Proposed Rule2026-01833
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage
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Published
January 30, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would revise the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule would revise definitions, add new Quality Assessment Performance Improvement (QAPI) requirements related to medically complex organs and donors, revise the designation requirements for OPOs, clarify when an OPO's service area is open for competition, and update the process for appeals. It also includes a discussion of factors we would consider when selecting a successor OPO during a competition under the tiered approach to re-certification. We are committed to holding all OPOs accountable for their performance and this proposed rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re- certification and de-certification of OPOs.
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[Federal Register Volume 91, Number 20 (Friday, January 30, 2026)]
[Proposed Rules]
[Pages 4190-4251]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01833]
[[Page 4189]]
Vol. 91
Friday,
No. 20
January 30, 2026
Part II
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;
Proposed Rule
Federal Register / Vol. 91, No. 20 / Friday, January 30, 2026 /
Proposed Rules
[[Page 4190]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 486
[CMS-3409-P]
RIN 0938-AU54
Medicare and Medicaid Programs; Organ Procurement Organizations
Conditions for Coverage: Revisions to the Conditions for Coverage
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the Conditions for Coverage
for Organ Procurement Organizations (OPOs) to clarify outstanding
procedural questions and enable OPOs to make better informed decisions
to achieve high performance resulting in the successful procurement,
distribution, and transplantation of more life-saving organs. This rule
would revise definitions, add new Quality Assessment Performance
Improvement (QAPI) requirements related to medically complex organs and
donors, revise the designation requirements for OPOs, clarify when an
OPO's service area is open for competition, and update the process for
appeals. It also includes a discussion of factors we would consider
when selecting a successor OPO during a competition under the tiered
approach to re-certification. We are committed to holding all OPOs
accountable for their performance and this proposed rule does not
revise the focus on improving the volume of donors and transplants
assessed in the outcome measures or the tier structure used for re-
certification and de-certification of OPOs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by March 31, 2026.
ADDRESSES: In commenting, please refer to file code CMS-3409-P.
Comments, including mass comment submissions, must be submitted in one
of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3409-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3409-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Diane Corning, (410) 786-8486; James
Cowher, (410) 786-1948; Claudia Molinar, (410) 786-8445; Danielle
Shearer, (410) 786-6617; or Jasmine Alexis, (410) 786-0861.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the commenter will take actions to harm an individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this rule may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
I. Executive Summary and Severability
A. Executive Summary
1. Purpose
At any given time, at least 100,000 people are on the waiting list
for a lifesaving transplant and every 8 minutes, another person is
added to the transplant waiting list.\1\ Many individuals on the organ
transplant waiting list will wait several years for a suitable donor,
while others will die before an organ becomes available. A variety of
factors affect wait times, including how well a waitlisted individual
matches with available donors, how sick the person is, and the
availability of organs in the local area. Despite continued growth in
organ donation, procurement, and transplantation, the need for
transplantable organs continues to grow. Optimal performance of organ
procurement organizations (OPOs) is critical to ensure that the maximum
possible number of transplantable human organs are available to the
yearly average of 100,000+ seriously ill people on waiting lists for a
lifesaving organ transplant.
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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 final rule), which,
among other changes, revised the previous outcome measures to drive
performance improvement and increase the number of transplantable
organs. OPOs are evaluated on their performance on both the donor and
transplantation measures. Since publishing the December 2020 final
rule, CMS has received many inquiries from OPOs and others seeking
clarification on operational and administrative elements. These
inquiries have increased in frequency and volume as the system moves
closer to the 2026 re-certification period. This proposed rule contains
operational and administrative provisions which would govern the
competition process, to provide programmatic clarity and address
interested party requests for additional guidance. Additionally, this
proposed rule contains provisions aimed at driving further improvement
in OPO operations, reflecting our continued commitment to enhancing the
organ procurement and transplant system, and better serving prospective
organ donors, their families, and patients on the transplant waitlist.
[[Page 4191]]
2. Summary of Major Provisions
a. Definition Changes (Sec. 486.302)
Adverse Event. The current definition of ``adverse event'' is ``an
untoward, undesirable, and usually unanticipated event that causes
death or serious injury or the risk thereof. As applied to OPOs,
adverse events include but are not limited to transmission of disease
from a donor to a beneficiary, avoidable loss of a medically suitable
potential donor for whom consent for donation has been obtained, or
delivery to a transplant center of the wrong organ or an organ whose
blood type does not match the blood type of the intended beneficiary.''
We propose to remove the examples in this definition and add a revised
list of examples to the QAPI requirements at Sec. 486.348(c).
Donor. We propose to revise the definition of the term ``donor'' to
clarify that an individual from whom only the pancreas is procured and
used for islet cell research is included in the definition of ``donor''
for purposes of the donation rate outcome measure, consistent with the
Public Health Service (PHS) Act's requirement that pancreata used for
islet cell transplantation or research be counted for purposes of
certification and re-certification.
Organ. The current definition of the term ``organ'' includes the
pancreas when it is used for research or islet cell transplantation.
This definition applies to the organ transplantation outcome measure,
counting a pancreas used for research in the same way that a
transplanted organ is counted. We propose to remove pancreata used for
research from the definition of ``organ'' and thus, such pancreata
would also be removed from the organ transplantation rate outcome
measure. Research activity would no longer count as a transplant for
purposes of certification and re-certification.
Medically Complex Organs and Donors. Organs from donors that fall
outside the generally accepted standards for transplantation due to
donor age or health status are underutilized. However, research has
indicated that many of these organs can be successfully transplanted
when appropriately placed with a transplant candidate.\2\ \3\ We
propose to define the term ``medically complex donor'' as a donor whose
medical history requires special or additional considerations to
identify the best recipient for the organs. These donors include, but
are not limited to, all Donation after Cardiac Death (DCD) donors and
donors with elevated Kidney Donor Profile Index (KDPI) scores. We also
propose that OPOs track procurement and placement of these organs as
part of their QAPI program. Additionally, we propose to define the term
``medically complex organ'' as an organ procured from a ``medically
complex donor''.
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\2\ Walls, DO, Lee-Riddle, Gs, Manderski, MB, Sawinski, DL, and
Abt, PL. Kidney transplant outcomes from donation afer circulatory
death donors of advanced age. Clinical Transplantation.
2020:34e13881. <a href="http://doi.org/10.111/ctr.13881">http://doi.org/10.111/ctr.13881</a>. Accessed at <a href="https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.13881">https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.13881</a>. Accessed on
September 23, 2025.
\3\ Haque, O, Yuan, Q, Uygun, K, and Markmann, JF. Evolving
utilization of donation after circulatory death livers in liver
transplantation: the day of DCD has come. Clinical Transplantation.
2021;35:e14211. <a href="https://doi.org/10.1111/ctr.14211">https://doi.org/10.1111/ctr.14211</a>. Accessed at
<a href="https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211">https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211</a>.
Accessed on September 21, 2015.
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Unsound Medical Practices. We are also proposing a new definition
for ``unsound medical practices.'' Unsound medical practices are
referenced in Sec. 486.312(b) as an example of circumstances in which
CMS may de-certify an OPO based on ``urgent need.'' However, there is
no definition of ``unsound medical practices'' in the regulations. We
propose to define unsound medical practices as failures by OPOs that
create an imminent threat to patient health and safety or pose a risk
to patients or the public. These practices include, but are not limited
to, failures in governance; patient or potential donor evaluation and
management; and procurement, allocation and transport practices and
procedures.
b. Requirements for Certification (Sec. 486.303)
We have historically interpreted the OPO Certification Act of 2000
(the Certification Act), which added section 371(b)(1)(D) of the Public
Health Service Act (PHS Act), to mean the Secretary lacks the authority
to certify new OPOs after January 1, 2000. However, we have reassessed
this view and determined that the statute was not intended to strip the
Secretary of his authority to certify new OPOs. Therefore, to align
with our reinterpretation of the Certification Act, we are proposing to
remove 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.
c. OPO Designation to Donation Service Areas (DSAs) (Sec. Sec. 486.308
and 486.309)
Designation is the process CMS utilizes to assign an OPO to a
specific geographic area, or donation service area (DSA), for a
specific period of time, called an agreement cycle. Currently, there
are 55 OPOs designated to 55 DSAs with the same 4-year agreement cycle.
We propose changes to the OPO designation process to facilitate
implementation of the tiered system for OPO re-certification and
competition that was finalized in the December 2020 final rule.
Specifically, we propose to add provisions to address the possibility
of one OPO being designated to more than one DSA. The current
regulatory structure does not address this situation and the potential
impacts it may have for competition and OPO re-certification. We will
address these impacts throughout the respective provisions in this
proposed rule. Finally, the tiered system for re-certification seeks to
incentivize continued performance improvement through increased
competition. Therefore, we propose to address all situations when an
OPO's DSA may be opened for competition from other OPOs.
d. OPO Agreements, Non-Renewal (Sec. 486.311) and De-Certification
(Sec. 486.312)
OPO agreements with CMS may be impacted by actions initiated by an
OPO or adverse determinations by CMS. Currently, there are three
categories of actions that impact an OPO's agreement, including
voluntary termination of the agreement by the OPO; involuntary
termination during the re-certification cycle as a result of
enforcement action for non-compliance with certification requirements;
and non-renewal of the agreement for non-compliance with the outcome
measures and other certification requirements. Generally, these actions
result in de-certification of the OPO. In our December 2020 final rule,
we implemented a tiered system for OPO re-certification that seeks to
drive OPO performance through increased competition. The current
requirements for de-certification do not address the possibility of an
OPO being unsuccessful in a competition for its own or another DSA and
no longer being designated to any DSA. We propose to address this
potential scenario as well as better categorize and clarify situations
that could lead to non-renewal of an agreement or de-certification of
an OPO. We also propose that a voluntary termination or a scenario in
which an OPO is no longer designated to any DSA after competition would
result in non-renewal of the OPO's agreement with CMS, while an OPO's
non-compliance with the outcome measures, non-compliance with the
process performance measures, and situations involving urgent need to
protect patient health and safety would
[[Page 4192]]
result in de-certification (see Section II.B. of this proposed rule,
``Regulatory History'' for more information on compliance
determinations). We also propose to address appeal rights based on CMS
determinations and which determinations may be appealable.
e. Appeals of Adverse Actions (Sec. 486.314)
As a result of significant changes made since the 2006 OPO final
rule, we reviewed the OPO appeals process set forth at Sec. 486.314
and are proposing the following changes. The current introductory
statement in the regulation states that OPOs can appeal a de-
certification on substantive and procedural grounds if the de-
certification is due to involuntary termination or non-renewal of its
agreement with CMS. We propose to revise the introductory text at Sec.
486.314 to state that OPOs may appeal a de-certification as described
at proposed Sec. 486.312(a) or the removal of designation to a tier 3
DSA without de-certification as specified at proposed Sec.
486.316(b)(2)(iii)(B), to comply with changes to that section. We also
propose to add references to the removal of designation for a DSA
assigned as tier 3 without de-certification alongside references to de-
certification in Sec. 486.314, as applicable, to reflect that an
appeal would be available in either scenario.
Throughout Sec. 486.314 we propose to modify the time periods in
this section for current requirements from ``business days'' to
``calendar days''. We also propose to use ``calendar days'' for all
proposed requirements. This is both for consistency and to avoid
confusion.
Throughout the current process, we are proposing changes to the
various time frames to reduce inefficiencies while preserving OPOs'
right to appeal.
We are also proposing a new paragraph at Sec. 486.314(l), CMS
Administrator discretionary review. We are proposing to codify a
process for the CMS Administrator to elect to review or decline to
review the hearing officer's decision. We are proposing specific time
periods for the review, if the Administrator elects to review, and
providing that the Administrator may remand the appeal to CMS for
review and redetermination of the certification decision. We are also
proposing to clarify the appeals process for OPOs that are de-certified
due to urgent need.
f. Re-Certification and Competition (Sec. 486.316)
Our December 2020 final rule included changes to our requirements
for OPO re-certification and competition processes to clarify how the
tiered system associated with the outcome measures would impact these
activities. We are proposing additional revisions to Sec. 486.316 to
include situations when an OPO is designated to more than one DSA. We
are proposing to evaluate each DSA for which an OPO is designated
separately on the outcome measures. This would address the potential
situation of an OPO having DSAs with different tier designations and
how this would impact re-certification and competition. Additionally,
it would enable CMS to selectively remove a DSA where an OPO is
underperforming and does not meet the outcome measures, while allowing
the OPO to retain its designation to another DSA if it meets the
performance requirements in that DSA. We also propose that we would
evaluate an OPO as a single entity across all DSAs for the process
performance requirements. The process performance measures are the
broad operational requirements for OPOs and include items such as
administration and governance, prospective donor and donor management,
organ preparation and transport, and quality assessment and performance
improvement, among other requirements. While an OPO may have varied
performance on the outcome measures at different times and in different
DSAs, if applicable, we expect OPOs to be in compliance with the
process performance measures at all times and in all DSAs.
g. Outcome Measures (Sec. 486.318)
The 2020 final rule revised the outcome measures for OPOs. We
propose to remove the previous and now obsolete outcome measures and
redesignate the current outcome measures within Sec. 486.318. We also
propose to revise the requirement for when CMS will hold an OPO
accountable on the outcome measures when it takes over another OPO's
DSA. We describe the different scenarios when this may occur and
factors we considered in proposing when we would hold the OPO
accountable on its outcome measure performance in the new DSA.
h. Human Resources (Sec. 486.326)
The current human resources requirement addresses the need for a
sufficient number of qualified staff to obtain all usable organs from
potential donors, and to ensure that required services are provided to
families of potential donors, hospitals, tissue banks, and individuals
and facilities that use organs for research. All OPOs are required to
ensure that all individuals who provide services and/or supervise
services are qualified to provide or supervise the services. We propose
to further specify that all OPOs are required to assure the current
State or local licensure, certification, or registration of OPO staff
that furnish clinical services. We also propose to add a requirement
that personnel performing clinical duties must act within the scope of
the State licensure, certification, or registration requirements.
i. Information Management (Sec. 486.330)
The current information management requirements at Sec. 486.330
focus on maintaining both donor records and records showing the
disposition of each organ recovered for the purpose of transplantation,
including information identifying transplant beneficiaries. We propose
to amend Sec. 486.330 by adding a requirement that OPOs maintain
records for organs that are procured for research, including pancreata
used for islet cell research.
j. Quality Assessment and Performance Improvement (QAPI) (Sec.
486.348)
The current QAPI requirements focus on OPOs developing,
implementing, and maintaining a comprehensive, data driven QAPI program
designed to monitor and evaluate performance of all donation services.
Section 486.348(c) requires OPOs to establish written policies to
address, at a minimum, the process for identification, reporting,
analysis, and prevention of adverse events and conduct a thorough
analysis of any adverse event to identify and implement effective
changes to prevent those types of incidences from recurring again. We
propose to include a revised list of examples of adverse events in this
section that is currently located in the ``adverse event'' definition
in Sec. 486.302.
To further the goal of improving procurement and transplantation of
medically complex organs, we propose to require each OPO as part of its
QAPI program in new Sec. 486.348(e) to: (1) assess its policies and
procedures regarding medically complex donors and medically complex
organs and ensure they are optimizing opportunities to recover and
place these organs for transplant; (2) assess its performance regarding
the number of medically complex donors by determining the number of
medically complex donors from whom the OPO has obtained consent for
donation, the number of organs recovered from those donors, and the
number of medically complex organs transplanted at least annually; and
(3) implement actions to improve its performance with medically complex
donors or medically complex
[[Page 4193]]
organs when the OPO identifies opportunities for such improvement.
3. Summary of Costs and Benefits
The December 2020 final rule, among establishing other
requirements, revised previous outcome measures to drive performance
improvement and increase the number of transplantable organs. The
December 2020 final rule's estimated costs were primarily driven by
increased expenses related to organ procurement. Secondary costs were
driven by the additional expense for OPOs to implement performance
improvement policies. Additional costs accounted for the potential of
OPO mergers.
The estimated benefits quantified were due to the number of lives
saved and lives extended and, in addition, reduced costs to CMS
payments for dialysis treatments for patients waiting on the transplant
waitlist.
This proposed rule is important due to its functional proximity to
the December 2020 final rule. Its purpose is to address and prevent
administrative and operational concerns related to the competition
process. This proposed rule would impose an estimated $19.1 million in
Year 1 and $6.3 million in subsequent years. Year 1 costs including
collection of information costs are approximately $17.9 million for
OPOs and $1.2 million for CMS. Recurring annual costs include
approximately $6.2 million for OPOs and $331,000 for CMS. Quantified
benefits are estimated at $884,000 annually with an additional one-time
benefit of $300,000.
These costs reflect clarifications and refinements to operational
and administrative requirements rather than fundamental system
restructuring.
B. Severability
To the extent a court may enjoin any part of the rule, the
Department intends that other provisions or parts of provisions should
remain in effect. Any provision of this rule held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give maximum
effect to the provisions permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this rule and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.
II. Organ Procurement Organizations (OPOs)
A. Background
OPOs are vital partners in the procurement, distribution, and
transplantation of human organs in a safe and effective manner for all
potential transplant recipients. The role of OPOs is critical to
ensuring that the maximum possible number of transplantable human
organs are available to individuals with organ failure who are on a
waiting list for an organ transplant. Section 371(b) of the PHS Act
sets out certain requirements for OPO certification. There are
currently 55 OPOs that are responsible for identifying patients who may
become prospective donors and recovering organs from deceased donors in
the United States (U.S.), and currently each OPO serves a single DSA
(55 in total). The Centers for Medicare & Medicaid Services (CMS) views
OPO performance as a critical element of the organ transplantation
system in the U.S. We established conditions for coverage (CfCs) for
OPOs at 42 CFR part 486, subpart G, and OPOs must meet these
requirements to receive payments from transplant hospitals
participating in the Medicare and Medicaid programs. The CfCs include
reliable, data-based outcome measures related to donor and transplant
volume that are used to assess OPO performance for Medicare
certification purposes and a three-tier certification structure that
incentivizes high OPO performance on these outcome measures. In
general, we are committed to using objective data to assess OPO
performance and continuously incentivize OPO performance improvement.
In 2024, there were a total of 48,150 organ transplants, compared
to 46,634 and 42,889 transplants in years 2023 and 2022,
respectively.\4\ Although the volume of transplants has increased over
time, there continues to be an ongoing shortage of transplantable
organs. At any given time, at least 100,000 people are on the waiting
list for a lifesaving organ transplant.\5\ Many people face tremendous
quality of life burdens, illness progression, or death while on the
waiting list. An OPO that is efficient in procuring organs and
delivering them to recipients will help more people on the waiting list
receive lifesaving organ transplants and reduce the waiting time, which
could ultimately save more lives and improve health outcomes.
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\4\ 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 January 6, 2026.
\5\ Organ Donation Statistics. <a href="https://www.organdonor.gov/learn/organ-donation-statistics">https://www.organdonor.gov/learn/organ-donation-statistics</a>. Accessed April 24, 2025.
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B. Regulatory History
The December 2020 final rule (85 FR 77898) revised the OPO CfCs
with the policy goal of increasing organ donation and transplantation
to better serve patients on the organ transplant waiting list. The
December 2020 final rule revised the outcome measures that are used to
assess OPO compliance for purposes of certification, shifting from
heavily risk-adjusted metrics that were not capable of demonstrating
changes in OPO performance to metrics that measure OPO volume and drive
OPO performance in areas most important to patients on the transplant
waiting list. It also revised the assessment criteria to move from a
bifurcated pass/fail system to a three tier system with dynamic
performance thresholds and incentives for achieving the highest level
of performance. Finally, the December 2020 final rule utilizes
increasing competition to drive performance improvement. An OPO's
performance in a DSA is ranked in comparison to the performance of all
other OPOs in their assigned DSAs relative to a numerical threshold,
using competition for higher ranking as a tier 1 as an incentive for
performance improvement. We believe that the absence of meaningful
competition contributed to the very slow pace of system improvement
prior to CMS initiating its OPO regulatory reform efforts in 2019,
culminating with publication of the December 2020 final rule.
Specifically, the December 2020 final rule measures OPO performance
on two outcome measures described in Sec. 486.318--the donation rate
and the transplantation rate. Both rates assess OPO performance within
the OPO's DSA, which is a geographical area that each OPO is assigned
to, meaning that the OPO is responsible for all organ procurement
activities that occur in that area, with certain exceptions. The
denominator for each measure is the donor potential of each DSA, based
on inpatient deaths within the DSA from patients 75 or younger with a
primary cause of death that is consistent with organ donation,
consistent with the OPO Certification Act of 2000.\6\ We estimate the
donor potential of each DSA using death certificate information
obtained from the Center for Disease Control and Preventions' (CDC),
National Center for Health Statistics' (NCHS's) Detailed Multiple Cause
of
[[Page 4194]]
Death (MCOD) file. The MCOD is published annually, reflecting data
collected from the previous full calendar year, and is publicly
available upon request. As such, there is an approximate 11 to 12 month
data lag to allow for all activities related to the collection and
compilation of the data. The MCOD comprises county-level national
mortality data that include a record for every death of a U.S. resident
recorded in the U.S. The MCOD files contain an extensive set of
variables derived from the death certificates which are standardized
across the 57 jurisdictions that provide CDC with the data.\7\ The
jurisdictions use the U.S. Standard Certificate of Death as a template
for their forms. We use the death certificate data to adjust the
denominator to better reflect the population in the DSA that will more
closely resemble individuals likely to have died in a manner consistent
with organ donation. As we described in the December 2020 final rule,
death that is consistent with organ donation means all deaths of
individuals 75 or younger from the State death certificates with the
primary cause of death listed as the ICD-10-CM codes I20-I25 (ischemic
heart disease); I60-I69 (cerebrovascular disease); V-1-Y89 (external
causes of death), which includes causes such as blunt trauma, gunshot
wounds, drug overdose, suicide, drowning, and asphyxiation. Our
methodology is designed to estimate the likely donor referral
population to normalize the inpatient deaths across the different DSAs.
While each DSA may face its own unique challenges, the method for
estimating donor potential is designed to be standardized and equally
applied to all OPOs, allowing for variances in performance when facing
challenges to be measured and for high performance to be incentivized.
Since the donor potential is part of a rate calculation, identifying
the exact, donor potential of those candidates that are universally
considered by all OPOs to be ideal is less relevant than providing
standardized, reasonable, and impartial criteria to estimate it and
applying those criteria consistently to all OPO DSAs.
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\6\ Public Law 106-505, section 701, codified at 42 U.S.C.
273(b)(1)(D)(ii)(II).
\7\ The 57 jurisdictions that provide data to the CDC are the 50
States, New York City, the District of Columbia, and the 5
territories. Data for New York City is reported separately from the
State of New York.
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The donation rate is calculated as the number of donors in the DSA
as a percentage of the donor potential. The donation rate assesses the
ability of the OPO to obtain consent for donation, successfully manage
the donor, procure and place at least one organ for transplantation (or
pancreas for islet cell transplantation or research), and ensure the
safe and timely transport of that organ for transplantation. By
including the donation rate, we incentivize OPOs to pursue all donors,
including the single organ donors. An OPO is more likely to meet the
donation rate measure if it procures organs from DCD or medically
complex donors where relatively fewer organs may be transplantable.
Incentivizing OPOs to pursue all potential donors means introducing
more opportunities for individual transplant waitlist candidates to
receive a good organ match, which is impacted by factors such as blood
type, body size, and immune system antibody compatibility. A wider
variety of donors means a better chance of good matches for more
patients.<SUP>8 9</SUP>
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\8\ Madbouly A and Bolon Y-T (2024) Race, ethnicity, ancestry,
and aspects that impact HLA data and matching for transplant. Front.
Genet. 15:1375352. doi: 10.3389/fgene.2024.1375352.
\9\ Tiercy JM, Claas F. Impact of HLA diversity on donor
selection in organ and stem cell transplantation. Hum Hered.
2013;76(3-4):178-86. doi: 10.1159/000358798. Epub 2014 May 21. PMID:
24861862.
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The transplantation rate is calculated as the number of organs
transplanted from donors in the DSA as a percentage of the donor
potential. Organs, including pancreatic islet cells, transplanted into
patients on the Organ Procurement and Transplantation Network (OPTN)
waiting list as part of research are included in the organ
transplantation rate. Pancreata that are used in islet cell research
are also included. The organ transplantation rate is an important
measure as it measures the benefit for patients from OPO performance.
The unique geographical challenges associated with servicing the Hawaii
DSA necessitated using a different outcome measure to evaluate the
OPO's transplantation performance in that DSA. Instead of using the
organ transplantation rate, we use the kidney transplantation rate.
Although we do not use the organ transplantation rate for the Hawaii
DSA, we continue to monitor the development and Food and Drug
Administration (FDA) clearance of organ transport devices and expect
the OPO serving the Hawaii DSA to adopt these new technologies when
they are available.
Our outcome measures and process measures, taken as a whole,
represent a reasonable effort to estimate the donor potential and other
related factors in the DSA. The outcome measures denominator, as
previously described in this section, is an estimate of donor potential
in each DSA. The outcome measure numerators measure OPO performance
(through the number of donors and organs transplanted) and are somewhat
related because if there are more donors, there are likely to be more
organs transplanted. However, these numerators are not the same, and
each is necessary to measure different OPO outcomes and to properly
incentivize OPOs to pursue all potential donors, succeed in obtaining
consent, successfully manage their care, and successfully deliver
viable organs for transplant. For example, OPOs that focus primarily on
medically complex donors that may yield fewer organs per donor may need
to seek more donations to have sufficient organs transplanted to
mathematically meet the threshold organ transplantation rates. On the
other hand, OPOs that are very effective at placing all possible organs
from younger, healthier donors with larger yields may achieve the
targeted organ transplantation rate, but not the donation rate, if they
choose not to pursue the medically complex and DCD donors with only one
or two transplantable organs. In measuring both donation and
transplantation rates, we seek to achieve both more donors and more
transplants. By focusing on the outcomes of OPO processes in the form
of donation and transplant rates, we have created a system in which a
wide variety of changeable factors, such as levels of public awareness
and understanding about organ donation, relationships with donor
hospitals, and the quality and timeliness of OPO interactions with
potential donors and their families all coalesce in an end result of
successful organ donation and transplantation.
Both outcome measures, and their threshold rates, are calculated
using a full single calendar year of data. There is typically an 11- to
12-month long data lag for the MCOD file following the close of the
calendar year. For example, the MCOD file containing data for deaths
that occurred in 2025 is not expected to be available until December
2026 or as late as early spring 2027. To account for this and assure
that CMS uses data from the same calendar year for both the numerators
and denominators to calculate the donation and transplantation rates
and threshold rates, there is a 1.5-year difference between the time
when OPOs submit data for the performance period and the time when that
data is fully analyzed by CMS and used to calculate OPO performance on
the outcome measures. CMS provides each OPO with a preview of its
calendar year data report and has a process established for OPOs to
[[Page 4195]]
provide feedback on their preview reports to assure accuracy before the
reports are made publicly available. For example, in 2025, CMS used
OPTN (numerator) and MCOD (denominator) data from calendar year 2023 to
develop an annual interim data report for each OPO. The MCOD file for
2023 became available early in 2025. CMS calculated each OPO's
performance on each outcome measure, provided each OPO with its own
preview reports and correction opportunities, and then made the 2023
performance data for all OPOs publicly available in late spring
2025.\10\ CMS repeats this process on an annual basis such that OPOs
and the public are aware of individual OPO performance and nationwide
performance trends.
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\10\ Quality, Certification, and Oversight Reports. <a href="https://qcor.cms.gov/main.jsp">https://qcor.cms.gov/main.jsp</a>.
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OPO performance on the outcome measures is assessed on an annual
basis. For each assessment period, threshold rates are established
based on the observed donation and transplantation rates during the 12-
month period immediately prior to the period being evaluated. In the
2025 annual interim data report described above, OPO performance using
2023 data is compared to the OPO performance data of 2022. The median
observed rate for each outcome measure in 2022 was used as the standard
to measure OPO performance in 2023. To establish the threshold rates
CMS calculates both the lowest observed rate among the top 25 percent
in the DSAs, and the median observed rate among the DSAs. To measure
OPO performance in a DSA, CMS uses a 95 percent confidence interval for
each DSA's donation and organ transplantation rates using a one-sided
test. A confidence interval is a statistical measure of precision. In
the context of OPO evaluations, it provides the range of outcome
measure values (donation rates or transplant rates) that are expected
to most reasonably describe the OPO's true performance based on the
available data. The confidence interval accounts for uncertainty to
describe a broader range of OPO performance levels that could plausibly
explain the observed donation and transplant outcomes. Confidence
intervals tend to be wider when there are fewer potential donors
because there is less information available to precisely measure the
OPO's influence on the observed outcomes, and it becomes more difficult
to confidently describe the OPO's performance with a very specific
range of quality measure values. For example, consider a hypothetical
situation where an OPO has just one potential donor. In this extreme
case, it would only be possible to observe a donation rate of 1/1 = 100
percent or 0/1 = 0 percent. However, it would be misleading to claim
that this OPO is always or never successful at recovering donor organs.
In fact, there is almost no information available about this OPO's
general performance because only one potential donor's outcome was
observed. The confidence interval would be very wide under this
scenario to appropriately reflect the low degree of certainty in the
OPO's true donation performance. Likewise, OPOs with DSAs that have a
larger donor potential, and thus a larger data set for performance
measurement, tend to have smaller confidence intervals. Confidence
intervals tend to be narrower for large data sets because it is easier
to confidently describe performance due to the large amount of
available data. Each OPO's confidence intervals for the donation and
transplant rate are compared to benchmark levels of performance based
on the prior year's observed rates. If the upper end of the OPO's
confidence interval does not meet or surpass the threshold value
established using the prior year's observed performance data, then
there is statistical evidence that the OPO is not performing at that
threshold level for donation or transplantation. For example, in the
2025 data report that is based on performance data from 2023, one OPO
had an observed donation rate of 15.17 and the upper limit of its
confidence interval was 16.64. The threshold rate for the outcome
measure using the observed performance of all OPOs in the previous data
year, 2022, was 12.49 for the median and 14.11 for the top 25 percent.
In comparing the upper end of this OPO's confidence interval, 16.64, to
the median performance threshold of 12.49 established using the
previous year's observed performance, we determine that this OPO has
met the median threshold rate for the donation outcome measure and
complies with the minimum standard to be eligible for designation to
tier 2 for that outcome measure. Likewise, in comparing the upper end
of this OPO's confidence interval, 16.64, to the top 25 percent
threshold of 14.11 as established using the previous year's observed
performance data, we determine that this OPO has met and exceeded the
top 25 percent threshold for the donation rate outcome measure. Indeed,
this OPO's observed performance of 15.17 exceeded the top 25 percent
threshold, meaning that even in the absence of a confidence interval it
would still have performed in the top 25 percent on the donation rate
outcome measure. In examining the 2025 public report, we note that 27
of the 42 OPOs that performed well enough to be in tier 1 on the
donation rate outcome measure qualified by their observed performance,
rather than by the upper limit of their calculated confidence interval.
The performance thresholds for OPO evaluation are determined from the
prior year's data, meaning that every OPO has the opportunity to
improve its donation and transplantation performance such that its
confidence intervals meet or surpass these threshold values. Even OPOs
with donation or transplant rates below the performance thresholds can
have confidence intervals that surpass these thresholds, depending on
the size of 95 percent confidence interval and proximity to the
benchmark. For example, in the 2025 public OPO data report, five OPOs
that performed in tier 2 for the transplantation outcome were
classified as tier 2 based on their confidence interval with an
observed age-adjusted rate below the median of 38.56. Therefore, ten
OPOs that performed in tier 2 on the transplantation outcome measure
had an observed performance level that met or exceeded the median
threshold and would be in tier 2 in the absence of a confidence
interval. As such, it is possible for more than half of OPOs to be at
or above the 25 percent and median thresholds. Indeed, in the 2025
public OPO report, 30 of the 55 OPOs (roughly 55 percent) performed
well enough on both measures to be in tier 1 and the majority of these
OPOs did so through their observed performance. This OPO performance
evaluation system is designed to create incentives for OPOs to rapidly
improve their performance in serving donor families and people on the
transplant waitlist and exceed the performance thresholds established
using the previous year's performance data.
Section 371(b)(1)(D)(ii)(II) of the PHS Act \11\ provides that a
qualified OPO must meet performance standards defined through
regulations promulgated by the Secretary that rely on outcome and
process performance measures that are based on empirical evidence,
obtained through reasonable efforts, of donor potential and other
related factors in each DSA. CMS established process measures (Sec.
486.320 through Sec. 486.360) related to DSA-specific factors like
relationships with donor hospitals in the DSA and OPO-specific
processes such as QAPI, and uses empirical evidence gathered upon
[[Page 4196]]
survey to assess compliance with these requirements. The process
measures complement the outcome measures, focusing on essential OPO-
level and DSA-level processes and factors to facilitate high
performance. While the December 2020 final rule added two new outcome
measures that use empirical data from the MCOD file and the procurement
and transplant data submitted by OPOs (Sec. 486.328) and transplant
centers (Sec. 482.45(b)(3)) to replace the self-reported, unverified
outcome measures that were implemented by the 2006 final rule,\12\ it
in no way replaced the essential process measure focus on other DSA-
specific factors. Indeed, the December 2020 final rule also established
a 3-tier system whereby OPOs are stratified into different tiers based
on their performance on both outcome measures and compliance with the
process performance measures. A successful OPO must meet the measures
for both processes and outcomes to be considered compliant with the
CfCs and eligible for re-certification. The consequences of being in
each tier based on outcome measure performance differ based on whether
the performance occurs as part of the annual assessment or if it occurs
during the final assessment period.\13\ Tier 1 DSAs have an upper limit
of the one-sided 95 percent confidence interval for the donation and
organ transplantation rate outcome measures that are at or above the
top 25 percent threshold rate. Tier 2 DSAs have an upper limit of the
one-sided 95 percent confidence interval for the donation and organ
transplantation rates that are at or above the median threshold rate
established for their DSA but are not tier 1 for both outcome measures
Tier 2 performance, meaning that an OPO DSA has met the median
threshold for both outcome measures but has not met the tier 1 top 25
percent threshold for both measures, is the minimum compliance standard
established in the OPO regulations. OPO DSAs that fall into tier 2 will
be opened for competition from other interested OPOs, to allow for the
replacement of an OPO performing at the minimum compliance standard
where there is a clearly better OPO prepared and capable of taking over
the DSA. As such, OPOs are incentivized to assure that each of their
DSAs are high performing such that they meet the top 25 percent
performance thresholds and are not open for competition. Instead of
using a 50 percent rate or a mean rate, we chose the median rate
because both the top 25 percent threshold rate and the median rate
represent the actual rates performed by one or two OPOs (when there is
an even number, the median is calculated by averaging the two rates in
the median). The mean rate, on the other hand, is a mathematical rate
that may not reflect the performance of an actual OPO and may be
dragged down by a small number of very low performing OPOs. A median,
however, is less affected by extremes in performance as compared to a
mean. By identifying the specific rate of an OPO, OPOs can directly
compare their performance with that of other OPOs. Likewise, we did not
choose to assess performance and thus compliance with the CfCs using a
standard deviation from the mean methodology for several reasons. Under
our methodology, all OPOs have the opportunity to cluster at the top
because the threshold rate is based on the previous year's rate,
meaning that all OPOs begin each year with a new opportunity to meet or
exceed the median from the previous year. As a contrast, the standard
deviation from the mean methodology generates a contemporaneous list of
OPOs that are a certain distance from the mean. As discussed
previously, the mean is problematic because several lower performing
OPOs could skew the calculated mean. Beyond this, the mean and the
standard deviations are generated contemporaneously with the ranking of
the OPOs, giving OPOs no notice of their targeted performance. And, by
nature of the statistical method of standard deviation, there will
always be an OPO below the targeted standard deviation from the mean,
meaning that not all OPOs would have the opportunity to be a top
performing OPO unless they all had identical rates. As the outcome
measures are used for certification and re-certification, consistent
with the requirements set forth in the PHS Act, we do not believe that
establishing a system in which at least one OPO must be determined to
be out of compliance and therefore de-certified during each re-
certification cycle is appropriate. Rather, we sought and continue to
seek a system where all OPOs perform at a high level, exceed the
previous year's median, and cluster at the top. As we stated in the
December 2020 final rule, ``Our goal in creating these tiers is to
reward the top performing OPOs (Tier 1), while giving OPOs in Tiers 2
and 3 sufficient incentives to improve their performance and achieve
ranking in the next level up . . . .'' \14\ We note that tier 3 DSAs,
which have an upper limit of the one-sided 95 percent confidence
interval for their donation or organ transplantation rates that are
below the median threshold rate established using the previous year's
data, are considered to be DSAs that fail to meet the outcome measures
and are non-compliant with the CfCs.
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\11\ 42 U.S.C. 273(b)(1)(D)(ii)(II).
\12\ 71 FR 31046.
\13\ 85 FR 77911.
\14\ 85 FR 77911-12.
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Our goal is for all OPOs to be compliant with the process measure
CfCs and the outcome measure CfCs, meeting or exceeding the prior
year's median performance threshold, such that no OPOs are ranked in
tier 3 and de-certified. As such, we have established a system of
incentives to reward high performance on the outcome measures. CMS
calculates the outcome measures and tier rankings annually and makes
that information publicly available in interim reports, and OPOs with
DSAs that rank in tier 2 or tier 3 must use their QAPI program to
identify opportunities for improvement and implement changes that lead
to improvement in these measures. Since publication of the December
2020 final rule the donation and transplantation system has entered a
period of accelerated improvement. Based on data provided in the 2025
OPO Public Performance Report \15\ the median donation rate increased
11 percent from 2021 to 2023, while historical records show that it
only increased 2.6 percent in the 3 years preceding CMS rulemaking
(2017 through 2019). Likewise, the median transplantation rate
increased 7.3 percent from 2021 to 2023, while it only increased 1
percent in the 3 years preceding CMS rulemaking (2017 through 2019).
Taken together, these data suggest that the sustained regulatory
pressure of our system of tiered incentives, coupled with reliable and
transparent performance metrics that drive continuous improvement and
improve accountability, is working as we intended to accelerate OPO
performance improvement in serving donors, their families, and patients
on the transplant waiting list. As we stated in the December 2019 OPO
proposed rule, ``Our ultimate definition of success, however, is to
encourage the performance of all OPOs to cluster around the highest
performers.'' \16\ In the 2023 data report (based on data collected in
2021) there were 15 OPOs with tier 1 DSAs, increasing to 25 in 2024
(data from 2022), and 30 in 2025 (data from 2023). While top performing
OPOs continue to improve on the
[[Page 4197]]
outcome measures, mid-performing OPOs are further accelerating their
own improvements to catch up to their peers. Finally, in the December
2019 OPO proposed rule, we predicted that OPOs achieving the standard
of the top 25 percent or a 20 percent increase, whichever is greater,
would lead to an improvement in donors from 10,000 in 2017 to over
12,000 in 2026 and in transplants from 32,000 in 2017 to almost 42,000
in 2026. In 2023, there were 14,571 deceased organ donors and 45,407
transplants, surpassing CMS' original predictions 3 years sooner than
predicted. These initial data suggest that the 3-tier methodology we
finalized in the December 2020 final rule has led to a sustained
improvement in organ procurement and transplant as intended.
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\15\ Quality, Certification, and Oversight Reports. <a href="https://qcor.cms.gov/main.jsp">https://qcor.cms.gov/main.jsp</a>. Accessed on June 12, 2025
\16\ 84 FR 70634.
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We have reason to believe, and research suggests,\17\ that this
acceleration in better service of patients on the transplant waiting
list is connected to the sustained regulatory pressures exerted by use
of the tier structure in the re-certification process to bring about
accountability. An OPO with a DSA that qualifies for tier 1 designation
will be re-certified, retaining its tier 1 DSA, provided that the OPO
is also found to be in compliance with all other OPO process
performance measure CfCs via the re-certification survey. An OPO with a
DSA that qualifies for tier 1 designation also qualifies to enter any
competitions that are conducted to fill DSAs that are open for
competition. An OPO with a DSA that qualifies for tier 2 designation
and is also found in compliance with all other OPO process measure CfCs
via the re-certification survey is also in compliance with the
regulations, but its tier 2 DSA will be open to competition from other
OPOs with tier 1 and tier 2 DSAs, should any eligible OPO choose to
compete for it. An OPO with a tier 2 DSA may compete for any DSAs that
are open for competition and must retain its DSA or obtain a new DSA in
competition to be designated to the DSA and have an agreement with CMS.
An OPO that only has DSAs designated to tier 3 will receive an initial
notice of de-certification determination due to non-compliance with the
OPO CfCs and has the appeal rights set forth at Sec. 486.314. Once de-
certified, an OPO cannot compete for either its own or any other open
DSA. CMS utilizes competition to drive performance to achieve a higher
tier ranking and to decide which OPOs should be awarded the opportunity
to compete for additional DSAs if and when they are open. The
conclusion of the 2022-2026 certification cycle will mark the first use
of the outcome measures and tiers system for re-certification purposes.
CMS publishes interim annual reports each year to provide transparency
in OPO performance and the opportunity for OPOs to implement
performance improvement plans. These reports are posted on the Quality,
Certification and Oversight Reports (QCOR) website.\18\
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\17\ Doby BL, Ross-Driscoll K, Shuck M, Wadsworth M, Durand CM,
Lynch RJ. Public discourse and policy change: Absence of harm from
increased oversight and transparency in OPO performance. Am J
Transplant. 2021;00:1-7. <a href="https://doi.org/10.1111/ajt.16527">https://doi.org/10.1111/ajt.16527</a>.
\18\ Quality, Certification and Oversight Reports. <a href="https://qcor.cms.gov/main.jsp">https://qcor.cms.gov/main.jsp</a>.
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In addition to the outcome measures and their implications with
respect to tier status and re-certification, OPOs must also comply with
the process performance measures set forth at Sec. Sec. 486.320
through 486.360 to be considered in compliance with the CfCs. While
tier assignment recognizes different levels of performance with respect
to the outcome measures, it does not guarantee compliance with other
requirements. Therefore, OPOs that are high performing on the outcome
measures could be found non-compliant with one or more of the process
performance measures during a survey, which could lead to de-
certification if the OPO is unable to remedy the non-compliance. The
process performance measures span a range of operational requirements.
Specifically, at Sec. 486.320 we require that an OPO must become a
member of, participate in, and abide by the rules and requirements of
the OPTN. At Sec. 486.322 we address relationships with donor
hospitals in the OPO's DSA, providing training to donor hospital staff,
and cooperating with tissue banks. At Sec. 486.324 we specify the
required members of the OPO advisory board, its authorities and
restrictions, limitations on the members of the board, and having
bylaws for board member conflicts of interest and other key concerns.
This condition also addresses the OPO's governing body and requires
each OPO to declare in policy whether it recovers organs from donors
after cardiac death. At Sec. 486.326 we include specific human
resources requirements that are further discussed in section III.I. of
this proposed rule. At Sec. 486.328 we include data reporting
requirements for reporting to the OPTN, Scientific Registry of
Transplant Recipients (SRTR), Department of Health and Human Services
(HHS), and to transplant hospitals. At Sec. 486.330 we address
maintaining records for all donors and the disposition of each organ
recovered for transplantation. This requirement is further discussed in
section III.J. of this proposed rule. At Sec. 486.342 we address
requesting consent from prospective donor families with discretion and
sensitivity, and at Sec. 486.344 we address written protocols for
donor evaluation, donor management, and organ placement and recovery to
maximize organ quality and optimize the number of donors and the number
of organs recovered and transplanted per donor. At Sec. 486.346 we
address organ preparation and transportation, covering topics including
organ testing for infectious diseases and tissue typing, documentation
provided to a transplant center and its verification for accuracy, and
the protocols for packaging, labeling, handling, and shipping organs.
The issue of organ transportation is further discussed in section
III.K. of this proposed rule. At Sec. 486.348 we include specific QAPI
requirements, addressing the components of the program, death record
reviews, adverse events, and the connection between performance on the
CMS outcome measures and QAPI activities. The requirements for QAPI are
further discussed in section III.K. of this proposed rule. Finally, at
Sec. 486.360 we address emergency preparedness standards for OPOs.
On February 2, 2021, we published a notice in the Federal Register
(86 FR 7814) temporarily delaying the effective date of the December
2020 final rule by 60 days and providing an additional 30-day public
comment period, during which we received over 150 timely public
comments. The comments received included both support for immediate
implementation of the December 2020 final rule and requests for
additional time before implementation. We considered the additional
public comments and the rule subsequently became effective on March 30,
2021.
On December 3, 2021, we published a ``Request for Information
(RFI); Health and Safety Requirements for Transplant Programs, Organ
Procurement Organizations, and End-Stage Renal Disease (ESRD)
Facilities'' (86 FR 68594) (``December 2021 RFI''), which solicited
comments that would help to inform potential changes that would create
system-wide improvements, including improvements in organ donation,
organ transplantation, quality of care in dialysis facilities, and
access to dialysis services.
We received almost 400 timely comments in response to the December
2021 RFI. Commenters included transplant recipients, those awaiting
transplants, donor families, and donor representatives. A range of
health care
[[Page 4198]]
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 this proposed rule and may be used in future
rulemaking for system-wide changes to advance organ transplant system
performance.
Recent peer reviewed research using the same method for estimating
donor potential from our December 2020 final rule highlights the
ability to detect variable performance both across OPOs and across
areas of practice within OPOs as well as how this information can be
leveraged for performance improvement to increase organ
donation.<SUP>19 20</SUP> One group of researchers found that 74
percent of differences in overall donor procurement rates could be
explained using model variables that represent different domains of OPO
practice activities, such as DCD procurement, and procurement of older
and minority patient populations.\21\ Having this type of in depth
performance data analysis available to OPOs for use in their QAPI
programs, based on impartial and reliable data and outcome measures, is
vital for OPOs to utilize in designing and implementing QAPI activities
to drive improvements. The ability of OPOs to use this type of
information to potentially implement appropriate practice changes will
be critical to their success in the future. It is our role, with a
continued focus on better patient outcomes, to maintain and enforce a
regulatory structure that capitalizes on recent developments in data
analysis and insights to enhance system-level and OPO-level
performance.
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\19\ Doby BL, Hanner K, Johnson S, Purnell TS, Shah MB, Lynch
RJ. Results of a data-driven performance improvement initiative in
organ donation. Am J Transplant. 2020;00:1-8. <a href="https://doi.org/10.1111/ajt.16442">https://doi.org/10.1111/ajt.16442</a>.
\20\ Lynch RJ, Doby BL, Goldberg DS, Lee KJ, Cimeno A, Karp SJ.
Procurement characteristics of high- and low-performing OPOs as seen
in OPTN/SRTR data. Am J Transplant. 2022 Feb;22(2):455-463. doi:
10.1111/ajt.16832. Epub 2021 Sep 29. PMID: 34510735.
\21\ Doby BL, Casey K, Ross-Driscoll K, Rahman Ovi M, Hossain
Bhuiyea MS, Isty IA, Lynch RJ, What is visible is fixable: visual
dashboards for multi-domain assessment of OPO performance, American
Journal of Transplantation, <a href="https://doi.org/10.1016/j.ajt.2023.08.020">https://doi.org/10.1016/j.ajt.2023.08.020</a>.
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To assist OPOs in improving performance, we developed two
initiatives that OPOs could participate in to facilitate organ
procurement and placement. The ESRD Treatment Choices Learning
Collaborative brought transplant centers, OPOs, donor hospitals,
patients, and donor families together to spread the use of highly
effective practices to increase kidney procurement, recovery, and
utilization.\22\ The program provided technical assistance to several
interested parties, including OPOs, with three aims: increasing the
number of deceased donor kidneys transplanted, decreasing the current
national discard rate of all procured kidneys, and increasing the
percentage of kidneys recovered for transplant in the greater than or
equal to 60 KDPI score group. Fifty-three OPOs participated in this
collaborative, which ended in August 2025. CMS, through its quality
improvement organizations, also initiated an OPO Special Innovation
Project (SIP) to provide technical assistance to OPOs for improvement
on the OPO performance outcome measures. In this program, OPOs had the
opportunity to actively participate in a variety of technical
assistance activities such as completing Root Cause Analyses (RCAs) and
Plan-Do-Study-Act (PDSA) cycles, implementing evidenced-based
strategies, and developing process and decision pathways. The objective
was for OPOs to permanently integrate effective processes to improve
and sustain improvements in their donation rate and transplant rate.
Forty OPOs participated in this program, which concluded in March 2025.
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\22\ <a href="https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model">https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model</a>.
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C. Statutory and Regulatory Provisions
To be an OPO, an entity must meet the applicable requirements of
both the Social Security Act (the Act) and the PHS Act. Section 1138(b)
of the Act provides the statutory qualifications and requirements that
an OPO must meet in order for its organ procurement costs to be paid
under the Medicare program or the Medicaid program. Section
1138(b)(1)(A) of the Act specifies that payment may be made for organ
procurement costs only if the agency is a qualified OPO operating under
a grant made under section 371(a) of the PHS Act or has been certified
or re-certified by the Secretary of the Department of Health and Human
Services (the Secretary) as meeting the standards to be a qualified OPO
within a certain time period. Section 1138(b)(1)(C) of the Act provides
that payment may be made for organ procurement costs only if the OPO
meets the performance-related standards prescribed by the Secretary.
Section 1138(b)(1)(F) of the Act requires that to receive payment under
the Medicare or Medicaid programs for organ procurement costs, the
entity must be designated by the Secretary. The requirements for such
designation are set forth in 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 Organ Procurement and Transplantation Network
(OPTN). OPOs must also comply with the regulations governing the
operation of the OPTN (42 CFR part 121). The Department of Health and
Human Services (HHS) has explained that only those OPTN policies
approved by the Secretary will be considered ``rules and requirements''
of the OPTN for purposes of section 1138 of the Act.\23\ The OPTN is a
membership organization that oversees the U.S. organ transplant system,
links all professionals in the U.S. organ procurement and
transplantation system, and maintains a national registry for matching
donated organs with recipients in need of transplantation. OPOs are
required under OPTN regulations (42 CFR 121.11(b)(2)) and Sec. 486.328
of our OPO CfCs to report information specified by the Secretary to the
OPTN, including the data used to calculate the outcome measures for
OPOs.
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\23\ 63 FR 16296.
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In addition, OPOs are required to comply with existing Federal
civil rights laws, including the Americans with Disabilities Act of
1990 (ADA), 42 U.S.C. 12101 et seq., Title VI of the Civil Rights Act
of 1964 (Title VI), 42 U.S.C. 2000d, Section 504 of the Rehabilitation
Act of 1973 (Section 504), 29 U.S.C. 794, and Section 1557 of the
Patient Protection and Affordable Care Act, 42 U.S.C. 18116.\24\ Title
VI protects individuals on the basis of race, color, and national
origin. Section 1557 protects individuals on the basis of race, color,
national origin, age, disability, or sex. Among other things, these
laws require OPOs to take reasonable steps to
[[Page 4199]]
ensure meaningful access to their programs by individuals with limited
English proficiency. Reasonable steps may include providing language
assistance services at no cost to the individual, such as providing
interpreters or translated material. Also, the ADA, Section 504 and
Section 1557 protect otherwise 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 organ transplant programs that receive Federal
financial assistance. 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 include providing substandard care to a prospective donor
with a disability based solely on that disability.
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\24\ Recipients of Federal financial assistance must comply with
Federal civil rights laws, including but not limited to Title VI of
the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act
of 1973, the Americans with Disabilities Act, and Section 1557 of
the Affordable Care Act.
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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,
health care providers and organ donation programs are required to
provide auxiliary aids and services (including sign language
interpreters) when necessary for effective communication between a
relative involved in a prospective donor or recipient's care and a
health care provider or procurement program.
Section 1102 of the Act gives the Secretary the authority to make
and publish such rules and regulations as may be necessary to the
efficient administration of the functions with which the Secretary is
charged under the Act. Moreover, section 1871 of the Act gives the
Secretary broad authority to establish regulations that are necessary
to carry out the administration of the Medicare program.
We established CfCs for OPOs at 42 CFR part 486, subpart G, and
OPOs must meet these requirements in order to be designated and
therefore able to receive payments from the Medicare and Medicaid
programs. These regulations set forth the certification and re-
certification processes, outcome requirements, and process performance
measures for OPOs. The outcome measures, found under Sec. 486.318, are
used to assess OPO performance for re-certification and competition
purposes (see Sec. 486.316(a) and (d)).
III. Provisions of the Proposed Regulations
In response to the December 2020 final rule, which revised the
regulations that establish the framework for OPO re-certification, we
have received questions on technical implementation of the rule from
OPOs and other interested parties. In this proposed rule, we seek to
clarify outstanding procedural and technical questions on the
implementation of the rule so that OPOs can better understand the
procedures for re-certification and de-certification that will be used
in 2026. We remain committed to holding OPOs accountable for their
performance and are proposing additional revisions to the OPO
regulations that will assist in driving improvements.
A. Definitions (Sec. 486.302)
We are proposing to revise our current regulations defining the
terms ``adverse event,'' ``donor,'' ``medically complex donors,''
``medically complex organs,'' ``organ,'' and ``unsound medical
practices'' at Sec. 486.302 to provide greater clarity.
1. Adverse Event
Section 486.302 currently defines ``adverse event'' as ``an
untoward, undesirable, and usually unanticipated event that causes
death or serious injury or the risk thereof. As applied to OPOs,
adverse events include, but are not limited to, transmission of disease
from a donor to a beneficiary, avoidable loss of a medically suitable
potential donor for whom consent for donation has been obtained, or
delivery to a transplant center of the wrong organ or an organ whose
blood type does not match the blood type of the intended beneficiary.''
Adverse events trigger QAPI requirements so that for each adverse
event, the OPO is required to ``conduct a thorough analysis of any
adverse event and must use the analysis to affect changes in the OPO's
policies and practices to prevent repeat incidents'' (Sec.
486.348(c)(2)).
Through feedback we have received, we are concerned that the
examples set forth in this definition are not being viewed as examples
but rather as an exhaustive list of the adverse events that apply to
OPOs. We do not believe an exhaustive list of adverse events is
possible, given the broad range of potential occurrences that might
qualify as ``an untoward, undesirable, and usually unanticipated event
that causes death or serious injury or the risk thereof.'' Thus, to
avoid any confusion, we are proposing to remove the second sentence of
the current definition and move a revised list of examples to Sec.
486.348(c) in the QAPI requirements. If this change is finalized as
proposed, OPOs should continue to identify ``adverse events'' according
to the definition in Sec. 486.302, regardless of whether the incident
is covered in the examples that we are proposing to insert into Sec.
486.348(c). We solicit public comment on the proposed changes to the
definition of adverse events.
2. Donor
The Pancreatic Islet Cell Transplantation Act of 2004 \25\
(hereafter referred to as ``PICTA 2004'') amended the PHS Act to add
section 371(c), which requires that ``[p]ancreata procured by an organ
procurement organization and used for islet cell transplantation or
research shall be counted for purposes of certification or re-
certification[.]'' In the December 2020 final rule we implemented the
requirements of PICTA 2004 in the definition of ``donor'' in the OPO
regulations at Sec. 486.302, stating that a donor is ``. . . a
deceased individual from whom at least one vascularized organ (heart,
liver, lung, kidney, pancreas, or intestine) is transplanted. An
individual also would be considered a donor if only the pancreas is
procured and is used for research or islet cell transplantation.''
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\25\ October 25, 2004, Public Law 108-362.
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OPOs are required by the OPTN to report data related to pancreata
procured and used for research, and this data is incorporated into
calculations used to assess compliance with the donor and transplant
outcome measures used for re-certification purposes. In finalizing the
definition of ``donor'' in 2020 we noted that, ``[w]e think that the
impact of pancreata for research on the overall rankings of OPOs will
continue to be minimal.'' \26\ This prediction was based upon a clear
downward trend in OPO-reported procurement of pancreata procured and
used for research, and our expectation of a leveling off or further
downward trend was further substantiated by a 2021 article titled,
``The Demise of Islet Allotransplantation in the US: A Call for an
Urgent Regulatory Update,'' \27\ which noted changes over time in the
pancreata islet cell research and transplantation
[[Page 4200]]
landscape, from its peak in the years 2000-2015 with numerous phase 1
and 2 clinical trials declining to only 11 patients receiving a
pancreatic islet cell transplant between 2018 and 2021. Upon review of
ongoing clinical trials for pancreatic islet cells as described on the
National Institute of Health's (NIH) website <a href="http://clinicaltrials.gov">clinicaltrials.gov</a>,\28\ we
identified 16 active clinical trials in October 2023 with a total
possible enrollment of 325 persons, which was consistent with the
procurement rates for research pancreata that existed prior to
publication of the December 2020 final rule, coinciding with the period
of decline noted in the 2021 article. We note that the number of active
clinical trials appears to have declined since October 2023, with a
total of 4 active clinical trials and a total possible enrollment of
108 persons identified in November 2025.
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\26\ 85 FR 77902.
\27\ Witkowski et al. The Demise of Islet Allotransplantation in
the US: A Call for an Urgent Regulatory Update The ``ISLETS FOR US''
Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. <a href="https://doi.org/10.1111/ajt.16397">https://doi.org/10.1111/ajt.16397</a>.
\28\ Accessed October 17, 2023.
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However, since the publication of the December 2020 final rule and
the updated definition of the term ``donor'', OPOs' reported
procurement of pancreata for research purposes has increased
dramatically, rising from 562 in 2020 to 573 in 2021, 1,448 in 2022,
1,819 in 2023, and 2,004 in 2024, based on internal CMS review of data
submitted by OPOs to the SRTR. The roughly 250 percent increase in
procurement between 2020 and 2024 has not been matched by a
corresponding increase in the number of clinical trials for pancreatic
islet cells reported to the NIH and made public on the
<a href="http://clinicaltrials.gov">clinicaltrials.gov</a> site. On January 18, 2024, we issued a memorandum
\29\ clarifying that for purposes of the definition of ``donor'', the
pancreata must be used for islet cell research or islet cell
transplantation, consistent with PICTA 2004, to be counted. On October
9, 2024, the OPTN and SRTR updated the disposition reason codes that
OPOs use when entering data regarding pancreata procured for any
research purpose. The updated disposition reason codes differentiate
pancreata procured and used for islet cell research activities from
pancreata used for all other research purposes to enhance the
specificity of data reported by OPOs. We propose to revise the
definition of the term ``donor'' to further reiterate the clarification
made in the January 2024 memorandum. The revised definition would state
that an individual from whom only the pancreas is procured and is used
for islet cell transplantation or for islet cell research is included
in the definition of ``donor.'' Procurement for other research uses
does not count for purposes of certification and re-certification.
These proposed revisions are intended to clarify the rule to improve
regulatory consistency with the requirements set forth in PICTA 2004,
which specifies that pancreata procured for ``islet cell
transplantation or research'' are required to be counted for
certification and re-certification of OPOs.
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\29\ QSO-24-04-[OPO], <a href="https://www.cms.gov/files/document/qso-24-04-opo.pdf">https://www.cms.gov/files/document/qso-24-04-opo.pdf</a>.
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Per the National Diabetes Statistics Report \30\ issued by the
Centers for Disease Control there were approximately 1.7 million
Americans living with diagnosed type 1 diabetes in 2021. Experts
estimate that 375,000 suffer from impaired hypoglycemic awareness and
66 percent suffer from recurrent severe hypoglycemic episodes
(SHE).\31\ Nearly 70,000 patients with type 1 diabetes fail to improve
for hypoglycemia avoidance despite patient education efforts and
advanced technologies, such as insulin pumps and continuous glucose
monitoring sensors.\32\ In 2020, hypoglycemia led to 202,000 emergency
department visits.\33\
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\30\ National Diabetes Statistics Report. <a href="https://www.cdc.gov/diabetes/php/data-research/index.html">https://www.cdc.gov/diabetes/php/data-research/index.html</a>. Accessed on March 25, 2025.
\31\ Byrne M, Hopkins D, Littlejohn W, et al. Outcomes for
Adults with Type 1 Diabetes Referred with Severe Hypoglycaemia and/
or Referred for Islet Transplantation to a Specialist Hypoglycaemia
Service. Horm Metab Res. 2014;47(01):9-15.
\32\ Rickels MR. Hypoglycemia-associated autonomic failure,
counterregulatory responses, and therapeutic options in type 1
diabetes. Ann N Y Acad Sci. 2019;1454(1):68-79.
\33\ National Diabetes Statistics Report. <a href="https://www.cdc.gov/diabetes/php/data-research/index.html">https://www.cdc.gov/diabetes/php/data-research/index.html</a>. Accessed on March 25, 2025.
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Although pancreas transplantation remains a therapeutic option that
effectively treats type 1 diabetes, it requires major surgery with a
significant risk of complications. Pancreatic islet allotransplantation
offers a minimally-invasive alternative that lowers morbidity and
mortality, improves glycemic control and prevents SHE, conferring
complete protection from SHE in more than 90 percent of patients.\34\
Federally funded clinical trials involving several U.S. academic
centers have been conducted for pancreatic islet allotransplantation
following results of a study conducted in 2000 where a series of seven
patients with type 1 diabetes remained insulin-free for a full year
following allotransplantation.\35\ ``Research,'' as the term is used in
the OPO regulations, for pancreatic islet allotransplantation involves
all stages of bona fide bench research conducted by a qualified
researcher that uses donor pancreatic islet cells to advance scientific
and healthcare knowledge, but occurs without transplanting pancreatic
islet cells into a patient. This may include safety studies, studies of
innovative routes of administration, and studies of modified allogenic
islet cell products.\36\ Islet cell research includes donor pancreata
used for research related to islet isolation as well as pancreata used
for islet cell research when the islets remain in the organ, such as
may be used in organ slice studies or in situ islet histology. In the
Congressional Record associated with passage of PICTA 2004, a member of
the U.S. House of Representatives described ``research that can result
in being able to replicate the islet cells so that every diabetic in
the country that wants one of these transplants can get that'' \37\
(emphasis added). Another Representative described the purpose of PICTA
2004 as follows, ``Pancreatic islet transplantation has been hailed as
the most important advance in diabetes research since the discovery of
insulin in 1921. The procedure, which involves transplanting insulin-
producing cells into an individual with juvenile diabetes, has been
performed on over 300 individuals, and the majority of them no longer
need to take insulin to stay alive. While significant research remains
to be done to expand this procedure to all who suffer with juvenile
diabetes, its promise is incredibly exciting . . .'' \38\ (emphasis
added). We believe that there continues to be a role for using donor
pancreata to advance islet cell research, fulfilling this stated vision
of widespread treatment for type 1 diabetes. Pancreatic islet cells
used for bona fide bench research conducted by a qualified researcher
would continue to be included in the definition of ``donor'' and OPOs
that procure pancreata that are used in bona fide pancreatic islet cell
research would continue to receive credit for these donors in the
donation outcome measure. As described in section III.J. of this
proposed rule, we would require OPOs to document information regarding
the islet cell
[[Page 4201]]
research to which donor pancreata are supplied. This documentation,
including information regarding approval from an institutional review
board or other similar entity, as appropriate, would allow CMS to
verify the existence of bona fide research activities conducted by a
qualified researcher to advance scientific and healthcare knowledge and
confirm that the research uses donor islet cells.
---------------------------------------------------------------------------
\34\ Witkowski et al. The Demise of Islet Allotransplantation in
the US: A Call for an Urgent Regulatory Update The ``ISLETS FOR US''
Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. doi:
10.1111/ajt.16397.
\35\ Witkowski et al. The Demise of Islet Allotransplantation in
the US: A Call for an Urgent Regulatory Update The ``ISLETS FOR US''
Collaborative. Am J Transplant. 2021 Apr;21(4):1365-1375. doi:
10.1111/ajt.16397.
\36\ Shapiro AMJ, Ricordi C, Hering BJ, et al. International
Trial of the Edmonton Protocol for Islet Transplantation, N Engl J
Med. 2006;355(13):1318-1330.
\37\ Congressional Record- House, H8074, October 5, 2004.
\38\ Congressional Record- House, H8074, October 5, 2004.
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We continue to believe that pancreata used for islet cell research
will have little effect on the rankings of OPOs when calculating the
donation outcome measure because the volume of bona fide pancreatic
islet cell research conducted by a qualified researcher, that is bench
only research with no transplants, is limited nationwide. By nature of
the status of the research field and the requirements needed to move
this treatment from research to standard clinical practice, the overall
impact of including these pancreata used for islet cell research to
implement the requirements of PICTA 2004 is limited. As described in
section III.J. of this proposed rule, we propose to require that OPOs
maintain specific documentation regarding pancreata used for islet cell
research. We intend to verify both the existence and accuracy of this
documentation to assure that OPOs accurately code reported pancreata
used for islet cell research when submitting data to the OPTN, thereby
upholding the integrity of the donor outcome measure.
As set forth in the PICTA 2004, a pancreas must be ``used for islet
cell transplantation or research'' to be subject to the requirement
that it be counted for certification or re-certification purposes. We
propose to continue to include the criterion that the pancreas be
``used'' for islet cell transplantation or research in the definition
of ``donor'' at Sec. 486.302. At the time PICTA 2004 was enacted, it
was not possible to cryopreserve pancreatic islet cells for future use.
However, such cryopreservation of pancreatic islet cells is now
possible and must be considered when deciding what activities
constitute ``use'' for purposes of implementing the statute. To ensure
that OPOs can accurately code data when entering it into the OPTN
system within five days of organ procurement, per the data standards
set forth by the OPTN, we consider ``use'' for purposes of islet cell
research to be the acceptance and either immediate use or
cryopreservation of the pancreatic islet cells by a bona fide
pancreatic islet cell research program to advance scientific and
healthcare knowledge. We have partnered with HRSA to implement enhanced
OPO data reporting that more accurately conveys the disposition and use
of pancreata, either for use in research that does not involve
transplantation or in transplants of the pancreata or its islet cells
to a patient on the OPTN waiting list. CMS uses data entered by OPOs
into the OPTN data system in calculating the outcome measures.
Requiring research pancreata to be ``used'' for islet cell research
to be included in the donation rate is consistent with how we treat
other organs in the donation rate outcome measure. We only consider
donors to be those for whom an organ was used for transplant.
Procurement for transplant without an actual transplant is insufficient
for inclusion in the donor outcome measure (see 84 FR 70631 and 85 FR
77903 for discussion of including only those organs that are used
rather than procured with intent to use). Likewise, procurement of
pancreata for islet cell research without actual use in that research
is insufficient for inclusion in the donation rate outcome measure.
3. Organ
In the December 2020 final rule, we implemented the requirements of
PICTA 2004 in the definition of ``organ'' in the OPO regulations at
Sec. 486.302, stating that an organ is ``. . . a human kidney, liver,
heart, lung, pancreas, or intestine (or multivisceral organs when
transplanted at the same time as an intestine). The pancreas counts as
an organ even if it is used for research or islet cell
transplantation.'' Although the term ``organ'' is used frequently
throughout the regulations, it has a specific relationship to the
``organ transplantation rate,'' which is defined as the number of
organs transplanted from donors in the DSA as a percentage of the donor
potential. Organs that are transplanted into patients on the OPTN
waiting list as part of research are explicitly included in the organ
transplantation rate. The definition of the organ transplantation rate
focuses entirely on transplant activities and the inclusion of bench
research activities in this rate has created significant concern in the
OPO and transplant communities. We agree with interested parties that
including bench research within the definition of ``organ'' and by
extension the ``organ transplantation rate'' has created a performance
incentive that is not serving patients on transplant waitlists because
the transplantation rate counts the use of a pancreas in islet cell
bench research as being equivalent to a pancreas or pancreatic islet
cell transplant. As such, the inclusion of pancreatic islet cell bench
research in the definition of ``organ'' has proven to be inconsistent
with the goals of the 2020 rulemaking to increase the number of
transplants in that OPOs may have used the placement of pancreata for
islet cell research to mask their performance in successfully
facilitating actual organ and pancreatic islet cell transplants.
Therefore, we propose to revise the definition of the term ``organ'' in
a way that would no longer include pancreata used for islet cell
research, unless the research is islet cell transplantation that occurs
under a research protocol.
While PICTA 2004 requires that pancreata used in islet cell
research be counted for purposes of certification and re-certification,
it does not require that these organs be included in all established
OPO outcome measures. In the 2006 OPO final rule (71 FR 30982) that
established the formerly used set of OPO outcome measures, one of the
three yield measures counted pancreata used for islet cell research
while a separate yield measure counted pancreata used for islet cell
transplantation. Previous CMS policy differentiated the treatment of
pancreatic islet cells based on their use for either transplantation or
research, and we propose to reinstate that differentiation as it
relates to current policy. Under our proposal, a pancreas that is used
for islet cell research without a transplant to a patient on the OPTN
waiting list would count towards the donation rate outcome measure, but
would not be included in the transplantation rate outcome measure. A
pancreatic islet allotransplant to a patient on the OPTN waiting list,
on the other hand, would be included in both the transplantation rate
outcome measure and the donation rate outcome measure, whether it is
conducted under standard or research protocols.\39\ This policy of only
including pancreatic islet cell transplants in the transplant outcome
measure advances the CMS goal of increasing the number of transplants
in service of those patients on the OPTN transplant waiting list.
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\39\ In accordance with the regulations set forth at 42 CFR
413.406, Medicare only covers and pays for reasonable costs of
acquisition of pancreata for islet cell transplants into Medicare
beneficiaries participating in a National Institute of Diabetes and
Digestive and Kidney Diseases clinical trial of islet cell
transplantation in accordance with section 733 of the Medicare
Prescription Drug, Improvement and Modernization Act of 2003.
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We are specifically soliciting comments on modifications to the
proposed definitions of donor and organ, including any additional
considerations that should be addressed in these definitions and
alternative approaches to meeting the statutory
[[Page 4202]]
requirements set forth by PICTA 2004. We are interested in information
regarding data sources to verify data submitted regarding pancreatic
islet cell research organs, alternative data sources for research
organs that are independently verified and nationally available for the
development of new outcome measures, and additional information that
focuses on pancreata used for islet cell research and the statutory
requirements for their counting in OPO certification and re-
certification.
4. Medically Complex Donors and Medically Complex Organs
Traditionally, some donors and their organs have been preferred
over others, based on the age and health status of the donor, by
transplant programs and surgeons. Organs from donors with less-
preferred characteristics may be perceived as less valuable for organ
transplantation or not appropriate for transplantation at all. To
address these misconceptions, we are proposing to both define and
utilize the terms ``medically complex donors'' and ``medically complex
organs.'' Moreover, in the QAPI CfC set out at section Sec. 486.348,
we propose to require that OPOs must track procurement and placement of
these organs, assess their policies and procedures regarding medically
complex donors and organs, and ensure they are optimizing the recovery
and placement of those organs for transplant.
Although we have not previously defined these less-preferred
organs, the OPO CfCs have differentiated between organs from different
types of donors. In the 2006 OPO final rule (71 FR 30982), we defined
``eligible organs'' as organs recovered from a donor that met the
``eligible death'' definition. Those donors had to be (1) 70 years old
or younger, (2) declared dead by the hospital's brain death criteria,
and (3) patients who did not meet certain exclusionary criteria, which
included, among other things, tuberculosis, human immunodeficiency
virus (HIV), multiple-system organ failure, and certain cancers. These
eligible deaths constituted the denominator for the donation rate
outcome measure. Other organs, such as those recovered from donors over
70 years old or from donors who were declared dead by cardiac death
criteria, were not ``eligible organs.'' Those donors and organs would
however be counted and added to the outcome measures when the OPO
obtained consent, and the organs were transplanted. In 2016, we
modified the definition of ``eligible death'' to, among other things,
include specific exclusionary criteria for kidneys, livers, hearts, and
lungs.\40\ Effective in 2022, we removed the ``eligible death''
definition and now the donor potential that is the denominator for the
outcome measures is based on the number of inpatient deaths of persons
75 and younger within the DSA with a primary cause of death that is
consistent with organ donation (currently 42 CFR
486.318(d)(1)(iv)).\41\
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\40\ 81 FR 79562.
\41\ Organ Procurement Organizations Conditions for Coverage;
Revisions to Outcome Measures Requirements for Organ Procurement
Organizations (85 FR 77898).
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As a result of these policies, some people in the organ transplant
community may have considered those organs that did not meet the
definition of ``eligible organ'' to be less valuable organs or did not
consider transplanting them into their patients despite many
individuals being on the waiting lists. These organs may have included
organs from DCD donors, from donors older than 70 or 75, or from
younger individuals with deteriorating health conditions.
Current research demonstrates that ``medically complex organs'' can
produce positive and similar outcomes to other organs, and better
outcomes than no transplant for patients. For example, recent research
has demonstrated that kidneys recovered from DCD donors have similar
long-term outcomes to organs from donors declared dead by brain death
or neurological criteria (brain death donors), although some increases
in complications related to graft function have been noted.\42\ Another
example is donors who have a KDPI over 50 percent. Recent research has
also demonstrated that transplant recipients who received these organs
had a lower mortality rate, and an improved quality of life compared to
patients who are on chronic renal dialysis.\43\
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\42\ Rijkse E, Ceuppens S, Qi H, IJzermans JNM, Hesselink DA,
Minnee RC. Implementation of donation after circulatory death kidney
transplantation can safely enlarge the donor pool: A systematic
review and meta-analysis Int J Surg. 2021 August;92:106021. doi:
10.1016/j.ijsu.2021.106021. Epub 2021 Jul 10. Accessed at <a href="https://pubmed.ncbi.nlm.nih.gov/34256169/">https://pubmed.ncbi.nlm.nih.gov/34256169/</a>. Accessed on September 29, 2022.
See also FN#2, Wall, et al.
\43\ Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D,
Klarenbach S, and Gill J. Systematic Review: Kidney Transplantation
Compared With Dialysis in Clinically Relevant Outcomes. <a href="https://doi.org/10.1111/j.1600-6143.2011.03686.x">https://doi.org/10.1111/j.1600-6143.2011.03686.x</a>. Accessed at <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/j.1600-6143.2011.03686.x">https://onlinelibrary.wiley.com/doi/full/10.1111/j.1600-6143.2011.03686.x</a>.
Accessed on September 29, 2022. See also FN#2, Wall, et al.
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In addition, we are concerned that OPOs are not actively pursuing
``medically complex'' donors and their organs because of a perception
that such organs may not be accepted by others in the transplant
community, despite many individuals waiting on the transplant lists.
Declining to use these organs, however, contributes to the chronic
undersupply of transplantable organs, as well as potentially increasing
mortality and decreasing quality of life for ESRD patients.
We believe that encouraging the pursuit of medically complex donors
and organs when there is medical evidence that these organs can improve
the quality of life or save the lives of more patients on the waiting
list, by increasing the overall number of transplantable organs. The
National Academies of Sciences, Engineering, and Medicine (NASEM)
issued a report regarding the transplant ecosystem, ``Realizing the
Promise of Equity in the Organ Transplantation System'' (NASEM 2022
organ transplant report).\44\ The NASEM 2022 organ transplant report
used the term ``medically complex'' to describe organs that were
recovered from donors who had medical histories that deserved special
considerations to identify the best recipient for that organ. The
proposed definitions for ``medically complex donor'' and ``medically
complex organ'' are primarily based upon the NASEM 2022 organ
transplant report's description of medically complex donors and organs.
Medically complex donors would include DCD donors and those with
elevated KDPI scores over 50 that require greater consideration in
choosing a potential recipient due to the DCD donation process and
possible kidney damage. Since DCD donors have not been declared dead by
brain death criteria, OPOs need protocols that address at a minimum:
how these potential donors should be evaluated; how life support would
be withdrawn, and the relationship between the time of consent to
donation and withdrawal of life support; the use of medications and
interventions not related to withdrawal of support; family members'
involvement prior to organ recovery; and the criteria for declaration
of death and the time period that must elapse prior to organ recovery
(Sec. 486.344(f)). We also believe DCD donors need to be identified
specifically because the number of recovered DCD organs has steadily
increased over the last decade. In 2024, there were 7,280 DCD donors,
which is an increase of 23.5 percent
[[Page 4203]]
over 2023.\45\ We also believe donors with elevated KDPI scores should
be considered medically complex. We are proposing that the term
medically complex donors include those with a KDPI score of 50 or
greater. However, we are specifically soliciting comments on at what
score should the KDPI be considered elevated so that the potential
donor would be considered ``medically complex'' and may revise the
proposed KDPI score threshold in the final rule in response to comments
received.
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\44\ NASEM. (2022). Accessed at <a href="https://nap.nationalacademies.org/catalog/26364/realizing-the-promise-of-equity-in-the-organ-transplantation-system">https://nap.nationalacademies.org/catalog/26364/realizing-the-promise-of-equity-in-the-organ-transplantation-system</a>. Accessed on May 10,
2022.
\45\ Organ transplants exceeded 48,000 in 2024; a 33 percent
increase for the transplants performed in 2023. OPTN. Jan 14, 2025.
Accessed at <a href="https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023">https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023</a>. Accessed on August 25, 2025.
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Medically complex donors and organs also include donors that are
HIV+ or have Hepatitis C. While HIV+ infection remains a serious
illness, fewer individuals are dying from it and it is now considered a
chronic disease.\46\ In addition, transplants from an HIV+ donor to an
HIV+ recipient must comply with the requirements set forth in the HIV
Organ Policy Equity Act (HOPE Act), which includes complying with
designated research protocols.\47\ Hepatitis C can be an acute or
chronic infection and, with treatment, most individuals can be
cured.\48\ While organs from donors that are HIV+ or have Hepatitis B
or C can be successfully transplanted, these transplants require
special or additional considerations in identifying the best potential
recipient for these organs. For example, one study found that with
appropriate consideration of both the DCD donor and the potential
recipient, DCD liver transplants could have outcomes that were both
acceptable and comparable to outcomes for non-DCD liver transplants.
The considerations included but were not limited to cold and warm
ischemic times, and comorbidities of the donor and the potential
recipient, such as age, obesity, and ``Model for End-Stage Liver
Disease'' (MELD) scores, which estimates the severity of the donor's
liver disease.\49\
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\46\ Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV
infection as a chronic disease. Lancet. 2013 Nov 2;382(9903):1525-
33. doi: 10.1016/S0140-6736(13)61809-7. Epub 2013 Oct 23. PMID:
24152939; PMCID: PMC4058441. Accessed on January 24, 2024.
\47\ Public Law 113-51 (2013); Final Human Immunodeficiency
Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research
Criteria for Transplantation of Organs Infected With HIV. A Notice
by the National Institutes of Health on November 25, 2015 Federal
Register/Vol. 80, No. 227/Wednesday, November 25, 2015/Notices 73785
<a href="https://www.federalregister.gov/documents/2015/11/25">https://www.federalregister.gov/documents/2015/11/25</a>.
\48\ CDC. Hepatitis C. Accessed at <a href="https://www.cdc.gov/hepatitis-c/about/index.htmlhttps://www.cdc.gov/hepatitis/hcv/index.htm">https://www.cdc.gov/hepatitis-c/about/index.htmlhttps://www.cdc.gov/hepatitis/hcv/index.htm</a>. Reviewed October 31, 2023. Accessed on January 24, 2024.
\49\ Haque, O, Yuan, Q, Uygun, K, and Markmann, JF. Evolving
utilization of donation after circulatory death livers in liver
transplantation: the day of DCD has come. Clinical Transplantation.
2021;35:e14211. <a href="https://doi.org/10.1111/ctr.14211">https://doi.org/10.1111/ctr.14211</a>. Accessed at
<a href="https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211">https://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.14211</a>.
Accessed on September 21, 2015.
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Hence, medically complex organs can be successfully transplanted
and enhance and even prolong patients' lives; however, they have not
been fully utilized. To encourage the use of these organs, we are
proposing to define the term ``medically complex donor'' in Sec.
486.302 as a donor whose medical history requires special or additional
considerations to identify the best recipient for the organs. These
donors would include all DCD donors and donors with elevated KDPI
scores of 50 or more. We also propose to define the term ``medically
complex organ'' as an organ procured from a ``medically complex
donor''.
We believe that defining ``medically complex organs'' and
``medically complex donors'' and including these organs and donors in
OPOs' QAPI programs could result in more of these organs being procured
and increase the number of transplantable organs for patients on the
various waiting lists. However, we are also concerned that there could
be unintended consequences resulting from this proposal. For example,
could this requirement put unreasonable pressure on OPOs to procure
medically complex organs? Thus, we are specifically soliciting comments
on modifications to the proposed definitions of ``medically complex
donor'' and ``medically complex organ'', including any specific
criteria that should be added. We are also specifically soliciting
comments on how to define an ``elevated KDPI''. Is 50 or more
appropriate? If not, what KDPI score should be used? Also, are there
any unforeseen consequences to this proposal?
5. Unsound Medical Practices
In the 2006 final rule, CMS finalized 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''.
Through feedback we have received, we recognize the need to clearly
define what constitutes ``unsound medical practices''. Therefore, we
propose at Sec. 486.302, to add a definition for ``unsound medical
practices''. We propose that the term ``unsound medical practices''
would refer to failures by OPOs that create an imminent threat to
patient health and safety or pose a risk to patients or the public.
These practices include, but are not limited to, failures in
governance; patient or potential donor evaluation and management; and
procurement, allocation, and transport practices and procedures. Some
examples of unsound medical practices include, but are not limited to,
failure to ensure the potential donor is declared dead according to
applicable State law and hospital policies; negligent or deliberate
failure to perform necessary and customary tests to determine whether a
potential donor meets exclusionary criteria, such as certain
malignancies or active infections; and pursuing patients with
inappropriately high neurologic function as potential donors. Our
intent is to ensure that instances of actions that constitute unsound
medical practices are addressed appropriately and that OPOs continue to
provide high quality care to patients, potential donors and potential
transplant recipients. We solicit public comment on the proposed
definition of ``unsound medical practices''.
B. Requirements for Certification (Sec. 486.303)
Section 486.303(e) requires that to be ``certified as a qualified
organ procurement organization,'' an organization must have ``been re-
certified as an OPO under the Medicare program from January 1, 2002
through December 31, 2005.'' The Certification Act amended the PHS Act
to add subparagraph (D) to section 371(b)(1), which defines a qualified
OPO as an organization that ``has met the other requirements of this
section and has been certified or recertified by the Secretary within
the previous 4-year period as meeting the performance standards to be a
qualified organ procurement organization through a process'' defined in
regulations.\50\ Section 371(b) of the PHS Act sets forth requirements
that an OPO must meet to be certified. These requirements are also
[[Page 4204]]
set forth in our regulations at Sec. 486.303. Once certified, section
371(b)(1)(D)(ii)(I) of the PHS Act requires that OPOs must be re-
certified not more frequently than once every 4 years.
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\50\ 42 U.S.C. 273(b)(1)(D).
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After the Certification Act was passed, CMS proposed to remove
language from our regulations that referred to new entities or
organizations becoming OPOs.\51\ We explained that ``given the
provision in (b)(1)(D) added by the OPO Certification Act . . . it
appears impossible for the Secretary to give a grant to an organization
that was not one of the 59 OPOs that was certified by the Secretary as
meeting the performance standards in the 4-year period before January
1, 2000.'' \52\ We also proposed adding Sec. 486.303(e), requiring
that OPOs have been re-certified as an OPO under the Medicare program
from January 1, 2002 through December 31, 2005.\53\ When finalizing the
proposal, we reiterated that ``we currently do not have the authority
to permit new entities to take over part or all of an OPO's service
area,'' which ``would be possible only if the Congress enacts
legislation to change the requirement in the PHS Act because currently
to be re-certified, an OPO must have been certified as of January 1,
2000.'' \54\ We have since repeated this interpretation.\55\
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\51\ 70 FR 6091.
\52\ 70 FR 6091.
\53\ 70 FR 6090.
\54\ 71 FR 30998.
\55\ 85 FR 77898.
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However, upon further review, we no longer believe that the
Certification Act is best read to require all qualified OPOs to have
been previously certified as of January 1, 2000. Instead, it is better
read to mean that whenever the agency initially certifies or
recertifies that an OPO meets the Secretary's performance standards
within a 4-year period, OPOs must demonstrate at the end of that period
that they still meet the agency's performance standards. Section
371(b)(1)(D)(ii) of the PHS Act specifically provides that a qualified
OPO may be ``certified or recertified'' through ``a process'' that is
``defined through regulations . . . promulgated by the Secretary.''
There is no language in that provision requiring that an OPO show it
was certified as of January 1, 2000 as part of those standards. In
fact, the statute requires the Secretary to ``use multiple outcome
measures as part of the certification process.'' \56\ That the statute
contemplates creation of a certification process indicates that the
Secretary is not limited to recertifying OPOs. Thus, nothing in the
text of the statute supports reading it to strip the Secretary of his
authority to certify either an entirely new OPO or one that was
previously decertified.
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\56\ 42 U.S.C. 273(b)(1)(D)(ii)(III) (emphasis added).
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This interpretation of the Certification Act is reinforced by the
statutory history. The prefatory language in section 371(b)(1)(D) of
the PHS Act is drawn from section 1138(b)(1)(A) of the Social Security
Act. The main change Congress made was to swap out a reference to a
qualified OPO needing to have been certified or recertified ``within
the previous 2 years'' to a reference to a qualified OPO needing to
have been certified or recertified ``within the previous 4-year
period.'' Congress made legislative findings explaining that this
change requires the agency ``to extend the period for recertifications
of an organ procurement organization from 2 years to 4 years.'' \57\
This use of familiar statutory language with a single targeted change
that Congress explained does not indicate that Congress meant also to
silently restructure the OPO market by prohibiting all new entrants.
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\57\ Public Law 106-505 Sec. 701(b)(5), 144 Stat. at 2347.
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We acknowledge that this is a change in our understanding of the
Certification Act. Executive Order 14219 directs Federal agencies to
review existing regulations for potential candidates for rescission,
prioritizing those that can no longer be justified under several recent
decisions of the U.S. Supreme Court, including Loper Bright Enterprises
v. Raimondo, 603 U.S. 369 (2024). In Loper Bright, the Court explained
that statutes have a ``single, best meaning'' that agencies must
follow. Because we believe this is the best reading of the statute, it
is consistent with the rationale of Loper Bright to adopt it.
Additionally, OPOs were able to operate even with new entrants before
2000, and we have confidence they will be able to do so in the future.
We have not previously cited independent policy reasons that would
justify exercising our express authority to promulgate performance
standards to include a requirement that OPOs have been re-certified as
an OPO under the Medicare program from January 1, 2002 through December
31, 2005. By contrast, we believe that removing this requirement would
address concerns about market consolidation by creating a more diverse
and robust market that enhances competition among OPOs. This proposal
could also introduce innovation from new entities and increase the
number of organs available for transplant.
Therefore, to align with our reinterpretation of the Certification
Act and the directive in Executive Order 14219 to remove regulatory
requirements that can no longer be justified in light of Loper Bright,
we are proposing to remove Sec. 486.303(e). We acknowledge that our
prior rule removed references to newly certified OPOs and we are not,
at this time, proposing to reinstate those references or to otherwise
provide for the certification of new OPOs. However, we anticipate
addressing the certification of new OPOs in the near term and are
soliciting public comments on factors CMS should consider when
certifying new OPOs. We specifically request public comments related
to:
<bullet> The specific elements of the existing OPO regulations that
an entity should be required to meet in order to become a newly
certified OPO;
<bullet> The outcome and process performance measures organizations
seeking certification should meet. What empirical evidence of organ
donor potential and other related factors should be considered?
<bullet> Other criteria for evaluating the suitability of a
potential new OPO to serve an open DSA;
<bullet> The process by which a newly certified OPO might obtain
designation to a DSA.
++ Should newly certified OPOs be given priority for designation to
open DSAs, compete against existing OPOs in open competition, or only
compete in competitions against other newly certified OPOs?
++ If newly certified OPOs compete against currently certified
OPOs, should the competition selection criteria be revised? If so, what
factors should be considered for selection criteria given the lack of
historical outcome and process performance data for new OPOs?
We would particularly appreciate comments that identify which
specific provisions commenters would recommend we consider changing,
and what specific changes commenters would recommend.
C. Designation of One OPO for Each Service Area (Sec. 486.308)
We propose to revise requirements at Sec. 486.308 to further
address changes made in the December 2020 final rule related to when a
DSA is open for competition. Additionally, we intend to clarify how an
OPO is assigned to a DSA and how we determine the OPO designation
period. As described in section II.A. of this proposed rule, a DSA is a
donation service area, and each OPO is currently designated to a DSA
for organ procurement activities.
[[Page 4205]]
There are OPO-specific qualifications, processes, and timeframes
found in the requirements at section 371(b) of the PHS Act and section
1138 of the Act. Section 371(b) of the PHS Act and Sec. 486.303 list
the requirements that an OPO must meet to be certified. Once certified,
section 371(b)(1)(D)(ii)(I) of the PHS Act requires that OPOs must be
re-certified not more frequently than once every 4 years. The re-
certification cycle, defined at Sec. 486.302, is the 4-year cycle
during which an OPO is certified.
Only a certified OPO may be designated to a DSA. Once an OPO is
designated for a DSA, certain organ procurement costs are eligible for
Medicare and Medicaid payment under section 1138(b)(1)(F) of the Act.
OPOs sign an agreement with CMS called a Health Insurance Benefits
Agreement, Form CMS-576A, to provide services for the duration of an
``agreement cycle'', defined at Sec. 486.302 as ``the time period of
at least 4 years when an agreement is in effect between CMS and an
OPO''. OPOs must periodically submit a Request for Designation as an
OPO under section 1138 of the Act, Form CMS-576, and supporting
documentation for a specific DSA. This is normally conducted during the
re-certification process.
CMS evaluates OPOs periodically to ensure that the organizations
continue to meet the requirements for certification. As referenced
previously, under section 371(b)(1)(D)(ii)(I) of the PHS Act, re-
certifications of qualified OPOs must not be more frequent than once
every 4 years. In most cases, near the end of the agreement cycle there
is a re-certification survey to ensure that the OPO continues to comply
with statutory and regulatory requirements for certification. Surveys
may also be conducted at other times to investigate complaints and
allegations of non-compliance with the CfCs. Surveys are conducted by
CMS staff from the various CMS locations and Federal contract
surveyors. Currently, the agreement cycle for the designation period is
4 years and 6 months in duration and is reflected on the Form CMS-576A
(CMS-R-13; OMB No. 0938-0512) that the OPO signs. The additional 6
months between the end of the re-certification cycle and the end of the
agreement cycle provides time for an OPO to appeal a de-certification
determination to the agency on substantive or procedural grounds and to
enable the agency to select a successor OPO if necessary. The current
re-certification cycle began on August 1, 2022, and will end on July
31, 2026. However, the current OPO agreement cycle began on August 1,
2022, and is scheduled to end on January 31, 2027.
To implement changes for OPO DSA designation and competition, we
propose to revise Sec. 486.308(a) and (b). 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 propose to relocate and revise the information
pertaining to designation and relocate requirements for competition.
Specifically, we propose to add introductory text (referred to as
condition statement of the CfC) at Sec. 486.308 to clarify that CMS
designates only one OPO to a DSA. We will not designate multiple OPOs
for one DSA, consistent with section 1138(b)(2) of the Act, but we may
designate a single OPO for more than one DSA as discussed in sections
III.D. of this proposed rule. We also propose to relocate the
requirement that re-certification must occur not more frequently than
once every 4 years from Sec. 486.308(b)(2) to the introductory text at
Sec. 486.308 without change as part of the reorganization of these
requirements.
We propose to revise the current requirements at Sec.
486.308(b)(1) to address designation periods and relocate the
requirements to proposed Sec. 486.308(a). The current requirements
indicate that ``[a]n OPO is normally designated for a 4-year agreement
cycle. The period may be shorter, for example, if an OPO has
voluntarily terminated its agreement with CMS and CMS selects a
successor OPO for the balance of the 4-year agreement cycle. In rare
situations, a designation period may be longer, for example, a
designation may be extended if additional time is needed to select a
successor OPO to replace an OPO that has been de-certified.'' We
propose to redesignate and revise the requirements related to the
length of designation periods from Sec. 486.308(b)(1) to proposed
Sec. 486.308(a) to clarify that the planned duration of the
designation period is at least 4 years for renewal of an OPO agreement.
We propose, at revised Sec. 486.308(a)(1), to retain the
flexibility to shorten or extend the agreement cycle in certain limited
circumstances. However, we are proposing to clarify this provision by
identifying involuntary termination, in addition to voluntary
termination of an OPO's contract with CMS as the two circumstances
under which an OPO's designation period may be shortened. A voluntary
termination occurs when an OPO requests to voluntarily terminate its
agreement with CMS. An involuntary termination that would shorten a
designation period occurs when an OPO is de-certified due to non-
compliance with CMS requirements, as specified at proposed Sec.
486.312(a)(1) or (a)(4). In the event of non-compliance with the
process performance measures (Sec. Sec. 486.320 through 486.360), an
OPO would normally be afforded the opportunity to submit a plan of
correction to remedy non-compliance within a specific period of time.
If the plan of correction is acceptable, involuntary termination would
be averted provided the plan was successfully implemented by the OPO
resulting in correction of noncompliance and verified by CMS. (See 42
CFR 488, subpart A). We propose at new 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). At paragraph (a)(2) we
propose that CMS would conduct a competition for all vacated DSAs.
We also propose at new Sec. 486.308(a)(3) that the designation
period for any newly acquired DSA following a competition, or as the
result of being assigned a DSA as specified at Sec. 486.316(e), will
be the remaining portion of the agreement for the OPO's current re-
certification cycle. For instance, if an OPO is designated to a new DSA
following a competition in 2027, it would be designated for the
remainder of the original OPO's re-certification cycle that would be
anticipated to end in 2030. The successor OPO would fulfill the
remaining portion of this re-certification cycle. We propose at Sec.
486.308(a)(4) that if an OPO does not fulfill the term of its
agreement, whether voluntarily or involuntarily, and there is
insufficient time to conduct a competition to select a successor OPO
for its DSA, we may designate another OPO, without a competition. We
would exercise this option only if there were concern for continuity of
organ donation in the DSA in situations such as a termination for
urgent need, a cessation of business, or because the incumbent OPO was
unable to sustain services to provide an orderly transition to a
successor OPO. In selecting an OPO under these
[[Page 4206]]
circumstances, we 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.. We solicit public comment on these factors, how
these factors should be weighed in making a decision, and whether other
factors should be considered in this situation.
The December 2020 final rule was limited in scope and focused on
revisions to the outcome measures at Sec. 486.318, leaving certain
operational aspects to be revised through additional rulemaking. Given
the tiered system for re-certification that was implemented in that
rule, we are now clarifying when a DSA is open for competition and how
competition affects designation. Currently, 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 propose to relocate this language to Sec. 486.308(b) and
amend it to conform with requirements for competition at Sec. 486.316
and outcome measures at Sec. 486.318.
We propose to address all instances when a DSA is open for
competition.
<bullet> We propose to amend Sec. 486.308(b)(1) to reflect that a
DSA becomes open for competition when an OPO's DSA is assigned tier 3
status in the final assessment period and all administrative appeals
are exhausted. An OPO's DSA is assigned tier 3 status if it has outcome
measures currently described at Sec. 486.318(e)(6) (tier 3),
redesignated as proposed Sec. 486.318(b)(6), and Sec. 486.316(a)(3).
<bullet> We also propose conforming changes at Sec. 486.308(b)(2)
to clarify that an OPO's DSA is open for competition when the DSA is
assigned to tier 2 for the outcome measures in the final assessment
period, as currently described at Sec. 486.318(e)(5), proposed to be
redesignated to Sec. 486.318(b)(5), and Sec. 486.316(a)(2).
<bullet> We propose to add Sec. 486.308(b)(3), stating that an
OPO's DSAs are open for competition when the OPO is not in compliance
with the process performance measures at Sec. Sec. 486.320 through
486.360, as specified at Sec. 486.312(a)(1) and Sec. 486.316(b)(1),
all administrative appeals are exhausted, and the OPO is pending de-
certification.
<bullet> Finally, we propose at new Sec. 486.308(b)(4) that a DSA
would be open for competition when an OPO requests to voluntarily
terminate its agreement to participate as specified in Sec.
486.312(a), redesignated as proposed Sec. 486.311(a)(2). However, this
provision would not apply to a voluntary termination associated with an
OPO's change in control or ownership or service area as specified at
Sec. 486.310, in which case the OPO is voluntarily terminating its
agreement to participate in a merger with another OPO.
We solicit public comment on these proposed changes and ways to
provide clarity to the designation and competition process.
D. Designation of an OPO to More Than One Service Area (Sec. 486.309)
We propose to remove obsolete requirements at Sec. 486.309 and add
new requirements to address situations if an OPO is responsible for
more than one DSA. The current requirements at Sec. 486.309 addressed
the re-certification from August 1, 2006, through July 31, 2010
indicating that an OPO would be considered to be re-certified for the
period of August 1, 2006 through July 31, 2010 if an OPO met the
standards to be a qualified OPO within a 4-year period ending December
31, 2001 and has an agreement with the Secretary that is scheduled to
terminate on July 31, 2006. Since this time period has passed, these
requirements are now obsolete.
Since the December 2020 final rule was issued, some OPOs have
requested guidance on how an OPO could manage more than one DSA.
Section 1138(b)(2) of the Act provides that the Secretary may not
designate more than one OPO for each service area and the current OPO
CfCs only address one OPO being designated to only one DSA. Given that
OPOs have expressed interest in this area and the statute does not
explicitly restrict this situation, we are proposing requirements to
address one OPO being designated to more than one DSA. Currently, there
is a limited market in regard to the number of OPOs and DSAs, with 55
OPOs in total, each serving a single DSA (55 in total). Therefore,
permitting an OPO to separately maintain multiple DSAs could maintain
some level of market diversity to support future competition. This
proposal would also mitigate risk of geographic consolidation when OPOs
maintain separate DSAs rather than merging DSAs into one service area.
Finally, some OPOs have expressed concern for assuming responsibility
for DSAs where other OPOs have historically underperformed and merging
those areas with their existing DSA. These OPOs have indicated they
would prefer to manage DSAs separately to ensure they could improve
performance without risk to their existing DSA.
We are proposing that an OPO may be responsible for more than one
DSA when a new DSA is added following a change in control, ownership,
or service area as specified at Sec. 486.310, as result of a
competition as specified at Sec. 486.316, or following a voluntary or
involuntary termination of an OPO's agreement as specified at Sec.
486.311(a)(2) or Sec. 486.312(a) respectively, or there is
insufficient time to conduct a competition as specified at proposed
Sec. 486.308(a)(4). In these instances described previously, the OPO
would need to determine how best to manage its organization for the
respective areas. Some OPOs may find it beneficial to merge all
assigned DSAs into a single DSA; however, other OPOs may not want to
merge a new DSA into an existing DSA and may find it beneficial to
maintain a separate designation for each DSA. We propose to revise
Sec. 486.309 to give OPOs more flexibility to address this situation.
We are considering alternative policies on how an OPO could manage more
than one DSA, which are discussed in detail in section VII.C. of this
proposed rule.
Section 1138(b)(1)(C) of the Act permits the Secretary to provide
payment with respect to organ procurement costs attributed to an organ
procurement agency only if the agency meets performance-related
standards prescribed by the Secretary. Additionally, section 371(b) of
the PHS Act requires the Secretary to utilize outcome and process
performance measures for the process of certification and re-
certification of OPOs based on empirical evidence of organ donor
potential and other related factors in each service area of qualified
OPOs. Since OPOs have historically only been designated to one DSA,
these requirements have not yet been applied to an OPO that is
designated to more than one DSA. We propose to clarify application of
both the outcome and process performance measures when an OPO may be
designated to multiple DSAs. Our existing regulations require that OPOs
must meet the minimum standards for both outcome measures at Sec.
486.318 and the process performance measures at Sec. Sec. 486.320
through 486.360 (see Sec. 486.303(h)). The process measures are the
broad operational requirements for OPOs and include items such as
administration and governance, donor management, organ preparation and
transport, and QAPI. An OPO found out of compliance with a process
performance measure is subject to being de-certified at any time (Sec.
486.312(b)) but may be able to resolve the non-compliance within
prescribed
[[Page 4207]]
timeframes (see generally Sec. 488.28 and State Operations Manual
(SOM), CMS Pub. 100-07, Chapter 2, Section 2728).\58\
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\58\ <a href="https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c02.pdf">https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c02.pdf</a>.
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OPOs must meet outcome measures for re-certification and payment
purposes. To meet the outcome measures, an OPO is evaluated by
measuring the donation rate and the transplantation rate in their DSA.
In general, the outcome measures are assessed annually based on
calendar year data and the final assessment period is used for re-
certification (Sec. 486.302 (definition of ``Assessment Period'')).
We are proposing that when an OPO consolidates multiple DSAs,
regardless of contiguity, into a single DSA we would assess the OPO's
performance on the outcome measures as a single DSA. The outcome
measures for that merged DSA, however, would be used for any future
assessment periods, including the final assessment, and potential
disparate performance between the former two separate DSAs would not be
reflected in the outcome measure data for the consolidated DSA. At the
final assessment period, if the OPO could not satisfy the outcome
measures for the merged DSA, the OPO would be de-certified (subject to
the available appeal rights).
An OPO with one DSA faces de-certification if it is non-compliant
with any of the CfCs, including the process performance measures
(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 obtains a new additional DSA to
choose to maintain separate DSAs, rather than consolidating its new DSA
with its existing DSA. While the OPO would still be required to meet
the process performance measures in the conditions for coverage for all
of its DSAs to avoid de-certification, we propose that we would
consider the OPO's performance on the outcome measures separately for
each DSA when the OPO chooses to maintain separate DSAs. This would
enable the OPO to meet the outcome measures in one DSA, even if the OPO
did not satisfy the outcome measures in a separate DSA at the time of
re-certification. If at the time of re-certification an OPO met the
outcome measures at Sec. 486.318 for one of its DSAs (tier 1 as
specified at Sec. 486.318(e)(4), proposed to be redesignated as Sec.
486.318(b)(4) or tier 2 as specified at Sec. 486.318(e)(5), proposed
to be redesignated as Sec. 486.318(b)(5)) and did not meet the outcome
measures for another of its DSAs (tier 3 as specified at Sec.
486.318(e)(6), proposed to be redesignated as Sec. 486.318(b)(6)), CMS
would remove designation for the DSA in which the OPO has tier 3
performance, and the DSA would be opened for competition. The OPO would
be able to appeal the decision to remove the designation prior to the
competition due to its failure to meet the outcome measures in that
DSA. In this instance, the OPO would not be given a notice of de-
certification as specified in proposed Sec. 486.312(b) and would
instead receive a notice of removal of designation to a DSA without de-
certification (proposed Sec. 486.314(a)(2)). If all of an OPO's DSAs
have tier 3 performance, the OPO fails to meet the performance
standards to be a qualified OPO and would be sent a notice of an
initial de-certification determination as specified at proposed
Sec. Sec. 486.312(b), 486.314(a)(1), and 486.316(b)(2)(iii)(A). The
OPO would have the opportunity to appeal the de-certification
determination. If the CMS determination is upheld on appeal, the OPO
would be de-certified and all of its DSAs opened for competition. De-
certification is discussed in detail in section III.E. and appeals are
discussed in section III.F. of this proposed rule.
To give OPOs this additional flexibility to maintain separate DSAs,
we propose to add a new requirement for OPO designation of more than
one DSA at Sec. 486.309 to replace the current requirements. First, we
propose a new section heading at Sec. 486.309 for OPO designation to
more than one service area. Second, at Sec. 486.309(a), we propose
three circumstances for which an OPO may be designated to more than one
DSA. Such circumstances include a change in control, ownership or
service area as specified at Sec. 486.310 (proposed paragraph (a)(1));
following a competition as specified at Sec. 486.316 (proposed
paragraph (a)(2)); or following a voluntary or involuntary termination
of an OPO's agreement with CMS, when a new OPO was assigned to the DSA
and there was insufficient time to conduct a competition as specified
at Sec. 486.308(a)(4) (proposed paragraph (a)(3)). Third, we propose
at Sec. 486.309(b), that when requirements of paragraphs (a)(1) or
(a)(2) of proposed Sec. 486.309 are met after a change in ownership,
control or service area or competition, the OPO may choose to
consolidate the DSAs, maintain separate DSAs, or a combination thereof
if more than two DSAs are involved. If we were to assign an OPO to a
DSA after a voluntary or involuntary termination, as proposed at Sec.
486.309(a)(3), we would not permit the DSA to be consolidated to
facilitate future competition for that DSA and would open that DSA for
competition at the end of the designation period. Designation of an OPO
to a DSA in this situation would be a temporary measure intended to
maintain organ procurement services to provide time to facilitate an
orderly transition of the DSA to a successor OPO following a
competition.
We propose, at Sec. 486.309(c), that when an OPO is designated to
more than one DSA, CMS would remove designation to a tier 3 DSA in the
event of non-compliance with the outcome measures for that DSA at the
end of the re-certification cycle (that is, donation or organ
transplantation rates are below the median threshold rates
established), as specified at proposed Sec. 486.316(a)(3) and Sec.
486.318(e)(6), proposed to be redesignated as Sec. 486.318(b)(6). At
paragraph (c)(1), we propose that removal of designation will not
result in de-certification until an OPO is no longer designated to any
DSA due to tier 3 outcome measure performance in all of its DSAs, as
specified at Sec. 486.316(b)(2)(iii)(A). We also propose at paragraph
(c)(2) that an OPO may appeal the decision to remove its designation to
a tier 3 DSA as specified at Sec. 486.314 and that the DSA will be
opened to competition after all appeals are exhausted for that DSA. We
request public comment on these proposed changes in Sec. 486.309,
including additional factors that OPOs may want to consider related to
consolidating DSAs versus keeping them separate as well as alternative
policy approaches to address a single OPO being designated to more than
one DSA.
We note that the OPO Life Alliance Organ Recovery Agency (LAORA)'s
DSA was opened for competition with the application deadline closing on
December 8, 2025, as a result of the OPO's pending de-certification. In
the competition announcement, CMS indicated that the successor OPO to
this DSA would be required to maintain the DSA separately from their
existing DSA. We note this agency decision was based on both the long
history of underperformance in this DSA and CMS' desire to carefully
monitor the changes after the successor OPO assumes responsibility for
the DSA. This has prompted the consideration of alternative policies
regarding the process for when an OPO manages more than one DSA, which
are discussed in detail in section VII.C. of this proposed rule.
We seek to provide sufficient flexibility to OPOs so that they can
[[Page 4208]]
determine how to best tailor their operations for maximum benefit to
improve organ procurement within existing statutory and regulatory
requirements. As previously stated, some OPOs may determine it to be
beneficial to consolidate DSAs while others may determine that
maintaining separate DSAs is advantageous. We believe the factors
considered in this decision can be wide ranging and include items such
as contiguity of DSAs, existing size of DSAs, geographic
characteristics, population factors, DSA healthcare infrastructure and
networks, leadership preferences, and financial considerations, among
others. We seek public comment on the factors OPOs believe to be most
important in making decisions related to DSA management and the
benefits of DSA consolidation versus DSAs being managed separately.
Additionally, we seek public comment on alternatives being considered
as discussed in Section VII.C. of this proposed rule.
E. 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 propose to establish a new CfC at Sec.
486.311 for non-renewal of an OPO agreement. Additionally, we propose
to revise Sec. 486.312 to address enforcement actions that may result
in de-certification of an OPO.
In the December 2020 final rule, we finalized a new tier
designation process for re-certification of OPOs. OPOs are designated
to DSAs that are assigned as either tier 1, tier 2, or tier 3 based
upon their performance on the outcome measures set forth in Sec.
486.318 and their re-certification survey. This tiered system for re-
certification and competition became effective on March 30, 2021, and
is currently being implemented during the 2022 through 2026 re-
certification cycle that began on August 1, 2022, and is scheduled to
end on July 31, 2026. OPOs with DSAs that are in tier 3 during the
final assessment period in the re-certification cycle will be
decertified, pending appeals. OPOs with DSAs that are in tier 2 during
the final assessment period in the re-certification cycle will be
required to compete to retain their DSA, but they may also compete for
any other DSA that is open for competition. An important distinction
between tier 3 DSAs and tier 2 DSAs is that only tier 3 DSAs reflect
that the OPO is out of compliance with the outcome measures for that
DSA. Therefore, an OPO with all of its DSAs in tier 3 may be de-
certified. Alternatively, an OPO with a tier 2 DSA is in compliance
with the outcome measures for that DSA, and provided it is also in
compliance the process performance measures, is re-certified as meeting
the performance standards to be a qualified OPO and will have its
agreement renewed provided it is successful in a competition for that
or another open DSA.
The competition process means there is a possibility that an OPO
with a tier 2 DSA would not be successful in the competition to retain
its DSA. If the OPO is not designated for its DSA (and it did not win a
competition for any other open DSA), the OPO would no longer be
designated as an OPO at the end of the current agreement.
The current requirements for non-renewal of an agreement are
located at Sec. 486.312(c) and state that ``CMS will not voluntarily
renew its agreement with an OPO if the OPO fails to meet the
requirements for certification at Sec. 486.318, based on findings from
the most recent re-certification cycle, or the other requirements for
certification at Sec. 486.303. CMS will de-certify the OPO as of the
ending date of the agreement.'' This requirement does not address the
differences between tier 2 and tier 3, which is that an OPO with one or
more tier 2 DSAs, while in compliance with the outcome measures in
those DSAs, is not de-certified but will not be offered a new agreement
if it does not retain any of its DSAs or successfully compete for an
open DSA; whereas OPOs with tier 3 DSAs are out of compliance with the
outcome measures in those DSAs, potentially resulting in de-
certification. To address this issue, we propose a new CfC at Sec.
486.311, non-renewal of agreement.
We propose, at Sec. 486.311(a)(1), to address non-renewal for OPOs
with tier 2 DSAs that are unsuccessful in competition. We propose that
CMS will not renew an agreement with an OPO if the OPO is subject to a
competition (as set forth at Sec. 486.316(a)(2)), the OPO is
unsuccessful in the competition, and the OPO is no longer designated to
any DSA. The OPO would not be afforded appeal rights for loss of a
competition, consistent with our long-standing policy, as described in
the 2006 final rule. (see 71 FR 30998). In the 2006 final rule, we
stated, ``The statute requires only that we provide the opportunity to
appeal a de- certification. An appeals process following a competition
would be both expensive and unwieldly. We believe it would increase
uncertainty for the OPO that prevailed in the competition and that this
may disrupt the new OPO's ability to increase organ donation in the
service area''. We also stated that ``our competition decision is
final'' (71 FR 30998). This position is based on our intent to be able
to choose the OPO most likely to increase organ donation and best serve
the interests of all impacted by the actions and outcomes of the OPO.
OPOs do not have an intrinsic right to be awarded a DSA following a
competition and CMS may select the OPO most appropriate for that DSA.
In our proposed approach, an OPO with tier 2 DSAs that fails to
retain any of its DSAs in competition would not be de-certified and
could secure another agreement if it were successful in a concurrent or
subsequent competition for another DSA, assigned a DSA by CMS (see
Sec. 486.316(e)), or selected for an open DSA under proposed Sec.
486.308(a)(4). Since the OPO is compliant with the CfCs, it would be
re-certified without being designated to a DSA. This would permit the
OPO to compete in any additional open competitions during the following
4-year re-certification period. If the OPO is successful in a
competition, assigned a DSA by CMS under Sec. 486.316(e), or selected
for an open DSA under Sec. 486.308(a)(4), it could then be designated
to a DSA during this period. If the OPO does not obtain a new DSA
through competition, assignment under Sec. 486.316(e), or selection
under proposed Sec. 486.308(a)(4) by the end of the re-certification
cycle following the non-renewal of the OPO's agreement, it would not
meet outcome measure standards for that cycle. Consequentially, the OPO
would be de-certified at that time in accordance with the requirements
at proposed Sec. 486.312(a)(3). The OPO would be afforded appeal
rights for the de-certification in accordance with the requirements at
Sec. 486.314. For instance, during the anticipated 2026 re-
certification cycle, an OPO with a single tier 2 DSA that did not win
any competition would be re-certified for the duration of the next
recertification cycle that would extend to 2030. However, the OPO would
not be designated to a DSA unless it was successful in subsequent
competition or assigned a new DSA by CMS prior to the end of the re-
certification cycle in 2030. Therefore, if the OPO was not designated
to any DSA at the end of the re-certification cycle in 2030, it would
be de-certified at that time.
We propose at Sec. 486.311(b) that we would provide notification
to the OPO at least 90 days before the effective date of the non-
renewal and that the notice would state the reasons for non-renewal and
include the end date of the agreement.
[[Page 4209]]
We also propose, at Sec. 486.311(a)(2), that non-renewal of an
agreement (currently at Sec. 486.312(c)) would include a voluntary
termination of an agreement by an OPO. The current requirement for
voluntary termination of an agreement is located at Sec. 486.312(a).
If an OPO wishes to terminate its agreement with CMS, it must send
written notice of its intention to terminate and the proposed effective
date. Currently, we may approve the proposed date, set a different date
no later than 6 months after the proposed effective date, or set a date
less than 6 months after the proposed effective date if we determine
that a different date would not disrupt services to the service area.
Additionally, if we determine that a designated OPO has ceased to
furnish organ procurement services to its service area, the cessation
of services is deemed to constitute a voluntary termination by the OPO.
The current rule states that we will de-certify the OPO as of the
effective date of the voluntary termination. We propose to relocate and
revise the voluntary termination of agreement provision from Sec.
486.312(a) to Sec. 486.311(a)(2) and remove the requirement that we
would de-certify the OPO. An OPO voluntarily withdrawing from its
agreement or ceasing to furnish organ procurement services has taken an
affirmative step to end its duties under the OPO agreement, but that
action does not entitle the OPO to appeal a de-certification on
substantive or procedural grounds. As such, the voluntarily withdrawing
OPO would not be afforded appeal rights. The OPO would no longer have
an agreement, and would no longer be designated to any DSAs, as of the
effective date determined by CMS. We note that in Section III.C. of
this proposed rule, we provide an alternative considered related to
voluntary withdrawal. In this section, we consider an alternative
approach of permitting an OPO with more than one DSA to withdraw from a
specific DSA without effectively ending its agreement with CMS. We seek
public comment on this alternative approach as well as the benefits and
risks of establishing such a policy.
We also propose a public notice requirement at Sec. 486.311(c)
consistent with the current public notice requirements at Sec.
486.312(e) to inform the public of the change. We would provide public
notice in the service area of the date that a new OPO will be
designated for the DSA. We also propose new Sec. 486.311(d) to provide
that no payment under titles XVIII or XIX of the Act will be made with
respect to organ procurement costs attributable to an OPO that no
longer has an agreement with CMS.
We propose to reorganize and revise the requirements at Sec.
486.312 to clarify the actions we may take related to de-certification
of an OPO. The current requirements pertain to (a) voluntary
termination of agreement, (b) involuntary termination of agreement, (c)
non-renewal of agreement, (d) notice to OPO, and (e) public notice. As
mentioned earlier in this proposed rule, requirements for non-renewal
of agreement (currently Sec. 486.312(c)) and voluntary termination
(currently Sec. 486.312(a)) would be relocated to proposed Sec.
486.311(a).
We propose to relocate and revise the requirements for involuntary
termination of agreement at Sec. 486.312(b) to proposed Sec.
486.312(a). Involuntary termination would result in de-certification of
the OPO. Specifically, we propose at paragraph (a)(1) that we may
involuntarily terminate an OPO during the re-certification cycle if the
OPO no longer meets the requirements for certification at Sec.
486.303, including the conditions for coverage at Sec. Sec. 486.320
through 486.360, as specified at proposed Sec. 486.316(b)(1). The
conditions for coverage at Sec. Sec. 486.320 through 486.360 are
generally referred to as process performance measures. Non-compliance
means the OPO has one or more condition-level deficiencies that it is
unable to resolve within a specified timeframe. We propose at paragraph
(a)(2) that we may involuntarily terminate an OPO if the OPO is only
designated to tier 3 DSAs in the final assessment period, as described
at proposed Sec. 486.316(b)(2)(iii)(A), at the end of the agreement.
At paragraph (a)(3) we propose that we would de-certify an OPO if it is
no longer designated to any DSA and does not have data available from
the final assessment period to demonstrate compliance with the outcome
measures at the end of the re-certification cycle. This would address
the potential outcome of a tier 2 OPO that was re-certified but did not
have an agreement renewed because it did not win a competition as
specified at proposed Sec. 486.311(a)(1) and was not otherwise
assigned a DSA by CMS. Finally, we propose to relocate and revise the
requirements for immediate termination in cases of urgent need, such as
the discovery of unsound medical practices, currently located at Sec.
486.312(b) to proposed new paragraph at Sec. 486.312(a)(4). We also
propose to revise and relocate the requirements regarding notice of de-
certification to the OPO by redesignating and revising Sec. 486.312(d)
as paragraph Sec. 486.312(b). We propose that except in cases of
urgent need, the initial notice of de-certification would be provided
to the OPO at least 90 calendar days before the effective date of the
de-certification. In cases of urgent need, the notice would be provided
at least 3 calendar days prior to the effective date of the de-
certification. The notice would state the reasons for de-certification,
explain the available appeal rights, and include the effective date of
the de-certification.
We also propose to revise and redesignate the requirements
pertaining to public notice of de-certification currently at Sec.
486.312(e) to Sec. 486.312(c). The current requirements indicate that
``[o]nce CMS approves the date for a voluntary termination, the OPO
must provide prompt public notice in the service area of the date of
de-certification and such other information as CMS may require. In the
case of involuntary termination or nonrenewal of an agreement, CMS also
provides notice to the public in the service area of the date of de-
certification. No payment under titles XVIII or XIX of the Act will be
made with respect to organ procurement costs attributable to the OPO on
or after the effective date of de-certification.'' We are proposing to
remove the requirement that the OPO provide public notice in these
situations. We have proposed to revise this requirement to indicate
that CMS will provide public notice in the service area of the date of
de-certification and the date that a new OPO will be designated for the
DSA.
We believe that this proposed reorganization will provide greater
clarity into the actions that may occur as a result of the tiered
system and competition under the outcome measures. Grouping items based
on potential outcomes and impact to the OPO agreement and certification
status better aligns with the program requirements, including any
appeals process that may follow an adverse action. We solicit public
comment on these proposed changes and additional factors to consider or
changes to assist in refining the requirements of this section.
F. Appeals (Sec. 486.314)
The Organ Procurement Organization Certification Act of 2000 \59\
required the Secretary to issue regulations that allow an OPO to appeal
a de-certification on substantive and procedural grounds. To
[[Page 4210]]
fulfill this statutory requirement, Sec. 486.314 Appeals, was
finalized in the 2006 OPO final rule (71 FR 30982). The introductory
text at Sec. 486.314 states that ``[i]f an OPO's de-certification is
due to involuntary termination or non-renewal of its agreement with
CMS, the OPO may appeal the de-certification on substantive and
procedural grounds.'' In the December 2020 final rule (85 FR 77898), we
finalized new outcome measures and made some changes to the re-
certification and competition processes. As a result of significant
changes made since the 2006 final rule, we reviewed the OPO appeals
process to consider what, if any, changes should be proposed. Based
upon that review, we are proposing the following changes to Sec.
486.314 as described below.
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\59\ Section 701(c)(3) of the Organ Procurement Organization
Certification Act of 2000. 114 STAT. 2346, Public Law 106-305.
Published November 13, 2000.
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We propose to revise the introductory text at Sec. 486.314 to
allow an OPO to appeal a de-certification as described at Sec.
486.312(a) or the removal of a designation to a tier 3 DSA without de-
certification as described at Sec. 486.316(b)(2)(iii)(B). As a result
of the competition process as set forth at revised Sec. 486.316, some
OPOs might eventually be designated for more than one DSA. Thus, an OPO
may not be de-certified because at least one of their DSAs is assigned
to tier 1 or tier 2 in the final assessment period of the re-
certification cycle. However, if one of the OPO's DSAs is assigned to
tier 3 in the final assessment period, the OPO could lose its
designation for that DSA. Although the removal of a designation for a
DSA is not a de-certification if the OPO retains at least one DSA that
is not assigned to tier 3, the OPO has been found to be non-compliant
with the outcome measures in the tier 3 DSA. Thus, we believe that an
OPO should also have appeal rights for the removal of designation to a
DSA without de-certification. Consequently, we propose to add
references to the removal of designation for a DSA assigned as tier 3
without de-certification alongside references to de-certification in
Sec. 486.314, as applicable, to reflect that an appeal would be
available in either scenario. We propose to revise paragraph (a) for
the notice of initial determination and add new paragraphs (a)(1) and
(a)(2) to address de-certification and removal of a DSA without de-
certification respectively.
We propose to modify the time periods in this section for existing
requirements from ``business days'' to ``calendar days''. We also
propose to use ``calendar days'' for all proposed requirements. CMS
will compute time periods based on ``calendar days'' according to the
process described in Federal Rules of Civil Procedure (FRCP), Rule
6(a)(1).\60\ This is for both consistency and to avoid confusion in the
appeals process.
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\60\ FRCP, Rule 6(a)(1) (providing that when a time period is
stated in days or a longer unit of time, ``(A) exclude the day of
the event that triggers the period; (B) count every day, including
intermediate Saturdays, Sundays, and legal holidays; and (C) include
the last day of the period, but if the last day is a Saturday,
Sunday, or legal holiday, the period continues to run until the end
of the next day that is not a Saturday, Sunday, or legal
holiday.'').
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Currently, the OPO has 15 business days from receipt of the notice
to request reconsideration from CMS. If the OPO does not request a
reconsideration within those 15 business days, the OPO has no right to
further administrative review. We propose to change this to 20 calendar
days as set forth in proposed Sec. 486.314(b)(1). CMS currently has 10
business days from receipt of the reconsideration request to make a
written reconsidered determination that would affirm, reverse, or
modify the initial de-certification determination. We propose to modify
this to 15 calendar days to make a written reconsidered determination
that would affirm or reverse the initial de-certification
determination, as set forth in proposed Sec. 486.314(b)(3). We are
also proposing that CMS has the right to extend this time based on a
determination that additional time is necessary to thoroughly review,
make a decision and the extension does not prejudice either party. We
also propose to remove the option for the reconsideration official to
``modify'' the initial de-certification determination. We do not
believe it is appropriate for the reconsideration official to modify
the determination. Not only does he or she usually only have 15
calendar days to review the initial de-certification determination, but
also we believe there will be insufficient time and information for the
official to develop a modification to that determination.
Currently, if the de-certification decision is upheld, the OPO then
has 40 business days from receipt of CMS' reconsideration decision to
request a hearing before a CMS hearing officer. If an OPO does not
request a hearing or its request is not received timely, the OPO has no
right to further administrative review. The hearing officer must set a
date for the hearing that is no more than 60 calendar days after
receiving that request for a hearing and must render his or her
decision within 20 business days of the hearing.
We propose at Sec. 486.314(c) to reduce the number of days within
which an OPO must request a hearing before a CMS hearing officer from
40 business days to 15 calendar days. We did not previously explain the
40-business day timeline beyond stating that the appeals process
generally ``will protect a de-certified OPO's rights, provide it with
sufficient time to pursue its appeal, and ensure that it receives a
fair hearing''.\61\ However, a full 40 business days could contribute
to disruptions in organ procurement activities in the DSA and unduly
extend the appeals process. This proposed change is limited to the
request for a hearing before a CMS hearing officer. The shorter
timeline to request a hearing would continue to sufficiently protect an
OPO's rights, including time to pursue an appeal and receive a fair
hearing. The only decision the OPO needs to make before filing its
request for a hearing is whether it wants to challenge the de-
certification or the removal of a designation to a DSA without de-
certification. However, we also believe that in making the decision to
appeal, the OPO would have also begun gathering relevant documents and
other evidence, as well as formulating the arguments it would need for
the hearing. If the OPO requests a hearing, the hearing officer must
set a hearing date that is not more than 60 calendar days following the
receipt of the request for a hearing (Sec. 486.314(f)). The OPO and
CMS would have additional time from the date the hearing is requested
until the hearing date to more fully prepare their legal arguments and
factual support for the hearing. Both the OPO and CMS could submit
briefs, have witnesses testify, and submit additional evidence during
the hearing as currently allowed under Sec. 486.314(g). During the
conduct of the hearing, the hearing officer would inquire fully into
all relevant and material document and witness testimonies (Sec.
486.314(g)). Requiring OPOs to file a request for a hearing before a
CMS hearing officer within 15 calendar days of receiving the notice of
the reconsideration determination balances the OPO's interest in
providing ample time to file an appeal with the interests of patients'
access to organ transplants by shortening the time required for the
appeals process. During the appeals process, some resources will by
necessity be devoted to the appeal, which means that not all the OPO's
resources will be devoted to organ procurement activities. Hence, an
efficient appeals process is necessary to resolve the appeal and either
have the OPO devote all its resources to the procurement activities in
the DSA or proceed with identifying and transitioning to a successor
OPO.
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\61\ 71 FR 30994.
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[[Page 4211]]
Also, Sec. 486.314(d) currently states that the hearing officer
sends the administrative record to both parties within 10 business days
of receipt of the request for a hearing. Because the Office of Hearings
now uses an electronic case management system in which both parties
have access to each other's filings, the reconsideration official does
not need to forward their administrative record to the hearing officer
unless and until there has been a request for a hearing. We propose to
revise Sec. 486.314(d) to state that upon receipt of a request for a
hearing, the hearing officer will promptly request the administrative
record from the reconsideration official. We also propose that the
hearing officer, within 15 calendar days of receipt of the request for
a hearing, would send the administrative record to both parties, or
make it available through their electronic filing system, rather than
the current 10 business days. Now that there is an electronic filing
system available, we believe this would be a timely and efficient way
to share the administrative record and we want to encourage its use.
Additionally, we propose to revise and redesignate paragraph Sec.
486.314(i) and redesignate paragraphs (j) and (k) to incorporate new
paragraphs for requirements to update the appeals process.
Specifically, we propose redesignating the current paragraph (i) to
paragraph (k) to address the hearing officer's decision and to extend
the time for the hearing officer to render their decision to 90
calendar days. Under current Sec. 486.314(i), the CMS hearing officer
has 20 business days to render their decision. We are concerned that 20
business days may not be enough for the hearing officer to complete
their tasks. In addition to conducting the hearing and rendering a
decision, the hearing officer must develop an administrative record of
the hearing that is sufficient for any subsequent review. This could
include post-hearing activities, such as the hearing officer, at their
discretion, permitting the filing of post-hearing briefs on issues
raised at the hearing. Thus, we propose to revise and redesignate the
current requirements at Sec. 486.314(i) to paragraph (k), extend the
time for the hearing officer to issue their decision to 90 calendar
days, and provide that the hearing officer has the right to extend that
time upon notifying both the OPO and CMS, if the extension does not
unduly prejudice either of the parties and is necessary for the hearing
officer to issue a legally sufficient decision. We also propose that
the hearing officer can affirm or reverse the notice of de-
certification or removal of designation to a DSA without de-
certification. The hearing officer would then promptly forward his or
her decision and the administrative record to the CMS Administrator to
decide whether or not to exercise discretionary review of the hearing
officer's decision.
We propose a new (i) that will set forth requirements related to
scope of review. In the appeals process, we believe OPOs should have
the burden to demonstrate that they are entitled to relief. This is not
explicitly stated in the current version of Sec. 486.314. Since it is
the OPO that is challenging the notice of de-certification or the
removal of designation for a DSA without de-certification, we believe
the burden of proof on the OPO is implicit. Thus, we propose in new
paragraph (i) to clarify that OPOs have the burden of proof by a
preponderance of the evidence.
We also propose to revise and redesignate the current paragraph (j)
to paragraph (n). This subsection already provides CMS the authority to
extend its agreement with an OPO to allow for competition and, if
necessary, transition of the service area to a successor OPO. However,
we are concerned that the effective date of de-certification or removal
of designation for a DSA may be significantly delayed by the appeal
process. Hence, we propose adding the appeals process to the reasons an
extension of the agreement past the expiration date might be necessary.
We are also soliciting comments regarding whether there should be any
limitations on CMS' authority to extend the OPO's agreement with CMS.
In particular, we are considering what, if any, conditions we should
place on the extension, and what, if any, maximum amount of time CMS
could extend the agreement.
We also propose establishing an additional provision in the
administrative appeals process. The CMS Administrator has the right to
review CMS hearing officers' decisions, regardless of whether the
hearing officer reversed or affirmed the de-certification or the
removal of designation for a tier 3 DSA without de-certification.
However, the Administrator's review is not currently addressed in the
appeals section. Without requirements addressing the Administrator's
review, OPOs and the public would not be aware of the procedures that
would be followed after the hearing officer renders their decision. The
CMS Administrator's discretionary review is a crucial phase of the
appeals process, and we want to provide clarity to ensure that all
parties and the public have a clear understanding of the process. The
proposed requirements will also clarify when the appeals process is
exhausted and, if the OPO is de-certified, when CMS will move forward
with competition for the open DSA. Therefore, we propose new Sec.
486.314(l) to codify the process for discretionary review by the CMS
Administrator of the hearing officer's decision. Specifically, we
propose that the CMS Administrator has 30 calendar days from receipt of
the hearing officer's decision to elect to review or decline to review
the hearing officer's decision. If the CMS Administrator elects to
review the hearing officer's decision within the 30-day period, the CMS
Administrator will promptly notify the OPO and CMS of his or her
election to review and the parties' right to submit written arguments
within 15 calendar days of the notification. If the Administrator does
not elect to review the decision within 30 calendar days of its
receipt, the hearing officer's decision is final.
We propose that within 45 calendar days of notification of the CMS
Administrator electing to review the hearing officer's decision, the
CMS Administrator must render a final decision, in writing, to the
parties. The CMS Administrator can affirm, reverse, or remand the
hearing officer's decision to CMS as discussed below. We are also
proposing that the CMS Administrator has the right to extend this time
if he or she determines they need more time to thoroughly review and
make a decision and the extension does not prejudice either party. We
propose that the CMS Administrator's review be limited to the hearing's
administrative record developed by the hearing officer and written
arguments submitted by the OPO or CMS. The CMS Administrator's
administrative record would be composed of all documents submitted to
the hearing officer or developed in the course of the hearing,
including the hearing officer's decision, as well as written arguments
from the OPO or CMS explaining why either or both parties believe the
hearing officer's determination was correct or incorrect, and the CMS
Administrator's written decision explaining his or her decision and the
reason for that decision.
We propose that our decision whether to de-certify an OPO or remove
its designation to a particular DSA would become final if the OPO does
not request review by a hearing officer in the time allowed under these
regulations, or after the CMS Administrator declines to review the
hearing officer's decision, renders a final decision in writing to the
parties, or does not render a final decision or a remand in writing to
the parties within 45 calendar days of electing to review
[[Page 4212]]
the hearing officer's decision or by the extended deadline if the
Administrator extends the 45-day period. As noted below, a decision
would not take effect until (among other things) all administrative
appeals are exhausted to avoid any undue prejudice to the OPO.
We also propose to revise and redesignate current (k) to new
paragraph (o) at Sec. 486.314 to clarify when the OPO's DSA is opened
for competition. Consistent with our current rule, an OPO will not be
de-certified or lose its designation to a DSA until all administrative
appeals are exhausted. If at the end of the appeals process the notice
of de-certification or removal of designation for a DSA without de-
certification has not been reversed or remanded, the decision is final.
At that time, the OPO's DSA would be competed and a successor OPO would
be chosen. CMS would then determine a transition period that is
sufficient for the new OPO to take full responsibility for the DSA.
After the transition period is determined by CMS, CMS would forward to
the de-certified OPO a written communication indicating the effective
date of de-certification, at which time Medicare and Medicaid payments
may no longer be made for organ procurement costs attributable to the
OPO. For an OPO that loses its designation to a tier 3 DSA without
being de-certified, CMS would forward a written communication
indicating the effective date of the decision, at which time Medicare
and Medicaid payments may no longer be made for organ procurement costs
attributable to the affected OPO for that particular DSA. We would not
begin the competition process before the appeals process is exhausted.
We believe that there might be circumstances in which the CMS
Administrator could want CMS to conduct further review or have other
instructions for CMS regarding the appeal. For example, the CMS
Administrator might want further analysis of data. Hence, we propose
that the CMS Administrator may remand the appeal to CMS for any
appropriate reason in proposed (m). Remanding the appeal means that the
appeal is sent back to CMS for re-evaluation and a new initial
determination regarding de-certification or removal of designation for
a DSA without de-certification. Also, if the appeal is remanded to CMS,
the agency will comply with any instructions in the remand. We are not
proposing remand authority for the hearing officer.
We propose a new subsection (p) to address de-certification due to
urgent need. We have received feedback that there is some confusion
about how the appeals process would proceed for an OPO de-certified due
to urgent need. The appeals process is the same regardless of the
reason for the OPO's de-certification. However, if an OPO is de-
certified due to urgent need, it may be de-certified immediately
(proposed 42 CFR 486.312(a)(4)). In such circumstances, the affected
OPO's service area would be reassigned to one or more other OPOs as set
forth at proposed Sec. 486.308(a)(4) by the effective date specified
in the notice of de-certification provided under proposed Sec.
486.312(b). Hence, if the de-certified OPO pursues an appeal, it would
not be operating its DSA while proceeding through the appeals process.
Notwithstanding the reason for the de-certification, if the initial
notice of de-certification is reversed in the appeals process, the OPO
will be recertified for the next re-certification cycle. However, its
tier status does not change. If the CMS Administrator chooses to modify
the hearing officer's decision, CMS will comply with his or her
determination.
We are soliciting public comments on these proposed changes to the
appeals process. We are especially interested in comments on the
proposed time frames for the different stages of the appeals process.
G. Re-Certification and Competition (Sec. 486.316)
In section III.D. of this proposed rule, we discussed the proposal
regarding OPO designation to more than one DSA. In that section, we
proposed that we would evaluate each DSA separately on the outcome
measures at Sec. 486.318. However, we also proposed that an OPO would
be evaluated across all DSAs on the process performance measures at
Sec. Sec. 486.320 through 486.360. The current requirements at Sec.
486.316 address OPO re-certification and competition. These
requirements do not currently address the potential situation of one
OPO being designated to more than one DSA and the impact this may have
on the re-certification and competition processes. We propose 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 propose to revise Sec. 486.316(a) to address the impact of the
OPO outcome measures at Sec. 486.318 on OPO designation at the time of
re-certification. We propose that an OPO's performance on the outcome
measures and tier assignment in each DSA at the final assessment period
of the agreement cycle would determine OPO designation to the DSA.
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
as specified at Sec. 486.318(e)(4), (5), and (6) respectively,
redesignated as proposed Sec. 486.318(b)(4), (5), and (6). We propose,
at Sec. 486.316(a)(1), that an OPO with a DSA that is assigned to tier
1, as specified at Sec. 486.318(e)(4), redesignated as proposed Sec.
486.318(b)(4), would retain designation to the DSA for another
agreement period. An OPO with a tier 1 DSA would be eligible to compete
for any open DSAs, provided that CMS determined it to be in compliance
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.
At Sec. 486.316(a)(2), we propose that an OPO with a DSA that was
assigned to tier 2, as specified at Sec. 486.318(e)(5), redesignated
as proposed Sec. 486.318(b)(5), would have to successfully compete and
be awarded a DSA in a competition to retain designation to a DSA for
another agreement period. An OPO with tier 2 DSAs would be eligible to
compete for any open DSAs provided that CMS determined the OPO to be in
compliance 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. We also propose, at Sec.
486.316(a)(3), that an OPO with a DSA that is assigned to tier 3, as
specified at Sec. 486.318(e)(6), redesignated as proposed Sec.
486.318(b)(6), would have the designation removed at the end of the
agreement period. Additionally, an OPO with all of its DSAs assigned to
tier 3 would not be eligible to compete in competitions for any open
DSAs.
In paragraph (b) of proposed Sec. 486.316, we propose how
performance on the process performance measures (Sec. Sec. 486.320
through 486.360) and outcome measures (Sec. 486.318) will impact OPO
re-certification and competition.
At proposed Sec. 486.316(b)(1), we address compliance with the
process performance measures. We propose an OPO must maintain
compliance with the process performance measures at all times and that
non-compliance with the requirements at Sec. Sec. 486.320 through
486.360 in any DSA would result in the OPO receiving an initial de-
certification determination. We propose that the OPO has the right to
appeal the de-certification. If the OPO does not appeal the
determination, or the OPO appeals
[[Page 4213]]
and the determination is upheld after the appeal process is completed,
the OPO's service areas are opened for competition from other OPOs that
qualify to compete for open service areas.
At proposed Sec. 486.316(b)(2), we describe the proposed impact of
tier assignment during the final assessment period to OPO designation
at the time of re-certification. At paragraph (i), we propose that an
OPO designated to at least one DSA that is assigned to tier 1 in the
final assessment period would be re-certified for another re-
certification cycle, as long as it is compliant with conditions for
coverage at Sec. Sec. 486.320 through 486.360 during the most recent
survey. At paragraph (ii), we propose that an OPO that is designated to
at least one DSA that is assigned to tier 2 in the final assessment
period and is not designated to any DSA assigned to tier 1, will be re-
certified for another recertification cycle, as long as it is compliant
with conditions for coverage at Sec. Sec. 486.320 through 486.360
during the most recent survey. The OPO will be eligible to compete in
competitions for any open DSA. However, their agreement will not be
renewed if they are not successful in at least one competition in
accordance with Sec. 486.311(a)(1). We propose that if the OPO is
successful in a competition, it will then be designated to a DSA and
receive a new agreement. We also propose that if the OPO is not
successful in at least one competition, it will receive a notice of
non-renewal as specified in Sec. 486.311(b). Because the OPO is re-
certified, it will remain eligible to compete in future competitions,
be assigned a DSA under Sec. 486.316(e), or be selected for an open
DSA under Sec. 486.308(a)(4) during the next re-certification cycle.
At paragraph (b)(2)(iii), we propose that an OPO that is designated
to a DSA that is assigned to tier 3 in the final assessment period will
receive one of two notices. At sub-paragraph (A) the OPO will receive
notice of its initial de-certification determination 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
as specified at proposed Sec. 486.318(c)(3) or (4) at the end of the
re-certification cycle. At sub-paragraph (B), the OPO will receive a
notice of removal of designation to the DSA assigned as tier 3 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 as specified at proposed Sec. 486.318(c)(3) or (4) at the end
of the re-certification cycle.
We are proposing changes at Sec. 486.318(f), proposed to be
redesignated as Sec. 486.318(c), to address when we would hold an OPO
accountable on the outcome measures when it acquires a new area, such
as after a change of control or ownership or service area, a
competition, or assignment of a DSA by CMS. We refer readers to section
III.H of this proposed rule for additional information on this topic.
At paragraph 486.316(b)(2)(iv), we propose that an OPO would have the
right to appeal a de-certification or removal of designation to the DSA
assigned as tier 3 as established in Sec. 486.314. If an OPO does 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 address the competition requirements at proposed Sec.
486.316(b)(3). We propose that DSAs assigned as tier 2 or tier 3 in the
final assessment period would be opened for competition. The OPO's tier
2 or tier 3 service area is opened for competition from other OPOs that
qualify to compete for open service areas as set forth in proposed
Sec. 486.316(c). Competition for DSAs assigned to tier 3 will not
begin until after any applicable appeal under Sec. 486.314 has been
exhausted.
In proposed Sec. 486.316(c), we list existing criteria to compete
for an open DSA and proposed to redesignate these as paragraphs (1) and
(2). 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 at Sec. 486.318(e)(4), or tier 2 at Sec.
486.318(e)(5), redesignated as proposed Sec. 486.318(b)(4) and (b)(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 must compete for the
entire DSA. At proposed paragraph (2), we propose to amend 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 propose 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. This would enable the
OPO to participate in subsequent competitions and enter into a new
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 at Sec. 486.318 for that re-certification cycle and would de-
certified at that time.
We propose to revise text at Sec. 486.316(d) to describe the
selection and designation of an OPO following a competition more
accurately. The current text states that ``CMS will designate an OPO
for an open service area based on the following criteria.'' We propose
to revise this to state, ``CMS will select an OPO for designation to an
open DSA based on the following criteria''. We also propose to make a
conforming change at Sec. 486.316(d)(2) to include relative success in
meeting the process performance measures and other conditions at
Sec. Sec. 486.320 through 486.360.
Discussion of OPO Criteria for Selection at Sec. 486.316(d)
In the December 2021 RFI (86 FR 68594), we solicited public
comments on potential changes to the requirements that transplant
programs, OPOs, and ESRD facilities must meet to participate in the
Medicare and Medicaid programs. One topic from the December 2021 RFI
that received considerable comments and that we are addressing in this
proposed rule is the competition process for OPOs that may occur at the
end of the 2022 through 2026 OPO certification cycle. Our goals in
developing the tiered re-certification system were to ensure that OPOs
are held to a high level of performance expectations and that all OPOs
are pushed to perform better to better serve patients awaiting a
transplant. In creating the tiered approach, we sought to reward the
top performing OPOs (tier 1 DSAs), while giving OPOs with DSAs in tiers
2 and 3 sufficient incentives to improve their performance and achieve
ranking in the next level. Additionally, we sought to give OPOs with
tier 2 DSAs the opportunity to demonstrate that the OPO could perform
better than other OPOs in a particular service area. While we
previously expressed this intent in rulemaking, many commenters in the
recent RFI expressed concern for how OPOs with tier 2 DSAs would be
evaluated in future competitions and requested clarification of the
competitive process. These commenters recommended that CMS provide
special consideration when evaluating OPOs
[[Page 4214]]
with tier 2 DSAs. Specifically, they stated that CMS should give
particular attention in cases where an OPO with a tier 2 DSA has one of
its two outcome measures for that DSA in tier 1. In these instances,
commenters recommended that CMS recognize and give significant weight
to sustained improvement in the incumbent OPO's existing DSA when
evaluating the OPO in a competitive process against an OPO with tier 1
performance in both outcome measures.
We seek to clarify the existing selection criteria for evaluating
OPOs in a competition and how this will be utilized in future
competitions under the tier system for re-certification; however, we
are not proposing any new regulatory changes. Currently, we consider
the following four criteria when designating an OPO for an open service
area, as stated in Sec. 486.316(d):
<bullet> Performance on the outcome measures at Sec. 486.318.
<bullet> Relative success in meeting the process performance
measures and other conditions at Sec. Sec. 486.320 through 486.348,
proposed to be amended to Sec. Sec. 486.320 through 486.360.
<bullet> Success in identifying and overcoming barriers to donation
within its own service area and the relevance of those barriers to
barriers in the DSA that is open for competition. 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 them, and the results.
<bullet> Contiguity to the open service area.
In our 2006 final rule (71 FR 30999), we stated that we would
evaluate the first three criteria equally and use the fourth criterion,
contiguity, as a deciding factor if we determine that two competing
OPOs were equally competent to take over an open area. Additionally, in
the 2006 final rule where we described the competition requirements (71
FR 30998), we stated, ``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,
and the organ donation and transplantation system in the United
States.'' \62\ We believe the existing selection criteria would
continue to provide sufficient objective measures in designating the
most appropriate OPO to be awarded a DSA in a competition. The criteria
also provide a sufficient level of discretion in rating OPOs that would
address the concerns raised by commenters in the RFI. For instance,
when considering performance on the outcome measures, we may consider
the degree to which the top performing OPO's performance on the outcome
measures exceeds the performance of other competitors and may judge
small differences in performance among competitors to be relatively
insignificant (see Sec. 486.316(d)(1). Additionally, continuous
improvement in outcome measures over successive years would be
considered and we would expect an OPO to address any such improvement
in describing how it identified and overcame barriers in its DSA (see
Sec. 486.316(d)(4). We would also consider each OPO's relative success
in meeting the process performance measures, the conditions for
coverage, during the most recent re-certification period (see Sec.
486.316(d)(2). By ``relative success,'' we mean that we will judge
whether the OPO satisfied the requirements necessary to meet the
process performance measures. Noncompliance deficiencies cited on
surveys, including complaint surveys since the last re-certification,
are other aspects we would consider when ranking OPOs in competition.
Finally, the degree to which an OPO had identified and overcome
barriers to donation identified in its own DSA would be considered (see
Sec. 486.316(d)(4). This would provide the OPO the opportunity to
describe the barriers it has faced and document its performance gains
over time.\63\ 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. CMS will evaluate the OPOs based on the
information and data provided in describing the barriers in its service
area, the impact to organ donation, the steps (or plan) the OPO
implemented to overcome the barriers, and the results. CMS will also
consider the extent to which the OPO identified and addressed the
relevance of barriers to donation within its own service area to
barriers in the open DSA. This information is important for competing
OPOs in demonstrating a record of performance gains and a trajectory of
improvement that could enable CMS to make the determination that the
OPO is likely to continue improving, is likely to achieve tier 1 status
in the near term and should be designated to the DSA. Our goal in the
competitive selection process is to ensure that we designate OPOs to
DSAs that will continue to accelerate system improvement and better
serve patients awaiting transplants.
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\62\ 71 FR 30998.
\63\ 42 CFR 486.316(d).
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We received comments on the issue of contiguity in response to the
December 2021 RFI. While some commenters highlighted the use of
technology to aid in operating non-contiguous DSAs or indicated their
opinion that contiguity no longer mattered, other commenters provided
information to validate retaining this criterion as a means to
selecting an OPO when they were otherwise ranked equally. Some of the
rationales included observations about efficiencies related to resource
utilization and distribution; agreements and networks with regional
partners covering geographic areas that overlap both DSAs; and
potentially familiarity with the geographic area, demographics, high
volume transplant centers, and local courier relationships. While we
believe that OPOs could operate non-contiguous DSAs successfully, we
also believe there is benefit to geographic proximity. Consistent with
Sec. 486.316(d)(3) and the policy described in the 2006 final rule, we
will continue to utilize contiguity in situations when OPOs are ranked
equally and will give positive consideration to a competing OPO that is
contiguous to the open DSA.
We anticipate this preamble discussion will alleviate the concerns
of commenters that may have been under the impression that we would
rigidly apply the selection criteria based on tier standing alone. We
also believe this information will assist OPOs in determining both a
strategy for competition and the information that may be most
beneficial when participating in a competition for an open DSA.
However, we solicit public comment on alternative factors that we may
not have considered regarding the implementation of the tiered approach
to re-certification and competition.
Finally, we propose to remove the current text in Sec. 486.316(g)
and replace it with a new paragraph (g). Currently, paragraph (g)
addresses an e
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