[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/.
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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\
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\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.
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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.
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\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.
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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.
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\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).
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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