85750 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[REG–110878–24] 

RIN 1545–BR35 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AC25 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 147 

[CMS 9887–P] 

RIN 0938–AV57 

Enhancing Coverage of Preventive 

Services Under the Affordable Care 

Act 

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-sharing 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-thecounter 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, 

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) 693–8335. 

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 employmentbased 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. 

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 


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1 29 U.S.C. 1185d. 

2 26 U.S.C. 9815. 

3 42 U.S.C. 300gg–13. 

4The items and services described in these 

recommendations and guidelines are referred to in 

this preamble as ‘‘recommended preventive 

services.’’ 

5The 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. 

6On 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/factsheets-and-faqs/downloads/faqs-part-58.pdf. 

8Consistent 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. 

9For 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. 

10See 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. 

11The 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. 

12The HRSA-supported Guidelines, as amended 

in December 2016, refer, under the header 

‘‘Contraception,’’ to: ‘‘the full range of femalecontrolled U.S. Food and Drug Administrationapproved 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 awarenessbased methods, including the lactation amenorrhea 

method.’’ See https://www.hrsa.gov/womensguidelines-2016/index.html. 

13See HRSA, ‘‘Women’s Preventive Services 

Guidelines: Current Guidelines,’’ available at 

https://www.hrsa.gov/womens-guidelines. 

14The 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. 

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 costsharing 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 (HRSAsupported 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 HRSAsupported 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 HRSAsupported 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 

contraceptive methods and counseling, 

stated, ‘‘as prescribed.’’ The 

‘‘Frequency’’ column does not appear in 

the 2016, 2019, or 2021 updated HRSAsupported Guidelines for any preventive 

service, and the updated HRSAsupported 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 


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15See 86 FR 59741, 59742 (Oct. 28, 2021). 

16HRSA stated that this change was made to 

allow women to purchase male condoms for 

pregnancy prevention. See id. 

17See 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). 

24These 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. 

26See 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/acapart-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-and-FAQs/ 

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-part54.pdf.; and FAQs about Affordable Care Act 

Implementation Part 64 (Jan. 22, 2024) available at 

https://www.dol.gov/agencies/ebsa/about-ebsa/ouractivities/resource-center/faqs/aca-part-64 and 

https://www.cms.gov/files/document/faqs-part64.pdf. 

27As 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 

‘‘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 ‘‘femalecontrolled,’’ 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 HRSAsupported 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 costsharing 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 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: 


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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 85753 

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/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ 

faqs-part-54.pdf. 

28See 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. 

29See 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. 

30As 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. 

31FAQs 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-andFAQs/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 awarenessbased methods, including the lactation amenorrhea 

method, although less effective, should be provided 

for women desiring an alternative method.’’ 

32See 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. 

33See 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.’’) 

34See id. at introduction and Q3. 

35 Id. at Q2. 

36FAQs Part 31, Q2 (April 20, 2016), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part31.pdf and https://www.cms.gov/CCIIO/Resources/ 

Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final4-20-16.pdf. 

37FAQs about Affordable Care Act 

Implementation Part 47 (July 19, 2021), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part47.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-humanimmunodeficiency-virus-hiv-infection-preexposure-prophylaxis. 

• 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 method 30

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 

provider 33 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 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 


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38FAQs Part 51, Q9 (Jan. 10, 2022), available at 

https://www.dol.gov/sites/dolgov/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part51.pdf and https://www.cms.gov/CCIIO/Resources/ 

Fact-Sheets-and-FAQs/Downloads/FAQs-Part51.pdf. 

39FAQs Part 54, Q1 (July 28, 2022), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ 

faqs-part-54.pdf. 

40 Id. at Q2. 

41 Id. at Q3. 

42 Id. at Q5. 

43See 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 

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 followup 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 HRSAsupported 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 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-the-counter (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 devices 44 that are required to 


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product’’ in these proposed rules to refer to the 

same products for which the term ‘‘drug-led 

device’’ was used in FAQs Part 64. 

45FAQs Part 64 (Jan. 22, 2024), available at 

https://www.dol.gov/sites/dolgov/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part64.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. 

50 88 FR 41815. 

51 Id. 

52FDA (July 13, 2023). ‘‘FDA Approves First 

Nonprescription Daily Oral Contraceptive,’’ 

available at https://www.fda.gov/news-events/pressannouncements/fda-approves-first-nonprescriptiondaily-oral-contraceptive. 

53Progestin-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. 

54See 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/acogpraises-fda-approval-of-over-the-counter-access-tobirth-control-pill. 

55See 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., 

Age ́nor, 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. 

57A 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. 

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

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-ofpocket 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 


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58Lupkin, S., NPR (March 18, 2024). ‘‘First overthe-counter birth control pill now for sale online,’’ 

available at https://npr.org/sections/health-shots/ 

2024/03/04/1235404522/opill-over-counter-birthcontrol-pill-contraceptive-shop. 

59 88 FR 68519 (Oct. 4, 2023). 

60For 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. 

61See section I.A of this preamble for a 

discussion of the ‘‘as prescribed’’ language. 

62See, 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. 

63See 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-assistanceresources/temp-sep-unwinding-faq.pdf. 

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-the-Counter 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 products 60 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. 

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 lowerincome 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 HRSAsupported 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 costsharing and prescription requirements 

would allow people to access evidencebased 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 


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64See 88 FR 68519, 68523–24 (Oct. 4, 2023). 

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 burdens 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 longestablished 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 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 


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65 42 U.S.C. 300gg–15a. 

66 42 U.S.C. 18031(e)(3). 

67 77 FR 18310 (Mar. 27, 2012). 

68 85 FR 72158 (Nov. 12, 2020). 

69The 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/aboutebsa/our-activities/resource-center/faqs/aca-part49.pdf and https://www.cms.gov/CCIIO/Resources/ 

Fact-Sheets-and-FAQs/Downloads/FAQs-Part49.pdf. 

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. 

F. Transparency in Coverage Under the 

ACA and Implementing Regulations 

Section 2715A of the PHS Act 65

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 innetwork 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 Establishment 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.69

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 selfservice 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-ofnetwork 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 costsharing 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 costsharing liability that applies for nonpreventive 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 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 


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70 26 CFR 54.9815–2713(a)(4); 29 CFR 2590.715– 

2713(a)(4); and 45 CFR 147.130(a)(4). 

71See 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/about-ebsa/our-activities/ 

resource-center/faqs/aca-part-64.pdf and https://

www.cms.gov/files/document/faqs-part-64.pdf. 

72See, 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. 

73U.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. 

74See 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/factsheets-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/Fact-Sheets-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/hhsguidance-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-part54.pdf; FAQs Part 64 (Jan. 22, 2024) available at 

https://www.dol.gov/agencies/ebsa/about-ebsa/ouractivities/resource-center/faqs/aca-part-64 and 

https://www.cms.gov/files/document/faqs-part64.pdf. 

75See 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.’’) 

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 individual 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 54.9815– 

2713(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 


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76For 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. 

77The 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. 

78Similarly, 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. 

79See 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. 

easily accessible, transparent, and 

sufficiently expedient exceptions 

process that is not unduly burdensome 

on a participant, beneficiary, or enrollee 

or attending provider 76 (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 provider 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 brandname 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 participant, 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 

individual 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 


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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 85761 

80FAQs Part 54, Q9 (July 28, 2022), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ 

faqs-part-54.pdf. 

81FAQs Part 54, Q10 (July 28, 2022), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.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. 

82A ‘‘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. 

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, preservice 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 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-of-pocket 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 


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85762 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 

83Separately 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). 

84FAQs Part 54, Q9 (July 28, 2022), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ 

faqs-part-54.pdf. 

85Nelson, 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 Metaanalysis,’’ JAMA, available at https://

jamanetwork.com/journals/jama/fullarticle/ 

2797874. 

86See CDC, ‘‘Reproductive Health, Unintended 

Pregnancy,’’ available at https://www.cdc.gov/ 

reproductive-health/hcp/unintended-pregnancy/ 

index.html. 

87See 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-Bendezu ́, 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. 

88 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. 

89Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

90Steinberg, 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. 

91See 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. 

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 54.9815– 

2713(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 

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 


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92See, 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/statesabortion-bans-community-health-center-patientsface-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/jamainternal

medicine/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. 

93See, 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/equitableaccess-to-sexual-and-reproductive-health-care-forall-youth/the-importance-of-access-tocontraception. 

94U.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%20PBMInsurer%20Report.pdf. 

95State of Vermont Department of Financial 

Regulation (Nov. 13, 2023). ‘‘Contraceptive Services 

Claims Restitution Information,’’ available at 

https://dfr.vermont.gov/contraceptive-servicesclaims-restitution-information. 

96Sen. Bernie Sanders (June 17, 2024). Letter to 

Hon. Gene Dodaro, Comptroller General of the 

United States, available at https://

www.documentcloud.org/documents/24764790- 

61724-gao-aca-contraception-coverage-letter. 

97CMS, ‘‘Compliance and Enforcement, Federal 

Market Conduct Examination Final Reports,’’ 

available at https://www.cms.gov/marketplace/ 

private-health-insurance/consumer-protectionsenforcement. 

98See, 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/laws-andregulations/laws/affordable-care-act/for-employersand-advisers/letter-from-secretaries-becerra-yellenand-walsh-on-the-aca-contraceptive-coveragerequirement.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). 

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 investigation 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 


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85764 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 

99 88 FR 41815 at 41816 (June 23, 2023). 

100See 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. 

101The 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. 

102 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-andFAQs/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-part54.pdf. 

103The 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. 

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 out-of-pocket 

costs for people who do not use 

insurance coverage to obtain OTC 

contraceptive 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 items 100 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 costsharing 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. 

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 obtained 103 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, including 

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 


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104CA, 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-privateinsurance-coverage-requirements-for-otccontraception-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). 

105The 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. 

106See 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. 

107Nothing 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. 

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 54.9815–2713, 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 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-ofnetwork 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 nonpharmacy 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 innetwork 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-ofpocket 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 


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108The Departments note that plans and issuers 

would not be required to reimburse the cost of OTC 

contraceptive items that have already been 

reimbursed by an account-based plan, such as a 

health flexible spending arrangement (FSA) or 

health reimbursement arrangement (HRA). As of 

January 2020, section 3702 of the CARES Act 

amended the definition of qualifying medical 

expenses so that the expenses for certain OTC 

medications purchased without a prescription are 

eligible for reimbursement under certain 

arrangements, such as health savings accounts 

(HSAs), HRAs, and health FSAs. An individual 

generally may not submit claims to multiple 

sources of coverage to be reimbursed more than 

once for the same medical expense. Therefore, the 

cost (or the portion of the cost) of OTC 

contraception that has already been paid or 

reimbursed by a plan or issuer cannot also be 

reimbursed by an HSA, HRA, or health FSA. 

109 26 CFR 54.9815–2713(a)(4), 29 CFR 2590.715– 

2713(a)(4), and 45 CFR 147.130(a)(4). 

110See, e.g., 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/Fact-Sheets-and-FAQs/aca_

implementation_faqs12.html; FAQs 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. 

111See section II.A of the preamble to these 

proposed rules for a description of existing 

guidance regarding the use of an exceptions process 

and the proposal in these proposed rules to require 

plans and issuers to provide an exceptions process 

when utilizing reasonable medical management for 

recommended preventive services. 

that a plan or issuer that does not 

preference the use of a mail-order 

pharmacy for coverage of prescriptiononly recommended preventive services 

would not preference the use of a mailorder 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 postpurchase 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 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 costsharing 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, beneficiaries, 

and enrollees can access out-of-network 

OTC contraceptive items with no out-ofpocket 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-of-network 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-ofpocket 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, postpurchase reimbursement programs that 

require an individual to submit multiple 

documents or involve numerous steps 

that unduly delay an individual’s 

reimbursement for an OTC 

contraceptive item would not be 

reasonable under these proposed rules. 

Further, the Departments would 

strongly encourage plans and issuers to 

consider implementing additional 

methods for providing coverage of OTC 

contraceptive items without cost 

sharing, in addition to or in lieu of a 

traditional post-purchase 

reimbursement process. For example, 

plans and issuers could consider 

providing access to pre-paid accounts 

that are programmed to cover upfront 

costs associated with OTC contraceptive 

items at the point of sale, either by 

issuing physical debit or credit cards or 

providing access to a linked smartphone 

application or QR code to participants, 

beneficiaries, or enrollees, provided 

funds were sufficient to cover costs 

associated with OTC contraceptive 

items, the mechanism for delivery was 

programmed with sufficient guardrails 

to prevent funds from being applied to 

items that were not covered, and the 

method of access was otherwise 

implemented consistent with applicable 

law. Subject to the requirements for 

utilizing reasonable medical 

management techniques 109 and 

consistent with previously issued 

guidance 110 (including providing access 

to an easily accessible, transparent, and 

sufficiently expedient exceptions 

process that is not unduly burdensome 

on the individual, a provider, or other 

authorized representative),111 plans and 

issuers would be able to utilize 

reasonable medical management 

techniques to contain costs and promote 

efficient delivery of care, and could 

consider how to do so within the 


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112 26 CFR 54.9815–2713(a)(4); 29 CFR 2590.715– 

2713(a)(4); and 45 CFR 147.130(a)(4). 

113See FAQs Part 54, Q3 (July 28, 2022), 

available at https://www.dol.gov/sites/dolgov/files/ 

EBSA/about-ebsa/our-activities/resource-center/ 

faqs/aca-part-54.pdf. 

114See sections II.A.1 (for discussion of proposal 

to amend the general requirements related to 

reasonable medical management) and II.A.2.b (for 

discussion of proposed amendment regarding 

reasonable medical management for contraceptive 

drugs and drug-led combination products, 

including OTC contraceptive items) of the preamble 

to these proposed rules. 

115 In States that have implemented a 12-month 

prescription limitation, plans and issuers are 

required to cover without cost sharing a supply of 

up to 12 months when indicated by the prescribing 

provider. See Power to Decide (August 2023), 

‘‘Coverage for an Extended Supply of 

Contraception,’’ available at https://

powertodecide.org/sites/default/files/2023-08/ 

Extended%20Supply%20of%20Contraception.pdf. 

Since the comment submission period for the OTC 

Preventive Products RFI closed, additional States 

have enacted coverage requirements related to 

extended contraceptive supplies. See NCSL, ‘‘State 

Contraception Policies,’’ available at https://

www.ncsl.org/health/state-contraception-policies. 

context of such an approach for out-ofnetwork coverage of OTC contraceptive 

items. For example, a plan or issuer 

would be able to program a debit or 

credit card or linked account to limit 

reimbursement to a set amount within a 

specified period of time, provided such 

limitations do not unreasonably limit 

coverage of covered OTC contraceptive 

items. 

The Departments are aware that some 

OTC contraceptive items, such as 

software applications granted marketing 

authorization by the FDA for use as 

contraception, are typically not 

furnished by in-network providers (for 

example, because consumers purchase 

them directly from a manufacturer or 

vendor website). As with other 

recommended preventive services for 

which a plan or issuer does not have an 

in-network provider who can provide 

the item or service, the plan or issuer 

would be required to cover the item or 

service when delivered by an out-ofnetwork provider and could not impose 

cost sharing with respect to the item or 

service. The Departments request 

comment on whether additional 

guidance is necessary to ensure that 

individuals would be able to use their 

health coverage to obtain OTC 

contraceptive items that are typically 

obtained outside of the traditional 

system of network providers with zero 

cost sharing and without unnecessarily 

burdensome reimbursement 

requirements, while permitting plans 

and issuers to utilize reasonable medical 

management techniques. 

The Departments request comment on 

how plans and issuers would likely 

operationalize out-of-network coverage 

and whether the Departments should 

adopt specific standards for out-ofnetwork coverage with respect to OTC 

contraceptive items. In addition, 

participants, beneficiaries, and enrollees 

would benefit if plans and issuers 

provide access to a broad network of 

providers with the capacity to provide 

the full range of OTC contraceptive 

items, and the Departments request 

comment on how to support and 

incentivize plans and issuers to develop 

such networks. 

(2) Reasonable Medical Management 

Techniques for OTC Contraceptive 

Services 

As discussed in section II.A.1 of this 

preamble, to the extent not specified in 

the applicable recommendation or 

guideline, plans and issuers may rely on 

the relevant clinical evidence base and 

established reasonable medical 

management techniques to determine 

the frequency, method, treatment, or 

setting for coverage of a recommended 

preventive health service.112 In prior 

guidance, the Departments have stated 

that if a plan or issuer utilizes medical 

management techniques within a 

specified category of contraception (or, 

with respect to contraceptive categories 

not specifically described in the HRSAsupported Guidelines, a group of 

substantially similar services or 

products), the use of those techniques 

will not be considered reasonable unless 

the plan or issuer has an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that is not 

unduly burdensome on the individual 

or their attending provider (or other 

individual acting as the individual’s 

authorized representative) allowing 

such individual to obtain coverage for a 

service or FDA-approved, -cleared, or 

-granted product determined to be 

medically necessary, as determined by 

the individual’s attending provider.113

The Departments are not proposing 

amendments to the medical 

management provisions specific to OTC 

contraceptive items. Therefore, these 

standards, as well as the new standards 

proposed in these rules,114 would apply 

to a plan’s or issuer’s use of medical 

management techniques with respect to 

OTC contraceptive items in the same 

manner and to the same extent as they 

would apply to other recommended 

preventive services. 

The Departments recognize that plans 

and issuers may encounter unique 

issues related to medical management if 

the Departments finalize the proposed 

requirements to cover OTC 

contraceptive items. In the OTC 

Preventive Products RFI, the 

Departments requested comment on 

what types of reasonable medical 

management techniques plans and 

issuers would consider implementing if 

recommended OTC preventive products 

were required to be covered without 

cost sharing. In response, some 

commenters suggested plans and issuers 

could limit the number of products an 

individual could obtain during a given 

period as a guardrail for OTC 

contraceptive services. One commenter 

stated that quantity limits would help 

prevent inequitable distribution and 

stockpiling for resale of OTC 

contraceptive services. Another 

commenter urged the Departments to 

allow plans and issuers to limit the 

initial purchase of OTC contraceptive 

services until there is more 

understanding of the cost implications 

and distribution channels for OTC 

preventive services. Other commenters 

discouraged the use of quantity limits as 

a medical management technique out of 

concern that such limits would 

discourage continuation of use, by 

creating new access barriers for 

individuals that already face challenges 

engaging with the health care system, in 

particular individuals that are members 

of underserved communities. In 

addition, a commenter expressed 

concern about the difficulty in 

predicting the need for emergency 

contraception. 

Some commenters advocated for 12- 

month quantity limits for monthly OTC 

contraceptive services in order to 

balance the health equity concerns of 

individuals with the implementation 

challenges that may arise for retailers 

and plans and issuers transitioning to 

covering OTC contraceptive services 

without a prescription and without cost 

sharing. Some commenters noted that 

there is already ample precedent for 

requiring coverage of extended supplies 

of contraceptives, with at least 25 States 

and the District of Columbia requiring 

Medicaid and private payers to cover 

the dispensing of an extended (usually 

12-month) supply of prescription 

contraceptives.115 One commenter to 

the OTC Preventive Products RFI stated 

that purchasing contraceptive items in 

larger dispensing quantities may create 

opportunities for plans and issuers to 

negotiate pricing discounts that will 

decrease per-unit costs for plans and 

issuers as well as suppliers and 

distributors. The Departments note that 

when the OTC oral contraceptive 

became available in March 2024 for sale 

online and in stores under the brand 

name Opill®, the manufacturer’s 

suggested retail price for a 6-month 

supply was cheaper (per-month) than 


lotter on DSK11XQN23PROD with PROPOSALS4
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116Lupkin, S., NPR (March 18, 2024). ‘‘First overthe-counter birth control pill now for sale online,’’ 

available at https://npr.org/sections/health-shots/ 

2024/03/04/1235404522/opill-over-counter-birthcontrol-pill-contraceptive-shop. 

117See Steenland, M., Rodriguez, M., 

Marchbanks, P., and Curtis, K. (2013). ‘‘How does 

the number of oral contraceptive pill packs 

dispensed or prescribed affect continuation and 

other measures of consistent and correct use? A 

systematic review,’’ Contraception, available at 

https://www.sciencedirect.com/science/article/pii/

S0010782412007317?via%3Dihub. 

118See Judge-Golden, C. P., Smith, K. J., Mor, M. 

K., and Borrero, S. (2019). ‘‘Financial Implications 

of 12-Month Dispensing of Oral Contraceptive Pills 

in the Veterans Affairs Health Care System,’’ JAMA 

Internal Medicine, available at https://doi.org/ 

10.1001/jamainternmed2019.1678 (study of the 

Veterans Affairs health care system finding that a 

12-month supply better supports continuous usage 

of contraceptive items than a 3-month supply and 

decreases the risk of unwanted pregnancies, and 

concluding that a 12-month dispensing option 

would likely result in a $2 million dollar annual 

cost-savings for the Veterans Affairs health care 

system). 

119See Kripke, C. (2000). ‘‘Advance Provision for 

Emergency Oral Contraception,’’ American Family 

Physician, available at https://www.aafp.org/pubs/ 

afp/issues/2007/0901/p654.html; Jackson R.A., 

Bimla Schwarz, E., Freedman L, Darney P. (2003). 

‘‘Advance supply of emergency contraception: 

effect on use and usual contraception—a 

randomized trial,’’ Obstetrics and Gynecology, 

available at https://pubmed.ncbi.nlm.nih.gov/ 

12850599. 

120See 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. 

121 Id. 

122See 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/democratsoversight.house.gov/files/2022-10-25.COR%20PBMInsurer%20Report.pdf. 

the manufacturer’s suggested retail price 

for a 1-month supply.116

Literature on contraception shows 

that dispensing a multi-month supply of 

prescription oral contraceptive pills at 

one time during the plan year is 

generally associated with increased 

continuation of contraception use, 

decreased occurrence of unintended 

pregnancy, and greater cost savings, but 

also more pill waste, compared to 

dispensing a single month’s 

supply.117 118 Research also shows that 

advance provision of emergency 

contraception significantly increases its 

use without adversely affecting the use 

of routine contraception,119 which 

suggests that it may be beneficial for 

women to receive more than one unit of 

emergency contraception at a time, in 

order to realize the benefits of advance 

provision for future use. Limitations on 

the supply of OTC contraception 

dispensed at one time should take into 

account the clinical evidence base 

regarding benefits to consumers, 

including as described in this section 

II.a.2. 

Given the evidence regarding benefits 

to consumers of a multi-month supply 

of prescription oral contraceptive pills, 

the Departments would generally not 

consider coverage limitations that only 

allow for a 1-month supply of an OTC 

oral contraception per instance of 

dispensing to be reasonable or 

consistent with the requirement to cover 

recommended preventive services under 

26 CFR 54.9815–2713(a)(4), 29 CFR 

2590.715–2713(a)(4), and 45 CFR 

147.130(a)(4) if there is no clinical basis 

for limiting the quantity to be dispensed 

at one time. The Departments seek 

comment, with respect to all forms of 

OTC contraceptives, on whether other 

quantity limits (such as a 6-month limit 

on OTC oral contraception or a 3-unit 

limit on OTC emergency contraception 

per instance of dispensing) should be 

considered reasonable or unreasonable, 

and what additional facts and 

circumstances should be considered 

when determining the reasonableness of 

a particular quantity limit with respect 

to OTC contraception, such as initial 

success with a shorter supply of OTC 

contraception. The Departments also 

request comment on the circumstances 

under which participants, beneficiaries, 

and enrollees who receive an initial 

extended quantity of OTC contraception 

could access a different form of 

contraception without incurring cost 

sharing before finishing the initial 

extended quantity (for example, before a 

6-month supply is exhausted). 

Some commenters to the OTC 

Preventive Products RFI suggested 

individuals should be required to 

submit evidence to a plan or issuer that 

a particular form of prescription birth 

control is inappropriate before receiving 

coverage for an OTC contraceptive 

service. The Departments previously 

issued guidance that it is not a 

reasonable medical management 

technique to require individuals to fail 

first using numerous other services or 

FDA-approved, -cleared, or -granted 

contraceptive products before the plan 

or issuer will approve coverage for the 

service or FDA-approved, -cleared, or 

-granted contraceptive product that is 

medically necessary for the individual, 

as determined by the individual’s 

attending provider.120 Within the 

context of medical management of OTC 

contraceptive items, the Departments 

would not consider it reasonable either 

to impose a prescription requirement for 

OTC contraception as a form of medical 

management, including requiring an 

individual to fail first using a 

prescription-only contraceptive item 

before providing coverage of an OTC 

contraceptive item without cost sharing, 

or to require an individual to fail first 

with numerous prescription or OTC 

contraceptive items before the plan or 

issuer will approve coverage for a 

medically necessary OTC contraceptive 

item. 

Other commenters suggested that a 

plan or issuer could consider 

implementing age-based limitations or 

gender-based requirements instead of 

offering benefits to all individuals with 

reproductive capacity. The Departments 

would not consider age- and genderbased medical management with respect 

to OTC contraceptive services to be 

reasonable unless the medical 

management technique relies on a 

clinical rationale for limiting access to 

individuals of a certain age or gender 

and is consistent with FDA approvals of 

any particular OTC contraceptive 

product. The Departments have stated 

in previous guidance that imposing an 

age limit on contraceptive coverage 

instead of providing these benefits to all 

women would not be considered a 

reasonable medical management 

technique.121

A commenter suggested that 

implementing prior authorization 

requirements with respect to certain 

OTC items would not be an 

unreasonable medical management 

technique. However, such medical 

management techniques create barriers 

for consumers accessing contraceptive 

services with a prescription 122 and 

would create similar barriers for 

consumers accessing contraceptives 

services without a prescription, with the 

added challenge that consumers seeking 

to obtain OTC contraceptive items are 

likely navigating such requirements 

without the assistance of a provider. 

Such requirements could be used as a 

means of circumventing the requirement 

to provide coverage of contraception 

without cost sharing and without a 

prescription. Therefore, under these 

proposed rules, coverage requirements 

that, in practice, operate as substitutes 

for a prescription coverage requirement 

by requiring the involvement of a 

provider (such as prior authorization 

processes that require provider 

involvement or other clinical expertise 

or a requirement that individuals 

receive counseling from a pharmacist 

prior to accessing an OTC contraceptive 

item) would not be considered 

reasonable medical management 

techniques with respect to OTC 

contraceptive items. 


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123See also 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. 

124See 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. 

125FAQs Part 64 (Jan. 22, 2024), available at 

https://www.dol.gov/agencies/ebsa/about-ebsa/ouractivities/resource-center/faqs/aca-part-64 and 

https://www.cms.gov/files/document/faqs-part64.pdf. 

Under these proposed rules, plans 

and issuers generally could adopt 

medical management techniques with 

respect to OTC contraceptive items that 

are not described as unreasonable in 

this preamble as long as they are 

otherwise consistent with proposed 26 

CFR 54.9815–2713(a)(4), 29 CFR 

2590.715–2713(a)(4), and 45 CFR 

147.130(a)(4) and existing guidance and 

the plan or issuer makes available an 

exceptions process as described in these 

proposed rules. The Departments 

request comment on what other medical 

management techniques plans and 

issuers would consider applying to OTC 

contraceptive items, including whether 

such techniques should be considered 

reasonable or unreasonable. The 

Departments request comment on the 

proposed interpretation of reasonable 

medical management requirements with 

respect to OTC contraceptive items, 

including whether any final regulations 

should specify or use examples to 

illustrate in the regulatory text the 

Departments’ interpretation of 

reasonable medical management for 

OTC contraceptive items. 

(3) Other Considerations 

The Departments acknowledge the 

concerns raised by commenters to the 

OTC Preventive Products RFI, such as 

risks to patient privacy, of 

overconsumption, and of fraud, waste, 

or abuse, that some commenters believe 

could be exacerbated with increased 

coverage with no cost sharing of OTC 

contraceptive items. These concerns 

could be heightened with respect to 

OTC items and services that do not 

require the input of a provider in the 

form of a prescription and may be 

further increased within the context of 

out-of-network providers with whom 

plans and issuers do not have 

contractual relationships. For example, 

plans and issuers may wish to ensure 

that individuals are obtaining OTC 

contraceptive items to prevent 

pregnancy rather than solely to address 

another underlying condition (such as 

to treat anemia or manage premenstrual 

symptoms) or to ensure that an 

individual is obtaining condoms for the 

use of a woman covered under the plan, 

rather than for use by another 

individual. Several commenters to the 

OTC Preventive Products RFI 

highlighted concerns that coverage of 

OTC preventive products without cost 

sharing could incentivize 

overconsumption or waste of such 

products. Additionally, OTC 

contraceptive items may present 

particular challenges with respect to 

patient privacy, given the deeply 

personal nature of reproductive health 

care and the dynamic nature of State 

laws governing access to reproductive 

health care. 

The Departments anticipate that plans 

and issuers with a network of providers 

would mitigate these risks by using 

existing claims processing systems with 

respect to in-network coverage, but 

acknowledge that coverage through 

pathways other than an in-network 

pharmacy may present privacy 

challenges (for example, because nonprovider retailers are not required to 

implement the same privacy and 

security safeguards as they are with 

respect to back-pharmacy transactions). 

The Departments request comment on 

how best to encourage plans and issuers 

to develop mechanisms that promote 

access to OTC contraceptive items in 

accordance with these proposed 

regulations, if finalized, while 

protecting patient privacy and allowing 

plans and issuers to identify and 

address risks including waste, fraud, 

and abuse. 

The Departments further request 

comment on how the proposed 

exceptions process requirement should 

apply with respect to OTC 

contraceptives items, for which no 

provider involvement is generally 

required. The proposed exceptions 

process requirement described in 

section II.A.1 of this preamble refers to 

the determination of an individual’s 

attending provider. Thus, the 

Departments request comment on what 

information individuals should be 

required to provide to seek an exception 

to access coverage for an OTC 

contraceptive item that is not typically 

covered, including how plans and 

issuers could determine whether an 

OTC contraceptive item is medically 

necessary, and whether any additional 

changes are necessary for an exceptions 

process when used to seek coverage, 

without cost sharing, for an OTC 

contraceptive item. 

The Departments also request 

comment on whether it would be 

beneficial to define a new term to refer 

to contraception that would be subject 

to the proposed amendments to 26 CFR 

54.9815–2713(a)(6), 29 CFR 2590.715– 

2713(a)(6), and 45 CFR 147.130(a)(6); 

and if so, request feedback on the 

appropriate term and scope of the 

definition. For example, the 

Departments request comment on 

whether to define ‘‘contraceptive item,’’ 

‘‘contraceptive product,’’ or 

‘‘contraceptive items and services’’ 

within the context of these proposed 

rules; and whether the term would refer 

to all contraceptive items and services 

recommended under the HRSAsupported Guidelines, all contraceptive 

items and services recommended under 

26 CFR 54.9815–2713(a)(1), 29 CFR 

2590.715–2713(a)(1), and 45 CFR 

147.130(a)(1); or another subset of 

recommended preventive services. 

b. Therapeutic Equivalence Approach to 

Reasonable Medical Management for 

Contraceptive Drugs and Drug-Led 

Combination Products 

As discussed in section II.A.2 of this 

preamble, despite repeated clarification 

in guidance, the Departments have 

continued to receive complaints and 

reports that participants, beneficiaries, 

and enrollees are being denied coverage 

for contraceptives that their attending 

providers have prescribed, in some 

cases due to the application of medical 

management techniques that are not 

reasonable based on all the relevant 

facts and circumstances.123 The 

Departments are also aware of 

investigations and other credible reports 

that have documented plans and issuers 

using potentially unreasonable medical 

management techniques.124 In response 

to these reports, the Departments issued 

FAQs Part 64 on January 22, 2024, 

which set forth a therapeutic 

equivalence approach that plans and 

issuers can, but are not required to, use 

(in combination with an easily 

accessible, transparent, and sufficiently 

expedient exceptions process) to 

comply with PHS Act section 2713 and 

its implementing regulations with 

respect to FDA-approved contraceptive 

drugs and drug-led devices, as an 

alternative to standards that had been 

set forth in previous guidance and 

described in section II.A.1 of this 

preamble.125 The Departments have 

determined that it is necessary to 

require the therapeutic equivalence 

approach to ensure coverage of the full 

range of FDA-approved contraceptive 

items that are drugs and drug-led 

combination products. The proposed 

therapeutic equivalence approach 

would serve as a guardrail against the 

widespread use of narrow drug 

formularies, which the Departments 


lotter on DSK11XQN23PROD with PROPOSALS4
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126See Dieguez, G., Sawhney, T., and 

Mirchandani, H., Milliman (2016). ‘‘Evolution of 

the Use of Restrictions in Commercial 

Formularies,’’ available at https://

www.milliman.com/-/media/milliman/ 

importedfiles/uploadedfiles/insight/2016/evolutionrestrictions-commercial-formularies.ashx; Rucker, 

J., Benfield, M., Jenkins, N., Enright, D., Henderson, 

R., Chambers, J. (2023). ‘‘Commercial Coverage of 

Specialty Drugs, 2017–2021’’ Health Affairs 

Scholar, available at https://academic.oup.com/ 

healthaffairsscholar/article/1/2/qxad030/7236995. 

127FAQs Part 64, Q2 (Jan. 22, 2024), available at 

https://www.dol.gov/agencies/ebsa/about-ebsa/ouractivities/resource-center/faqs/aca-part-64 and 

https://www.cms.gov/files/document/faqs-part64.pdf. 

128FDA, ‘‘Orange Book Preface,’’ available at 

https://www.fda.gov/drugs/development-approvalprocess-drugs/orange-book-preface. 

129FAQs Part 54, Q8 (July 28, 2022), available at 

https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ 

faqs-part-54.pdf. 

130The Departments acknowledge that the 

proposed therapeutic equivalence standard would 

require plans and issuers to cover more 

contraceptive drugs and drug-led combination 

products than under FAQs Part XXVI, Q2, which 

specified that a plan or issuer must cover at least 

one form of contraception in each method that is 

identified by the FDA. The Departments have 

determined that this approach is necessary to 

ensure coverage of the full range FDA-approved 

contraceptive drugs and drug-led combination 

products, as required under section 2713 of the PHS 

Act, while still permitting plans and issuers to 

contain costs by not requiring plans and issuers to 

cover items for which there is at least one 

therapeutic equivalent drug or drug-led 

combination product, as applicable, for which the 

plan or issuer provides coverage without imposing 

any cost-sharing requirements. The FDA defines 

‘‘therapeutic equivalents’’ at 21 CFR 314.3(b) as 

approved drug products that are pharmaceutical 

equivalents (meaning, in general, that they contain 

identical amounts of the identical active drug 

ingredient in the identical dosage form and route 

of administration) and bioequivalents (meaning, in 

understand plans and issuers use to 

limit costs, but can have the effect of 

limiting access to medically appropriate 

contraceptive drugs and drug-led 

combination products.126 This proposed 

regulation would limit the use of such 

techniques with respect to 

recommended contraceptive drugs and 

drug-led combination products. 

Therefore, the Departments propose to 

amend 26 CFR 54.9815–2713, 29 CFR 

2590.715–2713, and 45 CFR 147.130 to 

add a new paragraph (a)(6)(iii) that 

would specify that a plan’s or issuer’s 

medical management techniques are not 

considered to be reasonable unless the 

plan or issuer provides coverage for 

recommended preventive services that 

are contraceptive drugs and drug-led 

combination products, other than those 

items for which there is at least one 

therapeutic equivalent drug or drug-led 

combination product, as applicable, for 

which the plan or issuer provides 

coverage without imposing any costsharing requirements, consistent with 

the therapeutic equivalence approach 

described in FAQs Part 64. The 

Departments also propose to define 

‘‘therapeutic equivalent’’ for purposes of 

this proposed provision as having the 

meaning given the term ‘‘therapeutic 

equivalents’’ in 21 CFR 314.3(b), which 

defines ‘‘therapeutic equivalents’’ as 

‘‘approved drug products that are 

pharmaceutical equivalents for which 

bioequivalence has been demonstrated, 

and that can be expected to have the 

same clinical effect and safety profile 

when administered to patients under 

the conditions specified in the 

labeling.’’ 

Under this proposal, consistent with 

FAQs Part 64, a therapeutic equivalent 

drug or drug-led combination product 

would be one that is designated with a 

code with the first letter ‘‘A’’ in the 

FDA’s Approved Drug Products with 

Therapeutic Equivalence Evaluations 

(Orange Book).127 If the Orange Book 

does not identify a therapeutic 

equivalent for a given drug or drug-led 

combination product, that drug or drugled combination product would have no 

therapeutic equivalent for purposes of 

these proposed rules, and a plan or 

issuer would not be permitted to use 

medical management techniques to 

deny coverage of (or impose cost sharing 

on) that drug or drug-led combination 

product. For example, assume that there 

are six oral contraceptives (Pill A, Pill 

B, Pill W, Pill X, Pill Y, and Pill Z) listed 

in the Orange Book that are within the 

HRSA-supported Guidelines category of 

contraceptives known as ‘‘oral 

contraceptives (combined pill).’’ If the 

Orange Book does not identify a 

therapeutic equivalent for either Pill A 

or Pill B, but identifies the latter four 

(Pill W, Pill X, Pill Y, and Pill Z) as 

therapeutic equivalents of each other, 

then under these proposed rules, the 

plan would be required to cover without 

cost sharing Pill A and Pill B, for which 

there are no therapeutic equivalents. 

The plan could utilize reasonable 

medical management techniques that 

result in it covering only one of Pill W, 

Pill X, Pill Y, or Pill Z without cost 

sharing because all four are 

therapeutically equivalent to each other 

(provided the plan has an exceptions 

process that ensures an individual can 

receive coverage, without cost sharing, 

for any of Pill W, Pill X, Pill Y, or Pill 

Z, in the circumstances discussed in 

more detail in section II.A.1 of this 

preamble). 

In the Orange Book, the FDA 

evaluates only multisource prescription 

drug products for therapeutic 

equivalence.128 Therefore, the FDA does 

not evaluate therapeutic equivalence for 

OTC drugs or OTC drug-led 

combination products and the Orange 

Book does not categorize such products 

as a ‘‘therapeutic equivalent’’ of any 

other drug or drug-led combination 

product. As described in section II.A.2, 

the Departments are proposing to 

require plans and issuers to provide 

coverage of OTC contraceptives without 

cost sharing and without requiring a 

prescription. If both the therapeutic 

equivalence proposal described in this 

preamble section and the OTC 

contraceptive coverage proposal are 

finalized, plans and issuers would be 

required to cover all OTC contraceptive 

items that are drugs and drug-led 

combination products without cost 

sharing. The Departments request 

comment on the potential impacts to 

interested parties, including 

participants, beneficiaries, and enrollees 

and plans and issuers, if both proposals 

are finalized. The Departments further 

request comment on whether an 

alternative approach to therapeutic 

equivalence would be appropriate for 

OTC contraceptive drugs and drug-led 

combination products. If so, the 

Departments request comment on what 

medical management techniques would 

be appropriate and reasonable while 

balancing the goals of increasing 

consumer access to OTC contraceptive 

drugs and drug-led combination 

products and containing costs. For 

example, the Departments seek 

comment on whether plans and issuers 

should be permitted to provide coverage 

without cost-sharing or prescription 

requirements of a preferred generic 

version of an OTC contraceptive, while 

only covering the brand version without 

cost-sharing or prescription 

requirements subject to an exceptions 

process. 

In addition to satisfying the 

therapeutic equivalence approach, the 

Departments would not consider a 

plan’s or issuer’s medical management 

techniques with respect to 

recommended contraceptive services to 

be reasonable unless the plan or issuer 

meets existing standards under 

applicable regulations and guidance, to 

the extent not superseded by the other 

proposals in these proposed rules. For 

example, as described in FAQs Part 54, 

Q8, a plan’s or issuer’s medical 

management techniques would 

generally be considered reasonable only 

if the plan or issuer utilizes reasonable 

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).129 130 Therefore, if a plan or 


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general, that the rate and extent of the active 

ingredient at the site of action are the same), and 

that can be expected to have the same clinical effect 

and safety profile when administered to patients 

under the conditions specified in the labeling. The 

contraceptives described in the HRSA-supported 

Guidelines do not refer to therapeutic equivalence, 

and as a result, there may be multiple drugs or 

drug-led combination products within a category 

that are not therapeutically equivalent to each 

other. For example, within the ‘‘oral contraceptives 

(combined pill)’’ category identified in the HRSAsupported Guidelines, there could exist multiple 

products that are oral contraceptive combined pills 

but are not therapeutically equivalent because, for 

example, they contain different amounts of the 

same active ingredients. Under this proposal, a plan 

or issuer would be required to cover, without cost 

sharing, at least one oral contraceptive combined 

pill that has a therapeutic equivalent, as well as 

each non-therapeutic equivalent oral contraceptive 

combined pill, rather than at least one form of an 

oral contraceptive combined pill in the category. 

issuer provided coverage consistent 

with the proposed therapeutic 

equivalence approach, but used medical 

management techniques to deny 

coverage or impose cost sharing for all 

contraceptives in another category (or 

other groups of substantially similar 

products), such as the category for 

sterilization surgery for women, the 

plan’s or issuer’s medical management 

techniques would not be considered to 

be reasonable. Similarly, consistent with 

FAQs Part 54, Q8, the Departments 

would not consider a plan’s or issuer’s 

medical management techniques to be 

reasonable if the plan or issuer requires 

an individual to fail first using 

numerous contraceptives within a 

category prior to providing coverage 

consistent with the proposed 

therapeutic equivalence approach. 

In addition, consistent with FAQs 

Part 64, the Departments would not 

consider the use of medical 

management techniques to be 

reasonable where a plan or issuer 

provides coverage consistent with the 

proposed therapeutic equivalence 

approach but fails to provide an 

exceptions process that meets the 

standards proposed in these rules. 

Requiring plans and issuers that utilize 

reasonable medical management to both 

apply the therapeutic equivalence 

approach and provide an exceptions 

process would be particularly important 

in instances where the plan’s or issuer’s 

preferred method is not medically 

appropriate for an individual. Consider 

an example in which there are three 

products within the HRSA-supported 

Guidelines category of ‘‘the 

contraceptive patch’’ (Patch A, Patch B, 

and Patch C) and the Orange Book 

identifies all three products as 

therapeutic equivalents to each other. 

Under the proposed therapeutic 

equivalence approach, a plan or issuer 

would be permitted to utilize reasonable 

medical management techniques that 

result in it generally covering only one 

of Patch A, Patch B, or Patch C without 

cost sharing because all are 

therapeutically equivalent to each other. 

However, without an exceptions 

process, a person who, for example, has 

an allergy to a non-therapeutic 

ingredient in Patch A such as a dye or 

an adhesive could not access an 

alternative such as Patch B or Patch C 

that is determined to be medically 

necessary by the individual’s attending 

provider, and as a result, would be 

denied the coverage required under PHS 

Act section 2713. 

The Departments propose to define 

‘‘drug-led combination product’’ at 26 

CFR 54.9815–2713(a)(6)(i)(A), 29 CFR 

2590.715–2713(a)(6)(i)(A), and 45 CFR 

147.130(a)(6)(i)(A) as ‘‘a combination 

product, as defined under 21 CFR 3.2(e), 

that comprises a drug and a device, and 

for which the drug component provides 

the primary mode of action.’’ The term 

‘‘combination products’’ refers to the 

existing FDA definition of ‘‘combination 

product’’ at 21 CFR 3.2(e), and would 

apply only to drug-led combination 

products within the context of the 

proposed therapeutic equivalence 

approach discussed in this section 

II.A.2.b of this preamble. While this 

proposal would not prevent plans and 

issuers from applying a therapeutic 

equivalence approach to other 

recommended preventive services, the 

Departments request comment on 

whether plans and issuers utilizing 

reasonable medical management of 

recommended preventive services other 

than contraceptive drugs and drug-led 

combination products should be 

required to apply the therapeutic 

equivalence approach as described in 

these proposed rules. 

B. Communicating OTC Contraceptive 

Coverage Requirements 

Because plans and issuers have not 

traditionally provided coverage for 

health items that can be purchased 

directly by a consumer without a 

prescription, participants, beneficiaries, 

and enrollees may not be aware that 

their health plan or coverage would 

cover OTC contraceptive items without 

cost sharing and without a prescription 

if these proposed rules are finalized. 

The Departments expect that without 

sufficient communication about this 

new coverage requirement from plans 

and issuers, consumers’ lack of 

awareness may lead to minimal use of 

this benefit. Therefore, these proposed 

rules propose new requirements under 

26 CFR 54.9815–2715A2, 29 CFR 

2590.715–2715A2, and 45 CFR 147.211 

that would ensure participants, 

beneficiaries, and enrollees are 

informed of this new coverage. 

Section 2715A of the PHS Act 

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. Through section 

1311(e)(3)(C) of the ACA, section 2715A 

of the PHS Act requires plans and 

issuers to permit individuals to learn 

the amount of cost sharing (including 

deductibles, copayments, and 

coinsurance) associated with a specific 

item or service furnished by an innetwork provider upon the individual’s 

request. 

Under the Departments’ rulemaking 

authority in section 9833 of the Code, 

section 734 of ERISA, and 2792 of the 

PHS Act to implement section 2715A of 

the PHS Act, the Departments propose 

to require that plans and issuers permit 

individuals to learn the amount of cost 

sharing associated with OTC 

contraceptive items covered by their 

plan or coverage without a prescription. 

Specifically, the Departments propose to 

amend 26 CFR 54.9815–2715A2, 29 CFR 

2590.715–2715A2, and 45 CFR 147.211 

to add a new paragraph (b)(1)(vi) that 

would require plans and issuers to 

provide information to participants, 

beneficiaries, and enrollees explaining 

that OTC contraceptive items are 

covered without cost sharing and 

without a prescription consistent with 

these proposed rules when participants, 

beneficiaries, and enrollees request costsharing information for any covered 

contraceptive item or service. By 

promoting awareness of coverage of 

OTC contraceptive items without costsharing or prescription requirements, 

these proposals serve as important 

companions to proposed 26 CFR 

54.9815–2713(a)(6), 29 CFR 2590.715– 

2713(a)(6), and 45 CFR 147.130(a)(6), 

described in section II.A.2.a of this 

preamble. 

In accordance with PHS Act section 

2715A and ACA section 1311(e)(3)(C), 

under current 26 CFR 54.9815– 

2715A2(b), 29 CFR 2590.715– 

2715A2(b), and 45 CFR 147.211(b), 

plans and issuers must disclose an 

estimate of the participant’s, 

beneficiary’s, or enrollee’s cost-sharing 

liability for all covered items or services 

furnished by a provider or providers, 

through the Transparency in Coverage 

internet-based self-service tool or, if 

requested by the individual, paper. 

Under current rules, if a participant, 

beneficiary, or enrollee uses the selfservice tool to look up contraceptive 

items or services with respect to an innetwork pharmacy (or to look up the 


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131The Departments issued proposed rules to 

rescind the moral exemption to the contraceptive 

coverage requirement under 45 CFR 147.133. 88 FR 

7236 (Feb. 2, 2023). 

132See sections II.A.1 and II.A.2.b of the preamble 

to these proposed rules, respectively, for a 

discussion of the exceptions process and 

therapeutic equivalence approach proposals. 

out-of-network cost sharing for these 

items or services for a plan or issuer that 

does not have a provider in its network 

that can provide the preventive item), 

the self-service tool would display the 

non-zero dollar cost-sharing liability for 

the individual that is associated with 

being billed as non-preventive (if 

applicable), along with a statement that 

the contraceptive item or service may 

not be subject to cost sharing if it is 

billed as preventive. For contraceptive 

items that are only covered by the plan 

or coverage for preventive purposes 

(including because they are only 

indicated for preventive purposes), 

current rules require the self-service tool 

to reflect a zero-dollar cost-sharing 

liability. The Departments note also that 

some contraceptive items may be 

covered for non-preventive purposes 

(either with or without a prescription), 

and in this case the self-service tool 

would reflect the non-zero dollar costsharing liability. The Departments also 

note that under current rules, plans and 

issuers are not required to disclose any 

cost-sharing information through the 

self-service tool for non-covered items 

and services, including with respect to 

contraceptive items and services. 

Nothing in these proposed rules alters 

these disclosure requirements. 

As discussed in section II.A.2 of this 

preamble, the Departments are 

proposing to require plans and issuers 

to cover OTC contraceptive items 

without a prescription and without 

imposing cost-sharing requirements. To 

ensure individuals are aware that OTC 

contraceptive items are covered 

consistent with these proposed rules, 

plans and issuers would be required to 

inform individuals of this benefit under 

the plan or coverage. Participants, 

beneficiaries, and enrollees should have 

access to more robust information to 

ensure they understand their plan’s or 

issuer’s policies regarding coverage of 

OTC contraceptive items without a 

prescription and without cost sharing, 

and in the Departments’ view, the selfservice tool would offer an effective 

means of communicating such 

information. Therefore, the Departments 

propose to require plans and issuers to 

make an additional cost-sharing 

information disclosure to participants, 

beneficiaries, and enrollees in new 

proposed 26 CFR 54.9815– 

2715A2(b)(1)(vi), 29 CFR 2590.715– 

2715A2(b)(1)(vi), and 45 CFR 

147.211(b)(1)(vi). Specifically, if a 

participant, beneficiary, or enrollee 

requests cost-sharing information for 

any covered contraceptive item or 

service through a self-service tool, the 

proposed rules would require the 

response through the self-service tool or, 

if requested, on paper to include with 

the information a statement explaining 

that OTC contraceptive items are 

covered without cost sharing and 

without a prescription. This statement 

would be required to include a phone 

number and internet link that a 

participant, beneficiary, or enrollee 

could use to learn more information 

about the plan’s or policy’s 

contraception coverage. This could be a 

link to an existing web page and a 

general customer service line that the 

plan or issuer already maintains. 

The requirement to provide this 

information would be triggered by a 

search in the self-service tool for any 

covered contraceptive items or services, 

including items or services that are not 

drugs or drug-led combination products 

or are not available without a 

prescription, so that any user seeking 

options to prevent pregnancy would be 

made aware that OTC contraceptive 

items are covered without cost sharing. 

Under this proposed requirement, the 

disclosure would be required regardless 

of whether the user is searching for costsharing information for contraceptive 

items and services from an in-network 

or out-of-network provider, or if the 

plan or coverage maintains no network 

of providers. As such, plans and issuers, 

including those without a network of 

providers, would be required to disclose 

that they will cover OTC contraceptive 

items without cost sharing or a 

prescription in accordance with 

proposed 26 CFR 54.9815–2713(a)(6), 29 

CFR 2590.715–2713(a)(6), and 45 CFR 

147.130(a)(3)(ii). The Departments note 

that because the self-service tool 

requirements apply to covered items 

and services, the disclosure 

requirements proposed in this section 

would not apply to plans and issuers 

that do not cover contraceptive items or 

services based on an objection under 45 

CFR 147.132 or 147.133.131 The 

Departments request comment on 

whether and how these proposed 

requirements should apply to entities 

that have an objection to only some 

contraceptive items and services. 

The Departments also request 

comment on whether plans and issuers 

should have the option to include in the 

statement either a phone number or an 

internet link—rather than both—to 

where a participant, beneficiary, or 

enrollee can learn more about the plan’s 

or policy’s contraception coverage. The 

Departments are interested in better 

understanding the benefits and burdens 

associated with each approach. 

The Departments also request 

comment on whether plans and issuers 

should be required to include in this 

statement the general names or types of 

OTC contraceptive items that are 

covered without a prescription and 

without cost sharing (for example, 

‘‘daily oral contraceptive,’’ ‘‘Plan B 

(levonorgestrel),’’ or ‘‘condoms’’). Under 

this approach, users would not need to 

call the provided phone number or 

navigate to the linked web page and 

could simply copy and paste the 

provided product names into the selfservice tool’s search field to find local 

pharmacies where they can access the 

product without a prescription and 

without cost sharing. In particular, the 

Departments request comment on the 

burdens on plans and issuers to provide 

a list that may need to be updated in the 

self-service tool’s statement as 

circumstances change (such as if 

additional OTC contraceptive items 

come to market or new therapeutic 

equivalents become available) or that 

could require multiple alternative 

disclosures for a plan or issuer that has 

coverage options across geographic 

regions based on availability in the 

specific market. In addition, the 

Departments request comment on 

potential benefits to consumers of 

listing in the tool itself the OTC 

contraceptive items covered without a 

prescription and without cost sharing, 

rather than having to gather this 

information by clicking an internet link 

or calling a customer service line. 

The Departments also request 

comment on whether plans and issuers 

should be required to include in the 

statement information on coverage of 

therapeutic equivalents or the 

exceptions process under these 

proposed rules and, if so, how 

disclosures should be presented to 

ensure the additional information is 

meaningful and actionable for 

consumers.132 For example, the 

Departments request comment on 

whether the statement should indicate 

that an exceptions process is available 

so individuals can receive coverage for 

any recommended preventive service, 

including an OTC contraceptive item, 

that is medically necessary for the 

individual; and, if so, how to present 

this information in a way that would be 

meaningful and actionable for 

consumers. Similarly, the Departments 

request comment on whether the 


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statement should disclose that plans 

and issuers must cover all FDAapproved contraceptive drugs and drugled combination products without cost 

sharing, other than those for which 

there is at least one therapeutic 

equivalent drug or drug-led combination 

product that the plan or issuer covers 

without cost sharing; and, if so, how to 

present this information in a way that 

would be meaningful and actionable for 

consumers. 

The Departments also request 

comment regarding the challenges of 

implementing and maintaining such 

statements, information about their 

potential effectiveness in improving 

access to OTC contraceptive items, and 

other information that could help 

inform potential future disclosures 

related to other recommended 

preventive services. The Departments 

also request comment on whether 

additional self-service tool requirements 

need to be specified to ensure plans and 

issuers fully inform participants, 

beneficiaries, and enrollees of the 

availability of covered OTC 

contraceptive items without cost 

sharing. 

Lastly, the Departments believe that 

broadly disseminating information on 

the availability and coverage of OTC 

contraceptive items without cost sharing 

to eligible individuals and members of 

the public would increase access to this 

benefit, if finalized as proposed, and 

would allow individuals to select the 

plan that best meets their needs. 

Therefore, the Departments request 

comment on how plans and issuers 

could efficiently and effectively provide 

such information to eligible individuals, 

participants, beneficiaries, enrollees, 

and members of the public, including 

the relative benefits and burdens of 

doing so. For example, the Departments 

are interested in whether it would be 

feasible for plans and issuers to provide 

general coverage and cost-sharing 

information on a public website. 

Similarly, the Departments are 

interested in whether plans and issuers 

should be required to provide more 

tailored cost and benefit information to 

participants, beneficiaries, or enrollees 

when they provide other relevant plan 

documents, such as Summaries of 

Benefits and Coverage (SBCs) or drug 

formularies. The Departments also 

request comment on how plans and 

issuers can make information available 

to participants, beneficiaries, and 

enrollees about the specific steps they 

would need to take to access OTC 

contraceptive items without cost 

sharing, particularly when plans and 

issuers do not have network providers 

available that can provide access to such 

items. Lastly, the Departments request 

comment on additional ways to 

communicate this information 

effectively to individuals in vulnerable 

and underserved communities. 

C. Applicability 

The proposed amendments to 26 CFR 

54.9815–2713(a)(4), 29 CFR 2590.715– 

2713(a)(4), and 45 CFR 147.130(a)(4) 

regarding an exceptions process would 

apply on the effective date of the final 

rules. The Departments assume that 

most plans and issuers generally already 

have in place an exceptions process for 

recommended preventive services to 

align with previously issued guidance, 

although the Departments acknowledge 

in section IV.B.2.d of this preamble that 

some plans and issuers could incur 

costs to develop or update an exceptions 

process to comply with these proposed 

rules, if finalized. While prior guidance 

has generally focused on the use of an 

exceptions process in the context of 

contraceptive coverage and coverage of 

PrEP to prevent HIV, the Departments 

expect that plans and issuers could 

adapt existing exceptions processes to 

accommodate additional recommended 

preventive services as necessary to 

comply with the proposed amendments 

by the effective date of the final rules. 

The Departments propose delayed 

applicability dates for the proposed 

amendments to the preventive services 

regulations that are specific to 

contraceptive items. Specifically, the 

Departments propose that the proposed 

provisions of 26 CFR 54.9815– 

2713(a)(6), 29 CFR 2590.715–2713(a)(6), 

and 45 CFR 147.130(a)(6) would apply 

for plan years (in the individual market, 

policy years) beginning on or after 

January 1, 2026. These proposed rules, 

if finalized, would mandate the use of 

the currently optional therapeutic 

equivalence approach described in 

FAQs Part 64, where applicable, and 

newly require the coverage of OTC 

contraceptive items without a 

prescription. In the Departments’ view, 

the proposed applicability dates 

appropriately balance the need for 

improved access to coverage of 

recommended preventive services with 

the time necessary for plans and issuers 

to make the systems and operational 

changes to implement these proposals. 

Until any final rules are issued and 

applicable, the Departments would 

continue to consider plans and issuers 

that provide coverage consistent with 

the therapeutic equivalence approach 

and have an easily accessible, 

transparent, and sufficiently expedient 

exceptions process that is not unduly 

burdensome as outlined in FAQs Part 64 

to be in compliance with section 2713 

of the PHS Act and its implementing 

regulations with respect to coverage of 

recommended contraceptives that are 

drugs and drug-led devices. 

To align with applicability dates for 

the proposed requirements for OTC 

contraceptive items and therapeutic 

equivalents, the proposed requirements 

in 26 CFR 54.9815–2715A2, 29 CFR 

2590.715–2715A2 and 45 CFR 147.211 

that would direct plans and issuers to 

disclose information related to 

contraceptive coverage in the selfservice tool would be applicable to 

plans and issuers for plan years (or in 

the individual market, policy years) 

beginning on or after January 1, 2026. 

The Departments request comment on 

the proposed applicability dates. With 

respect to the proposed delayed 

applicability dates, the Departments 

request comment on whether an earlier 

applicability date (such as the effective 

date of any final rules) would be 

feasible. 

III. Severability 

In the event that any provision of 

these proposed rules, if finalized, is 

held to be invalid or unenforceable by 

its terms, or as applied to any person or 

circumstance, the Departments intend 

that these rules shall be construed so as 

to continue to give maximum effect to 

these rules as permitted by law, unless 

the holding shall be one of utter 

invalidity or unenforceability. In the 

event a provision is found to be utterly 

invalid or unenforceable, the provision 

shall be severable from these proposed 

rules as finalized, as well as the final 

rules they amend and shall not affect 

the remainder thereof or the application 

of the provision to persons not similarly 

situated or to dissimilar circumstances. 

In these rules, the Departments are 

proposing several amendments to 

reduce barriers to coverage and promote 

access to recommended preventive 

services, including OTC contraceptive 

items. The Departments’ authority 

under section 9833 of the Code, section 

734 of ERISA, sections 2713, 2715A, 

and 2792 of the PHS Act, and sections 

1311(e)(3)(C) and 1321 of the ACA to 

propose these amendments is wellestablished in law and long-standing 

practice and should be upheld in any 

legal challenge. However, in the event 

that any portion of the final rules related 

to any of the proposals in these rules, if 

finalized, is declared invalid, the 

Departments intend that the other 

provisions would be severable, except 

as described in this section of the 

preamble. For example, if a court were 

to find unlawful (1) the requirement that 

plans and issuers utilizing medical 

management techniques provide an 


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133 In sections IV.A, IV.B, and IV.C of this 

preamble, ‘‘the Departments’’ refers to the 

Departments of HHS and Labor. 

134Executive Order 12866 of September 30, 1993, 

58 FR 51735 (October 4, 1993). 

135Executive Order 13563 of January 18, 2011, 76 

FR 3821 (January 21, 2011). 

136Executive Order 14094 of April 6, 2023, 88 FR 

21879 (April 11, 2023). 

137Executive Order 13132 of August 4, 1999, 64 

FR 43255 (August 10, 1999). 

138Executive Order 14094 of April 6, 2023, 88 FR 

21879 at 21879 (April 11, 2023). 

exceptions process in order for such 

techniques to be considered reasonable; 

(2) the requirement to provide coverage 

for OTC contraceptive items without 

requiring a prescription or imposing 

cost sharing; or (3) the therapeutic 

equivalence approach to reasonable 

medical management for contraceptive 

items that are drugs and drug-led 

combination products, the Departments 

intend the remaining provisions of the 

rules to stand. Additionally, the 

Departments intend for the proposed 

amendments to the preventive services 

regulations to remain in place in the 

event that a court were to find unlawful 

any portion of the rules, if finalized, 

with respect to the proposals related to 

disclosing information related to 

contraceptive coverage through the selfservice tool. However, the Departments 

do not intend for the disclosure through 

the self-service tool to remain in place 

in the event that a court were to find 

unlawful the requirement to provide 

coverage for OTC contraceptive items 

without requiring a prescription or 

imposing cost sharing, as the disclosure 

requirements would not provide 

meaningful information to consumers in 

the absence of these underlying 

coverage requirements. 

IV. Regulatory Impact Analysis 

A. Summary—Departments of Health 

and Human Services and Labor 133

These proposed rules would make 

several changes to the requirements for 

non-grandfathered group health plans 

and health insurance issuers offering 

non-grandfathered group or individual 

health insurance coverage to provide 

coverage of certain recommended 

preventive services without cost sharing 

under section 2713 of the PHS Act and 

its implementing regulations. First, 

these proposed rules would provide that 

medical management techniques used 

by plans and issuers with respect to 

recommended preventive services, 

including contraceptive items, would 

not be considered reasonable unless the 

plan or issuer provides an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that 

allows an individual to 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. These proposed 

rules also would require plans and 

issuers to cover recommended OTC 

contraceptive items without a 

prescription and without imposing costsharing requirements. These proposed 

rules would further require plans and 

issuers to cover all recommended 

contraceptive items that are drugs and 

drug-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. Lastly, 

these proposed rules would amend the 

Transparency in Coverage final rules 

implementing section 2715A of the PHS 

Act and section 1311(e)(3) of the ACA 

by requiring plans and issuers to 

provide information related to 

contraceptive coverage and cost-sharing 

requirements, including a statement 

explaining the coverage of OTC 

contraceptive items without cost 

sharing, in their Transparency in 

Coverage internet-based self-service tool 

or, if requested by the individual, on 

paper. 

The Departments have examined the 

impacts of these proposed rules as 

required by Executive Order 12866 on 

Regulatory Planning and Review 

(September 30, 1993),134 Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011),135 Executive Order 14094 on 

Modernizing Regulatory Review (April 

6, 2023),136 the Regulatory Flexibility 

Act (RFA) (September 19, 1980, Pub. L. 

96–354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995, Pub. L. 104–4), and 

Executive Order 13132 on Federalism 

(August 4, 1999).137

B. Executive Orders 12866, 13563, and 

14094—Departments of Health and 

Human Services and Labor 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 14094 

(Modernizing Regulatory Review) 

amends section 3(f) of Executive Order 

12866 (Regulatory Planning and 

Review). The amended section 3(f) of 

Executive Order 12866 defines a 

‘‘significant regulatory action’’ as an 

action that is likely to result in a rule: 

(1) having an annual effect on the 

economy of $200 million or more in any 

1 year (adjusted every 3 years by the 

Administrator of the Office of 

Information and Regulatory Affairs 

(OIRA) in the Office of Management and 

Budget (OMB) for changes in gross 

domestic product), or adversely 

affecting in a material way the economy, 

a sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

Territorial, or Tribal governments or 

communities; (2) creating a serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlement 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) raising legal or policy 

issues for which centralized review 

would meaningfully further the 

President’s priorities or the principles 

set forth in Executive Order 12866, as 

specifically authorized in a timely 

manner by the Administrator of OIRA in 

each case.138

A regulatory impact analysis (RIA) 

must be prepared for rules deemed 

significant under section 3(f). Based on 

the Departments’ estimates, OMB’s 

OIRA has determined this rulemaking is 

significant under section 3(f)(1) as 

measured by the $200 million or more 

in any 1 year threshold. Therefore, OMB 

has reviewed these proposed rules, and 

the Departments have provided the 

following assessment of their impact. 

1. Need for Regulatory Action 

As discussed in section II of this 

preamble, ongoing complaints and 

reports of noncompliance with section 

2713 of the PHS Act and its 

implementing regulations indicate that 

participants, beneficiaries, and enrollees 

face barriers when attempting to use 

their coverage to access recommended 

preventive services without cost 

sharing. As a result of these concerns 

and other significant activity related to 

preventive services, the Departments are 

proposing to amend the regulations 

governing coverage of recommended 

preventive services in order to ensure 

that participants, beneficiaries, and 

enrollees would be able to access the 

full range of recommended preventive 

services to which they are entitled, with 

particular focus on strengthening 

coverage requirements with respect to 

recommended contraceptive items for 

women, as summarized in section IV.A 


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139The Departments expect self-insured group 

health plans to rely on TPAs to implement the 

proposed requirements and compensate them 

accordingly and thereby bear any implementation 

costs. 140Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings/. 

141 Daniels, K. and Abma, J.C., CDC (2020). 

‘‘Current Contraceptive Status Among Women Aged 

15–49: United States, 2017–2019,’’ NCHS Data Brief 

No. 388, available at https://www.cdc.gov/nchs/ 

products/databriefs/db388.htm. 

142 Id. 

143Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings/. 

of this preamble. The Departments 

consider these provisions to be timely 

and necessary given the ongoing 

documented challenges faced by 

consumers in accessing recommended 

preventive services, as discussed further 

in section IV.B.2.a of this preamble. 

2. Summary of Impacts 

In accordance with Executive Order 

12866 and OMB Circular A–4, table 1 

depicts an accounting statement 

summarizing the Departments’ 

assessment of the benefits, costs, and 

transfers associated with these 

regulatory actions. The Departments are 

unable to quantify all benefits, costs, 

and transfers associated with these 

proposed rules, but have sought, where 

possible, to describe these nonquantified impacts. 

TABLE 1—ACCOUNTING TABLE

Benefits 

Non-Quantified: 

• Potential reduction in unintended pregnancies and improved health outcomes for covered individuals. 

• Increased convenience and decreased costs for covered individuals who no longer need to obtain a prescription to obtain recommended OTC contraceptive 

items without cost sharing. 

• Decreased costs to plans and issuers due to improved health outcomes associated with increased coverage of recommended preventive services without cost 

sharing and avoided unintended pregnancies. 

• Potential benefits associated with increased awareness of coverage of OTC contraceptive items without a prescription and without cost sharing. 

Costs Estimate Year dollar Discount 

rate 

Period covered 

Annualized Monetized ($/year) ............................................................... $9.9 million .................................... 2024 2 percent ........... 2026–2035 

Quantified: 

• Costs to issuers and TPAs, on behalf of self-insured group health plans, associated with the disclosure of coverage and cost-sharing requirements for OTC 

contraceptive items, including one-time costs of approximately $35.1 million for integrating the contraception statement language into the existing Transparency in Coverage internet-based self-service tool and creating or updating a webpage to provide information about coverage benefits, and annual costs of 

approximately $6.1 million for programming updates, webpage maintenance, training customer service representatives, and responding to calls to provide assistance; these costs would ultimately be incurred by plans and issuers.139

Non-Quantified: 

• Increased costs to plans and issuers due to changes in utilization of recommended preventive services. 

• Potential administrative costs to plans and issuers associated with the establishment of or use of an existing exceptions process that allows an individual to 

receive coverage without cost-sharing requirements for a medically necessary recommended preventive service. 

• Cost to pharmacies, plans, and issuers to update billing processes and systems for covered OTC products. 

Transfers Estimate Year dollar Discount 

rate 

Period covered 

Annualized Monetized (Excluding Federal Budgetary) ($/year) ............. $468.6 million ................................ 2024 2 percent ........... 2026–2035 

Annualized Monetized Federal Budgetary ($/year) ................................ $300.1 million ................................ 2024 2 percent ........... 2026–2035 

Quantified: 

• Transfers totaling approximately $768.7 million per year from plans and issuers to covered individuals caused by reduced out-of-pocket costs for contraceptive 

items, which plans and issuers would recoup in the form of higher premiums. 

Æ The increase in premiums could increase the cost of employer-sponsored insurance and reduce the share of total employee compensation subject to taxation, reducing Federal tax revenue by approximately $217 million per year. 

Æ Net Federal spending on premium tax credits for Exchange plans could increase by approximately $83.1 million per year. 

Æ Premiums paid (directly or indirectly, through declines in after-tax wages) by covered individuals could increase by approximately $468.6 million per year. 

Non-Quantified: 

• Transfers from plans and issuers to covered individuals caused by reduced out-of-pocket costs for other recommended preventive services for which coverage without cost sharing would be accessible through an exceptions process, which plans and issuers would recoup in the form of higher premiums. This 

could result in an increase in premiums paid by covered individuals and an increase in net Federal spending on premium tax credits for Exchange plans. 

• Potential transfers from plans and issuers to firms in the medicine and medical device supply chain due to decreased bargaining leverage on prices for contraceptive items. 

a. Background 

Nine in ten women report using 

contraception at some point in their 

lifetime.140 Estimates from the CDC 

indicate that 65.3 percent of women 

ages 15–49 used some form of 

contraception between 2017 and 2019, 

including permanent or one or more 

forms of reversible contraception listed 

in the FDA’s Birth Control Guide.141

The majority of women used reversible 

contraception such as oral contraceptive 

pills (14 percent), long-acting reversible 

contraceptives (LARCs) such as 

intrauterine device (IUDs) (10.4 

percent), or the male condom (8.4 

percent). The most common form of 

contraception is female sterilization 

(18.1 percent), a nonreversible 

method.142

The 2022 KFF Women’s Health 

Survey (of U.S. women ages 18–49) 

found that nearly two-thirds of survey 

respondents who were not currently 

trying to get pregnant reported avoiding 

a pregnancy in the next month as being 

‘‘very important.’’ 143 The same survey 

found that among women who use 

contraception, 61 percent use it only to 

prevent pregnancy, 24 percent use it 

both to prevent pregnancy and for some 

other reason, and 15 percent use it 

solely for a reason not related to 


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144 Id. 

145Teal, S. and Edelman, A. (2021). 

‘‘Contraception Selection, Effectiveness, and 

Adverse Effects: A Review,’’ JAMA, available at 

https://pubmed.ncbi.nlm.nih.gov/34962522. 

146Britton, L.E., Alspaugh, A., Greene, M.Z., and 

McLemore, M.R. (2020). ‘‘An Evidence-Based 

Update on Contraception,’’ American Journal of 

Nursing, available at https://www.ncbi.nlm.nih.gov/ 

pmc/articles/PMC7533104. 

147 Id. 

148 Id. 

149Burke, K. and Potter, J. (2023). ‘‘Meeting 

Preferences for Specific Contraceptive Methods: An 

Overdue Indicator,’’ Studies in Family Planning, 

available at https://onlinelibrary.wiley.com/doi/ 

full/10.1111/sifp.12218. 

150Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings and Burke, K. 

and Potter, J. (2023). ‘‘Meeting Preferences for 

Specific Contraceptive Methods: An Overdue 

Indicator,’’ Studies in Family Planning, available at 

https://onlinelibrary.wiley.com/doi/full/10.1111/ 

sifp.12218. 

151Burke, K. and Potter, J. (2023). ‘‘Meeting 

Preferences for Specific Contraceptive Methods: An 

Overdue Indicator,’’ Studies in Family Planning, 

available at https://onlinelibrary.wiley.com/doi/ 

full/10.1111/sifp.12218. 

152 Id. 

153This figure was the same (39 percent) among 

the subset of respondents with private health 

insurance coverage. See Long, M., Frederiksen, B., 

Ranji, U., Diep, K., and Salganicoff, A., KFF (2022). 

‘‘Interest in Using Over-the-Counter Oral 

Contraceptive Pills: Findings from the 2022 KFF 

Women’s Health Survey,’’ available at https://

www.kff.org/womens-health-policy/issue-brief/ 

interest-using-over-the-counter-oral-contraceptivepills-findings-2022-kff-womens-health-survey. 

154 Id. 

155 Id. 

156Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

157Long, M., Diep, K., Sobel, L. and Salganicoff, 

A., KFF (2023). ‘‘Over-the-Counter Oral 

Contraceptive Pills,’’ available at https://

www.kff.org/womens-health-policy/issue-brief/overthe-counter-oral-contraceptive-pills. 

158As noted in section I.A, these proposed rules 

would not modify Federal conscience protections 

related to contraceptive coverage for employers, 

plans and issuers. See fn. 24. 

preventing pregnancy (for example, 

managing a medical condition or 

preventing a sexually transmitted 

infection).144 Individuals’ contraceptive 

needs, including because of side effects, 

can vary depending on their health 

history, medical needs, allergies, and 

other factors. A recent study that 

reviewed two decades of literature on 

contraception found that hormonal 

contraceptives can impact medical 

conditions associated with hormonal 

fluctuations, including acne, 

endometriosis, and premenstrual 

dysphoric disorder.145 This and other 

studies detail that combined hormonal 

contraceptives and progestin-only pills 

often have different side effects for 

women with varying backgrounds or 

medical conditions.146 Studies 

emphasize that it is difficult to predict 

how individuals will react to oral 

contraceptives, with one noting that 

‘‘certain side effects . . . may be 

considered beneficial by some people 

but unacceptable by others,’’ and that 

‘‘different formulations have different 

side effect profiles, so patients may need 

to try another formulation if an 

undesirable side effect occurs.’’ 147

Studies point to the fact that optimal 

contraception selection depends on a 

person’s health needs and personal 

factors and preferences.148

A growing body of research finds 

there is a mismatch between preferred 

and commonly used contraception 

methods.149 These studies find that 

LARCs and hormonal methods generally 

have higher rates of satisfaction than 

condoms, withdrawal, and no method of 

contraception. Nearly 25 percent of all 

people, and nearly 30 percent of people 

earning under 200 percent of the 

Federal Poverty Line, are not using their 

preferred method. People report using 

less preferred methods due to issues 

with side effects, cost and affordability, 

inadequate counseling, and other access 

barriers such as facilities not offering 

the preferred method.150 The mismatch 

between preferred and used method was 

found to be less common among those 

with higher incomes, those with 

insurance coverage, and those that have 

a usual source of care.151 The literature 

also finds that unsatisfied preferences 

were associated with discontinuation of 

contraception method and subsequently 

higher rates of pregnancy, indicating 

that reducing barriers that contribute to 

this satisfaction mismatch has the 

potential to reduce unwanted 

pregnancies, especially among 

underserved communities such as 

women of color and low-income 

communities.152

The 2022 KFF Women’s Health 

Survey found that 77 percent of 

respondents (and 79 percent of 

respondents with private health 

insurance coverage) favored making oral 

contraceptive pills available OTC 

without a prescription if research 

showed they are safe and effective, and 

39 percent of respondents indicated 

they would be likely to use oral 

contraceptive pills available OTC 

without a prescription.153 The survey 

further found that 29 percent of 

respondents currently using oral 

contraceptive pills would be ‘‘very 

likely’’ to use OTC oral contraceptive 

pills that do not require a prescription, 

as would 19 percent of respondents 

currently using other contraceptive 

methods and 15 percent of respondents 

currently not using any contraceptive 

method.154 These figures indicate that 

take-up of OTC contraceptive items 

available without a prescription and 

without cost sharing might be fairly 

high. When asked why they would be 

likely to use OTC oral contraceptive 

pills, most respondents reported that it 

is because they are more convenient (59 

percent) or faster (15 percent), while 8 

percent reported that they do not want 

a physical or pelvic exam, 7 percent 

reported that OTC oral contraceptive 

pills are more confidential, 6 percent 

reported that they think it would save 

money, and 3 percent reported that they 

do not want to have to use health 

insurance.155 Coverage of OTC 

contraceptive items without cost sharing 

or a prescription requirement would be 

particularly beneficial for certain 

contraceptive users considering that 33 

percent of hormonal contraceptive users 

indicated that they missed taking their 

birth control on time because they were 

not able to get their next supply on 

time 156 and 36 percent of oral 

contraceptive users have missed taking 

it on time for the same reason.157

More generally, as discussed in 

section II of this preamble, cost sharing 

reduces the use of preventive care, and 

some individuals may forego a 

preventive service entirely rather than 

being forced to choose between a form 

of care that their provider has 

determined would not be medically 

appropriate for them or to pay out-ofpocket for the care they need. 

b. Number of Affected Entities 

This section addresses entities that 

would be directly affected by these 

proposed rules. These proposed rules 

would apply to non-grandfathered 

group health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance 

coverage.158 For the purposes of this 

RIA, the term covered plans refers to 

these plan and coverage types. Health 

insurance company refers to a single 

entity that offers health insurance 

coverage in one or multiple States, 

which might own or be affiliated with 

one or multiple entities that are 

separately required to be licensed to 

engage in the business of insurance in 

each such State. Health insurance issuer 

or issuer means an insurance company, 

insurance service, or insurance 

organization (including a health 

maintenance organization (HMO)) that 

is required to be licensed to engage in 


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159The Departments estimate that there are 

594,404 ERISA-covered self-insured group health 

plans based on data from the 2022 Medical 

Expenditure Panel Survey Insurance Component 

(MEPS–IC) and the 2020 County Business Patterns 

from the Census Bureau. The 2020 KFF Employer 

Health Benefits Survey reported that in 2020, 16 

percent of firms offering health benefits offered at 

least one grandfathered health plan (see KFF, 2020 

Kaiser Employer Health Benefits Survey, available 

at https://files.kff.org/attachment/Report-EmployerHealth-Benefits-2020-Annual-Survey.pdf). Thus, the 

Departments have calculated the number of selfinsured, non-grandfathered plans in the following 

manner: 594,404 ERISA-covered self-insured group 

health plans × (100 percent minus 16 percent) = 

499,299. 

160The Departments estimate that there are 

2,195,857 ERISA-covered fully-insured group 

health plans based on data from the 2022 Medical 

Expenditure Panel Survey Insurance Component 

(MEPS–IC) and the 2020 County Business Patterns 

from the Census Bureau. The 2020 KFF Employer 

Health Benefits Survey reported that in 2020, 16 

percent of firms offering health benefits offered at 

least one grandfathered health plan (see KFF, 2020 

Kaiser Employer Health Benefits Survey, available 

at https://files.kff.org/attachment/Report-EmployerHealth-Benefits-2020-Annual-Survey.pdf). Thus, the 

Departments have calculated the number of fullyinsured, non-grandfathered plans in the following 

manner: 2,195,857 ERISA-covered fully-insured 

group health plans × (100 percent minus 16 

percent) = 1,844,520. 

161According to data from the 2022 Census of 

Governments, there are 90,887 State and local 

governmental entities (see U.S. Census Bureau, 

2022 Census of Governments, available at https:// 

www.census.gov/data/tables/2022/econ/gus/2022- 

governments.html). The Departments assume that 

each State and local governmental entity sponsors 

one health plan on average. Therefore, the 

Departments estimate that there are 90,887 nonFederal governmental health plans. The 2020 KFF 

Employer Health Benefits Survey reported that 16 

percent of employers offer at least one 

grandfathered plan (see KFF, 2020 Kaiser Employer 

Health Benefits Survey, available at https://

files.kff.org/attachment/Report-Employer-HealthBenefits-2020-Annual-Survey.pdf). The 

Departments therefore estimate there are 

approximately 76,345 non-grandfathered nonFederal governmental plans. 

162The Departments’ estimate of the number of 

health insurance companies and the number of 

issuers (issuer/State combinations) is based on 

medical loss ratio reports submitted by issuers for 

the 2022 reporting year (see Centers for Medicare 

& Medicaid Services, ‘‘Medical Loss Ratio Data and 

System Resources (2022),’’ available at https://

www.cms.gov/CCIIO/Resources/Data-Resources/ 

mlr). 

163U.S. Census Bureau (2017). 2017 SUSB 

Annual Data Tables by Establishment Industry 

(Data by Enterprise Receipts Size), available at 

https://www.census.gov/data/tables/2017/econ/ 

susb/2017-susb-annual.html. 

164The calculation (approximately 181,412,000 

individuals) is based on reports of private insurance 

coverage in the 2023 Current Population Survey 

Annual Social and Economic Supplement (CPS– 

ASEC). Private coverage in that survey includes 

employment-based (including non-government, 

non-Federal government, and Federal government 

employment), directly purchased (Exchange and 

non-Exchange), and TRICARE coverage. To arrive at 

the number of covered individuals (which excludes 

TRICARE enrollees), the Departments remove from 

the count respondent households for which the 

respondent is a member of the military. It also 

removes respondents who are over 65 or who report 

government insurance (such as Medicare, Medicaid, 

or VA) in addition to private insurance. The 

Departments view this calculation as an upper 

bound because the data are not sufficient to identify 

and exclude enrollees in grandfathered plans or 

individuals in non-ACA compliant individually 

purchased plans. The Departments do not have an 

estimate of the relevant number of enrollees in 

either of these plan types; the latest available data 

on percentage of enrollees in grandfathered plans is 

from the 2020 KFF Employer Health Benefits 

Survey. See KFF, 2020 Kaiser Employer Health 

Benefits Survey, available at https://files.kff.org/ 

attachment/Report-Employer-Health-Benefits-2020- 

Annual-Survey.pdf, reporting that 14 percent of 

individuals were enrolled in grandfathered plans. 

However, the number has been declining since 

2011, falling from 56 percent in 2011. See KFF, 

2018 Kaiser Employer Health Benefits Survey, 

Figure 13.3, available at https://files.kff.org/ 

attachment/Report-Employer-Health-BenefitsAnnual-Survey-2018). In the absence of more recent 

data, the Departments cannot rule out that the rate 

has continued to fall. 

165See CMS, ‘‘Open Enrollment Period Report: 

Final National Snapshot,’’ available at https://

www.cms.gov/newsroom/fact-sheets/marketplace2024-open-enrollment-period-report-final-nationalsnapshot (reporting 21,310,538 Exchange enrollees). 

The estimated conversion between total enrollees 

and policyholders—15 enrollees per 11 

policyholders—is based on medical loss ratio 

reports submitted by issuers for the 2021 reporting 

year, in which the number of policyholders in 

individual health insurance coverage offered in the 

individual market was approximately 11 million, 

and the number of enrollees was approximately 

15,000,000. See CMS (2022), ‘‘Medical Loss Ratio 

Data and System Resources,’’ https://www.cms.gov/ 

CCIIO/Resources/Data-Resources/mlr. 

166The calculation is based on the reports of 

private insurance coverage in the 2023 CPS–ASEC. 

The calculation specifically includes all individuals 

who report their sex as female and are of age 15 to 

49 years. Private insurance coverage includes those 

covered by directly purchased (Exchange and nonExchange) and employment-based health insurance. 

Those in the armed services are excluded from the 

calculation. 

167See CDC, ‘‘2017–2019 NSFG: Public-Use Data 

Files, Codebooks, and Documentation,’’ available at 

https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_

puf.htm. 

the business of insurance in a State and 

that is subject to State law that regulates 

insurance. 

The Departments estimate that there 

are 499,299 ERISA-covered self-insured, 

non-grandfathered group health 

plans 159 and 1,844,520 ERISA-covered 

fully-insured, non-grandfathered group 

health plans.160 The Departments 

further estimate that there are 76,345 

non-grandfathered non-Federal 

governmental plans sponsored by State 

and local governmental entities.161

Issuers and third-party administrators 

(TPAs) provide key support for plan 

compliance with laws and regulations. 

Plans often have TPAs provide expertise 

in plan design, establish networks, and 

administer claims. For medications, 

issuers and TPAs often provide these 

services via contracted or affiliated 

PBMs. 

The Departments assume that issuers 

and TPAs would be the organizations 

performing the work of redesigning 

prescription drug formularies, 

negotiating new or amended network 

arrangements with pharmacies, and 

developing any necessary amendments 

and changes to billing systems and 

procedures. 

The Departments estimate that these 

proposed rules would affect 479 health 

insurance companies nationwide that 

provide coverage in the group and 

individual health insurance markets, 

with 1,467 issuers (health insurance 

company/State combinations).162

These proposed rules would also 

affect pharmacies, given the coverage 

requirements for OTC contraceptives 

proposed in these proposed rules. 

According to the Census Bureau’s 

Statistics of U.S. Businesses, there are 

19,234 firms in the pharmacies and drug 

stores sector in the U.S. as of 2017.163

Because these proposed rules have the 

potential to impact the gross premiums 

of covered plans—either directly as paid 

by plan participants and enrollees and/ 

or indirectly by their employers in lieu 

of salary or other benefits—all 

participants, beneficiaries, and enrollees 

in affected plans may potentially be 

affected by these proposed rules, 

regardless of their use of contraceptive 

items. For purposes of this RIA, covered 

individuals refers to participants, 

beneficiaries, and enrollees in covered 

plans that are subject to the proposed 

rules. 

There are an estimated 181.4 million 

individuals in plans that would be 

affected by these proposed rules.164

Within this total, there are an estimated 

21 million covered individuals enrolled 

in coverage provided through an 

Exchange (with approximately 16 

million policyholders).165 This separate 

tally of Exchange enrollees is used as an 

input to the estimation of the net 

Federal spending impact of these 

proposed rules in the transfers section 

IV.B.2.e of this preamble. 

Among individuals in covered plans, 

the Departments estimate that 51.71 

million individuals (28.5 percent) are 

women of reproductive age (15–49).166

The Departments calculate, based on 

data from the 2017–2019 National 

Survey of Family Growth (NSFG),167

that 29.4 percent of women of 

reproductive age who have private 

health insurance are using contraceptive 

items that are (only now, in the case of 

oral contraceptive pills) available OTC 

(oral contraception pills, condoms, and/ 

or emergency contraception) in a given 

enrollment month. This estimate is 

somewhat higher than the 2020 estimate 

by the National Center for Health 

Statistics (approximately 22.4 percent), 

given that the Departments’ analysis 

restricts its calculations to women who 


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168See CDC, ‘‘Current Contraceptive Status 

Among Women Aged 15–49: United States, 2017– 

2019,’’ available at https://www.cdc.gov/nchs/data/ 

databriefs/db388-H.pdf (estimating that 

approximately 65 percent of women ages 15–49 

were currently using contraception. By method, 

these included female sterilization (18.1 percent), 

oral contraceptive pills (14.0 percent), LARCs (10.4 

percent), male condoms (8.4 percent), male 

sterilization (5.6 percent), Depo-Provera, 

contraceptive ring, or patch (3.1 percent), and 5.7 

percent across all other methods (includes 

diaphragm, withdrawal, periodic abstinence with 

safe period assessed via calendar rhythm, 

temperature, or cervical mucus test)). 

169Approximately 181.4 million individuals in 

covered plans, times 28.5 percent who are women 

of reproductive age, times 29.4 percent of these who 

are assumed to use recommended OTC 

contraceptives, per the NSFG analysis (see https:// 

www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm). 

170Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

171See CDC, ‘‘Reproductive Health, Unintended 

Pregnancy,’’ available at https://www.cdc.gov/ 

reproductive-health/hcp/unintended-pregnancy/ 

index.html (finding that 41.6 percent of pregnancies 

were unintended). 

172Fiffick, A.N., Iyer, T.K., Cochran, T., and 

Batur, P. (2023). ‘‘Update on Current Contraceptive 

Options: A Case-based Discussion of Efficacy, 

Eligibility, and Use.’’ Cleveland Clinic Journal of 

Medicine, available at: https://www.ccjm.org/ 

content/ccjom/90/3/181.full.pdf. 

report enrollment in private health 

insurance coverage.168 Thus, the 

Departments estimate that 15.2 million 

individuals (8.4 percent of all 

individuals in covered plans) are 

women of reproductive age using these 

forms of contraceptives.169 The 

Departments request comment on this 

analysis. 

Table 2 summarizes the number of 

entities that would be affected by these 

proposed rules. 

TABLE 2—NUMBER OF AFFECTED ENTITIES

Affected entity Number of entities 

ERISA-covered non-grandfathered group health plans ................................................................................................................ 2,343,819 

ERISA-covered self-insured, non-grandfathered group health plans .................................................................................... 499,299 

ERISA-covered fully-insured, non-grandfathered group health plans ................................................................................... 1,844,520 

Non-grandfathered non-Federal governmental plans ................................................................................................................... 76,345 

Issuers (health insurance company/State combinations) .............................................................................................................. 1,467 

Pharmacies and drug stores ......................................................................................................................................................... 19,234 

Covered individuals ....................................................................................................................................................................... 181,412,000 

c. Benefits 

This analysis provides a qualitative 

discussion of the benefits associated 

with these proposed rules, as the 

Departments do not have the data 

necessary to quantify these benefits. The 

Departments request comment and data 

on how to quantify these benefits. 

(1) Enhanced Coverage of a Wider Range 

of Preventive Services Without Cost 

Sharing for Eligible Individuals Leading 

to a Potential Reduction in Unintended 

Pregnancies and Improved Health 

Outcomes for Individuals 

The potential for these proposed rules 

to facilitate greater coverage of a wider 

range of preventive services without 

cost sharing for eligible individuals 

could lead to important benefits to 

health and satisfaction (for example, in 

the form of better matches between 

chosen contraceptive items and 

individuals’ medical needs and 

preferences). There is clear evidence 

that many contraceptive users are not 

using their preferred form of 

contraception because of concerns about 

side effects, cost, or availability, for 

example.170 Greater flexibility in 

contraceptive choice could directly 

improve quality of life, including by 

minimizing side effects and facilitating 

covered individuals in optimizing 

contraceptive use according to their 

unique needs and preferences. 

Improved satisfaction with one’s 

contraceptive method, including by 

reducing unwanted side effects, would 

be an important benefit of these 

proposed rules. Given the many 

variations of contraceptive drugs or 

drug-led combination products, each 

with different hormonal properties, 

dosage levels, physical properties, 

delivery mechanisms, side effects, and 

benefits, there is significant need for 

individual tailoring and choice. Better 

aligning contraceptive use with a 

method or product with preferred health 

outcomes could be a source of major 

health improvements for covered 

individuals, as discussed further in this 

section. The ability to select among 

more contraceptive options at zero cost 

may facilitate such alignment, helping 

more women find a contraceptive that 

works best for their medical needs. 

Increased coverage of medically 

necessary preventive services without 

cost-sharing requirements through the 

use of an exceptions process would 

have a similar effect of expanding 

covered individuals’ ability to access 

and use appropriate recommended 

preventive services by eliminating a 

financial barrier to receiving medically 

necessary care. 

The Departments recognize the 

potential for a reduction in unintended 

pregnancies and improved health 

outcomes as a result of these proposed 

rules. First, a reduction in unintended 

pregnancies and improved health 

outcomes could result from increases in 

the share of covered women who use 

contraception.171 Second, these 

proposed rules could induce some 

contraceptive switching among covered 

women already using reversible 

contraception that could create a closer 

match between the contraceptive 

method or product with the best 

medical outcomes for the individual 

and the method or product they 

currently use. In such cases, individuals 

able to switch to a method or product 

with the best medical outcome for them 

may more reliably adhere to the relevant 

usage recommendations.172

Any benefit of reducing unintended 

or unplanned pregnancies would scale 

in proportion to the extent of new (or 

more reliable) use of contraception. The 

Departments do not have the data 

necessary to precisely estimate the 

extent of such an expansion in 

contraception use along both the 

extensive (new use) and intensive (more 

reliable use) margins, but anticipate 

relatively small effects on the number of 

women newly using any contraceptives 

as a result of the proposed rules, as 

discussed later in this section. 


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173Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings/#ContraceptiveCoverage. 

174Sonfield, A., Tapales, A., Jones, R.K., and 

Finer, L.B. (2015). ‘‘Impact of the Federal 

Contraceptive Coverage Guarantee on Out-of-Pocket 

Payments for Contraceptives: 2014 Update,’’ 

Contraception, available at https://pubmed.ncbi.

nlm.nih.gov/25288034/. 

175Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

176 Id. 

177 Id. (‘‘Among reproductive age females who are 

able to conceive and are not pregnant or trying to 

become pregnant who are not using contraception, 

four in ten say it is because they did not want to 

use birth control (42 [percent]). One in three 

females who are not currently using contraception 

report concern about side effects (32 [percent]), and 

one in five (22 [percent]) say they don’t really mind 

if they become pregnant.’’) 

178He, K., Dalton, V.K., Zochowski, M.K., and 

Hall, K.S. (2017). ‘‘Women’s Contraceptive 

Preference-Use Mismatch,’’ Journal of Women’s 

Health, available at https://pubmed.ncbi.nlm

.nih.gov/27710196 and Burke, K. and Potter, J. 

(2023). ‘‘Meeting Preferences for Specific 

Contraceptive Methods: An Overdue Indicator,’’ 

Studies in Family Planning, available at https://

pubmed.ncbi.nlm.nih.gov/36705876. 

179Behn, M., Pace L.E., and Leighton, K. (2019). 

‘‘The Trump Administration’s Final Regulations 

Limit Insurance Coverage of Contraception,’’ 

Women’s Health Issues, available at https://

www.whijournal.com/article/S1049-3867(18)30751- 

5/fulltext. 

180Pace, L., Dusetzina, S., and Keating, N. (2016). 

‘‘Early Impact of the Affordable Care Act on Oral 

Contraceptive Cost Sharing, Discontinuation, and 

Nonadherence,’’ Health Affairs, available at https:// 

www.healthaffairs.org/doi/10.1377/hlthaff.2015.

1624. 

181Burke, K. and Potter, J. (2023). ‘‘Meeting 

Preferences for Specific Contraceptive Methods: An 

Overdue Indicator,’’ Studies in Family Planning, 

available at https://pubmed.ncbi.nlm.nih.gov/ 

36705876. 

Studies have consistently shown that 

approximately 70 percent of privately 

insured women who use contraception 

have the cost of their method covered in 

full by private health insurance.173

These studies include evidence on the 

share of privately-insured women who 

do not pay cost sharing for oral 

contraceptives after passage of the 

ACA.174 That these proposed rules 

would apply to a population of 

privately-insured women who already 

have coverage of certain contraceptives 

without cost sharing suggests the 

possibility of a small net effect on any 

contraception use for covered 

individuals. For example, in the 2022 

KFF Women’s Health Survey, only 4 

percent of respondents reported cost as 

a reason for not using birth control, and 

this figure included individuals who 

did not have health insurance.175

Nonetheless, it is plausible that by 

providing coverage without cost sharing 

for a wider variety of contraceptive 

items, these proposed rules could 

induce new take-up among covered 

individuals who were previously 

dissuaded from contraceptive use 

because of cost and accessibility 

considerations related to their preferred 

method, as discussed in section IV.B.2.a 

of this RIA. Further, medication 

adherence and consistent use of 

contraception could be improved if 

more covered individuals have coverage 

of their preferred method without cost 

sharing. In the 2022 KFF Women’s 

Health Survey, among female 

contraceptive users ages 18–49 who 

were not using their preferred 

contraceptive method, 12 percent of 

survey respondents indicated that the 

primary reason for not doing so was 

because they could not afford it.176 A 

third of women report not using 

contraception due to concerns over side 

effects,177 the burden of which could be 

lessened by expanding the selection of 

covered contraceptive product choice 

available without cost sharing. Such 

considerations could be important given 

that women using contraception— 

especially women with low incomes 

and women using less effective 

contraceptive methods—often report a 

mismatch between their most preferred 

contraceptive method and the method 

they usually use.178

Historically, more comprehensive 

coverage of contraceptive services has 

been shown to improve the consistent 

use of the most effective short-acting 

methods of contraception, and the 

removal of cost sharing also increases 

the use of more effective LARC 

methods.179 One study found that 

following the implementation of the 

ACA contraceptive coverage 

requirement, the discontinuation of use 

of oral contraceptive pills fell and 

nonadherence to brand-name oral 

contraceptive pills also declined.180

Therefore, beyond the direct benefits 

of improved satisfaction with 

contraceptive method—due to, for 

example, reductions in side effects— 

remedying the misalignment between 

contraceptive preference and 

contraceptive use could lead to fewer 

unplanned pregnancies because of 

lower rates of discontinuation.181

While the Departments do not 

anticipate that the proposed 

requirement in these proposed rules to 

cover OTC contraception without cost 

sharing would substantially affect the 

overall rate of birth control use, to the 

extent that access to and use of OTC and 

other contraceptive items, without cost 

sharing, is increased, it is expected to 

provide better matching of preferred 

contraceptive items and thus may 

ultimately improve health outcomes. 

The Departments also anticipate that 

improved health outcomes would result 

from enhanced coverage of a wider 

range of recommended preventive 

services without cost sharing through 

the use of an exceptions process for 

recommended preventive services 

offered by plans and issuers. Covered 

individuals would have coverage of 

medically necessary preventive services 

because of this provision, whereas 

under current regulations they might be 

more likely to pay for such services outof-pocket or forgo such services. 

The Departments request comment on 

this analysis. 

(2) Increased Convenience and 

Decreased Costs for Covered Individuals 

Who No Longer Need a Prescription To 

Obtain Recommended OTC 

Contraceptive Items 

The Departments anticipate that some 

covered individuals would benefit from 

the provision of these proposed rules 

that would require plans to cover 

recommended OTC contraceptive items 

without a prescription and without cost 

sharing because these individuals 

would face reduced transportation costs, 

childcare costs, and/or time costs that 

would otherwise be incurred due to 

scheduling, travelling to, and attending 

health care provider visits in order to 

obtain prescriptions for contraceptives. 

Some covered individuals would also 

benefit from this provision if they 

cannot secure timely access to 

appointments to obtain a prescription, 

particularly if the individuals are in 

areas with primary care shortages. Outof-pocket visit costs, if any, would also 

be avoided. Any such effects would be 

proportional to the number of covered 

individuals forgoing such provider 

visits as a result of this proposed 

provision, and therefore dependent on 

both the share of contraceptive users 

who switch methods from a prescription 

contraceptive to an OTC product and on 

the subset of these switchers who forgo 

provider visits that would otherwise 

have been needed for a contraceptive 

prescription. 

As discussed further in section 

IV.B.2.f of this preamble, the 

Departments do not anticipate a 

significant share of covered individuals 

to both switch methods from 

prescription contraceptives to OTC 

contraceptives and make fewer 

preventive health care visits. The 

Departments assume that even among 

covered women who would avail 


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85780 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 

182Swan, L.E.T. (2021). ‘‘The Impact of US Policy 

on Contraceptive Access: A Policy Analysis,’’ 

Reproductive Health, available at https://

reproductive-health-journal.biomedcentral.com/ 

articles/10.1186/s12978-021-01289-3 and Planned 

Parenthood Federation of America (2014). ‘‘New 

Study on Birth Control Use Shows That, When 

Fully Implemented, the Affordable Care Act Could 

Dramatically Reduce Unintended Pregnancy in the 

U.S.,’’ available at https://

www.plannedparenthood.org/about-us/newsroom/ 

press-releases/new-study-birth-control-use-showswhen-fully-implemented-affordable-care-act-coulddramatically. 

183Bertko, J., Glied, S., Miller, E., Simmons, A., 

and Wilson, L., ASPE (2012). ‘‘The Cost of Covering 

Contraceptives through Health Insurance,’’ 

available at https://aspe.hhs.gov/reports/costcovering-contraceptives-through-health-insurance. 

184 Id. 

185Trussell, J., Leveque, J.A., Koenig, J.D., 

London, R., Borden, S., Henneberry, J., LaGuardia, 

K., Stewart, F., Wilson, G., Wysocki, S., and Strauss, 

M. (1995). ‘‘The Economic Value of Contraception: 

A Comparison of 15 Methods,’’ American Journal of 

Public Health, available at http://

ajph.aphapublications.org/doi/pdf/10.2105/ 

AJPH.85.4.494. 

themselves of the new OTC benefit in 

these proposed rules, nearly all would 

continue to utilize preventive care 

visits. Therefore, while the benefits of 

reduced burdens associated with 

reduced health care visits could be 

significant for any individuals who see 

providers less frequently as a result of 

this proposed provision, the 

Departments do not anticipate such 

averted benefits (or costs) would accrue 

to a significant fraction of covered 

individuals. The Departments request 

comment on this analysis. 

(3) Potential Benefits of Increased 

Transparency by Expanding Awareness 

of Coverage of OTC Contraceptive Items 

Without a Prescription and Without 

Cost Sharing 

Studies have found that increased 

transparency about contraceptive care 

options and service costs are essential 

for improving contraceptive access by 

increasing public awareness and 

understanding about current health care 

policy and opportunities, and when 

women are fully informed about 

available contraceptive methods and 

find them affordable, they are more 

likely to use them consistently.182

Overall, making information about 

OTC contraceptive coverage without a 

prescription and without cost sharing 

available to participants, beneficiaries, 

and enrollees can result in better health 

outcomes, as discussed in more detail in 

this section IV.B.2.c of this preamble. 

The Departments request comment on 

this analysis. 

d. Costs 

This section provides a qualitative 

and quantitative discussion of the costs 

associated with these proposed rules. 

The Department request comment and 

data on how to better quantify these 

costs. 

(1) Increased Costs to Plans and Issuers 

Due to a Change in Utilization of 

Preventive Services, and Decreased 

Costs Due to Improved Health Outcomes 

and Avoided Unintended Pregnancies 

Previous analysis by the Office of the 

Assistant Secretary for Planning and 

Evaluation (ASPE), which evaluated the 

impacts of the ACA’s original 

contraceptive coverage requirements, 

found no likely net impact on gross 

costs of expanding utilization for 

contraception: ‘‘While the costs of 

contraceptives for individual women 

can be substantial and can influence 

choice of contraceptive methods, 

available data indicate that providing 

contraceptive coverage as part of a 

health insurance benefit does not add to 

the cost of providing insurance 

coverage.’’ 183 This conclusion was 

reached based on a review of the 

literature and of case studies on how 

expanding access to reproductive care 

affected insurance costs and gross 

premiums. For example, in 1999, 

Congress required the health plans in 

the Federal Employees Health Benefits 

(FEHB) program to cover the full range 

of FDA-approved contraceptive 

methods. ASPE concluded: ‘‘When 

medical costs associated with 

unintended pregnancies are taken into 

account, including costs of prenatal 

care, pregnancy complications, and 

deliveries, the net effect on premiums is 

close to zero.’’ 184 This conclusion 

echoes the conclusion of earlier 

studies.185 The Departments are aware 

that the health insurance market has 

evolved since the publication of this 

study but are of the view that the 

general results of this analysis are still 

relevant today. 

The Departments assume that, unlike 

the initial introduction of contraceptive 

coverage requirements under the ACA, 

these proposed rules would have small 

impacts on the fraction of covered 

women using contraception, as 

approximately 70 percent of this 

population of covered women that uses 

contraception already has coverage for 

contraception through private insurance 

without cost sharing. 

Nonetheless, in line with the findings 

of ASPE and others, the Departments 

assume that any increase in 

contraception utilization, however 

small, induced by these proposed rules 

would not increase net insurer claims 

costs and thus not increase gross 

premiums. This effect is separate from 

the transfers created by shifting the outof-pocket cost burden from the covered 

individual to the plan, which are 

accounted for separately. The 

Departments request comment on this 

analysis. 

The Departments also anticipate that 

the establishment or use of an existing 

exceptions process by plans and issuers 

that would allow covered individuals to 

access coverage of certain recommended 

preventive services without cost sharing 

would also lead to a decrease in out-ofpocket costs for these preventive 

services and a corresponding increase in 

utilization or switching from other 

preventive services. The Departments 

expect that this change would increase 

net claims costs initially and potentially 

over time. Plans and issuers could 

experience claims cost savings that at 

least partially offset these new costs, 

due to improved health outcomes 

associated with increased utilization of 

certain recommended preventive 

services. 

The Departments request comment 

and data on how the costs to plans and 

issuers would change due to a change in 

utilization of preventive services 

associated with these proposed rules. 

(2) Costs to Pharmacies and Plans and 

Issuers To Update Billing Processes and 

Systems for Covered OTC Products 

The Departments anticipate that 

pharmacies, as well as plans and 

issuers, would incur some upfront and 

annual operational and administrative 

costs in order to comply with the 

coverage requirements for OTC 

contraceptives in these proposed rules, 

but do not have information necessary 

to estimate such costs. 

For pharmacies, the Departments 

anticipate costs would include updating 

real-time claims adjudication systems 

and processes for their point-of-sale 

systems. The Departments are aware 

that there are uncertainties regarding 

how pharmacies could adapt existing 

systems, including the requirements in 

some point-of-sale systems to fill in a 

‘‘prescriber NPI,’’ which would not exist 

in its usual form for OTC products. The 

Departments are aware of at least one 

large pharmacy chain that has already 

implemented insurance coverage for an 

OTC oral contraceptive pill at the 

pharmacy counter by setting up codes 

for insurance reimbursement with realtime claim adjudication. The 

Departments lack information regarding 

how widespread such existing 

capabilities are among pharmacies and 

thus the costs of transitioning systems 

and processes that do not yet have these 


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186One analogous example of widespread 

implementation of over-the-counter insurance 

coverage is the recent COVID–19 pandemic when 

COVID tests were available over-the-counter at no 

cost sharing. See Huber, K., T. Roades, A. Higgins, 

M. Aspinall, C. Silcox, and M. McClellan, Duke 

University Margolis Center for Health Policy, 

(2022). ‘‘Over the Counter COVID–19 Testing: 

Insurance Coverage Strategies to Support Equitable 

Access,’’ available at https://healthpolicy.duke.edu/ 

sites/default/files/2022-05/Margolis%20OTC%20

Testing.pdf. It remains unclear how these 

preparations might affect the cost of 

implementation of these proposed rules, but it is 

likely that this prior work may—to some extent— 

mitigate costs. 

187The Departments assume that fully-insured 

group health plans would depend on health 

insurance issuers and self-insured group health 

plans would rely on TPAs to implement the 

proposed requirements. The Departments expect 

self-insured group health plans would compensate 

TPAs accordingly and thereby bear any 

implementation costs. 

188The Departments expect that while 

participants, beneficiaries, and enrollees will 

continue to request cost-sharing information on 

paper in certain circumstances, the proposed 

additional disclosure would impose negligible 

additional burden on plans and issuers as the 

disclosure will likely be no more than one or two 

sentences and would only be required when a 

participant, beneficiary, or enrollee requests costsharing information for a subset of covered items 

and services, covered contraceptive items and 

services. 

capabilities.186 The Departments request 

comment on the potential changes that 

pharmacies would have to make to their 

systems and processes and the 

corresponding burden and costs. 

The Departments anticipate that plans 

and issuers would incur costs associated 

with updating IT systems and processes 

to process claims. Plans and issuers 

would also have to develop, if they have 

not already, processes aimed at 

preventing fraud, waste, and abuse for 

OTC products, which could include 

processes to monitor utilization. Plans 

and issuers routinely do such 

monitoring for prescription products in 

order to, for example, enforce 

reasonable quantity limits. The 

Departments request comment on the 

costs and any associated burden that 

would be borne by plans and issuers to 

update their systems and processes. 

The Departments do not anticipate 

significant costs associated with 

formulary redesign to accommodate 

OTC products, as formularies are 

regularly updated even in the absence of 

any relevant policy changes and plans 

and issuers are already required to cover 

OTC products without cost sharing 

when the patient has a prescription. For 

the same reason, the Departments do not 

anticipate significant costs associated 

with formulary redesign to comply with 

the provision of the proposed rules 

requiring coverage of every 

recommended contraceptive drug and 

drug-led combination product without 

cost sharing unless a therapeutic 

equivalent is covered without cost 

sharing. 

The Departments also anticipate some 

costs to pharmacies, as well as plans 

and issuers, associated with negotiating 

new contract terms for OTC coverage. 

Despite the costs to pharmacies 

identified in this section, the 

Departments anticipate that pharmacies 

would see increased revenues from sales 

of covered OTC contraceptives, and that 

associated profit increases (if they 

occur) might offset these costs from the 

pharmacies’ perspective. 

The Departments request comment on 

the potential costs (and revenues) to 

pharmacies and costs to plans and 

issuers associated With the changes in 

these proposed rules. 

(3) Potential Administrative Costs to 

Plans and Issuers Associated With the 

Establishment or Use of an Existing 

Exceptions Process 

Plans and issuers could incur 

administrative costs associated with the 

establishment or use of an existing 

exceptions process that allows an 

individual to receive coverage without 

cost-sharing requirements for a 

medically necessary recommended 

preventive service. The Departments 

assume that most plans and issuers have 

an exceptions process in place that they 

would be able to adapt for the provision 

in these proposed rules. However, those 

that do not would incur costs to develop 

one. The Departments do not have 

information about the percentage of 

plans and issuers that currently have an 

exceptions process in place that could 

be adapted for the provision in these 

proposed rules or the upfront and 

recurring costs that plans and issuers 

would incur to establish one. The 

Departments request comment on the 

potential costs to plans and issuers 

associated with this provision. 

(4) Costs to Issuers and TPAs (on Behalf 

of Self-Insured Group Health Plans) 

Associated With the Disclosure of 

Coverage and Cost-Sharing 

Requirements for OTC Contraceptive 

Items 

As detailed in section IV.D of this 

preamble, issuers and TPAs,187 on 

behalf of self-insured group health 

plans, would incur costs associated with 

the disclosure of coverage and costsharing requirements for OTC 

contraceptive items. Specifically, 

issuers and TPAs would incur one-time 

costs of $35,089,261 to integrate the 

contraception statement language into 

the existing Transparency in Coverage 

internet-based self-service tool,188 and 

to create or update a web page to 

provide information about coverage of 

contraceptive items and services. 

Additionally, issuers and TPAs would 

incur annual costs of $6,091,096 for 

programming updates, web page 

maintenance, training customer service 

representatives, and responding to calls 

to provide assistance. These costs would 

ultimately be incurred by plans and 

issuers and, in turn, by covered 

individuals through a minimal impact 

on premiums. The Departments request 

comment on the costs to issuers and 

TPAs associated with this provision. 

e. Transfers 

Eliminating cost sharing for some 

contraceptive items has the potential to 

affect transfers associated with 

contraceptive items and insurance 

coverage. Specifically, the Departments 

expect these proposed rules would 

result in transfers from plans and 

issuers to covered individuals resulting 

from reduced out-of-pocket costs for 

contraceptive items, which are 

estimated to be mostly paid by covered 

individuals experiencing higher 

premiums, with a smaller portion paid 

by the Federal government through 

premium tax credit (PTC) spending. The 

Departments also expect these proposed 

rules would result in transfers from 

plans and issuers (and potentially 

premium-payers and the Federal 

government) to pharmacies, drug 

wholesalers, and drug manufacturers 

resulting from anticipated shifts in 

formulary design and utilization 

management that could affect plan-paid 

prices for some contraceptive items. 

Lastly, the Departments expect these 

proposed rules would result in transfers 

associated with the use of an exceptions 

process for covered individuals to 

access coverage without cost sharing of 

certain recommended preventive 

services but are unable to quantify the 

magnitudes of these transfers due to a 

lack of data, as discussed later in this 

section. 

(1a) Transfers From Plans and Issuers to 

Covered Individuals Resulting From 

Reduced Out-of-Pocket Costs for 

Contraceptive Items 

The Departments expect that the 

proposed elimination of cost sharing for 

a wider variety of contraceptive items 

would lead to transfers from plans and 

issuers to covered individuals due to 

reduced out-of-pocket spending on 

contraceptive services. (Analysis of who 

ultimately pays these transfers is 

presented in the next sub-section.) 

These transfers would accrue to covered 

individuals who are women of 

reproductive age, who use a 

contraceptive method, who—in the 


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189Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings/. 190The Departments note that studies of out-ofpocket spending for contraception based on 

examination of health care claims cannot speak to 

the issue of an insured woman not making use of 

insurance for a contraceptive purchase—a case that 

would not generate an insurance claim. 

191This is the sum of the 6 percent of users whose 

plan does not cover contraception, the 4 percent of 

users who reported ‘‘Other,’’ and the 3 percent of 

users who had coverage but did not use it. The 

Departments note that these proposed rules could 

induce this final category of users to switch to a 

covered OTC method, but the Departments do not 

assume this is the case. 

192Frederiksen, 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,’’ Fig. 14, available at 

https://www.kff.org/report-section/contraception-inthe-united-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

193 8.4 percent of covered individuals are women 

of reproductive age who are currently using 

contraception, and 16 percent of these women face 

some out-of-pocket costs for contraception = 1.3 

percent. 

194The Departments calculate the typical 

monthly out-of-pocket costs for those individuals 

who use insurance but pay a non-zero amount by 

estimating a weighted average of out-of-pocket 

amounts as reported in the KFF survey: 24 percent 

reporting $50 or more, 13 precent reporting $25– 

$49, 19 percent reporting $15–$24, 26 percent 

reporting $5–$14, and 6 percent reporting $1–$4, 

and 12 percent reporting ‘‘Don’t know.’’ Taking 

midpoints of these ranges, assuming a $50 monthly 

payment for the top category, and excluding 

individuals who report ‘‘don’t know’’ yields $26.29 

per month (=((.24*50)+(.13*37)+ 

(0.19*19.5)+(.26*9.5)+(.06*2.5))/(1¥.12)) or 

$315.50 annually. The Departments assume that the 

estimated 16 percent of covered women with partial 

coverage would face zero cost sharing under these 

proposed rules, while the remaining 14 percent of 

covered women, who currently do not report using 

insurance for contraceptives, would not experience 

a significant decline in out-of-pocket costs. 

195Approximately 1.3 percent of the covered 

population (approximately 181.4 million 

individuals) times a $316 reduction in out-of-pocket 

costs = $768.7 million. 

196Approximately $768.7 million in new plan 

costs divided across 181.4 million covered 

individuals = $4.24 in annual premiums. Of the 

181.4 million covered individuals, the CMS 2023 

Open Enrollment Report indicates there are 16.4 

million consumers enrolled in health insurance 

plans purchased through an Exchange and that the 

average annual premium for single coverage for 

Exchange coverage is $7,260 ($605 per individual 

per month). The Departments assume that the 

average annual premium for off-Exchange single 

coverage would be comparable to this figure. 2023 

KFF data indicate that the average annual premium 

for (single) group comprehensive insurance is 

$8,435. The Departments assume that the average 

annual premium for (single) non-Federal 

government plan coverage would be comparable to 

this figure. Based on these figures and assumptions, 

the weighted average annual premium would be 

expected to increase by about 0.05 percent. See 

CMS, ‘‘Health Insurance Marketplaces 2023 Open 

Enrollment Report,’’ available at https://

www.cms.gov/files/document/health-insuranceexchanges-2023-open-enrollment-report-final.pdf 

and KFF, ‘‘2023 Employer Health Benefits Survey,’’ 

available at https://www.kff.org/health-costs/report/ 

2023-employer-health-benefits-survey. 

197The Departments have estimated this net 

Federal spending transfer effect by assuming that 

the expected $4.24 increase in annual gross 

premiums will apply to the second-lowest-cost 

silver plans in each market, and that each dollar of 

increased silver plan premiums generates exactly a 

dollar of additional net Federal PTC spending for 

individuals receiving PTCs. A $4.24 increase in per 

capita annual gross premiums, times 21,310,538 

Exchange annual enrollees (as reported above), 

times 92 percent of enrollees receiving PTCs, equals 

approximately $83.1 million. This estimate does not 

account for the expiration of the enhanced PTC 

subsidies at the end of 2025, which would likely 

reduce the level of Exchange enrollment (or at least 

reduce enrollment growth), reduce the share of 

enrollees receiving PTCs, and therefore reduce net 

Federal PTC spending. Source of fraction receiving 

PTCs: Effectuated Enrollment: Early 2024 Snapshot 

and Full Year 2023 Average, available at https://

www.cms.gov/files/document/early-2024-and-fullyear-2023-effectuated-enrollment-report.pdf. 

absence of the proposed changes— 

would otherwise pay some non-zero 

cost-sharing amount for contraceptives, 

and whose out-of-pocket costs would be 

reduced by these proposed rules. As per 

the calculation in section IV.B.2.b of 

this preamble, approximately 15.2 

million individuals (8.4 percent of 

individuals in covered plans) are 

women of reproductive age using those 

noted forms of contraceptives. The 2022 

KFF Women’s Health Survey showed 

that among privately-insured women 

using contraception, 70 percent reported 

that insurance covered their 

contraceptive method with no cost 

sharing, and 16 percent reported that 

insurance paid some but not all of the 

cost.189 The remaining 13 percent of 

respondents paid out-of-pocket despite 

being insured, believed contraception 

not to be covered by insurance, or 

replied in some other way.190

In terms of consumer response, lack of 

knowledge about plan benefits and 

features as well as preference for noncovered contraceptive items (for 

example, a branded drug in the presence 

of a generic drug with no cost sharing) 

may explain some of the incomplete 

take-up of zero cost-sharing options 

under the status quo, and such frictions 

and preferences might persist to some 

degree under the proposed rules. 

Therefore, the Departments assume 

that—as under the status quo—some 

covered women would continue to pay 

out-of-pocket for contraceptives, 

including by not using insurance when 

insurance could cover some or all of the 

out-of-pocket costs. The Departments 

operationalize this assumption by 

assuming that the 16 percent of women 

who currently use insurance but face 

non-zero cost sharing due to partial 

insurance coverage would instead face 

zero cost sharing under these proposed 

rules, while the 13 percent 191 of 

contraceptive users who are insured but 

do not use insurance coverage for their 

contraceptive items would continue to 

not use insurance coverage.192 The 

Departments estimate that among the 

subset of covered individuals for whom 

contraceptives are covered with nonzero cost sharing (16 percent of 

contraceptive users and therefore 

estimated to be approximately 1.3 

percent of the total covered 

population) 193 these proposed rules 

would decrease average cost sharing by 

a maximum of $316 per year.194

Therefore, the Departments estimate a 

total transfer of approximately $768.7 

million per year to contraceptive users 

in the form of reduced out-of-pocket 

payments.195

(1b) Transfers From Covered Individuals 

and From the Federal Government to 

Plans and Issuers in the Form of Higher 

Premiums (Analysis of Who Pays for the 

Transfers Estimated Above) 

The Departments assume these 

proposed provisions would cause plans 

and issuers to increase premiums to 

approximately offset the new net costs 

incurred by lower cost sharing. In other 

words, the Departments assume the cost 

of decreased cost sharing would be 

passed on to premium payers. From a 

total decline in out-of-pocket payments 

of $768.7 million per year, the 

Departments estimate that these 

proposed rules would increase annual 

gross premiums by about $4.24 per 

covered individual or less than 0.1 

percent.196 Premium payers include 

employer plan participants—both 

directly through employee contributions 

to premiums and indirectly by 

reductions in salary compensation or 

other benefits—and individuals 

purchasing plans outside of the 

employment context (on or off an 

Exchange). Because these proposed 

provisions would increase the cost of 

employer-sponsored insurance and 

reduce the share of total compensation 

subject to taxation, the Departments 

estimate these changes would reduce 

Federal tax revenue by $217 million 

annually. Because these proposed 

provisions are expected to increase 

gross premiums for individual health 

insurance coverage purchased on the 

Exchanges, the Departments estimate 

and anticipate an $83.1 million annual 

increase in net Federal premium tax 

credit (PTC) spending.197 The annual 

Federal budgetary transfers would 

therefore amount to an estimated $300.1 

million ($217 million reduction in 

Federal tax revenue plus $83.1 million 

increase in net Federal PTC spending). 


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198For a useful overview of the management tools 

employed by managed care organizations, see Glied, 

S., National Bureau of Economic Research (1999), 

‘‘Managed Care,’’ available at https://

papers.ssrn.com/sol3/papers.cfm?abstract_

id=202746. 

199Lakdawalla, D. and Yin, W., National Bureau 

of Economic Research (2009). ‘‘Insurer Bargaining 

and Negotiated Drug Prices in Medicare Part D,’’ 

available at https://www.nber.org/papers/w15330; 

Lakdawalla, D.N. (2018). ‘‘Economics of the 

Pharmaceutical Industry,’’ Journal of Economic 

Literature, available at https://www.aeaweb.org/ 

articles?id=10.1257/jel.20161327. 

200See Geruso, M., Layton, T., and Prinz, D. 

(2019). ‘‘Screening in Contract Design: Evidence 

from the ACA Health Insurance Exchanges,’’ 

American Economic Journal: Economic Policy, 

available at https://www.aeaweb.org/articles/pdf/ 

doi/10.1257/pol.20170014 (finding that when plans 

are limited in their ability to expose their enrollees 

to cost-sharing, as with cost-sharing-reduction 

enrollees in Exchange plans, plans may respond by 

relying more heavily on non-price barriers to 

access, such as step-therapy and prior 

authorization). 

The remainder of the estimated $768.7 

million in annual transfers, or 

approximately $468.6 million ($768.7 

million minus $300.1 million), is 

expected to be paid by covered 

participants and enrollees (directly or 

indirectly, as discussed earlier in this 

section) through increased premiums 

paid to plans and issuers and 

subsequent reductions to employees’ 

taxable wages. However, the 

Departments acknowledge that 

employers could also offset plan or 

coverage cost increases through 

increased prices for consumers, reduced 

production costs (for example, layoffs, 

other reductions to labor costs, or other 

production cost reductions), or lower 

profits, for example. The Departments 

request comment on and evidence 

regarding the extent to which new net 

costs incurred by lower cost sharing for 

contraceptive items would be passed 

along to covered individuals through 

increases in premiums. 

(2) Transfers Associated With the Use of 

an Exceptions Process 

The Departments anticipate that the 

increased access to coverage without 

cost sharing of other recommended 

preventive services through the use of 

an exceptions process would generate 

transfers caused by reduced out-ofpocket costs for other recommended 

preventive services for which coverage 

without cost sharing would be 

accessible through an exceptions 

process. 

More specifically, the Departments 

anticipate that the increased access to 

coverage without cost sharing of other 

preventive services through the use of 

an exceptions process would generate 

transfers; on an intermediate basis, they 

would flow from plans and issuers to 

covered individuals, but these transfers 

are expected to be ultimately paid by a 

combination of other covered 

individuals, experiencing higher 

premiums, and by the Federal 

government in the form of higher net 

Federal PTC spending for Exchange 

plans caused by higher premiums 

(approximately equal in size to the total 

reduction in out-of-pocket costs for 

other preventive services for which 

coverage without cost sharing would be 

accessible through the use of an 

exceptions process). 

It is uncertain how plan and issuer 

expenditure would change due to use of 

an exceptions process to allow covered 

individuals to access coverage of 

recommended preventive services 

without cost sharing. The Departments 

do not have data that would allow for 

a quantification of these effects. The 

Departments request comment on the 

transfers associated with the exceptions 

process and their likely magnitudes. 

(3) Potential Transfers From Plans and 

Issuers to Pharmacies, Drug 

Wholesalers, and Drug Manufacturers 

Resulting From Anticipated Shifts in 

Formulary Design That Could Affect 

Plan-Paid Prices for Some Contraceptive 

Items 

These proposed rules would require 

plans and issuers to cover a wider range 

of recommended contraceptive items 

without cost sharing. This is likely to 

affect the relative price negotiating 

power between entities in the drug 

supply chain (manufacturers, 

wholesalers, and pharmacies) and plans 

and issuers, including their affiliated or 

subcontracted PBMs. This could lead to 

higher negotiated prices to plans, 

issuers, and their PBMs. If so, it would 

increase total plan costs for 

recommended contraceptive items and 

would ultimately cause increases in 

plan premiums. 

Plans and issuers place downward 

pressure on negotiated prices for drugs 

and devices and limit spending in 

several ways: 198 through the threat of 

exclusion of a product from a drug 

formulary; through the threat of setting 

high consumer cost sharing that would 

steer covered individuals away from 

high cost or ineffective products; and 

through the threat of erecting non-price 

barriers to access, such as prior 

authorization, step-therapy, or 

requirements for a provider-requested 

exception to access a product.199 Plans 

and issuers also place downward 

pressure on negotiated prices for drugs 

and devices and limit spending by 

contracting with providers whose 

prescribing patterns align with the costcontrol goals of the plans and issuers. 

Because drug and device suppliers 

desire favorable coverage and favorable 

provider prescribing behavior in order 

to attract higher volumes of covered 

individuals to use their products, these 

tools place powerful downward 

pressures on negotiated (net-of-rebate) 

prices paid by plans. Research has 

shown that when plans and issuers are 

unable to use cost sharing, they rely on 

non-price barriers to access, such as 

prior authorization and step therapy, to 

steer consumers across medication 

options, and ultimately constrain 

overall plan costs.200

The provisions of these proposed 

rules would clarify the use of reasonable 

medical management that plans and 

issuers can use with respect to covering 

recommended preventive services, 

including contraceptive items, without 

cost sharing under the ACA. This 

clarification could impact their 

bargaining power against drug 

suppliers, removing some sources of 

downward pressure on prices. The 

Departments do not have sufficient data 

to estimate the magnitude of these 

effects. The Departments anticipate that 

they are unlikely to be significant for 

contraceptive products for which there 

are available therapeutic equivalents. 

For such products, competition across 

two or more therapeutic equivalents is 

a key constraint on prices even in the 

absence of cost sharing and other plan 

and issuer tools. The Departments 

anticipate that price effects could be 

larger for products for which there is no 

therapeutic equivalent. The 

Departments request comment and data 

regarding these potential transfers. 

f. Uncertainty 

As noted throughout this RIA, due to 

a lack of data and information, there are 

several areas of uncertainty regarding 

the potential impacts of these proposed 

rules. The Departments are unable to 

forecast with high confidence how the 

provisions of these proposed rules 

would affect the choice of contraceptive 

method or product among covered 

women or how many covered women 

would continue to use contraceptives 

with non-zero cost sharing. Further, the 

Departments are unable to forecast with 

high confidence whether or the extent to 

which the pharmaceutical and medical 

device supply chain entities (including 

manufacturers, wholesalers, and 

pharmacies) might respond in pricing 

negotiations with PBMs and issuers to 

both the new patterns of consumer takeup of contraceptive items—as the set of 

options without cost sharing would 

expand under these proposed rules— 

and to the provisions of these proposed 


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85784 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 

201FDA, Center for Drug Evaluation and 

Research, ‘‘Plan B One-Step Information,’’ available 

at https://www.fda.gov/drugs/postmarket-drugsafety-information-patients-and-providers/plan-bone-step-15-mg-levonorgestrel-information. 

202 Guttmacher Institute (2021). ‘‘Use of 

Emergency Contraception in the United States,’’ 

available at https://www.guttmacher.org/fact-sheet/ 

use-emergency-contraception-united-states. 

203Rose, A.J., Timble, J.W., Setoldji, C., Friedberg, 

M.W., Malsberger, R., and Kahn, K.L. (2019). 

‘‘Primary Care Visit Regularity and Patient 

Outcomes: an Observational Study,’’ Journal of 

General Internal Medicine, available at https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC6318173 

and Hostetter, J., Schwarz, N., Klug, M., Wynne, J., 

and Basson, M.D. (2020), ‘‘Primary Care Visits 

Increase Utilization of Evidence-Based Preventative 

Health Measures,’’ BMC Family Practice, available 

at https://bmcprimcare.biomedcentral.com/articles/ 

10.1186/s12875-020-01216-8. 

204 Gao, J., Moran, E., Grimm, R., Toporek, A., 

Ruser, C. (2022). ‘‘The Effect of Primary Care Visits 

on Total Patient Care Cost: Evidence from the 

Veterans Health Administration,’’ Journal of 

Primary Care Community Health, available at 

https://www.ncbi.nlm.nih.gov/pmc/articles/ 

PMC9793026 (examining the correlation between 

additional in-person primary care visits and total 

health care costs among Veterans Health 

Administration patients and finding that the first 

visit was associated with the largest savings, with 

diminishing returns for subsequent visits). 

205Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings (finding that 60 

percent of reproductive age females who have used 

birth control pills in the past 12 months said they 

would be likely or very likely to use over-thecounter birth control pills). 

206 In 2016, the average cost per visit to a primary 

care physician was $106 compared to $103 for an 

office visit to a NP or PA. See Hargraves, J., Frost 

A. (2018). ‘‘HCCI Brief: Trends in Primary Care 

Visits,’’ available at https://healthcostinstitute.org/ 

hcci-originals-dropdown/all-hcci-reports/trends-inprimary-care-visits. 

207Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

208Switching oral contraceptives can increase the 

chance of pregnancy and can often cause side 

effects. See Lesnewski, R., Prine, L., and Ginzburg, 

R. (2011). ‘‘Preventing Gaps When Switching 

Contraceptives,’’ American Family Physician 

rules that would clarify plans’ and 

issuers’ ability to use reasonable 

medical management. As a result, there 

is some uncertainty about the potential 

impact on premiums. 

The Departments expect that the 

administrative and operational costs 

associated with these proposed rules 

would primarily fall on plans, issuers, 

and pharmacies. As discussed in section 

IV.B.2.d of this preamble and discussed 

in comments in response to the OTC 

Preventive Products RFI, these entities 

would incur costs associated with 

updating IT systems and processes to 

accommodate insurance coverage of 

OTC contraceptives. Commenters noted 

that various systems would likely need 

to be updated or created, such as to 

accommodate new information 

requirements for claims, but provided 

no further information related to any 

associated burdens or costs. Therefore, 

the Departments lack information on the 

scope and size of such activities and 

costs. 

The Departments are uncertain about 

the number of women who would 

switch contraceptive methods to OTC 

contraceptives as a result of these 

proposed rules. Since the first FDAapproved daily OTC oral contraceptive 

pill was approved in July 2023 and 

became widely available for purchase 

(including by being carried by major 

pharmacy chains and online retailers) 

beginning in March 2024, it is too soon 

to predict with confidence the extent of 

switching to an OTC contraceptive from 

other prescription products. 

A reasonable analog to daily OTC oral 

contraception is the increased use of 

emergency contraception since its 

approval for OTC use in the early 2000s. 

The FDA approved nonprescription 

availability of emergency contraception 

(Plan B) for women 18 years or older in 

August 2006.201 This was expanded to 

women 17 years and older in 2009 and 

without age restrictions in 2013. The 

Guttmacher Institute reports that 

between 2008 and 2015, the use of 

emergency contraceptive pills increased 

significantly across nearly all social and 

demographic groups.202 For example, 

the report shows that use among 25–29- 

year-olds more than doubled during this 

time, increasing from 16 percent of 

women ever having used emergency 

contraception to 36 percent. While these 

data do not allow us to forecast 

switching from prescription to OTC 

birth control, they do suggest that takeup of OTC contraceptive items may 

increase. 

There is also insufficient data to 

forecast the extent to which take-up of 

OTC oral contraception would result in 

fewer visits to health care providers and 

the scope for potential negative health 

consequences due to this reduction in 

contact with health care providers. 

Research finds that fewer primary care 

visits may lead to less interaction with 

preventive care services such as 

mammograms, vaccinations, and 

colonoscopies, and may result in more 

emergency room visits and 

hospitalizations, all of which could lead 

to greater health care expenditures in 

the future.203 However, the same work 

finds that the likelihood of preventive 

services uptake does not increase with 

respect to the number of visits, 

suggesting that while increased 

engagement with primary care improves 

compliance with these preventive 

interventions, the benefits of visits may 

diminish in value past a certain 

frequency.204 Applied to this uncertain 

setting, this body of research suggests a 

possibility that covering recommended 

OTC contraceptive items without cost 

sharing and without a prescription 

could be associated with negative health 

consequences if it leads to a reduction 

in provider visits that specifically 

reduces interaction with preventive 

services. However, there is no evidence 

to suggest that such a policy to increase 

coverage of recommended OTC 

contraceptive items would affect the 

strong incentives for women to continue 

to seek preventive care, via a provider 

visit, outside of their need to obtain a 

prescription for contraception. Among 

these incentives, the ACA requires plans 

and issuers to cover, without cost 

sharing, an annual well-woman visit as 

well as other recommended preventive 

services. 

Further, there is significant 

uncertainty about the potential changes 

in take-up of OTC contraceptives that 

would be caused by these proposed 

rules and the impact of any such change 

on the frequency of provider visits. In a 

survey about hypothetical use that 

predated the introduction of an FDAapproved daily OTC oral contraceptive 

pill, many female respondents indicated 

they would be likely to switch to an 

OTC contraceptive if it was available to 

them.205 Women may be motivated to 

make such a switch by the potential 

reduction in required provider visits to 

maintain a prescription. The costs of 

seeing a provider include costs such as 

transportation and childcare during the 

appointment time, or the opportunity 

costs of time associated with the visit. 

If these proposed rules reduce the 

frequency or likelihood of health care 

provider visits among women, the 

revenue of providers who otherwise 

would have performed and billed for 

services would be impacted, 

representing a cost of at least $100 per 

visit, on average.206

Nonetheless, practical considerations 

surrounding OTC contraceptive items 

may limit the number of covered 

individuals who take up this option in 

practice. First, contraceptives have 

numerous side effects, which vary by 

person and product.207 Women are 

likely to have a preference for a given 

contraceptive they have already become 

accustomed to; in this case, they may 

perceive switching as involving some 

risk of generating a worse match.208 A 


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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Proposed Rules 85785 

Journal, available at https://www.aafp.org/pubs/ 

afp/issues/2011/0301/p567.html and Burgess, L. 

(2023). ‘‘How to Switch Birth Control Pills 

Properly,’’ Medical News Today, available at 

https://www.medicalnewstoday.com/articles/ 

322356. 209 Guttmacher Institute (2023). ‘‘PharmacistPrescribed Contraceptives,’’ available at https://

www.guttmacher.org/state-policy/explore/ 

pharmacist-prescribed-contraceptives. 210The 2022 KFF Women’s Health Survey finds 

that 8 percent of women ages 18–49 get their birth 

control from places other than the doctor’s office, 

a clinic, or online, where ‘‘other’’ includes 

pharmacies. When asked about where women 

would prefer to get their birth control, only 12 

percent said ‘‘other’’. See 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-atexperiences-preferences-and-coverage-findings. 

211Long, M., Frederickson, B., Ranji, U., and 

Salganicoff A., KFF (2020). ‘‘Women’s Health Care 

Utilization and Costs: Findings from the 2020 KFF 

Women’s Health Survey,’’ available at https://

www.kff.org/womens-health-policy/issue-brief/ 

womens-health-care-utilization-and-costs-findingsfrom-the-2020-kff-womens-health-survey/. 

212Frederiksen, 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-theunited-states-a-closer-look-at-experiencespreferences-and-coverage-findings. 

213See, e.g., Bernstein, A. and Jones, K.M. (2019). 

‘‘The Economic Effects of Contraceptive Access: A 

Review of the Evidence,’’ Institute for Women’s 

Policy Research, available at https://iwpr.org/wpcontent/uploads/2020/07/B381_ContraceptionAccess_Final.pdf. 

214See 88 FR 68519 (Oct. 4, 2023). 

215BLS, ‘‘May 2023 National Occupational 

Employment and Wage Estimates, United States,’’ 

available at https://www.bls.gov/oes/current/oes_

nat.htm. 

commenter to the OTC Preventive 

Products RFI noted these considerations 

in explaining why the extent of 

switching to OTC products would likely 

be moderate. 

One way to understand how 

important such factors may be is to 

examine the experience with 

pharmacist-prescribed contraceptives. 

As of 2023, 28 states and the District of 

Columbia allowed pharmacists to 

provide contraceptives, 21 of which do 

not require any physician follow-up.209

However, less than 10 percent of women 

currently opt to take advantage of 

pharmacist provision.210 Some women 

may be unaware of this option, while 

others might find that the added 

convenience may not be enough to 

offset a significant preference towards 

consulting with a physician and 

obtaining a prescription for 

contraception. There are several 

considerations that may explain this 

preference: first, most women (73 

percent) see a family or internal 

medicine doctor as their usual source of 

care.211 Thus, it is likely that many 

women are prescribed birth control 

through their primary care physician 

(PCP), and that these visits are likely to 

continue on a semi-regular basis 

regardless of how birth control is 

obtained.212 Next, practitioners are able 

to renew birth control pills over the 

phone or via telemedicine applications, 

eliminating the net potential benefit of 

reducing follow-up visits by switching 

to an OTC pill. Finally, some women 

currently procure contraception from a 

clinical visit that does not include a 

significant medical exam, thus lowering 

the health benefit of such a provider 

interaction (other than its prescribing 

function)—in contrast to other visit 

types with PCPs. Therefore, despite the 

potential time and money savings of 

forgone visits that would be enabled by 

wider OTC contraceptive coverage 

without cost sharing, this evidence 

suggests these factors may not 

significantly impact the use of 

recommended preventive services. 

Informed by the existing research 

discussed in this section, the 

Departments anticipate approximately 

no impact of the proposed rules on the 

frequency of recommended preventive 

services visits with PCPs, nurse 

practitioners, or physician assistants, 

and thus approximately no impact on 

health outcomes of covered women 

through this channel. Similarly, the 

Departments anticipate approximately 

no impact of the proposed rules on 

revenues of these health care providers. 

The Departments note that although the 

option of switching to OTC 

contraception may not provide 

significant value to all contraceptive 

users, the option may provide 

particularly high value for the subset of 

covered women in contraception 

deserts. The Departments request 

comment on this analysis. 

Finally, the Departments acknowledge 

the potential for long-term economic 

effects of increased coverage of certain 

recommended preventive services. 

Research suggests that access to 

contraception can increase educational 

attainment and labor force participation, 

for example, with follow-on potential to 

improve career outcomes and lifetime 

earnings.213 It is also possible that 

overall health outcomes might improve 

because of increased coverage of certain 

recommended preventive services, 

which, in turn, could reduce health care 

expenditures and therefore premiums in 

the future. Further long-term economic 

effects could be seen by entities and 

individuals directly or indirectly (public 

health insurance programs, uninsured 

or self-pay individuals, and suppliers in 

the pharmaceutical industry, for 

example) affected by these proposed 

rules, to the extent that prices for 

different recommended preventive 

services change as a result of these 

proposed rules. However, due to a lack 

of data and clear understanding of how 

preventive services utilization will 

evolve given these proposed rules, the 

Departments are unable to develop 

monetized estimates of these potential 

benefits, costs, and transfers. 

Due to the lack of data, the 

Departments are unable to develop 

monetized estimates of the benefits to 

covered individuals anticipated to arise 

from these proposed rules, including a 

potential reduction in unintended 

pregnancies and improved health 

outcomes for individuals and greater 

flexibility in utilizing a wider range of 

recommended preventive services 

without cost sharing for eligible 

individuals. 

g. Regulatory Review Cost Estimation 

Due to the uncertainty involved with 

quantifying the number of entities that 

will review these proposed rules, the 

Departments assume that the total 

number of unique entities that may 

review these proposed rules will equal 

the number of health insurance 

companies (479) plus the number of 

TPAs (205) (on behalf of self-insured 

group health plans) plus the States, 

Territories, and Washington DC (56) 

plus the number of unique commenters 

(364) to the OTC Preventive Products 

RFI.214 That sum yields 1,104 unique 

entities. The Departments acknowledge 

that this assumption may understate or 

overstate the number of reviewers and 

therefore the costs of reviewing these 

proposed rules. The Departments 

request comment on the approach in 

estimating the number of entities which 

will review these proposed rules. 

Using the median wage information 

from the BLS for business operations 

specialist (13–1199) to account for labor 

costs (including a 100 percent increase 

to account for the cost of fringe benefits 

and other indirect costs), the 

Departments estimate that the cost of 

reviewing this rule is $76.52 per hour, 

including overhead and fringe 

benefits.215 Assuming an average 

reading speed of 200 words per minute, 

the Departments estimate that it would 

take approximately 3.25 hours for the 

staff to review these proposed rules. For 

each entity that reviews the rule, the 

estimated cost is $248.69 (3.25 hours × 

$76.52). Therefore, the Departments 

estimate that the total cost of reviewing 

this regulation is approximately 

$274,554 ($248.69 × 1,104). 


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C. Regulatory Alternatives— 

Departments of Health and Human 

Services and Labor 

In developing these proposed rules, 

the Departments considered various 

alternative approaches. 

The Departments considered 

proposing to require plans and issuers 

to cover all recommended preventive 

services, with no cost sharing and 

without applying reasonable medical 

management techniques. However, as 

discussed in section II.A of this 

preamble, the Departments have 

determined that allowing plans and 

issuers to utilize reasonable medical 

management techniques, when paired 

with requirements to provide an 

exceptions process, as proposed in these 

rules, strikes an appropriate balance 

between the statutory requirement that 

plans and issuers cover recommended 

preventive services at no cost and the 

importance of allowing plans and 

issuers to impose reasonable limitations 

in order to contain costs (including 

costs that would be passed on to 

consumers in the form of increased 

premiums) and promote efficient 

delivery of care. The provision of 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) would ensure 

that covered individuals can access 

coverage of medically necessary 

recommended preventive services 

without cost sharing even if such 

services are typically not covered or are 

otherwise subject to reasonable medical 

management techniques. 

With respect to the proposal to 

require plans and issuers utilizing 

reasonable medical management 

techniques to provide an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that is not 

unduly burdensome, the Departments 

considered limiting this proposal to 

contraceptive items only or to a subset 

of recommended preventive services 

rather than to all preventive services. 

However, the Departments concluded 

that an exceptions process should be 

required for all recommended 

preventive services in order to fully 

implement the requirements under 

section 2713 of the PHS Act to ensure 

that plans and issuers provide coverage 

of recommended preventive services 

without cost-sharing requirements, 

consistent with prior guidance. Without 

such a process, individuals could be 

forced to pay out-of-pocket or forego the 

medically necessary form of a 

recommended preventive service if it 

differs from the form covered by their 

plan or issuer. While prior guidance has 

generally focused on the use of an 

exceptions process in the context of 

contraceptive coverage, it has not been 

exclusively limited to that context, nor 

are the Departments aware of any legal 

or policy reason for limiting 

applicability of an exceptions process to 

one or a subset of recommended 

preventive services. Therefore, the 

Departments determined it was 

appropriate to propose that a plan or 

issuer would be required to provide an 

exceptions process with respect to any 

recommended preventive service for 

which it utilizes medical management 

techniques in order for such techniques 

to be considered reasonable. 

The Departments considered whether 

to propose to require plans and issuers 

to provide coverage without cost sharing 

of all or a subset of recommended OTC 

preventive products. The Departments 

similarly considered whether to propose 

that the therapeutic equivalence 

approach be applicable to all or some 

broader subset of recommended 

preventive services that are drugs and 

drug-led combination products, rather 

than only to contraceptive drugs and 

drug-led combination products. 

However, the Departments decided to 

take an incremental approach, 

beginning first with recommended 

contraceptive items. As discussed in 

section II.A.2 of this preamble, section 

2713 of the PHS Act and its 

implementing regulations do not 

exclude from their coverage requirement 

coverage of OTC recommended 

preventive services. However, in 

consideration of comments in response 

to the OTC Preventive Products RFI 

cautioning against swift implementation 

of a coverage requirement for all OTC 

preventive products, the Departments 

determined it would be advisable to 

propose an initial implementation of 

such a requirement, applicable only to 

recommended OTC contraceptive items. 

Similarly, the Departments are of the 

view that it is advisable to initially 

propose to require the use of a 

therapeutic equivalence approach for 

the same set of recommended 

preventive services—that is, to 

contraceptive drugs and drug-led 

combination products—as in prior 

guidance. This incremental approach to 

coverage, with respect to recommended 

OTC contraceptive items and 

therapeutic equivalence, would provide 

plans and issuers, providers, retailers, 

and other interested parties with the 

opportunity to gather implementation 

data before the Departments determine 

whether additional guidance or 

rulemaking is appropriate. Further, for 

the reasons outlined in sections I and 

II.A of this preamble, it is particularly 

necessary to support access to 

contraceptive items at this time. 

With respect to the Departments’ 

effort to ensure individuals are made 

aware that OTC contraceptive items are 

covered without cost sharing and 

without a prescription, the Departments 

also considered proposing to require 

plans and issuers to create a publicfacing web page with comprehensive 

information about their contraceptive 

coverage policy, including related to 

therapeutic equivalents, exceptions 

processes, network information, and 

OTC coverage. However, the 

Departments understand that at least 

some group health plans do not 

maintain a website for employee health 

benefit plans, and the Departments 

believe more information is needed to 

assess whether it would be feasible for 

plans and issuers to provide information 

about contraceptive coverage on a 

public website in cases where they do 

not maintain such a website, such as by 

entering into a written agreement under 

which a plan’s health insurance issuer 

or TPA, as applicable, posts the 

information on its public website where 

information is normally made available 

to participants, beneficiaries, and 

enrollees, on the plan’s behalf. The 

Departments also considered proposing 

to require the statement to include more 

information about coverage of 

therapeutic equivalents and requested 

comment on this approach, given the 

Departments’ desire to maximize the 

statement’s effectiveness by keeping it 

brief, and that therapeutic equivalent 

coverage policies will not differ between 

plans and thus a plan-specific 

disclosure may be less essential. 

The Departments also considered 

proposing to require that information 

about coverage of OTC contraceptive 

items without cost sharing and without 

a prescription be included on SBCs. 

However, due to the space limitations, 

the Departments are concerned that the 

SBC would not provide a sufficiently 

robust disclosure. The Departments 

decided to seek comment on the SBC’s 

utility for informing participants, 

beneficiaries, and enrollees of coverage 

of OTC contraceptive items without cost 

sharing and without a prescription. 

D. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

of 1995 (PRA), the Departments are 

required to provide 60-day notice in the 

Federal Register and solicit public 

comment before a collection of 

information requirement is submitted to 

OMB for review and approval. To fairly 


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216The CALC tool was built to assist acquisition 

professionals with market research and price 

analysis for labor categories on multiple U.S. 

General Services Administration (GSA) & Veterans 

Administration (VA) contracts. The Departments 

chose to use wages derived from the CALC database 

because, even though the Bureau of Labor Statistics 

(BLS) data set is valuable to economists, 

researchers, and others that would be interested in 

larger, more macro-trends in parts of the economy, 

the CALC data set is meant to help market research 

based on existing government contracts in 

determining how much a project/product will cost 

based on the required skill sets needed. The CALC 

data set factors the fully burdened hourly rates 

(base pay + benefits) into the wages whereas BLS 

does not. CALC occupations and wages provide the 

Departments with data that aligns more with, and 

provides more detail related to, the occupations 

required for the implementation of the requirements 

in these proposed rules. CALC information and 

wage rates are available at https://buy.gsa.gov/ 

pricing/. 

217The Departments’ estimate of the number of 

health insurance companies and the number of 

issuers (issuer/State combinations) is based on 

medical loss ratio reports submitted by issuers for 

the 2022 reporting year. See CMS (2022), ‘‘Medical 

Loss Ratio Data and System Resources,’’ available 

at https://www.cms.gov/CCIIO/Resources/DataResources/mlr. 

218Non-issuer TPAs estimate is based on data 

derived from the 2016 benefit year reinsurance 

program contributions. 

evaluate whether an information 

collection should be approved by OMB, 

section 3506(c)(2)(A) of the PRA 

requires that the Departments solicit 

comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of an agency. 

• The accuracy of the Departments’ 

estimate of the information collection 

burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

As part of the continuing effort to 

reduce paperwork and respondent 

burden, the Departments conduct a 

preclearance consultation program to 

provide the general public and Federal 

agencies with an opportunity to 

comment on proposed and continuing 

collections of information in accordance 

with the PRA. This helps to ensure that 

the public understands the 

Departments’ collection instructions, 

respondents can provide the requested 

data in the desired format, reporting 

burden (time and financial resources) is 

minimized, collection instruments are 

clearly understood, and the 

Departments can properly assess the 

impact of collection requirements on 

respondents. Under the PRA, an agency 

may not conduct or sponsor, and an 

individual is not required to respond to, 

a collection of information unless it 

displays a valid OMB control number. 

The Departments have submitted a 

copy of these proposed rules to OMB in 

accordance with 44 U.S.C. 3507(d) for 

review of the proposed (revised) 

information collections described in this 

section. The Departments request public 

comment on these information 

collections. Commenters may submit 

their comments on the Departments’ 

PRA analysis in the same way they send 

comments in response to this NPRM as 

a whole (for example, through the 

https://www.regulations.gov website), 

including as part of a comment 

responding to the broader NPRM. To 

obtain copies of the supporting 

statements and any related forms for the 

proposed collections, please visit 

https://www.reginfo.gov. 

1. Wage Estimates 

The Departments generally used data 

from the Contract Awarded Labor 

Category (CALC) database tool 216 to 

derive average labor costs for estimating 

the burden and equivalent costs 

associated with the information 

collection requirements (ICRs). Table 3 

presents the estimated mean hourly 

wages, which include both base pay and 

benefits, used in the burden and 

equivalent cost estimates. 

TABLE 3—HOURLY WAGES USED IN BURDEN AND EQUIVALENT COST ESTIMATES

CALC occupation title Mean hourly wage 

($/hour) 

Project Manager/Team Lead ....................................................................................................................................................... $146.15 

Sr. Developer/Lead ...................................................................................................................................................................... 197.27 

Designer ....................................................................................................................................................................................... 107.10 

Training Specialist ....................................................................................................................................................................... 99.95 

Customer Service Representative ............................................................................................................................................... 45.83 

Web Database/Application Developer IV .................................................................................................................................... 170.35 

2. ICR Regarding Requirements for 

Contraceptive Disclosure to 

Participants, Beneficiaries, or Enrollees 

on the Internet-Based Self-Service Tool 

(26 CFR 54.9815–2715A2, 29 CFR 

2590.715–2715A2, and 45 CFR 147.211) 

The Departments propose in new 26 

CFR 54.9815–2715A2(b)(1)(vi), 29 CFR 

2590.715–2715A2(b)(1)(vi), and 45 CFR 

147.211(b)(1)(vi) that if a participant, 

beneficiary, or enrollee requests costsharing information for any covered 

contraceptive item or service using a 

plan’s or issuer’s internet-based selfservice tool or requests such 

information be provided on paper, a 

plan or issuer would be required to 

provide a statement explaining the 

availability of OTC contraceptive items 

without a prescription and without cost 

sharing, along with a phone number and 

internet link to where a participant, 

beneficiary, or enrollee can learn more 

information about the plan’s or policy’s 

contraception coverage. The 

Departments propose to require plans 

and issuers to incorporate this 

disclosure into their existing self-service 

tool for plan years (in the individual 

market, policy years) beginning on or 

after January 1, 2026. 

The Departments assume that fullyinsured group health plans would 

depend on health insurance issuers and 

self-insured group health plans would 

rely on TPAs to implement the 

proposed requirements. Based on recent 

data, the Departments estimate that 

approximately 1,467 issuers 217 and 205 

TPAs 218 would implement the 

proposed requirements on behalf of 

plans and issuers. 

The Departments assume that issuers 

and TPAs have already built self-service 

tools (first applicable for plan years (or 

policy years) beginning on or after 

January 1, 2023) and would only be 

required to modify their existing tools to 

incorporate the proposed new 

contraceptive statement. This statement 

would explain that OTC contraceptive 

items are covered without a prescription 

and without cost sharing and would 

provide a customer service phone 

number and internet link for a 

participant, beneficiary, or enrollee that 

wishes to speak with a customer service 

representative or gain additional 

information about the plan’s or policy’s 

contraception coverage. The 


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219Note that the Departments expect self-insured 

group health plans would rely on TPAs to 

implement the proposed requirements and compensate them accordingly and thereby bear any 

implementation costs. 

introduction of the new contraception 

statement would impose the following 

additional burden on issuers and 

TPAs: 219 (1) first-year one-time 

development costs needed to integrate 

the contraception statement language 

into the existing self-service tool. This 

would involve design changes to the 

existing web user interface to enable 

identification of services that would 

trigger the static statement to the 

consumer. Additionally, the statement 

would be required to include a link to 

information about the participant’s, 

beneficiary’s, or enrollee’s contraception 

coverage benefits. Issuers and TPAs 

would incur one-time costs to create or 

update a web page to provide this 

information; (2) annual costs of 

programming updates, web page 

maintenance, and maintaining the list of 

contraceptive items and services 

required to be coded to trigger the 

statement; (3) annual costs associated 

with training customer service 

representatives to assist consumers with 

inquiries related to the new 

contraceptive statement, and (4) annual 

costs for customer service 

representatives to respond to calls. 

The Departments estimate that for 

each issuer or TPA, on average, it would 

take a Project Manager/Team Lead 40 

hours (at $146.15 per hour), a Senior 

Developer/lead 20 hours (at $197.27 per 

hour), a Designer 25 hours at ($107.10 

per hour), and a Web Database/ 

Application Developer IV 50 hours (at 

$170.35 per hour) to integrate the 

contraception statement language into 

the existing self-service tool, make 

design changes, and create or update a 

web page to provide further details 

regarding the plan’s or policy’s 

contraceptive coverage. The 

Departments estimate the total hour 

burden per issuer or TPA would be 

approximately 135 hours, with an 

equivalent cost of approximately 

$20,986 per issuer or TPA. For all 1,672 

issuers and TPAs, the total first-year 

one-time total hour burden is estimated 

to be 225,720 hours, with an equivalent 

total cost of approximately $35,089,261 

as shown in table 4. 

TABLE 4—TOTAL FIRST YEAR ESTIMATED ONE-TIME COST AND HOUR BURDEN TO INCORPORATE THE NEW CONTRACEPTIVE STATEMENT IN THE INTERNET-BASED SELF-SERVICE TOOL, MAKE DESIGN CHANGES, AND DEVELOP OR UPDATE

A WEB PAGE TO PROVIDE FURTHER DETAILS REGARDING THE PLAN’S OR POLICY’S CONTRACEPTION COVERAGE FOR

ALL HEALTH INSURANCE ISSUERS AND TPAS

Number of respondents Number of responses Burden hours per respondent Total burden hours Total cost 

1,672 1,672 135 225,720 $35,089,261 

In addition to the one-time cost and 

hour burden estimated above, issuers 

and TPAs would incur ongoing annual 

costs for website maintenance, 

programming updates, and updates to 

the list of contraceptive items and 

services required to be coded to trigger 

the statement. The Departments 

estimate that for each issuer and TPA, 

it would take a Web Database/ 

Application Developer IV 5 hours (at 

$170.35 per hour) to complete this task. 

For all 1,672 issuers and TPAs, the total 

annual maintenance burden related to 

the new contraceptive statement would 

be 8,360 hours with an equivalent total 

cost of approximately $1,424,126 as 

shown in table 5. 

TABLE 5—ESTIMATED ANNUAL COST AND HOUR BURDEN FOR MAINTENANCE OF INTERNET-BASED SELF-SERVICE TOOL

RELATED TO THE NEW CONTRACEPTIVE STATEMENT FOR ALL ISSUERS AND TPAS

Number of respondents Number of responses Burden hours per respondent Total burden hours Total cost 

1,672 1,672 5 8,360 $1,424,126 

Issuers and TPAs would also incur an 

ongoing annual burden and cost 

associated with customer service 

representative training related to the 

new contraceptive statement. The 

Departments assume that the 

introduction of the new contraception 

statement would not necessitate hiring 

additional full-time customer service 

representatives. Instead, the 

Departments expect issuers and TPAs 

would utilize their existing customer 

service representatives for this task. 

Therefore, the Departments estimate 

that for each issuer and TPA, one 

Training Specialist would spend 5 

hours at a cost of $99.95 per hour to 

train 5 customer service representatives 

on how to respond to participants, 

beneficiaries, and enrollees if they call 

in because of the new contraception 

statement, who would also require 5 

hours to complete the training at a cost 

of $45.83 per hour. For all 1,672 issuers 

and TPAs, the total annual training hour 

burden would be 50,160 hours, with an 

equivalent total annual cost of 

approximately $2,751,276 as shown in 

table 6. 

TABLE 6—ESTIMATED ANNUAL COST AND HOUR BURDEN FOR ALL ISSUERS AND TPAS TO TRAIN CUSTOMER SERVICE

REPRESENTATIVES TO PROVIDE ASSISTANCE TO CONSUMERS RELATED TO NEW CONTRACEPTIVE STATEMENT IN THE

INTERNET-BASED SELF-SERVICE TOOL

Number of respondents Number of responses Burden hours per respondent Total burden hours Total cost 

1,672 1,672 30 50,160 $2,751,276 


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220Available at https://www.reginfo.gov/public/ 

do/PRAViewICR?ref_nbr=202410-0938-006. 

After the training, customer service 

representatives would be expected to 

respond to the potential increase in calls 

resulting from the new contraception 

statement. The Departments estimate 

that for each issuer and TPA, it would 

take 5 customer service representatives 

5 hours (at $45.83 per hour) to complete 

this task. For all 1,672 issuers and TPAs, 

the total annual cost of responding to 

these calls would be 41,800 hours, with 

an equivalent total cost of 

approximately $1,915,694 as shown in 

table 7. 

TABLE 7—ESTIMATED ANNUAL COST AND HOUR BURDEN FOR ALL ISSUERS AND TPAS TO RESPOND TO CALLS

REGARDING THE NEW CONTRACEPTIVE STATEMENT ON THE INTERNET-BASED SELF-SERVICE TOOL

Number of respondents Number of responses Burden hours per respondent Total burden hours Total cost 

1,672 1,672 25 41,800 $1,915,694 

Taking into account their segment of 

jurisdiction over issuers and TPAs, HHS 

would assume 50 percent of the total 

burden, while the Departments of Labor 

and the Treasury would each assume 25 

percent. Tables 8 to 10 display the share 

of each Department’s total burden hours 

to implement the new contraceptive 

statement. 

TABLE 8—ESTIMATED HHS SHARE OF TOTAL BURDEN HOURS FOR IMPLEMENTING THE NEW CONTRACEPTIVE STATEMENT

Year Number of 

respondents 

Number of 

responses 

Burden hours per 

respondent 

Total burden 

hours 

Year 1 .......................................................................................................... 836 836 135 112,860 

Year 2 .......................................................................................................... 836 836 60 50,160 

Year 3 .......................................................................................................... 836 836 60 50,160 

3-Year Average ............................................................................................ 836 836 85 71,060 

TABLE 9—ESTIMATED DEPARTMENT OF LABOR’S SHARE OF TOTAL BURDEN HOURS FOR IMPLEMENTING THE NEW

CONTRACEPTIVE STATEMENT

Year Number of 

respondents 

Number of 

responses 

Burden hours per 

respondent 

Total burden 

hours 

Year 1 .......................................................................................................... 418 418 135 56,430 

Year 2 .......................................................................................................... 418 418 60 25,080 

Year 3 .......................................................................................................... 418 418 60 25,080 

3-Year Average ............................................................................................ 418 418 85 35,530 

TABLE 10—ESTIMATED DEPARTMENT OF THE TREASURY’S SHARE OF TOTAL BURDEN HOURS FOR IMPLEMENTING THE

NEW CONTRACEPTIVE STATEMENT

Year Number of 

respondents 

Number of 

responses 

Burden hours per 

respondent 

Total burden 

hours 

Year 1 .......................................................................................................... 418 418 135 56,430 

Year 2 .......................................................................................................... 418 418 60 25,080 

Year 3 .......................................................................................................... 418 418 60 25,080 

3-Year Average ............................................................................................ 418 418 85 35,530 

The burden related to the 

Transparency in Coverage disclosure of 

certain cost-sharing information for 

HHS is currently approved under OMB 

control number 0938–1429 (CMS– 

10715, Transparency in Coverage).220

HHS will revise this information 

collection request to account for the 

additional burden associated with the 

contraceptive disclosure. This 

information collection request was 

approved as a host for common forms. 

The burden related to the Transparency 

in Coverage disclosure of certain costsharing information for DOL and 

Treasury was submitted to OMB for 

each respective Department under 

0938–1429 as Request for Common 

Form (RCF) submissions. Upon OMB 

approval of the RCF submissions, DOL 

and Treasury will update and submit 

their information collection requests. 

TABLE 11—SUMMARY OF PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

Regulation section OMB control No. Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

Total cost 

45 CFR 47.211 .................................. 0938–1429 836 836 85 71,060 $119 $8,721,124 

26 CFR 54.9815–2715A2 ................. 0938–1429 418 418 85 35,530 119 4,360,562 


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221 5 U.S.C. 601, et seq. 

222Small Business Administration (2023). ‘‘Table 

of Size Standards (last updated March 2023),’’ 

available at https://www.sba.gov/document/ 

support--table-size-standards. 

223Based on internal calculations. See CMS, 

Medical Loss Ratio Data and System Resources, 

available at https://www.cms.gov/CCIIO/Resources/ 

Data-Resources/mlr.html. 

224The Departments estimate that there are 

594,404 ERISA-covered self-insured group health 

plans based on data from the 2022 Medical 

Expenditure Panel Survey Insurance Component 

(MEPS–IC) and the 2020 County Business Patterns 

from the Census Bureau. The 2020 KFF Employer 

Health Benefits Survey reported that in 2020, 16 

percent of firms offering health benefits offered at 

least one grandfathered health plan (see KFF, 2020 

Kaiser Employer Health Benefits Survey, available 

at https://files.kff.org/attachment/Report-EmployerHealth-Benefits-2020-Annual-Survey.pdf). Thus, the 

Departments have calculated the number of selfinsured, non-grandfathered plans in the following 

manner: 594,404 ERISA-covered self-insured group 

health plans × (100 percent minus 16 percent) = 

499,299. 

225The Departments estimate that there are 

2,195,857 ERISA-covered fully-insured group 

health plans based on data from the 2022 Medical 

Expenditure Panel Survey Insurance Component 

(MEPS–IC) and the 2020 County Business Patterns 

from the Census Bureau. The 2020 KFF Employer 

Health Benefits Survey reported that in 2020, 16 

percent of firms offering health benefits offered at 

least one grandfathered health plan (see KFF, 2020 

Kaiser Employer Health Benefits Survey, available 

at https://files.kff.org/attachment/Report-EmployerHealth-Benefits-2020-Annual-Survey.pdf). Thus, the 

Departments have calculated the number of fullyinsured, non-grandfathered plans in the following 

manner: 2,195,857 ERISA-covered fully-insured 

group health plans × (100 percent minus 16 

percent) =1,844,520. 

226According to data from the 2022 Census of 

Governments, there are 90,887 State and local 

governmental entities (see U.S. Census Bureau, 

2022 Census of Governments, available at https:// 

www.census.gov/data/tables/2022/econ/gus/2022- 

governments.html). The Departments assume that 

each State and local governmental entity sponsors 

one health plan on average. Therefore, the 

Departments estimate that there are 90,887 nonFederal governmental health plans. The 2020 KFF 

Employer Health Benefits Survey reported that 16 

percent of employers offer at least one 

grandfathered plan (see KFF, 2020 Kaiser Employer 

TABLE 11—SUMMARY OF PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS—Continued 

Regulation section OMB control No. Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

Total cost 

29 CFR 2590.715–2715A2 ............... 0938–1429 418 418 85 35,530 119 4,360,562 

Total ........................................... .............................. 1,672 1,672 ........................ 142,120 ........................ 17,442,248 

The Departments seek comment on 

the assumptions made and the burden 

estimates discussed in this section. 

E. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

(RFA) 221 requires agencies to analyze 

options for regulatory relief of small 

entities and to prepare an initial 

regulatory flexibility analysis to 

describe the impact of a proposed rule 

on small entities, unless the head of the 

agency can certify that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

The RFA generally defines a ‘‘small 

entity’’ as (1) a proprietary firm meeting 

the size standards of the Small Business 

Administration (SBA), (2) a not-forprofit organization that is not dominant 

in its field, or (3) a small government 

jurisdiction with a population of less 

than 50,000. States and individuals are 

not included in the definition of ‘‘small 

entity.’’ The data and conclusions 

presented in this section amount to the 

Departments’ initial regulatory 

flexibility analysis under the RFA. 

1. Need for Regulatory Action, 

Objectives, and Legal Basis 

As discussed in section II of this 

preamble, ongoing complaints and 

reports of noncompliance with section 

2713 of the PHS Act and its 

implementing regulations indicate that 

consumers face barriers when 

attempting to use their health plan or 

coverage to access recommended 

preventive services without cost 

sharing. As a result of these concerns 

and other significant activity related to 

preventive services, the Departments are 

proposing to amend the regulations 

governing coverage of recommended 

preventive services in order to ensure 

that participants, beneficiaries, and 

enrollees can access the full range of 

recommended preventive services to 

which they are entitled, with particular 

focus on strengthening coverage 

requirements with respect to 

recommended contraceptive items for 

women, as summarized in section IV.A 

of this preamble. The Departments 

consider these provisions to be timely 

and necessary given the documented 

challenges faced by consumers in 

accessing recommended preventive 

services, as discussed in section IV.B.2.a 

of this preamble. 

2. Number of Affected Small Entities 

and Compliance Requirements and 

Costs 

The provisions in these proposed 

rules would affect small entities 

including health insurance issuers, 

ERISA-covered non-grandfathered group 

health plans, non-grandfathered nonFederal governmental plans, and 

pharmacies. 

The Departments anticipate that 

health insurance issuers, many of which 

are part of larger health insurance 

companies or holding groups, would 

incur costs associated with the 

provisions in these proposed rules, as 

described in section IV.B.2.d of this 

preamble. Health insurance companies 

are generally classified under the North 

American Industry Classification 

System (NAICS) code 524114 (Direct 

Health and Medical Insurance Carriers). 

According to SBA size standards,222

entities with average annual receipts of 

$47 million or less are considered small 

entities for this NAICS code. The 

Departments expect that few, if any, 

insurance companies underwriting 

health insurance policies fall below 

these size thresholds. Based on data 

from medical loss ratio annual report 

submissions for the 2022 reporting year, 

approximately 87 out of 487 health 

insurance companies nationwide had 

total premium revenue of $47 million or 

less.223 This estimate may overstate the 

actual number of small health insurance 

companies that may be affected, since 

over 76 percent of these small 

companies belong to larger holding 

groups, and many, if not all, of these 

small companies are likely to have nonhealth lines of business that will result 

in their revenues exceeding $47 million. 

Plans and plan sponsors would incur 

some costs associated with meeting the 

requirements of these proposed rules, 

whether directly or indirectly through 

compensation paid to a TPA. However, 

the Departments anticipate that most of 

these costs would ultimately be passed 

on to plan participants, as discussed in 

section IV.B.2.e of this preamble. As 

noted in section IV.B.2.b of this 

preamble, the Departments estimate that 

there are 499,299 ERISA-covered selfinsured, non-grandfathered group health 

plans 224 and 1,844,520 ERISA-covered 

fully-insured, non-grandfathered group 

health plans.225 The Departments 

further estimate that there are 76,345 

non-grandfathered non-Federal 

governmental plans sponsored by State 

and local governmental entities.226


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Health Benefits Survey, available at https://

files.kff.org/attachment/Report-Employer-HealthBenefits-2020-Annual-Survey.pdf). The 

Departments therefore estimate there are 

approximately 76,345 non-grandfathered nonFederal governmental plans. 

227Based on data from the 2022 MEPS–IC, the 

2020 County Business Patterns from the Census 

Bureau, and the 2020 Kaiser Employer Health 

Benefits Survey, the Departments estimate that 

approximately 2,189,444 ERISA-covered nongrandfathered group health plans have less than 100 

participants, or approximately 93 percent of the 

total number of ERISA-covered non-grandfathered 

group health plans. 

228U.S. Census Bureau (2017). 2017 SUSB 

Annual Data Tables by Establishment Industry 

(Data by Enterprise Receipts Size), available at 

https://www.census.gov/data/tables/2017/econ/ 

susb/2017-susb-annual.html. 

229Adjusted for inflation between 2017 and 2023 

using the consumer price index for all urban 

consumers (CPI–U). See U.S. Bureau of Labor 

Statistics (2024), Consumer Price Index, available at 

https://www.bls.gov/cpi/tables/supplemental-files/ 

(Historical CPI–U, August 2024). 

230CA, CO, MD, NJ, NM, NY, WA. KFF, (March 

2024). ‘‘State Private Insurance Coverage 

Requirements for OTC Contraception Without a 

Prescription,’’ available at https://www.kff.org/ 

other/state-indicator/state-private-insurancecoverage-requirements-for-otc-contraceptionwithout-a-prescription. 

Due to limited data, the Departments 

are unable to quantify the percentages of 

these plans whose sponsors might be 

considered small entities under the RFA 

but anticipate that most could be.227

The Departments request comment and 

data on the number of plan sponsors 

that might be small entities, as well as 

the potential economic impacts of these 

proposed rules on plan sponsors. 

The Departments anticipate that 

pharmacies would incur costs to update 

billing processes and systems for 

covered OTC contraceptive items, as 

discussed in section IV.B.2.d of this 

preamble. Pharmacies are classified 

under NAICS code 456110 (Pharmacies 

and Drug Retailers) with a size standard 

of $37.5 million or less. According to 

the Census Bureau’s Statistics of U.S. 

Businesses, there are 19,234 firms in the 

pharmacies and drug stores sector in the 

U.S. as of 2017.228 Based on these firms’ 

receipts in 2017 (adjusted for inflation 

between 2017 and 2023), 18,879, or 98.2 

percent, of these firms, accounting for 

22.0 percent of receipts in the sector, 

operate below the SBA size standard 

and are therefore considered small 

entities.229 The Departments request 

comment on this analysis. 

3. Duplication, Overlap, and Conflict 

With Other Rules and Regulations 

The Departments do not anticipate 

that these proposed rules would cause 

any duplication, overlap, or conflict 

with other rules and regulations. 

4. Significant Alternatives 

The Departments considered various 

alternatives to the provisions proposed 

in these proposed rules in section IV.C. 

In light of this discussion of regulatory 

alternatives, the Departments are of the 

view that there are no significant 

alternatives that would both achieve the 

policy objectives and goals of these 

proposed rules and be less burdensome 

to small entities. 

F. Special Analyses—Department of the 

Treasury 

Pursuant to the Memorandum of 

Agreement, Review of Treasury 

Regulations under Executive Order 

12866 (June 9, 2023), tax regulatory 

actions issued by the IRS are not subject 

to the requirements of section 6 of 

Executive Order 12866, as amended. 

Therefore, a regulatory impact 

assessment is not required. Pursuant to 

section 7805(f) of the Code, these 

regulations have been submitted to the 

Chief Counsel for Advocacy of the Small 

Business Administration for comment 

on their impact on small business. 

G. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits before issuing a 

proposed rule that includes any Federal 

mandate that may result in expenditures 

in any one year by State, local, or Tribal 

governments, in the aggregate, or by the 

private sector, of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold is approximately $183 

million in 2024. These proposed rules 

would not impose a mandate that will 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

more than $183 million in any one year. 

As discussed in section IV.B.2.e of this 

preamble, the Departments expect that 

most, if not all, of the transfer effects 

would be incurred by covered 

individuals (directly or indirectly) and 

the Federal government. The 

Departments also anticipate that the 

total costs to plans, issuers, and 

pharmacies identified in section 

IV.B.2.d of this preamble would be 

below the threshold. The Departments 

therefore anticipate that State, local, and 

Tribal governments, in the aggregate, or 

the private sector would not experience 

an increase in expenditure that meets 

this threshold. 

H. Federalism 

Executive Order 13132 outlines 

fundamental principles of federalism. It 

requires adherence to specific criteria by 

Federal agencies in formulating and 

implementing policies that have 

‘‘substantial direct effects’’ on the 

States, the relationship between the 

National Government and States, or on 

the distribution of power and 

responsibilities among the various 

levels of government. Federal agencies 

promulgating regulations that have 

these federalism implications must 

consult with State and local officials 

and describe the extent of their 

consultation and the nature of the 

concerns of State and local officials in 

the preamble to the proposed rules. 

In the Departments’ view, these 

proposed rules have federalism 

implications because they may have 

direct effects on the States, the 

relationship between the Federal 

government and the States, or on the 

distribution of power and 

responsibilities among various levels of 

government. However, the federalism 

implications are substantially mitigated 

because, with respect to health 

insurance issuers, 45 States are either 

enforcing the requirements related to 

coverage of specified preventive 

services (including contraception) 

without cost sharing pursuant to State 

law or otherwise are working 

collaboratively with HHS to ensure that 

issuers meet these standards. In five 

States, HHS ensures that issuers comply 

with these requirements. In addition, 

seven States have passed laws requiring 

State-regulated health plans to cover, 

without cost sharing, certain OTC 

contraceptive items without a 

prescription.230 Therefore, these 

proposed rules would not be likely to 

require substantial additional oversight 

of States by HHS. 

In general, through section 514, 

ERISA supersedes State laws to the 

extent that they relate to any covered 

employee benefit plan, and preserves 

State laws that regulate insurance, 

banking, or securities. While ERISA 

prohibits States from regulating a plan 

as an insurance or investment company 

or bank, the preemption provisions of 

section 731 of ERISA and section 2724 

of the PHS Act (implemented in 29 CFR 

2590.731(a) and 45 CFR 146.143(a)) 

apply so that the ACA’s preventive 

service requirements are not to be 

‘‘construed to supersede any provision 

of State law which establishes, 

implements, or continues in effect any 

standard or requirement solely relating 

to health insurance issuers in 

connection with’’ group or individual 

health insurance coverage ‘‘except to the 

extent that such standard or 

requirement prevents the application 

of’’ a Federal requirement. The 

conference report accompanying the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 


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231See Conf. Rep. No. 104–736, pg. 205, reprinted 

in 1996 U.S. Code Cong. & Admin. News 2018, 

available at https://www.congress.gov/ 

congressional-report/104th-congress/house-report/ 

736/1. 

232See ERISA section 731 and PHS Act section 

2724(a); 29 CFR 2590.731(a) and 45 CFR 146.143(a) 

and 148.210. See also FAQs Part 54, Q11 and Q12 

(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. 

indicates that this is intended to be the 

‘‘narrowest’’ preemption of State 

laws.231

States may continue to apply State 

law requirements except to the extent 

that such requirements prevent the 

application of the preventive services 

requirements in section 2713 of the PHS 

Act.232 State insurance laws that are 

more stringent than the Federal 

requirements are unlikely to prevent the 

application of the preventive services 

requirements and be preempted. 

Accordingly, States have significant 

latitude to impose requirements on 

health insurance issuers that are more 

restrictive than the Federal law. 

The Departments request comment on 

the potential impacts on States (if any) 

associated with these proposed rules. 

Throughout the process of developing 

these proposed rules, to the extent 

feasible within the specific preemption 

provisions of HIPAA as it applies to the 

preventive services requirements, the 

Departments have attempted to balance 

the States’ interests in regulating health 

insurance issuers, and Congress’ intent 

to provide uniform minimum 

protections to consumers in every State. 

By doing so, it is the Departments’ view 

that they have complied with the 

requirements of Executive Order 13132. 

Statutory Authority 

The Department of the Treasury 

regulations are proposed to be adopted 

pursuant to the authority contained in 

sections 7805 and 9833 of the Code. 

The Department of Labor regulations 

are proposed to be adopted pursuant to 

the authority contained in 29 U.S.C. 

1002, 1135, 1182, 1185d, 1191a, 1191b, 

and 1191c; Secretary of Labor’s Order 1– 

2011, 77 FR 1088 (Jan. 9, 2012). 

The Department of Health and Human 

Services regulations are proposed to be 

adopted pursuant to the authority 

contained in sections 2701 through 

2763, 2791, 2792, and 2794 of the PHS 

Act (42 U.S.C. 300gg–63, 300gg–91, 

300gg–92 and 300gg–94), as amended; 

sections 1311 and 1321 of PPACA (42 

U.S.C. 13031 and 18041). 

List of Subjects 

26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 2590 

Continuation coverage, Disclosure, 

Employee benefit plans, Group health 

plans, Health care, Health insurance, 

Medical child support, Reporting and 

recordkeeping requirements. 

45 CFR Part 147 

Health care, Health insurance, 

Reporting and recordkeeping 

requirements, and State regulation of 

health insurance. 

Douglas W. O’Donnell, 

Deputy Commissioner, Internal Revenue 

Service. 

Lisa M. Gomez, 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

Proposed Amendments to the 

Regulations 

Accordingly, the Treasury Department 

and IRS propose to amend 26 CFR part 

54 as follows: 

PART 54—PENSION EXCISE TAXES 

■ Paragraph 1.The authority citation for 

part 54 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

* * * * * 

■ Par. 2. Section 54.9815–2713 is 

amended by revising paragraph (a)(4), 

adding paragraph (a)(6), and revising 

paragraph (d) to read as follows: 

§ 54.9815–2713 Coverage of preventive 

health services. 

(a) * * * 

(4) Reasonable medical management. 

(i) Nothing prevents a plan or issuer 

from using reasonable medical 

management techniques to determine 

the frequency, method, treatment, or 

setting for an item or service described 

in paragraph (a)(1) of this section to the 

extent not specified in the relevant 

recommendation or guideline. To the 

extent not specified in a 

recommendation or guideline described 

in paragraph (a)(1) of this section, a plan 

or issuer may rely on the relevant 

clinical evidence base and established 

reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for 

coverage of a recommended preventive 

health service. 

(ii) For a medical management 

technique to be considered reasonable 

under paragraph (a)(4)(i) of this section, 

a plan or issuer must have an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that is not 

unduly burdensome on a participant, 

beneficiary, or attending provider (or 

other person acting as the individual’s 

authorized representative) that ensures 

the individual can receive coverage, 

without cost-sharing requirements, for 

the item or service specified in a 

recommendation or guideline described 

in paragraph (a)(1) of this section, 

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. 

* * * * * 

(6) Contraceptive items—(i) 

Definitions. For purposes of this 

paragraph (a)(6)— 

(A) Drug-led combination product 

means a combination product, as 

defined under 21 CFR 3.2(e), that 

comprises a drug and a device, and for 

which the drug component provides the 

primary mode of action. 

(B) Therapeutic equivalent has the 

meaning given the term therapeutic 

equivalents in 21 CFR 314.3(b). 

(ii) Over-the-counter contraception. 

Subject to § 54.9815–2713A and 45 CFR 

147.132 and 147.133, a plan or issuer is 

not considered to comply with 

paragraph (a)(1) of this section with 

respect to a contraceptive item that can 

be lawfully obtained by a participant or 

beneficiary without a prescription and 

for which the applicable 

recommendation or guideline does not 

require a prescription, unless the plan 

or issuer provides coverage for the 

contraceptive item without requiring a 

prescription and without imposing any 

cost-sharing requirements in accordance 

with paragraph (a)(1) of this section. 

(iii) Therapeutic equivalents. For 

purposes of paragraph (a)(4) of this 

section, a plan’s or issuer’s medical 

management techniques are not 

considered to be reasonable unless the 

plan or issuer provides coverage, 

without imposing any cost-sharing 

requirements, for all contraceptive items 

recommended under paragraph (a)(1) of 

this section that are drugs or drug-led 

combination products, other than those 

items for which there is at least one 

therapeutic equivalent drug or drug-led 

combination product, as applicable, for 

which the plan or issuer provides 


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coverage without imposing any costsharing requirements. 

* * * * * 

(d) Applicability date. The provisions 

of this section apply for plan years 

beginning on or after September 23, 

2010. Notwithstanding the previous 

sentence, the provisions of paragraph 

(a)(4)(ii) of this section apply beginning 

on [EFFECTIVE DATE OF FINAL RULE] 

and the provisions of paragraph (a)(6) of 

this section apply for plan years 

beginning on or after January 1, 2026. 

See § 54.9815–1251 for determining the 

application of this section to 

grandfathered health plans (providing 

that these rules regarding coverage of 

preventive health services do not apply 

to grandfathered health plans). 

■ Par. 3. Section 54.9815–2715A2 is 

amended by: 

■ a. Redesignating paragraphs (b)(1)(vi) 

and (vii) as paragraphs (b)(1)(vii) and 

(viii); 

■ b. Adding new paragraph (b)(1)(vi); 

and 

■ c. Revising paragraph (c)(1). 

The addition and revision read as 

follows: 

§ 54.9815–2715A2 Transparency in 

coverage—required disclosures to 

participants and beneficiaries. 

* * * * * 

(b) * * * 

(1) * * * 

(vi) If a participant or beneficiary 

requests cost-sharing information for 

any covered contraceptive item or 

service, a statement explaining that 

over-the-counter contraceptive items are 

covered without a prescription and 

without cost sharing in accordance with 

§ 54.9815–2713(a)(6), along with a 

phone number and internet link to 

where a participant or beneficiary can 

learn more information about the plan 

or policy’s contraception coverage. 

* * * * * 

(c) * * * 

(1) The provisions of this section 

apply for plan years beginning on or 

after January 1, 2023, with respect to the 

500 items and services to be posted on 

a publicly available website, and with 

respect to all covered items and 

services, for plan years beginning on or 

after January 1, 2024. Notwithstanding 

the previous sentence, the provisions of 

paragraph (b)(1)(vi) of this section apply 

for plan years beginning on or after 

January 1, 2026. 

* * * * * 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

For the reasons stated in the 

preamble, the Department of Labor 

proposes to amend 29 CFR part 2590 as 

set forth below: 

PART 2590—RULES AND 

REGULATIONS FOR GROUP HEALTH 

PLANS 

■ 1. The authority citation for part 2590 

continues to read as follows: 

Authority: 29 U.S.C. 1027, 1059, 1135, 

1161–1168, 1169, 1181–1183, 1181 note, 

1185, 1185a–n, 1191, 1191a, 1191b, and 

1191c; sec. 101(g), Pub. L.104–191, 110 Stat. 

1936; sec. 401(b), Pub. L. 105–200, 112 Stat. 

645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 

110–343, 122 Stat. 3881; sec. 1001, 1201, and 

1562(e), Pub. L. 111–148, 124 Stat. 119, as 

amended by Pub. L. 111–152, 124 Stat. 1029; 

Division M, Pub. L. 113–235, 128 Stat. 2130; 

Pub. L. 116–260 134 Stat. 1182; Secretary of 

Labor’s Order 1–2011, 77 FR 1088 (Jan. 9, 

2012). 

■ 2. Section 2590.715–2713 is amended 

by revising paragraph (a)(4), adding 

paragraph (a)(6), and revising paragraph 

(d) to read as follows: 

§ 2590.715–2713 Coverage of preventive 

health services. 

(a) * * * 

(4) Reasonable medical management. 

(i) Nothing prevents a plan or issuer 

from using reasonable medical 

management techniques to determine 

the frequency, method, treatment, or 

setting for an item or service described 

in paragraph (a)(1) of this section to the 

extent not specified in the relevant 

recommendation or guideline. To the 

extent not specified in a 

recommendation or guideline described 

in paragraph (a)(1) of this section, a plan 

or issuer may rely on the relevant 

clinical evidence base and established 

reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for 

coverage of a recommended preventive 

health service. 

(ii) For a medical management 

technique to be considered reasonable 

under paragraph (a)(4)(i) of this section, 

a plan or issuer must have an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that is not 

unduly burdensome on a participant, 

beneficiary, or attending provider (or 

other person acting as the individual’s 

authorized representative) that ensures 

the individual can receive coverage, 

without cost-sharing requirements, for 

the item or service specified in a 

recommendation or guideline described 

in paragraph (a)(1) of this section, 

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. 

* * * * * 

(6) Contraceptive items—(i) 

Definitions. For purposes of this 

paragraph (a)(6)— 

(A) Drug-led combination product 

means a combination product, as 

defined under 21 CFR 3.2(e), that 

comprises a drug and a device, and for 

which the drug component provides the 

primary mode of action. 

(B) Therapeutic equivalent has the 

meaning given the term therapeutic 

equivalents in 21 CFR 314.3(b). 

(ii) Over-the-counter contraception. 

Subject to § 2590.715–2713A and 45 

CFR 147.132 and 147.133, a plan or 

issuer is not considered to comply with 

paragraph (a)(1) of this section with 

respect to a contraceptive item that can 

be lawfully obtained by a participant or 

beneficiary without a prescription and 

for which the applicable 

recommendation or guideline does not 

require a prescription, unless the plan 

or issuer provides coverage for the 

contraceptive item without requiring a 

prescription and without imposing any 

cost-sharing requirements in accordance 

with paragraph (a)(1) of this section. 

(iii) Therapeutic equivalents. For 

purposes of paragraph (a)(4) of this 

section, a plan’s or issuer’s medical 

management techniques are not 

considered to be reasonable unless the 

plan or issuer provides coverage, 

without imposing any cost-sharing 

requirements, for all contraceptive items 

recommended under paragraph (a)(1) of 

this section that are drugs or drug-led 

combination products, other than those 

items for which there is at least one 

therapeutic equivalent drug or drug-led 

combination product, as applicable, for 

which the plan or issuer provides 

coverage without imposing any costsharing requirements. 

* * * * * 

(d) Applicability date. The provisions 

of this section apply for plan years 

beginning on or after September 23, 

2010. Notwithstanding the previous 

sentence, the provisions of paragraph 

(a)(4)(ii) of this section apply beginning 

on [EFFECTIVE DATE OF FINAL RULE] 

and the provisions of paragraph (a)(6) of 

this section apply for plan years 

beginning on or after January 1, 2026. 

See § 2590.715–1251 for determining 

the application of this section to 

grandfathered health plans (providing 

that these rules regarding coverage of 

preventive health services do not apply 

to grandfathered health plans). 

* * * * * 

■ 3. Section 2590.715–2715A2 is 

amended by— 

■ a. Redesignating paragraphs (b)(1)(vi) 

and (vii) as paragraphs (b)(1)(vii) and 

(viii); 


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■ b. Adding new paragraph (b)(1)(vi); 

and 

■ c. Revising paragraph (c)(1). 

The addition and revision read as 

follows: 

§ 2590.715–2715A2 Transparency in 

coverage—required disclosures to 

participants and beneficiaries. 

* * * * * 

(b) * * * 

(1) * * * 

(vi) If a participant or beneficiary 

requests cost-sharing information for 

any covered contraceptive item or 

service, a statement explaining that 

over-the-counter contraceptive items are 

covered without a prescription and 

without cost sharing in accordance with 

§ 2590.715–2713(a)(6), along with a 

phone number and internet link to 

where a participant or beneficiary can 

learn more information about the plan 

or policy’s contraception coverage. 

* * * * * 

(c) * * * 

(1) The provisions of this section 

apply for plan years beginning on or 

after January 1, 2023, with respect to the 

500 items and services to be posted on 

a publicly available website, and with 

respect to all covered items and 

services, for plan years beginning on or 

after January 1, 2024. Notwithstanding 

the previous sentence, the provisions of 

paragraph (b)(1)(vi) of this section apply 

for plan years beginning on or after 

January 1, 2026. 

* * * * * 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

For the reasons stated in the 

preamble, the Department of Health and 

Human Services proposes to amend 45 

CFR part 147 as set forth below: 

PART 147—HEALTH INSURANCE 

REFORM REQUIREMENTS FOR THE 

GROUP AND INDIVIDUAL HEALTH 

INSURANCE MARKETS 

■ 1. The authority citation for part 147 

continues to read as follows: 

Authority: 42 U.S.C. 300gg through 300gg– 

63, 300gg–91, 300gg–92, and 300gg–111 

through 300gg–139, as amended, and section 

3203, Pub. L. 116–136, 134 Stat. 281. 

■ 2. Section 147.130 is amended by 

revising paragraph (a)(4), adding 

paragraph (a)(6), and revising paragraph 

(d) to read as follows: 

§ 147.130 Coverage of preventive health 

services. 

(a) * * * 

(4) Reasonable medical management. 

(i) Nothing prevents a plan or issuer 

from using reasonable medical 

management techniques to determine 

the frequency, method, treatment, or 

setting for an item or service described 

in paragraph (a)(1) of this section to the 

extent not specified in the relevant 

recommendation or guideline. To the 

extent not specified in a 

recommendation or guideline described 

in paragraph (a)(1) of this section, a plan 

or issuer may rely on the relevant 

clinical evidence base and established 

reasonable medical management 

techniques to determine the frequency, 

method, treatment, or setting for 

coverage of a recommended preventive 

health service. 

(ii) For a medical management 

technique to be considered reasonable 

under paragraph (a)(4)(i) of this section, 

a plan or issuer must have an easily 

accessible, transparent, and sufficiently 

expedient exceptions process that is not 

unduly burdensome on a participant, 

beneficiary, enrollee, or attending 

provider (or other person acting as the 

individual’s authorized representative) 

that ensures the individual can receive 

coverage, without cost-sharing 

requirements, for the item or service 

specified in a recommendation or 

guideline described in paragraph (a)(1) 

of this section, 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. 

* * * * * 

(6) Contraceptive items—(i) 

Definitions. For purposes of this 

paragraph (a)(6)— 

(A) Drug-led combination product 

means a combination product, as 

defined under 21 CFR 3.2(e), that 

comprises a drug and a device, and for 

which the drug component provides the 

primary mode of action. 

(B) Therapeutic equivalent has the 

meaning given the term therapeutic 

equivalents in 21 CFR 314.3(b). 

(ii) Over-the-counter contraception. 

Subject to §§ 147.131, 147.132, and 

147.133, a plan or issuer is not 

considered to comply with paragraph 

(a)(1) of this section with respect to a 

contraceptive item that can be lawfully 

obtained by a participant, beneficiary, or 

enrollee without a prescription and for 

which the applicable recommendation 

or guideline does not require a 

prescription, unless the plan or issuer 

provides coverage for the contraceptive 

item without requiring a prescription 

and without imposing any cost-sharing 

requirements in accordance with 

paragraph (a)(1) of this section. 

(iii) Therapeutic equivalents. For 

purposes of paragraph (a)(4) of this 

section, a plan’s or issuer’s medical 

management techniques are not 

considered to be reasonable unless the 

plan or issuer provides coverage, 

without imposing any cost-sharing 

requirements, for all contraceptive items 

recommended under paragraph (a)(1) of 

this section that are drugs or drug-led 

combination products, other than those 

items for which there is at least one 

therapeutic equivalent drug or drug-led 

combination product, as applicable, for 

which the plan or issuer provides 

coverage without imposing any costsharing requirements. 

* * * * * 

(d) Applicability date. The provisions 

of this section apply for plan years (in 

the individual market, for policy years) 

beginning on or after September 23, 

2010. Notwithstanding the previous 

sentence, the provisions of paragraph 

(a)(4)(ii) of this section apply beginning 

on [EFFECTIVE DATE OF FINAL RULE] 

and the provisions of paragraph (a)(6) of 

this section apply for plan years (in the 

individual market, for policy years), 

beginning on or after January 1, 2026. 

See § 147.140 of this part for 

determining the application of this 

section to grandfathered health plans 

(providing that these rules regarding 

coverage of preventive health services 

do not apply to grandfathered health 

plans). 

* * * * * 

■ 3. Section 147.211 is amended by— 

■ a. Redesignating paragraphs (b)(1)(vi) 

and (vii) as paragraphs (b)(1)(vii) and 

(viii); 

■ b. Adding new paragraph (b)(1)(vi); 

and 

■ c. Revising paragraph (c)(1). 

The addition and revision read as 

follows: 

§ 147.211 Transparency in coverage— 

required disclosures to participants, 

beneficiaries, or enrollees. 

* * * * * 

(b) * * * 

(1) * * * 

(vi) If a participant, beneficiary, or 

enrollee requests cost-sharing 

information for any covered 

contraceptive item or service, a 

statement explaining that over-thecounter contraceptive items are covered 

without a prescription and without cost 

sharing in accordance with 

§ 147.130(a)(6), along with a phone 

number and internet link to where a 

participant, beneficiary, or enrollee can 

learn more information about the plan 

or policy’s contraception coverage. 

* * * * * 

(c) * * * 

(1) The provisions of this section 

apply for plan years (in the individual 


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market, for policy years) beginning on or 

after January 1, 2023, with respect to the 

500 items and services to be posted on 

a publicly available website, and with 

respect to all covered items and 

services, for plan years (in the 

individual market, for policy years) 

beginning on or after January 1, 2024. 

Notwithstanding the previous sentence, 

the provisions of paragraph (b)(1)(vi) of 

this section apply for plan years (in the 

individual market, for policy years) 

beginning on or after January 1, 2026. 

* * * * * 

[FR Doc. 2024–24675 Filed 10–23–24; 4:15 pm] 

BILLING CODE 4150–29–P; 4830–01–P; 4120–01–P 


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