A coalition of non-profit organizations involved in organ procurement for transplantation is suing the U.S. Department of Health and Human Services. They argue that the department's new method for evaluating their operations violates federal law and could result in many providers losing their certification. Below is a summary of the litigation, as well as other resources.

Litigation Summary

The Centers for Medicare & Medicaid Services’ (CMS) OPO Rule that will decertify up to 75% of the nonprofit Organ Procurement Organizations (OPOs) supplying organs to transplant surgeons violates Congressional statute according to lawyers representing 7 OPOs. This rule will destabilize the nation’s organ donation system and harm waiting transplant patients if it is allowed to take effect, according to attorneys for suing CMS and the Department of Health and Human Services (HHS).

In a motion for Summary Judgement in LifeLink Foundation et al. v. HHS and CMS (M.D. Fla., Case No. 8:25-cv-02042), seven OPOs argue that CMS’ so-called Final Rule disregards Congress’ explicit directions in amending the law governing organ transplants as it pertains to OPO recertification.

The suit seeks to vacate the Final Rule and prevent CMS from enforcing it during future certification cycles because the rule exceeds statutory authority. Plaintiffs argue the agency’s approach turns a collaborative public-health network into a “Hunger Games–style competition” that could destabilize the national donation system and harm patients awaiting transplants. The plaintiffs seek relief from CMS’ unlawful “arbitrary and capricious decision-making” and from its knowing reliance on error-prone and unstable data, such as death certificate statistics that fluctuate widely from year to year.

In 2000, Congress found that CMS’ decades of “cutting corners” on regulatory oversight “interfered with the effectiveness of organ procurement organizations in raising the level of organ donation.” So, in Congress’ amendments to the OPOs’ governing statute, CMS was ordered to develop methodologies to evaluate OPOs more holistically, using both “process” and “multiple outcome” measures.

Instead, CMS repeatedly ignored Congress and defied federal law, ultimately establishing a Final Rule in 2020 that relies solely on two outcome metrics — essentially one metric disguised as two — and lacks any of the required process measurements that would indicate whether an OPO is complying with rules and best practices, enforcing policies, providing effective training and responding to incidents. The motion describes the Final Rule as “more radical and regressive” than CMS’ previous failed regulatory schemes.

The Final Rule’s system that subjects all but the top 25% of OPOs to potential decertification and replacement has no legal basis, and no empirical justification in a time of improving national organ donation rates, the motion states. CMS went forward with the Final Rule, never responding to numerous public comments from medical organizations and experts that documented the rule’s statistical flaws and detailed its departures from what Congress mandated the agency to do.

“CMS assumes that if it decertifies or replaces potentially dozens of organ procurement organizations, there will be other organizations capable of stepping in and increasing donation and transplantation rates in the service areas they take over. But it provides no record support for that unfounded assumption. Nor can it deny the severe harm that will be caused if its unreliable metrics result in decertifying or replacing the wrong organizations,” the motion argues.

• Challenge to CMS OPO Rule: Seven Organ Procurement Organizations (OPOs) are suing the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS), asserting that CMS’s Final Rule on OPO recertification violates federal law and exceeds the agency’s statutory authority.

• Core Legal Argument: Plaintiffs argue that Congress directed CMS to create a holistic evaluation system including both process and multiple outcome measures. Instead, CMS’s 2020 Final Rule relies almost entirely on outcome metrics derived from unstable death certificate data, ignoring the process-based standards mandated by statute.

• Alleged Consequences of the Rule: The plaintiffs report that CMS’s policy could decertify up to 75% of existing OPOs, destabilizing the national organ donation system, disrupting transplant services, and harming patients on waiting lists. They describe the approach as turning a collaborative public-health network into a “Hunger Games–style competition.”

• Procedural and Data Concerns: The motion criticizes CMS for ignoring public comments, relying on statistically flawed data, and offering no evidence that replacement OPOs could operate effectively in decertified areas. Plaintiffs claim CMS acted arbitrarily and capriciously by dismissing expert warnings about the rule’s instability.

• Relief Sought: The OPOs seek to vacate the Final Rule and block CMS from enforcing it in future certification cycles, asserting that the rule is “radical and regressive,” lacks empirical support, and contradicts Congress’s intent to strengthen—not weaken—OPO performance oversight.