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Congressional Letter to CMS

On November 2, 2023, 44 bi-partisan members of Congress took the first positive step forward in organ donation and transplant reform since CMS adopted its flawed governing RULE. We applaud Congresswomen Miller-Meeks and Schrier for leading this vital public health question, as many experts in the field (a leading array of which you can hear on this site) and the landmark NASEM study have decisively articulated that the RULE contains serious flaws. These include the illogical performance metrics, relying on old data, and the potential chaos ensuing in 2026 from shuttering 40% of the OPOs based on flawed premises. Let this be the start of a genuine reform discussion.

 

Dear Administrator Brooks-LaSure:

We write today regarding the Centers for Medicare & Medicaid Services (CMS) final rule, titled, “Medicare and Medicaid Programs: Organ Procurement Organizations (OPO) Conditions for Coverage: Revisions to the Outcome Measures Requirements for Organ Procurement Organizations; Final Rule,” (OPO Final Rule).

OPOs are organizations responsible for evaluating and procuring organs for transplant from deceased donors. The rule revised the method by which CMS measures the performance of OPOs for recertification purposes. Effective for the 2026 recertification cycle, OPOs will be measured every year on their relative performance on two outcome measures – (1) Donation Rates – the number of organs from the donation service area (DSA) that are donated as a percentage of potential donors; and (2) Transplantation Rates – the number of organs from the DSA that are transplanted as a percentage of potential donors.

The Final Rule is complex, and accordingly, there are numerous unanswered questions regarding how this process will work relating to the ground rules for competition, the process that will be followed for OPOs that want to acquire decertified OPOs, and how to engage in proactive mergers. CMS must implement the OPO Final Rule effectively, without weakening standards to protect patients and without delay.

Notably, this process is entering a high level of activity as the decertification of OPOs in 2026 is based on calendar year (CY) 2024 performance, and OPOs are still without guidance from CMS regarding the details of how the OPO recertification and competition processes will be administered.

We ask that CMS immediately prioritize this issue and provide comprehensive guidance regarding implementing the final rule. We respectfully request answers to the following questions:

  1. Is CMS considering policies to help ensure successful transitions so that high-performing OPOs serve all patients?

  2. If no OPO seeks to assume the operations of a decertified OPO’s DSA, how will CMS decide which higher-performing OPO to assign that DSA? Conversely, how will CMS determine which of several high-performing OPOs interested in taking over a newly opened DSA will be selected?

  3. After a winning OPO candidate is selected, how long will the OPO have to take over operations in the DSA of the decertified OPO? Will there be a defined transition period?

  4. Will there be a specific timeframe within the decertification cycle when mergers can or must occur?

  5. If a merger occurs during or after the reporting year, will the OPOs and the DSAs be evaluated separately or jointly for recertification?

  6. Suppose a single OPO manages multiple DSAs, and one falls into Tier 2 or 3. Will this negatively impact the OPO's ability to maintain its other existing DSAs or take on new DSAs in the future?

  7. Will CMS consider offering time-limited protections to permit OPOs that take over another DSA enough time to get improvements in place without jeopardizing the higher-tier work that is taking place in their OPO?

We appreciate you taking the time to look into this request. Sincerely,

Congressperson Mariannette Miller-Meeks, M.D., Congressperson Kim Schrier, M.D., Congressperson Dan Crenshaw, Congressperson Ami Bera, M.D., Congressperson Larry Bucshon, M.D., Congressperson David Rouzer, Congressperson Bill Johnson, Congressperson Donald G. Davis, Congressperson Mark Pocan, Congressperson Earl L. "Buddy" Carter, Congressperson Robert E. Latta, Congressperson Russ Fulcher, Congressperson Donald Norcross, Congressperson Don Bacon, Congressperson Jefferson Van Drew, Congressperson Donald M. Payne, Jr., Congressperson Diana Harshbarger, Congressperson Suzan K. DelBene, Congressperson Nicholas A. Langworthy, Congressperson Dean Phillips, Congressperson Bill Pascrell, Jr., Congressperson Thomas H. Kean, Jr., Congressperson Mike Carey, Congressperson Brian Fitzpatrick, Congressperson Susan Wild, Congressperson Michael C. Burgess, M.D., Congressperson Debie Dingell, Congressperson Vern Buchanan, Congressperson Pete Stauber, Congressperson Bonnie Watson Coleman, Congressperson Angie Craig, Congressperson Josh Gottheimer, Congressperson Jen A. Kiggans, Congressperson Gregory F. Murphy, M.D., Congressperson John Rose, Congressperson Davd J. Trone, Congressperson A. Drew Ferguson IV, Congressperson Carol D. Miller, Congressperson Daniel T. Kildee, Congressperson Ronny L. Jackson, M.D., Congressperson Mary Sattler Peltola, Congressperson Michael Guest, Congressperson Monica De La Cruz, and Congressperson Brad R. Wenstrup, D.P.M.