SID&T RESPONDS TO HOUSE OVERSIGHT COMMITTEE CHAIRMAN’S LETTER TO HHS/CMS

“Dear Secretary Becerra and Administrator Brooks-LaSure:

The Committee on Oversight and Accountability is conducting oversight of regulations governing our nation’s organ procurement organizations (OPOs). As you know, in 2020 the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule titled, Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations (Final Rule). The Committee seeks your assistance in understanding why, four years later, CMS has still not issued necessary guidance regarding competition and decertification around the Final Rule. CMS’ inaction has created lack of clarity, increased uncertainty for Americans who need a transplant, and threatens to erode accountability for OPOs.”

SCIENCE IN DONATION AND TRANSPLANT’S RESPONSE:

• Science in Donation & Transplant praises Chairman Comer for taking CMS to task for its failures regarding the RULE governing donation and transplant. Still, we strongly desire the Committee to have the facts regarding the Rule.

• No one wants to protect failing healthcare institutions, but patients deserve those organizations' performances to be judged based on peer-reviewed science, not special interest scheming.

• Sadly, CMS is incapable of responding, as years of independent research have shown that its Tier system for evaluating Organ Procurement Organizations is fatally flawed and unworkable.

Everyone wants to save every possible life. However, the undeniable scientific and common-sense facts show that CMS has yet to learn which OPOs perform well because of their faulty premises, leading to negative headlines about donations and transplants based on falsehoods.

• Chairman Comer, the patients awaiting donations, the donor families, and the OPO staff tasked with approaching potential donors all need you to help review the facts and reach the proper solution.

• In 2022, The National Academies of Sciences, Engineering, and Medicine (NASEM) completed a congressionally authorized [1] and funded landmark report entitled Realizing the Promise of Equity in the Organ Transplantation System [2] that provides critical recommendations to instill accountability, increase equity, and improve outcomes throughout America’s organ donation ecosystem. This crucial research deserves House Oversight’s full attention as it provides clear, actionable recommendations for federal policymakers and represents the National Academies' evidence-based, peer-reviewed consensus position

• Legislation is needed to direct CMS to incorporate the NASEM recommendations, allowing a responsible evaluation of the metrics and performance standards for Organ Procurement Organizations and transplant hospitals/centers.

• The well-meaning efforts to improve the world’s leading organ donation and transplant system were co-opted by special interests interested not in enhancing the OPO system but in taking it over based on sponsored-content faulty science those interests funded. That so-called science was the basis for CMS’ faulty RULE and subsequent House and Senate hearings that, unfortunately, have had the opposite effect of Congress’ initial intent.

• For example, the RULE specifically ignored Congress's will regarding using death certificate data [3].

• In October 2023, 44 bipartisan members of Congress wrote CMS asking a series of questions concerning the RULE implementation, which, unsurprisingly, was virtually ignored.