Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 68519 

PBERG, NY WP (Lat. 44°42′06.25′′ N, long. 073°31′22.18′′ W) 

MUTNA, NY WP (Lat. 45°00′20.84′′ N, long. 073°33′27.65′′ W) 

* * * * * 

Issued in Washington, DC, on September 

28, 2023. 

Karen L. Chiodini, 

Acting Manager, Rules and Regulations 

Group. 

[FR Doc. 2023–21895 Filed 10–3–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–ZA31 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 147 

[CMS–9891–NC] 

RIN 0938–ZB81 

Request for Information; Coverage of 

Over-the-Counter Preventive Services 

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: Request for information. 

SUMMARY: This document is a request for 

information (RFI) regarding the 

application of the preventive services 

requirements under section 2713 of the 

Public Health Service Act (PHS Act) to 

over-the-counter (OTC) preventive items 

and services available without a 

prescription by a health care provider. 

The Department of the Treasury, the 

Department of Labor, and the 

Department of Health and Human 

Services (the Departments) are issuing 

this RFI to gather input from the public 

regarding the potential benefits and 

costs of requiring non-grandfathered 

group health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance 

coverage to cover OTC preventive items 

and services without cost sharing and 

without a prescription by a health care 

provider; seek comment on 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. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. ET on December 4, 2023. 

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–ZA31. 

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, 200 

Constitution Avenue NW., Washington, 

DC 20210, Attention: 1210–ZA31. 

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: 

http://www.regulations.gov. Follow the 

search instructions on that website to 

view public comments. 

FOR FURTHER INFORMATION CONTACT: 

Jason Sandoval, Internal Revenue 

Service, Department of the Treasury, at 

(202) 317–5500. 

Matthew Meidell or Rebecca Miller, 

Employee Benefits Security 

Administration, Department of Labor, at 

(202) 693–8335. 

Kei Helm, Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, at (667) 

290–9656. 

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 nonfederal 

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 

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 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) 

and section 9815(a)(1) to the Internal 

Revenue Code (Code) 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. 


lotter on DSK11XQN23PROD with PROPOSALS1
68520 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 

1The USPSTF published updated breast cancer 

screening recommendations in January 2016. 

However, section 223 of title II of Division H of the 

Consolidated Appropriations Act, 2023 (Pub. L. 

117–328) 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, 2025. 

2 26 CFR 54.9815–2713(a)(4), 29 CFR 2590.715– 

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

3 26 CFR 54.9815–2713(a)(3), 29 CFR 2590.715– 

2713(a)(3), and 45 CFR 147.130(a)(3). 

4Civil Action No. 4:20–cv–00283–O (N. D. Tex. 

Mar. 30, 2023). 

5The Braidwood court also concluded that the 

requirement under PHS Act section 2713(a)(1) to 

cover pre-exposure prophylaxis (PrEP) with 

effective antiretroviral therapy for persons who are 

at high risk of HIV acquisition, consistent with a 

June 11, 2019 USPSTF recommendation, violated 

the rights of some of the plaintiffs before the court 

under the Religious Freedom Restoration Act. The 

court enjoined the Departments from implementing 

or enforcing the PrEP coverage requirement as 

against these plaintiffs. 

6No. 23–10326 (5th Cir. May 15, 2023). 

7See FAQs about Affordable Care Act and 

Coronavirus Aid, Relief, and Economic Security Act 

Implementation Part 59 (Apr. 13, 2023), available at 

https://www.dol.gov/agencies/ebsa/about-ebsa/ouractivities/resource-center/faqs/aca-part-59 and 

https://www.cms.gov/files/document/faqs-part59.pdf (FAQs Part 59). 

8This RFI’s use of the term ‘‘prescription’’ 

encompasses an order for an item or service, as well 

as a medication order by a health care provider. 

9This RFI uses the term ‘‘OTC preventive 

products’’ to refer to preventive items or services 

recommended by the applicable recommendation or 

guidelines under PHS Act section 2713 and its 

implementing regulations and that may be made 

available to an individual without a prescription by 

a health care provider. 

10https://www.uspreventiveservicestaskforce.org/ 

uspstf/recommendation/tobacco-use-in-adults-andpregnant-women-counseling-and-interventions. 

11https://www.uspreventiveservicestaskforce.org/ 

uspstf/recommendation/folic-acid-for-theprevention-of-neural-tube-defects-preventivemedication. 

12https://www.hrsa.gov/womens-guidelines. 

The sections of the PHS Act 

incorporated into ERISA and the Code 

are sections 2701 through 2728. 

Section 2713 of the PHS Act, 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 provide coverage without 

imposing any cost-sharing requirements 

for the following items and services: 

• 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 2009.1

• 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. 

• 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). 

• With respect to women, 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. 

The Departments’ regulations under 

section 2713 of the PHS Act at 26 CFR 

54.9815–2713, 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. In addition, the regulations 

allow plans and issuers 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.2

Moreover, if a plan or issuer has a 

provider in its network that can provide 

a recommended preventive service, the 

plan or issuer is not required to provide 

coverage or waive cost sharing for the 

item or service when furnished by an 

out-of-network provider.3

On March 30, 2023, the United States 

District Court for the Northern District 

of Texas issued a final judgment in 

Braidwood Management Inc. v. 

Becerra 4 (Braidwood). The court held 

that the USPSTF’s recommendations, 

operating in conjunction with PHS Act 

section 2713(a)(1), violate the 

Appointments Clause of Article II of the 

United States Constitution and are 

therefore unlawful. The Braidwood 

decision vacated any and all actions 

taken by the Departments to implement 

or enforce PHS Act section 2713(a)(1)’s 

preventive service coverage 

requirements in response to an ‘‘A’’ or 

‘‘B’’ recommendation by the USPSTF on 

or after March 23, 2010, and enjoined 

the Departments from implementing or 

enforcing PHS Act section 2713(a)(1)’s 

preventive service coverage 

requirements in response to an ‘‘A’’ or 

‘‘B’’ rating from the USPSTF in the 

future.5 The Department of Justice filed 

a notice of appeal on March 31, 2023, 

and a motion for a partial stay pending 

appeal on April 12, 2023. On June 13, 

2023, after a joint stipulation by the 

parties, the United States Court of 

Appeals for the Fifth Circuit granted the 

government’s motion for a partial stay.6

As a result of the partial stay, and 

subject to the enforcement exceptions 

set forth therein for the Braidwood 

plaintiffs, the Departments may 

continue to implement and enforce the 

coverage requirements for items or 

services recommended with an ‘‘A’’ or 

‘‘B’’ rating from the USPSTF on or after 

March 23, 2010. 

The Braidwood decision did not 

enjoin enforcement of PHS Act section 

2713 or vacate its implementing 

regulations and guidance related to 

immunizations recommended by ACIP 

or preventive care and screenings 

provided for in comprehensive 

guidelines supported by HRSA; 

therefore, those requirements are not 

impacted by the Braidwood decision.7

B. Overview of Guidance Related to the 

Coverage of Recommended OTC 

Preventive Services 

While most recommended preventive 

services require a health care provider 

to either provide a prescription 8 for an 

item or service, or to directly furnish a 

service, several preventive products are 

available to consumers without the 

involvement of a provider (OTC 

preventive products).9 Some examples 

include certain types of tobacco 

cessation pharmacotherapy, which are 

currently recommended by the USPSTF 

with an ‘‘A’’ rating for nonpregnant 

adults who use tobacco,10 and folic acid 

supplements, which are recommended 

by the USPSTF with an ‘‘A’’ rating to 

prevent neural tube defects for all 

persons planning to or who could 

become pregnant.11 In addition, the 

guidelines for women’s preventive 

health services adopted and released by 

HRSA (HRSA-supported Guidelines) 

include recommendations for OTC 

preventive products, such as 

breastfeeding supplies (for example, 

breast pumps and breast milk storage 

supplies) and certain contraceptives.12

As discussed further in section I.E of 

this RFI, an OTC progestin-only daily 

oral contraceptive was recently 

approved by the Food and Drug 

Administration (FDA) and is expected 


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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 68521 

13See FAQs about Affordable Care Act 

Implementation Part XII (Feb. 20, 2013), Q4 and 

Q15, available at https://www.dol.gov/sites/dolgov/ 

files/EBSA/about-ebsa/our-activities/resourcecenter/faqs/aca-part-xii.pdf and https://

www.cms.gov/cciio/resources/fact-sheets-and-faqs/ 

aca_implementation_faqs12. 

14See FAQs about Affordable Care Act 

Implementation Part 54 (July 28, 2022), Q5, 

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. 

15 Id. 

16Pub. L. 116–127. 

17Pub. L. 116–136. 18Under section 6001(c) of the FFCRA, the 

Departments were authorized to implement the 

requirements of section 6001 of the FFCRA through 

sub-regulatory guidance, program instruction, or 

otherwise. See FAQs about Families First 

Coronavirus Response Act and Coronavirus Aid, 

Relief, and Economic Security Act Implementation 

Part 42 (Apr. 11, 2020), available at https://

www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/ 

our-activities/resource-center/faqs/aca-part-42.pdf 

and https://www.cms.gov/files/document/FFCRAPart-42-FAQs.pdf (FAQs Part 42); FAQs about 

Families First Coronavirus Response Act and 

Coronavirus Aid, Relief, and Economic Security Act 

Implementation Part 43 (June 23, 2020), available at 

https://www.dol.gov/sites/dolgov/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part43.pdf and https://www.cms.gov/files/document/ 

FFCRA-Part-43-FAQs.pdf (FAQs Part 43); FAQs 

about Families First Coronavirus Response Act and 

Coronavirus Aid, Relief, and Economic Security Act 

Implementation Part 44 (Feb. 26, 2021), available at 

https://www.dol.gov/sites/dolgov/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part44.pdf and https://www.cms.gov/files/document/ 

faqs-part-44.pdf (FAQs Part 44); FAQs about 

Affordable Care Act Implementation Part 50, Health 

Insurance Portability and Accountability Act and 

Coronavirus Aid, Relief, and Economic Security Act 

Implementation (Oct. 4, 2021), available at https:// 

www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/ 

our-activities/resource-center/faqs/aca-part-50.pdf 

and https://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/FAQs-Part-50.pdf 

(FAQs Part 50); 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.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/FAQs-Part-51.pdf (FAQs Part 51); 

FAQs about Families First Coronavirus Response 

Act and Coronavirus Aid, Relief, and Economic 

Security Act Implementation Part 52 (Feb. 4, 2022), 

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

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

faqs/aca-part-52.pdf and https://www.cms.gov/ 

CCIIO/Resources/Fact-Sheets-and-FAQs/ 

Downloads/FAQs-Part-52.pdf (FAQs Part 52); and 

FAQs about Families First Coronavirus Response 

Act, Coronavirus Aid, Relief, and Economic 

Security Act, and Health Insurance Portability and 

Accountability Act Implementation Part 58, 

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

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

aca-part-58.pdf and https://www.cms.gov/cciio/ 

resources/fact-sheets-and-faqs/downloads/faqspart-58.pdf. 

19FAQs Part 51, 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-andFAQs/Downloads/FAQs-Part-51.pdf. 

20The direct coverage safe harbor established in 

FAQs Part 51, Q2, provides that the Departments 

will not take enforcement action against a plan or 

issuer that limited coverage of OTC COVID–19 

diagnostic tests from non-preferred pharmacies or 

other retailers to no less than the actual price, or 

$12 per test (whichever was lower), provided it 

arranged for direct coverage of OTC COVID–19 

diagnostic tests through both its pharmacy network 

and a direct-to-consumer shipping program. 

Additionally, it provides that the Departments will 

not take enforcement action against any plan or 

issuer that limited the number of OTC COVID–19 

diagnostic tests for each participant, beneficiary, or 

enrollee to no less than eight tests per 30-day period 

(or per calendar month). See FAQs Part 51, Q3. 

21See FAQs Part 51, Q4. 

22FAQs Part 52, available at https://www.dol.gov/ 

sites/dolgov/files/EBSA/about-ebsa/our-activities/ 

resource-center/faqs/aca-part-52.pdf and https://

www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/FAQs-Part-52.pdf. 

23See FAQs Part 52, Q1. Under this modification, 

plans and issuers were required to provide direct 

coverage by ensuring participants, beneficiaries, 

and enrollees have adequate access to OTC COVID– 

19 tests with no upfront out-of-pocket expenditure, 

generally by establishing at least one direct-toconsumer shipping mechanism and at least one inperson mechanism. 

to become available soon. Additional 

recommended preventive products may 

also become available OTC in the future. 

Since publishing the regulations 

implementing PHS Act section 2713, the 

Departments have received questions 

from interested parties regarding 

coverage issues related to certain 

recommended preventive services, 

including with respect to OTC 

preventive products. On February 20, 

2013, in Frequently Asked Questions 

(FAQs) about Affordable Care Act 

Implementation Part XII, the 

Departments provided guidance 

interpreting the statutory and regulatory 

requirements to cover recommended 

preventive services without cost sharing 

to mean that preventive products that 

are generally available without a 

prescription, including folic acid and 

certain contraceptive products (such as 

contraceptive sponges and spermicides), 

must be covered without cost sharing 

only when prescribed by a health care 

provider.13 On July 28, 2022, in FAQs 

Part 54, the Departments reaffirmed 

that, consistent with the HRSAsupported Guidelines, plans and issuers 

must cover without cost sharing FDAapproved emergency contraception 

(levonorgestrel or ulipristal acetate), 

including OTC products, when such 

products are prescribed for an 

individual by their attending provider.14

In the same guidance, the Departments 

also clarified that plans and issuers are 

required to cover such OTC 

contraceptives without cost sharing 

including when they are prescribed for 

advanced provision, and encouraged 

plans and issuers to cover OTC 

emergency contraceptive products with 

no cost sharing when they are 

purchased without a prescription by a 

health care provider.15

C. Coverage of OTC COVID–19 

Diagnostic Tests Under the Families 

First Coronavirus Response Act and the 

Coronavirus Aid, Relief, and Economic 

Security Act 

Under section 6001 of the Families 

First Coronavirus Response Act 

(FFCRA),16 as amended by the 

Coronavirus Aid, Relief, and Economic 

Security Act (CARES Act),17 and 

implementing guidance,18 plans and 

issuers were required to cover OTC 

COVID–19 diagnostic tests without a 

prescription by a health care provider or 

individualized clinical assessment, 

purchased on or after January 15, 2022, 

through the end of the COVID–19 Public 

Health Emergency (PHE) declared by the 

Secretary of HHS under section 319 of 

the PHS Act (COVID–19 PHE). OTC 

COVID–19 diagnostic tests covered 

pursuant to the FFCRA and CARES Act 

requirements and implementing 

guidance are not OTC preventive 

products subject to the preventive 

service requirements of section 2713 of 

the PHS Act. However, interested 

parties’ recent experiences 

operationalizing coverage requirements 

for OTC COVID–19 diagnostic tests 

without cost sharing and without a 

prescription by a health care provider 

are relevant to the considerations 

included in this RFI. 

On January 10, 2022, the Departments 

issued FAQs Part 51, which specified 

that plans and issuers were required to 

cover OTC COVID–19 diagnostic tests 

available without an order or 

individualized clinical assessment by a 

health care provider, purchased on or 

after January 15, 2022 through the end 

of the COVID–19 PHE, and without 

imposing cost- sharing requirements, 

prior authorization, or other medical 

management requirements.19 FAQs Part 

51 also established two enforcement 

safe harbors intended to facilitate 

consumer access to OTC COVID–19 

tests during the COVID–19 PHE 20 and 

clarified that plans and issuers were 

permitted to take reasonable steps to 

prevent, detect, and address fraud and 

abuse when providing coverage of OTC 

COVID–19 diagnostic tests during the 

COVID–19 PHE.21

On February 4, 2022, the Departments 

published FAQs Part 52, which further 

clarified the coverage requirements for 

OTC COVID–19 diagnostic tests 22 and 

modified the requirements for the direct 

coverage safe harbor.23 FAQs Part 52 

also clarified that plans and issuers 

could address suspected fraud and 

abuse by limiting coverage of OTC 

COVID–19 diagnostic tests to those 


lotter on DSK11XQN23PROD with PROPOSALS1
68522 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 

24See FAQs Part 52, Q3. 

25See FAQs Part 52, Q4. 

26 86 FR 7793. 

27 87 FR 20689. 

28 597 U.S. _(2022). 

29 87 FR 42053. 

30 88 FR 41815. 

31 88 FR 7236 (Feb. 2, 2023). The references to 

‘‘women’’ in this RFI should be considered to 

include any individual potentially capable of 

becoming pregnant, including cisgender women, 

transgender men, and non-binary individuals in 

accordance with FAQs about Affordable Care Act 

implementation Part XXVI (May 11, 2015), Q5, 

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. 

32FDA Approves First Nonprescription Daily 

Oral Contraceptive, July 13, 2023, https://

www.fda.gov/news-events/press-announcements/ 

fda-approves-first-nonprescription-daily-oralcontraceptive. 

33Progestin-only oral contraceptives are a 

product that is already available in a prescription 

form and are a category of contraceptives listed in 

the HRSA-supported Guidelines. 

34See American Medical Association. (2023). 

AMA Applauds FDA Approval of OTC Birth 

Control. https://www.ama-assn.org/press-center/ 

press-releases/ama-applauds-fda-approval-otcbirth-control; The American College of 

Obstetricians and Gynecologist. (2023). ACOG 

Praises FDA Approval of Over-the-Counter Access 

to Birth Control Pill. https://www.acog.org/news/ 

news-releases/2023/07/acog-praises-fda-approvalof-over-the-counter-access-to-birth-control-pill. 

35See 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. 

https://doi.org/10.1016/ 

j.contraception.2023.109950; Thompson, E.L., 

Galvin, A.M., Garg, A., Diener, A., Deckard, A., 

Griner, S.B., & Kline, N.S. (2023). A socioecological 

perspective to contraceptive access for women 

experiencing homelessness in the United States. 

Contraception, https://doi.org/10.1016/ 

j.contraception.2023.109991; Bessett, D., Prager, J., 

Havard, J., Murphy, D.J., Age ́nor, M., & Foster, A.M. 

(2015). Barriers to contraceptive access after health 

care reform: Experiences of young adults in 

Massachusetts. Women’s Health Issues, 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, 110, 30–35. https://doi.org/ 

10.1016/j.contraception.2022.02.008. 

36 Grindlay, K., Grossman, D. (2016). Prescription 

Birth Control Access Among US Women At Risk of 

Unintended Pregnancy. Journal of Women’s Health. 

https://www.liebertpub.com/doi/10.1089/jwh.2015.

5312. 

37A recent study found that over 12 million adult 

women and nearly two million young women aged 

15–17 would 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, Alexandra, James Trussell, 

Daniel Grossman, and Kate Grindlay (2020). 

‘‘Modeling the Impacts of Price of an Over-theCounter Progestin-Only Pill on Use and Unintended 

Pregnancy among U.S. Women.’’ Women’s Health 

Issues, 30(3): 153–160, available at https://doi.org/ 

10.1016/j.whi.2020.01.003. 

purchased through established retailers 

(and disallow reimbursement for tests 

purchased from a private individual or 

from a seller that uses an online auction 

or resale marketplace).24 In addition, the 

guidance clarified that the OTC COVID– 

19 diagnostic tests that must be covered 

by plans and issuers according to FAQs 

Part 51 did not include COVID–19 tests 

that use a self-collected sample but 

require processing by a laboratory or 

other health care provider to return 

results.25

D. Executive Orders on the Affordable 

Care Act and Reproductive Health 

On January 28, 2021, the President 

issued Executive Order 14009, 

‘‘Strengthening Medicaid and the 

Affordable Care Act’’ (E.O. 14009).26

Section 3 of E.O. 14009 directs the 

Secretaries of the Treasury, Labor, and 

HHS (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. 

Furthermore, the President issued 

Executive Order 14070, ‘‘Continuing To 

Strengthen Americans’ Access to 

Affordable, Quality Health Coverage’’ 

(E.O. 14070) on April 5, 2022.27 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. Accordingly, the 

Departments believe that improving the 

access to and affordability of OTC 

preventive products would take critical 

steps to further the goals of E.O. 14009 

and E.O. 14070. 

Similarly, following the June 24, 

2022, U.S. Supreme Court decision in 

Dobbs v. Jackson Women’s Health 

Organization 28 (Dobbs), the President 

issued Executive Order 14076, 

‘‘Protecting Access to Reproductive 

Healthcare Services’’ (E.O. 14076) on 

July 8, 2022.29 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.’’ 

On June 23, 2023, the President issued 

Executive Order 14101, ‘‘Strengthening 

Access to Affordable, High-Quality 

Contraception and Family Planning 

Services’’ (E.O. 14101).30 Section 2 of 

E.O. 14101 directs the Secretaries to 

consider issuing guidance to further 

improve Americans’ ability to access 

contraception, without out-of-pocket 

expenses, under the ACA and to 

consider additional actions to promote 

increased access to OTC contraception, 

including emergency contraception. As 

stated in the preamble to the proposed 

rules on coverage of certain preventive 

services under the ACA, it is especially 

critical to ensure women’s access to 

reproductive health care and 

contraceptive services without cost 

sharing in light of the Supreme Court’s 

decision in Dobbs.31

E. FDA Approval of Daily OTC 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 

by a health care provider.32 33 Many 

interested parties have applauded the 

availability of a daily OTC oral 

contraceptive for its potential to 

improve access to affordable 

contraception.34 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.35

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 

physician, and difficulty accessing a 

pharmacy.36 Accordingly, the 

availability of a daily OTC oral 

contraceptive without a prescription by 

a health care provider may improve 

access and use if the product is 

affordable and/or covered by insurance 

without cost sharing, and as a result, 

could reduce the number of unintended 

pregnancies.37

II. Solicitation of Comments 

In light of E.O. 14009, E.O. 14070, 

E.O. 14076, E.O. 14101, and the FDA 

approval of a progestin-only oral 

contraceptive as the first daily oral 

contraceptive available without a 

prescription by a health care provider, 

the Departments are of the view that 

requiring plans and issuers to cover, 

without cost sharing, OTC preventive 

products without a prescription by a 


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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 68523 

38E.O. 14101. (2023). 

health care provider under section 2713 

of the PHS Act is an important option 

to consider for expanding access to 

contraceptive care. The Departments are 

also of the view that this option would 

align with the goals of the ACA as well 

as the Biden-Harris Administration’s 

policies to expand utilization of 

preventive care and services by 

minimizing cost barriers. However, the 

Departments recognize that most plans 

and issuers currently do not cover OTC 

preventive products without a 

prescription by a health care provider. 

Therefore, the Departments are issuing 

this RFI to solicit information that will 

improve the Departments’ 

understanding of the issues related to 

consumer access to OTC preventive 

products without cost sharing and 

without a prescription by a health care 

provider. 

The Departments are seeking to gather 

input from the public to better 

understand the potential benefits and 

challenges to individuals, plans, issuers, 

health care providers, retailers, and 

other interested parties that may be 

realized by or arise in promoting greater 

access to OTC preventive products, 

including contraceptives, without cost 

sharing and without a prescription by a 

health care provider. For example, the 

Departments would like to understand 

the current barriers individuals face to 

receiving OTC preventive products with 

a prescription. Additionally, the 

Departments are interested in input on 

any operational challenges to plans, 

issuers, third-party administrators, 

pharmacy benefit managers (PBMs), and 

retailers if plans and issuers are 

required to cover, without imposing 

cost-sharing requirements on the 

consumer, OTC preventive products 

purchased without a prescription by a 

health care provider, including other 

OTC preventive products as they might 

become available on the market. The 

Departments are also interested in 

lessons learned from these interested 

parties’ experiences providing coverage 

for and facilitating the provision of OTC 

COVID–19 diagnostic tests during the 

COVID–19 PHE. The Departments 

request information on the potential 

obstacles and benefits that would be 

associated with interpreting the 

preventive services coverage 

requirement under PHS Act section 

2713 to require coverage of OTC 

preventive products without cost 

sharing and without a prescription by a 

health care provider, and estimates of 

the impact of any such potential 

changes, both generally and with 

respect to the following specific areas: 

A. Access to and Utilization of OTC 

Preventive Products 

• What is the current cost differential 

for consumers between an OTC 

preventive product purchased without a 

prescription by a health care provider, 

and the same OTC preventive product 

(for example, breast pumps and 

breastfeeding supplies) when it is 

prescribed? How common is it for plans 

and issuers to provide coverage for OTC 

preventive products without requiring a 

prescription by a health care provider? 

Share any available measurements of 

utilization of coverage for OTC 

preventive products when prescribed 

and when not prescribed by a health 

care provider. 

• When coverage is offered for OTC 

preventive products that are prescribed 

by a health care provider, do cost 

sharing or other aspects of coverage vary 

by type of OTC preventive product? For 

example, are different cost-sharing 

requirements or medical management 

techniques imposed for OTC tobacco 

cessation products than for OTC breast 

pumps? Do coverage requirements or 

medical management techniques differ 

across different types of OTC 

contraceptives, such as between 

emergency contraception and condoms, 

or between medications and devices? 

What medical management techniques 

do plans and issuers commonly apply to 

OTC preventive products when the 

items are prescribed? If plans and 

issuers impose quantity and/or 

frequency limits or establish brand 

preferences for equivalent products, 

how do they determine such limits and 

preferences? 

• How does a plan’s or issuer’s 

practice of covering OTC preventive 

products only when prescribed by a 

health care provider affect individuals’ 

access to OTC preventive products? 

What other practices (for example, 

reasonable medical management 

techniques, network restrictions, or 

formulary restrictions) are employed by 

plans and issuers that restrict access to 

recommended preventive products that 

are available OTC? 

• If the Departments were to require 

plans and issuers to cover OTC 

preventive products without cost 

sharing and without a prescription by a 

health care provider, what would be 

optimal ways to communicate these 

changes to help ensure that participants, 

beneficiaries, and enrollees are educated 

about any steps they need to take to 

access these products, including to get 

reimbursed for purchasing OTC 

preventive products without a 

prescription by a health care provider? 

Similarly, what would be optimal ways 

to communicate the changes to retailers? 

B. Implementation Issues 

• In the event that the Departments 

require plans and issuers to cover OTC 

preventive products without cost 

sharing and without requiring a 

prescription by a health care provider 

under section 2713 of the PHS Act, what 

operational challenges would plans and 

issuers face in implementing the 

requirement? What operational 

challenges would retailers (including 

pharmacies) face if the requirement is 

implemented (for example, location of 

transaction, privacy concerns, or 

workload at point of sale)? How would 

these challenges impact participants, 

beneficiaries, and enrollees? How would 

these challenges impact the goal of E.O. 

14101 to increase access to affordable 

contraception? 38 What operational 

challenges may be associated with the 

use of telepharmacies and mail orders 

both within and across states or 

localities for OTC preventive products? 

• If plans and issuers were required 

to cover OTC preventive products 

without cost sharing and without 

requiring a prescription by a health care 

provider, how could plans and issuers 

ensure that participants, beneficiaries, 

and enrollees who purchase OTC 

preventive products do not incur out-ofpocket costs at the point of sale, or are 

timely and correctly reimbursed, such 

as through post-purchase 

reimbursement by the plan or issuer or 

other mechanisms? Would utilization 

rates differ depending on whether the 

products were covered without cost to 

the individual at the point of sale or 

were reimbursed following purchase? 

Should plans and issuers be required to 

cover costs associated with shipping 

and/or taxes for OTC preventive 

products? What is the best way to 

eliminate out-of-pocket costs to 

participants, beneficiaries, and 

enrollees, while ensuring that they have 

different options to obtain such 

products (such as via direct mail and in 

person)? What other issues related to 

consumer reimbursement would arise if 

plans and issuers were required to cover 

OTC preventive products without cost 

sharing and without a prescription by a 

health care provider? 

• What issues related to 

reimbursement to retailers and 

providers would arise if plans and 

issuers are required to cover OTC 

preventive products without cost 

sharing and without a prescription by a 

health care provider? How might 

contracts between plans or issuers and 


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68524 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules 

39 Kreitzer, R.J., Watts Smith, C., et al. (2021). 

‘‘Affordable but Inaccessible? Contraception Deserts 

in the US States.’’ Journal of Health Politics, Policy 

and Law 46(2): 277–304. 

40See Mann, E., Chen, A., and Johnson, C. (2022). 

Doctor Knows Best? Provider Bias In the Context of 

Contraceptive Counseling in the United States. 

Contraception. https://www.sciencedirect.com/ 

science/article/pii/S0010782421004728; Swan, T., 

Lefmann, T. (2023). Health Care Provider Bias in 

the Appalachian Region: The Frequency and Impact 

of Contraceptive Coercion. Health Services 

Research. https://onlinelibrary.wiley.com/doi/epdf/ 

10.1111/1475-6773.14157; Hooper, M.W., Payne, 

M., & Parkinson, K.A. (2017). Tobacco cessation 

pharmacotherapy use among racial/ethnic 

minorities in the United States: Considerations for 

primary care. Family Medicine and Community 

Health, https://fmch.bmj.com/content/5/3/193; and 

Geter, A., Herron, A.R., & Sutton, M.Y. (2018). HIVrelated stigma by healthcare providers in the United 

States: a systematic review. AIDS patient care and 

STDs, https://doi.org/10.1089/apc.2018.0114. 

PBMs, network pharmacies, or other 

service providers need to be modified to 

cover OTC preventive products without 

cost sharing and without a prescription 

by a health care provider? How do plans 

and issuers anticipate accounting for 

any retail markups, discounts or 

coupons, or manufacturer rebates? 

• How do pharmacies or other 

retailers currently submit claims to 

plans and issuers for OTC preventive 

products and are there barriers 

associated with doing so? If plans and 

issuers were required to cover OTC 

preventive products without cost 

sharing and without requiring a 

prescription by a health care provider, 

would pharmacies or other retailers be 

able to ensure that a consumer does not 

incur out-of-pocket costs at the point of 

sale? If not, what barriers prevent this, 

and would addressing those barriers 

require changes to claims systems or 

additional guidance? 

• If plans and issuers were required 

to cover OTC preventive products 

without cost sharing and without 

requiring a prescription by a health care 

provider, what types of reasonable 

medical management techniques related 

to frequency, method, treatment, or 

setting would plans and issuers 

consider implementing with respect to 

these products, in instances where an 

applicable recommendation or guideline 

did not specify the frequency, method, 

treatment, or setting for the provision of 

the recommended preventive service? 

How would such techniques differ or 

compare to strategies used currently? 

What additional guidance would be 

necessary to help plans and issuers 

understand what types of medical 

management techniques are considered 

to be reasonable when applied to OTC 

preventive products? 

• If plans and issuers were required 

to cover OTC preventive products 

without cost sharing and without 

requiring a prescription by a health care 

provider, what guardrails would plans 

and issuers consider implementing to 

mitigate fraud, waste, and abuse? 

• What operational challenges arose 

while plans and issuers were required to 

provide OTC COVID–19 diagnostic tests 

without cost sharing and without a 

prescription or provider involvement 

during the COVID–19 PHE that were not 

addressed through guidance issued by 

the Departments? Were there particular 

operational challenges experienced by 

retailers? What lessons learned from 

those experiences could be applied to 

efforts to require coverage for OTC 

preventive products without cost 

sharing and without a prescription by a 

health care provider? Would plans’ and 

issuers’ provision of direct coverage for 

OTC COVID–19 diagnostic tests to 

participants, beneficiaries, and enrollees 

by providing payments to sellers 

directly (without requiring upfront 

payment by consumers and subsequent 

reimbursement by the plans and issuers) 

be a model that could be used to 

implement an OTC coverage 

requirement for preventive products? 

The Departments are particularly 

interested in the experience of 

consumers, plan sponsors, retailers, 

plans, issuers, PBMs, and other service 

providers related to techniques that 

were implemented during the COVID– 

19 PHE to prevent, detect, and respond 

to fraud, waste, and abuse related to the 

provision of OTC COVID–19 diagnostic 

tests. 

• What other strategies could the 

Departments implement to increase 

utilization of OTC preventive products, 

other than, or in addition to, requiring 

plans and issuers to cover such products 

without cost sharing and without a 

prescription by a health care provider? 

Should the Departments look to any 

specific strategies implemented by 

states, localities, plans, issuers, or large 

employers to increase utilization of OTC 

preventive products? Are there any state 

laws or regulations currently in place, or 

expected to be proposed, that could 

hinder utilization and access to OTC 

preventive products? If so, what specific 

requirements in federal regulations 

could mitigate these barriers to access? 

Do workplace wellness programs 

provide access to OTC preventive 

products? If so, how do such programs 

manage frequency, method, treatment, 

and setting to ensure effectiveness, 

efficiency, and access for workers? Does 

access for workers differ based on their 

employer’s size? If so, how? 

C. Health Equity 

• Under current standards and 

requirements, do certain populations 

face additional or disproportionately 

burdensome challenges to accessing 

OTC preventive products? Do the 

current standards that require coverage 

of only prescribed OTC preventive 

products without cost sharing pose a 

substantial burden (for example, excess 

demand for appointments) on health 

care providers working in, or 

disproportionately serving, underserved 

communities? If plans and issuers were 

required to cover OTC preventive 

products without cost sharing and 

without requiring a prescription by a 

health care provider, how would such a 

requirement improve access for these 

populations? For example, is there 

evidence that coverage of OTC 

contraceptive medications or devices 

without a prescription by a health care 

provider would significantly impact 

access in ‘‘contraceptive deserts’’ (areas 

with low access to family planning 

resources)? 39 Could a requirement to 

cover OTC preventive products without 

cost sharing and without a prescription 

by a health care provider potentially 

increase the retail prices of such 

products for individuals who purchase 

them without insurance? If so, what are 

options for addressing such retail price 

increases? 

• Research suggests that provider bias 

may play a role in limiting access to 

certain recommended preventive 

services, including, for example, 

contraceptives and other family 

planning services, tobacco cessation 

pharmacotherapy, and medication to 

reduce the risk of acquiring HIV.40 Has 

permitting plans and issuers to require 

a prescription to obtain coverage for 

OTC preventive services led to lower 

utilization rates for certain 

recommended preventive services 

among particular populations with 

respect to different provider types or 

settings? 

D. Economic Impacts 

• What are the current annual 

utilization costs and annual operational 

costs to plans and issuers related to 

coverage of OTC preventive products 

when such products are prescribed by a 

health care provider? Do the costs to 

plans, issuers, and third-party 

administrators vary for small versus 

large entities? If so, what are the costs 

for small entities as compared to large 

entities? 

• How would a requirement to cover 

OTC preventive products without cost 

sharing and without a prescription by a 

health care provider affect utilization 

costs and operational costs to plans, 

issuers, plan sponsors, third-party 

administrators, PBMs, and retailers? 

What would be the resulting premium 


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impacts, in the short- and long-term? 

Would utilization of OTC preventive 

products significantly replace 

utilization of non-OTC preventive 

products among participants, 

beneficiaries, and enrollees? Would 

there be an impact on the cost of nonOTC preventive products? What are the 

estimated initial and ongoing time and 

cost burdens on (or savings for) plans, 

issuers, plan sponsors, third-party 

administrators, PBMs, and retailers if 

plans and issuers were required to cover 

OTC preventive products without cost 

sharing and without a prescription by a 

health care provider? 

• How would a requirement for plans 

and issuers to cover OTC preventive 

products without cost sharing and 

without a prescription by a health care 

provider affect price negotiations, 

pricing decisions, market power, 

discount or rebate programs, and 

marketing practices for these products? 

Would the costs to plans, issuers, thirdparty administrators, PBMs, and 

providers vary for small versus large 

entities? If so, what are the impacts for 

small entities as compared to large 

entities? What would the net impact of 

these changes be on prices for and the 

availability of OTC preventive products? 

• To what degree would any potential 

increases in costs or premiums 

associated with a requirement for plans 

and issuers to cover OTC preventive 

products without cost sharing and 

without a prescription by a health care 

provider be offset by greater access to 

OTC preventive products (for example, 

due to improved health outcomes from 

greater uptake of recommended 

preventive products, or fewer office 

visits as a result of participants, 

beneficiaries, and enrollees no longer 

requiring an office visit to obtain a 

prescription for OTC preventive 

products)? 

• Identify and provide estimates 

related to the potential societal and 

economic impacts (for example, 

benefits, costs, and transfers) on 

individuals and families, as well as on 

health care providers, if OTC preventive 

products were required to be covered 

without cost sharing and without a 

prescription by a health care provider. 

Would these impacts vary based on 

region, state, socioeconomic status, race, 

sex, age, insured status, or other factors? 

For example, would there be potential 

reductions in unintended pregnancies 

or maternal deaths due to participants, 

beneficiaries, and enrollees no longer 

requiring a prescription for OTC oral 

contraceptives? As another example, 

would there be increases in the length 

of time that children are breastfed if 

OTC preventive products such as 

breastfeeding supplies were required to 

be covered without cost sharing and 

without a prescription by a health care 

provider? Would smoking cessation 

rates improve with increased access to 

OTC tobacco cessation products? 

• Identify and provide any 

information regarding the potential 

impact on health outcomes and quality 

of life of participants, beneficiaries, and 

enrollees if plans and issuers were 

required to cover OTC preventive 

products without cost sharing and 

without a prescription by a health care 

provider. 

• Identify and provide estimates 

related to the potential economic 

impacts (short- and long-term) on health 

care providers, retailers, and 

pharmacists if OTC preventive products 

were required to be covered without 

cost sharing and without a prescription 

by a health care provider. How would 

the claim processing burden for health 

care providers, retailers, and 

pharmacists change? How would the 

number of visits to health care 

providers, retailers, and pharmacists 

change? 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

However, section II of this document 

does contain a general solicitation of 

comments in the form of an RFI. In 

accordance with the implementing 

regulations of the Paperwork Reduction 

Act of 1995 (PRA), specifically 5 CFR 

1320.3(h)(4), this general solicitation is 

exempt from the PRA. Facts or opinions 

submitted in response to general 

solicitations of comments from the 

public, published in the Federal 

Register or other publications, 

regardless of the form or format thereof, 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the agency’s full 

consideration, are not generally 

considered information collections and 

therefore not subject to the PRA. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the PRA. 

Signed at Washington DC. 

Rachel D. Levy, 

Associate Chief Counsel, (Employee Benefits, 

Exempt Organizations, and Employment 

Taxes), Internal Revenue Service, Department 

of the Treasury. 

Signed at Washington DC. 

Carol A. Weiser, 

Benefits Tax Counsel, Department of the 

Treasury. 

Signed at Washington DC. 

Lisa M. Gomez, 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2023–21969 Filed 10–3–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 300 

[REG–106203–23] 

RIN 1545–BQ77 

Preparer Tax Identification Number 

(PTIN) User Fee Update 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to interim final rule. 

SUMMARY: In the Rules and Regulations 

section of this issue of the Federal 

Register, the Department of the Treasury 

(Treasury Department) and the IRS are 

issuing interim final regulations that 

amend the current regulations to reduce 

the amount of the user fee imposed on 

tax return preparers to apply for or 

renew a preparer tax identification 

number (PTIN). The text of the interim 

final regulations also serves as the text 

of these proposed regulations. 

DATES: Electronic or written comments 

and requests for a public hearing must 

be received by December 4, 2023. 

ADDRESSES: Commenters are strongly 

encouraged to submit public comments 

electronically. Submit electronic 

submissions via the Federal 

eRulemaking Portal at https:// 

www.regulations.gov (indicate IRS and 

REG–106203–23) by following the 

online instructions for submitting 

comments. Requests for a public hearing 

must be submitted as prescribed in the 

‘‘Comments and Requests for a Public 

Hearing’’ section. Once submitted to the 

Federal eRulemaking Portal, comments 

cannot be edited or withdrawn. The 

Treasury Department and the IRS will 


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