[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6273-6276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00280]



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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP94


Fertility Counseling and Treatment for Certain Veterans and 
Spouses

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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SUMMARY: The Department of Veterans Affairs (VA) amends its regulation 
regarding fertility counseling and treatment available to certain 
veterans and spouses. VA currently provides certain infertility 
services other than in vitro fertilization (IVF) to veterans as part of 
the medical benefits package. IVF is the process of fertilization by 
manually fertilizing an egg, and then transferring the embryo to the 
uterus. This interim final rulemaking adds a new section authorizing 
IVF for a veteran with a service-connected disability that results in 
the inability of the veteran to procreate without the use of fertility 
treatment. In addition, we add a new section stating that VA may 
provide fertility counseling and treatment using assisted reproductive 
technologies (ART), including IVF, to a spouse of a veteran with a 
service-connected disability that results in the inability of the 
veteran to procreate without the use of fertility treatment. VA will 
provide ART treatment, including IVF, to these veterans and spouses as 
specified in the Continuing Appropriations and Military Construction, 
Veterans Affairs, and Related Agencies Appropriations Act, 2017, and 
Zika Response and Preparedness Act to the extent such services are 
consistent with the services available to enrolled veterans under the 
medical benefits package.

DATES: Effective Date: This rule is effective on January 19, 2017.
    Comment date: Comments must be received on or before March 20, 
2017.

ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. (This is not a toll-free number.) Comments should indicate 
that they are submitted in response to ``RIN 2900AP94--Fertility 
Counseling and Treatment for Certain Veterans and Spouses.'' Copies of 
comments received will be available for public inspection in the Office 
of Regulation Policy and Management, Room 1068, between the hours of 
8:00 a.m. and 4:30 p.m. Monday through Friday (except holidays). Please 
call (202) 461-4902 for an appointment. (This is not a toll-free 
number.) In addition, during the comment period, comments may be viewed 
online through the Federal Docket Management System (FDMS) at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Patricia M. Hayes, Ph.D., Chief 
Consultant, Women's Health Services, Patient Care Services, Veterans 
Health Administration, Department of Veterans Affairs, 810 Vermont Ave. 
NW., Washington, DC 20420. (202) 461-0373. (This is not a toll-free 
number.)

SUPPLEMENTARY INFORMATION: Section 260 of the Continuing Appropriations 
and Military Construction, Veterans Affairs, and Related Agencies 
Appropriations Act, 2017, and Zika Response and Preparedness Act 
(Public Law 114-223) states that VA may use appropriated funds 
available to VA for the Medical Services account to provide fertility 
counseling and treatment using assisted reproductive technology (ART) 
to a covered veteran or the spouse of a covered veteran, or adoption 
reimbursement to a covered veteran. This rulemaking expands the types 
of ART treatment available to certain veterans and makes fertility 
counseling and treatment including ART treatment available to spouses 
of those veterans, consistent with this statutory authority. 
Reimbursement of adoption expenses will be the subject of a separate 
rulemaking.
    According to this law, Veterans who will receive this benefit are 
those with a service-connected disability that results in the inability 
of the veteran to procreate without the use of fertility treatment. The 
ART treatments referred to in this law are those relating to 
reproductive assistance provided to a member of the Armed Forces who 
incurs a serious injury or illness on active duty pursuant to title 10 
of the United States Code (U.S.C.) section 1074(c)(4)(A), as described 
in a policy memorandum issued by the Assistant Secretary of Defense for 
Health Affairs on April 3, 2012, titled ``Policy for Assisted 
Reproductive Services for the Benefit of Seriously or Severely Ill/
Injured (Category II or III) Active Duty Service Members,'' and the 
guidance issued to implement such policy, including any limitations on 
the amount of such benefits available to such a member. See Public Law 
114-223, section 260(b)(2) and (3). The implementing guidance is 
contained in a document attached to the policy memorandum. We will 
refer to the April 3, 2012, policy memorandum and guidance issued by 
the Department of Defense (DoD) to implement that policy collectively 
as DoD policy guidance. DoD has established a system for categorizing 
injured servicemembers for purposes of coordinating care. Those in 
Category II have a serious injury or illness, are unlikely to return to 
duty within a time specified by their Military Department, and may be 
medically separated from the military. Servicemembers in Category III 
have a severe or catastrophic injury or illness, are highly unlikely to 
return to duty, and will most likely be medically separated from the 
military.
    ART is defined at Public Law 114-223, section 260(b)(3) to mean the 
benefits relating to reproductive assistance in DoD policy guidance, 
including any limitations on the amount of such benefits in that 
policy. DoD policy guidance addresses assisted reproductive services 
available to servicemembers, providing specific guidance on the 
availability of IVF, as well as a wide range of services that VA 
considers as fertility treatment. Under this statute, VA is authorized 
to provide ART benefits, consistent with DoD policy guidance, to a 
veteran with a service-connected disability that results in the 
inability of the veteran to procreate without the use of fertility 
treatment, as well as the spouse of that veteran. The conference report 
accompanying this legislation makes clear that the implementing 
guidance developed by the Secretary shall not be materially different 
from, and in no way more expansive than, DoD's policy. Joint 
Explanatory Statement. 162 Congressional Record at S6011 (2016).
    The Veterans' Health Care Eligibility Reform Act of 1996, Public 
Law 104-262, mandated that VA implement a national enrollment system to 
manage the delivery of healthcare services. A key component of managing 
delivery of healthcare services to eligible veterans is identifying the 
medical services provided by VA. The medical benefits package, defining 
the medical services provided to all enrolled veterans by VA, is found 
at 38 CFR 17.38. VA may provide services under the medical benefits 
package that are determined by appropriate healthcare professionals to 
be needed to promote, preserve, or restore the health of the individual 
and to be in accord with generally accepted standards of medical 
practice.
    As part of the medical benefits package, VA provides many different 
types of fertility treatments and procedures to veterans. These include 
infertility counseling, laboratory blood

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testing, surgical correction of structural pathology, reversal of a 
vasectomy or tubal ligation, medication, and various other diagnostic 
studies or treatments and procedures. This list is not all-inclusive. 
Most of the ART evaluation and treatment modalities offered by VA are 
consistent with DoD policy guidance. The exception is IVF. DoD offers 
IVF to servicemembers who have sustained serious or severe illness/
injury while on active duty that led to the loss of their natural 
procreative ability, while IVF is excluded from VA's medical benefits 
package under Sec.  17.38(c)(2). IVF is the process of fertilization by 
manually fertilizing an egg, and then transferring the embryo to the 
uterus. IVF is a common and medically accepted procedure for addressing 
infertility that cannot be overcome with other types of infertility 
treatment. Although we are not revising the medical benefits package 
itself, we are revising paragraph (c)(2) to add a note referencing the 
benefit available in Sec.  17.380, as discussed below. We believe that 
this clarification will help veterans better understand the benefits 
available from VA.
    Pursuant to Public Law 114-223 section 260, VA is adding new Sec.  
17.380 which states that IVF may be provided when clinically 
appropriate to a veteran who has a service-connected disability that 
results in the inability of the veteran to procreate without the use of 
fertility treatment, as well as a spouse of such veteran. Per 38 U.S.C. 
101(2), the term veteran means a person who served in the active 
military, naval, or air service, and who was discharged or released 
therefrom under conditions other than dishonorable. Under this 
provision, IVF services available to such veterans are the same as 
those provided by DoD to a member of the Armed Forces who incurs a 
serious injury or illness on active duty pursuant to 10 U.S.C. 
1074(c)(4)(A), as described in DoD policy guidance, including any 
limitations on the amount of such benefits available to such a member. 
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 a sperm. This definition 
parallels requirements in DoD policy guidance for an active duty 
service member who is seriously or severely ill/injured (Category II or 
III) to receive fertility counseling and treatment using ART. Public 
Law 114-223 provides appropriations for FY 2017. The benefits 
authorized under section 260 are thereby limited to FY2017. Paragraph 
(b) of Sec.  17.380 states that the authority to provide IVF to covered 
veterans under this section expires September 30, 2017. If the 
authority is extended, we will amend this section accordingly.
    In addition, VA adds a new Sec.  17.412. This new section states 
that VA may provide fertility counseling and treatment using ART to a 
spouse of a veteran with a service-connected disability that results in 
the inability of the veteran to procreate without the use of fertility 
treatment to the extent such services are available to enrolled 
veterans under the medical benefits package. It also states that VA may 
provide IVF to a spouse of a veteran with a service-connected 
disability that results in the inability of the veteran to procreate 
without the use of fertility treatment. Such health care services may 
be provided when clinically appropriate and consistent with the 
benefits relating to reproductive assistance provided to a member of 
the Armed Forces who incurs a serious injury or illness on active duty 
as described in DoD policy guidance.
    Paragraph (b) states that authority to provide fertility counseling 
and treatment including IVF to spouses of covered veterans under this 
section expires September 30, 2017. If the authority is extended we 
will amend this section accordingly.
    DoD policy guidance addresses various issues including eligibility 
for ART, testing to predict fertility potential, infertility testing 
and treatment (including correction of the physical cause of 
infertility), provisions on the total number of IVF cycles that may be 
provided, and required processes and procedures. VA intends to issue 
policy and develop clinical guidelines consistent with DoD policy 
guidance.
    Finally, we also revise the center heading immediately preceding 
Sec.  17.410 to read ``Hospital Care and Medical Services for Spouses 
and Families.'' VA provides medical care to certain families of Camp 
LeJeune veterans under Sec.  17.410, and the center heading referred to 
those services. The current rulemaking adds a new section immediately 
following Sec.  17.410, and VA believes the center heading should be 
revised to avoid any confusion.

Administrative Procedure Act

    In accordance with U.S.C. 553(b)(B) and (d)(3), the Secretary of 
Veterans Affairs has concluded that there is good cause to publish this 
rule as an interim final rule without prior opportunity for public 
comment and to publish this rule with an immediate effective date. As 
stated above, this rule makes IVF treatment available to certain 
veterans, and fertility counseling and treatment using ART to the 
spouses of those veterans. The Secretary finds that it is impracticable 
and contrary to the public interest to delay this rule for the purpose 
of soliciting advance public comment or to have a delayed effective 
date. This rulemaking will benefit those veterans and spouses most in 
need of ART services including IVF, and delay might cause a significant 
hardship for affected veterans and spouses. The Joint Theater Trauma 
Registry (JTTR) reflects the most common single cause of battle 
injuries is explosive devices (36.3%). Such trauma frequently results 
in genitourinary injury. For example, 1 in 5 warriors were evacuated 
from Operation Enduring Freedom (OEF) combat in October 2011 with a 
genitourinary injury. This increasingly common trauma can have 
catastrophic reproductive results. While the JTTR tracks combat trauma 
only for OEF and Operation Iraqi Freedom, genitourinary or spinal cord 
injury, or pelvic trauma related to combat injuries was also common in 
previous combat operations, and these injuries may make it impossible 
for affected veterans to procreate without the use of fertility 
treatment. In many cases ART, including IVF, is the only viable option 
for procreation. Further, since age is a factor in successful 
fertilization and completion of a pregnancy, rulemaking delay may 
result in some veterans or spouses losing fertility potential prior to 
a later effective date. In addition, this rulemaking will ensure that 
covered veterans leaving service at this time, and their spouses, will 
experience continuity of care when transferring from health care 
provided by DoD to that provided by VA, with no difference in the level 
or types of available ART. For the above reason, the Secretary issues 
this rule as an interim final rule. VA will consider and address 
comments that are received within 60 days of the date this interim 
final rule is published in the Federal Register.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
final rulemaking, represents VA's implementation of its legal authority 
on

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this subject. Other than future amendments to this regulation or 
governing statutes, no contrary guidance or procedures are authorized. 
All existing or subsequent VA guidance must be read to conform with 
this rulemaking if possible or, if not possible, such guidance is 
superseded by this rulemaking.

Paperwork Reduction Act

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

Regulatory Flexibility Act

    The Secretary hereby certifies that this interim final rule will 
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. This interim final rule will directly affect only 
individuals and will not directly affect small entities. Therefore, 
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial 
and final regulatory flexibility analysis requirements of 5 U.S.C. 603 
and 604.

Executive Order 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. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined not to be 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 Web 
site at http://www.va.gov/orpm/, by following the link for ``VA 
Regulations Published From FY 2004 Through Fiscal Year to Date.''

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 interim final rule will have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.007, Blind Rehabilitation 
Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans 
Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans 
Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, 
Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical 
Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 
64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless 
Providers Grant and Per Diem Program.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, 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, Reporting and recordkeeping requirements, 
Travel and transportation expenses, Veterans.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document 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. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on December 23, 2016, for publication.

Janet Coleman,
Chief, Regulation Policy & Management, Office of the Secretary, 
Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 38 CFR part 17 
as follows:

PART 17--MEDICAL

0
 1. The authority citation for part 17 is revised to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections.
    Section 17.38 also issued under 38 U.S.C. 101, 501, 1701, 1705, 
1710, 1710A, 1721, 1722, 1782, and 1786.
    Sections 17.380 and 17.412 are also issued under sec. 260, Pub. 
L. 114-223, 130 Stat. 857.
    Section 17.415 is also issued under 38 U.S.C. 7301, 7304, 7402, 
and 7403.
    Sections 17.640 and 17.647 are also issued under sec. 4, Pub. L. 
114-2, 129 Stat. 30.
    Sections 17.641 through 17.646 are also issued under 38 U.S.C. 
501(a) and sec. 4, Pub. L. 114-2, 129 Stat. 30.


0
2. Amend Sec.  17.38 by:
0
a. Revising paragraph (c)(2).
0
b. Removing the sectional authority citation.
    The revision reads as follows:


Sec.  17.38  Medical benefits package.

* * * * *
    (c) * * *
    (2) In vitro fertilization. Note: See Sec.  17.380.
* * * * *

0
3. Add an undesignated center heading and Sec.  17.380 to read as 
follows:

In Vitro Fertilization Treatment


Sec.  17.380  In vitro fertilization treatment.

    (a)(1) In vitro fertilization may be provided when clinically 
appropriate to--
    (i) A veteran who has a service-connected disability that results 
in the inability of the veteran to procreate without the use of 
fertility treatment; and,

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    (ii) The spouse of such veteran, as provided in Sec.  17.412.
    (2) 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.
    (3) In vitro fertilization treatment will be provided under this 
section when clinically appropriate and to the same extent such 
treatment is provided to a member of the Armed Forces who incurs a 
serious injury or illness on active duty pursuant to 10 U.S.C. 
1074(c)(4)(A), as described in the April 3, 2012, memorandum issued by 
the Assistant Secretary of Defense for Health Affairs on the subject of 
``Policy for Assisted Reproductive Services for the Benefit of 
Seriously or Severely Ill/Injured (Category II or III) Active Duty 
Service Members,'' and the guidance issued by the Department of Defense 
to implement such policy, including any limitations on the amount of 
such benefits available to such a member.
    (b) Authority to provide in vitro fertilization treatment to 
covered veterans under this section expires September 30, 2017.

0
4. Revise the undesignated center heading immediately preceding Sec.  
17.410 to read as follows:

Hospital Care and Medical Services for Spouses and Families

0
5. Add Sec.  17.412 to read as follows:


Sec.  17.412  Fertility counseling and treatment for certain spouses.

    (a)(1) VA may provide fertility counseling and treatment to a 
spouse of a veteran described in Sec.  17.380 to the extent such 
services are available to a veteran under Sec.  17.38, and consistent 
with the benefits relating to reproductive assistance provided to a 
member of the Armed Forces who incurs a serious injury or illness on 
active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in the 
April 3, 2012, memorandum issued by the Assistant Secretary of Defense 
for Health Affairs on the subject of ``Policy for Assisted Reproductive 
Services for the Benefit of Seriously or Severely Ill/Injured (Category 
II or III) Active Duty Service Members,'' and the guidance issued by 
the Department of Defense to implement such policy, including any 
limitations on the amount of such benefits available to such a member.
    (2) VA may provide in vitro fertilization to a spouse of a veteran 
described in Sec.  17.380 when clinically appropriate and consistent 
with the benefits relating to reproductive assistance provided to a 
member of the Armed Forces who incurs a serious injury or illness on 
active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in the 
April 3, 2012, memorandum issued by the Assistant Secretary of Defense 
for Health Affairs on the subject of ``Policy for Assisted Reproductive 
Services for the Benefit of Seriously or Severely Ill/Injured (Category 
II or III) Active Duty Service Members,'' and the guidance issued by 
the Department of Defense to implement such policy, including any 
limitations on the amount of such benefits available to such a member.
    (b) Authority to provide fertility counseling and treatment, 
including in vitro fertilization under this section, expires September 
30, 2017.

[FR Doc. 2017-00280 Filed 1-18-17; 8:45 am]
 BILLING CODE 8320-01-P