Proposed Rule2026-09479
Excepted Fertility Benefits
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 13, 2026
Issuing agencies
Treasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
This document contains proposed rules that would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code, and the Public Health Service Act to establish certain fertility benefits as a new category of limited excepted benefits. Excepted benefits are generally exempt from the market requirements that were added to those laws by the Health Insurance Portability and Accountability Act, the Patient Protection and Affordable Care Act, the No Surprises Act, and certain other Federal laws specifically related to group health plans and group and individual health insurance coverage.
Full Text
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<title>Federal Register, Volume 91 Issue 92 (Wednesday, May 13, 2026)</title>
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[Federal Register Volume 91, Number 92 (Wednesday, May 13, 2026)]
[Proposed Rules]
[Pages 27140-27173]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09479]
[[Page 27139]]
Vol. 91
Wednesday,
No. 92
May 13, 2026
Part II
Department of the Treasury
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Internal Revenue Service
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26 CFR Part 54
Department of Labor
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Employee Benefits Security Administration
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29 CFR Part 2590
Department of Health and Human Services
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45 CFR Part 146
Excepted Fertility Benefits; Proposed Rule
Federal Register / Vol. 91 , No. 92 / Wednesday, May 13, 2026 /
Proposed Rules
[[Page 27140]]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG-118484-25]
RIN 1545-BS02
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC40
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 146
[CMS-9879-P]
RIN 0938-AV94
Excepted Fertility Benefits
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Proposed rules.
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SUMMARY: This document contains proposed rules that would amend the
regulations regarding excepted benefits under the Employee Retirement
Income Security Act of 1974, the Internal Revenue Code, and the Public
Health Service Act to establish certain fertility benefits as a new
category of limited excepted benefits. Excepted benefits are generally
exempt from the market requirements that were added to those laws by
the Health Insurance Portability and Accountability Act, the Patient
Protection and Affordable Care Act, the No Surprises Act, and certain
other Federal laws specifically related to group health plans and group
and individual health insurance coverage.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than July 13, 2026.
ADDRESSES: Written comments may be submitted to the address specified
below. Any comment that is submitted will be shared with Treasury,
Internal Revenue Service (IRS), and the Department of Health and Human
Services (HHS). Please do not submit duplicates.
Comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. All comments are posted on the
internet exactly as received and can be retrieved by most internet
search engines. No deletions, modifications, or redactions will be made
to the comments received, as they are public records. Comments may be
submitted anonymously.
In commenting, please refer to file code 1210-AC40. The Departments
cannot accept comments by facsimile (FAX) transmission.
Comments must be submitted in one of the following two ways (please
choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By mail. You may mail written comments to the following address
ONLY: Office of Health Plan Standards and Compliance Assistance,
Employee Benefits Security Administration, Room N-5653, U.S. Department
of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention:
1210-AC40.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. The comments are posted on
the following website as soon as possible after they have been
received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions
on that website to view public comments. The Departments encourage
commenters to include supporting facts, research, and evidence in their
comments. When doing so, commenters are encouraged to provide citations
to the materials referenced, including active hyperlinks. Likewise,
commenters who reference materials that have not been published are
encouraged to upload relevant data collection instruments, data sets,
and detailed findings as a part of their comment. Providing such
citations and documentation will assist the Departments in analyzing
the comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
summary of not more than 100 words in length of this proposed rule, in
plain language may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
FOR FURTHER INFORMATION CONTACT: Alexander Krupnick, Internal Revenue
Service, Department of the Treasury, at 202-317-5500; Rebecca Miller
and David Sydlik, Employee Benefits Security Administration, Department
of Labor, at 202-693-8335; David Mlawsky, Centers for Medicare &
Medicaid Services, Department of Health and Human Services, at 410-786-
6851.
Customer Service Information: Individuals interested in obtaining
information from DOL concerning private employment-based health
coverage laws may call the Employee Benefits Security Administration
(EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the DOL's
website (<a href="https://www.dol.gov/agencies/ebsa">https://www.dol.gov/agencies/ebsa</a>).
In addition, information from HHS on private health insurance
coverage and coverage provided by self-funded, non-Federal governmental
group health plans can be found on the Centers for Medicare & Medicaid
Services (CMS) website (<a href="https://www.cms.gov/marketplace/about/oversight">https://www.cms.gov/marketplace/about/oversight</a>), and information on health care reform can be found at
<a href="https://www.healthcare.gov/">https://www.healthcare.gov/</a> or <a href="https://www.hhs.gov/healthcare/index.html">https://www.hhs.gov/healthcare/index.html</a>.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
1. Statutory Provisions
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) \1\ added chapter 100 to the Internal Revenue Code (Code), part
7 to the Employee Retirement Income Security Act (ERISA), and title
XXVII to the Public Health Service Act (PHS Act), which set forth
portability and nondiscrimination rules with respect to health
coverage. These provisions of the Code, ERISA, and the PHS Act were
later augmented by other laws, including the Mental Health Parity Act
of 1996; \2\ the Newborns' and Mothers' Health Protection Act; \3\ the
Women's Health and Cancer Rights Act; \4\ the Genetic Information
Nondiscrimination Act of 2008; \5\ the Paul Wellstone and Pete Domenici
Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA); \6\ the
Children's Health Insurance Program Reauthorization Act of 2009; \7\
Michelle's Law; \8\ the Patient
[[Page 27141]]
Protection and Affordable Care Act,\9\ as amended by the Health Care
and Education Reconciliation Act of 2010 (collectively known as the
Affordable Care Act or ACA); \10\ Division BB of the Consolidated
Appropriations Act, 2021, which includes the No Surprises Act; \11\ and
Division J of the Consolidated Appropriations Act, 2026.\12\
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\1\ Public Law 104-191 (Aug. 21, 1996).
\2\ Public Law 104-204 (Sept. 26, 1996).
\3\ Public Law 104-204 (Sept. 26, 1996).
\4\ Public Law 105-277 (Oct. 21, 1998).
\5\ Public Law 110-233 (May 21, 2008).
\6\ Public Law 110-343 (Oct. 3, 2008).
\7\ Public Law 111-3 (Feb. 4, 2009).
\8\ Public Law 110-381 (Oct. 9, 2008).
\9\ Public Law 111-148 (Mar. 23, 2010).
\10\ Public Law 111-152 (Mar. 30, 2010).
\11\ Public Law 116-260 (Dec. 27, 2020).
\12\ Public Law 119-75 (Feb. 3, 2026).
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The ACA reorganized, amended, and added to the provisions of part A
of title XXVII of the PHS Act relating to health coverage requirements
for group health plans and health insurance issuers in the group and
individual markets. The term ``group health plan'' includes both
insured and self-insured group health plans. The ACA also added section
715 to ERISA and section 9815 to the Code to incorporate the provisions
of part A of title XXVII of the PHS Act into ERISA and the Code, making
them applicable to group health plans and health insurance issuers
providing health insurance coverage in connection with group health
plans. The provisions of the PHS Act incorporated into ERISA and the
Code, as amended or added by the ACA, are sections 2701 through 2728
(market requirements).
In accordance with Code section 9831(b) and (c), ERISA section
732(b) and (c), and PHS Act sections 2722(b) and (c) and 2763, the
market requirements of chapter 100 of the Code, part 7 of ERISA, and
title XXVII of the PHS Act do not apply to a group health plan or a
health insurance issuer in the group or individual market in relation
to the provision of excepted benefits described in Code section
9832(c), ERISA section 733(c), and PHS Act section 2791(c).\13\ There
are four statutory categories of excepted benefits: benefits that are
excepted in all circumstances; limited excepted benefits, which are the
subject of this rulemaking; independent, noncoordinated excepted
benefits; and supplemental excepted benefits.
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\13\ HHS does not interpret the ACA amendments to PHS Act
section 2722(b) and (c) (formerly PHS Act section 2721(c) and (d))
as restricting the exemption for excepted benefits so it applies
only with respect to subpart 2 of part A of title XXVII of the PHS
Act, and it does not intend to use its resources to enforce the
market requirements with respect to excepted benefits offered by
non-federal governmental plan sponsors and encourages States to
adopt a similar approach with respect to issuers of excepted
benefits. See 75 FR 34538, 34539-40 (Jun. 17, 2010).
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The first category, under section 9832(c)(1) of the Code, section
733(c)(1) of ERISA, and section 2791(c)(1) of the PHS Act, includes
benefits that are generally not health coverage (such as automobile
insurance, liability insurance, workers' compensation, and accidental
death and dismemberment coverage). The benefits in this category are
excepted in all circumstances. In contrast, the benefits in the second,
third, and fourth categories are types of health coverage that are
excepted only if certain conditions are met.
The second category of excepted benefits is limited excepted
benefits. Under section 9832(c)(2)(A) and (B) of the Code, section
733(c)(2)(A) and (B) of ERISA, and section 2791(c)(2)(A) and (B) of the
PHS Act, limited excepted benefits include limited-scope dental or
vision benefits, and benefits for long-term care, nursing home care,
home health care, or community-based care that are offered separately,
or any combination thereof. Section 9832(c)(2)(C) of the Code, section
733(c)(2)(C) of ERISA, and section 2791(c)(2)(C) of the PHS Act further
provide that limited excepted benefits also include such other, similar
limited benefits as are specified in regulations.\14\ To be a limited
excepted benefit, the benefits must either: (1) be provided under a
separate policy, certificate, or contract of insurance; or (2)
otherwise not be an integral part of the plan.\15\
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\14\ Moreover, section 9833 of the Code, section 734 of ERISA,
and section 2792 of the PHS Act authorize the Secretaries of
Treasury, Labor, and HHS (collectively, the Secretaries) to
promulgate such regulations as may be necessary or appropriate to
carry out the provisions of chapter 100 of the Code, part 7 of
ERISA, and title XXVII of the PHS Act.
\15\ See Code section 9831(c)(1), ERISA section 732(c)(1), and
PHS Act section 2722(c)(1) and 2763(b); see also 79 FR 59130, 59131-
59134 (Oct. 1, 2014) (discussing the application of these
requirements to benefits such as limited-scope dental and vision
benefits and employee assistance programs).
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The third category of excepted benefits, referred to as
``noncoordinated excepted benefits,'' includes both coverage for only a
specified disease or illness (such as cancer-only policies), and
hospital indemnity or other fixed indemnity insurance. These benefits
are excepted under section 9831(c)(2) of the Code, section 732(c)(2) of
ERISA, and section 2722(c)(2) of the PHS Act only if all of the
following conditions are met: (1) the benefits are provided under a
separate policy, certificate, or contract of insurance; (2) there is no
coordination between the provision of such benefits and any exclusion
of benefits under any group health plan maintained by the same plan
sponsor; and (3) the benefits are paid with respect to any event
without regard to whether benefits are provided under any group health
plan maintained by the same plan sponsor or, with respect to individual
coverage, under any health insurance coverage maintained by the same
health insurance issuer.
The fourth category, under section 9832(c)(4) of the Code, section
733(c)(4) of ERISA, and section 2791(c)(4) of the PHS Act, is
supplemental excepted benefits. These benefits are excepted only if
they are provided under a separate policy, certificate, or contract of
insurance and are Medicare supplemental health insurance (also known as
Medigap), TRICARE supplemental programs, or ``similar supplemental
coverage provided to coverage under a group health plan.'' \16\
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\16\ To be considered ``similar supplemental coverage'' and thus
a supplemental excepted benefit, the coverage, whether offered in
the group or individual market, must supplement coverage provided
under a group health plan. This category does not include coverage
that supplements individual health insurance coverage. See 89 FR
23338, 23342 fn. 36 (Apr. 3, 2024).
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2. Limited Excepted Benefit Regulations
As stated in section I.A.1 of this preamble, under section
9832(c)(2) of the Code, section 733(c)(2) of ERISA, and section
2791(c)(2) of the PHS Act, limited excepted benefits include limited
scope vision or dental benefits, benefits for long-term care, nursing
home care, home health care, or community-based care that are offered
separately, or any combination thereof. Under section 9832(c)(2)(C) of
the Code, section 733(c)(2)(C) of ERISA, and section 2791(c)(2)(C) of
the PHS Act, the Departments have the authority and discretion to
specify in regulations additional limited excepted benefits that are
similar to the limited benefits specified in section 9832(c)(2)(A) and
(B) of the Code, section 733(c)(2)(A) and (B) of ERISA, and section
2791(c)(2)(A) and (B) of the PHS Act and that either are provided under
a separate policy, certificate, or contract of insurance, or are
otherwise not an integral part of a plan.
In 1997, the Departments published interim final regulations
defining limited-scope dental and vision benefits, as well as long-term
care benefits.\17\ The 1997 interim final rules did not define the
terms limited-scope dental and limited-scope vision benefits. The
preamble to the 1997 interim final rules stated that limited-scope
dental and vision benefits typically do not include medical services,
such as procedures associated with oral cancer or mouth injury or
ophthalmological services treating an eye disease or eye injury.\18\
Following
[[Page 27142]]
these interim final regulations, the Departments also published a
notice clarifying the conditions under which it is appropriate to treat
benefits under a health flexible spending arrangement (health FSA) as
limited excepted benefits.\19\ In 2004, the Departments published final
regulations defining the conditions under which limited-scope dental
and vision benefits, long-term care benefits, and health FSAs would be
considered limited excepted benefits.\20\ In contrast with the scope of
services covered by limited-scope dental and vision benefits
contemplated in the preamble of the 1997 interim final rules, the 2004
final rules defined limited-scope dental and vision benefits more
broadly. Under the 2004 final rules, limited-scope dental benefits are
benefits substantially all of which are for treatment of the mouth
(including any organ or structure within the mouth). Limited-scope
vision benefits are benefits substantially all of which are for
treatment of the eye.
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\17\ 62 FR 16894 (Apr. 8, 1997).
\18\ Id. at 16903.
\19\ 62 FR 67688 (Dec. 29, 1997).
\20\ 69 FR 78720 (Dec. 30, 2004).
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In 2014, the Departments amended the excepted benefit regulations
for limited-scope dental and vision benefits, as well as for certain
employee assistance programs (EAPs).\21\ Under the 2014 final rules,
the Departments removed the requirement that participants pay an
additional premium or contribution for limited-scope dental or vision
benefits to qualify as benefits that are not an integral part of the
plan in order to qualify as excepted benefits. The 2014 final rules
also established four requirements that an EAP must meet in order to be
an excepted benefit. The first requirement is that the EAP does not
provide significant benefits in the nature of medical care. The second
requirement is that the EAP cannot be coordinated with the benefits
under another group health plan. To satisfy this requirement,
participants in the other group health plan must not be required to use
and exhaust benefits under the EAP before an individual is eligible for
benefits under the other group health plan, and participant eligibility
for the EAP must not be dependent on participation in another group
health plan. The third requirement that an EAP must satisfy in order to
be an excepted benefit is that no employee premiums or contributions
may be required as a condition of participation in the EAP. The fourth
requirement is that an EAP may not impose any cost-sharing
requirements. Following the 2014 final rules, the Departments also
finalized rules for a pilot program for limited wraparound benefits as
limited excepted benefits in the group market if five conditions were
satisfied.\22\ This pilot program was available for a limited time and
has since sunset. Most recently, in 2019, the Departments finalized
rules establishing an excepted benefit Health Reimbursement Arrangement
(HRA) as a limited excepted benefit, which can be used to reimburse
certain medical care expenses, subject to the requirements at 26 CFR
54.9831-1(c)(3)(viii), 29 CFR 2590.732(c)(3)(viii), and 45 CFR
146.145(b)(3)(viii).\23\
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\21\ 79 FR 59130 (Oct. 1, 2014).
\22\ 80 FR 13995 (Mar. 18, 2015).
\23\ 84 FR 28888 (Jun. 20, 2019).
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3. Recent Executive Orders and Access to Fertility Benefits and
Services
On February 18, 2025, President Trump issued Executive Order 14216,
``Expanding Access to In Vitro Fertilization'' (Executive Order
14216).\24\ In Executive Order 14216, President Trump highlighted the
importance of family formation, and emphasized that ``as a Nation, our
public policy must make it easier for loving and longing mothers and
fathers to have children.'' Executive Order 14216 seeks to ensure
reliable access to in vitro fertilization (IVF) and provide more
affordable treatment options, recognizing both the medical necessity of
infertility treatment for affected individuals and the broader
importance of supporting American families in achieving their family
formation goals. As part of the Executive Order, President Trump made
it the policy of the Administration to ensure reliable access to IVF
treatment, including by easing unnecessary statutory or regulatory
burdens to make IVF treatment drastically more affordable. Separately,
on January 31, 2025, President Trump issued Executive Order 14192
``Unleashing Prosperity Through Deregulation'' (Executive Order 14192).
In Executive Order 14192, President Trump emphasized that the
application of complicated Federal regulation imposes massive costs on
the lives of millions of Americans, creates a substantial restraint on
our economic growth and ability to build and innovate, and hampers our
global competitiveness.\25\ Therefore, President Trump emphasized that
it was the policy of the government to alleviate unnecessary regulatory
burdens placed on the American people.
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\24\ Exec. Order No. 14216, 90 FR 10451 (Feb. 18, 2025).
\25\ Exec. Order No. 14192, 90 FR 9065 (Feb. 6, 2025).
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The Departments recognize that family formation is a longstanding
priority for millions of Americans in the United States, and access to
fertility benefits and services plays a role in supporting their
ability to build families. However, the United States is currently
experiencing a declining fertility rate. Between 2014 and 2024 the
number of births declined by 9 percent and the general fertility rate
declined by 14 percent, from 62.9 births per 1,000 females ages 15 to
44 to 53.8.\26\ The total fertility rate has remained below replacement
level for over a decade. Since 1990, the U.S. total fertility rate
declined from about the replacement level of 2.1 births per woman--the
fertility level needed for a population to replace itself from one
generation to the next--to 1.6 births per woman in 2023.\27\ Even as
the birth rate has fallen, however, Americans continue to report that
their ideal family size includes an average of 2.7 children.\28\
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\26\ See Joyce Martin, M.P.H., Brady Hamilton, Ph.D., and
Michelle Osterman, M.H.S, National Vital Statistics System, Data
Brief Number 535 (Jul. 2025), <a href="https://www.cdc.gov/nchs/data/databriefs/db535.pdf">https://www.cdc.gov/nchs/data/databriefs/db535.pdf</a>; see also Michelle J.K. Osterman, M.H.S, et.
al., Births: Final Data for 2023, National Vital Statistics Report,
Volume 74, No. 1 (Mar. 18, 2025), <a href="https://www.cdc.gov/nchs/data/nvsr/nvsr74/nvsr74-1.pdf">https://www.cdc.gov/nchs/data/nvsr/nvsr74/nvsr74-1.pdf</a>.
\27\ See Anne Driscoll, Ph.D., and Brady Hamilton, Ph.D.,
Effects of Age-specific Fertility Trends on Overall Fertility
Trends: United States, 1990-2023, National Vital Statistics Reports,
Vol. 74, No. 3 (Mar. 6, 2025), <a href="https://www.cdc.gov/nchs/data/nvsr/nvsr74/nvsr74-3.pdf">https://www.cdc.gov/nchs/data/nvsr/nvsr74/nvsr74-3.pdf</a>.
\28\ Megan Brenan, Americans' Ideal Family Size Remains Above
Two Children, Gallup (Sept. 4, 2025), <a href="https://news.gallup.com/poll/694640/americans-ideal-family-size-remains-above-two-children.aspx">https://news.gallup.com/poll/694640/americans-ideal-family-size-remains-above-two-children.aspx</a>.
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Infertility is a common problem in the United States, with recent
CDC data highlighting that one in five Americans suffer from
infertility.\29\ While infertility stems from a variety of factors
affecting both men and women, including, but not limited to, age,
ovulation, uterine, and ejaculation disorders, chronic reproductive
health conditions, medications, and genetic disorders, it can also be
unexplained after medical tests reveal no obvious fertility problems.
Possible reasons for unexplained infertility include an undiagnosed
underlying condition, sperm and egg quality,\30\ or environmental
factors.\31\
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\29\ Infertility: Frequently Asked Questions (May 15, 2024),
<a href="https://www.cdc.gov/reproductive-health/infertility-faq/index.html">https://www.cdc.gov/reproductive-health/infertility-faq/index.html</a>.
\30\ Cleveland Clinic, Unexplained Infertility (June 6, 2022),
<a href="https://my.clevelandclinic.org/health/diseases/23187-unexplained-infertility">https://my.clevelandclinic.org/health/diseases/23187-unexplained-infertility</a>.
\31\ See Jie Lin, et. al., Association between heavy metals
exposure and infertility among American women aged 20-44: A cross-
sectional analysis from 2013 to 2018 NHANES data (Feb. 13, 2023),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9971928/">https://pmc.ncbi.nlm.nih.gov/articles/PMC9971928/</a>; Amran, N. H.,
Zaid, S. S. M., Mokhtar, M. H., Manaf, L. A. & Othman, S., Exposure
to Microplastics during Early Developmental Stage: Review of Current
Evidence, Toxics 10, 597 (Oct. 10, 2022), <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9611505/">https://pmc.ncbi.nlm.nih.gov/articles/PMC9611505/</a>.
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Fertility treatments, including medication, surgery, intrauterine
insemination (IUI), and assisted reproductive technology (ART)
procedures such as IVF, as well as less invasive pre-conception care
options that address the root causes of infertility, allow those who
experience infertility a potential path to expand their families.\32\
In 2022, 98,289 infants born (or about 2.7% of all infants born) in the
United States were conceived through the use of ART.\33\ While ART has
been available for more than three decades, families seeking to avail
themselves of these technologies often face access challenges related
to cost.\34\ IVF is the most commonly used form of ART and more than
99% of ART procedures performed are IVF.\35\ A single cycle of IVF has
recently been estimated to cost between $15,000 and $20,000.\36\
However, given that the average number of cycles that are needed to
become pregnant from IVF is 2.5, the average cost of IVF to conceive
successfully can exceed $40,000.\37\ Often, less invasive fertility
treatments are more affordable than ART for a wide variety of reasons,
but may still present significant cost barriers to patients depending
on which treatments are most clinically appropriate for each specific
patient.
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\32\ U.S. Department of Health and Human Services, Use Across
the United States (Mar. 13, 2024), <a href="https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z">https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z</a>.
\33\ U.S. Centers for Disease Control and Prevention, National
ART Summary (Dec. 10, 2024), <a href="https://www.cdc.gov/art/php/national-summary/index.html?cove-tab=2">https://www.cdc.gov/art/php/national-summary/index.html?cove-tab=2</a>.
\34\ See World Health Organization, Infertility (Nov. 28, 2025),
<a href="https://www.who.int/news-room/fact-sheets/detail/infertility">https://www.who.int/news-room/fact-sheets/detail/infertility</a> (These
proposed rules contains links to non-United States Government
websites. The Departments are providing these links because they
contain additional information relevant to the topic(s) discussed in
this proposed rule or that otherwise may be useful to the reader.
The Departments cannot attest to the accuracy of information
provided on the cited third-party websites or any other linked
third-party site. The Departments are providing these links for
reference only; linking to a non-United States Government website
does not constitute an endorsement by the Departments or any of
their employees of the sponsors or the information and/or any
products presented on the website. Also, the privacy protections
generally provided by United States Government websites do not apply
to third-party sites).
\35\ Saswati Sunderam, Ph.D. et. al., Assisted Reproductive
Technology Surveillance--United States, 2018, Morbidity and
Mortality Weekly Report (Feb. 18, 2024).
\36\ U.S. Department of Health and Human Services, Fact Sheet:
In Vitro Fertilization (IVF) Use Across the United States (Mar. 13,
2024), <a href="https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z">https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z</a>.
\37\ Id.; see also Society for Assisted Reproductive Technology,
Preliminary National Summary Report 2024, Final Primary Outcome Per
Egg Retrieval Cycle, Patient's Own Eggs, First IVF, <a href="https://www.sartcorsonline.com/Csr/Public?ClinicPKID=0&reportingYear=2024&newReport=True">https://www.sartcorsonline.com/Csr/Public?ClinicPKID=0&reportingYear=2024&newReport=True</a> (last accessed
Apr. 16, 2026) (finding that a preliminary national summary report
for 2024 from the Society for Assisted Reproductive Technology
reported that the rate of live births following first-use IVF for
women under the age of 35 using their own oocytes is only 13.8%).
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4. Coverage of Fertility Benefits (EHBs, State Insurance Laws, and
Employer Sponsored Plans)
Historically, employer-sponsored group health plans have not
covered most fertility treatments, including prescription fertility
medications as well as IVF and non-IVF treatments.\38\ Though coverage
is now increasing, the majority of employer-sponsored group health
plans do not offer coverage of many fertility benefits, with some
estimates indicating that approximately 60 percent of employers do not
offer fertility benefits.\39\ Of those that do offer fertility
benefits, many have claims for such benefits administered under a
separate contract from their major medical coverage, with many
employers offering their fertility benefits through specialty
vendors.\40\ Accordingly, even where fertility benefits are offered by
an employer, they are often treated as a separate offering from the
main group health plan, with separate claims processes, provider
networks, and other plan administration features. Further, while
insured plans may be required to cover fertility benefits, including
IVF, as an Essential Health Benefit (EHB) or by applicable State law,
such requirements generally do not apply to self-insured group health
plans, which cover more than half of the people covered by private-
sector employer-sponsored health coverage.\41\
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\38\ Cara McMullin, Organizations Adding More Fertility and
Adoption Support, International Foundation of Employee Benefits
Plans (Aug. 22, 2024), <a href="https://blog.ifebp.org/organizations-adding-more-fertility-and-adoption-support/">https://blog.ifebp.org/organizations-adding-more-fertility-and-adoption-support/</a>; Mercer, Mercer National Survey
of Employer-Sponsored Health Plans (2024).
\39\ Cara McMullin, Organizations Adding More Fertility and
Adoption Support, International Foundation of Employee Benefits
Plans (Aug. 22, 2024), <a href="https://blog.ifebp.org/organizations-adding-more-fertility-and-adoption-support/">https://blog.ifebp.org/organizations-adding-more-fertility-and-adoption-support/</a>.
\40\ Ron Shinkman, Compared: Progyny, Kindbody, Carrot, and
Maven as fertility benefit coverage increases 33% in two years (Apr.
20, 2023), <a href="https://www.fertilitybridge.com/news-articles/fertility-benefit-coverage-progyny-kindbody-carrot-maven">https://www.fertilitybridge.com/news-articles/fertility-benefit-coverage-progyny-kindbody-carrot-maven</a>.
\41\ KFF, Share of Private-Sector Enrollees Enrolled in Self-
Insured Plans (2024), <a href="https://www.kff.org/state-health-policy-data/state-indicator/share-of-private-sector-enrollees-enrolled-in-self-insured-plans/">https://www.kff.org/state-health-policy-data/state-indicator/share-of-private-sector-enrollees-enrolled-in-self-insured-plans/</a>.
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Coverage of fertility benefits as an EHB varies by State and
issuer. EHBs are defined under ACA section 1302 and 45 CFR 156 subpart
B. Non-grandfathered health insurance coverage offered in the
individual or small group market is required to cover 10 categories of
EHBs.\42\ Under ACA section 1302(b)(2)(A) and 45 CFR 156.111, States
select an EHB-benchmark plan for their State, which must provide a
scope of benefits that is equal to the scope of benefits provided under
a typical employer plan. Where benefits are not EHBs, they are not
required to be covered (unless a separate Federal or State insurance
law applies) and are not subject to certain protections that apply to
EHBs, such as PHS Act section 2707(b)'s maximum out-of-pocket
requirements and section 2711's prohibition on annual and lifetime
dollar limits.\43\ While large group health insurance plans and self-
insured group health plans are not required to cover EHBs under the
ACA, they must comply with the requirements of PHS Act section 2707(b)
and section 2711 for those EHBs that they cover.\44\
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\42\ PHS Act section 2707(a); ACA section 1302(a)-(b). The 10
categories of essential health benefits are ambulatory patient
services; emergency services; hospitalization; maternity and newborn
care; mental health and substance use disorder services, including
behavioral health treatment; prescription drugs; rehabilitative and
habilitative services and devices; laboratory services; preventive
and wellness services and chronic disease management; and pediatric
services, including oral and vision care.
\43\ PHS Act sections 2707(b) and 2711; see also 26 CFR 54.9815-
2711, 29 CFR 2590.715-2711, and 45 CFR 147.126.
\44\ PHS Act sections 2707(b) and 2711. Final regulations
implementing PHS Act section 2711 provide that, for plan years
beginning on or after January 1, 2020, a group health plan or health
insurance issuer that is not required to provide EHB under section
1302(b) of the ACA must define EHB, for purposes of the prohibition
on lifetime and annual limits, in a manner consistent with an EHB-
benchmark plan selected by a State in accordance with 45 CFR
156.111, including coverage of any additional required benefits that
are considered EHB consistent with 45 CFR 155.170(a)(2). 26 CFR
54.9815-2711(c)(2); 29 CFR 2590.715-2711(c)(2); 45 CFR
147.126(c)(2).
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Other insurance laws requiring coverage of fertility benefits vary
at the State level.\45\ Currently, 15 States and
[[Page 27144]]
the District of Columbia require that health insurance coverage include
IVF benefits.\46\ State IVF coverage requirements often include
procedural limitations on coverage, such as establishing a benefit-
specific waiting period before coverage is provided. For example, some
of these waiting periods require a participant or beneficiary to fail
to get pregnant or fail to carry a baby to full term for a specified
period of time prior to being eligible for IVF coverage. The length of
this waiting period may vary depending on the age of the person
attempting to get pregnant. Under some State laws, a diagnosis of
infertility by a licensed physician allows a covered individual to
access fertility benefits before the waiting period requirement has
been satisfied. Some State laws also contain coverage limitations based
on dollar amount or other quantitative limitations, or both, but
coverage limitations are present in all State IVF coverage
requirements.\47\ For example, a limit on the total number of IVF
treatment cycles or oocyte retrievals is common, with limits ranging
from one cycle of IVF treatment to three, the latter of which is more
common.\48\ In contrast, some State laws include explicit dollar-amount
lifetime caps as low as $15,000 and as high as $100,000.\49\ Some
States also require coverage of other ART procedures in addition to
IVF, such as gamete intrafallopian transfer (GIFT) and zygote intra-
fallopian transfer (ZIFT).\50\
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\45\ See KFF, Mandated Coverage of Infertility Treatment,
<a href="https://www.kff.org/state-health-policy-data/state-indicator/infertility-coverage/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D">https://www.kff.org/state-health-policy-data/state-indicator/infertility-coverage/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D</a> (last accessed Apr. 16, 2026) (finding 23 States and
the District of Columbia have required various levels of fertility-
related care coverage for private insurance, while 15 States and the
District of Columbia have required various levels of IVF coverage);
see also RESOLVE, Insurance Coverage by State (2024), <a href="https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/">https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/</a> (last accessed Apr. 16, 2026) (finding that 25
States have infertility insurance laws, 21 States have laws
requiring coverage of fertility preservation treatments, and only 15
States have IVF coverage requirements).
\46\ See id. (Some States require coverage of other ART
procedures in addition to IVF, such as gamete intrafallopian
transfer (GIFT), Zygote intra-fallopian transfer (ZIFT), and
pronuclear stage tubal transfer (PROST)); see also OPM, 2025 FEHB
IVF Information (Oct. 1, 2024), <a href="https://www.opm.gov/healthcare-insurance/healthcare/reference-materials/reference/2025-fehb-ivf-information.pdf">https://www.opm.gov/healthcare-insurance/healthcare/reference-materials/reference/2025-fehb-ivf-information.pdf</a> (Additionally, for plan year 2025 all Federal
Employees Health Benefits (FEHB) Program carriers are required to
cover three cycles of IVF-related drugs).
\47\ See RESOLVE, Insurance Coverage by State, <a href="https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/">https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/</a> (last accessed Apr. 16, 2026).
\48\ Arkansas sets the maximum lifetime coverage amount at
$15,000. See Ark. Code Sec. 23-85-137(d); 054-00.1-6 Ark. Code. R.
(2025). Maryland and Rhode Island set their respective lifetime
maximum coverage limitations at $100,000. Md. Ins. Code Ann. Sec.
15-810(e) (2021); 27 R.I. Gen. Laws Sec. 27-18-30(g) (2017).
\49\ See RESOLVE, Insurance Coverage by State, <a href="https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/">https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/</a> (last accessed Apr. 16, 2026).
\50\ See, e.g., Ark. Code Sec. 20-16-2603(1)(D), (E); DC Code
Sec. 31-3834.06(i)(3).
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A few States also recently enacted legislation that addresses
coverage for other fertility treatments in an attempt to address the
root causes of infertility and give couples more information about
their reproductive health. For example, in 2025, Arkansas enacted the
Reproductive Empowerment and Support Through Optimal Restoration Act
(RESTORE Act), which amended State law \51\ to require that fertility
treatment coverage also include fertility treatments that address
reproductive health conditions and male factor infertility.\52\ The
RESTORE Act, among other things, attempts to address the gap in
research and care for female reproductive health and treat the
underlying reproductive health conditions causing infertility.\53\ The
RESTORE Act requires coverage for medical treatments including
ultrasounds; blood tests; hormone panel tests; laparoscopic or
exploratory surgery; examination of a patient's overall health and
lifestyle; eliminating environmental endocrine disruptors; assessing
the health and fertility health of a patient's partner; natural
procreative technology; fertility awareness-based methods; and
fertility education and medical management.\54\
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\51\ Ark. Code Sec. 23-85-137.
\52\ Reproductive Empowerment and Support Through Optimal
Restoration (RESTORE) Act, H.B. 1142 (2025).
\53\ Cf. Chuck Grassley, Grassley, Hyde-Smith, Lankford
Introduce Bill to Help Address Infertility (Jun. 14, 2024)
(introducing similar legislation in the U.S. Senate), <a href="https://www.grassley.senate.gov/news/news-releases/grassley-hyde-smith-lankford-introduce-bill-to-help-address-infertility">https://www.grassley.senate.gov/news/news-releases/grassley-hyde-smith-lankford-introduce-bill-to-help-address-infertility</a>.
\54\ Ark. Code Sec. 20-16-2603(8).
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5. FAQs Part 72
On October 15, 2025, President Trump announced that the Departments
would clarify the existing categories of excepted benefits employers
can use to offer fertility benefits, including the categories of
independent, noncoordinated excepted benefits and limited excepted
benefits. The Departments then contemporaneously issued FAQs about
Affordable Care Act Implementation Part 72 (FAQs Part 72) \55\
highlighting their commitment to exploring ways to leverage their
existing authority to protect IVF access, reduce costs for IVF, and
encourage the adoption of a full range of fertility benefits by
employers, including treatments to restore fertility by addressing root
causes of infertility, in accordance with Executive Order 14216.
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\55\ FAQs about Affordable Care Act Implementation Part 72 (Oct.
16, 2025), <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-72">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-72</a> and <a href="https://www.cms.gov/files/document/faqs-part-72.pdf">https://www.cms.gov/files/document/faqs-part-72.pdf</a>.
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FAQs Part 72 clarifies the existing categories of excepted benefits
employers can use to offer fertility benefits, including the categories
of independent, noncoordinated excepted benefits and limited excepted
benefits. Additionally, in FAQs Part 72, the Departments announced
their intention to undertake notice and comment rulemaking to provide
additional ways that certain fertility benefits may be offered as a
limited excepted benefit, if certain conditions are met. In accordance
with the directives in Executive Order 14216 and Executive Order 14192
and the commitment expressed in FAQs Part 72, in consideration of the
concerns highlighted in this section of the preamble, the Departments
are now issuing these proposed rules to reduce the regulatory burden
for employers seeking to offer fertility benefits to their employees.
As discussed later in section II.A.6 of this preamble, HHS is
considering and soliciting comments on whether similar approaches would
be appropriate to reduce regulatory burden and improve access to
fertility benefits for individuals in the individual market.
II. Overview of the Proposed Rules--Departments of the Treasury, Labor,
and HHS
A. Proposed Standards
Many employers, for a variety of reasons, do not cover fertility
benefits as part of their major medical coverage. Additionally, there
may be scenarios in which an employer wants to offer fertility benefits
without regard to whether their employees have other coverage at all,
or without regard to whether their employees have coverage that is
subject to and satisfies the market requirements. The Departments wish
to support and encourage employers in their offering of fertility
benefits and to ensure that employees are able to afford a range of
fertility treatments to make it easier to have children. Therefore, the
Departments propose to utilize the Departments' statutory authority
under Code section 9832(c)(2)(C), ERISA section 733(c)(2)(C), and PHS
Act section 2791(c)(2)(C) to recognize fertility benefits as other
similar limited excepted benefits, if specific conditions are
satisfied.
Under proposed paragraph (c)(3)(i) of 26 CFR 54.9831-1 and 29 CFR
2590.732 and proposed paragraph (b)(3)(i) of 45 CFR 146.145, fertility
benefits would be excepted benefits if they satisfy the
[[Page 27145]]
requirements of proposed paragraph (c)(3)(ix) of 26 CFR 54.9831-1 and
29 CFR 2590.732 and proposed paragraph (b)(3)(ix) of 45 CFR 146.145.
Under proposed paragraph (c)(3)(ix) of 26 CFR 54.9831-1 and 29 CFR
2590.732 and proposed paragraph (b)(3)(ix) of 45 CFR 146.145, fertility
benefits would be a new type of limited excepted benefit if they are
provided under a separate policy, certificate, or contract of insurance
or are otherwise not an integral part of the plan as described in
proposed paragraph (c)(3)(ix)(C) of 26 CFR 54.9831-1 and 29 CFR
2590.732, and proposed paragraph (b)(3)(ix)(C) of 45 CFR 146.145, and
satisfy the requirements of proposed paragraph (c)(3)(ix)(A), (B), and
(D) of 26 CFR 54.9831-1 and 29 CFR 2590.732, and proposed paragraph
(b)(3)(ix)(A), (B), and (D) of 45 CFR 146.145.
As explained in section I.A.1 of this preamble, the Departments
have statutory authority to create additional categories of limited
excepted benefits that are similar to the limited excepted benefits
specified in statute, and that are provided under a separate policy,
certificate, or contract of insurance, or are otherwise not an integral
part of a plan.\56\ Similar to adult dental and vision coverage,
fertility benefits are often not considered EHBs, are often not covered
by self-funded group health plans at all or solely to a limited extent,
and are often not administered under the same contract as benefits
offered through an employer's major medical plan. The Departments'
proposal to specify in regulations excepted fertility benefits as a new
additional category of other similar limited excepted benefits is
consistent with the market reality that fertility benefits are often
not covered or, in the minority of cases in which such benefits are
covered, are administered under a separate contract from a plan
sponsor's major medical plan, along with the statutory framework
applicable to limited excepted benefits. This proposal also aligns with
the priorities of the Trump Administration expressed in Executive Order
14216 to protect IVF access and reduce out-of-pocket and health plan
costs for IVF treatment.
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\56\ See Code section 9831(c)(1), ERISA section 732(c)(1), and
PHS Act section 2722(c)(1).
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Additionally, the ability to offer a separate excepted fertility
benefit that is not subject to the market requirements captured in
chapter 100 of the Code, part 7 of ERISA, and title XXVII of the PHS
Act is consistent with Executive Order 14192's goals of reducing
regulatory burden, as excepted benefits are not subject to certain
market requirements imposed on other group health plans and group
health insurance coverage. The Departments are soliciting comments on
the proposal to establish excepted fertility benefits as a new category
of limited excepted benefits, the limits of the category itself, and
the associated proposed conditions for such benefits to qualify as a
limited excepted benefit set forth below.
1. Benefits Covered
As stated in section I.A.1 of this preamble, under the Code, ERISA,
and the PHS Act, limited excepted benefits include limited-scope dental
or vision benefits, benefits for long-term care, nursing home care,
home health care, or community-based care that are offered separately,
or any combination thereof, and may include ``such other similar,
limited benefits as are specified in regulations'' by the
Departments.\57\ Thus, in proposing to create excepted fertility
benefits as a new category of limited excepted benefits, the
Departments determined that fertility benefits are similar to the
limited excepted benefits identified in section 9832(c)(2) of the Code,
section 733(c)(2) of ERISA, and section 2791(c)(2) of the PHS Act
because they are benefits that are often excluded from major medical
coverage offered by employers and are often administered under a
separate contract. In developing this proposal, the Departments
considered in what manner a fertility benefit would be sufficiently
limited to be similar to the other categories of limited excepted
benefits.
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\57\ Code section 9832(c)(2)(C), ERISA section 733(c)(2)(C), and
PHS Act section 2791(c)(2)(C).
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The Departments have consistently applied limiting principles in
prior rulemakings when exercising their statutory authority to specify
in regulations additional categories of limited excepted benefits.\58\
For example, a health FSA is a limited excepted benefit only if the
arrangement is structured so that the maximum benefit payable to any
participant in the class for a year does not exceed two times the
participant's salary reduction election under the arrangement for the
year (or, if greater, $500 plus the amount of the participant's salary
reduction election).\59\ Additionally, limited wraparound coverage was
recognized as a limited excepted benefit during a temporary pilot
program only if it was limited in amount, such that the cost of
coverage per employee (and any covered dependents) under the limited
wraparound coverage did not exceed the greater of the maximum permitted
annual salary reduction contribution toward a health FSA or 15 percent
of the cost of coverage under the primary plan.\60\ As stated earlier
in this preamble, the statutorily identified dental and vision excepted
benefits are limited by implementing regulations in the scope of
coverage provided instead of dollar amount, such that substantially all
of the benefits thereunder are for the treatment of the mouth
(including any organ or structure within the mouth) and treatment of
the eye, respectively.\61\
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\58\ See 83 FR 54420, 54437 (Oct. 29, 2018).
\59\ 26 CFR 54.9831-1(c)(3)(v); 29 CFR 2590.732(c)(3)(v); 45 CFR
146.145(b)(3)(v).
\60\ 26 CFR 54.9831-1(c)(3)(vii)(B), 29 CFR
2590.732(c)(3)(vii)(B), and 45 CFR 146.145(b)(3)(vii)(B).
\61\ 26 CFR 54.9831-1(c)(3)(iii), 29 CFR 2590.732(c)(3)(iii),
and 45 CFR 146.145(b)(3)(iii).
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The Departments propose to apply a limiting principle that is
similar to limited-scope dental and vision excepted benefits for
fertility benefits to qualify as a limited excepted benefit, in
addition to proposing to apply a lifetime dollar limit. Under these
proposed rules, the Departments propose to add paragraph (c)(3)(ix)(A)
to 26 CFR 54.9831-1 and 29 CFR 2590.732 and paragraph (b)(3)(ix)(A) to
45 CFR 146.145, to specify that fertility benefits would be recognized
as limited excepted benefits when coverage is limited to benefits
substantially all of which are for the diagnosis, mitigation, or
treatment of infertility or infertility-related reproductive health
conditions and substantially all of which are provided by medical
professionals authorized to practice under applicable law.\62\
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\62\ The Departments do not intend for this excepted fertility
benefit to include coverage for abortion or abortion-related
services. As proposed, this excepted fertility benefit would be for
the diagnosis, mitigation, or treatment of infertility or
infertility-related reproductive health conditions.
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The Departments also propose to specify that such benefits may
include medically appropriate items or services targeted to address
infertility-related reproductive health conditions, in order to clarify
that this provision would include benefits for items and services to
address underlying medical causes of the infertility. Similar to
limited-scope dental and vision benefits, and benefits for long term
care, nursing care, and home care and community-based care, this
proposed excepted fertility benefit is for targeted, limited benefits
that are not typically covered under an employer's major medical plan
and are often administered under a separate contract. The definition of
limited-scope dental and vision benefits under 26 CFR 54.9831-
1(c)(3)(iii), 29 CFR 2590.732(c)(3)(iii), and 45 CFR 146.145(b)(3)(iii)
allows for coverage of
[[Page 27146]]
a range of services from preventive care visits through more intensive
care such as major restorative care, orthodontics, and ophthalmological
services. The Departments propose to allow for a similar scope of
coverage for the excepted fertility benefit in order to provide
meaningful coverage for individuals facing challenges with infertility
or infertility-related reproductive health conditions. As detailed
further below, under these proposed rules, fertility benefits that
provide coverage for some or all of a similar range of items and
services--from preventive care to initial treatments to more intensive
care--would fall within the scope of coverage necessary to qualify as
limited excepted benefits.
Consistent with the Departments' goal of preserving flexibility for
employers to design and offer their benefits in a way that is tailored
towards their workforce, the Departments intend that excepted fertility
benefits could provide coverage for the services of fertility
counselors and general education on fertility, provided that
substantially all of the fertility benefits are still at the direction
of a medical professional authorized to practice under applicable law.
This is also consistent with many families' desire to pursue non-IVF
fertility treatment options.\63\ As such, the Departments are proposing
language to codify that excepted fertility benefits must be for items
and services, substantially all of which are provided by medical
professionals authorized to practice under applicable law.
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\63\ A recent survey of 1,010 adults in the United States,
United Kingdom, Ireland, and Canada, who are trying to conceive,
have tried to achieve pregnancy in the last five years, or plan to
try to achieve pregnancy in the next five years revealed that 89% of
women preferred to use a less invasive fertility treatment if
supported by evidence before trying IVF. Furthermore, the survey
showed that 78% of respondents said that having a better
understanding of non-IVF options would make them more likely to
pursue other fertility options first. Carrot, Beyond IVF: What
people really want from fertility care (March 2026), <a href="https://content.get-carrot.com/rs/418-PQJ-171/images/2026-Beyond-IVF-Report.pdf?version=0">https://content.get-carrot.com/rs/418-PQJ-171/images/2026-Beyond-IVF-Report.pdf?version=0</a> (last accessed Apr. 16, 2026).
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Additionally, the Departments recognize that the causes of
infertility and infertility-related conditions may vary by individual
based on their overall health, specific health conditions, age, and
environmental and socioeconomic factors. For example, maintaining a
healthy weight and eating a healthy diet can help men and women address
infertility.\64\ Common reproductive health conditions, such as
polycystic ovary syndrome, endometriosis, or uterine fibroids also can
cause infertility for women.\65\ Furthermore, there are many underlying
endocrinopathies that cause infertility including thyroid disorders,
hyperprolactinemia, acromegaly, Cushing's disease, hypogonadotropic
hypogonadism, and primary ovarian disorders.\66\ For men, fertility can
be impacted by conditions such as varicoceles, obstruction in the vas
deferens, and male hypogonadism.\67\ Therefore, under these proposed
rules, excepted fertility benefits may include coverage to diagnose,
mitigate and treat infertility and infertility-related conditions and
may include medically appropriate items or services targeted to address
such conditions.
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\64\ American College of Obstetricians & Gynecologists, Treating
Infertility, Frequently Asked Questions, What lifestyle changes may
help improve my chances for pregnancy?, <a href="https://www.acog.org/womens-health/faqs/treating-infertility">https://www.acog.org/womens-health/faqs/treating-infertility</a> (last accessed Apr. 16, 2026).
\65\ U.S. Centers for Disease Control and Prevention, Common
Reproductive Health Concerns for Women (May 15, 2024), <a href="https://www.cdc.gov/reproductive-health/women-health/common-concerns.html">https://www.cdc.gov/reproductive-health/women-health/common-concerns.html</a>.
\66\ Unuane D, Tournaye H, Velkeniers B, Poppe K. Endocrine
disorders & female infertility. Best Pract Res Clin Endocrinol
Metab. (2011).
\67\ Mayo Clinic, Diagnosis and Treatment, Male infertility
(Dec. 28, 2022), <a href="https://www.mayoclinic.org/diseases-conditions/male-infertility/symptoms-causes/syc-20374773">https://www.mayoclinic.org/diseases-conditions/male-infertility/symptoms-causes/syc-20374773</a>.
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The Departments note that fertility benefits that may be excepted
fertility benefits under these proposed rules may include benefits that
are typically covered by major medical plans, including as an EHB. To
the extent the group health plan or health insurance issuer of group
health insurance coverage offers a major medical plan that both covers
any such benefits as an EHB as well as under an excepted fertility
benefit, there may be overlapping coverage. Nothing in these proposed
rules would prevent such overlapping coverage and coordination-of-
benefits provisions under the terms of the plan or coverage, and
applicable State and Federal law would continue to apply.\68\
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\68\ See, e.g., 42 CFR 411 (providing Medicare Secondary Payer
rules); see also McGurl v. Trucking Employees of North Jersey
Welfare Fund, Inc., 124 F.3d 471 (3d Cir. 1997) (utilizing ERISA
common law authority to determine which plan would take precedence
where coordination of benefits provisions conflicted).
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As stated earlier in this section of the preamble, under these
proposed rules, excepted fertility benefits may include benefits to
diagnose infertility. Examples of benefits for the diagnosis of
infertility include, but are not limited to, benefits for lab tests,
imaging, and diagnostic procedures such as laparoscopies and
hysteroscopies. Such benefits may also include, for example, benefits
for evaluation with hysteroscopy or laparoscopy for patients with a
history of endometriosis, pelvic infections, or ectopic pregnancy,\69\
as well as blood tests to measure hormones for both men and women,
semen analyses to assess the quality and health of the sperm for men,
and urine tests to measure levels of luteinizing hormone for women.\70\
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\69\ Tammy Lindsay, MD, and Kirsten Vitrikas, MD, Evaluation and
Treatment of Infertility, Am Fam Physician, March 1, 2015; 91(5),
<a href="https://www.aafp.org/pubs/afp/issues/2015/0301/p308.pdf">https://www.aafp.org/pubs/afp/issues/2015/0301/p308.pdf</a> (During a
hysteroscopy, a licensed medical professional inserts a hysteroscope
(a thin, lighted tube) through the cervix into the uterus and checks
for any irregular signs. During a laparoscopy, a licensed medical
professional makes a small cut beneath the navel and places a thin
viewing device through the cut to check the fallopian tubes,
ovaries, and uterus); Mayo Clinic, Diagnosis and Treatment, <a href="https://www.mayoclinic.org/diseases-conditions/infertility/diagnosis-treatment/drc-20354322">https://www.mayoclinic.org/diseases-conditions/infertility/diagnosis-treatment/drc-20354322</a> (last accessed Apr. 16, 2026).
\70\ American College of Obstetricians & Gynecologists,
Evaluating Infertility, Frequently Asked Questions, What does the
basic testing for women include?, <a href="https://www.acog.org/womens-health/faqs/evaluating-infertility">https://www.acog.org/womens-health/faqs/evaluating-infertility</a> (last accessed Apr. 16, 2026).
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Additionally, under these proposed rules, an excepted fertility
benefit may also include benefits to mitigate infertility and address
infertility-related reproductive health conditions including, for
example, examination of a patient's overall health and lifestyle and
elimination of environmental endocrine disruptors.\71\ Benefits to
mitigate infertility under these proposed rules may also include, but
are not limited to, fertility awareness-based methods, fertility
education and medical management, surgical procedures, and pre-
conception care with a focus on fertility awareness.
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\71\ See Heather Patisaul, Reproductive Toxicology: Endocrine
disruption and reproductive disorders: impacts on sexually dimorphic
neuroendocrine pathways, <a href="https://rep.bioscientifica.com/view/journals/rep/162/5/REP-20-0596.xml">https://rep.bioscientifica.com/view/journals/rep/162/5/REP-20-0596.xml</a> (Oct. 5, 2021).
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Under these proposed rules, benefits to mitigate infertility that
would be considered excepted fertility benefits may furthermore include
assessment of the health and fertility of a patient's partner (where
the partner is also a participant or a beneficiary under the plan or
coverage). Male-factor infertility treatments are also a component of
infertility mitigation.\72\ They can include an evaluation of a
patient's medical history, a physical examination, analysis of a
patient's semen, and surgical approaches, including robotic
surgery.\73\ Additional methods of
[[Page 27147]]
mitigation include ultrasound scanning, urinalysis, genetic tests,
testicular biopsies, and other tests to determine sperm function.
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\72\ See Jefferson Health, Male Factor Infertility (last
accessed Apr. 16, 2026), <a href="https://www.jeffersonhealth.org/conditions-and-treatments/male-factor-infertility">https://www.jeffersonhealth.org/conditions-and-treatments/male-factor-infertility</a>.
\73\ Mourad Assidi, Ph.D., Infertility in Men: Advances towards
a Comprehensive and Integrative Strategy for Precision Theranostics.
Cells (May 22, 2022), <a href="https://doi.org/10.3390/cells11101711">https://doi.org/10.3390/cells11101711</a>.
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Another example of a benefit to treat infertility that would be an
excepted fertility benefit under these proposed rules is ovulation
induction, which includes either oral or injectable medications, that
can help improve ovulation patterns or increase the number of eggs
released each month.\74\ Additionally, although hysteroscopy and
laparoscopy are tests that can help diagnose infertility, these tests
can also help with the treatment of infertility. For example, a
laparoscopy can remove growths called fibroids or endometriosis tissue
which can lead to infertility.\75\ Treatment of infertility may also
include IVF, where egg production is stimulated through medication and
eggs are surgically retrieved from the ovaries prior to ovulation and
fertilized with sperm in a laboratory environment before being
transferred into the uterus.\76\ People who have absent or blocked
fallopian tubes, endometriosis, ovulatory dysfunction, or low sperm
count, among others, are generally considered candidates for IVF.\77\
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\74\ Johns Hopkins Medicine, Gynecology & Obstetrics Fertility
Center, Infertility Services: Ovulation Induction, <a href="https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ovulation-induction-intercourse">https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ovulation-induction-intercourse</a> (last accessed Apr. 16, 2026).
\75\ Mayo Clinic, Diagnosis and Treatment, <a href="https://www.mayoclinic.org/diseases-conditions/infertility/diagnosis-treatment/drc-20354322">https://www.mayoclinic.org/diseases-conditions/infertility/diagnosis-treatment/drc-20354322</a> (last accessed Apr. 16, 2026); see also
American College of Obstetricians & Gynecologists, Treating
Infertility, Frequently Asked Questions, What are gonadotropins?,
<a href="https://www.acog.org/womens-health/faqs/treating-infertility">https://www.acog.org/womens-health/faqs/treating-infertility</a> (last
accessed Apr. 16, 2026) (Gonadotropins are another drug used to
trigger ovulation. Gonadotropins are used if other drugs are not
successful or if many eggs are needed for infertility treatments.
Gonadotropins are given in a series of shots early in the menstrual
cycle.).
\76\ Johns Hopkins Medicine, Gynecology & Obstetrics Fertility
Center, Infertility Services: In Vitro Fertilization (IVF), <a href="https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ivf">https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ivf</a> (last accessed Apr. 16,
2026).
\77\ Johns Hopkins Medicine, Gynecology & Obstetrics Fertility
Center, Infertility Services: In Vitro Fertilization (IVF), <a href="https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ivf">https://www.hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fertility-center/infertility-services/ivf</a> (last accessed Apr. 16,
2026).
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IVF is the most commonly used ART procedure and one of the most
effective for treating infertility.\78\ Other types of ART, such as
GIFT and ZIFT, are much less common. In a national report on ART
looking at the chance of a live birth, the data showed a 41.7 percent
chance of live birth with an intended egg retrieval for women under the
age of 35.\79\ Between 2004 and 2013, among women ages 18 to 43 using
autologous oocytes (i.e. the individual's own eggs), the live birth
rate per IVF cycle was 35.5 percent.\80\ The Departments recognize that
based on the cost of IVF treatment, employers and issuers may choose to
limit the benefits available for IVF under an excepted fertility
benefit.
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\78\ U.S. Department of Health and Human Services, Fact Sheet:
In Vitro Fertilization (IVF) Use Across the United States (Mar. 13,
2024), <a href="https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z">https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z</a>.
\79\ Society for Assisted Reproductive Technology, Preliminary
National Summary Report for 2024, National Summary Report (last
accessed Apr. 16, 2026), <a href="https://www.sartcorsonline.com/CSR/PublicSnapshotReport?ClinicPKID=&reportingYear=2024&fromDisclaimer=true">https://www.sartcorsonline.com/CSR/PublicSnapshotReport?ClinicPKID=&reportingYear=2024&fromDisclaimer=true</a>.
\80\ Luke, B. et al., Likelihood of success at each stage of IVF
treatment by maternal age and oocyte source: analysis of the 2004-13
cycles in the SART CORS, Fertility and Sterility (Sept. 2017),
<a href="https://www.fertstert.org/article/S0015-0282">https://www.fertstert.org/article/S0015-0282</a>(17)31538-8/fulltext.
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These proposed rules are generally intended to provide employers
and health insurance issuers with flexibility to cover a broad spectrum
of treatments and interventions for fertility-related and pre-
conception care as part of the excepted fertility benefit. The
Departments believe allowing employers and health insurance issuers
this flexibility creates the opportunity for fertility benefits to help
individuals address their specific fertility needs, regardless of
whether they need pre-conception care related to the underlying cause
of infertility or more invasive treatments and procedures, like IVF.
Furthermore, to the extent that issuers are assuming financial risk for
providing fertility benefits under a separate contract from major
medical insurance, the Departments believe the assumption of such risk
for a patient's financial exposure and fertility outcome creates a
powerful incentive for the issuer to help patients access the highest-
quality interventions based on each specific patient's needs at the
lowest cost. The Departments solicit comments on the proposals related
to the scope of excepted fertility benefits, including the illustrative
examples provided in this preamble.
2. Lifetime Dollar Amount
In addition to the proposed limitation on the scope of coverage,
the Departments are also proposing to establish a lifetime dollar limit
for the proposed excepted fertility benefits. Under these proposed
rules, at paragraph (c)(3)(ix)(B) of 26 CFR 54.9831-1 and 29 CFR
2590.732 and paragraph (b)(3)(ix)(B) of 45 CFR 146.145, the Departments
propose that the total lifetime benefit per participant, together with
their beneficiaries (if such beneficiaries are eligible for the
excepted fertility benefit), would not exceed $120,000. This proposed
maximum lifetime dollar limit would be indexed for medical inflation to
keep up with the rising cost of medical items and services. As
illustrated in proposed Example 3, to the extent the plan or issuer of
the excepted fertility benefits paid $120,000 in benefits (plus the
increase due to medical inflation applicable for the plan year) for any
participant, together with their beneficiaries if eligible, counting
plan payments for both the current plan year to date and any previous
plan years, the excepted fertility benefits would be exhausted and no
further coverage or additional benefits could be provided by the plan
or issuer.\81\ Further, a fertility benefit that provides benefits in
excess of the maximum lifetime dollar limitation for any participant,
together with their beneficiaries if eligible, would fail to meet the
requirements of proposed paragraph (c)(3)(ix) of 26 CFR 54.9831-1 and
29 CFR 2590.732 and paragraph (b)(3)(ix) of 45 CFR 146.145.
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\81\ If consistent with the plan's terms, the excepted fertility
benefit plan may, in future years, cover additional benefits for
such participant or beneficiary based on the then-applicable
lifetime total benefit maximum, as increased by medical inflation.
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The Departments are proposing that for plan years beginning after
December 31, 2027, the maximum lifetime dollar amount would be
increased by an amount equal to $120,000 multiplied by the difference
between the overall medical care component of the CPI-U (unadjusted)
published by the Department of Labor for December of the previous plan
year and 587.144 (the overall medical care component of the CPI-U
(unadjusted) for December 2025), divided by 587.144.\82\ This method is
similar to the method utilized to account for medical inflation in the
Departments' grandfathered plan regulations.\83\ The Departments seek
comment regarding whether an alternative method of calculating medical
inflation may more accurately reflect the rising costs of fertility
treatment.
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\82\ See Bureau of Labor Statistics, Medical care in U.S. city
average, all urban consumers, not seasonally adjusted, <a href="https://data.bls.gov/timeseries/CUUR0000SAM?output_view=data">https://data.bls.gov/timeseries/CUUR0000SAM?output_view=data</a>.
\83\ 26 CFR 54.9815-1251(g)(4)(i), 29 CFR 2590.715-
1251(g)(4)(i), and 45 CFR 147.140(g)(4)(i).
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The Departments have applied limits on other limited excepted
benefits specified in regulations, such as the
[[Page 27148]]
limited health FSA and the excepted benefit HRA. These types of
account-based limited excepted benefits can be used to reimburse a wide
range of medical care expenses as defined under section 213(d) of the
Code. The Departments recognize that certain limited excepted benefits
that are not limited in scope by benefit type (as compared to limited-
scope dental or limited-scope vision benefits) must be limited in some
way to constitute the type of ancillary benefit contemplated within the
meaning of ``similar, limited benefits'' under Code section
9832(c)(2)(C), ERISA section 733(c)(2)(C), and PHS Act section
2791(c)(2)(C). For example, a health FSA is an excepted benefit only if
the arrangement is structured so that the maximum benefit payable to
any participant in the class for a year does not exceed two times the
participant's salary reduction election under the arrangement for the
year (or, if greater, $500 plus the amount of the participant's salary
reduction election).\84\ An excepted benefit HRA may not exceed $1,800,
indexed for inflation for plan years beginning after December 31,
2020.\85\
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\84\ 26 CFR 54.9831-1(c)(3)(v), 29 CFR 2590. 732(c)(3)(v), and
45 CFR 146.145(b)(3)(v).
\85\ 26 CFR 54.9831-1(c)(3)(viii), 29 CFR 2590. 732(c)(3)(viii),
and 45 CFR 146.145(b)(3)(viii).
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In the context of the proposed excepted fertility benefit, as
stated earlier in this preamble, the Departments recognize that the
causes of infertility and infertility-related conditions may vary by
individual based on various factors such as overall health, specific
health conditions, age, and environmental and socioeconomic factors.
Given the potential for an expansive understanding of the items and
services that may constitute benefits for the diagnosis, mitigation, or
treatment of infertility and its causes, the establishment of a total
lifetime dollar limit, together with the limit in scope, would ensure
the Departments, in the exercise of their statutory authority to
specify this new category of limited excepted benefits, give
appropriate meaning to the term ``limited.'' For excepted fertility
benefits, a total lifetime dollar limit, as opposed to the annual
dollar limit utilized for other excepted benefits such as excepted
benefit HRAs and limited health FSAs, is more appropriate because
applying a maximum lifetime dollar limit would be similar to the
structure of several States' insurance laws (which impose a lifetime
limit on coverage of IVF) as well as the structure of the majority of
employer plans that currently offer IVF coverage.\86\ The Departments
request comment on the proposal to apply a limit on scope of coverage
and a lifetime dollar limit and whether fertility benefits that meet
both requirements would be sufficiently ``similar'' and ``limited'' to
constitute the type of benefit contemplated within the meaning of
``similar, limited benefits'' under Code section 9832(c)(2)(C), ERISA
section 733(c)(2)(C), and PHS Act section 2791(c)(2)(C).
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\86\ See 054.00.1 Ark. Admin. Code Sec. 6; see also 27 R.I.
Gen. Laws Sec. 27-18-30(g); see also Md. Code Ann., Ins. Sec. 15-
810(e); see also Mercer, National Survey of Employer-Sponsored
Health Plans (2024).
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In proposing the lifetime dollar amount be limited to $120,000
(plus medical inflation for plan years beginning after December 31,
2027), the Departments considered the main cost drivers of fertility
benefits, including IVF. One source estimates the average cost of one
IVF cycle in the U.S. ranges from $15,000 to $20,000.\87\ Another
source suggests that the cost is higher, costing $24,373 to $38,015 for
IVF and $61,377 for successful pregnancy via IVF.\88\ Even less costly
procedures like IUI can be several thousand dollars per treatment.\89\
Beyond the cost of the procedures involved, a patient faces other
associated costs such as imaging, bloodwork, and medications. Given
that the average number of cycles that are needed to achieve a
successful pregnancy from IVF is 2.5, the total cost of IVF can exceed
$40,000, or even $60,000, depending on the source.\90\ The Departments
are therefore proposing a $120,000 lifetime dollar limit because it
would give employers and health insurance issuers the flexibility to
offer benefits sufficient to meaningfully provide a benefit that covers
the needs of their employees, including successful conceptions via IVF.
The Departments do not intend that employers and issuers offering
fertility benefits would be unduly constrained in designing a
meaningful fertility benefit, and accordingly, the Departments are
proposing a dollar limit that reflects the cost of fertility treatment
for many individuals and is in line with the lifetime maximum benefits
of several State insurance laws (which are currently as high as
$100,000).\91\ The Departments also believe setting such dollar limit
would reduce the amount of disruption for employers who may choose to
transition their current fertility benefits to an excepted fertility
benefit, as such employers could retain any current dollar limit, as
long as it is $120,000 or lower, while adding a limiting principle.
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\87\ Alina Salganicoff, Brittni Frederiksen, and Usha Ranji,
Will Trump's Announcement Expand Access to IVF?, KFF (Oct. 27,
2025), <a href="https://www.kff.org/womens-health-policy/will-trumps-announcement-expand-access-to-ivf/?spm=a2700.accio_bizSeo.0.0.25a87e47NpdtI2">https://www.kff.org/womens-health-policy/will-trumps-announcement-expand-access-to-ivf/?spm=a2700.accio_bizSeo.0.0.25a87e47NpdtI2</a>.
\88\ Patricia Katz et. al., Costs of infertility treatment:
results from an 18-month prospective cohort study, Fertil Steril.
(March 1, 2011).
\89\ Penn Medicine, Intrauterine insemination (IUI), <a href="https://www.pennmedicine.org/treatments/intrauterine-insemination">https://www.pennmedicine.org/treatments/intrauterine-insemination</a> (last
accessed Apr. 16, 2026).
\90\ Patricia Katz et. al., Costs of infertility treatment:
results from an 18-month prospective cohort study, Fertil Steril.
(March 1, 2011); U.S. Department of Health and Human Services, Fact
Sheet: In Vitro Fertilization (IVF) Use Across the United States
(Mar. 13, 2024), <a href="https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z">https://us.pagefreezer.com/en-US/wa/browse/0a7f82bb-be6e-448a-ae11-373d22c37842?find-by-timestamp=2025-01-02T05:49:59Z&url=https:%2F%2Fwww.hhs.gov%2Fabout%2Fnews%2F2024%2F03%2F13%2Ffact-sheet-in-vitro-fertilization-ivf-use-across-united-states.html×tamp=2025-01-02T07:03:02Z</a>.
\91\ See Mercer, National Survey of Employer-Sponsored Health
Plans (2024) (The median lifetime dollar limit for employer-
sponsored IVF coverage was $20,000 in 2023); Md. Ins. Code Ann.
Sec. 15-810(e) (2021); 27 R.I. Gen. Laws Sec. 27-18-30(g) (2017).
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While the Departments considered proposing an alternative, lower
lifetime dollar limit (e.g. $50,000), they determined that such a limit
may constrain employers and health insurance issuers that want to offer
a fertility benefit sufficient to cover multiple fertility treatments,
including for those families who wish to have more than one child.
While the Departments acknowledge the proposed $120,000 lifetime dollar
limit would be a considerable benefit, the Departments are of the view
that this limiting principle, in conjunction with the proposed
limitation on the scope of benefits covered by the excepted fertility
benefit, aligns with the meaning of the term ``similar, limited
benefits'' under Code section 9832(c)(2)(C), ERISA section
733(c)(2)(C), and PHS Act section 2791(c)(2)(C). The fact that the
statute sets forth benefits for ``long-term care, nursing home care,
home health care, community-based care, or any combination thereof'' as
a category of limited benefits, which can cost an average of
$120,900,\92\ suggests that Congress contemplated that the limited
excepted benefits category could include other benefits of comparable
value, including the proposed excepted fertility benefit category.
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\92\ See HHS Office of the Assistance Secretary for Planning and
Evaluation, Office of Behavioral Health, Disability, and Aging
Policy, Long-Term Services and Supports for Older Americans: Risks
and Financing, 2022 (Aug. 2022), <a href="https://aspe.hhs.gov/sites/default/files/documents/08b8b7825f7bc12d2c79261fd7641c88/ltss-risks-financing-2022.pdf">https://aspe.hhs.gov/sites/default/files/documents/08b8b7825f7bc12d2c79261fd7641c88/ltss-risks-financing-2022.pdf</a>.
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The Departments also note that other States have made fertility
benefits an
[[Page 27149]]
EHB. EHBs are prohibited from having annual or lifetime dollar limits,
but may have non-dollar limits, such as limits on the number of IVF
cycles covered. Proposing a lifetime dollar limit for the excepted
fertility benefits would not undermine these State insurance
requirements. Fertility benefits that are EHB in a State must be
covered by the non-grandfathered individual and small group major
medical health insurance coverage in that State.
The Departments solicit comment on whether a different maximum
dollar amount is necessary to achieve the goals of sufficiently
limiting the scope of the excepted fertility benefits. The Departments
also solicit comment on whether a maximum dollar amount is unnecessary
and the Departments should instead rely on the definition of excepted
fertility benefits to limit their scope.
The Departments are also considering whether the dollar limit
should be a maximum lifetime dollar amount as proposed, or whether the
amount should be a maximum annual limit (e.g., up to $15,000) where any
unused portion could carry over to the following plan year, similar to
what is allowed for excepted benefit HRAs.\93\ The advantage of such a
cumulative annual amount under the latter arrangement is that it would
encourage participants to enroll in the excepted fertility benefit
before they may be planning to use the benefit in order to build up the
benefit to be used at a later date.\94\ Accordingly, the Departments
solicit comment on whether instead of a lifetime dollar limit, a
maximum annual cumulative limit should apply to the excepted fertility
benefit, and what the annual dollar amount should be under such an
alternative approach.
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\93\ See 26 CFR 54.9831-1(c)(3)(viii)(B)(2); 29 CFR
2590.732(c)(3)(viii)(B)(2); and 146.145(b)(3)(viii)(B)(2).
\94\ Under the current proposal, a plan sponsor could similarly
design an excepted fertility benefit such that it imposes an annual
dollar limitation where any unused portion could carry over to
subsequent plan years, up to the lifetime dollar amount at proposed
paragraph (c)(3)(ix)(B) of 26 CFR 54.9831-1 and 29 CFR 2590.732 and
paragraph (b)(3)(ix)(B) of 45 CFR 146.145.
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3. Not an Integral Part of the Plan
To be a limited excepted benefit under Code section 9831(c)(1),
ERISA section 732(c)(1), and PHS Act section 2722(c)(1), benefits must:
(1) be provided under a separate policy, certificate, or contract of
insurance; or (2) otherwise not be an integral part of the plan. While
only insured coverage may qualify under the first test, both insured
and self-insured coverage may qualify under the second test.\95\
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\95\ 79 FR 59130, 59131 (Oct. 1, 2014).
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Under these proposed rules, for a fertility benefit in the group
market to be considered not an integral part of the plan, the
Departments propose that a group health plan that is not limited to
excepted benefits and that is not an HRA or other account-based group
health plan must be made available by the same plan sponsor for the
plan year to the participants offered the fertility benefit. Only
individuals eligible to participate in the traditional group health
plan would be eligible to participate in the excepted fertility
benefit. However, while the plan sponsor would be required to offer a
traditional group health plan to all individuals offered the fertility
benefit, participants in the fertility benefit (and beneficiaries, if
eligible for the fertility benefit) would not be required to enroll in
that traditional group health plan in order for the fertility benefit
to qualify as a limited excepted benefit. This proposed standard is
similar to rules for health FSAs at paragraph (c)(3)(v) of 26 CFR
54.9831-1 and 29 CFR 2590.732, and paragraph (b)(3)(v) of 45 CFR
146.145 and for excepted benefit HRAs at paragraph (c)(3)(viii) of 26
CFR 54.9831-1 and 29 CFR 2590.732, and (b)(3)(viii) of 45 CFR 146.145.
Participants (and beneficiaries, if eligible for the fertility benefit)
enrolling in the fertility benefit may decline coverage for the other
group health plan coverage. For example, a participant may decline the
other group health plan coverage if the participant can opt out of that
coverage, whether or not there is a contribution required for the
coverage.\96\ This may be an attractive option for participants who
have enrolled in group health plan coverage through another household
member, such as a spouse, but would still like to take advantage of
this excepted fertility benefit. The Departments solicit comments on
this approach.
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\96\ This is also consistent with the standard applicable to
limited scope dental benefits, limited scope vision benefits, and
long-term care benefits that are limited excepted benefits. See 26
CFR 54.9831-1(c)(3)(ii)(A), 29 CFR 2590.732(c)(3)(ii)(A), and 45 CFR
146.145(b)(3)(ii)(A).
---------------------------------------------------------------------------
The Departments are also considering whether additional safeguards
are necessary to ensure that such coverage is not an integral part of
the plan. For example, the rule for EAPs to qualify as limited excepted
benefits requires at paragraph (c)(3)(vi)(C) of 26 CFR 54.9831-1 and 29
CFR 2590.732 and paragraph (b)(3)(vi)(C) of 45 CFR 146.145 that no
employee premiums or contributions be required as a condition of
participation in the EAP. Additionally, paragraph (c)(3)(vi)(D) of 26
CFR 54.9831-1 and 29 CFR 2590.732 and paragraph (b)(3)(vi)(D) of 45 CFR
146.145 provides that EAPs that qualify as limited excepted benefits
have no cost sharing. As compared to EAPs, excepted fertility benefits
may provide a broader scope of benefits. Accordingly, the Departments
are not proposing to prohibit plans and issuers from charging a premium
or contribution or imposing cost sharing for excepted fertility
benefits. In addition, there are other categories of limited excepted
benefits that are permitted to charge a premium or contribution and/or
impose cost-sharing that the Departments believe are more analogous to
the proposed excepted fertility benefits (e.g., limited-scope dental or
vision benefits and benefits for long-term care). The Departments
solicit comments on whether an additional safeguard that no employee
premium or contribution be required as a condition of participation in
the excepted fertility benefit should be imposed, or whether plans and
issuers should have the flexibility to charge premiums or contributions
and impose cost sharing, as they do for limited-scope dental, vision,
and long-term care coverage.
4. Notice Requirements
In order to ensure that participants and beneficiaries who are
eligible to participate in an excepted fertility benefit are informed
about its availability and understand the scope of coverage provided,
the Departments propose, under their statutory authority in section
9833 of the Code, section 734 of ERISA, and section 2792 of the PHS
Act, to require that plans and issuers provide written notice to plan
participants and beneficiaries in accordance with proposed paragraph
(c)(3)(ix)(D) of 26 CFR 54.9831-1 and 29 CFR 2590.732 and proposed
paragraph (b)(3)(ix)(D) of 45 CFR 146.145 for fertility benefits to
qualify as limited excepted benefits. Under these proposed rules, if a
single notice is provided to a participant and any beneficiaries at the
participant's last known address, then the requirement to provide the
notice to the participant and any beneficiaries would generally be
satisfied. However, if a beneficiary's last known address is different
from the participant's last known address, a separate notice provided
to the beneficiary at the beneficiary's last known address would be
required. In either case, such address could include an electronic
address, if otherwise allowed under the relevant
[[Page 27150]]
disclosure requirements applicable to the plan.\97\
---------------------------------------------------------------------------
\97\ See 29 CFR 2520.104b-1.
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Such a notice requirement would be in addition to any notice
requirements otherwise applicable to excepted benefits. For excepted
benefits that are ERISA welfare benefit plans, such disclosure
requirements would include the Summary Plan Description (SPD) under
ERISA section 102 and 29 CFR 2520.102-3(j)(2) and (3) and 2520.104b-
2(a). The Departments recognize that SPDs often contain far too much
detail for a summary document and intend that participants and
beneficiaries have information on the excepted fertility benefits in a
shorter, more reader-friendly format.\98\ The proposed notice
requirement would instead be expected to function as an executive
summary or ``quick reference guide'' for the excepted fertility
benefits.\99\ While the excepted fertility benefits notice would be a
separate notice, it could be provided with other ERISA-required
documents. For example, if multiple documents are furnished together as
part of an open enrollment packet, the excepted fertility benefits
notice could be included as part of the packet. Under these proposed
rules, the notice for non-Federal governmental plans would similarly be
expected to function as an executive summary and be a separate notice
that could be provided with other documents.
---------------------------------------------------------------------------
\98\ See ERISA Advisory Council, Mandated Disclosure for
Retirement Plans--Enhancing Effectiveness for Participants and
Sponsors (Nov. 2017), <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2017-mandated-disclosure-for-retirement-plans.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2017-mandated-disclosure-for-retirement-plans.pdf</a>; see also ERISA Advisory Council, Advisory
Council Report of the Working Group on Health and Welfare Benefit
Plans' Communications (2005), <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/about-us/erisa-advisory-council/2005-health-and-welfare-benefit-plans-communications">https://www.dol.gov/agencies/ebsa/about-ebsa/about-us/erisa-advisory-council/2005-health-and-welfare-benefit-plans-communications</a>.
\99\ Id.
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Under these proposed rules, the Departments would require issuers
and plan sponsors of both insured and self-insured excepted fertility
benefits to provide this notice. The Departments require a notice for
other types of limited excepted benefits, such as excepted benefit HRAs
at paragraph (c)(3)(viii) of 26 CFR 54.9831-1 and 29 CFR 2590.732 and
paragraph (b)(3)(viii) of 45 CFR 146.145. The Departments are of the
view that participants and beneficiaries should be aware of the
availability of any excepted fertility coverage offered, so that they
can utilize it expeditiously. Additionally, participants and
beneficiaries may be unfamiliar with how benefits for the diagnosis,
mitigation, and treatment of infertility generally work under the plan.
Therefore, the Departments intend that the proposed notice would be an
important educational tool that would help participants and
beneficiaries navigate their excepted fertility benefits. It is also
important that participants understand what would be covered under
their excepted fertility benefits, as opposed to under their
traditional group health plan. Therefore, in the Departments' view, it
is appropriate to require this additional disclosure.\100\ The
Departments solicit comments on this approach, and whether there are
alternative approaches that may better accomplish the same goal of
informing eligible participants and beneficiaries about the
availability of excepted fertility benefits and the scope of coverage
provided.
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\100\ See ERISA sections 505 and 734, PHS Act sections 2761 and
2792, ACA section 1321(a)(1) and (c), and Code section 7805
(providing the Secretaries of Labor, HHS, and the Treasury the
authority to promulgate regulations as may be necessary or
appropriate to carry out provisions of ERISA, the PHS Act, and the
Code).
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a. Notice Content
The Departments propose in proposed paragraph (c)(3)(ix)(D)(1) of
26 CFR 54.9831-1 and 29 CFR 2590.732 and proposed paragraph
(b)(3)(ix)(D)(1) of 45 CFR 146.145 that this notice would include a
description of the coverage. This description would be required to
include a summary of benefits and limitations of the coverage,
including the lifetime dollar limit established by the plan or issuer
that complies with the maximum lifetime dollar limit described in
proposed paragraph (c)(3)(ix)(B) (or paragraph (b)(3)(ix)(B), as
applicable). As proposed, the notice would also include information on
how to identify and utilize a network provider, if applicable, and how
to submit a claim for reimbursement. This could include, for example,
any electronic and paper filing options, the required information
needed for such a claim, and a brief description of the documentation
that must be submitted in order for the plan or issuer to be able to
process the claim promptly. Finally, the notice would be required to
include accurate information on whether the benefit utilizes the same
claims procedure as for the sponsor's other group health plans.
Participants and beneficiaries would need such information in order to
properly utilize their fertility benefits and receive the promised
coverage. The Departments solicit comments on this approach, including
whether any additional elements should be required for the notice.
Furthermore, the notice would be required to be written and
presented in a manner calculated to be understood by the average plan
participant. In determining whether this standard has been satisfied,
the plan or issuer would be required to take into account such factors
as the level of comprehension and education of typical participants and
beneficiaries in the plan or coverage and the complexity of the terms
of the plan or coverage. Accounting for these factors would likely
require limiting or eliminating the use of technical jargon, complex
medical terminology except where necessary, and defining any technical
terms of art used. This would also generally require eliminating long,
complex sentences, and providing information in plain English (i.e., at
or below an 8th-grade reading level) so that the information provided
would not have the effect of misleading, misinforming, confusing, or
failing to inform participants or beneficiaries. The Departments
solicit comments on this approach.
b. Notice Timing
Under proposed paragraph (c)(3)(ix)(D)(2) of 26 CFR 54.9831-1 and
29 CFR 2590.732 and proposed paragraph (b)(3)(ix)(D)(2) of 45 CFR
146.145, a plan or issuer would be required to provide the notice no
later than the first date on which the participant is eligible to
enroll in coverage, and annually thereafter. This would allow
individuals to be informed about their coverage and generally would
align with the timing of disclosures that participants and
beneficiaries currently receive from their group health plan, such as
the summary of benefits and coverage.\101\ Additionally, this notice
would be required to be provided upon request of the participant or
beneficiary. This would ensure that participants and beneficiaries
would have such information available to them when needed. The
Departments solicit comments on this approach.
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\101\ See 26 CFR 54.9815-2715(a)(1)(i), 29 CFR 2590.715-
2715(a)(1)(i), and 45 CFR 147.200(a)(1)(i).
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5. Examples
In proposed 26 CFR 54.9831-1(c)(3)(ix)(E), 29 CFR
2590.732(c)(3)(ix)(E), and 45 CFR 146.145(b)(3)(ix)(E), the Departments
also propose including several examples in order to illustrate the
requirements of these proposed rules and provide clarity. In example 1
of these proposed rules, an employer offers benefits for fertility
counseling through a separate policy of insurance that satisfy the
[[Page 27151]]
requirements of proposed paragraph (c)(3)(ix)(A) and (B) (or paragraph
(b)(3)(ix)(A) and (B), as applicable). The issuer of the fertility
counseling coverage also provides notice to plan participants and
beneficiaries at or before the time individuals are given the
opportunity to enroll in the coverage and annually thereafter. The
notice is written in a manner calculated to be understood by the
average plan participant and includes a description of the coverage,
including a summary of benefits and limitations of the coverage, how to
identify and utilize a network provider, how to submit a claim for
reimbursement, and that the benefit utilizes the same claims procedure
as for the sponsor's other group health plans. The fertility counseling
coverage also has a lifetime dollar limit that complies with proposed
26 CFR 54.9831-1(c)(3)(ix)(B), 29 CFR 2590.732(c)(3)(ix)(B) and 45 CFR
146.145(b)(3)(ix)(B).
In example 1 of these proposed rules, the benefits under the
fertility counseling coverage satisfy the requirements to be considered
a limited excepted benefit under proposed paragraph (c)(3)(ix) (or
paragraph (b)(3)(ix), as applicable). The employer provides fertility
benefits that do not exceed the maximum lifetime limit which are
limited as required and are provided by the employer through a separate
fully insured policy. Additionally, the plan provides written notice in
accordance with proposed paragraph (c)(3)(ix)(D) (or paragraph
(b)(3)(ix)(D), as applicable). Therefore, the benefits would qualify as
an excepted fertility benefit that is a limited excepted benefit.
In example 2 of these proposed rules, an employer sponsors a group
health plan that is not limited to excepted benefits, that is not an
HRA or other account-based group health plan and also offers fertility
benefits for the mitigation or treatment of infertility that satisfy
the requirements of proposed paragraph (c)(3)(ix)(A) (or paragraph
(b)(3)(ix)(A), as applicable). The fertility benefits are self-funded
by the employer. The employer offers both the group health plan and the
fertility benefits to participants and permits participants to enroll
in either or both benefit options or decline to participate in either
or both options for the plan year. The employer also includes a
lifetime dollar limit on fertility benefits that satisfies the
requirements of proposed paragraph (c)(3)(ix)(B) (or (b)(3)(ix)(B), as
applicable) and provides written notice to participants in accordance
with the requirements of proposed paragraph (c)(3)(ix)(D) (or paragraph
(b)(3)(ix)(D), as applicable).
In example 2 of these proposed rules, the fertility benefits
satisfy the conditions in proposed paragraph (c)(3)(ix) (or paragraph
(b)(3)(ix), as applicable). Because the fertility benefits are not
provided under a separate policy, certificate, or contract of
insurance, the requirements under paragraphs (c)(3)(ix)(C) (or
paragraph (b)(3)(ix)(C), as applicable) apply. The fertility benefits
are not an integral part of the group health plan because the employer
offers, to participants that are offered the fertility benefit,
coverage under another group health plan that is not limited to
excepted benefits for the plan year, and that is not an HRA or other
account-based group health plan and participants may decline coverage
for such other group health plan coverage. In addition, the fertility
benefit plan offers fertility benefits for the mitigation or treatment
of infertility that satisfy the requirements of paragraph (c)(3)(ix)(A)
(or paragraph (b)(3)(ix)(A), as applicable), includes a lifetime limit
on fertility benefits that complies with paragraph (c)(3)(ix)(B) (or
paragraph (b)(3)(ix)(B), as applicable), and provides written notice as
required by paragraph (c)(3)(ix)(D) (or paragraph (b)(3)(ix)(D), as
applicable).
Example 3 of these proposed rules illustrates the application of
the lifetime limit on dollar amounts for the excepted fertility
benefit. In example 3, an employer sponsors a fertility benefit plan
for the mitigation or treatment of infertility that satisfies the
requirements of paragraph (c)(3)(ix)(A), (C) and (D) (or paragraph
(b)(3)(ix)(A), (C) and (D), as applicable) in a plan year. The
fertility benefits are self-funded by the employer. The fertility
benefit plan imposes a lifetime, per participant limitation on benefits
of $120,000. During the plan year, the fertility benefit plan covers a
given participant's claims for treatment of infertility by medical
professionals authorized to practice under applicable law totaling
$65,000. In December of the plan year, the overall medical care
component of the CPI-U (unadjusted) published by the Department of
Labor is 625.522. During the following plan year, the plan again covers
$65,000 in claims for the same participant for treatment of infertility
by medical professionals authorized to practice under applicable law
pursuant to such plan's terms.
In this example, the plan fails to satisfy the conditions to be an
excepted fertility benefit because lifetime benefits to the participant
in the following plan year exceed $127,843.66, which is the proposed
excepted fertility benefit lifetime dollar limit indexed for medical
inflation for the relevant plan year. For purposes of calculating the
lifetime dollar limit adjusted for medical inflation in this example,
medical inflation is calculated by subtracting 587.144 (the overall
medical care component of the CPI-U (unadjusted) for December 2025)
from 625.522 (the overall medical care component of the CPI-U
(unadjusted) published by the Department of Labor for December of the
previous plan year) and dividing that amount by 587.144 ((625.522-
587.144)/587.144). This amount is multiplied by $120,000 which
determines the dollar amount of medical inflation ($7,843.66). Because
the fertility benefit covers benefits beyond the permissible lifetime
dollar limit adjusted for medical inflation ($127,843.66)), the plan
fails to satisfy the condition that the benefit be limited in amount.
The employer may still cover fertility benefits that are in excess of
the lifetime limit through its group health plan that is not limited to
excepted benefits and that is not an HRA or other account-based group
health plan, provided it otherwise complies with the market
requirements of chapter 100 of the code, part 7 of ERISA, or title
XXVII of the PHS Act, as applicable.
6. Applicability
This proposal to create an excepted fertility benefit as a new
category of limited excepted benefits would apply to group health plans
and health insurance issuers offering group health insurance coverage
for plan years beginning on or after January 1, 2027. The Departments
solicit comments on this proposed applicability date, including how
long it may take group health plan sponsors and health insurance
issuers in the group market to make the necessary amendments for their
existing fertility benefits coverage to qualify as limited excepted
benefits or to newly offer a limited benefit for excepted fertility
benefits, if so desired, and with respect to insurance coverage, for
States to review and approve such filings. The Departments also solicit
comment on whether these proposed rules, if finalized, should instead
be applicable upon the effective date of the final rules in order to
grant group health plan sponsors and health insurance issuers
flexibility to offer this new category of limited excepted benefits
immediately, if desired.
In accordance with the directives in Executive Order 14216 and the
commitment expressed in FAQs Part 72, these proposed rules would reduce
the regulatory burden for employers with
[[Page 27152]]
respect to offering fertility benefits to their employees because they
would establish a new pathway for plan sponsors to offer fertility
benefits as a limited excepted benefit that generally would not be
subject to the parallel market requirements of chapter 100 of the Code,
part 7 of ERISA, and title XXVII of the PHS Act.
As proposed, these rules would apply to group health plans and
health insurance issuers offering group health insurance coverage. The
Departments are generally aware of how employers provide fertility
benefits in the group market, including through specialty vendors. The
Departments believe that employers would utilize excepted fertility
benefits to expand their fertility coverage offerings. The Departments
have less information, however, on how excepted fertility benefits
might work in the individual market, including whether there would be
interest from issuers to offer these benefits on a stand-alone basis in
such market.
HHS is considering whether the final rules should adopt similar
standards for the individual market to reduce regulatory burden and
promote access to fertility coverage for individuals and their
dependents. Specifically, HHS is considering an approach under which it
would exercise its authority under section 2791(c)(2)(C) of the PHS Act
to recognize certain fertility benefits as limited excepted benefits in
the individual market under sections 2722(c)(1) and 2763(b) of the PHS
Act for policy years beginning on or after January 1, 2027, if certain
conditions are met.
Under the approach HHS is considering, the individual market
excepted benefit regulations at 45 CFR 148.220(b) would provide that
fertility benefits constitute excepted fertility benefits in the
individual market, if the benefits are offered under a separate policy,
certificate, or contract of insurance and satisfy the conditions in
proposed 45 CFR 146.145(b)(3)(ix)(A), (B), and (D) that the benefits be
limited in scope, be subject to a maximum lifetime dollar amount, and
the issuer provides written notice informing individuals and their
dependents of the availability of coverage and describing the coverage.
Under this approach, certain proposed group market standards for
excepted fertility benefits would be modified or inapplicable with
respect to the individual market. For example, an issuer of excepted
fertility benefits in the individual market would be required to
provide notice to individuals and their dependents containing similar
content as the group market. The notice would be provided with any
application materials provided to individuals or dependents prior to
enrollment, and annually thereafter at the time of coverage renewal, as
well as upon request of an individual or dependent. This would allow
individuals and their dependents to be informed about the fertility
benefit coverage before enrolling or reenrolling in coverage and
generally would align with the proposed notice timing standard for the
group market. Unlike in the group market, the notice in the individual
market would not be required to include information on whether the
excepted fertility benefit utilizes the same claims procedure as the
sponsor's other group health plans, as there is no plan sponsor in the
individual market.
Also under the approach HHS is considering, the individual market
excepted benefit regulations would not incorporate the proposed group
market standard at 45 CFR 146.145(b)(3)(ix)(C) that benefits not be an
integral part of a plan, as the reference to ``plan'' in section
2722(c)(2) of the PHS Act has been interpreted as referring to a group
health plan.\102\ Furthermore, HHS's individual market excepted
benefits regulations at 45 CFR 148.220 provide that individual coverage
is excepted only if the benefits are offered under a separate policy,
certificate, or contract of insurance. Therefore, the requirement that
the benefits not be an integral part of a plan would not apply under
the approach HHS is considering for the individual market.
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\102\ See, e.g., 79 FR 59130, 59131 (Oct. 1, 2014) (``To be
excepted under this second category, the statute (specifically,
ERISA section 732(c)(1), PHS Act section 2722(c)(1), and section
9831(c)(1) of the Code) provides that limited benefits must either:
(1) Be provided under a separate policy, certificate, or contract of
insurance; or (2) otherwise not be an integral part of a group
health plan, whether insured or self-insured.'').
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HHS seeks comments on all aspects of this approach, including
whether it would be appropriate to create a new category of limited
excepted benefits for excepted fertility benefits in the individual
market, the standards HHS is considering, and any additional standards
or considerations that may be appropriate for the individual market.
7. Severability
The Departments are proposing amendments to recognize excepted
fertility benefits as a new category of limited excepted benefits. The
Departments' authority to propose these amendments is well-established
in law and practice. However, in the event that any portion of these
proposed rules, if finalized, is declared invalid, the Departments
intend that the other provisions, which could still function sensibly,
would be severable. Overall, the aim of the Departments is to ensure
that employers and issuers can offer fertility benefits that qualify as
limited excepted benefits. The proposed group market requirements under
paragraphs (c)(3)(ix)(A), (B) and (C) of 26 CFR 54.9831-1, and 29 CFR
2590.732 and paragraph (b)(3)(ix)(A), (B) and (C) of 45 CFR 146.145,
while part of a comprehensive regulatory scheme, are also separate
requirements and can stand independently of each other and the
Departments' other group market excepted benefits regulations.
Similarly, the proposed notice requirements at paragraphs
(c)(3)(ix)(D) of 26 CFR 54.9831-1, and 29 CFR 2590.732 and paragraph
(b)(3)(ix)(D) of 45 CFR 146.145 are separate requirements that can
stand independently of the standards under paragraphs (c)(3)(ix)(A),
(B), and (C) of 26 CFR 54.9831-1, and 29 CFR 2590.732 and paragraph
(b)(3)(ix)(A), (B), and (C) of 45 CFR 146.145. Consequently, following
any potential legal challenge, a court's decision to invalidate one
standard should not affect any provision that relates to a separate
standard. As indicated, this discussion of the application of
severability to the provisions in these proposed rules offers examples
and is not exhaustive of other potential applications. Therefore, these
proposed rules specify that if any provision of paragraph (c)(3)(ix) of
26 CFR 54.9831-1 and 29 CFR 2590.732, and paragraph (b)(3)(ix) of 45
CFR 146.145 is held to be invalid or unenforceable by its terms, or as
applied to any person or circumstance, or stayed pending further agency
action, the provision would be construed so as to continue to give the
maximum effect to the provision permitted by law. For example, if the
notice requirement were to be struck down, an employer could still
offer an excepted fertility benefit that met the other conditions of
paragraph (c)(3)(ix) of 26 CFR 54.9831-1 and 29 CFR 2590.732, and
paragraph (b)(3)(ix) of 45 CFR 146.145. However, if such holding is one
of invalidity or unenforceability, these proposed rules specify the
provision would be severable from this section and would not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.
[[Page 27153]]
III. Regulatory Impact Analysis
A. Summary
These proposed rules would establish fertility benefits as a new
category of limited excepted benefits, the limits of the category
itself, and the associated proposed conditions for such benefits to
qualify as a limited excepted benefit. The Departments have examined
the impacts of these proposed rules as required by Executive Order
12866,\103\ Executive Order 13563,\104\ Executive Order 14192,\105\ the
Paperwork Reduction Act of 1995,\106\ the Regulatory Flexibility
Act,\107\ section 202 of the Unfunded Mandates Reform Act of 1995,\108\
and Executive Order 13132.\109\
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\103\ Regulatory Planning and Review, 58 FR 51735 (Oct. 4,
1993).
\104\ Improving Regulation and Regulatory Review, 76 FR 3821
(Jan. 18, 2011).
\105\ 90 FR 9065 (January 31, 2025).
\106\ 44 U.S.C. 3506(c)(2)(A) (1995).
\107\ 5 U.S.C. 601 et seq. (1980).
\108\ 2 U.S.C. 1501 et seq. (1995).
\109\ Federalism, 64 FR 153 (Aug. 4, 1999).
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B. Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health,
and safety effects; distributive impacts; and equity). Executive Order
13563 emphasizes the importance of quantifying costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility.
Under Executive Order 12866, ``significant'' regulatory actions are
subject to review by the Office of Management and Budget (OMB). Section
3(f) of the Executive Order defines a ``significant regulatory action''
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, territorial, or Tribal governments
or communities (also referred to as ``economically significant'');
(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.
Based on the Departments' estimates, OMB's Office of Information
and Regulatory Affairs (OIRA) has determined this rulemaking is
significant per section 3(f). The Departments have provided an
assessment of the potential costs, benefits, and transfers, associated
with these proposed rules, and OMB has reviewed these proposed rules.
Executive Order 14192, titled ``Unleashing Prosperity Through
Deregulation,'' was issued on January 31, 2025. Section 3(a) of
Executive Order 14192 requires an agency, unless prohibited by law, to
identify at least ten existing regulations to be repealed when the
agency issues a new regulation. In furtherance of this requirement,
section 3(c) of Executive Order 14192 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with
prior regulations. A significant regulatory action (as defined in
section 3(f) of Executive Order 12866) that would impose total costs
greater than zero is considered an Executive Order 14192 regulatory
action. These proposed rules, if finalized as proposed, are therefore
expected to be regulatory actions under Executive Order 14192.
C. Need for Regulatory Action
Executive Order 14216, ``Expanding Access to In Vitro
Fertilization,'' states that the policy of the Trump Administration is
to provide support, awareness, and access to affordable fertility
treatments, including reliable access to IVF treatment, by easing
unnecessary statutory or regulatory burdens to make IVF and fertility
treatments drastically more affordable.\110\
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\110\ 90 FR 10451 (Feb. 18, 2025).
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These proposed rules would help address the increasing need for
fertility services through the addition of a new type of limited
excepted benefit that provides coverage for items and services to
diagnose, mitigate, or treat infertility or infertility-related
reproductive health conditions. By proposing to expand the
classification of limited excepted benefits to include this coverage,
the Departments anticipate greater coverage for such items and services
could help address coverage gaps and prohibitively expensive medical
care that limits access to and utilization of such items and services.
1. Background
The decline in fertility rates has been an increasing concern in
the United States. Since 1990, the general fertility rate, which is the
number of births per 1,000 women aged 15 to 44, has declined by 23
percent in the United States. This has resulted in over half a million
fewer births in the United States in 2023 compared to 1990. Across the
population, the general fertility rate has broadly declined with the
total fertility rate now estimated at 1.6 births per woman, well below
the 2.1 births per woman required for population stability (referred to
as the ``replacement rate'').\111\
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\111\ Anne Driscoll and Brady Hamilton, Effects of Age-Specific
Fertility Trends on Overall Fertility Trends: United States, 1990-
2023, Centers for Disease Control and Prevention, National Vital
Statistics Reports, Vol. 74, No. 3 (Mar. 6, 2025), <a href="https://stacks.cdc.gov/view/cdc/174576">https://stacks.cdc.gov/view/cdc/174576</a>.
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The decline in births has been driven by women under 30, who had
nearly 1.2 million fewer births in 2023 than in 1990, a decline of
nearly 40 percent.\112\ This has coincided with increasing delays to
childbirth, indicated by the age of the mother at their child's first
birth, which has steadily increased from 24.2 years of age in 1990 to
27.5 in 2023.<SUP>113 114</SUP> Similarly, the age of the father at
their first child's birth has also increased over time.\115\ Though
individuals may intentionally delay childbirth to later in life,
advanced maternal age increases the risks associated with pregnancy
complications.\116\ This, coupled with the declining natural fertility
associated with older age, could result in some intentionally delayed
pregnancies not occurring and leading to missed birth opportunities.
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\112\ Id.
\113\ T.J. Matthew and Brady Hamilton, Mean Age of Mother, 1970-
2000, Centers for Disease Control and Prevention, National Vital
Statistics Reports, Vol. 51, No. 1 (Dec. 11, 2002), <a href="https://www.cdc.gov/nchs/data/nvsr/nvsr51/nvsr51_01.pdf">https://www.cdc.gov/nchs/data/nvsr/nvsr51/nvsr51_01.pdf</a>.
\114\ Andrea Brown, Brady Hamilton, Dmitry Kissin and Joyce
Martin, Trends in Mean Age of Mother: 2016--2023 (Jun. 13, 2025),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC12278045/">https://pmc.ncbi.nlm.nih.gov/articles/PMC12278045/</a>.
\115\ Gladys Martinez and Kimberly Daniels, Fertility of Men and
Women Aged 15-49 in the United States: National Survey of Family
Growth, 2015-2019, Centers for Disease Control and Prevention,
National Center for Health Statistics, National Health Statistics
Reports, No. 179 (Jan. 10, 2023), <a href="https://www.cdc.gov/nchs/data/nhsr/nhsr179.pdf">https://www.cdc.gov/nchs/data/nhsr/nhsr179.pdf</a>.
\116\ Siddharth Zabak, Ashish Varma, Spandan Bansod, and Meera
Pohane. Exploring the Complex Landscape of Delayed Childbearing:
Factors, History, and Long-Term Implications (Sept. 30, 2023),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC10616531/">https://pmc.ncbi.nlm.nih.gov/articles/PMC10616531/</a>.
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While women under 30 have experienced a significant decline in
birth rates, women over 30 have experienced growth in their birth rates
[[Page 27154]]
and now account for 51 percent of all births in the United States.\117\
The number of births to women over 40 nearly tripled between 1990 and
2023, while births to women aged 35 to 39 nearly doubled and births to
women aged 30 to 34 increased moderately. This resulted in
approximately 600,000 additional births to women over 30 in 2023 when
compared to 1990, though this growth was not sufficient to offset the
considerable decline in births to women under 30.
---------------------------------------------------------------------------
\117\ Anne Driscoll and Brady Hamilton, Effects of Age-Specific
Fertility Trends on Overall Fertility Trends: United States, 1990-
2023, Centers for Disease Control and Prevention, National Vital
Statistics Reports, Vol. 74, No. 3 (Mar. 6, 2025), <a href="https://stacks.cdc.gov/view/cdc/174576">https://stacks.cdc.gov/view/cdc/174576</a>.
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These changes in reproductive patterns have not been reflected in
individuals' stated preferences, as the average ideal number of
children reported in surveys has remained between 2.4 and 2.7 for
nearly half a century.\118\ Distinct from an ``ideal,'' the intended
family size has also been stable across a similar time period,
indicating most individuals intend to have between two and three
children.\119\ As fertility rates are forecasted to continue declining
while both men and women further delay childbirth to later in life, the
growing divergence between intended reproduction rates and actual rates
suggests that access to medical care that can assist in reproduction
will become even more integral to prospective parents.\120\
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\118\ Gallup News Service, Americans' Ideal Family Size Remains
Above Two Children (Sept. 4, 2025), <a href="https://news.gallup.com/poll/694640/americans-ideal-family-size-remains-above-two-children.aspx">https://news.gallup.com/poll/694640/americans-ideal-family-size-remains-above-two-children.aspx</a>.
\119\ Kellie Hagewen and S. Philip Morgan, Intended and Ideal
Family Size in the United States, 1970-2002, Population Development
and Review, Vol. 31(3) (Sept. 1, 2005), <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC2849141/">https://pmc.ncbi.nlm.nih.gov/articles/PMC2849141/</a>.
\120\ Global Burden of Disease 2021 Fertility and Forecasting
Collaborators, Global Fertility in 204 Countries and Territories,
1950-2021 with Forecasts to 2100: A Comprehensive Demographic
Analysis for the Global Burden of Disease Study 2021, The Lancet
Vol. 403, 2057-99 (May, 2024), <a href="https://www.sciencedirect.com/science/article/pii/S0140673624005506">https://www.sciencedirect.com/science/article/pii/S0140673624005506</a>.
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A 2024 report from the National Center for Health Statistics
illustrates that, as women age, fecundity--the ability to produce
offspring--declines while fertility issues increase, a health outcome
that is similarly observed in men.\121\ As such, many medical providers
will typically diagnose and treat fertility issues in women aged 35 or
older after they have attempted to conceive for at least six
months.\122\
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\121\ Colleen Nugent and Anjani Chandra, Infertility and
Impaired Fecundity in Women and Men in the United States, 2015-2019,
Centers for Disease Control and Prevention, National Health
Statistics Reports, No. 202 (Apr. 24, 2024), <a href="https://www.cdc.gov/nchs/data/nhsr/nhsr202.pdf">https://www.cdc.gov/nchs/data/nhsr/nhsr202.pdf</a>.
\122\ Infertility: Frequently Asked Questions, Centers for
Disease Control and Prevention, Division of Reproductive Health (May
15, 2024), <a href="https://www.cdc.gov/reproductive-health/infertility-faq/index.html">https://www.cdc.gov/reproductive-health/infertility-faq/index.html</a>.
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Declining fertility in later life, coinciding with intentional
delays to reproduction, has generated demand for assistive reproductive
medical care. A 2024 survey from KFF indicated that 13 percent of women
have reported that they or their partner required fertility treatments
to help them become pregnant or prevent a miscarriage.\123\
Additionally, data from the 2022-2023 National Survey of Family Growth
(NSFG) indicate that among respondents ages 25 to 45, approximately 12
percent of women and 7 percent of men reported having sought medical
care to help in having a child.\124\ The KFF Women's Health Survey
reported that among women of reproductive age who reported that they or
their partner have needed fertility services, approximately 22 percent
did not receive any services.\125\ This suggests a small but
significant number of reproductive age adults require but do not
receive the necessary medical care to conceive. Given the continual
rise of average parental age at first birth over the past several
decades, reproductive medical treatments are expected to become
increasingly important to a greater share of women and men trying to
conceive. In 2022 approximately 2.7 percent of all live births in the
United States were born with the use of ART, such as
IVF.<SUP>126 127</SUP>
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\123\ KFF, Women's Health Survey 2024 (Oct. 21, 2024), <a href="https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/">https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/</a>.
\124\ National Center for Health Statistics, National Survey of
Family Growth, 2022-2023, Public Use Data File (last accessed April
16, 2026), <a href="https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg">https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg</a>.
\125\ KFF, Women's Health Survey 2024 (Oct. 21, 2024), <a href="https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/">https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/</a>.
\126\ Michelle Osterman, Brady Hamilton, Joyce Martin, Anne
Driscoll, and Claudia Valenzuela, Births: Final Data for 2022,
National Center for Health Statistics, National Vital Statistics
Reports, Vol 73. No. 2 (Apr. 4, 2024), <a href="https://www.cdc.gov/nchs/data/nvsr/nvsr73/nvsr73-02-tables.pdf">https://www.cdc.gov/nchs/data/nvsr/nvsr73/nvsr73-02-tables.pdf</a>.
\127\ Centers for Disease Control and Prevention, National ART
Summary, (Dec. 10, 2024), <a href="https://www.cdc.gov/art/php/national-summary/index.html?cove-tab=2">https://www.cdc.gov/art/php/national-summary/index.html?cove-tab=2</a>.
---------------------------------------------------------------------------
Given the numerous and complex issues that could potentially
contribute to, or accompany, infertility, medical care to resolve
infertility can be lengthy, expensive, and multifaceted, addressing
numerous potential causes through diagnostics and treatment from a
variety of specialists. As such, diagnosing and treating fertility
issues can be complex and prohibitively expensive for many people who
are hoping to conceive. As infertility is not commonly considered a
disease by insurers and benefits for infertility are frequently not
included as a covered service by health plans, many of those hoping to
utilize medical care for assistance with reproduction struggle to
afford such high-cost procedures, as discussed in sections III.C.2 and
3 of this preamble.
2. Lack of Coverage for Fertility Services
The 2022-2023 NSFG indicates that for all female respondents
indicating they had ever sought medical care to help conceive,
approximately 66 percent had diagnostic fertility testing done on
themselves or a male partner.\128\ Nearly 1 in 3 of those who had
diagnostic fertility testing (33 percent) stated that none of the costs
were covered by their insurance. Similarly, 40 percent of female
respondents utilizing IVF indicated that none of the costs were covered
by their insurance, while 29 percent reported no coverage for commonly
prescribed medications to improve ovulation. This is consistent with
other research showing a considerable absence of coverage for
fertility-related medical care. A report by the KFF found that in 2024,
37 percent of large firms (200 or more employees) reported providing
coverage for fertility medications, while IVF was covered by 27 percent
of large firms.\129\ Other infertility treatments were covered at even
lower rates.
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\128\ National Center for Health Statistics, National Survey of
Family Growth, 2022-2023, Public Use Data File (last accessed April
16, 2026), <a href="https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg">https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg</a>.
\129\ KFF, 2024 Annual Survey of Employer Health Benefits (Oct.
2024), <a href="https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2024-Annual-Survey.pdf">https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2024-Annual-Survey.pdf</a>.
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[[Page 27155]]
3. Prohibitive Costs of Certain Fertility Services
Access to fertility services can be limited by financial barriers,
as is the case with many healthcare services that are not widely
covered by health insurance. The 2024 KFF Women's Health Survey
indicates that among the approximately 12 percent of reproductive age
women that reported needing and not receiving fertility services, cost
was the most commonly cited barrier to acquiring the necessary medical
care.\130\ A 2024 study found that the average cost for preliminary
diagnostic fertility testing in the United States was approximately
$1,600.\131\ A 2010 study of women undergoing infertility treatment
reported that median per-person treatment costs, inclusive of out-of-
pocket and insurer expenditures, ranged from approximately $1,200 to
$38,000 depending on treatment type, while median total costs for those
women with successful pregnancy outcomes ranged from approximately
$6,000 to $73,000 depending on treatment type.\132\ Across all women
seeking infertility treatment, the median cost was approximately
$15,000. These costs only included fertility treatment expenses and did
not include any associated healthcare costs, such as for labor and
delivery. A 2014 study, examining the out-of-pocket expenses for common
fertility treatments among couples with commercial health insurance,
found that the median overall out-of-pocket expense was approximately
$5,300 across all couples seeking fertility care, while those using IVF
had median out-of-pocket expenses exceeding $19,000.\133\ More recent
data suggests that in 2024, a single cycle of fertility drugs cost over
$5,000, and the full cost of an IVF cycle ranged from $15,000 to
$20,000, with many individuals requiring multiple cycles.\134\
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\130\ KFF, 2024 Women's Health Survey (Oct. 21, 2024), <a href="https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/">https://www.kff.org/womens-health-policy/access-to-fertility-care-findings-from-the-2024-kff-womens-health-survey/</a>.
\131\ Naveena Daram, Malika Day, Rose Maxwell, and Megan Ozcan,
Disparities in Infertility Workup Costs Across the United States,
Fertility and Sterility Reports, Vol. 5 No. 4 (Oct. 5, 2024),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC11705584/">https://pmc.ncbi.nlm.nih.gov/articles/PMC11705584/</a>.
\132\ Patricia Katz, Jonathan Showstack, James Smith, Robert
Nachtigall, Susan Millstein, Holly Wing, Michael Eisenberg, Lauri
Pasch, Mary Croughan, and Nancy Adler, Costs of Infertility
Treatment: Results from an 18-month Prospective Cohort Study,
Journal of Fertility & Sterility, Vol. 95 No. 3 (Mar. 1, 2011),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC3043157/pdf/nihms253376.pdf">https://pmc.ncbi.nlm.nih.gov/articles/PMC3043157/pdf/nihms253376.pdf</a>.
\133\ Alex Wu, Anobel Odisho, Samuel Washington, Patricia Katz,
and James Smith, Out-of-Pocket Fertility Patient Expense: Data from
a Multicenter Prospective Infertility Cohort, Journal of Urology,
Vol. 191, No. 2 (Feb. 1, 2014), <a href="https://www.auajournals.org/doi/10.1016/j.juro.2013.08.083">https://www.auajournals.org/doi/10.1016/j.juro.2013.08.083</a>.
\134\ Alina Salganicoff, Brittni Frederiksen, and Usha Ranji,
Will Trump's Announcement Expand Access to IVF?, KFF (Oct. 27,
2025), <a href="https://www.kff.org/womens-health-policy/will-trumps-announcement-expand-access-to-ivf/?spm=a2700.accio_bizSeo.0.0.25a87e47NpdtI2">https://www.kff.org/womens-health-policy/will-trumps-announcement-expand-access-to-ivf/?spm=a2700.accio_bizSeo.0.0.25a87e47NpdtI2</a>.
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The NSFG indicates that of the female respondents that had none of
their medical costs for fertility-related medical care covered by
insurance, approximately 28 percent reported combined family incomes of
less than $50,000 in the previous year.\135\ For these and many other
families already grappling with the costs associated with raising a
child, the financial burden of obtaining medical care to assist in
reproduction may impose a barrier to accessing care or place undue
hardship on individuals intending to have a child.
---------------------------------------------------------------------------
\135\ National Center for Health Statistics, National Survey of
Family Growth, 2022-2023, Public Use Data File (last accessed April
16, 2026), <a href="https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg">https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg</a>.
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4. Summary
The previous sections illustrate the growing need for fertility
services, the lack of widely available and affordable insurance
coverage for such services, and the prohibitive costs associated with
obtaining these services out-of-pocket. These proposed rules would
establish, as a new limited excepted benefit category, standalone
coverage for the diagnostic procedures, mitigation, and treatments for
infertility or infertility-related reproductive health conditions. This
would allow group health plans and health insurance issuers in the
group market to offer fertility-related benefits that generally are not
subject to the market requirements of part 7 of ERISA and parallel
provisions in title XXVII of the PHS Act and chapter 100 of the Code,
thereby providing a more flexible pathway for employers that wish to
provide coverage for fertility services to do so and allow employers to
provide these benefits for employees, regardless of whether they enroll
in their major medical coverage. This, in turn, would potentially
reduce out-of-pocket costs and increase access and utilization for
families with fertility issues and unable to bear the full cost of
treatments.
D. Regulatory Baseline
While the Departments have exercised their rulemaking authority for
limited excepted benefits that are not an integral part of a group
health plan,\136\ they have not previously included coverage for the
diagnosis, mitigation, or treatment of infertility or infertility-
related reproductive health conditions. Traditional group health plans
may provide coverage for some medical services or care related to
fertility issues, though this coverage varies widely and may not
include comprehensive coverage that includes medication or treatment
for infertility. Separately, as of November 2025, 23 States and the
District of Columbia require various levels of fertility-related care
coverage for private insurance, though these requirements do not apply
to self-insured plans.\137\ Fifteen States and the District of Columbia
require various levels of IVF coverage as well, though these
requirements also do not apply to self-insured plans.\138\
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\136\ See 26 CFR 54.9831-1(c)(3)(v), (vi), (vii), and (viii); 29
CFR 2590.732(c)(3)(v), (vi), (vii), and (viii); and 45 CFR
146.145(b)(3)(v), (vi), (vii), and (viii).
\137\ KFF, Mandated Coverage of Infertility Treatment (Nov.
2025), <a href="https://www.kff.org/state-health-policy-data/state-indicator/infertility-coverage/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D">https://www.kff.org/state-health-policy-data/state-indicator/infertility-coverage/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D</a> (The States listed in the KFF report are Arkansas,
California, Colorado, Connecticut, Delaware, Georgia, Hawaii,
Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts,
Montana, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode
Island, Texas, Utah and West Virginia as well as the District of
Columbia).
\138\ RESOLVE, Insurance Coverage by State (last accessed Apr.
16, 2026), <a href="https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/">https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/</a> (The States listed as
requiring IVF treatments are Arkansas, California, Colorado,
Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland,
Massachusetts, New Hampshire, New Jersey, New York, Rhode Island,
and Utah as well as the District of Columbia).
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The baseline for these proposed rules reflects the current legal
and regulatory framework. Therefore, it accounts for group health
insurance coverage already subject to State requirements that would not
be eligible to utilize the excepted benefit to meet those requirements.
Benefits, costs, and transfers associated with these proposed rules are
measured as changes relative to this baseline.
E. Summary of Impacts
In accordance with OMB Circular A-4, Table 1 depicts an accounting
statement summarizing the Departments' assessment of the benefits,
costs, and transfers associated with this proposed regulatory action.
These proposed rules would impact individuals who elect to enroll in
standalone coverage of fertility-related items and services that could
include coverage of diagnostic procedures, medications, and treatments
for infertility or infertility-related reproductive health conditions.
As such, they would also impact issuers and plan sponsors of such
coverage as well as the plans themselves. The
[[Page 27156]]
Departments are unable to quantify all benefits, costs, and transfers
of the rulemaking but have sought, where possible, to describe these
non-quantified impacts.
Table 1--Accounting Statement
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Benefits:
----------------------------------------------------------------------------------------------------------------
Non-Quantified:
<bullet> Potentially improved access to and utilization of medical care for fertility-related health.
<bullet> Potentially improved fertility-related health and birth outcomes, including more births, for
participants and beneficiaries.
<bullet> Potential increased tenure and productivity of covered employees.
----------------------------------------------------------------------------------------------------------------
Costs: Estimate Year dollar Discount Period
(percent) covered
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($million/year)........ $1.49 2026 7 2027-2036
1.48 2026 3 2027-2036
----------------------------------------------------------------------------------------------------------------
Quantified: $1.88 million (first year), $1.43 million (subsequent years).
<bullet> Prepare and send notice to eligible participants and beneficiaries. ($1.58 million in the first
year; $1.43 in subsequent years).
<bullet> One time rule familiarization costs for issuers. ($304,000 in the first year).
Non-Quantified:
<bullet> Increased number of births could lead to increased health care expenditures for employers, plan
participants, and government programs.
----------------------------------------------------------------------------------------------------------------
Transfers:
----------------------------------------------------------------------------------------------------------------
Non-Quantified:
<bullet> Transfer of some financial risk from participants and beneficiaries to plans.
<bullet> Transfer of financial contributions from low-utilization participants and beneficiaries to high-
utilization participants and beneficiaries.
<bullet> Transfer of Tax Revenue from Government to participants, beneficiaries and employers through Tax-
Advantaged Employee Benefits.
----------------------------------------------------------------------------------------------------------------
Perpetual Time Horizon Costs:...................................................................................
----------------------------------------------------------------------------------------------------------------
<bullet> Annualized Cost (in 2024 dollars): $1.41 million.
----------------------------------------------------------------------------------------------------------------
F. Affected Entities
These proposed rules would impact group health plans and issuers
offering excepted fertility benefits, and the participants and
beneficiaries in those plans. The Departments expect that participants
and beneficiaries seeking more expansive coverage of benefits for the
diagnosis, mitigation, and treatment of infertility or infertility-
related reproductive health conditions, particularly those between the
ages of 25 and 45 who currently lack, but are seeking, coverage for
such services, would be most likely to enroll. The Departments lack
data that would allow for the estimation of the number of excepted
fertility benefit plans that would arise due to these proposed rules.
Table 2 summarizes the number of group health plans, group health
insurance issuers, participants, and other entities that could be
affected by these proposed rules. These estimates are discussed in
greater detail in this section (III.F.1-3) of this preamble.
Table 2--Affected Entities
------------------------------------------------------------------------
------------------------------------------------------------------------
Group Health Insurance Companies........................ 373
Group Health Insurance Issuers.......................... 811
Group Health Plans and Sponsoring Employers............. 522,811
Participants and Eligible Employees \139\............... 54,411,264
Participants and Eligible Employees Likely to Enroll.... 743,361
------------------------------------------------------------------------
The Departments seek comments on the number of entities that would
be affected by these proposed rules. In particular, the Departments
seek comments on the number of issuers and plans that might offer
coverage of diagnostic procedures, medications, and treatments for
infertility as limited excepted benefits as well as the expected number
of participants that might enroll in these plans.
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\139\ The Departments acknowledge that beneficiaries may also be
affected by these proposed rules. However, since notices are likely
to be sent out at the policy holder level, and the Departments lack
sufficient data on the number of beneficiaries, the Departments'
calculations will only include affected participants and eligible
employees.
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1. Group Health Insurance Issuers
The Departments estimate that these proposed rules could affect up
to 373 health insurance companies offering group health insurance
coverage (811 group health insurance issuers when considering the total
number of subsidiaries licensed to sell health insurance in a specific
State).\140\ These entities provide insurance coverage to fully insured
plans as well as administrative services such as plan management to
level-funded and self-insured group health plans.
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\140\ A health insurance company is a legal entity with
subsidiaries that are each licensed to sell health insurance in one
specific State, while an issuer is one of those subsidiaries. Data
source: Centers for Medicare and Medicaid Services, 2023 Medical
Loss Ratio Data, <a href="https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources">https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources</a>.
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Issuers in States with a fertility benefit requirement are already
providing some level of coverage for the diagnosis, mitigation, or
treatment of infertility. Issuers in States without a
[[Page 27157]]
fertility benefit requirement could also be providing some level of
coverage. The Departments are uncertain how many of these issuers
currently provide fertility benefits as part of their coverage or how
many of these issuers would likely offer excepted fertility benefits in
response to these proposed rules. Issuers already providing coverage
for fertility benefits voluntarily could be the issuers most likely to
elect to offer excepted fertility benefits, but it is unknown how many
would do so. There are also service providers that specialize in
coverage or benefit management of fertility-related benefits that could
be well positioned to provide coverage of an excepted fertility benefit
or help design and manage such coverage. The Departments utilize the
number of group health insurance issuers (811) as an estimate of the
upper bound of the number of issuers that could provide excepted
fertility benefit coverage. The Departments request comments on the
number of issuers that might provide such coverage.
2. Group Health Plans
These proposed rules would impact non-Federal group health plans
\141\ and employers that decide to sponsor excepted fertility benefits.
Currently, 15 States and the District of Columbia have laws mandating
insurance coverage for IVF.\142\ However, issuers providing insured
coverage to fully insured group health plans in States already
requiring IVF coverage would likely not be able to meet State
requirements by offering those benefits through excepted benefit plans.
As a result, the Departments have excluded fully insured group health
plan sponsors in the 15 States and the District of Columbia that
currently require IVF benefits in their analysis, while including all
self-insured plan sponsors and fully insured plan sponsors in all other
States.\143\
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\141\ This includes private-sector and public-sector employer-
sponsored health plans, except those offered by the Federal
government.
\142\ RESOLVE, Insurance Coverage by State (2026), <a href="https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/">https://resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state/</a>. The States listed as requiring IVF treatments
are Arkansas, California, Colorado, Connecticut, Delaware, Hawaii,
Illinois, Maine, Maryland, Massachusetts, New Hampshire, New Jersey,
New York, Rhode Island, and Utah as well as the District of
Columbia.
\143\ The Departments separately looks at a high-cost scenario
which assumes that those mandates do not preclude plans from
offering the excepted benefit/in the Uncertainty Section.
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Additionally, the Departments assume that plan sponsors that
already offer fertility benefits as part of their comprehensive health
plans would offer excepted fertility benefits on a more limited basis,
similar to plans that offer dental and/or vision benefits that also
offer these benefits in standalone plans. The Departments relied on
dental and vision excepted benefit offer rates as a proxy for excepted
fertility benefits offer rates, although because those benefits are
substantially less expensive and affect a larger population, this may
overstate the actual offer rates for excepted fertility benefits.
Finally, the Departments assume that the smallest of plans, those with
fewer than 10 participants, would be unlikely to offer such an excepted
benefit as the prevalence of infertility among such a small group would
likely impact few, if any, participants and the potential costs may be
prohibitive for these small groups.
Based on these assumptions, the Departments estimate that there are
32,545 State and local government employer-sponsored plans, in addition
to 490,266 private sector employer-sponsored plans, that could be
affected by these proposed rules. In total, these proposed rules are
expected to affect 522,811 plans and entities. These calculations are
detailed in the table below. The Departments request comments on these
assumptions.
Table 3--Affected Plan Counts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Not currently offering Currently
Plans \1\ offering Expected to offer \2\
(A) (A) x 73% = (B) (A) x 27% = (C)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Entities:
Self-insured (States with Requirements)........................ 11,081 8,089 2,992 5,818
Self-insured (States without Requirements)..................... 21,581 15,754 5,827 11,330
Fully insured (States without Requirements).................... 29,327 21,409 7,918 15,397
------------------------------------------------------------------------------------
Total Public............................................... 61,988 45,251 16,737 32,545
--------------------------------------------------------------------------------------------------------------------------------------------------------
Private Entities:
Self-insured (States with Requirements)........................ 217,651 158,885 58,766 114,271
Self-insured (States without Requirements)..................... 401,392 293,016 108,376 210,739
Fully insured (States without Requirements).................... 314,761 229,775 84,985 165,256
------------------------------------------------------------------------------------
Total Private.............................................. 933,803 681,677 252,127 490,266
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Plans.......................................................... 995,792 726,928 268,864 522,811
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Totals displayed in the table may not sum due to rounding.
\1\ Estimated from the KFF 2024 Employer Health Benefits Survey where 27% indicated that they offered IVF benefits for fertility-related treatment.
\2\ Estimated from the Agency for Healthcare Research and Quality (AHRQ) 2023 Medical Expenditure Panel Survey--Insurance Component (MEPS), which
indicated 17.9% of establishments with medical coverage of vision and dental benefits offered excepted benefit plans for vision and dental benefits,
while 65.3% of establishments with no medical coverage of vision and dental benefits offered excepted benefit plans for vision and dental benefits.
3. Participants and Beneficiaries
These proposed rules would impact individuals who are currently
eligible for an employer-sponsored health plan. However, because 15
States and the District of Columbia have required some level of IVF
benefits for fully insured plans in their States, the Departments have
limited this analysis to plans and participants in non-Federal group
health plans in States without such requirements and only self-insured
plans and their participants in non-Federal group health plans in
States with such requirements.\144\ Additionally, the Departments have
limited this analysis to participants in plans with 10 or more
participants, as those would be the most likely to offer the excepted
benefit. Finally, in order to capture the number of eligible employees
that could be offered these plans, the Departments use the number of
current employer sponsored health insurance participants and then
divide this number by the take-up rate of eligible employees offered
employer
[[Page 27158]]
coverage. This provides an estimate of the number of employees eligible
for coverage.
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\144\ The Departments also include a sensitivity analysis that
relaxes this restriction in the Uncertainty section.
---------------------------------------------------------------------------
The estimates in this analysis use imperfect proxies to provide
estimates of the number of excepted fertility benefit plans that might
be offered and potential enrollment in those plans. The estimates are
likely an overestimate due to reasons discussed in section III.K.
Plans and issuers that decide to offer these benefits would need to
provide notices to plan participants and beneficiaries. Therefore, the
Departments first estimate the number of participants in non-Federal
group health plans, both by whether they are fully insured or self-
insured and also whether they are in States with an IVF mandate.
Utilizing data from the 2024 Auxiliary Database and the MEPS-IC, the
Departments estimate that there are 78.9 million employees eligible for
non-Federal, group insurance arrangements in States without fertility
requirements and an additional 24.7 million employees eligible for non-
Federal, self-insured group insurance arrangements in States with
fertility requirements.<SUP>145 146</SUP>
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\145\ Employee Benefits Security Administration, Health
Insurance Coverage Bulletin Abstract of Auxiliary Data for the March
2024 Annual Social and Economic Supplement to the Current Population
Survey, U.S. Department of Labor (Aug. 30, 2024), <a href="https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2023.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2023.pdf</a> (The Departments
used this source for the number of policyholders at non-Federal
group health plans by State and plan funding. The Departments then
used Tables I.B.2.a (private-sector) and III.B.2.b (State and local
government) on the percent of employees eligible for health
insurance that are enrolled from the 2024 MEPS-IC to augment these
counts to estimate employees eligible for coverage). The Departments
utilize this data source for all subsequent participant counts.
\146\ This estimate is calculated as: 24,738,866 participants
enrolled in non-Federal, self-insured employer-sponsored insurance
arrangements in States with fertility requirements + 78,870,061
participants enrolled in non-Federal, employer-sponsored insurance
arrangements in States without fertility requirements = 103,608,927
participants in non-Federal group health plans.
---------------------------------------------------------------------------
The Departments assume that participants already offered fertility
benefits as part of their comprehensive health plans would be offered
excepted fertility benefits on a more limited basis, similar to the
rate at which dental and/or vision benefits are also offered in
standalone plans. The Departments have been unable to find data on the
share of participants in group health plans that have fertility
benefits coverage in their comprehensive plan. However, the KFF 2024
Employer Health Benefits Survey reported that 27 percent of plans with
200 or more participants offer coverage for IVF. While this likely
overstates coverage in smaller plans, the Departments use this
assumption to estimate that there are 75.6 million individuals eligible
for non-Federal, group insurance arrangements that are not currently
offered fertility benefits coverage and an additional 28.0 million
individuals eligible for non-Federal, group insurance arrangements that
are currently offered fertility benefits coverage.<SUP>147 148</SUP>
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\147\ KFF, 2024 Annual Survey of Employer Health Benefits (Oct.
2024), <a href="https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2024-Annual-Survey.pdf">https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2024-Annual-Survey.pdf</a>.
\148\ This estimate is calculated as: 103,608,927 participants
in non-Federal group health plans x 73 percent not offering coverage
= 75,634,517 participants enrolled in non-Federal group health plans
that do not offer fertility benefits. Additionally, 103,608,927
participants in non-Federal group health plans x 27 percent offering
coverage = 27,974,410 participants enrolled in non-Federal group
health plans that do offer fertility benefits.
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Data from the Agency for Healthcare Research and Quality (AHRQ)
suggest approximately 66 percent of private sector employees without
medical coverage for vision and dental benefits are offered excepted
benefits for vision and dental coverage, while 17 percent of private
sector employees with medical coverage for vision and dental benefits
are offered additional excepted benefits for vision and dental
coverage. Utilizing this statistic to estimate how many individuals may
be offered excepted fertility benefits, the Departments estimate that
approximately 54.4 million participants and beneficiaries would be
offered excepted fertility benefits.<SUP>149 150</SUP>
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\149\ Agency for Healthcare Research and Quality, 2023 Medical
Expenditure Panel Survey--Insurance Component, <a href="https://meps.ahrq.gov/survey_comp/survey_ic.jsp">https://meps.ahrq.gov/survey_comp/survey_ic.jsp</a>.
\150\ This estimate is calculated as: (75,634,517 participants
in non-Federal group health plans without offer of fertility
coverage x 65.8 percent offer rate) + (27,974,410 participants in
non-Federal group health plans with offer of fertility coverage x
16.6 percent offer rate) = 54,411,264 eligible participants in non-
Federal group health plans offered coverage of excepted fertility
benefit.
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Additionally, the Departments estimate that of those 54.4 million
plan participants and beneficiaries that would be offered excepted
fertility benefits, approximately 26.2 million participants and
beneficiaries are aged 25 to 45. This population is expected to be the
most likely to take advantage of an offered excepted fertility
benefit.\151\
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\151\ The estimate is calculated as: (36,384,174 participants
aged 25 to 45 enrolled in non-federal, employer-sponsored health
insurance without offer of fertility coverage in group plan x 65.8
percent offer rate) + (13,457,160 participants aged 25 to 45
enrolled in non-federal, employer-sponsored health insurance with
offer of fertility coverage in group plan x 16.6 percent offer rate)
= 26,174,675 participants aged 25 to 45 enrolled in non-federal,
employer-sponsored health insurance offered excepted fertility
benefits coverage.
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Using data from the NSFG, the Departments estimate that
approximately 3 percent of female respondents in private health plans
aged 25 to 45 are currently seeking medical assistance for themselves
or their partner to become pregnant.\152\ As such, the Departments
estimate that approximately 743,361 participants or beneficiaries in
non-Federal employer-sponsored health plans aged 25 to 45 would seek
medical assistance to become pregnant each year.\153\ The Departments
estimate an equal share would likely enroll in excepted fertility
benefits coverage, resulting in an estimated 743,361 individuals
enrolling annually.\154\ The Departments acknowledge the uncertainty
around this estimate of the number of individuals that would enroll and
request comment on ways to improve it.
---------------------------------------------------------------------------
\152\ National Center for Health Statistics, National Survey of
Family Growth, 2022-2023, Public Use Data File (last accessed April
16, 2026), <a href="https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg">https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg</a>
(This estimate is calculated as: 15.73 percent of female respondents
aged 25 to 45 indicating they or their partner having ever sought
medical assistance to become pregnant x 18.08 percent of those
respondents indicating that they or their partner sought medical
assistance in the past year = 2.84 percent of respondents seeking
medical assistance to become pregnant in the past year).
\153\ This estimate is calculated as: 26,174,675 estimated
participants offered excepted benefits aged 25 to 45 x 2.84 percent
currently seeking medical assistance for fertility = 743,361
participants and beneficiaries in covered plans seeking fertility-
related medical care annually.
\154\ National Center for Health Statistics, National Survey of
Family Growth, 2022-2023, Public Use Data File (last accessed April
16, 2026), <a href="https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg">https://www.cdc.gov/nchs/nsfg/nsfg-2022-2023-puf.htm#nsfg</a>.
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G. Requests for Comments
The Departments invite comments addressing their estimates of the
benefits, costs, and transfers associated with this proposed
rulemaking, as well as any quantifiable data that could inform any
aspect of the analysis. Specifically, the Departments request comments
on the following:
1. Does the offering of excepted benefits vary by plan sponsor
size? For other excepted benefits, what share of plans elect to offer
them? Are similar rates for fertility benefits anticipated given the
higher costs?
2. Would employers that already offer fertility benefits through
their health plan choose instead to only offer this coverage through an
excepted benefit? If so, what share of employers already offering this
benefit would choose to do so? Would this vary by employer size?
3. How many plans that provide excepted fertility benefits might be
created under these proposed rules? Would there be a significant number
of
[[Page 27159]]
employers offering excepted fertility benefits immediately upon the
applicability acdate of a final rule? Would there be a more gradual
increase in the number of employers offering an excepted fertility
benefit?
4. How would State requirements impact employers' decision to offer
the excepted benefit?
5. What share of total premiums for the excepted fertility benefit
plans would plan sponsors contribute? How would this vary by plan size?
6. What is the expected take-up rate for the benefit if premiums
were expected to approach the full cost of treatment without coverage?
H. Benefits
1. Increased Utilization of Fertility Services
The Departments expect that these proposed rules, if finalized,
would reduce barriers to accessing diagnostic procedures, medications,
and treatments for infertility and infertility-related reproductive
health conditions and would allow individuals who are attempting to
conceive an opportunity to more readily assess their treatment needs or
address any medical impediments that might prevent them from having
children. Having coverage increases the likelihood of healthcare
utilization and improves health outcomes for participants and
beneficiaries.\155\ Having coverage for these services may allow
participants and beneficiaries to more quickly establish a diagnosis
(and understanding of the cause) of their infertility, enabling them to
access more advanced treatments sooner than if care was delayed due to
a lack of coverage. Additionally, having coverage for infertility
medications and treatments may result in more expeditious resolution of
fertility-related health issues for many individuals, limiting
potential delays or impediments to seeking care. As such, the
Departments anticipate that these proposed rules would result in an
increase in the utilization of diagnostic fertility testing as well as
subsequent medications and treatments.
---------------------------------------------------------------------------
\155\ Joseph Freeman, Srikanth Kadiyala, Janice Bell and Diane
Martin, The Causal Effect of Health Insurance on Utilization and
Outcomes in Adults: A Systematic Review of US Studies, Medical Care,
Vol. 46, No. 10 (Oct., 2008), <a href="https://pubmed.ncbi.nlm.nih.gov/18815523/">https://pubmed.ncbi.nlm.nih.gov/18815523/</a>.
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These proposed rules would not require that employers or issuers
offer these benefits, specify the scope of these benefits, or require
that employers contribute financially to any coverage that they offer.
These proposed rules also provide for a wide scope of potential benefit
designs that could significantly vary which items and services are
covered in such plans. Participation in these plans would likely be
influenced by how generous the excepted benefits are and whether
employers contribute, thereby potentially offsetting some of the cost
of coverage for participants and beneficiaries. As a result, the
Departments lack the data necessary to estimate the potential increase
in utilization of fertility-related medical services resulting from
these proposed rules. However, it is assumed that the covered, affected
population would have high rates of enrollment in standalone fertility
coverage and utilization of those covered fertility-related medical
services, provided the participant's or covered individual's premium
cost is less than the full cost of treatment without this coverage. The
Departments request comments or data that may provide insight into
potential plan design and utilization.
2. Improved Health Outcomes Among Patients
Given how complex the underlying causes of infertility can be, as
well as the relationship between age and infertility, more expansive
health benefits coverage for the diagnosis, mitigation, and treatment
of infertility has the potential to improve health outcomes among
participants and beneficiaries. The Departments expect the utilization
of fertility-related medical care to expand and treatment to occur
earlier than if participants and beneficiaries did not have coverage
made available in accordance with these proposed rules, if finalized.
This has the potential to improve health outcomes for participants and
beneficiaries experiencing infertility by allowing them to more readily
obtain a diagnosis of infertility and to seek treatment sooner. As
increased patient age is associated with higher rates of infertility as
well as poorer outcomes for infertility treatments such as IVF, an
earlier diagnosis and potential access to medication or treatment could
improve later pregnancy-related health outcomes.\156\
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\156\ Laxmi Shingshetty, Natalie Cameron, David McLernon, and
Siladitya Bhattacharya, Predictors of Success After In Vitro
Fertilization, Journal of Fertility and Sterility, Vol. 121, No.5
(Mar. 16, 2024), <a href="https://www.fertstert.org/article/S0015-0282">https://www.fertstert.org/article/S0015-0282</a>(24)00173-0/pdf.
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States that have required more comprehensive insurance coverage for
fertility-related treatments have also experienced better healthcare
outcomes for these interventions, such as lower rates of multiple
births, fewer embryo transfers per IVF cycle, and higher rates of live
birth, suggesting that more insurance coverage may lead to better
fertility outcomes.\157\ While the lack of data to estimate the
increase in utilization of fertility-related medical care limits
further extrapolation to health and birth outcomes, the significant
improvement in pregnancy outcomes from those receiving fertility-
related treatments suggests that a significant share of the
participants and beneficiaries gaining access to coverage for such
treatments could result in many achieving positive birth outcomes that
would not occur in the absence of these proposed rules.\158\ As such,
this increased utilization of fertility-related medical care that the
Departments anticipate arising from these proposed rules is expected to
produce better health outcomes for participants and beneficiaries as
well as more live births. This is consistent with a 2025 study
utilizing claims data for both covered and uncovered IVF cycles which
found that ``[i]nsurance coverage for IVF was significantly associated
with a higher cumulative live birth rate but not multiple birth rate.
This finding was driven by higher live birth rates per cycle and more
IVF cycles initiated among insured patients.'' \159\
---------------------------------------------------------------------------
\157\ Benjamin Peipert, Esther Chung, Benjamin Harris, and Tarun
Jain, Impact of Comprehensive State Insurance Mandates on In Vitro
Fertilization Utilization, Embryo Transfer Practices and Outcomes in
the United States, American Journal of Gynecology (2022), <a href="https://pubmed.ncbi.nlm.nih.gov/35283088/">https://pubmed.ncbi.nlm.nih.gov/35283088/</a>.
\158\ James Smith, Michael Eisenberg, Susan Millstein, Robert
Nachtigall, Natalia Sadetsky, Marcelle Cedars, and Patricia Katz,
Fertility Treatments and Outcomes among Couples Seeking Fertility
Care: Data from a Prospective Fertility Cohort in the United States,
Journal of Fertility and Sterility Vol. 95, No.1 (Jul. 25, 2010),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC2966858/">https://pmc.ncbi.nlm.nih.gov/articles/PMC2966858/</a>.
\159\ Benjamin Peipert, Phyllis Yan, Rodney Dunn, David Suh,
Brandon Swinney, Edward Norton, Vanessa Dalton, Erica Marsh, Marissa
Steinberg Weiss, and James Dupree. Insurance Coverage and IVF
Outcomes in the United States: A National Claims-Based Study of
Privately Insured Patients, Fertility and Sterility, Volume 124,
Issue 6, e87 (Oct. 29, 2025), <a href="https://www.fertstert.org/action/showPdf?pii=S0015-0282%2825%2900880-5">https://www.fertstert.org/action/showPdf?pii=S0015-0282%2825%2900880-5</a>.
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Additionally, individuals who have better fertility-related health
outcomes may also experience improvements to their mental health, as
infertility is associated with increased risk of common psychiatric
disorders such as anxiety or depression.<SUP>160 161</SUP> Persistent
[[Page 27160]]
infertility has also been associated with an increased use of mental
health medication, both among women experiencing infertility as well as
their partners, in addition to an increased incidence of divorce.\162\
However, successful delivery can also be associated with increased risk
of mental health disorders, such as postpartum anxiety and
depression.\163\ The Departments lack the necessary data to compare
these effects and quantify the value of these changes to health
outcomes and live births and request comment on any data that might
allow for quantification of the benefits related to these proposed
rules.
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\160\ Myles Doyle and Angela Carballedo, Infertility and Mental
Health, Advances in Psychiatric Treatment, Vol. 20 (2014), <a href="https://www.cambridge.org/core/services/aop-cambridge-core/content/view/12C29995CD4A52912CF84503C721EB62/S1355514600011822a.pdf/infertility_and_mental_health.pdf">https://www.cambridge.org/core/services/aop-cambridge-core/content/view/12C29995CD4A52912CF84503C721EB62/S1355514600011822a.pdf/infertility_and_mental_health.pdf</a>.
\161\ Brent Hanson, Erica Johnstone, Jessie Dorais, Bob Silver,
C. Matthew Peterson and James Hotaling, Female Infertility,
Infertility-Associated Diagnoses, and Comorbidities: A Review,
Journal of Assisted Reproduction Technologies (Nov. 5, 2017),
<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC5306404/pdf/10815_2016_Article_836.pdf">https://pmc.ncbi.nlm.nih.gov/articles/PMC5306404/pdf/10815_2016_Article_836.pdf</a>.
\162\ Sarah Bogl, Jasmin Moshfegh, Petra Persson, and Maria
Polyakova, The Economics of Infertility: Evidence from Reproductive
Medicine, National Bureau of Economic Research, Working Paper 32445
(May. 2024), <a href="https://www.nber.org/papers/w32445">https://www.nber.org/papers/w32445</a>.
\163\ Om Suryawanshi, and Sandhya Pajai. A comprehensive review
on postpartum depression, Cureus (Dec. 20, 2022), <a href="https://doi.org/10.7759/cureus.32745">https://doi.org/10.7759/cureus.32745</a>.
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3. Increased Tenure and Productivity of Covered Employees
Employers could also benefit from these proposed rules as research
suggests that returns on investments for fertility benefits are
significant for employers. A 2023 Maven report found that ``workers
whose employer-provided health care plans covered IVF treatment were
more likely to remain in their job long-term, and more likely recommend
[sic] their employer to others.'' \164\ Additionally, there are
downstream benefits to offering fertility benefits, such as reducing
potential stays in neonatal intensive care units and associated high-
risk maternity-related expenses by prioritizing first-line
interventions and medical policies that lead to more singleton births,
fewer preterm births and ultimately lower health care costs.\165\
Finally, because these proposed rules would offer flexibility in the
manner and generosity of the excepted fertility benefits and would not
require a set contribution by plan sponsors, employers and plan
sponsors would be able to determine how and at what level they want to
provide these benefits in order to maximize the net returns for plan
sponsors. The Departments request comments on quantifying the value of
these benefits.
---------------------------------------------------------------------------
\164\ Michelle Travis, Why Reproductive Health Benefits Are a
Good Investment for Employers, Forbes (Mar. 26, 2025), <a href="https://www.forbes.com/sites/michelletravis/2025/03/26/why-employers-should-invest-in-reproductive-health-benefits/">https://www.forbes.com/sites/michelletravis/2025/03/26/why-employers-should-invest-in-reproductive-health-benefits/</a>.
\165\ Benjamin Peipert, Esther Chung, Benjamin Harris, and Tarun
Jain, Impact of Comprehensive State Insurance Mandates on In Vitro
Fertilization Utilization, Embryo Transfer Practices and Outcomes in
the United States, American Journal of Gynecology (Mar. 11, 2022),
<a href="https://pubmed.ncbi.nlm.nih.gov/35283088/">https://pubmed.ncbi.nlm.nih.gov/35283088/</a>.
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4. Improved Birth Outcomes for Participants
The Departments believe that these proposed rules would likely
result in additional births due to greater access to fertility-related
care. A recent study of women in the United States using self-reported
infertility and treatment status found that 10 percent of women who
undergo fertility treatments achieve a live birth.\166\ However, while
the Departments are able to estimate the number of women that would
receive fertility coverage under an excepted benefit plan and pursue
treatment, it is unclear how many of these women would receive
treatment absent these proposed rules. As a result, the Departments are
unable to estimate the number of births that would arise from changes
to improved treatment access due to these proposed rules, though the
Departments acknowledge that an increase in births would provide
substantial benefits to individuals and their families, as well as
society.
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\166\ Theresa Boyer, Linh Tran, Michael Fang, Elizabeth Selvin,
and Anum S. Minhas, The Fertility Cascade: Infertility Prevalence,
Access to Treatment, and Successful Live Birth, American Journal of
Obstetrics and Gynecology (Jan. 2026), <a href="https://www.ajog.org/article/S0002-9378">https://www.ajog.org/article/S0002-9378</a>(25)00573-3/abstract.
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I. Costs
1. Plan Administration Expenses
As excepted fertility benefits would constitute a new category of
limited excepted benefits, employers that elect to offer such coverage
would incur certain administrative costs to initiate and maintain a
plan.
The Departments anticipate that the administrative costs of such a
program would be considerably lower than those for traditional group
health plans given that limited excepted benefits are exempt from ERISA
Part 7 requirements. Additionally, the Departments are of the view that
many of the issuers that elect to offer coverage for such plans would
mostly likely be those that already provide fertility-related coverage
in traditional group health plans, which the Departments believe would
mitigate many of the startup expenses to issuers. For those issuers
that do not currently offer coverage of fertility-related medical care
in traditional group health plans, the Departments assume that these
issuers could utilize existing providers that offer carve out coverage
as a way to offer excepted fertility benefit. Some of these costs could
also be offset through the use of third-party administrators that could
more efficiently service the plan documentation and reporting
requirements than could a plan sponsor. The Departments lack sufficient
data on the exact value of such administrative costs and request
comments on the average administrative expenditures for an excepted
fertility benefit plan in addition to the other assumptions stated.
Additionally, the Departments estimate the 811 issuers acting as
service providers to plans would incur a one-time cost of approximately
$304,255 to familiarize themselves with these proposed rules as they
help plan sponsors develop excepted fertility benefit plans in response
to these proposed rules.\167\
---------------------------------------------------------------------------
\167\ This cost is estimated as: 2 hours x $187.58 hourly wage
rate for attorney x 811 issuers = $304,255. The one-hour time
estimate is derived from the amount of time it would take for the
rule to be reviewed at an average reading rate of 250 words per
minute.
---------------------------------------------------------------------------
2. Employer Contributions
Employers that elect to offer excepted fertility benefits coverage
could also elect to make contributions towards plan premiums, though
there would be no requirement that they contribute under these proposed
rules. Employer contributions would be expected to vary widely based on
factors such as employer size, plan type, and coverage level. For
excepted benefits like vision and dental insurance, the employer costs
are often lower than for traditional group health plans and, as such,
employers may cover a higher share of the premium expense. The 2023 KFF
Employer Health Benefits Survey indicates that about half of small
firms and two-thirds of large firms that offer dental plans contribute
toward the premiums.\168\ For vision plans, this rate is approximately
one-quarter and one-third, respectively. The potentially high costs of
fertility-related items and services may limit the share of premiums
that employers would be willing to cover if electing to offer such a
plan. The Departments request comments on the share of employers that
might elect to contribute towards the plan premiums for fertility-
related items and services, and the share of total
[[Page 27161]]
premiums they might elect to contribute.
---------------------------------------------------------------------------
\168\ KFF, 2023 Employer Health Benefits Survey (Oct.. 2023),
<a href="https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2023-Annual-Survey.pdf">https://files.kff.org/attachment/Employer-Health-Benefits-Survey-2023-Annual-Survey.pdf</a>.
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3. Notice to Participants and Eligible Employees
These proposed rules aim to establish, as a limited excepted
benefit, standalone coverage for diagnostic procedures, medications,
and treatments related to infertility. This coverage would be available
to eligible participants and beneficiaries of employer-sponsored health
plans. Under these proposed rules, the Departments propose to require
that a notice be sent to eligible participants and beneficiaries. This
notice would include a description of the coverage, including a summary
of benefits and limitations of the coverage, how to identify and
utilize a network provider, if applicable, as well as procedures for
claims reimbursement, including whether the benefit utilizes the same
claim procedures as for the sponsor's other group health plans. The
notice is expected to be approximately one page in length, would be
sent to eligible employees, and any printed notices would be sent with
minimal additional costs.\169\
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\169\ The Departments assume that for private sector plans,
approximately 58% of plan documents would be sent electronically,
while 42% would be physical notices mailed to participants. For
public sector plans, approximately 34% of plan documents would be
sent electronically, while 66% would be physical notices mailed to
participants.
---------------------------------------------------------------------------
The Departments expect this notice would be prepared by attorneys
for the issuers of such benefits or service providers assisting a plan
at a burden of approximately 2 hours. This is estimated to result in a
total cost for all issuers of approximately $0.3 million in the first
year.\170\ In each subsequent year, the Departments anticipate that
attorneys for the issuer or service provider would review and provide
any required updates to the notice at a burden of approximately 1 hour,
incurring a total annual cost for all issuers of approximately $0.2
million.\171\ The Departments estimate that approximately 25.5 million
paper notices would be sent to eligible employees each year at an
annual cost of approximately $1.3 million to produce the
notices.<SUP>172 173</SUP>
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\170\ This cost is estimated as: 2 hours x $187.58 hourly wage
rate for attorney x 811 issuers = $304,255.
\171\ This cost is estimated as: 1 hours x $187.58 hourly wage
rate for attorney x 811 issuers = $152,127.
\172\ This is estimated as: (42,849,310 potentially eligible
private-sector individuals x 42 percent notice mailing rate) +
(11,561,954 potentially eligible public-sector individuals x 66
percent notice mailing rate) = 25,499,052 notices mailed.
\173\ This cost is estimated as: 25,499,052 notices mailed x
$0.05 material cost per notice = $1,274,953.
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4. Increased Health Expenditures Due to Additional Births
The introduction of excepted fertility benefit coverage has the
potential to increase the birth rate by making it easier for
individuals to access treatments that support conception and pregnancy.
Pregnancy and even uncomplicated births are costly medical events,
often involving pre-natal care, hospital stays, specialized care, and
follow-up services. This could lead to increased expenditures for
employers, plan participants and government programs. Due to the
uncertainty regarding the number of women that would become pregnant as
a result of these proposed rules, carry to term and give birth, and any
additional medical items or services that may be required during the
process, the Departments are not able to quantify the costs that would
arise from expanded access to fertility-related medical care under
these proposed rules, if finalized.
5. Summary of Quantified Costs
The quantified costs associated with these proposed rules are
summarized in Table 4.
Table 4--Summary of Quantified Costs
------------------------------------------------------------------------
First year Subsequent years
------------------------------------------------------------------------
Prepare Notices..................... $304,255 $0
Review and Update Notices........... 0 152,127
Distribute Notices.................. 1,274,953 1,274,953
Rule Familiarization................ 304,255 0
-----------------------------------
Total Costs..................... 1,883,462 1,427,080
------------------------------------------------------------------------
* Totals displayed in the table may not sum due to rounding.
J. Transfers
The following sections are primarily qualitative discussions of
transfers that the Departments expect would occur due to these proposed
rules. The Departments request comments or data that might help in
quantifying these transfers.
1. Transfers of Contributions From Participants to Plans
The Departments anticipate that, upon enrollment in an excepted
fertility benefit plan, most participants would begin to make premium
contributions to maintain their coverage. These premium contributions
would represent a transfer from participants and beneficiaries that
utilize fertility-related medical care below the value of their premium
contributions to those participants and beneficiaries who utilize their
benefits beyond the value of their premium contributions. The
Departments lack data on the potential expenditures related to these
transfers and request comments on how best to estimate the value of
these transfers.
2. Transfers of Risk From Participants and Beneficiaries to Issuers or
Self-Insured Plans
As discussed in section III.C, large shares of insured individuals
currently lack coverage for diagnostic procedures, medications, and
treatments for infertility. When issuers or plan sponsors offer
excepted fertility benefits to participants and beneficiaries, the
issuers or self-insured plans assume some risk in covering the costs
related to the utilization of these items and services. While these
participants and beneficiaries previously paid such expenses out-of-
pocket, issuers and plans would bear some of the risk associated with
the expenditures under these proposed rules, if finalized. As such,
these proposed rules would result in a transfer of risk from
participants and beneficiaries to issuers or plans offering excepted
fertility benefits.
[[Page 27162]]
3. Transfers of Tax Revenue From Government to Individuals and
Employers Through Tax-Advantaged Employee Benefits
When employers and employees are permitted to pay plan premiums for
excepted benefits with pre-tax dollars, these contributions are
excluded from taxable income. As a result, both employer and employee
tax liabilities are reduced. This is turn impacts the federal
government as the expansion of pre-tax benefits decreases overall tax
receipts, constituting a transfer from the government to individuals
and employers. The magnitude of these impacts would depend on the
number of employers that would offer excepted fertility benefits and
the level of employee participation. It would also depend on the
marginal tax rate of the individual, the premiums associated with these
plans, and the amount of any employer contribution.
The favorable tax treatment is likely to encourage greater offering
of excepted fertility benefit plans, thereby expanding access to
valuable fertility items and services. It could also make enrollment in
an excepted fertility benefit plan more attractive and affordable for
employees as the ability to pay premiums with pre-tax dollars could
reduce
[…truncated; see source link]Indexed from Federal Register on May 13, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.