[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.

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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.
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    \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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    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]
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