[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Rules and Regulations]
[Pages 59438-59445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0906-AB23


Removing Financial Disincentives to Living Organ Donation

AGENCY: Health Resources and Services Administration (HRSA), Health and 
Human Services Department (HHS).

ACTION: Final rule.

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SUMMARY: This final rule amends the regulations implementing the 
National Organ Transplant Act of 1984, as amended (NOTA), to remove 
financial barriers to organ donation by expanding the scope of 
reimbursable expenses incurred by living organ donors to include lost 
wages, and child-care and elder-care expenses incurred by a caregiver. 
HHS is committed to reducing the number of individuals on the organ 
transplant waiting list by increasing the number of organs available 
for transplant. This final rule is associated with Section 8 of the 
Executive Order (E.O.) 13879 titled ``Advancing American Kidney 
Health,'' issued on July 10, 2019, which directed HHS to propose a 
regulation allowing living organ donors to be reimbursed for related 
lost wages, child-care expenses, and elder-care expenses through the 
Reimbursement of Travel and Subsistence Expenses Incurred toward Living 
Organ Donation program authorized under section 377 of the Public 
Health Service (PHS) Act, as amended.

DATES: This final rule is effective on October 22, 2020.

FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of 
Transplantation, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, 
Room 08W63, Rockville, MD 20857; by email at [email protected]; or by 
telephone (301) 443-7577.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    On December 20, 2019, HHS published a notice of proposed rulemaking 
(NPRM) in the Federal Register (84 FR 70139) to amend the regulations 
implementing the NOTA to remove financial barriers to organ donation by 
expanding the scope of reimbursable expenses incurred by living organ 
donors. The NPRM provided for a 60-day comment period, and HHS received 
267 comment letters raising a variety of issues. HHS has carefully 
considered all comments in developing this rule, as outlined in Section 
V below, and presents a summary of all significant comments and 
Departmental responses.

II. Background

    As discussed in the NPRM, every 10 minutes, another person is added 
to the national organ transplant waiting list, and approximately 20 
people die every day while waiting for a transplant.\1\ The current 
approach to acquiring organs for transplantation relies on the altruism 
of deceased donors and their families and the voluntarism and altruism 
of living organ donors.
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    \1\ Information from https://www.organdonor.gov/statistics-stories/statistics.html#glance and accessed on August 26, 2019.
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    Living organ donation offers a viable transplant option, primarily 
for kidney and liver transplant candidates, and helps to reduce the 
overall number of individuals on the national organ transplant waiting 
list, thus improving the transplantation system overall. The 
President's E.O. 13879, ``Advancing American Kidney Health,'' 
emphasized that supporting living organ donors can help address the 
current demand for kidney transplants. That E.O. directed the HHS 
Secretary to propose a regulation that would expand the definition of 
allowable costs that can be reimbursed under HRSA's current 
Reimbursement of Travel and Subsistence Expenses Incurred toward Living 
Organ Donation program. This final rule addresses this E.O. 
requirement, which also included language specifically addressing 
reimbursement of lost wages along with child-care and elder-care 
expenses.
    Living organ donation also delivers several additional benefits for 
the recipient, as described in the NPRM, including receipt of a better 
quality organ in a shorter time period and better clinical outcomes 
than those who continue on dialysis or receive a deceased donor kidney 
transplant.\2\ However, all such benefits must be weighed against the 
donor risks, which include surgical and anesthesia-related 
complications and infections as well as the uncertainty of the long-
term health effects on donors following living organ donation, which 
are currently being studied.
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    \2\ Data from https://srtr.transplant.hrsa.gov/annual_reports/2017/Kidney.aspx.
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A. HRSA's Reimbursement of Travel and Subsistence Expenses Incurred 
Toward Living Organ Donation Program

    Congress provided specific authority under section 377 of the 
Public Health Service (PHS) Act, as amended, 42 U.S.C. 274f,\3\ to the 
Secretary of Health and Human Services (the Secretary) for 
reimbursement of travel and subsistence expenses, which encompasses 
costs for travel to medical and clinical appointments, lodging, and 
meals, incurred by eligible individuals making living donations of 
their organs, and other individuals accompanying the living organ 
donors.
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    \3\ Available at https://www.govinfo.gov/content/pkg/PLAW-108publ216/pdf/PLAW-108publ216.pdf.
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    Within the same section of the PHS Act, Congress also authorized 
the Secretary to reimburse ``incidental non-medical expenses'' incurred 
by living organ donors under 42 U.S.C. 274f(a)(2), if the Secretary 
determines by regulation that reimbursements for such expenses are 
appropriate.
    The National Living Donor Assistance Center (NLDAC) \4\ operates 
the living organ donor reimbursement program funded by HRSA's 
Reimbursement of Travel and Subsistence Expenses Incurred toward Living 
Organ Donation grants program. Under the authority provided under 
section 377 of the PHS Act, as amended, the program is operated via 
cooperative agreement. The program's purpose is to help remove 
financial disincentives for living organ donations. In adherence to the 
authority outlined in the PHS Act, the program's Eligibility Guidelines 
currently provide that ``qualifying expenses'' include those incurred 
by the donor and his/her accompanying person(s) as part of: (1) Donor 
evaluation, (2) hospitalization for the living donor surgical 
procedure, and/or (3) medical or surgical follow-up, clinic visits, or 
hospitalization within two calendar years following the living donation 
procedure.\5\ It is important to note that not all applicants or 
recipients of reimbursements will go on to donate an organ. Many 
factors may prevent an intended and willing donor from proceeding with 
the donation. Such circumstances include present health status of the 
intended donor or recipient that would prevent the transplant or 
donation from proceeding, perceived long-term risks to the intended 
donor, or unforeseen events outside the intended donor's control.
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    \4\ The Center's website is available at https://www.livingdonorassistance.org/home/default.aspx.
    \5\ The Eligibility Guidelines for HRSA's reimbursement program 
are available at https://www.govinfo.gov/content/pkg/FR-2009-06-19/pdf/E9-14425.pdf.

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[[Page 59439]]

    The criteria for reimbursement are based on the incomes of both the 
recipient and potential living organ donor and include only the 
aforementioned qualifying expenses. Under federal law, HRSA's 
reimbursement program cannot reimburse any living organ donor for 
travel and other qualifying expenses if the donor can be reimbursed for 
these expenses from any of the following sources: (1) Any state 
compensation program, an insurance policy, or any federal or state 
health benefits program; (2) an entity that provides health services on 
a prepaid basis; or (3) the recipient of the organ. HRSA notes that 
some living organ donors may receive assistance from other sources, 
such as private insurers' programs; however, HRSA's reimbursement 
program specifically aims to assist lower-income donors who lack other 
forms of financial support.
    Through this final rule, the Secretary determines that 
reimbursement for lost wages, and child-care and elder-care expenses 
incurred by a caregiver, is appropriate for living organ donors who 
incur such expenses toward their organ donation.

B. Executive Order 13879: Advancing American Kidney Health

    In E.O. 13879, ``Advancing American Kidney Health,'' issued on July 
10, 2019, the President directed HHS to propose a regulation to allow 
living organ donors to be reimbursed for related lost wages, child-care 
expenses, and elder-care expenses through the Reimbursement of Travel 
and Subsistence Expenses Incurred toward Living Organ Donation program 
authorized by 42 U.S.C. 274f. This final rule aligns with the goals of 
the President's mandate.
    The E.O. further directed HHS to raise the limit on the income of 
living organ donors eligible for reimbursement under the program. The 
limit on donor income is set through the reimbursement program's 
Eligibility Guidelines. HRSA has proposed a revision to the Eligibility 
Guidelines increasing the upper threshold for living organ donor and 
organ recipient household income from 300 percent to 350 percent of the 
HHS Poverty Guidelines in effect at the time of eligibility 
determination. HRSA sought and received public comment on this planned 
revision to the Eligibility Guidelines through a separately published 
Federal Register notice. Therefore, this final rule does not address 
that aspect of the Executive Order.

C. Advisory Committee on Organ Transplantation Recommendations

    In May 2019, the HHS Advisory Committee on Organ Transplantation 
(ACOT) voted to provide recommendations to the Secretary which, if 
adopted, would increase access to organs from living organ donors by 
providing living organ donors with additional support and resources and 
by removing disincentives that may have prevented them from donating. 
This final rule is responsive to those recommendations.

D. Section 301 of NOTA

    Section 301 of NOTA generally makes it ``unlawful for any person to 
knowingly acquire, receive, or otherwise transfer any human organ for 
valuable consideration for use in human transplantation if the transfer 
affects interstate commerce.'' \6\ Therefore, reimbursement payments 
received via HRSA's reimbursement program must not violate section 301 
of NOTA, which outlaws the purchase and sale of organs. Certain 
expenses are specifically excluded from the scope of valuable 
consideration, including ``expenses of travel, housing, and lost wages 
incurred by the donor of a human organ in connection with the donation 
of the organ.'' 42 U.S.C. 274e(c)(2). Section 301 of NOTA does not 
expressly state whether reimbursement for child-care or elder-care 
expenses incurred by a donor in connection with the donation constitute 
prohibited ``valuable consideration.'' HHS has determined, and the U.S. 
Department of Justice, Office of Legal Counsel, concurred, that the 
reimbursement of child-care and elder-care expenses as described here 
is not valuable consideration under section 301 of NOTA. Therefore, 
this prohibition does not pose a barrier to the Secretary's 
determination, made through this final rule, that the reimbursement of 
such expenses is appropriate under the authority provided by 42 U.S.C. 
274f(a)(2).
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    \6\ See 42 U.S.C. 274e(a).
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III. Summary of This Rule

    This rule codifies the proposed amendments to the OPTN Final Rule 
described in the December 2019 NPRM and removes barriers and 
disincentives to living organ donation by adding lost wages, and child-
care and elder-care expenses incurred by caregivers, as reimbursable 
expenses for living organ donors. This rule constitutes the Secretary's 
determination by regulation that reimbursement may be appropriately 
provided for lost wages, and child-care and elder-care expenses 
incurred by caregivers who make living donations of their organs, as 
authorized by section 377(a)(2) of the PHS Act. A new regulatory 
section is added at Sec.  121.14 to list the categories of ``incidental 
non-medical expenses'' that the Secretary has determined are 
appropriate for reimbursement.
    The other criteria of HRSA's reimbursement program, as provided in 
the program's Eligibility Guidelines, remain applicable and will still 
need to be met for reimbursement to be provided to living organ donors 
and other individuals evaluated for living organ donation for lost 
wages and child-care and elder-care expenses incurred by caregivers 
while making donations of their organs. Concurrently with the 
publication of this final rule, HRSA will revise the Eligibility 
Guidelines to address eligibility criteria for these reimbursable 
expenses.

A. Lost Wages

    Some potential living organ donors may be willing and available to 
donate an organ to a family member, friend, or an unknown recipient, 
but might be unable to afford the loss in income while out of work 
during the transplant process, which includes the pre-transplant 
evaluation, surgery, subsequent recovery time, and follow-up 
appointments. Through this final rule, HRSA determines that lost wages 
are an appropriate reimbursable expense for living organ donors, and 
adds lost wages as a category of reimbursable incidental non-medical 
expenses at Sec.  121.14(a)(1).

B. Child-Care Expenses and Elder-Care Expenses

    Included among the many costs associated with living organ donation 
are, for many individuals, the costs of child-care and elder-care. Such 
costs can be incurred throughout the organ donation process, from the 
transplant pre-evaluation through the hospital stay, during the 
recovery period, and while the living donor attends necessary follow-up 
medical appointments. Through this final rule, HRSA determines that 
child-care and elder-care expenses incurred by caregivers are 
appropriate reimbursable expenses for living organ donors, and adds 
child-care expenses at Sec.  121.14(a)(2) and elder-care expenses at 
Sec.  121.14(a)(3) as categories of reimbursable non-medical incidental 
expenditures.

IV. Public Comments and Responses

    HRSA received a total of 267 comments from the public, including 
professional and patient stakeholder organizations, prior and potential 
living

[[Page 59440]]

kidney donors, donor stakeholder organizations, and clinical 
professionals. The vast majority (261) of commenters were in favor of 
the proposed rule, although several suggested modifications to the 
proposed rule (see details below). Only two commenters opposed the 
spirit of the proposed rule and expressed concern about the well-being 
of living organ donors.
    All comments were considered in developing this rule. This section 
presents a summary of all major issues raised by commenters, grouped by 
subject, as well as responses to the comments.

1. Additional Financial Barriers to Organ Donation/Foregone Medical 
Insurance Benefits

    HRSA specifically sought public comment on any literature or 
evidence on additional financial barriers to living organ donation, 
including whether foregone medical insurance benefits pose a 
significant barrier to living organ donation. In the NPRM, HRSA noted 
an interest in public comment regarding whether such expenses should be 
included in future rulemaking. Only three commenters from professional 
societies explicitly addressed HRSA's request for comments on whether 
``foregone medical insurance benefits'' pose a significant barrier to 
living organ donation. These commenters did not provide literature or 
evidence in support of this additional category, but suggested it was 
appropriate for reimbursement to address concerns regarding potential 
impacts due to time away from work after donation.
    Response: HRSA appreciates the feedback on the inclusion of 
``foregone medical insurance benefits'' as a potential category of 
expenses eligible for reimbursement. HRSA reiterates its interest in 
receiving any detailed literature or evidence regarding how these 
expenses pose a barrier to living organ donation.

2. Definition of Lost Wages

    We received five comments suggesting that HRSA include lost income 
as a reimbursable non-medical expense rather than ``lost wages.'' The 
commenters argue that lost income would more accurately reflect the 
potential disincentives to living organ donation. Specifically, the 
commenters suggest that lost wages may not include income received by 
independent contractors or others who do not receive a standard hourly, 
weekly, or monthly wage. The commenters further suggest that ``lost 
income'' would include foregone sick days, vacation pay, or disability 
payments that would otherwise have been available to the living organ 
donor.
    Response: HRSA intends to proceed with the use of the term ``lost 
wages'' when describing available reimbursable incidental non-medical 
expense. The term ``lost wages''' is consistent with the direction to 
HHS provided in the July 2019 ``Advancing American Kidney Health'' 
E.O., and reflects the terminology used in the categories of expenses 
excluded from valuable consideration as defined in section 301 of NOTA.
    HRSA does wish to make clear that ``lost wages'' need not be 
limited to consideration of traditional wage rate income. HRSA agrees 
that living organ donors with non-traditional or irregular income 
should be eligible for reimbursement of lost wages through the program 
if sufficient documentation of the lost wages is provided. The program 
will provide eligible donors with informational packets containing 
documentation requirements for reimbursement of lost wages through 
participating transplant programs; information will also be posted on 
the program's website. Regarding the inclusion of reimbursement for 
foregone sick days, vacation pay, or disability payments, HRSA is not 
including these categories as reimbursable incidental non-medical 
expenses at this time. More analysis is needed to determine whether 
including such expenses would be consistent with the statutory 
requirement that HRSA's reimbursement program cannot cover donor 
expenses that can be reimbursed from certain other sources, as detailed 
in 42 U.S.C. 274f(d).
3. Additional Incidental Non-Medical Expenses
    We received two comments suggesting that pet care expenses also be 
included as reimbursable incidental non-medical expenses, given that a 
large proportion of potential donors are also pet owners who may incur 
expenses for pet care during their recovery after organ donation.
    Response: HRSA appreciates the feedback on the inclusion of pet 
care as a reimbursable incidental non-medical expense. HRSA is not 
aware of literature or evidence regarding the impact pet care expenses 
may have as a disincentive to living organ donation. Therefore, HRSA is 
not including pet care as a reimbursable expense at this time. However, 
HRSA is interested in any evidence regarding the impact of pet care 
expenses posing a barrier to living organ donation.

4. Other Comments

a. Insurance Access
    Eight commenters suggested that HHS take action to address the 
potential that living organ donors may be adversely impacted in access 
to health or life insurance, post-donation. The commenters cite 
experience and literature describing increased insurance premiums and a 
higher likelihood of denial of coverage for living organ donors. 
Several commenters raised the issue of medical problems that might 
arise post-donation and whether those expenses would be covered by 
health insurance. One commenter described the experience of a family 
member who had subsequent difficulty getting health insurance coverage, 
despite being in good health. Another individual stated that he was so 
concerned about his insurance company canceling his coverage that he 
never informed his insurance company that he had donated an organ. One 
commenter asked that HRSA consider the limited coverage that the 
average health insurance plan provides to living organ donors, and 
expressed concern that living organ donors who experience complications 
related to the donation may be personally responsible for the medical 
costs.
    Response: HRSA acknowledges and appreciates commenters sharing 
these concerns. The purpose of HRSA's reimbursement program is to 
provide living organ donors with support by reimbursing non-medical 
expenses that pose a disincentive to living organ donation. HRSA will 
continue to analyze these issues.
b. Other Uncovered Medical Expenses
    Approximately 14 commenters suggested that HRSA's reimbursement 
program be expanded to cover medical expenses related to the living 
organ donation that are not otherwise covered by their or the 
recipient's health insurance.
    Response: The purpose of HRSA's reimbursement program is to provide 
living organ donors with support by reimbursing non-medical expenses 
that pose a disincentive to living organ donation. The statute 
authorizing HRSA's reimbursement program, section 377 of the Public 
Health Service Act, does not provide authority for the program to 
reimburse living organ donors for medical expenses related to living 
organ donation. Therefore, it is beyond the purview of the program to 
cover additional medical expenses or serve as a form of supplemental 
health insurance for living organ donors.

[[Page 59441]]

b. Payer of Last Resort
    Approximately four commenters expressed concern about the 
description of HRSA's reimbursement program as a payer of last resort. 
The commenters suggest that this description may go beyond the 
requirements of section 377 of the Public Health Service Act, that 
requires that the program not cover expenses ``of a donating individual 
to the extent that payment has been made, or can reasonably be expected 
to be made, concerning such expenses (1) under any State compensation 
program, under an insurance policy, or under any Federal or State 
health benefits program; (2) by an entity that provides health services 
on a prepaid basis; or (3) by the recipient of the organ.'' The 
commenters also suggest that the complexity of this structure unduly 
burdens the living organ donor by requiring documentation that the 
expenses are not otherwise covered, which could be a disincentive to 
living organ donation. Another commenter stated that this description 
is too narrow, and inconsistent with the benefits of reimbursing living 
organ donors. And finally, one commenter believed that the phrase 
implies that the program's reimbursement should be as limited as 
possible and could be considered to indicate that transplant recipients 
should be required to reimburse their donors as a matter of course.
    Response: HRSA accepts these comments, and will no longer use the 
phrase ``payer of last resort'' to explain HRSA's reimbursement 
program. HRSA did not intend to imply any limitation of reimbursable 
expenses beyond the statutory requirements. However; per statute, 
HRSA's reimbursement program cannot cover donor expenses that can be 
reimbursed from certain other sources, as detailed in 42 U.S.C. 
274f(d)--(1) any State compensation program, an insurance policy, or a 
Federal or State health benefits program; (2) an entity that provides 
health services on a prepaid basis; or (3) the recipient of the organ. 
Regarding the concern about how living organ donors might need to 
document that their potentially reimbursable expenses are not covered 
by other programs or individuals, HRSA maintains that sufficient 
documentation will be required to assure that its reimbursement program 
is operating within the authority of section 377 of the Public Health 
Service Act.
c. Compensation for Intangible Risks
    Approximately eight commenters suggested that the program also 
address compensation for intangible risks incurred by living organ 
donors, including the surgical risks of donation, the long-term risks 
to donor health, the inconvenience and discomfort of surgery, and the 
concern that a friend or relative may need a kidney in the future.
    Response: As previously discussed, HRSA's reimbursement program is 
limited by statute and may not provide compensation to living organ 
donors beyond reimbursement for eligible expenses. Undertaking a 
``risk,'' whether it be a long-term health risk or surgical risk, is 
not an eligible expense.
d. Donor Caretaker
    Six commenters suggested that HRSA's reimbursement program expand 
coverage to allow for reimbursement of expenses incurred by a ``donor 
caretaker'' who provides care for the living organ donor during post-
operative recovery. The commenters stated that, since living donors 
rely on caretakers as they recover from surgery, these caretakers 
should be compensated for lost income. In addition, they argued that 
potential financial burdens that might be incurred by the donor's 
caretaker(s) constitute a disincentive for living organ donation. As 
such, they believe that removing this disincentive by covering ``donor 
caretaker'' expenses would increase living organ donation rates.
    Response: Individuals eligible for reimbursement of expenses under 
HRSA's reimbursement program are limited to those who meet the 
statutory definition of ``donating individual'' and those referenced in 
the statutory definition of ``qualifying expenses'' for the program.\7\ 
This statutory language limits reimbursement for expenses incurred by 
actual living organ donors, or ``individuals who in good faith incur 
qualifying expenses toward the intended donation of an organ,'' to 
allow for expenses incurred by potential donors who are ruled out for 
organ donation. The statute also allows for reimbursement for 
qualifying expenses incurred by up to two individuals who ``accompany 
or assist the donating individual'' for the purposes of living organ 
donation.
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    \7\ See 42 U.S.C. 274f(c).
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    To date, HRSA has allowed for the reimbursement of travel and 
subsistence expenses related to the donation procedure for up to two 
``donor caretakers'' providing assistance to the donating individual, 
whether the expenses were incurred before or after the donation 
procedure. This final rule allows that the additional expenses of lost 
wages, child-care, and elder-care are eligible for reimbursement, 
whether incurred by the donor or by the up to two accompanying or 
assisting individuals. Reimbursement of these expenses for accompanying 
or assisting individuals will be subject to availability of funds and 
as provided in the program's Eligibility Guidelines.
f. Change in Eligibility Criteria and ``Primary Caregiver''
    HRSA received 31 comments encouraging a change in the program's 
eligibility criteria, including raising the threshold income level. A 
subset of those comments also questioned the references to ``primary 
caregiver'' in the NPRM preamble, and recommended removing the 
``primary'' qualifier. The commenters expressed concern that the 
references to ``primary caregiver'' appeared to limit the number of 
individuals eligible for reimbursement for child-care and elder-care 
expenses. For example, one commenter expressed concern that it will be 
difficult to determine the ``primary caregiver'' and that all donors 
with caretaker responsibilities for children or elders should receive 
reimbursement if they need to pay someone else to take on those 
responsibilities during their recovery.
    Response: With regard to a change in the current program 
eligibility criteria, note that, as previously stated, HRSA will revise 
the current Eligibility Guidelines, including consideration of an 
increase to the upper threshold for living organ donor and organ 
recipient household income. HRSA intends to publish a Federal Register 
notice during fiscal year 2020 regarding this issue.
    With regard to the preamble's references to ``primary caregiver,'' 
HRSA recognizes there may have been some confusion with regard to this 
term. HRSA intends that all donors and potential donors with caregiver 
responsibilities for children or elders should be eligible for 
reimbursement for child-care or elder-care expenses. HRSA originally 
included this qualifier not to limit eligibility, but rather to 
indicate that any caregiver, despite their familial relationship, may 
be eligible for reimbursement under the program. Based on an analysis 
of the feedback, HRSA no longer uses the qualifier ``primary'' for 
``caregiver'' in the preamble language in this final rule. HRSA intends 
to further address which individuals are eligible caregivers in the 
program's Eligibility Guidelines.
g. Safety of Living Organ Donation
    Two commenters expressed complete opposition to the rule based on 
concern about the overall safety of living organ donation and well-
being of living organ donors. These commenters expressed

[[Page 59442]]

specific concern regarding the potential risk to the living organ 
donor's health, the invasiveness of the procedure, and the cost of the 
surgery.
    Response: HRSA recognizes that living organ donation is not without 
risk. We note in the preamble that the benefits of living organ 
donation must be weighed against risks to the donor. For anyone 
considering living organ donation, it is critical to gather as much 
information as possible to make an informed decision. Potential living 
organ donors should also ensure that they undergo a thorough screening 
prior to donation and receive counseling regarding informed consent.\8\ 
Access to follow-up care and maintenance of a healthy lifestyle post-
donation are also beneficial to the short- and long-term health of the 
living donor.\9\ HRSA emphasizes that the decision to become a living 
organ donor is an individual choice. The purpose of this rule is to 
expand the scope of financial support available to those who decide to 
become living organ donors, in the form of reimbursement for qualifying 
expenses.
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    \8\ See Ann Intern Med. 2018;168:276-284. doi:10.7326/M17-1235.
    \9\ See Kidney Disease: Improving Global Outcomes (KDIGO) Living 
Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the 
Evaluation and Care of Living Kidney Donors. Transplantation 2017; 
101(Suppl 8S):S1-S109.
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h. Impact of Rule Change on Other Existing Program
    Four commenters (two public and two professional stakeholder 
organizations) expressed support for the concept of supporting living 
organ donors but opposition to the proposed rule. These commenters, 
including a non-profit organization that operates a national registry 
in the United States that lists kidney donors and recipients in need of 
a kidney transplant, argue that the proposal does not go far enough in 
providing reimbursement for living organ donors and would supplant an 
existing program established and operated by this organization that 
provides a broader array of support. The range of support from the 
referenced program includes reimbursement for lost wages, as well as 
``donation life insurance,'' ``donation disability insurance,'' and 
legal support, should it be necessary.
    These four comments suggest restructuring HHS' approach to 
addressing living organ donor expenses to allow for a public-private 
collaboration between HHS and this organization.
    Response: HRSA appreciates the feedback and will continue to 
consider innovative models for future actions to support living organ 
donors. Nevertheless, HRSA is proceeding with finalizing the proposal 
outlined in the NPRM through this final rule. HRSA wishes to note that 
other entities, including the non-profit organization referenced above, 
are eligible to compete for future cooperative agreements for the 
operation of the living organ donor reimbursement program. Those 
entities are encouraged to submit proposals.
i. Miscellaneous
    Other commenters raised a variety of issues that do not pertain 
directly to the expansion of reimbursable incidental non-medical 
expenses under the program, which was the focus of the proposed rule. 
HRSA will continue to analyze these issues.
     Allowing non-directed donors to receive reimbursement 
through the program which is currently tied to recipient income levels.
     Removing donor residence requirement to allow non-U.S. 
residents/citizens to participate in the program.

V. Statutory and Regulatory Requirements

Executive Orders 12866, 13563, and 13771: Regulatory Planning and 
Review

    HHS examined the effects of this rule as required by E.O. 12866 on 
Regulatory Planning and Review, E.O. 13563 on Improving Regulation and 
Regulatory Review, the Regulatory Flexibility Act (Pub. L. 96-354), the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), E.O. 13132 on 
Federalism, and E.O. 13771 on Reducing Regulation and Controlling 
Regulatory Costs.
    E.O. 12866 and E.O. 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). E.O. 13563 supplements and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866, which emphasizes the 
importance of quantifying both costs and benefits, of reducing costs, 
of harmonizing rules, and of promoting flexibility.
    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 one 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 outlined in the Executive Order. A regulatory impact 
analysis must be prepared for major rules with economically significant 
effects ($100 million or more in any 1 year), and a ``significant'' 
regulatory action is subject to review by the Office of Management and 
Budget (OMB). This rule has been determined to be a significant 
regulatory action. Accordingly, the rule has been reviewed by OMB.
    E.O. 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 rule is neither regulatory nor 
deregulatory for purposes of E.O. 13771. There are no additional costs; 
as finalized, this rule will only change how HRSA expends the 
appropriated funds.

Summary of Impacts

    Research into similar legislative changes and changes to financial 
incentives have demonstrated increases in organ donations; thus, the 
agency estimates that these proposed regulatory changes will increase 
the number of living organ transplants. The agency expects this 
increase for two primary reasons. As described in more detail in the 
following paragraph, studies have shown that reimbursement measures 
have increased organ donations anywhere from 14 percent to 65 percent, 
depending on the particular circumstances of the study. Secondly, donor 
income also appears to play a role in living organ donor transplant 
rates.
    Research showed the implementation of new laws, including a move 
toward reimbursing lost wages and providing other benefits, yielded the 
country of Israel a 65 percent increase in kidney transplants from 
living donors.\10\ In the United States, paying donation-related

[[Page 59443]]

travel costs through NLDAC increased the number of living donor kidney 
transplants by approximately 14 percent over baseline in participating 
transplant centers,\11\ with a separate survey of NLDAC donors 
revealing that 75 percent of donors would not have donated without 
reimbursement.\12\ In addition, tax incentive legislation in New York 
increased living kidney donations to non-family members by 52 
percent.\13\ Finally, a study looking at longitudinal trends found that 
income was strongly associated with donation, with higher rates of 
donation observed in higher-income populations and donation rates 
declining among the lowest earners after the last recession.\14\
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    \10\ Lavee, J., Ashkenazi, T., Stoler, A., Cohen, J., & Beyar, 
R. (2012). Preliminary Marked Increase in the National Organ 
Donation Rate in Israel Following Implementation of a New Organ 
Transplantation Law. American Journal of Transplantation,13 (3), 
780-785, 2012. doi:10.1111/ajt.12001.
    \11\ Schnier, K.E., Merion, R.M., Turgeon, N., & Howard, D. 
(2018). Subsidizing altruism in living organ donation. Economic 
Inquiry, 56(1), 398-423.
    \12\ Merion RM et al. Analysis of dialysis cost and median 
waiting time on return on investment (ROI) of the US National Living 
Donor Assistance Center (NLDAC) program [abstract]. Transplantation. 
2016;100:S310.
    \13\ Bilgel, F., & Galle, B. (2015). Financial incentives for 
kidney donation: a comparative case study using synthetic controls. 
Journal of Health Economics. 43, 103-117.
    \14\ Gill, J., Dong, J., Rose, C., Johnston, O., Landsberg, D., 
& Gill, J. (2013). The effect of race and income on living kidney 
donation in the United States. Journal of the American Society of 
Nephrology. 24(11), 1872-1879.
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    Currently, the United States averages approximately 6,500 living 
organ donations per year. Determining how many of these, or any 
additional, living organ donors will be eligible for the financial 
incentives involves the interplay of several factors, as does 
calculating the cost of these incentives.
    First, not all living donors will be eligible for these 
reimbursements. As previously stated, the E.O. titled ``Advancing 
American Kidney Health'' also directed HHS to propose raising the limit 
on the income of living organ donors eligible to be reimbursed under 
the program. The income eligibility threshold is the first criterion in 
determining whether a potential donor is eligible to receive 
reimbursement of expenses incurred.
    Second, not all program-eligible living organ donors will incur 
expenses relating to each one of the new categories of reimbursements 
(lost wages, child-care, elder-care) offered through the regulatory 
change. Each donor's circumstances differ; some might request 
reimbursement for all three types of added reimbursable expenses, some 
for one or two, and some for none at all.
    Third, donors' specific circumstances will determine the 
reimbursable amounts. Individual wages differ, as do the type, level, 
and amount of child-care and/or elder-care required to compensate those 
donors who are caregivers.
    Fourth, while living organ donors typically face a 4-6 week post-
surgical recovery time, individual recovery times will vary. Surgical 
complications or personal health issues might slow that process, and 
the physical demands of the donor's work (e.g., strenuous versus 
sedentary) might dictate how quickly she or he can return to work.
    Given these individual differences, HRSA is using median weekly 
figures for each expense to estimate the expected costs per individual 
of these regulatory changes. Please note that the lost wages category 
correlates to a typical 40-hour workweek, while child-care and elder-
care are extrapolated out to a full 7-day week, on the presumption that 
caregivers will require assistance caring for children and the elderly 
on the weekends as well.
     Wages: $28 per hour \15\ for 40 hours per week is a weekly 
average wage of $1,120 per week or $4,480-$6,720 over 4-6 weeks.
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    \15\ Information from the U.S. Bureau of Labor Statistics and 
available at https://www.bls.gov/news.release/empsit.nr0.htm.
---------------------------------------------------------------------------

     Child-care: At $420 per full week \16\ child-care will 
cost $1,680-$2,520 over 4-6 weeks.
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    \16\ National Center for Education Statistics and available at 
https://nces.ed.gov/programs/digest/d18/tables/dt18_202.30c.asp.
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     Elder-care: At $504 per full week \17\ elder-care will 
cost $2,016-$3,024 over 4-6 weeks.
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    \17\ Paying for senior care, https://www.payingforseniorcare.com/longtermcare/costs.html#Non-Medical-Home-Care.
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    Funding for this program is a fixed amount that is determined 
through annual federal discretionary appropriations. These regulatory 
changes will result in expanded coverage and a potential increase in 
user demand of the living organ donor reimbursement program. Expanding 
the list of eligible expenses could increase the average reimbursement. 
The number of individuals receiving reimbursement and/or the amount of 
reimbursement per individual in any given fiscal year will be dependent 
upon annual appropriations. Therefore, increases in the average 
reimbursement without increases in appropriations could result in fewer 
individuals being served by the program. Based on the uncertainty of 
annual appropriation levels for the program, HRSA is considering a 
range of methods to ensure the ongoing viability of this program, such 
as a reimbursement cap.
    In relation to caps on reimbursements, under current program 
guidelines, NLDAC limits donors to a maximum of $6,000 for 
reimbursement of solely travel and subsistence; a correlating 
demonstration project, on lost wages, limits reimbursement of solely 
lost wages to a maximum of $5,000; donors receiving reimbursements from 
both programs are capped at receiving a combined maximum of $8,000. In 
fiscal year 2018, the average NLDAC reimbursement was $1,934 per donor, 
which is lower than the current cap level. Approximately nine (9) 
percent of participants exceeded a reimbursement of $5,500 or more. 
HRSA may adjust the cap to account for the additions of lost wages, 
child-care, and elder-care. HRSA acknowledges that this cap may not 
cover the entirety of reimbursable expenses incurred by some donors; 
however, this assistance does align with one of the major goals of the 
reimbursement program: To reduce financial disincentives and 
disparities, not to necessarily make donors whole financially.
    While expanding the list of expenses eligible for reimbursement for 
living organ donors will increase the average amount of reimbursement, 
the federal government can expect to save overall due to an increase in 
additional organ transplants performed and the aversion of dialysis. 
The costs/savings incurred by kidney transplantation vary by donor 
type. One study using Medicare claims data \18\ estimated End-Stage 
Renal Disease (ESRD) expenditures to be $292,117 over ten years per 
beneficiary on dialysis. Living donor kidney transplants (LDKT) was 
cost-saving at ten years, reducing expected medical expenditures for 
ESRD treatment by 13 percent ($259,119) compared to maintenance 
dialysis.
---------------------------------------------------------------------------

    \18\ Axelrod DA, Schnitzler MA, Xiao H, et al. An economic 
assessment of contemporary kidney transplant practice. Am J 
Transplant. 2018;18:1168-1176. https://doi.org/10.1111/ajt.14702.
---------------------------------------------------------------------------

    The approximately $33,000 in Medicare savings per beneficiary over 
ten years for LDKT compared to maintenance dialysis is likely a lower 
bound, since living donation is likely to reduce the number of 
beneficiaries under the age of 65 who would be eligible for Medicare 
enrollment. The lower bound conditional savings can be adjusted to 
account for additional savings through reduced Medicare enrollment by 
considering the share of potential new live donations across three main 
scenarios.
    The LDKT expected cost of $259,119 over ten years per beneficiary 
projected by Axelrod et al. (2018) assumes Medicare primary payer 
status. For roughly 25 percent of LDKTs, Medicare is assumed as the 
primary payer

[[Page 59444]]

regardless of transplant success; therefore, the projected spending 
need not be adjusted. For the next 25 percent of LDKTs, the assumption 
was that the beneficiary is on dialysis, and Medicare is the primary 
payer. Still, they would eventually no longer need dialysis and/or 
leave Medicare enrollment if they had a transplant, and are not 
otherwise eligible for Medicare due to age or disability. Therefore, 
the expected Medicare spending for these cases was adjusted downward by 
33 percent. This projected a savings of approximately $119,000 over ten 
years relative to the baseline spending projection of $292,117 over ten 
years for beneficiaries on dialysis. For the remaining 50 percent of 
LDKTs it was assumed that Medicare is not the primary payer when the 
transplant occurs. In this case, it was assumed that Medicare spending 
is nominal relative to baseline spending of $292,117 over 10 years for 
beneficiaries on dialysis, and amounts were adjusted downward by 33 
percent (that is, for these beneficiaries, Medicare would have become 
the primary payer after 30 months of coordinated medical services; it 
takes 30 months for Medicare to become the primary payer for diagnosed 
end stage renal disease patients, absent the transplant), which 
projected a savings of approximately $195,000 over 10 years. The 
projected weighted average federal budgetary savings to the Medicare 
program for LDKT is $136,000 over 10 years per beneficiary.
    Therefore, a hypothetical 20 percent increase in the rate of LDKT 
in model markets in a single year, representing about 500 new kidney 
transplants mainly from relatives of recipients, would produce 
approximately $68 million in federal budgetary savings to the Medicare 
program over ten years (and multiples thereof for each successive year 
if the living donor kidney transplant rate was thusly elevated). 
Overall, having more end stage renal disease (ESRD) individuals 
receiving transplants will ultimately decrease Medicare 
expenditures.\19\
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    \19\ Obtained from proposed rule CMS-5527-P Specialty Care 
Models to Improve Quality of Care and Reduce Expenditures posted on 
July 18, 2019, and information available at https://www.federalregister.gov/documents/2019/07/18/2019-14902/medicare-program-specialty-care-models-to-improve-quality-of-care-and-reduce-expenditures.
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A. Regulatory Flexibility Analysis
    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the 
Small Business Regulatory Enforcement and Fairness Act of 1996, which 
amended the RFA, require HHS to analyze options for regulatory relief 
of small businesses. If a rule has a significant economic effect on a 
substantial number of small entities, the Secretary must specifically 
consider the economic effect of the rule on small entities and analyze 
regulatory options that could lessen the impact of the rule. HHS will 
use an RFA threshold of at least a 3 percent impact on at least 5 
percent of small entities. HHS has determined, and the Secretary 
certifies that this rule will not have a significant impact on the 
operations of a substantial number of small manufacturers; therefore, 
we are not preparing an analysis of impact for the purposes of the RFA.
B. Unfunded Mandates Reform Act
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any federal mandate that may result in the expenditure by 
state, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year.'' In 2019, that threshold was $154 million. 
HHS does not expect this rule to exceed the threshold.
C. Executive Order 13132--Federalism
    HHS has reviewed this rule in accordance with E.O. 13132 regarding 
federalism and has determined that it does not have ``federalism 
implications.'' This rule would not ``have substantial direct effects 
on the States, or the relationship between the national government and 
the States, or on the distribution of power and responsibilities among 
the various levels of government.''
D. Collection of Information
    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA) 
requires that OMB approve all collections of information by a federal 
agency from the public before they can be implemented. This rule is 
projected to have no impact on current reporting and recordkeeping 
burden, as the amendments outlined in this rule will not impose any 
data collection requirements under the PRA.

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements, Transplant centers.

    Dated: September 15, 2020.
Thomas J. Engels,
Administrator, Health Resources and Services Administration.
    Approved: September 16, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

    Accordingly, by the authority vested in me as the Secretary of 
Health and Human Services, and for the reasons set forth in the 
preamble, 42 CFR part 121 is amended as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

0
1. The authority citation for part 121 is revised to read as follows:

    Authority:  Sections 215, 371-377, and 377E of the PHS Act (42 
U.S.C. 216, 273-274d, 274f-5); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh); 
section 301 of the National Organ Transplant Act, as amended (42 
U.S.C. 274e); and E.O. 13879, 84 FR 33817.


0
2. Revise Sec.  121.1 to read as follows:


Sec.  121.1   Applicability.

    (a) The provisions of this part, with the exception of Sec. Sec.  
121.13 and 121.14, apply to the operation of the Organ Procurement and 
Transplantation Network (OPTN) and the Scientific Registry.
    (b) The provisions of Sec.  121.13 apply to the prohibition set 
forth in section 301 of the National Organ Transplant Act, as amended.
    (c) The provisions of Sec.  121.14 apply to the reimbursement of 
specified incidental non-medical expenses incurred toward living organ 
donation under section 377 of the Public Health Service Act, as 
amended.
    (d) In accordance with section 1138 of the Social Security Act, 
hospitals in which organ transplants are performed and which 
participate in the programs under titles XVIII or XIX of the Social 
Security Act, and organ procurement organizations designated under 
section 1138(b) of the Social Security Act, are subject to the 
requirements of this part.

0
3. Add Sec.  121.14 to read as follows:


Sec.  121.14   Reimbursement for living organ donors: incidental non-
medical expenses.

    (a) The following incidental non-medical expenses incurred by 
donating individuals toward making living donations of their organs may 
be reimbursed:
    (1) Lost wages;
    (2) Child-care expenses; and
    (3) Elder-care expenses.

[[Page 59445]]

    (b) [Reserved]

[FR Doc. 2020-20804 Filed 9-18-20; 8:45 am]
BILLING CODE 4165-15-P