New Federal Guidance for Organ Procurement

2026 will prove to be a pivotal year for organ procurement organizations (OPOs). For the first time, the impact of the Center for Medicare and Medicaid Services’ (CMS) 2020 outcome measures will be fully felt, as the year marks the end of the first certification cycle governed by the new benchmarks. In the meantime, OPOs are challenging the 2020 rule in several federal lawsuits and, as that litigation progresses, CMS is accepting comments on a new proposed rule, which we discussed in a prior alert. 

Adding to the regulatory uncertainty are recent allegations of patient safety issues that have been the subject of media reports and congressional hearings. CMS has been eager to demonstrate that it is taking action to address these issues and restore public trust in the organ transplant system. At CMS’s Quality Conference in early March 2026, CMS administrator Dr. Mehmet Oz stated that the agency intends to “sharpen” and “strengthen” federal oversight of OPOs.

As part of these efforts, CMS circulated a press release that shares new guidance for donor hospitals and OPOs in the form of a CMS Quality, Safety & Oversight Group (QSOG) and Survey & Operations Group (SOG) Memorandum along with updates to its State Operations Manual (SOM) Interpretative Guidance. Below, we discuss the key points of CMS’s QSOG memorandum, updates from the SOM Interpretative Guidance, and takeaways from CMS’s Quality Conference.

New Guidance Clarifies Obligations for OPOs and Donor Hospitals

The QSOG memorandum clarifies the respective roles and responsibilities of OPOs and donor hospitals, the latter of which CMS defines as hospitals that have the “potential to admit patients who may become organ donors and are therefore responsible for identifying and referring potential donors to the designated OPO.” CMS refers to OPO and hospital conditions of participation (CoP) set forth at 42 C.F.R. Part 486 and Part 482, respectively, and states that noncompliance can result in termination of an OPO’s participation in the Medicare program — or, for a donor hospital, termination of its participation in the Medicare and Medicaid programs.

CMS makes conforming changes to its Interpretative Guidance to align with its QSOG memorandum. Surveyors rely upon Interpretative Guidance in conducting on-site surveys of OPOs to assess compliance. CMS’s revisions also bring its Interpretative Guidance up to date, as CMS had not updated its guidance to reflect its 2020 outcome measures until now.

The QSOG memorandum and Interpretative Guidance focus on allegations that OPOs are engaging in aggressive tactics to acquire organs, including pressuring patients and families to donate, making determinations of death, and attempting to procure organs from potential donors who have showed signs of life after death has been declared.  

We address each of these topics below.

• • Obtaining Consent to Donation
  • Declaration of Death
  • Donors Showing Signs of Life After Declaration of Death

Obtaining Consent to Donation

CMS repeatedly stresses in the QSOG memorandum that the procurement process must include “sensitive and respectful discussions,” and that families are not to be “rushed, pressured, or forced into premature decision-making.” Agreements between OPOs and donor hospitals should delineate their respective roles and responsibilities, which should be clearly communicated to patient families and legally authorized representative (LAR). CMS states that hospitals are required to protect each patient’s right to be free from all forms of abuse or harassment per 42 C.F.R. § 482.413(c)(3), and that these patient rights must be extended to the patient’s family or LAR responsible for making decisions about the patient’s care.

In the QSOG memorandum and Interpretative Guidance, CMS directs surveyors to, when possible, observe the OPO and hospital staff discussing organ donation with the family (or LAR) regarding the informed consent and the organ donation and recovery processes. If observation is not feasible, CMS states that the surveyor could interview an individual who has had “an experience with the OPO/hospital in the last six months.” CMS further revises its Interpretative Guidance to state that during a donor record review, the surveyor should confirm that consent of the patient, family, or LAR is documented.

CMS cautions that a hospital could be cited for noncompliance with 42 C.F.R. § 482.413(c) regardless of which entity provided the pressure. The agency also states that if noncompliance is found during an OPO or hospital survey, the surveyor must issue a citation, even if the OPO or hospital shows evidence that they implemented a corrective action after the noncompliance occurred.

Declaration of Death

The QSOG memorandum emphasizes that the decision to withdraw life support and the subsequent declaration of death, if death occurs, is solely the responsibility of the patient’s attending physician or a hospital physician designee. It states that the “OPO may not be involved in the decision or timing of withdrawal of life support or declaring death in any way.” 

An OPO must have written protocols consistent with current standards of practice that discuss the wait time between death declaration and the beginning of recovery. Surveyors should review a sample of donation after cardiac death (DCD) donor records and cite an OPO for noncompliance with 42 C.F.R. § 486.322(a) if it fails to follow the OPO-donor hospital agreement on initiating organ recovery, is inappropriately involved (or present) in the operating room during withdrawal of life support, or fails to adhere to the waiting period between the hospital’s pronouncement of death and the OPO/surgical team’s procurement of organs.

CMS also responds to public concerns relating to the “potential impact of sedatives used before or during withdrawal of life support” and their “effect on the clinical determination that the patient’s death has occurred or is imminent.” CMS states that it is critical that hospitals develop policies that address all steps before organ recovery and, in particular, the withdrawal or continuation of palliative sedation. CMS’s Interpretative Guidance directs surveyors to ensure that OPOs have written protocols on the types of drugs, especially the use of sedatives, anxiolytics, and paralytics that may be used to “maintain perfusion of organs until the time of transplant,” consistent with current standards of practice that identify situations which would require notification of the OPO medical director.

Donors Showing Signs of Life After Declaration of Death

In response to allegations that OPOs have attempted to procure organs after donors have shown signs of life after being declared dead, the QSOG memorandum states that the hospital should have “clear and specific policies” that ensure that processes governing declarations of death and organ procurement are “transparent,” and that the protocols used to pronounce death are based on accepted medical standards with the “utmost respect for the patient and their family staff.”

CMS specifies that the OPO and hospital agreement should include procedures that must be followed if signs of life are observed at any time during the recovery process, including “immediate reassessment and documentation of a patient’s neurological and cardiac status to ensure patient safety and protocol adherence.” If signs of life are observed before or during the recovery of an organ, “OPOs are expected to immediately stop the procurement process” and, since the patient is no longer a potential donor, the hospital should then follow its plan for continued patient care.

In conducting onsite surveys, surveyors should obtain a list of all referrals that were evaluated for donation suitability for the previous four years. This list should identify whether the referral followed brain or circulatory death, and the final disposition of the donation process, including organ recovery or a reason for cessation of procurement. Reasons for cessation could include signs of life or other clinical indicators of unsuitability for donation.

Regulatory Timeline and Next Steps for OPOs

CMS’s press release sets forth the projected timeline of key events that should help those in the organ transplant ecosystem plan for this important year. The proposed schedule reveals that CMS does not intend to initiate recertifications and decertifications until late in the year and following finalization of its Proposed Rule.

• • Spring 2026: CMS will publish the 2026 OPO performance reports based on 2024 data. 
  • Summer 2026: CMS will complete onsite recertification survey reviews for applicable OPOs to ensure compliance with federal standards. CMS stated during its Quality Conference that it intends to survey “every single” OPO by the end of July 2026.
  • Late 2026 (Projected): CMS anticipates finalizing its Proposed Rule relating to OPO Conditions for Coverage Final Rule (CMS-3409-P). Comments are due by March 31, 2026. 

In the Proposed Rule and in pending litigation, CMS articulated a position that contradicts the agency’s longstanding statutory interpretation that it is prohibited from certifying new OPOs. During CMS’s Quality Conference, CMS requested feedback from the organ transplant community on how CMS can effectuate this new position and “bring in new OPOs.”

• • After finalization of CMS’s rule (effective 60 days after publication): CMS will initiate recertification or decertification actions for Tier 2 and Tier 3 OPOs.
  • January 2027: Current OPO agreements expire. CMS states that it will issue extensions as necessary 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.

Our team is ready and available to assist health care entities that may have an interest in submitting comments to CMS. For further details or clarification on what specific proposed program provisions could mean for your business, please contact any author of this alert or your preferred Crowell & Moring lawyer.