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

Issuing agencies

Abstract

This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule revises definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals. We are committed to holding all OPOs accountable for their performance and this final 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.

Full Text

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<title>Federal Register, Volume 91 Issue 211 (Tuesday, November 3, 2026)</title>
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[Federal Register Volume 91, Number 211 (Tuesday, November 3, 2026)]
[Rules and Regulations]
[Pages 69390-69444]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22381]



[[Page 69389]]

Vol. 91

Tuesday,

No. 211

November 3, 2026

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 486





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

Federal Register / Vol. 91 , No. 211 / Tuesday, November 3, 2026 / 
Rules and Regulations

[[Page 69390]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 486

[CMS-3409-F]
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: Final rule.

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SUMMARY: This final rule revises the Conditions for Coverage for Organ 
Procurement Organizations (OPOs) to clarify outstanding procedural 
questions and provide additional operational flexibility for OPOs to 
achieve high performance resulting in the successful procurement, 
distribution, and transplantation of more life-saving organs. This rule 
revises definitions, revises the designation requirements for OPOs, 
clarifies when an OPO's service area is open for competition, and 
updates the process for appeals. We are committed to holding all OPOs 
accountable for their performance and this final 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: These regulations are effective on January 4, 2027.

FOR FURTHER INFORMATION CONTACT: The Clinical Standards Group, (410) 
786-6633, <a href="/cdn-cgi/l/email-protection#e5ad808489918d848b81b6848380919cac8b94908c978c8096a5868896cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="90d8f5f1fce4f8f1fef4c3f1f6f5e4e9d9fee1e5f9e2f9f5e3d0f3fde3bef8f8e3bef7ffe6">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

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 for an organ transplant, including how well a 
waitlisted individual matches with available donors, how sick the 
person is, and the availability of organs in the region. Despite 
continued growth in organ donation, procurement, and transplantation, 
the need for transplantable organs continues to grow. The success of 
organ procurement organizations (OPOs) in performing their essential 
functions (obtaining consent for donation, working with the Organ 
Procurement and Transplantation Network (OPTN) to match organs with 
recipients, procuring viable organs, and delivering those organs in 
transplantable condition to their recipients) is a rate limiting factor 
on the success of the entire organ transplant system. Therefore, 
optimal performance of OPOs is critical to ensure that the maximum 
possible number of transplantable human organs are available to the 
yearly average of more than 100,000 seriously ill people on waiting 
lists for a lifesaving organ transplant.
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    \1\ Organ Donation Statistics. <a href="https://www.organdonor.gov/learn/organ-donation-statistics">https://www.organdonor.gov/learn/organ-donation-statistics</a>. Accessed on April 29, 2025.
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    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 OPO 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 OPO final 
rule, CMS has received many inquiries from OPOs and others seeking 
clarification on operational and administrative elements. These 
inquiries increased in frequency and volume as the system moved closer 
to the end of the 2022-2026 re-certification cycle. Therefore, CMS 
published a proposed rule, ``Medicare and Medicaid Programs; Organ 
Procurement Organization Conditions for Coverage: Revisions to the 
Outcome Measure Requirements for Organ Procurement Organizations'' on 
January 30, 2026 (91 FR 4190, hereinafter referred to as the January 
2026 OPO proposed rule).
    The proposed rule contained operational and administrative 
provisions which would govern the competition process, provide 
programmatic clarity, and address interested party requests for 
additional guidance. Additionally, the proposed rule contained 
provisions aimed at driving further quality and 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.

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 as 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.

C. Summary of Costs and Benefits

    This final rule is important due to its functional relationship to 
the December 2020 OPO final rule. Its purpose is to clarify and refine 
operational and administrative requirements related to OPO designation, 
re-certification, competition, appeals, information management, and 
Quality Assessment and Performance Improvement (QAPI), while 
maintaining the accountability framework established in the December 
2020 OPO final rule.
    We estimate that this final rule will cost approximately $16.5 
million in the first year and $7.9 million annually thereafter. These 
costs are incremental to the broader framework established in the 
December 2020 OPO final rule and reflect targeted operational and 
administrative refinements rather than fundamental system 
restructuring. We also estimate that this final rule will result in 
approximately $598,000 in annual benefits due to reduced implementation 
inquiry and compliance-interpretation burden, as well as an additional 
one-time benefit associated with clarified requirements and 
implementation efficiencies.

[[Page 69391]]

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 Public 
Health Service (PHS) Act sets out certain requirements for OPO 
certification. There are currently 54 OPOs that are responsible for 
identifying patients who may become prospective donors and recovering 
organs from deceased donors in the United States (U.S.). These 54 OPOs 
currently serve 55 Donation Service Areas (DSAs), because each OPO 
serves at least one DSA and one OPO currently serves more than one DSA. 
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 for 
their organ procurement costs to be eligible for payment under 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 and re-
certification purposes and a three-tier 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 2025, there were a total of 49,065 organ transplants, compared 
to 48,150 and 46,634 transplants in years 2024 and 2023, 
respectively.\2\ 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.\3\ 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.
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    \2\ Organ Procurement and Transplantation Network (OPTN) Data. 
<a href="https://hrsa.unos.org/data/view-data-reports/national-data/">https://hrsa.unos.org/data/view-data-reports/national-data/</a>. 
Accessed May 12, 2026.
    \3\ Organ Donation Statistics. <a href="https://www.organdonor.gov/learn/organ-donation-statistics">https://www.organdonor.gov/learn/organ-donation-statistics</a>. Accessed May 12, 2026.
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B. Regulatory History

    The December 2020 OPO 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 OPO 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 OPO final rule utilizes 
increasing competition to drive performance improvement. An OPO's 
performance in its DSA(s) 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 OPO final 
rule.
    On February 2, 2021, we published a notice in the Federal Register 
(86 FR 7814) temporarily delaying the effective date of the December 
2020 OPO 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 OPO 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 providers, including donor hospitals, transplant programs, 
ESRD suppliers, hospital systems, OPOs, and tissue banks; researchers 
and academic institutions; professional organizations; trade groups 
such as technology and pharmaceutical companies as well as insurers; 
and advocacy and philanthropic organizations also provided comments. 
These comments informed the proposed rule and may be used in future 
rulemaking for system-wide changes to advance organ transplant system 
performance.
    On January 30, 2026, we published the January 2026 OPO proposed 
rule (91 FR 4190). In the rule we proposed to: revise several 
definitions; remove the requirement that an OPO have been re-certified 
from 2002 through 2005 to be eligible for certification; revise the 
designation framework to account for scenarios where an OPO is 
designated to more than one DSA and clarify when DSAs are open for 
competition; clarify and categorize actions affecting OPO agreements, 
including non-renewal and de-certification; revise the appeal process; 
refine re-certification and competition policies, including evaluating 
each DSA separately for outcome measures and an OPO as a single entity 
for process performance; address OPO accountability on outcome measures 
when taking over another OPO's DSA; require appropriate staff 
licensure; expand information management requirements to include 
records for organs procured for research; and add new Quality 
Assessment and Performance Improvement (QAPI) requirements related to 
medically complex donors and organs.

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 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

[[Page 69392]]

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, as described in section 371(b) of the 
PHS Act, 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 Sec.  486.304 and include being 
certified as a qualified OPO by CMS. Regulations at Sec.  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 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 as enforceable will be considered 
``rules and requirements'' of the OPTN for purposes of section 1138 of 
the Act.\4\ 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 (Sec.  
121.11(b)(2)) and Sec.  486.328 of the OPO CfCs to report information 
specified by the Secretary to the OPTN, including the data used to 
calculate the outcome measures for OPOs.
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    \4\ 54 FR 51802.
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    In addition, OPOs are required to comply with existing Federal 
civil rights laws, including Title VI of the Civil Rights Act of 1964 
(Title VI), 42 U.S.C. 2000d, section 504 of the Rehabilitation Act of 
1973, 29 U.S.C. 794, section 1557 of the Affordable Care Act, 42 U.S.C. 
18116, and the Age Discrimination Act of 1975, 42 U.S.C. 6101 et 
seq.\5\ Title VI protects individuals from discrimination on the basis 
of race, color, and national origin. Section 1557 of the Affordable 
Care Act protects individuals from discrimination on the basis of race, 
color, national origin, age, disability, or sex. Among other things, 
these laws require OPOs to ensure nondiscrimination on the bases 
protected in the operation of their programs. Also, section 504 of the 
Rehabilitation Act and section 1557 of the Affordable Care Act protect 
qualified individuals with a disability, including prospective organ 
recipients with a disability and prospective organ donors with a 
disability, from discrimination in the administration of covered organ 
transplant programs. Under these laws, OPOs must ensure that qualified 
individuals with disabilities are afforded opportunities to participate 
in or benefit from the organ donation programs that are equal to 
opportunities afforded to others. Furthermore, OPOs and transplant 
teams risk violating these Federal civil rights laws through 
discriminatory actions during the organ donation process. Such 
violations may include providing a prospective donor with a disability 
with a benefit or service that is not as effective as the benefits or 
services provided to those prospective donors without a disability, 
based solely on that disability.
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    \5\ Recipients of Federal financial assistance must comply with 
applicable 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 Age Discrimination Act of 1975, and 
section 1557 of the Affordable Care Act.
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    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, 
covered 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 for 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. These 
regulations set forth the certification and re-certification processes, 
outcome requirements, and process performance measures for OPOs. The 
outcome measures, found under Sec.  486.318, are used to assess OPO 
outcome performance for re-certification and competition purposes (see 
Sec.  486.316(a) and (d)).

III. Summary of the Proposed Provisions and Responses to Public 
Comments

    In response to the January 2026 OPO proposed rule, we received 129 
timely pieces of correspondence. Commenters included individual OPOs, 
transplant hospitals, national associations and coalitions, academic 
researchers, advocacy organizations, health care professionals and 
corporations, donor families, and numerous individuals from the general 
public.
    In this final rule, we provide a summary of each proposed 
provision, a summary of the public comments received and our responses 
to them, and an explanation for any changes in the policies that we are 
finalizing. We note that this final rule is written in order by topic 
as they appear in the regulations.

A. General Comments

    Comment: Most commenters supported CMS' overarching goals of 
strengthening safety, accountability, and public trust in the organ 
donation and transplantation system. A commenter stated that the recent 
increase in organ procurement demonstrates the effectiveness of 
increased accountability under the 2020 framework. However, some 
commenters expressed concerns about whether the proposed rule would 
drive meaningful improvement and recommended that CMS provide greater 
clarity regarding certain proposals.
    Response: We believe the proposals we are finalizing will enforce 
accountability in organ procurement and support broader goals of 
improving patient safety and transparency in the organ procurement and 
transplantation system. We have reviewed the proposals and, where 
appropriate, have revised or clarified provisions in this final rule to 
better reflect the intent of the underlying policy and to support 
effective implementation. These revisions are discussed in detail in 
the

[[Page 69393]]

relevant sections later in this section of the preamble.
    Comment: Many commenters expressed concern that the proposed rule 
does not adequately address their longstanding concerns with the 2020 
Final Rule, particularly with respect to the outcome measures. 
Specifically, commenters stated that the outcome metrics: (1) do not 
reliably or accurately assess the comparative performance of OPOs, 
noting that the donation and transplantation measures are calculated 
using the same denominator; (2) are biased against large OPOs; (3) fail 
to account for demographic and geographic differences across service 
areas; (4) evaluate OPOs based on factors outside their control; and 
(5) are calculated using data that does not accurately estimate donor 
potential and contains errors. Commenters also expressed concern that 
significant fluctuations in the data confirm that a 12-month 
measurement period is insufficient as a basis for CMS' outcome metric 
calculations. Commenters recommended that CMS replace the tiering 
system with an Observed-to-Expected (O/E) model; replace the use of 
cause, age, and location consistent with organ donation (CALC) 
methodology and death certificate data with hospital referral data, 
include risk adjusted outcome measures; and use multi-year measurement 
periods.
    Response: The comments regarding the type of outcome measures that 
CMS uses, risk adjustment, data sources, and the number of data years 
used for assessing compliance with the CfCs, all set forth in the 
December 2020 OPO final rule, are outside the scope of this final rule, 
which is intended to clarify and refine CMS policies and processes for 
implementing the accountability framework established in the December 
2020 OPO final rule. While we proposed a regulatory refinement that 
will affect the outcome measures as it relates to the inclusion of 
pancreata used for islet cell research in those calculations, we did 
not propose any changes to the type of outcome measures that CMS uses, 
risk adjustment of those measures, data sources, or the number of data 
years used for assessing compliance with the CfCs. We stand by the 
underlying outcome measure framework set forth in the December 2020 OPO 
final rule.
    Comment: Commenters stated that the current tiered system creates 
perverse incentives for OPOs to prioritize increasing donation and 
transplant rates over patient-centered care and ethical decision-
making.
    Response: Procuring organs from donors in a safe, ethical, and 
transparent manner supports performance on the CMS outcome measures. 
Research has shown that approaching potential donor families with 
sensitivity and compassion, providing adequate explanations of brain 
death, and allowing potential donor families sufficient time to make 
decisions all support higher donation rates.\6\ By extension, we 
believe that OPOs that do not engage in patient-centered care and 
violate the CfCs (for example, pressuring next of kin for consent for 
organ donation) ultimately harm their own performance and that of the 
entire transplant system as these practices contribute to public 
mistrust in the system. CMS policies holding OPOs accountable for their 
outcomes, thereby increasing the number of lifesaving organs available 
for transplantation, are not responsible for poor OPO decision making. 
Additionally, under the process measures, an OPO is responsible for 
ensuring proper training and supervision of its staff (Sec.  
486.326(c)) and otherwise maintaining compliance with process 
performance requirements at Sec. Sec.  486.320 through 486.360 and 
should never jeopardize the health and safety of potential donors in 
the interest of bolstering its performance.
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    \6\ Rodrigue JR, Cornell DL, Howard RJ. Organ donation decision: 
comparison of donor and nondonor families. Am J Transplant. 2006 
Jan;6(1):190-8. doi: 10.1111/j.1600-6143.2005.01130.x. PMID: 
16433774; PMCID: PMC2365918.
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    Comment: Several commenters stated that CMS would de-certify and 
replace an unreasonable number of OPOs, potentially disrupting the 
organ donation and transplantation system. They emphasized that 
stability is critical to maintaining relationships with donor families 
and hospital partners and to ensuring that organs are not lost due to 
operational disruption. They recommended that CMS prioritize 
sustainable performance improvement strategies such as technical 
assistance and corrective action plans and establish alternative 
pathways for remediation and performance improvement as a means of 
avoiding de-certification and minimizing disruption to the system. 
Commenters stated these options would enable a cure for any non-
compliance, be less burdensome than an appeal, and provide a 
collaborative resolution-focused approach that would better serve 
patients.
    Response: We disagree with the commenters' premise that 
prioritizing system stability and retaining current OPOs in their low 
performing DSAs is preferable to replacing these low performers with 
OPOs that have demonstrated better performance. The outcome measures 
and tier system are designed such that all OPOs have an equal 
opportunity to succeed. OPO performance in a DSA is measured against 
the median observed performance level of the previous year, meaning 
that each OPO begins each assessment period with a blank slate and need 
only achieve the performance level of the previous year's median. All 
OPOs are capable of meeting the previous year's median performance 
level in their DSAs and it is our intent to drive improved performance 
across all OPOs to the extent that the minimum performance standard is 
met in every DSA, and, ultimately, to save more lives.
    We appreciate commenters' recommendations to establish alternative 
remediation pathways prior to de-certification. These pathways already 
exist and are required by regulation. Section 486.348(d) requires OPOs 
to identify and address performance deficiencies that might lead to 
regulatory action (that is, de-certification). The performance of each 
OPO is assessed annually, and this information is provided to each OPO. 
OPOs are required to evaluate their outcome measure performance through 
their Quality Assessment and Performance Improvement (QAPI) programs 
and implement corrective actions when performance falls statistically 
significantly below the top 25th percentile during an assessment 
period. As such, lower performing OPOs are already expected to develop 
plans to correct their actions in ways that improve performance and 
ultimately meet the minimum CMS performance standards. In addition, for 
the 2022-2026 certification cycle, CMS provided direct technical 
assistance to OPOs through the OPO Special Innovation Project (SIP), 
conducted by CMS-funded Quality Improvement Organizations (QIOs) from 
December 2023 through March 2025, and facilitated OPO collaboration 
through the ESRD Treatment Choices Learning Collaborative.
    OPOs may remedy non-compliance with the process performance 
measures at Sec. Sec.  486.320 through Sec.  486.360 by submitting an 
acceptable plan of correction to CMS (see Sec.  488.28) and 
implementing corrective actions to achieve and sustain compliance. 
However, there is no opportunity to remedy past failure to meet the 
minimum standards for compliance with the outcome measures at Sec.  
486.318 because those standards are based on OPO performance in the 
final assessment period of the re-certification cycle. Actions taken 
after the final

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assessment period cannot cure the OPO's failure to meet the outcome 
measure standards as set forth at Sec.  486.318. As discussed 
previously in this final rule, OPOs have an opportunity to address 
performance deficiencies in advance of the final assessment period as 
set forth in Sec.  486.348(d).
    We did not propose to modify the outcome measure performance 
standards to allow for alternative pathways to compliance, and any 
suggestions to that effect are outside the scope of this rule. 
Furthermore, as we explained in the December 2020 OPO final rule, 
allowing a poorly performing OPO to continue serving the DSA through a 
systems improvement agreement or similar mechanism would not benefit 
the patients in that DSA who would be better served by a higher 
performing OPO (85 FR 77912). OPOs that do not meet the outcome 
measures in a DSA in the final assessment period will either be de-
certified under the requirements of Sec.  486.312(a)(2) or (3) or have 
designation removed from the DSA if it has more than one DSA as 
specified at Sec.  486.316(a)(3).
    While we agree with commenters that system stability is a factor 
for consideration, we also note that such stability led to stagnation 
in performance. We do not agree with the premise that replacing a low 
performing OPO with a higher-performing OPO that is willing and able to 
provide those services will result in long term system disruptions that 
decrease donation and transplantation or otherwise disrupt the overall 
accelerated progress that the system has made in light of increased 
oversight. Retaining an OPO in a DSA where it has failed to meet CMS 
regulatory standards would not best serve the people in that DSA or the 
system at large. We are committed to ensuring that any transition 
between OPOs is conducted in a manner that minimizes disruption to 
organ procurement activities.
    We also note that Health Resources and Services Administration 
(HRSA) and the OPTN continue to provide resources and technical support 
to assist OPOs in improving performance and strengthening organ 
procurement and transplantation practices.
    Comment: Commenters raised concerns regarding the timing of the 
proposed rule in relation to the 2022 through 2026 re-certification 
cycle. Many commenters requested that CMS refrain from issuing de-
certification notices or conducting competitions and instead develop a 
revised re-certification process that more accurately and fairly 
measures OPO performance or delay implementation to allow time to 
assess the impact of new requirements on OPO performance. Some 
commenters stated that any finalized policies should not be applied to 
the 2022 through 2026 re-certification cycle, noting that OPOs cannot 
retroactively adjust past performance to comply with new standards. 
Several commenters requested clarity in when changes to the definitions 
would become effective. Some commenters expressed concerns that CMS 
would apply the changes retroactively.
    Response: The January 2026 OPO proposed rule, and this subsequent 
final rule, seek to address operational questions that CMS has received 
from interested parties and provide additional detail on how the 
policies adopted in the December 2020 OPO final rule will be 
effectuated. CMS will not retroactively apply these provisions to any 
OPO, but will apply them prospectively, as of the effective date of 
this final rule, in effectuating the enforcement framework adopted in 
the December 2020 OPO final rule. While we proposed and are finalizing 
a change to the definition of ``organ'', which has implications for how 
the transplantation rate outcome measure will be calculated and 
reported to OPOs, this change will only apply as a regulatory 
requirement to outcome measure data reporting after the effective date 
of this final rule, beginning with the 2027 assessment period (as 
defined in Sec.  486.302). In addition, we note that in assessing OPO 
performance in 2027, we will take steps to ensure OPO performance is 
appropriately and accurately compared to 2026 performance based on the 
updated definition of ``organ.'' Data from the 2027 assessment period 
will be used to calculate performance described in the 2029 OPO Public 
Performance Report. OPO performance in 2027 will be measured against 
the median and top 25 percent thresholds set by OPO performance in 
2026. To ensure that 2027 performance is appropriately measured against 
2026 performance, for purposes of the 2029 OPO Public Performance 
Reports we will recalculate the median and top 25 percent thresholds 
for 2026 applying the revised definition of ``organ'' that excludes 
pancreata used for islet cell research and not transplanted from the 
transplantation rate. This recalculation will model what the 
transplantation rate outcome measure performance would have been in 
2026, had the revised definition been effective at that time. This will 
ensure a comparison of like data sets, establish an accurate and 
consistent performance threshold for the 2027 performance data to be 
measured against, and ensure that OPOs are not evaluated against 2026 
performance data that include a broader range of procured organs in the 
transplantation rate. Therefore, the 2029 OPO Public Performance 
Report, based upon the 2027 assessment period performance data 
evaluated against recalculated 2026 performance thresholds for the 
transplantation rate, will provide OPOs with accurate information about 
their performance. We will continue applying the revised definition to 
future outcome measure calculations.
    We note that the data reported by OPOs and the coding guidance that 
they use to perform this data reporting will not change when the 
revised definition of ``organ'' is applied to the organ transplantation 
rate. Existing data coding practices, as required by the OPTN 
(consistent with Sec.  486.328) already support CMS' ability to 
calculate performance on the organ transplantation rate outcome measure 
with and without pancreata used for islet cell research. What will 
change is how CMS selects the organ disposition codes that OPOs and 
transplant programs already enter into the data reporting system and 
applies those codes to the organ transplantation rate calculation.
    Likewise, OPOs will not be required to comply with changes to the 
CfCs finalized in this rule, such as changes to address situations in 
which a single OPO is simultaneously designated to more than one DSA, 
until the effective date of this final rule. As some commenters noted, 
OPO performance for the 2022 through 2026 re-certification cycle is 
already complete. Given that the policies finalized in this rule will 
not impact OPO performance for the 2022 through 2026 re-certification 
cycle, there is no need to delay enforcement decisions for that cycle 
to assess any impact of this rule on OPO performance.
    Comment: Several commenters stated that the proposed rule placed 
disproportionate emphasis on OPO performance without adequately 
accounting for the roles of other interested parties in the donation 
and transplant system. They stated that greater shared accountability 
is needed across OPOs, donor hospitals, and transplant centers, 
including improved transparency around transplant center acceptance 
practices and better alignment of performance expectations across the 
system.
    Response: We agree that organ transplantation is a system that 
includes many actors, each performing their essential functions to the 
best of their

[[Page 69395]]

ability. Coordination and collaboration among OPOs, donor hospitals, 
and transplant centers are important to supporting timely organ 
recovery, placement, and transplantation. We will consider these 
comments for potential future rulemaking for other related members of 
the organ donation and transplantation ecosystem.
    Comment: Several commenters suggested that CMS issue guidance prior 
to implementation. They encouraged CMS to continue interested parties' 
engagement and collaborate with HRSA and OPTN to ensure alignment and 
avoid duplicative or conflicting regulatory requirements.
    Response: We appreciate the commenters' suggestions, and we intend 
to continue working closely with HRSA and the OPTN to avoid duplicative 
or conflicting regulatory requirements. We will provide guidance 
through sub-regulatory channels, including updates to the State 
Operations Manual (SOM), to support compliance with these requirements.
    Comment: CMS received several comments pertaining to issues that 
are outside the scope of the proposed rule. Those comments concerned 
transplant program outcome measures/harmonizing outcome measures, 
inclusion of new risk-adjusted outcome measures, harmonization of 
Federal requirements with State anatomical gift laws, donor registry 
enrollment and informed consent, the intersection between donation 
after circulatory death (DCD) processes and first-person authorization 
(FPA), public education regarding clinical processes associated with 
organ donation, including DCD, revising the definition of organ to 
include lifesaving tissue, clearer authorization communication 
requirements, the use of a DNA-authenticated blockchain system to 
secure the organ transplant process, a requirement to make all patient 
records available to a potential donor's next of kin, and donor care 
units/organ recovery centers.
    Response: We thank the commenters for their feedback. However, 
these issues are outside the scope of the final rule.

B. Definitions (Sec.  486.302)

    We proposed to revise our current regulations defining the terms 
``adverse event,'' ``donor,'' ``medically complex donors,'' ``medically 
complex organs'', ``organ,'' and ``unsound medical practices'' at Sec.  
486.302 to provide greater clarity.
1. General Comments
    Comment: Commenters urged CMS to test any new definitions more 
thoroughly to assess downstream effects on measures and re-
certification decisions.
    Response: We have carefully considered the impact of these 
definition changes on the meaning and application of the regulations 
where these terms are used, as well as public comments we received on 
these proposed changes. The changes are prospective in nature and OPOs 
are expected to comply with them upon the effective date of this final 
rule. We do not expect significant downstream effects on measures and 
re-certification decisions as a result of any definition changes 
finalized in this rule. For example, we conducted an internal analysis 
based on preliminary data used for the 2026 OPO report to assess the 
projected impact of revising the definition of ``organ'' to exclude 
pancreata used for islet cell research from the organ transplantation 
rate and noted minimal effects on OPO tier status. We expect similarly 
minimal effects on OPO tier status when this change takes effect. In 
addition, the change to the definition of organ is appropriate to meet 
our regulatory goals of incentivizing organ transplants while complying 
with the requirements of the Pancreatic Islet Cell Transplantation Act 
of 2004 (PICTA 2004).
    Comment: Some commenters recommended that any definitions should be 
aligned or harmonized with OPTN and HRSA definitions to promote 
consistency in interpretation and implementation of requirements. A few 
commenters noted that OPTN and HRSA are working on revising various 
requirements that could affect proposed changes to definitions.
    Response: CMS and HRSA continually work to align policies as 
appropriate to the statutory authorities that govern our actions and 
the regulatory approaches that we employ. We note that ``alignment'' 
does not always require exact duplication, as there are instances when 
a compatible, nuanced approach is better suited to addressing an issue 
than a broad, standardized approach. Currently, the OPTN does not have 
a comprehensive, standardized definition for ``adverse events.'' 
However, the OPTN does require that a narrow set of high-severity 
patient safety events (``HRSA-reportable'' or ``Wakefield'' events) be 
reported to HRSA and to the OPTN Patient Safety Reporting Portal. Those 
events include: (1) wrong organ transplants or near misses, (2) 
transplants into the wrong recipient or near misses, and (3) suspected 
or confirmed donor-derived HIV transmission.\7\ Our current definition 
of ``adverse event'' is broad enough to encompass the OPTN and HRSA 
requirements for reportable events. Additionally, alignment of 
requirements is one factor that CMS considered related to the proposed 
definitions for medically complex organ and medically complex donor. 
Please see section III.B.4. of this final rule for additional 
discussion.
---------------------------------------------------------------------------

    \7\ Organ Procurement and Transplantation Network. OPTN 
Policies, 18.5 Reporting of Patient Safety Events. Accessed at 
<a href="https://www.hrsa.gov/sites/default/files/hrsa/optn/optn_policies.pdf">https://www.hrsa.gov/sites/default/files/hrsa/optn/optn_policies.pdf</a>. Accessed on May 22, 2026 and Letter from HRSA 
Administrator Dr. Mary Wakefield to OPTN President Dr. John Lake 
dated August 5, 2011.
---------------------------------------------------------------------------

2. 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.'' 
We proposed to relocate the illustrative examples of adverse events 
from the definition of ``adverse event'' to the QAPI requirements at 
Sec.  486.348(c). We also proposed revising the list to clarify that 
the list of examples does not constitute an exhaustive list of adverse 
events. We solicited public comment on the proposed changes to the 
definition of adverse events. The following is a summary of the 
comments we received and our responses.
    Comment: Commenters stated that the proposed definition of 
``adverse events'' was overly broad, ambiguous, and susceptible to 
inconsistent interpretation by both OPOs and surveyors. They expressed 
concern that legitimate disagreements between the OPO and a surveyor on 
whether an incident was an adverse event could result in inappropriate 
and inconsistent deficiency determinations and other inconsistent 
enforcement actions, which would limit the QAPI requirements' 
usefulness as a quality improvement tool.
    Response: While we proposed to move a revised, non-exhaustive list 
of examples of adverse events from the definitions section to the QAPI 
section at Sec.  486.348(c)(3), we note that the

[[Page 69396]]

remaining definition at Sec.  486.302, defining an ``adverse event'' as 
``an untoward, undesirable, and usually unanticipated event that causes 
death or serious injury or the risk thereof,'' is the same one that was 
adopted in the 2006 final rule (71 FR 30982, 31046). CMS and OPOs have 
been applying this definition for the last 20 years. We are not aware 
of any evidence that inconsistent interpretation by OPOs or surveyors 
or legitimate disagreements between the OPO and a surveyor on whether 
an incident was an adverse event has resulted in inappropriate or 
inconsistent deficiency determinations or other inconsistent 
enforcement actions. We encourage OPOs to seek guidance from CMS 
related to whether an incident is an adverse event if they are ever 
unsure about a particular incident. In addition, CMS provides sub-
regulatory guidance, particularly surveyor guidelines in Appendix Y of 
the State Operations Manual.
    Comment: Several commenters requested objective criteria to ensure 
clarity and uniformity. They recommend limiting the definition of 
``adverse events'' to clinical or operational failures that pose risks 
to patient safety. Others recommend restricting the scope of reportable 
``adverse events'' to violations of the OPO's internal policies, OPTN 
policies and bylaws, and Federal regulations.
    Response: While we agree with the commenters that clinical or 
operational failures that pose risks to patient safety and violations 
of the OPO's internal policies, OPTN policies and bylaws, and Federal 
regulations may all constitute ``adverse events'', we disagree that the 
regulatory definition of the term should be restricted to them. We 
believe that a restrictive definition would likely leave out possible 
incidents that should be identified as ``adverse events'' and require 
compliance with Sec.  486.348(c)(1) and (2). We believe the definition 
of the term ``adverse events'' set forth in Sec.  486.302, coupled with 
the revised, non-exhaustive list of examples we proposed to move to the 
QAPI requirements at Sec.  486.348 (c)(3) provides sufficient guidance 
on whether an incident constitutes an adverse event.
    Comment: Most commenters supported our proposed revision to move 
the list of examples of incidents that would be considered ``adverse 
events'' from the definition in Sec.  486.302 to the QAPI section at 
Sec.  486.348 of the regulations. Some commenters agreed that this 
shift from defining the term with examples to using them in the context 
of QAPI emphasized that the list was not exhaustive. However, some 
commenters disagreed with relocating the list of examples, and a 
commenter suggested that removing the list of examples would result in 
more confusion.
    Response: We agree that retaining and revising the examples and 
moving them to the QAPI section of the regulations clarifies that the 
list of examples is not exhaustive. We reiterate that the list of 
examples is not being removed from the CfCs. It is being moved to the 
QAPI requirements related to adverse events (Sec.  486.348(c)(3)), 
which should reduce confusion.
    Comment: Several commenters sought clarification about whether 
``risk thereof'' includes near-misses or latent safety conditions.
    Response: The definition of ``adverse events'' would include 
actions or omissions that could have resulted in death or serious 
injury but were somehow stopped before that could happen (that is, a 
``near miss''). We would also note that OPTN Patient Safety Portal 
reportable events \8\ also include events that could have resulted, but 
did not, in death or serious injury. Regarding latent safety 
conditions, we believe that depends upon whether the latent safety 
conditions resulted in an incident sufficient to constitute an adverse 
event. We believe these instances would be very fact-specific scenarios 
and would encourage an OPO to speak with or consult with CMS for 
further guidance.
---------------------------------------------------------------------------

    \8\ Organ Procurement and Transplantation Network. OPTN 
Policies, 18.5 Reporting of Patient Safety Events, Table 18-3 
Required Reporting by Transplant Hospitals. <a href="https://www.hrsa.gov/sites/default/files/hrsa/optn/optn_policies.pdf">https://www.hrsa.gov/sites/default/files/hrsa/optn/optn_policies.pdf</a>. Accessed on May 22, 
2026.
---------------------------------------------------------------------------

    Final Rule Action: After consideration of the public comments, we 
are finalizing the ``adverse event'' definition as proposed.
3. Donor and Organ
    Section 486.302 currently defines ``donor'' as ``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.'' We proposed 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 transplantation or for islet cell research is included in the 
definition of ``donor'' for purposes of the donation rate outcome 
measure. This clarification would ensure consistency and continued 
compliance with the statutory requirement \9\ that pancreata used for 
islet cell transplantation or research be counted for purposes of 
certification and re-certification. We solicited public comment on the 
proposed changes to the definition of ``donor''.
---------------------------------------------------------------------------

    \9\ Section 371(c) of the PHS Act.
---------------------------------------------------------------------------

    Additionally, section 486.302 currently defines ``organ'' as ``. . 
. 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.'' The inclusion of pancreata 
used for islet cell bench research within the definition of ``organ''--
and by extension the ``organ transplantation rate''--is inconsistent 
with CMS' goals to increase the number of actual transplants, as it 
creates a perverse performance incentive that allows OPOs to count 
research activity as equivalent to a transplant, potentially masking 
poor performance in facilitating actual organ placements for patients 
on transplant waitlists. Therefore, we proposed to remove pancreata 
used for research from the definition of ``organ'', meaning that such 
pancreata are removed from the organ transplantation rate outcome 
measure. Research activity would no longer count as a transplant for 
purposes of certification and re-certification. We solicited public 
comment on the proposed changes to the definitions of ``donor'' and 
``organ''. The following is a summary of the comments we received and 
our responses.
    Comment: The majority of commenters were supportive of the proposed 
changes to the definitions of ``donor'' and ``organ''. However, some 
commenters indicated that the proposed changes did not go far enough 
and recommended additional changes. Many commenters stated that 
pancreata procured for islet cell research should be removed entirely 
from the outcome measures while others proposed alternative ways to 
count pancreata. Several commenters stated that CMS should create a 
separate outcome measure specifically for pancreata. A commenter 
recommended creating a process performance measure for pancreatic islet 
cell procurement.
    Response: We appreciate the support for revisions to the 
definitions of ``donor'' and ``organ''. PICTA 2004, which amended the 
PHS Act to add section 371(c), requires pancreata procured and used for 
islet cell transplantation or research to be counted for certification 
and re-

[[Page 69397]]

certification purposes. Therefore, we cannot remove pancreata from the 
numerical outcome measures entirely or assess compliance through an 
observed process performance measure. At this time, establishing a 
separate outcome measure is contrary to CMS policy goals, as it would 
overly incentivize pursuit of donors for islet cell research, likely to 
the detriment of pursuit of donors for transplantable organs. The organ 
quality standards and procurement process for research organs differ 
from those of organs for transplant, focusing less on optimal organ 
transplant viability that may require precise organ retrieval timing 
and techniques and costly perfusion equipment for delivery to the 
transplant program. Establishing a standard that may be easier for OPOs 
to meet could incentivize OPOs to shift procurement resources away from 
transplantable organs, and that shift would not be consistent with 
patient needs and our policy goals. As such, we believe the proposed 
changes to the definitions are the most appropriate approach to 
accomplish our policy goals. This would enable counting donors when 
pancreata were procured for islet cell transplantation or islet cell 
research, but pancreatic islet cells would only count as a transplant 
when actually transplanted into a recipient, including transplantation 
that is conducted under research protocols.
    Comment: Several commenters recommended narrowing the scope of 
research that would qualify for inclusion of pancreata in the outcome 
measures. A commenter recommended that CMS only include ``pancreata 
recovered for research focused on pancreatic islet cell transplantation 
and conducted under FDA approved clinical research.'' Another commenter 
stated that OPOs may not have access to requested research protocols or 
other documentation necessary to evidence that the pancreata were 
actually used for bona fide islet cell research.
    Response: We thank commenters for these recommendations. Our 
proposed revisions to the definition of ``donor'' were intended to 
emphasize that pancreata must be procured and used for islet cell 
research or islet cell transplantation, consistent with PICTA 2004, to 
be counted in the outcome measures. We previously clarified this point 
in a memorandum issued on January 18, 2024. With respect to the 
commenter's suggestion to restrict pancreatic islet cell research to 
only include ``FDA approved clinical research,'' PICTA 2004 requires 
pancreata procured by an OPO and used for islet cell transplantation or 
research to be counted for certification or re-certification decisions. 
That statutory requirement is not limited to clinical research that FDA 
has allowed to proceed. We also note that we have previously worked 
with HRSA to revise and clarify coding for pancreata submitted for 
research (See QSO-24-19-OPO). If an OPO is unable to obtain records 
demonstrating the pancreata were used for research for islet cell 
transplantation, it should not code the disposition as ``accepted for 
islet cell research'' to be included in the CMS outcome metrics.
    Comment: Several commenters stated they supported the changes and 
the exclusion of pancreata islet cells used for research from the 
transplant rate when the islet cells are not transplanted. A commenter 
indicated that the proposal strikes a balance between the statutory 
requirements and concerns about accurate measurement of transplantation 
rates, suggesting it will facilitate more consistent reporting.
    Response: We thank commenters for acknowledging the importance of 
this change. In our proposed rule, we stated 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. Our proposed change to the 
definitions of ``donor'' and ``organ'' are refinements to remove 
pancreatic islet cell bench research from the transplant rate while 
appropriately retaining it in measurement of the donation rate. These 
changes better incentivize both pancreata islet cell research and 
transplantation via the donation rate and pancreatic islet cell 
transplantation via the transplant rate while more precisely measuring 
performance and complying with the PICTA 2004.
    Comment: Several commenters indicated that research on pancreatic 
islet cells when not transplanted, sometimes called ``bench research'', 
does not involve living persons so approval by an institution review 
board (IRB) is generally not required. In these instances, the OPO 
would not have a record of approval from an IRB.
    Response: We acknowledge this consideration and how it may impact 
records for organ disposition when those organs are sent for research. 
The requirements at Sec.  486.330(b)(2) as finalized in this rule only 
require an OPO to maintain information documenting approval of an IRB 
or other formal authorizing body ``as appropriate.'' Where no such 
approval is required, the OPO is not required to maintain approval 
documentation. The OPO would, however, continue to be required to 
maintain records showing the disposition of the organ as set forth in 
Sec.  486.330(b)(2), including the research institution, principal 
investigator, and study contacts. Regardless of the information that is 
available, if an OPO is coding and reporting pancreata procurement and 
disposition in a manner that would count in the outcome measures, it 
must be able to provide CMS and the OPTN with sufficient records to 
support and justify the coded disposition for pancreatic islet cell 
research.
    Comment: Several commenters state that the changes risk creating 
inconsistent treatment of pancreata across the two outcome measures 
that may introduce gaming.
    Response: The changes to the definition of ``donor'' and ``organ'' 
increase specificity of reporting and better align the incentives of 
the measures (more donors and more transplants) to mitigate any 
potential gaming. These changes fairly count donors of organs that are 
used for transplantation or islet cell research and transplants that 
directly benefit patients on the waitlist while complying with the 
PICTA 2004.
    Comment: A commenter questioned the rationale for excluding 
pancreata used for bona fide islet cell research from the transplant 
rate. The commenter stated that this exclusion could inadvertently 
discourage OPOs from supporting research that advances transplantation 
science.
    Response: Pancreata will continue to be counted in the donation 
rate when procured for islet cell research regardless of whether the 
final disposition is bench research or transplantation. Pancreatic 
islet cells will continue to be counted in the transplant rate when 
actually transplanted. This change continues to incentivize transplant 
science and transplantation of pancreatic islet cells.
    Comment: A commenter recommended that CMS allow supplemental QAPI 
tracking for pancreata recovered for islet cell research to enhance the 
integrity of tracking this information.
    Response: We appreciate this comment. While we have not proposed a 
corresponding QAPI requirement for tracking pancreata procured for 
islet cell research at this time, nothing prevents OPOs from utilizing 
their QAPI program for this purpose. We will continue to monitor 
procurement practices in this area and may consider a corresponding 
QAPI requirement in future rulemaking.
    Final Rule Action: We are finalizing as proposed the definition of 
``donor'', at Sec.  486.302, as a deceased individual

[[Page 69398]]

from whom at least one vascularized organ (heart, liver, lung, kidney, 
pancreas, or intestine) is transplanted. An individual will also be 
considered a donor if only the pancreas is procured and is used for 
islet cell transplantation or for islet cell research. Additionally, we 
are finalizing as proposed the definition of ``organ'' as 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 islet cell 
transplantation.
4. Medically Complex Donors and Medically Complex Organs
    We proposed to add a definition for ``medically complex donor'' and 
``medically complex organ''. We proposed 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 would include all DCD donors and donors with 
elevated KDPI scores of 50 or more. We also proposed to define the term 
``medically complex organ'' as an organ procured from a ``medically 
complex donor''. These definitions are linked to a proposed new QAPI 
requirement that would require OPOs to facilitate appropriate placement 
and utilization of these organs, to increase the pool of organs 
available for transplantation. We solicited public comments on the 
proposed definitions of ``medically complex donors'' and ``medically 
complex organs''. The following is a summary of the comments we 
received and our responses.
    Comment: Comments on the definition for ``medically complex donor'' 
were mixed. Some commenters strongly supported DCD and HIV+ patients 
being included in the definitions. While some supported a KPDI of 50 or 
greater, others suggested a score of 85 or greater. Other commenters 
wanted to include additional comorbidities, such as hypertension or 
diabetes. Several commenters stated that the proposed definition 
already applied to most of their deceased donors and raised burden 
concerns. Other commenters expressed concern that the proposed 
thresholds, such as KDPI scores, could disadvantage underserved 
communities. Some commenters recommended using other criteria, such as 
the criteria previously used for expanded criteria donors (ECDs). Some 
commenters mentioned considering clinical indications, in addition to 
medical history.
    Response: We would like to thank all the commenters for their 
valuable input into this definition. After considering the public 
comments we received, we have determined that there is a lack of 
consensus among relevant interested parties as to what constitutes a 
``medically complex donor.'' Comments on this topic varied 
significantly, making it extremely difficult to describe a narrowed or 
specific population of donors. Some commenters recommended utilizing 
the previous construct of ``expanded criteria donor.'' However, this is 
no longer utilized by the OPTN nor is it reported by the SRTR. 
Commenters raised valid concerns regarding burden if the definitions 
were overly broad which could hamper their QAPI activities from those 
donors that they believe to be most challenging for placement of 
organs. In addition, evolving practice patterns, such as the increase 
in DCD donation, and increased use of technology, such as advanced 
perfusion technology, are advancing the recovery and placement of 
organs that were previously considered difficult to place for 
transplantation. Hence, after consideration of public comments, we are 
not finalizing these definitions at this time. We will monitor for new 
constructs that may emerge in the future that would support this 
proposal, including a consensus on consistent, nationally accepted 
standards for what constitutes a medically complex donor. Therefore, we 
will continue to monitor this issue and consider revisiting a proposal 
regarding medical complexity in the future.
    Comment: Some commenters stated that the usefulness of this 
requirement for OPOs will be limited without corresponding requirements 
for donor hospitals and transplant programs. For example, some 
commenters thought that transplant programs should be held accountable 
for not accepting medically complex organs.
    Response: As explained previously in this final rule, we will not 
be finalizing these definitions. However, we may consider proposing 
requirements regarding medical complexity in the future. If we do, the 
commenters' recommendations about corresponding requirements for donor 
hospitals and transplant programs and accountability will be 
considered. at that time.
    Final Rule Action: After consideration of the public comments we 
received, we are not finalizing the following definitions: ``Medically 
complex donor'' and ``Medically complex organ''. Additionally, we are 
not finalizing the corresponding QAPI requirement as discussed in 
section III.L. of this final rule.
5. Unsound Medical Practices
    In the 2006 final rule, CMS finalized Sec.  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 Sec.  
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''.
    We proposed 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.'' This definition was proposed to ensure that 
unsound medical practices would be addressed appropriately, and that 
OPOs would continue to provide high quality care to patients, potential 
donors and potential transplant recipients. We solicited public comment 
on the proposed definition of ``unsound medical practices''. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters expressed support for CMS' goal of 
clarifying the definition of ``unsound medical practices'' and 
establishing strong regulatory consequences for conduct that poses an 
imminent threat to patient safety. Commenters generally agreed that 
egregious breaches of medical or ethical standards warrant serious 
enforcement action and that OPOs engaging in reckless or dangerous 
practices should be held accountable. However, many commenters 
expressed concerns that the proposed definition of ``unsound medical 
practices'' is overly broad and vague. They stated that the definition, 
as proposed, could permit CMS to penalize OPOs even when they are in 
compliance with existing regulations and may grant CMS excessive 
discretion, potentially leading to inconsistent or arbitrary 
enforcement.
    Response: We appreciate the opportunity to clarify our intent in 
proposing this definition. The proposed definition of ``unsound medical 
practices'' was intended to provide a

[[Page 69399]]

clear, enforceable basis for urgent de-certification to protect 
patients and maintain public trust in the donation and transplantation 
system. We chose not to be overly prescriptive and specify the exact 
practices or instances that constitute unsound medical practice, as a 
narrow definition would risk creating regulatory gaps that could allow 
unsafe practices to go unaddressed. Rather, we focused on the outcomes 
of those specific practices and instances and their impacts on health 
and safety so that we could evaluate each case individually. We 
disagree that this outcome-oriented approach would lead to arbitrary or 
inconsistent enforcement. Making individualized determinations that are 
based on health and safety impacts does not equate to arbitrary 
enforcement. When we receive complaints or identify potential issues, 
trained surveyors investigate allegations of unsafe practices that 
arise, and all determinations are based on the evidence gathered during 
those investigations. CMS surveyors receive extensive training in 
assessing facilities for non-compliance, determining the seriousness of 
outcomes that pose imminent threats to patient health, and deciding 
when rapid action is needed to ensure safety to eliminate a risk to 
patients or the public. Additionally, any determination of unsound 
medical practices would be made carefully after consideration by CMS, 
given the seriousness of this determination and enforcement actions 
that would ensue.
    Comment: Several commenters expressed concerns that the proposed 
definition could be interpreted to permit de-certification based on a 
single, isolated incident. They recommended that CMS clarify that 
findings of unsound medical practices would be based on objective 
evidence of repeated or sustained failures and that immediate de-
certification would be reserved for the most egregious cases involving 
clear, severe violations that pose an imminent threat to patient safety 
or public trust.
    Response: A single event may constitute ``unsound medical 
practices'' and the finding of ``unsound medical practices'' is not 
limited to patterns of repeated unsafe practices. If a single event 
creates an imminent threat to patient health and safety or poses a risk 
to patients or the public, then it can constitute ``unsound medical 
practices'' and CMS can act immediately to protect patients. This gives 
CMS a clear, enforceable basis for urgent de-certification to protect 
patients and maintain public trust in the system. The question is not 
whether the situation is isolated or recurring, but whether it meets 
the threshold established by the definition. We will evaluate each 
situation based on the totality of the evidence and the specific 
circumstances involved before making a determination.
    Comment: Many commenters requested that CMS more clearly 
distinguish between ``adverse events'' and ``unsound medical 
practices,'' noting that the two concepts carry different regulatory 
consequences. They also requested clarification on how QAPI findings 
would be used in enforcement decisions and suggested that less severe 
or correctable deficiencies be addressed through standard compliance 
mechanisms such as plans of correction and enhanced oversight, 
consistent with CMS' approach to immediate jeopardy with other provider 
types.
    Response: We agree that ``adverse events'' and ``unsound medical 
practices'' are distinct concepts that carry different regulatory 
consequences. Adverse events, while serious, generally can be addressed 
through an OPO's internal QAPI program if they do not rise to the 
degree of severity and impact on patient or public health and safety to 
be considered unsound medical practices. Section 486.348(c) requires 
that OPOs establish written policies to address, at a minimum, the 
process to identify, report, analyze, and prevent adverse events that 
occur during the organ donation process. It also requires that OPOs 
conduct a thorough analysis of any identified adverse event and use 
that analysis to drive process improvement by effecting changes in 
their policies and practices to prevent repeat incidents. ``Unsound 
medical practices'' are failures by the OPO in which the OPO knows, or 
should have known, that its inaction, actions, or outcomes has caused, 
or is likely to cause, serious injury, harm, impairment, or death to a 
potential or actual donor or an organ recipient, creating an imminent 
threat to patient health and safety or public safety. The critical 
distinction between an ``adverse event'' that can be addressed through 
a QAPI program under Sec.  486.348(c) and ``unsound medical practices'' 
that may support de-certification for urgent need lies not in whether 
an incident is isolated or repeated, but rather in the degree of 
severity and impact on patient or public health and safety and the need 
for immediate action. If an adverse event is of such severity and 
impact to health and safety that it rises to the level of an unsound 
medical practice, standard compliance mechanisms such as QAPI are 
insufficient to address the concern. Therefore, CMS would apply its 
regulatory standards for unsound medical practices within the context 
of de-certification due to urgent need and proceed accordingly. Less 
severe deficiencies would be addressed through standard compliance 
mechanisms--such as acceptable plans of correction and additional 
oversight. We believe the definitions of adverse events and unsound 
medical practices strike the appropriate balance between providing CMS 
with the enforcement flexibility necessary to protect patient and 
public safety and ensuring that enforcement actions are based on 
objective, evidence-based findings.
    Comment: Several commenters objected to the inclusion of ``failures 
in governance'' within the definition, stating that governance issues 
are administrative rather than clinical in nature and do not directly 
threaten patient health and safety.
    Response: We disagree that ``failures in governance'' are solely 
administrative in nature or that they cannot directly threaten patient 
health and safety. Governance establishes the oversight and 
accountability framework necessary to ensure that clinical practices 
are performed safely and in accordance with applicable requirements. 
For example, a circumstance in which an OPO's governing board directs 
staff to undertake actions that are inconsistent with standards of 
practice, OPO policies, CMS rules and requirements, and/or local, 
State, or Federal laws that knowingly create an imminent threat to 
patient health/safety or pose a risk to patients or the public, would 
reflect a failure in governance. Specifically, it would reflect a 
failure of the governing board to enforce established policies and 
procedures, placing patients at immediate risk of serious harm. 
Therefore, we are finalizing a definition of unsound medical practices 
that includes failures in governance.
    Comment: A commenter recommended that CMS expand the definition to 
include OPO staff conduct toward patients' families, such as overly 
assertive behavior in the consent process and failure to collaborate 
with hospital staff in establishing referral criteria and donation 
protocols.
    Response: Approaching donor families with compassion, sensitivity, 
and respect during the donation process and allowing for adequate time 
to make a decision are incredibly important practices and have been 
shown to improve donation consent rates.\10\

[[Page 69400]]

Families should never feel rushed, coerced, or disregarded when making 
decisions about organ donation. Overly assertive or pressuring behavior 
not only undermines public trust in the donation system but may also 
constitute a violation of existing requirements under Sec.  486.342, 
which mandates that OPOs encourage discretion and sensitivity with 
respect to the circumstances, views, and beliefs of potential donor 
families. Complaints against an OPO may be submitted through various 
channels, including CMS,\11\ State survey agencies, HRSA,\12\ the OPO, 
or the hospital. Similarly, CMS emphasizes the importance of strong 
collaboration between OPOs and hospital staff throughout the donation 
and procurement process. These collaborative responsibilities are 
reflected in existing requirements under Sec.  486.322(a), which 
requires OPOs and donor hospitals to establish written agreements 
defining certain responsibilities and protocols--including definitions 
of ``timely referral'' and ``imminent death.'' Additional guidance is 
available in the SOM, Appendix Y--Organ Procurement Organizations. 
While we are not expanding the definition of ``unsound medical 
practices'' to include these areas at this time, the existing 
regulatory framework provides clear expectations for OPO conduct toward 
patients' families, such as overly assertive behavior in the consent 
process and failure to collaborate with hospital staff in establishing 
referral criteria and donation protocols.
---------------------------------------------------------------------------

    \10\ Rodrigue JR, Cornell DL, Howard RJ. Organ donation 
decision: comparison of donor and nondonor families. Am. J. 
Transplant. 2006 Jan;6(1):190-8. doi: 10.1111/j.1600-
6143.2005.01130.x. PMID: 16433774; PMCID: PMC2365918.
    \11\ Complaints or issues related to OPOs may be submitted to 
the following email address: <a href="/cdn-cgi/l/email-protection#89dac6cea4c6d9c6c9eae4faa7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="c2918d85ef8d928d82a1afb1ecaaaab1eca5adb4">[email&#160;protected]</span></a>.
    \12\ Reporting Allegations of Misconduct. <a href="https://www.hrsa.gov/optn/about/contact-us/report-misconduct">https://www.hrsa.gov/optn/about/contact-us/report-misconduct</a>. Accessed May 26, 2026.
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    Comment: Several commenters objected to the term ``unsound medical 
practices'' itself, stating that OPOs do not practice medicine or 
provide care to living patients and instead function in a coordination 
and procurement role. They suggested alternative terms such as 
``unsound donation practices'' or ``unsound procurement practices,'' to 
better reflect OPO responsibilities and reduce potential confusion 
among interested parties and the public.
    Response: The term ``unsound medical practices'' is not intended to 
refer to clinical activities outside the scope of an OPO's activities; 
rather, it is intended to encompass the full range of OPO activities 
during the donation and procurement process, including transport of a 
viable organ intended for a living person. We do not believe that 
either ``unsound procurement practices'' or ``unsound donation 
practices'' adequately captures that full range. For instance, 
``unsound procurement practices'' would be too narrow because the 
proposed definition includes ``procurement . . . practices and 
procedures'' as a subset of unsound medical practices. Similarly, 
``unsound donation practices'' may be overly limiting and would not 
necessarily encompass additional activities included in the definition, 
such as transport practices and procedures. The term ``unsound medical 
practices'' best reflects the full range of OPO activities the 
definition is intended to cover and avoids the ambiguity that either 
alternative term would introduce.
    Comment: Many commenters expressed concerns that examples of 
``unsound medical practices'' provided in the proposed rule are 
unclear, overly broad, and, in some cases, inconsistent with the role 
of OPOs. Commenters stated that the example, ``failure to ensure the 
potential donor is declared dead according to applicable State law and 
hospital policies,'' inaccurately suggests that OPOs are responsible 
for, or influence, the clinical determination of death. They 
recommended that CMS revise the example to clarify that the OPO's role 
is limited to verifying that death has been declared in accordance with 
applicable requirements.
    Several commenters also raised concerns that the phrase ``necessary 
and customary tests'' lacks specificity and is not clearly defined. 
They recommended that CMS provide additional detail regarding what 
constitutes such testing and align any requirements with existing OPTN 
policies governing donor evaluation. Commenters further emphasized that 
OPOs should only be held accountable for testing activities within 
their direct control. Some commenters expressed concern that unclear or 
expanded testing requirements could create operational burdens, delay 
the donation process, and potentially increase organ non-use.
    Additionally, commenters stated that the example ``pursuing 
patients with inappropriately high neurologic function'' lacks clinical 
specificity and is not defined in current CMS or OPTN policy. They 
cautioned that this language could lead to inconsistent interpretation 
and discourage appropriate donor evaluation, including for patients 
with severe neurologic injury, donation after circulatory death 
candidates, or individuals with conditions such as ALS or spinal cord 
injury, thereby potentially reducing donation opportunities.
    A commenter suggested expanding the examples of unsound medical 
practices to include failures by OPOs to utilize perfusion technologies 
when procuring and transplanting organs. Overall, several commenters 
urged CMS to revise the examples to more clearly reflect OPO 
responsibilities and include objective clinical criteria where 
applicable.
    Response: We appreciate commenters' requests for additional 
clarification regarding the scope and intent of the examples discussed 
in the proposed rule. The examples referenced in the proposed rule are 
illustrative only and are not intended to be interpreted as part of the 
regulatory definition of ``unsound medical practices.''
    Regarding the example referencing ``failure to ensure the potential 
donor is declared dead according to applicable State law and hospital 
policies,'' we note that the decision to withdraw life support and the 
subsequent declaration of death, if death occurs, are solely the 
responsibility of the patient's attending physician or a hospital 
physician designee in accordance with hospital policy and applicable 
State law.\13\ OPOs may not be involved in the decision to withdraw 
life support, the timing of withdrawal, or the declaration of death in 
any way. However, OPOs are required to verify that the pronouncement of 
death for potential donors adheres to applicable local, State, and 
Federal laws (Sec.  486.344(b)(1)), including in cases involving DCD. 
Following the declaration of death and prior to initiating the organ 
recovery process, the OPO should confirm that death has been pronounced 
and obtain documentation of the pronouncement of death.
---------------------------------------------------------------------------

    \13\ Organ Procurement Organizations (OPOs) and Donor Hospitals' 
Responsibilities Memo. <a href="https://www.cms.gov/files/document/qso-26-05-opo-original-release-date-2026-03-11-pdf.pdf">https://www.cms.gov/files/document/qso-26-05-opo-original-release-date-2026-03-11-pdf.pdf</a>.
---------------------------------------------------------------------------

    Regarding the example referencing ``necessary and customary 
tests,'' we do not intend to establish a new requirement or expand 
existing testing expectations. Under OPTN Policy 2.9, OPOs are required 
to ensure that infectious disease testing is performed for all 
potential deceased donors. This includes standardized screening for 
communicable diseases, as well as additional testing as clinically 
indicated by donor risk assessment. OPOs are also responsible for 
ensuring that specimens are collected within appropriate timeframes, 
that testing is performed in Clinical Laboratory Improvement Amendment 
(CLIA) certified laboratories, and that all required and relevant 
results are accurately documented and communicated to transplant 
centers in a timely manner.

[[Page 69401]]

These testing requirements align with Sec.  486.346 by promoting safe 
organ recovery and minimizing the risk of disease transmission through 
transplantation.
    Finally, regarding the example referencing ``pursuing patients with 
inappropriately high neurologic function,'' this example is not 
intended to establish clinical eligibility criteria, define neurologic 
thresholds, substitute for clinical judgment, or discourage OPOs from 
pursuing particular categories of potential donors. Rather, it is 
intended to emphasize the importance of adhering to established 
clinical and regulatory safeguards, including requirements related to 
the determination of death and appropriate donor evaluation, to protect 
patient safety. OPOs are expected to immediately cease the procurement 
process if signs of life are observed at any point before or during 
organ recovery. A prior declaration of death by the attending hospital 
physician does not authorize an OPO to continue the donation process if 
signs of life are subsequently detected. Failure to adhere to these 
safeguards could constitute conduct that poses an imminent threat to 
patient health and safety.\14\
---------------------------------------------------------------------------

    \14\ Additional information regarding the roles of OPOs and 
donor hospitals during the organ donation and procurement process is 
available via sub-regulatory memoranda (QSO-26-05-[OPO & 
Transplant]), accessible at <a href="https://www.cms.gov/files/document/qso-26-05-opo-original-release-date-2026-03-11-pdf.pdf">https://www.cms.gov/files/document/qso-26-05-opo-original-release-date-2026-03-11-pdf.pdf</a>.
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    Comment: Several commenters urged CMS to align implementation 
guidance with OPTN and HRSA standards and to consider issuing 
additional surveyor guidance to promote national consistency.
    Response: We intend to develop and issue implementation and 
surveyor guidelines to provide additional clarity regarding the 
application of the definition of ``unsound medical practices,'' 
including how surveyors will identify, document, and evaluate any 
conduct that may constitute unsound medical practices.
    Final Rule Action: After consideration of the public comments we 
received, we are finalizing as proposed. We 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.

C. Requirements for Certification (Sec.  486.303)

    CMS has historically interpreted the OPO Certification Act of 2000 
(the Certification Act), which added section 371(b)(1)(D) of the PHS 
Act, to mean the Secretary lacks the authority to certify new OPOs. 
Upon recent reassessment, however, we determined that the statute was 
not intended to strip the Secretary of his authority to certify new 
OPOs. Therefore, we proposed to remove Sec.  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. This eliminates 
a regulatory barrier that prevents the Secretary from implementing a 
process for certifying new OPOs. We also believe that removing this 
requirement would address concerns about market consolidation by 
creating a more diverse and robust market that enhances competition 
among OPOs.
    We also solicited public comments on a process to certify new OPOs. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters stated that CMS lacks statutory 
authority to certify new OPOs and that CMS' reinterpretation of the PHS 
Act expands its authority beyond what Congress authorized. Commenters 
stated that Congress unambiguously used the past tense in requiring 
OPOs to ``ha[ve] been certified or re-certified by the Secretary within 
the previous 4-year period,'' 42 U.S.C. 273(b)(1)(D), and that entities 
not yet in existence as of January 1, 2000, cannot satisfy that 
requirement.
    Additionally, commenters noted that Congress required the Secretary 
to ``use multiple outcome measures as part of the certification 
process,'' (42 U.S.C. 273(b)(1)(D)(ii)(III)). Commenters stated that 
outcomes are, by definition, retrospective and therefore Congress must 
have intended that CMS could certify only OPOs already in existence.
    Commenters also stated CMS cannot create new performance measures 
to justify certifying new entities or lawfully permit newly certified 
OPOs to compete with established, statutorily qualified organizations, 
and noted that the statute does not authorize CMS to favor new 
entrants. They recommended that any policy changes to allow the 
certification of new OPOs should be pursued through legislative action 
rather than regulatory interpretation.
    Response: We appreciate these comments and disagree that CMS lacks 
the authority to certify new OPOs. 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 re-certified 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.
    While we have previously interpreted the Certification Act to strip 
CMS of its prior authority to certify new OPOs, we no longer believe 
that interpretation to be the best reading of the statute. 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, the statute is better read to mean that 
whenever the agency initially certifies a new OPO or recertifies an 
existing OPO as meeting the Secretary's performance standards within a 
4-year period, OPOs must demonstrate at the end of that period that 
they continue to meet those standards. We note also that 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.
    Section 371(b)(1)(D)(ii) of the PHS Act specifically provides that 
a qualified OPO is an OPO that, among other things, ``has been 
certified or re-certified . . . within the previous 4-year period'' 
through ``a process'' that is ``defined through regulations . . . 
promulgated by the Secretary.'' There is no language in that provision 
requiring an OPO to demonstrate that it was certified as of January 1, 
2000, as part of those standards. This language is past tense in that 
it refers to an OPO that ``has been'' certified or re-recertified 
within the previous 4-year period. But the statutory language does not 
indicate that the ``previous 4-year period'' refers only to the 4-year 
period prior to enactment of the statute, as commenters suggest. A new 
OPO could meet this standard upon initial certification. In addition, 
the statute requires the Secretary to ``use multiple outcome measures 
as part of the certification process'' (emphasis added). The fact that 
the statute contemplates a certification process that uses outcome 
measures, rather than restricting the application of outcome

[[Page 69402]]

measures to re-certification, further indicates that the Secretary is 
not limited to recertifying existing OPOs and that Congress considered 
it possible to use outcome measures in the certification process. 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 de-certified.
    Comment: A few commenters supported CMS' goal of ensuring that all 
communities are served by high-performing OPOs and acknowledged that 
permitting new entities may improve accountability and performance 
across the system, but only if the new entities can demonstrate 
sufficient readiness and capability. Many commenters expressed concern 
that certifying organizations without an established performance 
history could disrupt continuity of care and negatively affect both 
donors and transplant recipients. These commenters emphasized that any 
certification of new entities should be contingent on demonstrated 
operational readiness and capability, rather than projected 
performance.
    Commenters offered a range of recommendations on the certification 
of new OPOs. Many commenters suggested that new entities must be 
nonprofit organizations, while one OPO recommended that CMS allow any 
entity to become an OPO regardless of nonprofit status. Another 
commenter recommended that any new entity be required to meet all 
existing CfCs under 42 CFR part 486, subpart G, prior to certification, 
without exception or phased implementation. A commenter suggested that, 
in the absence of historical outcome data, CMS should permit new 
entities to demonstrate readiness through alternative evidence--such as 
leadership experience, operational readiness, and systems capability--
while still requiring compliance with applicable CfCs and process 
performance requirements. Two commenters proposed alternative 
certification pathways--one through an expedited process for applicants 
demonstrating clinical infrastructure, transplant center partnerships, 
and sufficient financial reserves, and another through accreditation by 
national accrediting organizations. Commenters also requested 
additional clarity on how new OPOs would be monitored, measured, and 
benchmarked, including whether they would be evaluated differently from 
incumbent OPOs. Commenters also sought clarification on whether OPOs 
de-certified in one cycle could be re-certified in a subsequent cycle 
and, if so, under what conditions.
    Commenters also offered a range of recommendations on the 
designation of a DSA to a new OPO. A few commenters stated that, at a 
minimum, new OPOs should be subject to the same competition selection 
criteria as existing OPOs when applying for an open DSA. Another 
commenter recommended that CMS develop a standardized DSA Readiness 
Assessment to ensure that a new OPO is capable of performing 
immediately upon designation. This commenter suggested that at a 
minimum, this assessment should include: established clinical and 
operational capacity with qualified staffing and 24/7 readiness; 
demonstrated ability to effectively engage with donor families and 
communities; data-driven and third-party validated analysis of donor 
potential; and evidence of financial stability to sustain operations. A 
commenter stated that new OPOs should not receive any advantage in the 
selection process, as they lack experience and historical performance 
data and cannot be presumed to outperform existing OPOs. Another 
commenter suggested that CMS limit the certification of new entities to 
scenarios in which an OPO has been de-certified and no existing OPO 
seeks to compete for the open DSA.
    Response: We agree that each DSA should be served by a qualified 
OPO capable of performing organ procurement services. Given the 
complexity and significance of establishing a certification process for 
new OPOs, we did not propose a specific initial certification framework 
in the January 2026 OPO proposed rule. We intend to address 
certification of new OPOs and the process by which a newly certified 
OPO might be designated to a DSA in future rulemaking and will take the 
recommendations received into consideration at that time.
    Final Rule Action: After consideration of the public comments we 
received, we are finalizing as proposed removing Sec.  486.303(e). We 
will address the process to certify new OPOs, as well as the process by 
which a newly certified OPO might be designated to a DSA, in future 
rulemaking.

D. Designation of One OPO for Each Service Area (Sec.  486.308)

    Currently, Sec.  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 Sec.  486.314 are exhausted.'' We proposed to revise requirements 
at Sec.  486.308 to further address changes made in the December 2020 
OPO final rule related to when a DSA is open for competition. 
Additionally, 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. Additionally, the period may be shorter due to involuntary 
termination of an OPO due to non-compliance with the process 
performance measures (Sec. Sec.  486.320 through 486.360). 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 
proposed to clarify how an OPO is assigned a DSA and how we determine 
the OPO designation period. Specifically, we proposed to (1) clarify 
the normal designation period and when CMS may adjust the length of the 
period; (2) clarify designation periods for newly acquired DSAs; (3) 
specify the circumstances that trigger a DSA to become available for 
competition; and (4) establish criteria for successor selection when 
insufficient time exists for a full competition process.
    We proposed to clarify all circumstances when a designation period 
may be adjusted. We proposed at Sec.  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 Sec.  486.316(f).
    We proposed at Sec.  486.308(a)(2) that CMS would conduct a 
competition for all vacated DSAs. We also proposed at Sec.  
486.308(a)(3) that the designation period for any newly acquired DSA, 
whether following a competition or as the result of being assigned a 
DSA, will be the remaining portion of the agreement for the acquiring 
OPO's existing re-certification cycle. We proposed at Sec.  
486.308(a)(4) that if an OPO does not fulfill the terms of its 
agreement, whether voluntarily or involuntarily, and there is 
insufficient time to conduct a competition to select a successor OPO 
for its DSA, CMS may designate another OPO without first

[[Page 69403]]

conducting a competition. We stated that 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 circumstances, CMS would consider the following 
factors: contiguity to the DSA; performance on outcome measures at 
Sec.  486.318; history of compliance with the process performance 
measures at Sec. Sec.  486.320 through 486.360; and willingness of the 
OPO to perform the responsibilities.
    Currently, Sec.  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 Sec.  486.314 are exhausted. We proposed to 
amend this language to conform with requirements for competition at 
Sec.  486.316 and outcome measures at Sec.  486.318 to implement the 
tiered system for competition from the December 2020 final rule and 
clarify competition requirements if an OPO were to voluntarily 
terminate its agreement. Additionally, with the exception of de-
certification for urgent need, revisions to this section clarify that 
de-certification would not occur until after any applicable appeal is 
completed, competition for the open DSA is completed, and the DSA is 
transitioned to the successor OPO.
    Specifically, we proposed to address all circumstances under which 
a DSA is open for competition. A DSA is open for competition when:
    <bullet> An OPO's DSA is assigned tier 3 status in the final 
assessment period and all administrative appeals are exhausted;
    <bullet> An OPO's DSA is assigned to tier 2 for outcome measures in 
the final assessment period;
    <bullet> An OPO is not in compliance with the process performance 
measures at Sec. Sec.  486.320 through 486.360, all administrative 
appeals are exhausted, and the OPO is pending de-certification; or
    <bullet> An OPO requests to voluntarily terminate its agreement to 
participate, except where the voluntary termination is associated with 
a change in control, ownership, or service area resulting from a merger 
with another OPO.
    We solicited public comment on these proposed changes at Sec.  
486.308. The following is a summary of the comments we received and our 
responses.
    Comment: A commenter recommended that CMS revise the OPO 
certification period to end on December 31 of the last year of the re-
certification cycle and start the next cycle on January 1. The 
commenter stated that this would provide the public and the OPO 
community more time to verify the outcome measures, appeals, and 
competition. The commenter stated that the outcome measures from the 
final assessment period should be available for at least 6 months prior 
to the expiration of the OPO contracts. The commenter stated that these 
changes would effectively minimize potential disruptions in the area if 
the incumbent OPO is not redesignated to the DSA.
    Response: The dates of the re-certification cycle and the OPO 
agreement period are not within the scope of this rule, as we did not 
propose any changes to them. We note that once OPO annual public 
aggregated performance reports are published, OPOs are provided a 
preview period to verify their data and outcomes and raise any concerns 
to CMS prior to the public report being posted. Re-certification cycles 
end on July 31 every four years. However, the current OPO agreements 
end 6 months later on January 31, 2027. Additionally, we may extend 
agreements beyond this timeframe under Sec.  486.314(n) (revised and 
moved from Sec.  486.314(j)), if necessary to complete appeals and any 
necessary competitions and facilitate an orderly transition of the DSA. 
An extension of an agreement under Sec.  486.314(j), or Sec.  
486.314(n) as finalized in this rule, serves the limited purpose of 
allowing for these processes, where necessary, and does not extend the 
agreement cycle.
    Comment: A commenter stated that the designation of a DSA to an OPO 
in the middle of the OPO's current agreement period should not shorten 
the designation period for the OPO. The commenter recommended that an 
OPO be permitted to complete the remainder of the agreement period for 
the newly designated DSA and should be re-certified at the end of that 
agreement period for at least another 4-year agreement term regardless 
of manner or circumstance of the designation of the new DSA.
    Response: We appreciate the opportunity to clarify the designation 
periods described at Sec.  486.308(a)(3), as finalized in this rule, 
and existing requirements at Sec.  486.310(b)(2) and our rationale for 
the requirements for when OPOs would be held accountable on the outcome 
measures at Sec.  486.318(c)(3) and (4), as finalized in this rule. If 
an OPO is designated to a DSA mid-cycle, meaning after August 1 of the 
first year of the re-certification cycle, we will designate the OPO to 
the new DSA for the remainder of that re-certification cycle regardless 
of the reason for the designation. The OPO's re-certification and 
designation to the new DSA for the subsequent re-certification cycle 
would be based on the nature of the circumstances that resulted in the 
designation and availability of outcome measures from the final 
assessment period. If the initial designation was the result of a 
competition or resulted from CMS assigning the DSA to the OPO, we would 
re-certify the OPO at the end of the re-certification cycle, provided 
it is in compliance with the process performance measures, and 
redesignate the OPO to the DSA to provide additional time for it to 
operate in the DSA before holding it accountable on the outcome 
measures in the subsequent re-certification cycle as specified at Sec.  
486.318(c)(4). This policy is due to the greater challenge of assuming 
responsibility for a DSA in potentially contentious or unanticipated 
circumstances. If the designation was the result of a change of control 
or ownership or service area under Sec.  486.310, which generally occur 
under planned, cooperative circumstances, we would hold the OPO 
accountable on the outcome measures after 12 months of data are 
available as specified at Sec.  486.318(c)(3). Re-certification and 
redesignation to the DSA would depend on the timing of the change that 
resulted in being designated to a new DSA and the availability of 
outcome measures for that DSA under new leadership. A change of control 
or ownership or service area results from extensive pre-planning, 
cooperation, and sharing of information, all of which are likely to 
advantage the OPO in meeting the CMS outcome measure standards. Given 
these built in features that support more timely compliance with the 
outcome measure standards, it is our policy that if outcome measure 
data are available for the new DSA at the time of re-certification, CMS 
would hold the OPO accountable on the outcome measures for that DSA. 
The OPO's re-certification and redesignation would depend on the OPO's 
performance and tier standing in the final assessment period, provided 
the OPO met all other process performance requirements. We believe this 
approach balances performance expectations and timeframes with the 
circumstances and challenges posed by the nature of the change. 
Therefore, we are not adopting the commenter's recommendations.
    Comment: Several commenters stated that an OPO that is 
involuntarily assigned a DSA will expend significant administrative and 
clinical resources in the newly assigned DSA to the possible

[[Page 69404]]

detriment of the OPO's original DSA. These commenters stated that the 
OPO should not be disadvantaged by the involuntary assignment and 
accommodation should be made to that OPO for both of its DSAs if 
performance decreases.
    Response: We thank the commenters for sharing these concerns. The 
instances when CMS would assign a DSA to an OPO include when there is 
insufficient time to conduct a competition as specified at Sec.  
486.308(a)(4), as finalized in this rule, and if there are no 
competitors in a competition as specified at Sec.  486.316(e). While we 
appreciate the additional responsibility that the OPO would be taking 
on, we will continue to require OPOs to meet the minimum performance 
standards on the outcome measures. However, in response to the concerns 
raised by commenters regarding the potential for assignment to 
temporarily lower an OPO's performance in its existing DSAs, and to 
avoid disadvantaging OPOs that are assigned a new DSA without a 
competition, we are adding a provision to Sec.  486.316(a)(2) to 
provide that when CMS assigns an OPO to a new DSA under Sec.  
486.308(a)(4) or Sec.  486.316(e), that OPO's new and existing DSAs 
will not be opened for competition at the end of that re-certification 
cycle if the OPO's performance in those DSAs qualifies for tier 2 in 
the final assessment period. But an OPO must satisfactorily meet the 
outcome measures in its original DSAs by achieving tier 1 or tier 2 
performance in the final assessment period to retain those DSAs. This 
provision would partially address concerns by commenters regarding the 
impact of unplanned expansion to an OPO's other DSAs. However, we 
cannot permit an OPO to retain its other DSAs if performance in those 
DSAs decreases to tier 3. Therefore, if an OPO's performance in its 
original DSA decreases to the extent that the DSA is assigned to tier 
3, we would issue an initial notice of de-certification or a notice of 
removal of designation to a tier 3 DSA without de-certification in 
accordance with the process set forth at Sec.  486.314(a). If the 
assignment occurs on a date later than January 1 of the first year of 
the agreement cycle, the OPO will be held accountable for its 
performance in the newly assigned DSA as set forth at Sec.  
486.318(c)(4).
    Comment: Several commenters expressed concern with proposed 
designation requirements at Sec.  486.308(a)(4), in the circumstance 
when CMS would designate an OPO to a DSA where there is insufficient 
time to conduct a competition. Commenters stated that the DSA should 
not be opened for competition and the OPO should retain designation 
until a full re-certification cycle is completed. Commenters stated 
that the OPO should retain the DSA if its performance is acceptable at 
that time. Commenters highlighted the significant undertaking of 
accepting a DSA in this circumstance and stated that they should be 
given the opportunity to retain the DSA if its performance supports 
this.
    Response: We agree with the commenters on this issue. While our 
standard approach is to provide competition for open DSAs, the 
commenters raise valid concerns regarding the commitment of 
administrative and clinical resources necessary to stabilize a DSA 
under these circumstances. We are modifying proposed Sec.  
486.308(a)(2) and (4) to indicate that we would not open a DSA for 
competition following assignment of the DSA to an OPO under the 
circumstances described in Sec.  486.308(a)(4). The OPO would retain 
designation to the DSA for the remainder of the designation period 
rather than opening for competition at the earliest possible time. In 
response to the concerns raised by commenters, we are modifying 
proposed Sec.  486.308(a)(3) to include assignment of a DSA where there 
is insufficient time to conduct a competition as another scenario in 
which the OPO will be designated for the remaining portion of the 
current re-certification cycle. We are also modifying the language of 
proposed Sec.  486.318(c)(4) to make clear that that an OPO that is 
assigned a new DSA under either Sec.  486.308(a)(4) or Sec.  486.316(e) 
will be assessed on the outcome measures in the new DSA for re-
certification purposes based on the final assessment period of the next 
full re-certification cycle. However, to facilitate assessment of the 
OPO's performance in the newly assigned DSA, we will retain the 
language of proposed Sec.  486.309(b), which excludes assignment of a 
DSA due to insufficient time to conduct a competition from the 
scenarios in which an OPO may choose to consolidate DSAs. Finally, we 
are adding regulatory references for competition (Sec.  486.316(d)) and 
assignment of a DSA by CMS (Sec.  486.308(a)(4)).
    Comment: Several commenters recommended that CMS better define the 
circumstances at Sec.  486.308(a)(4) under which it would designate an 
OPO to a DSA without conducting a competition. Commenters stated that 
CMS should prioritize continuity of donation operations and provide 
realistic timelines, recognizing that transitions involve complex 
operational, legal, and governance factors in addition to clinical 
operations. Another commenter stated that CMS should clearly explain 
how the objective factors identified to guide designation decisions are 
weighed when competition is not feasible.
    Response: We thank commenters for sharing these concerns and 
recommendations. While it may be difficult to predict every 
circumstance when we would assign a DSA to an OPO without conducting a 
competition as specified at Sec.  486.308(a)(4), we anticipate this 
would be an extremely rare occurrence that would be utilized to ensure 
continuity of organ donation activities. De-certification due to urgent 
need, as set forth at Sec.  486.312(a)(4), or an OPO ceasing operations 
or voluntarily terminating its agreement with CMS without adequate 
notice to conduct a competition could all necessitate CMS assignment of 
a DSA to preserve organ donation activities. Although we did not 
receive any comments specifying alternative factors to consider when 
assigning a DSA in this situation, a commenter requested information 
about how we would weigh various factors under consideration. These 
factors include contiguity to the DSA, performance on outcome measures 
at Sec.  486.318, history of compliance with the process performance 
measures at Sec. Sec.  486.320 through 486.360, and willingness of the 
OPO to perform the responsibilities for the remainder of the 
designation period. Additionally, we are finalizing a modification to 
the proposed language at Sec.  486.308(a)(4) to indicate that we would 
assign the DSA to a single OPO, rather than ``one or more''. Given that 
CMS will only select a successor OPO under Sec.  486.308(a)(4) when 
there is insufficient time to conduct a competition, we expect that 
there would also be insufficient time in that scenario to take 
additional action to divide the DSA among multiple successor OPOs. 
Accordingly, we are finalizing a modification to the proposed language 
of Sec.  486.308(a)(4) to reflect that CMS would only select a single 
successor OPO for designation to the DSA when that provision applies.
    Final Rule Action: We are finalizing the proposed changes to Sec.  
486.308 with modifications to paragraphs (a)(2), (3), and (4). After 
considering public comments, we are modifying paragraph (a)(2) to add 
``except as noted in paragraph (4)'' to include an exception to opening 
a DSA for competition. We are modifying paragraph (a)(3) to add 
regulatory references ``Sec.  486.316(d)'' and ``Sec.  486.308(a)(4)'' 
to the paragraph to identify all instances when CMS may

[[Page 69405]]

assign a DSA to an OPO. In paragraph (a)(4), we are removing the 
provision that we would open the DSA for competition after assigning a 
DSA to an OPO. Additionally, we are modifying the first sentence to 
indicate that we would select a single OPO when assigning a DSA in this 
situation. We are also modifying Sec.  486.316(a)(2) to address 
concerns of commenters to ensure that an OPO is not disproportionately 
impacted in the event an OPO's performance decreases or fails to 
improve after being assigned a DSA by CMS.

E. Designation of an OPO to More Than One Service Area (Sec.  486.309)

    Since the December 2020 OPO 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 proposed to replace obsolete 
requirements at Sec.  486.309 related to the re-certification of OPOs 
during August 1, 2006, through July 31, 2010 with new requirements to 
address situations in which an OPO is responsible for more than one 
DSA.
    Permitting an OPO to separately maintain multiple DSAs could 
maintain some level of market diversity to support future competition. 
OPOs have also 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 if they were to combine 
DSAs and have outcome measures assessed for the combined areas. To give 
OPOs additional flexibility to maintain separate DSAs, we proposed that 
an OPO could be assigned to more than one DSA: (1) following a change 
in control, ownership, or service area; (2) as the result of a 
competition; or (3) as a result of CMS assignment when there is 
insufficient time to conduct a competition. In these instances, the OPO 
would need to determine how best to manage its organization for the 
respective areas. We proposed that if an OPO was made responsible for 
more than one DSA following a change in control, ownership, or service 
area, or a competition, the OPO could choose to consolidate the DSAs, 
maintain separate DSAs, or a combination thereof if more than two DSAs 
were involved. Additionally, we proposed that if CMS were to assign a 
DSA to an OPO following a voluntary or involuntary termination, the OPO 
would be required to maintain the newly assigned DSA separately to 
facilitate future competition. We also proposed that the DSA would be 
opened for competition at the end of the designation period, as 
designation of an OPO to a DSA in this situation would be a temporary 
measure intended to maintain organ procurement services and to provide 
time to facilitate an orderly transition of the DSA to a successor OPO 
following a competition.
    We also proposed an approach for the application of both the 
outcome and process performance measures when an OPO is designated to 
multiple DSAs. We proposed that when an OPO consolidated multiple DSAs, 
regardless of contiguity, into a single DSA, we would assess the OPO's 
performance on the outcome measures as a single 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 (Sec. Sec.  486.320 through 486.360) or the 
outcome measures (Sec.  486.318), at the time of re-certification. 
However, our proposed approach would permit an OPO that obtained 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 proposed 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. Specifically, we proposed 
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. 
We proposed that such removal of designation would not result in de-
certification unless an OPO is no longer designated to any DSA due to 
tier 3 outcome measure performance across all of its DSAs (see 
corresponding requirements at Sec.  486.316). We also proposed that an 
OPO may appeal the decision to remove its designation to a tier 3 DSA, 
and that the removed DSA would be opened for competition after any 
appeal for that DSA is exhausted and the decision is upheld.
    We solicited public comment on the proposed changes in Sec.  
486.309. The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters were supportive of the proposal allowing 
OPOs to choose to maintain separate DSAs. They were also generally 
supportive of allowing OPOs the flexibility to manage their DSAs in a 
manner that best suits their organizational and operational needs, 
noting that the factors considered in these decisions may vary based on 
the DSA and the OPO. A commenter supported CMS retaining final 
authority over multi-DSA arrangements with clear criteria, including 
operational capacity and accountability safeguards, while still 
allowing OPOs the flexibility to maintain separate DSAs, as 
appropriate.
    Response: We agree that OPOs designated to serve more than one DSA 
should have flexibility to establish their organizational and 
operational structure in a manner that best enables them to most 
effectively provide organ procurement services. There are many 
organizational and operational factors OPOs would need to consider in 
determining how to best design their operations. As a result, some OPOs 
may determine that consolidating DSAs into a single DSA is beneficial, 
while others may determine that maintaining separate DSAs is more 
appropriate.
    Comment: A commenter requested confirmation that an OPO is 
permitted to establish a distinct Standard Acquisition Charge (SAC) for 
each DSA, regardless of whether those DSAs are operated through 
separate legal entities or unincorporated divisions within a single 
legal entity. The commenter also sought clarification on CMS' 
expectations for allocating shared overhead, executive, and 
administrative expenses across multiple DSAs in distinct cost reports, 
specifically asking whether time studies conducted one week per month 
would be a sufficient methodology or if an alternative mechanism is 
recommended.
    Response: We thank the commenter for raising this concern. We will 
develop and issue guidance to address cost reporting questions for OPOs 
with multiple DSAs.
    Final Rule Action: After consideration of the public comments we 
received, we are finalizing changes to Sec.  486.309 as proposed.

[[Page 69406]]

F. Non-Renewal of Agreement (Sec.  486.311) and De-Certification (Sec.  
486.312)

    To address the implementation of the tier system for re-
certification of OPOs, we proposed to establish a new CfC at Sec.  
486.311 for non-renewal of an OPO agreement. Additionally, we proposed 
to revise Sec.  486.312 to address enforcement actions that may result 
in de-certification of an OPO.
    We proposed changes to address implementation of the tiered system 
for re-certification and competition from the December 2020 final rule 
and to clarify the difference between non-renewal of an agreement and 
de-certification. We also proposed to revise the public notice 
requirements for when there is a non-renewal or de-certification to 
clarify that CMS would be providing these notices.
    We proposed that CMS would not renew an agreement with an OPO if 
the following conditions are met: the OPO's DSA is subject to a 
competition and the OPO is unsuccessful in the competition to retain 
its 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). We proposed that CMS 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 proposed 
that CMS would not renew an agreement in the case of a voluntary 
termination of an agreement by an OPO.
    In our proposed approach, an OPO with only tier 2 DSAs that fails 
to retain any of its DSAs in competition would be re-certified without 
designation to a DSA. This would permit the OPO to compete in any 
additional open competitions during the following 4-year certification 
period. If the OPO is successful in a concurrent or subsequent 
competition, assigned a DSA by CMS, or selected for an open DSA when 
there is insufficient time to conduct a competition, it could then be 
designated to another DSA during this period. If the OPO does not 
obtain a new DSA through competition, assignment, or selection 
(including circumstances where there is insufficient time to conduct a 
competition) for an open DSA by the end of the next re-certification 
cycle following the non-renewal of the OPO's agreement, it would not 
meet outcome measure standards for that cycle. Consequently, the OPO 
would be de-certified at that time. The OPO would have appeal rights 
for de-certification. While an appeal would not be available for the 
assignment of a DSA to tier 2 or the result of a competition, all OPOs 
are provided with a preview of their outcome measure results and an 
opportunity to raise concerns with the data before performance reports 
are finalized.
    The current requirement for voluntary termination of an agreement 
is located at Sec.  486.312. We proposed to relocate the voluntary 
termination of agreement provision from Sec.  486.312 to new Sec.  
486.311 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 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.
    For non-renewal of an agreement after a competition, we proposed 
that we would provide notification to the OPO at least 90 calendar days 
before the effective date of the non-renewal, and the notice would 
state the reasons for non-renewal and include the end date of the 
agreement.
    We also proposed a public notice requirement consistent with the 
current public notice requirements at Sec.  486.312 to inform the 
public in the affected service areas. We would inform the public of the 
date on which a new OPO will be designated for that DSA. We also 
proposed to retain the policy which states 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 proposed to revise the requirements at Sec.  486.312 to clarify 
the actions we may take to de-certify an OPO. Specifically, we proposed 
that we may de-certify an OPO if the OPO no longer meets the 
requirements for certification at Sec.  486.303, including the 
conditions for coverage at Sec. Sec.  486.320 through 486.360. We 
proposed that we may de-certify an OPO if the OPO is designated only to 
tier 3 DSAs in the final assessment period at the end of the re-
certification cycle as specified at 486.318(b)(6) and 
486.316(b)(iii)(3)(A). We also proposed 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 and was not otherwise assigned a DSA by CMS.
    We also proposed to relocate and revise the provision allowing for 
immediate de-certification in cases of urgent need, such as the 
discovery of unsound medical practices.
    We proposed to revise and relocate the requirements regarding 
notice of de-certification to the OPO. We proposed 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.
    Finally, we proposed to revise and redesignate the requirements 
pertaining to public notice of de-certification. We proposed to replace 
the requirement that the OPO provide public notice in situations of 
involuntary termination and de-certification with a new process that 
CMS will provide public notice. We proposed that CMS would notify the 
public within the service area of both the date of de-certification and 
the date that a new OPO will be designated for the DSA. We solicited 
public comment on these proposed changes in Sec. Sec.  486.311 and 
486.312. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters were supportive of the proposed changes 
in clarifying the differences between non-renewal and de-certification 
in the competition framework. These commenters recommended advance 
notice and transition plans to allow for orderly transfer of operations 
to the successor OPO. A commenter recommended collaboration with HRSA 
in implementing changes to relevant information technology (IT) 
systems.
    Response: We thank commenters for their support and 
recommendations. We are establishing notification requirements for non-
renewal at Sec.  486.311(c) and (d) for both the OPO and the public 
respectively. Additionally, we are finalizing a requirement at Sec.  
486.316(g) for transition plans to facilitate an orderly transfer of a 
DSA between an incumbent and successor OPO. CMS and HRSA have 
coordinated the transition of DSAs for several mergers and a recent de-

[[Page 69407]]

certification. We continue to collaborate to refine this process and 
ensure continuity of IT systems during the transition.
    Comment: Many commenters recommended due process considerations for 
an OPO that received a notice of non-renewal due to competition loss 
and was therefore no longer designated to a DSA. Commenters stated that 
non-renewal of an OPO's agreement would effectively be the same as de-
certification and the lack of due process protections was unfair and 
lacked transparency. A commenter stated that the absence of any 
mechanism to challenge the underlying competitive determination would 
be a serious procedural gap. Several commenters stated that CMS should 
ensure that procedural safeguards are commensurate with the operational 
and public health consequences of DSA removal and recommended that CMS 
establish a structured administrative review pathway for OPOs in this 
situation. Another commenter raised concerns for procedural equity, 
indicating that tier 3 OPOs were afforded a pathway to contest de-
certification, while tier 2 OPOs that lost their DSA through a 
competitive process would not have such a pathway.
    Response: We thank commenters for sharing their concerns but 
disagree with their recommendations. The competition process is 
designed to enable CMS to choose the OPO that is most likely to 
increase organ donation in the service area and thereby serve the best 
interests of organ donation, potential organ donors and recipients in 
the service area. OPOs with tier 2 DSAs that are unsuccessful in 
competition and no longer designated to a DSA may compete in concurrent 
or subsequent competitions for other DSAs or be assigned a DSA by CMS 
throughout the term of the re-certification cycle. While there could be 
a gap in designation, impacted OPOs may have multiple opportunities to 
demonstrate that they are the best qualified OPO for a specific DSA.
    Assignment of a DSA to tier 2 is not a determination that the OPO 
designated to that DSA is out of compliance with the outcome measure 
requirements. An OPO with a DSA that meets tier 2 performance standards 
has met the minimum performance standards for re-certification and will 
be re-certified, provided that it also meets the process performance 
measures at Sec. Sec.  486.320 through 486.360. However, it will not 
automatically retain its designation to the tier 2 DSA for another full 
agreement cycle. Instead, an OPO with a tier 2 DSA would compete to 
retain its designation to the DSA for another agreement cycle.
    To clarify this distinction between re-certification and the 
retention of designation to a DSA, we are revising Sec.  486.311 to 
clarify that when an OPO is unsuccessful in the competition process, as 
set forth at Sec.  486.316(a)(2), and the OPO is no longer designated 
to the DSA, CMS will not renew its agreement for designation to that 
DSA. This means that the OPO would enter into a new Form CMS 576A 
(Health Insurance Benefits Agreement) to reflect its re-certification 
for the next 4 year cycle, but the OPO would no longer be designated to 
a DSA as identified on its Form CMS 576 (Request for Designation as an 
OPO). This clarification reflects that OPOs that meet the tier 2 
thresholds for the outcome measures and are compliant with the process 
performance measures will be re-certified and will maintain an 
agreement with CMS reflecting their status as a certified OPO, but must 
be successful in competition for an open DSA (their original DSA or a 
different one) in order to have an agreement for designation to a DSA 
for another full agreement cycle. We are also making a conforming 
change to Sec.  486.316(b)(2)(ii) to clarify that an OPO with a tier 2 
DSA will not have the agreement for designation to a DSA renewed if it 
is not successful in at least one competition.
    When an OPO's DSA is assigned to tier 3 based on performance in the 
final assessment period, on the other hand, the OPO has failed to meet 
minimum outcome measure standards in that DSA, resulting in either de-
certification or removal of designation to the tier 3 DSA. In light of 
this adverse determination, OPOs with tier 3 DSAs are granted an 
appeal. Furthermore, as we have previously explained, allowing appeals 
of competition results would be unwieldy and would create uncertainty, 
both for the OPO that prevailed in competition and within the DSA (71 
FR 30998). As a result, we do not believe that appeal of competition 
results would best serve the interests of organ donation in the DSA. 
While some commenters cite operational and public health concerns for 
transitioning a DSA, we note the public health considerations for the 
nearly 100,000 people on the organ transplant waiting list, many of 
whom will die waiting for a lifesaving transplant. While OPOs with tier 
2 DSAs meet minimum outcome measure requirements, they may not be the 
best OPO to serve a DSA if there is a more capable OPO that can 
demonstrate the ability to procure more lifesaving organs.
    Comment: Several commenters indicated that consistent turnover of 
DSA assignments risks undermining important community relationships and 
could negatively affect donation rates in affected communities. A 
commenter was concerned that DSA reassignments and associated changes 
will lead to major setbacks in the important work Tier 3 OPOs have done 
in reaching out to diverse communities, educating the community, and 
establishing trust. The commenter stated that the loss of personnel, 
programs, and expertise that these communities have come to know and 
trust could upset the progress that has been made and detrimentally 
impact organ donation rates in these communities.
    Response: We appreciate the concerns expressed by these commenters 
and recognize that many OPOs have invested in building deep community 
ties. We believe every community should be served by a high performing 
OPO that meets our performance standards. Additionally, we believe it 
is vital to continue improving donation rates in diverse communities 
and replacing underperforming OPOs with higher performers that have a 
demonstrated record of overcoming challenges in their DSA is one way to 
further this goal. We anticipate that successor OPOs will apply the 
lessons learned in their own DSAs to newly designated DSAs and build 
upon those successes to engage all population groups throughout its 
newly designated DSA, including those groups associated with 
historically low donation rates in the DSA. Additionally, as CMS 
develops future requirements for new entities seeking to become 
certified OPOs, we anticipate developing and proposing criteria to 
evaluate their plans to engage all population groups for organ 
donation.
    Comment: A commenter recommended CMS consider other factors to cure 
tier 3 performance in a DSA when the OPO would be de-certified or have 
its designation removed. The commenter recommended that CMS retain the 
OPO's designation to the tier 3 DSA in the following circumstances: (1) 
if there were no competitors for the DSA; (2) if the OPO had 
substantially improved performance in the DSA despite remaining in tier 
3; (3) if the subsequent year's performance improved significantly; or 
(4) if performance during the assessment year was aberrant due to a 
natural disaster or other unusual circumstance. Another commenter 
recommended that CMS implement a process for an OPO to develop and 
submit a performance improvement or corrective action plan

[[Page 69408]]

that would include peer-assisted improvement initiatives with 
measurable goals and frequent reporting requirements.
    Response: We thank the commenter for sharing these recommendations. 
As previously explained, the outcome measure performance standards are 
set forth at Sec.  486.318, and we did not propose to modify those 
performance standards to allow for alternative pathways to compliance. 
Under section 1138(b)(1) of the Act and section 371(b)(1)(D) of the PHS 
Act, an OPO must meet the Secretary's performance standards to be 
recertified and to remain eligible for payment of its organ procurement 
costs under Medicare or Medicaid. Accordingly, an OPO that does not 
meet minimum performance standards on the outcome measures (tier 3) in 
any of its DSAs in the final assessment period is not compliant with 
the Secretary's performance standards and will be de-certified under 
Sec.  486.312(a)(2). An OPO that meets the minimum performance 
standards in at least one of its DSAs is eligible to be re-certified, 
but will have its designation removed from any DSA in which its outcome 
measure performance qualified as tier 3 as specified at Sec.  
486.316(a)(3). However, CMS regulations do allow for an extension of an 
OPO's agreement cycle in one limited scenario. Specifically, under 
Sec.  486.316(f), an OPO can seek a 1-year extension of its agreement 
cycle if there are extraordinary circumstances beyond the control of 
the OPO that has affected the data of the final assessment period so 
that it does not accurately capture their performance. An OPO must 
request this extension within 90 days of the end of the occurrence of 
the extraordinary circumstance but no later than the last day of the 
final assessment period.
    We note also that nothing in the current requirements prevent an 
OPO from engaging in a peer-assisted improvement initiative with 
another OPO and we encourage underperforming OPOs to consider this 
activity in advance of the final assessment period. However, this type 
of arrangement cannot be utilized to remedy non-compliance with the 
outcome measures based on tier 3 performance in the final assessment 
period.
    Comment: A commenter stated that they support maintaining CMS' 
authority to de-certify an OPO immediately in cases of urgent need, 
including unsound medical practices. The commenter stated that patient 
safety must remain the paramount concern, and CMS should not be 
constrained in addressing serious failures that pose imminent risk to 
donors or recipients. Another commenter stated that they advocate for 
low-performing OPOs to be de-certified and believes that every 
community deserves to be served by a high-performing OPO.
    Response: We thank the commenter for the support of this provision. 
We believe it is important to be able to respond swiftly in the event 
of urgent need, such as the discovery of unsound medical practices. We 
have undertaken further actions to strengthen this provision by adding 
a definition of ``unsound medical practices'' which could trigger an 
urgent need de-certification decision. See Section X of this final rule 
for more information on the definition of ``unsound medical 
practices''.
    Final Rule Action: After considering public comments, we are 
finalizing Sec.  486.311 with modifications to paragraphs (a)(1) and 
(b) clarify that the non-renewal of an agreement after loss of a 
competition is limited to the OPO's agreement for designation to a DSA, 
rather than a non-renewal of an agreement for certification. 
Additionally, we are finalizing Sec.  486.312 as proposed with a minor 
wording change at Sec.  486.312(b) to align with the corresponding 
requirement at Sec.  486.314(a)(1). In the proposed rule, Sec.  
486.312(b) stated ``Except in cases of urgent need, CMS gives written 
notice of the initial de-certification decision to an OPO at least 90 
calendar days before the effective date of the de-certification.'' The 
corrected language in this final rule aligns with the title of Sec.  
486.314(a)(1) and is revised as follows: ``Except in cases of urgent 
need, CMS provides an initial notice of de-certification to an OPO in 
writing at least 90 calendar days before the effective date of the de-
certification.''

G. Appeals (Sec.  486.314)

    We proposed several changes to the appeals process. We proposed 
modifying the timeframes in the appeal process and converting all 
timeframes to calendar days. We proposed to codify a process for 
discretionary review by the CMS Administrator and clarify the appeal 
process for OPOs that are de-certified based on urgent need. 
Additionally, we proposed to allow an OPO to appeal the removal of a 
designation to a tier 3 DSA without de-certification for situations 
where an OPO has another DSA that is assigned to performance tier 1 or 
2 in the final assessment period for re-certification. These changes 
would make sure that OPOs have timely appeal rights for any adverse 
determinations regarding an OPO's compliance with outcome measure 
standards in a particular DSA. For more details on the basis for our 
proposals related to the appeals process, see the January 2026 OPO 
proposed rule (91 FR 4209 through 4212).
    We proposed to modify the time periods in this section for existing 
requirements from ``business days'' to ``calendar days'' to facilitate 
consistent implementation of the process. We also proposed to use 
``calendar days'' for all proposed requirements to further facilitate 
consistent application.
    Currently, the OPO has 15 business days from receipt of the notice 
to request reconsideration from CMS, and we proposed to change this to 
20 calendar days. 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 proposed to modify this to 15 calendar 
days to make a written reconsidered determination that would affirm or 
reverse the initial de-certification determination. We also proposed 
that CMS would have the right to extend this time based on a 
determination that additional time was necessary to thoroughly review 
and make a decision and the extension did not prejudice either party. 
Finally, we proposed to remove the option for the reconsideration 
official to ``modify'' the initial de-certification determination. If 
the de-certification decision was upheld, the OPO then would have 40 
business days from receipt of CMS' reconsideration decision to request 
a hearing before a CMS hearing officer. The hearing officer would have 
to set a date for the hearing that was no more than 60 calendar days 
after receiving that request for a hearing and would have to render his 
or her decision within 20 business days of the hearing. We proposed 
reducing the number of days within which an OPO could request a hearing 
before a CMS hearing officer from 40 business days to 15 calendar days.
    The hearing officer would be required to send the administrative 
record to both parties (for example, CMS and OPO) 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 would not need to forward their administrative record to the 
hearing officer unless and until there had been a request for a 
hearing. We proposed that upon receipt of a request for a hearing, the 
hearing officer would

[[Page 69409]]

promptly request the administrative record from the reconsideration 
official. We also proposed 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.
    We proposed establishing requirements related to the scope of 
review and burden of proof related to an appeal. We proposed that the 
scope of review would be limited to (1) de-certification of an OPO and 
(2) removal of designation to a tier 3 DSA. The appeal must be based on 
substantive or procedural grounds. We also proposed that the OPO would 
bear the burden of proof by a preponderance of the evidence to 
demonstrate that the adverse determination by CMS should be reversed.
    Additionally, we proposed to change the time that the hearing 
officer would be allotted to render their decision to from 20 business 
days to 90 calendar days. We also proposed allowing the hearing officer 
to extend that time upon notifying both the OPO and CMS, if the 
extension did not unduly prejudice either of the parties and is 
necessary for the hearing officer to issue a legally sufficient 
decision. Consistent with CMS longstanding policy, the hearing officer 
could affirm or reverse the notice of de-certification. We proposed to 
add that the hearing officer could also affirm or reverse the removal 
of designation to a tier 3 DSA without de-certification. The hearing 
officer would then promptly forward the decision and the administrative 
record to the CMS Administrator.
    We proposed to codify the process for discretionary review of the 
hearing officer's decision by the CMS Administrator. Specifically, we 
proposed that the CMS Administrator would have 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 
elected to review the hearing officer's decision within the 30-day 
period, the CMS Administrator would promptly notify the OPO and CMS of 
his or her decision to review and the parties' right to submit written 
arguments within 15 calendar days of the notification. If the 
Administrator did not elect to review the decision within 30 calendar 
days of its receipt, the hearing officer's decision would be final.
    We proposed that within 45 calendar days of notification of the CMS 
Administrator electing to review the hearing officer's decision, the 
CMS Administrator would be required to render a final decision, in 
writing, to the parties. The CMS Administrator could affirm, reverse, 
or remand the hearing officer's decision to CMS. We believed that there 
might be circumstances in which the CMS Administrator would want CMS to 
conduct further review or have other instructions for CMS regarding the 
appeal. Hence, we proposed that the CMS Administrator could remand the 
appeal to CMS for any appropriate reason. Remanding the appeal means 
that the appeal would be 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 was 
remanded to CMS, the agency would comply with any instructions in the 
remand. We did not propose to establish remand authority for the 
hearing officer.
    We also proposed that the CMS Administrator would have the right to 
extend the review time if he or she determined they needed more time to 
thoroughly review and make a decision, provided the extension did not 
prejudice either party. We proposed that the CMS Administrator's review 
would be limited to the hearing's administrative record developed by 
the hearing officer and written arguments submitted by the OPO or CMS.
    We proposed that CMS' reconsideration decision on de-certification 
or designation removal would become final if the OPO did not request 
review by a hearing officer in the time allowed under these 
regulations, or after the CMS Administrator declined to review the 
hearing officer's decision, render a decision in writing to the 
parties, or did not render a final decision or a remand in writing to 
the parties within 45 calendar days of electing to review the hearing 
officer's decision (or by the extended deadline, if the Administrator 
extends the 45-day period).
    As noted later in this section of the preamble, a decision would 
not take effect until (among other things) all administrative appeals 
were exhausted to avoid any undue prejudice to the OPO. Given the range 
of tasks that must be completed, we also proposed that CMS could offer 
to extend an OPO's agreement if additional time would be needed for 
completion of the appeals process, competition of the service area and, 
if necessary, transition of the service area to a successor OPO.
    We proposed to clarify when the OPO's DSA would be opened for 
competition. Consistent with longstanding CMS policy, we proposed that 
an OPO would not be de-certified or lose its designation to a DSA until 
all administrative appeals were exhausted. If at the end of the appeals 
process the notice of de-certification or removal of designation has 
been confirmed, the decision would be final. At that time, the OPO's 
DSA would be opened for competition and a successor OPO would be 
chosen. CMS would then determine a transition period that was 
sufficient for the new OPO to take full responsibility for the DSA. 
After the transition period was determined by CMS, CMS would forward to 
the de-certified OPO a written communication indicating the effective 
date of de-certification. As of that effective date, Medicare and 
Medicaid payments would no longer be made for organ procurement costs 
attributable to the OPO. For an OPO that lost its designation to a tier 
3 DSA without being de-certified, CMS would forward a written 
communication indicating the effective date of the decision. As of that 
effective date, Medicare and Medicaid payments would 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 was exhausted.
    We also proposed to address special considerations regarding 
appeals in cases of de-certification due to urgent need. The appeals 
process would be the same for an OPO de-certified due to urgent need 
regardless of the reason for the OPO's de-certification. However, if an 
OPO was de-certified due to urgent need, it could be de-certified 
immediately. In such circumstances, the affected OPO's service area 
would be reassigned to one or more other OPOs by the effective date 
specified in the notice of de-certification provided. Hence, if the de-
certified OPO pursued an appeal, it would not be operating its DSA 
while proceeding through the appeals process.
    We solicited public comments on these proposed changes to the 
appeals process. The following is a summary of the comments we received 
and our responses.
General Comments
    Comment: Most commenters generally supported the proposed change 
from using business days to calendar days.
    Response: We thank the commenters for their support. We are 
finalizing the proposed change from calendar days to business days.
    Comment: Some commenters were concerned about the status of OPOs 
during the appeals process. They wanted to know what happens to their 
agreements with CMS and their

[[Page 69410]]

payments for organ procurement activities during that time.
    Response: When an OPO is going through the appeals process after 
receiving an initial notice of de-certification for non-compliance with 
the CfCs or a notice of removal of designation to a tier 3 DSA without 
de-certification, the OPO is still certified and designated to its 
DSA(s). During this period, the OPO's agreement is still in effect, and 
the OPO will remain eligible for payment. If the de-certification 
decision or the removal of designation decision is upheld, this status 
continues until the effective date of the de-certification or removal 
of designation to the tier 3 DSA. However, as set forth in Sec.  
486.314(p), if an OPO is de-certified due to urgent need, the affected 
OPO's service area will be reassigned to one or more other OPOs as set 
forth at Sec.  486.308(a)(4) by the effective date specified in the 
notice of de-certification provided under Sec.  486.312(b). The OPO has 
20 calendar days from receipt of that notice to file a request for 
reconsideration from CMS. The remainder of the appeals process proceeds 
as set forth in Sec.  486.314. As the OPO's de-certification for urgent 
need is already in effect during the appeal timeframe, the OPO is not 
eligible for payment for organ procurement activities during the 
appeals process.
    Comment: Some commenters questioned our authority to create an 
appeals process for OPOs and were concerned with the proposed 
timeframes. They indicated that with Medicare claim appeals there is 
typically a much longer timeframes for the provider to act, such as 120 
calendar days to request a redetermination, 180 calendar days to file 
for a reconsideration, and 60 calendar days to request review by an 
administrative law judge.
    Response: Section 371(b)(1)(D)(ii)(IV) of the PHS Act, added by the 
Certification Act,\15\ requires the Secretary to issue regulations that 
provide for an OPO to appeal a de-certification to the Secretary on 
substantive and procedural grounds. Hence, an appeal process is 
explicitly required by statute and the Secretary delegated to CMS 
authority to implement this statutory requirement through the OPO CfCs. 
We are not persuaded by the commenters' argument regarding the extended 
timeframes allowed in the Medicare claims process, as that process 
applies to a matter entirely distinct from OPO certification. Every DSA 
can only have one OPO designated at a time, meaning that an OPO has a 
mandated monopoly on organ procurement services for an entire 
geographic area. An OPO that fails to meet the standards to be a 
qualified OPO should be removed as promptly as possible to reduce 
uncertainty in the OPO's DSA and support the entire organ donation and 
transplantation system. An OPO that receives an initial notice of de-
certification (Sec.  486.314(a)(1), as finalized in this rule) 
continues to be designated for that DSA unless and until the OPO is de-
certified. The DSA cannot be transitioned to a successor OPO until the 
appeals process has been exhausted. OPOs must be afforded the right to 
appeal a de-certification on substantive or procedural grounds; 
however, that appeals process must be conducted in a timely manner to 
reduce uncertainty in the DSA and protect the rights of the patients on 
the waiting list. We believe the proposed changes that we are 
finalizing in this rule not only provide the appropriate balance needed 
to provide OPOs an adequate opportunity to appeal a de-certification, 
but also ensure that the rights of the patients on the waiting list, 
including the right to have an OPO that is in compliance with the OPO 
CfCs and to avoid any unnecessary disruptions in the organ procurement 
and placement of organs, are preserved.
---------------------------------------------------------------------------

    \15\ Public Law 106-505, section 701(c), 114 Stat. at 2347.
---------------------------------------------------------------------------

    Comment: Some commenters were concerned that the appeals 
requirements were very burdensome and weakened the due process 
protections to which OPOs are entitled. Several commenters criticized 
the proposed changes to the appeals process, especially the change for 
OPOs to request a hearing from 40 business days to 15 calendar days, as 
denying OPOs' right to a meaningful due process in the appeals process. 
Commenters stated that OPOs facing de-certification deserve a 
meaningful appeals process with sufficient opportunity to prepare and 
defend against the de-certification. They stated that these appeals are 
complex and often require extensive preparation, such as review of 
multi-year performance and outcome data, statistical methods, hospital-
level documentation, and thorough legal analysis. Commenters stated 
that this could be exceptionally difficult for smaller OPOs with fewer 
resources. Commenters further stated that the appeals process requires 
meaningful procedural protection, including clear standards, fair 
timelines, and transparent opportunities for participation. A few 
commenters recommended that the CMS hearing officer have the authority 
to grant filing extensions. This would provide flexibility for OPOs 
that need more time to file a request for hearing and still preserve 
their appeal rights.
    Response: A request for the hearing is not a formal document in 
which an OPO is required to submit its arguments about why the OPO 
should not be de-certified. The request does not require all the 
information, data, or legal analysis needed for the hearing. It serves 
only as a notice that the OPO seeks a hearing before a CMS hearing 
officer. The OPO may continue preparing for the hearing, including 
reviewing relevant data and developing legal analyses, both before and 
after the request for hearing is filed. An OPO is free to file a 
request for hearing to preserve its appeal rights and later withdraw 
that request if, in the course of preparing for the hearing, it 
determines that it no longer wants to proceed with the appeal process. 
We believe that the proposed changes provide OPOs with clear, 
transparent standards for participation in the appeal process and a 
meaningful opportunity to appeal on substantive and procedural grounds, 
while still ensuring the appeals process moves forward in a timely 
manner to reduce uncertainty in the DSA and protect the interests of 
patients on the transplant waiting list.
    Comment: Some commenters stated that the proposed changes to the 
appeals process granting CMS officials additional time, if needed, to 
fulfill their responsibilities without allowing OPOs to request 
additional time for required steps in the appeal process created an 
asymmetrical process that was inequitable and illegal. Other commenters 
were concerned about fairness and requested protection against 
conflicts of interest and for the hearing to have a standardized, 
objective process for all hearing officers. Some commenters recommended 
allowing the CMS hearing officer to grant extensions to file a request 
for a hearing.
    Response: Section 371(b)(1)(D)(ii)(IV) of the PHS Act provides that 
an OPO is entitled to appeal a de-certification on substantive and 
procedural grounds. An OPO subject to de-certification for non-
compliance with the CfCs will continue operating in its DSA pending 
resolution of any appeal unless the de-certification was based on 
urgent need. Accordingly, the appeals process must be efficient and 
timely to reduce any disruption to the organ procurement activities in 
the DSA and ensure that OPOs that fail to comply with minimum standards 
are removed as promptly as possible. We believe the requirements for 
appeals

[[Page 69411]]

that are being finalized in this rule provide OPOs with adequate notice 
and a meaningful opportunity to pursue their appeal. Permitting CMS 
officials the opportunity to extend timelines supports this by assuring 
that CMS officials have enough time to adequately consider the OPO's 
arguments, particularly since CMS officials are likely to be 
responsible for multiple appeals simultaneously. In addition, the 
hearing officer may extend the timeframe for issuing its decision 
beyond 90 calendar days only if the hearing officer determines that 90 
calendar days is insufficient for the hearing officer to develop the 
administrative record and render a legally sufficient decision and that 
extending the timeframe for issuing its decision would not unduly 
prejudice either the OPO or the government. The hearing officer must 
also provide notice of the extension to the OPO and the government.
    With respect to the commenters' concerns about fairness and 
conflicts of interest, we want to assure the commenters and the public 
that CMS hearing officers are highly qualified and hear numerous cases 
involving CMS and other parties across a range of programs and 
providers and suppliers. In addition, the powers and responsibilities 
of the hearing officer are clearly set out in Sec.  486.314.
    We do not believe it is necessary to grant the CMS hearing officer 
authority to grant an extension to file a request for a hearing. The 
appealing OPO should have sufficient time to file the request. As 
previously explained, the request for a hearing serves only as a notice 
that the OPO seeks a hearing before a CMS hearing officer. It does not 
require all the information, data, or legal analysis needed for the 
hearing. The OPO may continue preparing for the hearing, including 
reviewing relevant data and developing legal analyses, both before and 
after the request for a hearing is filed.
    Comment: Some commenters supported codifying a process for the CMS 
Administrator's review. However, several commenters did not support the 
discretionary nature of the review and stated that, due to the severe 
consequence of de-certification as the loss of eligibility for 
designation and reimbursement under Medicare or Medicaid, the CMS 
Administrator should be required to review every hearing officer 
decision.
    Response: We agree with commenters that de-certification warrants a 
meaningful opportunity to appeal on substantive and procedural grounds, 
as required by statute. We proposed that under Sec.  486.314(k)(3), 
each hearing officer's decision and the accompanying administrative 
record would be promptly forwarded to the CMS Administrator for his or 
her discretionary review. Thus, the CMS Administrator will have access 
to each hearing officer decision when deciding whether to exercise 
discretionary review. We continue to believe that it is appropriate to 
permit the CMS Administrator to exercise his or her judgement in 
determining whether to review the hearing officer decision. It is also 
important to note that prior to the CMS Administrator's discretionary 
review, the appealing OPO would have gone through reconsideration by a 
CMS official and a hearing before a CMS hearing officer. Thus, the 
appealing OPO has already had a meaningful review of its initial notice 
of de-certification or notice of removal of designation to a tier 3 DSA 
without de-certification.
    Comment: Some commenters stated that the OPOs should be allowed to 
submit new evidence during the appeals process, especially during the 
CMS Administrator's review. They pointed out that data used for the 
outcome measures could be up to two years old. As such, the OPO's 
performance could have substantially improved before it receives the 
initial notice of de-certification.
    Response: We acknowledge that there is a delay in obtaining the 
outcome measure denominator data due to the nature of the data source, 
and that the performance reflected in the calculated outcome measures 
reflect data collected two years prior. However, as stated previously, 
OPOs have a 4-year re-certification cycle. The data that will be used 
for the outcome measures are not collected until the third year of the 
re-certification cycle, meaning that OPOs had time prior to the final 
assessment period to improve their performance. CMS provides annual 
performance data reports to every OPO and requires those OPOs that have 
DSAs in tier 2 and tier 3 to conduct performance improvement projects 
that will contribute to improved performance on the CMS outcome 
measures. OPOs have sufficient time, regulatory structure, and 
incentives to improve their performance, including getting assistance 
from OPTN, HRSA, CMS, or consultants, before the data that will be used 
for re-certification begins to be collected. Hence, we believe OPOs 
have sufficient time to ensure compliance with the OPO CfCs.
    Final Rule Action: After consideration of the public comments we 
received, we are finalizing changes to Sec.  486.314 as proposed. 
However, we are modifying Sec.  486.314(p) to reflect a revision to 
Sec.  486.308(a)(4) which has been revised to indicate that CMS would 
only select a single successor OPO for designation to the DSA when 
there is insufficient time to conduct a competition.

H. Re-Certification and Competition (Sec.  486.316)

    The current requirements at Sec.  486.316 address OPO re-
certification and competition. These requirements do not currently 
address one OPO being designated to more than one DSA and the impact 
this may have on the re-certification and competition processes. We 
proposed to make conforming changes to this section to clarify the 
requirements related to OPO designation, re-certification, and 
competition to also include situations when an OPO is designated to 
more than one DSA.
    We proposed to address the impact of the OPO outcome measures on 
OPO designation at the time of re-certification. We proposed to 
determine OPO designation to the DSA based on its performance on the 
outcome measures and tier assignment in each DSA at the final 
assessment period of the agreement cycle. Depending on its performance 
on the outcome measures, an OPO's performance in each DSA would be 
assigned to tier 1, tier 2, or tier 3.
    We proposed that an OPO with a DSA that is assigned to tier 1 would 
retain designation to the DSA for another agreement period. We also 
proposed that an OPO with a DSA that is assigned to tier 1 would be re-
certified, provided that CMS also determined that the OPO is compliant 
with the requirements for certification at Sec.  486.303, including the 
process performance measures at Sec. Sec.  486.320 through 486.360 
during the most recent survey. Furthermore, we proposed that an OPO 
that was compliant with the requirements of Sec. Sec.  486.320 through 
486.360 and that has a tier 1 DSA would be eligible to compete for any 
open DSAs.
    We proposed that an OPO with a DSA that was assigned to tier 2 
would have to successfully compete and be awarded a DSA through a 
competition to retain designation to a DSA for another agreement 
period. We also proposed that an OPO with tier 2 DSAs would also need 
to be found compliant with the requirements for certification at Sec.  
486.303, including the conditions for coverage at Sec. Sec.  486.320 
through 486.360 during the most recent survey to be eligible for re-
certification. We proposed that an OPO that was compliant with the 
conditions for coverage at Sec. Sec.  486.320 through 486.360 and had a

[[Page 69412]]

DSA assigned to tier 2 would be eligible to compete for any open DSAs. 
We also proposed that if the OPO was not successful in at least one 
competition, it would receive a notice of non-renewal. As finalized in 
this rule, Sec.  486.311(a) clarifies that this notice of non-renewal 
is limited to the OPO's designation to the DSA and would not impact the 
OPO's agreement with CMS reflecting its status as a certified OPO (Form 
CMS 576A, Health Insurance Benefits Agreement). Because the OPO was re-
certified, we proposed that it would remain eligible to compete in 
future competitions, be assigned a DSA, or be selected for an open DSA 
during the next re-certification cycle.
    We proposed that an OPO with a DSA that was assigned to tier 3 
would have the designation to the tier 3 DSA removed at the end of the 
agreement period. Additionally, we proposed that an OPO with all of its 
DSAs assigned to tier 3 would not be eligible to compete in 
competitions for any open DSAs. We proposed that an OPO that was 
designated to a DSA that was assigned to tier 3 in the final assessment 
period would receive one of two notices. The OPO would receive an 
initial notice of de-certification, as specified at Sec.  
486.314(a)(1), for an OPO that has no other designated DSA that is 
assigned to tier 1 or tier 2, or no other designated DSA that is 
pending evaluation of its outcome measures at the end of the re-
certification cycle. The OPO would receive a notice of removal of 
designation to a tier 3 DSA without de-certification, as specified at 
Sec.  486.314(a)(2), for an OPO that has another designated DSA 
assigned as tier 1 or tier 2, or another designated DSA that is pending 
evaluation of its outcome measures at the end of the re-certification 
cycle. We proposed that an OPO would have the right to appeal a de-
certification or removal of designation to the DSA assigned as tier 3. 
If an OPO did not appeal the determination, or the OPO appeals and the 
determination is upheld after the appeal process is completed, the 
OPO's tier 3 DSA is opened for competition from other OPOs that qualify 
to compete for open service areas.
    We also proposed updates to the re-certification and competition 
requirements. We proposed that an OPO would have to maintain compliance 
with the process performance measures at all times. We proposed that 
non-compliance with the requirements at Sec. Sec.  486.320 through 
486.360 in any DSA at any time during the re-certification cycle would 
result in the OPO receiving an initial de-certification determination 
and that the OPO would have the right to appeal the de-certification 
due to non-compliance with the requirements at Sec. Sec.  486.320 
through 486.360. If the OPO did not appeal the determination, or the 
OPO appeals and the determination was upheld after the appeal process 
was completed, the OPO's service areas would be opened to competition 
from other OPOs that were qualified to compete for open service areas.
    We retained the existing policy that DSAs assigned as tier 2 or 
tier 3 in the final assessment period would be opened for competition, 
but proposed updated language to reflect that the tier assignment based 
on the outcome measures at Sec.  486.318 would be specific to the DSA 
and not assigned globally to the OPO since OPOs may have more than one 
DSA. A tier 2 or tier 3 service area would be opened for competition 
from other OPOs that qualify to compete for open service areas. 
Competition for DSAs assigned to tier 3 would not begin until after any 
applicable appeal under Sec.  486.314 had been exhausted.
    We retained the existing criteria to compete for an open DSA, but 
proposed updated language to reflect that tier assignment for the 
outcome measures at Sec.  486.318 would be specific to the DSA and not 
assigned globally to the OPO. To compete for an open DSA, an OPO would 
have to be designated to at least one DSA that meets the performance 
requirements for the outcome measures for tier 1 or tier 2, as 
specified at proposed Sec.  486.318(b)(4) or (5), respectively. The OPO 
would also have to meet the requirements for certification at Sec.  
486.303 and would have to meet the process performance measures at 
Sec. Sec.  486.320 through 486.360 during the most recent routine 
survey. Additionally, the OPO would have to compete for the entire open 
DSA. We proposed to revise these criteria to address competition 
eligibility for any OPO subject to non-renewal of their agreement for 
failure to be designated to a DSA after competition. We proposed that 
an OPO in this situation would be eligible to compete in additional 
competitions after its agreement expired and could enter into a new 
agreement with CMS, provided it had not been de-certified and met the 
criteria to compete at that time it entered the competition process 
that resulted in non-renewal. As explained in this final rule, we are 
clarifying that in this situation the OPO would enter into a new 
agreement with CMS reflecting its status as a certified OPO for the 
next re-certification cycle (Form CMS 576A, Health Insurance Benefits 
Agreement) but the OPO would no longer be designated to a DSA as 
identified on the Form CMS 576, Request for Designation as an OPO. This 
would enable the OPO to participate in subsequent competitions and 
enter into a new designation agreement with CMS if it was successful in 
a competition. If the OPO did not obtain a new DSA before the end of 
the next re-certification cycle, it would not be able to demonstrate 
compliance with the outcome measures for that re-certification cycle 
and would de-certified at that time.
    Finally, we proposed a new requirement to facilitate DSA 
transitions. We proposed to codify the requirement for OPOs to 
cooperate during transitions following a competition to facilitate a 
smooth transition and continuity of organ donation activities in the 
DSA. We proposed that an incumbent OPO must cooperate with a successor 
OPO that is newly designated to facilitate an orderly transition of the 
DSA and submit a transition plan, as specified by CMS, that provides 
details on how all aspects of the OPO operation will be transmitted, 
including timeframes, to a new OPO. We proposed that the successor OPO 
must submit a transition plan and periodic reports, as specified by 
CMS, related to progress on its transition activities until the process 
is completed. We also proposed that the successor OPO would be required 
to provide a final notice to CMS no later than 30 calendar days after 
completion of the transition and prior to the end of the incumbent 
OPO's agreement.
    We solicited public comment on these proposed changes to Sec.  
486.316. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposal to assess an OPO 
with multiple DSAs separately on the outcome measures. A commenter 
stated that evaluating each DSA separately on outcome measures ensures 
that OPOs serving multiple areas are held accountable for performance 
in each geographic region. Another commenter stated the specific 
proposals related to re-certification and competition for OPOs serving 
more than one DSA are logical and consistent with policies already 
finalized. Another commenter suggested that labeling the performance of 
the DSA rather than the OPO as a whole may decrease disincentives for 
high-performing OPOs to consider competing to provide service in a DSA 
with an outgoing underperforming (tier 3) OPO. Commenters stated that 
not only is this approach fair to an OPO on its face, but it may also 
advance the goal of ensuring continued provision of procurement

[[Page 69413]]

services to communities with an outgoing underperforming (tier 3) OPO.
    Response: We thank commenters for these responses. Our intention 
for this proposal at Sec.  486.316(a) was to support the provisions at 
Sec.  486.309 that would enable an OPO to be designated to more than 
one DSA as well as mitigate the geographical consolidation of DSAs. We 
believe that evaluating DSAs separately on outcome measure performance, 
when an OPO decides to operate them separately, is a reasonable and 
equitable approach. This also supports OPOs in deciding how to best 
operate when expanding beyond their initial DSA.
    Comment: A commenter requested clarification on how CMS would 
evaluate outcome measures when an OPO is designated to multiple DSAs 
and elects to merge or maintain separate DSAs. The commenter stated 
that each DSA is evaluated independently, resulting in the unit of 
accountability effectively shifting from the organization as a whole to 
the DSA level.
    Response: We thank the commenter for seeking additional 
clarification on the evaluation framework. The framework of evaluating 
outcome measure performance at the DSA level enables CMS to evaluate an 
OPO both at the DSA level, carefully monitoring variations and enabling 
OPOs to conduct targeted performance improvement activities where they 
are most needed, while also retaining an overall evaluation and 
accountability structure that assesses compliance with the process 
measures at the organization level.
    At Sec.  486.316(b)(1), we address compliance with the process 
performance measures at Sec. Sec.  486.320 through 486.360 and indicate 
that we will evaluate OPOs as a single entity across all DSAs. The 
process performance requirements are the broad operational requirements 
that are common across all DSAs and we expect compliance with these 
requirements at all times. Therefore, non-compliance with a process 
performance measure in one DSA would potentially impact an OPO's 
certification, affecting all DSAs if the OPO were to be de-certified. 
The OPO would have the opportunity to submit a corrective action plan 
to remedy the non-compliance and avoid de-certification, provided the 
plan of correction is acceptable in resolving the deficiency that 
resulted in the non-compliance determination.
    At the time of re-certification, we will evaluate each DSA managed 
by an OPO separately on the outcome measures from the final assessment 
period as specified at Sec.  486.316(a) to determine impact on DSA 
designation and subsequently make a re-certification decision based on 
the provisions at Sec.  486.316(b)(2). Under this framework, an OPO 
that is designated to at least one DSA that is assigned to tier 1 in 
the final assessment period will be re-certified for another re-
certification cycle, provided it is compliant with the process 
performance measures during the most recent survey as specified at 
Sec.  486.316(b)(2)(i). Additionally, an OPO that is designated to at 
least one DSA that is assigned to tier 2 but is not designated to any 
DSA assigned to tier 1 in the final assessment period will be re-
certified, provided it is compliant with the process performance 
measures during the most recent survey. The OPO will be eligible to 
compete in competitions for any open DSA but will not have its 
agreement for designation to a DSA renewed if it is not successful in 
at least one competition as specified at Sec.  486.311(a)(1) or 
assigned a DSA under the provision at Sec.  486.308(a)(4) or Sec.  
486.316(e) as specified at Sec.  486.316(b)(2)(ii). Finally, OPOs with 
tier 3 DSAs in the final assessment period will have designation to 
those DSAs removed as specified at Sec.  486.316(a)(3). We will 
consider the status of any other DSA in which the OPO is designated to 
make a re-certification decision as described at Sec.  
486.316(b)(2)(iii). If the OPO has no other DSA designated as tier 1 or 
tier 2, or no other DSA that is pending future evaluation of the 
outcome measures, as specified at Sec.  486.318(c)(3) or (4), it will 
receive an initial notice of de-certification as specified at Sec.  
486.314(a)(1). If the OPO has another designated DSA assigned as tier 1 
or tier 2, or another designated DSA that is pending evaluation of its 
outcome measures as specified at Sec.  486.318(c)(3) or (4), it will be 
re-certified and receive a notice of removal of designation to a tier 3 
DSA as specified at Sec.  486.314(a)(2). This re-certification 
framework enables removing a DSA where an OPO is not meeting the 
outcome measure standards while maintaining the OPO's designation to 
DSAs where it has not been determined to be out of compliance on 
outcome measure standards.
    Comment: A commenter urged CMS to provide details regarding the 
timeline for when the competition process will begin for open DSAs.
    Response: Competition for tier 3 DSAs will occur once any 
administrative appeals have been exhausted. CMS will announce specific 
timelines and details for any competitions in advance of these events.
    Comment: Several commenters recommended revisions to the criteria 
for selection. Other commenters recommended that CMS establish more 
objective criteria for selecting a successor OPO in a competition. Many 
of the commenters recommended giving weight to OPOs with a record of 
sustained performance improvement trajectories. Other commenters stated 
that incumbent tier 2 OPOs should be given priority when competing for 
their own DSA over other competitors.
    Response: We thank commenters for these recommendations. We did not 
propose changes to the content of the existing selection criteria; 
therefore, we are not finalizing any changes at this time. However, we 
will consider these comments for potential changes to the selection 
criteria in future rulemaking. In the proposed rule we sought to 
clarify how we would apply the criteria under the tiered system for re-
certification. Since implementing the 2020 final rule, OPOs have 
provided feedback expressing concern that CMS would rigidly apply the 
tiered structure in a competition and select a marginally better tier 1 
OPO over a relatively high performing incumbent tier 2 OPO. They 
indicated that any benefit of selecting a higher performing OPO in this 
situation would be offset by the disruption from transitioning the DSA 
to another OPO. We indicated in the proposed rule that the selection 
criteria would not be applied rigidly when considering performance on 
the outcome measures and that we would consider the degree in 
performance differences among competitors and consider small 
differences to be relatively insignificant. Additionally, we do not 
believe that it is necessary to consider and weigh incumbency in a DSA 
independently of other factors because the current criteria will be 
sensitive to this issue when the performance difference between 
competing OPOs is relatively small. Additionally, in the proposed rule 
we discussed the issue of sustained improvements and how that would be 
considered when an OPO describes how it overcame barriers in its DSA.
    Comment: Several commenters provided recommendations for 
considering contiguity in a competition. Some commenters recommended 
that CMS give greater weight to contiguity while others stated it is a 
less important factor.
    Response: We continue to believe that contiguity is important, but 
it may not be the deciding factor in every situation. While contiguity 
may make the expansion of services easier from a logistics standpoint, 
it should not outweigh other considerations relevant

[[Page 69414]]

to decisions about the OPO who is most likely to achieve performance 
improvement and best serve a DSA. We are not revising the criteria at 
this time.
    Comment: Several commenters requested greater specificity for 
expectations on what should be submitted to address the selection 
criteria. A commenter stated that CMS should provide a clear, objective 
definition of ``success overcoming barriers,'' specify what data and 
documentation CMS expects, and ensure the criteria are applied 
consistently and in a reviewable manner.
    Response: In the proposed rule, we stated that the competition 
application process would provide an OPO the opportunity to describe 
the barriers it has faced and document its performance gains over time. 
The regulation at Sec.  486.316(d)(4) states that we will consider an 
OPO's success in identifying and overcoming barriers to donation within 
its own service area and the relevance of those barriers to barriers in 
the open area. The regulation further states that an OPO competing for 
an open service area must submit information and data that describe the 
barriers in its service area, how they affected organ donation, what 
steps the OPO took to overcome the barriers, and the results. This 
information is important for competing OPOs in demonstrating a record 
of performance gains and a trajectory of improvement that could enable 
us to make the determination that the OPO is likely to continue 
improving, has the potential to achieve tier 1 status in the DSA in the 
near term, and should be designated to the DSA.
    We realize that an OPO may face different challenges over different 
time periods as it works to address performance in its DSA. We believe 
that it is important for OPOs to use a data driven approach to identify 
areas for improvement, monitor changes over time, and document actual 
performance improvement. Additionally, we expect clear identification 
of the barriers and evidence of a plan to address those barriers. 
Qualitative information can augment quantitative results in describing 
improvements. Data may include data reported to the OPTN, CMS outcome 
measures, and/or other data and information that is part of the OPO's 
QAPI program. Some OPOs have suggested that they have their own data 
teams that independently calculate and stratify CMS outcome measures to 
analyze performance. We encourage other OPOs and the SRTR to consider 
this approach as well. The SRTR could include this type of information 
in their OPO Specific Reports (OSRs).\16\
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    \16\ Organ Procurement Organization Reports (OSR). <a href="https://www.srtr.org/transplant-professionals/organ-procurement-organization-report/organ-procurement-organization-reports-osr/">https://www.srtr.org/transplant-professionals/organ-procurement-organization-report/organ-procurement-organization-reports-osr/</a> osr/. 
Access May 27, 2026.
---------------------------------------------------------------------------

    Comment: Several commenters shared concerns related to the proposal 
for DSA transitions, highlighting a range of issues that they believe 
may materialize. Commenters stated that there would need to be close 
coordination and cooperation among the incumbent OPO, successor OPO, 
and CMS since the competition and transition periods would occur over a 
relatively short timeframe. Several commenters stated that the 
incumbent OPO may have difficulty maintaining staff and services 
throughout the duration of the transition. Other commenters highlighted 
non-profit status requirements and State requirements such as licensure 
that would need to be met. A commenter mentioned that the successor OPO 
needed sufficient time to establish agreements with donor hospitals. 
Another commenter questioned how the transition would occur with two 
OPOs operating simultaneously during the transition.
    Response: We acknowledge that the transition of a DSA to a 
successor OPO will be a significant undertaking, which is a reason we 
are codifying a requirement for OPOs to cooperate to facilitate a 
smooth transition and continuity of organ donation activities in the 
DSA. Additionally, we note the competition application procedures in 
the State Operations Manual Chapter 2 (CMS Pub 100-07) include many 
planning and transition elements to be included in the applicant's 
transition plan to support a stable transition of a DSA should the 
competitor be successful in a competition and eventually designated to 
the DSA. CMS worked closely with the OPOs involved in the recent 
transition of the Southern Florida DSA that was previously designated 
to the Life Alliance Organ Recovery Agency to monitor the process, 
assist in addressing any challenges, and ensure there was sufficient 
time to complete all requirements necessary to transition the 
designation to the successor OPO. Since only one OPO can be designated 
to a DSA, it is critical that all requirements be completed to 
transition the designation at the appropriate time. Therefore, the 
process must ensure that only one OPO is designated to a DSA at any 
given time with designation for the incumbent ending at the same time 
designation to the successor OPO begins. This activity also requires 
close coordination between CMS and HRSA to ensure a seamless transition 
in the information technology system that transmits information to 
support organ allocation activities.
    Comment: A commenter stated that CMS does not have the authority to 
force a de-certified or replaced OPO to bear the costs of transitioning 
to a new OPO, specifically, the transfer of proprietary information 
without providing adequate compensation to the incumbent OPO for these 
activities. The commenter interpreted the proposed rule as suggesting 
that OPOs would be forced to transfer ``procedural manuals and other 
materials used in conducting OPO operations,'' that could include 
proprietary operational data, internal quality improvement analyses, 
workflow optimizations, and institutional knowledge developed by the 
incumbent OPO over an extended period of time.
    Response: We thank the commenter for sharing this concern but 
disagree with their interpretation of the proposal. The requirement 
that was proposed at Sec.  486.316(g) addresses transition of a DSA and 
requires that an incumbent OPO submit a transition plan that would 
provide details on how all aspects of the OPO operation will be 
transmitted, including timeframes, to a new OPO. This is separate from 
the existing information management requirement at Sec.  486.330(d), 
most recently updated in our 2006 final rule, that OPOs must maintain 
data in a format that can readily be transferred to a successor OPO. 
Records and data subject to this requirement include donor and 
transplant beneficiary records and procedural manuals and other 
materials used in conducting OPO operations, but only to the extent 
necessary to ensure uninterrupted service by a successor OPO. An OPO 
should discuss any concerns it has regarding information sharing with 
CMS during a transition.
    We expect the incoming OPO to have its own operations plan, 
including documentation and activities such as operational policies and 
procedures, QAPI data collection, and training programs, to serve the 
DSA in a way that improves performance, such that the type of 
information that the commenter characterizes as potentially proprietary 
would not be necessary to ensure uninterrupted service. Additionally, 
section 2812.4 of the SOM describes competition application materials 
to be submitted by an OPO competing for the DSA, including a transition 
plan that would address many of the operational aspects needed to 
transition the DSA. However, DSA-

[[Page 69415]]

specific information maintained by the incumbent and necessary to 
ensure uninterrupted service, such as donor and recipient data, must be 
maintained in a format that can readily be transferred to a successor 
OPO and provided to CMS in the event of a transfer, consistent with the 
longstanding requirement set forth in Sec.  486.330(d). Given that an 
OPO is required under Sec.  486.330(d) to maintain this information in 
a format that can readily be transferred to a successor OPO, we would 
not expect the OPO to incur significant costs related to the transfer 
of such information.
    Final Rule Action: We are finalizing the proposed changes to Sec.  
486.316 with a modification at Sec.  486.316(a)(2) to address the 
impact of outcome measures to OPO designation when an OPO is assigned a 
new DSA by CMS. We are clarifying that when DSAs are assigned by CMS 
under the provisions at Sec.  486.308(a)(4) or Sec.  486.316(e) as 
discussed in section III.D., we will not open any tier 2 DSA managed by 
that OPO for competition until a full 4-year re-certification cycle is 
completed for the newly assigned DSA. We are also clarifying the 
language at Sec.  486.316(b)(1) regarding the notice to the OPO. It is 
being revised from ``initial de-certification determination'' to an 
``initial notice of de-certification'' as specified at Sec.  
486.314(a)(1). Additionally, we are revising Sec.  486.316(c)(2) to 
clarify that a competition loss would result in non-renewal of the 
agreement for designation to a DSA.

I. Outcome Measures (Sec.  486.318)

    We proposed to remove obsolete outcome measure provisions that 
expired on July 31, 2022. The requirements for the previous outcome 
measures that were superseded by the December 2020 final rule are 
located at Sec.  486.318(a) through (c). These requirements are no 
longer in effect and have been superseded by new requirements at Sec.  
486.318(d) through (f). We proposed to remove the obsolete requirements 
at paragraphs (a) through (c) and to redesignate paragraphs (d) through 
(f) as paragraphs (a) through (c). We proposed a conforming change at 
the proposed redesignated paragraph (a)(1) (currently paragraph (d)(1)) 
by removing the reference to paragraph (d)(2) and replacing it with 
paragraph (a)(2). We proposed a conforming change at the proposed 
redesignated paragraph (b)(5) (currently paragraph (e)(5)) by removing 
the reference to paragraph (e)(4) and replacing it with paragraph 
(b)(4). We proposed a conforming change at the proposed redesignated 
paragraph (b)(7) (currently paragraph (e)(7)) by removing the reference 
to paragraphs (e)(4), (5), and (6) and replacing it with paragraphs 
(b)(4), (5), and (6).
    We also proposed revisions to address OPOs managing multiple 
service areas, such as replacing ``OPO'' with ``DSA'' when referencing 
the outcome measures as applied to each DSA. We proposed tailored 
timelines for assuring OPO accountability in cases of adding new DSAs 
due to a change of control, ownership, or service area (CHOW), an 
expansion following a competition, or an expansion due to CMS 
assignment. Specifically, we proposed that if an OPO expands through 
the CHOW process after January 1 of the first year of the agreement 
cycle, the OPO would be held accountable for its QAPI responsibilities 
related to outcome measure performance in the new DSA once 12 calendar 
months of data are available. The timing of the CHOW in the re-
certification cycle will impact whether the OPO is assessed for its 
performance on the outcome measures during the final assessment period 
for the current re-certification cycle or the subsequent re-
certification cycle. For OPOs that acquire a new DSA through 
competition or CMS assignment after January 1 of the first year of the 
agreement cycle, we proposed that outcome measure accountability would 
apply: (1) for QAPI purposes, once 12 calendar months of data are 
available; and (2) for re-certification purposes, in the final 
assessment period of the following re-certification cycle. We proposed 
these changes based on the nature of the transaction and availability 
of data and information to support the change. For instance, a 
voluntary merger would provide a new OPO with the sharing of critical 
insights into the existing operations; access to proprietary data sets 
and internal analyses; enable pre-formed relationships and contacts; 
leverage established financial, personnel, and physical resources; and 
include other intangible elements that smooth a transition. This 
greatly impacts an OPO's preplanning activities and readiness to assume 
responsibility for a new DSA. An OPO that has won a competition or has 
been assigned an open DSA when no OPO competes for it must begin with 
significantly limited information and resources. OPOs in these 
situations could have large information gaps coupled with potentially 
significant expansion demands. Therefore, we believe that an OPO that 
assumes responsibility for a new DSA after a competition or has been 
assigned a DSA by CMS should have an additional amount of time to 
demonstrate improvement before being held accountable on its 
performance for re-recertification purposes.
    We solicited public comment on these proposed changes to Sec.  
486.318. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters recommended that timeframe for 
accountability on the outcome measures for a new DSA acquired through a 
change of control or ownership or service areas, competition, or 
assignment by CMS should be the same. A commenter stated the proposal 
makes an arbitrary distinction between merger and competition. A 
commenter stated that the proposal puts OPOs that participate in 
mergers at a disadvantage due to the shorter timeframe for assessment 
on the outcome measures and risks related to a successor OPO taking 
over a DSA. Other commenters stated that impactful changes may take 
longer than 12 months with one commenter stating that operational 
integration in healthcare mergers typically unfold over a multi-year 
horizon due to the complexities involved. These commenters indicated 
that the timeframe for organizational stability as well as performance 
improvement is years. A commenter stated that last-minute changes will 
be more challenging even with good faith efforts and will take longer 
time frames.
    Response: We understand the concerns of commenters and our proposed 
approach that we will be finalizing balances providing an appropriate 
level of ti

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