Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program Eligibility Guidelines, 59530-59534 [2020-20805]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Health Resources and Services Administration

[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59530-59534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Reimbursement of Travel and Subsistence Expenses Toward Living 
Organ Donation Program Eligibility Guidelines

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

ACTION: Final notice; response to solicitation of comments and 
publication of final program eligibility guidelines

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SUMMARY: A notice was published in the Federal Register on March 31, 
2020, to solicit comments on the eligibility criteria that were 
proposed by HRSA concerning the Living Organ Donation Reimbursement 
Program (formerly Reimbursement of Travel and Subsistence Expenses 
toward Living Organ Donation Program). This final notice responds to 
comments, describes the revision to the eligibility criteria to 
incorporate the reimbursable categories of qualifying expenses added by 
an HHS final rule published elsewhere in the issue of the Federal 
Register, and finalizes the Program Eligibility Guidelines.

FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of 
Transplantation, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, 
Room 08W53A, Rockville, Maryland 20857; telephone (301) 443-7577; or 
email [email protected].

SUPPLEMENTARY INFORMATION: Congress has provided specific authority 
under section 377 of the Public Health Service (PHS) Act, as amended, 
42 U.S.C. 274f, for providing reimbursement of qualifying expenses 
incurred toward living organ donation with preference for those for 
whom paying such expenses would create a financial hardship. In August 
2019, HRSA awarded a 5-year, $16,250,000 cooperative agreement to the 
University of Kansas Medical Center Research Institute, Inc. to 
administer this Program.
    Congress requires that the Secretary in carrying out this Program 
give preference to those individuals the Secretary determines are more 
likely to be unable to pay for the qualifying expenses associated with 
the donation process. In addition, Congress requires that funds from 
the Program not be used to reimburse qualifying expenses associated 
with being a living organ donor, if the donor has received any payments 
or is expected to receive any payments related to these expenses from:
    (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.
    In addition, the authorizing statute requires the Secretary to give 
preference to living organ donors who are ``more likely to be otherwise 
unable to meet such expenses.''

Summary of Comments and HRSA Responses

    On March 31, 2020 (85 FR 17894), HRSA published a notice in the 
Federal Register requesting comments on the proposed eligibility 
criteria for the Program. HRSA requested public comment concerning 
proposed changes to the guidelines to: Increase the household income 
eligibility threshold to 350 percent of the HHS Poverty Guidelines 
(from the current threshold of 300 percent) for living organ donors and 
organ recipients, clarify the use of the existing preference categories 
in relation to the proposed household income eligibility threshold, and 
clarify that travel and subsistence expenses incurred by non-directed 
living organ donors \1\ qualify as reimbursable expenses under the 
Program. HRSA also proposed revision of the Program eligibility 
guidelines' background section to ensure that the information aligns 
with the Program's legislative authority. These proposed guidelines 
would apply to the Program regardless of the recipient of the 
cooperative agreement that administers the Program.
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    \1\ Living organ donations can be either ``directed'' (the organ 
is intended for an individual named or specified by the living organ 
donor), or ``non-directed'' (the organ is intended for an individual 
neither named nor specified by the donor) as defined at https://optn.transplant.hrsa.gov/resources/ethics/living-non-directed-organ-donation/.
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    HRSA received a total of seventy-seven comments from the public. 
Comments were received from individuals, including prior living donors, 
and professional and patient stakeholder organizations. None of the 
commenters opposed HRSA's efforts to expand eligibility under the 
Program, although two commenters expressed concern about the 
effectiveness of the Program, and most commenters expressed interest in 
further expanding the program. Sixty-eight of the commenters proposed 
that HRSA increase the income eligibility threshold for the recipient 
and the donor of the organ beyond the proposed 350 percent of the HHS 
Poverty Guidelines. HRSA assumes that recipients whose income

[[Page 59531]]

exceeds this level will have the ability to reimburse the living organ 
donor for the qualified expenses incurred toward living organ donation. 
HRSA also assumes that donors whose income is below this threshold are 
``more likely to be otherwise unable to meet such expenses.'' Fifty-one 
of these commenters specified that the threshold should be at least 500 
percent of the HHS Poverty Guidelines. Forty-four commenters suggested 
that eligibility should not be linked to the recipient's income. Four 
commenters remarked that reimbursement should be available to all 
living organ donors without conditions. Finally, three commenters 
expressed concern that the eligibility criteria do not adequately 
consider the financial burdens that may occur when both the living 
organ donor and the transplant recipient reside in the same household.
    HRSA wishes to thank the respondents for the quality and 
thoroughness of their comments. HRSA's response to the comments 
received and final decisions are discussed below.

I. Response to Comment To Increase the Income Threshold to 500 Percent 
of the HHS Poverty Guidelines

    Sixty-eight of the commenters proposed that HRSA increase the 
threshold beyond the proposed 350 percent of the HHS Poverty 
Guidelines, with many of these commenters specifying that the threshold 
should be at least 500 percent of the HHS Poverty Guidelines consistent 
with a recommendation of the HHS Advisory Committee on Organ 
Transplantation.
    HRSA notes that the authorizing statute requires the Program to 
give preference to individuals who are ``more likely to be otherwise 
unable to meet such expenses.'' The authorizing statute also requires 
that the Program not provide reimbursement for donor expenses that have 
been paid, or can reasonably be expected to be paid by other existing 
programs or by the recipient of the organ. Based on these requirements, 
and in an effort to provide for a transparent and administratively 
manageable mechanism to assess an individual's ability to pay for 
covered expenses, HRSA believes that an income threshold based on the 
recipient's income in relation to the HHS Poverty Guidelines provides a 
reasonable mechanism for evaluating this standard. HRSA also notes the 
importance of maintaining a mechanism for applicants to the Program to 
demonstrate financial hardship not adequately reflected by the 
recipient's income, which would indicate undue hardship if the 
recipient were to reimburse the donor's expenses.
    HRSA will closely monitor the Program's ability to adequately 
address the reimbursement needs of applicants meeting any of the four 
preference categories based on the 350 percent income threshold defined 
in the eligibility criteria, including those applicants who meet the 
financial hardship criteria. This is especially important to monitor in 
relation to HRSA's recent regulatory action permitting reimbursement of 
lost wages and child-care and elder-care expenses through the Program. 
This expansion of eligible expenses is expected to further remove 
financial disincentives to living organ donation and expand 
participation in the Program. However, the full impact of the expansion 
of eligible expenses and the increased income eligibility threshold on 
participation in the Program is not yet fully known. HRSA will monitor 
and analyze the impact of this change to inform future program 
operations

II. Response To Comment That Recipient Income Should Not Be Considered 
in Determining Eligibility

    Forty-four commenters suggested that eligibility should not be 
linked to the recipient's income. As stated previously, the authorizing 
statute requires that HRSA consider the recipient's ability to 
reimburse the donor's expenses and prohibits the Program from 
reimbursing expenses that can reasonably be expected to be covered by 
the transplant recipient. HRSA specifically sought input from the 
public regarding whether an organ recipient's reasonable ability to pay 
for a donor's expenses should remain tied to the Program's income 
eligibility threshold and whether or not the proposed threshold is 
appropriate and/or justified. Some respondents suggested that the 
Program require a certification from donors that they do not expect to 
be reimbursed by the recipient. Similarly, some commenters suggested 
that such a certification and means testing are not necessary because 
in practice donors' expenses are not being regularly reimbursed by 
recipients. However, these suggestions do not meet the statutory 
requirement that HRSA prohibit payment for expenses that ``can 
reasonably be expected to be made'' by the recipient of the organ. HRSA 
acknowledges that recipient income is not a full measure of whether 
recipients can reasonably be expected to reimburse their donor for 
qualified expenses. However, HRSA is prohibited by statute from 
reimbursing donor expenses that can reasonably be expected to be 
reimbursed by the recipient of the organ. Therefore, HRSA expects the 
recipient of the cooperative agreement to provide education and clarity 
on the process for demonstrating financial hardship. HRSA acknowledges 
that determining recipients' financial hardship may be administratively 
burdensome and is committed to working with the recipient of the 
cooperative agreement to develop procedures to minimize burden while 
meeting the statutory requirements. Therefore, HRSA has decided to 
maintain consideration of recipient income in the preference categories 
at this time.

III. Response to Comment That Reimbursement Should Be Provided to All 
Living Donors Without Regard to the Financial Situation of the Donor or 
Recipient

    Four respondents commented that reimbursement should be available 
to all living organ donors regardless of their financial situation. The 
authorizing statute prohibits HRSA from providing reimbursement to 
living organ donors if it is reasonable to expect the donor will 
receive reimbursement for these expenses from other sources, including 
the recipient of the organ. Thus, HRSA is required to establish 
criteria to assess the donor's ability to be reimbursed from these 
sources. Therefore, HRSA is maintaining these criteria with regard to 
donors eligible for reimbursement.

IV. Response to Concern That Financial Burden Is Not Adequately 
Addressed for Situations Where Donor and Recipient Reside in Same 
Household

    Three commenters suggested that the Program does not adequately 
address the financial hardship often experienced when the donor and 
recipient reside in the same household and incur expenses and potential 
loss of income as a result of their surgeries. HRSA acknowledges the 
importance of ensuring that the Program consider the financial hardship 
that some households may experience as a result of living organ 
donation. HRSA is open to working with the recipient of the cooperative 
agreement to ensure that the Program's process for requesting 
consideration of financial hardship is sufficient to meet the needs of 
these donor and recipient household pairs; however, HRSA does not 
believe that revision of the preference categories or eligibility 
criteria is warranted to address this concern.

[[Page 59532]]

V. Response to Comments That Program Is Insufficient and Should Be 
Restructured

    Two commenters argued that the Program is ineffective at providing 
the necessary protections for living organ donors and is inferior to 
the efforts of another existing program. Further, these commenters 
suggest that HRSA consider restructuring the reimbursement activity to 
collaborate with the other existing effort, which, in the commenters' 
description, provides a broader array of support. HRSA appreciates the 
feedback and will continue to consider other models for possible future 
actions to support living organ donors. HRSA is open to considering 
innovative approaches to this Program consistent with the provisions of 
the authorizing statute. To that end, HRSA notes that other entities, 
including the current recipient of the cooperative agreement referenced 
above, are eligible to compete for future cooperative agreements for 
the operation of the Program. Those entities are encouraged to submit 
proposals when the opportunity becomes available.

VI. Other Issues

    No commenters expressed concern about HRSA's proposed revisions to 
the eligibility criteria to clarify that travel and subsistence 
expenses incurred by non-directed living organ donors qualify as 
reimbursable expenses under the Program. Nor did HRSA receive comments 
expressing concern about revisions to the background section to ensure 
that the information aligns with the Program's legislative authority 
and that the guidelines would apply to the Program regardless of the 
recipient of the cooperative agreement that administers the Program. 
These changes to the guidelines will be finalized as proposed.

Inclusion of Additional Qualifying Expenses

    Elsewhere in this issue of the Federal Register, HHS is publishing 
a final rule that expands the scope of reimbursable expenses incurred 
by living organ donors to include lost wages and child-care and elder-
care expenses. This is the first time the Secretary determined that 
certain categories of ``incidental non-medical expenses'' incurred 
toward living organ donation are appropriate for reimbursement under 
this Program. In the notice of proposed rulemaking proposing to amend 
the Organ Procurement and Transplantation Network (OPTN) Final Rule to 
permit these expenses as ``incidental non-medical expenses,'' HHS 
clarified that reimbursement for such expenses is not ``valuable 
consideration'' for purposes of section 301 of NOTA 84 FR 70139 (Dec. 
17, 2019). Thus, such payments do not violate the criminal prohibition 
against the exchange of valuable consideration for organs for use in 
transplantation.
    This notice also revises the Program Eligibility Guidelines to 
incorporate these new qualifying expenses finalized through the OPTN 
Final Rule. Among other clarifying updates, a section has been added to 
the Guidelines to provide that qualifying expenses also include lost 
wages, child-care expenses, and elder-care expenses incurred by the 
donor and/or his/her accompanying or assisting person(s) as part of:

    1. Donor evaluation and/or
    2. Hospitalization for the living donor surgical procedure, and/
or
    3. Non-hospital post-surgery recovery time, and/or
    4. Medical or surgical follow-up, clinic visits, or 
hospitalization within 2 calendar years following the living 
donation procedure (or beyond the 2-year period if exceptional 
circumstances exist).

Conclusion

    HRSA has reviewed and considered all comments in response to the 
March 31, 2020, notice and has determined that no additional 
modifications of the eligibility criteria proposed in that notice are 
warranted at this time. HRSA is also incorporating changes to the 
Guidelines to include lost wages, child-care expenses, and elder-care 
expenses as qualifying expenses under the Program, in accordance with 
the final rule published elsewhere in this issue of the Federal 
Register.
    HRSA will continually monitor the effectiveness of the Program and 
the availability of funds for the Program. The final eligibility 
criteria are included in this document.

Living Organ Donation Reimbursement Program Eligibility Guidelines as 
Amended

    Section 3 of the Organ Donation and Recovery Improvement Act, 42 
U.S.C. 274f, establishes the authority and legislative parameters to 
provide qualifying expenses incurred towards living organ donation. 
HRSA provides this support to living organ donors through the Living 
Organ Donation Reimbursement Program (formerly Reimbursement of Travel 
and Subsistence Expenses toward Living Organ Donation Program) herein 
referred to as the Program, administered through a cooperative 
agreement. As provided for in the statutory authorization, the Program 
is authorized to provide reimbursement only in those circumstances when 
payment cannot reasonably be covered by other specified sources of 
reimbursement.
    The recipient of the cooperative agreement, under Federal law, 
cannot provide reimbursement to any living organ donor for listed 
qualifying expenses if the donor can receive reimbursement 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.

    In 2007, in response to public solicitation of comments, a 
threshold of income eligibility for the recipient and the donor of the 
organ was set at 300 percent of the HHS Poverty Guidelines in effect at 
the time of the eligibility determination. Pursuant to section 8 of 
Executive Order 13879, ``Advancing American Kidney Health'' (July 10, 
2019) and feedback from the organ donation and transplantation 
community, HRSA revised the threshold of income eligibility for the 
recipient and the donor of the organ to 350 percent of the HHS Poverty 
Guidelines, in effect at the time of the eligibility determination. 
HRSA assumes that recipients whose income exceeds this level will have 
the ability to reimburse the living organ donor for the travel, 
subsistence, and other incidental non-medical expenses authorized by 
the Secretary of HHS.
    HRSA provides an exception to this rule for financial hardships. A 
transplant social worker or appropriate transplant center 
representative, based on a complete recipient evaluation, can provide 
an official statement, notwithstanding the recipient's income level, 
that the recipient of the organ would face significant financial 
hardship if required to pay for the qualifying living organ donor 
expenses. A recipient's financial hardship is defined as circumstances 
in which the recipient's income exceeds 350 percent of the HHS Poverty 
Guidelines in effect at the time of the eligibility determination, but 
the individual will have difficulty paying the donor's expenses due to 
other significant expenses. Determination of hardship in a particular 
case requires a fact-specific analysis; examples of significant 
expenses include circumstances such as paying for medical expenses not 
covered by insurance or providing significant financial support for a 
family member not living in the household (e.g., elderly parent). 
Waiver requests by

[[Page 59533]]

the transplant center, on behalf of the donor, shall be made in writing 
and shall clearly describe the circumstances for the waiver request. 
The recipient of the cooperative agreement will review waiver requests 
and make a recommendation to HRSA to either approve or deny the 
request. HRSA will make the final determination and communicate its 
final determination to the recipient of the cooperative agreement. 
HRSA's determination will not be subject to appeal.
    All persons who wish to become living organ donors are eligible to 
receive reimbursement for their qualifying expenses if they cannot 
receive reimbursement from the sources outlined above and if all the 
requirements outlined in the Criteria for Donor Reimbursement Section 
are satisfied. However, because reimbursement is subject to the 
availability of funds, prospective living organ donors who are most 
likely not able to cover these expenses will receive priority. The 
ability to cover these expenses is determined based on an evaluation of 
(1) the donor and recipient's income, in relation to the HHS Poverty 
Guidelines and (2) financial hardship. As a general matter, income 
refers to the donor or recipient's total household income.
    A donor may also be able to demonstrate financial hardship, even if 
the donor's income exceeds 350 percent of the HHS Poverty Guidelines if 
the donor will have difficulty paying the qualifying expenses due to 
other significant expenses. Although all requests will be reviewed on a 
case-by-case basis, examples of significant expenses include 
circumstances such as providing significant financial support for a 
family member not living in the household (e.g., elderly parent), and 
loss of income due to donation process. Waiver requests by the 
transplant center, on behalf of the donor, shall be made in writing and 
shall clearly describe the circumstances for the waiver request. The 
recipient of the cooperative agreement will review waiver requests and 
make a recommendation to HRSA to either approve or deny the request. 
HRSA will make the final determination and communicate its final 
determination to the recipient of the cooperative agreement. HRSA's 
determination is not subject to appeal.
    Donors meeting the criteria for reimbursement will be given 
preference in the following order of priority, with non-directed donors 
placed in a category based solely on the donor's income:
    Preference Category 1: The donor's income and the recipient's 
income are each 350 percent or less of the HHS Poverty Guidelines in 
effect at the time of the eligibility determination in their respective 
states of primary residence.
    Preference Category 2: Although the donor's income exceeds 350 
percent of the HHS Poverty Guidelines in effect in the State of primary 
residence at the time of the eligibility determination, the donor 
demonstrates financial hardship. The recipient's income is at or below 
350 percent of the HHS Poverty Guidelines in effect in the State of 
primary residence at the time of the eligibility determination.
    Preference Category 3: Any living organ donor, regardless of income 
or financial hardship, if the recipient's income is at or below 350 
percent of the HHS Poverty Guidelines in effect in the recipient's 
State of primary residence at the time of the eligibility 
determination.
    Preference Category 4: Any living organ donor, regardless of income 
or financial hardship, if the recipient (with income above 350 percent 
of the HHS Poverty Guidelines in effect in the State of primary 
residence at the time of the eligibility determination) demonstrates 
financial hardship.
    The recipient of the cooperative agreement will accept and process 
applications beginning with Preference Category 1. The recipient of the 
cooperative agreement will inform participating transplant programs 
directly and the public via its website whenever funding levels allow 
it to accept and/or process applications under additional preference 
categories.
    The HHS Poverty Guidelines for 2020 are located at 85 FR 3060 
(January 14, 2020).

Criteria for Donor Reimbursement

    1. Any individual who in good faith incurs travel and other 
qualifying expenses toward the intended donation of an organ.
    2. Donor and recipient of the organ are U.S. citizens or lawfully 
present in the U.S.
    3. Donor and recipient have primary residences in the U.S. or its 
territories.
    4. Travel is originating from the donor's primary residence.
    5. Donor and recipient certify that they understand and are in 
compliance with Section 301 of NOTA (42 U.S.C. 274e) which states in 
part that it shall be 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. The transplant center where the donation procedure occurs 
certifies to its status of good standing with the OPTN.

Qualifying Expenses

    For the purposes of the Reimbursement of Travel and Subsistence 
Expenses toward Living Organ Donation Program, qualifying expenses 
include
    I. Travel, lodging, meals and incidental expenses incurred by the 
donor and/or his/her accompanying person(s) as part of:
    (1) Donor evaluation and/or
    (2) Hospitalization for the living donor surgical procedure, and/or
    (3) Medical or surgical follow-up, clinic visits, or 
hospitalization within 2 calendar years following the living donation 
procedure (or beyond the 2-year period if exceptional circumstances 
exist).
    II. Lost wages, child-care expenses, and elder-care expenses 
incurred by the donor and/or his/her accompanying or assisting 
person(s) as part of:
    (1) Donor evaluation and/or
    (2) Hospitalization for the living donor surgical procedure, and/or
    (3) Non-hospital post-surgery recovery time, and/or
    (4) Medical or surgical follow-up, clinic visits, or 
hospitalization within 2 calendar years following the living donation 
procedure (or beyond the 2-year period if exceptional circumstances 
exist).
    The recipient of the cooperative agreement will pay for a total of 
up to five trips; three for the donor and two for accompanying persons. 
However, in cases in which the transplant center requests the donor to 
return to the transplant center for additional visits as a result of 
donor complications or other health related issues, the recipient of 
the cooperative agreement may provide reimbursement for the additional 
visit(s) for the donor and an accompanying person. The accompanying 
persons need not be the same in each trip.
    Reimbursement for travel, lodging, meals, and incidental expenses, 
as appropriate, shall be provided at the Federal per diem rate, except 
for hotel accommodation, which shall be reimbursed at no more than 150 
percent of the Federal per diem rate.
    Donors may receive up to four weeks of reimbursement for lost 
wages, child-care expenses, and elder-care expenses associated with the 
surgery and recovery time. In addition, donors may receive 
reimbursement for up to two additional weeks for lost wages, child-care 
expenses, and elder-care expenses if the donor requires follow-up 
visits

[[Page 59534]]

and hospitalization as a result of donor complications or other health 
related issues.
    Reimbursement for lost wages is based on the donor providing 
appropriate documentation, such as pay stubs, to the program. 
Reimbursement of lost wages is not limited to traditional wage rate 
income. Donors may receive reimbursement for non-traditional or 
irregular income through the program if they provide sufficient 
documentation of the expected lost wages.
    In order to qualify for reimbursement of child-care expenses and 
elder-care expenses, a donor shall have caretaker responsibilities for:

    (1) A minor child and/or
    (2) An elder who requires caretaker assistance.

    Caretaker responsibilities are not limited to familial 
relationships between the donor and/or the accompanying or assisting 
person(s), and the aforementioned individuals.
    In considering requests for reimbursement for child-care expenses 
and elder-care expenses, the recipient of the cooperative agreement is 
encouraged to adopt a consistent application of ``child'' and 
``elder.'' The recipient of the cooperative agreement may consider 
applicable laws within the jurisdiction in which the caretaker resides 
in reviewing requests for reimbursement for expenses for care of a 
``child,'' and, in reviewing requests for reimbursement for elder-care 
expenses, may consider ``elder'' to refer to an individual age 60 and 
older, consistent with the Older Americans Act, 42 U.S.C. 3002(40).
    Requests for reimbursement for the expenses of persons accompanying 
or assisting the donor for travel, housing, meals, and incidental 
expenses are considered under the preference categories and processed 
for reimbursement at the same time as requests for reimbursement for 
expenses incurred by the donor. Requests for reimbursement for the 
expenses of persons accompanying or assisting the donor for lost wages, 
child-care expenses, and elder-care expenses are considered under the 
preference categories and will be processed separately. Requests for 
these expenses will be processed after all requests for expenses 
incurred by the donor, and expenses for persons accompanying or 
assisting the donor for qualifying expenses for travel, housing, meals, 
and incidental expenses, have been processed under all four preference 
categories.
    The total Federal reimbursement for all qualifying expenses during 
the donation process shall not exceed $6,000.
    For donor and recipient pairs participating in a paired exchange 
program, the applicable eligibility criteria for the originally 
intended recipient shall be considered for the purpose of reimbursement 
of qualifying donor expenses even though the final recipient of the 
donated organ may not be the recipient identified in the original 
donor-recipient pair.
    Given that non-directed donors have served as catalysts in 
transplant chains of multiple recipients, they are considered donating 
individuals eligible to receive reimbursement for qualifying expenses, 
if all other relevant program requirements are satisfied. In applying 
the preference categories to non-directed donors, the recipient of the 
cooperative agreement will review the household income of the non-
directed donor against the current income threshold in effect at the 
time of the eligibility determination.

Maximum Number of Prospective Donors per Recipient

 Kidney: One donor at a time with a maximum of three donors
 Liver: One donor at a time with a maximum of five donors
 Lung: Two donors at a time with a maximum of six donors

Special Provisions

    Many factors may prevent the intended and willing donor from 
proceeding with the donation. Circumstances that would prevent the 
transplant or donation from proceeding include: Present health status 
of the intended donor or recipient, perceived long-term risks to the 
intended donor, justified circumstances such as acts of God (e.g., 
major storms or hurricanes), or a circumstance when an intended donor 
proceeds toward donation in good faith, subject to a case-by-case 
evaluation by the recipient of the cooperative agreement, but then 
elects not to pursue donation. In such cases, the intended donor and 
accompanying persons may receive reimbursement for qualifying expenses 
incurred as if the donation had been completed. The recipient of the 
cooperative agreement will file a form with the Internal Revenue 
Service reporting funds disbursed as income for expenses not incurred.

    Dated: September 15, 2020.
Thomas J. Engels,
Administrator.
[FR Doc. 2020-20805 Filed 9-18-20; 8:45 am]
BILLING CODE 4165-15-P