The Centers for Medicare & Medicaid Services (CMS) issued new guidance clarifying and reinforcing the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals. The guidance discusses responsibilities of hospitals to provide patients with complete, life-saving medical treatment without regard to potential organ donation status and to allow families time to make decisions without pressure. The guidance also notes that a subsequent declaration of death is the responsibility of the patient’s physician and not the OPO. Hospitals are reminded that they must comply with the Medicare Condition of Participation, requiring that they have clear and specific policies for all aspects of the organ procurement and transplant process.
In significant change to previous guidance, the agency will require surveyors to cite noncompliance related to federal requirements once identified, even if the issue is subsequently addressed and corrected. This action is part of a broader Health and Human Services initiative to strengthen oversight of organ procurement organizations and to advance transparency, and accountability, and patient protections across the organ donation and procurement system.