Organ Donation Guidance From CMS Warns Against Coercion, Rushed Decision-Making

CMS is looking to improve accountability and protections for patients in the U.S. organ donation system.

On Wednesday, the agency issued guidance aimed at organ procurement organizations (OPOs) and donor hospitals that reinforces existing federal regulations and strengthens federal oversight.

CMS noted in a press release that there have been reports of some OPOs rushing certain aspects of organ donation and procurement, “pressuring families to make decisions during moments of grief.”

The main points of the guidance are:

• Hospitals must provide complete, life-saving medical treatment without regard to potential organ donation.
• Families must have appropriate time to process their loss before donation decisions begin.
• Patients and families must be free from coercion and protected from rushed decision-making and inappropriate pressure.
• OPOs are prohibited from influencing the timing of life support withdrawal or death declarations.
• Death must be declared according to accepted medical standards before organ recovery begins.

Furthermore, surveyors will be required to cite any noncompliance with the guidance, even if an identified issue is addressed and corrected.

The guidance comes in the form of a Quality, Safety & Oversight memo and a State Operations Manual appendix update.

“These guidelines contribute to [earning back Americans’ trust in physicians and hospitals] 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,” CMS Administrator Mehmet Oz, MD, MBA, said in a statement. “We’re restoring trust by promoting transparency, strengthening accountability, and respecting the dignity of patients and their families.”

In response, OPOs and hospitals pointed to their ongoing commitment to these principles.

Jeffrey Trageser, RN, president of the Association of Organ Procurement Organizations (AOPO), said in an emailed statement that “safeguards highlighted in CMS’s announcement reflect longstanding medical and ethical standards that already guide OPOs and hospitals across the United States.”

“Patient care and safety always come first,” Trageser stressed. “Decisions about medical treatment, end-of-life care, and the declaration of death are made by a patient’s treating physicians and are completely separate from the organ donation process. OPOs do not influence clinical decisions about life-saving treatment, the withdrawal of life support, or the determination of death.”

“Similarly, conversations about donation are designed to ensure that families are given the time, information, and support they need to make informed decisions,” he continued. “While organ donation must occur within a specific medical timeframe for organs to remain viable for transplant, highly skilled OPO professionals are trained to approach these discussions with compassion and respect, working closely with families during moments of profound loss.”

Beyond “core principles” reinforced in the guidance from CMS, Trageser noted that the AOPO and its members have been working to “support the development of uniform guidelines for complex donation practices, such as donation after circulatory death.”

“The system must continue to evolve as new technologies become available and best practices are shared in our community,” he said.

Adrienne Thomas, senior associate director of standards and care delivery policy at the American Hospital Association, said in a statement that the guidance “reaffirms hospitals’ role in caring for patients in accordance with each patient’s end-of-life wishes and emphasizes the need for discretion and sensitivity in working with patients and families.”

Thomas added that the guidance “also reminds hospitals that to comply with Medicare Conditions of Participation, hospitals must have clear and specific policies regarding all aspects of the organ procurement and transplant process and must ensure that its policies are based on accepted medical standards and carried out with the utmost respect for patients and families.”

CMS emphasized that the guidance is part of broader HHS efforts to “strengthen oversight of OPOs and advance transparency, accountability, and patient protections across the organ donation and procurement system,” and noted that it is working closely with the Health Resources and Services Administration (HRSA) to modernize the national organ procurement and transplant system.

This past summer, HHS announced “a major initiative to begin reforming the organ transplant system” after an investigation by HRSA found “disturbing practices” by an OPO serving Kentucky and parts of Ohio and West Virginia.

“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” HHS Secretary Robert F. Kennedy Jr. stated at the time. “The OPOs that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”

In September, HHS for the first time took steps to decertify another OPO, alleging years of unsafe practices and chronic under-performance.

And earlier this year, a proposed rule from CMS would require OPOs to assess their performance in placing organs from older donors or donors with less-than-optimal health status.

Public mistrust has been tied to a drop in certain organ donations from the recently deceased.

Currently, the U.S. organ donation system is meant to serve more than 100,000 Americans awaiting lifesaving transplants.