Fertility Counseling and Treatment for Certain Veterans and Spouses
| Published date | 07 March 2019 |
| Citation | 84 FR 8254 |
| Record Number | 2019-04096 |
| Section | Rules and Regulations |
| Court | Veterans Affairs Department |
Federal Register, Volume 84 Issue 45 (Thursday, March 7, 2019)
[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Rules and Regulations]
[Pages 8254-8257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04096]
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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: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, with
changes based on subsequent changes to our statutory authority, an
interim final rule adding a new section to the medical regulations
authorizing in vitro fertilization (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, the rule
added 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. As a result of this rulemaking, VA may provide
both a covered veteran and spouse of a covered veteran all ART
treatments available to enrolled veterans under the medical benefits
package, as well as IVF. The interim final rule was effective on the
date of publication. We provided a 60-day comment period, and received
13 comments from the public, all of which were supportive of this
rulemaking. However, the commenters raised several issues that we
address here. Following publication of the interim final rule, a
statute was enacted that made several substantive changes to VA's
authority to provide ART and IVF to covered veterans and spouses. This
final rule reflects those changes.
DATES: Effective Date: This rule is effective on March 7, 2019.
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. Patricia.hayes@va.gov (202) 461-0373. (This
is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On January 19, 2017, VA published an interim
final rule regarding fertility counseling and treatment available to
certain veterans and spouses. 82 FR 6275. This interim final rulemaking
added a new Sec. 17.380 to VA's medical regulations authorizing in
vitro fertilization (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. As explained in the preamble to
the interim final rulemaking, IVF is expressly excluded from the
medical benefits package at 38 CFR 17.38(c)(2), but to help clarify the
full scope of fertility treatment benefits available to veterans
through VA, the rulemaking added a Note to Sec. 17.38(c)(2) to
reference Sec. 17.380 of the same title. 82 FR at 6275. Section 17.380
is regulatory authority independent of the medical benefits package
that permits VA to use the ``Medical Services'' appropriation account
to provide IVF to certain veterans, as originally authorized by section
260 of the Continuing Appropriations and Military Construction,
Veterans Affairs, and Related Agencies Appropriations Act, 2017, and
Zika Response and Preparedness Act (Pub. L. 114-223) (the ``2017
Act''). In addition, consistent with the 2017 Act, we added a new Sec.
17.412 stating that VA may provide fertility counseling and treatment
using assisted reproductive technologies (ART) to a spouse of a covered
veteran to the extent such services are consistent with the services
available to enrolled veterans under the medical benefits package, as
well as IVF to the spouse of a covered veteran, subject to certain
limitations.
On February 21, 2017, VA published a correction to the interim
final rulemaking regarding the new regulations' expiration date. 82 FR
11152. In particular, we corrected both sections to reflect that
authority to provide health care services under these sections would
expire on September 30, 2018.
While the above-referenced 2017 Act was the original authority for
VA's IVF program, it lapsed once the relevant funding period ended.
VA's authority to use Medical Services Funds to provide
[[Page 8255]]
IVF services to the same cohort described in the 2017 Act was
subsequently renewed and extended in similar form in section 236 of
Division J, Military Construction, Veterans Affairs, and Related
Agencies Appropriations Act, 2018, Public Law 115-141 (March 23, 2018)
(the ``2018 Act''). Under this recent provision, VA's IVF authority is
subject to the funding period covered by the 2018 Act, and the
availability of appropriations, but notably the 2018 Act includes two
changes to the IVF authority as established under the 2017 Act.
As with the 2017 Act, the 2018 Act continues to require VA to
deliver benefits in a manner consistent with the benefits 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 (DoD) to implement such
policy, including any limitations on the amount of such benefits
available to the members. As mentioned, however, the 2018 Act included
two changes to the original IVF authority established under the 2017
Act. First, under the 2018 Act, VA's IVF authority is no longer subject
to the time periods regarding embryo cryopreservation and storage set
forth in part III(G) and in part IV(H) of the April 2012 DoD
memorandum. Second, the term ``assisted reproductive technology''
includes embryo cryopreservation and storage without limitation on the
duration of such cryopreservation and storage. See section
236(b)(3)(A)-(B), Div. J, of the 2018 Act. Thus, the DoD time-limits
applicable to the duration of embryo cryopreservation and storage no
longer apply to VA's IVF authority. Consequently, we are amending
Sec. Sec. 17.380(b) and 17.412(b) to reflect these changes. VA's IVF
authority is still subject to the other terms of the DoD program as
reflected in the DoD 2012 memorandum, including those relating to
ownership and future embryo use.
This final rulemaking thus implements VA's IVF authority as
described in the interim final rule and as extended and modified by the
2018 Act. The 2018 Act is essentially an extension of the original
authority, albeit with limited modifications aimed at increasing the
benefit to eligible veterans and their spouses. Consequently, the
interim final rule has been revised to accord with changes in the
statutory authority.
Reimbursement of adoption expenses, an infertility benefit first
authorized in the 2017 Act and subsequently renewed in the 2018 Act, is
the subject of a separate rulemaking.
We provided a 60-day period for public comment of the interim final
rule based on the original authority, i.e., the 2017 Act. The comment
period expired on March 20, 2017. We received 13 public comments, all
of which were generally supportive of the rule. Some commenters raised
specific issues. Several commenters asked whether the rule would be
applied retroactively to a course of IVF treatment completed prior to
the effective date of the rule. Another commenter asked whether Post-
traumatic stress disorder (PTSD) is considered a service-connected
disability that results in the inability of the veteran to procreate
without the use of fertility treatment. Several commenters stated that
IVF should be available to all veterans with a service-connected
disability. A commenter stated that VA should share the cost of IVF
with a veteran with a preexisting condition that results in the
inability of the veteran to procreate without the use of fertility
treatment. One commenter was concerned about the expiration of VA's
statutory authority at the end of FY 2018. Another commenter raised the
issues of cryopreservation and creating a nationwide network of
providers. We address these issues below.
Retroactivity
Three commenters asked whether the rule would be applied
retroactively to provide VA with the authority to reimburse veterans
for the private cost of IVF treatment completed prior to the
publication of the interim final rule. The commenters reference a
specific case involving two of these three commenters. One stated that
he is a veteran with a service-connected disability that resulted in
the inability to procreate without the use of fertility treatment. His
spouse, who was treated outside of the VA health care system, was
prescribed a course of IVF treatment that concluded prior to
publication of the interim final rule. The covered veteran incurred
out-of-pocket expenses related to this course of treatment and inquired
about reimbursement of those expenses.
The interim final rule was effective on January 19, 2017. It
therefore does not cover IVF services previously furnished to eligible
beneficiaries before that date. The Administrative Procedure Act
generally contemplates rulemaking to apply prospectively, and the term
``rule'' is defined at 5 U.S.C. 551(4) to mean, in pertinent part, ``an
agency statement of general or particular applicability and future
effect.'' The Supreme Court has stated that retroactivity is not
favored in the law and that retroactive rulemaking is only appropriate
when Congress has explicitly authorized it. Bowen v. Georgetown Univ.
Hosp., 488 U.S. 204 (1988); see also Landgraf v. USI Film Products, 511
U.S. 244 (2014). The statute is silent on the issue of retroactive
application of the statute or of the implementing regulation VA
published to exercise that authority. Given that the statute does not
expressly authorize VA to engage in rulemaking that would apply
retroactively to infertility treatment or counseling and IVF provided
to a covered veteran or spouse prior to the effective date of the rule,
we reiterate that VA has determined that such services provided prior
to the effective date of the interim final rule are not covered by the
rule.
We make no changes based on these comments.
Post-Traumatic Stress Disorder (PTSD)
One commenter inquired as to whether a diagnosis of PTSD would
qualify as a service-connected disability that results in the inability
of the veteran to procreate without the use of fertility treatment.
That is a medical determination that must be made on a case-by-case
basis. VA will provide benefits to a veteran with any service-connected
disability resulting in an inability to procreate without the use of
fertility treatment, regardless of the specific disability. We make no
changes based on this comment.
Expanded Coverage
Several commenters supported the rule but stated that IVF should be
available to all veterans with a service-connected disability. One
commenter stated that VA should share the cost of IVF with a veteran
with a preexisting condition that results in the inability of the
veteran to procreate without the use of fertility treatment.
The medical benefits package at 38 CFR 17.38 defines the medical
services provided to all enrolled veterans by VA. VA may provide care
under the medical benefits package that is determined by appropriate
healthcare professionals to be both necessary to promote, preserve, or
restore the health of the veteran and in accord with generally accepted
standards of medical practice. As part of the medical benefits package,
VA provides many different types of medically necessary fertility
treatments and procedures to enrolled veterans, irrespective of whether
their condition is service-connected. These include infertility
counseling, laboratory blood testing, surgical correction of structural
[[Page 8256]]
pathology, reversal of a vasectomy or tubal ligation, medication, and
various other diagnostic studies or treatments and procedures. This
list is not all-inclusive; however, IVF is expressly excluded from VA's
medical benefits package under Sec. 17.38(c)(2).
VA will continue to consider whether to remove the exclusion of IVF
from the medical benefits package. We note this type of decision is
multifactorial and complex, particularly because the benefit, if made
available, would have to be offered to all veteran-enrollees in need of
such care.
The comment related to cost-sharing for IVF (provided as part of
the medical benefits package) is thus premature. As a general matter,
we note that copayments do, by law, apply to some veterans receiving
care under the medical benefits package based on their enrollment
priority group status. To address the issue of copayments, we note that
the IVF program authorized under the 2017 Act, as renewed and extended
under the 2018 Act, does not establish copayment obligations. Moreover,
under the interim final rule, again as amended here to accord
technically with the 2018 Act, VA shares the cost of cryopreservation
and storage. Under the 2018 Act, the prior DoD time-limits on the
period of cryopreservation and storage no longer apply to VA's IVF
authority. We make no changes based on this comment, excluding the
needed execution of conforming amendments.
Expiration of Authority
One commenter was concerned that the Act is temporary, expiring on
September 30, 2018. Although the original authority lapsed, VA's IVF
authority was renewed and extended up through the funding period
covered by the 2018 Act. Although this treatment authority is still
temporary in nature (because it is again tied to a specific timeframe),
there has been no lapse in program operations. The commenter's specific
concern relating to the authority expiring after September 30, 2018,
has thus been rendered moot by the 2018 Act, although we note that, in
principle, this concern remains because the authority is still subject
to a delimiting date. However, Congress could again renew and extend
this authority. For this reason and to avoid the need to continually
update these regulations when a subsequent appropriations law (or other
law) renews this authority, we have revised Sec. Sec. 17.380(b) and
17.412(b) to eliminate the sentence therein that specifies the
expiration date. We make no other changes based on this comment.
Cryopreservation
One commenter stated that the fertility counseling and treatment
program would be most cost-efficient if servicemembers were allowed to
provide a sperm or egg for cryopreservation prior to entering active
combat. The commenter noted that delayed sample collection would
inevitably result in cases where the servicemember suffers a pelvic
injury so severe that sample collection is no longer medically
possible. The commenter asserted that cryopreservation of sperm or ovum
prior to entry into active combat would save money and allow
servicemembers who have prioritized childbearing to preserve the
ability to procreate. The commenter further noted that approximately 9%
of servicemembers wounded in action in Operation Iraqi Freedom and
Operation Enduring Freedom received genitourinary injuries. The
commenter also provided cost estimates related to cryopreservation and
related fertility treatment.
Semen cryopreservation (commonly called sperm banking) is a
procedure to preserve sperm cells. Oocyte cryopreservation (egg
freezing) is a process in which a woman's egg (oocytes) is extracted,
frozen and stored. The semen or egg can later be thawed and used to
create an embryo that can then be implanted in a uterus. VA does
provide cryopreservation services in those cases where an appropriate
health care professional determines that the care is needed to promote,
preserve, or restore the health of the veteran and is in accord with
generally accepted standards of medical practice. However, the decision
on whether to offer cryopreservation of sperm or ovum to servicemembers
prior to participating in combat operations lies with DoD, not VA. We
make no changes based on this comment.
Provider Network
One commenter recommended that VA establish a nationwide
standardized network of reproductive medicine providers. The commenter
stated this is most important for servicemembers and military families
who must frequently move to new duty stations. Further, veterans and
active duty servicemembers may provide a sample in one location and
then later receive treatment in a different location.
The creation of provider networks (for purposes of VA's ART program
or any other VHA clinical program) is beyond the scope of this
rulemaking. However, we note that VA is working with reproductive
medicine and infertility specialists both in VA and in the community to
provide necessary fertility counseling and treatment to veterans and
spouses covered by 38 CFR 17.380 and 17.412. We make no changes based
on this comment.
Based on the rationale set forth in the interim final rule and in
this document, VA adopts the interim final rule as a final rule, as
modified to accommodate the changes made by the 2018 Act, as noted
above.
Administrative Procedure Act
In accordance with 5 U.S.C. 553(b)(B), the Secretary of Veterans
Affairs concluded that there was good cause to publish amendments to
this rule without prior opportunity for public comment, and to publish
this rule with an immediate effective date. The 2018 Act revised our
authority to provide ART and IVF to covered veterans and spouses by
removing time limitations on cryopreservation and storage of embryos
reflected in the April 3, 2012 DoD memorandum titled ``Policy for
Assisted Reproductive Services for the Benefit of Seriously or Severely
Ill/Injured (Category II or III) Active Duty Service Members.'' Prior
to this revision VA was required to provide ART and IVF benefits to
covered veterans and spouses consistent with 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 that
memorandum. This final rule incorporates a specific requirement
mandated by Congress. Accordingly, this final rule is exempt from the
prior notice-and-comment and delayed-effective-date requirements of 5
U.S.C. 553(b) and (d).
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 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 final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
[[Page 8257]]
Regulatory Flexibility Act
The Secretary hereby certifies that 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 final rule directly affects 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 Orders 12866, 13563, and 13771
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,'' which requires review by the Office
of Management and Budget (OMB), 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
the Executive Order.
VA has examined the economic, interagency, budgetary, legal, and
policy implications of this regulatory action and determined that the
action is not a significant regulatory action under Executive Order
12866. VA's impact analysis can be found as a supporting document at
http://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of the
rulemaking and its impact analysis are available on VA's website at
http://www.va.gov/orpm by following the link for VA Regulations
Published from FY 2004 through FYTD. This rule is not an E.O. 13771
regulatory action because this rule is not significant under E.O.
12866.
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 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 64.012--Veterans
Prescription Service; 64.029--Purchase Care Program; 64.040--VHA
Inpatient Medicine; 64.041--VHA Outpatient Specialty Care; 64.042--VHA
Inpatient Surgery; 64.045--VHA Outpatient Ancillary Services; 64.047--
VHA Primary Care; 64.050--VHA Diagnostic Care.
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.
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. Robert L.
Wilkie, Secretary, Department of Veterans Affairs, approved this
document on January 11, 2019, for publication.
Dated: March 3, 2019.
Michael P. Shores,
Director, Office of Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, the VA amends 38 CFR
part 17 as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 is amended in the entry for
Sec. Sec. 17.380, 17.390 and 17.412 by adding ``, and sec. 236, div.
J, Pub. L 115-141, 132 Stat. 348'' immediately after ``857'' to read in
part as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
0
2. Amend Sec. 17.380 by revising paragraph (b) to read as follows:
Sec. 17.380 In vitro fertilization treatment.
* * * * *
(b) The time periods regarding embryo cryopreservation and storage
set forth in part III(G) and in part IV(H) of the memorandum referenced
in paragraph (a)(3) of this section do not apply. Embryo
cryopreservation and storage may be provided to an individual described
in paragraph (a)(1) of this section without limitation on the duration
of such cryopreservation and storage.
0
3. Amend Sec. 17.412 by revising paragraph (b) to read as follows:
Sec. 17.412 Fertility counseling and treatment for certain spouses.
* * * * *
(b) The time periods regarding embryo cryopreservation and storage
set forth in part III(G) and in part IV(H) of the memorandum referenced
in paragraph (a) of this section do not apply. Embryo cryopreservation
and storage may be provided to a spouse of a covered veteran without
limitation on the duration of such cryopreservation and storage.
[FR Doc. 2019-04096 Filed 3-6-19; 8:45 am]
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