Transplant Procedures With Live Donors and Related Care and Services
| Published date | 24 March 2021 |
| Citation | 86 FR 15628 |
| Record Number | 2021-05682 |
| Section | Proposed rules |
| Court | Veterans Affairs Department |
Federal Register, Volume 86 Issue 55 (Wednesday, March 24, 2021)
[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]
[[Page 15628]]
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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
[[Page 15629]]
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
[[Page 15630]]
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.
[[Page 15631]]
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
