On January 30, 2026, CMS published a proposed rule (2026 Proposed Rule) that clarifies parts of the agency’s requirements for recertification of Organ Procurement Organizations (OPOs). In particular, the proposed rule attempts to address certain ambiguities and operational challenges that have arisen in connection with the new recertification process established by CMS’s December 2020 final rule (2020 Final Rule).
Background
In 2000, Congress rejected CMS’s reliance on limited outcome metrics to measure OPO performance. It directed CMS to establish a recertification process that relies on both process measures and multiple outcome measures to assess OPO performance over a four-year period. Congress instructed that CMS’s measures of performance should go beyond considering only donor potential and instead also take account of other related factors in each OPO’s designated service area that are relevant to evaluating performance and increasing organ donation.
In 2019, President Trump signed Executive Order 13879, “Advancing American Kidney Health,” directing the HHS Secretary to improve the procurement and utilization of organs from deceased donors.
CMS responded by promulgating its 2020 Final Rule. The 2020 Final Rule established a new three-tier system that ranks OPOs based on the calculation of two limited outcome metrics (a donation rate and transplantation rate). Tier 1 OPOs—those deemed by CMS to be in the top 25% for both their donation rate and transplantation rate—are recertified; Tier 2 OPOs —those deemed to have one or both of their calculated rates above the median but below the top 25%—must compete to retain their service areas; Tier 3 OPOs—those deemed to have one or both calculated rates below the median—will be decertified and barred from participating in the nation’s organ donation system. The 2020 Final Rule also established a phased implementation schedule, with the two new outcome metrics taking effect on August 1, 2022, and the first recertification cycle based on those metrics set to conclude on July 31, 2026.
The 2020 Final Rule is available here.
The Final Rule is currently subject to litigation in lawsuits filed across the country, including in federal district courts in the Middle District of Florida, in the District of Columbia, and in the District of North Carolina. The lawsuits challenge CMS’s 2020 Final Rule on grounds that it does not comply with the statute or the requirements of reasoned decision-making under the Administrative Procedure Act.
As OPOs, transplant hospitals, and other stakeholders prepared for this inaugural cycle, several procedural and interpretive questions emerged that the 2020 Final Rule did not expressly address. CMS subsequently issued this 2026 Proposed Rule in an effort to address these questions.
Key Proposed Definitions
The 2026 Proposed Rule introduces several new and revised definitions:
- Adverse Event: CMS proposes to streamline the existing definition of an “adverse event” by removing specific examples from 42 C.F.R. § 486.302 and relocating them to Quality Assurance and Performance Improvement (QAPI) requirements at 42 C.F.R. § 486.348(c). The proposed examples of adverse events subject to relocation include (i) transmission of an infectious or communicable disease or malignancy from a donor to an organ recipient; (ii) avoidable loss of a medically suitable potential donor for whom consent for donation has been obtained; (iii) deviations from current standards of practice or OPO procedures that result in loss of a patient, potential donor, or transplantable organ(s); (iv) delivery of an organ that was not for the intended recipient or whose blood type does not match; (v) an organ that is lost, or delayed and arrived too late to be transplanted; and (vi) an organ that arrives in a condition incompatible with transplantation. CMS asserts that this change would eliminate any confusion that the list of examples constitutes an exhaustive list of adverse events.
- Unsound Medical Practices: CMS proposes to define “unsound medical practice” as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. Such practices would include but are not limited to (1) failures in governance; (2) patient or potential donor evaluation and management; and (3) procurement, allocation, and transport practices and procedures. CMS also provided a few examples of unsound medical practices, including (1) failure to ensure a potential donor is declared dead according to applicable State law and hospital policies; (2) negligent or deliberate failure to perform necessary and customary tests to determine whether a potential donor meets exclusionary criteria; and (3) pursuing patients with inappropriately high neurologic function as potential donors.
- Donor: CMS proposes to revise the definition of “donor” to clarify that an individual from whom only the pancreas is procured and used specifically for islet cell research is included in the definition for purposes of the donation rate outcome metric.
- Organ: CMS proposes to remove pancreata used for islet cell research from the definition of “organ,” thereby excluding such pancreata from the organ transplantation rate outcome metric. In other words, research activity would no longer count as a transplant for purposes of the transplantation rate outcome metric. A pancreas that is used for islet cell research without a transplant to a patient on the OPTN waiting list, however, would still count towards the donation rate outcome metric. In contrast, a pancreatic islet allotransplant to a patient on the OPTN waiting list would be included in both the transplantation rate and donation rate outcome metrics, regardless of whether it is conducted under standard or research protocols.
- Medically Complex Donor and Organs: CMS proposes to define “medically complex donor” as a donor whose medical history requires special or additional considerations to identify the best recipient for the organs, including all Donation after Cardiac Death (DCD) donors and donors with elevated Kidney Donor Profile Index (KDPI) scores of 50 or more. A “medically complex organ” would be defined as an organ procured from a medically complex donor. These definitions are linked to a proposed new QAPI requirement at 42 C.F.R. § 486.348(e) that would require OPOs to (1) assess policies and procedures regarding medically complex donors and organs; (2) track performance metrics including consent rates, recovery rates, and transplantation rates at least annually; and (3) implement actions to improve performance when opportunities are identified.
OPO Designation and Multi-DSA Framework
CMS’s proposed rule seeks to clarify OPO designation and establish a framework that would enable OPOs to manage service areas separately. The current regulatory structure does not address potential situations in which an OPO is responsible for multiple designated service areas and is assigned by CMS different tier designations.
Under the proposal, CMS would evaluate each OPO’s service area separately during the recertification process, using its two limited outcome metrics. CMS would then remove the OPO’s designation for any service area where CMS has assigned the organization a Tier 3 ranking without necessarily decertifying the entire OPO. Taking this approach would enable CMS to selectively prevent an OPO from continuing to serve an area where CMS has assigned the OPO to a lower tier while allowing the OPO to retain its designation for other service areas where CMS has assigned the OPO to a higher tier. An OPO would remain certified if it has at least one service area that CMS concludes satisfies its two outcome metrics (Tier 1 or Tier 2) and meets all other regulatory requirements. Conversely, an OPO assigned by CMS to Tier 3 in all of its designated service areas would be decertified and prevented from participating in the nation’s organ donation system.
When an OPO is designated to more than one service area (through a change in control or ownership, competition, or successor assignment), the OPO may choose to consolidate its designated service areas or maintain separate service areas (or some combination if more than two service areas are involved). CMS proposes that an OPO would be evaluated as a single entity across all designated service areas when applying its minimum process requirements, making clear that although an OPO may be assigned different tier rankings based on the application of CMS’s two outcome metrics in different service areas, OPOs must satisfy CMS’s minimum process requirements at all times and in all of their designated service areas.
CMS also proposes that OPOs that are assigned a service area by CMS would be provided additional time before becoming subject to CMS’s two outcome metrics for recertification purposes—specifically, in the final assessment period of the following agreement cycle. According to CMS, this extended timeframe would allow the newly assigned OPOs an opportunity to meet CMS’s two outcome metrics. In addition, CMS proposes to clarify rare instances when CMS may forgo the competitive bidding process and temporarily designate an OPO to a designated service area, considering factors such as contiguity to the service area, performance on outcome measures, history of compliance with process performance metrics, and willingness to perform responsibilities for the remainder of the designation period.
Non-Renewal of Tier 2 OPO Agreements
CMS proposes to clarify that OPOs assigned a Tier 2 ranking in their designated service area would be recertified but must compete to retain their service area or obtain a different service area. An important distinction between OPOs assigned a Tier 3 ranking and those assigned a Tier 2 ranking is that CMS has deemed only Tier 3 ranked OPOs to be out of compliance with its two outcome metrics for that service areas. If a Tier 2 OPO is unsuccessful in competing to retain its service area and not assigned to a different service area, the OPO’s agreement with CMS would not be renewed, but the OPO would still be eligible to compete or otherwise be selected for designation to an open service area throughout the next four-year recertification cycle.
CMS’s proposed rule states that OPOs assigned to Tier 2 that CMS decides should not be permitted to continue to be responsible for their service area have no appeal rights to challenge CMS’s decision. CMS states in the proposed rule that denying Tier 2 organizations any administrative review process is consistent with CMS’s policy that “our competition decision is final.” If the OPO is not successful in competing for a different service areas, the OPO would be decertified and would be afforded the limited appeal rights for the decertification.
Requirements for Certification
Many stakeholders have objected to CMS’s 2020 Final Rule on grounds that CMS plans to decertify or replace dozens of OPOs and note that, under the statute and existing regulations, CMS has no authority to certify new OPOs.
In response, CMS proposes to remove the regulatory requirement at 42 C.F.R. § 486.303(e) that limits certification to OPOs recertified between January 1, 2002 through December 31, 2005. Upon further review and while previously declaring the opposite, CMS no longer believes that the statute is best read to require all qualified OPOs to have been previously certified as of January 1, 2000. CMS instead now takes the position that whenever the agency initially certifies or recertifies that an OPO meets the Secretary’s performance standards within a 4-year period, OPOs must demonstrate at the end of that period that they still meet the agency’s performance standards. If permitted under the statute, removing this requirement would eliminate a regulatory barrier that previously prevented the Secretary from implementing a process for the certification of new OPOs.
CMS asserts that changing its regulations would address concerns about market consolidation by creating a more diverse and robust market that enhances competition among OPOs, potentially introducing innovation from new entities and increasing the number of organs available for transplant.
Administrative Appeals Process
CMS proposes several changes to the OPO appeals process at 42 C.F.R. § 486.314. Key changes include:
- Timeline Modifications: The proposal changes the reconsideration request period from 15 business days to 20 calendar days; the CMS reconsideration decision period from 10 business days to 15 calendar days; the request for hearing period from 40 business days to 15 calendar days; and the hearing officer decision period from 20 business days to 90 calendar days.
- New Appeal Categories: CMS proposes to allow OPOs to appeal the removal of designation to a Tier 3 service area without decertification, in addition to appealing full decertification. This addresses the potential situation of an OPO being designated to more than one service areas, where the OPO may not be decertified because it has been deemed a Tier 1 or Tier 2 organization in at least one of its service, but may lose designation in a service area where it has been assigned a Tier 3 ranking.
- Burden of Proof: The proposed rule states that OPOs bear the burden of proof by a preponderance of the evidence to demonstrate that the notice of decertification or removal of designation should be reversed.
- CMS Administrator Discretionary Review: CMS proposes to codify a process at new 42 C.F.R. 486.314(l) for the CMS Administrator to elect to review or decline to review the hearing officer’s decision within 30 calendar days of receipt. If the Administrator elects to review, the Administrator must render a final decision within 45 calendar days of notification and may affirm, reverse, or remand the hearing officer’s decision.
Comment Solicitation and Discussion on Emerging Topics
The 2026 Proposed Rule also addresses and solicits public comments on potential future regulatory requirements:
- Conflicts of Interest: CMS has expressed concerns related to the relationships between OPOs and tissue banks and officials from local morgues and medical examiner offices, which are the original sources of data used for outcome metrics. CMS is also concerned about inadequate transparency and oversight for conflicts of interest among OPO leaders and governing board members. CMS is soliciting public comment on areas where conflicts may exist, including firewalls within OPOs, potential impacts of additional CMS requirements, and alternatives for addressing conflicts of interest among OPO staff and board members.
- Allocation Out of Sequence: CMS has expressed concern that the proliferation of allocating organs out of sequence, including the use of “open offers” to preferred transplant programs rather than to specific patients on the match run list, creates inequities in the procurement and transplant system that erode public trust.
- Automated Electronic Referrals: CMS is soliciting public comment on automated electronic referrals from donor hospitals.
Comment Deadline
Comments on the 2026 Proposed Rule must be received by March 31, 2026.
The 2026 Proposed Rule is available here, and the CMS Fact Sheet on the 2026 Proposed Rule is available here.
