards improving the organ transplant system. 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.
According to data from HHS, this rule will save more than 7,000 lives every year. However, in its current form, the final rule would not provide for the decertification of failing OPOs until calendar year 2026. These reforms also have urgent implications for health equity, as failures of the current organ donation system disproportionately hurt patients of color.
The members pushed the administration to explore additional ways to accelerate the impact of the rule as quickly as possible. “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,” the members wrote. “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. 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.”
The full letter can be found here.
In addition to Senator Young, the letter was signed by Senate Finance Committee Chair Ron Wyden (D-Ore.); Senators Chuck Grassley (R-Iowa), Ben Cardin (D-Md.), Michael Bennet (D-Colo.), Joni Ernst (R-Iowa), and Jerry Moran (R-Kan.); House Committee on Oversight and Reform (COR) Chairwoman Carolyn B. Maloney (D-N.Y.) and Ranking Member James Comer (R-Ky.); House COR Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi (D-Ill.) and Ranking Member Michael Cloud (R-Texas); and House COR Member Congresswoman Katie Porter (D-Calif.).