[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Rules and Regulations]
[Pages 77898-77949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26329]



[[Page 77897]]

Vol. 85

Wednesday,

No. 232

December 2, 2020

Part IV





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 Outcome Measure Requirements 
for Organ Procurement Organizations; Final Rule

  Federal Register / Vol. 85 , No. 232 / Wednesday, December 2, 2020 / 
Rules and Regulations  

[[Page 77898]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 486

[CMS-3380-F]
RIN 0938-AU02


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

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule revises the Organ Procurement Organizations 
(OPOs) Conditions for Coverage (CfCs) to increase donation rates and 
organ transplantation rates by replacing the current outcome measures 
with new transparent, reliable, and objective outcome measures and 
increasing competition for open donation service areas (DSAs).

EFFECTIVE DATE: These regulations are effective on February 1, 2021, 
except for amendment number 3 (further amending Sec.  486.302), which 
is effective July 31, 2022.
    Implementation date: The regulations will be implemented on August 
1, 2022.

FOR FURTHER INFORMATION CONTACT: Diane Corning, (410) 786-8486; Jesse 
Roach, (410) 786-1000; Kristin Shifflett, (410) 786-4133; CAPT James 
Cowher, (410) 786-1948; or Alpha-Banu Wilson, (410) 786-8687.

SUPPLEMENTARY INFORMATION: 

Table of Contents

    To assist readers in referencing sections contained in this 
preamble, we are providing a Table of Contents.
I. Background
    A. The Importance of Organ Procurement Organizations and the 
Need To Reform the Organ Procurement System
    B. Statutory and Regulatory Provisions
    C. HHS Initiatives Related to OPO Services and Executive Order 
(E.O.) 13879
II. Summary of the Proposed Provisions and Responses to Public 
Comments
    A. General Comments
    B. Proposed Changes to Definitions (Sec.  486.302) and Proposed 
Changes to Outcome Requirements (Sec.  486.318)
    1. General Comments About the Outcome Measures
    2. Donation Rate Sec.  486.318(d)(1)
    3. Donor Definition Sec.  486.302 and the ``Zero Organ Donors''
    4. Organ Transplantation Rate Sec.  486.302 and Sec.  
486.318(d)(2)
    5. Organ Definition Sec.  486.302
    6. Donor Potential (Sec.  486.302 and Sec.  486.318(d)(4))
    a. Death That Is Consistent With Organ Donation Sec.  486.302
    i. Death Certificate Data
    ii. International Classification of Diseases, Tenth Revision, 
Clinical Modification (ICD-10-CM)
    b. Age 75 and Younger
    c. Inpatient Deaths
    d. Waiver Hospitals
    7. Risk-Adjustments Sec.  486.302 and Sec.  486.318(d)(2)
    a. Chronic Diseases
    b. Race
    c. Gender and Age
    d. Ventilator Status
    8. OPO Performance on Outcome Measures Sec.  486.318(e) and 
Sec.  486.302
    9. Non-Contiguous States, Commonwealths, Territories, or 
Possessions Sec.  486.318(e)(7)
    10. Assessment and Data for the Outcome Measures Sec.  
486.318(f)
    11. Implementation Timeline
    12. Definitions Sec.  486.302
    C. Re-Certification and Competition Processes (Sec.  486.316)
    1. Re-Certification of OPOs Sec.  486.316(a)
    2. De-Certification and Competition Sec.  486.316(b)
    3. Criteria to Compete Sec.  486.316(c)
    4. Criteria for Selection Sec.  486.316(d)
    5. Extension of the Agreement Cycle for Extraordinary 
Circumstances Sec.  486.316(f)
    D. Reporting of Data Sec.  486.328
    E. Proposed Change to the Quality Assessment and Performance 
Improvement Requirement (Sec.  486.348)
    1. Death Record Review in QAPI
    F. Response to Solicitation of Comments
    1. Out of Scope
III. Provisions of the Final Rule
    A. Proposed Changes to Definitions (Sec.  486.302) and Proposed 
Changes to Outcome Requirements (Sec.  486.318).
    B. Re-Certification and Competition Processes (Sec.  486.316)
    C. Proposed Change to the Quality Assessment and Performance 
Improvement Requirement (Sec.  486.348)
    D. Solicitation of Comments (Including Changes to Re-
Certification Cycle)
IV. Collection of Information Requirements
    A. ICRs Regarding Re-Certification and Competition Processes 
(Sec.  486.316)
    B. ICRs Regarding Condition: Reporting of Data (Sec.  486.328)
    C. ICRs Regarding Quality Assessment and Performance Improvement 
(Sec.  486.348)
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Scope of Review
    C. Effects on OPO Performance
    D. Anticipated Costs and Benefits
    1. Effects on Medical Costs
    2. Effects on Patients
    3. Implementation and Continuing Costs
    E. Effects on Medicare, Medicaid, and Private Payers
    F. Effects on Small Entities, Effects on Small Rural Hospitals, 
Unfunded Mandates, and Federalism
    1. Regulatory Flexibility Act
    2. Small Rural Hospitals
    3. Unfunded Mandates Reform Act
    4. Federalism
    G. Alternatives Considered
    1. Changes to the Denominator
    a. CALC as the Denominator
    b. All Deaths, Age <= 75 as the Denominator
    c. Total Population, Age <75
    2. Changing the Confidence Interval
    3. Changing the Threshold Rates
    H. Accounting Statement and Table
    I. Reducing Regulation and Controlling Regulatory Costs
    J. Conclusion
    Regulations Text

I. Background

A. The Importance of Organ Procurement Organizations and the Need To 
Reform the Organ Procurement System

    Organ procurement organizations (OPOs) are vital partners in the 
procurement, distribution, and transplantation of human organs in a 
safe and equitable manner for all potential transplant recipients. The 
role of OPOs is critical to ensuring that the maximum possible number 
of transplantable human organs is available to individuals with organ 
failure who are on a waiting list for an organ transplant. There are 
currently 58 OPOs that are responsible for identifying eligible donors 
and recovering organs from deceased donors in the United States (U.S.), 
with no current statutory authority to add new OPOs. Therefore, the 
Centers for Medicare & Medicaid Services (CMS) views OPO performance as 
a critical element of the organ transplantation system in the United 
States (U.S.)
    As of November 2020, a total of 108,725 people were on the waiting 
lists for a lifesaving organ transplant.\1\ Many people face tremendous 
quality of life burdens 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, which could ultimately save more lives.
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    \1\ Organ Procurement and Transplantation Network (OPTN) Data. 
https://optn.transplant.hrsa.gov/data/.
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    Based on public feedback and our own internal analysis of organ 
donation and transplantation rates, it is the agency's belief that the 
current OPO outcome measures are not sufficiently objective and 
transparent to ensure appropriate accountability in assessing OPO 
performance, nor do they properly incentivize the adoption of best 
practices and optimization of donation and organ placement rates.

[[Page 77899]]

    Given OPOs' important role in the organ donation system in the 
U.S., some stakeholders have stated that underperformers have faced few 
consequences for poor performance, by noting ``Performance varies 
across the OPO network, with many persistent underperformers failing to 
improve over the last decade.'' \2\ They further note that there are 
serious negative impacts to both organ transplantation and donation 
when OPOs are underperforming, in that ``[w]hen OPOs are inefficient or 
ineffective, donor hospitals are reluctant to refer potential donors, 
and transplant programs have fewer organ offers for patients on the 
waiting list. The end result is a bottleneck within the system that 
leads to avoidable deaths and increased national health care 
spending.'' \3\
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    \2\ The Bridgespan Group. Reforming Organ Donation in America. 
https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
    \3\ ORGANIZE. Organ Donation Reform Report, 2019.
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    Some stakeholders, including members of the OPO industry, have 
stated that the current OPO outcome measures should be reformed to 
incentivize improvements in OPO performance. Some of these stakeholders 
note that ``[e]xisting regulations need dramatic improvement to remove 
perverse incentives to organ procurement (for example, OPOs are 
evaluated on the number of organs procured per donor, which leads to 
older single-organ donors being overlooked) and increase continuous 
performance accountability.'' \2\ Reforming the current outcome 
measures can be achieved, they indicated, through metrics that improve 
accountability and ``by replacing current ineffective metrics for OPO 
performance with a simplified transparent metric that enables 
independent performance measurement.'' \2\

B. 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 Public Health Service 
Act (the PHS Act). Section 1138(b) of the Act provides the statutory 
qualifications and requirements that an OPO must meet in order for 
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 program or the 
Medicaid program for organ procurement costs, the entity must be 
designated by the Secretary. The requirements for such designation are 
set forth in 42 CFR 486.304 and include being certified as a qualified 
OPO by CMS.
    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 policies approved by 
the Secretary will be considered ``rules and requirements'' of the OPTN 
for purposes of section 1138 of the Act. The OPTN is a membership 
organization that links all professionals in the U.S. organ donation 
and transplantation system. Currently, the United Network for Organ 
Sharing (UNOS) serves as the contractor for the operation of the OPTN 
under contract with HHS. OPOs are required under the OPTN final rule 
(42 CFR 121.11(b)(2)) and 42 CFR 486.328 of the OPO CfCs to report 
information specified by the Secretary to the OPTN, including the data 
used to calculate the outcome measures for OPOs.
    In addition, OPOs are required to comply with title VI of the Civil 
Rights Act of 1964, 42 U.S.C. 2000d (title VI), section 504 of the 
Rehabilitation Act of 1973, 29 U.S.C. 794 and section 1557 of the 
Patient Protection and Affordable Care Act, 42 U.S.C. 18116 (section 
1557). Title VI and section 1557, protect individuals on the basis of 
race, color and national origin. Under these laws, OPOs are required to 
take reasonable steps to ensure meaningful access to their programs by 
individuals with limited English proficiency. Reasonable steps may 
include providing language assistance services at no cost, such as 
providing interpreters or translated material. Also, section 504 and 
section 1557 protect qualified individuals with a disability, including 
prospective organ recipients with a disability and prospective organ 
donors with a disability, from discrimination in the administration of 
organ transplant programs. Under these laws, OPOs must ensure that 
qualified individuals with a disability are afforded opportunities to 
participate in or benefit from the organ transplant programs that are 
equal to opportunities afforded others. Decisions to approve or deny 
organ transplants must be made based on objective facts related to the 
individual in question. ``Individuals with disabilities are also 
entitled to reasonable accommodations needed to participate in and 
benefit from a program, and auxiliary aids and services needed for 
effective communication. These rights extend in some circumstances to 
family members 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 donation program.'' Additionally, if 
eligibility criteria for being a transplant recipient require an 
individual to be able to comply with post-transplant regimens, it would 
be a reasonable accommodation to allow an individual with a 
developmental or intellectual, or other disability to meet that 
requirement with the assistance of a relative, attendant, or other 
individual.
    We established CfCs for OPOs at 42 CFR part 486, subpart G, and 
OPOs must meet these requirements in order to be 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 and became 
effective on July 31, 2006 (71 FR 30982), which we refer to as the 
``2006 OPO final rule''. The current 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)).
    Section 486.322 requires that an OPO must have a written agreement 
with 95 percent of the Medicare- and Medicaid-participating hospitals 
and critical access hospitals in its service area that have both a 
ventilator and an operating room, and have not been granted a waiver by 
CMS to work with another OPO. Meanwhile, 42 CFR 482.45

[[Page 77900]]

requires a hospital have written protocols that incorporate an 
agreement with an OPO under which it must notify, in a timely manner, 
the OPO or a third party designated by the OPO, of individuals whose 
death is imminent or who have died in the hospital. Potential organ 
donors may encounter Medicare- and Medicaid-certified providers prior 
to an emergency department visit or hospital admission to a critical 
care unit. Therefore, we expect that each OPO's responsibilities and 
work begins long before a hospital notifies the OPO of an impending 
death--through, but not limited to, extensive training and education of 
all Medicare and Medicaid-certified providers along the continuum of 
care and by fostering a collaborative relationship among them.

C. HHS Initiatives Related to OPO Services and Executive Order (E.O.) 
13879

    In 2000, the Secretary's Advisory Committee on Organ 
Transplantation (ACOT) was established under the general authority of 
section 222 of the PHS Act, as amended. See 42 CFR 121.12. ACOT is 
charged to: (1) Advise the Secretary, acting through the Administrator, 
Health Resources and Services Administration (HRSA) on all aspects of 
organ donation, procurement, allocation, and transplantation, and on 
such other matters that the Secretary determines; (2) advise the 
Secretary on federal efforts to maximize the number of deceased donor 
organs made available for transplantation and to support the safety of 
living organ donation; (3) at the request of the Secretary, review 
significant proposed OPTN policies submitted for the Secretary's 
approval to recommend whether they should be made enforceable; and (4) 
provide expert input to the Secretary on the latest advances in the 
science of transplantation, the OPTN's system of collecting, 
disseminating and ensuring the validity, accuracy, timeliness and 
usefulness of data, and additional medical, public health, patient 
safety, ethical, legal, financial coverage, social science, and 
socioeconomic issues that are relevant to transplantation.\4\
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    \4\ https://www.organdonor.gov/about-dot/acot/charter.html.
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    A 2012 recommendation by ACOT stated: ``The ACOT recognizes that 
the current CMS and HRSA/OPTN structure creates unnecessary burdens and 
inconsistent requirements on transplant centers (TCs) and OPOs and that 
the current system lacks responsiveness to advances in TCs and OPO 
performance metrics. The ACOT recommends that the Secretary direct CMS 
and HRSA to confer with the OPTN, Scientific Registry of Transplant 
Recipients (SRTR), the OPO community, and TCs representatives to 
conduct a comprehensive review of regulatory and other requirements, 
and to promulgate regulatory and policy changes to requirements for 
OPOs and TCs that unify mutual goals of increasing organ donation, 
improving recipient outcomes, and reducing organ wastage and 
administrative burden on TCs and OPOs. These revisions should include, 
but not be limited to, improved risk adjustment methodologies for TCs 
and a statistically sound method for yield measures for OPOs . . . .'' 
\5\
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    \5\ Available at: https://www.organdonor.gov/about-dot/acot/acotrecs55.html.
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    On July 10, 2019, President Trump issued Executive Order (E.O.) 
13879 titled ``Advancing American Kidney Health.'' The E.O. 13879 
states that it is the policy of the U.S. to ``prevent kidney failure 
whenever possible through better diagnosis, treatment, and incentives 
for preventive care; increase patient choice through affordable 
alternative treatments for end-stage renal disease (ESRD) by 
encouraging higher value care, educating patients on treatment 
alternatives, and encouraging the development of artificial kidneys; 
and increase access to kidney transplants by modernizing the organ 
recovery and transplantation systems and updating outmoded and 
counterproductive regulations.''
    Further, the E.O. 13879 aims to increase the utilization of 
available organs by ordering that, within 90 days of the date of the 
order, the Secretary propose a regulation to enhance the procurement 
and utilization of organs available through deceased donation by 
revising OPO rules and evaluation metrics to establish more 
transparent, reliable, and enforceable objective outcome measures for 
evaluating an OPO's performance. In conjunction with the E.O. 13879, 
HHS set a goal to deliver more organs for transplantation and aims to 
double the number of kidneys available for transplant by 2030.\6\
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    \6\ https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdf.
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    In accordance with the E.O. 13879, we published a proposed rule in 
the Federal Register on December 23, 2019 entitled, ``Medicare and 
Medicaid Programs; Organ Procurement Organizations Conditions for 
Coverage: Revisions to the Outcome Measure Requirements for Organ 
Procurement Organizations'' (84 FR 70628 through 70710), (referred to 
as the ``December 2019 OPO proposed rule''), which proposed to revise 
the current OPO outcome and process measures to be more transparent, 
reliable, and provide enforceable objective outcome measures of OPO 
performance. The December 2019 OPO proposed rule would improve upon the 
current measures by using objective and reliable data, incentivize OPOs 
to ensure all viable organs are transplanted, hold OPOs to greater 
oversight while driving higher performance, and as a result, save more 
lives.

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

    In response to the December 2019 OPO proposed rule (84 FR 70628 
through 70710), we received approximately 834 total comments. 
Commenters included individual OPOs, transplant hospitals, national 
associations and coalitions, academic researchers, advocacy 
organizations, health care professionals and corporations, donor 
families, and numerous individuals from of the general public. Most 
commenters supported the proposed rule's goals to improve organ 
donation and transplantation in the U.S. and to update the current OPO 
outcome measures.
    In this final rule, we provide a summary of each proposed 
provision, a summary of the public comments received and our responses 
to them, and an explanation for changes in the policies that we are 
finalizing. We note that this final rule is written in order by topic, 
discussing our primary reason for revising the regulations by revising 
the outcome measures first, and then discussing some necessary changes 
and cross-cutting requirements.

A. General Comments

    The majority of the comments received on the December 2019 OPO 
proposed rule were received from the general public and organ donor 
families.
    Comment: The majority of the commenters asked for OPOs to be held 
accountable for poor performance and for additional oversight of OPOs. 
Some of the commenters expressed concern that the OPOs are operating as 
monopolies that are engaged in fraud, waste, and abuse. Many commenters 
asked CMS to increase the accessibility of organs for transplant and 
ensure that donated organs reach the many individuals on the organ 
transplant waitlist.
    The comments received from donor families expressed support for the 
OPO in their service area and expressed concern that the proposed 
changes

[[Page 77901]]

would lead to the decertification of their assigned OPO.
    Response: We appreciate the commenters' feedback. The tremendous 
amount of comments that we received asking for OPOs to be held 
accountable strongly supports our commitment to reform the organ 
donation and transplantation system in the U.S. We believe that the 
changes we are making in assessing OPO performance will ensure positive 
outcomes and increases in the organ supply. There are other initiatives 
that HHS and CMS are currently undertaking that will also lead to 
improvements in organ donation and transplantation, such as the ESRD 
Treatment Choice (ETC) Kidney Transplant Learning Collaborative.
    We also appreciate the time taken by numerous donor families to 
develop and submit thorough and thoughtful comments on the proposed 
rule. We understand that the decision to donate a family member's 
organs is difficult, and we praise these families for their generosity. 
We acknowledge that the decision to donate their loved one's organs 
likely saved or improved the recipient's life. The changes that we 
discuss in this final rule are intended to ensure that donated organs 
are not wasted and reach those waiting for a lifesaving organ 
transplant. It is our goal to ensure that OPOs are held to a high level 
of performance expectations and that all OPOs are pushed to perform 
better. We acknowledge that through changes to the procurement and 
transplantation process (such as enacting best practices) we can effect 
visible changes that can lead to an increase in the number of organs 
available for transplant and decreases in organ discards. We 
acknowledge commenters' concerns regarding decertification of OPOs and 
note that that is a likely potential outcome due to these new measures. 
However, CMS is committed to ensuring patient access to high quality 
health care, including access to high performing OPOs. Additionally, we 
believe the measures will incentivize OPOs to improve result in upward 
performance across most, if not all, OPOs.
    Comment: Several commenters criticized our reference to the 
Bridgespan study \2\ and objected to our characterization of the 
failures of OPOs. These commenters also expressed concern about 
negative stories in the media suggesting that OPOs are poorly 
performing and do not care about the families they serve. The 
commenters stated that when media stories share inaccurate or outright 
false information about the OPO community, these stories have the 
strong potential to hurt public perceptions about donation.
    Response: We understand that there have been several news articles 
about the poor performance of some OPOs and some of these articles 
raise reasons about why the organ donation system needs to be reformed. 
Our independent assessment of OPO performance on outcome measures is 
the basis for our belief that more oversight is needed. As of November 
2020, a total of 108,591 people were on the waiting lists for 
lifesaving organ transplants. An OPO that is efficient in procuring 
organs and delivering them to recipients will help more people on the 
waiting list receive an organ transplant, which could ultimately save 
more lives. The current OPO outcome measures are not sufficiently 
objective and transparent to ensure public trust in assessing OPO 
performance, nor do they properly incentivize the adoption of best 
practices and optimization of donation and organ replacement rates. 
Given these concerns, as well as those regarding the data quality of 
self-reported measures, we are finalizing new outcome measures at Sec.  
486.318 to hold OPOs accountable as a crucial step in reforming the 
organ donation system.

B. Proposed Changes to Definitions (Sec.  486.302) and Proposed Changes 
to Outcome Requirements (Sec.  486.318)

    In the December 2019 OPO proposed rule, we proposed to revise the 
outcome measures for re-certification and the corresponding changes in 
definitions at Sec. Sec.  486.302 and 486.318 to replace the current 
outcome measures and definitions. We proposed at Sec.  486.302 the 
definition of ``donation rate'' as the number of donors as a percentage 
of the donor potential. We also proposed to add ``donor potential,'' as 
the number of inpatient deaths within the donation service area (DSA) 
among patients 75 years of age and younger with any cause of death that 
would not be an absolute contraindication to organ donation. We also 
proposed to define the term ``organ transplantation rate,'' which is 
discussed in more detail in section II.B.4 of this final rule and 
changes related to our use of ``death that is not an absolute 
contraindication to organ donation'' at Sec.  486.302 of this final 
rule. We refer readers to section II.B of this final rule for the other 
definitions we proposed at Sec.  486.302. We proposed to revise the 
outcome measures for re-certification at Sec.  486.318 to replace the 
current existing outcome measures with the proposed two new outcome 
measures that would be used to assess an OPO's performance: ``donation 
rate'' and ``organ transplantation rate'' effective for calendar year 
(CY) 2022. We have organized the comments by subject matter.
    The comments and our responses are below.
1. General Comments About the Outcome Measures
    Comment: Several commenters, supported our proposed new outcome 
measures while other commenters questioned the need for revising them. 
Some commenters in support of the proposed new outcome measures 
recognized that these measures are derived from objective data and 
would not present an increased burden on OPOs. One commenter was 
concerned that the proposed new outcome measures would result in the 
OPOs putting more pressure on families and next-of-kin to authorize 
organ donations. Other commenters expressed concern that increased 
pressure from the proposed outcome measures and the threat of de-
certification (discussed in section II.C of this final rule) would 
damage the relationships between the OPOs so that they will no longer 
cooperate with one another.
    Response: We appreciate the comments received on the proposed 
outcome measures. Under our current regulations, the outcome measures 
at Sec.  486.318 are used to assess OPO performance for re-
certification and to determine the selection of an OPO to take over a 
DSA as part of the competition for an open DSA. We think the increased 
transparency and objectivity of the proposed outcome measures will 
drive improvements in organ donation and transplantation while reducing 
reporting burdens for OPOs. As discussed in section II.B.1 of this 
final rule, there are aspects of our current outcome measures that we 
no longer find adequate; therefore, we believe that revising the 
current outcome measures would be consistent with the goal of E.O. 
13879, which directs CMS to establish more transparent, reliable, and 
enforceable objective measures for evaluating an OPO's performance. In 
addition, we believe revising the current outcome measures is a 
critical step towards achieving the Secretary's goal of doubling 
kidneys available for transplantation by 2030.
    Our proposed outcome measures are based on verifiable and objective 
data and are designed to increase organ transplantations by comparing 
an OPO's performance to the top performing OPOs. The top performing 
OPOs have demonstrated success in their role and responsibilities using 
practices that do not place inappropriate pressures on

[[Page 77902]]

families to consent to an organ donation. We note that studies have 
shown that giving families sufficient time to make their informed 
decisions and not putting too much pressure on families results in 
successful consent.\7\ We also note that by objectively identifying top 
performing OPOs, poorer performing OPOs can appropriately change and 
adopt their effective practices that improve their performance in 
donation and make more organs available for transplantation.
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    \7\ Siminoff, LA, Agyemang, AA, et al., ``Consent to organ 
donation: a review,'' Prog Transplant. 2013 Mar; 23(1): 99-104.
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    It is clear that our historical approach to measuring OPO 
performance has resulted in a wide range of performances. This 
variability is unacceptable to patients and CMS. Thus, CMS intends to 
hold these entities to revised and higher standards. These revised 
metrics are necessary in light that over the past 14 years, the sharing 
of best practices, if it has occurred, has not resulted in consistent 
improvements throughout the industry. CMS is committed to increasing 
the availability of organs for transplantation across all DSAs, and 
continues to believe that this higher standard is necessary to achieve 
this goal.
    Comment: We received multiple comments raising concerns that 
removing organs for research, other than the pancreata, as part of the 
outcome measures would hurt research by discouraging OPOs from using 
organs that are not transplanted for research. A commenter recommended 
CMS to include organs that are used in organ transplantation research 
in the outcome measures because the process for obtaining consent and 
managing these donors is the same as with organ transplantation. Other 
commenters suggested that we include organs for research as a ``third 
performance metric'' or incorporate it in some other way into our 
conditions. One commenter discussed our history of inclusion of organs 
for research and stated that OPOs would not pursue marginal organs 
because they would no longer get credit if the organ was not 
transplanted, whereas the old outcome measures allowed them to be 
counted to the organs for research measure.
    Response: We appreciate the comments raising concerns about the 
removal of other organs used for research as part of the outcome 
measures.
    The transplant and research communities commonly described the 
transplantation of organs into humans using research protocols (for 
example, deceased donor intervention research) as both transplants and 
research. Generally, such research involves the transplantation of 
organs into transplant candidates that is generally considered clinical 
care while simultaneously qualifying as human subject research. For the 
purpose of establishing the performance measures, we contend that 
organs used for research is meant to apply only to organs procured and 
used only for research purposes. Organs transplanted into human 
subjects are counted as part of clinical care. Although organs procured 
for research may sometimes involves the same procedures and practices 
of donor management as organs for transplantation, we cannot easily 
verify the procurement of organs for research unless they are 
transplanted into a patient on the OPTN waiting list. Furthermore, our 
concern is that having an outcome measure for organs procured for 
research may inadvertently incentivize OPOs to direct some organs for 
research rather than for transplantation. Except for pancreata when 
procured for research, as noted in the December 2019 OPO proposed rule, 
we are not adopting the commenters' suggestion to include organs 
donated for research in the outcomes measures.
    Pancreata procured for islet cell research are included in the 
outcome measures of this final rule. We carefully considered other 
options to address pancreata procured for research, such as creating a 
process measure for these organs, creating a unique outcome measure, 
and counting these organs in the outcome measures of this final rule as 
less than the full value of a transplanted organ. However, these 
alternative policy approaches did not meet the PHS Act, which states 
that ``Pancreata procured by an organ procurement organization (OPO) 
and used for islet cell transplantation or research shall be counted 
for purposes of certification or recertification . . . .'' To meet this 
statutory requirement, we have chosen to include pancreata for research 
in the outcome measures in the same way that organs procured for 
transplantation are included. We think that the impact of pancreata for 
research on the overall rankings of OPOs will continue to be minimal. 
From 2014 to 2018 (the most recent year of complete data), the number 
of pancreata procured for research has been 727, 716, 575, and 579. 
There is a clear downward trend, and we expect that this trend will 
continue or level off. Our internal analysis demonstrated little effect 
on the rankings of OPOs from including or excluding pancreata for 
research when calculating performance on both the donor and transplant 
measures of this final rule. A particular OPO may move up or down 1-3 
ranking spots based on the inclusion of this data, but no OPOs moved in 
such a way that it impacted whether they would be eligible for 
automatic recertification or would be automatically decertified. We 
will continue to monitor the trends of pancreata procured for research 
and will use the survey process to conduct further investigation into 
any anomalies that such monitoring reveal.
    Comment: We solicited comments as to whether we should consider 
assessing OPO performance based on organ-specific transplant rates and 
received a comment that broadly supported this approach, but we did not 
receive details about how we would measure success for the organ-
specific transplant rates or how it could be implemented.
    Response: We are not including organ-specific transplantation rates 
in our outcome measures because we do not believe that organ-specific 
transplantation rates would provide an additive assessment of OPO 
performance and achieve our goals of increasing organs available for 
transplantation.
2. Donation Rate Sec. Sec.  486.302 and 486.318(d)(1)
    In the December 2019 OPO proposed rule, we proposed to include at 
Sec.  486.302 the definition the ``donation rate'' as the number of 
donors as a percentage of the donor potential. In current regulations 
at Sec.  486.318(d)(1), we define the donation rate as being the 
eligible donors as a percentage of the eligible deaths.
    In addition, we proposed that Sec.  486.318(d)(1) specifies that 
the donation rate is calculated as the number of donors in the DSA as a 
percentage of the donor potential.
    Comment: The majority of the comments received supported the use of 
the donation rate to measure OPO performance.
    Response: We appreciate the comments received. We consider the 
donation rate to be an important outcome measure because it assesses 
the ability of the OPO to obtain consent from the donor family, 
successfully manage the donor, procure and place at least one organ for 
transplantation (or pancreas for research), and ensure the safe 
transport of that organ for transplantation. However, despite all these 
aspects of the OPO's role that the donation rate measures, for patients 
waiting for a life-saving organ

[[Page 77903]]

transplant, the primary measure of interest is the organ 
transplantation rate. Therefore, the donation rate can be seen as 
augmenting the organ transplantation rate. By including the donation 
rate, we incentivize OPOs to pursue all donors, especially the single 
organ donors. An OPO is more likely to meet the donation rate measure 
if they also procure organs from donors after cardiac death (DCD) or 
marginal donors where relatively fewer organs may be transplantable.
    Comment: One commenter suggested CMS measure the OPOs ability to 
obtain consent in calculating the donation rate. The commenter did not 
suggest how the consent would be used as an outcome measure.
    Response: Although obtaining consent is one part of the donation 
process, we are not adopting the commenter's suggestion to use 
obtaining consent as an outcome measure. We recognize the critical role 
of obtaining consent as the first part of donation, and without it, the 
rest of the donation process cannot occur. Our regulation at Sec.  
486.342 requires OPOs to have a written protocol to ensure that, in the 
absence of a donor document, the individual(s) responsible for making 
the donation decision are informed of their options to donate organs or 
tissues (when the OPO is making a request for tissues) or to decline to 
donate. As with our other CfCs, we survey to ensure compliance with 
this requirement, and those surveys typically occur every 4 years. 
However, we cannot verify success in obtaining consent relative to the 
donor referrals through independent, objective data on an annual basis 
and instead, rely on surveys. It would be unduly burdensome to OPOs to 
be routinely surveyed every year for us to identify and verify this 
information for purposes of the frequent assessment periods in which 
these outcome measures are calculated to trigger revisions to the 
Quality Assessment and Performance Improvement (QAPI) plan under the 
requirements at Sec.  486.348 (also discussed in section II.E of this 
final rule).
    Final Rule Action: We are finalizing as proposed the definition of 
donation rate at Sec.  486.302, which is defined as the number of 
donors as a percentage of the donor potential. Furthermore, we are 
finalizing at Sec.  486.318(d) that an OPO is evaluated by measuring 
the donation rate in their DSA and at Sec.  486.318(d)(1) the donation 
rate is calculated as the number of donors in the DSA as a percentage 
of the donor potential.
3. Donor Definition (Sec.  486.302) and the ``Zero Organ Donors''
    In the December 2019 OPO Proposed rule, we proposed to revise the 
definition of ``donor'' at Sec.  486.302 to mean 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 for research or 
islet cell transplantation. In general, the proposed definition of 
donor would change the current regulatory definition, requiring that at 
least one organ be transplanted, rather than being recovered for the 
purpose of transplantation, in order for the donor to be included in 
the donation rate. We also included donors who had pancreata procured 
for islet cell transplantation and research in the definition of donor 
to respond to the requirements of section 371(c) of the PHS Act.
    Comment: Several commenters stated that our proposed new definition 
of ``donor'' excluded ``zero organ donors.'' Some commenters had 
different definitions of ``zero organ donors'' including: (1) Donors 
who are taken to the operating room but cannot be a donor for one or 
more reasons; and (2) are donors in which the transplantable organs are 
turned down by transplant programs. These commenters claim that 
excluding ``zero organ donors'' in the donation rate would discourage 
OPOs from pursuing extended criteria or marginal and complex donors, 
which would be inconsistent with our goal of trying to increase 
donations, particularly of single organ donors.
    Response: We acknowledge that the general effect of our proposed 
definition of donor at Sec.  486.302 would be that, a patient must 
donate at least one organ that is actually transplanted to qualify as a 
``donor.'' We note that the definition also includes a patient who 
donates a pancreas for research. Although ``zero organ donors'' would 
not fall under this definition, we are not persuaded by comments that 
OPOs will not pursue the extended criteria or marginal, complex donors 
if we do not include ``zero organ donors'' in the outcome measures. Not 
only did we receive comments from some OPOs stating that they are 
committed to ``pursuing every organ every time even if no organs are 
transplanted,'' but an OPO that does not pursue these donors will be at 
risk of being identified as a poorer performer compared to other OPOs 
and could possibly face the prospect of being de-certified.
    Evidence demonstrates that the top performing OPOs are pursuing 
extended criteria and single-organ donors, and those OPOs are also 
successfully placing the organs at programs that transplant them. Some 
OPOs are relatively successful in recovering organs from more marginal 
candidates, saving those donors from being ``zero organ donors.'' We 
accessed the OPTN database on August 12, 2020 and found that from 2018 
and 2019, the OPO in Nevada had procured 80 kidneys that were 
categorized as having the highest Kidney Donor Profile Index (KDPI) 
scores of 86 through 100. These types of kidneys are primarily from 
extended criteria or marginal donors that are more likely to end up as 
``zero organ donors.'' Meanwhile, the local kidney transplant programs 
in their DSA transplanted zero kidneys with the highest KDPI scores, 
meaning that these organs were transplanted by programs outside of 
their DSA; this example suggests that the local demand was not driving 
the Nevada OPO's performance. In order for other OPOs to follow this 
example, they must also pursue the extended criteria and marginal 
donors, even if the local transplant program does not accept them. 
Using the comparative performance methodology and holding all OPOs to 
the performance of these top performing OPOs, we intend to incentivize 
all OPOs to pursue extended criteria and marginal donors, even if they 
may become zero organ donors.
    Comment: Some commenters recognized that ``zero organ donor'' 
counts are self-reported data and are difficult to verify, but 
suggested that CMS review the charts or use triggers to lead to a chart 
audit as a means of verifying these donors.
    Response: In changing the definition of donor, we are adhering to 
the principles described in the December 2019 OPO proposed rule that 
the outcome measures be more transparent, reliable, and objective 
measures of OPO performance. Part of ensuring reliability is moving 
away from self-reported data as much as is feasible and using data that 
can be easily verified. It would require an extraordinary effort for 
CMS to verify the zero organ donors as frequently as needed to 
calculate the annual assessments of OPO outcome measures that will be 
used to trigger revisions of the QAPI program that can spur OPOs to 
improve their performance, and to rank OPOs for certification purposes.
    Comment: We received several comments stating that because it is 
ultimately the transplant programs that decide whether an organ is 
transplanted (not the OPO) that redefining ``donor'' to require that 
the organ be transplanted would not be appropriate.

[[Page 77904]]

    Response: Transplant programs decide whether an organ will be 
transplanted; however, it is the OPO's responsibility to ensure that 
placement and transport of organs happen in a fast and effective 
manner. If the OPO engages in best practices for placement, packaging, 
and transportation of organs, such as using RFID tags to track organs 
in transit and assure that they are not forgotten or diverted, there 
should not be significant differences in the frequency of zero organ 
donors among OPOs because the occurrence of unexpected anatomical 
issues which contraindicate donation that arise after consent is 
secured are random and not statistically significant in one DSA 
compared to another.
    Comment: Several commenters stated that OPOs are obligated to the 
allocation system and that sometimes they run out of time trying to 
place certain organs. Therefore, the commenters stated that the OPOs 
should not be punished if they cannot place a transplantable organ.
    Response: We respectfully disagree with the commenters' assertion. 
The OPTN final rule has a section on wastage that explicitly allows 
transplant programs to transplant an organ into any medically suitable 
candidate to do otherwise would result in the organ not being used for 
transplantation (42 CFR 121.7(f)). Therefore, we do not believe the 
constraints of the allocation system justify not successfully placing a 
transplantable organ. We believe that this final rule will allow OPOs 
the opportunity to improve the placement of organs, and drive the 
transplant community to adopt the technologies necessary to optimize 
placement.
    Comment: We received a comment that there are some events, such as 
loss of an organ during transport, which OPOs cannot control.
    Response: By requiring that the organ be actually transplanted 
(with the exception of pancreata procured for research) in order to be 
counted in the donation rate, we are supporting those OPOs that work to 
successfully complete the final step of the donation process. 
Unfortunately, we are aware of incidences where organs are lost or 
damaged during transport.\8\ It is the responsibility of the OPO to 
arrange the appropriate transport to the transplant program. (See Sec.  
486.346 of this final rule.) Therefore, it is important that any 
measure of OPO performance not stop at the procurement of a 
transplantable organ, but also holds OPOs accountable for the 
subsequent steps for successful placement and transport of organs.
---------------------------------------------------------------------------

    \8\ Kaiser Health News, ``How Lifesaving Organs for Transplant 
Go Missing in Transit,'' February 10, 2020 https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/.
---------------------------------------------------------------------------

    Comment: One commenter suggested that donor families would be 
disappointed if they consented to the donation, but we did not allow 
the zero organ donor to be called a donor.
    Response: We appreciate every potential donor and are not 
discouraging OPOs from referring to ``zero organ donors'' as ``organ 
donors'' even if no organs are transplanted when speaking with 
families. The use of the term ``organ donors'' has different meanings 
in different settings. Many families consider their loved ones to be 
organ donors if they are eye and tissue donors or if the organs are 
donated for research. Therefore, we do not think our definition, used 
solely for assessing OPO performance for regulatory purposes, should 
affect the donor families' perception of the value of their loved one's 
donation or the terms used by OPOs or other organizations when liaising 
with families of potential donors.
    Comment: One commenter stated that it was important to encourage 
OPOs to pursue all donors and suggested that we include these ``zero 
organ donors'' in the performance measures even if they are not 
included in the outcome measures.
    Response: We will continue to work with OPOs on a more refined 
reporting process to capture information about zero organ donors and 
the reason for the organs not being retrieved or transplanted. We 
intend to continue the dialog with OPOs about the necessary data to 
collect and how to do so in a verifiable, burden neutral manner, and 
our CfCs may be revised in the future based on such modifications and 
further analysis of the data.
    Comment: One commenter supported our proposed definition of donor 
because they agreed that OPOs could ``game the system'' if we included 
``zero organ donors.''
    Response: We appreciate the comment and, as explained above, we are 
not including ``zero organ donors'' in the definition of ``donor.'' As 
we stated in the December 2019 OPO proposed rule, we have concerns with 
self-reported data. Our internal analysis of the OPTN data found a 
variation in the frequency of ``zero organ donors'' as defined as a 
donor in which an organ was procured for transplantation, but no organ 
was transplanted. We did not see an association between the OPO's 
performance and the percentage of these donors, however, we retain the 
concerns expressed in the December 2019 OPO proposed rule. The OPTN 
data show that in 2018, there were 1,255 organs procured from these 
zero organ donors, but never transplanted. In that same year 31,203 
organs were transplanted. Among the top performing OPOs, zero organ 
donors represented 2.73 percent to 11.86 percent of donors (the range 
among all OPOs was 0 percent to 17.02 percent) with counts ranging from 
3 to 59 zero organ donors.
    We do not understand the significance of this variation, but will 
continue to examine the data about ``zero organ donors'' and assess 
whether we can appropriately capture and verify the data for future 
inclusion in our outcome measures.
    Comment: We received a comment raising concerns that the change in 
the definition of donor could affect reimbursement from Medicare since 
the previous definition allowed OPOs to be reimbursed for the efforts 
to procure transplantable organs.
    Response: Our revised definition of donor does not impact Medicare 
reimbursement for organ procurement costs. We did not propose to change 
our rules for reimbursing OPOs for organ procurement costs. Our payment 
policies for organ procurement costs do not rely on our definition of 
donor under Sec.  486.302.
    Final Rule Action: We are finalizing as proposed in the December 
2019 OPO proposed rule, the definition for donor at Sec.  486.302 to 
mean 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.
4. Organ Transplantation Rate (Sec.  486.302 and Sec.  486.318(d))
    For our second measure, we proposed to assess the OPO's organ 
transplantation rate, which is defined as the number of organs 
transplanted from donors in the DSA as a percentage of the donor 
potential.
    Comment: We received a number of comments supporting our organ 
transplantation measure because it was a volumetric measure (that is, 
reflects the volume of organs transplanted). We had one OPO commenter 
provide an example of how they increased the procurement of lungs for 
transplantation, but the SRTR method for measuring observed to expected 
performance in organ transplantation did not capture their improved 
performance.
    Response: We appreciate the comments in support of the volumetric 
organ transplantation measure. As

[[Page 77905]]

stated earlier, the organ transplantation rate is an important measure 
as it directly measures the benefit for patients from OPO performance.
    Comment: Several commenters opposed the organ transplantation rate 
because it was too similar to, and not independent of, the donation 
rate since it shared the same denominator as the donation rate.
    Response: In both of our outcome measures, the denominator 
represents a reasonable effort to estimate of the donor potential and 
other related factors for the DSA, as required by the OPO Certification 
Act of 2000.\9\ The numerators measure OPO performance (through the 
number of donors and organs transplanted) and are somewhat correlated 
because if there are more donors, there are likely to be more organs 
transplanted. It is CMS' expectation that high-performing OPOs will 
likely perform well on both measures and low-performing OPOs will 
perform poorly on both measures. However, these numerators are not the 
same and each donor has a range of potential organs that could be 
transplanted. For example, OPOs that focus primarily on DCD and 
marginal donors may need to seek more donations in order to have 
sufficient organs transplanted to mathematically meet the organ 
transplantation rates. On the other hand, OPOs that are very effective 
at placing all possible organs from younger, healthier donors may 
achieve the targeted organ transplantation rate, but not the donation 
rate, if they choose not to pursue the marginal, complex and DCD donors 
with only one or two transplantable organs.
---------------------------------------------------------------------------

    \9\ 42 U.S.C. 273(b)(1)(D)(ii)(II).
---------------------------------------------------------------------------

    Comment: We received a number of comments from the OPO community 
recommending that we use the SRTR's Donor Yield model, which calculates 
an observed:expected (O:E) ratio for placing organs for transplantation 
(also called the SRTR O:E model). These commenters preferred the O:E 
measures because it includes 34 to 50 risk-adjustments, changes over 
time, and measures a different part of an OPO's performance from the 
donation rate (part that involves placement and transport an organ).
    Response: While the SRTR's O:E ratio may have value for 
understanding potential areas for improvement and may be used by the 
OPTN and OPOs for internal performance assessment, it is derived from 
the donation rate and is not capable of assessing the number of organ 
transplants. The SRTR O:E model ``uses a series of complex statistical 
models'' and relies on coefficients from a multinominal regression 
model.\10\ The validity of the model is dependent upon frequent updates 
to the regression analyses to determine which predictors are in the 
model (hence range of 34 to 50 risk-adjustments). Because of the 
complexity of the model and the need for frequent updating, it is not 
feasible for us to continually update the methodology through notice 
and comment rulemaking, which is necessary in order to enforce the 
current version of the model. Use of the SRTR O:E model in regulation 
has not been practicable. The mathematical complexity of the risk-
adjustments creates an opacity that is inconsistent with our goal of 
increasing transparency in our outcome measures.
---------------------------------------------------------------------------

    \10\ https://www.srtr.org/about-the-data/guide-to-key-opo-metrics/opoguidearticles/donor-yield/.
---------------------------------------------------------------------------

    Comment: We received comments suggesting we add the SRTR's donor 
yield model, which measures observed to expected performance in O:E 
measure with the organ transplantation rate or increase the level of 
performance on the O:E measure.
    Response: We appreciate the commenters recognizing that the O:E 
measure is based on the average performance of an OPO and suggesting 
that we retain the measure but increase the level of performance above 
what was expected so that OPOs would be held to the O:E ratio of the 
top performing OPOs. As previously discussed, we are not using the O:E 
measure because it is not capable of measuring volume, is directly 
correlated to the donation rate, and does not directly capture 
increases in organs being transplanted. Finally, adding this measure to 
the organ transplantation rate would introduce additional regulatory 
complexity and reduce the transparency of these outcome measures. 
Therefore, we are finalizing the organ transplantation rate as the 
second measure.
    Final Rule Action: We are finalizing the definition of organ 
transplantation rate with revisions at Sec.  486.302. The revised 
definition of ``Organ transplantation rate'' is the number of organs 
transplanted from donors in the DSA as a percentage of the donor 
potential. Organs transplanted into patients on the OPTN waiting list 
as part of research are included in the organ transplantation rate. 
This modification is a clarification that if the organ is transplanted, 
regardless whether it is part of normal clinical practice or research, 
it will be counted in the organ transplantation rate. We are also 
making further modifications to the definition of ``organ 
transplantation rate,'' which are discussed in more detail in section 
II.B.7 of this final rule. We are also finalizing as proposed at Sec.  
486.318(d) that the OPO is evaluated by measuring the organ 
transplantation rate in their DSA.
5. Organ Definition (Sec.  486.302)
    In the December 2019 OPO proposed rule, we specified how we would 
count the organs that would constitute the numerator for the organ 
transplantation rate. We proposed to include pancreata procured for 
islet cell transplantation and research in the definition of ``organ'' 
to meet the requirements of the Pancreatic Islet Cell Transplantation 
Act of 2004, which amended the PHS Act to include section 371(c). (84 
FR 70631) Section 371(c) of the PHS Act states that ``[p]ancreata 
procured by an organ procurement organized and used for islet cell 
transplantation or research shall be counted for purposes of 
certification or recertification under subsection (b).''
    Comment: Several commenters opposed our inclusion of pancreata for 
research in our outcome measures since procuring pancreata for research 
is not a normal function of OPOs and is highly dependent upon the 
demands of the local researchers. Some commenters supported the 
inclusion of pancreata procured and placed for research in the organ 
count. We received comments that including the pancreata for research 
would lead to artificial inflation of the organ transplantation rate; 
that we should use a third performance metric to assess performance for 
pancreata procured for research; and that we did not properly define 
the scope of ``pancreata procured for research.''
    Response: We agree with the commenters that pancreata for research 
are specific to the local research demands and may not reflect 
universal OPO practice. Nonetheless, their inclusion in the outcome 
measures is consistent with the requirements of the statute, and we are 
finalizing them as such. We intend to verify the accuracy of the data 
reported related to pancreata procured for research during the survey 
process, and believe that this is a sufficient disincentive for 
inflating the reported data. We considered creating a third outcome 
measure specifically for pancreata procured for research. However, 
there is no data source currently available to enable us to analyze 
performance and establish a meaningful measure. We will continue 
exploring ways to develop a data source and meaningful measure for 
consideration in future rulemaking.

[[Page 77906]]

    Comment: Commenters recommended CMS to include vascular composite 
allografts in the organ count for the organ transplantation rate.
    Response: We appreciate this suggestion but are not including 
vascular composite allografts (VCA) in our definition of organ. VCA 
transplantation is very localized and rarely performed. In 2019, 
approximately 15 such transplants occurred, the vast majority being the 
transplantation of a uterus (12 transplants) \11\. Inclusion of VCAs as 
organs would require a separate assessment throughout all CMS policies 
and regulations that is beyond the scope of this rule.
---------------------------------------------------------------------------

    \11\ OPTN database accessed on July 11, 2020 and number of 
transplants for abdominal wall, head & neck (cranial facial), head & 
neck (scalp), GU: Penile, GU: Uterus, upper limb: Bilateral, upper 
limb: Unilateral, and VCA were counted for 2018 and 2019. In 2018, 
there were 11 transplants.
---------------------------------------------------------------------------

    Final Rule Action: After consideration of public comments, we are 
finalizing our proposed definition of organ at Sec.  486.302 to mean 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.
6. Donor Potential (Sec. Sec.  486.302 and 486.318(d)(4))
    Under Sec.  486.318(d)(4), the donation rate, organ transplantation 
rate, and kidney transplantation rate use the ``Donor potential'' as 
defined under Sec.  486.302 as the denominator. In our December 2019 
OPO proposed rule, we proposed to define the donor potential 
(denominator) as total inpatient deaths in the DSA among patients 75 
years of age or younger with any cause of death that is not an absolute 
contraindication to organ donation. We proposed to use death 
certificate information that can currently be obtained from the Center 
for Disease Control and Preventions' (CDC), National Center for Health 
Statistics' (NCHS's) Detailed Multiple Cause of Death (MCOD) file as 
described in our December 2019 OPO proposed rule. The MCOD is published 
annually and is publicly available upon request. 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 (50 states, New York City, the District of Columbia and the five 
territories). The jurisdictions use the U.S. Standard Certificate of 
Death as a template for their forms.
    In order to provide a most robust and detailed discussion, we have 
divided the comments and responses to our definition of ``Donor 
potential'' into separate sections: The use of state death certificates 
for estimating the donor potential; the specific ICD-10-CM codes used 
to identify the donor potential; the age threshold for the deaths; the 
inpatient aspect of the deaths; and the effect of waiver hospitals.
a. Death That Is Consistent With Organ Donation (Sec.  486.302)
    Under Sec.  486.302, within our proposed definition of ``Donor 
potential,'' we use a separately defined term, ``Death that is not an 
absolute contraindication to organ donation.'' This term is 
characterized by two major parts: (1) The data source for calculating 
these deaths (state death certificate data) and (2) the ICD-10-CM codes 
for identifying these deaths.
    We proposed to use state death certificate information that can 
currently be obtained from the CDC, NCHS's MCOD file as described in 
our December 2019 OPO proposed rule to determine the donor potential. 
The MCOD is published annually and is publicly available upon request. 
The second part of the definition of ``Death that is not an absolute 
contraindication to organ donation'' describes all deaths except those 
identified by the specific ICD-10-CM codes listed in our definition 
that would preclude donation under any circumstance. As part of our 
proposed rule, we also considered the alternative of using the ICD-10-
CM codes that are consistent with organ donation in the methodology 
developed by Goldberg, et al.\12\ (84 FR 70662), also knowns as the 
``CALC'' methodology.
---------------------------------------------------------------------------

    \12\ Goldberg D, Karp S, et al., ``Importance of incorporating 
standardized, verifiable, objective metrics of organ procurement 
organization performance into discussions about organ allocation,'' 
AmJTransplant. 2019;00:1-6.
---------------------------------------------------------------------------

    We received numerous comments on both of these components and 
discuss responses to these comments separately.
i. Death Certificate Data
    Comment: We received numerous and varied comments regarding our use 
of the death certificate information reported to the CDC and currently 
found in the MCOD files. Many commenters supported the use of data 
derived from death certificates because it represents the best 
available option for obtaining objective data at this time to estimate 
the donor potential. However, several commenters referenced literature 
that found error rates of the death certificates ranging from 30 to 60 
percent. In addition, numerous commenters from the medical examiner/
coroner community questioned the accuracy of the death certificates.
    Response: We appreciate the commenters supporting our use of the 
MCOD file. As discussed in the December 2019 OPO proposed rule, we are 
aware of the error rates in the death certificate data reported in the 
literature, but continue to believe this data is the most complete 
information that is readily and publicly available, that can be used 
for estimating the donor potential at this time. Every state submits 
death certificate data to the CDC and the elements collected in the 
death certificates are standardized to the greatest degree possible. 
Errors in reporting on the death certificates are primarily from user 
error, where the individual completing the form makes a mistake. The 
same user errors likely plague other potential data sources, such as 
hospital records, and those data sources would come with significant 
added reporting burdens with limited to no additional benefit. We are 
not aware of differences in the error rates that would disadvantage one 
DSA over another DSA (84 FR 70632). In addition, we are not aware of 
any research that describes such differences. Based on our 
understanding of which professionals are responsible for completing the 
death certificates and comments from the public, we do not see a 
compelling reason why there would be a consistent disparity in the 
error rates from one DSA to another. Furthermore, no commenters have 
suggested a source of empirical evidence that could be obtained by 
reasonable effort of organ donor potential in each designated service 
area sufficient to meet our needs and expectations. The peer-reviewed 
research developed by Goldberg, et al. discussed throughout our 
December 2019 OPO proposed rule and this final rule supports the use of 
the death certificate data as the best and most comprehensive source 
for estimating the donor potential at this time.
    We appreciate the comments and knowledge from the coroner/medical 
examiner community about the error rates in the death certificates.
    Comment: We received one comment from the OPO in Alabama about 
errors in the electronic reporting of death certificate data resulting 
in misreporting inpatient deaths.
    Response: We thank the commenter for pointing out the error in 
reporting inpatient deaths in Alabama. We understand that the reporting 
error has been resolved for 2019 and was unique to Alabama. We do not 
have any reason

[[Page 77907]]

to believe that other states made this error. For purposes of the 
regulatory impact analysis in this final rule, which uses data from 
2018, we have made adjustments to the inpatient deaths in Alabama to be 
more consistent with historical rates of inpatient deaths prior to the 
error occurring. If there are future occurrences in which there are 
similar such errors, we have added an extraordinary circumstances 
exception (ECE) under Sec.  486.316(f) to allow OPOs to request a 1-
year extension to their agreement cycle if there are extraordinary 
circumstances beyond the control of the OPO that would affect the data 
being used. This ECE request is discussed in greater detail in section 
II.C.5 of this final rule, which discusses the data length used for 
calculating the outcome measures.
    Comment: We received a comment describing in detail the process by 
which the death certificate is completed in their particular state.
    Response: We thank the commenter for providing us with this 
detailed information. States have slightly different processes for 
completing the death certificates even though all states use the 
standardized death certificates. 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 (50 states, 
New York City, the District of Columbia and the five territories). The 
jurisdictions use the U.S. Standard Certificate of Death as a template 
for their forms. Although commenters expressed concerns with our use of 
the MCOD, they did not suggest a different source of empirical evidence 
that could be obtained without undue reporting burden and was of 
greater accuracy. Furthermore, this commenter did not provide any 
information to suggest that this different process for their state 
would result in less accurate information for that jurisdiction and we 
do not have reason to believe that a different process would 
disadvantage one OPO compared to another.
    Comment: We received a comment questioning whether our donor 
potential reflected the DSA because the publicly available CDC data on 
death certificates has the location of the death based on the 
individual's home rather than the location of the hospital.
    Response: Based upon this comment, we believe that the commenter is 
referring to the CDC Wide-ranging Online Data for Epidemiologic 
Research (WONDER) database, which is available on the CDC public 
website. This database has the person's residence at the time of death 
instead of the location of the death. The MCOD file, which we are using 
to calculate our outcome measures, has information on the location 
(county) of the inpatient death. The location of the patient's death is 
more relevant to attributing donor potential for each DSA. A CMS 
contractor will use information from the MCOD file to attribute deaths 
to each DSA.
    Comment: We received a comment that ``death certificate source is 
limited solely to statistical uses and cannot be used for regulatory 
purposes'' because section 308(d) of the PHS Act (42 U.S.C. 242m) 
provides that data collected by NCHS ``may be used only for the purpose 
of health statistical reporting and analysis.''
    Response: We have consulted with the CDC and concluded that our use 
of the MCOD represents a statistical analysis to characterize OPO 
performance and is consistent with the PHS Act. We are not using the 
data from the MCOD file to directly take legal, administrative or other 
actions against the hospitals and states that submit the data, nor are 
we taking regulatory action on the inpatient deaths in the DSA. Rather, 
we are using the data to ``normalize'' our outcomes of interest: The 
number of donors and the number of transplants in the DSA. The section 
of the PHS Act cited by the commenter refers to the confidentiality of 
the NCHS data and the limitations of the use of the data if ``an 
establishment or person supplying the information or described in it is 
identifiable.'' Our calculations use county level data that does not 
identify the specific hospitals submitting the death certificate data.
    Comment: We received comments that the death certificate data does 
not include information about co-morbidities or other chronic 
conditions that may make it unlikely for the person to be an organ 
donor.
    Response: Our goal in using the death certificate data was to use 
the best information available to calculate organ donor potential in 
each DSA. We are using the death certificate data to adjust the 
denominator to better reflect the population in the DSA that will more 
closely resemble individuals likely to become a deceased organ donor 
(individuals who are 75 and younger and died in the hospital with a 
cause of death consistent with organ donation). No risk-adjustment 
method is precise and we do not have evidence that the rate of co-
morbidities associated with these causes of deaths is significantly 
different from one DSA to another and would be the reason for the 
differences in performance.
    Comment: Several commenters suggested alternative sources for 
estimating the donor potential: Data from electronic health records, 
data from hospital chart reviews, insurance billing codes, and hospital 
reported data of ventilated neurological deaths. Commenters also raised 
concerns about the burdens of asking donor hospitals to report 
potential donors and ventilated deaths, a concern that applies to all 
of the suggested alternatives.
    Response: We thank the commenters for the suggestions of 
alternative data sources. All of the suggested data sources are subject 
to the same user error inaccuracies as the MCOD files. Furthermore, we 
note that none of these suggested alternative sources for estimating 
organ donor potential could be obtained by reasonable efforts and would 
not be feasible or practical for calculating the outcome measures. Many 
of the suggested data sources are not feasible to use or sufficiently 
comprehensive to estimate the donor potential for various reasons. 
First, not all hospitals have electronic health records that can 
transmit data or be shared; not all OPOs have the ability to receive 
electronic health record transmissions. Second, collecting data via 
hospital chart reviews would likely be burdensome. Third, there is no 
national or comprehensive database of all insurance claims, and 
collecting data from insurance claims would inappropriately not count 
those decedents who did not have insurance. We agree with those 
comments that raised concerns about the burden on donor hospitals if we 
asked them to report data on ventilated deaths, and agree that 
requiring those additional reporting requirements or combining all 
these disparate data sources to estimate the donor potential could not 
be obtained by reasonable efforts. CMS will continue to evaluate the 
benefit and applicability of future data sources as they become 
available.
    Final Rule Action: We are finalizing the death certificate 
information reported to the CDC and currently found in the MCOD files 
as the data source for calculating the donor potential of each DSA.
ii. International Classification of Diseases, Tenth Revision, Clinical 
Modification (ICD-10-CM)
    Comment: The vast majority of comments supporting the use of the 
state death certificate data from the CDC files also preferred using 
ICD-10-CM codes that represented the causes of

[[Page 77908]]

death that is consistent with organ donation rather than our proposed 
approach based on defining ``death that is not an absolute 
contraindication to organ donation.'' Some commenters suggested adding 
other ICD-10-CM codes to the list of ICD-10-CM codes we would exclude. 
One commenter stated that the ICD-10-CM codes consistent with organ 
donation provided a donor potential that was consistent with their own 
internal calculations. Another commenter provided an estimate of 
187,500 donor referrals in the U.S. based on extrapolation of their own 
data.
    Response: Given the overwhelming comments supporting the use of the 
ICD-10-CM codes from the methodology which is based on the cause, age, 
and location consistent with organ donation (CALC), we are finalizing 
the use of ICD-10-CM codes from the CALC methodology, which are 
inclusion codes, in estimating the donor potential. Our proposed 
methodology used the ICD-10-CM codes that are exclusion criteria and 
included significantly more codes. The ICD-10-CM codes that are 
considered as causes consistent with organ donation were identified in 
section V.G ``Alternatives Considered'' of the December 2019 OPO 
proposed rule, and were confirmed by the developers of the CALC 
methodology, although they were not specified in the published 
literature. As discussed in the December 2019 OPO proposed rule, the 
ICD-10-CM codes in the CALC methodology captures 98-99 percent of all 
donors. (84 FR 70666). The advantage of this inclusion method over the 
one we proposed is that given the description of the ICD-10-CM codes 
chosen, there are unlikely to be new causes of death that would lead to 
organ donation. However, as we have discovered during the COVID-19 
public health emergency (PHE), there is a likelihood of new, 
unanticipated contraindications for organ donation. If we used 
exclusion criteria in estimating the donor potential, we could have to 
update and change our rules much more frequently to adjust for these 
new contraindications to organ donation. We believe that these 
unplanned changes could be disruptive to OPO operations and efficiency. 
Therefore, we agree with commenters that the CALC methodology which 
identifies ICD-10-CM codes consistent with organ donation is preferable 
to the methodology we proposed. We discuss this methodology and the 
calculations that result from using this methodology in greater detail 
in the discussions of our regulatory impact analysis under section V of 
this final rule.
    In Sec.  486.302, we have added the definition ``Death that is 
consistent with organ donation'' as all deaths 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): Blunt trauma, gunshot 
wounds, drug overdose, suicide, drowning, and asphyxiation. From our 
calculations using 2017 data, the CALC methodology resulted in a donor 
potential of 101,479, which would be a reasonable estimate of the total 
U.S. donor potential if the donor referral is approximately 187,500 as 
suggested by a commenter who estimated this donor referral population 
based on their own referral data.
    We also conducted preliminary analyses examining whether there was 
additive value to excluding the ICD-10-CM codes that were 
contraindications to organ donation to the causes of death that is 
consistent with organ donation. We found little difference in the 
ranking and identification of OPOs at the different thresholds of 
interest. Therefore, we are not using any ICD-10-CM codes to exclude 
additional inpatient deaths from the ICD-10-CM codes that are 
consistent with organ donation.
    Comment: We received several comments questioning the donor 
potential and providing references that cited donor potential varying 
as low as 10,500 and as high as 272,000 (our estimate).
    Response: We know the donor potential cannot be as low as 10,500 
because there were 11,870 deceased donors in 2019, according to the 
OPTN (https://optn.transplant.hrsa.gov/news/organ-donation-again-sets-record-in-2019/). Our ``donor potential'' was not designed to identify 
an actual donor potential size as we have discovered that the true 
donor potential changes constantly as technology and demand for organ 
transplantation changes. Instead, our proposed methodology was designed 
to estimate the likely donor referral population to normalize the 
inpatient deaths across the different DSAs. Since the donor potential 
is part of a rate calculation, identifying the exact, true donor 
potential is less relevant than providing standardized, reasonable, and 
objective criteria to estimate it. We know that as public health crises 
occur, such as the opioid crisis or COVID-19, the donor potential may 
change. Also, as technology and practices change, the donor potential 
may change. When the 2006 OPO final rule was published, DCD was so 
infrequent that those potential donors were not included in the 
definition of an eligible death; yet in 2019, almost 23 percent of all 
deceased donors were DCD donors. Based on public comments, we believe 
the CALC methodology produces a very close estimate to the current 
donor potential for each DSA and it also has the flexibility to adjust 
to changes in the number of these causes of death in the DSA.
    Final Rule Action: We are finalizing under Sec.  486.302 that 
``Death that is consistent with organ donation'' means all deaths from 
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): Blunt 
trauma, gunshot wounds, drug overdose, suicide, drowning, and 
asphyxiation. We will not include in the final rule a definition of 
``death that is not an absolute contraindication to organ donation.''
b. Age 75 and Younger
    Comment: We received comments that the proposed age cut-off of age 
75 in our definition of ``donor potential'' was too high and suggested 
that we should use age 65 instead. On the other hand, we also received 
a comment that the proposed age cut-off of age 75 was too low because 
OPOs have procured livers from donors older than 75.
    Response: We proposed that the denominator for calculating the 
donation and organ transplant rates will be based on the number of 
inpatient deaths of someone 75 years old or younger because our 
previous definition of eligible death uses the age of 75 years old or 
younger. We do not concur with commenters' suggestion to lower the age 
threshold for the donor potential for our new outcome measures. 
Although we are aware that it is possible to for liver donors to be 
older than 75 years of age, we also recognize that the practice of 
using organs from older donors is still relatively new. Data from the 
OPTN lists the maximum age of liver donors as 65+. The number of living 
donations from this group between 2014 and 2019 ranged from 571 to 732 
with gradual increase over time.\13\ It is, however, a practice we want 
to encourage in order to increase the number of successful transplants; 
therefore, we are keeping our age limit at 75 years in order to reward 
OPOs who are successful with the donation and transplantation of organs 
from deceased individuals

[[Page 77909]]

greater than 75. OPOs who are successful in procuring these organs, 
particularly livers, from older donors may be able to count the donors 
and organs transplanted in the numerator of our outcome measures 
without having the death counted in the denominator.
---------------------------------------------------------------------------

    \13\ https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/.
---------------------------------------------------------------------------

    Final Rule Action: We are finalizing that the age cutoff of age 75 
for the donor potential definition in Sec.  486.302, as proposed 
without modification.
c. Inpatient Deaths
    We did not receive any comments as to whether the deaths should be 
limited to inpatient deaths. We are aware of preliminary studies 
suggesting that potential donors are identified in the emergency 
department as well as the inpatient setting. However, we believe those 
individuals are likely to become inpatients and thus, the location 
where they are identified, may not always correlate with where they 
die. Our data source is based on the location of death.
    Final Rule Action: We are finalizing that the definition of donor 
potential under Sec.  486.302 be limited to inpatient deaths.
d. Waiver Hospitals
    Comment: We received a number of comments inquiring how CMS is 
addressing the donor potential estimates in DSAs where some donor 
hospitals sought waivers to work with a different OPO. One commenter 
raised concerns that we made an error in calculating the donor 
potential because we assigned the donor potential to the wrong OPO.
    Response: Historically, DSAs have been divided based on counties 
and metropolitan statistical areas. However, donor hospitals can 
request the ability to work with an OPO outside their DSA through a 
waiver request (we refer to these donor hospitals as ``waiver 
hospitals'' under Sec.  486.308(e)). In estimating the donor potential 
for each DSA, we relied on the listing of counties found in the SRTR's 
OPO-specific reports, which listed both counties to an OPO when more 
than one OPO was servicing the county because of the waiver hospital. 
As a result, we erroneously double-counted the donor potential in 
several DSAs in the December 2019 OPO proposed rule. This inaccurate 
ranking would not have significantly altered our projections of the 
number of OPOs that would be automatically certified or decertified in 
accordance with the measure parameters set forth in the proposed rule.
    While there are no data sources which we can use to precisely 
attribute non-Medicare inpatient deaths to these waiver hospitals, we 
can apportion the donor potential to each OPO by calculating the 
percentage of Medicare inpatient deaths at each acute care and critical 
care hospital in the county as a proxy, and use that percentage to 
divide the donor potential and assign the percentage of the donor 
potential based on the Medicare percentage of inpatient deaths. At this 
time, the apportionment method we have described is the best solution 
to addressing donor potential for OPOs that work with waiver hospitals. 
We intend to explore other options that could improve the data about 
deaths that should be counted for waiver hospitals.
    Final Rule Action: In response to public comments, we are amending 
the definition of the donor potential at Sec.  486.302 to apportion the 
donor potential in a county where there is a donor hospital that has 
received a waiver to work with an OPO out of their DSA. For OPOs 
servicing a hospital with a waiver under Sec.  486.308(e), the donor 
potential of the county for that hospital will be adjusted using the 
proportion of Medicare beneficiary inpatient deaths in the hospital 
compared with the total Medicare beneficiary inpatient deaths in the 
county.
7. Risk-Adjustments Sec. Sec.  486.302 and 486.318(d)(2)
    In the December 2019 OPO proposed rule (84 FR 70628), we did not 
propose other risk-adjustments to the proposed outcome measures, but 
sought comments as to the accuracy of our assessment and whether 
additional risk adjustments were necessary. We sought comments on 
whether risk-adjustments are necessary and which ones, such as donor 
demographic characteristics (race, gender, age, disease condition) or 
DSA characteristics (number of ICU beds or level I and II trauma 
centers) would be significant and clinically appropriate in the context 
of our proposed approach to identifying OPOs in need of improved 
performance. Specifically, we requested public comments that provide 
evidence-based support, such as peer-reviewed literature, that would 
support those suggestions, as well as data sources that would be 
necessary to calculate the risk-adjustments recommended.
a. Chronic Diseases
    Comment: We received comments from some OPOs about the incidence of 
certain diseases in their DSA that would make their general population 
less likely to be organ donors or have more organs available for 
transplantation. We received comments describing the different 
incidences of diseases in the different parts of the country.
    Response: We appreciate the comments about the different incidences 
of disease in the different geographic areas and recognize that 
different DSAs may have different population characteristics. However, 
these differences are population-based differences, and we did not 
receive any data that these differences were reflected in the donor 
potential, resulting in a disadvantage to one OPO compared with other 
OPOs. As part of our proposed rule, we analyzed whether there was a 
correlation between the performance of the OPO and the number of 
patients on the waiting list in the DSA (84 FR 70633). We conducted the 
analysis to determine whether ``demand'' in the form of the number of 
patients on the waiting list for the transplant centers within the 
OPO's DSA, is correlated with performance. We did not find any 
correlation. We reviewed the original analysis to determine whether 
there was a negative correlation between the waiting list and OPO 
performance (that is, OPOs flagged were more likely to have a sicker 
population in its DSA). Here, we treated the waiting list as a 
surrogate for the magnitude of end-stage organ failure in the DSA. 
Again, there was no correlation between OPO performance and end-stage 
organ failure in the DSA. As discussed earlier, we had compared using 
just the CALC versus the CALC plus our exclusionary criteria. There was 
no additive value to removing these contraindications to organ 
donation.
    Comment: One commenter suggested that we use data from the U.S. 
Renal Data System (USRDS) to risk-adjust for chronic kidney disease 
because people with chronic kidney disease are less likely to be organ 
donors.
    Response: Although we examined the USRDS data, we did not consider 
using it to risk-adjust for chronic kidney disease because it is 
population data and does not necessarily reflect the donor potential. 
Furthermore, the USRDS data does not delineate the different levels of 
chronic kidney disease. People with early stage chronic kidney disease 
can donate extra-renal organs for transplantation as well as the 
kidneys.
b. Race
    Comment: We received several comments from OPOs describing the 
racial/ethnic characteristics of people in their DSA and claiming that 
if we risk-adjusted for race, their performance would be improved 
because they serve a smaller percentage of white people than the 
national average. We also received comments opposing risk-adjustments 
based on race because of

[[Page 77910]]

concern that these risk-adjustments would mask past poor performance in 
adopting practices that are responsive to the racial/ethnic composition 
of the DSA served.
    Response: As we stated in our December 2019 OPO proposed rule, we 
decided not to risk-adjust for race because of concerns that it 
reflects historically poorer performance with certain racial/ethnic 
populations, and that studies suggest that OPOs can adopt policies and 
practices responsive to the community they serve and have better 
results. When we assess OPO performance, as seen in Table 3 in our 
regulatory impact analysis of this final rule, we see a diversity in 
the population served by the highest performing OPOs. We also see poor 
performance among OPOs servicing predominantly white populations. We 
agree with commenters who raise concerns that risk-adjusting for race 
could mask poorer performance, and we have concerns that racial risk-
adjustments could perpetuate the stereotypes of different racial/ethnic 
groups and their willingness and ability to be organ donors.
    We have reviewed the analysis conducted by the SRTR implying that 
racial risk-adjustment would ensure that a ``correct'' decision is made 
when comparing OPO measures.\14\ We do not find these analyses 
compelling since the risk-adjustments reflect the biases and 
shortcomings of current OPO organ procurement practices, and we are not 
aware of a biological reason why race, as an independent factor, would 
affect the decision to be an organ donor or the number of organs 
transplanted. We agree with public comments and other literature 
opposing risk-adjustments for race.\15\ We believe OPOs should be 
adjusting their practices to meet the characteristics of the DSA. Based 
on the diverse populations serviced by the top performing OPOs, we 
believe that racial characteristics of the DSA should not be a reason 
for risk-adjusting OPO performance.
---------------------------------------------------------------------------

    \14\ Snyder JS, Wey A, et al., ``The Centers for Medicare and 
Medicaid Services' proposed metrics for recertification of organ 
procurement organizations: Evaluation by the Scientific Registry of 
Transplant Recipients,'' Am J Transplant, 11 Mar 2020.
    \15\ Goldberg D, Doby B, Siminoff L, et al., ``Rejecting bias: 
The case against race adjustment for OPO performance in communities 
of color,'' Am J Transplant, 2020;00:1-6.
---------------------------------------------------------------------------

    Although one of our previous outcome measure (the O:E measure) 
includes multiple risk-adjustments, such as for race, we are not 
including racial risk-adjustments in our final rule. The literature 
since 2005 (described in the December 2019 OPO rule), the public 
comments we received, and our examination of the demographics of the 
top performing OPOs, suggest that these factors, while they potentially 
pose hurdles for each OPO in their DSA, they are insufficient 
justification for additional risk adjustment. Therefore, we expect all 
OPOs to adjust their practices to overcome these hurdles and best 
service the populations within their respective DSAs.
c. Gender and Age
    Comment: We received comments that we should risk-adjust for 
identifiable variables in the donor potential data such as gender and 
age.
    Response: We do not know of a biological basis for why gender would 
be an independent factor in predicting the likelihood for being an 
organ donor or the number of organs transplanted.
    We do, however, agree that there is biological basis for age to 
predict the likelihood of being a donor and the number of organs 
transplanted from the donor potential. Our internal analysis found 
statistically significant differences in the average age of the donor 
potential when we ranked OPOs based on their outcome measures, 
suggesting that age has an effect the number of donors and organ that 
are transplanted.
    Since we are already including the age cut-off of 75 years and 
younger in our donor potential, we do not intend to further risk-adjust 
the donation rate for age. It is possible that the differences we see 
in performance based on the average age of the donor potential reflects 
OPO biases against older potential donors. Further risk-adjustments 
could mask these biases. Based on our methodology, in the DSAs where 
the population is older, OPOs have the opportunity to perform better 
because they have more opportunities for a donor who is older than 75 
years of age--and these donors count in the numerator, but not in the 
denominator.
    For the organ transplantation rate, there is no current risk 
adjustments for the average age of the donor potential. Our own 
internal analysis found that the average age of the donor potential 
correlated with performance on the organ transplantation rate, we will 
risk-adjust the organ transplantation rate based on the average age of 
the donor potential using the following method, provided here for full 
transparency and to allow others to replicate our methodology and 
calculations:
    1. The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 
55-59, 60-64, 65-69, 70-75.
    2. Calculate a national age-specific transplantation rate for each 
age group. An expected transplantation rate for each OPO is calculated 
as [sum](g=1) Gdg*Rg/[sum]gdg,\16\ where dg is the number of potential 
donors in the OPO in age group g, Rg is the age-specific national 
transplantation rate in age group g, and [sum]gdg is the OPO's total 
number individuals in the donor potential. This can be interpreted as 
the overall expected transplantation rate for an OPO if each of its 
age-specific transplantation rates were equal to the national age-
specific.
---------------------------------------------------------------------------

    \16\ [sum] is a mathematical symbol indicating summation.
---------------------------------------------------------------------------

    3. Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.
d. Ventilator Status
    Comment: We received comments stating that there were differences 
in ventilators in ICUs based on geography, and that including 
ventilator status would be important in deriving the donor potential.
    Response: While there are differences in ventilators in ICUs based 
on geography, we do not have evidence that additional information about 
ventilator use would improve the CALC methodology. Since publication of 
our proposed measures, there has been a published study confirming our 
analysis that additional adjustments on cancers, sepsis and ventilator 
status to the CALC measure does not alter the ranking of OPO 
performance.\17\
---------------------------------------------------------------------------

    \17\ Goldberg DS, Doby B, Lynch R, ``Addressing Critiques of the 
Proposed CMS Metric of Organ Procurement Organ Performance: More 
Data Isn't Better,'' Transplantation; 2019 Nov 26.
---------------------------------------------------------------------------

    Final Rule Action: We are finalizing with modification the 
definition of ``organ transplantation rate'' at Sec.  486.302 to be 
risk-adjusted for the average age of the donor potential using the 
following methodology:
    (1) The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 
55-59, 60-64, 65-69, 70-75.
    (2) Calculate a national age-specific transplantation rate for each 
age group. An expected transplantation rate for each OPO is calculated 
as [sum](g=1)Gdg*Rg/[sum]gdg, where dg is the number of potential 
donors in the OPO in age group g, Rg is the age-specific national 
transplantation rate in age

[[Page 77911]]

group g, and [sum]gdg is the OPO's total number of individuals in the 
donor potential. This can be interpreted as the overall expected 
transplantation rate for an OPO if each of its age-specific 
transplantation rates were equal to the national age-specific.
    (3) Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.

We are also finalizing at Sec.  486.318(d)(2) that the organ 
transplantation rate is calculated as the number of organs transplanted 
from donors in the DSA as a percentage of the donor potential. The 
organ transplantation rate is adjusted for the average age of the donor 
potential.
8. OPO Performance on Outcome Measures Sec.  486.318(e) and Sec.  
486.302
    In our December 2019 OPO proposed rule, we proposed to use our 
outcome measures in the context of a comparative donation rate and 
organ transplantation rate relative to the highest-performing OPOs. Our 
proposed definition of success would have been based on how OPOs 
perform on the outcome measures of donation rate and organ 
transplantation rate compared with the top 25 percent of donation and 
transplantation rates in DSAs with the goal of driving all OPO 
performances to cluster with the top performing OPOs. We proposed that 
OPOs would be assessed annually on these outcome measures and those 
whose outcome measures were below the top 25 percent would need to 
revise their QAPI to improve their performance. In the final year of 
the re-certification cycle, we proposed that OPOs whose outcome 
measures were below the top 25 percent will have failed their outcome 
measures for purposes of re-certification. We proposed to generate a 
one-tailed confidence interval for rates in each DSA to determine 
whether the OPO's outcome measures were statistically significantly the 
same or above the threshold rate of the top 25 percent. The top 25 
percent rate would be generated using the rates established in the 
prior assessment period.
    It is important to note that the outcome measures requirement does 
not require an OPO's performance be at or above the lowest rate for the 
top 25 percent of all of the OPOs. By determining confidence intervals, 
there is a range of values and the OPOs must not be statistically 
significantly difference from that range of values. For example, there 
are currently 58 OPOs. For the 58 current OPOs, twenty-five percent 
would be 15 OPOs (58 x .25 = 14.5). However, as discussed below, based 
on 2018 data, we estimate that 24 OPOs would meeting the criteria in 
Sec.  486.318 to be designated as a Tier 1 top performing OPO.
    We solicited public comments on whether or not comparing OPO 
performance should be based solely on the performance of the top 25 
percent of OPOs within these two outcome measures, whether a different 
percentile or calculation of OPO performance should be used, or whether 
additional outcome, structure, or process criteria could be used to 
inform stakeholders of OPO performance over time (84 FR 70634).
    The comments and responses are below.
    Comment: We received a diversity of comments in response to our 
proposed approach of establishing a threshold rate at the top 25 
percent performance for OPOs to achieve. Some commenters supported our 
aggressive threshold rate of performance to drive an increase and 
improvement in OPO performance.
    Response: We thank the commenters who support our aggressive 
threshold rates. We intend to finalize, as proposed at Sec.  
486.318(e)(4) that OPOs whose donation rate and organ transplantation 
rate in the DSA is statistically significantly at or above the top 25 
percent threshold rate will be considered have met the outcome measures 
for re-certification and their top performance will be recognized with 
a Tier 1 assignment. As a Tier 1 OPO, they will be rewarded by not 
being required to revise their QAPI to improve their performance in the 
outcome measures and their DSAs will not be opened for competition at 
the end of the re-certification cycle as long as they meet the other 
Conditions for Coverage during the re-certification survey.
    Comment: We received comments suggesting alternative threshold 
rates such as 50 percent or a tiered approach to ranking OPOs with 
different changes that must occur based on where the OPO falls in the 
tier system.
    Response: We thank the commenters for these suggestions. As we 
stated in the discussions of our alternatives in the December 2019 OPO 
proposed rule, we considered using a threshold rate based on the median 
or the geometric mean, but were concerned that this lower threshold 
rate would not incentivize OPOs to be higher performing. Furthermore, 
we ran the risk of top performing OPOs not being sufficiently 
incentivized to maintain their current performance level if we did not 
use an aggressive rate.
    However, we also recognized that our aggressive threshold rate 
could result in too many OPOs being de-certified, particularly in the 
first re-certification cycle, without enough OPOs with organizational 
capacity and interest to assume responsibility for those open DSAs. We 
also recognize that if we set a threshold rate too difficult to attain, 
we risked incentivizing poorer performing OPOs to not strive to improve 
while remaining certified for a full 4-year cycle. Therefore, we are 
modifying our proposal and finalizing a 3-tier system based on public 
comments whereby OPOs are stratified into different tiers based on 
their outcome measures. The consequences of being in each tier differ 
based on whether the performance occurs as part of the annual 
assessment or if it occurs during the final assessment period. OPOs in 
Tier 1 are the OPOs that would have reached the goal performance of the 
top 25 percent threshold rates. We consider these OPOs to be top 
performing Tier 1. Based on data from 2018, we estimate that 24 OPOs 
would be in Tier 1.
    The next tier will be identified as Tier 2 and will include OPOs in 
which both measures, donation rate and organ transplantation rate, have 
reached the median threshold rate or above (but are not in Tier 1). We 
estimate that there are 12 OPOs that would fall into Tier 2 based on 
2018 data. Tier 2 OPOs will be considered to have met the outcome 
measures under Sec.  486.318, and would not be decertified, but these 
OPOs will not be automatically re-certified. Since they have not 
reached the outcome measure requirements for Tier 1 status, their DSAs 
will be opened for competition and they will have to compete to retain 
their DSAs. Greater details about the competition process are discussed 
in section II.C of this final rule.
    And finally, the lowest tier will be identified as Tier 3 and will 
include OPOs who have one or both outcome measures that are 
statistically significantly below the median threshold rates. We 
estimate that there are 22 OPOs who fall into Tier 3 based on 2018 
data. Tier 3 OPOs will be considered as failing the outcome measures 
and will be de-certified. Greater details about the competition process 
are discussed in section II.C of this final rule.
    This 3-tier system was designed based on a combination of comments 
that we use the 50 percent threshold rate instead of the top 25 percent 
threshold rate and the comments to use a tier system with varying 
consequences to OPOs based on the tier they were in. Instead of using a 
50 percent rate or a mean rate, we chose

[[Page 77912]]

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. A median, however, is not affected by extremes in performance. By 
identifying a specific rate of an OPO, other OPOs can directly compare 
their performance with another OPO.
    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 
and give Tier 2 OPOs the opportunity to demonstrate that they deserve 
to retain their DSA. These rewards and incentives are described in 
greater detail in this section and in our discussion about competition 
in section II.C of the final rule and our regulatory impact analysis 
(RIA).
    Comments: We also received comments that the 25 percent threshold 
rate was too aggressive and too many OPOs would be de-certified 
(discussed in detail at section II.C of this final rule), resulting in 
chaos in the system. Some commenters suggested that if we were to use 
such an aggressive threshold rate, we should not automatically de-
certify OPOs who did not meet the threshold rates. Instead, we should 
consider a systems improvement agreement (SIA) similar to the ones for 
transplant program or the substantial changes they have made as part of 
their QAPI to avoid the disruption from de-certifying the OPO. In 
contrast, we received a comment that despite our aggressive threshold 
rate for performance, we should implement outcome measures that 
continually drive all OPOs to improve their performance.
    Response: We agree with some of the comments relating to a tiered 
approach. OPOs are not automatically decertified the first time that 
they do not meet the threshold rates. The performance of each OPOs will 
be assessed annually, this information will be provided to each OPO, 
and each OPO will then have an opportunity to improve and receive 
information about its performance following those improvements. Our 
annual outcome assessment is designed to inform the OPO regularly about 
their performance. Therefore, OPOs identified as being lower performing 
at the final assessment period of the agreement cycle would have a 
history of working with CMS to improve performance, as they would have 
been provided with their own performance information and making 
adjustments to their QAPI to improve their performance in the previous 
assessment periods. We expect to provide notice to OPOs of their 
performance and make the results public within 15 months of the end of 
each assessment period. For instance, performance on data from 2020 
will be provided to OPOs and made public by the end of the first 
quarter in 2022. This period is necessary to accommodate the timeframe 
for the CDC to process the data and make the MCOD available for public 
use as well as for CMS calculate the performance measures. 
Additionally, during this timeframe, CMS will share preliminary results 
with each OPO to provide the opportunity to review the information and 
raise any concerns prior to the results being made publicly available 
and taking any enforcement action. This preliminary review is 
consistent with past performance updates and while this is an informal 
process, it does afford each OPO the opportunity to address concerns 
regarding its results. We acknowledge the time lag in making this 
information available, however, all data sources have inherent delays 
in making their information available to the public. Additionally, OPOs 
should not be relying on any single source of information to conduct 
self-assessments of their performance and should be employing a variety 
of information as part of a comprehensive QAPI program for this 
purpose.
    We are not adopting public comments suggesting that poorly 
performing OPOs should be permitted to continue under an SIA. Allowing 
poorer performing OPOs the opportunity to continue servicing the DSA 
through a SIA would not benefit patients if there is a better 
performing OPO willing and able to service the DSA and provide patients 
with a higher standard of service.
    However, we recognize that there are some OPOs that fall below Tier 
1 but have made substantial changes designed to improve performance and 
have started to improve their performance. It may not be in our or 
patients' best interest to de-certify those OPOs, unless there is a 
better OPO prepared and capable of taking over the DSA. Thus, we 
created Tier 2 in response to the comments that we should lower our 
threshold rate for performance, and should not automatically de-certify 
OPOs who cannot reach Tier 1.
    The commenter who suggested the tier system proposed that we 
undertake certain administration actions (like require change in 
leadership) based on the OPO's tier. While we appreciate the 
suggestions, we do not believe that there is a one-size fits all 
approach for all the OPOs in Tier 2, or that the federal government 
should dictate the specific steps needed to increase the rates in a 
particular DSA. Based on our assessment of outcome measures for these 
OPOs in Table 3, the range of performance is quite varied, with some 
OPOs very close to Tier 1 and others at the bottom of Tier 2. We are 
reluctant to follow the comments suggesting that OPOs be given an 
opportunity to continue as the designated OPO for another cycle subject 
to an SIA. That suggestion assumes that all OPOs in Tier 2 are capable 
of improving their performance and that they just need more time to 
implement best practices and improvements. However, because all OPOs 
receive interim reports on performance levels, we do not agree that 
this is always the case. Moreover, we recognize that patients in the 
DSA well-served by a marginal OPO that is allowed to continue without 
facing competition from a high performing OPO. Requiring that OPOs in 
Tier 2 to engage in a competitive process with other interested OPOs, 
on the other hand, would incentivize continual improvement to the 
benefit of patients.
    Section 1138(b) of the Act and section 371 of the PHS Act required 
that the Secretary establish performance and outcome measures to be 
able to evaluate an OPO's performance prior to recertification. 
Requiring that Tier 2 OPOs compete for their DSA incentivizes best 
practices and optimizes organ donation and transplant rates. As already 
discussed and proposed, OPOs whose rates in the DSA fall under Tier 1 
are considered to have met the outcome measure requirements and their 
DSA is protected from competition. OPOs identified as being in Tier 3 
are considered to have failed the outcome measures under Sec.  486.318 
and will be de-certified, and following any administrative appeals, 
their DSAs will be open to competition.
    Instead of automatically de-certifying OPOs in Tier 2 (those who 
have a statistically significant donation and organ transplantation 
rate at or better than the median rate) or implementing an SIA, we will 
allow these OPOs to compete to retain their DSAs by opening their DSA 
for competition to all OPOs that have been identified as being in Tier 
1 and 2. In summary, all the DSAs for OPOs identified in Tiers 2 and 3 
will be open for competition as proposed in our December 2019 OPO 
proposed rule and all the OPOs who are identified in Tier 1 and 2 will 
be able to compete for an open DSA. Broadening the number of DSAs open 
to competition and the number of OPOs eligible to compete will result 
in greater improvements

[[Page 77913]]

among all OPOs. OPOs in Tier 1 will need to maintain or improve their 
performance if they want to successfully compete to take over a new 
DSA, and OPOs in Tier 2 will need to improve their performance to 
retain their DSA or takeover another open DSA. Since OPOs identified 
under Tier 2 would have been de-certified under our original proposed 
methodology, this new approach will give mid-performing OPOs, who 
otherwise would have been de-certified, the opportunity to demonstrate, 
through the competition process, that they have implemented the 
requisite changes to progress to becoming a Tier 1 OPO.
    Because OPOs have a 4-year exclusive agreement for each DSA with 
each re-certification cycle (see Sec.  486.308(a)), it is critical that 
we select the most capable OPO that we can find to service the area, 
rather than automatically re-certify the incumbent OPO in Tier 2 or 
trying to ``fix'' an OPO that has not been able to reach the same 
performance as the top performing OPO through an SIA. We believe a 
competition process whereby all OPOs have sufficient incentives to 
continue to improve will drive all OPOs to cluster near the top.
    Comments: We also received many comments suggesting we use a 
standard deviation from the mean because it was statistically superior.
    Response: We disagree with the comments that the standard deviation 
from the mean methodology is statistically superior for our purposes of 
calculating OPO performance measures.
    Under our methodology, all OPOs have the opportunity to cluster at 
the top because we generate confidence intervals for their donation and 
organ transplantation rates. The threshold rate is based on the 
previous year's rate and represents a specific rate to achieve or 
exceed. If all the remaining OPOs (below the top 25 percent threshold 
rate) had rates close to the threshold rate, their confidence interval 
could have all of them equal or exceed the threshold rate, resulting in 
clustering near the top. In Table 3, we show that 24 of 58 OPOs meet 
the top 25 percent threshold rate and this is 41 percent of all OPOs.
    The standard deviation from the mean method, on the other hand, 
generates a list of OPOs that are a certain distance from the mean. As 
we discussed earlier, the mean is problematic because several lower 
performing OPOs could skew the calculated mean. The mean and the 
standard deviations are also 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.
    Comments: We received comments implying that our goal was to reduce 
the number of OPOs and our methodology would result in an ever 
increasing threshold rate and ever-shrinking number of OPOs after each 
cycle.
    Response: We understand the concerns expressed by these comments, 
and want to reassure the public that our goal is to improve oversight 
of OPOs by reducing the variability in performance among OPOs and in 
the DSAs, not necessarily reducing the number of OPOs or forcing 
consolidation. Our methodology allows all OPOs the opportunity to 
perform as well as the top OPOs. We have proposed to change the 
outcomes measures because we agree with the public comments that the 
current OPO outcome measures are not sufficiently objective and 
transparent to ensure public trust in assessing OPO performance, nor do 
they properly incentivize the adoption of best practices and 
optimization of donation and organ transplantation rates.
    Our methodology may result in increasing the threshold rate without 
shrinking the number of OPOs or DSAs significantly. Our internal 
analysis reveals demonstrated improvements in OPO performance from 2017 
to 2018 and we anticipate OPO performance will continue to improve when 
incentivized by more transparent and accountable measures provided 
under this final rule. But, we recognize that there may be a rate at 
which OPOs cannot improve anymore and rates may cluster at the top. 
However, we intend to incentivize increases in the threshold rates for 
the top 25 percent and median as it would indicate that OPOs are 
procuring more organs for transplantation. Our methodology does not 
presume or require an increase in the threshold rates, and accounts for 
the performance of OPOs under similar circumstances or extraordinary 
circumstances.
    In order for there to be an ``ever-increasing threshold rate and 
ever-shrinking number of OPOs,'' the commenter assumed that we would 
require that DSAs merge when an OPO takes it over. Our methodology for 
assessing OPO performance is based on the outcome measures for the OPO 
in each DSA. In our December 2019 OPO proposed rule (84 FR 70636), we 
stated that our regulations do not require that DSAs merge when a new 
OPO takes over. It would be our preference to not merge DSAs so that we 
can properly assess whether the new OPO is improving performance in 
each DSA since merging DSAs would result in merging the data on 
performance. Since DSAs are not required to merge, one OPO could run 
several DSAs. If an OPO with multiple DSAs cannot reach the outcome 
measures to be re-certified for one DSA, they will be de-certified for 
that DSA, but could be re-certified for other DSAs (assuming their 
performance supports it). Using our estimates from 2018 data, the 
result after conclusion of the first certification cycle that 
implements the new measures (2022-2026) could be approximately 36 OPOs 
servicing 58 DSAs with reductions in OPOs but not in DSAs. With 58 DSAs 
being served by top performing OPOs each cycle, we would expect the 
threshold rate to increase until all DSAs have donation and organ 
transplantation rates that cluster near the top. Even if consolidation 
were to occur in the industry, we believe that the certification 
process would retain a sufficiently large number of OPOs s to maintain 
an adequately diversified market in U.S.
    Comment: We received some comments that our threshold rate of 25 
percent was arbitrary. We also received comments pointing out parts of 
the country where no OPO was top tier such as the New England area or 
the Gulf Coast.
    Response: We respectfully disagree with the commenter that our 
proposed threshold rate was arbitrary. It was chosen to mathematically 
achieve the Secretary's goal of doubling kidney transplants by 2030. It 
was also chosen because, when we assessed which OPOs were top 
performing, we found that that threshold rate of 25 percent provided us 
a diversity of OPOs serving a range of geographic areas and different 
donor potentials. The 25 percent threshold rate and our inclusion of a 
confidence interval was chosen to accommodate any uncertainty about 
what constitutes a top performing OPO.
    In our December 2019 OPO proposed rule, we presented maps 
stratifying OPO performance in quartiles. The purpose of these maps was 
to show that even though many OPOs did not meet the threshold rate, 
they were quite close. Our current data analyses in Tables 1 through 3 
also show that it is likely achievable for many more OPOs to reach the 
Tier 1 threshold rates. Additionally, our internal analysis indicates 
that the number of OPOs historically achieving Tier 1 status increased 
from 16 in 2017 to 24 in 2018, without any regulatory incentives, 
demonstrating that OPOs have the ability to improve their performance.

[[Page 77914]]

    Comment: We received a comment that the 95 percent confidence 
intervals (CI) were biased against large OPOs because they would likely 
have a narrow interval.
    Response: The purpose of the confidence interval was to ensure that 
the use of the threshold rate does not bias against small OPOs who may 
be prone to greater variability of rates due to smaller volumes. We do 
not concur with the commenters' assertion that our methodology is 
biased against large OPOs; they have a CI generated, but because they 
have more data, their CIs are proportionally smaller.
    We did not receive any comments on the proposed mathematical 
methodology which we use to calculate the ``Lowest rate among the top 
25 percent'' or the time period in which the rate will be calculated. 
Thus, we will be finalizing as proposed that the threshold rates for 
the donation and organ transplantation rates would be based on the 12-
month period immediately prior to the period being evaluated and 
finalizing the definition of the Lowest rate among the top 25 percent 
with technical edits to clarify that the rate is based on the donation 
and organ transplantation rates in the DSAs.
    Final Rule Action: Under Sec.  486.302, we are finalizing as 
proposed the definition that the ``Lowest rate among the top 25 
percent'' will be calculated by taking the number of total DSAs in the 
time period identified for establishing the threshold rate. The total 
number of DSAs will be multiplied by 0.25 and rounded to the closest 
integer (0.5 will round to the higher integer). The donation rates and 
organ transplantation rates in each DSA will be separately ranked and 
the threshold rate will be the rate that corresponds to that integer 
when counting down the ranking.
    We are finalizing Sec.  486.318(e) with revisions, that (1) For 
each assessment period, threshold rates will be established based on 
donation rates during the 12-month period immediately prior to the 
period being evaluated: The lowest rate among the top 25 percent in the 
DSAs (paragraph (e)(1)(i)), and the median rate among the DSAs 
(paragraph (e)(1)(ii)) and, (2) For each assessment period, threshold 
rates will be established based on the organ transplantation or kidney 
transplantation rates (as applicable) during the 12-month period prior 
to the period being evaluated: The lowest rate among the top 25 percent 
in DSAs (paragraph (e)(2)(i)), and the median rate among the DSAs 
(paragraph(e)(2)(ii)).
    We are finalizing as proposed at Sec.  486.318(e)(3) that the 95 
percent confidence interval for each DSA's donation and organ 
transplantation rates will be calculated using a one-sided test.
    In response to public comments, we are finalizing Sec.  
486.318(e)(4) through (6), the creation of three tiers to identify OPO 
performance.
    Tier 1--OPOs that have an upper limit of the one-sided 95 percent 
confidence interval for their donation and organ transplantation rates 
that are at or above the top 25 percent threshold rate established for 
their DSA will be identified at each assessment period.
    Tier 2--OPOs that have an upper limit of the one-sided 95 percent 
confidence interval for their donation and organ transplantation rates 
that are at or above the median threshold rate established for their 
DSA but is not in Tier 1 as described in paragraph (e)(4) will be 
identified at each assessment period.
    Tier 3--OPOs that 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 for their DSA will 
be identified at each assessment period. OPOs that have an upper limit 
of the one-sided 95 percent confidence interval for their donation and 
organ transplantation rates that are below the median threshold rate 
for their DSA are also included in Tier 3.
9. Non-Contiguous States, Commonwealths, Territories, or Possessions 
Sec.  486.318(e)(7)
    In the December 2019 OPO proposed rule (84 FR 70628), we did not 
propose different outcome measures for OPOs exclusively serving non-
contiguous states, commonwealths, territories, or possessions because 
we believe that OPOs servicing those areas should perform at the same 
level as the top 25 percent of OPOs. That being said, we sought 
comments on the burden and unique challenges that may face OPOs in the 
noncontiguous states, commonwealths, territories, or possessions, and 
whether using just the kidney transplantation rate for the Hawaii OPO 
would be an appropriate measure of performance as discussed in section 
V.G ``Alternatives Considered'' of the December 2019 OPO proposed rule.
    Comment: We received numerous comments in support of using a 
different standard for OPOs exclusively serving non-contiguous states, 
commonwealths, territories, or possessions. Both the Hawaii and Puerto 
Rico OPOs submitted comments describing the difficulty in placing 
extra-renal organs because of the geographic hurdles.
    Response: Based on information from the commenters regarding the 
unique geographical challenges of the OPO servicing the Hawaii DSA, we 
are persuaded to use one different outcome measure to evaluate the 
OPO's performance in the Hawaii DSA. Instead of using the organ 
transplantation rate as one measure, we will use the kidney 
transplantation rate for only the OPO serving the Hawaii DSA. We agree 
with the commenters that the OPO for this DSA has a clear geographic 
hurdle to placing extra-renal organs. We will use the same general 
methodology as the organ transplantation rate for calculating the 
kidney transplantation rate. We will not age-adjust the kidney 
transplantation rates for the same reason that we do not age-adjust the 
donation rates. The age of 75 cutoff provides sufficient age-
adjustments for kidney transplantations.
    Although we are not using the organ transplant rate for the Hawaii 
DSA, we will continue to monitor the development and FDA clearance of 
organ transport devices and expect the OPO serving the Hawaii DSA to 
adopt these new technologies when they are available. Moreover, we will 
also use the same donation rate measure for the Hawaii DSA in assessing 
the OPO's performance since almost all donors of other organs are also 
kidney donors. Like all of the other OPOs, the Hawaii DSA will be 
evaluated based on two outcome measures.
    We do not intend to give the OPO servicing Puerto Rico any special 
consideration for their organ transplantation rates. We made the 
initial decision to not provide special consideration to the Puerto 
Rico OPO because of its geographic proximity to parts of the 
continental U.S. that have significant need for organ transplants. Our 
analysis of 2018 data confirmed our assessment that the OPO based in 
Puerto Rico does not need special consideration because that OPO would 
be assigned as a Tier 1 OPO if the metrics where in effect at that 
time. We suspected that their performance in 2017 had been 
significantly hampered by the multiple, strong hurricanes, rather than 
by sustained geographic disparities that do not change from year to 
year. This suspicion was confirmed by the significantly higher level of 
performance that the Puerto Rico OPO attained in 2018 when the island 
was not as impacted by hurricane activity.
    Final Rule Action: We are finalizing in response to comments at 
Sec.  486.318(e)(7) that for the OPO exclusively serving the Hawaii 
DSA, the

[[Page 77915]]

kidney transplantation rate will be used instead of the organ 
transplantation rate. The comparative performance and designation to a 
tier will be the same as in paragraphs (e)(4), (5), and (6) except 
kidney transplantation rates will be used.
10. Assessment and Data for the Outcome Measures Sec. Sec.  486.302 and 
486.318(f)
    In the December 2019 OPO proposed rule, we proposed to assess OPO 
performance every year, using the most recent 12 months of data from 
the CDC's MCOD files. Based on the typical timing of the release of the 
MCOD files, we expect to calculate the outcome measures near the 
beginning of each calendar year, and the assessment period data will 
have a 1-year lag. We explained that the reason we were using only 1 
year of data is that we did not want to penalize OPOs who have made the 
effort to improve performance by using their older data in the outcome 
measure calculations.
    Comment: Some commenters stated that 1 year of data was appropriate 
for the assessment period for purposes of QAPI remediation, but felt 
that 3 years of data should be used for re-certification. Other 
commenters supported our use of 1 year of data for re-certification 
stating that 36 months of data was too long.
    Response: In the December 2019 OPO proposed rule, we stated that 
the reason we are using just 1 year of data is that we want to 
encourage and reward OPOs who make substantial efforts to improve their 
performance. If we use all the data from the agreement cycle in our 
QAPI and re-certification, the older data could mask the current 
performance of the OPO. It is CMS' belief that using the older data 
from the agreement cycle to assess OPO performance for re-certification 
may not accurately reflect the practices of the new OPO.
    Comment: We received a comment that OPOs who takeover a DSA should 
not be held accountable for the performance of the former poorer 
performing OPO.
    Response: Our assessment periods are normally from January 1 to 
December 31 based on the state death certificate data files that we 
receive. In our December 2019 OPO proposed rule at Sec.  486.318(f)(3), 
we proposed that if an OPO takes over another OPO's DSA on a date later 
than January 1st, we will hold the OPO accountable for its performance 
on the outcome measures in the new area once 12 months of data are 
available. This paragraph recognizes that we need 12 months of data to 
conduct our analysis and that the new OPO needs the opportunity to be 
serving the area before they can make changes in response to the 
outcome measures. Based on the timing of the state death certificate 
data, it is very likely that most, if not all, of the data at the 
beginning of a new agreement cycle for a new OPO, will reflect the 
practices of the prior OPO. However, since we believe it is important 
that the OPO be aware of the past performance in the DSA and can use 
that performance as a benchmark for improvement, we will continue to do 
the evaluation of the assessment period for purposes of ranking and 
assessing the new OPO and other OPOs. The new OPO would not be required 
to take actions in its QAPI program in response to the outcome measure, 
as required at Sec.  486.348(d), until 12 months of data are available. 
Since we are only using 1 year of data and outcome measures for the 
final assessment will include data from the middle of the re-
certification cycle, the new OPO will not be judged on the performance 
of the prior OPO and will have had 1-2 years to improve performance in 
the DSA.
    Comment: We received comments that use of only 1 year of data would 
be problematic for some OPOs servicing smaller DSAs that happened to 
have a ``bad year'' during the final assessment period of their 
agreement cycle. Because these OPOs are smaller, they have less data 
for analysis and their DSA could have greater variability in the number 
of deaths.
    Response: We recognize that OPOs serving smaller DSAs are 
mathematically subject to greater variability in their inpatient deaths 
and number of donors and organ transplants. For this reason, the one-
tailed confidence interval that we generate in calculating the donation 
and organ transplantation rates will account for the potential 
variability when we are using less data in the smaller OPOs.
    As also discussed in section II.C of this final rule, for OPOs 
receiving an ECE extension, their data will continue to be part of the 
annual calculations of the outcome measures, and the OPOs' performance 
will be ranked with the other OPOs; the difference is that they will 
not be up for re-certification in that particular year. All requests 
for an ECE extension must occur within 90 days after the end of the 
extraordinary circumstance but no later than the last day of the final 
assessment period. To seek an ECE exception, the OPO needs to describe 
the extraordinary circumstance, the time period in which it occurred, 
why it was beyond the control of the OPO, and why it affected the OPO's 
performance in such a way that the data does not accurately capture the 
OPO's performance.
    The intention of the ECE extension is to allow for those rare 
exceptions in which a natural disaster (such as a hurricane), a public 
health emergency or other similar catastrophe would disproportionately 
affect an OPO. We could also allow situations in which there are errors 
in the transmission of data to the CDC.
    We believe that OPOs will use the option of seeking the extension 
judiciously because the request to extend their agreement by 1 year is 
not without risk. Once an OPO is up for recertification off-cycle from 
the other OPOs, their DSA could potentially be opened for competition 
at a time when other OPOs are not up for re-certification. While this 
would not matter for an OPO in Tier 1, a Tier 2 OPO may be more 
vulnerable to losing its DSA in competition with other OPOs who have 
more capacity and interest in competing in an off-cycle year.
    Comment: We received comments that something could happen with 
staffing during that final year, such as a loss of a high-performing 
transplant coordinator, which could adversely affect outcomes during 
that final assessment period.
    Response: Loss of key staff would not be considered an event 
outside of the OPOs' control and are inevitable in all organizations. 
Staffing, contingency planning, and other such activities are within 
the control of an OPO. As such, staffing changes would not constitute 
an extraordinary event.
    Comment: We also received comments raising concerns about the data 
lag from CDC, with some commenters assuming that we are calculating 
rates using numerators and denominators from different time periods. We 
also received comments that the data lag would result in OPOs being re-
certified based on data that is more than 2 years old.
    Response: While there is a lag in the data from CDC, the numerator 
and denominator will be based on data from the same time period. We are 
adding clarifying language in our regulatory text at Sec.  
486.318(d)(3) to recognize that ``for calculating each measure, the 
data used is from the same time period as the data for the donor 
potential.'' Based on availability of the data from the CDC, the 
threshold rate determination and the final assessment period will use 
data from the middle of the agreement cycle. Therefore, OPOs would be 
notified of their performance on outcome measures for recertification 
approximately 15 months after the final assessment period just prior to 
the end of the

[[Page 77916]]

recertification cycle. Despite the lags in reporting death certificate 
data to the CDC, and even the lag in reporting donor and transplant 
information to the OPTN, the data is the best information available to 
empirically and transparently evaluate the OPOs' performance.
    Final Rule Action: We are finalizing as proposed at Sec.  
486.318(f)(1) that an OPO's performance on the outcome measures is 
based on an evaluation at least every 12 months, with the most recent 
12 months of data available from the OPTN and state death certificates, 
beginning January 1 of the first year of the agreement cycle and ending 
December 31, prior to the end of the agreement cycle.
    We are finalizing as proposed at Sec.  486.318(f)(3) that if an OPO 
takes over another OPO's DSA on a date later than January 1 of the 
first year of the agreement cycle so that 12 months of data are not 
available to evaluate the OPO's performance in its new DSA, we will 
evaluate the OPO's performance on the outcome measures in the new area 
once 12 months of data are available.
    In response to the comments and to provide additional clarity, we 
are also adding a new definition, ``Assessment period'' at Sec.  
486.302 to be a 12-month period in which an OPO's outcome measures will 
be evaluated for performance. The final assessment period is the 12-
month assessment period used to calculate outcome measures for re-
certification. We are finalizing at Sec.  486.318(f)(2) that the 
assessment period is the most recent 12 months prior to the evaluation 
of the outcome measures in which data is available.
    We are also finalizing under Sec.  486.318(d) a clarification for 
calculating each measure. All OPOs will be evaluated based on two 
measures. For all OPOs, the numerator for the donation rate is the 
number of donors in the DSA. For most OPOs, the numerator for the organ 
transplantation rate is the number of organs transplanted from donors 
in the DSA. For the OPO servicing the Hawaii DSA only, the donation 
rate will be the same as for all other OPOs but the kidney 
transplantation rate will be utilized in lieu of the organ 
transplantation rate. The numerator for the kidney transplantation rate 
is the number of kidneys transplanted from kidney donors in the DSA. 
The numbers of donors, organs transplanted, and kidneys transplanted 
are based on the data submitted to the OPTN as required in Sec.  
486.328 and Sec.  121.11. For calculating each measure, the data used 
is from the same time period as the data for the donor potential.
11. Implementation Timeline
    We requested comments on this proposed change in the December 2019 
OPO proposed rule to the applicability of the outcome measure 
requirements for the cycle beginning in 2022 and ending in 2026. The 
current OPO certification cycle is due to end on July 31, 2022 however, 
the OPO agreements for the certification period extend until January 
31, 2023. This extra timeframe in the agreement affords the opportunity 
for any appeals or competition that may occur from any potential 
enforcement action for non-compliance with the CfCs, including the 
outcome measures. Normally, absent enforcement action on the part of 
CMS, the OPO agreements are renewed on August 1 or shortly thereafter 
to coincide with the start of the next certification period.
    Comment: We received a number of comments from the general public 
and others that encouraged us to implement these new measures as soon 
as possible and to hold OPOs accountable now. We also received numerous 
comments from OPOs, supporting a delay of implementation of the new 
outcome measures to begin in 2022 and end in 2026.
    Response: We appreciate the robust comments related to this topic 
including the desire to drive performance improvements sooner while 
also being responsive to providing OPOs time to adapt to the new 
measures and improve performance where needed. We considered the option 
of extending the current agreements by 2 years and assessing OPOs based 
on data from 2023 holding OPOs accountable to the new performance 
measures in 2024. However, the effects of the current COVID-19 PHE are 
still uncertain in regards to the impact to the organ donation and 
transplantation system. We note that current data from the OPTN 
indicate that as of November 7, 2020, there were 28,506 deceased organ 
transplants conducted compared to 27,658 at this same time the year 
prior suggesting the impacts may not be as severe as originally 
anticipated.\18\ Therefore, we intend to implement the new measures as 
proposed, beginning in the 2022 recertification cycle. We believe 
extending implementation beyond this timeframe will negatively impact 
our efforts drive improvements to make these critically important life-
saving organs sooner.
---------------------------------------------------------------------------

    \18\ https://unos.org/covid/.
---------------------------------------------------------------------------

    OPOs will continue to receive performance measures under the 
current metrics until the end of the current certification cycle in 
2022. However, we intend to also begin providing OPOs an assessment of 
their performance under the new metrics in each DSA immediately using 
data from 2019. OPOs will receive results of their performance on the 
outcome measures from 2019 in the first quarter of 2021 with additional 
assessments being provided annually. We will rank OPO performance to 
provide information that may be utilized for purposes of QAPI programs 
interventions leading up to implementation of the new measures. OPOs 
will receive performance assessments in the first quarter of the year 
for their performance 2 years prior. As previously stated, this time 
lag is inherent the use of objective, reliable, and transparent 
publically available data sources. It affords the CDC time to collect 
all information and develop the report for public posting. 
Additionally, it provides time for CMS to receive and process 
information, conduct analysis, share preliminary results with OPO, and 
make the files public. Therefore, for the 2022-2026 certification 
period, the threshold rate will be established based on data from 2023 
and the final assessment period will utilize data from 2024. CMS will 
conduct activities for recertification in early 2026, including 
publication of tier ranking in performance measures and conducting 
onsite surveys of OPO operations. While we acknowledge that OPOs will 
not know the actual threshold rate that will be utilized for the final 
assessment period until after it is complete, they will have the 
results of prior years from which to trend and incorporate into their 
QAPI program to assist in improving performance. Additionally, we 
expect that OPOs implement a comprehensive data-driven QAPI program to 
monitor and evaluate their performance. Therefore, OPOs should already 
be including a range of data and activities for this purpose that will 
inform and drive performance toward success in achieving Tier 1 status 
on the outcome measures and the new QAPI requirement at Sec.  
486.348(d) will be one component of that comprehensive plan.
    Final Rule Action: This final rule will be effective 60 days after 
the publication date and the new outcome measures will be implemented 
on August 1, 2022 to coincide with the start of the next certification 
period.
12. Definitions Sec.  486.302
    In the December 2019 OPO rule, we proposed to remove several 
definitions from Sec.  486.302, since these terms would no longer 
apply. Specifically, we proposed to remove the definitions of

[[Page 77917]]

``eligible death,'' ``eligible donor,'' ``expected donation rate,'' 
``observed donation rate'', and ``Standard criteria donor (SCD)''. We 
proposed to revise the definition of ``Donor'' described in section 
II.B.3 of this final rule and we will add the terms ``Assessment 
period'' described in section II.B.10 of this final rule, ``Death that 
is consistent with organ donation'' described in section II.B.6 of this 
final rule, ``Donation rate'' described in section II.B.2 of this final 
rule, ``Donor potential'' described in section II.B.6 of this final 
rule, ``Kidney transplantation rate'' described in section II.B.9 of 
this final rule, ``Lowest rate among the top 25 percent'' described in 
section II.B.8 of this final rule, and ``Organ transplantation rate'' 
described in section II.B.4 of this final rule. Public comments related 
to these definitions and our responses are addressed in sections II.B 
of this final rule as described above. The addition of ``assessment 
period'' and ``kidney transplantation rate'' were not proposed, and are 
being added in response to public comments and to provide convenience 
in understanding the other definitions being defined in the regulation 
text. The term ``Lowest rate among the top 25 percent'' was proposed, 
and we did not receive any comments regarding our methodology for 
calculating this rate. Therefore, we are finalizing with technical 
edits. We will define these terms as follows:
     ``Assessment period'' is a 12-month period in which an 
OPO's outcome measures will be evaluated for performance. The final 
assessment period is the 12-month assessment period used to calculate 
outcome measures for re-certification.
     ``Death that is consistent with organ donation'' means all 
deaths 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): 
Blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and 
asphyxiation.
     ``Donor potential'' is the number of inpatient deaths with 
in the DSA among patients 75 and younger with a primary cause of death 
that is consistent with organ donation. For OPOs servicing a hospital 
with a waiver under Sec.  486.308(e), the donor potential of the county 
for that hospital will be adjusted using the proportion of Medicare 
beneficiary inpatient deaths in the hospital compared with the total 
Medicare beneficiary inpatient deaths in the county.
     ``Donation rate'' is the number of donors as a percentage 
of the donor potential.
     ``Kidney transplantation rate'' is the number of kidneys 
transplanted from donors in the DSA as a percentage of the donor 
potential.
     ``Lowest rate among the top 25 percent'' will be 
calculated by taking the number of DSAs in the time period identified 
for establishing the threshold rate. The total number of DSAs will be 
multiplied by 0.25 and rounded to the closest integer (0.5 will round 
to the higher integer). The donation rates and organ transplantation 
rates in each DSA will be separately ranked and the threshold rate will 
be the rate that corresponds to that integer when counting down the 
ranking.
     Organ means 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 if it is used 
for research or islet cell transplantation.

------------------------------------------------------------------------
                                                              Number of
                        Organ type                             organs
                                                            transplanted
------------------------------------------------------------------------
Right or Left Kidney......................................             1
Right and Left Kidney.....................................             2
Double/En-Bloc Kidney.....................................             2
Heart.....................................................             1
Intestine.................................................             1
Intestine Segment 1 or Segment 2..........................             1
Intestine Segment 1 and Segment 2.........................             2
Liver.....................................................             1
Liver Segment 1 or Segment 2..............................             1
Liver Segments 1 and Segment 2............................             2
Right or Left Lung........................................             1
Right and Left Lung.......................................             2
Double/En-bloc Lung.......................................             2
Pancreas (transplanted whole, research, islet transplant).             1
Pancreas Segment 1 or Segment 2...........................             1
Pancreas Segment 1 and Segment 2..........................             2
------------------------------------------------------------------------

     Organ transplantation rate is the number of organs 
transplanted from donors in the DSA as a percentage of the donor 
potential. Organs transplanted into patients on the OPTN waiting list 
as part of research are included in the organ transplantation rate. The 
organ transplantation rate will be risk-adjusted for the average age of 
the donor potential using the following methodology:
    (1) The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 
55-59, 60-64, 65-69, 70-75.
    (2) Calculate a national age-specific transplantation rate for each 
age group. An expected transplantation rate for each OPO is calculated 
as [sum](g=1)Gdg*Rg/[sum]gdg, where dg is the number of potential 
donors in the OPO in age group g, Rg is the age-specific national 
transplantation rate in age group g, and [sum]gdg is the OPO's total 
number of individuals in the donor potential. This can be interpreted 
as the overall expected transplantation rate for an OPO if each of its 
age-specific transplantation rates were equal to the national age-
specific.
    (3) Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.
    Comment: We received several public comments related to the 
deletion of definitions.
    Response: We have addressed all comments related to the deletion of 
definitions in our discussion about the outcome measures throughout 
section II.B of this final rule. Comments and responses were addressed 
in the manner to how they applied to the related new or revised 
definitions. Eligible death was described in the context of the donor 
potential in section II.B.6; eligible donor and standard donor criteria 
in the context of donor definition at section II.B.3; and expected 
donation rate in the context of risk adjustments at section II.B.7 of 
this final rule.
    Final Rule Action: Under Sec.  486.302, we are finalizing as 
proposed, the removal of the following definitions: ``Eligible death,'' 
``Eligible donor,'' ``Expected donation rate,'' ``Observed donation 
rate,'' and ``Standard criteria donor (SCD).'' We are also finalizing 
as proposed, by adding the definition of ``Donation rate.'' We are 
finalizing as proposed with modifications, the definitions of ``Donor 
potential'' and ``Organ transplantation rate.'' And we are finalizing 
the new definitions: ``Assessment period,'' ``Death that is consistent 
with organ donation,'' and ``Kidney transplantation rate.''

C. Re-Certification and Competition Processes (Sec.  486.316)

1. Re-Certification and Competition Processes Sec.  486.316(a)
    In the December 2019 OPO proposed rule, we proposed to revise Sec.  
486.316(a) to provide that the OPO must meet the performance 
requirements of the outcome measures at Sec.  486.318 at the end of the 
re-certification cycle; and has been shown by survey 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.
    We proposed revisions at Sec.  486.316(a)(1) to correspond to our 
proposed outcome measures that were

[[Page 77918]]

set forth at Sec.  486.318 in the December 2019 OPO proposed rule. To 
be consistent with the tier system finalized in this rule, we also need 
revised Sec.  486.316(a)(1), (a)(2) and (a)(3) to reflect that the OPO 
has been shown by a survey to be in compliance with the conditions for 
coverage from ``Sec. Sec.  486.320 through 486.360,'' so that it is 
included Sec.  486.360 Conditions for Coverage: Emergency Preparedness, 
which was effective on November 15, 2016 (81 FR 63859). We are 
finalizing the inclusion of Sec.  486.360 in Sec.  486.316(a)(1)(i), 
(a)(2)(i) and (a)(3)(i).
    In addition, we proposed to remove Sec.  486.316(a)(3), which 
provided that for the 2022 recertification cycle only, an OPO is 
recertified for an additional 4 years and its service area is not 
opened for competition when the OPO meets one out of the two outcome 
measure requirements described in Sec.  486.318(a)(1) and (3) for OPOs 
not operating exclusively in the noncontiguous States, Commonwealths, 
Territories, or possessions; or Sec.  486.318(b)(1) and (3) for OPOs 
operating exclusively in noncontiguous States, Commonwealths, 
Territories, and possessions. An OPO is not required to meet the second 
outcome measure described in Sec.  486.318(a)(2) or (b)(2) for the 2022 
recertification cycle. We intend to relocate paragraphs (a)(3) and 
(b)(2) to paragraph (g) due to the proposed new outcome measures set 
forth at Sec.  486.318 becoming effect at the start of the next 
recertification cycle in 2022.
    As described in sections II.B ``Proposed Changes to Definitions 
(Sec.  486.302)'' and ``Proposed Changes to Outcome Requirements (Sec.  
486.318)'' of this final rule, we are not only finalizing new outcome 
measures, but we are also finalizing a tier system. The tier system 
will determine whether the OPO is immediately re-certified, must 
compete to retain its DSA, or will receive an initial de-certification 
determination. Thus, we are amending our proposal and finalizing Sec.  
486.316(a) to incorporate the tier system.
    Final Rule Action: We are finalizing Sec.  486.316(a) by 
incorporating the language for the tier system to indicate the 
requirements for each tier. We are also finalizing the inclusion of 
Sec.  486.360 in the CfCs that all OPOs must meet for re-certification. 
We are also revising Sec.  486.316(a)(3) as discussed above.
2. De-Certification and Competition Processes Sec.  486.316(b)
    In the December 2019 OPO proposed rule, we proposed that if an OPO 
does not meet the performance requirements or the outcome measures as 
described in paragraph (b) of this section at the final assessment 
prior to the end of the re-certification cycle or the requirements 
described in paragraph (b)(2) of this section, the OPO would be de-
certified. If the OPO does not appeal, or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the 
decertification, the OPO's service area is opened for competition from 
other OPOs. The de-certified OPO is not permitted to compete for its 
open area or any other open area. 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.
    As discussed in section II.B of this final rule and based on the 
comments we received, we are finalizing new outcome measures, for all 
OPOs, and except for the Hawaii DSA, those measures are the donation 
and the organ transplantation rates. Based on public comments, we are 
also establishing a tier system that will be used to classify OPOs for 
purposes of re-certification, decertification, appeals, and 
competition. The outcome measures and tier system are discussed in 
detail in sections II.B.2, II.B.4, and II.B. 6 through 10 of this final 
rule.
    We requested comments on competition, including whether all DSAs 
should be opened at the end of the re-certification cycle for 
competition under Sec.  486.316. Only one of the commenters wanted all 
of the DSAs open for competition each re-certification cycle regardless 
of the OPO's performance. Most of the commenters, however, wanted more 
competition than existed under our prior rules and contended that more 
competition would improve OPO performance. Some commenters suggested 
that OPOs that were doing well should not have to compete to retain 
their DSAs because it would divert resources from their primary mission 
of procuring organs. This finalized rule does provide for more 
competition to drive improvements in performance. Prior to this 
finalized rule, OPOs were either re-certified or de-certified based on 
their outcome measures. In this final rule, OPOs will be assigned to a 
tier based on their outcome measures. Only those OPOs that are 
designated as Tier 1 OPOs will not have their DSAs opened for 
competition (Sec.  486.316(a)). Tier 3 OPOs will be decertified and, 
following any appeals, their DSAs will be opened for competition, 
unless the de-certification is reversed as a result of the appeals 
process. With respect to Tier 2 OPOs, those DSAs will also be opened 
for competition. The incumbent OPO will have to compete if the OPO 
wants to retain its DSA and the DSA will also be open for competition 
from any other OPO that is qualified to compete for open DSAs. If a 
Tier 2 OPO does not win the competition for its DSA and does not win 
the competition for any other open DSA it competes for, CMS will not 
renew its agreement with the OPO. The OPO will not be able to appeal 
this non-renewal, which is not a de-certification. The change to a 
tiered approach increases the number of DSAs open for competition and 
the number of OPOs eligible to compete for open DSAs, which is 
consistent with the recommendation of most public commenters. Although 
we proposed to change the criteria for competition at Sec.  486.316(c) 
to correspond to the new outcome measures in Sec.  486.318, we did not 
propose any changes to the selection criteria for competition at Sec.  
486.316(d). We appreciate all of the commenters that submitted comments 
on the competition process. Those comments have been reviewed and will 
be considered in any future rulemaking
    Comment: Some commenters contended that de-certification was too 
severe of a consequence for OPOs below the lowest rate among the top 25 
percent. Those commenters do not believe that this would provide 
incentive for OPOs to improve their performance.
    Response: The establishment of the tier system should provide OPOs 
with the incentive to improve their performance. We believe that it is 
realistic that all OPOs, even those that we have estimated would be de-
certified based on their past performance, can avoid de-certification 
by improving their performance. After considering public comments, we 
have lowered the level of performance that would lead to an OPO being 
decertified. We do not agree with the commenter that de-certification 
is too severe of a consequence for Tier 3 OPOs. If an OPO cannot 
achieve the outcome measures we are finalizing in this rule, or cannot 
demonstrate compliance with the OPO CfCs through its re-certification 
survey, we believe that de-certification is the appropriate 
consequence.
    In reviewing our proposal in light of this comment, however, we 
believe that the language in this section should be clarified. In the 
December 2019 OPO proposed rule, we said, ``the OPO is de-certified.'' 
We believe that statement could be misleading. As set forth in Sec.  
486.314(a), when CMS determines that an OPO will be de-certified 
because of involuntary termination or non-renewal of its agreement with 
CMS, CMS will

[[Page 77919]]

mail the OPO an initial de-certification determination. The OPO then 
has the appeal rights set forth in Sec.  486.314. Thus, we are revising 
the language from what we proposed at Sec.  486.316(b) by removing, 
``the OPO is de-certified'' and inserting ``CMS will send the OPO a 
notice of its initial de-certification determination and the OPO has 
the right to appeal as established in Sec.  486.314''. We have also 
separated the three requirements after the stem statement to improve 
clarity and readability.
    Comment: Some commenters contended that the OPO CfCs did not need 
the drastic changes we proposed. Some commenters contended that many 
OPOs were performing well and the system was not underperforming to the 
extent that the proposed rule contended.
    Response: We agree that some OPOs, as demonstrated by their 
performance on our assessment of their performances based the new 
outcome measures, are doing a great job in procuring transplantable 
organs and working with donor families. This is why we are finalizing 
the tier system that recognizes those OPO's superior performance. In 
addition, the estimated number of OPOs that would be de-certified under 
the proposed rule (refer to Table 3 in the 2019 December OPO proposed 
rule) was based on the past performance of the OPOs. We believe that 
OPOs will be incentivized to improve their performance because of the 
outcome measures and tier system finalized in this rule. At the end of 
the first re-certification that uses these outcome measures and tier 
system, we believe that fewer OPOs will be de-certified.
    Comment: One commenter was concerned about unintended consequences 
of the requirements that may come to light if the proposals were 
finalized.
    Response: In any change of regulation, there is always a 
possibility of unintended consequences. We have taken all of the 
appropriate steps necessary to consider and develop outcome measures 
that we believe will improve OPO performance and increase the number of 
transplantable organs for those individuals on the waiting lists. In 
addition, OPO performance and patient access impacts will be monitored 
closely. If any unintended consequences come to our attention, we will 
appropriately evaluate and address them at that time.
    Comment: Some commenters expressed concern that increased pressure 
from the new outcome measures and the threat of de-certification would 
damage the relationships between the OPOs so that they will no longer 
cooperate or share best practices with each other. The commenter noted 
that this was especially concerning since the OPTN is moving towards a 
geographical allocation system, which makes cooperation between OPOs 
even more important. One commenter contended that the proposal had 
already damaged some collaboration between OPOs.
    Response: While collaboration between OPOs is a worthy goal, such 
collaboration has not resolved the significant, ongoing disparities 
that exist in OPO outcomes. Thus, it is CMS' belief that it is 
necessary to revise the current policies. We believe that the need for 
additional organs presents such a great need as to outweigh any impacts 
to OPO collaboration. Thus, in order to achieve such a benefit, it is 
necessary for incentives for OPOs to improve performance or face 
competition and decertification.
    By finalizing a tiered system, only OPOs that are not in compliance 
with the outcome measures, or found to be not in compliance with the 
conditions for coverage at the re-certification survey, will be 
designated as Tier 3 and receive a notice of de-certification. Many 
OPOs that would have been de-certified under the proposed outcome 
measures will be designated in Tier 2 and have the opportunity to 
compete to retain their DSAs. While this approach may change the nature 
of recertification, we do not believe it should change the nature of 
OPO relationships with each other. Cooperation among other OPOs in 
procuring and placing organs could not only improve an OPO's 
performance on the outcome measures, but also increase the number of 
transplantable organs.
    Based upon this tiered system, OPOs that fail to meet the outcome 
measures as specified in Sec.  486.318(e)(6), that is an OPO that fails 
to meet the median threshold for the donation or transplantation 
measures, fails to meet the median threshold for the donation and 
transplantation measures or fails to demonstrate compliance with the 
OPO CfCs via the re-certification survey, will be the only OPOs that 
are designated into Tier 3. An OPO that qualifies for Tier 3 
designation will receive an initial notice of de-certification 
determination, has the appeal rights set forth at Sec.  486.314, and, 
if decertified, cannot compete for either its own or any other open 
DSA.
    Final Rule Action: We are modifying Sec.  486.316(b) to correspond 
to the tier system we are finalizing for OPOs. In addition, to clarify 
the requirements associated with this modification, we have also 
designated three requirements at paragraphs (b)(1) through (b)(3). 
Paragraph (b)(1) to clarify that the OPO will receive a notice of 
initial de-certification determination and the OPO has the right to 
appeal as established in Sec.  486.314. Paragraph (b)(2) clarifies that 
the DSA will be open for competition and the OPO cannot compete for its 
DSA or any other DSA that is open for competition. Paragraph (b)(3) 
clarifies that the OPO must continue to perform its functions in the 
DSA until a successor OPO is selected and there has been an orderly 
transition to the new OPO.
3. Criteria To Compete Sec.  486.316(c)
    The current requirements set forth at Sec.  486.316(c) state that 
for an OPO to compete for an open DSA, it must meet the criteria for 
re-certification and meeting the following criteria: (1) The OPO's 
performance on the donation rate outcome measure and yield outcome 
measure is at or above 100 percent of the mean national rate averaged 
over the 4 years of the re-certification cycle; (2) The OPO's donation 
rate is at least 15 percentage points higher than the donation rate of 
the OPO currently designated for the service area; and (3) The OPO must 
compete for the entire service area. We proposed to modify this section 
by requiring the OPO to meet the performance measures set forth in 
Sec.  486.318 and the requirements for certification at Sec.  486.303, 
including the CfCs at Sec. Sec.  486.320 through 486.360. We also 
proposed to retain the requirements that the OPO would have to compete 
for the entire DSA. Except for the last requirement, these proposed 
changes were necessary to correspond to the proposed outcome measures. 
We proposed to remove ``Sec.  486.348'' and insert ``Sec.  486.360'' so 
that it included Sec.  486.360 Conditions for Coverage: Emergency 
Preparedness, which was effective on November 15, 2016 (81 FR 63859). 
This change will be incorporated into Sec.  486.316(a) and Sec.  
486.316(c).
    Comment: Commenters generally supported the proposed changes, 
except for the requirement for the competing OPO(s) to compete for the 
entire open DSA. At least one commenter recommended that there would be 
more competition if an OPO could compete for a portion, rather than the 
entire, open DSA.
    Response: We respectfully disagree. Since the 2006 OPO final rule, 
we have required that any OPO that is competing for an open DSA must 
compete for the entire DSA. OPOs do not have the discretion to decide 
whether a DSA's boundaries should be adjusted. CMS can adjust or change 
the boundaries for a DSA consistent with statutory criteria. Moreover, 
we believe it would be

[[Page 77920]]

detrimental to patients and to the system if particular segments were 
carved out. Under the final rule, all of the OPOs that choose to 
compete would be competing for the same geographic territory.
    Final Rule Action: We are finalizing Sec.  486.316 (c) as proposed, 
with changes to address the tier system. Specifically, we are adding a 
reference to ``Tier 1 or Tier 2 at Sec.  486.318(e)(4) and (5) instead 
of the broader reference to Sec.  486.318 as we proposed.
4. Criteria for Selection Sec.  486.316(d)
    Section 486.316(d) originally stated that, ``CMS will designate an 
OPO for an open service area based on the following criteria.'' In the 
December 2019 OPO proposed rule, we proposed to modify the stem 
statement to read, ``CMS will consider the following criteria in 
designating an OPO for an open DSA.'' Our original intention was for 
the criteria listed in this section to be guidelines instead of a 
strict criteria for selection.
    We did not, however, solicit comments on all aspects of Sec.  
486.316(d), including the requirements that would be used for 
competition (84 FR 70635) on selection criteria. We did receive some 
comments for this requirement. However, we did not solicit comments in 
a manner that would allow us to receive comments and consider a full 
range of factors that may impact selections. Those comments have been 
reviewed and will be considered for future rulemaking.
    Final Rule Action: We are finalizing Sec.  486.316(d) as proposed.
5. Extension of the Agreement Cycle for Extraordinary Circumstances 
Sec.  486.316(f)
    We did not propose any exception to the outcome measures 
requirement if the OPO experienced a disaster or some sort of 
extraordinary circumstance that was beyond its control and negatively 
impacted the OPO's performance during the final assessment period of 
the re-certification cycle.
    Comment: We received comments that there may be natural disasters 
or events beyond the OPOs control that could happen during that final 
assessment period.
    Response: As discussed above, we recognize that there may be 
circumstances beyond the OPO's control that could adversely affect the 
data in the final assessment period of the agreement cycle. The 
consequences of these events for the QAPI revision is less significant 
because re-assessment of performance and making changes to improve 
performance is a continuous process. For re-certification, a natural 
disaster (such as a hurricane) or an infectious disease outbreak (such 
as an epidemic) that could impact DSAs disproportionately or have a 
disparate impact between the OPOs. Pursuant to these comments, we are 
revising the regulations at Sec.  486.316(f), as described in more 
detail below, to include an extension of the agreement cycle for 
extraordinary circumstances.
    These comments demonstrate that there could be extraordinary 
circumstances that are beyond an OPO's control that could negatively 
impact the OPO's performance on its outcome measures. This could result 
in an OPO's performance not being accurately captured by the outcome 
measures. It is our intention to set empirical and transparent metrics 
for performance, and understand that there are extraordinary 
circumstances that could compromise or skew the underlying data. These 
extraordinary circumstances could include problems with the data such 
as data submission or transfer, a natural disaster, or other events 
with disparate effects. Therefore, we are finalizing that an OPO may 
apply for an extension of its agreement with CMS for 1-year. This is 
only for the final assessment period of the re-certification cycle when 
there has been and extraordinary circumstance beyond the OPO's control. 
The OPO must request this extension within 90 days of the end of the 
occurrence but no later than the last day of the final assessment 
period.
    Final Rule Action: We are finalizing Sec.  486.316(f) that provides 
for OPOs to seek a 1-year extension of the agreement cycle if there are 
extraordinary circumstances beyond the control of the OPOs that has 
affected the data of the final assessment period so that it does not 
accurately capture their performance. OPOs must request this extension 
within 90 days of the end of the occurrence of the extraordinary 
circumstance but no later than that last day of the final assessment 
period.

D. Reporting of Data Sec.  486.328

    In the December 2019 OPO proposed rule, we proposed to eliminate 
the reporting of the ``Number of eligible deaths'' and modifying the 
reporting of the ``Number of eligible donors'' to ``Number of donors'' 
to correlate with the changes of our outcome measures. We also proposed 
to revise language in this section that incorrectly refers to the 
``Scientific Registry of Transplant Beneficiaries'' and ``DHHS.'' We 
did not receive any comments that we should continue to collect 
eligible death information if it is not being used, nor did we receive 
comments about the correction in the other language.
    Final Rule Action: We are finalizing at Sec.  486.328(a) by 
removing the word ``Beneficiaries'' and adding in its place the word 
``Recipients'' and by removing the acronym ``DHHS'' and adding in its 
place the acronym ``HHS.'' We are finalizing at Sec.  486.328(a)(4) by 
removing and reserving the reporting of the ``Number of eligible 
deaths,'' and revising at Sec.  486.328(a)(7) by removing the word 
``eligible and revising the language to say ``Number of donors.'' We 
are also removing and reserving paragraph (a)(4) of Sec.  486.328.

E. Proposed Change to the Quality Assessment and Performance 
Improvement Requirement (Sec.  486.348)

    In the December 2019 OPO proposed rule, we proposed at Sec.  
486.348(d) to require that OPOs include a process to evaluate and 
address their outcome measures in their QAPI program if their rates are 
statistically significantly lower than the top 25 percent at each 
assessment, for each assessment period except the final assessment. 
Failure to meet the outcome measure in the final assessment period 
would result in de-certification. For all other assessment periods, if 
the OPO does not meet the outcome measures, the OPO must identify 
opportunities for improvement and implement changes that lead to 
improvement in these measures.
    As we stated in the December 2019 OPO proposed rule (84 FR 70628), 
an OPO that was deemed compliant on its QAPI, but did not meet one or 
both of the proposed outcome measures that would be subject to 
decertification. We also sought comments as to whether Sec.  486.348(b) 
should be revised or removed altogether to eliminate death record 
reviews since we are no longer using eligible deaths.
    Comment: Most commenters supported the concept that ongoing 
performance improvement should be a goal of the organ procurement and 
transplantation community. However, commenters suggested that we 
include a process for performance improvement for OPOs which don't 
initially meet the metrics before proceeding with decertification. 
These commenters stated that a systematic approach to decertification 
provides structure and guidance to lower performing organizations and 
allows for guidance to improve. They also stated that this improvement 
will create more stability in the nationwide system and ultimately lead 
to the end goal of improving performance without disrupting the network 
of service providers. Commenters stated that using the most

[[Page 77921]]

recent 12 months of data gives a more accurate view of the OPOs 
performance, using the entire 4 years is too long. On the other hand, 
some commenter's stated that every 12 months is too often and should be 
only required at least once during the 4-year cycle.
    Response: We believe that all OPOs have the potential to improve. 
Thus, we are finalizing that every 12 months during the 4-year cycle, 
an OPO will be assessed for its performance on the outcome measures. 
During that assessment, if the OPO is performing lower than the 25 
percent threshold rate, they will have the opportunity to develop a 
performance improvement plan to improve performance through their QAPI 
program. The use of annual review allows the OPO to more swiftly 
identify and address potential problems. We proposed to require that 
OPOs include a process to evaluate and address their QAPI program if 
their rates are statistically significantly lower than the top 25 
percent at each assessment, for each assessment period, except for the 
final year. However, public comment supported completing QAPI in all 4 
years of the certification period, so we have decided to include the 
final year in the assessment to allow the OPO to identify opportunities 
for improvement and implement the changes to improve performance.
    Comment: One commenter suggested that the donor hospital CoPs 
should track organ donation and work to improve the donation process 
and that this information from donor hospitals should be tracked by 
CMS. By collecting and reviewing this data from donor hospitals, CMS 
would be able to use this data to identify ``best practices'' to share 
with the donation community. The commenter suggested CMS consider 
establishing a method to measure and ensure that all three entities 
(donor hospitals, OPOs, and transplant hospitals) are fulfilling the 
expectations outlined in federal regulations.
    Response: The actions of donor hospitals and their data submission 
are outside of the scope of this rule. We will consider this suggestion 
for future rulemaking related to the hospital Conditions of 
Participation.
    Comment: A few commenters questioned whether or not the OPOs are 
receiving all the information, resources and expertise that they need 
to be successful in their outcome measures and QAPI programs.
    Response: There are many organizations that are available to help 
OPOs perform the best job possible for organ donors and recipients. The 
OPTN, through its contract with UNOS, is an organization that provides 
tools, resources, and expertise to help OPOs improve the quality of 
service they provide, in order to achieve our joint goal of placing 
donated organs equitably and efficiently and saving more lives. This 
process involves continuously evaluating new advances and discoveries 
so policies can be adapted to best serve patients waiting for 
transplants. All transplant programs and organ procurement 
organizations throughout the country are OPTN members. We have heard 
from commenters and seen changes since the publication of the December 
2019 OPO proposed rule, such that we are confident that through 
collaboration and the sharing of best practices, the industry is 
capable of ongoing performance improvement.
    Final Rule Action: After consideration of the public comments, we 
are finalizing our proposal at Sec.  486.348(d) with modification. We 
will include the review of the QAPI program for all 4 years of the 
recertification cycle.
1. Death Record Review in QAPI
    In the December 2019 OPO proposed rule, we requested comments as to 
whether the requirement related to monthly death record reviews at 
Sec.  486.348(b) should be revised or removed altogether.
    Comment: We received mixed comments on whether we should eliminate 
the death record review as part of the QAPI at Sec.  486.348(b). Those 
who wanted to remove the requirements commented that death record 
reviews were a tremendous amount of work. Those who suggested that we 
should retain the requirement found value with the death record 
reviews.
    Response: We are not revising Sec.  486.348(b) to remove the 
requirement for the death record review. While we appreciate comments 
related to potential burden from these reviews, commenters also 
reported important added value from the information. The reviews 
support verifying accuracy of data reported to the OPTN by the OPO, 
identify potential missed opportunities for donation, facilitate 
collaboration with donor hospitals through sharing of results, and 
facilitate internal QAPI activities. Additionally, data from death 
record reviews may provide relevant information for judging OPO 
performance during the survey process.
    Final Rule Action: We will not revise Sec.  486.348(b) to remove 
the requirement for the death record review.

F. Solicitation of Comments

    We received many responses to our solicitation of comments in the 
December 2019 OPO proposed rule. The comments we received have been 
addressed in sections II.A, II.B, II.C of this final rule regarding 
outcome measures, general comments, competition process and 
recertification.
1. Out of Scope
    Comment: We received several comments pertaining to issues that are 
outside the scope of the proposed rule. Those comments concerned 
transplant program outcome measures/harmonizing outcome measures, 
comments about Medicare and Medicaid spending and FDA approval of drugs 
relating to organ transplants. In addition, some commenters sought to 
change instructions to donor hospitals through hospital CoPs, 
transplant program CoPs, and OPO governance issues.
    Response: We thank the commenters for their feedback. However, 
these issues are outside the scope of the final rule that focused 
primarily on the outcomes measures for OPOs and the consequences of 
recertification or decertification of OPOs because of the changes such 
measures. We will review these comments and consider for potential 
future rulemaking.

III. Provisions of the Final Rule

    In this final rule, we are adopting the provisions of the December 
2019 OPO proposed rule (84 FR 70628) with the following revisions:

A. Proposed Changes to Definitions (Sec.  486.302) and Proposed Changes 
to Outcome Requirements (Sec.  486.318).

     We are finalizing as proposed with modifications, the 
definitions of ``Donor potential'' and ``Organ transplantation rate.'' 
And we are finalizing the new definitions: ``Assessment period'' and 
``Death that is consistent with organ donation,'' and ``Kidney 
transplantation rate.
     We are finalizing our proposal at Sec.  486.318(d)(4) in 
this final rule using the death certificate data to calculate the donor 
potential.
     We are finalizing a modification to the definition of the 
``donor potential'' under Sec.  486.302 to apportion the donor 
potential in a county where there is a donor hospital that has sought a 
waiver to work with an OPO out of their designation service area. For 
OPOs servicing a hospital with a waiver under Sec.  486.308(e), the 
donor potential of the county for that hospital will be adjusted using 
the proportion of Medicare beneficiary inpatient deaths in the hospital 
compared with the total Medicare beneficiary inpatient deaths in the 
county.

[[Page 77922]]

     We are finalizing under Sec.  486.302 that ``death that is 
consistent with organ donation'' means all deaths from 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): Blunt trauma, gunshot 
wounds, drug overdose, suicide, drowning, and asphyxiation.
     We are finalizing the new definition, ``Assessment 
period'' under Sec.  486.302 to be a 12-month period in which an OPO's 
outcome measures will be evaluated for performance. The final 
assessment period is the 12-month assessment period used to calculate 
outcome measures for re-certification.
     We are finalizing that the kidney transplantation rate is 
the number of kidneys transplanted from kidney donors in the DSA as a 
percentage of the donor potential.
     We are finalizing as proposed that the age cutoff for the 
donor potential defined in Sec.  486.302 is 75 and younger.
     We are finalizing the definition of ``organ 
transplantation rate'' under Sec.  486.302 to be risk-adjusted for the 
average age of the donor potential using the following methodology:
    (1) The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 
55-59, 60-64, 65-69, 70-75.
    (2) Calculate a national age-specific transplantation rate for each 
age group. An expected transplantation rate for each OPO is calculated 
as [sum](g=1)Gdg*Rg/[sum]gdg, where dg is the number of potential 
donors in the OPO in age group g, Rg is the age-specific national 
transplantation rate in age group g, and [sum]gdg is the OPO's total 
number of individuals in the donor potential. This can be interpreted 
as the overall expected transplantation rate for an OPO if each of its 
age-specific transplantation rates were equal to the national age-
specific.
    (3) Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.
     We will be finalizing the implementation this final rule 
60 days after publication and the new outcome measures will be 
implemented on August 1, 2022 to coincide with the start of the next 
certification period.
     We are finalizing our proposal at Sec.  486.318(d)(1) that 
the donation rate will be one of the outcome measures for assessing OPO 
performance, and is defined as the number of donors as a percentage of 
the donor potential.
     We are finalizing our proposal at Sec.  486.318(d)(2) that 
the organ transplantation rate will be an outcome measure for assessing 
OPO performance, and is defined as the number of organs transplanted 
from donors in the DSA as a percentage of the donor potential.
     We are also finalizing under Sec.  486.318(d)(3) a 
clarification that for calculating each measure. The numerator for the 
donation rate is the number of donors in the DSA. The numerator for the 
organ transplantation rate is the number of organs transplanted from 
donors in the DSA. The numerator for the kidney transplantation rate is 
the number of kidneys transplanted from donors in the DSA. The numbers 
of donors, organs transplanted, and kidneys transplanted are based on 
the data submitted to the OPTN as required in Sec.  486.328 and Sec.  
121.11. For calculating each measure, the data used would be from the 
same time period as the data for the donor potential.
     We are finalizing our proposal that we will use the most 
recent 1 year of data for calculating the outcome measures for each 
assessment period under Sec.  486.318.
     We are finalizing Sec.  486.318(e)(4) through (6), the 
creation of three tiers to identify OPO performance.
    Tier 1--OPOs that have an upper limit of the one-sided 95 percent 
confidence interval for their donation and organ transplantation rates 
that are at or above the top 25 percent threshold rate established for 
their DSA will be identified at each assessment period.
    Tier 2--OPOs that have an upper limit of the one-sided 95 percent 
confidence interval for their donation and organ transplantation rates 
that are at or above the median threshold rate established for their 
DSA but is not in Tier 1 as described in paragraph (e)(4) will be 
identified at each assessment period.
    Tier 3--OPOs that 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 for their DSA will 
be identified at each assessment period. OPOs that have an upper limit 
of the one-sided 95 percent confidence interval for their donation and 
organ transplantation rates that are below the median threshold rate 
for their DSA are also included in Tier 3.
     We are finalizing under Sec.  486.318(e)(7) that for the 
OPO exclusively serving the DSA that includes the non-contiguous state 
of Hawaii and surrounding territories, the kidney transplantation rate 
will be used instead of the organ transplantation rate. The comparative 
performance and designation to a Tier will be the same as in paragraphs 
(e)(4), (5), and (6) except kidney transplantation rates will be used.

B. Re-Certification and Competition Processes (Sec.  486.316)

     We are modifying our proposed changes to Sec.  486.316(a), 
(b), and (c) to make corresponding changes for the tier system we are 
finalizing.
     We are modifying the language in Sec.  486.316(b) by 
removing ``the OPO is de-certified'' and inserting ``CMS will send the 
OPO a notice of its initial de-certification determination and the OPO 
has the right to appeal as established in Sec.  486.314''.
     We are finalizing under Sec.  486.316(f) that OPOs can 
seek a 1-year extension of the agreement cycle if there are 
extraordinary circumstances beyond the control of the OPO that has 
affected the data of the final assessment so that it does not 
accurately capture their performance. OPOs must request this extension 
within 90 days of the end of the occurrence of the extraordinary 
circumstance but no later than that last day of the final assessment 
period.

C. Proposed Change to the Quality Assessment and Performance 
Improvement Requirement (Sec.  486.348)

     We are finalizing our proposal at Sec.  486.348 with 
modification. We will include the review of the QAPI program for all 4 
years of the re-certification cycle.
     We are not revising Sec.  486.348(b) to remove the 
requirement for the death record review.

D. Solicitation of Comments (Including Changes to Re-Certification 
Cycle)

    We solicited comments in the December 2019 OPO proposed rule on the 
following issues:
     Should OPO outcome measures also include an assessment of 
organ transplantation rates by type of organ transplanted?
     We are proposing to use a performance measure that is 
based on the OPO's performance relative to the top 25 percent of 
donation rates and organ transplantation rates. Should CMS use a static 
level or a different criterion from what is being proposed? What 
statistical approach to the data or incentives can we use to encourage 
all OPOs to strive to be high performers? Can the current performance 
parameter, which requires that the donation rate be no more than 1.5 
standard deviations

[[Page 77923]]

below the mean national donation rate, be appropriately applied to 
achieve this goal? We are requesting that commenters explain and 
include any evidence or data they have to support their comments.
     What are the benefits, consequences, or unintended 
consequences, of using these two proposed measures and what are their 
potential impact on OPOs, transplant programs, organ donation, patient 
access, and transplant recipients?
     Are there potential additional compliance burdens on OPOs 
or transplant programs if the two proposed measures were finalized?
    We received robust public comments in response to this solicitation 
that have been summarized and responded to as part of the discussions 
in sections II.A through C of this final rule.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We received no comments on the need for information collection, the 
accuracy of our estimates, the quality or utility of the information to 
be collected, or the information collection burden estimates.
    We solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):

A. ICRs Regarding Extension of Agreement Cycle for Extraordinary 
Circumstances (Sec.  486.316)

    In this final rule at Sec.  486.316(f), we have added a paragraph 
in response to public comments allowing for an extension of the 
agreement cycle for extraordinary circumstances. OPOs may seek a 1-year 
extension of the agreement cycle if there are extraordinary 
circumstances beyond the control of the OPOs that has affected the data 
of the final assessment period so that it does not accurately capture 
their performance. OPOs must request this extension within 90 days of 
the end of the occurrence of the extraordinary circumstance but no 
later than the last day of the final assessment period. In section 
II.C.5 of this final rule, we state that to seek an ECE exception, the 
OPO needs to describe the extraordinary circumstance, the time period 
is which it occurred, why it was beyond the control of the OPO, and why 
it affected their performance in such a way that the data does not 
accurately capture.
    We will need to submit a revised information collection request for 
the OPO CfC (OMB Control Number 0938-0688, expiring February 2021) 
information to reflect the opportunity we are providing for OPOs to 
request an ECE. Since requesting an ECE will place the DSA off-cycle 
from the other DSAs for re-certification, we expect that OPOs will be 
judicious in deciding to request the 1-year ECE. It is difficult to 
predict extraordinary events, however for the purposes of our burden 
estimate, we anticipate four OPOs requesting an ECE with each 4-year 
re-certification cycle, resulting in an average of 1 request per year.
    We estimate that the OPO director ($107/hour), and a medical 
secretary ($35/hour) will need 1 hour each to collect relevant evidence 
to support the extraordinary circumstance, describe it in writing, and 
submit the information to CMS. All wages are adjusted upwards by 100 
percent to account for the cost of fringe benefits and overhead. The 
result would be an annual cost of $284 (2 hours x $142).\19\
---------------------------------------------------------------------------

    \19\ These and subsequent estimated wage costs are based on the 
Labor Department's Bureau of Labor Statistics annual occupational 
wage survey at https://www.bls.gov/oes/current/oes_nat.htm. We 
double the hourly wage estimate to account for the costs of overhead 
and fringe benefits.
---------------------------------------------------------------------------

B. ICRs Regarding Re-Certification and Competition Processes (Sec.  
486.316)

    At Sec.  486.316(b), we proposed to modify language that refers to 
the current outcome measure requirements that states that an OPO must 
meet two out of the three outcome measures at Sec.  486.318. They would 
instead be required to meet both newly proposed outcome measures, or 
face de-certification which may then be appealed by the OPO. If the OPO 
does not appeal or the OPO appeals and the reconsideration official and 
CMS hearing officer uphold the de-certification, the OPO's service area 
would be opened for competition by other OPOs.
    In the final rule, we maintain these requirements with some 
modifications. Most notably, we are creating a three-tier, rather than 
two-tier, performance system, with OPOs performing below the threshold 
rate established by the top 25 percent required to update their QAPI 
program at each assessment period and those OPOs who are in Tier 2 (has 
at least the donation rate and the organ transplantation rate at or 
above the median threshold rate) being allowed to compete to retain 
their DSA rather than automatically being decertified. These changes do 
not significantly affect the information to be collected or the net 
effect of the rule on information collection, since all DSAs with 
outcome measures below the threshold rate of the top 25 percent would 
remain subject to competition.
    The current information collection request for the OPO CfC (OMB 
Control Number 0938-0688, expiring February 28, 2021) estimates that 
one OPO would face de-certification per year, but under both the 
proposed and final rule, revised outcome measures, this number could 
potentially significantly increase after the first cycle of 
implementation. The intention for subsequent cycles is that the outcome 
measures of all DSAs would cluster at the top 25 percent threshold 
rate. We do not know exactly how many would be de-certified under these 
new measures. Based on the improvement required to meet the proposed 
rule measures, we estimated that it would be possible that 
approximately 7 to 33 OPOs could be de-certified. Given the change in 
the final rule to the three tier system and the potential for Tier 2 
OPOs to retain their certification, we believe that the number would be 
lower. The range of decertified OPOs would thus vary from zero OPOs 
that are decertified, to all Tier 3 OPOs being decertified and all Tier 
2 OPO DSAs being open for competition. Since there are 22 OPOs in the 
lowest tier, and all of these will presumably be trying to improve 
their performance using the assessment period data provided each year 
and their QAPI, it seems likely that at most about half of the OPOs 
(11) would be decertified based on their outcome measures in 2024. 
There would also be 12 OPOs in Tier 2 whose respective service areas 
would be opened for competition. If the 12 OPOs in Tier 2 were joined 
by the 22 OPOs in Tier 3, there would be 34 open DSAs subject to 
potential competition. Of course, with improved performance in response 
to the annual assessments, the number at

[[Page 77924]]

risk could be as low as zero. However, to be conservative we have 
chosen mid-point estimates to calculate estimated burden and potential 
impact.
    Under Sec.  486.316(d), Criteria for selection, we identify the 
factors that we will consider in awarding a DSA to an OPO competing for 
an open service area. In addition to factors that CMS will produce and 
collect from other aspects of the CfCs, OPO will need to submit 
information and data that describes the barriers in its service area, 
how they affected organ donation, what steps the OPO took to overcome 
them, and the results. In addition, Sec.  486.316(c) states that to 
compete for an open service area, an OPO must meet the performance 
requirements of the outcome measures at Sec.  486.318 and the 
requirements for certification at Sec.  486.303, including the CfCs at 
Sec. Sec.  486.320 through 486.360. The OPO must also compete for the 
entire service area.
    Since much of the information about the outcome measures is already 
calculated and collected by CMS and performance in the CfCs at 
Sec. Sec.  486.320 through 486.360 through the re-certification survey, 
the burden associated with this requirement is the time it would take 
to create a document that contains the required information and data 
related to the OPO's success in identifying and addressing the barriers 
in its own service area and how they relate to the open service area. 
We refer to this documentation as an application.
    While we have never de-certified an OPO under the current rules, we 
know from our past experience trying to de-certify an OPO that 
approximately 10 other OPOs were interested in taking over the open 
DSA. For purposes of estimation, we assume that about half of the DSAs 
opened for competition based on 2018 calculations would have improved 
sufficiently that they would not be opened for competition in 2024: 11 
DSAs with Tier 3 designation and 6 DSAs with Tier 2 designation. Since 
this final rule would expand the number of open DSAs, OPOs are likely 
to be more strategic in trying to take over an open DSA with more 
effort being placed to try to take over a DSA being de-certified 
instead of a DSA designated as Tier 2. For the Tier 3 DSAs, we assume 
that approximately 5 OPOs will apply for each open DSA, resulting in 55 
applications. For the 6 open Tier 2 DSAs, we assume that all incumbent 
OPOs will try to retain their DSA and an average of 2 other OPOs will 
try to take over the Tier 2 DSA, resulting in 18 more applications. In 
total, we estimate approximately 73 applications will be developed to 
compete for an open DSA at each re-certification cycle. We will revise 
these burden estimates after the first re-certification cycle for 
accuracy.
    We believe that developing each application would require the 
collective efforts of a QAPI director (Registered Nurse, $71/hour), 
organ procurement coordinator (RN or social worker, $71/hour), medical 
director ($107/hour), OPO director ($107/hour), and a medical secretary 
($35/hour). All wages are adjusted upwards by 100 percent to account 
for the cost of fringe benefits and overhead. Assuming, consistent with 
past rulemaking, that it would take these professionals 104 hours to 
develop such an application, we estimate that a total of 7,592 hours 
(73 applications x 104 hours) to complete the competition for each re-
certification cycle. We further estimate that 47 OPOs are eligible to 
compete for an open DSA and that all 12 of those OPOs (in Tier 2) will 
compete to retain their DSA and 4 OPOs (the top third) in Tier 2 will 
compete for another DSA. Of the remaining 23 OPOs who are in Tier 1, we 
estimate that at most (20) will try to compete for an open DSA.
    We estimate that on average, each competition would require 7,592 
burden hours for all 43 OPOs to complete 73 applications and would cost 
all 43 OPOs $644,152 (($71 RN x 30 hours x 73 applications) + ($71 
organ procurement coordinator x 30 hours x 73 applications) + ($107 
medical director x 12 hours x 73 applications) + ($107 OPO director x 
30 x 73 applications) + ($35 medical secretary x 2 hours x 73 
applications)). For the annual burden, each of these figures needs to 
be divided by 4, since competition for open service areas will 
typically occur every 4 years. Thus, the annual burden hours for all 43 
OPOs to prepare 73 plans would be 1,898 (7,592/4) and the annual cost 
estimate would be $161,038 ($644,152/4).

C. ICRs Regarding Condition: Reporting of Data (Sec.  486.328)

    We proposed to revise Sec.  486.318 to eliminate the reporting of 
the ``Number of eligible deaths'' and modify the reporting of ``Number 
of eligible donors'' to ``Number of donors.'' Although the current 
outcome measures include the potentially burdensome OPO self-defined 
and self-reported ``eligible deaths'' for evaluation purposes, the 
current information collection request for the OPO requirements (OMB 
Control Number 0938-0688, expiring February 28, 2021) does not 
attribute any burden to this requirement. This is because the type of 
data and how it is reported to the OPTN is already covered by the 
information collection requirements associated with the OPTN final rule 
(Sec.  121). The OMB control number for this collection is 0915-0157 
(expiring August 31, 2023). Thus, we are not attributing any 
quantifiable burden reduction to eliminating this requirement in the 
final rule.

D. ICRs Regarding Quality Assessment and Performance Improvement (Sec.  
486.348)

    At Sec.  486.348(d) we are requiring that OPOs include a process to 
evaluate and address their outcome measures in their QAPI program if 
their rates are statistically significantly lower than the top 25 
percent at each assessment. Assessments would occur at least every 12 
months with the most recent prior 12 months of available data, meaning 
there would be 4 assessments in each 4-year re-certification cycle that 
might require modifications to these OPOs' QAPI programs.
    As stated in the information collection request for the OPO 
requirements (OMB Control Number 0938-0688, expiring February 28, 
2021), we believe the information collection requirements associated 
with maintaining a QAPI program are exempt as defined in 5 CFR 
1320.3(b)(2) because the time, effort, and financial resources 
necessary to comply with this collection of information would be 
incurred by persons in the normal course of their activities. 
Accordingly, we do not believe this change would impose any additional 
ongoing quantifiable burden.

V. Regulatory Impact Analysis

A. Statement of Need

    All major government regulations should undergo periodic review to 
ensure that they do not unduly burden regulated entities or the 
American people, and that they accomplish their goals effectively and 
efficiently. It has been apparent for a number of years that the 
current system for organ donation and the rules under which OPO 
performance is measured do not create the necessary incentives to 
optimize organ donation and transplantation as evidenced by performance 
discrepancies among OPOs, the wide geographic and population diversity 
among both higher- and lower-performing OPOs, and the significant gap 
between the number of potential organ donors and the number of actual 
donors (see Tables 1 and 2). As discussed in the December 2019 OPO 
proposed rule, many anecdotal article titles identify a clear need for 
action: ``Reforms to Organ Donation System Would Save Thousands of 
Lives,

[[Page 77925]]

Millions of Taxpayer Dollars Annually,'' ``Lives Lost, Organs Wasted,'' 
and ``A Simple Bureaucratic Organ Donation Fix Will Save Thousands of 
Lives.'' \20\ All three of these articles include, or reference, in-
depth studies of the current organ donation system's problems and 
discuss reforms that could increase its performance. These articles 
were written by and published in: Goran Klintman, RealClearHealth, 
March 4, 2019; Kimberly Kindy, Lenny Bernstein, and Dan Keating, 
Washington Post, December 20, 2018; and Laura and John Arnold, STAT, 
July 24, 2019. These problems and the reforms needed to improve organ 
donation and transplantation have multiple dimensions, including the 
underperformance of many OPOs to procure and place organs at the levels 
of the best-performing OPOs. This is the basis for President Trump's 
July 10, 2019 Executive Order on Advancing American Kidney Health, to 
``increase access to kidney transplants by modernizing the organ 
recovery and transplantation systems and updating outmoded and 
counterproductive regulations.''
    The majority of the public comments agreed that these were major 
problems and that many lives could be saved if reforms were made. For 
example, one OPO which had just greatly increased its donor performance 
stated that ``we know that there are many more potential donors in our 
DSA [and] it is our intent to act on that belief . . . Substantial, not 
incremental, change is required in our system.''
    Relatedly, the Secretary issued a final rule on September 30, 2019, 
titled ``Medicare and Medicaid Programs; Regulatory Provisions To 
Promote Program Efficiency, Transparency, and Burden Reduction; Fire 
Safety Requirements for Certain Dialysis Facilities; Hospital and 
Critical Access Hospital (CAH) Changes To Promote Innovation, 
Flexibility, and Improvement in Patient Care'' (84 FR 51732), referred 
to as the ``2019 Burden Reduction final rule'', to reduce regulatory 
burden on several types of health care providers'') that directly 
addressed the same policy concern. Under that final rule, performance 
standards for transplant hospitals were revised to reduce the practice 
of transplanting only the best organs in the healthiest patients. Those 
performance standards rewarded high 1-year organ and patient survival 
rates by threatening program closure to hospitals that did not achieve 
such rates. In so doing, those performance standards gave no weight to 
maximizing treating the many patients on the waiting lists whose lives 
would be saved, even at a higher risk of failure. As discussed in the 
RIA for 2019 Burden Reduction final rule, lessening or eliminating 
those standards might reduce the number of ``transplant quality'' 
discarded organs, and through transplantation of those organs, save the 
lives of many patients each year. Because transplant programs had been 
notified over a year ago that these penalties were likely to be 
eliminated, the regulatory changes may have led to changes beginning in 
late 2018 and continuing in 2019 to utilize more organs than in 
previous years.
    Finally, the Executive Order directs the Secretary of HHS as 
follows: ``Within 90 days of the date of this order, the Secretary 
shall propose a regulation to enhance the procurement and utilization 
of organs available through deceased donation by revising Organ 
Procurement Organization (OPO) rules and evaluation metrics to 
establish more transparent, reliable, and enforceable objective metrics 
for evaluating an OPO's performance.'' That directive applied directly 
to the proposed rule that preceded this final rule.

B. Scope of Review

    We have examined the impacts of both the proposed rule and this 
final rule as required by E.O. 12866 on Regulatory Planning and Review 
(September 30, 1993), E.O. 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism 
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and 
Executive Order 13771 on Reducing Regulation and Controlling Regulatory 
Costs (January 30, 2017).
    Executive Order 13771 states that it is essential to manage the 
costs associated with the government imposition of private expenditures 
required to comply with federal regulations and establishes policies 
and procedures to reduce the costs of both new and existing federal 
regulations.
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    An RIA must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). We estimated 
and OMB has determined that this rule is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we prepared an RIA 
that presented our estimates of the costs and benefits of this 
rulemaking.
    Based on the public comments we received, our review of these 
comments, our review of new research literature, and the absence of any 
comments finding errors in our original analysis, we conclude that our 
estimates on the likely effects of the December 2019 OPO proposed rule 
may have been reasonable. In this final RIA, we have re-estimated some 
effects because of the substantive changes made in the final rule, but 
none of these re-estimates change the main conclusions previously 
reached on overall costs and benefits of this rule.

C. Effects on OPO Performance

    We proposed two new outcome measures that would be used to assess 
an OPO's performance: A measure of an OPO's donation rate and a measure 
of its organ transplantation rate in the DSA. In the December 2019 OPO 
proposed rule, these were two independent tiers that each allowed for 
only ``pass or fail'' levels of performance. As discussed earlier in 
the preamble, the final rule now contains a three-tier system for each 
outcome measure. Table 1 shows current performance using the donation 
rate outcome measure in this final rule, derived from data spanning 
January 1, 2018 to December 31, 2018. The final

[[Page 77926]]

rule contains a major change in the determination of the donor 
potential (denominator) for the outcome measures using the CALC 
methodology for estimating the donor potential as explained in section 
II.B.6 of the December 2019 OPO proposed rule and in section V.G 
``Alternatives Considered'' of this final rule. The CALC measure is 
endorsed by much of the peer-reviewed literature as technically 
superior. For the vast majority of OPOs, using the CALC methodology to 
estimate the denominator does not change their relative performance 
substantially from that in the December 2019 OPO proposed rule. For 
example, in Table 13a of the December 2019 OPO proposed rule, we showed 
that the top 18 performers on donation using the then-proposed measure 
were also the top 18 performers using the CALC measure. Seventeen of 
the 20 lowest donation performers on the then-proposed measures were 
also in the lowest performing group on the CALC measure.
    In both the proposed and final rules, the performance variable for 
the donation rate is the number of actual donors who had at least one 
organ transplanted, regardless of the number of organs that each 
provides. This measure focuses on the key tasks of obtaining family 
consent, clinically managing the donor, and arranging for the actual 
surgical and handling procedures involved in getting at least one organ 
from the deceased donor to placement in a patient on a waiting list. 
Hearts, lungs, livers, kidneys, intestines, and pancreas that are 
transplanted count towards this measure of success. Additionally, a 
pancreas that is procured and is used for research or islet cell 
transplantation also counts for this purpose.
    In the tables that follow, the first two digits of the letters in 
parentheses are, in most cases, the primary state of the OPO. Some OPOs 
serve more than one state, and some states have more than one OPO. The 
four digits after the OPO's name represents the digits identifying the 
DSA and remain unchanged even when the name of the OPO changes. In a 
few cases in the tables below, we have abbreviated an OPO name to 
improve simplicity of presentation. For a complete OPO listing and 
additional information, see the following link: https://optn.transplant.hrsa.gov/members/member-directory/?memberType=Organ%20Procurement%20Organizations.\21\ These tables show 
the performance required of each OPO to reach the performance standard, 
including an allowance for statistical ``confidence'' (one-tailed 
test), for the OPOs that fell below the standard. Confidence intervals 
are calculated based on test statistics derived from the assumed 
binomial and Poisson distribution for the donation rate and transplant 
rate, respectively. Specifically, the Wilson score interval with 
continuity correction (Newcombe 1998) is used to calculate the 
confidence interval for the donation rate of each OPO. The Wilson and 
Hilferty formula is used to calculate the confidence interval for the 
transplant rate of each OPO.\22\ In lay terms, these confidence levels 
are simply a way to provide for a ``margin of error'' when calculating 
the rates for each OPO given the different sizes of the donor 
potentials.
---------------------------------------------------------------------------

    \21\ Some of these OPOs have changed names in recent years, so 
some other published lists may be out of date. However, the codes 
shown in parentheses in our tables have not changed.
    \22\ Wilson and Hilferty 1931, Breslow and Day 1987, Kulkarni 
and Hemangi 2012.
---------------------------------------------------------------------------

    We are committed to using the best available data to continue our 
analysis of OPO performance, including, where possible, historical 
trends in OPO performance; a range of potential outcomes, including a 
scenario where high performers remain at steady state; and year over 
year OPO performance and distribution of scores and improvements within 
the past two certification cycles, using the final rule's outcome 
measures.

                     Table 1--OPO Donor Rate for 2018 With Top 25% and Median Cutoff Levels
                   [OPOs below Top 25 percent in italics and below median in bold and italics]
----------------------------------------------------------------------------------------------------------------
                                                                    Upper bound
                                                                     with 95%       Additional      Additional
                    OPO name                       Donation rate    confidence       donors to       donors to
                                                                     interval      reach median    reach top 25%
----------------------------------------------------------------------------------------------------------------
Midwest Transplant Network (MWOB)...............           17.85           19.62               0               0
DonorConnect (UTOP).............................           15.29           17.65               0               0
Nebraska Organ Recovery System (NEOR)...........           14.04           17.02               0               0
Gift of Life Donor Program (PADV)...............           15.59           16.63               0               0
OPO at the U. of Wisconsin (WIUW)...............           14.24           16.26               0               0
Lifesharing--A Donate Life Organization (CASD)..           13.42           15.39               0               0
LifeChoice Donor Services (CTOP)................           12.03           14.45               0               0
Nevada Donor Network (NVLV).....................           12.17           14.01               0               0
OurLegacy (FLFH)................................           12.42           13.97               0               0
Gift of Hope Organ & Tissue Donor Network (ILIP)           12.84           13.84               0               0
Versiti (WIDN)..................................           11.48           13.74               0               0
Donor Network of Arizona (AZOB).................           12.41           13.68               0               0
Lifeshare Carolinas (NCCM)......................           11.78           13.68               0               0
Donor Alliance (CORS)...........................           12.03           13.65               0               0
The Living Legacy Foundation of Maryland (MDPC).           11.98           13.63               0               0
LifeGift Organ Donation Center (TXGC)...........           11.96           12.96               0               0
Mid-America Transplant Services (MOMA)..........           11.27           12.64               0               0
Washington Regional Transplant Community (DCTC).           11.01           12.63               0               0
LifeShare of Oklahoma (OKOP)....................           11.15           12.56               0               0
ConnectLife (NYWN)..............................            9.75           12.32               0               0
LifeCenter Organ Donor Network (OHOV)...........           10.18           12.29               0               0
Southwest Transplant Alliance (TXSB)............           11.20           12.18               0               0
LifeBanc (OHLB).................................           10.60           12.05               0               0
Louisiana Organ Procurement Agency (LAOP).......           10.72           12.04               0               0
New England Organ Bank (MAOB)...................           10.82           11.85               0               0
LifeCenter Northwest (WALC).....................           10.74           11.85               0               0

[[Page 77927]]

 
LifeLink of Puerto Rico (PRLL)..................            9.95           11.71               0               0
LifeLink of Florida (FLWC)......................           10.54           11.68               0               0
Gift of Life Michigan (MIOP)....................           10.50           11.46               0               0
Tennessee Donor Services (TNDS).................           10.24           11.25               0               4
Life Connection of Ohio (OHLC)..................            9.23           11.18               0               2
LifeLink of Georgia (GALL)......................           10.16           11.16               0               6
Sharing Hope SC (SCOP)..........................            9.78           11.04               0               6
Donor Network West (CADN).......................           10.05           10.99               0              12
Legacy of Life (HIOP)...........................            8.35           10.82               0               3
Center for Organ Recovery and Education (PATF)..            9.64           10.79               0              12
Lifeline of Ohio (OHLP).........................            9.34           10.77               0               8
LifeSource--MN (MNOP)...........................            9.50           10.73               0              12
New Mexico Donor Services (NMOP)................            8.04           10.23               0               6
Sierra Donor Services (CAGS)....................            8.31           10.08               0              11
LifeQuest Organ Recovery Services (FLUF)........            8.74            9.94               0              24
Pacific Northwest Transplant Bank (ORUO)........            8.61            9.93               0              20
New Jersey Sharing Network OPO (NJTO)...........            8.71            9.89               0              26
Mississippi Organ Recovery Agency (MSOP)........            8.29            9.86               0              15
Legacy of Hope--Alabama (ALOB)..................            8.65            9.84               0              26
Texas Organ Sharing Alliance (TXSA).............            8.63            9.77               0              30
Finger Lakes Donor Recovery Network (NYFL)......            7.80            9.68               1              12
Iowa Donor Network (IAOP).......................            7.98            9.66               1              15
Center for Donation and Transplant (NYAP).......            7.45            9.33               3              14
LiveOnNY (NYRT).................................            8.50            9.33              13              68
LifeNet Health (VATB)...........................            7.97            9.07              12              43
OneLegacy (CAOP)................................            8.31            8.94              43             133
Indiana Donor Network (INOP)....................            7.79            8.81              19              54
Arkansas Regional Organ Recovery Agency (AROR)..            7.06            8.69               9              22
Carolina Donor Services (NCNC)..................            7.58            8.52              29              69
Kentucky Organ Donor Affiliates (KYDA)..........            7.15            8.25              26              54
Mid-South Transplant Foundation (TNMS)..........            6.66            8.19              14              28
Life Alliance Organ Recovery Agency (FLMP)......            6.87            7.86              38              71
----------------------------------------------------------------------------------------------------------------
Note: Cutoffs at 2017 OPO upper bound performance levels of Top 25 percent at 11.37 and median at 9.72.

    Table 2 shows the current range of organ transplantation 
performance, using the new standard of measuring the total number of 
organs transplanted from deceased donors (including all transplanted 
organs from each donor) as a percentage of the same donor potential 
used for the donation rate in the final rule.\23\ Table 2 includes both 
the unadjusted organ transplantation rate and the organ transplantation 
rate which reflects the rate once it is risk-adjusted for the average 
age in the donor potential. The organ transplantation rate as defined 
in Sec.  486.302 will be the basis for re-certification.
---------------------------------------------------------------------------

    \23\ These results would look similar if we used the current 
estimates of ``eligible'' deaths but would be an imperfect 
comparison since that is not a standardized measure.
---------------------------------------------------------------------------

    According to the NCHS, there are about 2.8 million deaths each year 
in the U.S., but the potential deceased donor pool is far lower because 
it only includes those who die in hospitals, who are age 75 or less, 
and who have primary causes of death consistent with organ donation. As 
previously discussed, the December 2019 proposed rule used as its 
measure of donors those inpatient deaths age 75 or less who have no 
contraindications to donation. We also proposed as an alternative the 
CALC methodology that uses the same hospital location and age criteria, 
but uses ICD-10-CM codes reflecting deaths that are consistent with 
donation--inclusion rather than exclusion. We believe the CALC measure 
is more widely accepted in the transplant community and now has a body 
of literature validating its consistency, thus, we have adopted it in 
this final rule.
    As shown in Table 2, the organ transplantation rates range from 
57.90 at the highest levels to 18.94 (using data from calendar year 
2018), a range of about three to one from highest to lowest. The top-
performing OPOs are geographically and demographically diverse, with 
potential donor pools ranging from about 463 deaths a year to almost 
3,566 a year (using the CALC methodology) as shown in Table 1. We 
recognize that some OPOs have fewer transplant programs within their 
service areas than others, but allocation policies are no longer based 
on the DSA and historically, OPOs had access to the organ match run, 
which lists all potential recipients for a donated organ in the entire 
country.

[[Page 77928]]



                   Table 2--OPO Transplant Rate for 2018 With Top 25% and Median Cutoff Levels
                   [OPOs below top 25 percent in italics and below median in bold and italics]
----------------------------------------------------------------------------------------------------------------
                                                      Organ                         Additional      Additional
           OPO name  (primary state)             transplantation    Upper bound      organs to       organs to
                                                       rate          at 95% CI     reach median    reach top 25%
----------------------------------------------------------------------------------------------------------------
Nebraska Organ Recovery System (NEOR)..........            57.90           65.22               0               0
OPO at the U. of Wisconsin (WIUW)..............            52.92           56.27               0               0
Midwest Transplant Network (MWOB)..............            52.44           55.29               0               0
Lifesharing--A Donate Life Organization (CASD).            48.49           52.74               0               0
DonorConnect (UTOP)............................            46.04           49.51               0               0
Nevada Donor Network (NVLV)....................            45.65           49.28               0               0
LifeLink of Puerto Rico (PRLL).................            40.31           44.99               0               0
Gift of Life Donor Program (PADV)..............            42.04           43.63               0               0
Gift of Hope Organ & Tissue Donor Network                  40.57           42.44               0               0
 (ILIP)........................................
LifeShare of Oklahoma (OKOP)...................            39.29           42.21               0               0
OurLegacy (FLFH)...............................            39.58           42.17               0               0
Gift of Life Michigan (MIOP)...................            39.43           41.46               0               0
LifeGift Organ Donation Center (TXGC)..........            39.20           41.03               0               0
Center for Organ Recovery and Education (PATF).            38.24           40.83               0               0
Donor Network of Arizona (AZOB)................            38.22           40.09               0               0
The Living Legacy Foundation of Maryland (MDPC)            36.24           38.64               0               0
LifeLink of Florida (FLWC).....................            36.40           38.63               0               0
Donor Network West (CADN)......................            36.04           37.90               0               0
Washington Regional Transplant Community (DCTC)            35.39           37.83               0               0
LifeCenter Northwest (WALC)....................            35.76           37.72               0               0
LiveOnNY (NYRT)................................            35.49           37.70               0               0
Versiti (WIDN).................................            33.95           37.45               0               0
LifeBanc (OHLB)................................            34.74           37.27               0               0
Southwest Transplant Alliance (TXSB)...........            35.29           37.00               0               0
Lifeshare Carolinas (NCCM).....................            33.72           36.51               0               0
Mid-America Transplant Services (MOMA).........            34.36           36.49               0               0
New England Organ Bank (MAOB)..................            34.45           36.30               0               0
Tennessee Donor Services (TNDS)................            34.18           36.04               0               2
LifeChoice Donor Services (CTOP)...............            32.17           35.53               0               4
Sierra Donor Services (CAGS)...................            31.69           35.25               0               7
New Jersey Sharing Network OPO (NJTO)..........            32.75           35.18               0              15
Louisiana Organ Procurement Agency (LAOP)......            32.74           34.86               0              23
ConnectLife (NYWN).............................            30.17           34.63               0               7
LifeLink of Georgia (GALL).....................            31.69           33.42               0              75
Pacific Northwest Transplant Bank (ORUO).......            30.65           33.31               0              36
Lifeline of Ohio (OHLP)........................            30.14           32.56               0              47
Center for Donation and Transplant (NYAP)......            28.06           32.51               0              18
LifeSource--MN (MNOP)..........................            30.23           32.27               0              71
Iowa Donor Network (IAOP)......................            29.11           32.23               0              32
OneLegacy (CAOP)...............................            30.88           32.18               0             202
Legacy of Hope--Alabama (ALOB).................            29.04           31.34              12              75
Mississippi Organ Recovery Agency (MSOP).......            28.21           31.22               8              44
Donor Alliance (CORS)..........................            29.26           31.15              15              81
Texas Organ Sharing Alliance (TXSA)............            28.57           30.48              31             110
Life Connection of Ohio (OHLC).................            27.26           30.02              17              50
Sharing Hope SC (SCOP).........................            28.05           29.89              42             120
LifeNet Health (VATB)..........................            27.65           29.68              44             117
Finger Lakes Donor Recovery Network (NYFL).....            26.16           29.30              19              47
LifeCenter Organ Donor Network (OHOV)..........            26.44           29.00              26              60
Arkansas Regional Organ Recovery Agency (AROR).            25.80           28.85              25              56
Carolina Donor Services (NCNC).................            26.82           28.62              80             173
LifeQuest Organ Recovery Services (FLUF).......            26.55           28.50              63             134
Legacy of Life (HIOP)..........................            22.91           27.01              20              35
New Mexico Donor Services (NMOP)...............            23.53           26.80              29              51
Indiana Donor Network (INOP)...................            25.06           26.58             135             236
Kentucky Organ Donor Affiliates (KYDA).........            24.17           26.00             110             184
Life Alliance Organ Recovery Agency (FLMP).....            23.81           25.59             130             211
Mid-South Transplant Foundation (TNMS).........            18.94           21.05             109             149
                                                ----------------------------------------------------------------
    Totals.....................................  ...............  ..............             915           2,472
----------------------------------------------------------------------------------------------------------------
Note: Cutoffs at 2017 OPO upper bound performance levels of Top 25% at 36.10 and median at 32.05.

    Both outcome measures as originally proposed and in the final rule 
address multiple goals not met by the current requirements: (1) They 
can be uniformly applied across all OPOs; (2) they capture not only 
success in obtaining donors but also success in placing as many organs 
as possible; (3) they capture virtually the entire pool of possible 
donors (not the pool as determined separately by each OPO); (4) they 
adjust for the geographic

[[Page 77929]]

differences in the number and causes of death; and (5) they meet 
central necessities for a workable performance standard that exhibits 
uniformity, timeliness, and stability year-to-year. Of particular 
importance, these measures, both as proposed and as made final, would 
replace the subjective and self-reported criteria of eligible donors 
and eligible deaths. The existing denominator standard allows OPOs to 
exclude from the calculated potential donor pool those cases where the 
next-of-kin did not authorize donation, a crucial task we believe all 
OPOs should be effective and continually improving at. For an extensive 
discussion of these and related issues, see ``Changing Metrics of Organ 
Procurement Organization Performance in Order to Increase Organ 
Donation Rates in the United States.'' \24\ The proposed and final 
measures do not control for every variable that can affect OPO 
performance for reasons beyond its control. For example, states without 
motorcycle helmet laws have higher rates of accidents that create 
potential donors. Some DSAs have greater transplant hospital 
competition than others, and more competition for transplantable organs 
is associated with greater use of organs that might otherwise be 
discarded.\25\ Regardless, it is our belief that the untapped donor and 
organ potential is sufficiently large in every DSA so that every OPO 
has both potential donors, organs, and transplant recipients to exceed 
its current performance level. We received no public comments 
presenting evidence to the contrary.
---------------------------------------------------------------------------

    \24\ Goldberg D, et al., ``Changing Metrics of Organ Procurement 
Organization Performance in Order to Increase Organ Donation Rates 
in the United States,'' Am J Transplant 2017; 17:3183-3192.
    \25\ Adler, et al. ``Is Donor Service Area Market Competition 
Associated with Organ Procurement Organization Performance?'' 
Transplantation 2016; 100; 1349-1355.
---------------------------------------------------------------------------

    One way to understand the potential is to compare current donation 
rates with the CALC methodology used to calculate potential donors in 
the final rule, a very important quantitative result: In 2018 there 
were about 10,000 deceased donors, which is only about 10 percent of 
the almost 100,000 potential donors in 2018 (https://srtr.transplant.hrsa.gov/annual_reports/2018/DOD.aspx). The highest 
performing OPOs at present do not quite reach a rate of 20 percent of 
potential donors becoming actual donors. Importantly, the final rule's 
criteria for potential donors already exclude most deaths, and focus on 
decedents with substantial potential to provide transplantable organs. 
Hence, all OPOs have a pool of potential donors many times higher than 
the number of donors and organs needed to meet the final rule's 
performance standards. Furthermore, in 2018, there were 1,073,084 death 
and imminent death referrals reported to the OPTN by OPOs,\26\ meaning 
that less than 1 percent of referrals became organ donors.
---------------------------------------------------------------------------

    \26\ OPTN 2018 Annual Report, https://srtr.transplant.hrsa.gov/annual_reports/2018/DOD.aspx.
---------------------------------------------------------------------------

    If the number of donors at the Tier 2 and Tier 3 OPOs were to reach 
the threshold rate of the top 25 percent, the number of annual donors 
would increase by approximately one thousand by the end of the 4-year 
performance period and increase the number of organ transplantations by 
about 2,500. As show in Tables 4 and 5, both donors and transplants 
could be far higher than these thresholds with as little as a 20 
percent overall rate of improvement over a 5-year period.
    We believe that all OPOs are capable of achieving these higher 
success rates; our estimates assume improvements at all current levels 
of performance due to better techniques and methods associated with 
organ procurement as well as the ``incentives'' provided to the top 
performing OPOs (that is, keeping their DSA free from competition and 
allowing them to compete for an open new DSA). For example, there have 
been major recent improvements in perfusion techniques used to preserve 
kidneys and extend the time period allowed between donation and 
transplantation. This technology rewards focusing efforts on extending 
the placement of organs beyond local areas for appropriate transplant 
candidates on waiting lists. These techniques are available to all 
OPOs, but have not been adopted by all. While there may be future 
improvements,\27\ our estimates do not factor in potential future major 
breakthroughs.
---------------------------------------------------------------------------

    \27\ https://www.nih.gov/news-events/news-releases/scientists-triple-storage-time-human-donor-livers.

                      Table 3--OPO Ratings and Tiers for Both Donation and Transplant Rates
                   [OPOs below top 25 percent in Italics and below median in bold and italics]
----------------------------------------------------------------------------------------------------------------
                                                                   Organ
  OPO name (primary state)     Donation rate      95% CI        transplant        95% CI             Tier
                                                                   rate
----------------------------------------------------------------------------------------------------------------
Nebraska Organ Recovery                14.04           17.02           57.90           65.22  Tier 1.
 System (NEOR).
OPO at the U. of Wisconsin             14.24           16.26           52.32           56.27
 (WIUW).
Midwest Transplant Network             17.85           19.62           52.44           55.29
 (MWOB).
Lifesharing--A Donate Life             13.42           15.39           48.49           52.74
 Organization (CASD).
DonorConnect (UTOP).........           15.29           17.65           46.04           49.51
Nevada Donor Network (NVLV).           12.17           14.01           45.65           49.28
LifeLink of Puerto Rico                 9.95           11.71           40.31           44.99
 (PRLL).
Gift of Life Donor Program             15.59           16.63           42.04           43.63
 (PADV).
Gift of Hope Organ & Tissue            12.84           13.84           40.57           42.44
 Donor Network (ILIP).
LifeShare of Oklahoma (OKOP)           11.15           12.56           39.29           42.21
OurLegacy (FLFH)............           12.42           13.97           39.58           42.17
Gift of Life Michigan (MIOP)           10.50           11.46           39.43           41.46
LifeGift Organ Donation                11.96           12.96           39.20           41.03
 Center (TXGC).
Donor Network of Arizona               12.41           13.68           38.22           40.09
 (AZOB).
The Living Legacy Foundation           11.98           13.63           36.24           38.64
 of Maryland (MDPC).
LifeLink of Florida (FLWC)..           10.54           11.68           36.40           38.63
Washington Regional                    11.01           12.63           35.39           37.83
 Transplant Community (DCTC).
LifeCenter Northwest (WALC).           10.74           11.85           35.76           37.72
Versiti (WIDN)..............           11.48           13.74           33.95           37.45
LifeBanc (OHLB).............           10.60           12.05           34.74           37.27

[[Page 77930]]

 
Southwest Transplant                   11.20           12.18           35.29           37.00
 Alliance (TXSB).
Lifeshare of the Carolinas             11.78           13.68           33.72           36.51
 (NCCM).
Mid-America Transplant                 11.27           12.64           34.36           36.49
 Services (MOMA).
New England Organ Bank                 10.82           11.85           34.45           36.30
 (MAOB).
----------------------------------------------------------------------------------------------------------------
Center for Organ Recovery               9.64           10.79           38.24           40.83  Tier 2.
 and Education (PATF).
Donor Network West (CADN)...           10.05           10.99           36.04           37.90
Tennessee Donor Services               10.24           11.25           34.18           36.04
 (TNDS).
LifeChoice Donor Services              12.03           14.45           32.17           35.53
 (CTOP).
Sierra Donor Services (CAGS)            8.31           10.08           31.69           35.25
New Jersey Sharing Network              8.71            9.89           32.75           35.18
 OPO (NJTO).
Louisiana Organ Procurement            10.72           12.04           32.74           34.86
 Agency (LAOP).
ConnectLife (NYWN)..........            9.75           12.32           30.17           34.63
LifeLink of Georgia (GALL)..           10.16           11.16           31.69           33.42
Pacific Northwest Transplant            8.61            9.93           30.65           33.31
 Bank (ORUO).
Lifeline of Ohio (OHLP).....            9.34           10.77           30.14           32.56
LifeSource--MN (MNOP).......            9.50           10.73           30.23           32.27
----------------------------------------------------------------------------------------------------------------
LiveOnNY (NYRT).............            8.50            9.33           35.49           37.70  Tier 3.
Center for Donation and                 7.45            9.33           28.06           32.51
 Transplant (NYAP).
Iowa Donor Network (IAOP)...            7.98            9.66           29.11           32.23
OneLegacy (CAOP)............            8.31            8.94           30.88           32.18
Legacy of Hope--Alabama                 8.65            9.84           29.04           31.34
 (ALOB).
Mississippi Organ Recovery              8.29            9.86           28.21           31.22
 Agency (MSOP).
Donor Alliance (CORS).......           12.03           13.65           29.26           31.15
Texas Organ Sharing Alliance            8.63            9.77           28.57           30.48
 (TXSA).
Life Connection of Ohio                 9.23           11.18           27.26           30.02
 (OHLC).
Sharing Hope SC (SCOP)......            9.78           11.04           28.05           29.89
LifeCenter Organ Donor                 10.18           12.29           26.44           29.00
 Network (OHOV).
LifeQuest Organ Recovery                8.74            9.94           26.55           28.50
 Services (FLUF).
Legacy of Life (HIOP).......            8.35           10.82           22.91          *27.01
New Mexico Donor Services               8.04           10.23           23.53           26.80
 (NMOP).
LifeNet Health (VATB).......            7.97            9.07           27.65           29.68
Finger Lakes Donor Recovery             7.80            9.68           26.16           29.30
 Network (NYFL).
Arkansas Regional Organ                 7.06            8.69           25.80           28.85
 Recovery Agency (AROR).
Carolina Donor Services                 7.58            8.52           26.82           28.62
 (NCNC).
Indiana Donor Network (INOP)            7.79            8.81           25.06           26.58
Kentucky Organ Donor                    7.15            8.25           24.17           26.00
 Affiliates (KYDA).
Life Alliance Organ Recovery            6.87            7.86           23.81           25.59
 Agency (FLMP).
Mid-South Transplant                    6.66            8.19           18.94           21.05
 Foundation (TNMS).
----------------------------------------------------------------------------------------------------------------
Note: For donors top 25 percent cutoff level at 11.37 and median at 9.72; for transplants at 36.10 and 32.05.
* Hawaii OPO's kidney transplantation rate will be used instead of the organ transplantation rate. It was in
  Tier 1 for kidney transplantations.
 

    Table 3 shows the combined results of the donation and organ 
transplantation rates and the tier assignment for each OPO. As seen by 
the markings in bold and italics, many OPOs are high or low on both 
outcome measures. Within the Tier 2 cohort, 8 of the 26 OPOs made it to 
Tier 2 based on performance on the donation rate only (because their 
organ transplantation rates were in Tier 3), whereas only 4 OPOs made 
it to Tier 2 based on their organ transplantation rates (because their 
donation rates were in Tier 3). This difference suggests that it may be 
easier for OPOs to reach Tier 2 through the donation rate--possibly by 
pursuing and successfully placing organs from the extended criteria 
donors. There only were only 12 OPOs whose donation and organ/kidney 
transplantation rates were at or above the median threshold rate, but 
not in Tier 1. Some OPOs were in Tier 1 on the donation rate, yet Tier 
3 in the organ transplantation rate, suggesting that OPOs could do more 
to strengthen their organ placement practices. Those OPOs with higher 
performance in their organ transplantation rate than their donation 
rate could increase their donation rates by increasing their single 
organ donors.
    Our estimates in Tables 4 (donors) and 5 (transplants) show what 
would be required for all OPOs to achieve either the median rate, the 
threshold rate of the top 25 percent, or an increase in performance by 
20 percent or to the rate of the top 25 percent, whichever is greater. 
(While not every OPO would make the same percentage gain, any 
combination of gains reaching the ``greater of'' estimate on average 
would produce the same total gains.) The importance of these estimates 
is not the exact numbers, but rather that even the currently best-
performing OPOs can increase performance over time with concomitant 
improvements in techniques and technology, and will face strong 
incentives to do so or risk losing their place in the top 25 percent.

[[Page 77931]]



                Table 4--Additional Donors To Reach Median, Top 25%, or Greater of Top 25% or 20%
----------------------------------------------------------------------------------------------------------------
                                                          Additional donors to reach:
                              ----------------------------------------------------------------------------------
   OPO name (primary state)       Potential     Actual donors                                  Higher of top 25%
                                donors (2018)      (2018)          Median          Top 25%        or 20% more
----------------------------------------------------------------------------------------------------------------
Midwest Transplant Network              1,423             254               0               0                 51
 (MWOB)......................
DonorConnect (UTOP)..........             752             115               0               0                 23
Nebraska Organ Recovery                   463              65               0               0                 13
 System (NEOR)...............
Gift of Life Donor Program              3,566             556               0               0                111
 (PADV)......................
OPO at the U. of Wisconsin                955             136               0               0                 27
 (WIUW)......................
Lifesharing--A Donate Life                954             128               0               0                 26
 Organization (CASD).........
LifeChoice Donor Services                 615              74               0               0                 15
 (CTOP)......................
Nevada Donor Network (NVLV)..           1,011             123               0               0                 25
OurLegacy (FLFH).............           1,417             176               0               0                 35
Gift of Hope Organ & Tissue             3,302             424               0               0                 85
 Donor Network (ILIP)........
Versiti (WIDN)...............             671              77               0               0                 15
Donor Network of Arizona                2,039             253               0               0                 51
 (AZOB)......................
Lifeshare Carolinas (NCCM)...             934             110               0               0                 22
Donor Alliance (CORS)........           1,272             153               0               0                 31
The Living Legacy Foundation            1,219             146               0               0                 29
 of Maryland (MDPC)..........
LifeGift Organ Donation                 3,145             376               0               0                 75
 Center (TXGC)...............
Mid-America Transplant                  1,659             187               0               0                 37
 Services (MOMA).............
Washington Regional                     1,190             131               0               0                 26
 Transplant Community (DCTC).
LifeShare of Oklahoma (OKOP).           1,561             174               0               0                 35
ConnectLife (NYWN)...........             482              47               0               0                  9
LifeCenter Organ Donor                    707              72               0               0                 14
 Network (OHOV)..............
Southwest Transplant Alliance           3,090             346               0               0                 69
 (TXSB)......................
LifeBanc (OHLB)..............           1,443             153               0               0                 31
Louisiana Organ Procurement             1,717             184               0               0                 37
 Agency (LAOP)...............
New England Organ Bank (MAOB)           2,790             302               0               0                 60
LifeCenter Northwest (WALC)..           2,420             260               0               0                 52
LifeLink of Puerto Rico                   955              95               0               0                 19
 (PRLL)......................
LifeLink of Florida (FLWC)...           2,248             237               0               0                 47
Gift of Life Michigan (MIOP).           3,057             321               0               0                 64
Tennessee Donor Services                2,735             280               0               4                 56
 (TNDS)......................
Life Connection of Ohio                   758              70               0               2                 14
 (OHLC)......................
LifeLink of Georgia (GALL)...           2,795             284               0               6                 57
Sharing Hope SC (SCOP).......           1,749             171               0               6                 34
Donor Network West (CADN)....           3,086             310               0              12                 62
Legacy of Life (HIOP)........             467              39               0               3                  8
Center for Organ Recovery and           2,044             197               0              12                 39
 Education (PATF)............
Lifeline of Ohio (OHLP)......           1,328             124               0               8                 25
LifeSource--MN (MNOP)........           1,810             172               0              12                 34
New Mexico Donor Services                 560              45               0               6                  9
 (NMOP)......................
Sierra Donor Services (CAGS).             842              70               0              11                 14
LifeQuest Organ Recovery                1,751             153               0              24                 31
 Services (FLUF).............
Pacific Northwest Transplant            1,463             126               0              20                 25
 Bank (ORUO).................
New Jersey Sharing Network              1,792             156               0              26                 31
 OPO (NJTO)..................
Mississippi Organ Recovery              1,037              86               0              15                 17
 Agency (MSOP)...............
Legacy of Hope--Alabama                 1,781             154               0              26                 31
 (ALOB)......................
Texas Organ Sharing Alliance            1,913             165               0              30                 33
 (TXSA)......................
Finger Lakes Donor Recovery               718              56               1              12                 12
 Network (NYFL)..............
Iowa Donor Network (IAOP)....             890              71               1              15                 15
Center for Donation and                   698              52               3              14                 14
 Transplant (NYAP)...........
LiveOnNY (NYRT)..............           3,435             292              13              68                 68
LifeNet Health (VATB)........           1,945             155              12              43                 43
OneLegacy (CAOP).............           5,634             468              43             133                133
Indiana Donor Network (INOP).           2,183             170              19              54                 54
Arkansas Regional Organ                   864              61               9              22                 22
 Recovery Agency (AROR)......
Carolina Donor Services                 2,506             190              29              69                 69
 (NCNC)......................
Kentucky Organ Donor                    1,803             129              26              54                 54
 Affiliates (KYDA)...........
Mid-South Transplant                      931              62              14              28                 28
 Foundation (TNMS)...........
Life Alliance Organ Recovery            2,111             145              38              71                 71
 Agency (FLMP)...............
                              ----------------------------------------------------------------------------------
    Totals...................          98,686          10,128             208             806              2,238
----------------------------------------------------------------------------------------------------------------

    Nothing guarantees that all OPOs will manage to meet the final rule 
outcome measures. Nevertheless, the administrative steps we propose to 
take, the periodic assessments, and the incentives for an OPO to 
maintain certification at the end of the 4-year evaluation period 
provide both means and incentives for all OPOs to meet or exceed our 
standards. Moreover, there are three additional reasons to expect 
performance increases (if any) to occur

[[Page 77932]]

in all three tiers. First, Tier 1 OPOs near the Tier 2 boundary will be 
concerned about maintaining ongoing performance levels high enough to 
guarantee Tier 1 performance at their final assessment period--since 
other OPOs may be achieving higher performance levels. Second, only by 
aiming higher than the minimum needed to gain or remain in Tier 1 
earlier in the final assessment period, is it possible to ensure that 
unexpected decreases at the end of the final assessment period do not 
result in loss of Tier 1 status. Third, there may be emerging best 
practices in both areas of performance that can be applied widely by 
all OPOs. For example, a current Tier 3 OPO could implement a specific 
management reform or operational innovation that substantially 
increases performance in increasing consent for donation. If the 
effects of this change are observed broadly, then the innovation could 
be adopted by others. While such an effective best practice could also 
reduce the likelihood of sharing such best practices, particularly for 
OPOs on the margins every OPO able to see the published annual 
performance results of all OPOs, and performance improvements or lack 
thereof will be readily apparent. Formal and informal communication 
channels would in any event prevent suppression of information on 
better practices.
    With continuous assessment and public disclosure of the 
information, OPOs that cannot achieve the outcome measures may decide 
to voluntarily de-certify and allow a high-performing OPO take over the 
DSA, even before the end of the 4 year re-certification cycle, or form 
a partnership with a high-performing OPO and allow that OPO to take 
over the management of the DSA, most likely through a merger or 
friendly takeover. Both our low-end and higher cost and performance 
calculations assume that this could be avoided through adoption of 
proven techniques and improved leadership and management by lower-
performing OPOs. Careful planning and implementation of OPO de-
certifications and OPO DSA competitions could ease such transitions, 
but each performance level can be reached or exceeded, or maintained, 
by constant OPO management improvements. The new outcome measures and 
performance expectations may give each OPO both the opportunity and 
incentives to assess its performance, innovate, and adopt best 
practices.

          Table 5--Additional Organ Transplants To Reach Median, Top 25%, or Greater of Top 25% or 20%
----------------------------------------------------------------------------------------------------------------
                                                                 Additional transplants to reach:
                                                 ---------------------------------------------------------------
            OPO name (primary state)                  Actual                                       Higher of top
                                                    transplants       Median          Top 25%       25% or 20%
                                                      (2018)                                           more
----------------------------------------------------------------------------------------------------------------
Nebraska Organ Recovery System (NEOR)...........             213               0               0              43
OPO at the U. of Wisconsin (WIUW)...............             487               0               0              97
Midwest Transplant Network (MWOB)...............             825               0               0             165
Lifesharing--A Donate Life Organization (CASD)..             404               0               0              81
DonorConnect (UTOP).............................             406               0               0              81
Nevada Donor Network (NVLV).....................             445               0               0              89
LifeLink of Puerto Rico (PRLL)..................             278               0               0              56
Gift of Life Donor Program (PADV)...............           1,688               0               0             338
Gift of Hope Organ & Tissue Donor Network (ILIP)           1,305               0               0             261
LifeShare of Oklahoma (OKOP)....................             548               0               0             110
OurLegacy (FLFH)................................             597               0               0             119
Gift of Life Michigan (MIOP)....................           1,106               0               0             221
LifeGift Organ Donation Center (TXGC)...........           1,240               0               0             248
Center for Organ Recovery and Education (PATF)..             680               0               0             136
Donor Network of Arizona (AZOB).................             934               0               0             187
The Living Legacy Foundation of Maryland (MDPC).             521               0               0             104
LifeLink of Florida (FLWC)......................             766               0               0             153
Donor Network West (CADN).......................           1,062               0               0             212
Washington Regional Transplant Community (DCTC).             490               0               0              98
LifeCenter Northwest (WALC).....................             883               0               0             177
LiveOnNY (NYRT).................................             923               0               0             185
Versiti (WIDN)..................................             241               0               0              48
LifeBanc (OHLB).................................             505               0               0             101
Southwest Transplant Alliance (TXSB)............           1,126               0               0             225
Lifeshare Carolinas (NCCM)......................             354               0               0              71
Mid-America Transplant Services (MOMA)..........             634               0               0             127
New England Organ Bank (MAOB)...................             946               0               0             189
Tennessee Donor Services (TNDS).................             922               0               2             184
LifeChoice Donor Services (CTOP)................             221               0               4              44
Sierra Donor Services (CAGS)....................             239               0               7              48
New Jersey Sharing Network OPO (NJTO)...........             538               0              15             108
Louisiana Organ Procurement Agency (LAOP).......             604               0              23             121
ConnectLife (NYWN)..............................             134               0               7              27
LifeLink of Georgia (GALL)......................             898               0              75             180
Pacific Northwest Transplant Bank (ORUO)........             401               0              36              80
Lifeline of Ohio (OHLP).........................             410               0              47              82
Center for Donation and Transplant (NYAP).......             145               0              18              29
LifeSource--MN (MNOP)...........................             572               0              71             114
Iowa Donor Network (IAOP).......................             247               0              32              49
OneLegacy (CAOP)................................           1,625               0             202             325
Legacy of Hope--Alabama (ALOB)..................             472              12              75              94
Mississippi Organ Recovery Agency (MSOP)........             264               8              44              53
Donor Alliance (CORS)...........................             491              15              81              98

[[Page 77933]]

 
Texas Organ Sharing Alliance (TXSA).............             574              31             110             115
Life Connection of Ohio (OHLC)..................             233              17              50              50
Sharing Hope SC (SCOP)..........................             555              42             120             120
LifeNet Health (VATB)...........................             521              44             117             117
Finger Lakes Donor Recovery Network (NYFL)......             188              19              47              47
LifeCenter Organ Donor Network (OHOV)...........             232              26              60              60
Arkansas Regional Organ Recovery Agency (AROR)..             208              25              56              56
Carolina Donor Services (NCNC)..................             638              80             173             173
LifeQuest Organ Recovery Services (FLUF)........             482              63             134             134
Legacy of Life (HIOP)...........................              95              20              35              35
New Mexico Donor Services (NMOP)................             136              29              51              51
Indiana Donor Network (INOP)....................             636             135             236             236
Kentucky Organ Donor Affiliates (KYDA)..........             454             110             184             184
Life Alliance Organ Recovery Agency (FLMP)......             493             130             211             211
Mid-South Transplant Foundation (TNMS)..........             196             109             149             149
                                                 ---------------------------------------------------------------
    Subtotal Transplants plus Pancreata Research          33,431             915           2,472           7,296
                                                 ---------------------------------------------------------------
    Total Actual Transplants....................          32,852             899           2,429           7,169
----------------------------------------------------------------------------------------------------------------

    The characteristics of the organ procurement ``market'' are unusual 
because it was established as a system of private monopolies by statute 
(NOTA). OPOs are part of the supply chain for final goods--organs for 
transplant--that are not transacted in a market (in the sense of a 
good's price being the mechanism whereby the quantity supplied and the 
quantity demanded achieve equality), and therefore care must be taken 
in using concepts such as market competition or equilibrium. In another 
example from the health care sector, which may provide a somewhat more 
appropriate extrapolation for purposes of this regulatory impact 
analysis than would results from other contexts with more standard 
market goods and services, one study found that many hospitals in the 
English public hospital system faced closure due to potential electoral 
defeat of their political party protectors in particular geographic 
areas vulnerable to election swings. To avoid the risk of being the 
hospital to be closed, hospitals in these situations improved both 
management practices and medical care performance (measured by 
reductions in death rates from heart attacks).\28\ While it is 
impossible to predict future achievement levels with any certainty from 
the impact of introducing significantly more competition into any 
particular monopolistic market (if this rule indeed avoids bringing 
about the potential consolidation noted above and the transaction 
frictions noted below), we have developed a hypothetical scenario for 
the first 4 years of competition that we believe is consistent with the 
results from other situations where large numbers of organizations 
faced potential closure. This scenario would nearly achieve about half 
of HHS' 2030 target of doubling kidneys available for transplantation 
(with 4 years remaining to attain that actual goal); and we can use it 
in estimating benefits and costs while allowing for either higher or 
lower results.
---------------------------------------------------------------------------

    \28\ Nicholas Bloom et al., The Impact of Competition on 
Management Quality: Evidence from Public Hospitals, Review of 
Economic Studies, 2015, at https://nbloom.people.stanford.edu/sites/g/files/sbiybj4746/f/bpsv.pdf.
---------------------------------------------------------------------------

    From the estimates in Tables 4 and 5, we assume that on average, 
OPOs may improve their organ procurement and transplantation 
performances by more than the minimums necessary to retain their DSAs 
with a margin for error. Striving for organizational survival as well 
as for professional and life-saving achievements are strong motivations 
to improve performance not only to the exact level needed for 
organizational survival, but also to allow for a margin of error. These 
projections are estimates and subject to change based on future events 
and decisions, but fall within the improvement ranges seen in recent 
years in some OPOs, as well as the consistently high performance levels 
in many OPOs. Additionally, for these projections, we assume CMS 
monitors OPO performance as frequently as every 12 months, using 
nationally consistent and timely data in both the numerator and 
denominator of performance measures, and intervening with QAPI requests 
when performance lags. Finally, these projections reflect the direct 
incentives to both OPOs and transplant hospitals to improve donation 
and transplantation rates from older donors to older patients, which 
ultimately facilitate the utilization of the large number of currently 
discarded, but transplantable, organs. For example, a transplant 
program that chooses to bypass a transplant quality organ from either 
its local OPO or some other OPO is also bypassing the revenues from the 
transplantation of that organ. Since the supply of organs is finite and 
limited, and many patients die while awaiting transplants, that lost 
revenue may never be replaced. Furthermore, the recent elimination of 
the potential for termination of transplant programs that did not 
achieve the highest possible success rates removes a strong 
disincentive for accepting and using all transplant quality organs.
    Unfortunately, there are many unknowns that impede predicting 
future outcomes under this final rule. In our most optimistic scenario, 
about 85 percent of all potential donors would still be potential 
rather than actual donors. These potential donors are concentrated 
among those in the age range of 55 to 75, but the vast majority could 
provide organs of transplant quality if donated. That said, this 
potential has been obvious for many years, and progress has been 
inexplicably slow--inexplicably slow except for the now-recently 
removed threat to survival for transplant

[[Page 77934]]

programs that did not achieve the highest possible success rates. In 
this regard, it is important to note that according to OPTN and NCHS 
mortality data, donation rates are highest among the young and far 
lower among potential donors in their 50s, 60s, and early 70s.\29\
---------------------------------------------------------------------------

    \29\ Organ donors <50 make up approximately 67 percent of 
donors, but make up less than 10 percent of deaths.
---------------------------------------------------------------------------

    More broadly, there were about 10,000 deceased donors in 2018. The 
highest tenth of OPOs (six of the 58) had an average donation rate of 
about 14 percent, and the lowest tenth (six of the 58) of about 7 
percent. Assuming that this higher level is potentially attainable in 
any DSA, under ideal circumstances, the total number of donors could 
increase by about half, to about 15,000--much higher than we project in 
our high performance scenario. There is no reason to assume that 14 
percent is an upper limit for the donation rate, given that there are 
potentially 100,000 donors every year. That said, it cannot be assumed 
that all OPOs can match the performance of the top tenth within a 4-
year period. Therefore, for purposes of describing a hypothetical level 
of performance by the end of the second re-certification cycle, in 
subsequent tables and estimates, we assume that the average donation 
rate may increase by about 20 percent--from 10,000 to 12,000 donors.
    We make a similar set of assumptions for the organ transplantation 
rate performance measure. In 2018, there were about 33,000 transplants 
from deceased donors. As shown in Table 2, there is more than a two to 
one difference between the top tenth (6 out of 58) and the lowest 
tenth: From an average rate of about 48 percent to about 22 percent. On 
average, there were about 3.3 organs transplanted per donor. The number 
of organs transplanted per donor varied widely, from an average of 
about 3.6 for the top tenth to about 2.8 for the bottom tenth. Assuming 
a 20 percent increase in number of donors and a 5 percent increase in 
organs per donor (to an average of 3.45), the number of annual organs 
transplanted would hypothetically rise from about 33,000 in 2018 to 
about 41,000 (12,000 x 3.45) by 2026 (Table 5 shows transplant 
increases not including the 5 percent increase, with the total growing 
to about 40,000).
    While there is no certainty that these or similar levels of 
performance will be realized, there is additional evidence beyond the 
known performance levels of the higher-achieving OPOs. As discussed in 
the December 2019 OPO proposed rule, the discard rate for kidneys in 
France has been about half the rate in the U.S., under rules that 
rewarded rather than penalized using higher risk organs.\30\ While most 
European countries use mandatory nation-wide ``opt-out'' rather than 
``opt-in'' policies and hence more strongly encourage organ donation 
than in the U.S. (where no states use ``opt-out''), a recent study 
shows that this policy does not explain European success rates and that 
many American states have organ donation rates higher than many 
European countries.\31\ One important policy difference that does seem 
to matter is that in France, as in most other European countries, 
organs from older donors are systematically matched for use by older 
patients, without penalizing transplant programs for the lower success 
rates that inevitably result.\32\ Performance results such as those 
achieved in France could be achievable in the U.S. with greater 
accountability for OPO performance, due to some combination of the 
removal of the outcome measures that penalized transplant programs that 
do not achieve their risk-adjusted expected 1-year graft and patient 
survival outcomes; and payment reform. The October 1, 2020 
implementation of a new Medicare Severity-Diagnosis Related Groups (MS-
DRGs) for kidney transplants with hemodialysis during the same stay 
(DRG 019; DRG 650 and DRG 651) raises payments in these cases, such 
that the increased costs associated with transplanting higher-risk 
kidneys is less of a financial disincentive.
---------------------------------------------------------------------------

    \30\ Olivier Aubert et al., ``Disparities in Acceptance of 
Deceased Donor Kidneys Between the United States and France and 
Estimated Effects of Increased U.S. Acceptance,'' JAMA Intern Med. 
Doi:10:1001/jamainternmed.2019.2322.
    \31\ Alexandra Glazier and Thomas Mone, ``Success in Opt-In 
Organ Donation Policy in the United States,'' August 8, 2019, 
doi:10.1001/JAMA.2019.9187.
    \32\ See Olivier Aubert, et al.
---------------------------------------------------------------------------

    We also have additional evidence from the U.S. that was not 
available at the time we proposed this rule. We now know that there 
were major gains in numbers of kidney transplants from 2017 to 2018. 
Moreover, there appears to have been another major increase in 2019. 
According to a recent summary from UNOS, the number of deceased organ 
donors increased by over 10 percent in 2019; 48 OPOs increased the 
total number of donors in 2019 over the previous year, and 41 OPOs set 
their all-time organ donation record in 2019.\33\ It will be some time 
before the various potential reasons for these increases can be 
determined. However, from what we are able to ascertain, these data 
demonstrate that the problem this rule is meant to address has already 
been lessened, possibly in part due to earlier regulatory 
interventions.
---------------------------------------------------------------------------

    \33\ See the following link at the UNOS website: https://unos.org/transplant/opos-increasing-organ-donation/.
---------------------------------------------------------------------------

    As discussed earlier in the preamble, we have considered the 
effects of COVID-19 on the time of the new standards imposed in this 
rule. The implementation of the rule may be slowed by a year, as a 
result of COVID-19. In terms of effects on donation and transplantation 
rates over time, we expect those to be minimal and possibly not even 
detectable in future data. The numbers of deaths and severe illnesses 
among younger Americans have been less than from the annual influenza 
virus. Among the elderly over the age of 75, who are by orders of 
magnitude the age group most severely affected by morbidity and 
mortality from COVID-19, both donations and transplants were rare 
before COVID-19 and will remain so with no particular COVID effect. We 
are not saying that there will be no effects leading to changes in 
donation and transplantation practices or results; simply that these 
will be very small in relation to the number of potential and actual 
donors and to the number of potential and actual transplant recipients.

D. Anticipated Costs and Benefits

    There are intrinsic connections between the costs and benefits 
examined in this section. Consider, for instance, the relatively low 
costs for OPOs and other entities in the health care industry 
(discussed in the subsequent discussion of ``Implementation and 
Continuing Costs''). Such low costs are plausible if OPO de-
certifications are rare, which could occur if enforcement is lax; if 
all or a significant portion of OPOs achieve the threshold rate of the 
top 25 percent; or if the potential for de-certification results in 
mergers or voluntary takeovers. Without strong enforcement, OPO 
behavior change may be minimal, in which case low costs would be 
accompanied by low longevity benefits and medical expenditure impacts 
(significantly lower than the estimates appearing in Tables 10 and 13).
    On the other end of the spectrum, if the competition and the 
potential for de-certification motivates substantial improvements, this 
would make substantial benefits and cost plausible. Foreseeable 
technological advances that we have not included in our analysis could 
also lead to substantial volume increases and resulting increases in 
both costs and benefits.
    In any scenario, OPOs undergoing such management change experience

[[Page 77935]]

difficult to quantify, transition costs including those related to 
changing a chief executive officer and/or board of directors, as well 
as cases involving litigation and prolonged management uncertainty, 
which could pose potentially much larger administrative and management 
costs in a few cases than those we have projected. Broader societal 
transition costs could include reduced organ recovery while the de-
certification process unfolds, even if improved practices increase 
transplant activity in the medium- to long-term. It may be the case 
that some boards of directors of low-performing OPOs, recognizing that 
major improvement is unlikely under current top management, replace 
those employees during the period before the de-certification deadline 
with proven managers from highly effective OPOs. The annual assessments 
conducted as part of this final rule and the creation of a publicly 
available tier ranking of OPO performance using objective data will 
provide OPO Boards the necessary information to make this type of 
decision. In either case, we would expect that most OPO operations 
would continue with operational reforms, but with few if any lower-
level staff being replaced and a small number of higher-level managers 
being replaced.
    We expect no costs for disruption of actual organ procurement at 
any OPOs for two reasons. First, we believe that almost all OPOs will 
be able to comply with the new tiered standards or will arrange a 
friendly merger with another OPO. There is no reason to expect 
performance disruption from a change in top leadership in such cases. 
In the relative handful of cases where the OPO is actually decertified 
and replaced, the newly responsible OPO would presumably arrange a 
smooth continuation of services in the DSA through negotiations with 
the outgoing Board of Directors and CEO to retain existing staff. No 
public comments suggested that any more disruptive outcome would ever 
be likely.
    1. Effects on Medical Costs. In the estimates that follow, we rely 
primarily on recent estimates by staff of the actuarial and consulting 
firm Milliman. Their study, ``2017 U.S. Organ and Tissue Transplant 
Cost Estimates and Discussion'' compares charges before, during, and 
after transplantation for all major and minor categories of 
transplant.\34\ The advantage of these estimates for our purposes is 
that they cover the pre-, intra-, and post-transplant costs on all 
organs using a consistent cost-estimating methodology. Unfortunately, 
accurate medical cost estimates are not publicly available from health 
insurance firms, since the network discounts received by private firms 
are generally treated as trade secrets, and Medicare's payments are 
typically not based directly on costs (with some exceptions, including 
payments to OPOs). Hence, Milliman uses ``charges'' for its estimates. 
As with likely excess of charges over costs, there is a netting off of 
non-transplantation costs--that is, costs associated with organ failure 
that are not affected by transplantation itself. For estimating 
purposes, we assume that these divergences between costs and charges 
largely cancel each other out, but that the net effect is that actual 
costs are about 20 percent less than the Milliman charge estimates.
---------------------------------------------------------------------------

    \34\ T. Scott Bentley and Steven J. Phillips, 2017, available to 
download at http://www.milliman.com/insight/2017/2017-U_S_-organ-and-tissue-transplant-cost-estimates-and-discussion/.
---------------------------------------------------------------------------

    In analyzing the medical costs of the rule, we first estimate the 
costs per transplant of the three most common organ transplants: 
Kidneys, livers, and hearts. Between them, they account for about 90 
percent of all transplants. Kidneys alone are over 60 percent of all 
organs transplanted.

                                Table 6--First Year Cost per Heart Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                                                      Immuno-
                                     Milliman     Likely  excess   Assumed  non-    suppressive         Net
              Heart                   charge        of charges       TX costs        drugs  (6      transplant
                                     estimate       over costs                        months)          cost
----------------------------------------------------------------------------------------------------------------
30 days pre-transplant..........          43,000           9,000          20,000               0          14,000
Procurement.....................         102,000               0               0               0         102,000
Hospital Transplant Admission...         887,000         177,000               0               0         710,000
Physician During Admission......          92,000          18,000               0               0          74,000
180 Days Medical Post Discharge.         223,000          45,000          60,000               0         118,000
180 Days Drugs Post Discharge...          34,000           7,000          10,000          15,000          32,000
                                 -------------------------------------------------------------------------------
    Total.......................       1,381,000         256,000          90,000          15,000       1,050,000
----------------------------------------------------------------------------------------------------------------

    As shown in Table 6, the one-time cost of a heart transplant is 
just over one million dollars after adjusting charges to costs and 
reducing the estimates to account for medical and drug costs, both pre- 
and post-discharge, that are unlikely to be transplant-related.

                                Table 7--First Year Cost per Liver Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                                                      Immuno-
                                     Milliman     Likely  excess   Assumed  non-    suppressive         Net
              Liver                   charge        of charges       TX costs        drugs  (6      transplant
                                     estimate       over costs                        months)          cost
----------------------------------------------------------------------------------------------------------------
30 days pre-transplant..........          41,000           8,000          10,000               0          23,000
Procurement.....................          94,000               0               0               0          94,000
Hospital Transplant Admission...         463,000          93,000               0               0         370,000
Physician During Admission......          56,000          11,000               0               0          45,000
180 Days Medical Post Discharge.         127,000          25,000          60,000               0          42,000
180 Days Drugs Post Discharge...          31,000           6,000          10,000          15,000          30,000
                                 -------------------------------------------------------------------------------

[[Page 77936]]

 
    Total.......................         812,000         143,000          80,000          15,000         604,000
----------------------------------------------------------------------------------------------------------------

    Table 7 shows the estimated average cost for a liver transplant, 
estimated on the same basis as heart transplants. Table 8 estimates 
kidney transplant costs, with an additional adjustment. In the case of 
a kidney transplant, there is an off-setting saving for the elimination 
of ESRD kidney dialysis costs. This is a substantial saving and in the 
first year alone, saves about one-third of the estimated transplant 
cost.

                                                   Table 8--First Year Cost per Kidney Transplant ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Likely                   Immuno-        Net         Annual
                                                                 Milliman    excess  of    Assumed    suppressive   transplant    dialysis    Net first
                            Kidney                                charge      charges       non-TX      drugs  (6      cost        costs      year cost
                                                                 estimate    over costs     costs       months)      subtotal     avoided
--------------------------------------------------------------------------------------------------------------------------------------------------------
30 days pre-transplant.......................................       30,000      (6,000)     (10,000)            0       14,000            0       14,000
Procurement..................................................       97,000            0            0            0       97,000            0       97,000
Hospital Transplant Admission................................      159,000     (32,000)            0            0      127,000            0      127,000
Physician During Admission...................................       25,000      (5,000)            0            0       20,000            0       20,000
180 Days Medical Post Discharge..............................       75,000     (15,000)     (60,000)            0            0   * (90,000)     (90,000)
180 Days Drugs Post Discharge................................       29,000      (6,000)     (10,000)       15,000       28,000            0       28,000
                                                              ------------------------------------------------------------------------------------------
    Total....................................................      415,000     (64,000)     (80,000)       15,000      286,000     (90,000)      196,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Estimated annual dialysis costs.

    Using these results, it is possible to estimate the extended 
effects of added and reduced costs over time. In Table 9, we provide a 
5-year projection, giving both results for a patient who survives all 5 
years with the transplanted organ, and the same estimate adjusted to 
assume only an 80 to 90 percent patient and organ survival rate for the 
full 5 years (the higher rate is for kidneys). These estimates do not 
account for all the varied circumstances that can arise, such as 
patients whose organs fail and who are then re-transplanted. They 
include the costs of immunosuppressive drugs. In the case of kidney 
transplants, the estimates assume a savings of $90,000 for ending 
dialysis, offset by a $30,000 cost for the immunosuppressive drugs. The 
weighted results take into account that kidneys account for about 65 
percent of transplants for these three organs. As shown in the table, 
kidney transplants actually reduce costs for the patients who survive 
the full 5-year period.

                          Table 9--Five Year Costs per Weighted Average Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                       Heart           Liver          Kidney         All three
                                                 ------------------------------------------------     organs
           Annual Percent of Total TX                                                                weighted
                                                        11%             24%             65%      ---------------
                                                                                                       100%
----------------------------------------------------------------------------------------------------------------
First Year......................................       1,050,000         604,000         196,000         387,860
Second Year.....................................          20,000          20,000        (60,000)        (32,000)
Third Year......................................          20,000          20,000        (60,000)        (32,000)
Fourth Year.....................................          20,000          20,000        (60,000)        (32,000)
Fifth Year......................................          20,000          20,000        (60,000)        (32,000)
                                                 ---------------------------------------------------------------
    Total.......................................       1,130,000         684,000        (44,000)         259,860
    80 to 90% Survival Total *..................       1,122,000         676,000        (20,000)         272,660
----------------------------------------------------------------------------------------------------------------
* Rate is higher for kidneys than for other organs. All deaths are assumed to occur prior to Year 2 (that is,
  before any dialysis-related savings can accrue).

    An annually growing performance increase to about 8,000 additional 
transplants in the last year of the next 4-year OPO performance period 
is essential in order to meet the HHS' 2030 goal of doubling the number 
of kidneys available for transplants. As Table 10 shows, this will 
require multi-billion dollar increases over current transplant spending 
levels by the middle of this decade (and far more by 2030). As we show 
in our benefit estimates, these levels are exceeded by the life-saving 
and life-extending benefits of these additional transplants. As 
discussed later in this analysis, most of the cost increases we 
estimate in this rule are reimbursed by private payers, rather than by 
Medicare.
    HHS has set a quantitative goal of doubling the number of kidneys 
available for transplant by 2030. While there are multiple pathways to 
achieve this goal, the main approach for achieving this ambitious goal 
is to increase the number of deceased donors. This will require 
continuous improvements over time, and we have estimated the 
approximate numbers that would have to be achieved in the next five 
years to move about half way towards an annual increase of 
approximately 16,000 more kidney

[[Page 77937]]

transplants by 2030, as shown in Table 10.
    In Tables 10 and 13, we show hypothetical projections for annual 
results for costs and benefits, respectively, as each cohort of new 
transplants arrives over the OPO performance period from 2021 to 2025--
assuming that both donor and transplant rates improve by an average of 
20 percent or to the top 25 percent level, whichever is higher, similar 
to the highest growth rates show in Tables 4 and 5 and using the 
estimate of 7,283 transplants shown in Table 5. As previously 
discussed, these are optimistic rates that assume a wide variation in 
improvements, including improvements by many OPOs in the top 25 percent 
as well as in the lower performers. These estimates include totals for 
all organs since one deceased donor normally provides multiple organs. 
The 7,000 increase shown for 2025 includes about 4,500 kidneys 
transplanted. These figures assume a 5-year patient and graft survival 
rate of 90 percent for kidney transplants. As can be seen, the costs 
grow substantially with each new cohort. These tables include an extra 
column that shows the effects of this 5-year cohort in the sixth and 
future years. While total costs grow over time with each new and larger 
cohort of new transplants, the savings from reduced kidney dialysis 
costs from previous kidney transplants grow over time, as do the 
benefits for those patients whose lives were both extended and improved 
by transplantation.

 Table 10--Higher Costs Over Time as Organ Transplants Hypothetically Increase To Reach Higher of 20% or Top 25%
                                                  ($ Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer term
 Increase over base year in number                                                                   effect from
    of transplants (20% annual         1,434        2,868        4,301        5,735        7,169       2021-2025
            increments)                                                                                cohorts
----------------------------------------------------------------------------------------------------------------
Costs for 2021-2 Cohort...........         $556        ($39)        ($39)        ($39)        ($39)        ($39)
Costs for 2022-3 Cohort...........  ...........        1,112         (78)         (78)         (78)         (78)
Costs for 2023-4 Cohort...........  ...........  ...........        1,668        (117)        (117)        (117)
Costs for 2024-5 Cohort...........  ...........  ...........  ...........        2,224        (156)        (156)
Costs for 2025-6 Cohort...........  ...........  ...........  ...........  ...........        2,781        (195)
                                   -----------------------------------------------------------------------------
    Total.........................          556        1,073        1,551        1,990        2,391        (585)
----------------------------------------------------------------------------------------------------------------

    Pancreas research projects do count in our performance measures, as 
explained earlier in the preamble. However, we do not include 
pancreatic research in our estimates of either costs or benefits since 
we have no basis for estimating either under current reporting. 
Experimental or other research procedures that involve transplantation 
of islets from an organ donor into a person on the waiting list for a 
pancreas are counted as transplants and included in our cost and 
benefit estimates, but the research projects displayed in Table 5 and 
excluded from Tables 10 to 15 are those specifically categorized under 
the OPTN's reporting instructions as research not involving a 
transplant. In 2016 to 2018 the number of such pancreas research 
projects have been between 500 and 600 a year (579 in 2018). This is 
1.73 percent of the number of transplants in 2018, and we project a 
similar fraction in our estimates for future years. Only bona fide 
research conducted by a qualified researcher using a pancreas from an 
organ donor would be counted, and it would be counted as a single 
research project regardless of the number of research activities 
performed using that one pancreas and its islets. It is also 
conceivable that a pancreas might be used for research when it would 
otherwise have been used for a transplant. We do not have data to 
quantify how frequently this may occur and have no basis for 
subtracting either lives lost or transplant cost savings from any such 
cases in our estimates of benefits and costs. In addition, any such use 
would likely raise issues of ethics, payment, and donor family consent. 
Regardless, we anticipate focusing on pancreatic research performance 
in both our payment and performance review functions to prevent abuse.
    We note that the expenditure data include procurement costs, which 
average almost $100,000 per organ transplanted across all three organ 
types. Accordingly, a cohort of 1,000 patients would involve total 
procurement costs of about $100 million, and a cohort of 8,000 patients 
about $800 million. These data do not include all organ types, nor all 
cost savings (notably end-of-life costs), but are a reasonable 
approximation to the magnitudes involved. The procurement costs are 
paid to OPOs by transplant centers and finance the costs associated 
with the actual donation and transportation of the organ to the 
transplant program as well as the general operations of the OPO. These 
costs are, as discussed later in this analysis, largely reimbursed by 
health insurance.
    Our estimates also do not include costs of changes or advances in 
treatment options for both liver and heart patients, such as new drug 
treatments for hepatitis C, one of the main causes of liver failure, or 
heart assist devices that can serve as a bridge while waiting for a 
heart transplant.
    In Table 11, we provide lower cost estimates using the same per-
transplant inputs but with aggregates reflecting only the minimum 
number of new annual transplants required to reach the top 25 percent. 
As in Table 10, these estimates reflect the timeline changes in the 
final rule and the need for OPOs to begin immediately to make the 
reforms needed to raise their performance. As is in Table 10, we 
exclude pancreas research from our projection. These are hypothetical 
costs assuming that every OPO could predict future success rates 
precisely and that all OPOs would act to achieve only the exact minimum 
level needed to avoid decertification. Compliance starts in 2021 to 
meet the timelines of this final rule.

[[Page 77938]]



 Table 11--Higher Costs Over Time as Organ Transplants Hypothetically Increase To Reach Higher of 20% or Top 25%
                                                  ($ Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer term
 Increase over base year in number                                                                   effect from
    of transplants (20% annual          180          360          539          719          899        2021-2025
            increments)                                                                                cohorts
----------------------------------------------------------------------------------------------------------------
Costs for 2021-2 Cohort...........          $70         ($5)         ($5)         ($5)         ($5)         ($5)
Costs for 2022-3 Cohort...........  ...........          139         (10)         (10)         (10)         (10)
Costs for 2023-4 Cohort...........  ...........  ...........          209         (15)         (15)         (15)
Costs for 2024-5 Cohort...........  ...........  ...........  ...........          279         (20)         (20)
Costs for 2025-6 Cohort...........  ...........  ...........  ...........  ...........          349         (24)
                                   -----------------------------------------------------------------------------
    Total.........................           70          135          195          250          300         (73)
----------------------------------------------------------------------------------------------------------------

    In Table 12, we describe an intermediate scenario where all lower-
performing OPOs (Tiers 2 and 3) achieve the top 25 percent threshold 
rate (but no more) for organs used in transplantation and the OPOs 
already in Tier 1 do not improve their performance. For the ease of 
analysis, both the lowest and intermediate scenarios assume that OPOs 
could predict their performance so as to achieve exactly the right 
level to avoid any decertification penalty. These scenarios illustrate 
that there are a range of outcomes that we are unable to predict with 
any precision since they will depend on OPO by OPO management and other 
decisions.

     Table 12--Intermediate Costs Over Time as Organ Transplants Hypothetically Increase To Reach Top 25% ($
                                                    Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer term
 Increase over base year in number                                                                   effect from
    of transplants (20% annual          486          972         1,457        1,943        2,429       2021-2025
            increments)                                                                                cohorts
----------------------------------------------------------------------------------------------------------------
Costs for 2021-2 Cohort...........         $188        ($13)        ($13)        ($13)        ($13)        ($13)
Costs for 2022-3 Cohort...........  ...........          377         (26)         (26)         (26)         (26)
Costs for 2023-4 Cohort...........  ...........  ...........          565         (40)         (40)         (40)
Costs for 2024-5 Cohort...........  ...........  ...........  ...........          754         (53)         (53)
Costs for 2025-6 Cohort...........  ...........  ...........  ...........  ...........          942         (66)
                                   -----------------------------------------------------------------------------
    Total.........................          188          364          526          674          810        (198)
----------------------------------------------------------------------------------------------------------------

    2. Effects on Patients. On average, organ transplants significantly 
extend lives. There is extensive literature on life expectancy before 
and after transplant, quality of life, and cost savings for kidney 
transplant patients. A recent literature synthesis found essentially 
universal agreement that kidney transplants were not only substantially 
life extending, but also cost reducing.\35\ The authors performed an 
extensive literature search and found that from 1968 to 2007, seventeen 
studies assessed the cost-effectiveness of renal transplantation. The 
authors concluded that ``[r]enal transplantation . . . is the most 
beneficial treatment option for patients with end-stage renal disease 
and is highly cost-effective compared to no therapy. In comparison to 
dialysis, renal transplantation has been found to reduce costs by 
nontrivial amounts while improving health both in terms of the number 
of years of life and the quality of those years of life'' (page 31). 
More recent studies and other syntheses have reached similar 
conclusions. For example, in the article, ``Systematic Review: Kidney 
Transplantation Compared with Dialysis in Clinically Relevant 
Outcome,'' the authors reviewed 110 studies and concluded that the vast 
majority of kidney transplant recipients showed major improvement in 
life quality and reductions in mortality compared to those remaining on 
dialysis.\36\ The Annual Data Report of the United States Renal Data 
System utilizes national data on ESRD, and reports that deaths per 
1,000 patient years in 2016 were about 134 for dialysis patients but 
only about 29 for transplant recipients.\37\ There are similar data on 
other organs. For example, in the RIA published in the 1998 final rule 
establishing the governance procedures for the OPTN (63 FR 16296), HHS 
estimated that ``the annual benefits of organ transplantation include 
about eleven thousand lives vastly improved by kidney transplantation, 
and another eight thousand lives both vastly improved and prolonged by 
transplantation of other major organs'' (63 FR 16323).
---------------------------------------------------------------------------

    \35\ Huang, E, et al., ''The Cost-Effectiveness of Renal 
Transplantation,'' When Altruism Isn't Enough, edited by Sally Satel 
(AEI Press, 2008).
    \36\ Tonelli M, et al., Am J Transplant 2011: 2093-2109.
    \37\ USRDS 2018 Annual Data Report report, volume 2, Figure 5.1; 
accessed at https://www.usrds.org/adr.aspx and https://www.usrds.org/2018/download/v2_c05_Mortality_18_usrds.pdf).
---------------------------------------------------------------------------

    Accordingly, the per-patient potential benefits are substantial. 
For each new kidney transplant, there would be an average of 10 
additional life years per transplant patient compared to those on 
dialysis.\38\ Using the more usual metric of survival rates, the 5-year 
survival rate for kidney transplant patients is 86 percent (Milliman, 
page 13).
---------------------------------------------------------------------------

    \38\ Wolfe RA et al., ``Comparisons of Mortality in All Patients 
on Dialysis, Patients on Dialysis Awaiting Transplantation, and 
Recipients of a First Cadaveric Transplant,'' NEJM, 1999, 341:1725-
30; accessed at http://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article).
---------------------------------------------------------------------------

    HHS ``Guidelines for Regulatory Impact Analysis'' explain the 
concept of Quality-adjusted life years (QALYs).\39\ QALYs enable 
estimates of the value that people are willing to pay for life-
prolonging and life-improving health care interventions of any kind 
(see sections 3.2 and 3.3 of the HHS Guidelines for a detailed 
explanation). The QALY amounts used in any estimate of overall 
benefits, including this one, are not meant to be precise estimates, 
but instead are rough statistical measures that allow an overall 
estimate of benefits expressed in dollars (usually by multiplying QALYs 
by a

[[Page 77939]]

dollar estimate of the value of a statistical life year).\40\
---------------------------------------------------------------------------

    \39\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
    \40\ Using such a measure to make coverage or reimbursement 
determinations is prohibited by Section 1182(e) of the Act. That 
prohibition does not apply to the situation addressed in this 
proposed rule, where the purpose is not to determine medical 
coverage for individual patients, but to measure overall success in 
raising the number of persons who obtain life-saving treatments.
---------------------------------------------------------------------------

    Table 13 provides estimates of the life-extending and life-
improving value of the rule assuming that it succeeds in improving OPO 
performance in early years at the magnitudes necessary to meet the 2030 
HHS goal (to do so we model achieving the 75th percentile, or a 20 
increase, whichever is higher, as shown in Table 5). The increase of 
7,283 transplants in Table 13 is taken from Table 5. For simplicity, we 
estimate that transplants occur halfway through the year.

 Table 13--Higher Benefits Over Time as Organ Transplants Hypothetically Increase To Reach Higher of 20% or Top
                                                25% ($ Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer term
 Increase over base year in number                                                                   effect from
    of transplants (20% annual         1,434        2,868        4,301        5,735        7,169      2021-2025
            increments)                                                                                cohorts
----------------------------------------------------------------------------------------------------------------
Benefits for 2021-2 Cohort........         $134         $268         $268         $268         $268         $268
Benefits for 2022-3 Cohort........  ...........          268          537          537          537          537
Benefits for 2023-4 Cohort........  ...........  ...........          403          805          805          805
Benefits for 2024-5 Cohort........  ...........  ...........  ...........          537        1,073        1,073
Benefits for 2025-6 Cohort........  ...........  ...........  ...........  ...........          671        1,342
                                   -----------------------------------------------------------------------------
    Total.........................          134          537        1,208        2,147        3,355        4,025
----------------------------------------------------------------------------------------------------------------

    Table 13 shows only the first 5 years of increasing transplants, 
with an extra year added with no new cohort to illustrate how the 
benefits for each group grow over time. Over a 10-year period, total 
life extending benefits from about 18,000 additional kidney transplants 
would be $23 billion (without discounting) from the five cohorts of 
additional transplants shown in Table 13 (28,000 organs x 65 percent of 
which are kidneys x \2/3\ patient survival rate x $1 million per 
surviving transplant recipient in life extending benefits = $23 
billion). A similar calculation for all additional transplant 
recipients reaches a total of $35 billion over 10 years, with even more 
years of benefits to most of the same recipients yet to come.\41\
---------------------------------------------------------------------------

    \41\ This method of calculating the value of kidney 
transplantation is similar to but substantially simplified from the 
method used in P.J. Held et al., ``A Cost-Benefit Analysis of 
Government Compensation of Kidney Donors,'' American Journal of 
Transplantation, 2016, pages 877-885 (plus 65 pages of supplementary 
details explaining all assumptions, data sources, and calculations). 
Factors for Hearts and Livers come from Elisa F. Long et al., 
``Comparative Survival and Cost-Effectiveness of Advance Therapies 
for End-Stage Heart Failure,'' http://circheartfailiure.ahajournals.org, April 7, 2017; and Fredrik Aberg 
et al., ``Cost of a Quality-Adjusted Life Year in Liver 
Transplantation: The Influence of the Indication and the Model for 
End-Stage Liver Disease Score,'' Liver Transplantation 17:1333-1343, 
2011.
---------------------------------------------------------------------------

    We note that these estimates are averages across patients who vary 
widely in age, medical condition, and life expectancy, as well as type 
of organ failure. For example, the sickest patients typically have very 
low life expectancies without transplant so they stand to gain the most 
years of life from a transplant. However, these same patients, on 
average, have slightly lower survival rates post-transplant. Organ and 
patient survival issues are complex and dealt with by detailed policies 
and procedures developed and used by the transplant community. These 
policies are reviewed and revised frequently based on actual experience 
and changing technology--over time, the success rate from using 
marginal organs and in transplanting older and sicker patients have 
both increased substantially. There are additional complexities that we 
have not used in these broad estimates, such as the ability of kidney 
transplant recipients to return to dialysis if a transplanted kidney 
fails, leading to both additional costs and additional benefits. For 
presentation purposes, we have not discounted future costs and benefits 
to ``present value'' in the preceding tables, but handle discounting in 
our annualized estimates shown in the Accounting Table that follows. 
For purposes of this analysis, the proper measure is the average gain 
across all patients who would receive transplants in the presence of 
the rule but not in its absence.
    Table 14 shows estimates using the same per-transplant life-saving 
benefits but with aggregates reflecting the lower figure of 1899 new 
annual transplants shown in Table 5 as an estimate of those number of 
transplanted need to meet the median threshold rates to avoid de-
certification based on the outcome measures. These are hypothetical 
benefits assuming that every OPO could predict future success rates 
precisely and that all OPOs would be able to act to achieve only the 
exact minimum level needed to avoid automatic decertification.

     Table 14--Lower Benefits Over Time as Organ Transplants Hypothetically Increase Only To Reach Median ($
                                                    Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer Term
 Increase over base year in number                                                                   Effect from
    of transplants (20% annual          180          360          539          719          899       2021-2025
            increments)                                                                                Cohorts
----------------------------------------------------------------------------------------------------------------
Benefits for 2021-2 Cohort........          $17          $34          $34          $34          $34          $34
Benefits for 2022-3 Cohort........  ...........           34           67           67           67           67
Benefits for 2023-4 Cohort........  ...........  ...........           50          101          101          101
Benefits for 2024-5 Cohort........  ...........  ...........  ...........           67          135          135
Benefits for 2025-6 Cohort........  ...........  ...........  ...........  ...........           84          168
                                   -----------------------------------------------------------------------------
    Total.........................           17           67          151          269          421          505
----------------------------------------------------------------------------------------------------------------


[[Page 77940]]

    Finally, we have estimates of benefits that correspond to the 
number of organ transplants needed for all OPOs to reach the level of 
the Top 25 percent of all OPOs. As shown in Tables 5 and 12, using 2018 
data we estimate that 2,429 additional transplants would be needed to 
reach that level. As is the case for our other estimates, this is a 
hypothetical level that in this case corresponds to an Intermediate 
level of performance. In the real world, it would be unlikely that an 
OPO would achieve that exact level of performance, and best practice 
suggests a more prudent approach would be to strive for a higher level 
if for no other reason than to avoid some unexpected shortfall. (As 
before, we estimate no QALY value for research projects that use 
pancreata, and have no basis for valuing research that does not include 
an actual transplant.)

 Table 15--Intermediate Benefits Over Time as Organ Transplants Hypothetically Increase Only To Reach Median ($
                                                    Millions)
----------------------------------------------------------------------------------------------------------------
               Year                     2022         2023         2024         2025         2026
---------------------------------------------------------------------------------------------------- Longer term
 Increase over base year in number                                                                   effect from
    of transplants (20% annual          486          972         1,457        1,943        2,429      2021-2025
            increments)                                                                                Cohorts
----------------------------------------------------------------------------------------------------------------
Benefits for 2021-2 Cohort........          $45          $91          $91          $91          $91          $91
Benefits for 2022-3 Cohort........  ...........           91          182          182          182          182
Benefits for 2023-4 Cohort........  ...........  ...........          136          273          273          273
Benefits for 2024-5 Cohort........  ...........  ...........  ...........          182          364          364
Benefits for 2025-6 Cohort........  ...........  ...........  ...........  ...........          227          455
                                   -----------------------------------------------------------------------------
    Total.........................           45          182          409          727        1,137        1,364
----------------------------------------------------------------------------------------------------------------

    3. Implementation and Continuing Costs. The requirements of this 
final rule would necessarily have to be read, understood, and 
implemented by all OPOs. This would create one-time as well as 
continuing costs. In some cases, these costs would be low, involving 
understanding the new outcome measures and learning where the OPO 
stands in relationship to other OPOs in meeting the new outcome 
measures. In other cases, the OPO may need to significantly change its 
practices and techniques, increase frontline staffing, and/or change 
senior leadership.
    In all cases, time will have to be spent deciding whether and how 
to change existing policy and procedures. These effects would be on 
primarily the 58 OPOs, but secondarily the approximately 750 transplant 
programs in about 250 transplant hospitals and to a lesser extent the 
6,000 donor hospitals. Ultimately, as OPO performance increases, donor 
hospitals may have more training activities, participate in more organ 
donation awareness activities, and have increased operating room or ICU 
activities associated with increased donations. Transplant programs 
similarly would need to perform more transplants if OPOs improve their 
performance. Most of the OPO costs are included in the acquisition 
costs associated with organ procurement and would be paid by Medicare 
and other health insurers, including the costs that management will 
incur in learning these new rules. Therefore, our estimates assume that 
ongoing management operations will continue at current levels and focus 
on costs needed to understand the new rules and plan changes needed for 
compliance, such as QAPI and ECE. We did not receive comments on our 
estimates as to skills and occupations involved or time likely to be 
spent.
    In total, there are about 400 potentially and directly affected 
entities or programs. For transplant hospitals (whose business levels 
will be indirectly affected), we assume that on average there would be 
1 hour of time spent by a lawyer, 2 hours of time by an administrator 
or health services manager, and two hours of time by other staff (we 
assume registered nurses or equivalent in wage costs) of each affected 
provider to understand the regulatory change(s) and make the 
appropriate changes in procedures. We further assume that for one-tenth 
of these providers, 2 hours of physician time would be needed to 
consider changes in facility policy. Average hourly costs for these 
professions, with wage rates doubled to account for fringe benefits and 
overhead costs, are $139 for lawyers (occupation code 23-1011), $109 
for medical and health services managers (occupation code 11-9111), $89 
for statisticians (occupation code 15-2041), $73 for registered nurses 
(occupation code 29-1141), $56 for healthcare social worker (21-1022), 
and $203 for physicians (occupation code 29-1060). The medical and 
health services managers would include such occupations as transplant 
administrator, organ procurement coordinator, and director of nursing. 
The statistician might instead be a computer analyst or operations 
research analyst at a similar wage. The underlying wage numbers are 
from BLS statistics for 2018.\42\
---------------------------------------------------------------------------

    \42\ https://www.bls.gov/oes/2018/may/oes_nat.htm.
---------------------------------------------------------------------------

    We assume that on average, an OPO would involve one person in each 
occupation listed in the preceding paragraph, and an average of 8 hours 
on an interdisciplinary team tasked with learning the new rules, 
understanding their implications for that OPO, and initiating plans to 
address performance levels as well as to deal with QAPI and ECE issues. 
Total costs, on average, would be $139 plus $109 plus $89 plus $73 plus 
$56 plus $203, for a total of $669 per hour and $5,352 (8 x $669) for 
eight hours. For the 58 OPOs, the first-year cost would therefore be 
about $310,000 (58 x $5,352).
    We also assume that some large fraction of OPOs would either 
voluntarily, or through decertification and takeover, have a new CEO 
and perhaps other senior managers, or a new Board of Directors, or both 
(or, in some cases, the takeover would simply involve an existing Board 
of Directors assuming an additional DSA responsibility). These costs 
could involve search costs, potentially higher salary costs for the 
replacement managers, and legal costs in the cases where the 
corporation is replaced or merged with the certified OPO newly placed 
in charge. The extent and magnitude of these types of cost are 
difficult to predict, as are the numbers of affected OPOs. The costs 
may be lower, for example, if the low-performing OPO concludes that it 
cannot meet the new requirements under current management, and 
voluntarily seeks a merger with another OPO or implements management 
reforms that do not raise long-term costs. Because we cannot predict 
the mix of these kinds of alternatives, we assume that these governance 
and top management-related costs will be $100,000 a year on average for 
the

[[Page 77941]]

bottom-performing half of all OPOs, for a total cost over a 5-year 
period of $14.5 million (29 x $100,000 x 5).
    We also assume that regardless of the precise reform or takeover 
option involved in a particular DSA, both outgoing and incoming 
management would undertake careful measures to maintain the integrity 
and performance of ongoing organ procurement and placement functions 
with minimal or no disruption. While the analogy is imperfect, and 
while staff morale problems are common in hospital merger situations, 
we are unaware of any evidence that patient care was substantially 
affected adversely by hospital mergers.\43\ Accordingly, we assume no 
major or continuing disruption in the provision of actual services 
related to organ donation or placement during such transitions.
---------------------------------------------------------------------------

    \43\ See Vivian Ho and Barton Hamilton, ``Hospital mergers and 
acquisitions: does market consolidation harm patients?,'' Journal of 
Health Economics, September 2000, at https://www.sciencedirect.com/science/article/abs/pii/S0167629600000527, and Tim Attebery, A Study 
to Examine the Relationship Between Hospital Mergers and Patient 
Experience, Ph.D. Dissertation, University of Alabama, 2018, at 
https://search.proquest.com/openview/4653015278eba7781f781fbf0fcbc6c8/1?pq-origsite=gscholar&cbl=18750&diss=y.
---------------------------------------------------------------------------

    There would also be continuing and far larger costs over time as 
OPOs and hospitals manage the substantial increases in numbers of 
donors and number of organs transplanted, while increasing and 
improving OPO management of current activities, improved procurement 
and placement techniques, QAPI, and ECE requests if needed. These 
procurement costs (including reimbursable overhead activities) are 
included in the cost estimates in Tables 6 to 8, and average 
approximately $100,000 per organ. Each additional 1,000 organs would 
cost about $100 million, with insurance reimbursement and patient cost-
sharing covering essentially all of those costs (see the next section 
of the analysis). As organ procurement grows, there are two significant 
effects. First, there are economies of scale as OPOs and hospitals 
expand their donor-related and transplant services. Second, there are 
substantial volume increases over time that require additional efforts. 
For each OPO these are potentially multi-million dollar annual cost 
(and revenue) increases that reflect additional work performed and 
donation and transplant increases achieved. For both cost savings and 
cost increases, effects are primarily from staffing changes; we assume 
there are relatively few fixed investments beyond rent and equipment. 
And in both cases, current reimbursement policies and programs pay for 
all reasonable costs. We received no comments on these and other 
workload, cost, and revenue issues and estimates and have left them 
only moderately changed.
    We do not expect substantial costs would be incurred by CMS. The 
data collection required for enforcement of the standards already 
exists and can readily be used to assess performance. OPOs are already 
reviewed and surveyed on a continuing basis. There would be additional 
costs for technical assistance, processing ECE requests, and reviewing 
QAPIs, as well as actions regarding any OPOs with major compliance 
problems. We anticipate increased appeals related activities, however 
our expectation is that these would be managed through any necessary 
reallocations of staff time from lower priority activities. The number 
of affected facilities is also small compared to the number of 
facilities that CMS works with on a regular basis. CMS estimates that 
these oversight activities are unlikely to require more than three or 
four additional person-years of effort, with annual costs of one 
million dollars or less.
    The preceding analysis does not reflect the potentially substantial 
transition costs associated with the potentially disruptive to top 
management process of decertification. However, as previously discussed 
we believe that these costs will fall almost entirely on the very 
highest levels of OPO governance, not on the ongoing processes of the 
OPO in procuring organs or arranging transplant placement performed by 
professional staff.

E. Effects on Medicare, Medicaid, and Private Payers

    The preceding cost estimates include all procurement and 
transplantation costs, regardless of payer. In practice, however, most 
of the costs are covered by insurance, and the remainder primarily by 
patients. Typical insurance shares, both public and private, range from 
100 percent (Medicaid) to 80-90 percent in private insurance and 
Medicare, taking into account hospital, physician, ESRD, and drug 
costs. While overall cost sharing by category of expense is broadly 
similar among insurance sources and across organ types, both the 
transplant cost and the shares paid by public and private insurance 
vary widely by organ type. Specifically, for heart and liver 
transplants, the vast majority of patients are enrolled in private 
insurance or in some cases in Medicaid because of the age restrictions 
of Medicare (unless disabled). According to the OPTN, in 2018 only 19 
percent of heart transplants and 22 percent of liver transplants were 
performed in recipients 65 and older. In contrast, the vast majority of 
kidney transplants (about 80 percent) are received by patients who have 
end-stage renal disease and, as ESRD patients, nearly all are entitled 
to Medicare regardless of age (about half of ESRD patients are also 
enrolled in Medicaid, but Medicare is ``primary'' and pays most costs). 
This ESRD/kidney transplant group also differs radically in initial 
transplant cost (much lower than for hearts and livers, as shown in 
Tables 6 through 8), and in cost over time. For kidney transplant 
recipients who live 4 years or more after the transplant year, total 
medical costs over time are lower than for dialysis, resulting in 
savings to Medicare (see Table 8). For ESRD patients who receive kidney 
transplants, the public insurance programs would likely save money over 
time.
    We do not have a definitive estimate of costs to each category of 
payer because those shares will change considerably over time as new 
cohorts of patients are served, and will also change depending on 
whether costs are estimated for 1, 5, or 10 years or beyond. For kidney 
transplant recipients, who account for almost two-thirds of 
transplants, Medicare cumulatively saves more money than the transplant 
cost by the fourth or fifth year after transplant. One simple 
calculation method is to consider the weighted average of costs billed 
to Medicare for each 1,000 patients transplanted and surviving 5 years. 
Taking into account all the preceding factors, the weighted average 
total cost billed by providers to all payers would be about $270 
million (see Table 9). The Medicare share of that would be about $40 
million, largely reflecting the lower initial costs of kidney 
transplants, the continuing dialysis savings, and the relatively small 
share of heart and liver transplants paid by Medicare. In the first 
year for these same 1,000 patients (the year of the actual transplant) 
the Medicare cost would be about $150 million of the $388 million 
total, reflecting the Medicare coverage of the majority of transplants 
as well as the lower average cost for those kidney transplants. Across 
the first 5 years after the final rule takes effect (years in which 
much of the dialysis savings are not yet realized), total costs shown 
in Table 10 over this period are about $10 billion and the average 
billed to Medicare would be about 25 percent of this, or $2.5 billion.

[[Page 77942]]

Of this, patients would pay on average almost 20 percent, reducing the 
Medicare costs to about $2 billion over the 5-year period. 
Alternatively, if costs only increase by the minimum needed to achieve 
required standards, total costs and the Medicare share might be only 
about one fourth as much (see Tables 11 and 12).

F. Effects on Small Entities, Effects on Small Rural Hospitals, 
Unfunded Mandates, and Federalism

1. Regulatory Flexibility Act
    The Regulatory Flexibility Act (RFA) requires agencies to analyze 
options for regulatory relief of small entities, if a rule has a 
significant impact on a substantial number of small entities. For 
purposes of the RFA, we estimate that most health care providers 
regulated by CMS are small entities as that term is used in the RFA 
(including small businesses, nonprofit organizations, and small 
governmental jurisdictions). The great majority of hospitals and most 
other health care providers and suppliers are small entities, either by 
being nonprofit organizations or by meeting the SBA definition of a 
small business (having revenues of less than $8.0 million to $41.5 
million in any 1 year, varying by type of provider and highest for 
hospitals). On average, the 58 OPOs have annual revenues of about $50 
million in a market with annual organ acquisition revenues of about $3 
billion annually.\44\ While few of these would meet SBA revenue size 
standards for ``small,'' all are, by law, non-profits. Accordingly, 
almost all of the direct effects on businesses that this rule would 
create will affect small entities.\45\
---------------------------------------------------------------------------

    \44\ Brigitte Sullivan, Executive Director, NYU Langone 
Transplant Institute, ``Maximizing Medicare Cost Report 
Reimbursement,'' 2015, online at http://organdonationalliance.org/wp-content/uploads/2015/08/ATC_BSullivan_CostReport_062016_S5N0001.pdf.
    \45\ We appreciate that some OPOs are hospital-based. For 
purposes of this analysis, we focus on their OPO functions 
separately from their other functions.
---------------------------------------------------------------------------

    The RFA requires that a Regulatory Flexibility Analysis be prepared 
if a proposed and subsequent final rule would have a ``significant 
economic impact'' on a ``substantial number'' of such entities. The HHS 
standard for ``significant economic impact'' is 3 percent or more of 
annual revenues. Although the HHS position is that this only applies to 
negative impacts because the RFA requires agencies to ``minimize'' 
economic impact, HHS practice in cases involving significant positive 
effects is to perform the analysis, regardless of the statutory issue. 
In the case of this rule, we expect most OPOs to prosper as they reform 
their practices to meet the new standards, but some may lose their 
certification and be replaced by existing, high performing OPOs. The 
HHS standard for ``substantial number'' is 5 percent or more of those 
that will be significantly impacted, but never fewer than 20. While 
there are only 8 OPOs that fall into Tier 3 and we expect that all or 
most of these will meet our outcome measures within 4 years, there is a 
possibility that a larger number would not have their agreements 
renewed because of loss in the competition phase. Hence, we are unable 
to certify that a Final Regulatory Flexibility Analysis is not required 
under the RFA. Accordingly, we prepared both Initial and Final 
Regulatory Flexibility Analyses and this RIA, together with the other 
preamble sections, meets the requirements for RFAs.
    The question arises as to whether transplant programs are affected 
entities. We believe they are not. They are all medical units within 
hospitals. Only the hospital itself can be a small entity, and many 
are, as a consequence of their non-profit status. However, nothing in 
this rule directly regulates either hospitals or their transplant 
programs. Moreover, nothing in this rule would have any adverse effects 
on those programs. They would, instead, likely gain revenues from 
increases in patients transplanted. The pattern of such increases is 
impossible to predict since organs are increasingly shared across OPO 
service area boundaries and, in many cases, across hundreds or 
thousands of miles. Regardless, in the aggregate, hospital revenues 
nationwide exceed 1 trillion dollars a year; the estimated costs of 
this rule assuming higher rather than lower levels of performance over 
the first 5 years are about $10 billion, averaging $2 billion a year, 
of which only half falls on transplant programs. This would be a 
fraction of 1 percent of hospital costs or revenues in the hospitals 
that host transplant programs, which are generally larger hospitals. 
Since organ acquisition costs are reimbursed by patient health 
insurance, net costs to hospitals with transplant programs are 
approximately zero and may actually be negative.\46\ Indeed, if any 
hospital determined that its transplant program was no longer a profit 
center, it could simply cease providing that service. Hence, we 
conclude that there would be no ``significant economic effect'' on a 
``substantial number'' of hospitals, and that increases in transplant 
volume will be neutral or positive.
---------------------------------------------------------------------------

    \46\ Patients are not ordinarily accepted on transplant waiting 
lists if they do not have the insurance or other means to ensure 
that they can pay not only the hospital and surgical fees, but also 
for the immunosuppressive drugs that are needed for post-transplant 
survival.
---------------------------------------------------------------------------

    The potential economic effects on OPOs depend on their ability to 
meet the thresholds established at the beginning of the 4-year 
performance period. OPOs who are in Tier 1 should experience positive 
impacts (a likely increase in organ donors and organ transplants that 
we estimate to likely be near 20 percent), with revenues from Medicare 
that reimburses reasonable kidney acquisition costs) and reimbursement 
from other health insurers. Those OPOs currently at Tier 3 that can 
achieve the threshold rates over the 4-year period may also benefit 
from the increased revenue associated with procuring more organs. For 
OPOs that cannot meet the new outcome measures or improve sufficiently 
to win the competition for their open DSA, they would incur costs to 
make the necessary changes to avert a loss of certification. Our final 
rule methodology is designed to allow all OPOs the opportunity to 
achieve the threshold rates; however, based on Tables 4 and 5, we 
believe that there are a range of potential outcomes, assuming high 
performers remain at steady state or substantially improve over time. 
Based on 2018 data, these potential outcomes include:
     Eight OPOs in Tier 3 would be subject to de-certification 
or loss of DSA because they would need to increase their donation and/
or transplantation rates by more than 50 percent to meet the Tier 1 
threshold rates. These eight are at the most serious risk.
     Approximately 12 DSAs that would be subject to potential 
takeover because their current OPOs would need to increase their 
donation and/or transplantation rates by more than 10 to 50 percent to 
meet the Tier 1 threshold rates.
     Approximately 12 DSAs whose current OPOs would need to 
achieve relatively little improvement but that would be still subject 
to potential takeover because they would need to increase their 
donation and/or transplantation rates by 1 to 10 percent to meet the 
Tier 1 threshold rates.
    In most cases of potential loss of certification for a DSA, we 
would reasonably expect another OPO to take over that service area, 
retaining the original staff of the OPO that is being taken over, but 
changing the leadership and many of the organ procurement practices. 
Conversely, it is also possible that an OPO taking over a new service 
area would need to increase its staff or

[[Page 77943]]

incur costs related to retraining, or implementation of best practices 
unfamiliar to the de-certified OPO's staff. We asked for comments on 
the costs associated with an OPO entering a new DSA after a 
decertification, including retraining, leadership, relationship 
building, and implementation of other best practices, but received no 
comments with which to inform our estimates. As indicated previously in 
this analysis, we have assumed that disruption costs to OPO organ 
procurement practices will be mainly related to replacement of Chief 
Executive Officers and/or Boards and Board members.
    Tables 1 to 3 present a list of all affected OPOs and of the gap 
between their current performance and the final rule standards. These 
tables use data from 2018 as the baseline year. Based on preliminary 
2019 data, which shows substantial overall national improvement in 
organ transplantations, if the donor potential remained steady in 2019 
as it did from 2017 to 2018, these estimates likely overstate the risk 
for many OPOs (and, by extension, the scope for potential benefits of 
this rule). These tables show for each OPO what it would have to 
achieve over a 4-year period to meet the outcome measures. Since the 
threshold rate using 2019 data would be established prior to the 
assessment period, each OPO would know from its own workload data and 
the latest potential donor data exactly where it stands at any point in 
time over the 4-year re-certification cycle. Since the reasonable and 
allowed cost of each OPO's increased effort and performance is covered 
by Medicare for kidney acquisitions, this is not a cost or revenue 
issue for the OPOs. Instead, our new outcome measures would create a 
senior leadership and potentially an organizational survival issue. The 
future of an OPO depends largely on its performance in obtaining donors 
and on utilization of those organs for transplantation.
    Since all OPOs are non-profit organizations and hence ``small 
entities,'' all of the alternatives and options presented throughout 
this preamble meet the RFA requirement that effects on these entities 
be addressed.
    Because the measures we have adopted are performance standards, 
they provide flexibility to the OPOs in meeting the standards. For 
example, in addition to all the possible internal reforms that an OPO 
could make, OPOs could merge, or service areas could be merged. These 
flexibilities are not limited to bilateral agreements and could involve 
multiple OPOs in partnership with each other or with transplant 
hospitals. OPO boards could replace the executive leadership and the 
new leadership could replace ineffective coordinators. They could work 
to improve working relationships with donor hospitals within their 
service areas through programs such as the Workplace Partnership for 
Life. Should cases arise where an OPO is unable to make the necessary 
changes or is constrained by circumstances beyond its control so that 
it cannot reach the performance levels of others, CMS can intervene 
with technical assistance or to facilitate mergers or other changes. 
The three tier system put in place by this final rule will facilitate 
OPO decisions on corrective actions calibrated to their performance 
tier. We believe that every OPO can meet these standards through good 
faith reforms to improve both donation and organ placement.
    The RFA contains a number of requirements for the content of an 
Initial or Final Regulatory Flexibility Analysis, including a 
description of the reasons why action is being considered, a statement 
of the objectives and legal basis for the rule, a description of any 
reporting or record-keeping requirements of the rule, and a description 
of any other Federal rules that duplicate, overlap, or conflict with 
the proposed or final rule (there are none in this case), among others. 
This RIA and the preamble taken as a whole meet these requirements. We 
note that the RFA emphasizes the use of performance rather than design 
standards, which is precisely what we proposed and are putting in place 
in this final rule.
2. Small Rural Hospitals
    Section 1102(b) of the Act requires us to prepare an RIA if a rule 
may have a significant impact on the operations of a substantial number 
of small rural hospitals. This analysis must conform to the provisions 
of section 604 of the RFA. For purposes of section 1102(b) of the Act, 
we define a small rural hospital as a hospital that is located outside 
of a metropolitan statistical area and has fewer than 100 beds. This 
rule's direct effects do not fall on hospitals and there are no small 
rural hospitals that operate transplant programs. Accordingly, the 
Secretary has determined that this rule will not have a significant 
impact on the operations of a substantial number of small rural 
hospitals.
3. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2020, that 
threshold is approximately $156 million. This rule contains no mandates 
that directly impose spending costs on state, local, or tribal 
governments, or by the private sector. Some OPOs would likely find that 
meeting these standards would require additional spending, but others 
may find that better performance can be achieved at little or no cost. 
In either case, reimbursement by both public and private payers would 
cover all reasonably estimated costs.
4. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. This rule would impose no such requirements.

G. Alternatives Considered

    Throughout the preamble sections, the proposed rule presented our 
proposals and sought comments on potential alternatives. We proposed to 
implement reform measures that (1) establish empirically-based outcome 
and process performance measures for OPOs, (2) that can be uniformly 
applied to all OPOs, (3) that would capture the entire pool of 
potential deceased-donors, (4) that would use transparent, reliable and 
objective data that would not require entity-specific judgments, (5) 
that use data that accounts for geographic differences in the number 
and causes of death, and (6) that use data that are easily captured and 
tallied on a continuing annual basis.
    In choosing the outcomes measures that we proposed and setting the 
threshold donation and organ transplantation rate at the top 25 percent 
of rates as the goal to achieve, but not automatically de-certifying 
OPOs who had at least one outcome measure at or above the median rate, 
we sought to strike a balance between the goals set forth by HHS and 
the potential disruption that could happen if only a few OPOs could 
comply with our standards. We also analyzed three types of alternatives 
that could be applied to all the OPOs: Changing the denominator, 
changing the confidence intervals, and changing the threshold rates. 
For changes to the denominator, we examined the impact of using the 
CALC measure as the denominator; using the total unadjusted number of

[[Page 77944]]

deaths in the DSA as denominator; and using the total population in the 
DSA as the denominator. For changes to the confidence interval, we 
examined the impact of changing the confidence interval (CI) to 90 and 
99 percent. For changes to the threshold rates, we examined the impact 
of setting the threshold at an absolute value based on the geometric 
mean or the median from the year 2016. For the Hawaii OPO, we analyzed 
one additional alternative to consider: Using the kidney donation and 
transplantation rates as a measure of success because of the 
geographical barriers to transporting the other organs for 
transplantation outside of Hawaii. We sought comments to these 
alternatives in addition to our proposed outcome measures.
    As explained in both preceding and following sections, we made 
changes in the final rule dealing with all of these issues.
Changes to the Denominator
CALC as the Denominator
    As discussed earlier in the preamble, the CALC method proposed by 
Goldberg et al., has been published in the literature and presented in 
various forums. It was endorsed by many commenters. This methodology 
uses the same NCHS database and also uses inpatient deaths to calculate 
the denominator. The primary difference between the ``cause, age and 
location'' consistent with donation methodology adopted in this final 
rule and the originally proposed methodology is that it uses the ICD-
10-CM codes to identify deaths that are consistent with donation (that 
is, inclusion criteria) whereas the original proposal would exclude 
ICD-10-CM codes that are an absolute contraindication to organ donation 
(that is, exclusion criteria). The developers of the CALC methodology 
believe that the ICD-10 codes used in their inclusion criteria captures 
nearly 99 percent of all deceased donors according to the OPTN: \12\
     I20-I25 (ischemic heart disease);
     I60-I69 (cerebrovascular disease);
     V-1-Y89 (external causes of morbidity and mortality): 
Blunt trauma, gunshot wound, drug overdose, suicide, drowning, and 
asphyxiation.
    We performed a comparative analysis of the CALC methodology and the 
originally proposed methodology. There was consistency in the OPOs that 
were flagged for donation and organ transplantation rates that were 
below the top 25 percent. Notably, the differences were in the total 
donor potential (denominator) with CALC method resulting in a donor 
potential of 101,479 inpatient deaths in 2017, whereas our proposed 
methodology had 272,105 inpatient deaths. Where there were differences 
in OPOs being flagged for the donation rates (the CALC method flagged 
more OPOs), the differences were minor (only a small number of donors 
per OPO). If all OPOs could increase their donation rates to the 
threshold rate, under the originally proposed methodology, there would 
be an additional 1,015 donors (approximately 10.43 percent increase), 
whereas the CALC methodology would yield an additional 1,223 donors 
(12.57 percent increase).
    For organs transplanted, we estimated that if all flagged OPOs were 
to increase their organs transplanted to the range of the top 25 
percent, then using the proposed methodology, there would be an 
additional 4,903 organs transplanted (15.24 percent increase); using 
the CALC methodology, there were would be 5,590 more organs 
transplanted (17.37 percent increase). Other than the approximately 2 
percent increase in donations and organ transplantation, another 
difference in the methodologies is the difference in how much of an 
increase each particular OPO would need to increase in organs 
transplanted. We sought comments on these differences and whether the 
CALC method is a more precise and/or accurate assessment of OPO 
performance. Again, the majority of commenters on the CALC option 
recommended use of CALC.
All Deaths, Age <= 75 as the Denominator
    In addition to analyzing the CALC method for the denominator, we 
also considered using the total number of deaths of people 75 years and 
younger, regardless of location or cause of death to define the donor 
potential. Using total number of deaths as the denominator, the donor 
potential was estimated at 1,376,541 deaths in 2017 of people 75 years 
and younger (compared with our donor potential of 272,105 inpatient 
deaths). Despite this large discrepancy in the denominator, we found 
very similar results for those OPOs being flagged by our methodology 
versus an approach that uses total deaths. If all OPOs were able to 
achieve the threshold 25 percent rate using this methodology, we found 
that it would have 933 additional donors (compared with the 1,105 with 
our proposed methodology) and 4,851 more organs transplanted, compared 
with the 4,903 organs from the originally proposed methodology. Similar 
to the CALC method, where there were differences in the OPOs being 
flagged for donation rates, the additional donors needed were mostly in 
the single digits. For the organ transplantation rates, the greatest 
differences were not in which OPOs were flagged, but rather, it was the 
differences by OPO in the number of additional organs that needed to be 
transplanted in order to reach the top 25 percent threshold rate. Few 
commenters regarded this as a preferred methodology, although like 
CALC, it would have created an objective and known baseline method of 
calculating performance.
Total Population, Age <75
    A third alternative denominator that we analyzed used the U.S. 
population from the 2010 census of persons less than 75 years old as 
the denominator.\47\ A population-based approach to re-certifying OPOs 
was used by the Department until the passage of the OPO Certification 
Act of 2000, which specifically raised concerns about ``[a]n exclusive 
reliance on population-based measures of performance that do not 
account for the potential in the population for organ donation and do 
not permit consideration of other outcome and process standards that 
would more accurately reflect the relative capability and performance 
of each organ procurement organization.'' While we considered this 
approach, no commenters favored it; and for the preceding and following 
reasons, we rejected it in favor of the CALC alternative. In the 
population-based approach, using the original two-tiered performance 
metric, we would have had 1,699 more organ donors and 7,000 more organs 
transplanted if all flagged OPOs were able to increase their 
performance to that of the top 25 percent. This increase does not seem 
realistic given how significantly it differs from the increases 
utilizing the CALC and total death analysis. A fundamental requirement 
to achieve these increases is a sufficient number of deaths that could 
lead to organ donation. A population based approach does not account 
for the death requirement and is problematic given variance in DSA 
mortality rates from 3.39 to 7.11. We also found a pattern where OPOs 
in the geographic areas with lower mortality rates, such as the Pacific 
Northwest, the Rocky Mountain area, New England, Los Angeles area, New 
York City area, and Hawaii, had depressed performance rates under this 
method, as compared to the OPOs in the areas of the country with the 
highest

[[Page 77945]]

rates of deaths consistent with organ donation.\48\ Although we stated 
that we would not consider a measure that is based solely on population 
size, we sought comments as to whether there are appropriate risk-
adjustments that could be used so that a population measure could be 
reflective of the organ donation potential. We received no such 
comments and dropped this option from consideration.
---------------------------------------------------------------------------

    \47\ For convenience, we used less than 75 years old rather than 
75 and younger because of how the Census data is publicly reported.
    \48\ Cannon RM, Jones CM, et al., ``Patterns of geographic 
variability in mortality and eligible deaths between organ 
procurement organizations,'' AmJTransplant. 2019;00:4 (Fig. 2).
---------------------------------------------------------------------------

Changing the Confidence Interval
    In addition to considering other denominator sources, we considered 
changing the way in which we measured success. One way in which we 
measure success is in the confidence that our rate is correctly 
identifying low performers. Our proposed methodology used a 95 percent 
CI, so we analyzed the effects of both the 90 percent and 99 percent 
CIs; that is, we increased and decreased our confidence that we 
appropriately flagged OPOs based on our donation and organ 
transplantation threshold rates. By changing to a 99 percent CI, 24 
OPOs were flagged for donation rates compared with 33 OPOs (95 percent 
CI); and, 35 OPOs were flagged for organ transplantation rates compared 
with 36 OPOs being flagged (95 percent CI). When we examined the 
effects of the 90 percent CI, the differences were even less 
noticeable: For donation rates, 35 (90 percent CI) versus 33 (95 
percent CI) and for transplantation rates, 38 (90 percent CI) versus 36 
(95 percent CI). These changes would, however, have put more OPOs at 
risk for purely statistical reasons. For this reason and absent any 
favorable comments we retained the 95 percent CI in the final rule.
Changing the Threshold Rates
    An alternative way to measure success would be to change the 
threshold rate by which OPOs are measured. We examined the impact of 
using a static, absolute threshold rate based on the geometric mean and 
the median based on data from 2016 for analyzing data from 2017.
    We considered use of a static, absolute threshold based on a 
geometric mean or median as a viable alternative to use instead of the 
higher relative performance metric that changes each year, but 
questioned whether this approach could inadvertently incentivize all 
OPO performances to move towards a static threshold, thus decreasing 
total donations and transplantations over time. We sought robust public 
comments that would support or refute these concerns and comments that 
would list the potential impacts, benefits, or consequences of 
implementing this approach. We specifically requested that commenters 
present data, studies, or other analysis to support their 
recommendations. We also sought comments on ways to incentivize 
continual improvement of all OPOs, including high performers and low 
performers. Additionally, we sought comments on ways to ensure that the 
rates for re-certification continue to be based upon current 
performance and appropriately reflect potential improvements and 
changes in technology (such as the development of an implantable, 
artificial kidney or bioengineered pancreatic islet cells). None of 
these requests led to public comments advocating such changes. 
Accordingly, we did not adopt such a measure in the final rule.
    There were other alternatives that we chose not to propose. We had 
previously received comment in response to our RFI that we should 
consider using the deaths referred from donor hospitals as our donor 
potential. This approach could rely on the regulatory requirement for 
hospitals to report imminent deaths to OPOs. We declined to propose 
this on the basis of concerns regarding its potential for inaccuracy. 
We stated that this approach would incorrectly place the requirement to 
report an imminent death solely on the donor hospital, although this is 
a joint responsibility shared with an OPO. We received no comments in 
favor of using donor referrals as our denominator, but received a 
number of comments that hospitals should report directly to CMS or the 
OPTN the ventilated deaths. The final rule does not make such changes 
because of the potential burden to donor hospitals, as discussed 
earlier in the preamble.
    Another option suggested by some members of the OPO community and 
commenters in response to the RFI and in comments to our proposed rule 
was to use ventilated deaths for donor potential. While we appreciated 
this suggestion, there are no standardized databases that would allow 
us to determine the ventilator status of deaths, and we were concerned 
this approach incorrectly assigns ``potential donor'' status solely 
based on the fact that the patient is on a ventilator in an ICU. This 
approach does not consider the role of OPOs in educating donor hospital 
staff about the range of potential donors, such that resuscitation 
efforts and inpatient treatment are sufficient and appropriate so that 
referrals can be made for organ donation, even for older, single-organ 
donors. Furthermore, asking hospitals to report the ventilator status 
of inpatient deaths or expecting OPOs to report that status would 
create an additional burden for all hospitals (not just transplant 
hospitals or just OPOs) and is inconsistent with one of our many goals 
in proposing these new performance measures: To reduce the reporting 
burdens so that resources can go towards increasing organ donation and 
transplantation. Therefore, we chose not to adopt this source for 
estimating the ``donor potential'' in our final rule.
    Also discussed in the preamble, we recognize that the OPO in Hawaii 
is at a considerable geographic disadvantage for placement of almost 
all the organs it could procure. As an alternative, we considered 
measuring the performance of the Hawaii OPO based solely on its kidney 
donation and transplantation rates, excluding other organs, because 
Hawaii has a kidney transplant program, yet has greater geographic 
barriers associated with transporting the extra-renal organs outside of 
the DSA. As set forth in section II.B, above, we are finalizing a 
requirement to measure the performance of the Hawaii OPO based its 
kidney transplantation rates and its organ donation rate. We did not 
adopt the kidney donation rate because almost all organ donors are also 
kidney donors, so the organ donation rate should be an appropriate 
proxy for the kidney donation rate.
    Using solely these measures, we found that the Hawaii OPO would be 
in the top 25 percent for the kidney transplantation rates and top 
median for the organ donation rates (but would need only 3 more donors 
to meet the top 25 percent threshold rate). If we were to use our 
proposed measure to assess the Hawaii OPO's performance, it would need 
one additional donor and 38 additional organs transplanted to meet the 
threshold rate for the top 25 percent of rates. The reason we did not 
propose this approach for assessing the Hawaii OPO is that we were 
aware of newer technologies that could significantly reduce the 
clinical impact of prolonged transport of extra-renal organs and prefer 
a policy that encourages the innovation and adoption of these types of 
technologies for the benefit of all potential recipients. We sought 
comments on this alternative or any other approach that would 
accurately measure the performance of the Hawaii OPO, such as a phased 
approach to implementing our new measures. The comments we received 
generally supported relying on a kidney performance measure alone, and 
we have adopted that approach in the final

[[Page 77946]]

rule. We believe that as technology improves, the Hawaii OPO will have 
both the life-saving incentive and ability to transport more organs 
across oceanic distances, but that any specific requirement imposed at 
this time would risk rapid obsolescence.
    In analyzing all these different alternatives, we recognized that 
there were many OPOs whose performance is in the top 25 percent, 
regardless of which methodology was used. These OPOs are truly high 
performers and should be the models for the other OPOs. We encourage 
those OPOs to continue to strive to be top performers and encourage the 
widespread uptake of their best practices.
    In summary, we welcomed comments both on the comparative advantages 
and disadvantages of alternatives within the scope of the OPO proposed 
rule, and suggestions for other alternatives that could be addressed in 
subsequent rule-makings or administrative actions to further improve 
performance of the organ donation and transplantation system. We 
received some suggestions for minor improvements in the standards we 
proposed many recommendations to adopt both CALC; a suggestion to adopt 
a system with tiers to identify performance and more graduated options 
that would recognize major progress towards the standards; numerous 
comments encouraging competition among OPOs; and comments encouraging 
us to take action more quickly. These last four and a number of more 
minor changes have been adopted in this final rule.

H. Accounting Statement and Table

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 16 we have prepared an accounting statement showing 
the classification of the benefits, transfers, and costs that we 
estimate may arise from the reforms under this final rule.
    These reforms' effects are likely to be more substantial in out-
years than in the nearer term, and the annualized estimates provided in 
this table display the effects that may be expected over the next 5 
years, rather than over a longer period of time. The performance 
uncertainties, technology uncertainties, and future policy 
uncertainties are so great that we are reluctant to project further 
into the future. This means, however, that the Accounting Table 
estimates do not include substantial out-year benefits to patients, 
additional savings to the ESRD program, and substantial costs to public 
and private insurance programs that will occur outside the 5-year 
estimating window. Also, the effects of this rule on organ recovery and 
transplantation are of unusual uncertainty even in the short run. The 
factors influencing both upper and lower bounds for benefit and cost 
reduction estimates are as discussed previously in this RIA.
    The rule generates a cluster of interrelated effects, so we are 
treating the increase in health care expenditures as ``negative 
benefits'' for purposes of the Accounting Table.

                         Table 16--Accounting Statement: Classification of Estimated Benefits, Transfers, and Costs ($ Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Units
                                                              Primary                                    -----------------------------------------------
                        Category                             estimate      Low estimate    High estimate                   Discount rate
                                                                                                           Year dollars         (%)       Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Health Benefits Annualized Monetized ($million/year)  ..............              <0           1,370           2,017               7       2022-2026
                                                          ..............              <0           1,430            2017               3       2022-2026
    Medical Expenditure Annualized Monetized ($million/   ..............              >0          -1,450            2017               7       2022-2026
     year)..............................................  ..............              >0          -1,450            2017               3       2022-2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits Notes: Because increased transplant activity imposes costs upfront but yields savings over time, a longer time horizon would show medical
 expenditure impacts falling in magnitude, potentially (for the portion of the range shown in the ``High Estimate'' column) to the point of being
 exceeded by longevity benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($million/year)................              10              10              10            2017               7       2022-2026
                                                                      10              10              10            2017               3       2022-2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Notes: Administrative costs in the event of OPO decertification and for regulatory compliance are believed to be relatively minor compared to the
 high costs and benefits of increasing donors and transplants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers...............................................                                         None quantified.
--------------------------------------------------------------------------------------------------------------------------------------------------------

I. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771 (January 30, 2017) requires that the costs 
associated with significant new regulations ``to the extent permitted 
by law, be offset by the elimination of existing costs associated with 
at least two prior regulations.'' This final rule has been designated a 
significant regulatory action as defined by Executive Order 12866, and 
is expected to be an E.O. 13771 regulatory action.

J. Conclusion

    This rule would substantially reform the incentives facing OPOs and 
as a result, increase organ procurement and transplants over time for 
all organs, while reducing continuing costs for dialysis and other 
treatments for patients with severe kidney disease. Organ transplants 
are life-saving and life-extending events. Predicting future behavior 
is particularly difficult when major changes in rewards, penalties, and 
incentives are created, so all estimates should be regarded as subject 
to substantial uncertainty.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 486

    Definitions, Medicare, Organ procurement.

    For the reasons set forth in the preamble, the Centers for Medicare 
&

[[Page 77947]]

Medicaid Services amends 42 CFR chapter IV, part 486 as set forth 
below:

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

0
1. The authority citation for part 486 continues to read as follows:

    Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.


0
2. Section 486.302 is amended by adding definitions for ``Assessment 
period'', ``Death that is consistent with organ donation'', ``Donation 
rate'', ``Donor potential'', ``Kidney Transplantation rate'', ``Lowest 
rate among the top 25 percent'', and ``Organ transplantation rate'' to 
read as follows:


Sec.  486.302  Definitions.

* * * * *
    Assessment period is a 12-month period in which an OPO's outcome 
measures will be evaluated for performance. The final assessment period 
is the 12-month assessment period used to calculate outcome measures 
for re-certification.
* * * * *
    Death that is consistent with organ donation means all deaths 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): Blunt 
trauma, gunshot wounds, drug overdose, suicide, drowning, and 
asphyxiation.
* * * * *
    Donation rate is the number of donors as a percentage of the donor 
potential.
* * * * *
    Donor potential is the number of inpatient deaths within the DSA 
among patients 75 and younger with a primary cause of death that is 
consistent with organ donation. For OPOs servicing a hospital with a 
waiver under Sec.  486.308(e), the donor potential of the county for 
that hospital will be adjusted using the proportion of Medicare 
beneficiary inpatient deaths in the hospital compared with the total 
Medicare beneficiary inpatient deaths in the county.
* * * * *
    Kidney transplantation rate is the number of kidneys transplanted 
from kidney donors in the DSA as a percentage of the donor potential.
* * * * *
    Lowest rate among the top 25 percent will be calculated by taking 
the number of total DSAs in the time period identified for establishing 
the threshold rate. The total number of DSAs will be multiplied by 0.25 
and rounded to the closest integer (0.5 will round to the higher 
integer). The donation rates and organ transplantation rates in each 
DSA will be separately ranked and the threshold rate will be the rate 
that corresponds to that integer when counting down the ranking.
* * * * *
    Organ transplantation rate is the number of organs transplanted 
from donors in the DSA as a percentage of the donor potential. Organs 
transplanted into patients on the OPTN waiting list as part of research 
are included in the organ transplantation rate. The organ 
transplantation rate will be risk-adjusted for the average age of the 
donor potential using the following methodology:
    (1) The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 
55-59, 60-64, 65-69, 70-75.
    (2) Calculate a national age-specific transplantation rate for each 
age group.
    An expected transplantation rate for each OPO is calculated as 
[sum](g=1)Gdg*Rg/[sum]gdg, where dg is the number of potential donors 
in the OPO in age group g, Rg is the age-specific national 
transplantation rate in age group g, and [sum]gdg is the OPO's total 
number of individuals in the donor potential. This can be interpreted 
as the overall expected transplantation rate for an OPO if each of its 
age-specific transplantation rates were equal to the national age-
specific.
    (3) Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.
* * * * *

0
3. Effective July 31, 2022, Sec.  486.302 is further amended by--
0
a. Revising the definition of ``Donor'';
0
b. Removing the definitions of ``Eligible death'', ``Eligible donor'', 
``Expected donation rate'', and ``Observed donation rate'';
0
c. Revising the definition of ``Organ''; and
0
d. Removing the definition of ``Standard criteria donor (SCD)''.
    The revisions reads as follows:


Sec.  486.302  Definitions.

* * * * *
    Donor means 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.
* * * * *
    Organ means 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.

------------------------------------------------------------------------
                                                              Number of
                        Organ type                             organs
                                                            transplanted
------------------------------------------------------------------------
(1) Right or Left Kidney..................................             1
(2) Right and Left Kidney.................................             2
(3) Double/En-Bloc Kidney.................................             2
(4) Heart.................................................             1
(5) Intestine.............................................             1
(6) Intestine Segment 1 or Segment 2......................             1
(7) Intestine Segment 1 and Segment 2.....................             2
(8) Liver.................................................             1
(9) Liver Segment 1 or Segment 2..........................             1
(10) Liver Segments 1 and Segment 2.......................             2
(11) Right or Left Lung...................................             1
(12) Right and Left Lung..................................             2
(13) Double/En-bloc Lung..................................             2
(14) Pancreas (transplanted whole, research, islet                     1
 transplant)..............................................
(15) Pancreas Segment 1 or Segment 2......................             1
(16) Pancreas Segment 1 and Segment 2.....................             2
------------------------------------------------------------------------

* * * * *

0
4. Section 486.316 is amended by revising paragraphs (a) through (c) 
and adding paragraphs (f) and (g) to read as follows:


Sec.  486.316  Re-certification and competition processes.

    (a) Re-certification of OPOs. Based upon performance on the outcome 
measures set forth in Sec.  486.318 and the re-certification survey, 
each OPO will be designated into either Tier 1, Tier 2, or Tier 3. The 
tier in which the OPO is designated will determine whether the OPO is 
re-certified (Tier 1), must compete to retain its DSA (Tier 2), or will 
receive an initial de-certification determination (Tier 3).
    (1) Tier 1. An OPO is re-certified for at least an additional 4 
years, the OPO's DSA is not opened for competition, and the OPO can 
compete for any open DSA if it meets all of the following:
    (i) It has been shown by survey 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; and
    (ii) It meets the outcome requirements as described in Sec.  
486.318(e)(4) for the final assessment period of the agreement cycle.
    (2) Tier 2. An OPO's DSA is open for competition and the OPO is 
eligible to compete to retain its DSA and for any

[[Page 77948]]

open DSA if it meets all of the following:
    (i) It has been shown by survey 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; and
    (ii) It meets the outcome requirements as described in Sec.  
486.318(e)(5) at the final assessment period of the agreement cycle.
    (3) Tier 3. An OPO will receive a notice of de-certification 
determination under Sec.  486.314 and cannot compete for any open DSA 
if it meets either of the following:
    (i) Has been shown by survey to not 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; or
    (ii) Has outcome requirements as described in Sec.  486.318(e)(6) 
at the final assessment period of the agreement cycle.
    (b) De-certification and competition. If an OPO fails to meet the 
outcome measures set forth in Sec.  486.318(e)(6) at the final 
assessment period prior to the end of the agreement cycle, or it meets 
the requirements described in paragraph (a)(3) of this section:
    (1) CMS will send the OPO a notice of its initial de-certification 
determination and the OPO has the right to appeal as established in 
Sec.  486.314;
    (2) If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from 
other OPOs that qualify to compete for open service areas as set forth 
in paragraph (c) of this section. The de-certified OPO is not permitted 
to compete for its open area or any other open area.
    (3) The OPO competing for the 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.
    (c) Criteria to compete. To compete for an open DSA, an OPO must 
meet the performance requirements of the outcome measures for Tier 1 or 
Tier 2 at Sec.  486.318(e)(4) and (5), and the requirements for 
certification at Sec.  486.303, including the conditions for coverage 
at Sec. Sec.  486.320 through 486.360 at the most recent routine 
survey. The OPO must compete for the entire DSA.
* * * * *
    (f) Extension of the agreement cycle for extraordinary 
circumstances. OPOs can seek a 1-year extension of the agreement cycle 
if there are extraordinary circumstances beyond the control of the OPOs 
that has affected the data of the final assessment period so that it 
does not accurately capture their performance. OPOs must request this 
extension within 90 days of the end of the occurrence of the 
extraordinary circumstance but no later than the last day of the final 
assessment period.
    (g) Exception. For the 2022 recertification cycle only, an OPO is 
recertified for an additional 4 years and its service area is not 
opened for competition when the OPO meets one out of the two outcome 
measure requirements described in Sec.  486.318(a)(1) and (3) for OPOs 
not operating exclusively in the noncontiguous States, Commonwealths, 
Territories, or possessions; or Sec.  486.318(b)(1) and (3) for OPOs 
operating exclusively in noncontiguous States, Commonwealths, 
Territories, and possessions. An OPO is not required to meet the second 
outcome measure described in Sec.  486.318(a)(2) or (b)(2) for the 2022 
recertification cycle. If an OPO does not meet one of the outcome 
measures as described in paragraphs Sec.  486.318(a)(1), (a)(3), 
(b)(1), or (b)(3), or has been shown by survey to not 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, the OPO 
is de-certified. If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from 
other OPOs. The de-certified OPO is not permitted to compete for its 
open area or any other open area. 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.

0
4. Section 486.318 is amended by adding paragraphs (a)(4), (b)(4), 
(c)(3), (d), (e), and (f) to read as follows:


Sec.  486.318  Condition: Outcome measures.

    (a) * * *
    (4) The outcome measures described in Sec.  486.318(a)(1) through 
(3) are effective until July 31, 2022.
    (b) * * *
    (4) The outcome measures described in Sec.  486.318(b)(1) through 
(3) are effective until July 31, 2022.
    (c) * * *
    (3) An OPO's performance on the outcome measures described in Sec.  
486.318(a)(1) through (3) and Sec.  486.318(b)(1) through (3) is based 
on the data described in Sec.  486.318(c)(1) and (2) until July 31, 
2022.
    (d) An OPO is evaluated by measuring the donation rate and the 
organ transplantation rate in their DSA.
    (1) For all OPOs, except as set forth in paragraph (d)(2) of this 
section, for all OPOs:
    (i) The donation rate is calculated as the number of donors in the 
DSA as a percentage of the donor potential.
    (ii) The organ transplantation rate is calculated as the number of 
organs transplanted from donors in the DSA as a percentage of the donor 
potential. The organ transplantation rate is adjusted for the average 
age of the donor potential.
    (iii) The numerator for the donation rate is the number of donors 
in the DSA. The numerator for the organ transplantation rate is the 
number of organs transplanted from donors in the DSA. The numbers of 
donors and organs transplanted are based on the data submitted to the 
OPTN as required in Sec.  486.328 and Sec.  121.11 of this title. For 
calculating each measure, the data used is from the same time period as 
the data for the donor potential.
    (iv) The denominator for the outcome measures is the donor 
potential and is based on inpatient deaths within the DSA from patients 
75 or younger with a primary cause of death that is consistent with 
organ donation. The data is obtained from the most recent 12-months 
data from state death certificates.
    (2) For the OPO representing the Hawaii DSA:
    (i) The donation rate is calculated as the number of donors in the 
DSA as a percentage of the donor potential.
    (ii) The kidney transplantation rate is calculated as the number of 
kidneys transplanted from kidney donors in the DSA as a percentage of 
the donor potential.
    (iii) The numerator for the donation rate is the number of donors 
in the DSA. The numerator for the kidney transplantation rate is the 
number of kidneys transplanted from kidney donors in the DSA. The 
numbers of donors and kidneys transplanted are based on the data 
submitted to the OPTN as required in Sec.  486.328 and Sec.  121.11 of 
this title. For calculating each measure, the data used is from the 
same time period as the data for the donor potential.
    (iv) The denominator for the outcome measures is the donor 
potential and is based on inpatient deaths within the DSA from patients 
75 or younger with a primary cause of death that is consistent with 
organ donation. The data is obtained from the most recent

[[Page 77949]]

12-months data from state death certificates.
    (e) An OPO must demonstrate a success rate on the outcome measures 
in accordance with the following parameters and requirements:
    (1) For each assessment period, threshold rates will be established 
based on donation rates during the 12-month period immediately prior to 
the period being evaluated:
    (i) The lowest rate among the top 25 percent in DSAs, and
    (ii) The median rate among the DSAs.
    (2) For each assessment period, threshold rates will be established 
based on the organ transplantation or kidney transplantation rates 
during the 12-month period prior to the period being evaluated:
    (i) The lowest rate among the top 25 percent, and
    (ii) The median rate among the DSAs.
    (3) The 95 percent confidence interval for each DSA's donation and 
organ transplantation rates will be calculated using a one-sided test.
    (4) Tier 1--OPOs that have an upper limit of the one-sided 95 
percent confidence interval for their donation and organ 
transplantation rates that are at or above the top 25 percent threshold 
rate established for their DSA will be identified at each assessment 
period.
    (5) Tier 2--OPOs that have an upper limit of the one-sided 95 
percent confidence interval for their donation and organ 
transplantation rates that are at or above the median threshold rate 
established for their DSA but is not in Tier 1 as described in 
paragraph (e)(4) of this section will be identified at each assessment 
period.
    (6) Tier 3--OPOs that 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 for their 
DSA will be identified at each assessment period. OPOs that have an 
upper limit of the one-sided 95 percent confidence interval for their 
donation and organ transplantation rates that are below the median 
threshold rate for their DSA are also included in Tier 3.
    (7) For the OPO exclusively serving the DSA that includes the non-
contiguous state of Hawaii and surrounding territories, the kidney 
transplantation rate will be used instead of the organ transplantation 
rate. The comparative performance and designation to a Tier will be the 
same as in paragraphs (e)(4), (5), and (6) of this section except 
kidney transplantation rates will be used.
    (f)(1) An OPO's performance on the outcome measures is based on an 
evaluation at least every 12 months, with the most recent 12 months of 
data available from the OPTN and state death certificates, beginning 
January 1 of the first year of the agreement cycle and ending December 
31, prior to the end of the agreement cycle.
    (2) An assessment period is the most recent 12 months prior to the 
evaluation of the outcome measures in which data is available.
    (3) If an OPO takes over another OPO's DSA on a date later than 
January 1 of the first year of the agreement cycle so that 12 months of 
data are not available to evaluate the OPO's performance in its new 
DSA, we will hold the OPO accountable for its performance on the 
outcome measures in the new area once 12 months of data are available.


Sec.  486.328  [Amended]

0
5. Section 486.328 is amended--
0
a. In paragraph (a) introductory text by removing the word 
``Beneficiaries'' and adding in its place the word ``Recipients'' and 
by removing the acronym ``DHHS'' and adding in its place the acronym 
``HHS'';
0
b. By removing and reserving paragraph (a)(4); and
0
c. In paragraph (a)(7), by removing, the word ``eligible''.

0
6. Section 486.348 is amended by adding paragraph (d) to read as 
follows:


Sec.  486.348  Condition: Quality assessment and performance 
improvement (QAPI).

* * * * *
    (d) Standard: Review of outcome measures. (1) An OPO must include a 
process to review its performance on the outcome measure requirements 
at Sec.  486.318. The process must be a continuous activity to improve 
performance.
    (2) An OPO must incorporate data on the outcome measures into their 
QAPI program.
    (3) If the outcome measure at each assessment period during the re-
certification cycle is statistically significantly lower than the top 
25 percent of donation rates or organ or kidney transplantation (Tier 2 
and Tier 3 OPOs) rates as described in Sec.  486.318(e)(5) and (6), the 
OPO must identify opportunities for improvement and implement changes 
that lead to improvement in these measures.

    Dated: November 19, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: November 20, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-26329 Filed 11-24-20; 4:15 pm]
 BILLING CODE 4120-01-P