Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 486 [CMS-3409-P] RIN 0938-AU54 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would revise the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule would revise definitions, add new Quality Assessment Performance Improvement (QAPI) requirements related to medically complex organs and donors, revise the designation requirements for OPOs, clarify when an OPO's service area is open for competition, and update the process for appeals. It also includes a discussion of factors we would consider when selecting a successor OPO during a competition under the tiered approach to re-certification. We are committed to holding all OPOs accountable for their performance and this proposed rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, by March 31, 2026.

ADDRESSES:

In commenting, please refer to file code CMS-3409-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3409-P, P.O. Box 8010, Baltimore, MD 21244-8010.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3409-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Diane Corning, (410) 786-8486; James Cowher, (410) 786-1948; Claudia Molinar, (410) 786-8445; Danielle Shearer, (410) 786-6617; or Jasmine Alexis, (410) 786-0861.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this rule may be found at https://www.regulations.gov/.

I. Executive Summary and Severability

A. Executive Summary

1. Purpose

At any given time, at least 100,000 people are on the waiting list for a lifesaving transplant and every 8 minutes, another person is added to the transplant waiting list. 1 Many individuals on the organ transplant waiting list will wait several years for a suitable donor, while others will die before an organ becomes available. A variety of factors affect wait times, including how well a waitlisted individual matches with available donors, how sick the person is, and the availability of organs in the local area. Despite continued growth in organ donation, procurement, and transplantation, the need for transplantable organs continues to grow. Optimal performance of organ procurement organizations (OPOs) is critical to ensure that the maximum possible number of transplantable human organs are available to the yearly average of 100,000+ seriously ill people on waiting lists for a lifesaving organ transplant.

1 Organ Donation Statistics. https://www.organdonor.gov/learn/organ-donation-statistics. Accessed on April 29, 2025.

In 2019, President Trump issued Executive Order 13879 “Advancing American Kidney Health,” directing the Secretary to enhance the procurement and utilization of organs available through deceased donation and to establish more transparent, reliable, and enforceable metrics for evaluating an OPO's performance. In response, CMS published the final rule, “Medicare and Medicaid Programs; Organ Procurement Organization Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations” in 2020 (85 FR 77898, referred to hereafter as the December 2020 final rule), which, among other changes, revised the previous outcome measures to drive performance improvement and increase the number of transplantable organs. OPOs are evaluated on their performance on both the donor and transplantation measures. Since publishing the December 2020 final rule, CMS has received many inquiries from OPOs and others seeking clarification on operational and administrative elements. These inquiries have increased in frequency and volume as the system moves closer to the 2026 re-certification period. This proposed rule contains operational and administrative provisions which would govern the competition process, to provide programmatic clarity and address interested party requests for additional guidance. Additionally, this proposed rule contains provisions aimed at driving further improvement in OPO operations, reflecting our continued commitment to enhancing the organ procurement and transplant system, and better serving prospective organ donors, their families, and patients on the transplant waitlist.

2. Summary of Major Provisions

a. Definition Changes (§ 486.302)

Adverse Event. The current definition of “adverse event” is “an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. As applied to OPOs, adverse events include but are not limited to transmission of disease from a donor to a beneficiary, avoidable loss of a medically suitable potential donor for whom consent for donation has been obtained, or delivery to a transplant center of the wrong organ or an organ whose blood type does not match the blood type of the intended beneficiary.” We propose to remove the examples in this definition and add a revised list of examples to the QAPI requirements at § 486.348(c).

Donor. We propose to revise the definition of the term “donor” to clarify that an individual from whom only the pancreas is procured and used for islet cell research is included in the definition of “donor” for purposes of the donation rate outcome measure, consistent with the Public Health Service (PHS) Act's requirement that pancreata used for islet cell transplantation or research be counted for purposes of certification and re-certification.

Organ. The current definition of the term “organ” includes the pancreas when it is used for research or islet cell transplantation. This definition applies to the organ transplantation outcome measure, counting a pancreas used for research in the same way that a transplanted organ is counted. We propose to remove pancreata used for research from the definition of “organ” and thus, such pancreata would also be removed from the organ transplantation rate outcome measure. Research activity would no longer count as a transplant for purposes of certification and re-certification.

Medically Complex Organs and Donors. Organs from donors that fall outside the generally accepted standards for transplantation due to donor age or health status are underutilized. However, research has indicated that many of these organs can be successfully transplanted when appropriately placed with a transplant candidate. 2 3 We propose to define the term “medically complex donor” as a donor whose medical history requires special or additional considerations to identify the best recipient for the organs. These donors include, but are not limited to, all Donation after Cardiac Death (DCD) donors and donors with elevated Kidney Donor Profile Index (KDPI) scores. We also propose that OPOs track procurement and placement of these organs as part of their QAPI program. Additionally, we propose to define the term “medically complex organ” as an organ procured from a “medically complex donor”.

2 Walls, DO, Lee-Riddle, Gs, Manderski, MB, Sawinski, DL, and Abt, PL. Kidney transplant outcomes from donation afer circulatory death donors of advanced age. Clinical Transplantation. 2020:34e13881. http://doi.org/10.111/ctr.13881. Accessed at https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.13881. Accessed on September 23, 2025.

3 Haque, O, Yuan, Q, Uygun, K, and Markmann, JF. Evolving utilization of donation after circulatory death livers in liver transplantation: the day of DCD has come. Clinical Transplantation. 2021;35:e14211. https://doi.org/10.1111/ctr.14211. Accessed at https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211. Accessed on September 21, 2015.

Unsound Medical Practices. We are also proposing a new definition for “unsound medical practices.” Unsound medical practices are referenced in § 486.312(b) as an example of circumstances in which CMS may de-certify an OPO based on “urgent need.” However, there is no definition of “unsound medical practices” in the regulations. We propose to define unsound medical practices as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. These practices include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation and transport practices and procedures.

b. Requirements for Certification (§ 486.303)

We have historically interpreted the OPO Certification Act of 2000 (the Certification Act), which added section 371(b)(1)(D) of the Public Health Service Act (PHS Act), to mean the Secretary lacks the authority to certify new OPOs after January 1, 2000. However, we have reassessed this view and determined that the statute was not intended to strip the Secretary of his authority to certify new OPOs. Therefore, to align with our reinterpretation of the Certification Act, we are proposing to remove § 486.303(e), which conditions OPO certification on an entity having been re-certified as an OPO from January 1, 2002, through December 31, 2005.

c. OPO Designation to Donation Service Areas (DSAs) (§§ 486.308 and 486.309)

Designation is the process CMS utilizes to assign an OPO to a specific geographic area, or donation service area (DSA), for a specific period of time, called an agreement cycle. Currently, there are 55 OPOs designated to 55 DSAs with the same 4-year agreement cycle. We propose changes to the OPO designation process to facilitate implementation of the tiered system for OPO re-certification and competition that was finalized in the December 2020 final rule. Specifically, we propose to add provisions to address the possibility of one OPO being designated to more than one DSA. The current regulatory structure does not address this situation and the potential impacts it may have for competition and OPO re-certification. We will address these impacts throughout the respective provisions in this proposed rule. Finally, the tiered system for re-certification seeks to incentivize continued performance improvement through increased competition. Therefore, we propose to address all situations when an OPO's DSA may be opened for competition from other OPOs.

d. OPO Agreements, Non-Renewal (§ 486.311) and De-Certification (§ 486.312)

OPO agreements with CMS may be impacted by actions initiated by an OPO or adverse determinations by CMS. Currently, there are three categories of actions that impact an OPO's agreement, including voluntary termination of the agreement by the OPO; involuntary termination during the re-certification cycle as a result of enforcement action for non-compliance with certification requirements; and non-renewal of the agreement for non-compliance with the outcome measures and other certification requirements. Generally, these actions result in de-certification of the OPO. In our December 2020 final rule, we implemented a tiered system for OPO re-certification that seeks to drive OPO performance through increased competition. The current requirements for de-certification do not address the possibility of an OPO being unsuccessful in a competition for its own or another DSA and no longer being designated to any DSA. We propose to address this potential scenario as well as better categorize and clarify situations that could lead to non-renewal of an agreement or de-certification of an OPO. We also propose that a voluntary termination or a scenario in which an OPO is no longer designated to any DSA after competition would result in non-renewal of the OPO's agreement with CMS, while an OPO's non-compliance with the outcome measures, non-compliance with the process performance measures, and situations involving urgent need to protect patient health and safety would

e. Appeals of Adverse Actions (§ 486.314)

As a result of significant changes made since the 2006 OPO final rule, we reviewed the OPO appeals process set forth at § 486.314 and are proposing the following changes. The current introductory statement in the regulation states that OPOs can appeal a de-certification on substantive and procedural grounds if the de-certification is due to involuntary termination or non-renewal of its agreement with CMS. We propose to revise the introductory text at § 486.314 to state that OPOs may appeal a de-certification as described at proposed § 486.312(a) or the removal of designation to a tier 3 DSA without de-certification as specified at proposed § 486.316(b)(2)(iii)(B), to comply with changes to that section. We also propose to add references to the removal of designation for a DSA assigned as tier 3 without de-certification alongside references to de-certification in § 486.314, as applicable, to reflect that an appeal would be available in either scenario.

Throughout § 486.314 we propose to modify the time periods in this section for current requirements from “business days” to “calendar days”. We also propose to use “calendar days” for all proposed requirements. This is both for consistency and to avoid confusion.

Throughout the current process, we are proposing changes to the various time frames to reduce inefficiencies while preserving OPOs' right to appeal.

We are also proposing a new paragraph at § 486.314( l ), CMS Administrator discretionary review. We are proposing to codify a process for the CMS Administrator to elect to review or decline to review the hearing officer's decision. We are proposing specific time periods for the review, if the Administrator elects to review, and providing that the Administrator may remand the appeal to CMS for review and redetermination of the certification decision. We are also proposing to clarify the appeals process for OPOs that are de-certified due to urgent need.

f. Re-Certification and Competition (§ 486.316)

Our December 2020 final rule included changes to our requirements for OPO re-certification and competition processes to clarify how the tiered system associated with the outcome measures would impact these activities. We are proposing additional revisions to § 486.316 to include situations when an OPO is designated to more than one DSA. We are proposing to evaluate each DSA for which an OPO is designated separately on the outcome measures. This would address the potential situation of an OPO having DSAs with different tier designations and how this would impact re-certification and competition. Additionally, it would enable CMS to selectively remove a DSA where an OPO is underperforming and does not meet the outcome measures, while allowing the OPO to retain its designation to another DSA if it meets the performance requirements in that DSA. We also propose that we would evaluate an OPO as a single entity across all DSAs for the process performance requirements. The process performance measures are the broad operational requirements for OPOs and include items such as administration and governance, prospective donor and donor management, organ preparation and transport, and quality assessment and performance improvement, among other requirements. While an OPO may have varied performance on the outcome measures at different times and in different DSAs, if applicable, we expect OPOs to be in compliance with the process performance measures at all times and in all DSAs.

g. Outcome Measures (§ 486.318)

The 2020 final rule revised the outcome measures for OPOs. We propose to remove the previous and now obsolete outcome measures and redesignate the current outcome measures within § 486.318. We also propose to revise the requirement for when CMS will hold an OPO accountable on the outcome measures when it takes over another OPO's DSA. We describe the different scenarios when this may occur and factors we considered in proposing when we would hold the OPO accountable on its outcome measure performance in the new DSA.

h. Human Resources (§ 486.326)

The current human resources requirement addresses the need for a sufficient number of qualified staff to obtain all usable organs from potential donors, and to ensure that required services are provided to families of potential donors, hospitals, tissue banks, and individuals and facilities that use organs for research. All OPOs are required to ensure that all individuals who provide services and/or supervise services are qualified to provide or supervise the services. We propose to further specify that all OPOs are required to assure the current State or local licensure, certification, or registration of OPO staff that furnish clinical services. We also propose to add a requirement that personnel performing clinical duties must act within the scope of the State licensure, certification, or registration requirements.

i. Information Management (§ 486.330)

The current information management requirements at § 486.330 focus on maintaining both donor records and records showing the disposition of each organ recovered for the purpose of transplantation, including information identifying transplant beneficiaries. We propose to amend § 486.330 by adding a requirement that OPOs maintain records for organs that are procured for research, including pancreata used for islet cell research.

j. Quality Assessment and Performance Improvement (QAPI) (§ 486.348)

The current QAPI requirements focus on OPOs developing, implementing, and maintaining a comprehensive, data driven QAPI program designed to monitor and evaluate performance of all donation services. Section 486.348(c) requires OPOs to establish written policies to address, at a minimum, the process for identification, reporting, analysis, and prevention of adverse events and conduct a thorough analysis of any adverse event to identify and implement effective changes to prevent those types of incidences from recurring again. We propose to include a revised list of examples of adverse events in this section that is currently located in the “adverse event” definition in § 486.302.

To further the goal of improving procurement and transplantation of medically complex organs, we propose to require each OPO as part of its QAPI program in new § 486.348(e) to: (1) assess its policies and procedures regarding medically complex donors and medically complex organs and ensure they are optimizing opportunities to recover and place these organs for transplant; (2) assess its performance regarding the number of medically complex donors by determining the number of medically complex donors from whom the OPO has obtained consent for donation, the number of organs recovered from those donors, and the number of medically complex organs transplanted at least annually; and (3) implement actions to improve its performance with medically complex donors or medically complex

3. Summary of Costs and Benefits

The December 2020 final rule, among establishing other requirements, revised previous outcome measures to drive performance improvement and increase the number of transplantable organs. The December 2020 final rule's estimated costs were primarily driven by increased expenses related to organ procurement. Secondary costs were driven by the additional expense for OPOs to implement performance improvement policies. Additional costs accounted for the potential of OPO mergers.

The estimated benefits quantified were due to the number of lives saved and lives extended and, in addition, reduced costs to CMS payments for dialysis treatments for patients waiting on the transplant waitlist.

This proposed rule is important due to its functional proximity to the December 2020 final rule. Its purpose is to address and prevent administrative and operational concerns related to the competition process. This proposed rule would impose an estimated $19.1 million in Year 1 and $6.3 million in subsequent years. Year 1 costs including collection of information costs are approximately $17.9 million for OPOs and $1.2 million for CMS. Recurring annual costs include approximately $6.2 million for OPOs and $331,000 for CMS. Quantified benefits are estimated at $884,000 annually with an additional one-time benefit of $300,000.

These costs reflect clarifications and refinements to operational and administrative requirements rather than fundamental system restructuring.

B. Severability

To the extent a court may enjoin any part of the rule, the Department intends that other provisions or parts of provisions should remain in effect. Any provision of this rule held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provisions permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this rule and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

II. Organ Procurement Organizations (OPOs)

A. Background

OPOs are vital partners in the procurement, distribution, and transplantation of human organs in a safe and effective manner for all potential transplant recipients. The role of OPOs is critical to ensuring that the maximum possible number of transplantable human organs are available to individuals with organ failure who are on a waiting list for an organ transplant. Section 371(b) of the PHS Act sets out certain requirements for OPO certification. There are currently 55 OPOs that are responsible for identifying patients who may become prospective donors and recovering organs from deceased donors in the United States (U.S.), and currently each OPO serves a single DSA (55 in total). The Centers for Medicare & Medicaid Services (CMS) views OPO performance as a critical element of the organ transplantation system in the U.S. We established conditions for coverage (CfCs) for OPOs at 42 CFR part 486, subpart G, and OPOs must meet these requirements to receive payments from transplant hospitals participating in the Medicare and Medicaid programs. The CfCs include reliable, data-based outcome measures related to donor and transplant volume that are used to assess OPO performance for Medicare certification purposes and a three-tier certification structure that incentivizes high OPO performance on these outcome measures. In general, we are committed to using objective data to assess OPO performance and continuously incentivize OPO performance improvement.

In 2024, there were a total of 48,150 organ transplants, compared to 46,634 and 42,889 transplants in years 2023 and 2022, respectively. 4 Although the volume of transplants has increased over time, there continues to be an ongoing shortage of transplantable organs. At any given time, at least 100,000 people are on the waiting list for a lifesaving organ transplant. 5 Many people face tremendous quality of life burdens, illness progression, or death while on the waiting list. An OPO that is efficient in procuring organs and delivering them to recipients will help more people on the waiting list receive lifesaving organ transplants and reduce the waiting time, which could ultimately save more lives and improve health outcomes.

4 Organ Procurement and Transplantation Network (OPTN) Data. https://hrsa.unos.org/data/view-data-reports/national-data/ . Accessed January 6, 2026.

5 Organ Donation Statistics. https://www.organdonor.gov/learn/organ-donation-statistics . Accessed April 24, 2025.

B. Regulatory History

The December 2020 final rule (85 FR 77898) revised the OPO CfCs with the policy goal of increasing organ donation and transplantation to better serve patients on the organ transplant waiting list. The December 2020 final rule revised the outcome measures that are used to assess OPO compliance for purposes of certification, shifting from heavily risk-adjusted metrics that were not capable of demonstrating changes in OPO performance to metrics that measure OPO volume and drive OPO performance in areas most important to patients on the transplant waiting list. It also revised the assessment criteria to move from a bifurcated pass/fail system to a three tier system with dynamic performance thresholds and incentives for achieving the highest level of performance. Finally, the December 2020 final rule utilizes increasing competition to drive performance improvement. An OPO's performance in a DSA is ranked in comparison to the performance of all other OPOs in their assigned DSAs relative to a numerical threshold, using competition for higher ranking as a tier 1 as an incentive for performance improvement. We believe that the absence of meaningful competition contributed to the very slow pace of system improvement prior to CMS initiating its OPO regulatory reform efforts in 2019, culminating with publication of the December 2020 final rule.

Specifically, the December 2020 final rule measures OPO performance on two outcome measures described in § 486.318—the donation rate and the transplantation rate. Both rates assess OPO performance within the OPO's DSA, which is a geographical area that each OPO is assigned to, meaning that the OPO is responsible for all organ procurement activities that occur in that area, with certain exceptions. The denominator for each measure is the donor potential of each DSA, based on inpatient deaths within the DSA from patients 75 or younger with a primary cause of death that is consistent with organ donation, consistent with the OPO Certification Act of 2000. 6 We estimate the donor potential of each DSA using death certificate information obtained from the Center for Disease Control and Preventions' (CDC), National Center for Health Statistics' (NCHS's) Detailed Multiple Cause of 7 The jurisdictions use the U.S. Standard Certificate of Death as a template for their forms. We use the death certificate data to adjust the denominator to better reflect the population in the DSA that will more closely resemble individuals likely to have died in a manner consistent with organ donation. As we described in the December 2020 final rule, death that is consistent with organ donation means all deaths of individuals 75 or younger from the State death certificates with the primary cause of death listed as the ICD-10-CM codes I20-I25 (ischemic heart disease); I60-I69 (cerebrovascular disease); V-1-Y89 (external causes of death), which includes causes such as blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and asphyxiation. Our methodology is designed to estimate the likely donor referral population to normalize the inpatient deaths across the different DSAs. While each DSA may face its own unique challenges, the method for estimating donor potential is designed to be standardized and equally applied to all OPOs, allowing for variances in performance when facing challenges to be measured and for high performance to be incentivized. Since the donor potential is part of a rate calculation, identifying the exact, donor potential of those candidates that are universally considered by all OPOs to be ideal is less relevant than providing standardized, reasonable, and impartial criteria to estimate it and applying those criteria consistently to all OPO DSAs.

6 Public Law 106-505, section 701, codified at 42 U.S.C. 273(b)(1)(D)(ii)(II).

7 The 57 jurisdictions that provide data to the CDC are the 50 States, New York City, the District of Columbia, and the 5 territories. Data for New York City is reported separately from the State of New York.

The donation rate is calculated as the number of donors in the DSA as a percentage of the donor potential. The donation rate assesses the ability of the OPO to obtain consent for donation, successfully manage the donor, procure and place at least one organ for transplantation (or pancreas for islet cell transplantation or research), and ensure the safe and timely transport of that organ for transplantation. By including the donation rate, we incentivize OPOs to pursue all donors, including the single organ donors. An OPO is more likely to meet the donation rate measure if it procures organs from DCD or medically complex donors where relatively fewer organs may be transplantable. Incentivizing OPOs to pursue all potential donors means introducing more opportunities for individual transplant waitlist candidates to receive a good organ match, which is impacted by factors such as blood type, body size, and immune system antibody compatibility. A wider variety of donors means a better chance of good matches for more patients. 8 9

8 Madbouly A and Bolon Y-T (2024) Race, ethnicity, ancestry, and aspects that impact HLA data and matching for transplant. Front. Genet. 15:1375352. doi: 10.3389/fgene.2024.1375352.

9 Tiercy JM, Claas F. Impact of HLA diversity on donor selection in organ and stem cell transplantation. Hum Hered. 2013;76(3-4):178-86. doi: 10.1159/000358798. Epub 2014 May 21. PMID: 24861862.

The transplantation rate is calculated as the number of organs transplanted from donors in the DSA as a percentage of the donor potential. Organs, including pancreatic islet cells, transplanted into patients on the Organ Procurement and Transplantation Network (OPTN) waiting list as part of research are included in the organ transplantation rate. Pancreata that are used in islet cell research are also included. The organ transplantation rate is an important measure as it measures the benefit for patients from OPO performance. The unique geographical challenges associated with servicing the Hawaii DSA necessitated using a different outcome measure to evaluate the OPO's transplantation performance in that DSA. Instead of using the organ transplantation rate, we use the kidney transplantation rate. Although we do not use the organ transplantation rate for the Hawaii DSA, we continue to monitor the development and Food and Drug Administration (FDA) clearance of organ transport devices and expect the OPO serving the Hawaii DSA to adopt these new technologies when they are available.

Our outcome measures and process measures, taken as a whole, represent a reasonable effort to estimate the donor potential and other related factors in the DSA. The outcome measures denominator, as previously described in this section, is an estimate of donor potential in each DSA. The outcome measure numerators measure OPO performance (through the number of donors and organs transplanted) and are somewhat related because if there are more donors, there are likely to be more organs transplanted. However, these numerators are not the same, and each is necessary to measure different OPO outcomes and to properly incentivize OPOs to pursue all potential donors, succeed in obtaining consent, successfully manage their care, and successfully deliver viable organs for transplant. For example, OPOs that focus primarily on medically complex donors that may yield fewer organs per donor may need to seek more donations to have sufficient organs transplanted to mathematically meet the threshold organ transplantation rates. On the other hand, OPOs that are very effective at placing all possible organs from younger, healthier donors with larger yields may achieve the targeted organ transplantation rate, but not the donation rate, if they choose not to pursue the medically complex and DCD donors with only one or two transplantable organs. In measuring both donation and transplantation rates, we seek to achieve both more donors and more transplants. By focusing on the outcomes of OPO processes in the form of donation and transplant rates, we have created a system in which a wide variety of changeable factors, such as levels of public awareness and understanding about organ donation, relationships with donor hospitals, and the quality and timeliness of OPO interactions with potential donors and their families all coalesce in an end result of successful organ donation and transplantation.

Both outcome measures, and their threshold rates, are calculated using a full single calendar year of data. There is typically an 11- to 12-month long data lag for the MCOD file following the close of the calendar year. For example, the MCOD file containing data for deaths that occurred in 2025 is not expected to be available until December 2026 or as late as early spring 2027. To account for this and assure that CMS uses data from the same calendar year for both the numerators and denominators to calculate the donation and transplantation rates and threshold rates, there is a 1.5-year difference between the time when OPOs submit data for the performance period and the time when that data is fully analyzed by CMS and used to calculate OPO performance on the outcome measures. CMS provides each OPO with a preview of its calendar year data report and has a process established for OPOs to 10 CMS repeats this process on an annual basis such that OPOs and the public are aware of individual OPO performance and nationwide performance trends.

10 Quality, Certification, and Oversight Reports. https://qcor.cms.gov/main.jsp.

OPO performance on the outcome measures is assessed on an annual basis. For each assessment period, threshold rates are established based on the observed donation and transplantation rates during the 12-month period immediately prior to the period being evaluated. In the 2025 annual interim data report described above, OPO performance using 2023 data is compared to the OPO performance data of 2022. The median observed rate for each outcome measure in 2022 was used as the standard to measure OPO performance in 2023. To establish the threshold rates CMS calculates both the lowest observed rate among the top 25 percent in the DSAs, and the median observed rate among the DSAs. To measure OPO performance in a DSA, CMS uses a 95 percent confidence interval for each DSA's donation and organ transplantation rates using a one-sided test. A confidence interval is a statistical measure of precision. In the context of OPO evaluations, it provides the range of outcome measure values (donation rates or transplant rates) that are expected to most reasonably describe the OPO's true performance based on the available data. The confidence interval accounts for uncertainty to describe a broader range of OPO performance levels that could plausibly explain the observed donation and transplant outcomes. Confidence intervals tend to be wider when there are fewer potential donors because there is less information available to precisely measure the OPO's influence on the observed outcomes, and it becomes more difficult to confidently describe the OPO's performance with a very specific range of quality measure values. For example, consider a hypothetical situation where an OPO has just one potential donor. In this extreme case, it would only be possible to observe a donation rate of 1/1 = 100 percent or 0/1 = 0 percent. However, it would be misleading to claim that this OPO is always or never successful at recovering donor organs. In fact, there is almost no information available about this OPO's general performance because only one potential donor's outcome was observed. The confidence interval would be very wide under this scenario to appropriately reflect the low degree of certainty in the OPO's true donation performance. Likewise, OPOs with DSAs that have a larger donor potential, and thus a larger data set for performance measurement, tend to have smaller confidence intervals. Confidence intervals tend to be narrower for large data sets because it is easier to confidently describe performance due to the large amount of available data. Each OPO's confidence intervals for the donation and transplant rate are compared to benchmark levels of performance based on the prior year's observed rates. If the upper end of the OPO's confidence interval does not meet or surpass the threshold value established using the prior year's observed performance data, then there is statistical evidence that the OPO is not performing at that threshold level for donation or transplantation. For example, in the 2025 data report that is based on performance data from 2023, one OPO had an observed donation rate of 15.17 and the upper limit of its confidence interval was 16.64. The threshold rate for the outcome measure using the observed performance of all OPOs in the previous data year, 2022, was 12.49 for the median and 14.11 for the top 25 percent. In comparing the upper end of this OPO's confidence interval, 16.64, to the median performance threshold of 12.49 established using the previous year's observed performance, we determine that this OPO has met the median threshold rate for the donation outcome measure and complies with the minimum standard to be eligible for designation to tier 2 for that outcome measure. Likewise, in comparing the upper end of this OPO's confidence interval, 16.64, to the top 25 percent threshold of 14.11 as established using the previous year's observed performance data, we determine that this OPO has met and exceeded the top 25 percent threshold for the donation rate outcome measure. Indeed, this OPO's observed performance of 15.17 exceeded the top 25 percent threshold, meaning that even in the absence of a confidence interval it would still have performed in the top 25 percent on the donation rate outcome measure. In examining the 2025 public report, we note that 27 of the 42 OPOs that performed well enough to be in tier 1 on the donation rate outcome measure qualified by their observed performance, rather than by the upper limit of their calculated confidence interval. The performance thresholds for OPO evaluation are determined from the prior year's data, meaning that every OPO has the opportunity to improve its donation and transplantation performance such that its confidence intervals meet or surpass these threshold values. Even OPOs with donation or transplant rates below the performance thresholds can have confidence intervals that surpass these thresholds, depending on the size of 95 percent confidence interval and proximity to the benchmark. For example, in the 2025 public OPO data report, five OPOs that performed in tier 2 for the transplantation outcome were classified as tier 2 based on their confidence interval with an observed age-adjusted rate below the median of 38.56. Therefore, ten OPOs that performed in tier 2 on the transplantation outcome measure had an observed performance level that met or exceeded the median threshold and would be in tier 2 in the absence of a confidence interval. As such, it is possible for more than half of OPOs to be at or above the 25 percent and median thresholds. Indeed, in the 2025 public OPO report, 30 of the 55 OPOs (roughly 55 percent) performed well enough on both measures to be in tier 1 and the majority of these OPOs did so through their observed performance. This OPO performance evaluation system is designed to create incentives for OPOs to rapidly improve their performance in serving donor families and people on the transplant waitlist and exceed the performance thresholds established using the previous year's performance data.

Section 371(b)(1)(D)(ii)(II) of the PHS Act 11 provides that a qualified OPO must meet performance standards defined through regulations promulgated by the Secretary that rely on outcome and process performance measures that are based on empirical evidence, obtained through reasonable efforts, of donor potential and other related factors in each DSA. CMS established process measures (§ 486.320 through § 486.360) related to DSA-specific factors like relationships with donor hospitals in the DSA and OPO-specific processes such as QAPI, and uses empirical evidence gathered upon 12 it in no way replaced the essential process measure focus on other DSA-specific factors. Indeed, the December 2020 final rule also established a 3-tier system whereby OPOs are stratified into different tiers based on their performance on both outcome measures and compliance with the process performance measures. A successful OPO must meet the measures for both processes and outcomes to be considered compliant with the CfCs and eligible for re-certification. The consequences of being in each tier based on outcome measure performance differ based on whether the performance occurs as part of the annual assessment or if it occurs during the final assessment period. 13 Tier 1 DSAs have an upper limit of the one-sided 95 percent confidence interval for the donation and organ transplantation rate outcome measures that are at or above the top 25 percent threshold rate. Tier 2 DSAs have an upper limit of the one-sided 95 percent confidence interval for the donation and organ transplantation rates that are at or above the median threshold rate established for their DSA but are not tier 1 for both outcome measures Tier 2 performance, meaning that an OPO DSA has met the median threshold for both outcome measures but has not met the tier 1 top 25 percent threshold for both measures, is the minimum compliance standard established in the OPO regulations. OPO DSAs that fall into tier 2 will be opened for competition from other interested OPOs, to allow for the replacement of an OPO performing at the minimum compliance standard where there is a clearly better OPO prepared and capable of taking over the DSA. As such, OPOs are incentivized to assure that each of their DSAs are high performing such that they meet the top 25 percent performance thresholds and are not open for competition. Instead of using a 50 percent rate or a mean rate, we chose the median rate because both the top 25 percent threshold rate and the median rate represent the actual rates performed by one or two OPOs (when there is an even number, the median is calculated by averaging the two rates in the median). The mean rate, on the other hand, is a mathematical rate that may not reflect the performance of an actual OPO and may be dragged down by a small number of very low performing OPOs. A median, however, is less affected by extremes in performance as compared to a mean. By identifying the specific rate of an OPO, OPOs can directly compare their performance with that of other OPOs. Likewise, we did not choose to assess performance and thus compliance with the CfCs using a standard deviation from the mean methodology for several reasons. Under our methodology, all OPOs have the opportunity to cluster at the top because the threshold rate is based on the previous year's rate, meaning that all OPOs begin each year with a new opportunity to meet or exceed the median from the previous year. As a contrast, the standard deviation from the mean methodology generates a contemporaneous list of OPOs that are a certain distance from the mean. As discussed previously, the mean is problematic because several lower performing OPOs could skew the calculated mean. Beyond this, the mean and the standard deviations are generated contemporaneously with the ranking of the OPOs, giving OPOs no notice of their targeted performance. And, by nature of the statistical method of standard deviation, there will always be an OPO below the targeted standard deviation from the mean, meaning that not all OPOs would have the opportunity to be a top performing OPO unless they all had identical rates. As the outcome measures are used for certification and re-certification, consistent with the requirements set forth in the PHS Act, we do not believe that establishing a system in which at least one OPO must be determined to be out of compliance and therefore de-certified during each re-certification cycle is appropriate. Rather, we sought and continue to seek a system where all OPOs perform at a high level, exceed the previous year's median, and cluster at the top. As we stated in the December 2020 final rule, “Our goal in creating these tiers is to reward the top performing OPOs (Tier 1), while giving OPOs in Tiers 2 and 3 sufficient incentives to improve their performance and achieve ranking in the next level up . . . .” 14 We note that tier 3 DSAs, which have an upper limit of the one-sided 95 percent confidence interval for their donation or organ transplantation rates that are below the median threshold rate established using the previous year's data, are considered to be DSAs that fail to meet the outcome measures and are non-compliant with the CfCs.

11 42 U.S.C. 273(b)(1)(D)(ii)(II).

12 71 FR 31046.

13 85 FR 77911.

14 85 FR 77911-12.

Our goal is for all OPOs to be compliant with the process measure CfCs and the outcome measure CfCs, meeting or exceeding the prior year's median performance threshold, such that no OPOs are ranked in tier 3 and de-certified. As such, we have established a system of incentives to reward high performance on the outcome measures. CMS calculates the outcome measures and tier rankings annually and makes that information publicly available in interim reports, and OPOs with DSAs that rank in tier 2 or tier 3 must use their QAPI program to identify opportunities for improvement and implement changes that lead to improvement in these measures. Since publication of the December 2020 final rule the donation and transplantation system has entered a period of accelerated improvement. Based on data provided in the 2025 OPO Public Performance Report 15 the median donation rate increased 11 percent from 2021 to 2023, while historical records show that it only increased 2.6 percent in the 3 years preceding CMS rulemaking (2017 through 2019). Likewise, the median transplantation rate increased 7.3 percent from 2021 to 2023, while it only increased 1 percent in the 3 years preceding CMS rulemaking (2017 through 2019). Taken together, these data suggest that the sustained regulatory pressure of our system of tiered incentives, coupled with reliable and transparent performance metrics that drive continuous improvement and improve accountability, is working as we intended to accelerate OPO performance improvement in serving donors, their families, and patients on the transplant waiting list. As we stated in the December 2019 OPO proposed rule, “Our ultimate definition of success, however, is to encourage the performance of all OPOs to cluster around the highest performers.” 16 In the 2023 data report (based on data collected in 2021) there were 15 OPOs with tier 1 DSAs, increasing to 25 in 2024 (data from 2022), and 30 in 2025 (data from 2023). While top performing OPOs continue to improve on the

15 Quality, Certification, and Oversight Reports. https://qcor.cms.gov/main.jsp . Accessed on June 12, 2025

16 84 FR 70634.

We have reason to believe, and research suggests, 17 that this acceleration in better service of patients on the transplant waiting list is connected to the sustained regulatory pressures exerted by use of the tier structure in the re-certification process to bring about accountability. An OPO with a DSA that qualifies for tier 1 designation will be re-certified, retaining its tier 1 DSA, provided that the OPO is also found to be in compliance with all other OPO process performance measure CfCs via the re-certification survey. An OPO with a DSA that qualifies for tier 1 designation also qualifies to enter any competitions that are conducted to fill DSAs that are open for competition. An OPO with a DSA that qualifies for tier 2 designation and is also found in compliance with all other OPO process measure CfCs via the re-certification survey is also in compliance with the regulations, but its tier 2 DSA will be open to competition from other OPOs with tier 1 and tier 2 DSAs, should any eligible OPO choose to compete for it. An OPO with a tier 2 DSA may compete for any DSAs that are open for competition and must retain its DSA or obtain a new DSA in competition to be designated to the DSA and have an agreement with CMS. An OPO that only has DSAs designated to tier 3 will receive an initial notice of de-certification determination due to non-compliance with the OPO CfCs and has the appeal rights set forth at § 486.314. Once de-certified, an OPO cannot compete for either its own or any other open DSA. CMS utilizes competition to drive performance to achieve a higher tier ranking and to decide which OPOs should be awarded the opportunity to compete for additional DSAs if and when they are open. The conclusion of the 2022-2026 certification cycle will mark the first use of the outcome measures and tiers system for re-certification purposes. CMS publishes interim annual reports each year to provide transparency in OPO performance and the opportunity for OPOs to implement performance improvement plans. These reports are posted on the Quality, Certification and Oversight Reports (QCOR) website. 18

17 Doby BL, Ross-Driscoll K, Shuck M, Wadsworth M, Durand CM, Lynch RJ. Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance. Am J Transplant. 2021;00:1-7. https://doi.org/10.1111/ajt.16527 .

18 Quality, Certification and Oversight Reports. https://qcor.cms.gov/main.jsp .

In addition to the outcome measures and their implications with respect to tier status and re-certification, OPOs must also comply with the process performance measures set forth at §§ 486.320 through 486.360 to be considered in compliance with the CfCs. While tier assignment recognizes different levels of performance with respect to the outcome measures, it does not guarantee compliance with other requirements. Therefore, OPOs that are high performing on the outcome measures could be found non-compliant with one or more of the process performance measures during a survey, which could lead to de-certification if the OPO is unable to remedy the non-compliance. The process performance measures span a range of operational requirements. Specifically, at § 486.320 we require that an OPO must become a member of, participate in, and abide by the rules and requirements of the OPTN. At § 486.322 we address relationships with donor hospitals in the OPO's DSA, providing training to donor hospital staff, and cooperating with tissue banks. At § 486.324 we specify the required members of the OPO advisory board, its authorities and restrictions, limitations on the members of the board, and having bylaws for board member conflicts of interest and other key concerns. This condition also addresses the OPO's governing body and requires each OPO to declare in policy whether it recovers organs from donors after cardiac death. At § 486.326 we include specific human resources requirements that are further discussed in section III.I. of this proposed rule. At § 486.328 we include data reporting requirements for reporting to the OPTN, Scientific Registry of Transplant Recipients (SRTR), Department of Health and Human Services (HHS), and to transplant hospitals. At § 486.330 we address maintaining records for all donors and the disposition of each organ recovered for transplantation. This requirement is further discussed in section III.J. of this proposed rule. At § 486.342 we address requesting consent from prospective donor families with discretion and sensitivity, and at § 486.344 we address written protocols for donor evaluation, donor management, and organ placement and recovery to maximize organ quality and optimize the number of donors and the number of organs recovered and transplanted per donor. At § 486.346 we address organ preparation and transportation, covering topics including organ testing for infectious diseases and tissue typing, documentation provided to a transplant center and its verification for accuracy, and the protocols for packaging, labeling, handling, and shipping organs. The issue of organ transportation is further discussed in section III.K. of this proposed rule. At § 486.348 we include specific QAPI requirements, addressing the components of the program, death record reviews, adverse events, and the connection between performance on the CMS outcome measures and QAPI activities. The requirements for QAPI are further discussed in section III.K. of this proposed rule. Finally, at § 486.360 we address emergency preparedness standards for OPOs.

On February 2, 2021, we published a notice in the Federal Register (86 FR 7814) temporarily delaying the effective date of the December 2020 final rule by 60 days and providing an additional 30-day public comment period, during which we received over 150 timely public comments. The comments received included both support for immediate implementation of the December 2020 final rule and requests for additional time before implementation. We considered the additional public comments and the rule subsequently became effective on March 30, 2021.

On December 3, 2021, we published a “Request for Information (RFI); Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease (ESRD) Facilities” (86 FR 68594) (“December 2021 RFI”), which solicited comments that would help to inform potential changes that would create system-wide improvements, including improvements in organ donation, organ transplantation, quality of care in dialysis facilities, and access to dialysis services.

We received almost 400 timely comments in response to the December 2021 RFI. Commenters included transplant recipients, those awaiting transplants, donor families, and donor representatives. A range of health care

Recent peer reviewed research using the same method for estimating donor potential from our December 2020 final rule highlights the ability to detect variable performance both across OPOs and across areas of practice within OPOs as well as how this information can be leveraged for performance improvement to increase organ donation. 19 20 One group of researchers found that 74 percent of differences in overall donor procurement rates could be explained using model variables that represent different domains of OPO practice activities, such as DCD procurement, and procurement of older and minority patient populations. 21 Having this type of in depth performance data analysis available to OPOs for use in their QAPI programs, based on impartial and reliable data and outcome measures, is vital for OPOs to utilize in designing and implementing QAPI activities to drive improvements. The ability of OPOs to use this type of information to potentially implement appropriate practice changes will be critical to their success in the future. It is our role, with a continued focus on better patient outcomes, to maintain and enforce a regulatory structure that capitalizes on recent developments in data analysis and insights to enhance system-level and OPO-level performance.

19 Doby BL, Hanner K, Johnson S, Purnell TS, Shah MB, Lynch RJ. Results of a data-driven performance improvement initiative in organ donation. Am J Transplant. 2020;00:1-8. https://doi.org/10.1111/ajt.16442 .

20 Lynch RJ, Doby BL, Goldberg DS, Lee KJ, Cimeno A, Karp SJ. Procurement characteristics of high- and low-performing OPOs as seen in OPTN/SRTR data. Am J Transplant. 2022 Feb;22(2):455-463. doi: 10.1111/ajt.16832. Epub 2021 Sep 29. PMID: 34510735.

21 Doby BL, Casey K, Ross-Driscoll K, Rahman Ovi M, Hossain Bhuiyea MS, Isty IA, Lynch RJ, What is visible is fixable: visual dashboards for multi-domain assessment of OPO performance, American Journal of Transplantation, https://doi.org/10.1016/j.ajt.2023.08.020 .

To assist OPOs in improving performance, we developed two initiatives that OPOs could participate in to facilitate organ procurement and placement. The ESRD Treatment Choices Learning Collaborative brought transplant centers, OPOs, donor hospitals, patients, and donor families together to spread the use of highly effective practices to increase kidney procurement, recovery, and utilization. 22 The program provided technical assistance to several interested parties, including OPOs, with three aims: increasing the number of deceased donor kidneys transplanted, decreasing the current national discard rate of all procured kidneys, and increasing the percentage of kidneys recovered for transplant in the greater than or equal to 60 KDPI score group. Fifty-three OPOs participated in this collaborative, which ended in August 2025. CMS, through its quality improvement organizations, also initiated an OPO Special Innovation Project (SIP) to provide technical assistance to OPOs for improvement on the OPO performance outcome measures. In this program, OPOs had the opportunity to actively participate in a variety of technical assistance activities such as completing Root Cause Analyses (RCAs) and Plan-Do-Study-Act (PDSA) cycles, implementing evidenced-based strategies, and developing process and decision pathways. The objective was for OPOs to permanently integrate effective processes to improve and sustain improvements in their donation rate and transplant rate. Forty OPOs participated in this program, which concluded in March 2025.

22 https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model .

C. Statutory and Regulatory Provisions

To be an OPO, an entity must meet the applicable requirements of both the Social Security Act (the Act) and the PHS Act. Section 1138(b) of the Act provides the statutory qualifications and requirements that an OPO must meet in order for its organ procurement costs to be paid under the Medicare program or the Medicaid program. Section 1138(b)(1)(A) of the Act specifies that payment may be made for organ procurement costs only if the agency is a qualified OPO operating under a grant made under section 371(a) of the PHS Act or has been certified or re-certified by the Secretary of the Department of Health and Human Services (the Secretary) as meeting the standards to be a qualified OPO within a certain time period. Section 1138(b)(1)(C) of the Act provides that payment may be made for organ procurement costs only if the OPO meets the performance-related standards prescribed by the Secretary. Section 1138(b)(1)(F) of the Act requires that to receive payment under the Medicare or Medicaid programs for organ procurement costs, the entity must be designated by the Secretary. The requirements for such designation are set forth in § 486.304 and include being certified as a qualified OPO by CMS. Regulations at § 486.303 address the requirements to be certified as a qualified OPO.

Pursuant to section 371(b)(1)(D)(ii)(II) of the PHS Act, the Secretary is required to establish outcome and process performance measures for OPOs to meet based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of the qualified OPO. Section 1138(b)(1)(D) of the Act requires an OPO to be a member of, and abide by the rules and requirements of, the Organ Procurement and Transplantation Network (OPTN). OPOs must also comply with the regulations governing the operation of the OPTN (42 CFR part 121). The Department of Health and Human Services (HHS) has explained that only those OPTN policies approved by the Secretary will be considered “rules and requirements” of the OPTN for purposes of section 1138 of the Act. 23 The OPTN is a membership organization that oversees the U.S. organ transplant system, links all professionals in the U.S. organ procurement and transplantation system, and maintains a national registry for matching donated organs with recipients in need of transplantation. OPOs are required under OPTN regulations (42 CFR 121.11(b)(2)) and § 486.328 of our OPO CfCs to report information specified by the Secretary to the OPTN, including the data used to calculate the outcome measures for OPOs.

23 63 FR 16296.

In addition, OPOs are required to comply with existing Federal civil rights laws, including the Americans with Disabilities Act of 1990 (ADA), 42 U.S.C. 12101 et seq., Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d, Section 504 of the Rehabilitation Act of 1973 (Section 504), 29 U.S.C. 794, and Section 1557 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18116. 24 Title VI protects individuals on the basis of race, color, and national origin. Section 1557 protects individuals on the basis of race, color, national origin, age, disability, or sex. Among other things, these laws require OPOs to take reasonable steps to

24 Recipients of Federal financial assistance must comply with Federal civil rights laws, including but not limited to Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act.

Qualified individuals with disabilities are also entitled to reasonable modifications needed to participate in and benefit from a program, as well as appropriate auxiliary aids and services needed for effective communication. These rights extend in some circumstances to companions of a prospective organ donor or recipient. For example, health care providers and organ donation programs are required to provide auxiliary aids and services (including sign language interpreters) when necessary for effective communication between a relative involved in a prospective donor or recipient's care and a health care provider or procurement program.

Section 1102 of the Act gives the Secretary the authority to make and publish such rules and regulations as may be necessary to the efficient administration of the functions with which the Secretary is charged under the Act. Moreover, section 1871 of the Act gives the Secretary broad authority to establish regulations that are necessary to carry out the administration of the Medicare program.

We established CfCs for OPOs at 42 CFR part 486, subpart G, and OPOs must meet these requirements in order to be designated and therefore able to receive payments from the Medicare and Medicaid programs. These regulations set forth the certification and re-certification processes, outcome requirements, and process performance measures for OPOs. The outcome measures, found under § 486.318, are used to assess OPO performance for re-certification and competition purposes (see § 486.316(a) and (d)).

III. Provisions of the Proposed Regulations

In response to the December 2020 final rule, which revised the regulations that establish the framework for OPO re-certification, we have received questions on technical implementation of the rule from OPOs and other interested parties. In this proposed rule, we seek to clarify outstanding procedural and technical questions on the implementation of the rule so that OPOs can better understand the procedures for re-certification and de-certification that will be used in 2026. We remain committed to holding OPOs accountable for their performance and are proposing additional revisions to the OPO regulations that will assist in driving improvements.

A. Definitions (§ 486.302)

We are proposing to revise our current regulations defining the terms “adverse event,” “donor,” “medically complex donors,” “medically complex organs,” “organ,” and “unsound medical practices” at § 486.302 to provide greater clarity.

1. Adverse Event

Section 486.302 currently defines “adverse event” as “an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. As applied to OPOs, adverse events include, but are not limited to, transmission of disease from a donor to a beneficiary, avoidable loss of a medically suitable potential donor for whom consent for donation has been obtained, or delivery to a transplant center of the wrong organ or an organ whose blood type does not match the blood type of the intended beneficiary.” Adverse events trigger QAPI requirements so that for each adverse event, the OPO is required to “conduct a thorough analysis of any adverse event and must use the analysis to affect changes in the OPO's policies and practices to prevent repeat incidents” (§ 486.348(c)(2)).

Through feedback we have received, we are concerned that the examples set forth in this definition are not being viewed as examples but rather as an exhaustive list of the adverse events that apply to OPOs. We do not believe an exhaustive list of adverse events is possible, given the broad range of potential occurrences that might qualify as “an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof.” Thus, to avoid any confusion, we are proposing to remove the second sentence of the current definition and move a revised list of examples to § 486.348(c) in the QAPI requirements. If this change is finalized as proposed, OPOs should continue to identify “adverse events” according to the definition in § 486.302, regardless of whether the incident is covered in the examples that we are proposing to insert into § 486.348(c). We solicit public comment on the proposed changes to the definition of adverse events.

2. Donor

The Pancreatic Islet Cell Transplantation Act of 2004 25 (hereafter referred to as “PICTA 2004”) amended the PHS Act to add section 371(c), which requires that “[p]ancreata procured by an organ procurement organization and used for islet cell transplantation or research shall be counted for purposes of certification or re-certification[.]” In the December 2020 final rule we implemented the requirements of PICTA 2004 in the definition of “donor” in the OPO regulations at § 486.302, stating that a donor is “. . . a deceased individual from whom at least one vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) is transplanted. An individual also would be considered a donor if only the pancreas is procured and is used for research or islet cell transplantation.”

25 October 25, 2004, Public Law 108-362.

OPOs are required by the OPTN to report data related to pancreata procured and used for research, and this data is incorporated into calculations used to assess compliance with the donor and transplant outcome measures used for re-certification purposes. In finalizing the definition of “donor” in 2020 we noted that, “[w]e think that the impact of pancreata for research on the overall rankings of OPOs will continue to be minimal.” 26 This prediction was based upon a clear downward trend in OPO-reported procurement of pancreata procured and used for research, and our expectation of a leveling off or further downward trend was further substantiated by a 2021 article titled, “The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update,” 27 which noted changes over time in the pancreata islet cell research and transplantation clinicaltrials.gov, 28 we identified 16 active clinical trials in October 2023 with a total possible enrollment of 325 persons, which was consistent with the procurement rates for research pancreata that existed prior to publication of the December 2020 final rule, coinciding with the period of decline noted in the 2021 article. We note that the number of active clinical trials appears to have declined since October 2023, with a total of 4 active clinical trials and a total possible enrollment of 108 persons identified in November 2025.

26 85 FR 77902.

27 Witkowski et al. The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The “ISLETS FOR US” Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. https://doi.org/10.1111/ajt.16397 .

28 Accessed October 17, 2023.

However, since the publication of the December 2020 final rule and the updated definition of the term “donor”, OPOs' reported procurement of pancreata for research purposes has increased dramatically, rising from 562 in 2020 to 573 in 2021, 1,448 in 2022, 1,819 in 2023, and 2,004 in 2024, based on internal CMS review of data submitted by OPOs to the SRTR. The roughly 250 percent increase in procurement between 2020 and 2024 has not been matched by a corresponding increase in the number of clinical trials for pancreatic islet cells reported to the NIH and made public on the clinicaltrials.gov site. On January 18, 2024, we issued a memorandum 29 clarifying that for purposes of the definition of “donor”, the pancreata must be used for islet cell research or islet cell transplantation, consistent with PICTA 2004, to be counted. On October 9, 2024, the OPTN and SRTR updated the disposition reason codes that OPOs use when entering data regarding pancreata procured for any research purpose. The updated disposition reason codes differentiate pancreata procured and used for islet cell research activities from pancreata used for all other research purposes to enhance the specificity of data reported by OPOs. We propose to revise the definition of the term “donor” to further reiterate the clarification made in the January 2024 memorandum. The revised definition would state that an individual from whom only the pancreas is procured and is used for islet cell transplantation or for islet cell research is included in the definition of “donor.” Procurement for other research uses does not count for purposes of certification and re-certification. These proposed revisions are intended to clarify the rule to improve regulatory consistency with the requirements set forth in PICTA 2004, which specifies that pancreata procured for “islet cell transplantation or research” are required to be counted for certification and re-certification of OPOs.

29 QSO-24-04-[OPO], https://www.cms.gov/files/document/qso-24-04-opo.pdf .

Per the National Diabetes Statistics Report 30 issued by the Centers for Disease Control there were approximately 1.7 million Americans living with diagnosed type 1 diabetes in 2021. Experts estimate that 375,000 suffer from impaired hypoglycemic awareness and 66 percent suffer from recurrent severe hypoglycemic episodes (SHE). 31 Nearly 70,000 patients with type 1 diabetes fail to improve for hypoglycemia avoidance despite patient education efforts and advanced technologies, such as insulin pumps and continuous glucose monitoring sensors. 32 In 2020, hypoglycemia led to 202,000 emergency department visits. 33

30 National Diabetes Statistics Report. https://www.cdc.gov/diabetes/php/data-research/index.html . Accessed on March 25, 2025.

31 Byrne M, Hopkins D, Littlejohn W, et al. Outcomes for Adults with Type 1 Diabetes Referred with Severe Hypoglycaemia and/or Referred for Islet Transplantation to a Specialist Hypoglycaemia Service. Horm Metab Res. 2014;47(01):9-15.

32 Rickels MR. Hypoglycemia-associated autonomic failure, counterregulatory responses, and therapeutic options in type 1 diabetes. Ann N Y Acad Sci. 2019;1454(1):68-79.

33 National Diabetes Statistics Report. https://www.cdc.gov/diabetes/php/data-research/index.html . Accessed on March 25, 2025.

Although pancreas transplantation remains a therapeutic option that effectively treats type 1 diabetes, it requires major surgery with a significant risk of complications. Pancreatic islet allotransplantation offers a minimally-invasive alternative that lowers morbidity and mortality, improves glycemic control and prevents SHE, conferring complete protection from SHE in more than 90 percent of patients. 34 Federally funded clinical trials involving several U.S. academic centers have been conducted for pancreatic islet allotransplantation following results of a study conducted in 2000 where a series of seven patients with type 1 diabetes remained insulin-free for a full year following allotransplantation. 35 “Research,” as the term is used in the OPO regulations, for pancreatic islet allotransplantation involves all stages of bona fide bench research conducted by a qualified researcher that uses donor pancreatic islet cells to advance scientific and healthcare knowledge, but occurs without transplanting pancreatic islet cells into a patient. This may include safety studies, studies of innovative routes of administration, and studies of modified allogenic islet cell products. 36 Islet cell research includes donor pancreata used for research related to islet isolation as well as pancreata used for islet cell research when the islets remain in the organ, such as may be used in organ slice studies or in situ islet histology. In the Congressional Record associated with passage of PICTA 2004, a member of the U.S. House of Representatives described “ research that can result in being able to replicate the islet cells so that every diabetic in the country that wants one of these transplants can get that ” 37 (emphasis added). Another Representative described the purpose of PICTA 2004 as follows, “Pancreatic islet transplantation has been hailed as the most important advance in diabetes research since the discovery of insulin in 1921. The procedure, which involves transplanting insulin-producing cells into an individual with juvenile diabetes, has been performed on over 300 individuals, and the majority of them no longer need to take insulin to stay alive. While significant research remains to be done to expand this procedure to all who suffer with juvenile diabetes, its promise is incredibly exciting . . .” 38 (emphasis added). We believe that there continues to be a role for using donor pancreata to advance islet cell research, fulfilling this stated vision of widespread treatment for type 1 diabetes. Pancreatic islet cells used for bona fide bench research conducted by a qualified researcher would continue to be included in the definition of “donor” and OPOs that procure pancreata that are used in bona fide pancreatic islet cell research would continue to receive credit for these donors in the donation outcome measure. As described in section III.J. of this proposed rule, we would require OPOs to document information regarding the islet cell bona fide research activities conducted by a qualified researcher to advance scientific and healthcare knowledge and confirm that the research uses donor islet cells.

34 Witkowski et al. The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The “ISLETS FOR US” Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. doi: 10.1111/ajt.16397.

35 Witkowski et al. The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The “ISLETS FOR US” Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. doi: 10.1111/ajt.16397.

36 Shapiro AMJ, Ricordi C, Hering BJ, et al. International Trial of the Edmonton Protocol for Islet Transplantation, N Engl J Med. 2006;355(13):1318-1330.

37 Congressional Record- House, H8074, October 5, 2004.

38 Congressional Record- House, H8074, October 5, 2004.

We continue to believe that pancreata used for islet cell research will have little effect on the rankings of OPOs when calculating the donation outcome measure because the volume of bona fide pancreatic islet cell research conducted by a qualified researcher, that is bench only research with no transplants, is limited nationwide. By nature of the status of the research field and the requirements needed to move this treatment from research to standard clinical practice, the overall impact of including these pancreata used for islet cell research to implement the requirements of PICTA 2004 is limited. As described in section III.J. of this proposed rule, we propose to require that OPOs maintain specific documentation regarding pancreata used for islet cell research. We intend to verify both the existence and accuracy of this documentation to assure that OPOs accurately code reported pancreata used for islet cell research when submitting data to the OPTN, thereby upholding the integrity of the donor outcome measure.

As set forth in the PICTA 2004, a pancreas must be “used for islet cell transplantation or research” to be subject to the requirement that it be counted for certification or re-certification purposes. We propose to continue to include the criterion that the pancreas be “used” for islet cell transplantation or research in the definition of “donor” at § 486.302. At the time PICTA 2004 was enacted, it was not possible to cryopreserve pancreatic islet cells for future use. However, such cryopreservation of pancreatic islet cells is now possible and must be considered when deciding what activities constitute “use” for purposes of implementing the statute. To ensure that OPOs can accurately code data when entering it into the OPTN system within five days of organ procurement, per the data standards set forth by the OPTN, we consider “use” for purposes of islet cell research to be the acceptance and either immediate use or cryopreservation of the pancreatic islet cells by a bona fide pancreatic islet cell research program to advance scientific and healthcare knowledge. We have partnered with HRSA to implement enhanced OPO data reporting that more accurately conveys the disposition and use of pancreata, either for use in research that does not involve transplantation or in transplants of the pancreata or its islet cells to a patient on the OPTN waiting list. CMS uses data entered by OPOs into the OPTN data system in calculating the outcome measures.

Requiring research pancreata to be “used” for islet cell research to be included in the donation rate is consistent with how we treat other organs in the donation rate outcome measure. We only consider donors to be those for whom an organ was used for transplant. Procurement for transplant without an actual transplant is insufficient for inclusion in the donor outcome measure (see 84 FR 70631 and 85 FR 77903 for discussion of including only those organs that are used rather than procured with intent to use). Likewise, procurement of pancreata for islet cell research without actual use in that research is insufficient for inclusion in the donation rate outcome measure.

3. Organ

In the December 2020 final rule, we implemented the requirements of PICTA 2004 in the definition of “organ” in the OPO regulations at § 486.302, stating that an organ is “. . . a human kidney, liver, heart, lung, pancreas, or intestine (or multivisceral organs when transplanted at the same time as an intestine). The pancreas counts as an organ even if it is used for research or islet cell transplantation.” Although the term “organ” is used frequently throughout the regulations, it has a specific relationship to the “organ transplantation rate,” which is defined as the number of organs transplanted from donors in the DSA as a percentage of the donor potential. Organs that are transplanted into patients on the OPTN waiting list as part of research are explicitly included in the organ transplantation rate. The definition of the organ transplantation rate focuses entirely on transplant activities and the inclusion of bench research activities in this rate has created significant concern in the OPO and transplant communities. We agree with interested parties that including bench research within the definition of “organ” and by extension the “organ transplantation rate” has created a performance incentive that is not serving patients on transplant waitlists because the transplantation rate counts the use of a pancreas in islet cell bench research as being equivalent to a pancreas or pancreatic islet cell transplant. As such, the inclusion of pancreatic islet cell bench research in the definition of “organ” has proven to be inconsistent with the goals of the 2020 rulemaking to increase the number of transplants in that OPOs may have used the placement of pancreata for islet cell research to mask their performance in successfully facilitating actual organ and pancreatic islet cell transplants. Therefore, we propose to revise the definition of the term “organ” in a way that would no longer include pancreata used for islet cell research, unless the research is islet cell transplantation that occurs under a research protocol.

While PICTA 2004 requires that pancreata used in islet cell research be counted for purposes of certification and re-certification, it does not require that these organs be included in all established OPO outcome measures. In the 2006 OPO final rule (71 FR 30982) that established the formerly used set of OPO outcome measures, one of the three yield measures counted pancreata used for islet cell research while a separate yield measure counted pancreata used for islet cell transplantation. Previous CMS policy differentiated the treatment of pancreatic islet cells based on their use for either transplantation or research, and we propose to reinstate that differentiation as it relates to current policy. Under our proposal, a pancreas that is used for islet cell research without a transplant to a patient on the OPTN waiting list would count towards the donation rate outcome measure, but would not be included in the transplantation rate outcome measure. A pancreatic islet allotransplant to a patient on the OPTN waiting list, on the other hand, would be included in both the transplantation rate outcome measure and the donation rate outcome measure, whether it is conducted under standard or research protocols. 39 This policy of only including pancreatic islet cell transplants in the transplant outcome measure advances the CMS goal of increasing the number of transplants in service of those patients on the OPTN transplant waiting list.

39 In accordance with the regulations set forth at 42 CFR 413.406, Medicare only covers and pays for reasonable costs of acquisition of pancreata for islet cell transplants into Medicare beneficiaries participating in a National Institute of Diabetes and Digestive and Kidney Diseases clinical trial of islet cell transplantation in accordance with section 733 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003.

We are specifically soliciting comments on modifications to the proposed definitions of donor and organ, including any additional considerations that should be addressed in these definitions and alternative approaches to meeting the statutory

4. Medically Complex Donors and Medically Complex Organs

Traditionally, some donors and their organs have been preferred over others, based on the age and health status of the donor, by transplant programs and surgeons. Organs from donors with less-preferred characteristics may be perceived as less valuable for organ transplantation or not appropriate for transplantation at all. To address these misconceptions, we are proposing to both define and utilize the terms “medically complex donors” and “medically complex organs.” Moreover, in the QAPI CfC set out at section § 486.348, we propose to require that OPOs must track procurement and placement of these organs, assess their policies and procedures regarding medically complex donors and organs, and ensure they are optimizing the recovery and placement of those organs for transplant.

Although we have not previously defined these less-preferred organs, the OPO CfCs have differentiated between organs from different types of donors. In the 2006 OPO final rule (71 FR 30982), we defined “eligible organs” as organs recovered from a donor that met the “eligible death” definition. Those donors had to be (1) 70 years old or younger, (2) declared dead by the hospital's brain death criteria, and (3) patients who did not meet certain exclusionary criteria, which included, among other things, tuberculosis, human immunodeficiency virus (HIV), multiple-system organ failure, and certain cancers. These eligible deaths constituted the denominator for the donation rate outcome measure. Other organs, such as those recovered from donors over 70 years old or from donors who were declared dead by cardiac death criteria, were not “eligible organs.” Those donors and organs would however be counted and added to the outcome measures when the OPO obtained consent, and the organs were transplanted. In 2016, we modified the definition of “eligible death” to, among other things, include specific exclusionary criteria for kidneys, livers, hearts, and lungs. 40 Effective in 2022, we removed the “eligible death” definition and now the donor potential that is the denominator for the outcome measures is based on the number of inpatient deaths of persons 75 and younger within the DSA with a primary cause of death that is consistent with organ donation (currently 42 CFR 486.318(d)(1)(iv)). 41

40 81 FR 79562.

41 Organ Procurement Organizations Conditions for Coverage; Revisions to Outcome Measures Requirements for Organ Procurement Organizations (85 FR 77898).

As a result of these policies, some people in the organ transplant community may have considered those organs that did not meet the definition of “eligible organ” to be less valuable organs or did not consider transplanting them into their patients despite many individuals being on the waiting lists. These organs may have included organs from DCD donors, from donors older than 70 or 75, or from younger individuals with deteriorating health conditions.

Current research demonstrates that “medically complex organs” can produce positive and similar outcomes to other organs, and better outcomes than no transplant for patients. For example, recent research has demonstrated that kidneys recovered from DCD donors have similar long-term outcomes to organs from donors declared dead by brain death or neurological criteria (brain death donors), although some increases in complications related to graft function have been noted. 42 Another example is donors who have a KDPI over 50 percent. Recent research has also demonstrated that transplant recipients who received these organs had a lower mortality rate, and an improved quality of life compared to patients who are on chronic renal dialysis. 43

42 Rijkse E, Ceuppens S, Qi H, IJzermans JNM, Hesselink DA, Minnee RC. Implementation of donation after circulatory death kidney transplantation can safely enlarge the donor pool: A systematic review and meta-analysis Int J Surg. 2021 August;92:106021. doi: 10.1016/j.ijsu.2021.106021. Epub 2021 Jul 10. Accessed at https://pubmed.ncbi.nlm.nih.gov/34256169/. Accessed on September 29, 2022. See also FN#2, Wall, et al.

43 Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, and Gill J. Systematic Review: Kidney Transplantation Compared With Dialysis in Clinically Relevant Outcomes. https://doi.org/10.1111/j.1600-6143.2011.03686.x. Accessed at https://onlinelibrary.wiley.com/doi/full/10.1111/j.1600-6143.2011.03686.x. Accessed on September 29, 2022. See also FN#2, Wall, et al.

In addition, we are concerned that OPOs are not actively pursuing “medically complex” donors and their organs because of a perception that such organs may not be accepted by others in the transplant community, despite many individuals waiting on the transplant lists. Declining to use these organs, however, contributes to the chronic undersupply of transplantable organs, as well as potentially increasing mortality and decreasing quality of life for ESRD patients.

We believe that encouraging the pursuit of medically complex donors and organs when there is medical evidence that these organs can improve the quality of life or save the lives of more patients on the waiting list, by increasing the overall number of transplantable organs. The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report regarding the transplant ecosystem, “Realizing the Promise of Equity in the Organ Transplantation System” (NASEM 2022 organ transplant report). 44 The NASEM 2022 organ transplant report used the term “medically complex” to describe organs that were recovered from donors who had medical histories that deserved special considerations to identify the best recipient for that organ. The proposed definitions for “medically complex donor” and “medically complex organ” are primarily based upon the NASEM 2022 organ transplant report's description of medically complex donors and organs. Medically complex donors would include DCD donors and those with elevated KDPI scores over 50 that require greater consideration in choosing a potential recipient due to the DCD donation process and possible kidney damage. Since DCD donors have not been declared dead by brain death criteria, OPOs need protocols that address at a minimum: how these potential donors should be evaluated; how life support would be withdrawn, and the relationship between the time of consent to donation and withdrawal of life support; the use of medications and interventions not related to withdrawal of support; family members' involvement prior to organ recovery; and the criteria for declaration of death and the time period that must elapse prior to organ recovery (§ 486.344(f)). We also believe DCD donors need to be identified specifically because the number of recovered DCD organs has steadily increased over the last decade. In 2024, there were 7,280 DCD donors, which is an increase of 23.5 percent 45 We also believe donors with elevated KDPI scores should be considered medically complex. We are proposing that the term medically complex donors include those with a KDPI score of 50 or greater. However, we are specifically soliciting comments on at what score should the KDPI be considered elevated so that the potential donor would be considered “medically complex” and may revise the proposed KDPI score threshold in the final rule in response to comments received.

44 NASEM. (2022). Accessed at https://nap.nationalacademies.org/catalog/26364/realizing-the-promise-of-equity-in-the-organ-transplantation-system. Accessed on May 10, 2022.

45 Organ transplants exceeded 48,000 in 2024; a 33 percent increase for the transplants performed in 2023. OPTN. Jan 14, 2025. Accessed at https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023. Accessed on August 25, 2025.

Medically complex donors and organs also include donors that are HIV+ or have Hepatitis C. While HIV+ infection remains a serious illness, fewer individuals are dying from it and it is now considered a chronic disease. 46 In addition, transplants from an HIV+ donor to an HIV+ recipient must comply with the requirements set forth in the HIV Organ Policy Equity Act (HOPE Act), which includes complying with designated research protocols. 47 Hepatitis C can be an acute or chronic infection and, with treatment, most individuals can be cured. 48 While organs from donors that are HIV+ or have Hepatitis B or C can be successfully transplanted, these transplants require special or additional considerations in identifying the best potential recipient for these organs. For example, one study found that with appropriate consideration of both the DCD donor and the potential recipient, DCD liver transplants could have outcomes that were both acceptable and comparable to outcomes for non-DCD liver transplants. The considerations included but were not limited to cold and warm ischemic times, and comorbidities of the donor and the potential recipient, such as age, obesity, and “Model for End-Stage Liver Disease” (MELD) scores, which estimates the severity of the donor's liver disease. 49

46 Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013 Nov 2;382(9903):1525-33. doi: 10.1016/S0140-6736(13)61809-7. Epub 2013 Oct 23. PMID: 24152939; PMCID: PMC4058441. Accessed on January 24, 2024.

47 Public Law 113-51 (2013); Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. A Notice by the National Institutes of Health on November 25, 2015 Federal Register /Vol. 80, No. 227/Wednesday, November 25, 2015/Notices 73785 https://www.federalregister.gov/documents/2015/11/25.

48 CDC. Hepatitis C. Accessed at https://www.cdc.gov/hepatitis-c/about/index.htmlhttps://www.cdc.gov/hepatitis/hcv/index.htm. Reviewed October 31, 2023. Accessed on January 24, 2024.

49 Haque, O, Yuan, Q, Uygun, K, and Markmann, JF. Evolving utilization of donation after circulatory death livers in liver transplantation: the day of DCD has come. Clinical Transplantation. 2021;35:e14211. https://doi.org/10.1111/ctr.14211. Accessed at https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211. Accessed on September 21, 2015.

Hence, medically complex organs can be successfully transplanted and enhance and even prolong patients' lives; however, they have not been fully utilized. To encourage the use of these organs, we are proposing to define the term “medically complex donor” in § 486.302 as a donor whose medical history requires special or additional considerations to identify the best recipient for the organs. These donors would include all DCD donors and donors with elevated KDPI scores of 50 or more. We also propose to define the term “medically complex organ” as an organ procured from a “medically complex donor”.

We believe that defining “medically complex organs” and “medically complex donors” and including these organs and donors in OPOs' QAPI programs could result in more of these organs being procured and increase the number of transplantable organs for patients on the various waiting lists. However, we are also concerned that there could be unintended consequences resulting from this proposal. For example, could this requirement put unreasonable pressure on OPOs to procure medically complex organs? Thus, we are specifically soliciting comments on modifications to the proposed definitions of “medically complex donor” and “medically complex organ”, including any specific criteria that should be added. We are also specifically soliciting comments on how to define an “elevated KDPI”. Is 50 or more appropriate? If not, what KDPI score should be used? Also, are there any unforeseen consequences to this proposal?

5. Unsound Medical Practices

In the 2006 final rule, CMS finalized § 486.312(b), which states CMS may terminate an OPO's agreement immediately in cases of urgent need, such as the discovery of unsound medical practices. In addition, we finalized a definition for “urgent need” in § 486.302. Urgent need occurs when an OPO's noncompliance with one or more conditions for coverage has caused, or is likely to cause, serious injury, harm, impairment, or death to a potential or actual organ donor or an organ recipient. While we referenced “unsound medical practices” as grounds for immediate termination, the OPO CfCs do not currently include a definition for “unsound medical practices”.

Through feedback we have received, we recognize the need to clearly define what constitutes “unsound medical practices”. Therefore, we propose at § 486.302, to add a definition for “unsound medical practices”. We propose that the term “unsound medical practices” would refer to failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. These practices include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation, and transport practices and procedures. Some examples of unsound medical practices include, but are not limited to, failure to ensure the potential donor is declared dead according to applicable State law and hospital policies; negligent or deliberate 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. Our intent is to ensure that instances of actions that constitute unsound medical practices are addressed appropriately and that OPOs continue to provide high quality care to patients, potential donors and potential transplant recipients. We solicit public comment on the proposed definition of “unsound medical practices”.

B. Requirements for Certification (§ 486.303)

Section 486.303(e) requires that to be “certified as a qualified organ procurement organization,” an organization must have “been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005.” The Certification Act amended the PHS Act to add subparagraph (D) to section 371(b)(1), which defines a qualified OPO as an organization that “has met the other requirements of this section and has been certified or recertified by the Secretary within the previous 4-year period as meeting the performance standards to be a qualified organ procurement organization through a process” defined in regulations. 50 Section 371(b) of the PHS Act sets forth requirements that an OPO must meet to be certified. These requirements are also

50 42 U.S.C. 273(b)(1)(D).

After the Certification Act was passed, CMS proposed to remove language from our regulations that referred to new entities or organizations becoming OPOs. 51 We explained that “given the provision in (b)(1)(D) added by the OPO Certification Act . . . it appears impossible for the Secretary to give a grant to an organization that was not one of the 59 OPOs that was certified by the Secretary as meeting the performance standards in the 4-year period before January 1, 2000.” 52 We also proposed adding § 486.303(e), requiring that OPOs have been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005. 53 When finalizing the proposal, we reiterated that “we currently do not have the authority to permit new entities to take over part or all of an OPO's service area,” which “would be possible only if the Congress enacts legislation to change the requirement in the PHS Act because currently to be re-certified, an OPO must have been certified as of January 1, 2000.” 54 We have since repeated this interpretation. 55

51 70 FR 6091.

52 70 FR 6091.

53 70 FR 6090.

54 71 FR 30998.

55 85 FR 77898.

However, upon further review, we no longer believe that the Certification Act is best read to require all qualified OPOs to have been previously certified as of January 1, 2000. Instead, it is better read to mean 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. Section 371(b)(1)(D)(ii) of the PHS Act specifically provides that a qualified OPO may be “certified or recertified” through “a process” that is “defined through regulations . . . promulgated by the Secretary.” There is no language in that provision requiring that an OPO show it was certified as of January 1, 2000 as part of those standards. In fact, the statute requires the Secretary to “use multiple outcome measures as part of the certification process.” 56 That the statute contemplates creation of a certification process indicates that the Secretary is not limited to re certifying OPOs. Thus, nothing in the text of the statute supports reading it to strip the Secretary of his authority to certify either an entirely new OPO or one that was previously decertified.

56 42 U.S.C. 273(b)(1)(D)(ii)(III) (emphasis added).

This interpretation of the Certification Act is reinforced by the statutory history. The prefatory language in section 371(b)(1)(D) of the PHS Act is drawn from section 1138(b)(1)(A) of the Social Security Act. The main change Congress made was to swap out a reference to a qualified OPO needing to have been certified or recertified “within the previous 2 years” to a reference to a qualified OPO needing to have been certified or recertified “within the previous 4-year period.” Congress made legislative findings explaining that this change requires the agency “to extend the period for recertifications of an organ procurement organization from 2 years to 4 years.” 57 This use of familiar statutory language with a single targeted change that Congress explained does not indicate that Congress meant also to silently restructure the OPO market by prohibiting all new entrants.

57 Public Law 106-505 § 701(b)(5), 144 Stat. at 2347.

We acknowledge that this is a change in our understanding of the Certification Act. Executive Order 14219 directs Federal agencies to review existing regulations for potential candidates for rescission, prioritizing those that can no longer be justified under several recent decisions of the U.S. Supreme Court, including Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024). In Loper Bright, the Court explained that statutes have a “single, best meaning” that agencies must follow. Because we believe this is the best reading of the statute, it is consistent with the rationale of Loper Bright to adopt it. Additionally, OPOs were able to operate even with new entrants before 2000, and we have confidence they will be able to do so in the future. We have not previously cited independent policy reasons that would justify exercising our express authority to promulgate performance standards to include a requirement that OPOs have been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005. By contrast, we believe that removing this requirement would address concerns about market consolidation by creating a more diverse and robust market that enhances competition among OPOs. This proposal could also introduce innovation from new entities and increase the number of organs available for transplant.

Therefore, to align with our reinterpretation of the Certification Act and the directive in Executive Order 14219 to remove regulatory requirements that can no longer be justified in light of Loper Bright, we are proposing to remove § 486.303(e). We acknowledge that our prior rule removed references to newly certified OPOs and we are not, at this time, proposing to reinstate those references or to otherwise provide for the certification of new OPOs. However, we anticipate addressing the certification of new OPOs in the near term and are soliciting public comments on factors CMS should consider when certifying new OPOs. We specifically request public comments related to:

• The specific elements of the existing OPO regulations that an entity should be required to meet in order to become a newly certified OPO;

• The outcome and process performance measures organizations seeking certification should meet. What empirical evidence of organ donor potential and other related factors should be considered?

• Other criteria for evaluating the suitability of a potential new OPO to serve an open DSA;

• The process by which a newly certified OPO might obtain designation to a DSA.

++ Should newly certified OPOs be given priority for designation to open DSAs, compete against existing OPOs in open competition, or only compete in competitions against other newly certified OPOs?

++ If newly certified OPOs compete against currently certified OPOs, should the competition selection criteria be revised? If so, what factors should be considered for selection criteria given the lack of historical outcome and process performance data for new OPOs?

We would particularly appreciate comments that identify which specific provisions commenters would recommend we consider changing, and what specific changes commenters would recommend.

C. Designation of One OPO for Each Service Area (§ 486.308)

We propose to revise requirements at § 486.308 to further address changes made in the December 2020 final rule related to when a DSA is open for competition. Additionally, we intend to clarify how an OPO is assigned to a DSA and how we determine the OPO designation period. As described in section II.A. of this proposed rule, a DSA is a donation service area, and each OPO is currently designated to a DSA for organ procurement activities.

There are OPO-specific qualifications, processes, and timeframes found in the requirements at section 371(b) of the PHS Act and section 1138 of the Act. Section 371(b) of the PHS Act and § 486.303 list the requirements that an OPO must meet to be certified. Once certified, section 371(b)(1)(D)(ii)(I) of the PHS Act requires that OPOs must be re-certified not more frequently than once every 4 years. The re-certification cycle, defined at § 486.302, is the 4-year cycle during which an OPO is certified.

Only a certified OPO may be designated to a DSA. Once an OPO is designated for a DSA, certain organ procurement costs are eligible for Medicare and Medicaid payment under section 1138(b)(1)(F) of the Act. OPOs sign an agreement with CMS called a Health Insurance Benefits Agreement, Form CMS-576A, to provide services for the duration of an “agreement cycle”, defined at § 486.302 as “the time period of at least 4 years when an agreement is in effect between CMS and an OPO”. OPOs must periodically submit a Request for Designation as an OPO under section 1138 of the Act, Form CMS-576, and supporting documentation for a specific DSA. This is normally conducted during the re-certification process.

CMS evaluates OPOs periodically to ensure that the organizations continue to meet the requirements for certification. As referenced previously, under section 371(b)(1)(D)(ii)(I) of the PHS Act, re-certifications of qualified OPOs must not be more frequent than once every 4 years. In most cases, near the end of the agreement cycle there is a re-certification survey to ensure that the OPO continues to comply with statutory and regulatory requirements for certification. Surveys may also be conducted at other times to investigate complaints and allegations of non-compliance with the CfCs. Surveys are conducted by CMS staff from the various CMS locations and Federal contract surveyors. Currently, the agreement cycle for the designation period is 4 years and 6 months in duration and is reflected on the Form CMS-576A (CMS-R-13; OMB No. 0938-0512) that the OPO signs. The additional 6 months between the end of the re-certification cycle and the end of the agreement cycle provides time for an OPO to appeal a de-certification determination to the agency on substantive or procedural grounds and to enable the agency to select a successor OPO if necessary. The current re-certification cycle began on August 1, 2022, and will end on July 31, 2026. However, the current OPO agreement cycle began on August 1, 2022, and is scheduled to end on January 31, 2027.

To implement changes for OPO DSA designation and competition, we propose to revise § 486.308(a) and (b). Currently, § 486.308(a) states that, “CMS designates only one OPO per service area. A service area is open for competition when the OPO for the service area is de-certified and all administrative appeals under § 486.314 are exhausted.” We propose to relocate and revise the information pertaining to designation and relocate requirements for competition. Specifically, we propose to add introductory text (referred to as condition statement of the CfC) at § 486.308 to clarify that CMS designates only one OPO to a DSA. We will not designate multiple OPOs for one DSA, consistent with section 1138(b)(2) of the Act, but we may designate a single OPO for more than one DSA as discussed in sections III.D. of this proposed rule. We also propose to relocate the requirement that re-certification must occur not more frequently than once every 4 years from § 486.308(b)(2) to the introductory text at § 486.308 without change as part of the reorganization of these requirements.

We propose to revise the current requirements at § 486.308(b)(1) to address designation periods and relocate the requirements to proposed § 486.308(a). The current requirements indicate that “[a]n OPO is normally designated for a 4-year agreement cycle. The period may be shorter, for example, if an OPO has voluntarily terminated its agreement with CMS and CMS selects a successor OPO for the balance of the 4-year agreement cycle. In rare situations, a designation period may be longer, for example, a designation may be extended if additional time is needed to select a successor OPO to replace an OPO that has been de-certified.” We propose to redesignate and revise the requirements related to the length of designation periods from § 486.308(b)(1) to proposed § 486.308(a) to clarify that the planned duration of the designation period is at least 4 years for renewal of an OPO agreement.

We propose, at revised § 486.308(a)(1), to retain the flexibility to shorten or extend the agreement cycle in certain limited circumstances. However, we are proposing to clarify this provision by identifying involuntary termination, in addition to voluntary termination of an OPO's contract with CMS as the two circumstances under which an OPO's designation period may be shortened. A voluntary termination occurs when an OPO requests to voluntarily terminate its agreement with CMS. An involuntary termination that would shorten a designation period occurs when an OPO is de-certified due to non-compliance with CMS requirements, as specified at proposed § 486.312(a)(1) or (a)(4). In the event of non-compliance with the process performance measures (§§ 486.320 through 486.360), an OPO would normally be afforded the opportunity to submit a plan of correction to remedy non-compliance within a specific period of time. If the plan of correction is acceptable, involuntary termination would be averted provided the plan was successfully implemented by the OPO resulting in correction of noncompliance and verified by CMS. (See 42 CFR 488, subpart A). We propose at new § 486.308(a)(1) that CMS may adjust the length of a designation period when (i) there is a voluntary termination of an OPO's agreement with CMS, (ii) there is an involuntary termination of an OPO's agreement with CMS, (iii) additional time is needed to complete an appeal, conduct a competition, select a successor OPO, or transition the DSA to a successor OPO, or (iv) there is an extension of the agreement cycle for extraordinary circumstances as specified at § 486.316(f). At paragraph (a)(2) we propose that CMS would conduct a competition for all vacated DSAs.

We also propose at new § 486.308(a)(3) that the designation period for any newly acquired DSA following a competition, or as the result of being assigned a DSA as specified at § 486.316(e), will be the remaining portion of the agreement for the OPO's current re-certification cycle. For instance, if an OPO is designated to a new DSA following a competition in 2027, it would be designated for the remainder of the original OPO's re-certification cycle that would be anticipated to end in 2030. The successor OPO would fulfill the remaining portion of this re-certification cycle. We propose at § 486.308(a)(4) that if an OPO does not fulfill the term of its agreement, whether voluntarily or involuntarily, and there is insufficient time to conduct a competition to select a successor OPO for its DSA, we may designate another OPO, without a competition. We would exercise this option only if there were concern for continuity of organ donation in the DSA in situations such as a termination for urgent need, a cessation of business, or because the incumbent OPO was unable to sustain services to provide an orderly transition to a successor OPO. In selecting an OPO under these

The December 2020 final rule was limited in scope and focused on revisions to the outcome measures at § 486.318, leaving certain operational aspects to be revised through additional rulemaking. Given the tiered system for re-certification that was implemented in that rule, we are now clarifying when a DSA is open for competition and how competition affects designation. Currently, § 486.308(a) states that a service area is open for competition when the OPO for the DSA is de-certified and all administrative appeals at § 486.314 are exhausted. We propose to relocate this language to § 486.308(b) and amend it to conform with requirements for competition at § 486.316 and outcome measures at § 486.318.

We propose to address all instances when a DSA is open for competition.

• We propose to amend § 486.308(b)(1) to reflect that a DSA becomes open for competition when an OPO's DSA is assigned tier 3 status in the final assessment period and all administrative appeals are exhausted. An OPO's DSA is assigned tier 3 status if it has outcome measures currently described at § 486.318(e)(6) (tier 3), redesignated as proposed § 486.318(b)(6), and § 486.316(a)(3).

• We also propose conforming changes at § 486.308(b)(2) to clarify that an OPO's DSA is open for competition when the DSA is assigned to tier 2 for the outcome measures in the final assessment period, as currently described at § 486.318(e)(5), proposed to be redesignated to § 486.318(b)(5), and § 486.316(a)(2).

• We propose to add § 486.308(b)(3), stating that an OPO's DSAs are open for competition when the OPO is not in compliance with the process performance measures at §§ 486.320 through 486.360, as specified at § 486.312(a)(1) and § 486.316(b)(1), all administrative appeals are exhausted, and the OPO is pending de-certification.

• Finally, we propose at new § 486.308(b)(4) that a DSA would be open for competition when an OPO requests to voluntarily terminate its agreement to participate as specified in § 486.312(a), redesignated as proposed § 486.311(a)(2). However, this provision would not apply to a voluntary termination associated with an OPO's change in control or ownership or service area as specified at § 486.310, in which case the OPO is voluntarily terminating its agreement to participate in a merger with another OPO.

We solicit public comment on these proposed changes and ways to provide clarity to the designation and competition process.

D. Designation of an OPO to More Than One Service Area (§ 486.309)

We propose to remove obsolete requirements at § 486.309 and add new requirements to address situations if an OPO is responsible for more than one DSA. The current requirements at § 486.309 addressed the re-certification from August 1, 2006, through July 31, 2010 indicating that an OPO would be considered to be re-certified for the period of August 1, 2006 through July 31, 2010 if an OPO met the standards to be a qualified OPO within a 4-year period ending December 31, 2001 and has an agreement with the Secretary that is scheduled to terminate on July 31, 2006. Since this time period has passed, these requirements are now obsolete.

Since the December 2020 final rule was issued, some OPOs have requested guidance on how an OPO could manage more than one DSA. Section 1138(b)(2) of the Act provides that the Secretary may not designate more than one OPO for each service area and the current OPO CfCs only address one OPO being designated to only one DSA. Given that OPOs have expressed interest in this area and the statute does not explicitly restrict this situation, we are proposing requirements to address one OPO being designated to more than one DSA. Currently, there is a limited market in regard to the number of OPOs and DSAs, with 55 OPOs in total, each serving a single DSA (55 in total). Therefore, permitting an OPO to separately maintain multiple DSAs could maintain some level of market diversity to support future competition. This proposal would also mitigate risk of geographic consolidation when OPOs maintain separate DSAs rather than merging DSAs into one service area. Finally, some OPOs have expressed concern for assuming responsibility for DSAs where other OPOs have historically underperformed and merging those areas with their existing DSA. These OPOs have indicated they would prefer to manage DSAs separately to ensure they could improve performance without risk to their existing DSA.

We are proposing that an OPO may be responsible for more than one DSA when a new DSA is added following a change in control, ownership, or service area as specified at § 486.310, as result of a competition as specified at § 486.316, or following a voluntary or involuntary termination of an OPO's agreement as specified at § 486.311(a)(2) or § 486.312(a) respectively, or there is insufficient time to conduct a competition as specified at proposed § 486.308(a)(4). In these instances described previously, the OPO would need to determine how best to manage its organization for the respective areas. Some OPOs may find it beneficial to merge all assigned DSAs into a single DSA; however, other OPOs may not want to merge a new DSA into an existing DSA and may find it beneficial to maintain a separate designation for each DSA. We propose to revise § 486.309 to give OPOs more flexibility to address this situation. We are considering alternative policies on how an OPO could manage more than one DSA, which are discussed in detail in section VII.C. of this proposed rule.

Section 1138(b)(1)(C) of the Act permits the Secretary to provide payment with respect to organ procurement costs attributed to an organ procurement agency only if the agency meets performance-related standards prescribed by the Secretary. Additionally, section 371(b) of the PHS Act requires the Secretary to utilize outcome and process performance measures for the process of certification and re-certification of OPOs based on empirical evidence of organ donor potential and other related factors in each service area of qualified OPOs. Since OPOs have historically only been designated to one DSA, these requirements have not yet been applied to an OPO that is designated to more than one DSA. We propose to clarify application of both the outcome and process performance measures when an OPO may be designated to multiple DSAs. Our existing regulations require that OPOs must meet the minimum standards for both outcome measures at § 486.318 and the process performance measures at §§ 486.320 through 486.360 (see § 486.303(h)). The process measures are the broad operational requirements for OPOs and include items such as administration and governance, donor management, organ preparation and transport, and QAPI. An OPO found out of compliance with a process performance measure is subject to being de-certified at any time (§ 486.312(b)) but may be able to resolve the non-compliance within prescribed 58

58 https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c02.pdf.

OPOs must meet outcome measures for re-certification and payment purposes. To meet the outcome measures, an OPO is evaluated by measuring the donation rate and the transplantation rate in their DSA. In general, the outcome measures are assessed annually based on calendar year data and the final assessment period is used for re-certification (§ 486.302 (definition of “Assessment Period”)).

We are proposing that when an OPO consolidates multiple DSAs, regardless of contiguity, into a single DSA we would assess the OPO's performance on the outcome measures as a single DSA. The outcome measures for that merged DSA, however, would be used for any future assessment periods, including the final assessment, and potential disparate performance between the former two separate DSAs would not be reflected in the outcome measure data for the consolidated DSA. At the final assessment period, if the OPO could not satisfy the outcome measures for the merged DSA, the OPO would be de-certified (subject to the available appeal rights).

An OPO with one DSA faces de-certification if it is non-compliant with any of the CfCs, including the process performance measures (§§ 486.320 through 486.360) or the outcome measures (§ 486.318) at the time of re-certification. However, our proposed approach would permit an OPO that obtains a new additional DSA to choose to maintain separate DSAs, rather than consolidating its new DSA with its existing DSA. While the OPO would still be required to meet the process performance measures in the conditions for coverage for all of its DSAs to avoid de-certification, we propose that we would consider the OPO's performance on the outcome measures separately for each DSA when the OPO chooses to maintain separate DSAs. This would enable the OPO to meet the outcome measures in one DSA, even if the OPO did not satisfy the outcome measures in a separate DSA at the time of re-certification. If at the time of re-certification an OPO met the outcome measures at § 486.318 for one of its DSAs (tier 1 as specified at § 486.318(e)(4), proposed to be redesignated as § 486.318(b)(4) or tier 2 as specified at § 486.318(e)(5), proposed to be redesignated as § 486.318(b)(5)) and did not meet the outcome measures for another of its DSAs (tier 3 as specified at § 486.318(e)(6), proposed to be redesignated as § 486.318(b)(6)), CMS would remove designation for the DSA in which the OPO has tier 3 performance, and the DSA would be opened for competition. The OPO would be able to appeal the decision to remove the designation prior to the competition due to its failure to meet the outcome measures in that DSA. In this instance, the OPO would not be given a notice of de-certification as specified in proposed § 486.312(b) and would instead receive a notice of removal of designation to a DSA without de-certification (proposed § 486.314(a)(2)). If all of an OPO's DSAs have tier 3 performance, the OPO fails to meet the performance standards to be a qualified OPO and would be sent a notice of an initial de-certification determination as specified at proposed §§ 486.312(b), 486.314(a)(1), and 486.316(b)(2)(iii)(A). The OPO would have the opportunity to appeal the de-certification determination. If the CMS determination is upheld on appeal, the OPO would be de-certified and all of its DSAs opened for competition. De-certification is discussed in detail in section III.E. and appeals are discussed in section III.F. of this proposed rule.

To give OPOs this additional flexibility to maintain separate DSAs, we propose to add a new requirement for OPO designation of more than one DSA at § 486.309 to replace the current requirements. First, we propose a new section heading at § 486.309 for OPO designation to more than one service area. Second, at § 486.309(a), we propose three circumstances for which an OPO may be designated to more than one DSA. Such circumstances include a change in control, ownership or service area as specified at § 486.310 (proposed paragraph (a)(1)); following a competition as specified at § 486.316 (proposed paragraph (a)(2)); or following a voluntary or involuntary termination of an OPO's agreement with CMS, when a new OPO was assigned to the DSA and there was insufficient time to conduct a competition as specified at § 486.308(a)(4) (proposed paragraph (a)(3)). Third, we propose at § 486.309(b), that when requirements of paragraphs (a)(1) or (a)(2) of proposed § 486.309 are met after a change in ownership, control or service area or competition, the OPO may choose to consolidate the DSAs, maintain separate DSAs, or a combination thereof if more than two DSAs are involved. If we were to assign an OPO to a DSA after a voluntary or involuntary termination, as proposed at § 486.309(a)(3), we would not permit the DSA to be consolidated to facilitate future competition for that DSA and would open that DSA for competition at the end of the designation period. Designation of an OPO to a DSA in this situation would be a temporary measure intended to maintain organ procurement services to provide time to facilitate an orderly transition of the DSA to a successor OPO following a competition.

We propose, at § 486.309(c), that when an OPO is designated to more than one DSA, CMS would remove designation to a tier 3 DSA in the event of non-compliance with the outcome measures for that DSA at the end of the re-certification cycle (that is, donation or organ transplantation rates are below the median threshold rates established), as specified at proposed § 486.316(a)(3) and § 486.318(e)(6), proposed to be redesignated as § 486.318(b)(6). At paragraph (c)(1), we propose that removal of designation will not result in de-certification until an OPO is no longer designated to any DSA due to tier 3 outcome measure performance in all of its DSAs, as specified at § 486.316(b)(2)(iii)(A). We also propose at paragraph (c)(2) that an OPO may appeal the decision to remove its designation to a tier 3 DSA as specified at § 486.314 and that the DSA will be opened to competition after all appeals are exhausted for that DSA. We request public comment on these proposed changes in § 486.309, including additional factors that OPOs may want to consider related to consolidating DSAs versus keeping them separate as well as alternative policy approaches to address a single OPO being designated to more than one DSA.

We note that the OPO Life Alliance Organ Recovery Agency (LAORA)'s DSA was opened for competition with the application deadline closing on December 8, 2025, as a result of the OPO's pending de-certification. In the competition announcement, CMS indicated that the successor OPO to this DSA would be required to maintain the DSA separately from their existing DSA. We note this agency decision was based on both the long history of underperformance in this DSA and CMS' desire to carefully monitor the changes after the successor OPO assumes responsibility for the DSA. This has prompted the consideration of alternative policies regarding the process for when an OPO manages more than one DSA, which are discussed in detail in section VII.C. of this proposed rule.

We seek to provide sufficient flexibility to OPOs so that they can

E. Non-Renewal of Agreement (§ 486.311) and De-Certification (§ 486.312)

To address the implementation of the tier system for re-certification of OPOs, we propose to establish a new CfC at § 486.311 for non-renewal of an OPO agreement. Additionally, we propose to revise § 486.312 to address enforcement actions that may result in de-certification of an OPO.

In the December 2020 final rule, we finalized a new tier designation process for re-certification of OPOs. OPOs are designated to DSAs that are assigned as either tier 1, tier 2, or tier 3 based upon their performance on the outcome measures set forth in § 486.318 and their re-certification survey. This tiered system for re-certification and competition became effective on March 30, 2021, and is currently being implemented during the 2022 through 2026 re-certification cycle that began on August 1, 2022, and is scheduled to end on July 31, 2026. OPOs with DSAs that are in tier 3 during the final assessment period in the re-certification cycle will be decertified, pending appeals. OPOs with DSAs that are in tier 2 during the final assessment period in the re-certification cycle will be required to compete to retain their DSA, but they may also compete for any other DSA that is open for competition. An important distinction between tier 3 DSAs and tier 2 DSAs is that only tier 3 DSAs reflect that the OPO is out of compliance with the outcome measures for that DSA. Therefore, an OPO with all of its DSAs in tier 3 may be de-certified. Alternatively, an OPO with a tier 2 DSA is in compliance with the outcome measures for that DSA, and provided it is also in compliance the process performance measures, is re-certified as meeting the performance standards to be a qualified OPO and will have its agreement renewed provided it is successful in a competition for that or another open DSA.

The competition process means there is a possibility that an OPO with a tier 2 DSA would not be successful in the competition to retain its DSA. If the OPO is not designated for its DSA (and it did not win a competition for any other open DSA), the OPO would no longer be designated as an OPO at the end of the current agreement.

The current requirements for non-renewal of an agreement are located at § 486.312(c) and state that “CMS will not voluntarily renew its agreement with an OPO if the OPO fails to meet the requirements for certification at § 486.318, based on findings from the most recent re-certification cycle, or the other requirements for certification at § 486.303. CMS will de-certify the OPO as of the ending date of the agreement.” This requirement does not address the differences between tier 2 and tier 3, which is that an OPO with one or more tier 2 DSAs, while in compliance with the outcome measures in those DSAs, is not de-certified but will not be offered a new agreement if it does not retain any of its DSAs or successfully compete for an open DSA; whereas OPOs with tier 3 DSAs are out of compliance with the outcome measures in those DSAs, potentially resulting in de-certification. To address this issue, we propose a new CfC at § 486.311, non-renewal of agreement.

We propose, at § 486.311(a)(1), to address non-renewal for OPOs with tier 2 DSAs that are unsuccessful in competition. We propose that CMS will not renew an agreement with an OPO if the OPO is subject to a competition (as set forth at § 486.316(a)(2)), the OPO is unsuccessful in the competition, and the OPO is no longer designated to any DSA. The OPO would not be afforded appeal rights for loss of a competition, consistent with our long-standing policy, as described in the 2006 final rule. (see 71 FR 30998). In the 2006 final rule, we stated, “The statute requires only that we provide the opportunity to appeal a de- certification. An appeals process following a competition would be both expensive and unwieldly. We believe it would increase uncertainty for the OPO that prevailed in the competition and that this may disrupt the new OPO's ability to increase organ donation in the service area”. We also stated that “our competition decision is final” (71 FR 30998). This position is based on our intent to be able to choose the OPO most likely to increase organ donation and best serve the interests of all impacted by the actions and outcomes of the OPO. OPOs do not have an intrinsic right to be awarded a DSA following a competition and CMS may select the OPO most appropriate for that DSA.

In our proposed approach, an OPO with tier 2 DSAs that fails to retain any of its DSAs in competition would not be de-certified and could secure another agreement if it were successful in a concurrent or subsequent competition for another DSA, assigned a DSA by CMS (see § 486.316(e)), or selected for an open DSA under proposed § 486.308(a)(4). Since the OPO is compliant with the CfCs, it would be re-certified without being designated to a DSA. This would permit the OPO to compete in any additional open competitions during the following 4-year re-certification period. If the OPO is successful in a competition, assigned a DSA by CMS under § 486.316(e), or selected for an open DSA under § 486.308(a)(4), it could then be designated to a DSA during this period. If the OPO does not obtain a new DSA through competition, assignment under § 486.316(e), or selection under proposed § 486.308(a)(4) by the end of the re-certification cycle following the non-renewal of the OPO's agreement, it would not meet outcome measure standards for that cycle. Consequentially, the OPO would be de-certified at that time in accordance with the requirements at proposed § 486.312(a)(3). The OPO would be afforded appeal rights for the de-certification in accordance with the requirements at § 486.314. For instance, during the anticipated 2026 re-certification cycle, an OPO with a single tier 2 DSA that did not win any competition would be re-certified for the duration of the next recertification cycle that would extend to 2030. However, the OPO would not be designated to a DSA unless it was successful in subsequent competition or assigned a new DSA by CMS prior to the end of the re-certification cycle in 2030. Therefore, if the OPO was not designated to any DSA at the end of the re-certification cycle in 2030, it would be de-certified at that time.

We propose at § 486.311(b) that we would provide notification to the OPO at least 90 days before the effective date of the non-renewal and that the notice would state the reasons for non-renewal and include the end date of the agreement.

We also propose, at § 486.311(a)(2), that non-renewal of an agreement (currently at § 486.312(c)) would include a voluntary termination of an agreement by an OPO. The current requirement for voluntary termination of an agreement is located at § 486.312(a). If an OPO wishes to terminate its agreement with CMS, it must send written notice of its intention to terminate and the proposed effective date. Currently, we may approve the proposed date, set a different date no later than 6 months after the proposed effective date, or set a date less than 6 months after the proposed effective date if we determine that a different date would not disrupt services to the service area. Additionally, if we determine that a designated OPO has ceased to furnish organ procurement services to its service area, the cessation of services is deemed to constitute a voluntary termination by the OPO. The current rule states that we will de-certify the OPO as of the effective date of the voluntary termination. We propose to relocate and revise the voluntary termination of agreement provision from § 486.312(a) to § 486.311(a)(2) and remove the requirement that we would de-certify the OPO. An OPO voluntarily withdrawing from its agreement or ceasing to furnish organ procurement services has taken an affirmative step to end its duties under the OPO agreement, but that action does not entitle the OPO to appeal a de-certification on substantive or procedural grounds. As such, the voluntarily withdrawing OPO would not be afforded appeal rights. The OPO would no longer have an agreement, and would no longer be designated to any DSAs, as of the effective date determined by CMS. We note that in Section III.C. of this proposed rule, we provide an alternative considered related to voluntary withdrawal. In this section, we consider an alternative approach of permitting an OPO with more than one DSA to withdraw from a specific DSA without effectively ending its agreement with CMS. We seek public comment on this alternative approach as well as the benefits and risks of establishing such a policy.

We also propose a public notice requirement at § 486.311(c) consistent with the current public notice requirements at § 486.312(e) to inform the public of the change. We would provide public notice in the service area of the date that a new OPO will be designated for the DSA. We also propose new § 486.311(d) to provide that no payment under titles XVIII or XIX of the Act will be made with respect to organ procurement costs attributable to an OPO that no longer has an agreement with CMS.

We propose to reorganize and revise the requirements at § 486.312 to clarify the actions we may take related to de-certification of an OPO. The current requirements pertain to (a) voluntary termination of agreement, (b) involuntary termination of agreement, (c) non-renewal of agreement, (d) notice to OPO, and (e) public notice. As mentioned earlier in this proposed rule, requirements for non-renewal of agreement (currently § 486.312(c)) and voluntary termination (currently § 486.312(a)) would be relocated to proposed § 486.311(a).

We propose to relocate and revise the requirements for involuntary termination of agreement at § 486.312(b) to proposed § 486.312(a). Involuntary termination would result in de-certification of the OPO. Specifically, we propose at paragraph (a)(1) that we may involuntarily terminate an OPO during the re-certification cycle if the OPO no longer meets the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360, as specified at proposed § 486.316(b)(1). The conditions for coverage at §§ 486.320 through 486.360 are generally referred to as process performance measures. Non-compliance means the OPO has one or more condition-level deficiencies that it is unable to resolve within a specified timeframe. We propose at paragraph (a)(2) that we may involuntarily terminate an OPO if the OPO is only designated to tier 3 DSAs in the final assessment period, as described at proposed § 486.316(b)(2)(iii)(A), at the end of the agreement. At paragraph (a)(3) we propose that we would de-certify an OPO if it is no longer designated to any DSA and does not have data available from the final assessment period to demonstrate compliance with the outcome measures at the end of the re-certification cycle. This would address the potential outcome of a tier 2 OPO that was re-certified but did not have an agreement renewed because it did not win a competition as specified at proposed § 486.311(a)(1) and was not otherwise assigned a DSA by CMS. Finally, we propose to relocate and revise the requirements for immediate termination in cases of urgent need, such as the discovery of unsound medical practices, currently located at § 486.312(b) to proposed new paragraph at § 486.312(a)(4). We also propose to revise and relocate the requirements regarding notice of de-certification to the OPO by redesignating and revising § 486.312(d) as paragraph § 486.312(b). We propose that except in cases of urgent need, the initial notice of de-certification would be provided to the OPO at least 90 calendar days before the effective date of the de-certification. In cases of urgent need, the notice would be provided at least 3 calendar days prior to the effective date of the de-certification. The notice would state the reasons for de-certification, explain the available appeal rights, and include the effective date of the de-certification.

We also propose to revise and redesignate the requirements pertaining to public notice of de-certification currently at § 486.312(e) to § 486.312(c). The current requirements indicate that “[o]nce CMS approves the date for a voluntary termination, the OPO must provide prompt public notice in the service area of the date of de-certification and such other information as CMS may require. In the case of involuntary termination or nonrenewal of an agreement, CMS also provides notice to the public in the service area of the date of de-certification. No payment under titles XVIII or XIX of the Act will be made with respect to organ procurement costs attributable to the OPO on or after the effective date of de-certification.” We are proposing to remove the requirement that the OPO provide public notice in these situations. We have proposed to revise this requirement to indicate that CMS will provide public notice in the service area of the date of de-certification and the date that a new OPO will be designated for the DSA.

We believe that this proposed reorganization will provide greater clarity into the actions that may occur as a result of the tiered system and competition under the outcome measures. Grouping items based on potential outcomes and impact to the OPO agreement and certification status better aligns with the program requirements, including any appeals process that may follow an adverse action. We solicit public comment on these proposed changes and additional factors to consider or changes to assist in refining the requirements of this section.

F. Appeals (§ 486.314)

The Organ Procurement Organization Certification Act of 2000 59 required the Secretary to issue regulations that allow an OPO to appeal a de-certification on substantive and procedural grounds. To

59 Section 701(c)(3) of the Organ Procurement Organization Certification Act of 2000. 114 STAT. 2346, Public Law 106-305. Published November 13, 2000.

We propose to revise the introductory text at § 486.314 to allow an OPO to appeal a de-certification as described at § 486.312(a) or the removal of a designation to a tier 3 DSA without de-certification as described at § 486.316(b)(2)(iii)(B). As a result of the competition process as set forth at revised § 486.316, some OPOs might eventually be designated for more than one DSA. Thus, an OPO may not be de-certified because at least one of their DSAs is assigned to tier 1 or tier 2 in the final assessment period of the re-certification cycle. However, if one of the OPO's DSAs is assigned to tier 3 in the final assessment period, the OPO could lose its designation for that DSA. Although the removal of a designation for a DSA is not a de-certification if the OPO retains at least one DSA that is not assigned to tier 3, the OPO has been found to be non-compliant with the outcome measures in the tier 3 DSA. Thus, we believe that an OPO should also have appeal rights for the removal of designation to a DSA without de-certification. Consequently, we propose to add references to the removal of designation for a DSA assigned as tier 3 without de-certification alongside references to de-certification in § 486.314, as applicable, to reflect that an appeal would be available in either scenario. We propose to revise paragraph (a) for the notice of initial determination and add new paragraphs (a)(1) and (a)(2) to address de-certification and removal of a DSA without de-certification respectively.

We propose to modify the time periods in this section for existing requirements from “business days” to “calendar days”. We also propose to use “calendar days” for all proposed requirements. CMS will compute time periods based on “calendar days” according to the process described in Federal Rules of Civil Procedure (FRCP), Rule 6(a)(1). 60 This is for both consistency and to avoid confusion in the appeals process.

60 FRCP, Rule 6(a)(1) (providing that when a time period is stated in days or a longer unit of time, “(A) exclude the day of the event that triggers the period; (B) count every day, including intermediate Saturdays, Sundays, and legal holidays; and (C) include the last day of the period, but if the last day is a Saturday, Sunday, or legal holiday, the period continues to run until the end of the next day that is not a Saturday, Sunday, or legal holiday.”).

Currently, the OPO has 15 business days from receipt of the notice to request reconsideration from CMS. If the OPO does not request a reconsideration within those 15 business days, the OPO has no right to further administrative review. We propose to change this to 20 calendar days as set forth in proposed § 486.314(b)(1). CMS currently has 10 business days from receipt of the reconsideration request to make a written reconsidered determination that would affirm, reverse, or modify the initial de-certification determination. We propose to modify this to 15 calendar days to make a written reconsidered determination that would affirm or reverse the initial de-certification determination, as set forth in proposed § 486.314(b)(3). We are also proposing that CMS has the right to extend this time based on a determination that additional time is necessary to thoroughly review, make a decision and the extension does not prejudice either party. We also propose to remove the option for the reconsideration official to “modify” the initial de-certification determination. We do not believe it is appropriate for the reconsideration official to modify the determination. Not only does he or she usually only have 15 calendar days to review the initial de-certification determination, but also we believe there will be insufficient time and information for the official to develop a modification to that determination.

Currently, if the de-certification decision is upheld, the OPO then has 40 business days from receipt of CMS' reconsideration decision to request a hearing before a CMS hearing officer. If an OPO does not request a hearing or its request is not received timely, the OPO has no right to further administrative review. The hearing officer must set a date for the hearing that is no more than 60 calendar days after receiving that request for a hearing and must render his or her decision within 20 business days of the hearing.

We propose at § 486.314(c) to reduce the number of days within which an OPO must request a hearing before a CMS hearing officer from 40 business days to 15 calendar days. We did not previously explain the 40-business day timeline beyond stating that the appeals process generally “will protect a de-certified OPO's rights, provide it with sufficient time to pursue its appeal, and ensure that it receives a fair hearing”. 61 However, a full 40 business days could contribute to disruptions in organ procurement activities in the DSA and unduly extend the appeals process. This proposed change is limited to the request for a hearing before a CMS hearing officer. The shorter timeline to request a hearing would continue to sufficiently protect an OPO's rights, including time to pursue an appeal and receive a fair hearing. The only decision the OPO needs to make before filing its request for a hearing is whether it wants to challenge the de-certification or the removal of a designation to a DSA without de-certification. However, we also believe that in making the decision to appeal, the OPO would have also begun gathering relevant documents and other evidence, as well as formulating the arguments it would need for the hearing. If the OPO requests a hearing, the hearing officer must set a hearing date that is not more than 60 calendar days following the receipt of the request for a hearing (§ 486.314(f)). The OPO and CMS would have additional time from the date the hearing is requested until the hearing date to more fully prepare their legal arguments and factual support for the hearing. Both the OPO and CMS could submit briefs, have witnesses testify, and submit additional evidence during the hearing as currently allowed under § 486.314(g). During the conduct of the hearing, the hearing officer would inquire fully into all relevant and material document and witness testimonies (§ 486.314(g)). Requiring OPOs to file a request for a hearing before a CMS hearing officer within 15 calendar days of receiving the notice of the reconsideration determination balances the OPO's interest in providing ample time to file an appeal with the interests of patients' access to organ transplants by shortening the time required for the appeals process. During the appeals process, some resources will by necessity be devoted to the appeal, which means that not all the OPO's resources will be devoted to organ procurement activities. Hence, an efficient appeals process is necessary to resolve the appeal and either have the OPO devote all its resources to the procurement activities in the DSA or proceed with identifying and transitioning to a successor OPO.

61 71 FR 30994.

Also, § 486.314(d) currently states that the hearing officer sends the administrative record to both parties within 10 business days of receipt of the request for a hearing. Because the Office of Hearings now uses an electronic case management system in which both parties have access to each other's filings, the reconsideration official does not need to forward their administrative record to the hearing officer unless and until there has been a request for a hearing. We propose to revise § 486.314(d) to state that upon receipt of a request for a hearing, the hearing officer will promptly request the administrative record from the reconsideration official. We also propose that the hearing officer, within 15 calendar days of receipt of the request for a hearing, would send the administrative record to both parties, or make it available through their electronic filing system, rather than the current 10 business days. Now that there is an electronic filing system available, we believe this would be a timely and efficient way to share the administrative record and we want to encourage its use.

Additionally, we propose to revise and redesignate paragraph § 486.314(i) and redesignate paragraphs (j) and (k) to incorporate new paragraphs for requirements to update the appeals process. Specifically, we propose redesignating the current paragraph (i) to paragraph (k) to address the hearing officer's decision and to extend the time for the hearing officer to render their decision to 90 calendar days. Under current § 486.314(i), the CMS hearing officer has 20 business days to render their decision. We are concerned that 20 business days may not be enough for the hearing officer to complete their tasks. In addition to conducting the hearing and rendering a decision, the hearing officer must develop an administrative record of the hearing that is sufficient for any subsequent review. This could include post-hearing activities, such as the hearing officer, at their discretion, permitting the filing of post-hearing briefs on issues raised at the hearing. Thus, we propose to revise and redesignate the current requirements at § 486.314(i) to paragraph (k), extend the time for the hearing officer to issue their decision to 90 calendar days, and provide that the hearing officer has the right to extend that time upon notifying both the OPO and CMS, if the extension does not unduly prejudice either of the parties and is necessary for the hearing officer to issue a legally sufficient decision. We also propose that the hearing officer can affirm or reverse the notice of de-certification or removal of designation to a DSA without de-certification. The hearing officer would then promptly forward his or her decision and the administrative record to the CMS Administrator to decide whether or not to exercise discretionary review of the hearing officer's decision.

We propose a new (i) that will set forth requirements related to scope of review. In the appeals process, we believe OPOs should have the burden to demonstrate that they are entitled to relief. This is not explicitly stated in the current version of § 486.314. Since it is the OPO that is challenging the notice of de-certification or the removal of designation for a DSA without de-certification, we believe the burden of proof on the OPO is implicit. Thus, we propose in new paragraph (i) to clarify that OPOs have the burden of proof by a preponderance of the evidence.

We also propose to revise and redesignate the current paragraph (j) to paragraph (n). This subsection already provides CMS the authority to extend its agreement with an OPO to allow for competition and, if necessary, transition of the service area to a successor OPO. However, we are concerned that the effective date of de-certification or removal of designation for a DSA may be significantly delayed by the appeal process. Hence, we propose adding the appeals process to the reasons an extension of the agreement past the expiration date might be necessary. We are also soliciting comments regarding whether there should be any limitations on CMS' authority to extend the OPO's agreement with CMS. In particular, we are considering what, if any, conditions we should place on the extension, and what, if any, maximum amount of time CMS could extend the agreement.

We also propose establishing an additional provision in the administrative appeals process. The CMS Administrator has the right to review CMS hearing officers' decisions, regardless of whether the hearing officer reversed or affirmed the de-certification or the removal of designation for a tier 3 DSA without de-certification. However, the Administrator's review is not currently addressed in the appeals section. Without requirements addressing the Administrator's review, OPOs and the public would not be aware of the procedures that would be followed after the hearing officer renders their decision. The CMS Administrator's discretionary review is a crucial phase of the appeals process, and we want to provide clarity to ensure that all parties and the public have a clear understanding of the process. The proposed requirements will also clarify when the appeals process is exhausted and, if the OPO is de-certified, when CMS will move forward with competition for the open DSA. Therefore, we propose new § 486.314( l ) to codify the process for discretionary review by the CMS Administrator of the hearing officer's decision. Specifically, we propose that the CMS Administrator has 30 calendar days from receipt of the hearing officer's decision to elect to review or decline to review the hearing officer's decision. If the CMS Administrator elects to review the hearing officer's decision within the 30-day period, the CMS Administrator will promptly notify the OPO and CMS of his or her election to review and the parties' right to submit written arguments within 15 calendar days of the notification. If the Administrator does not elect to review the decision within 30 calendar days of its receipt, the hearing officer's decision is final.

We propose that within 45 calendar days of notification of the CMS Administrator electing to review the hearing officer's decision, the CMS Administrator must render a final decision, in writing, to the parties. The CMS Administrator can affirm, reverse, or remand the hearing officer's decision to CMS as discussed below. We are also proposing that the CMS Administrator has the right to extend this time if he or she determines they need more time to thoroughly review and make a decision and the extension does not prejudice either party. We propose that the CMS Administrator's review be limited to the hearing's administrative record developed by the hearing officer and written arguments submitted by the OPO or CMS. The CMS Administrator's administrative record would be composed of all documents submitted to the hearing officer or developed in the course of the hearing, including the hearing officer's decision, as well as written arguments from the OPO or CMS explaining why either or both parties believe the hearing officer's determination was correct or incorrect, and the CMS Administrator's written decision explaining his or her decision and the reason for that decision.

We propose that our decision whether to de-certify an OPO or remove its designation to a particular DSA would become final if the OPO does not request review by a hearing officer in the time allowed under these regulations, or after the CMS Administrator declines to review the hearing officer's decision, renders a final decision in writing to the parties, or does not render a final decision or a remand in writing to the parties within 45 calendar days of electing to review

We also propose to revise and redesignate current (k) to new paragraph (o) at § 486.314 to clarify when the OPO's DSA is opened for competition. Consistent with our current rule, an OPO will not be de-certified or lose its designation to a DSA until all administrative appeals are exhausted. If at the end of the appeals process the notice of de-certification or removal of designation for a DSA without de-certification has not been reversed or remanded, the decision is final. At that time, the OPO's DSA would be competed and a successor OPO would be chosen. CMS would then determine a transition period that is sufficient for the new OPO to take full responsibility for the DSA. After the transition period is determined by CMS, CMS would forward to the de-certified OPO a written communication indicating the effective date of de-certification, at which time Medicare and Medicaid payments may no longer be made for organ procurement costs attributable to the OPO. For an OPO that loses its designation to a tier 3 DSA without being de-certified, CMS would forward a written communication indicating the effective date of the decision, at which time Medicare and Medicaid payments may no longer be made for organ procurement costs attributable to the affected OPO for that particular DSA. We would not begin the competition process before the appeals process is exhausted.

We believe that there might be circumstances in which the CMS Administrator could want CMS to conduct further review or have other instructions for CMS regarding the appeal. For example, the CMS Administrator might want further analysis of data. Hence, we propose that the CMS Administrator may remand the appeal to CMS for any appropriate reason in proposed (m). Remanding the appeal means that the appeal is sent back to CMS for re-evaluation and a new initial determination regarding de-certification or removal of designation for a DSA without de-certification. Also, if the appeal is remanded to CMS, the agency will comply with any instructions in the remand. We are not proposing remand authority for the hearing officer.

We propose a new subsection (p) to address de-certification due to urgent need. We have received feedback that there is some confusion about how the appeals process would proceed for an OPO de-certified due to urgent need. The appeals process is the same regardless of the reason for the OPO's de-certification. However, if an OPO is de-certified due to urgent need, it may be de-certified immediately (proposed 42 CFR 486.312(a)(4)). In such circumstances, the affected OPO's service area would be reassigned to one or more other OPOs as set forth at proposed § 486.308(a)(4) by the effective date specified in the notice of de-certification provided under proposed § 486.312(b). Hence, if the de-certified OPO pursues an appeal, it would not be operating its DSA while proceeding through the appeals process.

Notwithstanding the reason for the de-certification, if the initial notice of de-certifi

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