Instructions for Determining Eligibility for In Vitro Fertilization (IVF) Benefit, 23518-23521 [2024-07040]
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Federal Register / Vol. 89, No. 66 / Thursday, April 4, 2024 / Rules and Regulations
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Nasser Paydar,
Assistant Secretary for Postsecondary
Education.
[FR Doc. 2024–07131 Filed 4–3–24; 8:45 am]
BILLING CODE 4000–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
ddrumheller on DSK120RN23PROD with RULES1
Instructions for Determining Eligibility
for In Vitro Fertilization (IVF) Benefit
Department of Veterans Affairs.
General policy statement.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) announces that the
Secretary of Veterans Affairs issued
Instruction of the Secretary 01–24 on
March 28, 2024, which addresses the
SUMMARY:
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expansion of eligibility for IVF benefits
to qualified Veterans and their spouses.
VA’s authority to provide assisted
reproductive technology (ART) benefits
to veterans and their spouses, including
IVF coverage, references the benefits the
Department of Defense (DoD) provides
to active-duty service members. The
primary benefit provided by VA under
this authority is IVF. DoD previously
limited the IVF benefit to service
members who had a Category II or III
injury or illness and who together with
their legal spouse could produce and
carry a child who is biologically their
own. This limitation effectively limited
the benefit to service members who
were legally married and capable of
producing their own sperm and eggs
(gametes) within that marriage. On
March 8, 2024, DoD amended its policy
to cover IVF for service members with
a qualifying injury or illness who are
unmarried and to allow donated
gametes and embryos. VA is amending
its IVF policy to adopt conforming
changes.
DATES: Instructions for Determining
Eligibility for IVF Benefit is effective
March 28, 2024.
FOR FURTHER INFORMATION CONTACT:
Sally G. Haskell, MD, MS, Acting Chief
Officer, Office of Women’s Health,
Veterans Health Administration,
Department of Veterans Affairs, 810
Vermont Avenue NW, Washington, DC
20420, 202–461–0373. (This is not a
toll-free number.)
SUPPLEMENTARY INFORMATION:
Instruction of the Secretary 01–24
Notice is given that the Secretary of
Veterans Affairs issued Instruction of
the Secretary 01–24—Instructions for
Determining Eligibility for In Vitro
Fertilization (IVF) Benefit on March 28,
2024. The text of Instruction of the
Secretary 01–24 appears at the end of
this Federal Register document.
Background
On April 3, 2012, DoD implemented
its IVF policy in a memorandum titled
‘‘Policy for Assisted Reproductive
Services for the Benefit of Seriously or
Severely Ill/Injured (Category II or III)
Active Duty Service Members,’’
accompanied by implementation
guidance (collectively referred to
throughout this document as the ‘‘DoD
Policy’’). The DoD Policy restricted the
benefit to service members with a
qualifying injury or illness who,
together with their legal spouse, were
able to produce and carry a child who
is biologically their own. This
effectively limited the benefit to service
members who were legally married and
capable of producing a child who is
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biologically related to the service
member and their spouse.
Since 2016, Congress has authorized
VA to use medical services funds to
provide ART benefits, which includes
IVF coverage, to covered veterans or to
provide fertility treatment services
including ART to the spouses of covered
veterans as provided to a member of the
Armed Forces under the DoD Policy.
Public Law 114–223, Division A, Title
II, section 260 (Sept. 29, 2016). Congress
defined a ‘‘covered veteran’’ to be one
who has a service-connected disability
that results in the inability of the
veteran to procreate without the use of
fertility treatment. Congress has
continued to reauthorize the use of
medical services funds for this purpose
in subsequent appropriations laws, most
recently in March 2024 in Public Law
118–42, Division A, Title II, section 234.
VA implemented Congress’s
authorization by issuing 38 CFR 17.380
and 17.412, which clarified the
definition of a covered veteran for the
purposes of establishing eligibility for
IVF coverage and authorized fertility
treatment of the legal spouse of a
covered veteran, respectively. VA also
issued VHA Directive 1334 establishing
the full eligibility criteria for IVF
coverage, including the applicable
restrictions contained in the DoD Policy.
On March 8, 2024, DoD amended the
DoD Policy to eliminate the requirement
that to receive IVF and other ART
services, an active-duty service member,
along with their legal spouse, be able to
produce and carry a child who is
biologically their own. In the amended
policy, DoD expressly stated that
eligibility would not be based on marital
status and that donor sperm, eggs, and
embryos may be used in ART services,
including IVF.
VHA Directive 1334, paragraph 1.c.
provides that any substantive changes
made to DoD’s policy will supersede
conflicting terms in VHA Directive
1334. Therefore, in Instruction of the
Secretary 01–24, issued on March 28,
2024, the Secretary has directed VA
employees and officials to revise VHA
Directive 1334 to eliminate the
requirement that a covered veteran to be
married and be able to produce and
carry a child who is biologically their
own in order to qualify for IVF coverage.
These revisions allow VA to provide
IVF services for an unmarried covered
veteran. The revisions also allow for the
use of donor sperm, eggs, or embryos, as
long as the donated sperm, eggs, and
embryos are provided at no cost to VA.
Effectively, the revisions to VHA
Directive 1334 allow VA to expand the
provision of IVF services to covered
veterans who are unmarried, married to
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a partner who does not have oppositesex gametes, and/or incapable of
producing their own sperm and/or eggs.
Instruction of the Secretary 01–24
does not eliminate the statutorily
imposed requirement that a veteran
must have a service-connected disability
that results in the inability of the
veteran to procreate without the use of
fertility treatment to be considered a
‘‘covered veteran.’’ However, the
Instruction clarifies that the definition
of ‘‘a service-connected disability that
results in the inability of the veteran to
procreate without the use of fertility
treatment’’ provided for female veterans
who have ovarian function and a patent
uterine cavity in 38 CFR 17.380 will
also apply to female veterans without
ovarian function or a patent uterine
cavity. Previously, no definition was
provided for the female veteran
population that did not have ovarian
function or a patent uterine cavity
because the exclusion of donor sperm,
eggs, and embryos eliminated them from
eligibility. Now, the Secretary clarifies
they must meet the same definition as
female veteran with ovarian function
and a patent uterine cavity to be
considered a ‘‘covered veteran.’’
Text of Instruction of Secretary 01–24
MEMORANDUM FOR THE UNDER
SECRETARY FOR HEALTH AND THE
CHAIRMAN, BOARD OF VETERANS
APPEALS
Subject: Instructions for Determining
Eligibility for In Vitro Fertilization (IVF)
Benefit.
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Purpose
1. I am issuing this instruction to
clarify the impact for the Department of
Veterans Affairs (VA or the Department)
of the amendment to the Department of
Defense (DoD) Policy for Assisted
Reproductive Services (ART) for the
Benefit of Seriously or Severely Ill/
Injured (Category II or III) Active Duty
Service Members (hereinafter referred to
as the ‘‘DoD Policy’’) issued by DoD on
March 8, 2024. The amendments to the
DoD Policy are substantive and have
superseded the conflicting terms of
VHA Directive 1334(1), In Vitro
Fertilization Counseling and Services
Available to Certain Eligible Veterans
and Their Spouses, dated March 21,
2021, in accordance with paragraph 1.c.
of that Directive.
2. I am instructing VA employees to
not restrict eligibility for IVF services
based on marital status or the ability to
produce opposite-sex autologous
gametes, as described in more detail
below. Furthermore, the use of donor
gametes and donor embryos in the
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provision of the IVF benefit will be
allowed.
3. Additionally, I am issuing this
instruction to clarify the impact of the
policy changes on the definition of ‘‘a
service-connected disability that results
in the inability of the veteran to
procreate without the use of fertility
treatment’’, found in 38 CFR 17.380, as
the current definition does not
contemplate the use of donor gametes
and donor embryos.
4. I am instructing Department
employees to interpret the term ‘‘a
service-connected disability that results
in the inability of the veteran to
procreate without the use of fertility
treatment’’ as defined for a female
veteran with ovarian function and a
patent uterine cavity in 38 CFR 17.380
to also apply to a female veteran
without ovarian function or a patent
uterine cavity.
Background
5. The National Defense
Authorization Act for Fiscal Year 2008,
Public Law 110–181, section 1633, 122
Stat. 3, 459 (2008), authorized DoD to
provide IVF benefits for certain service
members.
6. On April 3, 2012, DoD
implemented its IVF policy in a
memorandum titled ‘‘Policy for Assisted
Reproductive Services for the Benefit of
Seriously or Severely Ill/Injured
(Category II or III) Active Duty Service
Members,’’ accompanied by
implementation guidance (collectively
referred to throughout this document as
the ‘‘DoD Policy’’).
7. DoD Policy clause IIIA provided:
It is the intent of this policy to provide
Invitro(sic) Fertilization (IVF) services only
to consenting male members whose injury or
illness prevents the successful delivery of
their sperm to their spouse’s egg and to
consenting female members whose injury or
illness prevents their egg from being
successfully fertilized by their spouse’s
sperm but who maintain ovarian function
and have a patent uterine cavity.
8. DoD Policy clause IIIE provided:
Third-party donation and surrogacy are not
covered benefits- the benefit is designed to
allow the member and spouse to become
biological parents through reproductive
technologies where Active Duty injury or
illness has made it impossible to conceive
naturally.
9. Since 2016, Congress has
authorized VA to use medical services
funds to provide fertility counseling and
treatment, including ART, to certain
covered veterans and to the spouses of
covered veterans. Public Law 114–223,
Division A, Title II, section 260 (Sept.
29, 2016).
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10. Congress defined a covered
veteran to be one who has a serviceconnected disability that results in the
inability of the veteran to procreate
without the use of fertility treatment. Id.
Congress continued to authorize the use
of medical services funds for this
purpose in subsequent appropriations
laws, most recently in March 2024 in
Public Law 118–42, Division A, Title II,
section 234.
11. On March 7, 2019, VA published
the final rule creating 38 CFR 17.380
implementing Congress’s authorization.
The regulation provided in pertinent
part:
For the purposes of this section, ‘‘a serviceconnected disability that results in the
inability of the veteran to procreate without
the use of fertility treatment’’ means, for a
male veteran, a service-connected injury or
illness that prevents the successful delivery
of sperm to an egg; and, for a female veteran
with ovarian function and a patent uterine
cavity, a service- connected injury or illness
that prevents the egg from being successfully
fertilized by sperm.
The regulation provides a definition
‘‘for a male veteran’’ and ‘‘for a female
veteran with ovarian function and a
patent uterine cavity’’. It does not
provide a definition for female veterans
without ovarian function and/or
without a patent uterine cavity.
12. As a result, female veterans
without ovarian function and/or a
patent uterine cavity are in an
undefined area of eligibility, neither
expressly excluded nor expressly
included in 38 CFR 17.380. This may
inadvertently result in veterans who
sustained service-connected disabilities
affecting ovarian function and/or the
uterine cavity not being considered
‘‘covered veterans’’ for the purposes of
fertility benefits.
13. In March 2021, VA issued
subregulatory guidance in the form of
VHA Directive 1334 to implement its
policy for providing IVF counseling and
services to eligible veterans and their
spouses.
14. VHA Directive 1334, paragraph
1.c., Purpose, notes that DoD Policy
governs VA’s provisions for IVF
counseling and services, and any
substantive changes made to DoD’s
policy will supersede conflicting terms
in VHA Directive 1334.
15. On the basis of DoD Policy clauses
IIIA and IIIE, VHA Directive 1334 had
the effect of limiting VHA to providing
IVF services to cisgender opposite-sex
legally married couples or other legally
married couples with opposite-sex
gametes/reproductive organs.
16. On March 8, 2024, DoD Policy was
amended. In relevant part, the
amendments eliminated the language in
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Policy Clause IIIA referred to in
paragraph 7, above. The amendment
also removed the prohibition on the use
of donor gametes in Policy Clause IIIE
and expressly allows for the use of
donor embryos in the fertility treatment
of qualified service members, provided
they are obtained at no cost to DoD.
Further, the policy was amended to
allow a qualified service-member to
receive ART services, as clinically
appropriate.
that prohibition would have prevented
such a female veteran from being
eligible for IVF services. However, with
the lifting of the prohibition on donor
gametes and donor embryos, VA must
address what the definitional
requirements are for a female veteran
without ovarian function and/or a
patent uterine cavity. Paragraph 35,
below, addresses these requirements.
20. VHA Directive 1334, paragraph
2.d., Background, is revised to read:
Qualifying as a Covered Veteran for
Purposes of Receiving IVF Services
17. This Instruction addresses the
effect of the DoD Policy amendment on
VA’s eligibility criteria for veterans and
their spouses to receive IVF counseling
and services through VHA. The
amendment of the DoD Policy
supersedes portions of VHA Directive
1334 which were based on the
unamended DoD Policy. The
amendment also necessitates
clarification of the definition of a
‘‘service-connected disability that
results in the inability of the veteran to
procreate without the use of fertility
treatment’’ in 38 CFR 17.380.
18. With the amendment to the DoD
Policy, VA IVF benefits will no longer
require that a covered Veteran be (1)
married,1 (2) in an opposite-sex
relationship, or (3) able to produce their
own gametes. Paragraphs 20 through 35
address these changes.
19. Further, lifting the prohibition on
donor gametes and donor embryos
necessitates clarification of the
definition of ‘‘a service-connected
disability that results in the inability of
the veteran to procreate without the use
of fertility treatment’’ found in 38 CFR
17.380. The text of the regulation
provides a definition for all male
veterans but only provides a definition
for a female veteran who has ovarian
function and a patent uterine cavity. In
that regard, the regulation does not
provide a definition for a female veteran
who does not have either ovarian
function or a patent uterine cavity. The
lack of a definition for a female veteran
without ovarian function or a patent
uterine cavity posed no problem in
applying the regulation when there was
a prohibition on the use of donated
gametes and donated embryos because
IVF counseling and services are available
to certain seriously injured Veterans no
longer able to procreate without the use of
fertility treatment. For male Veterans, their
service-connected injury or illness must
render the Veteran incapable of successfully
delivering their sperm to an egg. This
definition includes the inability to produce
sperm. For female Veterans, with or without
ovarian function or a patent uterine cavity,
their service-connected injury or illness must
render the Veteran incapable of having an egg
successfully fertilized by sperm. This
definition includes the inability to produce
an egg.
1 VA is only allowed to treat non-veterans when
specifically authorized by statute. Public Law 117–
328, Division J, Title II, section 234 authorizes VA
to provide fertility counseling and identified
treatment to ‘‘a covered veteran or the spouse of a
covered veteran.’’ Therefore, VA will not exclude
unmarried veterans from IVF care as discussed
throughout, but VA is only authorized to provide
IVF care to the non-veteran partner of a veteran if
that non-veteran partner is the spouse of the
covered veteran.
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21. VHA Directive 1334, paragraph
2.e., Background, is revised to read:
VA may furnish IVF fertility counseling
and treatment to Veterans as described herein
and their lawful spouses. More specifically,
consistent with the Memorandum, VA allows
for assisted reproductive services, including
evaluations, intrauterine insemination, sperm
retrieval, oocyte retrieval, in-vitro
fertilization, blastocyst transfer and embryo
transfer, to be available to eligible Veterans.
VA considers that the cryopreservation of
gametes (for both the Veteran and the
spouse), not only embryos, is within the
scope of available benefits described in the
Memorandum. Gamete and embryo
cryopreservation and storage are each
without limitation on duration until, as
explained below, the death of an eligible
Veteran. In determining clinical eligibility for
IVF services, VA treating providers are to use
the same evidence-based clinical eligibility
standards outlined in VHA Directive 1332(2),
Fertility Evaluation and Treatment.
22. VHA Directive 1334, paragraph
2.f. and g., Background, are struck from
the Directive.
23. VHA Directive 1334, paragraph
2.h., Background, is revised to read:
speaking, checked or limited by the death of
an eligible Veteran. This is also the practical
implication of Clause III.F. of the
Memorandum, which requires that VA obtain
the separate consent of the Veteran with third
party consent being prohibited.
25. VHA Directive 1334, paragraph
2.n., Background, is revised to read:
The Veteran’s and spouse’s respective
eligibility determinations will be made by
VHA’s Health Eligibility Center. Serviceconnected conditions covered under this
policy include, but are not limited to, polytrauma, genitourinary injury and spinal cord
injury and other anatomical, neurological,
infectious and physiological injury and/or
illness that are adjudicated by the Veterans
Benefits Administration to be serviceconnected after which VHA IVF program
staff will clinically determine if the serviceconnected condition meets the IVF clinical
eligibility criteria i.e., whether the serviceconnected condition results in loss of
procreative ability that cannot be corrected
without the use of fertility treatment.
26. VHA Directive 1334, paragraph
3.c., Definitions, is revised to read:
Consent to In Vitro Fertilization. Consent
to IVF requires the informed consent of all
parties receiving IVF benefits under this
policy. Each party must have decisionmaking capacity to consent to treatment.
Consent by a third party, including a proxy
decision-maker, is not permitted.
27. VHA Directive 1334, paragraph
3.d., Definitions, is revised to read:
Cryopreservation. Cryopreservation is the
freezing of gametes (oocytes or sperm),
zygotes (1-cell fertilized oocytes), embryos
(typically cryopreserved on day 2, 3, 5, or 6
of development), or gonadal (ovarian or
testicular) tissue to allow storage for future
use. Cryopreserved sperm can be used for
intrauterine insemination (IUI) or IVF after
thawing or rewarming. Cryopreserved
oocytes require IVF after thawing or
rewarming. Cryopreserved tissue may be reimplanted into the body or cultured in vitro
after thawing or rewarming. Duration of
embryo cryopreservation and storage are
without limitation under 38 CFR 17.380 and
17.412 until the death of an eligible Veteran,
provided VA continues to have authority to
provide these non-limited services.
28. VHA Directive 1334, paragraph
3.j., Definitions, is revised to read:
24. VHA Directive 1334, paragraph
2.j., Background, is revised to read:
Infertility. Infertility is a disease, condition,
or status characterized by any of the
following:
(1) The inability to achieve a successful
pregnancy as established by a patient’s
medical, sexual, and reproductive history,
age, physical findings, diagnostic testing, or
any combination of those factors; or
(2) The need for medical intervention,
including, but not limited to, the use of
donor gametes or donor embryos in order to
achieve a successful pregnancy, either as an
individual or with a partner.
Although the benefits of cryopreservation
and storage of gametes and embryos are not
time-limited, these benefits are, practically-
29. VHA Directive 1334, paragraph 6.
Eligibility Requirements, is revised to
read:
Covered veterans and their spouses may
utilize donor gametes and donor embryos
obtained at their own expense when
receiving IVF counseling and services under
this policy. No portion of this benefit will be
used to pay for procedures or associated fees
for the extraction, storage, or transportation
of donor gametes. The creation, storage, and
use of resulting embryos are covered by the
benefit.
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To be eligible for fertility services,
including IVF, the Veteran must have a
service-connected condition that results in
the inability to procreate without the use of
fertility treatment, as defined above. NOTE:
For additional eligibility information, see
appendix A.
30. VHA Directive 1334, paragraph
7.c.(1), Practices and Procedures, is
revised to read:
VA will cover costs of cryopreservation
and storage at an independent community
laboratory indefinitely up through the end of
life of the eligible Veterans. Storage of
cryopreserved gametes and embryos will take
place at an independent facility in the
community, per guidelines outlined in
appendix A.
31. VHA Directive 1334, paragraph
7.c.(3), Practices and Procedures, is
revised to read:
VA will pay the costs of cryopreservation
and storage of cryopreserved oocytes, sperm
and embryos indefinitely until the end of the
life the eligible Veteran, or until the
cryopreserved oocytes, sperm, or embryos are
transferred to a third party (for any purpose
outside this treatment program.
32. VHA Directive 1334, paragraph
7.e.(1), Practices and Procedures, is
struck from the directive.
Gestational surrogacy, as defined in
VHA Directive 1334, will remain
outside the scope of VA IVF Services.
Although the amended DoD Policy
allows for a third-party gestational
carrier in limited instances, Congress’s
authorization for VA to provide fertility
counseling and treatment, including
ART, is limited to providing these
services to a covered veteran and the
spouse of a covered veteran. Therefore,
VA may not provide IVF services to a
person who is neither the covered
veteran nor the spouse of a covered
Veteran.
33. VHA Directive 1334, Appendix A,
Eligibility Criteria, is revised to read:
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1. To be eligible for In Vitro Fertilization
(IVF) under 38 Code of Federal Regulations
(CFR) 17.380, a Veteran must have a serviceconnected disability that results in the
Veteran’s inability to procreate without the
use of fertility treatment.
2. Lawful spouses of eligible Veterans are
eligible for fertility counseling and treatment
under the program pursuant to 38 CFR
17.412.
34. VHA Directive 1334, Appendix B,
In Vitro Fertilization Services,
comparison table c is revised to strike:
1. ‘‘+ lawful eligible spouses’’ from the
‘‘Eligibility’’ line;
2. ‘‘naturally’’ from the ‘‘Service
connection’’ line;
3. the entirety of the ‘‘Marital status’’ line;
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4. the entirety of the ‘‘Couples’’ line;
5. ‘‘with opposite-sex gametes’’ from the
‘‘IUI’’ line;
6. ‘‘or an eligible Veteran’s lawful divorce’’
from the ‘‘Time limits for cryopreservation of
gametes’’ line;
7. ‘‘or an eligible Veteran’s lawful divorce’’
from the ‘‘Cryopreservation for embryos’’
line: and
8. ‘‘or an eligible Veteran’s lawful divorce’’
from the ‘‘Embryo storage paid by VA’’ line.
Additionally, the ‘‘no’’ from the
‘‘Donate sperm’’ line is revised to
‘‘Allowable but not paid for by VA
(Veteran pays for non-Veteran sperm
preparation or procedure to nonVeteran).’’
35. In 38 CFR 17.380, the term ‘‘a
service-connected disability that results
in the inability of the veteran to
procreate without the use of fertility
treatment’’ is interpreted to include:
for a female veteran without ovarian function
and/or patent uterine cavity, a serviceconnected injury or illness that prevents the
successful fertilization of an egg by sperm, to
include the service-connected loss of ovarian
function and/or a patent uterine cavity.
Applicability
36. This Instruction applies to
decisions to authorize benefits on or
after the date of this Instruction, in
which a veteran seeks fertility
counseling or IVF services under 38
CFR 17.380 and 17.412.
Signing Authority
Denis McDonough, Secretary of
Veterans Affairs, approved and signed
this document on March 28, 2024, 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.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy
& Management, Office of General Counsel,
Department of Veterans Affairs.
[FR Doc. 2024–07040 Filed 4–3–24; 8:45 am]
ACTION:
23521
Final rule.
The Environmental Protection
Agency (EPA) is taking final action to
approve revisions to the Maricopa
County Air Quality Department
(MCAQD) portion of the Arizona State
Implementation Plan (SIP). These
revisions concern a rule that includes
definitions for certain terms that are
necessary for the implementation of
local rules that regulate sources of air
pollution. We are approving a local rule
under the Clean Air Act (CAA or the
Act).
SUMMARY:
DATES:
This rule is effective May 6,
2024.
The EPA has established a
docket for this action under Docket ID
No. EPA–R09–OAR–2023–0599. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
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available only in hard copy form.
Publicly available docket materials are
available through https://
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you need assistance in a language other
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accommodation at no cost to you, please
contact the person identified in the FOR
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ADDRESSES:
Kira
Wiesinger, EPA Region IX, 75
Hawthorne St., San Francisco, CA
94105; phone: (415) 972–3827; email:
wiesinger.kira@epa.gov.
FOR FURTHER INFORMATION CONTACT:
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SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to the EPA.
ENVIRONMENTAL PROTECTION
AGENCY
Table of Contents
40 CFR Part 52
[EPA–R09–OAR–2023–0599; FRL–11591–
02–R9]
Air Plan Approval; Arizona; Maricopa
County Air Quality Department
Environmental Protection
Agency (EPA).
AGENCY:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
I. Proposed Action
On December 27, 2023 (88 FR 89355),
the EPA proposed to approve the
following rule into the Arizona SIP.
E:\FR\FM\04APR1.SGM
04APR1
Agencies
[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Rules and Regulations]
[Pages 23518-23521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07040]
=======================================================================
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
Instructions for Determining Eligibility for In Vitro
Fertilization (IVF) Benefit
AGENCY: Department of Veterans Affairs.
ACTION: General policy statement.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) announces that the
Secretary of Veterans Affairs issued Instruction of the Secretary 01-24
on March 28, 2024, which addresses the expansion of eligibility for IVF
benefits to qualified Veterans and their spouses. VA's authority to
provide assisted reproductive technology (ART) benefits to veterans and
their spouses, including IVF coverage, references the benefits the
Department of Defense (DoD) provides to active-duty service members.
The primary benefit provided by VA under this authority is IVF. DoD
previously limited the IVF benefit to service members who had a
Category II or III injury or illness and who together with their legal
spouse could produce and carry a child who is biologically their own.
This limitation effectively limited the benefit to service members who
were legally married and capable of producing their own sperm and eggs
(gametes) within that marriage. On March 8, 2024, DoD amended its
policy to cover IVF for service members with a qualifying injury or
illness who are unmarried and to allow donated gametes and embryos. VA
is amending its IVF policy to adopt conforming changes.
DATES: Instructions for Determining Eligibility for IVF Benefit is
effective March 28, 2024.
FOR FURTHER INFORMATION CONTACT: Sally G. Haskell, MD, MS, Acting Chief
Officer, Office of Women's Health, Veterans Health Administration,
Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC
20420, 202-461-0373. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Instruction of the Secretary 01-24 Notice is
given that the Secretary of Veterans Affairs issued Instruction of the
Secretary 01-24--Instructions for Determining Eligibility for In Vitro
Fertilization (IVF) Benefit on March 28, 2024. The text of Instruction
of the Secretary 01-24 appears at the end of this Federal Register
document.
Background
On April 3, 2012, DoD implemented its IVF policy in a memorandum
titled ``Policy for Assisted Reproductive Services for the Benefit of
Seriously or Severely Ill/Injured (Category II or III) Active Duty
Service Members,'' accompanied by implementation guidance (collectively
referred to throughout this document as the ``DoD Policy''). The DoD
Policy restricted the benefit to service members with a qualifying
injury or illness who, together with their legal spouse, were able to
produce and carry a child who is biologically their own. This
effectively limited the benefit to service members who were legally
married and capable of producing a child who is biologically related to
the service member and their spouse.
Since 2016, Congress has authorized VA to use medical services
funds to provide ART benefits, which includes IVF coverage, to covered
veterans or to provide fertility treatment services including ART to
the spouses of covered veterans as provided to a member of the Armed
Forces under the DoD Policy. Public Law 114-223, Division A, Title II,
section 260 (Sept. 29, 2016). Congress defined a ``covered veteran'' to
be one who has a service-connected disability that results in the
inability of the veteran to procreate without the use of fertility
treatment. Congress has continued to reauthorize the use of medical
services funds for this purpose in subsequent appropriations laws, most
recently in March 2024 in Public Law 118-42, Division A, Title II,
section 234.
VA implemented Congress's authorization by issuing 38 CFR 17.380
and 17.412, which clarified the definition of a covered veteran for the
purposes of establishing eligibility for IVF coverage and authorized
fertility treatment of the legal spouse of a covered veteran,
respectively. VA also issued VHA Directive 1334 establishing the full
eligibility criteria for IVF coverage, including the applicable
restrictions contained in the DoD Policy.
On March 8, 2024, DoD amended the DoD Policy to eliminate the
requirement that to receive IVF and other ART services, an active-duty
service member, along with their legal spouse, be able to produce and
carry a child who is biologically their own. In the amended policy, DoD
expressly stated that eligibility would not be based on marital status
and that donor sperm, eggs, and embryos may be used in ART services,
including IVF.
VHA Directive 1334, paragraph 1.c. provides that any substantive
changes made to DoD's policy will supersede conflicting terms in VHA
Directive 1334. Therefore, in Instruction of the Secretary 01-24,
issued on March 28, 2024, the Secretary has directed VA employees and
officials to revise VHA Directive 1334 to eliminate the requirement
that a covered veteran to be married and be able to produce and carry a
child who is biologically their own in order to qualify for IVF
coverage. These revisions allow VA to provide IVF services for an
unmarried covered veteran. The revisions also allow for the use of
donor sperm, eggs, or embryos, as long as the donated sperm, eggs, and
embryos are provided at no cost to VA. Effectively, the revisions to
VHA Directive 1334 allow VA to expand the provision of IVF services to
covered veterans who are unmarried, married to
[[Page 23519]]
a partner who does not have opposite-sex gametes, and/or incapable of
producing their own sperm and/or eggs.
Instruction of the Secretary 01-24 does not eliminate the
statutorily imposed requirement that a veteran must have a service-
connected disability that results in the inability of the veteran to
procreate without the use of fertility treatment to be considered a
``covered veteran.'' However, the Instruction clarifies that the
definition of ``a service-connected disability that results in the
inability of the veteran to procreate without the use of fertility
treatment'' provided for female veterans who have ovarian function and
a patent uterine cavity in 38 CFR 17.380 will also apply to female
veterans without ovarian function or a patent uterine cavity.
Previously, no definition was provided for the female veteran
population that did not have ovarian function or a patent uterine
cavity because the exclusion of donor sperm, eggs, and embryos
eliminated them from eligibility. Now, the Secretary clarifies they
must meet the same definition as female veteran with ovarian function
and a patent uterine cavity to be considered a ``covered veteran.''
Text of Instruction of Secretary 01-24
MEMORANDUM FOR THE UNDER SECRETARY FOR HEALTH AND THE CHAIRMAN, BOARD
OF VETERANS APPEALS
Subject: Instructions for Determining Eligibility for In Vitro
Fertilization (IVF) Benefit.
Purpose
1. I am issuing this instruction to clarify the impact for the
Department of Veterans Affairs (VA or the Department) of the amendment
to the Department of Defense (DoD) Policy for Assisted Reproductive
Services (ART) for the Benefit of Seriously or Severely Ill/Injured
(Category II or III) Active Duty Service Members (hereinafter referred
to as the ``DoD Policy'') issued by DoD on March 8, 2024. The
amendments to the DoD Policy are substantive and have superseded the
conflicting terms of VHA Directive 1334(1), In Vitro Fertilization
Counseling and Services Available to Certain Eligible Veterans and
Their Spouses, dated March 21, 2021, in accordance with paragraph 1.c.
of that Directive.
2. I am instructing VA employees to not restrict eligibility for
IVF services based on marital status or the ability to produce
opposite-sex autologous gametes, as described in more detail below.
Furthermore, the use of donor gametes and donor embryos in the
provision of the IVF benefit will be allowed.
3. Additionally, I am issuing this instruction to clarify the
impact of the policy changes on the definition of ``a service-connected
disability that results in the inability of the veteran to procreate
without the use of fertility treatment'', found in 38 CFR 17.380, as
the current definition does not contemplate the use of donor gametes
and donor embryos.
4. I am instructing Department employees to interpret the term ``a
service-connected disability that results in the inability of the
veteran to procreate without the use of fertility treatment'' as
defined for a female veteran with ovarian function and a patent uterine
cavity in 38 CFR 17.380 to also apply to a female veteran without
ovarian function or a patent uterine cavity.
Background
5. The National Defense Authorization Act for Fiscal Year 2008,
Public Law 110-181, section 1633, 122 Stat. 3, 459 (2008), authorized
DoD to provide IVF benefits for certain service members.
6. On April 3, 2012, DoD implemented its IVF policy in a memorandum
titled ``Policy for Assisted Reproductive Services for the Benefit of
Seriously or Severely Ill/Injured (Category II or III) Active Duty
Service Members,'' accompanied by implementation guidance (collectively
referred to throughout this document as the ``DoD Policy'').
7. DoD Policy clause IIIA provided:
It is the intent of this policy to provide Invitro(sic)
Fertilization (IVF) services only to consenting male members whose
injury or illness prevents the successful delivery of their sperm to
their spouse's egg and to consenting female members whose injury or
illness prevents their egg from being successfully fertilized by
their spouse's sperm but who maintain ovarian function and have a
patent uterine cavity.
8. DoD Policy clause IIIE provided:
Third-party donation and surrogacy are not covered benefits- the
benefit is designed to allow the member and spouse to become
biological parents through reproductive technologies where Active
Duty injury or illness has made it impossible to conceive naturally.
9. Since 2016, Congress has authorized VA to use medical services
funds to provide fertility counseling and treatment, including ART, to
certain covered veterans and to the spouses of covered veterans. Public
Law 114-223, Division A, Title II, section 260 (Sept. 29, 2016).
10. Congress defined a covered veteran to be one who has a service-
connected disability that results in the inability of the veteran to
procreate without the use of fertility treatment. Id. Congress
continued to authorize the use of medical services funds for this
purpose in subsequent appropriations laws, most recently in March 2024
in Public Law 118-42, Division A, Title II, section 234.
11. On March 7, 2019, VA published the final rule creating 38 CFR
17.380 implementing Congress's authorization. The regulation provided
in pertinent part:
For the purposes of this section, ``a service-connected
disability that results in the inability of the veteran to procreate
without the use of fertility treatment'' means, for a male veteran,
a service-connected injury or illness that prevents the successful
delivery of sperm to an egg; and, for a female veteran with ovarian
function and a patent uterine cavity, a service- connected injury or
illness that prevents the egg from being successfully fertilized by
sperm.
The regulation provides a definition ``for a male veteran'' and
``for a female veteran with ovarian function and a patent uterine
cavity''. It does not provide a definition for female veterans without
ovarian function and/or without a patent uterine cavity.
12. As a result, female veterans without ovarian function and/or a
patent uterine cavity are in an undefined area of eligibility, neither
expressly excluded nor expressly included in 38 CFR 17.380. This may
inadvertently result in veterans who sustained service-connected
disabilities affecting ovarian function and/or the uterine cavity not
being considered ``covered veterans'' for the purposes of fertility
benefits.
13. In March 2021, VA issued subregulatory guidance in the form of
VHA Directive 1334 to implement its policy for providing IVF counseling
and services to eligible veterans and their spouses.
14. VHA Directive 1334, paragraph 1.c., Purpose, notes that DoD
Policy governs VA's provisions for IVF counseling and services, and any
substantive changes made to DoD's policy will supersede conflicting
terms in VHA Directive 1334.
15. On the basis of DoD Policy clauses IIIA and IIIE, VHA Directive
1334 had the effect of limiting VHA to providing IVF services to
cisgender opposite-sex legally married couples or other legally married
couples with opposite-sex gametes/reproductive organs.
16. On March 8, 2024, DoD Policy was amended. In relevant part, the
amendments eliminated the language in
[[Page 23520]]
Policy Clause IIIA referred to in paragraph 7, above. The amendment
also removed the prohibition on the use of donor gametes in Policy
Clause IIIE and expressly allows for the use of donor embryos in the
fertility treatment of qualified service members, provided they are
obtained at no cost to DoD. Further, the policy was amended to allow a
qualified service-member to receive ART services, as clinically
appropriate.
Qualifying as a Covered Veteran for Purposes of Receiving IVF Services
17. This Instruction addresses the effect of the DoD Policy
amendment on VA's eligibility criteria for veterans and their spouses
to receive IVF counseling and services through VHA. The amendment of
the DoD Policy supersedes portions of VHA Directive 1334 which were
based on the unamended DoD Policy. The amendment also necessitates
clarification of the definition of a ``service-connected disability
that results in the inability of the veteran to procreate without the
use of fertility treatment'' in 38 CFR 17.380.
18. With the amendment to the DoD Policy, VA IVF benefits will no
longer require that a covered Veteran be (1) married,\1\ (2) in an
opposite-sex relationship, or (3) able to produce their own gametes.
Paragraphs 20 through 35 address these changes.
---------------------------------------------------------------------------
\1\ VA is only allowed to treat non-veterans when specifically
authorized by statute. Public Law 117-328, Division J, Title II,
section 234 authorizes VA to provide fertility counseling and
identified treatment to ``a covered veteran or the spouse of a
covered veteran.'' Therefore, VA will not exclude unmarried veterans
from IVF care as discussed throughout, but VA is only authorized to
provide IVF care to the non-veteran partner of a veteran if that
non-veteran partner is the spouse of the covered veteran.
---------------------------------------------------------------------------
19. Further, lifting the prohibition on donor gametes and donor
embryos necessitates clarification of the definition of ``a service-
connected disability that results in the inability of the veteran to
procreate without the use of fertility treatment'' found in 38 CFR
17.380. The text of the regulation provides a definition for all male
veterans but only provides a definition for a female veteran who has
ovarian function and a patent uterine cavity. In that regard, the
regulation does not provide a definition for a female veteran who does
not have either ovarian function or a patent uterine cavity. The lack
of a definition for a female veteran without ovarian function or a
patent uterine cavity posed no problem in applying the regulation when
there was a prohibition on the use of donated gametes and donated
embryos because that prohibition would have prevented such a female
veteran from being eligible for IVF services. However, with the lifting
of the prohibition on donor gametes and donor embryos, VA must address
what the definitional requirements are for a female veteran without
ovarian function and/or a patent uterine cavity. Paragraph 35, below,
addresses these requirements.
20. VHA Directive 1334, paragraph 2.d., Background, is revised to
read:
IVF counseling and services are available to certain seriously
injured Veterans no longer able to procreate without the use of
fertility treatment. For male Veterans, their service-connected
injury or illness must render the Veteran incapable of successfully
delivering their sperm to an egg. This definition includes the
inability to produce sperm. For female Veterans, with or without
ovarian function or a patent uterine cavity, their service-connected
injury or illness must render the Veteran incapable of having an egg
successfully fertilized by sperm. This definition includes the
inability to produce an egg.
21. VHA Directive 1334, paragraph 2.e., Background, is revised to
read:
VA may furnish IVF fertility counseling and treatment to
Veterans as described herein and their lawful spouses. More
specifically, consistent with the Memorandum, VA allows for assisted
reproductive services, including evaluations, intrauterine
insemination, sperm retrieval, oocyte retrieval, in-vitro
fertilization, blastocyst transfer and embryo transfer, to be
available to eligible Veterans. VA considers that the
cryopreservation of gametes (for both the Veteran and the spouse),
not only embryos, is within the scope of available benefits
described in the Memorandum. Gamete and embryo cryopreservation and
storage are each without limitation on duration until, as explained
below, the death of an eligible Veteran. In determining clinical
eligibility for IVF services, VA treating providers are to use the
same evidence-based clinical eligibility standards outlined in VHA
Directive 1332(2), Fertility Evaluation and Treatment.
22. VHA Directive 1334, paragraph 2.f. and g., Background, are
struck from the Directive.
23. VHA Directive 1334, paragraph 2.h., Background, is revised to
read:
Covered veterans and their spouses may utilize donor gametes and
donor embryos obtained at their own expense when receiving IVF
counseling and services under this policy. No portion of this
benefit will be used to pay for procedures or associated fees for
the extraction, storage, or transportation of donor gametes. The
creation, storage, and use of resulting embryos are covered by the
benefit.
24. VHA Directive 1334, paragraph 2.j., Background, is revised to
read:
Although the benefits of cryopreservation and storage of gametes
and embryos are not time-limited, these benefits are, practically-
speaking, checked or limited by the death of an eligible Veteran.
This is also the practical implication of Clause III.F. of the
Memorandum, which requires that VA obtain the separate consent of
the Veteran with third party consent being prohibited.
25. VHA Directive 1334, paragraph 2.n., Background, is revised to
read:
The Veteran's and spouse's respective eligibility determinations
will be made by VHA's Health Eligibility Center. Service-connected
conditions covered under this policy include, but are not limited
to, poly-trauma, genitourinary injury and spinal cord injury and
other anatomical, neurological, infectious and physiological injury
and/or illness that are adjudicated by the Veterans Benefits
Administration to be service-connected after which VHA IVF program
staff will clinically determine if the service-connected condition
meets the IVF clinical eligibility criteria i.e., whether the
service-connected condition results in loss of procreative ability
that cannot be corrected without the use of fertility treatment.
26. VHA Directive 1334, paragraph 3.c., Definitions, is revised to
read:
Consent to In Vitro Fertilization. Consent to IVF requires the
informed consent of all parties receiving IVF benefits under this
policy. Each party must have decision-making capacity to consent to
treatment. Consent by a third party, including a proxy decision-
maker, is not permitted.
27. VHA Directive 1334, paragraph 3.d., Definitions, is revised to
read:
Cryopreservation. Cryopreservation is the freezing of gametes
(oocytes or sperm), zygotes (1-cell fertilized oocytes), embryos
(typically cryopreserved on day 2, 3, 5, or 6 of development), or
gonadal (ovarian or testicular) tissue to allow storage for future
use. Cryopreserved sperm can be used for intrauterine insemination
(IUI) or IVF after thawing or rewarming. Cryopreserved oocytes
require IVF after thawing or rewarming. Cryopreserved tissue may be
re-implanted into the body or cultured in vitro after thawing or
rewarming. Duration of embryo cryopreservation and storage are
without limitation under 38 CFR 17.380 and 17.412 until the death of
an eligible Veteran, provided VA continues to have authority to
provide these non-limited services.
28. VHA Directive 1334, paragraph 3.j., Definitions, is revised to
read:
Infertility. Infertility is a disease, condition, or status
characterized by any of the following:
(1) The inability to achieve a successful pregnancy as
established by a patient's medical, sexual, and reproductive
history, age, physical findings, diagnostic testing, or any
combination of those factors; or
(2) The need for medical intervention, including, but not
limited to, the use of donor gametes or donor embryos in order to
achieve a successful pregnancy, either as an individual or with a
partner.
29. VHA Directive 1334, paragraph 6. Eligibility Requirements, is
revised to read:
[[Page 23521]]
To be eligible for fertility services, including IVF, the
Veteran must have a service-connected condition that results in the
inability to procreate without the use of fertility treatment, as
defined above. NOTE: For additional eligibility information, see
appendix A.
30. VHA Directive 1334, paragraph 7.c.(1), Practices and
Procedures, is revised to read:
VA will cover costs of cryopreservation and storage at an
independent community laboratory indefinitely up through the end of
life of the eligible Veterans. Storage of cryopreserved gametes and
embryos will take place at an independent facility in the community,
per guidelines outlined in appendix A.
31. VHA Directive 1334, paragraph 7.c.(3), Practices and
Procedures, is revised to read:
VA will pay the costs of cryopreservation and storage of
cryopreserved oocytes, sperm and embryos indefinitely until the end
of the life the eligible Veteran, or until the cryopreserved
oocytes, sperm, or embryos are transferred to a third party (for any
purpose outside this treatment program.
32. VHA Directive 1334, paragraph 7.e.(1), Practices and
Procedures, is struck from the directive.
Gestational surrogacy, as defined in VHA Directive 1334, will
remain outside the scope of VA IVF Services. Although the amended DoD
Policy allows for a third-party gestational carrier in limited
instances, Congress's authorization for VA to provide fertility
counseling and treatment, including ART, is limited to providing these
services to a covered veteran and the spouse of a covered veteran.
Therefore, VA may not provide IVF services to a person who is neither
the covered veteran nor the spouse of a covered Veteran.
33. VHA Directive 1334, Appendix A, Eligibility Criteria, is
revised to read:
1. To be eligible for In Vitro Fertilization (IVF) under 38 Code
of Federal Regulations (CFR) 17.380, a Veteran must have a service-
connected disability that results in the Veteran's inability to
procreate without the use of fertility treatment.
2. Lawful spouses of eligible Veterans are eligible for
fertility counseling and treatment under the program pursuant to 38
CFR 17.412.
34. VHA Directive 1334, Appendix B, In Vitro Fertilization
Services, comparison table c is revised to strike:
1. ``+ lawful eligible spouses'' from the ``Eligibility'' line;
2. ``naturally'' from the ``Service connection'' line;
3. the entirety of the ``Marital status'' line;
4. the entirety of the ``Couples'' line;
5. ``with opposite-sex gametes'' from the ``IUI'' line;
6. ``or an eligible Veteran's lawful divorce'' from the ``Time
limits for cryopreservation of gametes'' line;
7. ``or an eligible Veteran's lawful divorce'' from the
``Cryopreservation for embryos'' line: and
8. ``or an eligible Veteran's lawful divorce'' from the ``Embryo
storage paid by VA'' line.
Additionally, the ``no'' from the ``Donate sperm'' line is revised
to ``Allowable but not paid for by VA (Veteran pays for non-Veteran
sperm preparation or procedure to non-Veteran).''
35. In 38 CFR 17.380, the term ``a service-connected disability
that results in the inability of the veteran to procreate without the
use of fertility treatment'' is interpreted to include:
for a female veteran without ovarian function and/or patent uterine
cavity, a service-connected injury or illness that prevents the
successful fertilization of an egg by sperm, to include the service-
connected loss of ovarian function and/or a patent uterine cavity.
Applicability
36. This Instruction applies to decisions to authorize benefits on
or after the date of this Instruction, in which a veteran seeks
fertility counseling or IVF services under 38 CFR 17.380 and 17.412.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved and signed
this document on March 28, 2024, 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.
Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of
General Counsel, Department of Veterans Affairs.
[FR Doc. 2024-07040 Filed 4-3-24; 8:45 am]
BILLING CODE 8320-01-P