Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization, 70628-70710 [2019-27418]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Proposed Rules]
[Pages 70628-70710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27418]



[[Page 70627]]

Vol. 84

Monday,

No. 246

December 23, 2019

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 486





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

Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / 
Proposed Rules

[[Page 70628]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 486

[CMS-3380-P]
RIN 0938-AU02


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

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the Organ Procurement 
Organization (OPO) Conditions for Coverage (CfCs) to increase donation 
rates and organ transplantation rates by replacing the current measures 
with new transparent, reliable, and objective measures.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. EST on February 21, 
2020.

ADDRESSES: In commenting, please refer to file code CMS-3380-P when 
commenting on the issues in this proposed rule. Because of staff and 
resource limitations, we cannot accept comments by facsimile (FAX) 
transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may (and we encourage you to) submit 
electronic comments on this regulation to https://www.regulations.gov. 
Follow the instructions under the ``submit a comment'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3380-P, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments via 
express or overnight mail to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3380-P, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, we refer readers to the 
beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Diane Corning (410) 786-8486, Eric 
Laib (410) 786-9759, Jesse Roach (410) 786-1000, Alpha-Banu Wilson 
(410) 786-8687, or CAPT Hui-Hsing Wong (410) 786-9007.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

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 seriously ill people 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.). 
Therefore, OPO performance is a critical element of the organ 
transplantation system in the U.S.
    As of September 2019, a total of 112,846 people were on the waiting 
lists for a lifesaving organ transplant.\1\ Many people face tremendous 
quality of life burdens or even death while on the waiting list. An OPO 
that is efficient in procuring organs and delivering them to recipients 
will help more people on the waiting list receive lifesaving organ 
transplants, which could ultimately save more lives.
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    \1\ Organ Procurement and Transplantation Network (OPTN) Data. 
https://optn.transplant.hrsa.gov/data/.
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    Given OPOs' important role in the organ donation system in the 
U.S., some stakeholders have argued that underperformers have faced few 
consequences for poor performance. These stakeholders, mainly from 
advocacy organizations, have noted that ``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 centers have fewer organ offers for patients on the 
waiting list. The end result is a bottleneck within the system that 
leads to avoidable deaths and increased national health care 
spending.'' \3\
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    \2\ The Bridgespan Group. Reforming Organ Donation in America. 
https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
    \3\ ORGANIZE. Organ Donation Reform Report. 2019.
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    Some stakeholders, including members of the OPO industry, agree 
that the OPO outcome measures should be reformed. 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.'' \4\ Reforming the 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.'' \5\
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    \4\ The Bridgespan Group. Reforming Organ Donation in America. 
https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
    \5\ The Bridgespan Group. Reforming Organ Donation in America. 
https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-12-2018.pdf.
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    Based on public feedback and our own internal analysis of organ 
donation and transplantation rates, we agree 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

[[Page 70629]]

best practices and optimization of donation and organ placement rates.

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 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 
OPTN under contract. OPOs are required under the OPTN final rule (42 
CFR 121.11(b)(2)) and 42 CFR 486.328 of the OPO Conditions for Coverage 
(CfCs) to report specific information to the OPTN, including the data 
used to calculate the outcome measures for OPOs.
    In addition, OPOs are required to comply with 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, which 
protects qualified individuals with a disability, including prospective 
organ recipients with a disability and prospective organ donors with a 
disability, from unlawful 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 program 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.''
    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).
    Section 486.322 requires that an OPO must have a written agreement 
with 95 percent of the Medicare- and Medicaid-participating hospitals 
and critical access hospitals in its service area that have both a 
ventilator and an operating room, and have not been granted a waiver by 
CMS to work with another OPO. Meanwhile, 42 CFR 482.45 requires a 
hospital have written protocols that incorporate an agreement with an 
OPO under which it must notify, in a timely manner, the OPO or a third 
party designated by the OPO, of individuals whose death is imminent or 
who have died in the hospital. Potential organ donors may encounter 
Medicare- and Medicaid-certified providers prior to an emergency 
department visit or hospital admission to a critical care unit. 
Therefore, we expect that each OPO's responsibilities and work began 
long before a hospital notified the OPO of an impending death--through, 
but not limited to, extensive training and education of all Medicare 
and Medicaid-certified providers along the continuum of care and by 
fostering a collaborative relationship among them.

C. HHS Initiatives Related to OPO Services and Executive Order 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, and implementing regulations 
under 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.\6\
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    \6\ https://www.organdonor.gov/about-dot/acot/charter.html.
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    A 2012 recommendation by ACOT stated: ``The ACOT recognizes that 
the current CMS and HRSA/OPTN structure creates unnecessary burdens and 
inconsistent requirements on transplant centers (TCs) and OPOs and that 
the current system lacks responsiveness to advances in TCs and OPO 
performance metrics. The ACOT recommends that the Secretary direct CMS 
and HRSA to confer with the OPTN, Scientific Registry of Transplant 
Recipients (SRTR), the OPO community, and TCs representatives to 
conduct a comprehensive review of regulatory and other requirements, 
and to promulgate regulatory and policy changes to requirements for 
OPOs and TCs that

[[Page 70630]]

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--. . . .'' \7\
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    \7\ Available at: https://www.organdonor.gov/about-dot/acot/acotrecs55.html.
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    On July 10, 2019, President Trump issued Executive Order 13879 
titled Advancing American Kidney Health. The Executive Order 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 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 Executive Order 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 measures for 
evaluating an OPO's performance. In conjunction with the Executive 
Order, the Department set a goal to deliver more organs for 
transplantation and aims to double the number of kidneys available for 
transplant by 2030.\8\
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    \8\ https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdf.
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    In accordance with the Executive Order and in response to ACOT's 
recommendations and stakeholder feedback, we are proposing to revise 
the OPO outcome and process measures so that they are more transparent, 
reliable, and objective measures of OPO performance. We believe that 
these changes will lead to increased procurement opportunities for 
transplantation, increased organ utilization, and as a result, more 
lives saved.

II. Provisions of the Proposed Regulations

A. Proposed Changes to Outcome Requirements (Sec.  486.318)

    On May 31, 2006, CMS published the final rule, ``Medicare and 
Medicaid Programs: Conditions for Coverage for Organ Procurement 
Organizations (OPOs)'' in the Federal Register (71 FR 30982). That 
final rule established the CfCs that OPOs must comply with in order to 
receive Medicare and Medicaid reimbursement for organ procurement 
costs. It also set forth outcome measures at 42 CFR 486.318 and 
specifies the condition for reporting of data, 42 CFR 486.328. OPOs 
must report data to the OPTN in accordance with 42 CFR 121.11(b)(2) 
(describing data specified by the Secretary) and 42 CFR 486.328 
(describing data required by the Secretary) for the operations of the 
OPTN and for CMS's assessment of OPO performance. Under these 
authorities, OPOs must report data to the OPTN or the SRTR specified by 
the Secretary (including on OMB-approved forms pursuant to the 
Paperwork Reduction Act of 1995). The CfCs for OPOs at 42 CFR 
486.318(a) and (b) have required that an OPO must meet two of the three 
following outcome measures:
     The OPO's donation rate of eligible donors as a percentage 
of eligible deaths is no more than 1.5 standard deviations below the 
mean national donation rate of eligible donors as a percentage of 
eligible deaths, averaged over the 4 years of the re-certification 
cycle. Both the numerator and denominator of an individual OPO's 
donation rate ratio are adjusted by adding a 1 for each donation after 
cardiac death donor and each donor over the age of 70;
     The observed donation rate is not significantly lower than 
the expected donation rate for 18 or more months of the 36 months of 
data used for re-certification, as calculated by SRTR;
     The OPO data reports, averaged over the 4 years of the re-
certification cycle, must meet the rules and requirements of the most 
current OPTN aggregate donor yield measure.
    For the 2022 re-certification cycle only however, under 42 CFR 
486.316(a)(3), OPOs are not required to meet the second outcome measure 
(the observed donation rate is not significantly lower than the 
expected donation rate for 18 or more months of the 36 months of data 
used for re-certification, as calculated by SRTR). OPOs must instead 
meet one out of the two outcome measure requirements described in Sec.  
486.318(a)(1) and (3) for OPOs not operating exclusively in the 
noncontiguous States, Commonwealths, Territories, or possessions; or 
Sec.  486.318(b)(1) and (3) for OPOs operating exclusively in 
noncontiguous States, Commonwealths, Territories, and possessions (84 
FR 61434 through 61436).
    We have heard concerns from some stakeholders within the organ 
donation and transplantation community about these outcome measures 
since finalization in 2006. Some stakeholders contend that the current 
outcome measures are not reliable and transparent indicators of OPO 
performance. Most comments have centered on the self-defined and self-
reported nature of the data on ``eligible deaths'' that are used for 
the evaluation of the outcome measures. Stakeholders increasingly have 
brought to our attention that the interpretation of ``eligible deaths'' 
appears to be inconsistent across donation service areas (DSAs), and 
that ``all OPO data is unaudited and self-reported'' and therefore, 
``the accuracy and consistency of that data cannot be assured.'' \9\
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    \9\ Letter from Helen Irving, President and CEO, New York Organ 
Donor Network, to Howard Shelanksi, Administrator, Office of 
Information and Regulatory Affairs, Office of Management and Budget. 
Oct. 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/oira_0938/0938_10292013b-1.pdf
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    In addition, there were concerns about the donor yield outcome 
measure. According to stakeholders, there are ``pressures from donor 
yield reporting'' that ``drives OPOs to walk away from cases in which 
the donor only has one organ viable for transplant (such as for older 
patients, where it is common that only the liver is medically viable), 
even in cases where next of kin consents to donation.'' \10\ As a 
result, some commenters have suggested that ``the regulations may be 
causing OPOs to `game' the process of meeting [this] standard by only 
targeting `high-yield' organ candidates.'' \11\ Given these comments, 
we are concerned that potentially transplantable organs may be wasted, 
exacerbating the organ shortage problem.
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    \10\ ORGANIZE. Organ Donation Reform Report. 2019.
    \11\ Letter from Helen Irving, President and CEO, New York Organ 
Donor Network, to Howard Shelanksi, Administrator, Office of 
Information and Regulatory Affairs, Office of Management and Budget. 
Oct. 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/oira_0938/0938_10292013b-1.pdf.
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    To address some of these stakeholder concerns, we made several 
changes to these outcome measures since we finalized the CfCs for OPOs 
in 2006. In 2012, we modified the definition of ``donor document'' 
(that is, the document that an individual can sign to authorize the 
procurement of their own

[[Page 70631]]

organs after their death) (77 FR 29020). In 2013, we changed the 
requirement that an OPO had to meet three outcome measures to requiring 
that the OPO had to meet only two out of the three outcome measures (78 
FR 75141). In 2016, we modified our definition of ``eligible death'' to 
be consistent with the OPTN definition, modified current requirements 
for documentation of donor information that is sent to the transplant 
center with the organ, and modified the yield measure to the most 
current OPTN aggregate donor yield measure (81 FR 79830).
    In addition, in November 2019, we finalized a proposal to reconcile 
the definition of ``expected donation rate'' in the OPO CfCs with the 
definition currently used by the SRTR. The rule also finalized a policy 
that requires OPOs to meet one out of the two outcome measures for the 
2022 re-certification cycle only. OPOs therefore are not required to 
meet the second outcome measure (the observed donation rate is not 
significantly lower than the expected donation rate for 18 or more 
months of the 36 months of data used for re-certification, as 
calculated by SRTR) for the 2022 re-certification cycle. Absent 
additional regulatory changes, an OPO would be required to meet 2 of 
the 3 regulatory requirements for future evaluation cycles (84 FR 61434 
through 61436). We also published a Request for Information (RFI) in 
the CY 2020 OPPS/ASC proposed rule that solicited comments regarding 
what revisions may be appropriate for the current CfCs for OPOs that 
are set forth at 42 CFR 486.301 through 486.360 and the current 
Conditions of Participation (CoPs) for TCs that are set forth at 42 CFR 
482.68 through 482.104 (84 FR 39595 through 39598). That RFI also 
requested comments on two potential outcome measures, which we now 
describe in more detail in this proposed rule.
    In a continued effort to respond to these concerns and as required 
by Executive Order 13879 and controlling statutes, we are proposing to 
revise the outcome measures for re-certification at Sec.  486.318 to 
replace the existing outcome measures with two new outcome measures 
that would be used to assess an OPO's performance: ``donation rate'' 
and ``organ transplantation rate'' effective for CY 2022. The 
``donation rate'' would be measured as the number of actual deceased 
donors as a percentage of total inpatient deaths in the DSA among 
patients 75 years of age or younger with any cause of death that would 
not be an absolute contraindication to organ donation; and the ``organ 
transplantation rate'' would be measured as the number of organs 
procured within the DSA and transplanted as a percentage of total 
inpatient deaths in the DSA among patients 75 years of age or younger 
with any cause of death that would not be an absolute contraindication 
to organ donation.
    The first measure, ``donation rate'', would demonstrate the OPO's 
percentage of possible deceased donors who become actual donors and the 
second measure, ``organ transplantation rate'', would demonstrate the 
percentage of organs transplanted after procurement. We have chosen 
this combination of measures to reflect our view that OPOs should be 
expanding their efforts on both converting potential donors into actual 
donors and successfully placing all possible organs for 
transplantation. We chose to include actual organ donors who had at 
least one organ transplanted in our measure to encourage the pursuit of 
single-organ donors because we believe that these donors are the 
greatest opportunity for growth; it is our understanding that 
transplant centers have recently been willing to expand the definition 
of traditional organ donors and accept organs from these donors. We 
also chose the total number of organs transplanted to emphasize the 
role of the OPO in successful organ placement. We acknowledge concerns 
that donation rate and transplant rate measures may seem redundant and 
highly correlated; however, we believe that evidence of the high level 
of correlation is due to our current outcome measures that include both 
donation rates and organ transplant yield. We selected both donation 
rates and transplantation rates in order to reduce the risk that 
resources would be diverted to focus on one measure rather than 
increasing overall efforts to address both types of measures, which we 
believe could result in more single-organ donors and minimize 
discarding of transplantable organs. We are cautious in creating 
outcome measures that inadvertently decrease one or the other type of 
measure. For example, if we choose measures based only on donation 
rates, we are concerned whether there would be sufficient incentives to 
place as many as possible organs from each donor, which can be time-
consuming. Conversely, if we chose measures based solely on organ 
transplantation rates, we would be concerned that there would be fewer 
incentives to procure single organs from older donors or donors after 
cardiac death, as there would be to procure multiple organs from the 
younger, healthier donor after brain death.
    For the first measure, donation rate, the numerator is defined as 
the number of actual deceased donors in the DSA who had at least one 
organ transplanted based on data reported to the OPTN. In the current 
Sec.  486.302 Definitions, we define ``Donor'' to mean a deceased 
individual from whom at least one vascularized organ (heart, liver, 
lung, kidney, pancreas, or intestine) is recovered for the purpose of 
transplantation. We are proposing to change this definition to require 
that the organ be transplanted, not just recovered. There are three 
primary reasons for requiring that the organ be actually transplanted: 
(1) To discourage the discarding of procured organs, (2) to encourage 
transplantation of every organ, including those from single-organ 
donors, and (3) because it is easier to verify the existence of a donor 
who had at least one organ transplanted compared with donors who did 
not have an organ transplanted. We are seeking comments on the change 
in definition of ``donor.''
    For the second measure, organ transplantation rate, we are not 
changing the definition of ``Organ,'' but propose to provide 
clarification as to how the organs are counted (see Table 1) for 
purposes of determining the organ transplantation rate (as our current 
regulations do not provide the specificity that we now propose to more 
accurately track donations). We are excluding organs procured for 
research, but not transplanted, from our definition, except for 
pancreata that are procured for islet cell transplantation or research 
(transplanted or not transplanted), as this is required by section 
371(c) of the PHS Act. The numerator is defined as the number of actual 
organs transplanted based on data obtained from the OPTN. We are 
seeking comments on this proposed change and clarification.

                   Table 1--Organs Transplanted Count
------------------------------------------------------------------------
                                                             Number of
                       Organ type                             organs
                                                           transplanted
------------------------------------------------------------------------
Right or Left Kidney....................................               1
Right and Left Kidney...................................               2
Double/En-Bloc Kidney...................................               2
Heart...................................................               1
Intestine...............................................               1
Intestine Segment 1 or Segment 2........................               1
Intestine Segment 1 and Segment 2.......................               2
Liver...................................................               1

[[Page 70632]]

 
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                          1
 transplant)............................................
Pancreas Segment 1 or Segment 2.........................               1
Pancreas Segment 1 and Segment 2........................               2
------------------------------------------------------------------------

    Some members of the OPO community have stated that the proposed 
measure, organ transplantation rate, reflects the transplant hospitals' 
acceptance practices and that OPOs should not be held accountable for 
the transplant hospitals' decisions. We understand the role of 
transplant hospitals in the organ transplantation rate measure; 
however, we also recognize the influence OPOs have on transplant 
hospital practice through OPO advisory boards (Sec.  486.324(a)(5)), 
which include a transplant surgeon from every transplant hospital in 
the DSA. Although the historical basis of this requirement was so that 
transplant hospitals could advise OPOs about transplant practices and 
have input into their policies,\12\ we believe the relationship has 
evolved bilaterally, such that OPOs can educate transplant hospitals in 
the DSA about the performance of organs that were turned down by one 
hospital, but accepted by another. By serving on the OPO advisory 
board, transplant surgeons can learn more about the practices of the 
other transplant surgeons on the board, as well as about acceptance 
practices at transplant hospitals outside the DSA, and share that 
information with their own transplant hospitals. We also note that OPOs 
are often expected to place their organs outside of their DSA; our 
understanding of organ transplant practice is that there are numerous 
transplant hospitals throughout the country that successfully 
transplant ``less than perfect'' organs. It is our belief that given 
the unacceptable number of patients dying on the waiting list or on 
dialysis waiting for a transplant, there are transplant hospitals in 
the U.S. that will accept ``less than perfect,'' but still 
transplantable organs. As such, we believe it is the OPO's 
responsibility to ensure that those organs are transplanted, instead of 
discarded. Our goal for this rule and the organ transplantation rate 
measure is to incentivize the ``system'' to establish efficiencies that 
will result in substantial improvement of organ placement and 
transplantation.
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    \12\ Senate Report 104-256--Organ and Bone Marrow Transplant 
Program Reauthorization Act of 1995 and Sec.  486.324.
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    The numerators for these measures will be based on the actual 
donors who had at least one organ transplanted and the number of organs 
procured and transplanted from those donors in the DSA. Since the data 
for the numerators for both of these measures are already being 
submitted by the OPOs and verified by the transplant hospitals when 
they perform the transplant, we do not believe that these proposed 
changes create additional reporting burdens for the OPOs or the 
transplant hospitals.\13\ Also, we are confident in the veracity of the 
information as it can be corroborated by the OPTN, which has a record 
of all organs in which a match is run for allocation, and requires 
reporting of the transplantation by the OPO, as well as the transplant 
program, and requires documentation of the disposition of the organ.
---------------------------------------------------------------------------

    \13\ The data submitted to the OPTN has already been accounted 
for in the OPTN final rule's Paperwork Reduction Act analysis.
---------------------------------------------------------------------------

    For both measures, the denominator (that is, donor potential) is 
defined as the number of total inpatient deaths within the DSA among 
patients 75 years of age or younger with a cause of death that would 
not be an absolute contraindication to organ donation. For calculating 
the denominator, we would use data obtained from state death 
certificates. Currently, this information can be obtained from the 
Center for Disease Controls' (CDC), National Center for Health 
Statistics' (NCHS's) Detailed Multiple Cause of Death (MCOD) as 
described in more detail in this section. The MCOD is published 
annually and is publicly available upon request. The MCOD meets NCHS 
data privacy and security requirements.
    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.\14\
---------------------------------------------------------------------------

    \14\ https://www.cdc.gov/nchs/data/dvs/DEATH11-03final-acc.pdf.
---------------------------------------------------------------------------

    Within the standard certificate of death are key variables relevant 
to our measures such as where the death occurred: Hospital (inpatient, 
emergency room/outpatient, and dead on arrival) or somewhere other than 
a hospital (hospice facility, nursing home/long-term care facility, 
decedent's home, other). In addition, there is information on the cause 
of death. The information on the cause of death is based on free text 
entered by the certifier, usually a physician, medical examiner, or 
coroner. Based on the causes of death on the certificate, NCHS assigns 
a code from the International Classification of Diseases, Tenth 
Revision (ICD-10) to each cause of death reported. This coding is done 
centrally at NCHS with software designed for this purpose or manually 
using expert coders; they have been using ICD-10 codes since 1999. In 
addition to the underlying cause of death, each record has space for up 
to 20 multiple cause codes. The ICD-10 codes that could be assigned are 
found in CDC's Instruction Manual, Part 2e, Volume 1: ICD-10, 
International Statistical Classification of Diseases and Related Health 
Statistical Classification of Diseases and Related Health Problems. 
Tabular List, 2017; modified by the National Center for Health 
Statistics for use in the classification and analysis of medical 
mortality data in the U.S.\15\ Although there may be inaccuracies in 
the description of the causes of deaths in these death certificates, we 
have no evidence that there are differences in the rate of errors on 
inpatient death certificates based on the DSA and that any particular 
DSA would be disproportionately affected.
---------------------------------------------------------------------------

    \15\ https://www.cdc.gov/nchs/data/dvs/2e_volume1_2017.pdf.
---------------------------------------------------------------------------

    Deaths that are not an absolute contraindication to organ donation 
are calculated from those ICD-10 codes and would exclude clinical 
causes of death in which organs would never be used for 
transplantation. Our definition of ``a death that is not an absolute 
contraindication to organ donation'' means all deaths except those 
identified by the specific ICD-10 codes that would preclude donation 
under any circumstance. This information would be obtained from the 
state death certificates, and include both immediate cause of death and 
contributing causes of death. We have listed the three character 
categories of ICD-10 codes in Table 2 to be absolute contraindications 
to organ donation which was generated

[[Page 70633]]

from and reviewed by several sources (the current list of eligible 
deaths, public stakeholder input, and HHS medical advisors). We are 
interested in comments on whether all appropriate subcategories are 
included and whether other ICD-10 codes should also be excluded from 
the denominator.

           Table 2--ICD-10 Codes Excluded From the Denominator
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Tuberculosis...........................  All.
Other bacterial diseases...............  A39 Meningococcal infection.
                                         A40 Streptococcal septicaemia.
                                         A41 Other septicaemia.
Viral infections of the central nervous  A82 Rabies.
 system.
Viral infections characterized by skin   B03 Smallpox.
 and mucous membrane lesions.
Human immunodeficiency virus [HIV]       B20 Human immunodeficiency
 disease.                                 virus [HIV] disease with
                                          infectious and parasitic
                                          diseases.
                                         B21 Human immunodeficiency
                                          virus [HIV] disease with
                                          malignant neoplasms.
Sequelae of infectious and parasitic     B90 Sequelae of tuberculosis.
 diseases.
Malignant neoplasms of lip, oral cavity  All.
 and pharynx.
Malignant neoplasms of digestive organs  All.
Malignant neoplasms of respiratory and   All.
 intrathoracic organs.
Melanoma and other malignant neoplasms   C43 Malignant melanoma of skin.
 of skin.
Malignant neoplasms of bone and          All.
 articular cartilage.
Melanoma and other malignant neoplasms   All.
 of skin.
Malignant neoplasms of methothelial and  All.
 soft tissue.
Malignant neoplasm of breast...........  All.
Malignant neoplasms of female genital    All.
 organs.
Malignant neoplasms of male genital      All.
 organs.
Malignant neoplasms of thyroid and       All.
 other endocrine glands.
Malignant neoplasms of ill-defined,      All.
 secondary and unspecified sites.
Malignant neoplasms of lymphoid,         All.
 haematopoietic and related tissue.
Malignant neoplasms of independent       All.
 (primary) multiple sites.
Neoplasms of uncertain or unknown        D44 Neoplasm of uncertain or
 behavior.                                unknown behaviour of endocrine
                                          glands.
                                         D46 Meylodysplastic syndromes.
                                         D47 Other neoplasms of
                                          uncertain or unknown behavior
                                          of lymphoid, haematopietic and
                                          related tissue.
                                         D48 Neoplasms of uncertain or
                                          unknown behavior of other and
                                          unspecified sites.
Coagulation defects, purpura and other   D65 Disseminated intravascular
 haemorrhagic conditions.                 coagulation [defibrination
                                          syndrome].
                                         D69 Purpura and other
                                          haemorrhagic conditions.
Metabolic disorders....................  E84 Cystic fibrosis.
Infections specific to the perinatal     P36 Bacterial sepsis of
 period.                                  newborn.
------------------------------------------------------------------------

    One of our current measures used to measure OPO performance relies 
upon measuring the donation rate based on eligible deaths. While the 
``eligible death'' definition allows for a more narrow and definitive 
estimation of the organ donation potential, it also limits the pool of 
potential organ donors by which OPOs are evaluated and does not take 
into account the advances in medicine that could expand the pool of 
potential donors (such as, very effective treatments for hepatitis C 
allowing hepatitis C positive donors to donate to patients who do not 
have hepatitis C); \16\ further, it is subject to bias in 
interpretation and reporting. By using inpatient deaths from this 
objective data source and eliminating causes of death that are absolute 
contraindications to organ donation, we are targeting a specific 
population that is more likely to be organ donors and mitigating 
concerns that the data could be manipulated based upon varying 
interpretations of an eligible death.
---------------------------------------------------------------------------

    \16\ Woolley, AE, et al, ``Heart and Lung Transplants from HCV-
Infected Donors to Uninfected Recipients,'' NEJM, 2019; 390:1606-
1617.
---------------------------------------------------------------------------

    The denominator will be the number of inpatient deaths of someone 
75 years old or younger identified using the most recent prior 12 
months of available data from the state death certificates from the 
DSA, and the numerators will be based on the number of donors and 
organs transplanted during the same corresponding time period. We chose 
to calculate our measures based on the most recent prior 12 months of 
available data from the DSA because we do not want to penalize OPOs 
that have improved their performance by using older data. Also, since 
the purpose of our performing this assessment is to re-certify an OPO 
for another 4 years, historical performance from more than two years 
prior may be less reflective of current performance or less predictive 
of future performance. Finally, we are interested in comments on 
whether there are alternative or additional data sources or types we 
should consider, including those already being collected, when 
assessing OPO performance. As stated earlier, we acknowledge that there 
are certain limitations of the CDC Multiple Cause of Death File. We are 
therefore interested in whether there are additional data sources, such 
as those collected by the OPTN, which could supplement the precision of 
outcome measures. We are also interested in the availability and 
utility of additional types of data, such as donor enrollment 
practices, discarded organs, or referral management.
    In the regulatory impact analysis (RIA) section of this proposed 
rule, we present tables reflecting the results of our proposed measures 
using data from January 1, 2017 to December 31, 2017. We found a wide 
range of donation rates (1.65 to 6.45 donors/100 inpatient deaths) and 
organ transplantation rates (4.47 to 21.14 transplants/100 inpatient 
deaths). We did not find a correlation between the performance of OPOs 
and the number of deaths (reflecting experience with larger volumes of 
potential donors) or the number of patients on the waiting list 
(reflecting the demand for organs) in the DSA.

[[Page 70634]]

Although Cannon et al. found statistically significant clustering of 
the top 5 causes of death in organ donors (blunt trauma, gunshot 
wounds, drug overdose, cerebrovascular accidents, and cardiovascular 
disease), we compared the donation rates and organ transplantation 
rates using these proposed measures to the geographic variability in 
those top five causes of death and found no correlation between high 
OPO performance and distribution or incidence of those causes of 
death.\17\ We examined the characteristics of the DSAs among the top 25 
percent performing OPOs and found that they include geographic areas 
representative of all parts of the U.S. and diverse racial and ethnic 
populations. Despite this seemingly broader definition of potential 
organ donors, we did not notice any particular geographic patterns 
(including urban vs. rural) distinguishing the top performing OPOs from 
the rest of the cohort, leading us to conclude that our broad 
definition, inpatient deaths among those 75 and younger within the DSA, 
excluding causes of deaths that are an absolute contraindication for 
organ donation, appropriately describes the donor potential in a DSA 
and that the primary factors for differences in OPO performance using 
these measures are within the control of the OPOs to change. We are 
seeking comments as to the accuracy of our assessment and whether 
additional research is necessary to ensure that all DSAs will be 
impacted equally under the new measures. Specifically, we are 
requesting public comments that provide evidence-based support, such as 
peer-reviewed literature, that we should consider to inform our 
conclusion that our proposed definitions would not disadvantage any 
particular OPO as a result of population demographics or incidence of 
disease within a DSA.
---------------------------------------------------------------------------

    \17\ Cannon RM, Jones CM, et al, ``Patterns of geographic 
variability in mortality and eligible deaths between organ 
procurement organizations,'' AmJTransplant. 2019;00:4 (Fig. 2).
---------------------------------------------------------------------------

    Since our criteria for the denominator takes into consideration 
many of the clinical characteristics associated with possible organ 
donation (the age of the potential donor, the inpatient 
hospitalization, and contraindication to donation), we believe all 
appropriate risk-adjustments to the clinical characteristics of the 
donor potential have been made. We are aware of literature identifying 
racial disparities among organ donors, specifically that African 
Americans were less willing to donate their own organs compared with 
whites (72.6% v. 88.3%).\18\ However, we are concerned regarding the 
applicability of that study, given it was from 2000, and more recent 
evidence suggesting that the racial concordance of the OPO requester 
plays a role in the rate of authorization for organ donation.\19\ 
Further, we are not aware of any validated coefficients that reflect 
the likelihood of a particular racial/ethnic group to donate organs and 
we are concerned that any current risk-adjustments factors being used 
include the historical poorer performances. Based on the most recent 
literature and our internal analyses, we have decided not to risk-
adjust for race. We seek comments as to whether there is other 
literature or data regarding race or other demographics or other public 
health factors that warrant the consideration of further risk 
adjustment.
---------------------------------------------------------------------------

    \18\ Siminoff, LA, et al, ``Racial Disparities in Preferences 
and Perceptions Regarding Organ Donation,'' JGIM, 2006; 21:995-100.
    \19\ Bodenheimer, HC, et al, ``The Impact of Race on Organ 
Donation Authorization Discussed in the Context of Liver 
Transplantation,'' Transactions of the American Clinical and 
Climatological Association, Vol. 123, 2012.
---------------------------------------------------------------------------

    Similarly, we are not proposing any additional risk-adjustments to 
our measures other than the exclusion of the ICD-10 codes that are 
absolute contraindications to organ donation, the age of 75 and 
younger, and the requirement that the death occurred as an inpatient in 
the hospital. However, we are seeking comments on whether other 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. 
If risk adjustment were to be implemented, it would likely be done 
retrospectively by identifying risk factors that have a statistically 
significant impact on transplantation rates using regression analysis. 
We are interested in comments on specific risk adjustment public health 
emergencies or other local activities (for example, legislative changes 
on presumed consent). We are also requesting that commenters provide 
evidence and data sources that would be necessary to calculate the 
risk-adjustments recommended. Finally, we are seeking comments about 
any potential unintended consequence of using risk-adjustments to our 
measures. Depending on the substance of the public comments received, 
we could establish a risk adjustment methodology in the final rule.
    In order to ensure that our measures adjust to changes in medical 
technology and causes of death and in order to achieve the goal of 
doubling the number of kidneys available for transplantation by 2030, 
we are proposing to use our measures in the context of a comparative 
donation rate and organ transplantation rate relative to the highest-
performing OPOs. By using comparative rates, we assume that the highest 
performing OPOs are adjusting their practices to reflect medical 
technology and other factors that may impact the number of donors and 
organs transplanted. Our ultimate definition of success, however, is to 
encourage the performance of all OPOs to cluster around the highest 
performers. Therefore, our proposed definition of success will be 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 for OPOs. We acknowledge that there may be other 
success factors for assessing performance of OPOs outside of the two 
outcome measures of donation rate and organ transplantation rate. Thus, 
we are soliciting 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.
    In determining our calculations, we will establish a threshold 
donation rate and organ transplantation rate based on the lowest rate 
among the top 25 percent of donation rates and organ transplantation 
rates during the 12-month period prior to the time period that is being 
evaluated. For example, if we are doing an assessment on December 31, 
2024 and using data from January 1, 2023 to December 31, 2023, the 
threshold rates would be based on the lowest donation rate and organ 
transplantation rate of the top 25 percent donation and organ 
transplantation rates for the time period of January 1, 2022 to 
December 31, 2022. Since there are currently 58 OPOs, there are 15 OPO 
rates (rounded to the closest integer) in the top 25 percent. There are 
two primary benefits for using this separate cohort to establish the 
threshold rates: (1) The predetermined threshold rate obtained from an 
external source would be known to OPOs before their evaluation cycle 
and (2) from a

[[Page 70635]]

statistical standpoint, such a predetermined threshold rate would be 
considered a known constant, not subject to random variation. If we 
were to use a threshold rate based on the same time period being 
evaluated, then the threshold rate would not be known to OPOs before 
their evaluation cycle. From a statistical standpoint, such a threshold 
rate would not be considered a constant; in that case, its uncertainty 
would need to be accounted for in the testing procedure, resulting in 
lower statistical power. To avoid this problem, we instead use a 
predetermined threshold rate obtained from an external source.
    Then, we will determine whether the donation rates and organ 
transplantation rates for each of the OPOs are statistically 
significantly lower than the predetermined threshold rate by 
calculating the 95 percent confidence interval (CI) for each OPO and 
flagging those OPOs whose upper limit of the one-sided 95 percent CI is 
lower than the threshold rate. By using this approach, we allow all 
OPOs the opportunity to re-certify as long as their performance is not 
statistically significantly different from the top 25 percent.
    Importantly, Executive Order 13879 recognizes the problem of organ 
discards. In choosing the 25 percent cutoff, we hope to encourage OPOs 
to successfully place every organ they procure and to improve their 
donation rates. We analyzed the impact of these new outcome measures on 
data from January 1, 2017 to December 31, 2017 and determined that if 
all underperforming OPOs reached the threshold rate for that time 
period, we would have approximately 4,900 more organs transplanted. 
According to the OPTN data, from that same time period, there were a 
total of 4,905 organs discarded, of which 3,542 were kidneys.\20\ A 
recent study showed that if U.S. transplant centers expanded the type 
of deceased donor kidneys that they transplanted to include the lower 
quality kidneys, similar to those transplanted in France, there would 
be 17,435 more kidneys transplanted, resulting in 132,445 allograft 
years over an 11-year period.\21\
---------------------------------------------------------------------------

    \20\ OPTN databased accessed on August 28, 2019 (https://optn.transplant.hrsa.gov/data/view-data-reports/build-advanced/).
    \21\ Aubert, Reese, et al, ``Disparities in Acceptance of 
Deceased Donor Kidneys Between the United States and France and 
Estimated Effects of Increased US Acceptance, JAMA Intern Med. 
Published online August 26, 2019. Doi:10.1001/
jamainternmed.2019.2322.
---------------------------------------------------------------------------

    However, eliminating all inappropriate organ discards alone will 
not be enough to achieve the 4,900 more organs transplanted that we 
hope to achieve in setting the top 25 percent threshold. The reason we 
believe a top 25 percent threshold rate is appropriate is that we also 
found a wide variation in donation rates among OPOs, suggesting that 
there is significant opportunity, especially among the lower- 
performing OPOs, to increase their donation rates and subsequently, 
their organ transplantation rates. If we had not seen such a wide 
variation in donation rates, we would have aligned our expected 
increase in organs transplanted with the number of organs discarded 
that we believed could be transplantable and set a lower threshold 
rate, such as 30 percent or 40 percent. We are seeking comments on the 
threshold rate cutoffs for determining success and our methodology for 
calculating the threshold rates.
    Our proposed measures are similar to the measures presented in the 
study, ``Importance of incorporating standardized, verifiable, 
objective metrics of organ procurement organization performance into 
discussions about organ allocation.'' \22\ This study describes a 
similar approach using the NCHS data, but uses a cause, age, and 
location consistent (CALC) donation measure. We are actively 
considering this approach as well as other alternatives and have 
described them in greater detail in the RIA, Section G: Alternatives 
Considered.
---------------------------------------------------------------------------

    \22\ Goldberg D, Karp S, et al, ``Importance of incorporating 
standardized, verifiable, objective metrics of organ procurement 
organization performance into discussions about organ allocation,'' 
Am J Transplant. 2019;00:1-6.
---------------------------------------------------------------------------

    We believe that the consistency and quality of these proposed 
measures would be a significant improvement over the current measures 
because they would rely on independent data to measure donor potential. 
Stakeholders have increasingly brought to CMS' and HHS' attention that 
the self-reporting of data could inadvertently reward poor performance, 
suggesting that OPOs who are less proficient at identifying eligible 
deaths in their donation service area could have lower denominators, 
resulting in higher rates of donations. The current outcome measures 
also include potentially burdensome OPO self-defined and self-reported 
``eligible deaths'' for evaluation purposes. We believe that using CDC 
data on inpatient deaths from the state death certificates as the 
denominator would greatly reduce reporting burdens on OPOs and allow 
them to more efficiently utilize their resources to improving donation 
rates and organ transplantation rates.
    By establishing a definition of success that is compared with the 
top performing OPOs, we hope to increase the number of organs, 
particularly kidneys, to achieve the goal of doubling kidney 
transplantations by 2030. Therefore, we do not think it is appropriate 
for us to include a measure that assesses the OPO's actual donation or 
transplantation rates based on their expected donation or 
transplantation rates since that measure relies on average performances 
to assess OPOs. Our new measures are designed to drive OPOs to perform 
optimally by motivating them to pursue every organ, every time, rather 
than setting standards at or near the current average performance. For 
all the reasons stated above, we believe that the proposed changes to 
our outcome measures would standardize the assessment of OPO 
performance, reduce reporting burdens on OPOs, and increase the number 
of transplantable organs. We would expect OPOs to continue their 
quality improvement efforts through their Quality Assurance and 
Performance Improvement (QAPI) program, as required by our rules at 
Sec.  486.348, and they would continue to seek and implement best 
practices for organ procurement. We note that OPOs are already required 
to develop, implement, and maintain a comprehensive, data-driven QAPI 
program designed to monitor and evaluate performance of all donation 
services, and we expect them to use the data provided as part of their 
QAPI program.
    In the current regulations, we have specifically separated OPOs 
operating exclusively in noncontiguous States, Commonwealths, 
Territories, or possessions from the other OPOs. In this proposed rule, 
we are not proposing different outcome measures for these OPOs because 
we believe the residents of those areas deserve every opportunity for 
organ transplantation and that OPOs servicing those areas should 
perform at the same level as the top 25 percent of OPOs. Although these 
OPOs may not be in a DSA with transplant hospitals capable of 
transplanting all organs that possibly could be procured, organs are 
frequently offered to hospitals outside of the DSAs in which they are 
procured. Further, we believe that geographical distances may not be as 
much of a hurdle as previously believed. For example, the OPO in Puerto 
Rico is geographically proximal to the continental U.S. where there are 
numerous transplant hospitals. The OPO in Hawaii may have more 
difficulty placing all organs given how long it takes to reach the 
continental

[[Page 70636]]

U.S. from there; however, we understand that there are new technologies 
that could be employed to allow for transport for organs that cannot 
tolerate longer transport time (such as for kidneys, livers, and lungs) 
and that the geographic distance may be less of a barrier to placement 
of these organs. We are seeking comments on this proposed change, 
particularly 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 the RIA, 
Section G: Alternatives Considered.

B. Proposed Changes to Definitions (Sec.  486.302) and Re-Certification 
and Competition Processes (Sec.  486.316)

    In line with our proposal to change the outcome measures at Sec.  
486.318, as discussed in section II.A. of this document, we are 
proposing to modify language in Sec.  486.316(a)(1) that an OPO must 
meet two out of the three outcome measures at Sec.  486.318 and at 
Sec.  486.316 (a)(3) that for the 2022 re-certification cycle only that 
an OPO must meet one out of the two outcome measures described in Sec.  
486.318 (a)(1) and (3) and (b)(1) and (3). We are also proposing to 
remove several definitions from Sec.  486.302, since these terms would 
no longer apply. Specifically, we are proposing to remove the 
definitions of ``eligible death,'' ``eligible donor,'' ``expected 
donation rate,'' ``observed donation rate'', and ``Standard criteria 
donor (SCD)''. Finally, we are proposing to modify the definition of 
``donor'' as described in section II.A of this rule and are proposing 
to add the terms ``death that is not an absolute contraindication to 
organ donation,'' ``donation rate,'' ``donor potential,'' and ``organ 
transplantation rate.'' We are proposing to define these terms as 
follows:
     ``Death that is not an absolute contraindication to organ 
donation'': All deaths from the state death certificates except those 
with any cause of death identified by the specific ICD-10 codes that 
would preclude donation under any circumstance.
     ``Donor potential'': Is the number of inpatient deaths 
with in the DSA among patients 75 and younger with any cause of death 
that is not an absolute contraindication to organ donation.
     ``Donation rate'': Is the number of donors as a percentage 
of the donor potential.
     ``Organ transplantation rate'': The number of organs 
transplanted as a percentage of the donor potential.
    Accordingly, we are proposing to modify the reporting requirements 
in Sec.  486.328 to eliminate the reporting of the ``Number of eligible 
deaths'' and modifying the reporting of ``Number of eligible donors'' 
to ``Number of donors.'' In addition, we are proposing to revise the 
language that incorrectly refers to the ``Scientific Registry of 
Transplant Beneficiaries'' and ``DHHS'' in this section. We would 
instead include the terms ``Scientific Registry of Transplant 
Recipients'' and ``HHS.'' We are requesting comments on these 
proposals.
    Sections 486.316 (c) and (d) describe the criteria that an OPO must 
meet in order to compete for an open service area and the criteria for 
selection of an OPO for an open service area, respectively. Once an OPO 
is de-certified and their agreement is terminated, either voluntarily 
or involuntarily as described in Sec.  486.312, the OPO's service area 
is open to competition from other OPOs. Under Sec.  486.316(b), the OPO 
that has been de-certified is not permitted to compete for its service 
area or any other service area. If an OPO is interested in competing 
for an open service area, the OPO 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. 
These current requirements for competition once an OPO is de-certified 
will continue to apply if we finalize the changes to the outcome 
measures described in this proposed rule. If no OPO applies to compete 
for a de-certified OPO's open area, Sec.  486.316 (e) allows for CMS to 
select a single OPO to take over the entire open area or adjust the 
service area boundaries of two or more contiguous OPOs to incorporate 
the open area. CMS would select the new OPO to take over the entire 
open area based on the criteria set out at Sec.  486.316(d); however, 
our regulations do not require that the DSAs merge when a new OPO takes 
over. However, we acknowledge that decertification of multiple OPOs 
could require changes to OPTN policies. We are soliciting comments on 
our current regulations related to assigning an open DSA in the case 
where no OPO applies to compete for that open area or in the case where 
CMS selects an OPO to take over the entire open DSA, but the OPO 
refuses to do so.
    Our goal is to ensure continuous coverage of an OPO service area in 
the event an OPO is decertified. Although we would attempt to minimize 
disruptions to organ procurement services in an open service area as 
much as possible, we acknowledge that there is the potential for 
disruption when one or multiple OPOs are decertified. We are therefore 
seeking comments on ways that we can reduce any potential disruptions 
when an OPO is decertified and their service area is open to 
competition. We are particularly interested in comments on such 
potential options including ways that we could improve or ease the 
process of transitioning an open service area from the decertified OPO 
to another OPO and other related factors that may impact organ donation 
or the OPO's ability to meet the outcome measures.
    OPOs are also required to meet certain criteria in order to compete 
for an open service area. In general, OPOs must meet two out of the 
three outcome measures requirements at Sec.  486.318 (with the 
exception of the 2022 re-certification cycle where OPOs are required to 
meet one out of two outcome measures) and the OPO must be in compliance 
with the requirements for certification at Sec.  486.303, including the 
conditions for coverage at Sec. Sec.  486.320 through 486.360. The OPO 
that is applying to compete for the open service area must also meet 
additional criteria, including that 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; and
     Donation rate is at least 15 percentage points higher than 
the donation rate of the OPO currently designated for the service area.
     The OPO must also compete for the entire service area.
    These existing requirements, however, are not consistent with our 
proposed method of assessing an OPO's performance, which would compare 
OPOs to an established threshold rate (using the lowest rate among the 
top 25 percent of donation rates and organ transplantation rates during 
the 12-month period prior to the time period that is being evaluated). 
We therefore are proposing to remove the additional requirement for an 
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) and the 
requirement that an OPO's donation rate be at least 15 percentage 
points higher than the donation rate of the OPO currently designated 
for the service area. We believe that OPOs will be held to a high 
standard of performance under the new proposed outcome measures. This 
would ensure that any OPO that is seeking to compete for an open 
service

[[Page 70637]]

area performs significantly better than the de-certified OPO. By 
meeting the outcome measure requirements, an OPO would also demonstrate 
its ability to perform well in its own DSA. We are soliciting comments 
on whether there should be additional criteria beyond what we are 
proposing to include here to demonstrate that an OPO is performing 
significantly better than the de-certified OPO. We are not proposing to 
eliminate the requirement that OPOs compete for the entire service 
area. Maintaining this requirement will prevent competition of partial 
service areas, which may lead to OPOs attempting to obtain certain 
neighboring service areas purely for business reasons, with no regard 
to whether the OPO can increase organ donation in those areas.
    Finally, the current requirements list certain criteria for 
selection of an OPO for designation of an open service area including:
     Performance on the outcome measures at Sec.  486.318;
     Relative success in meeting the process performance 
measures and other conditions at Sec. Sec.  486.320 through 486.360;
     Contiguity to the open service area; and
     Success in identifying and overcoming barriers to donation 
within its own service area and the relevance of those barriers to 
barriers in the open area. 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.
    We are proposing to make a clarifying change to these requirements 
to emphasize that CMS will consider the current criteria when 
determining which OPO to designate for an open service area. Our 
original intent was to list these criteria as guidelines as opposed to 
requirements that an OPO must meet in order to be selected. For 
example, we could select a high performing OPO that meets the outcome 
measures and other CfC requirements, but may not be contiguous to the 
open service area. This change would provide clarity to the 
circumstances under which CMS would select an OPO to take over an open 
service area.
    We are soliciting comments on all of our proposed changes to Sec.  
486.316. We are especially interested in comments on whether the 
contiguity of an OPO to the open service area is still an important 
factor to consider when selecting an OPO to take over an open service 
area. Since we implemented the OPO CfCs in 2006, there have been 
advances in technology that have improved organ procurement and 
transplantation and that have changed the way and the speed, in which 
OPOs and transplant centers communicate with each other. It may be the 
case that an OPO that is taking over an open service area may no longer 
need to be contiguous to the open service, especially if that OPO is a 
high performer that could increase the number of organs procured and 
eventually transplanted in an open service area. We are seeking 
comments on whether this specific criterion is still applicable.
    We are also soliciting comments on whether we should reconsider 
opening the service area of every OPO for competition at the conclusion 
of every re-certification cycle, regardless of whether the OPO met the 
outcome performance standards for the prior re-certification cycle. 
Under our current regulations, OPOs that successfully pass the outcome 
and process performance measures and comply with our CfCs are 
automatically renewed. Only OPOs that are unsuccessful in meeting these 
regulatory requirements could be de-certified. We are seeking comments 
on an alternative approach where all OPO service areas would be open 
for competition at the end of each agreement cycle. Any OPO seeking to 
renew the agreement could face competition from another OPO that wanted 
to take over that DSA.
    In 2005, we proposed opening every OPO's service area for 
competition at the end of every re-certification cycle. Specifically, 
we proposed that once we determined that an OPO met the outcome 
measures at proposed Sec.  486.318 for the previous re-certification 
cycle and was found to be in compliance with the process performance 
measures at Sec. Sec.  486.320 through 486.360, that we would open the 
OPO's service area for competition from other OPOs. Some of the 
comments we received at the time included concerns that such a proposal 
would threaten cooperation and collaboration between OPOs, and would 
impact the sharing of best practices and change strategies between OPOs 
(71 FR 30996). In response to this feedback, we finalized a modified 
version of this proposal whereby this process would only occur in the 
service areas of OPOs that have been de-certified. We are seeking 
comments as to whether circumstances in the past 15 years have changed 
that would warrant our reconsidering our policy of limiting the 
competition to just open service areas. If we were to consider a policy 
to open the service areas of all OPOs, we seek comment on how much 
effort it would take to prepare a bid for the open service area, how 
this type of competition may affect organ donation, and how it would 
affect cooperation when transplant centers are receiving organs from 
outside the service area.

C. Proposed Changes to the Re-Certification Cycle (Sec.  486.302 and 
Sec.  486.318)

    In accordance with our rules at Sec.  486.308(b)(1), OPOs are re-
certified on a four-year cycle. Currently, OPOs are assessed based on 
36 months of data analysis. This data period begins six months after 
the certification period starts and ends six months prior to the end of 
the certification cycle. CMS analyzes these data and determines if the 
OPO is out of compliance with outcomes prior to the end of the current 
cycle and prior to the start of the next cycle. OPOs are given interim 
reports every six months during the certification period to gauge 
performance. The survey and certification administrative enforcement 
actions begin six months before the end of the certification period. 
For instance, the data collection period for the previous re-
certification cycle ended on December 31, 2017. Re-certification 
surveys were conducted January 1, 2018 through July 31, 2018 and 
outcomes measures were assessed for the 36 month period beginning 
January 1, 2015 through December 31, 2017, with the next certification 
cycle beginning on August 1, 2018. We recognize that waiting a full 36 
months to assess and take actions to improve OPO performance would 
result in numerous lost opportunities to procure and transplant 
potentially viable organs. Therefore, we propose that the outcome 
measures assessment occur at least every year and be based on data from 
the most recent 12 months of data from the state death certificates. 
OPOs that are flagged as having donation rates or organ transplantation 
rates that are statistically significantly less than the threshold 
rates established by the top 25 percent of OPOs are expected to take 
actions to improve their performance and include the specific actions 
that they will undertake to improve their outcome measures in their 
QAPI program. Currently, OPOs receive data on their performance from 
the SRTR every six months, so our proposed methodology would not 
provide assessments as frequently. But, this approach could provide for 
a continuous assessment of OPO performance and allow for more 
responsive performance improvement actions from low performers because 
of

[[Page 70638]]

the role of the QAPI program. In the spirit of transparency, we intend 
make these outcome measures public at each assessment.
    Although the assessments would occur at least once every 12 months, 
no OPO may be de-certified until the end of the re-certification cycle, 
except in cases of urgent need.\23\ We are proposing to use the most 
recent prior 12 months of data at the last assessment cycle before re-
certification to be the basis for de-certification. The reason we are 
proposing to use only the prior 12 months of data is that we do not 
want to penalize an OPO who has made legitimate and successful efforts 
to improve their performance by including the older data, nor do we 
want to reward an OPO whose recent performance has fallen to be able to 
rely on past performance as the basis for a subsequent four-year re-
certification. In the past, we have used 36 months of data to determine 
re-certification, so we are seeking comments on the use of the shorter 
length of data as opposed to all the data during the re-certification 
cycle. Although using the longer period of time would include data that 
does not reflect the OPO's current status, it would allow OPOs who had 
been performing adequately through most of the four-year cycle to 
remain certified even if they had a lapse in performance at the last 
cycle. We are also seeking comments on other approaches to use the data 
to identify high-performing OPOs for re-certification.
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    \23\ The Organ Procurement Organization Certification Act of 
2000 changed the re-certification cycle from every 2 years to every 
4 years; Sec.  486.312(d) and Sec.  486.302 states that CMS can give 
written notice of de-certification in cases of urgent need and 
defines urgent need as occurring when an OPO's noncompliance with 
one or more conditions for coverage has caused, or is likely to 
cause, serious injury, harm, impairment, or death to a potential or 
actual donor or an organ beneficiary.
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    After considering public comments and finalizing this rule, we 
expect to begin calculations of the outcomes measures before the 
beginning of the next re-certification cycle in 2022. We are requesting 
comments on this proposed change to the applicability of the outcome 
measure requirements for the cycle beginning in 2022 and ending in 
2026.

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

    QAPI requirements for OPOs were first established in 2006 (71 FR 
31054). OPOs are required to develop, implement, and maintain a 
comprehensive, data-driven QAPI program designed to monitor and 
evaluate performance of all donation services, including services 
provided under contract or arrangement under Sec.  486.348. In 
addition, an OPO's QAPI program must include objective measures to 
evaluate and demonstrate improved performance with regard to certain 
OPO activities, and the OPO must take actions that result in 
performance improvements and track performance to ensure that 
improvements are sustained.
    A QAPI program is an important, data driven process that allows 
health care entities to assess their functioning continuously and make 
changes to improve their quality and efficiency over time. Since we are 
proposing to revise the outcome measure requirements at Sec.  486.318 
and the re-certification process at Sec.  486.316, we believe that OPOs 
should also be required to include a process to address and improve 
poor performance on their outcome measures as part of their QAPI 
program. We currently do not have such a requirement for an OPO's QAPI 
program, but because OPOs are re-certified every 4 years, it is 
important that OPOs continuously strive to improve outcomes over the 
course of the re-certification cycle. An OPO's QAPI program provides a 
process to achieve these improvements. We, therefore, are proposing to 
require that OPOs include a process to evaluate and address their 
outcome measures in their QAPI program if their rates are statistically 
significantly lower than the top 25 percent at each assessment, for 
each assessment period except the final assessment. Failure to meet the 
outcome measure in the final assessment period would result in de-
certification. For all other assessment periods, if the OPO does not 
meet the outcome measures, the OPO must identify opportunities for 
improvement and implement changes that lead to improvement in these 
measures.
    As we have previously described in this proposed rule, we are 
proposing that an OPO's performance on the outcome measures be assessed 
at least every 12 months, based on the most recent prior 12 months of 
data. We would expect OPOs to use the data that are obtained from each 
assessment to drive changes to their QAPI program in order to improve 
their performance on the outcome measures. If proactive changes are 
made early in the re-certification cycle, an OPO would be able to begin 
to address poor performance on the outcome measures early in the re-
certification cycle and prior to the re-certification determination. We 
are additionally interested in whether the QAPI process is sufficiently 
robust to capture year over year improvements, as well as other 
quantitative factors that may not be captured in our proposed outcome 
metrics. As such, we encourage commenters to consider ways the QAPI 
process may be modified or enhanced to better assess OPO performance 
relative to past performance and to other OPOs. As proposed in this 
rule, an OPO that was deemed compliant on its QAPI, but did not meet 
one or both of the proposed outcome measures would be subject to 
decertification.

E. Solicitation of Comments

    In addition to our requests for comments throughout the preamble, 
we are specifically seeking the public's input on the following 
questions:
     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 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 centers, organ donation, patient 
access, and transplant recipients?
     Are there potential additional compliance burdens on OPOs 
or transplant centers if the two proposed measures were finalized? 
Please explain.
    In Sec.  486.316(c)(3), we require an OPO to compete for an entire 
service area as a criterion to compete for an open service area. At 
this time, we are not proposing to change this requirement but would 
like comments as to whether we should consider revising this subsection 
and redefining the open service area for competition. Although we have 
proposed eliminating the definition of ``eligible deaths,'' we have not 
proposed to remove the requirement that OPOs conduct monthly death 
record reviews. We are seeking comments as to whether Sec.  486.348(b)

[[Page 70639]]

should be revised or removed altogether to eliminate such reviews. 
Please include justifications and explanations in your comments.
    We encourage detailed comments that answer all of the 
aforementioned questions. Additionally, in the RIA, Section G: 
Alternatives considered, we discuss a number of different alternatives 
that we are actively considering. These alternatives examine different 
type of denominators, different statistical confidence intervals for 
calculations, and different threshold rates for assessment. We are 
actively considering these policy alternatives and are seeking comments 
on them.

III. 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 are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):

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

    At Sec.  486.316(b), we are proposing to modify language that 
refers to the current outcome measure requirements that states that an 
OPO must meet two out of the three outcome measures at Sec.  486.318. 
They would instead be required to meet both newly proposed outcome 
measures, or face de-certification which may then be appealed by the 
OPO. If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area would be opened for competition 
by other OPOs.
    The current information collection request for the OPO CfC (OMB 
Control Number 0938-0688, Exp. February 2021) estimates that one OPO 
would face de-certification per year, and under the proposed outcome 
measures, this number would have potential to increase. We do not know 
exactly how many would be de-certified under these new measures; 
however, based on the improvement required to meet the proposed 
measures it is possible that approximately 7 to 33 OPOs could be de-
certified. Assuming some number of these de-certifications are upheld, 
their respective service areas would be opened for competition.
    Under Sec.  486.316(b), 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. In addition, Sec.  486.316(c) states 
that to compete for an open service area, an OPO must meet the 
performance requirements of the outcome measures at Sec.  486.318 and 
the requirements for certification at Sec.  486.303, including the 
conditions for coverage at Sec. Sec.  486.320 through 486.348. The OPO 
must also compete for the entire service area.
    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 will refer to this documentation as a plan.
    Based on historical data and our previous experience with the OPOs, 
we would expect a total of nine OPOs will want to compete for a new 
service area and three of those OPOs may want to compete for more than 
one service area. Thus, we believe there will be a total of 12 plans 
that will need to be developed for the competition process.
    We believe that developing each plan 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 a plan, we estimate each competition would require 1,248 
burden hours for all 9 OPOs to complete 12 plans and would cost all 9 
OPOs $79,416 (($71 RN x 30 hours x 9 OPOs) + ($71 organ procurement 
coordinator x 30 hours x 9 OPOs) + ($107 medical director x 12 hours x 
9 OPOs) + ($107 OPO director x 30 x 9 OPOs) + ($35 medical secretary x 
2 hours x 9 OPOs)). 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 9 
OPOs to prepare 12 plans would be 312 (1,248/4) and the annual cost 
estimate would be $19,854 ($79,416/4).

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

    We are proposing to revise Sec.  486.318 to eliminate the reporting 
of the ``Number of eligible deaths'' and modify the reporting of 
``Number of eligible donors'' to ``Number of donors.'' Although the 
current outcome measures include the potentially burdensome OPO self-
defined and self-reported ``eligible deaths'' for evaluation purposes, 
the current information collection request for the OPO requirements 
(OMB Control Number 0938-0688, Exp. February 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 (42 CFR 
121). Thus, we are not attributing any quantifiable burden reduction to 
this proposed change.

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

    At Sec.  486.348(d) we are proposing 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. Assessments would occur at least 
every 12 months with the most recent prior 12 months of available data, 
meaning there would be 3 assessments in each 4 year re-certification 
cycle that might require modifications to an OPO's QAPI program.
    As stated in the information collection request for the OPO 
requirements (OMB Control Number 0938-0688, Exp. February 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 
proposed change would

[[Page 70640]]

impose any additional ongoing quantifiable burden.
    If you comment on these information collection, that is, reporting, 
recordkeeping or third-party disclosure requirements, please submit 
your comments electronically as specified in the ADDRESSES section of 
this proposed rule.
    Comments must be received on/by February 21, 2020.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Regulatory Impact Analysis

A. Statement of Need

    All major government regulations should undergo periodic review to 
ensure that they do not unduly burden regulated entities or the 
American people, and that they accomplish their goals effectively and 
efficiently. It has been apparent for a number of years that the 
current system for organ donation and the rules under which OPO 
performance is measured do not create the necessary incentives to 
optimize organ donation and transplantation as evidenced by performance 
discrepancies among OPOs, the wide geographic and population diversity 
among both higher- and lower-performing OPOs, and the significant gap 
between the number of potential organ donors and the number of actual 
donors (see the following Tables 3 and 4). Recent article titles tell 
the story as well: ``Reforms to Organ Donation System Would Save 
Thousands of Lives, Millions of Taxpayer Dollars Annually,'' ``Lives 
Lost, Organs Wasted,'' and ``A Simple Bureaucratic Organ Donation Fix 
Will Save Thousands of Lives.'' \24\ 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 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 and 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.''
---------------------------------------------------------------------------

    \24\ 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.
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    We note that the Secretary recently issued a final rule to reduce 
regulatory burden on several types of health care providers (``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, September 30, 2019) that 
directly addresses 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 and allowing transplantable organs to be discarded and sicker 
patients to die without a transplant. Those performance standards 
rewarded very high one-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 
regulatory impact analysis (RIA) for CMS-3346-F, there is the potential 
for regulatory reform to reduce the number of ``transplant quality'' 
discarded organs, and through transplantation of those organs, save the 
lives of many patients each year.
    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 applies directly 
to this proposed rule.

B. Scope of Review

    We have examined the impacts of this proposed 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), 
E.O. 13132 on Federalism (August 4, 1999), the Congressional Review Act 
(5 U.S.C. 804(2)) and E.O. 13771 on Reducing Regulation and Controlling 
Regulatory Costs (January 30, 2017).
    E.O. 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 E.O. 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 E.O.
    An RIA must be prepared for major rules with economically 
significant effects ($100 million or more in any one year). We estimate 
that this rulemaking is ``economically significant'' as measured by the 
$100 million threshold, and hence also a major rule under the 
Congressional Review Act. Accordingly, we have prepared an RIA that to 
the best of our ability presents the costs and benefits of this 
rulemaking.

C. Effects on OPO Performance

    We are proposing two new outcome measures that would be used to 
assess an OPO's performance: A measure of an OPO's donation rate and 
organ

[[Page 70641]]

transplantation rate. Table 3 shows current performance using the 
donation rate outcome measure that we propose derived from data 
spanning January 1, 2017 to December 31, 2017. The number of potential 
donors is similar to the measure used in the current regulatory 
provisions (on numbers of deceased persons that potentially qualify as 
organ donors, but the proposed measure would be nationally 
standardized, using an objective data source); however, the performance 
variable 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 task 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, kidneys, intestine, and pancreata (those transplanted or sent 
for research) count towards this measure of success.
    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. We 
are also including, in the Appendix, a map for each proposed measure 
that depicts geographic trends in performance. In a few cases in the 
tables below, we have abbreviated an OPO name to improve simplicity of 
presentation. For a complete OPO listing and additional information, 
see the following link: https://optn.transplant.hrsa.gov/members/member-directory/?memberType=Organ%20Procurement%20Organizations.\25\ 
These tables show the performance required of each OPO to reach the 
proposed 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 (Wilson and Hilferty 1931, Breslow 
and Day 1987, Kulkarni and Hemangi 2012) is used to calculate the 
confidence interval for the transplant rate of each OPO.
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    \25\ Some of these OPOs have changed names in recent years, so 
some other published lists may be out of date. However, the codes 
shown in parentheses in our tables have not changed.
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    We are committed to using all 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 proposed metrics.
BILLING CODE 4120-01-P

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    Table 4 shows the current range of organ transplantation 
performance, using the new proposed 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.\26\ According to the NCHS, there 
are about 2.8 million deaths each year in the U.S., but the potential 
donor pool is far lower because it only includes those who die in 
hospitals, who are age 75 or less, and who have no contraindications to 
donation (such as metastatic cancers). Table 4 shows that organ 
transplantation rates range from 19.44 at the highest levels to 4.47 
(using data from calendar year 2017), a range of about four to one from 
highest to lowest. The top one-fourth of OPOs achieve rates above 12 
donors/100 inpatient deaths, more than double the rates of many lower 
performing OPOs. The top-performing OPOs are geographically and 
demographically diverse, with potential donor pools ranging from about 
2,000 deaths a year to almost 10,000 a year. We recognize that some 
OPOs have fewer transplant programs within their service areas than 
others, but allocation policies allow OPOs to place organs outside 
their DSA. The organ match run, which lists all potential recipients 
for a donated organ, includes eligible patients on the waiting list for 
that particular organ and organs are often offered to hospitals outside 
of the DSAs in which the organs were procured.
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    \26\ These results would look similar if we used the current 
estimates of ``eligible'' deaths but would be an imperfect 
comparison since that is not a standardized measure.

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[GRAPHIC] [TIFF OMITTED] TP23DE19.027

BILLING CODE 4120-01-C
    Both proposed outcome measures 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 the 
entire pool of possible donors (not the pool as determined separately 
by each OPO); (4) they adjust for the geographic 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 would 
replace the non-standardized criteria for ``eligible'' donors as 
determined by each OPO. The existing denominator standard allows OPOs 
to exclude from the calculated potential donor pool those cases where 
the next-of-kin did not authorize donation, a crucial task we believe 
all OPOs should be effective and continually improving at. For an 
extensive discussion of these and related issues, see ``Changing 
Metrics of Organ Procurement Organization Performance in Order to 
Increase Organ Donation Rates in the United States.'' \27\ The proposed 
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.\28\ Regardless, it is our belief that the untapped donor and 
organ potential is sufficiently large in every DSA so that every OPO 
has

[[Page 70648]]

both potential donors, organs, and transplant recipients to exceed its 
current performance level.
---------------------------------------------------------------------------

    \27\ Goldberg D, et al, ``Changing Metrics of Organ Procurement 
Organization Performance in Order to Increase Organ Donation Rates 
in the United States,'' AmJTransplant 2017; 17:3183-3192.
    \28\ Adler, et al ``Is Donor Service Area Market Competition 
Associated with Organ Procurement Organization Performance?'' 
Transplantation 2016; 100; 1349-1355.
---------------------------------------------------------------------------

    Tables 3 and 4 also show a very important quantitative result: At 
present, there are about 10,000 deceased donors a year, which is only 
about three percent of the 272,000 potential donors in 2017. 
Importantly, the proposed criteria for potential donors already exclude 
many deaths, and focus on decedents with greater potential to provide 
transplantable organs. Hence, all OPOs will have a pool of potential 
donors many times higher than the number of donors and organs needed to 
meet the proposed performance standards.
    If the number of donors at the lower-performing OPOs were to reach 
what is now the 75th percentile of achievement, the number of donors 
would increase by over one thousand by the end of the four-year 
performance period. Both through this increase, and greater success in 
maximizing the number of organs actually transplanted from each donor, 
achieving the 75th percentile for the transplant rate would increase 
the number of such transplants from about 32,000 by as many as 6,000 by 
2024, and by as many as 10,000 by 2026, for a total of about 42,000 in 
that year (see Table 12). Achieving higher success rates would be 
unlikely to occur in just the lower performers, and these estimates 
assume improvements at all current levels of performance as better 
techniques and methods are identified and widely adopted. 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 OPOs. There may be future 
improvements as well, but our estimates do not assume any major 
breakthroughs will be routinely available in the near term. In 
September 2019, the National Institutes of Health reported that a new 
method of preserving livers for transplantation would potentially 
increase the viability of livers from nine to 27 hours, but this is 
still in a development stage.\29\ Our estimates in Tables 5 and 6 
assume that all OPOs would achieve either the 75th percentile targets, 
or increase performance on both measures by 20 percent, whichever is 
greater.
---------------------------------------------------------------------------

    \29\ https://www.nih.gov/news-events/news-releases/scientists-triple-storage-time-human-donor-livers.
---------------------------------------------------------------------------

    Nothing guarantees that all OPOs will manage to meet the standards 
if finalized as proposed. But, the administrative steps we propose to 
take, the periodic assessments, and the incentives for an OPO to 
maintain certification at the end of the four-year evaluation period 
will provide both means and incentives for all OPOs to meet or exceed 
our proposed standards. Furthermore, there is no need to wait until the 
end of the four-year period to take action regarding any OPOs that are 
underperforming. With continuous assessment and public disclosure of 
the information, OPOs who cannot achieve the outcome measures may 
decide to voluntarily de-certify and allow a high-performing OPO to 
take over the DSA, even before the end of the re-certification cycle or 
form a partnership with a high-performing OPO and allow that OPO to 
take over the management of the DSA. Our low-end cost and performance 
calculations assume that this could be avoided through adoption of 
proven techniques and improved leadership and management by lower-
performing OPOs, because careful planning and implementation of de-
certification and OPO replacement actions could ease such transitions. 
The new proposed outcome measures and performance expectations will 
give each OPO both the opportunity and market incentives to assess its 
performance and motivate the widespread adoption of best practices.
    While we cannot predict future achievement levels, we have 
developed a hypothetical scenario that we believe is likely to nearly 
achieve HHS' 2030 target in 2026 (with 4 years remaining to attain that 
goal) and that we can use in estimating benefits and costs while 
allowing for either higher or lower results. In Tables 5 and 6, we show 
the results of all OPOs achieving the minimum performance requirements, 
or improving by 20 percent, whichever is greater, by 2026. These 
projections are estimates and are 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 when the 
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 
will ultimately facilitate the utilization of the large number of 
discarded, but transplantable, organs. In assessing this 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 74, but the vast majority of them 
could provide organs of transplant quality if donated. 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.\30\ With advances in 
successful utilization of organs from older donors, we believe the 
upward potential for both donation and transplantation is higher than 
shown in tables 5 and 6.
---------------------------------------------------------------------------

    \30\ Organ donors <50 make up approximately 67 percent of 
donors, but make up less than 10 percent of deaths.
---------------------------------------------------------------------------

    Table 5 shows all OPOs achieving the minimum standard, or a 20 
percent increase, whichever is greater. With these parameters, the 
number of annual donors would rise from about 10,000 in 2017 to over 
12,000 by 2026.
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    Table 6 shows a similar magnitude of change for rates of 
transplantation. It shows an increase in the number of transplants, and 
a performance of achieving the minimum standard, or a 20 percent 
increase, whichever is greater. With these parameters, the number of 
annual transplants would rise from about 32,000 in 2017 to almost 
42,000 by 2026. (By contrast, Table 4 shows that, in isolation, 
achievement of the proposed minimum standard would yield 4,903 
additional transplants per year, roughly half the 9,474 [= 41,647-
32,173] implied by Table 6.)

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    While there is no certainty that these or higher levels of 
performance will be realized, there is additional evidence beyond the 
known performance levels of the higher-achieving OPOs. A recent study 
compared French and American organ utilization in the period from 2004 
to 2014.\31\ This study showed that the discard rate for kidneys from 
deceased donors was about nine percent in France and 18 percent in the 
U.S. The lower discard rate reflected a far greater use in France of 
kidneys from older donors that had inferior ``kidney donor risk index'' 
(KDRI) scores. The mean age of donor kidneys in France was 51 years and 
in the U.S., 37 years. Despite the higher use of seemingly less 
desirable organs, the study estimates that had the U.S. used French 
practices, there would have been about 132,000 additional years of 
graft (and patient) survival in the U.S. While most European countries 
use mandatory nation-wide ``opt-out'' rather than ``opt-in'' policies 
and hence more strongly encourage organ donation than in the U.S. 
(where no states use ``opt-out''), a recent study shows that this 
policy does not explain European success rates and that many American 
states have organ donation rates higher than many European 
countries.\32\ 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,

[[Page 70655]]

without penalizing transplant programs for the lower success rates that 
inevitably result.\33\ These results strongly suggest that with the 
regulatory penalties removed on transplant centers that do not achieve 
the highest possible one-year graft and patient survival outcomes (as 
discussed in the proposed rule, ``Medicare and Medicaid Programs; 
Regulatory Provisions To Promote Program Efficiency, Transparency, and 
Burden Reduction'' 83 FR 47686) and with the greater accountability for 
OPO performance proposed in this rule, performance results such as 
those achieved in France could be achievable in the U.S.
---------------------------------------------------------------------------

    \31\ Olivier Aubert et al, ``Disparities in Acceptance of 
Deceased Donor Kidneys Between the United States and France and 
Estimated Effects of Increased U.S. Acceptance,'' JAMA Intern Med. 
Doi:10:1001/jamainternmed.2019.2322.
    \32\ Alexandra Glazier and Thomas Mone, ``Success in Opt-In 
Organ Donation Policy in the United States,'' August 8, 2019, 
doi:10.1001/JAMA.2019.9187.
    \33\ See Olivier Aubert, et al.
---------------------------------------------------------------------------

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 set forth 
in the ``Implementation and Continuing Costs'' subsection; such low 
magnitudes are plausible primarily if OPO decertification is very rare. 
Without a credible threat of decertification, 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 below in Tables 11R and 12R).
    An opposite case is one in which decertification is common, thus 
motivating OPO behavior change and making non-negligible benefits 
plausible. OPOs undergoing management change would experience 
transition costs that are substantial (although difficult to quantify). 
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.
    1. Effects on Medical Costs. In the estimates that follow, we rely 
primarily on recent estimates by staff of the actuarial and consulting 
firm Milliman. Their study, ``2017 U.S. Organ and Tissue Transplant 
Cost Estimates and Discussion'' compares charges before, during, and 
after transplantation for all major and minor categories of 
transplant.\34\ The advantage of these estimates for our purposes is 
that they cover the pre-, intra-, and post-transplant costs on all 
organs using a consistent cost-estimating methodology. Unfortunately, 
accurate medical cost estimates are not publicly available from health 
insurance firms, since the network discounts received by private firms 
are generally treated as trade secrets, and Medicare's payments are 
typically not based directly on costs (with some exceptions, including 
payments to OPOs). Hence, Milliman uses ``charges'' for its estimates. 
As with likely excess of charges over costs, there's a netting off of 
non-transplantation costs--that is, costs associated with organ failure 
that are not affected by transplantation itself. For estimating 
purposes, we assume that these divergences between costs and charges 
largely cancel each other out, but that the net effect is that actual 
costs are about 20 percent less than the Milliman charge estimates.
---------------------------------------------------------------------------

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

    In analyzing the medical costs of the proposed 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 7 shows the data for hearts:

                                Table 7--First Year Cost per Heart Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                                                      Immuno-
                                     Milliman      Likely excess  Assumed non-TX    suppressive   Net transplant
              Heart                   charge        of charges         costs        drugs (six         cost
                                     estimate       over costs                        months)
----------------------------------------------------------------------------------------------------------------
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 7, 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 8--First Year Cost per Liver Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                                                      Immuno-
                                     Milliman      Likely excess  Assumed non-TX    suppressive   Net transplant
              Liver                   charge        of charges         costs        drugs (six         cost
                                     estimate       over costs                        months)
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................         812,000         143,000          80,000          15,000         604,000
----------------------------------------------------------------------------------------------------------------


[[Page 70656]]

    Table 8 shows the estimated average cost for a liver transplant, 
estimated on the same basis. Table 9 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 9--First Year Cost per Kidney Transplant ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Immuno-
                                             Milliman      Likely excess  Assumed non-TX    suppressive   Net transplant      Annual      Net first year
                 Kidney                       charge        of charges         costs        drugs (six     cost subtotal  dialysis costs       cost
                                             estimate       over costs                        months)                         avoided
--------------------------------------------------------------------------------------------------------------------------------------------------------
30 days pre-transplant..................          30,000         (6,000)        (10,000)               0          14,000               0          14,000
Procurement.............................          97,000               0               0               0          97,000               0          97,000
Hospital Transplant Admission...........         159,000        (32,000)               0               0         127,000               0         127,000
Physician During Admission..............          25,000         (5,000)               0               0          20,000               0          20,000
180 Days Medical Post Discharge.........          75,000        (15,000)        (60,000)               0               0      * (90,000)        (90,000)
180 Days Drugs Post Discharge...........          29,000         (6,000)        (10,000)          15,000          28,000               0          28,000
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................         415,000        (64,000)        (80,000)          15,000         286,000        (90,000)         196,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Estimated annual dialysis costs.

    Using these results, it is possible to estimate the extended 
effects of added and reduced costs over time. In Table 10 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 save money for the patients who survive the 
full 5-year period.

                          Table 10--Five Year Costs per Weighted Average Transplant ($)
----------------------------------------------------------------------------------------------------------------
                                                                                                     All three
                                                       Heart           Liver          Kidney          organs
                                                                                                     weighted
----------------------------------------------------------------------------------------------------------------
Annual Percent of Total TX......................             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 four-year OPO performance 
period would be essential in order to have enough growth in the second 
half of the decade to meet the HHS' 2030 goal of doubling the number of 
kidneys available for transplants. As Table 11 shows, that will require 
multi-billion dollar increases over current transplant spending levels 
by the middle of the next 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 
proposed rule are reimbursed by private payers, not 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, such as increasing the number of living donors, 
avoiding penalizing transplant programs for using kidneys with lower 
likelihood to transplantation success, and improving techniques for 
maintaining organs during the time before transplantation to reduce 
discards of organs shared outside the DSA, the main approach for 
achieving this ambitious goal is to increase the number of deceased 
donors. This will require continuing improvements over time, and we 
have estimated the approximate numbers that would have to be achieved 
in the next four-year OPO performance period to move about half way 
towards an annual increase of approximately 20,000 more kidneys 
available and (assuming a reduction in discard rates) approximately 
16,000

[[Page 70657]]

more kidney transplants by 2030, as shown in Table 11.
    In Tables 11 and 12 we show the annual results as each cohort of 
new transplants arrives over the OPO performance period from 2021 to 
2025. These estimates include totals for all organs since one deceased 
donor normally provides multiple organs. The 10,000 increase shown for 
2025 includes about 6,500 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 for 2026 that shows the 
effects of these same cohorts alone in the sixth year. 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 11--Costs Over Time as Organ Transplants Hypothetically Increase
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                         2021            2022            2023            2024            2025                    2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase Over Base Year in Number                  1,000           3,000           6,000           8,000          10,000  Same Cohorts
 Transplants.
Costs for 2021-2 Cohort.................            $388           ($29)           ($29)           ($29)           ($29)  ($29)
Costs for 2022-3 Cohort.................  ..............          $1,164           ($86)           ($86)           ($86)  ($86)
Costs for 2023-4 Cohort.................  ..............  ..............          $2,327          ($173)          ($173)  ($173)
Costs for 2024-5 Cohort.................  ..............  ..............  ..............          $3,103          ($230)  ($230)
Costs for 2025-6 Cohort.................  ..............  ..............  ..............  ..............          $3,879  ($288)
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................            $388          $1,135          $2,212          $2,815          $3,360  ($806)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 great bulk of the 
procurement costs are paid to OPOs and finance not only direct 
involvement with donor families and donations, but also management and 
direction of the OPO.
    Our estimates also do not include costs of changes in treatment 
options for both liver and heart patients, including new drug 
treatments for hepatitis C, one of the main causes of liver failure, 
and heart assist devices that can serve as a bridge while waiting for a 
heart transplant.
    Table 11R shows estimates using the same per-transplant inputs but 
with aggregates reflecting the 4,903 new annual transplants shown in 
Table 4; impacts are assumed to begin in 2023 because existing OPO 
contracts run through 2022, thus preventing any decertification before 
then. (We note that a steady new transplant level may be an 
oversimplification because the proposed policy, setting a threshold at 
the 75th percentile performance amongst OPOs, could lead to a continual 
ratcheting of the performance necessary for compliance, and we request 
comment that would allow for such year-to-year changes to be reflected 
in our analysis.) These estimates feed into the upper bound estimates 
that appear in the accounting statement (Table 19), below.

                                                Table 11R--Costs Over Time as Organ Transplants Increase
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                         2021            2022            2023            2024            2025                    2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase Over Base Year in Number                      0               0           4,903           4,903           4,903  Same Cohorts
 Transplants.
Costs for 2023-4 Cohort.................  ..............  ..............          $1,902          ($142)          ($142)  ($142)
Costs for 2024-5 Cohort.................  ..............  ..............  ..............          $1,902          ($142)  ($142)
Costs for 2025-6 Cohort.................  ..............  ..............  ..............  ..............          $1,902  ($142)
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................              $0              $0          $1,902          $1,760          $1,618  ($427)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    2. Effects on Patients. Every organ that is used for 
transplantation has a very high probability of substantially extending 
the life of the recipient. There is extensive literature on life 
expectancy before and after transplant, quality of life, and cost 
savings for kidney 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 have reached similar conclusions, as have 
other syntheses. For example, in the article, ``Systematic Review: 
Kidney Transplantation Compared with Dialysis in Clinically Relevant 
Outcome,'' the authors reviewed 110 studies and

[[Page 70658]]

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 and about 29 for transplant recipients (see 2018 
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). There are similar data on other organs. 
For example, in 1998, HHS published a final rule with comment period 
that established governance procedures for the OPTN (63 FR 16296). In 
the RIA for that rule, HHS estimated that ``the annual benefits of 
organ transplantation include about eleven thousand lives vastly 
improved by kidney transplantation, and another eight thousand lives 
both vastly improved and prolonged by transplantation of other major 
organs'' (63 FR 16323).
---------------------------------------------------------------------------

    \35\ Huang, E, et al,''The Cost-Effectiveness of Renal 
Transplantation,'' When Altruism Isn't Enough, edited by Sally Satel 
(AEI Press, 2008).
    \36\ Tonelli M, et al, AmJTransplant 2011: 2093-2109.
---------------------------------------------------------------------------

    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.\37\ Using the more usual metric of survival rates, the five-
year survival rate for kidney transplant patients is 86 percent 
(Milliman, page 13).
---------------------------------------------------------------------------

    \37\ Wolfe RA et al, ``Comparisons of Mortality in All Patients 
on Dialysis, Patients on Dialysis Awaiting Transplantation, and 
Recipients of a First Cadaveric Transplant,'' NEJM, 1999, 341:1725-
30; accessed at https://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article).
---------------------------------------------------------------------------

    HHS ``Guidelines for Regulatory Impact Analysis'' explain in some 
detail the concept of QALYs.\38\ QALYS, when multiplied by a monetary 
estimate such as the Value of a Statistical Life Year (VSLY), are 
estimates of the value that people are willing to pay for life-
prolonging and life-improving health care interventions of any kind 
(see sections 3.2 and 3.3 of the HHS Guidelines for a detailed 
explanation). The QALY and VSLY amounts used in any estimate of overall 
benefits, including this one, is not meant to be precise estimates, but 
instead are rough statistical measures that allow an overall estimate 
of benefits expressed in dollars.\39\
---------------------------------------------------------------------------

    \38\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
    \39\ Using such a measure to make coverage or reimbursement 
determinations is prohibited by Section 1182(e) of the Act. That 
prohibition does not apply to the situation addressed in this 
proposed rule, where the purpose is not to determine medical 
coverage for individual patients, but to measure overall success in 
raising the number of persons who obtain life-saving treatments.
---------------------------------------------------------------------------

    Table 12 provides estimates of the life-extending and life-
improving value of the proposed rule assuming that it succeeds in 
improving OPO performance in early years at the magnitudes necessary to 
meet the 2030 HHS goal. For simplicity, we estimate that transplants 
occur halfway through the year.

                        Table 12--Life-Extending and Improving Benefits Over First 5 Years as Transplants Hypothetically Increase
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                         2021            2022            2023            2024            2025                    2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase Over Base Year in Number                  1,000           3,000           6,000           8,000          10,000  Same Cohorts.
 Transplants.
2021-2 Cohort...........................             $94            $187            $187            $187            $187  $187.
2022-3 Cohort...........................  ..............            $281            $562            $562            $562  $562.
2023-4 Cohort...........................  ..............  ..............            $562          $1,123          $1,123  $1,123.
2024-5 Cohort...........................  ..............  ..............  ..............            $749          $1,497  $1,497.
2025-6 Cohort...........................  ..............  ..............  ..............  ..............            $936  $1,872.
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................             $94            $468          $1,310           $2620          $4,305  $5,241.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    This table 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 ten year period, total 
life extending benefits from about 18,000 additional kidney transplants 
would be $23 billion (without discounting) from the 2021 to 2025 
cohorts of additional transplants shown in Table 12 (28,000 organs 
times 65 percent of which are kidneys times \2/3\ patient survival rate 
times $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 ten years, 
with even more years of benefits to most of the same recipients yet to 
come.\40\
---------------------------------------------------------------------------

    \40\ This method of calculating the value of kidney 
transplantation is similar to but substantially simplified from the 
method used in P.J. Held et al, ``A Cost-Benefit Analysis of 
Government Compensation of Kidney Donors,'' American Journal of 
Transplantation, 2016, pages 877-885 (plus 65 pages of supplementary 
details explaining all assumptions, data sources, and calculations). 
Factors for Hearts and Livers come from Elisa F. Long et al, 
``Comparative Survival and Cost-Effectiveness of Advance Therapies 
for End-Stage Heart Failure,'' https://circheartfailiure.ahajournals.org, April 7, 2017; and Fredrik Aberg 
et al, ``Cost of a Quality-Adjusted Life Year in Liver 
Transplantation: The Influence of the Indication and the Model for 
End-Stage Liver Disease Score,'' Liver Transplantation 17:1333-1343, 
2011.
---------------------------------------------------------------------------

    We note that these estimates are averages across patients who vary 
widely in age, medical condition, and life expectancy, as well as type 
of organ failure. For example, the sickest patients typically have very 
low life expectancies without transplant, and hence stand to gain the 
most years of life from a transplant. Offsetting this, 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 previously marginal organs, and in 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

[[Page 70659]]

purposes of this analysis, the proper measure is the average gain 
across all patients who would receive transplants in the presence of 
the proposed rule but not in its absence.
    Table 12R shows estimates using the same per-transplant inputs but 
with aggregates reflecting the 4,903 new annual transplants shown in 
Table 4; increases are assumed to begin in 2023 because existing OPO 
contracts run through 2022, thus preventing any decertification before 
then. (We note that a steady new transplant level may be an 
oversimplification because the proposed policy, setting a threshold at 
the 75th percentile performance amongst OPOs, could lead to a continual 
ratcheting of the performance necessary for compliance, and we request 
comment that would allow for such year-to-year changes to be reflected 
in our analysis.) These estimates feed into the upper bound estimates 
that appear in the accounting statement (Table 19), below.

                               Table 12R--Life-Extending and Improving Benefits Over First 5 Years as Transplants Increase
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                         2021            2022            2023            2024            2025                    2026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase Over Base Year in Number                      0               0           4,903           4,903           4,903  Same Cohorts.
 Transplants.
Costs for 2023-4 Cohort.................  ..............  ..............            $461            $917            $917  $917.
Costs for 2024-5 Cohort.................  ..............  ..............  ..............            $461            $917  $917.
Costs for 2025-6 Cohort.................  ..............  ..............  ..............  ..............            $461  $917.
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................              $0              $0            $461          $1,378          $2,295  $2,751.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Implementation and Continuing Costs. The requirements of the 
final rule, if issued, would necessarily have to be read, understood, 
and implemented by all OPOs. This would create one-time costs even 
though the proposed requirements would not directly create unreimbursed 
cost burdens. In many cases, these costs would be very low, and may be 
as simple as learning where the OPO stands in relationship to other 
facilities in meeting the new performance standards. In some cases, the 
OPO would need to significantly adjust its procedures and techniques. 
In still other cases, time would have to be spent deciding how to 
change existing policy and procedures. These effects would be felt 
primarily by the 58 OPOs, but secondarily by the approximately 750 
transplant programs in about 250 transplant hospitals. Many of these 
hospitals would need to respond if OPOs implement new technologies or 
procedures to optimize their performance. These costs, however, are 
part of the acquisition costs associated with organ procurement and 
would be paid by Medicare and other health insurers. 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. We welcome comments on our 
estimates as to skills and occupations involved, and time likely to be 
spent.
    In total, there are about 800 affected entities or programs. We 
assume that on average there would be one hour of time spent by a 
lawyer, two 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, 
two 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, at https://www.bls.gov/oes/current/oes_nat.htm#23-0000.
    We assume that on average, an OPO would involve one person in each 
occupation and an average of eight hours on an interdisciplinary team 
tasked with learning the new rules, understanding their implications 
for that OPO, and initiating plans to address performance levels. Total 
costs, on average, would be $139 plus $109 plus $89 plus $73 plus $56 
plus $203, for a total of $669 per hour and $5,352 (8 x $669) for eight 
hours. For the 58 OPOs, the first-year cost would therefore be about 
$310,000 (58 x $5,352). A somewhat different mix of occupations would 
lead to a similar total cost. For transplant programs, we assume that 
only half as many hours would be needed, using a similar mix of 
occupations, for a total of $669 per hour and $2,676 ($669 x 4) for 
four hours. For 750 transplant programs the total first year cost would 
therefore be about $2,007,000 ($2,676 x 750).
    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. These procurement costs are 
included in the cost estimates shown in Tables 7 to 9 and summarized in 
Tables 10 and 11, 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 procurement 
grows, there would be two significant effects. First, there are 
economies of scale as OPOs and hospitals expand their donor-related and 
transplant services. Second, and more than offsetting such gains, 
substantial improvements over time would require additional efforts. 
Some OPOs would also likely incur additional costs as they consider and 
in some cases prepare for such actions as mergers or replacements. For 
both cost savings and cost increases, effects are primarily from 
staffing changes; we assume there are relatively few fixed investments 
in plant and equipment. And in both cases, current reimbursement 
policies and programs pay for all reasonable costs. We welcome comments 
and if possible, data on these and other workload, cost, and revenue 
issues and estimates.

[[Page 70660]]

    We do not expect substantial costs would be incurred by CMS. The 
data collection required for enforcement of the proposed standards 
already exists and can readily be used to assess performance. OPOs are 
already reviewed and assessed on a continuing basis. There would be 
additional costs for technical assistance and possibly more severe 
actions regarding any OPOs with major compliance problems, or increased 
appeals related activities, but 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. Regardless, 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 disruptive process of 
decertification. We request comment that would inform estimates of this 
category of costs.

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. Relatively few are Medicare 
patients. This is because these patients are overwhelmingly below age 
65 and ineligible for Medicare unless disabled. The age 65 and older 
percentage is only 17 percent for hearts, and 18 percent for livers. In 
sharp contrast, the vast majority of kidney transplants (about 80 
percent) are received by patients who have end-stage renal disease and, 
as ESRD patients, are nearly all 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 7 through 
10), and in cost over time. For kidney transplant patients 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 10). For ESRD patients who receive kidney transplants, the public 
insurance programs would 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 more. For kidney 
patients, 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 10). 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 would not yet be 
realized), total costs shown in Table 11 over this period are about $10 
billion and the average billed to Medicare would be about 25 percent of 
this, or $2.5 billion. Of this, patients would pay on average almost 20 
percent, reducing the Medicare costs to about $2 billion over the five 
year period.

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 proposed rule would have a significant impact on a 
substantial number of small entities. For purposes of the RFA, we 
estimate that almost all 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 $7.5 million to $38.5 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.\41\ 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 proposed rule would create 
will affect small entities.
---------------------------------------------------------------------------

    \41\ Brigitte Sullivan, Executive Director, NYU Langone 
Transplant Institute, ``Maximizing Medicare Cost Report 
Reimbursement,'' 2015, online at https://organdonationalliance.org/wp-content/uploads/2015/08/ATC_BSullivan_CostReport_062016_S5N0001.pdf.
---------------------------------------------------------------------------

    The RFA requires that an Initial Regulatory Flexibility Analysis 
(IRFA) be prepared if a proposed 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 some OPOs to prosper as they reform 
their practices to meet the standards under the proposed rule, but some 
may lose their certification and be replaced by more effective OPOs. 
The HHS standard for ``substantial number'' is 5 percent or more of 
those that will be significantly impacted, but never fewer than 20. 
There is a possibility that as many as 20 OPOs would lose certification 
and hence we are unable to certify that an Initial Regulatory 
Flexibility Analysis is not required under the RFA. Accordingly, we are 
preparing an IRFA.
    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 proposed rule directly

[[Page 70661]]

regulates either hospitals or their transplant programs. Moreover, 
nothing in this proposed 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 one 
trillion dollars a year; the estimated costs of this proposed rule 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 one 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.\42\ 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 (however, see the further discussion 
of payment issues in the Alternatives section).
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    \42\ Patients are not ordinarily accepted on transplant waiting 
lists if they do not have the insurance or other means to ensure 
that they can pay not only the hospital and surgical fees, but also 
for the immunosuppressive drugs that are needed for post-transplant 
survival.
---------------------------------------------------------------------------

    The potential economic effects on OPOs depend on their ability to 
meet the thresholds established at the beginning of the four-year 
performance period. OPOs who are at or above this threshold by the end 
of this period should face relatively small effects (a likely increase 
in organ donors and organs transplanted that we estimate to be likely 
to be near 20 percent, with revenues from Medicare that reimburse their 
incurred reasonable costs) and other health insurers. Those currently 
below the threshold that can achieve the threshold rate over the four-
year period will benefit from the increased revenue associated with 
procuring more organs. For OPOs that cannot meet the new performance 
standards, the issue would be making the necessary changes to avert a 
loss of certification. Our methodology was designed to allow all OPOs 
the opportunity to achieve the threshold rates; however, based on 
Tables 3 and 4, we believe that there are a range of potential 
outcomes, assuming the high performers remain at steady state. These 
include:
     Eight OPOs who would be subject to de-certification 
because they would need to increase their donation and/or 
transplantation rates by more than 50 percent to meet the threshold 
rates.
     Eighteen OPOs who would be subject to de-certification 
because they would need to increase their donation and/or 
transplantation rates by more than 25 percent to meet the threshold 
rates.
     Thirty-three OPOs who would be subject to de-certification 
because they would need to increase their donation and/or 
transplantation rates by more than 10 percent to meet the threshold 
rates.
    In most cases of potential decertification, we would reasonably 
expect another OPO to take over that service area, retaining the 
original staff, 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 
incur costs related to retraining, or implementation of best practices 
unfamiliar to the de-certified OPO's staff. We solicit comment 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.
    Tables 3 and 4 present a list of all affected OPOs and of the gap 
between their current performance and the proposed standards. These 
tables use as a base year 2017 data but for most OPOs, the potential 
donor data from the state death certificates are not likely to change 
substantially from updates between the proposed and final rule and 
between the final rule and first performance year. These tables show 
for each OPO what it would have to achieve over a four-year period to 
meet the proposed performance standards. Since the threshold rate 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 four-year performance period. 
Since the cost of each OPO's increased effort and performance is 
covered by Medicare, this is not primarily a cost or revenue issue for 
the OPOs. Instead, our new performance measures would create 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 ``small entities,'' all of the alternatives and 
options presented throughout this preamble meet the RFA requirement 
that effects on these entities be addressed. We emphasize, however, 
that we already know that many OPOs already meet or in many cases far 
exceed our proposed standards without any regulatory relief, and we 
know that the HHS goal for increasing kidney donation and 
transplantation can not be met without a substantial increase in 
performance. We also know that the current performance requirements 
permit most OPOs to perform far below the levels of their peers in 
serving the long waiting lists of patients in need of organ donation 
and transplantation.
    Because our proposals 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 leadership could replace 
any 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 any case 
arise where an OPO is unable to make the changes necessary to or 
constrained by circumstances beyond its control that it cannot reach 
the performance levels of others, CMS can intervene with technical 
assistance or to facilitate mergers or other changes. We believe that 
every OPO can meet the proposed 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 Regulatory Flexibility Analysis, including a description of the 
reasons why action is being considered, a statement of the objectives 
and legal basis for the proposed rule, a description of any reporting 
or record-keeping requirements of the proposed rule, and a description 
of any other Federal rules that duplicate, overlap, or conflict with 
the proposed rule (there are none in this case), among others. This RIA 
and the preamble taken as a whole meet these requirements. We welcome 
comments about effects on small entities and on alternatives that might 
improve the rule in meeting its stated objectives. We note that the RFA 
emphasizes the use of performance

[[Page 70662]]

rather than design standards, which is precisely what we propose.
    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 603 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 proposed 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 proposed 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 one year of $100 million in 1995 dollars, 
updated annually for inflation. In 2019, that threshold is 
approximately $154 million. This proposed rule contains no mandates 
that directly impose spending costs on State, local, or tribal 
governments, or by the private sector. Some OPOs would undoubtedly find 
that meeting the proposed 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. E.O. 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 proposed rule would impose no such requirements.

G. Alternatives Considered

    Throughout the preamble sections, we present our proposals and seek 
comments on potential alternatives. We seek to implement reform 
measures that (1) establish empirically-based outcome and process 
performance measures for OPOs, (2) that can be uniformly applied to all 
OPOs, (3) that would capture the entire pool of potential deceased-
donors, (4) that would use transparent, reliable and objective data 
that would not require entity-specific judgments, (5) that use data 
that accounts for geographic differences in the number and causes of 
death, and (6) that use data that are easily captured and tallied on a 
continuing annual basis.
    In choosing the outcomes measures that we are proposing and setting 
the threshold donation and organ transplantation rate at the top 25 
percent of rates, 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 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 are seeking comments to these 
alternatives in addition to our proposed outcome measures.

Changes to the Denominator

CALC as the Denominator

    The following table shows the likely effects of using the CALC to 
define the donor potential:
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    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. This methodology uses the same NCHS database and also 
uses inpatient deaths to calculate the denominator. The primary 
difference between the CALC methodology and our proposed methodology is 
that it uses the ICD-10 codes to identify deaths that are consistent 
with donation (that is, inclusion criteria) whereas we exclude ICD-10 
codes that are an absolute contraindications to organ donation (that 
is, exclusion criteria). The developers of the CALC methodology believe 
that the ICD-10 codes used in their inclusion criteria capture 98-99 
percent of all donors:
     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 our 
proposed methodology. There is 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 at the 
threshold rate, under our 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).
    We also compared the CALC methodology on organs transplanted, as 
shown in the following table:
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    For organs transplanted, if all flagged OPOs were to increase their 
organs transplanted to the range of the top 25 percent, then using the 
CMS 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 are seeking comments on these 
differences and whether the CALC method is a more precise and/or 
accurate assessment of OPO performance.

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. The following tables show the effects of measure the donor 
potential based on the total deaths:
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    Using total number of deaths as the denominator, the donor 
potential was 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 find 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 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 our 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.

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.\43\ A population-based approach to re-certifying OPOs 
was used by the Department until the passage of the OPO Certification 
Act of 2000, which specifically raised concerns about ``[a]n exclusive 
reliance on population-based measures of performance that do not 
account for the potential in the population for organ donation and do 
not permit consideration of other outcome and process standards that 
would more accurately reflect the relative capability and performance 
of each organ procurement organization.'' While we considered this 
approach, for this reason, and others that we discuss in further 
detail, we chose not to propose it. The following tables show the 
effects of using an eligible population as the donor potential:
---------------------------------------------------------------------------

    \43\ For convenience, we used less than 75 years old rather than 
75 and younger because of how the Census data is publicly reported.
---------------------------------------------------------------------------

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    In the population-based approach, we would have 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 rates of deaths consistent 
with organ

[[Page 70686]]

donation.\44\ Although we would not consider a measure which is based 
solely on population size, we are seeking 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.
---------------------------------------------------------------------------

    \44\ Cannon RM, Jones CM, et al, ``Patterns of geographic 
variability in mortality and eligible deaths between organ 
procurement organizations,'' AmJTransplant. 2019;00:4 (Fig. 2).
---------------------------------------------------------------------------

Changing the Confidence Interval

    In addition to considering other denominator sources, we considered 
changing the way in which we measured success. One way in which we 
measure success is in the confidence that our rate is flagging 
correctly. Our methodology uses 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. 
The following tables show the effects of these different CIs:
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    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).

[[Page 70692]]

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.
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    We are actively considering use of a static, absolute threshold as 
a viable alternative to use of a relative performance metric, but 
question whether this approach could inadvertently incentivize all OPO 
performances to move towards a static threshold, thus decreasing total 
donations and transplantations. We are interested in robust public 
comments that support or refute these concerns and comments that list 
the potential impacts, benefits, or consequences of implementing this 
approach. We specifically request that commenters present data, 
studies, or other analysis to support their recommendations. We also 
seek comments on ways to incentivize continual improvement of all OPOs, 
including high performers and low performers. Additionally, we are 
interested in 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).
    There were other alternatives that we chose not to propose. We 
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 believe 
that this approach incorrectly places the requirement to report an 
imminent death solely on the donor hospital, rather we believe this is 
a joint responsibility shared with an OPO.
    Another option suggested by some members of the OPO community and 
commenters in response to the RFI is using donor/ventilated deaths for 
donor potential. While we appreciate this suggestion, there are no 
standardized databases that would allow us to determine the ventilator 
status of deaths, and we are 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 are sufficient and 
appropriate referrals are 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 our goals 
in proposing these new performance measures: To reduce the reporting 
burdens so that resources can go towards increasing organ donation and 
transplantation.
    Also discussed in the preamble, we recognize that the OPO in Hawaii 
is at a considerable geographic disadvantage for placement of all the 
organs it could procure. As an alternative, we

[[Page 70697]]

considered measuring the performance of the Hawaii OPO based solely on 
its kidney donation and transplantation rates, excluding other organs, 
because Hawaii has a kidney transplant program, yet has greater 
geographic barriers associated with transporting the extra-renal organs 
outside of the DSA. These tables show the effects of the kidney 
donation and transplantation rates:
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    Using just these measures, the Hawaii OPO would be in the top 25 
percent for both kidney donation rates and kidney transplantation 
rates. 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 are aware of newer technologies that could 
significantly reduce the clinical impact of prolonged transport of 
extra-renal organs and would prefer a policy that encourages the 
innovation and adoption of these types of technologies for the benefit 
of all potential recipients. We are seeking 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.
    In analyzing all these different alternatives, we recognize 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 best practices. In summary, we welcome comments 
both on the comparative advantages and disadvantages of alternatives 
within the scope of this proposed rule, and suggestions for other 
alternatives that could be addressed in subsequent rule-makings or 
administrative actions to further improve performance of the organ 
donation and transplantation system.

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 18, we have prepared an accounting statement showing 
the classification of the benefits, transfers, and costs that we 
estimate will arise from the reforms if this proposed rule is adopted.
    These reforms will create substantial out-year effects, and the 
annualized estimates provided in this table display the effects that 
are 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 farther into the future. This means, however, that the 
Accounting Table estimates do not include very substantial out-year 
benefits to patients and savings to the ESRD program that will occur 
outside the five-year estimating window. Also, the effects of this 
proposed rule on organ recovery and transplantation are of unusual 
uncertainty even in the short run. The upper bound for benefit and cost 
reduction estimates are as discussed elsewhere in this regulatory 
impact analysis. We welcome comments on the estimates made in this 
proposed rule and on ways to improve their calculation or presentation.
    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 19--Accounting Statement: Classification of Estimated Benefits, Transfers, and Costs
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Units
                                                              Primary                                    -----------------------------------------------
                        Category                             estimate      Low estimate    High estimate                   Discount rate
                                                                                                           Year dollars      (percent)    Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Health Benefits Annualized Monetized ($million/year)  ..............              <0             698            2017               7       2021-2025
                                                          ..............              <0             769            2017               3       2021-2025

[[Page 70706]]

 
    Medical Expenditure Annualized Monetized ($million/   ..............              >0            -923            2017               7       2021-2025
     year)..............................................
                                                          ..............              >0            -996            2017               3       2021-2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits Notes: Because increased transplant activity imposes costs upfront but yields savings over time, a longer time horizon would show medical
 expenditure impacts falling in magnitude, potentially to the point of being exceeded by longevity benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($million/year)................  ..............           0.477  ..............            2017               7       2021-2025
                                                          ..............           0.445  ..............            2017               3       2021-2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Notes: Transition costs in the event of OPO decertification have not been estimated.
--------------------------------------------------------------------------------------------------------------------------------------------------------
    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 proposed rule has been 
designated a significant regulatory action as defined by Executive 
Order 12866, and, if finalized as proposed, is expected to be an E.O. 
13771 regulatory action.

J. Conclusion

    This proposed rule would substantially reform the incentives facing 
OPOs and as a result, substantially 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. Because organ transplants are life-saving and life-extending 
events, we believe that these benefits to patients will be far more 
consequential than the effects on medical treatments and costs. Our 
expectation is that the numbers of lives saved or extended will be many 
thousands each year, as estimated in the preceding analysis.
    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

    Medicare, Organ procurement, and Definitions.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV, part 486, as 
set forth below:

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

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

    Authority:  42 U.S.C. 1302 and 1395hh.

0
2. Section 486.302 is amended by--
0
a. Adding definitions for ``Death that is not an absolute 
contraindication to organ donation'' and ``Donation rate'';
0
b. Revising the definition of ``Donor'';
0
c. Adding a definition for ``Donor potential'';
0
d. Removing the definitions of ``Eligible death'', ``Eligible donor'', 
and ``Expected donation rate'';
0
e. Adding a definition for ``Lowest rate among the top 25 percent'';
0
f. Removing the definition of ``Observed donation rate'';
0
g. Revising the definition of ``Organ'';
0
h. Adding a definition for ``Organ transplantation rate''' and
0
i. Removing the definition of ``Standard criteria donor (SCD)''.
    The additions and revisions read as follows:


Sec.  486.302   Definitions.

* * * * *
    Death that is not an absolute contraindication to organ donation 
means all deaths from the state death certificates except those with 
any cause of death identified by the specific ICD-10 codes that would 
preclude donation under any circumstance.

Tuberculosis...........................  all.
Other bacterial diseases...............  A39 Meningococcal infection.
                                         A40 Streptococcal septicaemia.
                                         A41 Other septicaemia.
Viral infections of the central nervous  A82 Rabies.
 system.
Viral infections characterized by skin   B03 Smallpox.
 and mucous membrane lesions.
Human immunodeficiency virus [HIV]       B20 Human immunodeficiency
 disease.                                 virus [HIV] disease with
                                          infectious and parasitic
                                          diseases.
                                         B21 Human immunodeficiency
                                          virus [HIV] disease with
                                          malignant neoplasms.
Sequelae of infectious and parasitic     B90 Sequelae of tuberculosis.
 diseases.
Malignant neoplasms of lip, oral cavity  all.
 and pharynx.
Malignant neoplasms of digestive organs  all.
Malignant neoplasms of respiratory and   all.
 intrathoracic organs.
Melanoma and other malignant neoplasms   C43 Malignant melanoma of skin.
 of skin.
Malignant neoplasms of bone and          all.
 articular cartilage.

[[Page 70707]]

 
Melanoma and other malignant neoplasms   all.
 of skin.
Malignant neoplasms of methothelial and  all.
 soft tissue.
Malignant neoplasm of breast...........  all.
Malignant neoplasms of female genital    all.
 organs.
Malignant neoplasms of male genital      all.
 organs.
Malignant neoplasms of thyroid and       all.
 other endocrine glands.
Malignant neoplasms of ill-defined,      all.
 secondary and unspecified sites.
Malignant neoplasms of lymphoid,         all.
 haematopoietic and related tissue.
Malignant neoplasms of independent       all.
 (primary) multiple sites.
Neoplasms of uncertain or unknown        D44 Neoplasm of uncertain or
 behavior.                                unknown behaviour of endocrine
                                          glands.
                                         D46 Meylodysplastic syndromes.
                                         D47 Other neoplasms of
                                          uncertain or unknown behavior
                                          of lymphoid, haematopietic and
                                          related tissue.
                                         D48 Neoplasms of uncertain or
                                          unknown behavior of other and
                                          unspecified sites.
Coagulation defects, purpura and other   D65 Disseminated intravascular
 haemorrhagic conditions.                 coagulation [defibrination
                                          syndrome].
                                         D69 Purpura and other
                                          haemorrhagic conditions.
Metabolic disorders....................  E84 Cystic fibrosis.
Infections specific to the perinatal     P36 Bacterial sepsis of
 period.                                  newborn.
 

* * * * *
    Donation rate is the number of donors as a percentage of the donor 
potential.
* * * * *
    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.
* * * * *
    Donor potential is the number of inpatient deaths within the DSA 
among patients 75 and younger with any cause of death that is not an 
absolute contraindication to organ donation.
* * * * *
    Lowest rate among the top 25 percent will be calculated by taking 
the number of total OPOs in the time period identified for establishing 
the threshold rate. That number 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 will be separately 
ranked and the threshold rate will be the rate that corresponds to the 
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 even if it is used 
for research or islet cell transplantation.

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

    Organ transplantation rate is the number of organs transplanted 
from donors in the DSA as a percentage of the donor potential.
* * * * *
0
3. Section 486.316 is amended by revising paragraphs (a)(1) and (2), 
(b), (c), and (d) introductory text to read as follows:


Sec.  486.316   Re-certification and competition processes.

    (a) * * *
    (1) Meets the performance requirements of the outcome measures at 
Sec.  486.318 at the end of the certification cycle; and
    (2) Has been shown by survey to be in compliance with the 
requirements for certification at Sec.  486.303, including the 
conditions for coverage at Sec. Sec.  486.320 through 486.360.
    (b) De-certification and competition. If an OPO does not meet the 
performance requirements of the outcome measures as described in 
paragraph (a)(1) of this section at the final assessment prior to the 
end of the re-certification cycle or the requirements described in 
paragraph (a)(2) of this section the OPO is de-certified. If the OPO 
does not appeal or the OPO appeals and the reconsideration official and 
CMS hearing officer uphold the de-certification, the OPO's service area 
is opened for competition from other OPOs. The de-certified OPO is not 
permitted to compete for its open area or any other open area. An OPO 
competing for an open service area must submit information and data 
that describe the barriers in its service area, how they affected organ 
donation, what steps the OPO took to overcome them, and the results.
    (c) Criteria to compete. To compete for an open service area, an 
OPO must meet the performance requirements of the outcome measures at 
Sec.  486.318 and the requirements for certification at Sec.  486.303, 
including the conditions for coverage at Sec. Sec.  486.320 through 
486.360. The OPO must compete for the entire service area.
    (d) Criteria for selection. CMS will consider the following 
criteria in designating an OPO for an open service area:
* * * * *
0
4. Section 486.318 is revised to read as follows:


Sec.  486.318   Condition: Outcome measures.

    (a) Outcome measures. An OPO is evaluated by measuring the donation 
rate and the organ transplantation rate in their DSA.
    (1) The donation rate is calculated as the number of donors in the 
DSA as a percentage of the donor potential.
    (2) The organ transplantation rate is calculated as the number of 
organs transplanted from organs procured in the DSA as a percentage of 
the donor potential.
    (3) The numerator of donors and organs transplanted is based on the 
data submitted to the OPTN as required in Sec.  486.328 and/or 42 CFR 
121.11.
    (4) The denominator is the donor potential and is based on 
inpatient deaths within the DSA from patients 75

[[Page 70708]]

or younger with any cause of death that is an absolute contraindication 
to organ donation. The data is obtained from the most recent 12 months 
data from state death certificates.
    (5) These outcome measures will be effective beginning with the 
2022 re-certification cycle.
    (b) OPO performance on outcome measures. An OPO must demonstrate a 
success rate on the outcome measures in accordance with the following 
parameters and requirements:
    (1) For the assessment period, a threshold rate will be established 
based on the lowest rate among the top 25 percent of donation rates 
during the 12-month period immediately prior to the period being 
evaluated.
    (2) For the assessment period, a threshold rate will be established 
based on the lowest rate among the top 25 percent of organ 
transplantation rates during the 12-month period prior to the period 
being evaluated.
    (3) The 95 percent confidence interval for each OPO will be 
calculated using a one-sided test.
    (4) OPOs whose upper limit of the one-sided 95 percent confidence 
interval is less than the threshold rate established will be flagged.
    (c) Assessment and data for the outcome measures. (1) An OPO's 
performance on the outcome measures is based on an assessment at least 
every 12 months with the most recent 12 months of data from the OPTN 
and state death certificates, beginning December 31 of the first year 
of the re-certification cycle and ending December 31, prior to the end 
of the re-certification cycle.
    (2) If an OPO's performance falls below the outcome measure 
described in paragraph (b) of this section prior to the last cycle 
before the end of the certification period, the OPO must meet the 
requirements of Sec.  486.348(d)(3).
    (3) If an OPO takes over another OPO's service area on a date later 
than January 1 of the first year of the re-certification cycle so that 
12 months of data are not available to evaluate the OPO's performance 
in its new service area, we will not hold the OPO accountable for its 
performance in the new area until 12 months of data are available.


Sec.  486.328   [Amended]

0
5. Section 486.328 is amended--
0
a. In paragraph (a) introductory text by removing the word 
``Beneficiaries'' and adding in its place the word ``Recipients'' and 
by removing the acronym ``DHHS'' and adding in its place the acronym 
``HHS''.
0
b. By removing and reserving paragraph (a)(4); and
0
c. In paragraph (a)(7), by removing, the word ``eligible''.
0
6. Section 486.348 is amended by adding paragraph (d) to read as 
follows:


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

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

    Dated: September 27, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: November 7, 2019
Alex M. Azar II,
Secretary, Department of Health and Human Services.

    Note:  The following appendix will not appear in the Code of 
Federal Regulations.

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[FR Doc. 2019-27418 Filed 12-17-19; 4:15 pm]
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