Bulletin No. 2024–47

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

November 18, 2024

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

Bulletin No. 2024–47

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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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Bulletin No. 2024–47

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

November 18, 2024

1130

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

Bulletin No. 2024–47

1131

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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Bulletin No. 2024–47

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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November 18, 2024

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.

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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.

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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 standard internal appeals process to seek coverage of a recommended

preventive service, which could result

in a coverage delay of up to 30 calendar

days for a post-service claim or 15 calendar days for a pre-service claim. Such a

delay, when combined with the ability of

plans and issuers to use medical management techniques to limit coverage of recommended preventive services outside of

an exceptions process, is not aligned with

the statutory requirement to provide coverage without cost sharing for all required

preventive services, because many individuals would be compelled to pay out-ofpocket for the recommended preventive

service determined by their attending provider to be medically necessary or accept

the form of the recommended preventive

service covered by the plan or issuer as a

result of medical management techniques,

even if it may cause adverse effects that

an alternate form of the recommended

preventive service would not cause.

Therefore, a plan or issuer would not

have an easily accessible, transparent, and

sufficiently expedient exceptions process

that is not unduly burdensome on the

individual (or provider or other person

acting as the individual’s authorized representative) under these proposed rules

if the plan or issuer requires participants,

beneficiaries, or enrollees to appeal an

adverse benefit determination using the

plan’s or issuer’s internal claims and

appeals process as the means to obtain an

exception. The Departments request comment on whether plans and issuers should

be permitted to require an individual or

their authorized representative to use the

existing process for urgent care claims

under 26 CFR 54.9815-2719(b)(2)(ii)

(B), 29 CFR 2560.503-1(b)(2)(ii)(B), and

45 CFR 147.136(b)(2)(ii)(B) (regardless

of whether the recommended preventive

service meets the definition of a “claim

involving urgent care”) to obtain an

exception to the standard preventive services coverage policy. The Departments

also request comment on whether a health

plan that is subject to the essential health

benefit (EHB) prescription drug exception

process standards at 45 CFR 156.122(c)83

should be permitted to require an individual or their authorized representative

to use the existing standard or expedited

prescription drug exception request process when seeking an exception for a

recommended preventive service that is

a prescription drug, or all recommended

preventive services.

The Departments previously noted that

plans and issuers may develop a standard

exceptions process form with instructions

as part of ensuring that the plan’s or issuer’s exceptions process is easily accessible, transparent, sufficiently expedient,

and not unduly burdensome on the individual or provider (or other individual acting

as a patient’s authorized representative).84

A standardized form that is not unnecessarily long and that has clear instructions

could reduce burden on individuals or

their authorized representative. The proposed amendments at 26 CFR 54.98152713(a)(4)(ii), 29 CFR 2590.715-2713(a)

(4)(ii), and 45 CFR 147.130(a)(4)(ii)

would not require that plans and issuers

develop and utilize a standard exceptions

process form. However, the Departments

continue to encourage plans and issuers to

make any such standard exceptions process form, whether developed by a plan or

issuer, or the Medicare Part D Coverage

Determination form, readily available,

both in paper and electronically (such as

on a website). The Departments request

comment on whether the Medicare Part D

Coverage Determination form, or another

existing format, would be an appropriate

model for plans and issuers implementing

a standardized exceptions process under

these proposed rules. Alternatively, the

Departments request comment on whether

it would be beneficial to interested parties if the Departments developed and

made available a new standard form for

an exceptions process, what information

should be included in any such form,

and whether use of such a standardized

form should be required or optional. The

Departments anticipate that most, if not

all, plans and issuers have an existing

exceptions process for recommended preventive services, or a process for other

services that can be adapted to meet these

requirements for recommended preventive

services at minimal cost. The Departments

request comment on this assumption and

on all other aspects of this proposal.

2. Coverage of Contraceptive Items

Section 2713(a)(4) of the PHS Act was

enacted to ensure that plans and issuers

cover women’s preventive health needs.

Contraceptive coverage is an essential

component of women’s health care, as recognized by its inclusion in the HRSA-supported Guidelines, in part because contraception is effective at reducing unintended

pregnancies and associated negative

maternal-infant outcomes.85 Unintended

pregnancies, which account for approximately 42 percent of pregnancies annually

in the United States, are a major public

health concern.86, 87 Coverage requirements

that promote equitable access to medically appropriate contraceptive items and

Separately from requirements related to appeals of adverse benefit determinations, HHS regulations at 45 CFR 156.122(c) state that a health plan does not provide essential health benefits

(EHBs) unless it provides a standard and expedited exceptions process for prescription drugs through which an enrollee, the enrollee’s designee, or the enrollee’s prescribing physician (or

other prescriber) can receive a coverage determination within 72 hours (for a standard exception) or no later than 24 hours (for an expedited exception, in the case of exigent circumstances).

84

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.

85

Nelson, H., Darney, B., Ahrens, K., Burgess, A., Jungbauer, R., Cantor, A., Atchison, C., Eden, K., Goueth, R., Fu, R. (2002). “Associations of Unintended Pregnancy With Maternal and

Infant Health Outcomes: A Systematic Review and Meta-analysis,” JAMA, available at https://jamanetwork.com/journals/jama/fullarticle/2797874.

86

See CDC, “Reproductive Health, Unintended Pregnancy,” available at https://www.cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html.

87

See Bradford, K., Costanza, K., Fouladi, F., Hill, T., Nguyen, K., and Speer, K., NCSL (2023). “Supporting Moms’ Health in the Postpartum Period,” available at https://www.ncsl.org/

health/supporting-moms-health-in-the-postpartum-period; Nelson, et al., supra fn. 75; Cruz-Bendezú, A., Lovell, G. Roche, B., Perkins, M., Blake-Lamb, T., Taveras, E., and Simione M.

(2020). “Psychosocial status and prenatal care of unintended pregnancies among low-income women,” BMC Pregnancy and Childbirth, available at https://bmcpregnancychildbirth.

biomedcentral.com/articles/10.1186/s12884-020-03302-2; Blake, S., Kiely, Gard, C., El-Mohandes, A., El-Khorazaty, M.N. (2007). “Pregnancy Intentions and Happiness Among Pregnant

Black Women at High Risk for Adverse Infant Health Outcomes,” American Journal of Public Health, available at https://doi.org/10.1363/3919407; Finer, L., and Zolna, M. (2014). “Shifts

in intended and unintended pregnancies in the United States, 2001-2008,” American Journal of Public Health, available at https://pubmed.ncbi.nlm.nih.gov/24354819.

83

November 18, 2024

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services are an essential component of

high-quality reproductive health care with

wide-ranging social and economic benefits.88 Research shows that many women

are not using their contraceptive of choice,

for reasons that include concerns about

side effects, cost, lack of availability, or

inability to get a provider appointment.89

Coverage that allows individuals to identify and obtain a medically necessary contraceptive (accounting for variables such

as hormonal properties, side effects, and

delivery mechanisms, among other factors) without cost sharing could improve

quality of life, reduce behaviors such as

discontinuing contraception, and result

in more effective use of contraception to

prevent unintended pregnancy.90 As noted

in the preamble to the 2023 proposed

rules, increased contraceptive coverage

can improve access to care, and therefore

also help to address racial inequities in

reproductive health care that contribute to

lifelong disproportionate health outcomes

for women in underserved communities,

including disparate maternal health outcomes.91

Additionally, there has been significant

activity related to coverage of contraceptive services and several new developments, including legal developments, that

have affected women’s needs regarding

access to affordable contraception since

the publication of the July 2010 interim

final rules. The Departments continue to

receive complaints and are aware of other

reports documenting plans’ and issuers’

failure to provide coverage of the full

range of contraceptive services. Coverage

issues leading to lack of access to contraception were also substantiated in comments received in response to the OTC

Preventive Products RFI. Other developments have included the Dobbs decision

and subsequent State-level restrictions

on access to abortion and emergency

contraception, which have made it more

challenging for women in some States to

obtain contraception and quality family

planning care, including because health

care providers have been forced to close

or chosen to relocate to a different State;92

Executive Orders related to reproductive

health care; and FDA approval of the first

daily OTC oral contraceptive. As a result,

the Departments have determined that it is

necessary to propose amendments to the

regulations governing how plans and issuers cover contraception and, as discussed

in section II.B of this preamble, how they

communicate information about this coverage to participants, beneficiaries, and

enrollees.

The Departments are interested in minimizing barriers to coverage and expanding the scope of coverage without cost

sharing for all recommended preventive

services, in alignment with section 2713

of the PHS Act. The Departments also recognize that the proposals described in this

section II.A.2 of this preamble, if finalized, could require significant changes

to current plan and issuer operations.

Therefore, the Departments propose an

incremental approach in this rulemaking

with respect to the types of recommended

services addressed that is focused initially

on expanding coverage of contraception.

This incremental approach would facilitate implementation for plans, issuers,

and other interested parties and allow the

Departments to gather additional feedback

on challenges and benefits of adopting

these proposed policies before considering whether and how to propose similar

requirements with respect to other recommended preventive services. Focusing

first on contraceptive items is appropriate

due to ongoing and widely reported concerns regarding challenges faced by consumers in accessing contraceptive items

and services without cost sharing, as well

as recent developments affecting access to

reproductive health care.93

As described in FAQs Part 51, Q9,

FAQs Part 54, Q8, and sections I.B and

II.A.2 of this preamble, the Departments

continue to receive complaints and are

aware of other credible reports that some

plans and issuers frequently restrict access

to contraceptive items and services that

should be covered without cost sharing.

For instance, in addition to widespread

denials of exceptions process requests as

described in section II.A.1 of this preamble, the October 2022 Oversight Committee report identified at least 34 different

contraceptive items that were commonly

excluded from coverage or for which

cost-sharing requirements often were

applied.94 Additionally, a recent investiga-

Id., see also Sonfield, A., Hasstedt, K., Kavanaugh, M., and Anderson, R., (2013). “The Social and Economic Benefits of Women’s Ability to Determine Whether and When to Have Children,”

Guttmacher Institute, available at https://www.guttmacher.org/sites/default/files/report_pdf/social-economic-benefits.pdf.

89

Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available

at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.

90

Steinberg, J., Marthey, D., Xie, L., Boudreaux, M. (2021). “Contraceptive method type and satisfaction, confidence in use, and switching intentions,” Contraception, available at https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC8286312.

91

See 88 FR 7236, 7241 (Feb. 2, 2023), citing Sutton, M. Y., Anachebe, N. F., and Skanes H. (2021). “Racial and Ethnic Disparities in Reproductive Health Services and Outcomes, 2020,”

Obstetrics and Gynecology, available at https://doi.org/10.1097/AOG.0000000000004224; White House Blueprint for Addressing the Maternal Health Crisis (2022), available at https://

www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf.

92

See, e.g., Murphy, C., Shin, P., Jacobs, F., and Johnson, K. (2024). “In States with Abortion Bans, Community Health Center Patients Face Challenges Getting Reproductive Health Care,”

Commonwealth Fund, available at https://www.commonwealthfund.org/blog/2024/states-abortion-bans-community-health-center-patients-face-challenges-getting; Harper, C., Brown, K.,

and Arora, K. (2024). “Contraceptive Access in the US Post-Dobbs,” JAMA Internal Medicine, available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682;

Qato, D., Myerson, R., Shooshtari, A., Guadamuz, J., Alexander, G.C., (2024). “Use of Oral and Emergency Contraceptives After the US Supreme Court’s Dobbs Decision,” available at

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370.

93

See, e.g., Adler, A., Biggs, A.M., Kaller, S., Schroeder, R., Ralph, L. (2023). “Changes in the Frequency and Type of Barriers to Reproductive Health Care from 2017 to 2021,” JAMA

Network Open, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087056; Qato, D., Myerson, R., Shooshtari, A., Guadamuz, J., Alexander, G.C., (2024). “Use of Oral and

Emergency Contraceptives After the US Supreme Court’s Dobbs Decision,” available at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370; Harper, C., Brown, K.,

and Arora, K. (2024). “Contraceptive Access in the US Post-Dobbs,” JAMA Internal Medicine, available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682;

Kavanaugh, M. and Friedrich-Karnik, A. (2024). “Has the Fall of Roe changed contraceptive access and use? New research from four US states offers critical insights,” Health Affairs

Scholar, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10986283; and American Academy of Pediatrics, (updated July 2023) “The Importance of Access to Contraception

– Barriers to accessing contraception”, available at https://www.aap.org/en/patient-care/adolescent-sexual-health/equitable-access-to-sexual-and-reproductive-health-care-for-all-youth/

the-importance-of-access-to-contraception.

94

U.S. House of Representatives Committee on Oversight and Reform, “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private Insurance” (Oct.

25, 2022), available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.

88

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November 18, 2024

tion by the Vermont Department of Financial Regulation, the agency responsible

for regulating issuers in that State, found

that three issuers in Vermont violated

State and Federal law by failing to provide

coverage of contraceptive services without cost sharing. The investigation found

that between 2017 and 2021, the issuers

inappropriately charged patients $1.5 million for contraceptive items and services

that should have been provided free of

any out-of-pocket costs, resulting in a

finding that 9,000 people were entitled

to receive restitution for cost sharing that

was incorrectly applied for contraceptive

services.95 The investigation prompted a

Congressional request to the Government

Accountability Office for an investigation into plan and issuer compliance with

ACA requirements to cover contraceptive

items without cost sharing.96 In addition,

the Centers for Medicare & Medicaid

Services, as part of targeted market conduct examinations conducted on behalf of

HHS, has identified multiple violations of

the requirements of section 2713(a)(1) of

the PHS Act and implementing regulations

related to contraceptive coverage and continues to investigate additional complaints

alleging violations.97 Additional reports of

noncompliance documented by members

of Congress, advocacy organizations, and

media reports were cited by the Secretaries in their June 27, 2022 letter to group

health plan sponsors and issuers.98 Given

these reported instances of continued

obstacles for women in accessing contraception, and within the context of several

States’ efforts to restrict access to reproductive health care following the Dobbs

decision, the Departments have determined it is appropriate for these proposed

rules to begin with addressing barriers to

contraceptive services.

Furthermore, focusing on contraception is consistent with recent Executive

Orders. As described in section I.C of this

preamble, President Biden issued E.O.

14101, which directed the Secretaries to

consider actions that would, to the greatest extent permitted by law, ensure coverage of comprehensive contraceptive care,

including all contraceptives approved,

cleared, or granted by the FDA, without

cost sharing for participants, beneficiaries,

and enrollees; and streamline the process

for patients and health care providers to

request coverage, without cost sharing, of

medically necessary contraception. Further, section 2(b) of E.O. 14101 instructed

the Secretaries to consider actions that

would promote increased access to affordable OTC contraception.99 Consistent with

E.O. 14101, and in consideration of the

availability of OTC oral contraceptives,

these proposed rules would promote coverage and streamline access to all medically necessary contraception, including

the newly FDA-approved OTC daily oral

contraceptive, by removing prescription

and cost barriers for consumers.

The Departments acknowledge the

possibility that increasing coverage without cost sharing for recommended preventive services, as discussed in this section II.A.2 of this preamble, could lead

to greater demand for those services and

potentially higher prices charged by providers. These increased costs could result

in higher costs to consumers, both in the

form of higher premiums for people with

insurance and in the form of higher outof-pocket costs for people who do not use

insurance coverage to obtain OTC contra-

ceptive products. The potential increases

in cost further justify the incremental

approach taken in these proposed rules.

In addition, comments in response to the

OTC Preventive Products RFI suggested

that requiring coverage of all OTC preventive products may be challenging for

some types of preventive care. For these

reasons, the Departments propose to

amend the preventive services regulations

with respect to only contraceptive items100

at this time by inserting a new paragraph

(a)(6) at 26 CFR 54.9815‑2713, 29 CFR

2590.715-2713, and 45 CFR 147.130. The

Departments’ issuance of these proposals

implementing section 2713 of the PHS

Act is authorized by section 9833 of the

Code, section 734 of ERISA, and section

2792 of the PHS Act.

First, the Departments propose to

define the terms “drug-led combination

product”101 in proposed new paragraph (a)

(6)(i)(A) and “therapeutic equivalent” in

proposed new paragraph (a)(6)(i)(B) for

purposes of the proposed new paragraph

(a)(6). Second, the Departments propose

in proposed new paragraph (a)(6)(ii) to

require that plans and issuers cover, without requiring a prescription and without

imposing cost-sharing requirements, recommended contraceptive items that are

available OTC and for which the applicable recommendation or guideline does not

require a prescription. Third, the Departments propose in proposed new paragraph (a)(6)(iii) that, in order for medical

management techniques to be considered

reasonable, plans and issuers would be

required to utilize a therapeutic equivalence approach for recommended contraceptive drugs and drug-led combination

products.

State of Vermont Department of Financial Regulation (Nov. 13, 2023). “Contraceptive Services Claims Restitution Information,” available at https://dfr.vermont.gov/contraceptiveservices-claims-restitution-information.

96

Sen. Bernie Sanders (June 17, 2024). Letter to Hon. Gene Dodaro, Comptroller General of the United States, available at https://www.documentcloud.org/documents/24764790-61724gao-aca-contraception-coverage-letter.

97

CMS, “Compliance and Enforcement, Federal Market Conduct Examination Final Reports,” available at https://www.cms.gov/marketplace/private-health-insurance/consumer-protections-enforcement.

98

See, e.g., Secretaries Becerra, Yellen, and Walsh (June 27, 2022). Letter on the ACA contraceptive coverage requirement, available at https://www.dol.gov/sites/dolgov/files/ebsa/lawsand-regulations/laws/affordable-care-act/for-employers-and-advisers/letter-from-secretaries-becerra-yellen-and-walsh-on-the-aca-contraceptive-coverage-requirement.pdf (highlighting

reports of noncompliance documented by Members of the U.S. House of Representatives (in 2021 and 2022) and the U.S. Senate (in 2021 and 2022), the National Women’s Law Center, other

nonprofit organizations, and media reports).

99

88 FR 41815 at 41816 (June 23, 2023).

100

See section II.A.2 of the preamble to these proposed rules for comment solicitation regarding whether to expand the proposed coverage requirements to other recommended preventive

services.

101

The Departments are proposing to define the term “drug-led combination products” in these proposed rules instead of the term “drug-led devices” used in FAQs Part 64 to align these proposed rules with existing definitions at 21 CFR 3.2(e). The change in terminology should not be interpreted to suggest that the terms are interchangeable, as the term “drug-led combination

products” encompasses “drug-led devices” as well as other drug-led combination products for which the FDA evaluates therapeutic equivalence.

95

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The Departments request comment

on whether to finalize these policies only

with respect to contraception as proposed,

or to instead finalize these policies with

respect to all preventive services, or with

respect to a larger subset of preventive

services. In particular, the Departments

request comment on issues related to coverage of additional specific OTC preventive products without a prescription (for

example, tobacco cessation items) in addition to OTC contraceptive items, or all

OTC preventive products without a prescription. The Departments also request

comment on the experiences (particularly

with respect to administrative challenges,

consumer experiences, and costs) of any

plans and issuers that currently provide

coverage for any OTC preventive products without requiring a prescription, and

how those experiences could inform the

implementation of these proposed rules, if

finalized. The Departments further request

comment on whether and to what extent

these proposals could affect the ability of

plans and issuers to negotiate or otherwise

limit costs for contraceptive items, including OTC contraceptive items and contraceptive drugs and drug-led combination

products, and what additional rulemaking

or guidance would be necessary to ensure

that plans and issuers retain the ability to

do so.

Along with the incremental approach

proposed in this rulemaking focused on

contraception, the Departments anticipate issuing another notice of proposed

rulemaking in the near future to address

additional issues related to coverage of

preventive services more generally.

a. Coverage of OTC Contraceptive Items

Without Cost Sharing

As discussed in section I.B of this preamble, the Departments’ previously issued

guidance provides that preventive health

care items generally available OTC to

patients (such as folic acid and certain contraceptive products, including contraceptive sponges, spermicides, and emergency

contraception (levonorgestrel)) must be

covered without cost sharing under section 2713 of the PHS Act only when prescribed by a health care provider.102 This

approach reflected the traditional role of

health coverage in providing benefits for

health care items and services for which

there is provider involvement. However,

the FDA’s approval of a daily OTC oral

contraceptive without a prescription, in

combination with the reasons outlined

earlier in this preamble, have prompted

the Departments to revisit this approach.

As commenters to the OTC Preventive

Products RFI noted, neither section 2713

of the PHS Act and its implementing regulations nor the current HRSA-supported

Guidelines require a prescription as a condition of coverage without cost sharing

for recommended preventive services that

are available OTC, except to the extent a

particular recommendation or guideline

requires that an individual is prescribed

an item or service. Therefore, with respect

to contraceptive items that can be lawfully obtained103 by a participant, beneficiary, or enrollee without a prescription

and for which the applicable recommendation or guideline does not require a

prescription, the Departments propose

in new paragraph (a)(6)(ii) that a plan or

issuer would not be considered to comply with 26 CFR 54.9815-2713(a)(1), 29

CFR 2590.715-2713(a)(1), and 45 CFR

147.130(a)(1), unless the plan or issuer

provides coverage for the contraceptive

item without requiring a prescription

and without imposing any cost-sharing

requirements. As noted by many commenters to the OTC Preventive Products

RFI, out-of-pocket costs and prescription

requirements make it more difficult for

women to access contraception, includ-

ing contraceptive items that are available

without a prescription, such as oral contraceptives recently approved by the FDA

for OTC sale. The Departments agree with

commenters that these obstacles present

greater challenges to women in underserved communities, including those with

lower incomes and who are members of

underserved racial and ethnic groups,

reinforcing structural barriers to health

care and contributing to reproductive

health disparities. Although some plans

and issuers have voluntarily, or as required

by State law,104 provided coverage of OTC

contraceptive items without a prescription

and without cost-sharing requirements or

with limits on cost sharing, the Departments understand that many women lack

such coverage. In response to a specific

question regarding how commonly plans

and issuers provide coverage for OTC

preventive products without requiring a

prescription, many commenters asserted

that most plans and issuers cover OTC

preventive products only when they are

prescribed. The Departments have determined, therefore, that requiring (rather

than encouraging) coverage of OTC contraceptive items without cost sharing and

without a prescription, as proposed in

these rules, is critical to ensuring that coverage requirements provide women with

access to contraceptives as required under

section 2713 of the PHS Act and the applicable HRSA-supported Guidelines, and to

realizing the goal of promoting access to

reproductive health care.

Under this proposal, the requirement to

cover OTC contraceptive items would be

subject to the specific coverage requirements applicable to all recommended

preventive services in 26 CFR 54.98152713, 29 CFR 2590.715-2713, and 45

CFR 147.130. However, the Departments

recognize that the provision and coverage of OTC contraceptive items present

unique issues that plans and issuers may

See FAQs Part XII, Q4 and Q15 (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 Part 54, Q5-6 (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.

103

The Departments intend for this proposal to apply only to contraceptive items that are legally sold without a prescription. Nothing in this proposal would require a plan or issuer to provide

coverage without cost sharing for a contraceptive item for which the FDA requires a prescription, if a participant, beneficiary, or enrollee acquires the item without a prescription.

104

CA, CO, MD, NM, NJ, NY, and WA require some coverage of OTC contraceptive items. See KFF (Updated March 2024). “State Private Insurance Coverage Requirements for OTC Contraception Without a Prescription,” available at https://www.kff.org/other/state-indicator/state-private-insurance-coverage-requirements-for-otc-contraception-without-a-prescription. See,

e.g., Cal. Health & Saf. Code section 1367.25(b)(1)(A) (barring prescription requirements for OTC FDA-approved contraceptive drugs, devices, and products and requiring point-of-sale

coverage of OTC contraception at in-network pharmacies); Md. Code, Ins. section 15-826.1 (requiring coverage without a prescription for all FDA-approved contraceptive drugs available

OTC and limiting cost-sharing for OTC contraceptive drugs to the amount that would apply to the same drug dispensed under a prescription).

102

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November 18, 2024

not encounter when covering other recommended services. Therefore, the following

sections of this preamble discuss how

plans and issuers would be expected to

comply with certain existing requirements

with respect to coverage of OTC contraceptive items.105

(1) In-Network and Out-of-Network

Coverage of OTC Contraceptive Items

Under section 2713 of the PHS Act

and its implementing regulations at 26

CFR 54.9815‑2713(a)(3)(i) and (ii), 29

CFR 2590.715-2713(a)(3)(i) and (ii), and

45 CFR 147.130(a)(3)(i) and (ii), a plan

or issuer is not required to provide coverage for recommended preventive services

delivered by an out-of-network provider if

the plan or issuer has a network of providers. Similarly, nothing precludes a plan or

issuer that has a network of providers from

imposing cost‑sharing requirements on

recommended preventive services delivered by an out-of-network provider. However, if a plan or issuer does not have a

provider in its network who can provide a

recommended preventive service, the plan

or issuer must cover the recommended

preventive service, without cost sharing,

when furnished by an out-of-network provider.106 Nothing under section 2713 of the

PHS Act nor its implementing regulations

requires a plan or issuer to establish a provider network.

The Departments are not proposing to

amend these requirements with respect

to OTC contraceptive items. Therefore, a

plan or issuer that has a network of providers that can provide OTC contraceptive

items would not be required to provide

coverage, or waive cost sharing, for OTC

contraceptive items that are provided by

an out-of-network provider. For example,

if a plan or issuer has a network of pharmacies (including mail-order pharmacies)

that can provide OTC contraceptive items

without a prescription, the plan or issuer

would not be required to provide coverage

(nor waive cost sharing) if a participant,

beneficiary, or enrollee obtains a covered

OTC contraceptive item at an out-of-network pharmacy or other retailer.107

The Departments understand, based on

responses to the OTC Preventive Products RFI and communications with plans

and issuers regarding coverage of OTC

COVID-19 diagnostic tests during and

after the COVID-19 PHE, that network

contracts between plans and issuers and

pharmacies that are located in a retail store

typically include only the pharmacies as

the in-network providers. The retail stores

at which the pharmacies are located are

treated as separate entities. In these cases,

the pharmacy point of sale would be considered an in-network provider at which

an OTC contraceptive would be covered

without cost sharing, but a non-pharmacy

point of sale (for example, a cash register,

self-check-out, or vending machine in the

front of a retail store, unaffiliated with the

pharmacy department) would not be considered an in-network provider. Although

participants, beneficiaries, and enrollees

would typically be able to purchase OTC

contraceptives from the front of the retail

store, these proposed rules would not

require a plan or issuer with a network

of pharmacies to also cover without cost

sharing OTC contraceptive items that are

purchased at a retail store that is co-located with an in-network pharmacy. If the

plan or issuer has a network of pharmacies

that provide coverage for OTC contraceptive items without cost sharing, that plan

or issuer would be considered to have a

network of providers to provide benefits

for OTC contraceptive items and therefore

would not be required to cover OTC contraceptive items purchased at a retail store

that is not part of its network. For example, emergency contraception could be

available in multiple locations in the same

retail store: behind the pharmacy counter

through an in-network pharmacy where a

consumer typically provides health coverage information to allow the pharmacy to

process a claim for coverage; and “off the

shelf” in a non-pharmacy section of the

same store. This could result in a participant, beneficiary, or enrollee being able

to access an OTC contraceptive item at

an in-network pharmacy without paying

any out-of-pocket costs at the pharmacy

counter point of sale, while being liable

for the full cost of the identical OTC contraceptive item if it was purchased at a

non-pharmacy point of sale. The Departments request comment on the potential

impact on consumers, pharmacies, and

retail stores with this proposed approach.

The Departments would expect that

in-network coverage for OTC contraceptive items and services would be provided

in a manner that is comparable to coverage for other recommended preventive

services. For example, the Departments

would expect that a plan or issuer that

does not preference the use of a mail-order pharmacy for coverage of prescription-only recommended preventive services would not preference the use of

a mail-order pharmacy for coverage of

OTC contraceptives. As another example, a plan or issuer should not impose

shipping costs on an OTC contraceptive

item that is furnished via mail order if the

plan or issuer would not impose shipping

costs on a comparable prescription product. Likewise, to the extent that a plan or

issuer generally covers a recommended

preventive service that requires a prescription without cost sharing at the in-network

pharmacy point of sale, without requiring consumers to pursue post-purchase

reimbursement, the Departments would

expect that the plan or issuer would generally cover OTC contraceptive items at

the in-network pharmacy point of sale

in the same manner. Plans and issuers

that require participants, beneficiaries, or

enrollees to present information, such as

an insurance card, to allow an in-network

pharmacy to process a claim for a prescription-only recommended preventive

service may require similar information to

process a claim for an OTC contraceptive

item. The Departments request comment

on the appropriate approach for coverage

The requirements regarding office visits would not be relevant with respect to coverage of OTC contraceptive items, and the requirements regarding timing do not raise unique issues with

respect to OTC contraceptive items.

106

See FAQs Part XXII, Q3 (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.

107

Nothing in the statute or preventive services regulations prevents a plan or issuer from providing coverage without cost sharing for out-of-network recommended preventive services, and

the Departments encourage plans and issuers to do so.

105

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Bulletin No. 2024–47

in a scenario in which a plan’s or issuer’s

preferred OTC contraceptive item is out

of stock at an in-network pharmacy, while

a non-preferred version is available. Specifically, the Departments request comment on whether plans or issuers should

be required to cover the non-preferred

version without cost-sharing requirements at the in-network pharmacy, without requiring the consumer to pursue

an exceptions process when a preferred

version is unavailable at an in-network

pharmacy. The Departments also request

comment on whether and how plans and

issuers should document the unavailability of a preferred OTC contraceptive for

coverage purposes.

As noted earlier, plans and issuers are

not required to establish a provider network in order to provide coverage of recommended preventive services and would

not be required to contract with providers

for the purpose of providing in-network

coverage of OTC contraceptive items if

these proposed rules are finalized. Under

26 CFR 54.9815-2713(a)(3)(ii), 29 CFR

2590.715-2713(a)(3)(ii), and 45 CFR

147.130(a)(3)(ii), a plan or issuer that

lacks an in-network provider who can provide an OTC contraceptive item would be

obligated to cover the OTC contraceptive

item when provided by an out-of-network

provider without imposing cost sharing.

In the absence of a provider network,

the Departments encourage plans and

issuers to establish processes to ensure

that participants, beneficiaries, and enrollees can obtain OTC contraceptive items

from out-of-network providers without

incurring out-of-pocket costs and without encountering significant barriers to

access.108 The Departments are not proposing to specify in these proposed rules how

a plan or issuer would do so, but would

encourage plans and issuers to establish

a robust approach with multiple entry

points to ensure that participants, benefi-

ciaries, and enrollees can access out-ofnetwork OTC contraceptive items with no

out‑of‑pocket costs and without friction at

the point of sale. The Departments request

comment on what additional standards or

guidance would be helpful to ensure that

participants, beneficiaries, and enrollees

can use their health coverage to access

OTC contraceptive items from out-ofnetwork providers without cost sharing,

while allowing plans and issuers flexibility to effectively implement the requirement to cover OTC contraceptive items,

if finalized.

If these requirements are finalized,

plans and issuers should ensure that processes that require participants, beneficiaries, or enrollees to pay out-of-pocket

for OTC contraceptive items and pursue

reimbursement do not present unreasonable barriers to accessing OTC contraceptive items provided by either an

in-network or out-of-network provider. A

traditional post-purchase reimbursement

process might require consumers to bear

the upfront cost of an OTC contraceptive

item as well as the administrative burden

of requesting reimbursement, providing

documentation either on paper or electronically, and absorbing the financial impact

of a delayed reimbursement while a reimbursement request is being reviewed and

processed by the plan or issuer. For example, while it would be reasonable for a

plan or issuer to require a form and receipt

or other proof of purchase, post-purchase

reimbursement programs that require an

individual to submit multiple docume

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