[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Proposed Rules]
[Pages 68519-68525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21969]


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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.

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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 employment-based health coverage laws may 
call the Employee Benefits Security Administration (EBSA) Toll-Free 
Hotline at 1-866-444-EBSA (3272) or visit the DOL's website 
(www.dol.gov/ebsa). In addition, information from HHS on private health 
insurance coverage and on 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.

[[Page 68520]]

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:
    <bullet> 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\
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    \1\ The 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.
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    <bullet> 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.
    <bullet> 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).
    <bullet> 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\
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    \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).
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    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.
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    \4\ Civil Action No. 4:20-cv-00283-O (N. D. Tex. Mar. 30, 2023).
    \5\ The 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.
    \6\ No. 23-10326 (5th Cir. May 15, 2023).
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    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\
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    \7\ See 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/our-activities/resource-center/faqs/aca-part-59 and https://www.cms.gov/files/document/faqs-part-59.pdf (FAQs Part 59).
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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

[[Page 68521]]

to become available soon. Additional recommended preventive products 
may also become available OTC in the future.
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    \8\ This 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.
    \9\ This 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.
    \10\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions.
    \11\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication.
    \12\ https://www.hrsa.gov/womens-guidelines.
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    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 HRSA-supported Guidelines, plans 
and issuers must cover without cost sharing FDA-approved 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\
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    \13\ See 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/resource-center/faqs/aca-part-xii.pdf and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12.
    \14\ See 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.
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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.
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    \16\ Pub. L. 116-127.
    \17\ Pub. L. 116-136.
    \18\ Under 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/FFCRA-Part-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/about-ebsa/our-activities/resource-center/faqs/aca-part-43.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/about-ebsa/our-activities/resource-center/faqs/aca-part-44.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/Fact-Sheets-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-and-FAQs/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/faqs-part-58.pdf.
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    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\
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    \19\ FAQs 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-and-FAQs/Downloads/FAQs-Part-51.pdf.
    \20\ The 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.
    \21\ See FAQs Part 51, Q4.
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    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

[[Page 68522]]

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\
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    \22\ FAQs 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-and-FAQs/Downloads/FAQs-Part-52.pdf.
    \23\ See 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-to-consumer shipping 
mechanism and at least one in-person mechanism.
    \24\ See FAQs Part 52, Q3.
    \25\ See FAQs Part 52, Q4.
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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.
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    \26\ 86 FR 7793.
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    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.
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    \27\ 87 FR 20689.
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    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\
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    \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.
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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.<SUP>32 33</SUP> 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\
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    \32\ FDA Approves First Nonprescription Daily Oral 
Contraceptive, July 13, 2023, https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive.
    \33\ Progestin-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.
    \34\ See 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-otc-birth-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-approval-of-over-the-counter-access-to-birth-control-pill.
    \35\ See Key, K., Wollum, A., Asetoyer, C., Cervantes, M., 
Lindsey, A., Rivera, R., Robinson Flint, J., Zuniga, C., Sanchez, 
J., and Baum, S. (2023). Challenges accessing contraceptive care and 
interest in over-the-counter oral contraceptive pill use among 
Black, Indigenous, and people of color: An online cross-sectional 
survey. Contraception. 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., Ag[eacute]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.
    \37\ A 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-the-Counter 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.
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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

[[Page 68523]]

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

    <bullet> 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.
    <bullet> 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?
    <bullet> 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?
    <bullet> 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

    <bullet> 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?
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    \38\ E.O. 14101. (2023).
---------------------------------------------------------------------------

    <bullet> 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-of-pocket 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?
    <bullet> 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

[[Page 68524]]

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?
    <bullet> 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?
    <bullet> 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?
    <bullet> 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?
    <bullet> 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.
    <bullet> 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

    <bullet> 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?
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    <bullet> 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?
---------------------------------------------------------------------------

    \40\ See 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). HIV-related stigma by 
healthcare providers in the United States: a systematic review. AIDS 
patient care and STDs, https://doi.org/10.1089/apc.2018.0114.
---------------------------------------------------------------------------

D. Economic Impacts

    <bullet> 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?
    <bullet> 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

[[Page 68525]]

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 non-OTC 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?
    <bullet> 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, third-party 
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?
    <bullet> 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)?
    <bullet> 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?
    <bullet> 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.
    <bullet> 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