[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Proposed Rules]
[Pages 15628-15634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05682]



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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AQ65


Transplant Procedures With Live Donors and Related Care and 
Services

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its 
medical regulations to implement legislation providing it stand-alone 
authority to provide surgical procedures to remove a solid organ or 
bone marrow from a live donor for transplantation into a veteran and to 
furnish the live donor any care or services before and after the 
surgical procedure required in connection with the veteran's 
transplantation procedure. This rulemaking would implement the mandates 
of section 153 of the VA MISSION Act of 2018.

DATES: Comments must be received on or before May 24, 2021.

ADDRESSES: Comments may be submitted through www.Regulations.gov. 
Comments received will be available at regulations.gov for public 
viewing, inspection or copies.

FOR FURTHER INFORMATION CONTACT: Mani Murugavel, DNP, NE-BC, CSSGB, RN, 
National Director, Clinical Services, National Surgery Office (10NC2), 
Veterans Health Administration, 810 Vermont Avenue NW, Washington, DC 
20420, (202) 461-7130. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: VA provides eligible veterans complete 
medical and hospital services as authorized in chapters 17 and 73 of 
title 38, United States Code (U.S.C.). Consistent with that authority, 
VA has administered the VA transplant program to provide eligible 
veterans timely, high-quality care and treatment.
    Moreover, VA transplant programs are members of the Organ 
Procurement and Transplantation Network (OPTN) established by section 
372 of Public Law (Pub. L.) 98-507 (1984), as amended, and codified at 
42 U.S.C. 274. The regulatory scheme in part 121 of title 42, Code of 
Federal Regulations (CFR) governs OPTN operations, and the provisions 
of section 373 of Public Law 98-507 (codified at 42 U.S.C. 274a) 
require the operation of a Scientific Registry (``Registry'') to allow 
for an ongoing evaluation of the scientific and clinical status of 
solid organ transplantation. Approved transplant programs must thus 
report specified data to the Registry. Admission to and membership in 
the OPTN is governed by 42 CFR 121.3; the provisions of 42 CFR 121.9 
establish the requirements for OPTN-designated transplant programs and 
expressly include VA transplant programs. Id. at Sec.  121.9(a)(3). The 
OPTN Board of Directors is charged with developing policies that are 
enforceable once approved by the Secretary of Health and Human 
Services. Id. at Sec.  121.4. Compliance with OPTN rules and policies 
by designated transplant programs is required by 42 CFR 121.10. VA 
designated transplant programs comply with approved and applicable OPTN 
by-laws and policies. In addition, clinical standards of care and 
patient safety standards apply to VA's delivery of care, including 
transplant care.
    Section 153 of Public Law 115-182, the John S. McCain III, Daniel 
K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and 
Strengthening Integrated Outside Networks Act of 2018, or the VA 
MISSION Act of 2018 (June 6, 2018), as amended, Public Law 115-251 
(Sep. 29, 2018) added section 1788 to title 38, United States Code. It 
codified and clarified VA's authority to provide a person a surgical 
procedure to remove a solid organ, part of a solid organ, or bone 
marrow (including peripheral blood stem cells) to donate to, and 
transplant into, an intended veteran-recipient (hereinafter referred to 
as ``intended recipient''). It clarifies that a person is eligible for 
the surgical procedure even if not otherwise eligible for VA health 
care. This law also requires VA to furnish the person with any care and 
services required in connection with the intended recipient's 
transplantation procedure. This can include non-medical care and 
services. It also authorizes VA to provide these benefits through 
agreements with community providers.
    Prior to enactment of 38 U.S.C. 1788, VA had long deemed live donor 
care and services to be integral and medically necessary to the 
treatment of veterans who are eligible for a transplantation procedure 
under our general treatment authority. 38 U.S.C. 1710 (authorizing the 
provision of medically needed treatment). VA, through its OPTN-
designated transplant programs, therefore provided surgical procedures 
for a person otherwise ineligible for VA health care to obtain a solid 
organ, part of a solid organ, or bone marrow, as well as providing pre- 
and post-surgical care and services. This included limited follow-up as 
specified and required by OPTN policy. VA also invoked available 
purchased care authorities when necessary to obtain community care for 
live donors. New section 1788 provides stand-alone authority to treat 
live donors, directly or through community providers. (VA previously 
relied on its general treatment authority to provide live donor care, 
which was clinically deemed to be integral to the transplant treatment 
of the Veteran.)
    This proposed rule would establish new 38 CFR 17.395 to implement 
the mandates of section 1788, as added by the VA MISSION Act of 2018, 
as amended. We interpret section 1788 to remove perceived obstacles to 
donating a solid organ, part of a solid organ, or bone marrow. For 
instance, some prospective live donors fear being held financially 
responsible for the cost of their live donor care, including pre- or 
post-evaluations and care, or not being followed-up after they 
participate in the transplant procedure. This regulation addresses 
these concerns, helping us to address our ultimate objective: To help 
veteran-transplant candidates receive a solid organ, part of a solid 
organ, or bone marrow from a live donor. H.R. Rep. No. 115-671, pt. 1, 
at 15 (2018).
    Initially, we note that section 1788 states, in subsection (a), 
that VA may ``provide for'' an operation of a live donor as specified 
therein, but in subsection (b), it states that, with respect to a live 
donor receiving an operation under subsection (a), VA shall ``furnish'' 
any care or services before and after conducting the transplant 
procedure that may be required in connection with the veteran's 
transplant procedure. We find the difference in wording (``provide 
for'' vs. ``furnish'') to be a distinction without a difference. The 
proposed regulation would therefore use ``provide'' throughout 
regardless if the operation or the care and services are provided 
within VA or in the community.
    Proposed paragraph (a) would be titled ``Scope.'' It would inform 
the reader that the section provides for medical and non-medical care 
and services of persons who volunteer to donate a solid organ, part of 
a solid organ, or bone marrow for transplantation into an eligible 
veteran transplant candidate, irrespective of a donor's eligibility to 
receive VA health care for any reason other than to donate a solid 
organ, part of a solid organ, or bone marrow. It further explains that 
this section prescribes the type, timing, and duration of hospital care 
and medical services VA provides, including medical care or services 
purchased by agreement from a non-VA facility. It also provides for 
non-medical care and services essential to the prospective live donor's 
or the live donor's participation

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and for VA reimbursement for that care and services. It clarifies that 
the section does not provide VA medical benefits for eligible veteran 
transplant candidates.
    Proposed paragraph (b) would be titled ``Definitions'' and would 
define terms for this section. In general, it includes the terms that 
describe the individuals who may volunteer to donate or are donating a 
solid organ, part of a solid organ, or bone marrow, and the veterans 
who receive them throughout the course of the donation process (up 
through the period of a live donor's follow-up after the organ donation 
procedure). Two of the terms, ``kidney paired donation'' and ``live 
donor follow-up'', describe processes within the broader process of 
organ donation and transplantation. Although we propose to list the 
terms alphabetically in the regulation, we will describe the terms by 
like topics for clarity here.
    The term ``prospective live donor'' would be defined as a person 
who has volunteered to donate a solid organ, part of a solid organ, or 
bone marrow, to an intended recipient, and who has agreed to 
participate in any activity VA deems necessary to carry out the 
intended recipient's transplant procedure. For example, a person who 
completes and submits a medical history or takes any other first step 
in the sequence of events potentially leading to their donation of a 
solid organ, part of a solid organ, or bone marrow would be a 
prospective live donor. A person would be considered a prospective live 
donor from the time the person volunteers to donate a solid organ, part 
of a solid organ, or bone marrow, through the screening process to 
determine whether the person is a match to the intended recipient.
    The term ``live donor'' would be defined to comport with OPTN 
policy(ies) as an individual who is: (1) Medically suitable for 
donation; (2) is a compatible match to an identified transplant 
candidate; and (3) has provided informed consent to undergo elective 
removal of one solid organ, part of a solid organ, or of bone marrow. 
Therefore, the individual would be considered a live donor after it has 
been determined that the individual is medically suitable for donation, 
is a match to the intended recipient, and the individual has provided 
informed consent to donate. OPTN policy requires that a medical 
evaluation of the live donor be performed by the recovery hospital 
(i.e., the hospital at which the recovery of the organ from the live 
donor will take place) and by a physician or surgeon experienced in 
living donation. Organ Procurement and Transplantation Network, Policy 
14: Living Donation. U.S. Department of Health and Human Services, 
Health Resources and Services Administration. Retrieved from: https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf (Accessed: 12 
March 2020). This evaluation includes general donor history, general 
family history, social history, physical exam, general laboratory and 
imaging tests, and additional screenings. Id. This leads to a 
determination as to whether the live donor is a compatible match to the 
identified transplant candidate. OPTN policy also requires informed 
consent be obtained from the live donor prior to organ recovery. Id. 
Pursuant to OPTN policy, the recovery hospital and evaluating physician 
or surgeon are responsible for compliance with OPTN policies for live 
donor selection. Id. The determination of whether an individual meets 
the definition of ``live donor'' involves clinical determinations that 
VA will not challenge when made by a provider in the community.
    These clinical determinations can be made by either VA or the 
community provider, and will depend on the particular circumstances of 
the donation process. Thus, we would not define in the regulation who 
makes these determinations that an individual meets this proposed 
definition of ``live donor.''
    We would define the term ``live donor follow-up'' to comport with 
OPTN policy(ies) and applicable standards of care and patient safety 
standards for the follow-up of live donors of solid organs as: For live 
donors of a solid organ or part of a solid organ, the collection of 
clinically relevant post-donation live donor data and the provision of 
recommended clinical laboratory tests and evaluations consistent with 
OPTN policy; and the provision of direct medical care required to 
address reasonably foreseeable donor health complications resulting 
directly from the donation procedure. Examples of clinically relevant 
post-donation living donor data would include physical capacity, 
current weight, and kidney function. Examples of provision of 
recommended clinical laboratory tests and evaluations would include 
serum creatinine and urine protein. Examples of direct medical care 
required would include treatment of an incisional hernia or infection 
related to the donation procedure.
    To clarify, OPTN policy requires reporting of these data and 
related outcomes to help ensure donor safety and well-being. These data 
also help transplant centers provide information to future donors on 
risks and health consequences of donation. (Organ Procurement and 
Transplantation Network: Procedures to collect post-donation follow-up 
data from living donors. U.S. Department of Health and Human Services, 
Health Resources and Services Administration. Retrieved from https://optn.transplant.hrsa.gov/resources/guidance/procedures-to-collect-post-donation-follow-up-data-from-living-donors/ (Accessed: 22 January 
2020)). The goal of follow-up is, thus, to promote positive donor 
outcomes and thereby encourage further voluntary donations in an 
``atmosphere of safety.'' Ibid.
    We would define ``live donor follow-up'' for live donors of bone 
marrow as: For live donors of bone marrow, the provision of direct 
medical care required to address reasonably foreseeable donor health 
complications resulting directly from the donation procedure. We define 
this follow-up differently from follow-up for solid organ and part of a 
solid organ donors because bone marrow donors typically need far less 
follow-up than donors of solid organs. The OPTN does not regulate bone 
marrow transplantation and therefore does not require live donors of 
bone marrow to be followed for data and medical monitoring after 
donation as it does for solid organ donors. VA would nonetheless afford 
bone marrow donors follow-up care directly related to the bone marrow 
donation for a period not greater than two years, as explained in 
proposed paragraph (c)(4). We note that during this period of follow-up 
care, VA would collect data on the outcome of the bone marrow 
transplant. This is necessary because of data reporting requirements, 
such as reporting of adverse outcomes, with which VA must comply.
    The term ``initial prospective live donor'' would be defined as the 
intended recipient's prospective live donor who volunteers to donate a 
kidney to a recipient other than the intended recipient through kidney 
paired donation. To clarify, the initial prospective live donor would 
be an individual who agrees to participate in a kidney paired donation 
exchange so the transplant candidate to whom a prospective live donor 
sought to donate a kidney will be eligible to receive a kidney from 
another person through a kidney paired donation exchange.
    The initial prospective live donor might know upon volunteering 
that he or she will not match the intended recipient, or evaluation 
might reveal the initial prospective live donor and the intended 
recipient do not match. The intended recipient's initial prospective 
live donor would nonetheless provide a

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kidney for kidney paired donation. Kidney paired donation is often not 
a direct swap. A series of persons might each provide a kidney for 
kidney paired donation. In due course, the initial prospective live 
donor's intended recipient would receive a matching kidney.
    The term ``kidney paired donation'' would be defined as one 
prospective live donor's voluntary donation of a kidney for 
transplantation into a recipient other than an intended recipient, 
paired with the transplantation into the intended recipient of a 
compatible kidney from a different live donor.
    The term ``transplant candidate'' would be defined as an enrolled 
veteran or a veteran otherwise eligible for VA's medical benefits 
package who VA determines has a medical need for a solid organ, part of 
a solid organ, or bone marrow transplant.
    The term ``intended recipient'' would be defined as the transplant 
candidate who VA identifies to receive a live donor's solid organ, part 
of a solid organ, or bone marrow.
    The term ``transplant recipient'' would be defined as a transplant 
candidate who has undergone transplantation and received a solid organ, 
part of a solid organ, or bone marrow from a live donor.
    Proposed paragraph (c) would be titled ``Hospital care and medical 
services'' and would establish the types of hospital care and medical 
services VA would provide a prospective live donor or a live donor.
    Paragraph (c)(1) would describe the types and purposes of hospital 
care and medical services VA would provide to a prospective live donor 
prior to the surgical removal of the solid organ, part of a solid 
organ, or bone marrow. In particular, VA would provide examinations, 
tests, and studies necessary to qualify a prospective live donor to 
donate a solid organ, part of a solid organ, or bone marrow. This 
typically includes initial screening, blood tests, physical 
examination, psychological evaluation, informed consent, and final 
evaluation.
    Paragraph (c)(2) would describe the type and purpose of hospital 
care and medical services VA would provide the live donor during the 
period of the removal of the solid organ, part of a solid organ, or 
bone marrow. In particular, VA would provide the surgical procedure to 
remove a solid organ, part of a solid organ, or bone marrow from the 
living donor whose solid organ, part of a solid organ, or bone marrow 
will be transplanted into an intended recipient. This includes the care 
and services required to meet the immediate preoperative and 
postoperative standards of care and patient safety standards 
appropriate to the specific procedure. This surgical procedure would be 
limited to that required for the donor transplant procedure. For 
example, it would exclude any surgical procedure to treat a disease 
inadvertently discovered during the surgical procedure to remove the 
organ or bone marrow.
    Paragraph (c)(3) would describe the type and purpose of follow-up 
that VA would provide a live donor of a solid organ or part of a solid 
organ after the surgical procedure. It would qualify the type of 
follow-up as all hospital care, medical services, and other services 
which are ``necessary and appropriate.'' The care and service provided 
would be as described in the definition of ``Live donor follow-up'' In 
paragraph (b). In addition, it would define the period of follow-up to 
be a period not less than that which the Organ Procurement and 
Transplantation Network prescribes or recommends or for a period of 2 
years, whichever is greater. The OPTN-established period for live donor 
follow-up is expected to capture any complications associated with a 
live donor's participation in a solid organ transplant procedure. VA 
therefore believes that this is sufficient time to ensure proper 
follow-up.
    Paragraph (c)(4) would describe the follow-up of bone marrow 
donors, which is less extensive than for live donors of a solid organ 
or part of a solid organ. VA has no protocol, requirement, or 
recommendation from OPTN for the follow-up of bone marrow donors. 
Donation of bone marrow is different from donation of a solid organ or 
part of a solid organ because the donor's bone marrow regenerates and 
replaces itself. In this sense, bone marrow donation is like blood 
donation, for which there is also no follow-up, because of the body's 
ability to regenerate and replace the lost blood volume. Effects of 
donation such as pain at the site of the bone marrow extraction or 
fatigue are minimal and resolve within a short time. This approach is 
aligned with community standards, as neither OPTN nor applicable 
standards of care or patient safety standards provide for the follow-up 
of bone marrow donors. Nonetheless, under proposed paragraph (c)(4), VA 
would provide direct medical care required to address reasonably 
foreseeable live donor health complications resulting directly from the 
bone marrow donation procedure for a period not greater than 2 years.
    Proposed paragraph (c)(5) would clarify the legal authority that 
applies to care and services provided under paragraphs (c)(1) through 
(4) for a prospective live donor or a live donor who is also a veteran 
enrolled in VA's health care system. We note that a prospective live 
donor who also happens to be a veteran enrolled in VA's health care 
system would receive care and services authorized in paragraphs (c)(1) 
and (c)(2) only under this section, not as part of VA's medical 
benefits package available to enrollees pursuant to 38 CFR 17.38. These 
health care benefits are outside the scope of VA's treatment authority 
in section 1710, as implemented by the medical benefits package 
codified at 38 CFR 17.38, because they are not medically necessary. 
Serving as a prospective live donor is voluntary and not based on the 
medical needs of the prospective live donor; rather, it furthers only 
the necessary medical needs of the intended recipient. For live donors 
who are also veterans enrolled in VA's health care system, the care and 
services authorized under paragraphs (c)(1) and (c)(2) are not 
medically necessary for the live donor, as stated above; however, after 
they undergo the transplant operation or procedure, we believe they 
will have their own medical needs apart from those of the transplant 
recipient. We therefore think it necessary to provide a live donor who 
is enrolled in VA's health care system the option to receive care and 
services authorized under paragraphs (c)(3) and (c)(4) as an enrolled 
veteran, if desired. Proposed paragraph (c)(5) would therefore provide 
that a live donor who is also an enrollee may opt to receive his or her 
care and services authorized under paragraph (c)(3) under either the 
medical benefits package in Sec.  17.38 of this chapter or under this 
section, but not both at the same time. Similarly, proposed paragraph 
(c)(5) would also state that a live donor who is also an enrollee may 
opt to receive his or her care and services authorized under paragraph 
(c)(4) under either the medical benefits package in Sec.  17.38 or 
under this section, but not both at the same time. To clarify, the live 
donor may opt to receive the benefits authorized in paragraphs (c)(3) 
and (c)(4) only under one authority, as combining them would not be 
feasible. We note that, upon request, VA would explain the benefit 
implications for the veteran under each program, such as the difference 
in travel and lodging benefits. In either case, however, the follow-up 
of a live donor would terminate per the terms of this program.

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    Proposed paragraph (d) of this section would be titled ``Non-
hospital care and non-medical services'' and would describe the costs 
of non-hospital care and non-medical services for which VA may 
reimburse the prospective live donor or live donor. (This benefit is 
wholly separate from veteran beneficiary travel benefits under 38 
U.S.C. 111.) Section 1788(b) provides for VA to ``furnish'' a live 
donor any care or services before and after the veteran's 
transplantation procedure required in connection with that procedure.
    We note that 38 U.S.C. 1788(b) provides broad authority for VA to 
furnish to a live donor any care or services before and after 
conducting the transplant procedure that may be required in connection 
with such procedure. As explained in the subsequent paragraph, VA 
believes that reimbursing live donors for travel costs, including 
temporary lodging as VA determines to be needed, is appropriate. 
However, VA takes this opportunity to invite public comment on whether 
VA should consider paying for other non-hospital care and non-medical 
services.
    VA believes reimbursement for travel costs, including temporary 
lodging as appropriate, may be required for a prospective live donor or 
live donor and a needed attendant or support person. VA has authority 
to reimburse these travel costs under 38 U.S.C. 1788(b). Section 
1788(b) does not, however, specify reimbursement rates or limitations. 
Because VA has an established travel reimbursement program for 
veterans, see 38 CFR part 70, we would identify the modes of travel and 
payment principles and derive the rates of travel reimbursement for 
travel and temporary lodging from 38 CFR 70.30 as set forth in 
paragraph (d) of the proposed regulation. The deductibles set forth in 
Sec.  70.31 would not apply regardless of whether the donor or other 
traveler is a veteran or a non-veteran. Imposing the deductible would 
be contrary to the purposes of section 1788; that is, it would impose a 
barrier to participation, and so VA would not reduce the travel 
reimbursement of a prospective live donor or live donor who happens to 
be a veteran and who is not traveling as a veteran. Taxes associated 
with temporary lodging would be reimbursed to the extent and consistent 
with the manner in which VA covers such expenses under 38 CFR 70.30. 
Prospective live donors and live donors would also not be subject to 
eligibility or any other criteria of 38 CFR part 70.
    Proposed paragraph (d)(1) would provide that, if VA determines the 
prospective live donor's or live donor's presence or proximity is 
necessary, VA would reimburse the travel costs of the prospective live 
donor or live donor and, if applicable, one needed attendant or support 
person, for travel between the prospective live donor's or live donor's 
residence and the site of the hospital care or medical services 
authorized in proposed paragraph (c). While there may be instances when 
VA contracts with providers in the community for the transplant 
procedure, VA would retain the authority to make the determination as 
to whether the prospective live donor's or live donor's presence or 
proximity is necessary. This would ensure consistency across the 
country in administering these benefits and this program and would 
ensure that there are no unauthorized commitments made by non-VA 
providers, as this determination can lead to reimbursement for travel 
costs related to the transplant procedure. It would thus be fiscally 
responsible for VA to retain this authority. In determining whether the 
prospective live donor's or live donor's presence or proximity is 
necessary, VA would obtain and consider input from the transplant care 
team, including the provider responsible for the intended recipient's 
transplant procedure, the provider responsible for the prospective live 
donor's or live donor's donation procedure, and a VA transplant 
specialist not participating in the care of the recipient, as 
indicated. This would be consistent with OPTN policies that focus on 
donor advocacy and on having decisions related to the donor not be 
solely directed by the transplant recipient's care team.
    Proposed paragraph (d)(2) would provide for VA reimbursement of the 
prospective live donor or live donor for temporary lodging, including 
for a needed attendant or support person, while the prospective live 
donor or live donor is hospitalized for the organ removal procedure or 
while participating in the live donor program which requires the 
prospective live donor's or live donor's presence away from home at 
least overnight as determined necessary by VA. VA considers a 
prospective live donor's or live donor's need for temporary lodging or 
the assistance of a needed attendant before or after the donation 
procedure to be determinations to be made by VA. Consistent with the 
intent to remove barriers to live donors donating a solid organ, part 
of a solid organ, or bone marrow, VA considers these costs to be 
essential, and therefore medically necessary, to the treatment of 
intended recipients. As explained in the preceding discussion regarding 
proposed paragraph (d)(1), while there may be instances when VA 
contracts with providers in the community for the transplant procedure, 
VA would similarly retain the authority to make the determination as to 
whether the prospective live donor's or live donor's presence or 
proximity is necessary. This would ensure consistency across the 
country in administering these benefits and this program. It would 
ensure that there are no unauthorized commitments made by non-VA 
providers, as this determination can lead to reimbursement for travel 
costs related to the transplant procedure, and it would thus be 
fiscally responsible for VA to retain this authority. In determining 
whether the prospective live donor's or live donor's presence or 
proximity is necessary, VA would obtain and consider input from the 
transplant care team, including the provider responsible for the 
intended recipient's transplant procedure, the provider responsible for 
the prospective live donor's or live donor's donation procedure, and a 
VA transplant specialist not participating in the care of the 
recipient, as indicated. This would also be consistent with OPTN 
policies that focus on donor advocacy and on having decisions related 
to the donor not be solely directed by the transplant recipient's care 
team, as to avoid any potential conflicts.
    Proposed paragraph (e) of this section, titled ``Use of non-VA 
facilities and non-VA service providers,'' construes 38 U.S.C. 1788(c) 
as it applies to 38 U.S.C. 1788(a) and (b). It would provide for VA to 
purchase community care and to purchase travel services to facilitate a 
prospective live donor's or a live donor's donation. The agreements 
under this paragraph must be governed by 38 U.S.C. 8153, or by any 
other applicable authority in title 38, United States Code, permitting 
VA to purchase such care and services in the community. Paragraph 
(e)(1)(i) would provide for VA to enter into agreements with non-VA 
facilities for them to provide a surgical procedure and care and 
services described in paragraph (c) of this section. Paragraph 
(e)(1)(ii) would provide for VA to enter agreements with service 
facilities and providers for non-hospital care or non-medical services 
(i.e., travel services and lodging) that are described and otherwise 
reimbursable under paragraph (d) of this section. Proposed paragraph 
(e)(2), as 38 U.S.C. 1788(c) requires, would limit hospital care and 
medical services under these

[[Page 15632]]

agreements to those described in paragraph (c) of this section and 
would limit travel services to those described in paragraph (d) of this 
section. To avoid repetition, paragraph (e) would identify the hospital 
care and medical services to which it applies as those described in 
paragraph (c) of this section. It would identify the travel services to 
which it applies as those described in paragraph (d) of this section.
    Proposed paragraph (f) of this section, titled ``Participation 
terminated without completion of the intended recipient's 
transplantation procedure,'' would ensure that a prospective live donor 
or live donor is not financially penalized because of termination of 
the transplantation process. Proposed paragraph (f)(1) would state that 
VA would provide the prospective live donor or live donor the care and 
services described in this section for any VA-authorized participation 
in the intended recipient's organ or bone marrow transplantation 
process even if the transplantation procedure for which the prospective 
live donor or live donor volunteered to donate a solid organ, part of a 
solid organ, or bone marrow is not completed. There are any number of 
reasons an intended recipient might not receive a prospective live 
donor's solid organ, part of a solid organ, or bone marrow. Any of 
these could occur at any time during the transplantation process. 
Rather than identify discrete steps or procedures for which VA will 
pay, this paragraph prescribes that VA authorization for a prospective 
live donor to participate in the transplantation process is the event 
that triggers VA's commitment to pay all of that donor's transplant 
costs authorized under this section up through the point when that 
individual's participation in the transplantation process ends. For 
example, if VA authorizes the prospective live donor to undergo 
assessments and diagnostic testing to assess suitability for donation, 
VA would pay for these costs even if the screening results subsequently 
disqualify the prospective donor. In addition, VA's obligations to the 
live donor under this section would be honored throughout the live 
donor's participation in the transplantation process even if the live 
donor's removal surgery reveals a previously unidentified disqualifying 
medical condition or the intended recipient dies before transplantation 
occurs.
    A prospective live donor or a live donor may withdraw their 
informed consent at any time and for any reason. In these cases, VA 
will recognize and honor the donor's right to autonomy. Therefore, 
paragraph (f)(2) makes that clear and also provides that, in the case 
of revocation of consent, VA would still pay all the costs authorized 
under this section for the prospective live donor or live donor up 
until when the donor revokes consent and ends participation. To 
condition payment of these donors' costs on their completion of the 
live donor transplantation process would be coercive. Whatever a 
prospective live donor's or a live donor's reasons to revoke their 
informed consent, they could feel pressured to proceed against their 
wishes if revocation meant VA would not be financially liable for costs 
they had already incurred. Donor participation under these 
circumstances would be coercive. Even the appearance of coercion could 
impugn the integrity of the program. This paragraph seeks to avoid even 
that appearance. Apart from this concern, including this provision 
furthers the purpose of section 1788 by removing obstacles to donor 
participation in the program.
    Proposed paragraph (g) of this section, titled ``Limitation on VA 
obligation in kidney paired donations,'' would limit VA's obligation to 
provide the care or services paragraph (c) of this section describes in 
the context of kidney paired donations. Kidney paired donation 
increases an intended recipient's pool of potential live kidney donors 
and often involves a series of matched donor exchanges. If a 
prospective live donor and the intended recipient do not match, that 
individual can become an initial prospective live donor. An initial 
prospective live donor agrees to donate his or her kidney to a 
different individual who is a match, and the intended recipient is 
ultimately paired with a different prospective live donor who is a 
match.
    In a paired kidney donation, VA would provide the initial 
prospective live donor the examinations, tests, and studies described 
in proposed paragraph (c)(1) of this section. These are the same care 
and services that VA would provide a prospective live donor before 
kidney removal. Another party (such as a health insurance company or 
the intended recipient) would be responsible, however, for the costs of 
the initial prospective live donor's surgical, post-operative, live 
donor follow-up, and other care and services. The proposed regulation 
would identify as the live donor in kidney paired donation the person 
who is determined independently to match the intended recipient and 
whose kidney the intended recipient receives. VA would provide this 
live donor's surgical procedure and all care and services, including 
live donor follow-up, provided to live organ donors under this 
regulation.
    More specifically, proposed paragraph (g)(1) would establish that 
VA will provide any procedure, care, or services under this section to 
the initial prospective live donor who elects to participate in a 
kidney paired donation matching program, but only for the examinations, 
tests, and studies described in paragraph (c)(1) for a prospective live 
donor before kidney removal. Proposed paragraph (g)(2) would establish 
that VA would provide any procedure, care, or services under this 
section to the live donor whose kidney the intended recipient will 
receive or has received but only for the services described in 
paragraphs (c)(2) and (c)(3). VA may use a non-VA facility as 
authorized in paragraph (e) to provide any care or services required in 
a kidney paired donation, limited, however, as described in paragraph 
(g) of this section.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
The Office of Information and Regulatory Affairs has determined that 
this rule is a significant regulatory action under Executive Order 
12866.
    VA's impact analysis can be found as a supporting document at 
http://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published. Additionally, a copy of the 
rulemaking and its impact analysis are available on VA's website at 
http://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published From FY 2004 Through Fiscal Year to Date.''

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not 
have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act (5 
U.S.C. 601-612). VA has determined that this rule would not have a 
significant impact on a substantial number of small entities

[[Page 15633]]

because the proposed rule does not directly regulate or impose costs on 
small entities and any effects would be indirect. Therefore, pursuant 
to 5 U.S.C. 605(b), the initial and final regulatory flexibility 
analysis requirements of 5 U.S.C. 603 and 604 do not apply.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule 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. This proposed rule will have no such effect 
on State, local, and tribal governments, or on the private sector.

Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.029, Purchased Care Program; 64.047, VHA Primary 
Care; 64.042, 64. 045, VHA Ancillary Outpatient Services; 64.042, VHA 
Inpatient Surgery; 64.040, VHA Inpatient Medicine; 64.041,VHA 
Outpatient Specialty Care; 64.035 Veterans Transportation Program.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

Signing Authority

    The Secretary of Veterans Affairs approved this document on March 
12, 2021 and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs.

Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons stated in the preamble, the Department of Veterans 
Affairs proposes to amend 38 CFR part 17 as set forth below:

PART 17--MEDICAL

0
1. The general authority citation for part 17 continues and an 
authority citation for Sec.  17.395 is added in numerical order to read 
as follows:

    Authority: 38 U.S.C. 501 and as noted in specific sections.
* * * * *
    Section 17.395 is also issued under 38 U.S.C. 1788.

0
2. Add an undesignated center heading following 38 CFR 17.390 to read 
as follows:

Hospital Care, Medical Services, and Other Services for Live Donors

0
3. Add Sec.  17.395 to read as follows:


Sec.  17.395  Transplant procedures with live donors, and related 
services.

    (a) Scope. This section provides for medical and non-medical care 
and services of persons who volunteer to donate a solid organ, part of 
a solid organ, or bone marrow for transplantation into an eligible 
veteran transplant candidate, irrespective of a donor's eligibility to 
receive VA health care for any reason other than to donate a solid 
organ, part of a solid organ, or bone marrow. It prescribes the type, 
timing, and duration of hospital care and medical services VA provides, 
including medical care or services purchased by agreement from a non-VA 
facility. It also provides for non-medical care and services essential 
to the prospective live donor's or live donor's participation and for 
VA reimbursement for that care and services. The section does not 
provide for eligible veteran transplant candidates' VA medical 
benefits.
    (b) Definitions. For purposes of this section:
    Initial prospective live donor means an intended recipient's 
prospective live donor who volunteers to donate a kidney to a recipient 
other than the intended recipient through kidney paired donation.
    Intended recipient means the transplant candidate who VA identifies 
to receive a live donor's solid organ, part of a solid organ, or bone 
marrow.
    Kidney paired donation means one prospective live donor's voluntary 
donation of a kidney for transplantation into a recipient other than an 
intended recipient, paired with the transplantation into the intended 
recipient of a compatible kidney from a different live donor.
    Live donor means an individual who is:
    (1) Medically suitable for donation;
    (2) Is a compatible match to an identified veteran transplant 
candidate; and
    (3) Has provided informed consent to undergo elective removal of 
one solid organ, part of a solid organ, or of bone marrow.

Live Donor Follow-Up Means

    (1) For live donors of a solid organ or part of a solid organ, the 
collection of clinically relevant post-donation live donor data and the 
provision of recommended clinical laboratory tests and evaluations 
consistent with Organ Procurement and Transplantation Network policy, 
and the provision of direct medical care required to address reasonably 
foreseeable donor health complications resulting directly from the 
donation procedure.
    (2) For live donors of bone marrow, the provision of direct medical 
care required to address reasonably foreseeable donor health 
complications resulting directly from the donation procedure.
    Prospective live donor means a person who has volunteered to donate 
a solid organ, part of a solid organ, or bone marrow to an intended 
recipient, and who has agreed to participate in any activity VA deems 
necessary to carry out the intended recipient's transplant procedure.
    Transplant candidate means an enrolled veteran or a veteran 
otherwise eligible for VA's medical benefits package who VA determines 
has a medical need for a solid organ, part of a solid organ, or bone 
marrow transplant.
    Transplant recipient means a transplant candidate who has undergone 
transplantation and received a solid organ, part of a solid organ, or 
bone marrow from a live donor.
    (c) Hospital care and medical services. To obtain a solid organ, 
part of a solid organ, or bone marrow for a VA transplant candidate, VA 
may provide the following hospital care and medical services to a 
prospective live donor or live donor:
    (1) Before removal of a solid organ, part of a solid organ, or bone 
marrow, VA will provide examinations, tests, and studies necessary to 
qualify a

[[Page 15634]]

prospective live donor to donate a solid organ, part of a solid organ, 
or bone marrow.
    (2) During removal of a solid organ, part of a solid organ, or bone 
marrow, VA will provide the surgical procedure to remove a solid organ, 
part of a solid organ, or bone marrow from the living donor whose solid 
organ, part of a solid organ, or bone marrow will be transplanted into 
an intended recipient.
    (3) After removal of a solid organ or part of a solid organ, VA 
will provide all hospital care, medical services, and other services 
which are necessary and appropriate to live donor follow-up as defined 
in paragraph (b) of this section for a period not less than that which 
the Organ Procurement and Transplantation Network prescribes or 
recommends or for a period of 2 years, whichever is greater.
    (4) After bone marrow removal, VA will provide direct medical care 
required to address reasonably foreseeable live donor health 
complications resulting directly from the bone marrow donation 
procedure for a period not greater than 2 years.
    (5) A prospective live donor who is also a veteran enrolled in VA's 
health care system may receive care and services authorized in 
paragraphs (c)(1) and (c)(2) only under this section. A live donor who 
is also a veteran enrolled in VA's health care system may opt to 
receive the care and services authorized under paragraph (c)(3) or 
(c)(4) under either the medical benefits package codified at Sec.  
17.38 of this part or under this section, but not both at the same 
time.
    (d) Non-hospital care and non-medical services. If VA determines 
the prospective live donor's or the live donor's presence or proximity 
is necessary, VA will reimburse the travel costs of the prospective 
live donor or live donor, including one needed attendant or support 
person, at the rates provided in Sec.  70.30 of this chapter, without 
the deductibles required by Sec.  70.31 of this chapter, for:
    (1) Travel between the prospective live donor's or live donor's 
residence and the site of hospital care or medical services authorized 
in paragraph (c) of this section; and
    (2) Temporary lodging:
    (i) While the live donor is hospitalized for the organ removal 
procedure; or
    (ii) While the prospective live donor's or live donor's 
participation in the live donor program requires the prospective live 
donor's or live donor's presence away from home at least overnight and 
the prospective live donor's or live donor's presence or proximity is 
determined necessary by VA.
    (e) Use of non-VA facilities and non-VA service providers. (1) If 
and only if VA and a non-VA facility or non-VA service provider have an 
agreement governed by 38 U.S.C. 8153 or any other applicable authority 
in title 38, United States Code, a non-VA facility may provide--
    (i) A surgical procedure and care and services described in 
paragraph (c) of this section; or
    (ii) Non-hospital care or non-medical services described and 
otherwise reimbursable under paragraph (d) of this section.
    (2) The prospective live donor or live donor is eligible for 
hospital care and medical services, or travel services, at a non-VA 
facility solely for the procedure, care, and services described in 
paragraphs (c) and (d) of this section as governed by an agreement 
described in paragraph (e)(1) of this section.
    (f) Participation terminated without completion of the intended 
recipient's transplantation procedure.
    (1) VA will provide the prospective live donor or live donor the 
care and services described in this section for any VA-authorized 
participation in the intended recipient's organ or bone marrow 
transplantation process even if the transplantation procedure for which 
the prospective live donor or live donor volunteered to donate a solid 
organ, part of a solid organ, or bone marrow is not completed.
    (2) A prospective live donor or a live donor may withdraw his or 
her informed consent at any time and for any reason. In the case of 
revocation of consent, VA will pay all the costs authorized under this 
section for the prospective live donor or live donor up until when the 
donor revokes consent and ends his or her participation.
    (g) Limitation on VA obligation in kidney paired donations. In 
kidney paired donations, VA's obligation to provide any procedure, 
care, or services under this section extends:
    (1) To the initial prospective live donor who elects to participate 
in a kidney paired donation matching program, but only for the 
examinations, tests, and studies described in paragraph (c)(1) of this 
section for a prospective live donor before kidney removal.
    (2) To the live donor whose kidney the intended recipient will 
receive or has received but only for the services described in 
paragraphs (c)(2) and (c)(3).

[FR Doc. 2021-05682 Filed 3-23-21; 8:45 am]
BILLING CODE 8320-01-P