CMS Strengthens Patient Protections and Accountability in Organ Donation System

New Guidance Reinforces Clear Safeguards for Patients and Families

The Centers for Medicare & Medicaid Services (CMS) today issued new guidance to strengthen public trust and ensure patients and their families are treated with dignity and care throughout the organ donation process. The guidance clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion. This action follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief.

"Americans' trust in physicians and hospitals decreased more than 40% between 2020 and 2024. In this administration, we're committed to earning it back," said CMS Administrator Dr. Mehmet Oz. "These guidelines contribute to that effort by directing hospitals to give every patient the same life-saving care, regardless of organ donor status, and to avoid rushing or coercing families into organ donation decisions. We're restoring trust by promoting transparency, strengthening accountability, and respecting the dignity of patients and their families."

CMS is releasing guidance that reinforces clear safeguards through a Quality, Safety, & Oversight (QSO) memo and State Operations Manual (SOM) appendix update:

• Medical care comes first: Hospitals must provide complete, life-saving medical treatment without regard to potential organ donation.
• Families are given time to make an informed decision: Families must have appropriate time to process their loss before donation decisions begin.
• No coercion: Patients and families are protected from rushed decision-making and inappropriate pressure.
• OPOs cannot influence critical decisions: OPOs are prohibited from influencing the timing of life support withdrawal or death declarations.
• Medical standards upheld: Death must be declared according to accepted medical standards before organ recovery begins.

The memo and SOM appendix reinforce existing federal regulations and strengthen oversight. CMS is requiring surveyors to cite noncompliance related to these federal requirements once identified even if the issue is subsequently addressed and corrected-a significant change that increases accountability and ensures consistent enforcement.

The organ donation system serves more than 100,000 Americans currently waiting for lifesaving organ transplants. This action is part of a broader HHS effort to strengthen oversight of OPOs and advance transparency, accountability, and patient protections across the organ donation and procurement system. CMS is working closely with the Health Resources and Services Administration (HRSA) to modernize the national organ procurement and transplant system. This new guidance will strengthen oversight of OPOs and advance transparency, accountability, and patient protections across the organ donation and procurement system.

CMS will continue strengthened oversight of OPOs through 2027, with these upcoming OPO activities:

March 2026 - CMS will highlight national priorities in organ donation and transplantation at the 2026 CMS Quality Conference , reinforcing expectations for access, collaboration, and accountability. Additionally, the public comment period will close on the proposed Conditions for Coverage revisions. See via the Federal Register .

Spring 2026 - CMS will publish the 2026 OPO performance reports, based on 2024 data, on CMS QCOR , affirming CMS's commitment to transparency and public accountability.

Summer 2026 - CMS will complete onsite recertification survey reviews for applicable OPOs to ensure compliance with federal standards.

Late 2026 (Projected) - CMS anticipates issuing the OPO Conditions for Coverage Final Rule (CMS-3409-P).

Following the final rule going into effect 60 days after publication - CMS will initiate recertification or decertification actions for Tier 2 and Tier 3 OPOs, consistent with regulatory timelines.

January 2027 - Current OPO agreements expire; if there is insufficient time prior to the expiration of an OPO agreement to allow for competition of an open service area and, if necessary, transition of the service area to a successor OPO, CMS will issue extensions as necessary to ensure continuity of the nation's organ donation and transplantation system.

To view the QSO Memo, visit: https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos/policy-memos-states-cms-locations/organ-procurement-organizations-opos-donor-hospitals-responsibilities

To view the SOM Appendix, visit: https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos/policy-memos-states-cms-locations/revisions-organ-procurement-organization-opo-interpretive-guidance-state-operations-manual-appendix

To visit HRSA's page on organ procurement and transplantation, visit: https://www.hrsa.gov/optn-modernization .

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