[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]
[[Page 6273]]
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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]
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