What Organ Procurement Organizations Need to Know About CMS's New Proposed Rule

What You Need to Know

Key Takeaways

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Table of Contents

FAQs: What OPOs Need to Know About the Proposed Rule

• • • Could an OPO serve more than one DSA if the Proposed Rule is promulgated?
    • Would OPOs serving more than one DSA be required to merge their DSAs?
    • Which OPOs would be automatically recertified at the end of the recertification cycle?
    • Which OPOs would be automatically decertified?
    • Can CMS decertify an OPO before the end of a cycle??
    • What would differentiate non-renewal from decertification?
    • Would OPOs still have the right to appeal a decertification decision?
    • Can CMS certify a new or previously decertified OPO?
    • What criteria would CMS use when selecting a DSA?
    • Could CMS appoint a successor OPO to an open DSA without competition?
    • Would the Proposed Rule introduce any new patient safety requirements?

Next Steps for OPOs

Background

Proposed rulemaking issued by the Centers for Medicare and Medicaid Services (CMS) indicates that the federal government has no immediate plans to alleviate the regulatory pressure on organ procurement organizations (OPOs).

On January 28, 2026, CMS issued CMS–3409–P, a long-awaited proposed rule intended to govern OPO oversight. The rule, which is likely to invite substantial public input during its comment period, offers further clarification and guidance following the agency’s issuance of a 2020 Final Rule, which introduces a performance-based tiering system for OPOs, guarantees recertification only for top-tier OPOs, and requires organizations in lower tiers to compete for designated service areas (DSAs). CMS has previously estimated that approximately half of all existing OPOs would not qualify for automatic recertification and would need to compete to retain their assigned DSAs under the Final Rule’s new tier system. As we have written before, this forecast prompted several OPOs to characterize the rule as an existential risk to the transplant industry and file legal challenges against its enforcement; as of this writing, all three of those cases are still ongoing.

CMS makes clear in the Proposed Rule that the agency both views the Final Rule positively and intends to maintain its requirements. Touting recent data, CMS reports that median donation and transplantation rates have demonstrated “accelerated improvement” since the 2020 Final Rule’s promulgation and further asserts that these trends prove that the rule’s “sustained regulatory pressure” and “reliable and transparent performance metrics” are “working.”

CMS also appears to rebut arguments raised in pending litigation during the Proposed Rule's preamble. Plaintiff opponents have challenged the Final Rule under the Administrative Procedure Act (APA), alleging among other arguments that CMS did not include “process” measures in its recertification process as required by statute, relied on flawed state death certificate data, and imposed two highly correlated outcome measures and a confidence interval that is biased against larger OPOs.

The agency speaks to these concerns in the Proposed Rule, highlighting all process performance measures and Quality Assurance Performance Improvement (QAPI) requirements identified in its regulations and further stating that decertification can be based on an OPO’s failure to adhere to process requirements as well as a failure to deliver upon outcome measures. CMS also renews its defense of the use of state death certificate data to derive donor potential (which serves as the denominator in both outcome measures), stating that the “exact donor potential” is less relevant than providing “standardized, reasonable, and impartial criteria” for use across all OPO DSAs.

Lastly, the agency asserts that while its two outcome measures share a common denominator, and thus are “somewhat related,” the numerators are not the same. While CMS acknowledges that confidence intervals “tend to be narrower for larger data sets,” it also points out that, in many cases, the confidence interval proved to be irrelevant; as an example, CMS states that 27 of the 42 OPOs that performed well enough to have their DSAs placed into Tier 1 qualified by their observed performance, irrespective of the confidence interval.

Put simply, CMS has used the publication of the Proposed Rule as an opportunity to reiterate its commitment to enforcing the 2020 Final Rule’s outcome measures and clarify how its performance tiering system will function in practice. More specifically, the Proposed Rule:

• • • Offers OPOs insight into the agency’s vision for the recertification process;
    • Clarifies regulations regarding the assignment of multiple DSAs to one OPO;
    • Revises the “non-renewal” option for OPOs;
    • Outlines the agency’s criteria for selecting an OPO for DSA assignment;
    • Clarifies the agency’s expectations regarding patient safety and the reporting of adverse medical events.

FAQs: What OPOs Need to Know About the Proposed Rule

In addition to addressing the concerns noted above, CMS introduces other proposed changes and clarifications to the Final Rule that would substantively impact OPOs and how they operate if the Proposed Rule is issued as drafted.  Below, we summarize some of the more important aspects of the Proposed Rule through questions that OPOs may have or questions we are seeing from industry stakeholders.

Could an OPO serve more than one DSA if the Proposed Rule is promulgated?

Yes. CMS proposes revising its regulations to clarify that tier status will be associated with DSAs rather than OPOs (as is currently the case under the 2020 Final Rule). This change would permit an OPO to oversee multiple DSAs.     

Would OPOs serving more than one DSA be required to merge their DSAs?

No. If promulgated, the Proposed Rule would allow OPOs to decide independently whether they prefer to merge multiple DSA into one, oversee multiple DSAs, or some combination of the two.

This decision is consequential. If the OPO chooses to merge all its assigned DSAs into one, the OPO’s recertification at the end of the next cycle will rest and fall on its performance vis-à-vis outcome metrics in that one DSA. If, on the other hand, the OPO does not merge its DSAs, its performance will be evaluated independently for each DSA. CMS also proposes that an OPO will be evaluated as a “single entity across all DSAs” for compliance with process performance measures.

Which OPOs would be automatically recertified at the end of the recertification cycle?

According to the Proposed Rule, OPOs assigned to at least one Tier 1 or Tier 2 DSA would not be considered out of compliance with CMS’s Conditions of Participation (CoP) (assuming it is compliant with other, non-outcome requirements). An OPO assigned to at least one Tier 1 DSA would be recertified at the end of the recertification cycle.

Which OPOs would be automatically decertified?

Under the Proposed Rule, an OPO assigned to only Tier 3 DSA(s) would be considered non-compliant with CMS’s outcome measures and decertified.

An OPO assigned to more than one DSA, one of which falls within Tier 3, will be removed from designation to the Tier 3 DSA. CMS will notify the OPO that it will remove the OPO’s designation to the Tier 3, and the OPO will have the opportunity to appeal that removal. However, the OPO will still be permitted to compete for open DSAs if it maintains Tier 1 or 2 status in other DSA(s). 

Can CMS decertify an OPO before the end of a cycle?

Yes. CMS’s proposed definition of unsound medical practices refers to failures by OPOs that create an “imminent threat to patient health and safety or pose a risk to patients or the public.” CMS provides examples of such unsound medical practices, including the “failure to perform necessary and customary tests to determine whether a potential donor meets exclusionary criteria, such as certain malignancies or active infections,” and “pursuing patients with inappropriately high neurologic function as potential donors.” These examples appear to reference specific accounts presented by family members and whistleblowers who have testified on unsafe or unethical transplant experiences before Congress. 

What would differentiate non-renewal from decertification?

“Decertification” refers to the involuntary removal of a DSA from an OPO’s purview due to underperformance or unsound medical practices. CMS proposes a definition of non-renewals to include two scenarios: (1) when an OPO seeks to voluntarily terminate its agreement; and (2) when an OPO assigned to a Tier 2 DSA is unsuccessful in the competition process and is no longer designated to any DSA. 

In both instances of non-renewal, the OPO will not be considered out of compliance with CMS’s outcome measures and will not be “decertified.”

Would OPOs still have the right to appeal a decertification decision?

Yes. CMS proposes amendments to its appeal regulations to clarify that an administrative appeal is available to: (1) an OPO that is facing decertification because it is assigned to DSA(s) that fall only within Tier 3; and (2) an OPO whose DSA is being removed because of its placement in Tier 3. CMS reiterates that an OPO will not be decertified or lose its designation to a Tier 3 DSA until all administrative appeals are exhausted. At that time, the DSA would be opened for competition and a successor OPO would be selected.

However, CMS proposes revising its appeals regulations to remove the option for a reconsideration official to “modify” its initial decertification decision, which CMS states is not “appropriate.” CMS proposes to shorten the period for an OPO to seek appeal to a hearing officer; the agency seeks to clarify that OPOs bear the burden of proof by a preponderance of the evidence and allow for discretionary review of the hearing officer’s decision by the CMS Administrator. 

Can CMS certify a new or previously decertified OPO?

Yes. CMS recently reversed its longstanding position that all participating OPOs must have been certified as of January 1, 2000; the agency now asserts its authority to either certify an “entirely new OPO,” or one that was “previously decertified.” This position, which CMS characterizes as the “single, best meaning” of the statute per the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), was first articulated in a cross-motion for summary judgment filed by CMS in pending litigation commenced by a group of OPOs to challenge CMS’s 2020 Final Rule.   Under CMS’s new interpretation, any DSA vacancies that are not filled by an existing OPO through the competition process can be assumed by (a) newly certified OPO(s). 

What criteria would CMS use when selecting a DSA?

CMS’s proposed criteria are included below, which the agency has stated that it will not apply “rigidly” based on tier standing alone. The agency will determine OPO suitability for DSA assignment by assessing:

• • • Performance on the outcome measures
    • Relative success in meeting process performance measures and other conditions
    • Contiguity in the open service area
    • Success in identifying and overcoming barriers to donation within the OPO’s own service area and the relevance of those barriers to barriers in the open area

CMS also proposes adjusting the length of the designation period as needed. While the agency provides that an OPO is “normally designated for an agreement cycle of 4 years,” it suggests this period may be extended if, for example, additional time is needed to complete an appeal, conduct a competition, select a successor OPO, or transition the DSA to the successor OPO. 

Could CMS appoint a successor OPO to an open DSA without competition?

Yes. If there is insufficient time to conduct a competition, CMS proposes that the agency “designate” an OPO as the successor for an unmanaged DSA. CMS states that it would exercise this option only if there are concerns for continuity of organ donation or if the incumbent OPO was unable to sustain services long enough to facilitate an orderly transition.

Would the Proposed Rule introduce any new patient safety requirements?

Yes. CMS suggests revising its regulations relating to OPO’s QAPIs by defining the term “adverse event” to specifically include the transmission of an “infectious or communicable” disease or other disease that may be transmissible from a donor to an organ recipient, such as the “transmission, dissemination, and seeding of malignancies.” Acknowledging that reports of “failure to ensure that death has been verified” demonstrate “deviations from the current standards of practice” and could contribute to “mistrust” in the organ donation process, the agency proposes to include in OPO QAPI programs a requirement to report and investigate adverse events resulting from deviations from the current standards of practice or an OPO’s own policies and procedures regarding the evaluation and management of patients or potential donors.

CMS also proposes to add regulatory provisions requiring that OPO personnel performing clinical duties are properly licensed, certified, or registered in accordance with applicable federal, state, and local laws, and are acting within the scope of such license, certification, or registration. Finally, the agency introduced proposed definitions for “medically complex organs” and “medically complex donors” and suggested including these organs and donors in OPOs’ QAPI programs to ensure that OPOs are “optimizing” opportunities to “recover and place those organs for transplant.”

Next Steps for OPOs

Given the crucial role that OPOs play in the intricate organ transplant ecosystem—which encompasses donor hospitals, transplant hospitals, tissue banks, histocompatibility laboratories, donors and transplant recipients—the Proposed Rule will likely have far reaching implications not only for OPOs, but also for all entities within the industry. We strongly encourage all concerned entities to submit comments on the Proposed Rule to CMS before the comment period expires on March 31, 2026. Potential commentors should note that the agency is actively seeking public input on ways to leverage technology to improve and the notification process between hospitals and OPOs. Donor hospitals may be particularly interested in commenting on this issue, as they will be directly impacted by any federal decisions regarding the use of automatic electronic referrals.

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.