Filed Date: Dec. 12, 2025
Case Ongoing
Clearinghouse coding complete
In this lawsuit, Organ Procurement Organizations challenge new requirements set forth by the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services, alleging that these new requirements will create chaos and upend a carefully constructed system.
On December 12, 2025, Plaintiffs, a coalition of nonprofit Organ Procurement Organizations (OPO), filed this lawsuit in U.S. District Court for the District of Columbia against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). OPOs are local, non-profit organizations that facilitate organ transplants. OPOs operate under a tailored statutory framework that provides oversight and structure. Plaintiffs sought to challenge HHS and CMS's new requirements for OPO recertification and designation (the Outcome Rule). The Outcome Rule evaluates OPOs based on the rate of organ donations from donors within the OPOs serviced-area and the rate of transplants of organs from donors in the OPOs serviced-area. The OPOs assert The Outcome Rule stands to upend the nation's organ donation system because the policy sorts OPOs based on these performance metrics, and based on that performance, the bottom tier of OPOs will be decertified. The OPOs allege that for the first review cycle, CMS estimated that The Outcome Rule could eliminate nearly 40% of the nation’s OPOs.
Filing under the Administrative Procedure Act (APA), the OPOs alleged that The Outcome Rule is contrary to law and contrary to statutory authorization because it fails to provide clear, meaningful standards for certification. Instead, the OPOs alleged that the Outcome Rule lacks clarity by determining certification only based on comparative ranking. The OPOs also alleged that The Outcome Rule was an arbitrary and capricious agency action, meaning that it was not reasonably explained and failed to follow procedure adequately.
Plaintiffs sought declaratory and injunctive relief barring Defendants from enforcing the provisions of the Outcome Rule. The case was assigned to Sparkle L. Sooknanan.
On March 20, 2026, Plaintiffs moved for summary judgment. On April 24, 2026, Defendants filed a cross motion for summary judgment.
This case is ongoing.
Summary Authors
Sadie Henderson (6/19/2026)
Zoe Hayes (3/31/2026)
For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/72031487/parties/new-england-donor-services-inc-v-united-states-department-of-health-and/
Sverdlov, Alexander V. (District of Columbia)
Zwingli, Sam (District of Columbia)
Brown, Allison Ilene (District of Columbia)
See docket on RECAP: https://www.courtlistener.com/docket/72031487/new-england-donor-services-inc-v-united-states-department-of-health-and/
Last updated July 5, 2026, 3:53 a.m.
State / Territory:
Case Type(s):
Healthcare Access and Reproductive Issues
Special Collection(s):
Trump Administration 2.0: Challenges to the Government
Key Dates
Filing Date: Dec. 12, 2025
Case Ongoing: Yes
Plaintiffs
Plaintiff Description:
A coalition of nonprofit Organ Procurement Organizations.
Plaintiff Type(s):
Public Interest Lawyer: No
Filed Pro Se: No
Class Action Sought: No
Class Action Outcome: Not sought
Defendants
Federal
Centers for Medicare & Medicaid Services
United States Department of Health and Human Services
Case Details
Causes of Action:
Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
Other Dockets:
District of District of Columbia 1:25-cv-04329
Available Documents:
Outcome
Prevailing Party: None Yet / None
Relief Sought:
Relief Granted:
Source of Relief:
Content of Injunction:
Reinstatement (job, contract, grant, etc.)
Issues
Medical/Mental Health Care:
Case Summary of New England Donor Services, Inc. v. United States Department of Health and Human Services, Civil Rights Litig. Clearinghouse, https://clearinghouse.net/case/47506/ (last updated 3/31/2026).