# Bulletin No. 2024–47

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/agency%3Airs%3Adf60f4cef631d254

## Record

- **Collection:** Agency decision
- **Document type:** Agency decision

## Text

HIGHLIGHTS
OF THIS ISSUE




Bulletin No. 2024–47
November 18, 2024

These synopses are intended only as aids to the reader in
identifying the subject matter covered. They may not be
relied upon as authoritative interpretations.

EMPLOYEE PLANS
Notice 2024-80, page 1120.

Section 415 of the Internal Revenue Code (the Code) provides
for dollar limitations on benefits and contributions under qualified retirement plans. Section 415(d) requires that the Secretary of the Treasury annually adjust these limits for cost of
living increases. Other limitations applicable to deferred compensation plans are also affected by these adjustments under
§ 415. Under § 415(d), the adjustments are to be made under
adjustment procedures similar to those used to adjust benefit
amounts under § 215(i)(2)(A) of the Social Security Act.

EMPLOYEE PLANS, EXCISE TAX
REG-110878-24, page 1125.

These proposed rules would amend the regulations regarding coverage of certain preventive services under section
2713 of the Public Health Service Act. The proposed rules
also contain separate requirements applicable to coverage
of contraceptive items that are preventive services. Specifically, these proposed rules would require plans and issuers to cover recommended over the-counter contraceptive
items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed
rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-

Finding Lists begin on page ii.

led combination products without imposing cost sharing
requirements, unless a therapeutic equivalent of the drug
or drug-led combination product is covered without cost
sharing. Finally, these proposed rules would amend the regulations implementing section 2715A of the Public Health
Service Act and section 1311(e)(3) of the Affordable Care
Act by adding a disclosure requirement pertaining to coverage and cost-sharing requirements for over-the-counter
contraceptive items. These proposed rules would not modify Federal conscience protections related to contraceptive
coverage for employers, plans, issuers, and providers.

EXEMPT ORGANIZATIONS
Announcement 2024-37, page 1124.

Revocation of IRC 501(c)(3) Organizations for failure to
meet the code section requirements. Contributions made to
the organizations by individual donors are no longer deductible under IRC 170(b)(1)(A).

INCOME TAX
Rev. Proc. 2024-41, page 1122.

This revenue procedure publishes the amounts of unused
housing credit carryovers allocated to qualified states
under § 42(h)(3)(D) of the Internal Revenue Code for calendar year 2024.

The IRS Mission
Provide America’s taxpayers top-quality service by helping
them understand and meet their tax responsibilities and
enforce the law with integrity and fairness to all.

Introduction
The Internal Revenue Bulletin is the authoritative instrument
of the Commissioner of Internal Revenue for announcing official rulings and procedures of the Internal Revenue Service
and for publishing Treasury Decisions, Executive Orders, Tax
Conventions, legislation, court decisions, and other items of
general interest. It is published weekly.
It is the policy of the Service to publish in the Bulletin all substantive rulings necessary to promote a uniform application
of the tax laws, including all rulings that supersede, revoke,
modify, or amend any of those previously published in the
Bulletin. All published rulings apply retroactively unless otherwise indicated. Procedures relating solely to matters of internal management are not published; however, statements of
internal practices and procedures that affect the rights and
duties of taxpayers are published.
Revenue rulings represent the conclusions of the Service
on the application of the law to the pivotal facts stated in
the revenue ruling. In those based on positions taken in rulings to taxpayers or technical advice to Service field offices,
identifying details and information of a confidential nature are
deleted to prevent unwarranted invasions of privacy and to
comply with statutory requirements.
Rulings and procedures reported in the Bulletin do not have the
force and effect of Treasury Department Regulations, but they
may be used as precedents. Unpublished rulings will not be
relied on, used, or cited as precedents by Service personnel in
the disposition of other cases. In applying published rulings and
procedures, the effect of subsequent legislation, regulations,
court decisions, rulings, and procedures must be considered,
and Service personnel and others concerned are cautioned

against reaching the same conclusions in other cases unless
the facts and circumstances are substantially the same.
The Bulletin is divided into four parts as follows:
Part I.—1986 Code.
This part includes rulings and decisions based on provisions
of the Internal Revenue Code of 1986.
Part II.—Treaties and Tax Legislation.
This part is divided into two subparts as follows: Subpart A,
Tax Conventions and Other Related Items, and Subpart B,
Legislation and Related Committee Reports.
Part III.—Administrative, Procedural, and Miscellaneous.
To the extent practicable, pertinent cross references to these
subjects are contained in the other Parts and Subparts. Also
included in this part are Bank Secrecy Act Administrative
Rulings. Bank Secrecy Act Administrative Rulings are issued
by the Department of the Treasury’s Office of the Assistant
Secretary (Enforcement).
Part IV.—Items of General Interest.
This part includes notices of proposed rulemakings, disbarment and suspension lists, and announcements.
The last Bulletin for each month includes a cumulative index
for the matters published during the preceding months. These
monthly indexes are cumulated on a semiannual basis, and are
published in the last Bulletin of each semiannual period.

The contents of this publication are not copyrighted and may be reprinted freely. A citation of the Internal Revenue Bulletin as the source would be appropriate.

November 18, 2024 

Bulletin No. 2024–47

Part III
2025 Amounts Relating to
Retirement Plans and IRAs,
as Adjusted for Changes in
Cost-of-Living
Notice 2024-80
Section 415 of the Internal Revenue
Code (“Code”) provides for limitations
on benefits and contributions under qualified retirement plans. Section 415(d)
requires that the Secretary of the Treasury annually adjust these limitations for
cost-of-living increases. Under section
415(d), the adjustments are to be made
under adjustment procedures similar
to those used to adjust benefit amounts
under section 215(i)(2)(A) of the Social
Security Act. Other amounts applicable to deferred compensation plans are
also adjusted for cost-of-living increases
using a variation of the methodology
used for the adjustments under section
415(d).
Cost-of-Living Adjusted Limitations
for 2025
Effective January 1, 2025, the limitation on the annual benefit under a defined
benefit plan under section 415(b)(1)(A) of
the Code is increased from $275,000 to
$280,000.
For a participant who separated from
service before January 1, 2025, the participant’s limitation under a defined benefit plan under section 415(b)(1)(B) is
computed by multiplying the participant’s
compensation limitation, as adjusted
through 2024, by 1.0262.
The limitation for defined contribution plans under section 415(c)(1)(A)
is increased in 2025 from $69,000 to
$70,000.
The Code provides that various other
amounts are to be adjusted at the same
time and in the same manner as the limitation of section 415(b)(1)(A). After taking into account the applicable rounding
rules, the amounts for 2025 are as follows:
The limitation under section 402(g)(1)
on the exclusion for elective deferrals

November 18, 2024

described in section 402(g)(3), which
includes elective deferrals made to the
Thrift Savings Plan, is increased from
$23,000 to $23,500.
The limitation on deferrals under section 457(e)(15) concerning deferred
compensation plans of state and local
governments and tax-exempt organizations is increased from $23,000 to
$23,500.
The limitation under section 414(v)
(2)(B)(i) for catch-up contributions
to an applicable employer plan other
than a plan described in section 401(k)
(11) or section 408(p) that generally applies for individuals aged 50
or over remains $7,500. The limitation under section 414(v)(2)(E)(i) for
catch-up contributions to an applicable employer plan other than a plan
described in section 401(k)(11) or
section 408(p) that applies for individuals who attain age 60, 61, 62,
or 63 in 2025 is $11,250. The Roth
catch-up wage threshold for 2024,
which under section 414(v)(7)(A) is
used to determine whether an individual’s catch-up contributions to an
applicable employer plan (other than
a plan described in section 408(k) or
(p)) for 2025 must be designated Roth
contributions, remains $145,000.
The limitation under section 408(p)
(2)(E)(i)(III) that generally applies to
salary reduction contributions under a
SIMPLE retirement account or elective contributions under a SIMPLE
401(k) plan is increased from $16,000
to $16,500. The limitation for certain
of those accounts or plans under section 408(p)(2)(E)(i)(I) or (II) remains
$17,600.
The limitation under section 414(v)
(2)(B)(ii) for catch-up contributions to an applicable employer
plan described in section 401(k)
(11) or section 408(p) that generally
applies for individuals aged 50 or
over remains $3,500. The limitation
under section 414(v)(2)(E)(ii) for
catch-up contributions to an applica-

1120

ble employer plan described in section 401(k)(11) or section 408(p) that
applies for individuals who attain age
60, 61, 62, or 63 in 2025 is $5,250. The
limitation under section 414(v)(2)(B)
(iii) for catch-up contributions to certain accounts or plans described in
section 401(k)(11) or section 408(p)
that generally applies for individuals
aged 50 or over remains $3,850.
The limitation under section 401(k)
(16)(D)(i)(II) and 403(b)(16)(D)(i)
(II) that generally applies for elective
contributions made to a starter 401(k)
deferral-only arrangement described
in section 401(k)(16)(B) or a safe harbor deferral-only plan described in
section 403(b)(16)(B), respectively,
remains $6,000. This limitation is
increased for individuals who attain
age 50 before the end of the taxable
year by $1,000.
The threshold used in the definition of
“highly compensated employee” under
section 414(q)(1)(B) is increased from
$155,000 to $160,000.
The threshold under section 416(i)
(1)(A)(i) concerning the definition of
“key employee” for top-heavy plan
purposes is increased from $220,000 to
$230,000.
The annual compensation limitation
under sections 401(a)(17), 404(l),
408(k)(3)(C), and 408(k)(6)(D)(ii) is
increased from $345,000 to $350,000.
The annual compensation limitation
under section 401(a)(17) for eligible
participants in certain governmental
plans that, under the plan as in effect
on July 1, 1993, allowed cost-of-living adjustments to the compensation limitation under the plan under
section 401(a)(17) to be taken into
account, is increased from $505,000
to $520,000.
The limitation under section 402A(e)
(3)(A)(i) concerning pension-linked
emergency savings accounts that may
be included in certain types of defined
contribution plans remains $2,500.

Bulletin No. 2024–47

The compensation threshold under section 408(k)(2)(C) regarding simplified
employee pensions remains $750.
The amount under section 409(o)(1)
(C)(ii) for determining the maximum
account balance in an employee stock
ownership plan subject to a 5‑year
distribution period is increased from
$1,380,000 to $1,415,000, while the
dollar amount used to determine the
lengthening of the 5-year distribution
period is increased from $275,000 to
$280,000.
The limitation on the aggregate amount
of length of service awards accruing
with respect to any year of service
for any bona fide volunteer under
section 457(e)(11)(B)(ii) concerning
deferred compensation plans of state
and local governments and tax-exempt
organizations remains $7,500.
The limitation under section 664(g)
(7) concerning the qualified gratuitous
transfer of qualified employer securities to an employee stock ownership
plan remains $60,000.
The compensation amount under §
1.61-21(f)(5)(i) of the Income Tax
Regulations concerning the definition
of “control employee” for fringe benefit valuation purposes is increased
from $135,000 to $140,000. The compensation amount under § 1.61-21(f)
(5)(iii) is increased from $275,000 to
$285,000.
The limitation on premiums paid for
a qualifying longevity annuity contract under § 1.401(a)(9)-6(q)(2)(ii) is
increased from $200,000 to $210,000.
The $1,000,000,000 threshold used
to determine whether a multiemployer
plan is a systemically important plan
under section 432(e)(9)(H)(v)(III)(aa) is
adjusted using the cost-of-living adjustment provided under section 432(e)(9)(H)
(v)(III)(bb). After taking the applicable
rounding rule into account, the threshold
used to determine whether a multiemployer plan is a systemically important
plan under section 432(e)(9)(H)(v)(III)

Bulletin No. 2024–47

(aa) is increased from $1,369,000,000 to
$1,441,000,000.
The Code also provides that several
retirement-related amounts are to be
adjusted using a variation of the methodology used for the cost-of-living adjustments under section 1(f)(3). After taking
the applicable rounding rules into account,
the amounts for 2025 are as follows:
The adjusted gross income limitation
under section 25B(b)(1)(A) for determining the retirement savings contributions credit for married taxpayers
filing a joint return is increased from
$46,000 to $47,500; the limitation
under section 25B(b)(1)(B) is increased
from $50,000 to $51,000; and the limitation under sections 25B(b)(1)(C)
and 25B(b)(1)(D) is increased from
$76,500 to $79,000.
The adjusted gross income limitation
under section 25B(b)(1)(A) for determining the retirement savings contributions credit for taxpayers filing as
head of household is increased from
$34,500 to $35,625; the limitation
under section 25B(b)(1)(B) is increased
from $37,500 to $38,250; and the limitation under sections 25B(b)(1)(C)
and 25B(b)(1)(D) is increased from
$57,375 to $59,250.
The adjusted gross income limitation
under section 25B(b)(1)(A) for determining the retirement savings contributions credit for all other taxpayers
is increased from $23,000 to $23,750;
the limitation under section 25B(b)
(1)(B) is increased from $25,000 to
$25,500; and the limitation under
sections 25B(b)(1)(C) and 25B(b)
(1)(D) is increased from $38,250 to
$39,500.
The deductible amount under section
219(b)(5)(A), which limits the amount
of an individual’s deductible qualified
retirement contributions for a taxable
year remains $7,000. The increase
in the deductible amount pursuant to
section 219(b)(5)(B)(ii) for individuals who have attained age 50 before
the close of the taxable year remains
$1,000.

1121

The applicable amount under section
219(g)(3)(B)(i) for determining the
deductible amount of an IRA contribution for taxpayers who are active
participants filing a joint return or as
a qualifying widow(er) is increased
from $123,000 to $126,000. The applicable amount under section 219(g)(3)
(B)(ii) for all other taxpayers who are
active participants (other than married
taxpayers filing separate returns) is
increased from $77,000 to $79,000.
If an individual or the individual’s
spouse is an active participant, the
applicable amount under section
219(g)(3)(B)(iii) for a married individual filing a separate return is not
subject to an annual cost-of-living
adjustment and remains $0. The applicable amount under section 219(g)
(7)(A) for a taxpayer who is not an
active participant but whose spouse is
an active participant is increased from
$230,000 to $236,000.
In light of the changes to the applicable amounts, under section 219(g)
(2)(A), the deduction for taxpayers
making contributions to a traditional
IRA is phased out for single individuals and heads of household who are
active participants in a qualified plan
(or another retirement plan specified in section 219(g)(5)) and have
adjusted gross incomes (as defined
in section 219(g)(3)(A)) between
$79,000 and $89,000, increased from
between $77,000 and $87,000. For
married couples filing jointly, if the
spouse who makes the IRA contribution is an active participant, the
income phase‑out range is between
$126,000 and $146,000, increased
from between $123,000 and $143,000.
For an IRA contributor who is not an
active participant and is married to
someone who is an active participant,
the deduction is phased out if the couple’s income is between $236,000 and
$246,000, increased from between
$230,000 and $240,000. For a married
individual filing a separate return who
is an active participant, the phaseout range is not subject to an annual
cost‑of‑living adjustment and remains
$0 to $10,000.

November 18, 2024

The adjusted gross income limitation
under section 408A(c)(3)(B)(ii)(I)
for determining the maximum Roth
IRA contribution for married taxpayers filing a joint return or for taxpayers filing as a qualifying widow(er) is
increased from $230,000 to $236,000.
The adjusted gross income limitation
under section 408A(c)(3)(B)(ii)(II) for
all other taxpayers (other than married
taxpayers filing separate returns) is
increased from $146,000 to $150,000.
The applicable amount under section
408A(c)(3)(B)(ii)(III) for a married
individual filing a separate return is
not subject to an annual cost-of-living
adjustment and remains $0.
In light of the changes to the adjusted
gross income limitations, under section 408A(c)(3)(A), the adjusted gross
income phase-out range for taxpayers
making contributions to a Roth IRA is
between $236,000 and $246,000 for
married couples filing jointly, increased
from between $230,000 and $240,000.
For singles and heads of household,
the income phase-out range is between
$150,000 and $165,000, increased
from between $146,000 and $161,000.
For a married individual filing a separate return, the phase-out range is
not subject to an annual cost-of-living
adjustment and remains between $0
and $10,000.
The aggregate amount of qualified
charitable distributions that are not
includible in gross income under section 408(d)(8)(A) is increased from
$105,000 to $108,000. The amount of

qualified charitable distributions made
directly to a split-interest entity that are
not includible in gross income under
section 408(d)(8)(F)(i)(II) pursuant to
a one-time election is increased from
$53,000 to $54,000.
The annual compensation limitation
under section 45E(f)(2)(C) for employees excluded from the calculation of the
additional small employer pension plan
startup cost credit for certain employer
contributions is $105,000.1
The limitation under section 72(t)(2)
(K)(ii)(I) for eligible distributions
to victims of domestic abuse from
applicable eligible retirement plans is
increased from $10,000 to $10,300.
The limitation under section 401(a)
(39)(B)(i)(III) on a qualified longterm care distribution from a qualified
defined contribution plan with respect
to certified long-term care insurance
applicable for distributions made after
December 29, 2025, is $2,600.
The limitation under section 408(p)(2)
(A)(iv) for additional nonelective contributions for an employee to a SIMPLE retirement account or a SIMPLE
401(k) plan is increased from $5,000 to
$5,100.

Taxes). However, other personnel from
the IRS participated in the development
of this guidance. For further information
regarding this notice, contact Mr. Morgan
at (202) 317‑6700 (not a toll-free number).

Rev. Proc. 2024-41
SECTION 1. PURPOSE
This revenue procedure publishes the
amounts of unused housing credit carryovers allocated to qualified states under
§ 42(h)(3)(D) of the Internal Revenue
Code for calendar year 2024.
SECTION 2. BACKGROUND
Rev. Proc. 2019-45, 2019-48 I.R.B.
524, provides guidance to state housing
credit agencies of qualified states on the
procedure for requesting an allocation of
unused housing credit carryovers under
§ 42(h)(3)(D). The amount of unused
housing credit carryovers allocated to
qualified states for a calendar year from
a national pool of unused credit authority
(the National Pool) is published by the
Internal Revenue Service in the Internal
Revenue Bulletin. This revenue procedure
publishes these amounts for calendar year
2024.

Drafting Information

SECTION 3. PROCEDURE

The principal author of this notice is
Tom Morgan of the Office of Associate Chief Counsel (Employee Benefits,
Exempt Organizations, and Employment

The unused housing credit carryover
amount allocated from the National Pool
by the Secretary to each qualified state for
calendar year 2024 is as follows:

Pursuant to section 45E(f)(2)(C)(iii), for a taxable year beginning in a calendar year after 2023, this limitation is equal to the initial limitation of $100,000, multiplied by the cost-of-living
adjustment determined under section 1(f)(3) for the calendar year in which the taxable year begins, determined by substituting “calendar year 2007” for “calendar year 2016” in section
1(f)(3)(A)(ii). Because the specification of a 2007 base period to be used for computing an adjustment that is first made for 2024 appears to be an error that has been identified as the subject
of future legislative correction, the IRS will calculate and apply the limitation in section 45E(f)(2)(C) by substituting “calendar year 2022” for “calendar year 2007” in section 45E(f)(2)(C)
(iii). Using that substitution, the limitation for 2024 was $105,000.
1

November 18, 2024

1122

Bulletin No. 2024–47

Qualified State
Alaska
California
Connecticut
Delaware
Florida
Georgia
Illinois
Iowa
Kansas
Maryland
Massachusetts
Michigan
Minnesota
Nebraska
New Jersey
New Mexico
New York
North Carolina
Ohio
Oregon
Pennsylvania
Rhode Island
South Dakota
Texas
Utah
Vermont
Virginia
Washington
West Virginia

Amount Allocated
10,879
577,985
53,655
15,306
335,393
163,601
186,154
47,571
43,618
91,674
103,854
148,886
85,113
29,346
137,815
31,363
290,307
160,727
174,825
62,795
192,266
16,257
13,637
452,467
50,697
9,604
129,283
115,891
26,256

EFFECTIVE DATE

DRAFTING INFORMATION

This revenue procedure is effective
for allocations of housing credit dollar
amounts attributable to the National Pool
component of a qualified state’s housing
credit ceiling for calendar year 2024.

The principal author of this revenue
procedure is Waheed Olayan of the Office
of Associate Chief Counsel (Passthroughs
and Special Industries). For further information regarding this revenue procedure,

contact Mr. Olayan at (202) 317-6239 (not
a toll-free number).

Section 42 - Low-Income Housing Credit.
26 CFR 1.42-14.

Allocation rules for post-1989 State housing credit ceiling amounts.

Guidance is provided to state housing credit agencies of qualified states that request an allocation of unused housing credit carryover
under section 42(h)(3)(D) of the Internal Revenue Code. See Rev. Proc. 2023-32.

Bulletin No. 2024–47

1123

November 18, 2024

Part IV
Deletions From Cumulative
List of Organizations,
Contributions to Which are
Deductible Under Section
170 of the Code
Announcement 2024-37
Table of Contents
The Internal Revenue Service has
revoked its determination that the organizations listed below qualify as organizations described in sections 501(c)(3) and
170(c)(2) of the Internal Revenue Code
of 1986.

Name Of Organization
Out of the Closet Foundation Inc
Saved in America incorporated

November 18, 2024

Generally, the IRS will not disallow
deductions for contributions made to a
listed organization on or before the date
of announcement in the Internal Revenue
Bulletin that an organization no longer
qualifies. However, the IRS is not precluded from disallowing a deduction for
any contributions made after an organization ceases to qualify under section 170(c)
(2) if the organization has not timely filed
a suit for declaratory judgment under section 7428 and if the contributor (1) had
knowledge of the revocation of the ruling
or determination letter, (2) was aware that
such revocation was imminent, or (3) was
in part responsible for or was aware of the
activities or omissions of the organization
that brought about this revocation.

Effective Date of Revocation
1/1/2021
1/1/2019

1124

If on the other hand a suit for declaratory
judgment has been timely filed, contributions from individuals and organizations described in section 170(c)(2) that
are otherwise allowable will continue
to be deductible. Protection under section 7428(c) would begin on November
01, 2024, and would end on the date the
court first determines the organization is
not described in section 170(c)(2) as more
particularly set for in section 7428(c)(1).
For individual contributors, the maximum
deduction protected is $1,000, with a husband and wife treated as one contributor.
This benefit is not extended to any individual, in whole or in part, for the acts or
omissions of the organization that were
the basis for revocation.

Location
New York, NY
Valley Center, CA

Bulletin No. 2024–47

Notice of Proposed
Rulemaking
Enhancing Coverage of
Preventive Services Under
the Affordable Care Act
REG-110878-24
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 rule.
SUMMARY: This document sets forth
proposed rules that would amend the
regulations regarding coverage of certain preventive services under the Public
Health Service Act. Specifically, this document proposes rules that would provide
that medical management techniques
used by non-grandfathered group health
plans and health insurance issuers offering non-grandfathered group or individual
health insurance coverage with respect
to such preventive services would not
be considered reasonable unless the plan
or issuer provides an easily accessible,
transparent, and sufficiently expedient
exceptions process that would allow an
individual to receive coverage without
cost sharing for the preventive service
that is medically necessary with respect to
the individual, as determined by the individual’s attending provider, even if such
service is not generally covered under the
plan or coverage. These proposed rules
also contain separate requirements that
would apply to coverage of contraceptive
items that are preventive services under
the Public Health Service Act. Specifically, these proposed rules would require
plans and issuers to cover certain recommended over‑the-counter contraceptive
items without requiring a prescription and
without imposing cost-sharing requirements. In addition, the proposed rules
would require plans and issuers to cover
certain recommended contraceptive items
that are drugs and drug-led combination
products without imposing cost‑shar-

Bulletin No. 2024–47

ing requirements, unless a therapeutic
equivalent of the drug or drug-led combination product is covered without cost
sharing. Finally, this document proposes
to require a disclosure pertaining to coverage and cost-sharing requirements for
over-the-counter contraceptive items in
plans’ and issuers’ Transparency in Coverage internet-based self-service tools or,
if requested by the individual, on paper.
These proposed rules would not modify
Federal conscience protections related
to contraceptive coverage for employers,
plans and issuers.
DATES: To be assured consideration,
comments must be received at one of the
addresses provided below by December
27, 2024.
ADDRESSES: Written comments may be
submitted to the address specified below.
Any comment that is submitted will be
shared with the Department of the Treasury,
Internal Revenue Service, and the Department of Health and Human Services (HHS).
Commenters should 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-AC25.
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
https://www.regulations.gov. 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,

1125

Washington, DC 20210,
Attention: 1210-AC25.
Always allow sufficient time for mailed
comments to be received before the close
of the comment period. Because of staff
and resource limitations, the Departments
cannot accept comments by facsimile
(FAX) transmission.
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: https://www.regulations.
gov. Follow the search instructions on that
website to view public comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a summary
of these proposed rules of not more than
100 words in length, in plain language,
may be found at https://www.regulations.
gov/.
FOR FURTHER INFORMATION
CONTACT: Regan Rusher, Internal Revenue Service, Department of the Treasury,
at (202) 317-5500. Matthew Meidell,
Employee Benefits Security Administration, Department of Labor, at (202) 6938335. Rebecca Miller, Employee Benefits Security Administration, Department
of Labor, at (202) 693-8335. Geraldine
Doetzer, Centers for Medicare & Medicaid Services, Department of Health and
Human Services at (667) 290–8855. Kendra May, Centers for Medicare & Medicaid Services, Department of Health and
Human Services at (301) 448-3996.
Customer Service Information: Individuals interested in obtaining information
from the Department of Labor (DOL) concerning 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 (www.dol.gov/ebsa). In
addition, information from HHS on private
health insurance coverage and on non-Federal governmental plans can be found on
the Centers for Medicare & Medicaid Services (CMS) website (www.cms.gov/cciio),
and information on health care reform can
be found at www.HealthCare.gov.

November 18, 2024

SUPPLEMENTARY INFORMATION:
I. Background
A. Coverage of Preventive Services
Under the Affordable Care Act and
Implementing Regulations
The Patient Protection and Affordable
Care Act (Pub. L. 111-148) was enacted
on March 23, 2010. The Health Care
and Education Reconciliation Act of
2010 (Pub. L. 111-152) was enacted on
March 30, 2010. These statutes are collectively known as the Affordable Care Act
(ACA). The ACA reorganized, amended,
and added to the provisions of part A of
title XXVII of the Public Health Service
Act (PHS Act) relating to group health
plans and health insurance issuers in the
group and individual markets. The ACA
added section 715(a)(1) to the Employee
Retirement Income Security Act of 1974
(ERISA)1 and section 9815(a)(1) to the
Internal Revenue Code (Code)2 to incorporate the provisions of part A of title
XXVII of the PHS Act into ERISA and
the Code, and to make them applicable to
group health plans and health insurance
issuers providing health insurance coverage in connection with group health plans.

Section 2713 of the PHS Act,3 as added
by section 1001 of the ACA and incorporated into ERISA and the Code, and
its implementing regulations require that
non-grandfathered group health plans
and health insurance issuers offering
non-grandfathered group or individual
health insurance coverage (plans and issuers) provide coverage without imposing
any cost-sharing requirements for the following items and services:4
Evidence-based items or services that
have in effect a rating of “A” or “B” in the
current recommendations of the United
States Preventive Services Task Force
(USPSTF) with respect to the individual
involved, except for the recommendations
of the USPSTF regarding breast cancer
screening, mammography, and prevention
issued in or around November 2009;5,6
Immunizations for routine use in children, adolescents, and adults that have
in effect a recommendation from the
Advisory Committee on Immunization
Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) with
respect to the individual involved;7
With respect to infants, children, and
adolescents, evidence-informed preventive care and screenings provided for
in comprehensive guidelines supported

by the Health Resources and Services
Administration (HRSA); and
With respect to women,8 such additional preventive care and screenings not
described in the USPSTF recommendations in PHS Act section 2713(a)(1), as
provided for in comprehensive guidelines
supported by HRSA.9
On August 1, 2011, HRSA established
the HRSA-supported Women’s Preventive
Services Guidelines (HRSA-supported
Guidelines) based on recommendations
from a Department of Health and Human
Services’ (HHS) commissioned study
by the Institute of Medicine.10 Among
other recommended items and services,
the 2011 HRSA-supported Guidelines
addressed contraceptive methods and
counseling as a type of preventive service
and included all Food and Drug Administration (FDA)-approved “contraceptive
methods, sterilization procedures, and
patient education and counseling for all
women with reproductive capacity.”11 The
HRSA-supported Guidelines’ recommendation on contraception has been updated
several times, including in 2016,12 and
most recently in 2021.13 The 2011
HRSA-supported Guidelines included for
each type of preventive service a column
labeled “Frequency,” which for contra-

29 U.S.C. 1185d.
26 U.S.C. 9815.
3
42 U.S.C. 300gg–13.
4
The items and services described in these recommendations and guidelines are referred to in this preamble as “recommended preventive services.”
5
The USPSTF published updated breast cancer screening recommendations in April 2024. However, section 223 of title II of Division D of the Further Consolidated Appropriations Act,
2024 (Pub. L. 118–47) requires that for purposes of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued before 2009
remain in effect until January 1, 2026.
6
On September 19, 2024, the Departments filed a petition for a writ of certiorari requesting U.S. Supreme Court review of the decision of the U.S. Court of Appeals for the Fifth Circuit in
Braidwood Management v. Becerra, which found in part that the actions taken by the Departments under section 2713(a) of the PHS Act to require coverage of certain preventive services
recommended by the USPSTF are unconstitutional and unenforceable by the Departments as to the named plaintiffs. See 104 F.4th 930 (5th Cir. 2024), petition for cert. filed (U.S. Sept. 19,
2024) (No. 24-316).
7
In addition, under section 3203 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted on March 27, 2020 (Pub. L.116-136), plans and issuers must cover, without
cost-sharing requirements, any qualifying coronavirus preventive service pursuant to section 2713(a) of the PHS Act and its implementing regulations (or any successor regulations). The
term “qualifying coronavirus preventive service” means an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019 (COVID-19) and that is (1) an
evidence-based item or service that has in effect a rating of “A” or “B” in the current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from ACIP
with respect to the individual involved. See FAQs about Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Health Insurance Portability and
Accountability Act Implementation Part 58, Q4 (Mar. 29, 2023), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf and
https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf.
8
Consistent with the terminology in the statute, for purposes of coverage of contraceptive items, these proposed rules use the term “women” to refer to all individuals potentially capable of
becoming pregnant. Plans and issuers are required to cover contraceptive services for all such individuals consistent with the requirements in 26 CFR 54.9815-2713, 29 CFR 2590.715-2713,
and 45 CFR 147.130. See FAQs about Affordable Care Act Implementation Part XXVI, Q5 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/
resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.
9
For accommodations and exemptions with respect to coverage of recommended contraceptive services, see 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, and 45 CFR 147.131 through
147.133.
10
See HRSA (2011), “Women’s Preventive Services: Required Health Plan Coverage,” available at: https://web.archive.org/web/20130526033922/https:/www.hrsa.gov/womensguidelines/
index.html; see also Institute of Medicine, “Clinical Preventive Services for Women: Closing the Gaps” (2011), available at https://nap.nationalacademies.org/read/13181/chapter/7.
11
The references in this preamble to “contraception,” “contraceptive,” “contraceptive coverage,” “contraceptive services,” “contraceptive product,” or “contraceptive item” generally
include all contraceptives, sterilization, and related patient education and counseling recommended by the currently applicable HRSA-supported Guidelines, unless otherwise indicated.
12
The HRSA-supported Guidelines, as amended in December 2016, refer, under the header “Contraception,” to: “the full range of female-controlled U.S. Food and Drug Administration-approved contraceptive methods, effective family planning practices, and sterilization procedures,” “contraceptive counseling, initiation of contraceptive use, and follow-up care (e.g., management, and evaluation as well as changes to and removal or discontinuation of the contraceptive method),” and “instruction in fertility awareness-based methods, including the lactation
amenorrhea method.” See https://www.hrsa.gov/womens-guidelines-2016/index.html.
13
See HRSA, “Women’s Preventive Services Guidelines: Current Guidelines,” available at https://www.hrsa.gov/womens-guidelines.
1
2

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1126

Bulletin No. 2024–47

ceptive methods and counseling, stated,
“as prescribed.” The “Frequency” column
does not appear in the 2016, 2019, or 2021
updated HRSA-supported Guidelines for
any preventive service, and the updated
HRSA-supported Guidelines do not contain language that specifies frequency in
accordance with a prescription for contraceptive methods (or contraceptives) by a
health care provider Plans and issuers are
required to provide coverage of women’s
preventive services, including contraceptive items and services, without cost sharing, consistent with the 2021 HRSA-supported Guidelines, for plan years and
policy years beginning on or after December 30, 2022.14 The 2021 HRSA‑supported Guidelines refer, under the header
“Contraception,” to “the full range of
contraceptives and contraceptive care
to prevent unintended pregnancies and
improve birth outcomes.” The term “contraceptive methods” was replaced in 2021
by “contraceptives.”15 With the removal of
the phrase “female-controlled,” as HRSA
explained,16 male condoms are included
in the 2021 HRSA‑supported Guidelines,
which also include “screening, education,
counseling, and provision of contraceptives (including in the immediate postpartum period)” including “follow‑up
care (e.g., management, evaluation and
changes, including the removal, continuation, and discontinuation of contraceptives).”17 The 2021 HRSA-supported
Guidelines recommend “the full range
of U.S. Food and Drug Administration
(FDA)‑approved, -granted, or -cleared
contraceptives, effective family planning
practices, and sterilization procedures be
available as part of contraceptive care.”18

The Departments of the Treasury,
Labor, and HHS (the Departments) previously issued rulemaking to implement
the preventive services requirements of
section 2713 of the PHS Act, using their
authority under section 9833 of the Code,
section 734 of ERISA, and section 2792
of the PHS Act.19 On July 19, 2010, the
Departments issued interim final rules
(July 2010 interim final rules) at 26 CFR
54.9815-2713T, 29 CFR 2590.715-2713,
and 45 CFR 147.130, which require that
plans and issuers provide coverage of
recommended preventive services generally for plan years or policy years that
begin on or after September 23, 2010; or,
if later, for plan years or policy years that
begin on or after the date that is one year
after the recommendation or guideline
is issued.20 Among other provisions, the
July 2010 interim final rules allow plans
and issuers to rely on the relevant clinical evidence base to impose reasonable
medical management techniques to determine the frequency, method, treatment, or
setting for coverage of a recommended
preventive health item or service, to the
extent not specified in the applicable recommendation or guideline.21 Additionally,
if a plan or issuer has a provider in its
network that can provide a recommended
preventive service, the July 2010 interim
final rules specify that the plan or issuer is
not required to provide coverage or waive
cost sharing for the item or service when
delivered by an out-of-network provider.22
However, if a plan or issuer does not have
in its network a provider who can provide
a recommended preventive service (or the
plan or coverage does not have a network),
the plan or issuer must cover the item or

service when performed by an out‑of‑network provider, and may not impose any
cost-sharing requirements with respect
to the item or service. The Departments
finalized these rules on July 14, 2015.23
The Departments have also previously
issued rules that provide exemptions from
the contraceptive coverage requirement
for entities and individuals with moral
or religious objections to contraceptive
coverage, and accommodations through
which objecting entities are not required
to contract, arrange, pay, or provide a
referral for contraceptive coverage, while
at the same time ensuring that participants, beneficiaries, and enrollees enrolled
in coverage sponsored or arranged by an
objecting entity could separately obtain
contraceptive services at no additional
cost.24 Most recently, on February 2, 2023,
the Departments issued proposed rules
(2023 proposed rules) to rescind the moral
exemption to the contraceptive coverage requirement and to establish a new
“individual contraceptive arrangement,”
an independent pathway that individuals
enrolled in plans or coverage sponsored,
arranged, or provided by objecting entities
could use to obtain contraceptive services
at no cost directly from a provider or facility that furnishes contraceptive services.25
B. Guidance Related to the Coverage of
Recommended Preventive Services
Since publishing the July 2010 interim
final rules, the Departments have issued
extensive guidance related to the requirement to cover recommended preventive
services, including contraceptive services, without cost sharing under section

The Departments’ regulations under section 2713 of the PHS Act at 26 CFR 54.9815-2713T, 29 CFR 2590.715-2713, and 45 CFR 147.130 require that plans and issuers provide coverage
of recommended preventive services generally for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual
market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued.
15
See 86 FR 59741, 59742 (Oct. 28, 2021).
16
HRSA stated that this change was made to allow women to purchase male condoms for pregnancy prevention. See id.
17
See HRSA, Women’s Preventive Services Guidelines, available at https://www.hrsa.gov/womens-guidelines/index.html (version last reviewed March 2024, accessed September 25, 2024).
18
Id.
19
26 U.S.C. 9833, 29 U.S.C. 1191c, and 42 U.S.C. 300gg-92.
20
75 FR 41726 (July 19, 2010).
21
26 CFR 54.9815-2713T(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
22
26 CFR 54.9815-2713T(a)(3); 29 CFR 2590.715-2713(a)(3); and 45 CFR 147.130(a)(3).
23
80 FR 41318 (July 14, 2015).
24
These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers. The rules related to optional accommodations
for certain eligible entities (26 CFR 54.9815-2713A, 29 CFR 2510.3-16 and 2590.715-2713A, and 45 CFR 147.131) and religious (45 CFR 147.132) and moral (45 CFR 147.133) exemptions
in connection with the coverage of certain recommended preventive services—as well as the conscience protections that apply to certain health care providers, patients, and other participants (45 CFR part 88)—are outside the scope of these proposed rules. For a detailed overview of the regulatory and judicial history of Departmental rules specifically related to optional
accommodations and religious and moral exemptions from the contraceptive coverage requirement, see 88 FR 7236, 7237-40 (Feb. 2, 2023). For additional information on the Department
of Health and Human Services’ final rule on enforcement of religious freedom and conscience laws, see 89 FR 2078 (Jan. 11, 2024).
25
88 FR 7236.
14

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1127

November 18, 2024

2713 of the PHS Act and its implementing
regulations. These guidance documents
respond to questions from interested parties regarding the requirement to provide
coverage for recommended preventive
services without cost sharing.26 Cumulatively, this body of guidance interprets key
elements of the preventive health services
recommendations and guidelines and
coverage requirements, including with
respect to the allowed use of reasonable
medical management techniques.27 These
guidance documents include:
Frequently Asked Questions on February 20, 2013 (FAQs Part XII), which,
among other things, clarified the scope
of reasonable medical management with
respect to recommended preventive services, including contraceptive items and
services. The FAQs specified that plans
and issuers must cover “the full range
of FDA-approved contraceptive methods” and must design reasonable medical management techniques to include
accommodations for the specific medical

needs of an individual. FAQs Part XII,
Q14 noted that plans may, for example,
cover a generic drug without cost sharing and impose cost sharing for equivalent branded drugs. If, however, a generic
version is not available, or would not be
medically appropriate for the patient (as
determined by the attending provider, in
consultation with the patient), then a plan
or issuer must have a mechanism to provide coverage for the brand name drug
without any cost sharing.28 FAQs Part XII
also interpreted the statutory and regulatory requirements to cover recommended
preventive services without cost sharing
to mean that recommended preventive
services (including contraceptive products) that are generally available without a
prescription must be covered without cost
sharing only when prescribed by a health
care provider.29
Frequently Asked Questions on
May 11, 2015 (FAQs Part XXVI), which
clarified that plans and issuers must cover,
without cost sharing, at least one form

of contraception in each method30 that is
identified by the FDA in its Birth Control
Guide.31 FAQs Part XXVI further clarified
the scope of reasonable medical management techniques by specifying that if multiple services and FDA-approved items
within a contraceptive category are medically appropriate for an individual, the
plan or issuer may use reasonable medical management techniques to determine
which specific products to cover without
cost sharing with respect to that individual and, subject to the relevant facts and
circumstances, generally may impose cost
sharing (including full cost sharing) on
some items and services to encourage an
individual to use other specific items and
services within the chosen contraceptive
category.32 However, if the individual’s
attending provider33 recommends a particular service or FDA-approved, -cleared,
or -granted item based on a determination
of medical necessity with respect to that
individual, the plan or issuer must defer to
the determination of the attending provider

See FAQs about Affordable Care Act Implementation Part XII (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/
aca-part-xii.pdf and www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html; FAQs about Affordable Care Act Implementation Part XXVI (May 11, 2015),
available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/aca_implementation_faqs26.pdf; FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and Women’s Health and Cancer Rights
Act Implementation (April 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/cciio/
resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf; FAQs about Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act, and Coronavirus
Aid, Relief, and Economic Security Act Implementation (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.
pdf and https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf; FAQs about Affordable Care Act Implementation Part 54 (July 28, 2022), available
at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.; and FAQs about
Affordable Care Act Implementation Part 64 (Jan. 22, 2024) available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.
cms.gov/files/document/faqs-part-64.pdf.
27
As noted in section I.A of the preamble to these proposed rules, under 26 CFR 54.9815-2713T(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4), plans and issuers may use
“reasonable medical management techniques” to determine the frequency, method, treatment, or setting for a recommended preventive service, to the extent this information is not specified
in a recommendation or guideline. Plans and issuers may rely on established techniques and the relevant clinical evidence base to determine the frequency, method, treatment, or setting
for coverage of a recommended preventive health item or service where cost sharing must be waived. Whether a medical management technique is reasonable depends on all the relevant
facts and circumstances. See FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and
https://www.cms.gov/files/document/faqs-part-54.pdf.
28
See FAQs Part XII, Q14 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and https://www.cms.gov/
cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12.
29
See id. at Q4 and Q15. As noted elsewhere in this section I.B, the language “as prescribed” appeared in the HRSA-supported Guidelines until 2016.
30
As noted in FDA’s Birth Control Guide (Chart), published in May 2024, available at https://www.fda.gov/media/150299/download, the FDA approves, clears, and grants marketing authorization for individual contraceptive products, not “methods.” However, for purposes of this chart, which includes birth control options broader than products, the term “methods” is used.
Similarly, FAQs Part XXVI used the term “methods” consistent with the then-current FDA Birth Control Guide.
31
FAQs Part XXVI referenced the then-current 2015 FDA Birth Control Guide, which identified 18 contraceptive methods for women, but noted that the “FDA Birth Control Guide additionally lists sterilization surgery for men and male condoms, but the HRSA Guidelines exclude services relating to a man’s reproductive capacity.” See FAQs Part XXVI, fn. 12, available at
https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/
aca_implementation_faqs26.pdf. The 2021 HRSA-supported Guidelines incorporated by reference a subsequent update of the FDA Birth Control Guide (as published on December 22,
2021), and now describes the full range of contraceptives to include: “(1) sterilization surgery for women, (2) implantable rods, (3) copper intrauterine devices, (4) intrauterine devices
with progestin (all durations and doses), (5) injectable contraceptives, (6) oral contraceptives (combined pill), 7) oral contraceptives (progestin only), (8) oral contraceptives (extended
or continuous use), (9) the contraceptive patch, (10) vaginal contraceptive rings, (11) diaphragms, (12) contraceptive sponges, (13) cervical caps, (14) condoms, (15) spermicides, (16)
emergency contraception (levonorgestrel), and (17) emergency contraception (ulipristal acetate), and any additional contraceptives approved, granted, or cleared by the FDA.” See FAQs
Part 64 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/document/
faqs-part-64.pdf. The 2021 HRSA-supported Guidelines also state: “Additionally, instruction in fertility awareness-based methods, including the lactation amenorrhea method, although less
effective, should be provided for women desiring an alternative method.”
32
See FAQs Part XXVI, Q3 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf. For example, a plan could use cost sharing to encourage use of one of several FDA-approved
intrauterine devices (IUDs) with progestin by imposing cost sharing on the more costly IUD with progestin while waiving cost sharing for a less costly IUD with progestin.
33
See id. at Q1, fn. 13 (“An attending provider means an individual who is licensed under applicable State law, who is acting within the scope of the provider’s license, and who is directly
responsible for providing care to the patient relating to the recommended preventive services. Therefore, a plan, issuer, hospital, or managed care organization is not an attending provider.”)
26

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with respect to the individual involved,
and cover that item or service without cost
sharing.34 Additionally, FAQs Part XXVI
specified that to the extent a plan or issuer
uses reasonable medical management
techniques within a specified method of
contraception, the plan or issuer must
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on the individual or a provider (or other individual
acting as a patient’s authorized representative) to ensure coverage without cost
sharing of any service or FDA-approved
item within the specified method of contraception that has been recommended by
the individual’s attending provider based
on a determination of medical necessity.35
Frequently Asked Questions on
April 20, 2016 (FAQs Part 31), which
further clarified the requirements on plans
and issuers with respect to the development and implementation of an exceptions
process, including that plans and issuers
that meet all other requirements are permitted to develop and utilize a standard
exceptions process form (such as the
Medicare Part D Coverage Determination
Request Form) and instructions as part of
the exceptions process.36
Frequently Asked Questions on
July 19, 2021 (FAQs Part 47), which followed USPSTF’s release on June 11, 2019
of a recommendation with an “A” rating
that clinicians offer preexposure prophylaxis (PrEP) with “effective antiretroviral
therapy to persons who are at high risk
of human immunodeficiency virus (HIV)
acquisition.”37 FAQs Part 47 clarified that
plans and issuers are required to cover,
without cost sharing, all items and services that USPSTF recommends should
be received prior to being prescribed PrEP
and for ongoing follow-up and monitoring. These items and services include

specific baseline and monitoring services,
such as laboratory testing and adherence
counseling. The FAQs also clarified that
plans and issuers utilizing reasonable
medical management must have an easily
accessible, transparent, and sufficiently
expedient exceptions process that is not
unduly burdensome on the individual or a
provider (or other individual acting as an
authorized representative).
Frequently Asked Questions on January 10, 2022 (FAQs Part 51), which
acknowledged complaints received about
compliance with the contraceptive coverage requirement and clarified currently
applicable guidance. Specifically, FAQs
Part 51, Q9 was issued in response to
complaints and public reports of potential violations of the contraceptive coverage requirement, including that plans and
issuers and pharmacy benefit managers
(PBMs) were not adhering to requirements
for utilizing reasonable medical management techniques. The FAQs also highlighted several examples of such potential
violations, including denying coverage
for all or particular brand name contraceptives, even after the individual’s attending
provider determines and communicates to
the plan or issuer that a particular service
or FDA-approved, -cleared, or ­‑granted
contraceptive product is medically necessary with respect to that individual; requiring individuals to fail first using numerous
other services or FDA-approved, -cleared,
or -granted contraceptive products within
the same method of contraception before
the plan or issuer will approve coverage
for a service or FDA-approved, -cleared,
or -granted contraceptive product that is
medically appropriate for the individual,
as determined by the individual’s attending health care provider; requiring individuals to fail first using numerous other
services or FDA-approved, -cleared, or

-granted contraceptive products in other
contraceptive methods before the plan or
issuer will approve coverage for a service
or FDA-approved, -cleared, or -granted
contraceptive product that is medically
appropriate for the individual, as determined by the individual’s attending health
care provider; and failing to provide an
acceptable exceptions process (for example, by requiring individuals to appeal
an adverse benefit determination using
the plan’s or issuer’s internal claims and
appeals process, rather than providing an
exceptions process that is easily accessible, transparent, sufficiently expedient,
and not unduly burdensome).38
Frequently Asked Questions on
July 28, 2022 (FAQs Part 54), which
further clarified the contraceptive coverage requirement and currently applicable
guidance. These FAQs clarified that plans
and issuers must cover, without imposing
cost-sharing requirements, items and services that are integral to a recommended
contraceptive service.39 The FAQs also
stated that plans and issuers must cover
any FDA‑approved, -cleared, or -granted
contraceptive products and services that
an individual and their attending provider
have determined to be medically appropriate for the individual, regardless of
whether those products or services are specifically identified in the categories listed
in the HRSA-supported Guidelines.40 For
contraceptive services or FDA-approved,
-cleared, or ‑granted contraceptive products not included in a category described
in the HRSA-supported Guidelines, the
FAQs stated that plans and issuers may
use reasonable medical management techniques to determine which specific products to cover without cost sharing only if
multiple, substantially similar services or
products that are not included in a category described in the HRSA-supported

See id. at introduction and Q3.
Id. at Q2.
36
FAQs Part 31, Q2 (April 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/
CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
37
FAQs about Affordable Care Act Implementation Part 47 (July 19, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/acapart-47.pdf and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf. Note that USPSTF subsequently updated the recommendation referenced in FAQs
Part 47. See USPSTF, Prevention of Acquisition of HIV: Preexposure Prophylaxis, updated August 22, 2023, available at https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis.
38
FAQs Part 51, Q9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and https://www.cms.gov/CCIIO/
Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf.
39
FAQs Part 54, Q1 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
40
Id. at Q2.
34
35

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November 18, 2024

Guidelines are medically appropriate for
the individual. The FAQs further stated
that if the individual’s attending provider recommends a particular service
or FDA‑approved, -cleared, or -granted
product not included in a category
described in the HRSA‑supported Guidelines based on a determination of medical
necessity with respect to that individual,
the plan or issuer must cover that service
or product without cost sharing. The plan
or issuer must defer to the determination
of the attending provider and must make
available an easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome
so the individual or their provider (or
other individual acting as the individual’s
authorized representative) can obtain coverage for the medically necessary service
or product for the individual without cost
sharing as required under PHS Act section
2713 and its implementing regulations
and guidance.41 The FAQs also encouraged plans and issuers to cover over-thecounter (OTC) emergency contraceptive
products with no cost sharing when they
are purchased by consumers without a
prescription.42 FAQs Part 54, Q8 further
acknowledged that the Departments continued to receive complaints and reports
that participants, beneficiaries, and enrollees were being denied contraceptive coverage, in some cases due to the application
of medical management techniques that
were not reasonable based on all of the
relevant facts and circumstances. In addition to summarizing ongoing complaints
similar to those highlighted in FAQs Part
51, Q9, the Departments also noted that
they were aware of complaints that plans
and issuers or PBMs were imposing age
limits on contraceptive coverage rather
than providing these benefits to all individuals with reproductive capacity. FAQs

Part 54, Q13 also described actions within
the scope of the authority of the Departments of Labor and HHS to enforce the
requirements of PHS Act section 2713.43
Frequently Asked Questions on January 22, 2024 (FAQs Part 64), which
provided further clarifications regarding
contraceptive coverage requirements,
including providing guidance regarding
a therapeutic equivalence approach. The
FAQs explained that plans and issuers
could adopt a therapeutic equivalence
approach (in combination with an easily accessible, transparent, and sufficiently expedient exceptions process that
is not unduly burdensome) to ensure the
plan’s or issuer’s medical management
techniques for contraceptive drugs and
drug-led devices44 that are required to be
covered under PHS Act section 2713 are
reasonable.45 Specifically, with respect
to FDA-approved contraceptive drugs
and drug-led devices, if a plan or issuer
utilizes medical management techniques
within a specified category described in
the HRSA-supported Guidelines (or group
of substantially similar products that are
not included in a specified category), the
Departments will generally consider such
medical management techniques to be
reasonable if the plan or issuer covers all
FDA-approved contraceptive drugs and
drug-led devices in that category (or group
of substantially similar products) without
cost sharing, other than those for which
there is at least one therapeutic equivalent
drug or drug-led device that the plan or
issuer covers without cost sharing.
C. Executive Orders on the Affordable
Care Act and Reproductive Health
On January 28, 2021, President Biden
issued Executive Order 14009, “Strengthening Medicaid and the Affordable Care

Act” (E.O. 14009).46 Section 3 of E.O.
14009 directs the Secretaries of the
Departments (the Secretaries) to review
all existing regulations, guidance documents, and policies to determine whether
such actions are inconsistent with protecting and strengthening Medicaid and the
ACA and making high-quality health care
accessible and affordable for every American.
On April 5, 2022, President Biden
issued Executive Order 14070, “Continuing To Strengthen Americans’ Access
to Affordable, Quality Health Coverage”
(E.O. 14070).47 Section 2 of E.O. 14070
reaffirms the goals and policy of E.O.
14009 and further directs agencies with
responsibilities related to Americans’
access to health coverage to consider and
pursue agency actions that improve the
comprehensiveness of coverage and protect consumers from low-quality coverage.
Following the U.S. Supreme Court
decision in Dobbs v. Jackson Women’s
Health Organization (Dobbs),48 President Biden issued Executive Order
14076, “Protecting Access to Reproductive Healthcare Services” (E.O. 14076)
on July 8, 2022. Section 3 of E.O. 14076
requires the Secretary of HHS to identify
potential actions to “protect and expand
access to the full range of reproductive
healthcare services, including actions to
enhance family planning services such
as access to emergency contraception”
and identify “ways to increase outreach
and education about access to reproductive healthcare services, including by
launching a public awareness initiative
to provide timely and accurate information about such access, which shall…
include promoting awareness of and
access to the full range of contraceptive
services.”49

Id. at Q3.
Id. at Q5.
43
See FAQs Part 54, Q5, Q8, and Q13 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://
www.cms.gov/files/document/faqs-part-54.pdf.
44
In FAQs Part 64, the term “drug-led device” referred to a combination product, as defined under 21 CFR 3.2(e), that is comprised of a drug and a device, and for which the drug component
provides the primary mode of action. The primary mode of action of a combination product is the single mode of action (that is, the action provided by the drug, device, or biological product)
that provides the most important therapeutic action of the combination product. See 21 U.S.C. 353(g)(1)(C) and 21 CFR 3.2(m). As further discussed in section II.A.2 of the preamble to
these proposed rules, the Departments propose a substantially similar definition of the term “drug-led combination product” in these proposed rules to refer to the same products for which
the term “drug-led device” was used in FAQs Part 64.
45
FAQs Part 64 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/document/faqs-part-64.pdf.
46
86 FR 7793.
47
87 FR 20689.
48
597 U.S. 215 (2022).
49
87 FR 42053.
41
42

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Bulletin No. 2024–47

On June 23, 2023, President Biden
issued Executive Order 14101, “Strengthening Access to Affordable, High-Quality
Contraception and Family Planning Services” (E.O. 14101).50 Section 2 of E.O.
14101 directs the Secretaries to consider
issuing guidance “to further improve
Americans’ ability to access contraception,
without out-of-pocket expenses, under
the Affordable Care Act” and to consider
additional actions “to promote increased
access to affordable over‑the‑counter contraception, including emergency contraception.”51
D. FDA Approval of Daily Over-theCounter Oral Contraceptive
On July 13, 2023, the FDA announced
that it had approved a progestin-only birth
control pill as the first daily oral contraceptive for use in the United States available
without a prescription.52, 53 Interested parties, including health care provider associations, have supported the availability
of a daily OTC oral contraceptive for its
potential to improve access to affordable
contraception, thereby improving management of family planning and reducing
unintended pregnancies.54 Studies have
shown that challenges with access and
costs are among the most common reasons cited by women for not using contraception or having gaps in contraceptive

use.55 One large, nationally representative
study found 29 percent of women reported
encountering barriers to obtaining or filling an initial prescription or refills of oral
contraceptive pills, specifically citing
insurance coverage, getting an appointment, not having a regular provider, and
difficulty accessing a pharmacy.56 Accordingly, the availability of a daily OTC
oral contraceptive could improve access
to contraception if the product is affordable, including if it is covered by insurance without cost sharing, and as a result,
could reduce the number of unintended
pregnancies.57 Beginning in March 2024,
an OTC oral contraceptive has become
widely available for sale online and in
stores under the brand name Opill®, with
a manufacturer’s suggested retail price
ranging from $19.99 for a 1-month supply
to $89.99 for a 6-month supply.58
E. OTC Preventive Products Request for
Information
As discussed in sections I.A and I.C of
this preamble, the Biden-Harris Administration has prioritized access to comprehensive, high-quality contraception and
family planning services as critical components of women’s reproductive health
and overall public health. In response
to E.O. 14009, E.O. 14070, E.O.14076,
and E.O. 14101, and following the FDA

approval of an OTC oral contraceptive,
as discussed in section I.D of this preamble, the Departments issued a “Request
for Information; Coverage of Over-theCounter Preventive Services” on October 4, 2023 (OTC Preventive Products
RFI).59 The Departments issued the OTC
Preventive Products RFI to gather public
feedback regarding the potential benefits
and costs of requiring plans and issuers
to cover OTC preventive products60 without cost sharing and without a prescription; learn of any potential challenges
associated with providing such coverage;
understand whether and how providing
such coverage would benefit consumers; and assess any potential burden that
plans and issuers would face if required
to provide such coverage.
The Departments received 376 unique
comments in response to the OTC Preventive Products RFI, including comments from individuals; plans and issuers; PBMs; State government agencies;
and advocacy organizations representing
consumers, health care providers, group
health plans, hospitals, and durable medical equipment suppliers. The Departments
reviewed comments received in response
to the OTC Preventive Products RFI as
part of the development of these proposed
rules. However, these proposed rules do
not address all the issues on which information was requested.

88 FR 41815.
Id.
52
FDA (July 13, 2023). “FDA Approves First Nonprescription Daily Oral Contraceptive,” available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive.
53
Progestin-only oral contraceptives are a product that is already available in a prescription form and are a category of contraceptives listed in the FDA Birth Control Guide, as referenced
in the HRSA-supported Guidelines.
54
See American Medical Association (2023). “AMA Applauds FDA Approval of OTC Birth Control,” available at https://www.ama-assn.org/press-center/press-releases/ama-applauds-fdaapproval-otc-birth-control; The American College of Obstetricians and Gynecologists (2023). “ACOG Praises FDA Approval of Over-the-Counter Access to Birth Control Pill,” available
at https://www.acog.org/news/news-releases/2023/07/acog-praises-fda-approval-of-over-the-counter-access-to-birth-control-pill.
55
See Key, K., Wollum, A., Asetoyer, C., Cervantes, M., Lindsey, A., Rivera, R., Robinson Flint, J., Zuniga, C., Sanchez, J., and Baum, S. (2023). “Challenges accessing contraceptive care and
interest in over-the-counter oral contraceptive pill use among Black, Indigenous, and people of color: An online cross-sectional survey,” Contraception, available at https://doi.org/10.1016/j.
contraception.2023.109950; Thompson, E. L., Galvin, A. M., Garg, A., Diener, A., Deckard, A., Griner, S. B., and Kline, N. S. (2023). “A socioecological perspective to contraceptive access
for women experiencing homelessness in the United States,” Contraception, available at https://doi.org/10.1016/j.contraception.2023.109991; Bessett, D., Prager, J., Havard, J., Murphy,
D. J., Agénor, M., and Foster, A. M. (2015). “Barriers to contraceptive access after health care reform: Experiences of young adults in Massachusetts,” Women’s Health Issues, available at
https://doi.org/10.1016/j.whi.2014.11.002; and Johnson, E. R. (2022). “Health care access and contraceptive use among adult women in the United States in 2017,” Contraception, available
at https://doi.org/10.1016/j.contraception.2022.02.008.
56
Grindlay, K., Grossman, D. (2016). “Prescription Birth Control Access Among U.S. Women At Risk of Unintended Pregnancy,” Journal of Women’s Health, available at https://www.
liebertpub.com/doi/10.1089/jwh.2015.5312.
57
A recent study found that over 12 million adult women and nearly two million young women aged 15-17 would likely be interested in using an OTC oral contraceptive if it were free to them,
but the numbers declined to 7.1 million adult women and 760,000 young women if the out-of-pocket cost of the contraceptive was $15. The same study indicated that the levels of interest
would translate to an estimated eight percent decrease in unintended pregnancies (approximately 320,000 fewer) in one year among adult women when cost sharing was $0, and an estimated
five percent decrease (approximately 199,000 fewer unintended pregnancies) if there were a monthly out-of-pocket cost of $15. See Wollum, A., Trussell, J., Grossman, D., and Grindlay, K.
(2020). “Modeling the Impacts of Price of an Over-the-Counter Progestin-Only Pill on Use and Unintended Pregnancy among U.S. Women,” Women’s Health Issues, available at https://
www.sciencedirect.com/science/article/pii/S1049386720300037/pdfft?md5=903aee27ef3468f62abaf9091e0a957c&pid=1-s2.0-S1049386720300037-main.pdf.
58
Lupkin, S., NPR (March 18, 2024). “First over-the-counter birth control pill now for sale online,” available at https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-overcounter-birth-control-pill-contraceptive-shop.
59
88 FR 68519 (Oct. 4, 2023).
60
For consistency with the OTC Preventive Products RFI, this preamble uses the term “OTC preventive products” to refer to recommended preventive services that may be made available
to an individual without a prescription.
50
51

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November 18, 2024

Many commenters stated that requiring plans and issuers to cover all recommended preventive services would promote health equity and improve health
outcomes by reducing costs and administrative barriers to accessing preventive
health care. Many commenters highlighted that prescription and cost-sharing
requirements represent a particular barrier
for people with lower incomes and Black,
Indigenous, and People of Color (BIPOC)
communities, and that requiring coverage of OTC preventive products without
cost sharing and without a prescription
would significantly lower these barriers,
thereby increasing access to OTC preventive products in a manner that would be
especially beneficial to lower-income and
underserved populations.
Many commenters highlighted the particular benefit to women of requiring plans
and issuers to cover OTC contraceptive
items without requiring a prescription and
without cost‑sharing requirements. Several commenters pointed out that neither
section 2713 of the PHS Act nor its implementing regulations impose a specific prescription requirement on recommended
contraceptive items. These commenters
also highlighted HRSA’s removal of “as
prescribed” language which appeared in
the 2011 HRSA-supported Guidelines but
does not appear in the 2016 or any subsequent version of the HRSA-supported
Guidelines.61 In the view of these commenters, the existing prescription requirement is therefore based only on agency
guidance that is within the authority of the
Departments to revise.62
Another commenter noted that, in the
United States, approximately one-third
of childbearing-aged women and those
capable of becoming pregnant experience difficulties obtaining hormonal
contraception, and that coverage of OTC
oral contraception without a prescription
and without cost sharing would improve
access to reproductive care for this group.
Several commenters highlighted the burdens of a prescription requirement on
people seeking contraception, including

requesting time off from work, unnecessary visits to the doctor, appointment
wait times, and finding childcare, while
a few other commenters specifically
emphasized the importance of waiving
cost sharing to make OTC contraceptive
services truly accessible. One commenter
noted that access to affordable contraception was particularly important within the
context of widespread Medicaid coverage losses following the termination on
March 31, 2023 of the continuous enrollment condition previously associated with
the COVID-19 public health emergency
(PHE).63 Many other commenters supported requiring coverage of OTC contraceptive services in order to ensure that
women can access effective, affordable
means of preventing unintended pregnancies in the wake of the Dobbs decision.
In addition to comments highlighting
the benefits to women of removing prescription and cost-sharing requirements
for coverage of OTC contraceptive items,
several commenters noted that consumers
would benefit from increased access to
other specific OTC preventive products if
plans and issuers were required to cover
those other products without a prescription
and without cost sharing. For example,
several commenters stated that coverage
based on prescription requirements limits
access to OTC tobacco cessation products. One of these commenters emphasized that prescription requirements are a
particular barrier with respect to tobacco
cessation because of the nature of nicotine
addiction, which typically requires multiple quit attempts. In that commenter’s
view, removing cost-sharing and prescription requirements would allow people to
access evidence-based treatment when
they are motivated to make a quit attempt,
without having to wait for a medical
appointment. Conversely, another commenter who acknowledged that removing
cost sharing on OTC tobacco cessation
products could have a positive effect on
access to these products, particularly for
people with low incomes, also emphasized the role of clinicians in screening

for and diagnosing tobacco use disorder
and recommending or prescribing effective treatments. This commenter encouraged the Departments to make an effort to
preserve the clinician-patient relationship
with respect to tobacco cessation products
to ensure that patients are properly connected to care, including biomedical and
psychiatric services that may be comorbid
with tobacco use disorder.
Another commenter noted that a
woman who is not pregnant or planning
to become pregnant may not be under the
care of a prescribing health care provider
but could still benefit from the USPSTF
recommendation that women who could
become pregnant should consume a daily
folic acid supplement. A few commenters described the disparate occurrence of
spina bifida in newborns born to Spanish-speaking people, which commenters
believe could be reduced if plans and
issuers were required to cover OTC folic
acid without cost sharing or prescription
requirements.
However, several commenters identified operational barriers to widespread
implementation of a requirement to cover
all recommended OTC preventive products without cost sharing or a prescription. A few commenters noted potential
strains on pharmacies, retailers, and the
existing health care delivery system;
fraud and abuse threats; and potential cost
increases for plan sponsors and plan participants. For example, one commenter
cited the administrative and cost burdens
that pharmacies and retailers could incur
if they were required to cover the upfront
costs of OTC preventive products and
pursue post-claim reimbursements. In
that commenter’s view, requiring plans
and issuers to provide coverage of OTC
preventive products without cost sharing
could also facilitate fraudulent behavior,
including sale to unauthorized persons or
re-sale outside of the health care market,
that could in turn create a shadow market based on overuse and misuse. This
commenter highlighted the existing significant clinical and administrative bur-

See section I.A of this preamble for a discussion of the “as prescribed” language.
See, e.g., FAQs Part XII, Q4 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.gov/
CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html.
63
See Center for Medicare and Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight, Temporary Special Enrollment Period (SEP) for Consumers Losing Medicaid or the Children’s Health Insurance Program (CHIP) Coverage Due to Unwinding of the Medicaid Continuous Enrollment Condition— Frequently Asked Questions (FAQ)
(Jan. 27, 2023), available at https://www.cms.gov/technical-assistance-resources/temp-sep-unwinding-faq.pdf.
61
62

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dens that already strain pharmacist and
retailer resources (ranging from filling
and dispensing medications to providing immunizations, patient counseling,
and information about insurance eligibility and coverage), and expressed concern that the responsibility for educating
consumers about potential access to and
appropriateness of OTC contraceptives
would fall to pharmacists and retailers
at the point of sale. Another commenter
noted that requiring coverage of OTC
preventive products such as contraceptives, OTC naloxone, and smoking cessation products without cost sharing or
a prescription would increase access
to such products but advised that such
requirements would increase administrative burden on pharmacists by increasing
workload and costs and decreasing reimbursement for vital patient counseling
and additional services. One commenter
indicated that using a credit card (rather
than a debit card or paper reimbursement system) would facilitate coverage
of OTC preventive products, but also
noted that the use of a credit card without a fixed spending limit would be more
likely to lead to fraud and would necessitate implementing systems for freezing
or repaying cards in the case of misuse.
Another commenter indicated general
support for access to recommended preventive products without cost sharing
but stated that prescription requirements
were necessary for many products to
ensure that individual patients receive
appropriate care. In that commenter’s
view, the cost associated with applying
a market-wide OTC preventive products
coverage requirement would disrupt and
likely outweigh any benefits of changing long-established coverage patterns.
This commenter recommended that the
Departments consider establishing a
standing order for Opill® only, in order to
conduct a targeted roll-out of a potential
broader OTC preventive products coverage requirement without overburdening
the health care system by attempting to
implement the changes for all OTC preventive products at once. The same commenter, however, warned against requiring coverage of OTC products that do

64

not have meaningful market competition,
such as Opill®, to avoid inadvertently
driving up retail prices. Another commenter shared similar concerns regarding
the potential for generating demand for
preventive items and services that would
ultimately be unused. A few commenters
noted the particular cost and negative
environmental impact that could be realized if OTC breastfeeding supplies with
no cost sharing led to overconsumption
of such products. One commenter urged
the Departments to avoid rushing to
require coverage of all OTC preventive
products in order to provide sufficient
advanced notice to allow plan sponsors
to address operational and implementation issues.
While several commenters expressed
concern that current prescription requirements restrict access to breastfeeding
services and supplies, many commenters stated that removing the prescription
requirement for breastfeeding services
and supplies could have a detrimental
effect on breastfeeding parents and newborns. These commenters stated that consumers currently benefit from the expertise provided by lactation consultants and
other specially trained staff at durable
medical equipment suppliers contracted
with plans and issuers to provide breast
pumps. These commenters also expressed
the view that removing the prescription
requirement would make it more likely
that a consumer would be forced to select
breastfeeding supplies in a retail environment with fewer breast pump options and
less privacy and support.
In the OTC Preventive Products RFI,
the Departments also requested feedback from interested parties based on
their experiences with the requirement to
cover OTC COVID-19 diagnostic tests
during the COVID-19 PHE.64 During
the COVID-19 PHE, plans and issuers
were required to cover OTC COVID-19
diagnostic tests without a prescription
from a health care provider and without
imposing any cost-sharing requirements,
prior authorization, or other medical
management requirements. However, the
Departments permitted plans and issuers
that met certain safe harbor requirements

to implement cost and quantity limits to
contain costs and combat potential fraud
and abuse with respect to coverage of
OTC COVID-19 diagnostic tests. A few
commenters encouraged the Departments to use experiences with coverage
of OTC COVID-19 diagnostic tests as
a roadmap for future coverage of other
recommended preventive services. However, another commenter cautioned the
Departments against regulating the routine use of recommended preventive
services by applying requirements used
during an unprecedented public health
emergency, in order to avoid issues the
commenter reported taking place during
the COVID-19 PHE, such as overconsumption of COVID-19 diagnostic tests,
price gouging of products by manufacturers, and limited opportunities for health
plans to contain waste and abuse. Another
commenter acknowledged that coverage
requirements for OTC COVID-19 diagnostic tests improved patient access to
the tests by removing the barriers related
to out-of-pocket costs and obtaining
prescriptions but described a number of
other issues associated with the testing
coverage requirement. According to this
commenter, implementation challenges
included below-cost reimbursement,
inconsistent requirements across plans
and providers, and lack of reimbursement for pharmacies. In particular, this
commenter noted that the average cost to
a retail pharmacy provider to dispense a
drug – separate from the cost of acquiring
the medication itself – is $12.40, and that
any future OTC coverage requirements
should reimburse pharmacies for both the
acquisition and dispensing of products.
Another commenter, citing the speed
with which the OTC COVID-19 diagnostic testing program was implemented,
urged the Departments to proceed deliberately with the implementation of any
broader OTC preventive products coverage requirements. According to this commenter, the rapid implementation of the
testing coverage requirements during the
PHE contributed to consumer confusion
and led to many thousands of consumers
failing to seek reimbursement for tests
that were eligible to be covered.

See 88 FR 68519, 68523-24 (Oct. 4, 2023).

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F. Transparency in Coverage Under the
ACA and Implementing Regulations
Section 2715A of the PHS Act65 provides that non-grandfathered group health
plans and health insurance issuers offering non-grandfathered group or individual
health insurance coverage must comply
with section 1311(e)(3) of the ACA,66
which addresses transparency in health
coverage and imposes certain reporting
and disclosure requirements for health
plans that are seeking certification as qualified health plans (QHPs) to be offered on
an American Health Benefits Exchange
(generally referred to as an Exchange
or Marketplace) (as defined by section
1311(b)(1) of the ACA). A plan or issuer
of coverage that is not offered through
an Exchange and that is subject to section 2715A of the PHS Act is required
to submit the required information to the
Secretary of HHS and the relevant State’s
insurance commissioner, and to make that
information available to the public.
Section 1311(e)(3)(C) of the ACA
requires plans, as a requirement of certification as a QHP, to permit individuals
to learn about the amount of cost sharing
(including deductibles, copayments, and
coinsurance) that the individual would be
responsible for paying with respect to the
furnishing of a specific item or service by
an in-network provider in a timely manner
upon the request of the individual. Section
1311(e)(3)(C) of the ACA specifies that,
at a minimum, such information must be
made available to the individual through
an internet website and through other
means for individuals without access to
the internet.
On March 27, 2012, HHS issued the
“Patient Protection and Affordable Care
Act; Establishment of Exchanges and
Qualified Health Plans; Exchange Standards for Employers” final rule (Exchange
Establishment final rule) that implemented
sections 1311(e)(3)(A) through (C) of the
ACA at 45 CFR 155.1040(a) through (c)
and 156.220.67 The Exchange Establish-

ment final rule created standards for QHP
issuers to submit specific information
related to transparency in coverage.
On November 12, 2020, the Departments issued “Transparency in Coverage”
final rules (Transparency in Coverage final
rules) implementing transparency reporting requirements for non-grandfathered
group health plans and health insurance
issuers offering non-grandfathered group
and individual health insurance coverage.68 Implementing section 1311(e)(3)(C)
of the ACA and section 2715A of the PHS
Act, these rules require plans and issuers
to disclose cost-sharing information for
all covered items and services available
to a participant, beneficiary, or enrollee
through an internet-based self-service tool
via the plan’s or issuer’s member portal or,
if requested by the individual, on paper.70
The requirement to disclose cost-sharing
information for all covered items and
services includes covered contraceptive
items or services.
The Transparency in Coverage final
rules enumerate seven cost-related elements that plans and issuers must disclose
in response to a search query by a participant, beneficiary, or enrollee for a covered
item or service furnished by a provider
or providers. The self-service tool must
provide an estimate of the participant’s,
beneficiary’s, or enrollee’s cost-sharing
liability for the covered item or service,
which is calculated based on the following elements: (a) accumulated amounts
with respect to any deductibles or maximum out-of-pocket limits; and either (b)
the in-network rate, comprising a negotiated rate or underlying fee schedule rate
as applicable to the payment model; or
(c) an out-of-network allowed amount or
any other rate that provides a more accurate estimate of an amount a plan or issuer
will pay for the requested covered item or
service from an out‑of‑network provider.
Self-service tool results must also reflect a
list of the items and services included in a
bundled payment arrangement, if applicable; notification that coverage of a specific

item or service is subject to a prerequisite,
as applicable; and certain disclaimers in
plain language describing the limitations
of the estimate or other qualifications
regarding the cost-sharing information
disclosed.
With respect to requests for cost-sharing information for items or services that
are recommended preventive services
under section 2713 of the PHS Act, if the
plan or issuer cannot determine whether
the request is for preventive or non-preventive purposes, the plan or issuer must
display the cost-sharing liability that
applies for non-preventive purposes along
with a statement that the item or service
may not be subject to cost sharing if it is
billed as a preventive service. Displaying a non-zero cost-sharing liability in
these circumstances helps protect against
unexpected medical bills by ensuring
participants, beneficiaries, and enrollees
are aware of their potential cost-sharing liability while the statement ensures
that consumers are made aware they can
access recommended preventive services without cost sharing. Alternatively,
the Transparency in Coverage final rules
permit a plan or issuer to allow a participant, beneficiary, or enrollee to request
cost-sharing information for the specific
preventive or non-preventive item or service by including terms such as “preventive,” “non-preventive,” or “diagnostic”
as a means to request the most accurate
cost‑sharing information.
Plans and issuers must ensure users
can search for cost-sharing information
for a covered item or service by a specific
in-network provider or by all in-network
providers using either a descriptive term
or a billing code. For covered items or services furnished by out-of-network providers, users can search for an out-of-network
allowed amount, percentage of billed
charges, or other rate that provides a reasonably accurate estimate of the amount
a plan or issuer will pay for a covered
item or service provided by out-of-network providers. Users must also be able

42 U.S.C. 300gg-15a.
42 U.S.C. 18031(e)(3).
67
77 FR 18310 (Mar. 27, 2012).
68
85 FR 72158 (Nov. 12, 2020).
69
The Consolidated Appropriations Act, 2021 imposed a largely duplicative requirement and added a requirement that the information also be provided by telephone, upon request. See also
FAQs Part 49, Q3 (Aug. 20, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf and https://www.cms.gov/CCIIO/
Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf.
65
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to input other factors utilized by the plan
or issuer that are relevant for determining
the applicable cost-sharing information or
out-of-network allowed amount, such as
location of service, facility name, or dosage and permit refining and reordering of
search results.
II. Overview of the Proposed Rules
A. Coverage of Recommended Preventive
Services
1. Reasonable Medical Management
of Recommended Preventive Services:
Exceptions Process
The Departments’ regulations implementing section 2713 of the PHS Act aim
to strike a balance between ensuring participants, beneficiaries, and enrollees do
not face undue barriers to accessing their
coverage of recommended preventive
services as required by law and allowing
plans and issuers to contain costs, promote efficient delivery of care, and minimize risks of fraud, waste, and abuse. To
this end, current regulations permit plans
and issuers to use reasonable medical
management techniques to determine the
frequency, method, treatment, or setting
for coverage of a recommended preventive service, to the extent not specified
in the applicable recommendation or
guideline.70 The Departments have previously explained, in the context of certain
recommended preventive services, that
they generally do not consider medical
management techniques with respect to
recommended preventive services to be
reasonable absent the availability of an
exceptions process.71

As noted in previously issued guidance
and described in section I.B of this preamble, the Departments continue to receive
complaints of potential violations related
to the application of medical management techniques that are not reasonable,
including failing to provide an exceptions
process that meets the standards set forth
in guidance.72 Further, the U.S. House of
Representatives’ Committee on Oversight
and Reform (Oversight Committee) published a report in October 2022 documenting the findings of its investigation into
contraceptive coverage for individuals
enrolled in private health coverage. The
Oversight Committee found that insurers
and PBMs surveyed denied an average of
at least 40 percent of exception requests
related to contraceptive coverage, with
one PBM denying more than 80 percent of requests in a year.73 To reinforce
the requirement that medical management techniques must be reasonable, the
Departments propose to codify that plans
and issuers that utilize reasonable medical
management techniques with respect to
recommended preventive services would
be required to accommodate any individual for whom a particular item or service
would not be medically appropriate, as
determined by the individual’s attending
provider, by having a mechanism for covering or waiving the otherwise applicable
cost sharing for the medically necessary
item or service. Specifically, under these
proposed rules, consistent with previous
guidance,74 if utilizing reasonable medical
management techniques, a plan or issuer
would be required to have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly
burdensome on the individual or a provider

(or other person acting as the individual’s
authorized representative) under which
the plan or issuer covers without cost sharing the recommended preventive service
according to the frequency, method, treatment, or setting determined to be medically necessary with respect to the individual, as determined by the individual’s
attending provider. The exceptions process would ensure that an individual can
access medically necessary recommended
preventive services without cost sharing
and would prevent medical management
from functioning as an unreasonable barrier to coverage under section 2713 of the
PHS Act. The Departments are authorized
to issue this proposal, implementing section 2713 of the PHS Act, by section 9833
of the Code, section 734 of ERISA, and
section 2792 of the PHS Act. Nothing in
this proposal, if finalized, would require
an entity to provide coverage or payments
for a contraceptive for which they have an
exemption under 26 CFR 54.9815-2713A,
29 CFR 2590.715-2713A, and 45 CFR
147.131 through 45 CFR 147.133.
While prior guidance has generally
focused on the use of an exceptions process in the context of coverage of contraceptive services, it has not been limited
to that context. For example, the Departments’ guidance with respect to coverage
of PrEP to prevent HIV acquisition has
similarly stated that where a plan or issuer
uses reasonable medical management
techniques – such as covering a generic
version of PrEP without cost sharing and
imposing cost sharing on an equivalent
branded version – a plan or issuer must
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on the indi-

26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
See FAQs Part XXVI, Q2 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf; FAQs Part 64, Q4 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/document/faqs-part-64.pdf.
72
See, e.g., FAQs Part 51, Q9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf; FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.
73
U.S. House of Representatives Committee on Oversight and Reform, (Oct. 25, 2022). “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private
Insurance,” available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.
74
See FAQs Part XXVI, Q3 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf; FAQs Part 31, Q2 (Apr. 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/
about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf. See also FAQs Part XII,
Q14 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/aca_implementation_faqs12.html; FAQs Part 51, Q8-9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/
faqs/aca-part-51.pdf and https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf; FAQs Part 54, Q9, (July 28, 2022), available at https://www.dol.gov/
sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf; FAQs Part 64 (Jan. 22, 2024) available at
https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.cms.gov/files/document/faqs-part-64.pdf.
70
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vidual or a provider (or other individual
acting as an authorized representative)
that waives otherwise applicable cost
sharing for the particular PrEP medication
(generic or branded) for any individual
for whom the plan’s or issuer’s preferred
medication “would be medically inappropriate, as determined by the individual’s
health care provider.”75
Therefore, the Departments propose to
reorganize and amend 26 CFR 54.98152713(a)(4), 29 CFR 2590.715-2713(a)(4),
and 45 CFR 147.130(a)(4) by adding a
new paragraph (a)(4)(i) to include existing
language with minor technical edits for
clarity and to add a new paragraph (a)(4)
(ii) to specify that, in order for a plan’s or
issuer’s medical management techniques
with respect to a recommended preventive service to be considered reasonable,
the plan or issuer would be required to
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on a participant, beneficiary, or enrollee or attending
provider76 (or other person acting as the
individual’s authorized representative).
Under this proposal, an exceptions process would be required to ensure that an
individual can receive coverage, without
cost-sharing requirements, for a recommended preventive service according
to the frequency, method, treatment, or
setting that is medically necessary with
respect to the individual, as determined
by the individual’s attending provider. For
example, a plan or issuer may typically
provide coverage without cost sharing for
only a generic version of a recommended
preventive service; an individual who
experiences side effects from the covered
generic version and whose attending pro-

vider has determined that the brand-name
version of the recommended preventive
services is medically necessary for the
individual would be able to use the exceptions process to obtain the brand-name
version without cost sharing, even though
the plan or issuer typically does not provide coverage for the brand-name version
(or provides coverage with cost sharing)
This proposed change is necessary to
effectuate the statutory requirement under
PHS Act section 2713 that plans and issuers provide coverage of recommended
preventive services without cost sharing,
because without such an exceptions process, a plan’s or issuer’s medical management techniques could have the effect of
preventing an individual from receiving
coverage without cost sharing of medically necessary recommended preventive
services.
Under this proposal and consistent with
previous guidance, a plan or issuer would
be required to defer to the determination of
an individual’s attending provider regarding medical necessity with respect to the
individual. Previously issued guidance
has used the terms “medically necessary”
and “medically appropriate” interchangeably when referring to the appropriate
standard for this clinical determination.
However, in these proposed rules, the
Departments propose to use the phrase
“medically necessary” to establish uniform terminology and avoid confusion
from the use of different terms.77 The
Departments have determined that a standard based on “medical necessity” would
more accurately comport with the goal of
allowing plans and issuers to use reasonable medical management techniques to
control costs, while ensuring every par-

ticipant, beneficiary, and enrollee receives
coverage without cost sharing for a form
of a recommended preventive service that
is suitable for the individual.
These proposed rules use the term
“medically appropriate” to refer to a
range of potential options that are generally acceptable to address a condition or
achieve a preventive health goal. However, a preventive service that is medically appropriate for most individuals (to
whom the recommendation or guidelines
applies) may not be medically appropriate to address a condition or achieve
a preventive health goal in the context
of other health factors specific to a certain individual. In these cases, another
form of the preventive service would be
medically necessary for that individual.
In making a determination of whether a
service is medically necessary, a provider
might consider factors such as severity of
side effects, differences in permanence
and reversibility of a recommended preventive service, and ability to adhere to
the appropriate use of the recommended
preventive service, as determined by the
attending provider. Under these proposed
rules, if the recommended preventive service covered by the plan or issuer is not
medically appropriate for the individual,
as determined by the individual’s attending provider, the plan or issuer would be
required, through the exceptions process,
to cover without cost sharing an alternative recommended preventive service that
the individual’s attending provider determines is medically necessary for that individual.78
For example, if a plan typically covers
a generic tobacco cessation product (Gum
A) without cost sharing, but an individ-

See FAQs Part 47, introduction to Q3 (July 19, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf and https://
www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf (“[T]he Departments have clarified in previous guidance that plans and issuers must accommodate any
individual for whom a particular medication (generic or brand name) would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for
waiving the otherwise applicable cost sharing for the brand or non-preferred brand version. If utilizing reasonable medical management techniques, plans and issuers must have an easily
accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome.”)
76
For purposes of these proposed rules, consistent with previous guidance described in section I.B of this preamble, an attending provider would mean an individual who is licensed under
applicable State law, who is acting within the scope of the provider’s license, and who is directly responsible for providing care to the patient relating to the recommended preventive services.
Therefore, a plan, issuer, hospital, or managed care organization would not be an attending provider. The reference to an “attending provider” (rather than simply a “provider,” as referenced
in previously issued guidance) is based on the Departments’ understanding that an attending provider is likely to act as an individual’s authorized representative when pursuing an exceptions
process, and for consistency with the requirement that an attending provider determine medical necessity. See also, fn. 33.
77
The Departments proposal to use the term and standard of “medically necessary” with respect to the exceptions process in these proposed rules should not be interpreted as changing the
standard or meaning of the Departments’ previously published guidance with respect to the coverage of preventive services.
78
Similarly, if the plan or issuer uses reasonable medical management techniques to limit the frequency or setting under which a recommended preventive service is covered without cost sharing and the individual’s attending provider makes a determination that a different frequency or setting is medically necessary for a participant, beneficiary, or enrollee, under these proposed
rules, the plan or issuer would be required to provide coverage without cost sharing for the recommended preventive service according to the frequency or setting the individual’s attending
provider determines to be medically necessary with respect to the individual.
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ual is allergic to an inactive ingredient in
Gum A and the individual’s attending provider determines that Gum B is medically
necessary for the individual to achieve
the preventive health benefits of the recommended preventive service without
adverse side effects, then the plan or issuer
would be required to provide coverage of
Gum B without cost sharing through the
exceptions process. However, if Gum A is
medically appropriate for the individual,
the plan would not be required to provide
coverage of Gum B without cost sharing
through the exceptions process solely on
the basis that Gum B is also medically
appropriate for the individual.
The Departments request comment on
the terminology used in the context of the
exceptions process. The Departments also
request comment generally on any operational or technical barriers to implementing the proposed requirement that plans
and issuers defer to the attending provider’s determination of medical necessity
using an exceptions process for recommended preventive services separate from
the required internal claims and appeals
process,79 and what additional guidance or
requirements would support implementation of this requirement (for example, with
respect to documentation of the determination or communication with the individual or their attending provider or other
representative regarding a request for a
coverage exception).
Consistent with prior guidance, the
Departments would determine whether a
plan’s or issuer’s exceptions process is easily
accessible, transparent, sufficiently expedient, and not unduly burdensome based on all
relevant facts and circumstances, including
whether and how a plan or issuer provides
notice of the availability of an exceptions
process and what steps an individual or their
provider or other authorized representative
is required to initiate and complete in order
to seek an exception.80

For this purpose, the Departments
would consider an exceptions process to
be easily accessible if plan documentation
includes relevant information regarding
the exceptions process under the plan or
coverage, including how to access the
exceptions process without initiating an
appeal pursuant to the plan’s or issuer’s
internal claims and appeals procedures,
the types of reasonable information the
plan or issuer requires as part of a request
for an exception, and contact information
for a representative of the plan or issuer
who can answer questions related to the
exceptions process. The Departments
would also encourage plans and issuers to
make this information available in a format and manner that is readily accessible,
such as electronically (on a website, for
example) and on paper. The Departments
request comment on how plans and issuers
could ensure that this information is readily available and accessible, such as any
specific formats, mechanisms, or other
best practices that could promote access to
information about the exceptions process.
The Departments would consider an
exceptions process to be transparent if, at
a minimum, the information relevant to
the exceptions process (including, if used,
a standard exceptions process form with
instructions) is included and prominently
displayed in plan documents (including in,
or along with, the summary plan description for plans subject to ERISA), and in
any other plan materials, including on the
plan’s or issuer’s website, that describe
the terms of the plan’s or issuer’s coverage of preventive services. The Departments request comment on the extent to
which plans and issuers currently make
such information available and accessible
and to whom (for example, to prospective
and current participants, beneficiaries, and
enrollees and their providers), whether
any additional individuals or groups
should have access to this information

if this proposal is finalized, and whether
the Departments should finalize more
specific standards regarding transparency
or accessibility of information about the
exceptions process in regulation.
The Departments would consider an
exceptions process to be sufficiently expedient if it makes a determination of a claim
according to a timeframe and in a manner
that takes into account the nature of the
claim (for example, pre‑service or post-service) and the medical exigencies involved
for a claim involving urgent care. The
Departments request comment on appropriate additional standards for an exceptions process to be considered sufficiently
expedient under these proposed rules. Specifically, the Departments request comment
on whether the regulations should contain
specific timeframes, and if so, what timeframes would be appropriate, as well as
whether the regulations should specify the
manner in which plans and issuers should
issue a determination (for example, on
paper, electronically, or both).
For example, as the Departments specifically noted in prior guidance, it would
be unduly burdensome on participants,
beneficiaries, and enrollees for a plan
or issuer to deny coverage without cost
sharing and require an individual or their
authorized representative to file an appeal
under the plan’s or issuer’s process for
appealing adverse benefit determinations
in order to obtain an exception to the
standard contraceptive coverage policy.81
Under 26 CFR 54.9815-2719, 29 CFR
2560.503-1, 29 CFR 2590.715-2719, and
45 CFR 147.136, plans and issuers must
render a determination on an internal
appeal in no more than 15 calendar days
(in the case of a pre-service claim) or no
more than 30 calendar days (in the case
of a post-service claim). Because most
claims for recommended preventive services likely would not meet the definition of a “claim involving urgent care,”82

See section 2719 of the PHS Act (42 U.S.C. 300gg-19); 26 CFR 54.9815-2719; 29 CFR 2590.715-2719; and 45 CFR 147.136.
FAQs Part 54, Q9 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
81
FAQs Part 54, Q10 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf. An adverse benefit determination means an adverse benefit determination as defined in 29 CFR 2560.503-1, as well as any rescission of coverage, as described in
45 CFR 147.128 (whether or not, in connection with the rescission, there is an adverse effect on any particular benefit at that time). See 26 CFR 54.9815-2719, 29 CFR 2560.503-1, 29 CFR
2590.715-2719, and 45 CFR 147.136 for regulations related to internal claims and appeals processes.
82
A “claim involving urgent care,” defined at 29 CFR 2560.503-1(m)(1) and adopted at 26 CFR 54.9815-2719(b)(2)(ii)(B), 29 CFR 2590.715-2719(b)(2)(ii)(B), and 45 CFR 147.136(b)(2)(ii)
(B), is “any claim for medical care or treatment with respect to which the application of the time periods for making non-urgent care determinations—(A) Could seriously jeopardize the life
or health of the claimant or the ability of the claimant to regain maximum function, or, (B) In the opinion of a physician with knowledge of the claimant’s medical condition, would subject the
claimant to severe pain that cannot be adequately managed without the care or treatment that is the subject of the claim.” Plans and issuers generally must render determinations regarding
claims involving urgent care as soon as possible, accounting for medical exigencies, and not later than 72 hours after receipt of the claim by the plan.
79
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the expedited timelines that apply to an
appeal of a claim involving urgent care
likely would not apply to a claim for a
recommended preventive service. In the
absence of a separate exceptions process,
an individual could therefore be required
to pursue a standar

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/agency%3Airs%3Adf60f4cef631d254. Public record. Not legal advice.