Evaluation of CMS's New Performance Framework for OPOs
The Centers for Medicare & Medicaid Services (CMS) is evaluating the future certification and service territories of organ procurement organizations (OPOs) under a controversial new performance framework. As CMS moves towards its 2026 Proposed Rule, supported by a 2020 regulation, OPOs are challenging these measures in court. Specifically, the U.S. District Court for the Middle District of Florida is deliberating whether it has jurisdiction over a pre-enforcement lawsuit against CMS's 2020 Final Rule, which introduced a competitive, tier-based performance structure. This system places lower-performing OPOs at risk of losing both their designated service areas (DSAs) and their Medicare certifications.
Under the regulation implemented in 2022, OPOs undergo evaluation over a four-year certification period set to conclude this year. The results will determine their eligibility for Medicare reimbursement and their ability to maintain DSAs for the upcoming cycle. Critics within the organ transplant community argue that the rule introduces substantial operational risks, seeking to impede its application during CMS’s upcoming recertification reviews.
In the ongoing Florida lawsuit, CMS contends the court lacks jurisdiction because claims should first undergo the Medicare statute's administrative review. In contrast, plaintiffs argue the case is rooted in the National Organ Transplant Act (NOTA) rather than the Medicare statute, contending the administrative process is inadequate for broad regulatory challenges. They emphasize that Tier 2 OPOs, meeting participation conditions, must still compete for DSAs without a direct appeal path if unsuccessful.
The court has yet to decide, seeking further insight and evaluating whether it can examine the issue without halting reviews entirely, as covered by a U.S. Supreme Court precedent. Both parties have been asked to provide additional information by May 20, 2026. CMS has responded, clarifying that the 2020 rule does not specifically address the raised court inquiries. CMS referenced its January 2026 Proposed Rule, indicating that Tier 2 OPOs would be re-certified even without a DSA. However, failure by 2030 would result in decertification, subject to appeal. CMS also suggested that Tier 3 OPOs could advocate for Tier 2 concerns during appeals.
Plaintiffs, however, cited a recent U.S. Court of Appeals for the Second Circuit decision, asserting their claims originate from NOTA, distinct from Medicare. They dispute CMS's assertion that Tier 3 OPOs can adequately represent Tier 2 interests. The court's decision on jurisdiction will significantly impact whether the case progresses on substantive grounds. A ruling favoring CMS could prevent OPOs from legally opposing CMS actions before certification and decertification. Conversely, allowing the lawsuit to advance would enable OPOs to seek judicial relief before CMS's certification decisions take effect.
This case remains uncertain, with significant implications for Tier 2 OPOs and the broader transplant system. The court is navigating complex regulatory interpretations and the gaps between CMS’s rule and its preamble guidance. Beyond this case, OPOs face increased regulatory scrutiny from CMS focused on performance measures and patient safety, further emphasizing the evolving landscape of regulatory oversight affecting their operations.