77898 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

1Organ Procurement and Transplantation 

Network (OPTN) Data. https://

optn.transplant.hrsa.gov/data/. 

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. 

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 § 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 

(§ 486.302) and Proposed Changes to 

Outcome Requirements (§ 486.318) 

1. General Comments About the Outcome 

Measures 

2. Donation Rate § 486.318(d)(1) 

3. Donor Definition § 486.302 and the 

‘‘Zero Organ Donors’’ 

4. Organ Transplantation Rate § 486.302 

and § 486.318(d)(2) 

5. Organ Definition § 486.302 

6. Donor Potential (§ 486.302 and 

§ 486.318(d)(4)) 

a. Death That Is Consistent With Organ 

Donation § 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 § 486.302 and 

§ 486.318(d)(2) 

a. Chronic Diseases 

b. Race 

c. Gender and Age 

d. Ventilator Status 

8. OPO Performance on Outcome Measures 

§ 486.318(e) and § 486.302 

9. Non-Contiguous States, 

Commonwealths, Territories, or 

Possessions § 486.318(e)(7) 

10. Assessment and Data for the Outcome 

Measures § 486.318(f) 

11. Implementation Timeline 

12. Definitions § 486.302 

C. Re-Certification and Competition 

Processes (§ 486.316) 

1. Re-Certification of OPOs § 486.316(a) 

2. De-Certification and Competition 

§ 486.316(b) 

3. Criteria to Compete § 486.316(c) 

4. Criteria for Selection § 486.316(d) 

5. Extension of the Agreement Cycle for 

Extraordinary Circumstances § 486.316(f) 

D. Reporting of Data § 486.328 

E. Proposed Change to the Quality 

Assessment and Performance 

Improvement Requirement (§ 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 

(§ 486.302) and Proposed Changes to 

Outcome Requirements (§ 486.318). 

B. Re-Certification and Competition 

Processes (§ 486.316) 

C. Proposed Change to the Quality 

Assessment and Performance 

Improvement Requirement (§ 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 (§ 486.316) 

B. ICRs Regarding Condition: Reporting of 

Data (§ 486.328) 

C. ICRs Regarding Quality Assessment and 

Performance Improvement (§ 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. 

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. 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77899 

2The Bridgespan Group. Reforming Organ 

Donation in America. https://www.bridgespan.org/ 

bridgespan/Images/articles/reforming-organdonation-in-america/reforming-organ-donation-inamerica-12-2018.pdf. 

3ORGANIZE. Organ Donation Reform Report, 

2019. 

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

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 

§ 486.318, are used to assess OPO 

performance for re-certification and 

competition purposes (see § 486.316(a) 

and (d)). 

Section 486.322 requires that an OPO 

must have a written agreement with 95 

percent of the Medicare- and Medicaidparticipating 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 

77900 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

4https://www.organdonor.gov/about-dot/acot/ 

charter.html. 

5Available at: https://www.organdonor.gov/ 

about-dot/acot/acotrecs55.html. 

6https://aspe.hhs.gov/system/files/pdf/262046/ 

AdvancingAmericanKidneyHealth.pdf. 

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 Medicareand 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 Medicaidcertified 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

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

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

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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 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 selfreported measures, we are finalizing 

new outcome measures at § 486.318 to 

hold OPOs accountable as a crucial step 

in reforming the organ donation system. 

B. Proposed Changes to Definitions 

(§ 486.302) and Proposed Changes to 

Outcome Requirements (§ 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 

§§ 486.302 and 486.318 to replace the 

current outcome measures and 

definitions. We proposed at § 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 § 486.302 of this final rule. 

We refer readers to section II.B of this 

final rule for the other definitions we 

proposed at § 486.302. We proposed to 

revise the outcome measures for recertification at § 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 

§ 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 

77902 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

7Siminoff, LA, Agyemang, AA, et al., ‘‘Consent to 

organ donation: a review,’’ Prog Transplant. 2013 

Mar; 23(1): 99–104. 

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. 

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 §§ 486.302 and 

486.318(d)(1) 

In the December 2019 OPO proposed 

rule, we proposed to include at 

§ 486.302 the definition the ‘‘donation 

rate’’ as the number of donors as a 

percentage of the donor potential. In 

current regulations at § 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 

§ 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 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 § 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 § 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 § 486.302, which is defined as the 

number of donors as a percentage of the 

donor potential. Furthermore, we are 

finalizing at § 486.318(d) that an OPO is 

evaluated by measuring the donation 

rate in their DSA and at § 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 (§ 486.302) and the 

‘‘Zero Organ Donors’’ 

In the December 2019 OPO Proposed 

rule, we proposed to revise the 

definition of ‘‘donor’’ at § 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 § 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. 

77904 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

8 Kaiser Health News, ‘‘How Lifesaving Organs for 

Transplant Go Missing in Transit,’’ February 10, 

2020 https://khn.org/news/how-lifesaving-organsfor-transplant-go-missing-in-transit/. 

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 § 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. 

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 § 486.302. 

Final Rule Action: We are finalizing 

as proposed in the December 2019 OPO 

proposed rule, the definition for donor 

at § 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 

(§ 486.302 and § 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77905 

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

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

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. 

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 riskadjustments, 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. 

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 § 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 

§ 486.318(d) that the OPO is evaluated 

by measuring the organ transplantation 

rate in their DSA. 

5. Organ Definition (§ 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. 

77906 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

11OPTN 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. 

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. 

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. 

Final Rule Action: After consideration 

of public comments, we are finalizing 

our proposed definition of organ at 

§ 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 (§§ 486.302 and 

486.318(d)(4)) 

Under § 486.318(d)(4), the donation 

rate, organ transplantation rate, and 

kidney transplantation rate use the 

‘‘Donor potential’’ as defined under 

§ 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 (§ 486.302) 

Under § 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. 

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 

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

77908 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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

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 § 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-in2019/). 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 § 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 

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

Final Rule Action: We are finalizing 

that the age cutoff of age 75 for the 

donor potential definition in § 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 § 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 § 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 nonMedicare 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 

§ 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 § 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 §§ 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 evidencebased support, such as peer-reviewed 

literature, that would support those 

suggestions, as well as data sources that 

would be necessary to calculate the riskadjustments 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 riskadjusted 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 riskadjustments based on race because of 

77910 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

14Snyder 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. 

16è is a mathematical symbol indicating 

summation. 

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. 

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 riskadjustments 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. 

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 riskadjust 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 è(g=1) 

Gdg*Rg/ègdg,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 

ègdg 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. 

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

Final Rule Action: We are finalizing 

with modification the definition of 

‘‘organ transplantation rate’’ at § 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 

è(g=1)Gdg*Rg/ègdg, 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77911 

group g, and ègdg 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 § 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 § 486.318(e) and § 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 × .25 = 

14.5). However, as discussed below, 

based on 2018 data, we estimate that 24 

OPOs would meeting the criteria in 

§ 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 § 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 § 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 

77912 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 wellserved 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 § 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 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 recertification cycle (see § 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 ‘‘everincreasing threshold rate and evershrinking 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. 

77914 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 § 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 § 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 

§ 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 § 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 § 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 

§ 486.318(e)(7) that for the OPO 

exclusively serving the Hawaii DSA, the 

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

§ 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 

§ 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 recertification. 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 § 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 

77916 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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

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 § 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 

§ 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 § 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 § 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 

§ 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 § 486.328 and § 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 lifesaving organs sooner. 

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 § 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 § 486.302 

In the December 2019 OPO rule, we 

proposed to remove several definitions 

from § 486.302, since these terms would 

no longer apply. Specifically, we 

proposed to remove the definitions of 

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

§ 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. 

Organ type 

Number of 

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 

è(g=1)Gdg*Rg/ègdg, 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 ègdg 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 § 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 (§ 486.316) 

1. Re-Certification and Competition 

Processes § 486.316(a) 

In the December 2019 OPO proposed 

rule, we proposed to revise § 486.316(a) 

to provide that the OPO must meet the 

performance requirements of the 

outcome measures at § 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 § 486.303, including the 

conditions for coverage at §§ 486.320 

through 486.360. 

We proposed revisions at 

§ 486.316(a)(1) to correspond to our 

proposed outcome measures that were 

77918 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

set forth at § 486.318 in the December 

2019 OPO proposed rule. To be 

consistent with the tier system finalized 

in this rule, we also need revised 

§ 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 

‘‘§§ 486.320 through 486.360,’’ so that it 

is included § 486.360 Conditions for 

Coverage: Emergency Preparedness, 

which was effective on November 15, 

2016 (81 FR 63859). We are finalizing 

the inclusion of § 486.360 in 

§ 486.316(a)(1)(i), (a)(2)(i) and (a)(3)(i). 

In addition, we proposed to remove 

§ 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 

§ 486.318(a)(1) and (3) for OPOs not 

operating exclusively in the 

noncontiguous States, Commonwealths, 

Territories, or possessions; or 

§ 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 § 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 § 486.318 

becoming effect at the start of the next 

recertification cycle in 2022. 

As described in sections II.B 

‘‘Proposed Changes to Definitions 

(§ 486.302)’’ and ‘‘Proposed Changes to 

Outcome Requirements (§ 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 § 486.316(a) to 

incorporate the tier system. 

Final Rule Action: We are finalizing 

§ 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 § 486.360 

in the CfCs that all OPOs must meet for 

re-certification. We are also revising 

§ 486.316(a)(3) as discussed above. 

2. De-Certification and Competition 

Processes § 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 recertification 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 § 486.316. Only one of the 

commenters wanted all of the DSAs 

open for competition each recertification 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 decertified 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 (§ 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 

§ 486.316(c) to correspond to the new 

outcome measures in § 486.318, we did 

not propose any changes to the selection 

criteria for competition at § 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 decertification 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 decertified.’’ We believe that statement 

could be misleading. As set forth in 

§ 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77919 

mail the OPO an initial de-certification 

determination. The OPO then has the 

appeal rights set forth in § 486.314. 

Thus, we are revising the language from 

what we proposed at § 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 § 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 recertification 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 decertification 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 decertified 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 § 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 

§ 486.314, and, if decertified, cannot 

compete for either its own or any other 

open DSA. 

Final Rule Action: We are modifying 

§ 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 decertification determination and the OPO 

has the right to appeal as established in 

§ 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 § 486.316(c) 

The current requirements set forth at 

§ 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 § 486.318 and the requirements for 

certification at § 486.303, including the 

CfCs at §§ 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 ‘‘§ 486.348’’ and 

insert ‘‘§ 486.360’’ so that it included 

§ 486.360 Conditions for Coverage: 

Emergency Preparedness, which was 

effective on November 15, 2016 (81 FR 

63859). This change will be 

incorporated into § 486.316(a) and 

§ 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 

77920 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 

§ 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 § 486.318(e)(4) and (5) instead 

of the broader reference to § 486.318 as 

we proposed. 

4. Criteria for Selection § 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 § 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 

§ 486.316(d) as proposed. 

5. Extension of the Agreement Cycle for 

Extraordinary Circumstances 

§ 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 recertification 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 § 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 

§ 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 § 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 

§ 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 § 486.328(a)(4) by removing 

and reserving the reporting of the 

‘‘Number of eligible deaths,’’ and 

revising at § 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 § 486.328. 

E. Proposed Change to the Quality 

Assessment and Performance 

Improvement Requirement (§ 486.348) 

In the December 2019 OPO proposed 

rule, we proposed at § 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 decertification. 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 

§ 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 

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

§ 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 § 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 

§ 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 

§ 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 

(§ 486.302) and Proposed Changes to 

Outcome Requirements (§ 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 

§ 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 § 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 

§ 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. 

77922 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

• We are finalizing under § 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 

§ 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 § 486.302 is 75 and younger. 

• We are finalizing the definition of 

‘‘organ transplantation rate’’ under 

§ 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 

è(g=1)Gdg*Rg/ègdg, 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 ègdg 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 

§ 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 

§ 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 

§ 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 § 486.328 and 

§ 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 § 486.318. 

• We are finalizing § 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 

§ 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 (§ 486.316) 

• We are modifying our proposed 

changes to § 486.316(a), (b), and (c) to 

make corresponding changes for the tier 

system we are finalizing. 

• We are modifying the language in 

§ 486.316(b) by removing ‘‘the OPO is 

de-certified’’ and inserting ‘‘CMS will 

send the OPO a notice of its initial decertification determination and the OPO 

has the right to appeal as established in 

§ 486.314’’. 

• We are finalizing under § 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 (§ 486.348) 

• We are finalizing our proposal at 

§ 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 § 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77923 

19These 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. 

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 (§ 486.316) 

In this final rule at § 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 × $142).19

B. ICRs Regarding Re-Certification and 

Competition Processes (§ 486.316) 

At § 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 

§ 486.318. They would instead be 

required to meet both newly proposed 

outcome measures, or face decertification 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 decertification, 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 threetier, 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 

77924 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

risk could be as low as zero. However, 

to be conservative we have chosen midpoint estimates to calculate estimated 

burden and potential impact. 

Under § 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, § 486.316(c) 

states that to compete for an open 

service area, an OPO must meet the 

performance requirements of the 

outcome measures at § 486.318 and the 

requirements for certification at 

§ 486.303, including the CfCs at 

§§ 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 §§ 486.320 

through 486.360 through the recertification 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 decertify 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 × 

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 × 30 hours × 

73 applications) + ($71 organ 

procurement coordinator x 30 hours × 

73 applications) + ($107 medical 

director × 12 hours × 73 applications) + 

($107 OPO director × 30 × 73 

applications) + ($35 medical secretary × 

2 hours × 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 (§ 486.328) 

We proposed to revise § 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 (§ 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 

(§ 486.348) 

At § 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 lowerperforming 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, 

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

77926 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

21Some 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. 

22Wilson and Hilferty 1931, Breslow and Day 

1987, Kulkarni and Hemangi 2012. 

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 thenproposed 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/?member

Type=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. 

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] 

OPO name Donation rate 

Upper bound 

with 95% 

confidence 

interval 

Additional 

donors to 

reach median 

Additional 

donors to 

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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77927 

23These 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. 

TABLE 1—OPO DONOR RATE FOR 2018 WITH TOP 25% AND MEDIAN CUTOFF LEVELS—Continued 

[OPOs below Top 25 percent in italics and below median in bold and italics] 

OPO name Donation rate 

Upper bound 

with 95% 

confidence 

interval 

Additional 

donors to 

reach median 

Additional 

donors to 

reach top 25% 

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 riskadjusted for the average age in the donor 

potential. The organ transplantation rate 

as defined in § 486.302 will be the basis 

for re-certification. 

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. 

77928 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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] 

OPO name 

(primary state) 

Organ 

transplantation 

rate 

Upper bound 

at 95% CI 

Additional 

organs to 

reach median 

Additional 

organs to 

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 (ILIP) ........................................ 40.57 42.44 0 0 

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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77929 

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. 

25Adler, et al. ‘‘Is Donor Service Area Market 

Competition Associated with Organ Procurement 

Organization Performance?’’ Transplantation 2016; 

100; 1349–1355. 

26OPTN 2018 Annual Report, https://

srtr.transplant.hrsa.gov/annual_reports/2018/ 

DOD.aspx. 

27https://www.nih.gov/news-events/newsreleases/scientists-triple-storage-time-humandonor-livers. 

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 selfreported 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 nextof-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. 

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. 

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. 

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] 

OPO name 

(primary state) Donation rate 95% CI 

Organ 

transplant 

rate 

95% CI Tier 

Nebraska Organ Recovery System (NEOR) ....................... 14.04 17.02 57.90 65.22 Tier 1. 

OPO at the U. of Wisconsin (WIUW) .................................. 14.24 16.26 52.32 56.27 

Midwest Transplant Network (MWOB) ................................ 17.85 19.62 52.44 55.29 

Lifesharing—A Donate Life Organization (CASD) .............. 13.42 15.39 48.49 52.74 

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 (PRLL) ........................................... 9.95 11.71 40.31 44.99 

Gift of Life Donor Program (PADV) ..................................... 15.59 16.63 42.04 43.63 

Gift of Hope Organ & Tissue Donor Network (ILIP) ........... 12.84 13.84 40.57 42.44 

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 Center (TXGC) ............................. 11.96 12.96 39.20 41.03 

Donor Network of Arizona (AZOB) ...................................... 12.41 13.68 38.22 40.09 

The Living Legacy Foundation of Maryland (MDPC) .......... 11.98 13.63 36.24 38.64 

LifeLink of Florida (FLWC) .................................................. 10.54 11.68 36.40 38.63 

Washington Regional Transplant Community (DCTC) ....... 11.01 12.63 35.39 37.83 

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 

77930 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

TABLE 3—OPO RATINGS AND TIERS FOR BOTH DONATION AND TRANSPLANT RATES—Continued 

[OPOs below top 25 percent in Italics and below median in bold and italics] 

OPO name 

(primary state) Donation rate 95% CI 

Organ 

transplant 

rate 

95% CI Tier 

Southwest Transplant Alliance (TXSB) ............................... 11.20 12.18 35.29 37.00 

Lifeshare of the Carolinas (NCCM) ..................................... 11.78 13.68 33.72 36.51 

Mid-America Transplant Services (MOMA) ......................... 11.27 12.64 34.36 36.49 

New England Organ Bank (MAOB) .................................... 10.82 11.85 34.45 36.30 

Center for Organ Recovery and Education (PATF) ............ 9.64 10.79 38.24 40.83 Tier 2. 

Donor Network West (CADN) ............................................. 10.05 10.99 36.04 37.90 

Tennessee Donor Services (TNDS) .................................... 10.24 11.25 34.18 36.04 

LifeChoice Donor Services (CTOP) .................................... 12.03 14.45 32.17 35.53 

Sierra Donor Services (CAGS) ........................................... 8.31 10.08 31.69 35.25 

New Jersey Sharing Network OPO (NJTO) ........................ 8.71 9.89 32.75 35.18 

Louisiana Organ Procurement Agency (LAOP) .................. 10.72 12.04 32.74 34.86 

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 Bank (ORUO) ....................... 8.61 9.93 30.65 33.31 

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 Transplant (NYAP) ...................... 7.45 9.33 28.06 32.51 

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 (ALOB) .................................... 8.65 9.84 29.04 31.34 

Mississippi Organ Recovery Agency (MSOP) .................... 8.29 9.86 28.21 31.22 

Donor Alliance (CORS) ....................................................... 12.03 13.65 29.26 31.15 

Texas Organ Sharing Alliance (TXSA) ............................... 8.63 9.77 28.57 30.48 

Life Connection of Ohio (OHLC) ......................................... 9.23 11.18 27.26 30.02 

Sharing Hope SC (SCOP) ................................................... 9.78 11.04 28.05 29.89 

LifeCenter Organ Donor Network (OHOV) ......................... 10.18 12.29 26.44 29.00 

LifeQuest Organ Recovery Services (FLUF) ...................... 8.74 9.94 26.55 28.50 

Legacy of Life (HIOP) .......................................................... 8.35 10.82 22.91 *27.01 

New Mexico Donor Services (NMOP) ................................. 8.04 10.23 23.53 26.80 

LifeNet Health (VATB) ......................................................... 7.97 9.07 27.65 29.68 

Finger Lakes Donor Recovery Network (NYFL) ................. 7.80 9.68 26.16 29.30 

Arkansas Regional Organ Recovery Agency (AROR) ........ 7.06 8.69 25.80 28.85 

Carolina Donor Services (NCNC) ....................................... 7.58 8.52 26.82 28.62 

Indiana Donor Network (INOP) ........................................... 7.79 8.81 25.06 26.58 

Kentucky Organ Donor Affiliates (KYDA) ............................ 7.15 8.25 24.17 26.00 

Life Alliance Organ Recovery Agency (FLMP) ................... 6.87 7.86 23.81 25.59 

Mid-South Transplant Foundation (TNMS) ......................... 6.66 8.19 18.94 21.05 

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. 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77931 

TABLE 4—ADDITIONAL DONORS TO REACH MEDIAN, TOP 25%, OR GREATER OF TOP 25% OR 20% 

OPO name 

(primary state) 

Additional donors to reach: 

Potential 

donors 

(2018) 

Actual donors 

(2018) Median Top 25% 

Higher of top 

25% or 20% 

more 

Midwest Transplant Network (MWOB) .......................... 1,423 254 0 0 51 

DonorConnect (UTOP) .................................................. 752 115 0 0 23 

Nebraska Organ Recovery System (NEOR) ................. 463 65 0 0 13 

Gift of Life Donor Program (PADV) ............................... 3,566 556 0 0 111 

OPO at the U. of Wisconsin (WIUW) ............................ 955 136 0 0 27 

Lifesharing—A Donate Life Organization (CASD) ......... 954 128 0 0 26 

LifeChoice Donor Services (CTOP) ............................... 615 74 0 0 15 

Nevada Donor Network (NVLV) .................................... 1,011 123 0 0 25 

OurLegacy (FLFH) ......................................................... 1,417 176 0 0 35 

Gift of Hope Organ & Tissue Donor Network (ILIP) ...... 3,302 424 0 0 85 

Versiti (WIDN) ................................................................ 671 77 0 0 15 

Donor Network of Arizona (AZOB) ................................ 2,039 253 0 0 51 

Lifeshare Carolinas (NCCM) .......................................... 934 110 0 0 22 

Donor Alliance (CORS) .................................................. 1,272 153 0 0 31 

The Living Legacy Foundation of Maryland (MDPC) .... 1,219 146 0 0 29 

LifeGift Organ Donation Center (TXGC) ....................... 3,145 376 0 0 75 

Mid-America Transplant Services (MOMA) ................... 1,659 187 0 0 37 

Washington Regional Transplant Community (DCTC) .. 1,190 131 0 0 26 

LifeShare of Oklahoma (OKOP) .................................... 1,561 174 0 0 35 

ConnectLife (NYWN) ..................................................... 482 47 0 0 9 

LifeCenter Organ Donor Network (OHOV) .................... 707 72 0 0 14 

Southwest Transplant Alliance (TXSB) ......................... 3,090 346 0 0 69 

LifeBanc (OHLB) ............................................................ 1,443 153 0 0 31 

Louisiana Organ Procurement Agency (LAOP) ............ 1,717 184 0 0 37 

New England Organ Bank (MAOB) ............................... 2,790 302 0 0 60 

LifeCenter Northwest (WALC) ....................................... 2,420 260 0 0 52 

LifeLink of Puerto Rico (PRLL) ...................................... 955 95 0 0 19 

LifeLink of Florida (FLWC) ............................................. 2,248 237 0 0 47 

Gift of Life Michigan (MIOP) .......................................... 3,057 321 0 0 64 

Tennessee Donor Services (TNDS) .............................. 2,735 280 0 4 56 

Life Connection of Ohio (OHLC) ................................... 758 70 0 2 14 

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 Education (PATF) ...... 2,044 197 0 12 39 

Lifeline of Ohio (OHLP) ................................................. 1,328 124 0 8 25 

LifeSource—MN (MNOP) .............................................. 1,810 172 0 12 34 

New Mexico Donor Services (NMOP) ........................... 560 45 0 6 9 

Sierra Donor Services (CAGS) ...................................... 842 70 0 11 14 

LifeQuest Organ Recovery Services (FLUF) ................. 1,751 153 0 24 31 

Pacific Northwest Transplant Bank (ORUO) ................. 1,463 126 0 20 25 

New Jersey Sharing Network OPO (NJTO) .................. 1,792 156 0 26 31 

Mississippi Organ Recovery Agency (MSOP) ............... 1,037 86 0 15 17 

Legacy of Hope—Alabama (ALOB) ............................... 1,781 154 0 26 31 

Texas Organ Sharing Alliance (TXSA) .......................... 1,913 165 0 30 33 

Finger Lakes Donor Recovery Network (NYFL) ............ 718 56 1 12 12 

Iowa Donor Network (IAOP) .......................................... 890 71 1 15 15 

Center for Donation and Transplant (NYAP) ................. 698 52 3 14 14 

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 Recovery Agency (AROR) .. 864 61 9 22 22 

Carolina Donor Services (NCNC) .................................. 2,506 190 29 69 69 

Kentucky Organ Donor Affiliates (KYDA) ...................... 1,803 129 26 54 54 

Mid-South Transplant Foundation (TNMS) .................... 931 62 14 28 28 

Life Alliance Organ Recovery Agency (FLMP) .............. 2,111 145 38 71 71 

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 

77932 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 decertify 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 highperforming 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% 

OPO name 

(primary state) 

Additional transplants to reach: 

Actual 

transplants 

(2018) 

Median Top 25% 

Higher of top 

25% or 20% 

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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77933 

28Nicholas 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. 

TABLE 5—ADDITIONAL ORGAN TRANSPLANTS TO REACH MEDIAN, TOP 25%, OR GREATER OF TOP 25% OR 20%— 

Continued 

OPO name 

(primary state) 

Additional transplants to reach: 

Actual 

transplants 

(2018) 

Median Top 25% 

Higher of top 

25% or 20% 

more 

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. 

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 

77934 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

29Organ donors <50 make up approximately 67 

percent of donors, but make up less than 10 percent 

of deaths. 

30Olivier 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. 

31Alexandra Glazier and Thomas Mone, ‘‘Success 

in Opt-In Organ Donation Policy in the United 

States,’’ August 8, 2019, doi:10.1001/ 

JAMA.2019.9187. 

32See Olivier Aubert, et al. 

33See the following link at the UNOS website: 

https://unos.org/transplant/opos-increasing-organdonation/. 

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

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 

× 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 ‘‘optin’’ 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. 

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 alltime 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. 

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 decertification 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77935 

34T. Scott Bentley and Steven J. Phillips, 2017, 

available to download at http://www.milliman.com/ 

insight/2017/2017-U_S_-organ-and-tissuetransplant-cost-estimates-and-discussion/. 

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 decertification 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 higherlevel 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 posttransplant 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. 

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 ($) 

Heart 

Milliman 

charge 

estimate 

Likely 

excess of 

charges 

over costs 

Assumed 

non-TX costs 

Immunosuppressive 

drugs 

(6 months) 

Net 

transplant 

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 ($) 

Liver 

Milliman 

charge 

estimate 

Likely 

excess of 

charges 

over costs 

Assumed 

non-TX costs 

Immunosuppressive 

drugs 

(6 months) 

Net 

transplant 

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 

77936 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

TABLE 7—FIRST YEAR COST PER LIVER TRANSPLANT ($)—Continued 

Liver 

Milliman 

charge 

estimate 

Likely 

excess of 

charges 

over costs 

Assumed 

non-TX costs 

Immunosuppressive 

drugs 

(6 months) 

Net 

transplant 

cost 

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 ($) 

Kidney 

Milliman 

charge 

estimate 

Likely 

excess 

of charges 

over costs 

Assumed 

non-TX 

costs 

Immunosuppressive 

drugs 

(6 months) 

Net 

transplant 

cost 

subtotal 

Annual 

dialysis 

costs 

avoided 

Net first 

year cost 

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 ($) 

Annual Percent of Total TX 

Heart Liver Kidney All three 

organs 

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 

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

effect from 

2021–2025 

cohorts Increase over base year in number of transplants (20% annual increments) 1,434 2,868 4,301 5,735 7,169 

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. 

77938 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

35Huang, E, et al., ’’The Cost-Effectiveness of 

Renal Transplantation,’’ When Altruism Isn’t 

Enough, edited by Sally Satel (AEI Press, 2008). 

36Tonelli M, et al., Am J Transplant 2011: 2093– 

2109. 

37USRDS 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). 

38Wolfe 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). 

39https://aspe.hhs.gov/pdf-report/guidelinesregulatory-impact-analysis. 

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 

effect from 

2021–2025 

cohorts Increase over base year in number of transplants (20% annual increments) 180 360 539 719 899 

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 lowerperforming 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 

effect from 

2021–2025 

cohorts Increase over base year in number of transplants (20% annual increments) 486 972 1,457 1,943 2,429 

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). 

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). 

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 lifeprolonging 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77939 

40Using 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. 

41This 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 CostEffectiveness of Advance Therapies for End-Stage 

Heart Failure,’’ http://circheartfailiure.aha

journals.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. 

dollar estimate of the value of a 

statistical life year).40

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 

effect from 

2021–2025 

cohorts Increase over base year in number of transplants (20% annual increments) 1,434 2,868 4,301 5,735 7,169 

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 × 65 percent 

of which are kidneys × 2⁄3 patient 

survival rate × $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

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 decertification 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 Effect 

from 2021– 

2025 

Cohorts 

Increase over base year in number of transplants (20% annual increments) 180 360 539 719 899 

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 

77940 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

42https://www.bls.gov/oes/2018/may/oes_

nat.htm. 

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 

effect from 

2021–2025 

Cohorts Increase over base year in number of transplants (20% annual increments) 486 972 1,457 1,943 2,429 

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

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 × $669) for 

eight hours. For the 58 OPOs, the firstyear cost would therefore be about 

$310,000 (58 × $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 lowperforming 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77941 

43See 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/4653015278eba

7781f781fbf0fcbc6c8/1?pqorigsite=gscholar&cbl=18750&diss=y. 

bottom-performing half of all OPOs, for 

a total cost over a 5-year period of $14.5 

million (29 × $100,000 × 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. 

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 multimillion 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. 

77942 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

44Brigitte Sullivan, Executive Director, NYU 

Langone Transplant Institute, ‘‘Maximizing 

Medicare Cost Report Reimbursement,’’ 2015, 

online at http://organdonationalliance.org/wpcontent/uploads/2015/08/ATC_BSullivan_

CostReport_062016_S5N0001.pdf. 

45We appreciate that some OPOs are hospitalbased. For purposes of this analysis, we focus on 

their OPO functions separately from their other 

functions. 

46Patients 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. 

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

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. 

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 

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

77944 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

47For convenience, we used less than 75 years 

old rather than 75 and younger because of how the 

Census data is publicly reported. 

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 recertifying 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 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 77945 

48Cannon RM, Jones CM, et al., ‘‘Patterns of 

geographic variability in mortality and eligible 

deaths between organ procurement organizations,’’ 

AmJTransplant. 2019;00:4 (Fig. 2). 

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. 

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 extrarenal 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 

77946 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 rulemakings 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 outyear 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) 

Category Primary 

estimate Low estimate High estimate 

Units 

Year dollars Discount rate 

(%) 

Period 

covered 

Benefits: 

Health Benefits Annualized Monetized ($million/year) ....................... ........................ <0 

<0 

1,370 

1,430 

2,017 

2017 

7 

3 

2022–2026 

2022–2026 

Medical Expenditure Annualized 

Monetized ($million/year) .............. ........................ >0 

>0 

¥1,450 

¥1,450 

2017 

2017 

7 

3 

2022–2026 

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 

10 

10 

10 

2017 

2017 

7 

3 

2022–2026 

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 & 

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

■ 1. The authority citation for part 486 

continues to read as follows: 

Authority: 42 U.S.C. 273, 1302, 1320b–8, 

and 1395hh. 

■ 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: 

§ 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 

§ 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 

è(g=1)Gdg*Rg/ègdg, 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 ègdg 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. 

* * * * * 

■ 3. Effective July 31, 2022, § 486.302 is 

further amended by— 

■ a. Revising the definition of ‘‘Donor’’; 

■ b. Removing the definitions of 

‘‘Eligible death’’, ‘‘Eligible donor’’, 

‘‘Expected donation rate’’, and 

‘‘Observed donation rate’’; 

■ c. Revising the definition of ‘‘Organ’’; 

and 

■ d. Removing the definition of 

‘‘Standard criteria donor (SCD)’’. 

The revisions reads as follows: 

§ 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. 

Organ type 

Number of 

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 transplant) ................... 1 

(15) Pancreas Segment 1 or Segment 

2 ....................................................... 1 

(16) Pancreas Segment 1 and Segment 2 .............................................. 2 

* * * * * 

■ 4. Section 486.316 is amended by 

revising paragraphs (a) through (c) and 

adding paragraphs (f) and (g) to read as 

follows: 

§ 486.316 Re-certification and competition 

processes. 

(a) Re-certification of OPOs. Based 

upon performance on the outcome 

measures set forth in § 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 § 486.303, including the 

conditions for coverage at §§ 486.320 

through 486.360; and 

(ii) It meets the outcome requirements 

as described in § 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 

77948 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Rules and Regulations 

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 § 486.303, including the 

conditions for coverage at §§ 486.320 

through 486.360; and 

(ii) It meets the outcome requirements 

as described in § 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 § 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 § 486.303, including 

the conditions for coverage at 

§§ 486.320 through 486.360; or 

(ii) Has outcome requirements as 

described in § 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 § 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 § 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 decertified 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 § 486.318(e)(4) and (5), and the 

requirements for certification at 

§ 486.303, including the conditions for 

coverage at §§ 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 

§ 486.318(a)(1) and (3) for OPOs not 

operating exclusively in the 

noncontiguous States, Commonwealths, 

Territories, or possessions; or 

§ 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 § 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 

§ 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 § 486.303, including the 

conditions for coverage at §§ 486.320 

through 486.360, the OPO is decertified. 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. 

■ 4. Section 486.318 is amended by 

adding paragraphs (a)(4), (b)(4), (c)(3), 

(d), (e), and (f) to read as follows: 

§ 486.318 Condition: Outcome measures. 

(a) * * * 

(4) The outcome measures described 

in § 486.318(a)(1) through (3) are 

effective until July 31, 2022. 

(b) * * * 

(4) The outcome measures described 

in § 486.318(b)(1) through (3) are 

effective until July 31, 2022. 

(c) * * * 

(3) An OPO’s performance on the 

outcome measures described in 

§ 486.318(a)(1) through (3) and 

§ 486.318(b)(1) through (3) is based on 

the data described in § 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 

§ 486.328 and § 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 § 486.328 and 

§ 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 

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

§ 486.328 [Amended] 

■ 5. Section 486.328 is amended— 

■ 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’’; 

■ b. By removing and reserving 

paragraph (a)(4); and 

■ c. In paragraph (a)(7), by removing, 

the word ‘‘eligible’’. 

■ 6. Section 486.348 is amended by 

adding paragraph (d) to read as follows: 

§ 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 

§ 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 recertification 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 

§ 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