Proposed Rule2024-24675
Enhancing Coverage of Preventive Services Under the Affordable Care Act
Primary source
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Published
October 28, 2024
Issuing agencies
Treasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
This document sets forth proposed rules that would amend the regulations regarding coverage of certain preventive services under the Public Health Service Act. Specifically, this document proposes rules that would provide that medical management techniques used by non- grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage with respect to such preventive services would not be considered reasonable unless the plan or issuer provides an easily accessible, transparent, and sufficiently expedient exceptions process that would allow an individual to receive coverage without cost sharing for the preventive service that is medically necessary with respect to the individual, as determined by the individual's attending provider, even if such service is not generally covered under the plan or coverage. These proposed rules also contain separate requirements that would apply to coverage of contraceptive items that are preventive services under the Public Health Service Act. Specifically, these proposed rules would require plans and issuers to cover certain recommended over-the-counter contraceptive items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost-sharing requirements, unless a therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. Finally, this document proposes to require a disclosure pertaining to coverage and cost-sharing requirements for over-the-counter contraceptive items in plans' and issuers' Transparency in Coverage internet-based self-service tools or, if requested by the individual, on paper. These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers.
Full Text
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<title>Federal Register, Volume 89 Issue 208 (Monday, October 28, 2024)</title>
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[Federal Register Volume 89, Number 208 (Monday, October 28, 2024)]
[Proposed Rules]
[Pages 85750-85795]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24675]
[[Page 85749]]
Vol. 89
Monday,
No. 208
October 28, 2024
Part IV
Department of the Treasury
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Internal Revenue Service
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26 CFR Part 54
Department of Labor
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Employee Benefits Security Administration
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29 CFR Part 2590
Department of Health and Human Services
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45 CFR Part 147
Enhancing Coverage of Preventive Services Under the Affordable Care
Act; Proposed Rule
Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 /
Proposed Rules
[[Page 85750]]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG-110878-24]
RIN 1545-BR35
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC25
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS 9887-P]
RIN 0938-AV57
Enhancing Coverage of Preventive Services Under the Affordable
Care Act
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Proposed rule.
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SUMMARY: This document sets forth proposed rules that would amend the
regulations regarding coverage of certain preventive services under the
Public Health Service Act. Specifically, this document proposes rules
that would provide that medical management techniques used by non-
grandfathered group health plans and health insurance issuers offering
non-grandfathered group or individual health insurance coverage with
respect to such preventive services would not be considered reasonable
unless the plan or issuer provides an easily accessible, transparent,
and sufficiently expedient exceptions process that would allow an
individual to receive coverage without cost sharing for the preventive
service that is medically necessary with respect to the individual, as
determined by the individual's attending provider, even if such service
is not generally covered under the plan or coverage. These proposed
rules also contain separate requirements that would apply to coverage
of contraceptive items that are preventive services under the Public
Health Service Act. Specifically, these proposed rules would require
plans and issuers to cover certain recommended over-the-counter
contraceptive items without requiring a prescription and without
imposing cost-sharing requirements. In addition, the proposed rules
would require plans and issuers to cover certain recommended
contraceptive items that are drugs and drug-led combination products
without imposing cost-sharing requirements, unless a therapeutic
equivalent of the drug or drug-led combination product is covered
without cost sharing. Finally, this document proposes to require a
disclosure pertaining to coverage and cost-sharing requirements for
over-the-counter contraceptive items in plans' and issuers'
Transparency in Coverage internet-based self-service tools or, if
requested by the individual, on paper. These proposed rules would not
modify Federal conscience protections related to contraceptive coverage
for employers, plans and issuers.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below by December 27, 2024.
ADDRESSES: Written comments may be submitted to the address specified
below. Any comment that is submitted will be shared with the Department
of the Treasury, Internal Revenue Service, and the Department of Health
and Human Services (HHS). Commenters should not submit duplicates.
Comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. All comments are posted on the
internet exactly as received and can be retrieved by most internet
search engines. No deletions, modifications, or redactions will be made
to the comments received, as they are public records. Comments may be
submitted anonymously.
In commenting, please refer to file code 1210-AC25.
Comments must be submitted in one of the following two ways (please
choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By mail. You may mail written comments to the following address
ONLY: Office of Health Plan Standards and Compliance Assistance,
Employee Benefits Security Administration, Room N-5653, U.S. Department
of Labor, Washington, DC 20210, Attention: 1210-AC25.
Always allow sufficient time for mailed comments to be received
before the close of the comment period. Because of staff and resource
limitations, the Departments cannot accept comments by facsimile (FAX)
transmission.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. The comments are posted on
the following website as soon as possible after they have been
received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions
on that website to view public comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
summary of these proposed rules of not more than 100 words in length,
in plain language, may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
FOR FURTHER INFORMATION CONTACT: Regan Rusher, Internal Revenue
Service, Department of the Treasury, at (202) 317-5500. Matthew
Meidell, Employee Benefits Security Administration, Department of
Labor, at (202) 693-8335. Rebecca Miller, Employee Benefits Security
Administration, Department of Labor, at (202) 693-8335. Geraldine
Doetzer, Centers for Medicare & Medicaid Services, Department of Health
and Human Services at (667) 290-8855. Kendra May, Centers for Medicare
& Medicaid Services, Department of Health and Human Services at (301)
448-3996.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor (DOL) concerning 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 (<a href="http://www.dol.gov/ebsa">www.dol.gov/ebsa</a>). In addition, information
from HHS on private health insurance coverage and on non-Federal
governmental plans can be found on the Centers for Medicare & Medicaid
Services (CMS) website (<a href="http://www.cms.gov/cciio">www.cms.gov/cciio</a>), and information on health
care reform can be found at <a href="http://www.HealthCare.gov">www.HealthCare.gov</a>.
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
[[Page 85751]]
30, 2010. These statutes are collectively known as the Affordable Care
Act (ACA). The ACA reorganized, amended, and added to the provisions of
part A of title XXVII of the Public Health Service Act (PHS Act)
relating to group health plans and health insurance issuers in the
group and individual markets. The ACA added section 715(a)(1) to the
Employee Retirement Income Security Act of 1974 (ERISA) \1\ and section
9815(a)(1) to the Internal Revenue Code (Code) \2\ to incorporate the
provisions of part A of title XXVII of the PHS Act into ERISA and the
Code, and to make them applicable to group health plans and health
insurance issuers providing health insurance coverage in connection
with group health plans.
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\1\ 29 U.S.C. 1185d.
\2\ 26 U.S.C. 9815.
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Section 2713 of the PHS Act,\3\ as added by section 1001 of the ACA
and incorporated into ERISA and the Code, and its implementing
regulations require that non-grandfathered group health plans and
health insurance issuers offering non-grandfathered group or individual
health insurance coverage (plans and issuers) provide coverage without
imposing any cost-sharing requirements for the following items and
services: \4\
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\3\ 42 U.S.C. 300gg-13.
\4\ The items and services described in these recommendations
and guidelines are referred to in this preamble as ``recommended
preventive services.''
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<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; <SUP>5 6</SUP>
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\5\ The USPSTF published updated breast cancer screening
recommendations in April 2024. However, section 223 of title II of
Division D of the Further Consolidated Appropriations Act, 2024
(Pub. L. 118-47) requires that for purposes of PHS Act section 2713,
USPSTF recommendations relating to breast cancer screening,
mammography, and prevention issued before 2009 remain in effect
until January 1, 2026.
\6\ On September 19, 2024, the Departments filed a petition for
a writ of certiorari requesting U.S. Supreme Court review of the
decision of the U.S. Court of Appeals for the Fifth Circuit in
Braidwood Management v. Becerra, which found in part that the
actions taken by the Departments under section 2713(a) of the PHS
Act to require coverage of certain preventive services recommended
by the USPSTF are unconstitutional and unenforceable by the
Departments as to the named plaintiffs. See 104 F.4th 930 (5th Cir.
2024), petition for cert. filed (U.S. Sept. 19, 2024) (No. 24-316).
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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;
\7\
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\7\ In addition, under section 3203 of the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act), enacted on March 27,
2020 (Pub. L. 116-136), plans and issuers must cover, without cost-
sharing requirements, any qualifying coronavirus preventive service
pursuant to section 2713(a) of the PHS Act and its implementing
regulations (or any successor regulations). The term ``qualifying
coronavirus preventive service'' means an item, service, or
immunization that is intended to prevent or mitigate coronavirus
disease 2019 (COVID-19) and that is (1) an evidence-based item or
service that has in effect a rating of ``A'' or ``B'' in the current
USPSTF recommendations; or (2) an immunization that has in effect a
recommendation from ACIP with respect to the individual involved.
See FAQs about Families First Coronavirus Response Act, Coronavirus
Aid, Relief, and Economic Security Act, and Health Insurance
Portability and Accountability Act Implementation Part 58, Q4 (Mar.
29, 2023), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf</a> and
<a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf</a>.
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<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); and
<bullet> With respect to women,\8\ such additional preventive care
and screenings not described in the USPSTF recommendations in PHS Act
section 2713(a)(1), as provided for in comprehensive guidelines
supported by HRSA.\9\
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\8\ Consistent with the terminology in the statute, for purposes
of coverage of contraceptive items, these proposed rules use the
term ``women'' to refer to all individuals potentially capable of
becoming pregnant. Plans and issuers are required to cover
contraceptive services for all such individuals consistent with the
requirements in 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45
CFR 147.130. See FAQs about Affordable Care Act Implementation Part
XXVI, Q5 (May 11, 2015), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>.
\9\ For accommodations and exemptions with respect to coverage
of recommended contraceptive services, see 26 CFR 54.9815-2713A, 29
CFR 2590.715-2713A, and 45 CFR 147.131 through 147.133.
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On August 1, 2011, HRSA established the HRSA-supported Women's
Preventive Services Guidelines (HRSA-supported Guidelines) based on
recommendations from a Department of Health and Human Services' (HHS)
commissioned study by the Institute of Medicine.\10\ Among other
recommended items and services, the 2011 HRSA-supported Guidelines
addressed contraceptive methods and counseling as a type of preventive
service and included all Food and Drug Administration (FDA)-approved
``contraceptive methods, sterilization procedures, and patient
education and counseling for all women with reproductive capacity.''
\11\ The HRSA-supported Guidelines' recommendation on contraception has
been updated several times, including in 2016,\12\ and most recently in
2021.\13\ The 2011 HRSA-supported Guidelines included for each type of
preventive service a column labeled ``Frequency,'' which for
contraceptive methods and counseling, stated, ``as prescribed.'' The
``Frequency'' column does not appear in the 2016, 2019, or 2021 updated
HRSA-supported Guidelines for any preventive service, and the updated
HRSA-supported Guidelines do not contain language that specifies
frequency in accordance with a prescription for contraceptive methods
(or contraceptives) by a health care provider Plans and issuers are
required to provide coverage of women's preventive services, including
contraceptive items and services, without cost sharing, consistent with
the 2021 HRSA-supported Guidelines, for plan years and policy years
beginning on or after December 30, 2022.\14\ The 2021 HRSA-supported
Guidelines refer, under the header
[[Page 85752]]
``Contraception,'' to ``the full range of contraceptives and
contraceptive care to prevent unintended pregnancies and improve birth
outcomes.'' The term ``contraceptive methods'' was replaced in 2021 by
``contraceptives.'' \15\ With the removal of the phrase ``female-
controlled,'' as HRSA explained,\16\ male condoms are included in the
2021 HRSA-supported Guidelines, which also include ``screening,
education, counseling, and provision of contraceptives (including in
the immediate postpartum period)'' including ``follow-up care (e.g.,
management, evaluation and changes, including the removal,
continuation, and discontinuation of contraceptives).'' \17\ The 2021
HRSA-supported Guidelines recommend ``the full range of U.S. Food and
Drug Administration (FDA)-approved, -granted, or -cleared
contraceptives, effective family planning practices, and sterilization
procedures be available as part of contraceptive care.'' \18\
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\10\ See HRSA (2011), ``Women's Preventive Services: Required
Health Plan Coverage,'' available at: <a href="https://web.archive.org/web/20130526033922/https:/www.hrsa.gov/womensguidelines/index.html">https://web.archive.org/web/20130526033922/https:/www.hrsa.gov/womensguidelines/index.html</a>; see
also Institute of Medicine, ``Clinical Preventive Services for
Women: Closing the Gaps'' (2011), available at <a href="https://nap.nationalacademies.org/read/13181/chapter/7">https://nap.nationalacademies.org/read/13181/chapter/7</a>.
\11\ The references in this preamble to ``contraception,''
``contraceptive,'' ``contraceptive coverage,'' ``contraceptive
services,'' ``contraceptive product,'' or ``contraceptive item''
generally include all contraceptives, sterilization, and related
patient education and counseling recommended by the currently
applicable HRSA-supported Guidelines, unless otherwise indicated.
\12\ The HRSA-supported Guidelines, as amended in December 2016,
refer, under the header ``Contraception,'' to: ``the full range of
female-controlled U.S. Food and Drug Administration-approved
contraceptive methods, effective family planning practices, and
sterilization procedures,'' ``contraceptive counseling, initiation
of contraceptive use, and follow-up care (e.g., management, and
evaluation as well as changes to and removal or discontinuation of
the contraceptive method),'' and ``instruction in fertility
awareness-based methods, including the lactation amenorrhea
method.'' See <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>-2016/
index.html.
\13\ See HRSA, ``Women's Preventive Services Guidelines: Current
Guidelines,'' available at <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
\14\ The Departments' regulations under section 2713 of the PHS
Act at 26 CFR 54.9815-2713T, 29 CFR 2590.715-2713, and 45 CFR
147.130 require that plans and issuers provide coverage of
recommended preventive services generally for plan years (in the
individual market, policy years) that begin on or after September
23, 2010, or, if later, for plan years (in the individual market,
policy years) that begin on or after the date that is one year after
the date the recommendation or guideline is issued.
\15\ See 86 FR 59741, 59742 (Oct. 28, 2021).
\16\ HRSA stated that this change was made to allow women to
purchase male condoms for pregnancy prevention. See id.
\17\ See HRSA, Women's Preventive Services Guidelines, available
at <a href="https://www.hrsa.gov/womens-guidelines/index.html">https://www.hrsa.gov/womens-guidelines/index.html</a> (version last
reviewed March 2024, accessed September 25, 2024).
\18\ Id.
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The Departments of the Treasury, Labor, and HHS (the Departments)
previously issued rulemaking to implement the preventive services
requirements of section 2713 of the PHS Act, using their authority
under section 9833 of the Code, section 734 of ERISA, and section 2792
of the PHS Act.\19\ On July 19, 2010, the Departments issued interim
final rules (July 2010 interim final rules) at 26 CFR 54.9815-2713T, 29
CFR 2590.715-2713, and 45 CFR 147.130, which require that plans and
issuers provide coverage of recommended preventive services generally
for plan years or policy years that begin on or after September 23,
2010; or, if later, for plan years or policy years that begin on or
after the date that is one year after the recommendation or guideline
is issued.\20\ Among other provisions, the July 2010 interim final
rules allow plans and issuers to rely on the relevant clinical evidence
base to impose reasonable medical management techniques to determine
the frequency, method, treatment, or setting for coverage of a
recommended preventive health item or service, to the extent not
specified in the applicable recommendation or guideline.\21\
Additionally, if a plan or issuer has a provider in its network that
can provide a recommended preventive service, the July 2010 interim
final rules specify that the plan or issuer is not required to provide
coverage or waive cost sharing for the item or service when delivered
by an out-of-network provider.\22\ However, if a plan or issuer does
not have in its network a provider who can provide a recommended
preventive service (or the plan or coverage does not have a network),
the plan or issuer must cover the item or service when performed by an
out-of-network provider, and may not impose any cost-sharing
requirements with respect to the item or service. The Departments
finalized these rules on July 14, 2015.\23\
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\19\ 26 U.S.C. 9833, 29 U.S.C. 1191c, and 42 U.S.C. 300gg-92.
\20\ 75 FR 41726 (July 19, 2010).
\21\ 26 CFR 54.9815-2713T(a)(4); 29 CFR 2590.715-2713(a)(4); and
45 CFR 147.130(a)(4).
\22\ 26 CFR 54.9815-2713T(a)(3); 29 CFR 2590.715-2713(a)(3); and
45 CFR 147.130(a)(3).
\23\ 80 FR 41318 (July 14, 2015).
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The Departments have also previously issued rules that provide
exemptions from the contraceptive coverage requirement for entities and
individuals with moral or religious objections to contraceptive
coverage, and accommodations through which objecting entities are not
required to contract, arrange, pay, or provide a referral for
contraceptive coverage, while at the same time ensuring that
participants, beneficiaries, and enrollees enrolled in coverage
sponsored or arranged by an objecting entity could separately obtain
contraceptive services at no additional cost.\24\ Most recently, on
February 2, 2023, the Departments issued proposed rules (2023 proposed
rules) to rescind the moral exemption to the contraceptive coverage
requirement and to establish a new ``individual contraceptive
arrangement,'' an independent pathway that individuals enrolled in
plans or coverage sponsored, arranged, or provided by objecting
entities could use to obtain contraceptive services at no cost directly
from a provider or facility that furnishes contraceptive services.\25\
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\24\ These proposed rules would not modify Federal conscience
protections related to contraceptive coverage for employers, plans
and issuers. The rules related to optional accommodations for
certain eligible entities (26 CFR 54.9815-2713A, 29 CFR 2510.3-16
and 2590.715-2713A, and 45 CFR 147.131) and religious (45 CFR
147.132) and moral (45 CFR 147.133) exemptions in connection with
the coverage of certain recommended preventive services--as well as
the conscience protections that apply to certain health care
providers, patients, and other participants (45 CFR part 88)--are
outside the scope of these proposed rules. For a detailed overview
of the regulatory and judicial history of Departmental rules
specifically related to optional accommodations and religious and
moral exemptions from the contraceptive coverage requirement, see 88
FR 7236, 7237-40 (Feb. 2, 2023). For additional information on the
Department of Health and Human Services' final rule on enforcement
of religious freedom and conscience laws, see 89 FR 2078 (Jan. 11,
2024).
\25\ 88 FR 7236.
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B. Guidance Related to the Coverage of Recommended Preventive Services
Since publishing the July 2010 interim final rules, the Departments
have issued extensive guidance related to the requirement to cover
recommended preventive services, including contraceptive services,
without cost sharing under section 2713 of the PHS Act and its
implementing regulations. These guidance documents respond to questions
from interested parties regarding the requirement to provide coverage
for recommended preventive services without cost sharing.\26\
Cumulatively, this body of guidance interprets key elements of the
preventive health services recommendations and guidelines and coverage
requirements, including with respect to the allowed use of reasonable
medical management techniques.\27\ These guidance documents include:
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\26\ See FAQs about Affordable Care Act Implementation Part XII
(Feb. 20, 2013), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>; FAQs about Affordable Care Act
Implementation Part XXVI (May 11, 2015), available at https://
www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/
resource-center/faqs/aca-part-xxvi.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>; FAQs about Affordable Care Act
Implementation Part 31, Mental Health Parity Implementation, and
Women's Health and Cancer Rights Act Implementation (April 20,
2016), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf</a> and
<a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf</a>; 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 <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf</a>; FAQs about Affordable Care Act
Implementation Part 54 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.; and FAQs about Affordable Care Act
Implementation Part 64 (Jan. 22, 2024) available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
\27\ As noted in section I.A of the preamble to these proposed
rules, under 26 CFR 54.9815-2713T(a)(4), 29 CFR 2590.715-2713(a)(4),
and 45 CFR 147.130(a)(4), plans and issuers may use ``reasonable
medical management techniques'' to determine the frequency, method,
treatment, or setting for a recommended preventive service, to the
extent this information is not specified in a recommendation or
guideline. Plans and issuers may rely on established techniques and
the relevant clinical evidence base to determine the frequency,
method, treatment, or setting for coverage of a recommended
preventive health item or service where cost sharing must be waived.
Whether a medical management technique is reasonable depends on all
the relevant facts and circumstances. See FAQs Part 54, Q8 (July 28,
2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and
<a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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[[Page 85753]]
<bullet> Frequently Asked Questions on February 20, 2013 (FAQs Part
XII), which, among other things, clarified the scope of reasonable
medical management with respect to recommended preventive services,
including contraceptive items and services. The FAQs specified that
plans and issuers must cover ``the full range of FDA-approved
contraceptive methods'' and must design reasonable medical management
techniques to include accommodations for the specific medical needs of
an individual. FAQs Part XII, Q14 noted that plans may, for example,
cover a generic drug without cost sharing and impose cost sharing for
equivalent branded drugs. If, however, a generic version is not
available, or would not be medically appropriate for the patient (as
determined by the attending provider, in consultation with the
patient), then a plan or issuer must have a mechanism to provide
coverage for the brand name drug without any cost sharing.\28\ FAQs
Part XII also interpreted the statutory and regulatory requirements to
cover recommended preventive services without cost sharing to mean that
recommended preventive services (including contraceptive products) that
are generally available without a prescription must be covered without
cost sharing only when prescribed by a health care provider.\29\
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\28\ See FAQs Part XII, Q14 (Feb. 20, 2013), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12</a>.
\29\ See id. at Q4 and Q15. As noted elsewhere in this section
I.B, the language ``as prescribed'' appeared in the HRSA-supported
Guidelines until 2016.
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<bullet> Frequently Asked Questions on May 11, 2015 (FAQs Part
XXVI), which clarified that plans and issuers must cover, without cost
sharing, at least one form of contraception in each method \30\ that is
identified by the FDA in its Birth Control Guide.\31\ FAQs Part XXVI
further clarified the scope of reasonable medical management techniques
by specifying that if multiple services and FDA-approved items within a
contraceptive category are medically appropriate for an individual, the
plan or issuer may use reasonable medical management techniques to
determine which specific products to cover without cost sharing with
respect to that individual and, subject to the relevant facts and
circumstances, generally may impose cost sharing (including full cost
sharing) on some items and services to encourage an individual to use
other specific items and services within the chosen contraceptive
category.\32\ However, if the individual's attending provider \33\
recommends a particular service or FDA-approved, -cleared, or -granted
item based on a determination of medical necessity with respect to that
individual, the plan or issuer must defer to the determination of the
attending provider with respect to the individual involved, and cover
that item or service without cost sharing.\34\ Additionally, FAQs Part
XXVI specified that to the extent a plan or issuer uses reasonable
medical management techniques within a specified method of
contraception, the plan or issuer must have an easily accessible,
transparent, and sufficiently expedient exceptions process that is not
unduly burdensome on the individual or a provider (or other individual
acting as a patient's authorized representative) to ensure coverage
without cost sharing of any service or FDA-approved item within the
specified method of contraception that has been recommended by the
individual's attending provider based on a determination of medical
necessity.\35\
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\30\ As noted in FDA's Birth Control Guide (Chart), published in
May 2024, available at <a href="https://www.fda.gov/media/150299/download">https://www.fda.gov/media/150299/download</a>,
the FDA approves, clears, and grants marketing authorization for
individual contraceptive products, not ``methods.'' However, for
purposes of this chart, which includes birth control options broader
than products, the term ``methods'' is used. Similarly, FAQs Part
XXVI used the term ``methods'' consistent with the then-current FDA
Birth Control Guide.
\31\ FAQs Part XXVI referenced the then-current 2015 FDA Birth
Control Guide, which identified 18 contraceptive methods for women,
but noted that the ``FDA Birth Control Guide additionally lists
sterilization surgery for men and male condoms, but the HRSA
Guidelines exclude services relating to a man's reproductive
capacity.'' See FAQs Part XXVI, fn. 12, available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>. The 2021 HRSA-supported Guidelines
incorporated by reference a subsequent update of the FDA Birth
Control Guide (as published on December 22, 2021), and now describes
the full range of contraceptives to include: ``(1) sterilization
surgery for women, (2) implantable rods, (3) copper intrauterine
devices, (4) intrauterine devices with progestin (all durations and
doses), (5) injectable contraceptives, (6) oral contraceptives
(combined pill), 7) oral contraceptives (progestin only), (8) oral
contraceptives (extended or continuous use), (9) the contraceptive
patch, (10) vaginal contraceptive rings, (11) diaphragms, (12)
contraceptive sponges, (13) cervical caps, (14) condoms, (15)
spermicides, (16) emergency contraception (levonorgestrel), and (17)
emergency contraception (ulipristal acetate), and any additional
contraceptives approved, granted, or cleared by the FDA.'' See FAQs
Part 64 (Jan. 22, 2024), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>. The 2021 HRSA-supported Guidelines also state:
``Additionally, instruction in fertility awareness-based methods,
including the lactation amenorrhea method, although less effective,
should be provided for women desiring an alternative method.''
\32\ See FAQs Part XXVI, Q3 (May 11, 2015), available at https:/
/www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/
resource-center/faqs/aca-part-xxvi.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>. For example, a plan could use cost
sharing to encourage use of one of several FDA-approved intrauterine
devices (IUDs) with progestin by imposing cost sharing on the more
costly IUD with progestin while waiving cost sharing for a less
costly IUD with progestin.
\33\ See id. at Q1, fn. 13 (``An attending provider means an
individual who is licensed under applicable State law, who is acting
within the scope of the provider's license, and who is directly
responsible for providing care to the patient relating to the
recommended preventive services. Therefore, a plan, issuer,
hospital, or managed care organization is not an attending
provider.'')
\34\ See id. at introduction and Q3.
\35\ Id. at Q2.
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<bullet> Frequently Asked Questions on April 20, 2016 (FAQs Part
31), which further clarified the requirements on plans and issuers with
respect to the development and implementation of an exceptions process,
including that plans and issuers that meet all other requirements are
permitted to develop and utilize a standard exceptions process form
(such as the Medicare Part D Coverage Determination Request Form) and
instructions as part of the exceptions process.\36\
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\36\ FAQs Part 31, Q2 (April 20, 2016), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf</a> and https://www.cms.gov/CCIIO/
Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
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<bullet> Frequently Asked Questions on July 19, 2021 (FAQs Part
47), which followed USPSTF's release on June 11, 2019 of a
recommendation with an ``A'' rating that clinicians offer preexposure
prophylaxis (PrEP) with ``effective antiretroviral therapy to persons
who are at high risk of human immunodeficiency virus (HIV)
acquisition.'' \37\ FAQs Part 47 clarified
[[Page 85754]]
that plans and issuers are required to cover, without cost sharing, all
items and services that USPSTF recommends should be received prior to
being prescribed PrEP and for ongoing follow-up and monitoring. These
items and services include specific baseline and monitoring services,
such as laboratory testing and adherence counseling. The FAQs also
clarified that plans and issuers utilizing reasonable medical
management must have an easily accessible, transparent, and
sufficiently expedient exceptions process that is not unduly burdensome
on the individual or a provider (or other individual acting as an
authorized representative).
---------------------------------------------------------------------------
\37\ FAQs about Affordable Care Act Implementation Part 47 (July
19, 2021), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf</a> and
<a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf</a>. Note that USPSTF subsequently updated the
recommendation referenced in FAQs Part 47. See USPSTF, Prevention of
Acquisition of HIV: Preexposure Prophylaxis, updated August 22,
2023, available at <a href="https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis">https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis</a>.
---------------------------------------------------------------------------
<bullet> Frequently Asked Questions on January 10, 2022 (FAQs Part
51), which acknowledged complaints received about compliance with the
contraceptive coverage requirement and clarified currently applicable
guidance. Specifically, FAQs Part 51, Q9 was issued in response to
complaints and public reports of potential violations of the
contraceptive coverage requirement, including that plans and issuers
and pharmacy benefit managers (PBMs) were not adhering to requirements
for utilizing reasonable medical management techniques. The FAQs also
highlighted several examples of such potential violations, including
denying coverage for all or particular brand name contraceptives, even
after the individual's attending provider determines and communicates
to the plan or issuer that a particular service or FDA-approved, -
cleared, or -granted contraceptive product is medically necessary with
respect to that individual; requiring individuals to fail first using
numerous other services or FDA-approved, -cleared, or -granted
contraceptive products within the same method of contraception before
the plan or issuer will approve coverage for a service or FDA-approved,
-cleared, or -granted contraceptive product that is medically
appropriate for the individual, as determined by the individual's
attending health care provider; requiring individuals to fail first
using numerous other services or FDA-approved, -cleared, or -granted
contraceptive products in other contraceptive methods before the plan
or issuer will approve coverage for a service or FDA-approved, -
cleared, or -granted contraceptive product that is medically
appropriate for the individual, as determined by the individual's
attending health care provider; and failing to provide an acceptable
exceptions process (for example, by requiring individuals to appeal an
adverse benefit determination using the plan's or issuer's internal
claims and appeals process, rather than providing an exceptions process
that is easily accessible, transparent, sufficiently expedient, and not
unduly burdensome).\38\
---------------------------------------------------------------------------
\38\ FAQs Part 51, Q9 (Jan. 10, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a>.
---------------------------------------------------------------------------
<bullet> Frequently Asked Questions on July 28, 2022 (FAQs Part
54), which further clarified the contraceptive coverage requirement and
currently applicable guidance. These FAQs clarified that plans and
issuers must cover, without imposing cost-sharing requirements, items
and services that are integral to a recommended contraceptive
service.\39\ The FAQs also stated that plans and issuers must cover any
FDA-approved, -cleared, or -granted contraceptive products and services
that an individual and their attending provider have determined to be
medically appropriate for the individual, regardless of whether those
products or services are specifically identified in the categories
listed in the HRSA-supported Guidelines.\40\ For contraceptive services
or FDA-approved, -cleared, or -granted contraceptive products not
included in a category described in the HRSA-supported Guidelines, the
FAQs stated that plans and issuers may use reasonable medical
management techniques to determine which specific products to cover
without cost sharing only if multiple, substantially similar services
or products that are not included in a category described in the HRSA-
supported Guidelines are medically appropriate for the individual. The
FAQs further stated that if the individual's attending provider
recommends a particular service or FDA-approved, -cleared, or -granted
product not included in a category described in the HRSA-supported
Guidelines based on a determination of medical necessity with respect
to that individual, the plan or issuer must cover that service or
product without cost sharing. The plan or issuer must defer to the
determination of the attending provider and must make available an
easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome so the individual or their
provider (or other individual acting as the individual's authorized
representative) can obtain coverage for the medically necessary service
or product for the individual without cost sharing as required under
PHS Act section 2713 and its implementing regulations and guidance.\41\
The FAQs also encouraged plans and issuers to cover over-the-counter
(OTC) emergency contraceptive products with no cost sharing when they
are purchased by consumers without a prescription.\42\ FAQs Part 54, Q8
further acknowledged that the Departments continued to receive
complaints and reports that participants, beneficiaries, and enrollees
were being denied contraceptive coverage, in some cases due to the
application of medical management techniques that were not reasonable
based on all of the relevant facts and circumstances. In addition to
summarizing ongoing complaints similar to those highlighted in FAQs
Part 51, Q9, the Departments also noted that they were aware of
complaints that plans and issuers or PBMs were imposing age limits on
contraceptive coverage rather than providing these benefits to all
individuals with reproductive capacity. FAQs Part 54, Q13 also
described actions within the scope of the authority of the Departments
of Labor and HHS to enforce the requirements of PHS Act section
2713.\43\
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\39\ FAQs Part 54, Q1 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\40\ Id. at Q2.
\41\ Id. at Q3.
\42\ Id. at Q5.
\43\ See FAQs Part 54, Q5, Q8, and Q13 (July 28, 2022),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
---------------------------------------------------------------------------
<bullet> Frequently Asked Questions on January 22, 2024 (FAQs Part
64), which provided further clarifications regarding contraceptive
coverage requirements, including providing guidance regarding a
therapeutic equivalence approach. The FAQs explained that plans and
issuers could adopt a therapeutic equivalence approach (in combination
with an easily accessible, transparent, and sufficiently expedient
exceptions process that is not unduly burdensome) to ensure the plan's
or issuer's medical management techniques for contraceptive drugs and
drug-led devices \44\ that are required to
[[Page 85755]]
be covered under PHS Act section 2713 are reasonable.\45\ Specifically,
with respect to FDA-approved contraceptive drugs and drug-led devices,
if a plan or issuer utilizes medical management techniques within a
specified category described in the HRSA-supported Guidelines (or group
of substantially similar products that are not included in a specified
category), the Departments will generally consider such medical
management techniques to be reasonable if the plan or issuer covers all
FDA-approved contraceptive drugs and drug-led devices in that category
(or group of substantially similar products) without cost sharing,
other than those for which there is at least one therapeutic equivalent
drug or drug-led device that the plan or issuer covers without cost
sharing.
---------------------------------------------------------------------------
\44\ In FAQs Part 64, the term ``drug-led device'' referred to a
combination product, as defined under 21 CFR 3.2(e), that is
comprised of a drug and a device, and for which the drug component
provides the primary mode of action. The primary mode of action of a
combination product is the single mode of action (that is, the
action provided by the drug, device, or biological product) that
provides the most important therapeutic action of the combination
product. See 21 U.S.C. 353(g)(1)(C) and 21 CFR 3.2(m). As further
discussed in section II.A.2 of the preamble to these proposed rules,
the Departments propose a substantially similar definition of the
term ``drug-led combination product'' in these proposed rules to
refer to the same products for which the term ``drug-led device''
was used in FAQs Part 64.
\45\ FAQs Part 64 (Jan. 22, 2024), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
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C. Executive Orders on the Affordable Care Act and Reproductive Health
On January 28, 2021, President Biden issued Executive Order 14009,
``Strengthening Medicaid and the Affordable Care Act'' (E.O.
14009).\46\ Section 3 of E.O. 14009 directs the Secretaries of the
Departments (the Secretaries) to review all existing regulations,
guidance documents, and policies to determine whether such actions are
inconsistent with protecting and strengthening Medicaid and the ACA and
making high-quality health care accessible and affordable for every
American.
---------------------------------------------------------------------------
\46\ 86 FR 7793.
---------------------------------------------------------------------------
On April 5, 2022, President Biden issued Executive Order 14070,
``Continuing To Strengthen Americans' Access to Affordable, Quality
Health Coverage'' (E.O. 14070).\47\ Section 2 of E.O. 14070 reaffirms
the goals and policy of E.O. 14009 and further directs agencies with
responsibilities related to Americans' access to health coverage to
consider and pursue agency actions that improve the comprehensiveness
of coverage and protect consumers from low-quality coverage.
---------------------------------------------------------------------------
\47\ 87 FR 20689.
---------------------------------------------------------------------------
Following the U.S. Supreme Court decision in Dobbs v. Jackson
Women's Health Organization (Dobbs),\48\ President Biden issued
Executive Order 14076, ``Protecting Access to Reproductive Healthcare
Services'' (E.O. 14076) on July 8, 2022. Section 3 of E.O. 14076
requires the Secretary of HHS to identify potential actions to
``protect and expand access to the full range of reproductive
healthcare services, including actions to enhance family planning
services such as access to emergency contraception'' and identify
``ways to increase outreach and education about access to reproductive
healthcare services, including by launching a public awareness
initiative to provide timely and accurate information about such
access, which shall . . . include promoting awareness of and access to
the full range of contraceptive services.'' \49\
---------------------------------------------------------------------------
\48\ 597 U.S. 215 (2022).
\49\ 87 FR 42053.
---------------------------------------------------------------------------
On June 23, 2023, President Biden issued Executive Order 14101,
``Strengthening Access to Affordable, High-Quality Contraception and
Family Planning Services'' (E.O. 14101).\50\ Section 2 of E.O. 14101
directs the Secretaries to consider issuing guidance ``to further
improve Americans' ability to access contraception, without out-of-
pocket expenses, under the Affordable Care Act'' and to consider
additional actions ``to promote increased access to affordable over-
the-counter contraception, including emergency contraception.'' \51\
---------------------------------------------------------------------------
\50\ 88 FR 41815.
\51\ Id.
---------------------------------------------------------------------------
D. FDA Approval of Daily Over-the-Counter 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.<SUP>52 53</SUP> Interested parties, including health care
provider associations, have supported the availability of a daily OTC
oral contraceptive for its potential to improve access to affordable
contraception, thereby improving management of family planning and
reducing unintended pregnancies.\54\ Studies have shown that challenges
with access and costs are among the most common reasons cited by women
for not using contraception or having gaps in contraceptive use.\55\
One large, nationally representative study found 29 percent of women
reported encountering barriers to obtaining or filling an initial
prescription or refills of oral contraceptive pills, specifically
citing insurance coverage, getting an appointment, not having a regular
provider, and difficulty accessing a pharmacy.\56\ Accordingly, the
availability of a daily OTC oral contraceptive could improve access to
contraception if the product is affordable, including if it is covered
by insurance without cost sharing, and as a result, could reduce the
number of unintended pregnancies.\57\ Beginning in March 2024, an OTC
oral contraceptive has become widely available for sale online and in
stores under the brand name Opill[supreg], with a manufacturer's
[[Page 85756]]
suggested retail price ranging from $19.99 for a 1-month supply to
$89.99 for a 6-month supply.\58\
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\52\ FDA (July 13, 2023). ``FDA Approves First Nonprescription
Daily Oral Contraceptive,'' available at <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive">https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive</a>.
\53\ Progestin-only oral contraceptives are a product that is
already available in a prescription form and are a category of
contraceptives listed in the FDA Birth Control Guide, as referenced
in the HRSA-supported Guidelines.
\54\ See American Medical Association (2023). ``AMA Applauds FDA
Approval of OTC Birth Control,'' available at <a href="https://www.ama-assn.org/press-center/press-releases/ama-applauds-fda-approval-otc-birth-control">https://www.ama-assn.org/press-center/press-releases/ama-applauds-fda-approval-otc-birth-control</a>; The American College of Obstetricians and
Gynecologists (2023). ``ACOG Praises FDA Approval of Over-the-
Counter Access to Birth Control Pill,'' available at <a href="https://www.acog.org/news/news-releases/2023/07/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</a>.
\55\ See Key, K., Wollum, A., Asetoyer, C., Cervantes, M.,
Lindsey, A., Rivera, R., Robinson Flint, J., Zuniga, C., Sanchez,
J., and Baum, S. (2023). ``Challenges accessing contraceptive care
and interest in over-the-counter oral contraceptive pill use among
Black, Indigenous, and people of color: An online cross-sectional
survey,'' Contraception, available at <a href="https://doi.org/10.1016/j.contraception.2023.109950">https://doi.org/10.1016/j.contraception.2023.109950</a>; Thompson, E. L., Galvin, A. M., Garg,
A., Diener, A., Deckard, A., Griner, S. B., and Kline, N. S. (2023).
``A socioecological perspective to contraceptive access for women
experiencing homelessness in the United States,'' Contraception,
available at <a href="https://doi.org/10.1016/j.contraception.2023.109991">https://doi.org/10.1016/j.contraception.2023.109991</a>;
Bessett, D., Prager, J., Havard, J., Murphy, D. J., Ag[eacute]nor,
M., and Foster, A. M. (2015). ``Barriers to contraceptive access
after health care reform: Experiences of young adults in
Massachusetts,'' Women's Health Issues, available at <a href="https://doi.org/10.1016/j.whi.2014.11.002">https://doi.org/10.1016/j.whi.2014.11.002</a>; and Johnson, E. R. (2022).
``Health care access and contraceptive use among adult women in the
United States in 2017,'' Contraception, available at <a href="https://doi.org/10.1016/j.contraception.2022.02.008">https://doi.org/10.1016/j.contraception.2022.02.008</a>.
\56\ Grindlay, K., Grossman, D. (2016). ``Prescription Birth
Control Access Among U.S. Women At Risk of Unintended Pregnancy,''
Journal of Women's Health, available at <a href="https://www.liebertpub.com/doi/10.1089/jwh.2015.5312">https://www.liebertpub.com/doi/10.1089/jwh.2015.5312</a>.
\57\ A recent study found that over 12 million adult women and
nearly two million young women aged 15-17 would likely be interested
in using an OTC oral contraceptive if it were free to them, but the
numbers declined to 7.1 million adult women and 760,000 young women
if the out-of-pocket cost of the contraceptive was $15. The same
study indicated that the levels of interest would translate to an
estimated eight percent decrease in unintended pregnancies
(approximately 320,000 fewer) in one year among adult women when
cost sharing was $0, and an estimated five percent decrease
(approximately 199,000 fewer unintended pregnancies) if there were a
monthly out-of-pocket cost of $15. See Wollum, A., Trussell, J.,
Grossman, D., and Grindlay, K. (2020). ``Modeling the Impacts of
Price of an Over-the-Counter Progestin-Only Pill on Use and
Unintended Pregnancy among U.S. Women,'' Women's Health Issues,
available at <a href="https://www.sciencedirect.com/science/article/pii/S1049386720300037/pdfft?md5=903aee27ef3468f62abaf9091e0a957c&pid=1-s2.0-S1049386720300037-main.pdf">https://www.sciencedirect.com/science/article/pii/S1049386720300037/pdfft?md5=903aee27ef3468f62abaf9091e0a957c&pid=1-s2.0-S1049386720300037-main.pdf</a>.
\58\ Lupkin, S., NPR (March 18, 2024). ``First over-the-counter
birth control pill now for sale online,'' available at <a href="https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-counter-birth-control-pill-contraceptive-shop">https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-counter-birth-control-pill-contraceptive-shop</a>.
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E. OTC Preventive Products Request for Information
As discussed in sections I.A and I.C of this preamble, the Biden-
Harris Administration has prioritized access to comprehensive, high-
quality contraception and family planning services as critical
components of women's reproductive health and overall public health. In
response to E.O. 14009, E.O. 14070, E.O.14076, and E.O. 14101, and
following the FDA approval of an OTC oral contraceptive, as discussed
in section I.D of this preamble, the Departments issued a ``Request for
Information; Coverage of Over-the-Counter Preventive Services'' on
October 4, 2023 (OTC Preventive Products RFI).\59\ The Departments
issued the OTC Preventive Products RFI to gather public feedback
regarding the potential benefits and costs of requiring plans and
issuers to cover OTC preventive products \60\ without cost sharing and
without a prescription; learn of any potential challenges associated
with providing such coverage; understand whether and how providing such
coverage would benefit consumers; and assess any potential burden that
plans and issuers would face if required to provide such coverage.
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\59\ 88 FR 68519 (Oct. 4, 2023).
\60\ For consistency with the OTC Preventive Products RFI, this
preamble uses the term ``OTC preventive products'' to refer to
recommended preventive services that may be made available to an
individual without a prescription.
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The Departments received 376 unique comments in response to the OTC
Preventive Products RFI, including comments from individuals; plans and
issuers; PBMs; State government agencies; and advocacy organizations
representing consumers, health care providers, group health plans,
hospitals, and durable medical equipment suppliers. The Departments
reviewed comments received in response to the OTC Preventive Products
RFI as part of the development of these proposed rules. However, these
proposed rules do not address all the issues on which information was
requested.
Many commenters stated that requiring plans and issuers to cover
all recommended preventive services would promote health equity and
improve health outcomes by reducing costs and administrative barriers
to accessing preventive health care. Many commenters highlighted that
prescription and cost-sharing requirements represent a particular
barrier for people with lower incomes and Black, Indigenous, and People
of Color (BIPOC) communities, and that requiring coverage of OTC
preventive products without cost sharing and without a prescription
would significantly lower these barriers, thereby increasing access to
OTC preventive products in a manner that would be especially beneficial
to lower-income and underserved populations.
Many commenters highlighted the particular benefit to women of
requiring plans and issuers to cover OTC contraceptive items without
requiring a prescription and without cost-sharing requirements. Several
commenters pointed out that neither section 2713 of the PHS Act nor its
implementing regulations impose a specific prescription requirement on
recommended contraceptive items. These commenters also highlighted
HRSA's removal of ``as prescribed'' language which appeared in the 2011
HRSA-supported Guidelines but does not appear in the 2016 or any
subsequent version of the HRSA-supported Guidelines.\61\ In the view of
these commenters, the existing prescription requirement is therefore
based only on agency guidance that is within the authority of the
Departments to revise.\62\
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\61\ See section I.A of this preamble for a discussion of the
``as prescribed'' language.
\62\ See, e.g., FAQs Part XII, Q4 (Feb. 20, 2013), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>.
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Another commenter noted that, in the United States, approximately
one-third of childbearing-aged women and those capable of becoming
pregnant experience difficulties obtaining hormonal contraception, and
that coverage of OTC oral contraception without a prescription and
without cost sharing would improve access to reproductive care for this
group. Several commenters highlighted the burdens of a prescription
requirement on people seeking contraception, including requesting time
off from work, unnecessary visits to the doctor, appointment wait
times, and finding childcare, while a few other commenters specifically
emphasized the importance of waiving cost sharing to make OTC
contraceptive services truly accessible. One commenter noted that
access to affordable contraception was particularly important within
the context of widespread Medicaid coverage losses following the
termination on March 31, 2023 of the continuous enrollment condition
previously associated with the COVID-19 public health emergency
(PHE).\63\ Many other commenters supported requiring coverage of OTC
contraceptive services in order to ensure that women can access
effective, affordable means of preventing unintended pregnancies in the
wake of the Dobbs decision.
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\63\ See Center for Medicare and Medicaid Services (CMS), Center
for Consumer Information and Insurance Oversight, Temporary Special
Enrollment Period (SEP) for Consumers Losing Medicaid or the
Children's Health Insurance Program (CHIP) Coverage Due to Unwinding
of the Medicaid Continuous Enrollment Condition--Frequently Asked
Questions (FAQ) (Jan. 27, 2023), available at <a href="https://www.cms.gov/technical-assistance-resources/temp-sep-unwinding-faq.pdf">https://www.cms.gov/technical-assistance-resources/temp-sep-unwinding-faq.pdf</a>.
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In addition to comments highlighting the benefits to women of
removing prescription and cost-sharing requirements for coverage of OTC
contraceptive items, several commenters noted that consumers would
benefit from increased access to other specific OTC preventive products
if plans and issuers were required to cover those other products
without a prescription and without cost sharing. For example, several
commenters stated that coverage based on prescription requirements
limits access to OTC tobacco cessation products. One of these
commenters emphasized that prescription requirements are a particular
barrier with respect to tobacco cessation because of the nature of
nicotine addiction, which typically requires multiple quit attempts. In
that commenter's view, removing cost-sharing and prescription
requirements would allow people to access evidence-based treatment when
they are motivated to make a quit attempt, without having to wait for a
medical appointment. Conversely, another commenter who acknowledged
that removing cost sharing on OTC tobacco cessation products could have
a positive effect on access to these products, particularly for people
with low incomes, also emphasized the role of clinicians in screening
for and diagnosing tobacco use disorder and recommending or prescribing
effective treatments. This commenter encouraged the Departments to make
an effort to preserve the clinician-patient relationship with respect
to tobacco cessation products to ensure that patients are properly
connected to care, including biomedical and psychiatric services that
may be comorbid with tobacco use disorder.
Another commenter noted that a woman who is not pregnant or
planning
[[Page 85757]]
to become pregnant may not be under the care of a prescribing health
care provider but could still benefit from the USPSTF recommendation
that women who could become pregnant should consume a daily folic acid
supplement. A few commenters described the disparate occurrence of
spina bifida in newborns born to Spanish-speaking people, which
commenters believe could be reduced if plans and issuers were required
to cover OTC folic acid without cost sharing or prescription
requirements.
However, several commenters identified operational barriers to
widespread implementation of a requirement to cover all recommended OTC
preventive products without cost sharing or a prescription. A few
commenters noted potential strains on pharmacies, retailers, and the
existing health care delivery system; fraud and abuse threats; and
potential cost increases for plan sponsors and plan participants. For
example, one commenter cited the administrative and cost burdens that
pharmacies and retailers could incur if they were required to cover the
upfront costs of OTC preventive products and pursue post-claim
reimbursements. In that commenter's view, requiring plans and issuers
to provide coverage of OTC preventive products without cost sharing
could also facilitate fraudulent behavior, including sale to
unauthorized persons or re-sale outside of the health care market, that
could in turn create a shadow market based on overuse and misuse. This
commenter highlighted the existing significant clinical and
administrative burdens that already strain pharmacist and retailer
resources (ranging from filling and dispensing medications to providing
immunizations, patient counseling, and information about insurance
eligibility and coverage), and expressed concern that the
responsibility for educating consumers about potential access to and
appropriateness of OTC contraceptives would fall to pharmacists and
retailers at the point of sale. Another commenter noted that requiring
coverage of OTC preventive products such as contraceptives, OTC
naloxone, and smoking cessation products without cost sharing or a
prescription would increase access to such products but advised that
such requirements would increase administrative burden on pharmacists
by increasing workload and costs and decreasing reimbursement for vital
patient counseling and additional services. One commenter indicated
that using a credit card (rather than a debit card or paper
reimbursement system) would facilitate coverage of OTC preventive
products, but also noted that the use of a credit card without a fixed
spending limit would be more likely to lead to fraud and would
necessitate implementing systems for freezing or repaying cards in the
case of misuse. Another commenter indicated general support for access
to recommended preventive products without cost sharing but stated that
prescription requirements were necessary for many products to ensure
that individual patients receive appropriate care. In that commenter's
view, the cost associated with applying a market-wide OTC preventive
products coverage requirement would disrupt and likely outweigh any
benefits of changing long-established coverage patterns. This commenter
recommended that the Departments consider establishing a standing order
for Opill[supreg] only, in order to conduct a targeted roll-out of a
potential broader OTC preventive products coverage requirement without
overburdening the health care system by attempting to implement the
changes for all OTC preventive products at once. The same commenter,
however, warned against requiring coverage of OTC products that do not
have meaningful market competition, such as Opill[supreg], to avoid
inadvertently driving up retail prices. Another commenter shared
similar concerns regarding the potential for generating demand for
preventive items and services that would ultimately be unused. A few
commenters noted the particular cost and negative environmental impact
that could be realized if OTC breastfeeding supplies with no cost
sharing led to overconsumption of such products. One commenter urged
the Departments to avoid rushing to require coverage of all OTC
preventive products in order to provide sufficient advanced notice to
allow plan sponsors to address operational and implementation issues.
While several commenters expressed concern that current
prescription requirements restrict access to breastfeeding services and
supplies, many commenters stated that removing the prescription
requirement for breastfeeding services and supplies could have a
detrimental effect on breastfeeding parents and newborns. These
commenters stated that consumers currently benefit from the expertise
provided by lactation consultants and other specially trained staff at
durable medical equipment suppliers contracted with plans and issuers
to provide breast pumps. These commenters also expressed the view that
removing the prescription requirement would make it more likely that a
consumer would be forced to select breastfeeding supplies in a retail
environment with fewer breast pump options and less privacy and
support.
In the OTC Preventive Products RFI, the Departments also requested
feedback from interested parties based on their experiences with the
requirement to cover OTC COVID-19 diagnostic tests during the COVID-19
PHE.\64\ During the COVID-19 PHE, plans and issuers were required to
cover OTC COVID-19 diagnostic tests without a prescription from a
health care provider and without imposing any cost-sharing
requirements, prior authorization, or other medical management
requirements. However, the Departments permitted plans and issuers that
met certain safe harbor requirements to implement cost and quantity
limits to contain costs and combat potential fraud and abuse with
respect to coverage of OTC COVID-19 diagnostic tests. A few commenters
encouraged the Departments to use experiences with coverage of OTC
COVID-19 diagnostic tests as a roadmap for future coverage of other
recommended preventive services. However, another commenter cautioned
the Departments against regulating the routine use of recommended
preventive services by applying requirements used during an
unprecedented public health emergency, in order to avoid issues the
commenter reported taking place during the COVID-19 PHE, such as
overconsumption of COVID-19 diagnostic tests, price gouging of products
by manufacturers, and limited opportunities for health plans to contain
waste and abuse. Another commenter acknowledged that coverage
requirements for OTC COVID-19 diagnostic tests improved patient access
to the tests by removing the barriers related to out-of-pocket costs
and obtaining prescriptions but described a number of other issues
associated with the testing coverage requirement. According to this
commenter, implementation challenges included below-cost reimbursement,
inconsistent requirements across plans and providers, and lack of
reimbursement for pharmacies. In particular, this commenter noted that
the average cost to a retail pharmacy provider to dispense a drug--
separate from the cost of acquiring the medication itself--is $12.40,
and that any future OTC coverage requirements should reimburse
pharmacies for both the acquisition and dispensing of products. Another
commenter, citing the speed with which
[[Page 85758]]
the OTC COVID-19 diagnostic testing program was implemented, urged the
Departments to proceed deliberately with the implementation of any
broader OTC preventive products coverage requirements. According to
this commenter, the rapid implementation of the testing coverage
requirements during the PHE contributed to consumer confusion and led
to many thousands of consumers failing to seek reimbursement for tests
that were eligible to be covered.
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\64\ See 88 FR 68519, 68523-24 (Oct. 4, 2023).
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F. Transparency in Coverage Under the ACA and Implementing Regulations
Section 2715A of the PHS Act \65\ provides that non-grandfathered
group health plans and health insurance issuers offering non-
grandfathered group or individual health insurance coverage must comply
with section 1311(e)(3) of the ACA,\66\ which addresses transparency in
health coverage and imposes certain reporting and disclosure
requirements for health plans that are seeking certification as
qualified health plans (QHPs) to be offered on an American Health
Benefits Exchange (generally referred to as an Exchange or Marketplace)
(as defined by section 1311(b)(1) of the ACA). A plan or issuer of
coverage that is not offered through an Exchange and that is subject to
section 2715A of the PHS Act is required to submit the required
information to the Secretary of HHS and the relevant State's insurance
commissioner, and to make that information available to the public.
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\65\ 42 U.S.C. 300gg-15a.
\66\ 42 U.S.C. 18031(e)(3).
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Section 1311(e)(3)(C) of the ACA requires plans, as a requirement
of certification as a QHP, to permit individuals to learn about the
amount of cost sharing (including deductibles, copayments, and
coinsurance) that the individual would be responsible for paying with
respect to the furnishing of a specific item or service by an in-
network provider in a timely manner upon the request of the individual.
Section 1311(e)(3)(C) of the ACA specifies that, at a minimum, such
information must be made available to the individual through an
internet website and through other means for individuals without access
to the internet.
On March 27, 2012, HHS issued the ``Patient Protection and
Affordable Care Act; Establishment of Exchanges and Qualified Health
Plans; Exchange Standards for Employers'' final rule (Exchange
Establishment final rule) that implemented sections 1311(e)(3)(A)
through (C) of the ACA at 45 CFR 155.1040(a) through (c) and
156.220.\67\ The Exchange Establishment final rule created standards
for QHP issuers to submit specific information related to transparency
in coverage.
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\67\ 77 FR 18310 (Mar. 27, 2012).
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On November 12, 2020, the Departments issued ``Transparency in
Coverage'' final rules (Transparency in Coverage final rules)
implementing transparency reporting requirements for non-grandfathered
group health plans and health insurance issuers offering non-
grandfathered group and individual health insurance coverage.\68\
Implementing section 1311(e)(3)(C) of the ACA and section 2715A of the
PHS Act, these rules require plans and issuers to disclose cost-sharing
information for all covered items and services available to a
participant, beneficiary, or enrollee through an internet-based self-
service tool via the plan's or issuer's member portal or, if requested
by the individual, on paper.\69\ The requirement to disclose cost-
sharing information for all covered items and services includes covered
contraceptive items or services.
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\68\ 85 FR 72158 (Nov. 12, 2020).
\69\ The Consolidated Appropriations Act, 2021 imposed a largely
duplicative requirement and added a requirement that the information
also be provided by telephone, upon request. See also FAQs Part 49,
Q3 (Aug. 20, 2021), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf</a>.
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The Transparency in Coverage final rules enumerate seven cost-
related elements that plans and issuers must disclose in response to a
search query by a participant, beneficiary, or enrollee for a covered
item or service furnished by a provider or providers. The self-service
tool must provide an estimate of the participant's, beneficiary's, or
enrollee's cost-sharing liability for the covered item or service,
which is calculated based on the following elements: (a) accumulated
amounts with respect to any deductibles or maximum out-of-pocket
limits; and either (b) the in-network rate, comprising a negotiated
rate or underlying fee schedule rate as applicable to the payment
model; or (c) an out-of-network allowed amount or any other rate that
provides a more accurate estimate of an amount a plan or issuer will
pay for the requested covered item or service from an out-of-network
provider. Self-service tool results must also reflect a list of the
items and services included in a bundled payment arrangement, if
applicable; notification that coverage of a specific item or service is
subject to a prerequisite, as applicable; and certain disclaimers in
plain language describing the limitations of the estimate or other
qualifications regarding the cost-sharing information disclosed.
With respect to requests for cost-sharing information for items or
services that are recommended preventive services under section 2713 of
the PHS Act, if the plan or issuer cannot determine whether the request
is for preventive or non-preventive purposes, the plan or issuer must
display the cost-sharing liability that applies for non-preventive
purposes along with a statement that the item or service may not be
subject to cost sharing if it is billed as a preventive service.
Displaying a non-zero cost-sharing liability in these circumstances
helps protect against unexpected medical bills by ensuring
participants, beneficiaries, and enrollees are aware of their potential
cost-sharing liability while the statement ensures that consumers are
made aware they can access recommended preventive services without cost
sharing. Alternatively, the Transparency in Coverage final rules permit
a plan or issuer to allow a participant, beneficiary, or enrollee to
request cost-sharing information for the specific preventive or non-
preventive item or service by including terms such as ``preventive,''
``non-preventive,'' or ``diagnostic'' as a means to request the most
accurate cost-sharing information.
Plans and issuers must ensure users can search for cost-sharing
information for a covered item or service by a specific in-network
provider or by all in-network providers using either a descriptive term
or a billing code. For covered items or services furnished by out-of-
network providers, users can search for an out-of-network allowed
amount, percentage of billed charges, or other rate that provides a
reasonably accurate estimate of the amount a plan or issuer will pay
for a covered item or service provided by out-of-network providers.
Users must also be able to input other factors utilized by the plan or
issuer that are relevant for determining the applicable cost-sharing
information or out-of-network allowed amount, such as location of
service, facility name, or dosage and permit refining and reordering of
search results.
II. Overview of the Proposed Rules
A. Coverage of Recommended Preventive Services
1. Reasonable Medical Management of Recommended Preventive Services:
Exceptions Process
The Departments' regulations implementing section 2713 of the PHS
Act aim to strike a balance between
[[Page 85759]]
ensuring participants, beneficiaries, and enrollees do not face undue
barriers to accessing their coverage of recommended preventive services
as required by law and allowing plans and issuers to contain costs,
promote efficient delivery of care, and minimize risks of fraud, waste,
and abuse. To this end, current regulations permit plans and issuers to
use reasonable medical management techniques to determine the
frequency, method, treatment, or setting for coverage of a recommended
preventive service, to the extent not specified in the applicable
recommendation or guideline.\70\ The Departments have previously
explained, in the context of certain recommended preventive services,
that they generally do not consider medical management techniques with
respect to recommended preventive services to be reasonable absent the
availability of an exceptions process.\71\
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\70\ 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and
45 CFR 147.130(a)(4).
\71\ See FAQs Part XXVI, Q2 (May 11, 2015), available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>; FAQs Part 64, Q4 (Jan. 22, 2024),
available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
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As noted in previously issued guidance and described in section I.B
of this preamble, the Departments continue to receive complaints of
potential violations related to the application of medical management
techniques that are not reasonable, including failing to provide an
exceptions process that meets the standards set forth in guidance.\72\
Further, the U.S. House of Representatives' Committee on Oversight and
Reform (Oversight Committee) published a report in October 2022
documenting the findings of its investigation into contraceptive
coverage for individuals enrolled in private health coverage. The
Oversight Committee found that insurers and PBMs surveyed denied an
average of at least 40 percent of exception requests related to
contraceptive coverage, with one PBM denying more than 80 percent of
requests in a year.\73\ To reinforce the requirement that medical
management techniques must be reasonable, the Departments propose to
codify that plans and issuers that utilize reasonable medical
management techniques with respect to recommended preventive services
would be required to accommodate any individual for whom a particular
item or service would not be medically appropriate, as determined by
the individual's attending provider, by having a mechanism for covering
or waiving the otherwise applicable cost sharing for the medically
necessary item or service. Specifically, under these proposed rules,
consistent with previous guidance,\74\ if utilizing reasonable medical
management techniques, a plan or issuer would be required to have an
easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome on the individual or a provider
(or other person acting as the individual's authorized representative)
under which the plan or issuer covers without cost sharing the
recommended preventive service according to the frequency, method,
treatment, or setting determined to be medically necessary with respect
to the individual, as determined by the individual's attending
provider. The exceptions process would ensure that an individual can
access medically necessary recommended preventive services without cost
sharing and would prevent medical management from functioning as an
unreasonable barrier to coverage under section 2713 of the PHS Act. The
Departments are authorized to issue this proposal, implementing section
2713 of the PHS Act, by section 9833 of the Code, section 734 of ERISA,
and section 2792 of the PHS Act. Nothing in this proposal, if
finalized, would require an entity to provide coverage or payments for
a contraceptive for which they have an exemption under 26 CFR 54.9815-
2713A, 29 CFR 2590.715-2713A, and 45 CFR 147.131 through 45 CFR
147.133.
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\72\ See, e.g., FAQs Part 51, Q9 (Jan. 10, 2022), available at
<a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a>; FAQs Part 54, Q8 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\73\ U.S. House of Representatives Committee on Oversight and
Reform, (Oct. 25, 2022). ``Barriers to Birth Control: An Analysis of
Contraceptive Coverage and Costs for Patients with Private
Insurance,'' available at <a href="https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf">https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf</a>.
\74\ See FAQs Part XXVI, Q3 (May 11, 2015), available at https:/
/www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/
resource-center/faqs/aca-part-xxvi.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>; FAQs Part 31, Q2 (Apr. 20, 2016),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf</a>. See also FAQs Part XII, Q14 (Feb. 20, 2013),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and
<a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>; FAQs Part 51, Q8-9 (Jan. 10, 2022),
available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf</a>; FAQs Part 54, Q9, (July 28, 2022), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>; FAQs Part 64 (Jan. 22,
2024) available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
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While prior guidance has generally focused on the use of an
exceptions process in the context of coverage of contraceptive
services, it has not been limited to that context. For example, the
Departments' guidance with respect to coverage of PrEP to prevent HIV
acquisition has similarly stated that where a plan or issuer uses
reasonable medical management techniques--such as covering a generic
version of PrEP without cost sharing and imposing cost sharing on an
equivalent branded version--a plan or issuer must have an easily
accessible, transparent, and sufficiently expedient exceptions process
that is not unduly burdensome on the individual or a provider (or other
individual acting as an authorized representative) that waives
otherwise applicable cost sharing for the particular PrEP medication
(generic or branded) for any individual for whom the plan's or issuer's
preferred medication ``would be medically inappropriate, as determined
by the individual's health care provider.'' \75\
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\75\ See FAQs Part 47, introduction to Q3 (July 19, 2021),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf</a> (``[T]he Departments have clarified in previous guidance
that plans and issuers must accommodate any individual for whom a
particular medication (generic or brand name) would be medically
inappropriate, as determined by the individual's health care
provider, by having a mechanism for waiving the otherwise applicable
cost sharing for the brand or non-preferred brand version. If
utilizing reasonable medical management techniques, plans and
issuers must have an easily accessible, transparent, and
sufficiently expedient exceptions process that is not unduly
burdensome.'')
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Therefore, the Departments propose to reorganize and amend 26 CFR
54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR
147.130(a)(4) by adding a new paragraph (a)(4)(i) to include existing
language with minor technical edits for clarity and to add a new
paragraph (a)(4)(ii) to specify that, in order for a plan's or issuer's
medical management techniques with respect to a recommended preventive
service to be considered reasonable, the plan or issuer would be
required to have an
[[Page 85760]]
easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome on a participant, beneficiary, or
enrollee or attending provider \76\ (or other person acting as the
individual's authorized representative). Under this proposal, an
exceptions process would be required to ensure that an individual can
receive coverage, without cost-sharing requirements, for a recommended
preventive service according to the frequency, method, treatment, or
setting that is medically necessary with respect to the individual, as
determined by the individual's attending provider. For example, a plan
or issuer may typically provide coverage without cost sharing for only
a generic version of a recommended preventive service; an individual
who experiences side effects from the covered generic version and whose
attending provider has determined that the brand-name version of the
recommended preventive services is medically necessary for the
individual would be able to use the exceptions process to obtain the
brand-name version without cost sharing, even though the plan or issuer
typically does not provide coverage for the brand-name version (or
provides coverage with cost sharing) This proposed change is necessary
to effectuate the statutory requirement under PHS Act section 2713 that
plans and issuers provide coverage of recommended preventive services
without cost sharing, because without such an exceptions process, a
plan's or issuer's medical management techniques could have the effect
of preventing an individual from receiving coverage without cost
sharing of medically necessary recommended preventive services.
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\76\ For purposes of these proposed rules, consistent with
previous guidance described in section I.B of this preamble, an
attending provider would mean an individual who is licensed under
applicable State law, who is acting within the scope of the
provider's license, and who is directly responsible for providing
care to the patient relating to the recommended preventive services.
Therefore, a plan, issuer, hospital, or managed care organization
would not be an attending provider. The reference to an ``attending
provider'' (rather than simply a ``provider,'' as referenced in
previously issued guidance) is based on the Departments'
understanding that an attending provider is likely to act as an
individual's authorized representative when pursuing an exceptions
process, and for consistency with the requirement that an attending
provider determine medical necessity. See also, fn. 33.
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Under this proposal and consistent with previous guidance, a plan
or issuer would be required to defer to the determination of an
individual's attending provider regarding medical necessity with
respect to the individual. Previously issued guidance has used the
terms ``medically necessary'' and ``medically appropriate''
interchangeably when referring to the appropriate standard for this
clinical determination. However, in these proposed rules, the
Departments propose to use the phrase ``medically necessary'' to
establish uniform terminology and avoid confusion from the use of
different terms.\77\ The Departments have determined that a standard
based on ``medical necessity'' would more accurately comport with the
goal of allowing plans and issuers to use reasonable medical management
techniques to control costs, while ensuring every participant,
beneficiary, and enrollee receives coverage without cost sharing for a
form of a recommended preventive service that is suitable for the
individual.
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\77\ The Departments proposal to use the term and standard of
``medically necessary'' with respect to the exceptions process in
these proposed rules should not be interpreted as changing the
standard or meaning of the Departments' previously published
guidance with respect to the coverage of preventive services.
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These proposed rules use the term ``medically appropriate'' to
refer to a range of potential options that are generally acceptable to
address a condition or achieve a preventive health goal. However, a
preventive service that is medically appropriate for most individuals
(to whom the recommendation or guidelines applies) may not be medically
appropriate to address a condition or achieve a preventive health goal
in the context of other health factors specific to a certain
individual. In these cases, another form of the preventive service
would be medically necessary for that individual. In making a
determination of whether a service is medically necessary, a provider
might consider factors such as severity of side effects, differences in
permanence and reversibility of a recommended preventive service, and
ability to adhere to the appropriate use of the recommended preventive
service, as determined by the attending provider. Under these proposed
rules, if the recommended preventive service covered by the plan or
issuer is not medically appropriate for the individual, as determined
by the individual's attending provider, the plan or issuer would be
required, through the exceptions process, to cover without cost sharing
an alternative recommended preventive service that the individual's
attending provider determines is medically necessary for that
individual.\78\
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\78\ Similarly, if the plan or issuer uses reasonable medical
management techniques to limit the frequency or setting under which
a recommended preventive service is covered without cost sharing and
the individual's attending provider makes a determination that a
different frequency or setting is medically necessary for a
participant, beneficiary, or enrollee, under these proposed rules,
the plan or issuer would be required to provide coverage without
cost sharing for the recommended preventive service according to the
frequency or setting the individual's attending provider determines
to be medically necessary with respect to the individual.
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For example, if a plan typically covers a generic tobacco cessation
product (Gum A) without cost sharing, but an individual is allergic to
an inactive ingredient in Gum A and the individual's attending provider
determines that Gum B is medically necessary for the individual to
achieve the preventive health benefits of the recommended preventive
service without adverse side effects, then the plan or issuer would be
required to provide coverage of Gum B without cost sharing through the
exceptions process. However, if Gum A is medically appropriate for the
individual, the plan would not be required to provide coverage of Gum B
without cost sharing through the exceptions process solely on the basis
that Gum B is also medically appropriate for the individual.
The Departments request comment on the terminology used in the
context of the exceptions process. The Departments also request comment
generally on any operational or technical barriers to implementing the
proposed requirement that plans and issuers defer to the attending
provider's determination of medical necessity using an exceptions
process for recommended preventive services separate from the required
internal claims and appeals process,\79\ and what additional guidance
or requirements would support implementation of this requirement (for
example, with respect to documentation of the determination or
communication with the individual or their attending provider or other
representative regarding a request for a coverage exception).
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\79\ See section 2719 of the PHS Act (42 U.S.C. 300gg-19); 26
CFR 54.9815-2719; 29 CFR 2590.715-2719; and 45 CFR 147.136.
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Consistent with prior guidance, the Departments would determine
whether a plan's or issuer's exceptions process is easily accessible,
transparent, sufficiently expedient, and not unduly burdensome based on
all relevant facts and circumstances, including whether and how a plan
or issuer provides notice of the availability of an exceptions process
and what steps an individual or their provider or other authorized
representative is required to
[[Page 85761]]
initiate and complete in order to seek an exception.\80\
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\80\ FAQs Part 54, Q9 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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For this purpose, the Departments would consider an exceptions
process to be easily accessible if plan documentation includes relevant
information regarding the exceptions process under the plan or
coverage, including how to access the exceptions process without
initiating an appeal pursuant to the plan's or issuer's internal claims
and appeals procedures, the types of reasonable information the plan or
issuer requires as part of a request for an exception, and contact
information for a representative of the plan or issuer who can answer
questions related to the exceptions process. The Departments would also
encourage plans and issuers to make this information available in a
format and manner that is readily accessible, such as electronically
(on a website, for example) and on paper. The Departments request
comment on how plans and issuers could ensure that this information is
readily available and accessible, such as any specific formats,
mechanisms, or other best practices that could promote access to
information about the exceptions process.
The Departments would consider an exceptions process to be
transparent if, at a minimum, the information relevant to the
exceptions process (including, if used, a standard exceptions process
form with instructions) is included and prominently displayed in plan
documents (including in, or along with, the summary plan description
for plans subject to ERISA), and in any other plan materials, including
on the plan's or issuer's website, that describe the terms of the
plan's or issuer's coverage of preventive services. The Departments
request comment on the extent to which plans and issuers currently make
such information available and accessible and to whom (for example, to
prospective and current participants, beneficiaries, and enrollees and
their providers), whether any additional individuals or groups should
have access to this information if this proposal is finalized, and
whether the Departments should finalize more specific standards
regarding transparency or accessibility of information about the
exceptions process in regulation.
The Departments would consider an exceptions process to be
sufficiently expedient if it makes a determination of a claim according
to a timeframe and in a manner that takes into account the nature of
the claim (for example, pre-service or post-service) and the medical
exigencies involved for a claim involving urgent care. The Departments
request comment on appropriate additional standards for an exceptions
process to be considered sufficiently expedient under these proposed
rules. Specifically, the Departments request comment on whether the
regulations should contain specific timeframes, and if so, what
timeframes would be appropriate, as well as whether the regulations
should specify the manner in which plans and issuers should issue a
determination (for example, on paper, electronically, or both).
For example, as the Departments specifically noted in prior
guidance, it would be unduly burdensome on participants, beneficiaries,
and enrollees for a plan or issuer to deny coverage without cost
sharing and require an individual or their authorized representative to
file an appeal under the plan's or issuer's process for appealing
adverse benefit determinations in order to obtain an exception to the
standard contraceptive coverage policy.\81\ Under 26 CFR 54.9815-2719,
29 CFR 2560.503-1, 29 CFR 2590.715-2719, and 45 CFR 147.136, plans and
issuers must render a determination on an internal appeal in no more
than 15 calendar days (in the case of a pre-service claim) or no more
than 30 calendar days (in the case of a post-service claim). Because
most claims for recommended preventive services likely would not meet
the definition of a ``claim involving urgent care,'' \82\ the expedited
timelines that apply to an appeal of a claim involving urgent care
likely would not apply to a claim for a recommended preventive service.
In the absence of a separate exceptions process, an individual could
therefore be required to pursue a standard internal appeals process to
seek coverage of a recommended preventive service, which could result
in a coverage delay of up to 30 calendar days for a post-service claim
or 15 calendar days for a pre-service claim. Such a delay, when
combined with the ability of plans and issuers to use medical
management techniques to limit coverage of recommended preventive
services outside of an exceptions process, is not aligned with the
statutory requirement to provide coverage without cost sharing for all
required preventive services, because many individuals would be
compelled to pay out-of-pocket for the recommended preventive service
determined by their attending provider to be medically necessary or
accept the form of the recommended preventive service covered by the
plan or issuer as a result of medical management techniques, even if it
may cause adverse effects that an alternate form of the recommended
preventive service would not cause.
---------------------------------------------------------------------------
\81\ FAQs Part 54, Q10 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>. An adverse benefit determination means an
adverse benefit determination as defined in 29 CFR 2560.503-1, as
well as any rescission of coverage, as described in 45 CFR 147.128
(whether or not, in connection with the rescission, there is an
adverse effect on any particular benefit at that time). See 26 CFR
54.9815-2719, 29 CFR 2560.503-1, 29 CFR 2590.715-2719, and 45 CFR
147.136 for regulations related to internal claims and appeals
processes.
\82\ A ``claim involving urgent care,'' defined at 29 CFR
2560.503-1(m)(1) and adopted at 26 CFR 54.9815-2719(b)(2)(ii)(B), 29
CFR 2590.715-2719(b)(2)(ii)(B), and 45 CFR 147.136(b)(2)(ii)(B), is
``any claim for medical care or treatment with respect to which the
application of the time periods for making non-urgent care
determinations--(A) Could seriously jeopardize the life or health of
the claimant or the ability of the claimant to regain maximum
function, or, (B) In the opinion of a physician with knowledge of
the claimant's medical condition, would subject the claimant to
severe pain that cannot be adequately managed without the care or
treatment that is the subject of the claim.'' Plans and issuers
generally must render determinations regarding claims involving
urgent care as soon as possible, accounting for medical exigencies,
and not later than 72 hours after receipt of the claim by the plan.
---------------------------------------------------------------------------
Therefore, a plan or issuer would not have an easily accessible,
transparent, and sufficiently expedient exceptions process that is not
unduly burdensome on the individual (or provider or other person acting
as the individual's authorized representative) under these proposed
rules if the plan or issuer requires participants, beneficiaries, or
enrollees to appeal an adverse benefit determination using the plan's
or issuer's internal claims and appeals process as the means to obtain
an exception. The Departments request comment on whether plans and
issuers should be permitted to require an individual or their
authorized representative to use the existing process for urgent care
claims under 26 CFR 54.9815-2719(b)(2)(ii)(B), 29 CFR 2560.503-
1(b)(2)(ii)(B), and 45 CFR 147.136(b)(2)(ii)(B) (regardless of whether
the recommended preventive service meets the definition of a ``claim
involving urgent care'') to obtain an exception to the standard
preventive services coverage policy. The Departments also request
comment on whether a health plan that is subject to the essential
health benefit (EHB) prescription drug exception process
[[Page 85762]]
standards at 45 CFR 156.122(c) \83\ should be permitted to require an
individual or their authorized representative to use the existing
standard or expedited prescription drug exception request process when
seeking an exception for a recommended preventive service that is a
prescription drug, or all recommended preventive services.
---------------------------------------------------------------------------
\83\ Separately from requirements related to appeals of adverse
benefit determinations, HHS regulations at 45 CFR 156.122(c) state
that a health plan does not provide essential health benefits (EHBs)
unless it provides a standard and expedited exceptions process for
prescription drugs through which an enrollee, the enrollee's
designee, or the enrollee's prescribing physician (or other
prescriber) can receive a coverage determination within 72 hours
(for a standard exception) or no later than 24 hours (for an
expedited exception, in the case of exigent circumstances).
---------------------------------------------------------------------------
The Departments previously noted that plans and issuers may develop
a standard exceptions process form with instructions as part of
ensuring that the plan's or issuer's exceptions process is easily
accessible, transparent, sufficiently expedient, and not unduly
burdensome on the individual or provider (or other individual acting as
a patient's authorized representative).\84\ A standardized form that is
not unnecessarily long and that has clear instructions could reduce
burden on individuals or their authorized representative. The proposed
amendments at 26 CFR 54.9815-2713(a)(4)(ii), 29 CFR 2590.715-
2713(a)(4)(ii), and 45 CFR 147.130(a)(4)(ii) would not require that
plans and issuers develop and utilize a standard exceptions process
form. However, the Departments continue to encourage plans and issuers
to make any such standard exceptions process form, whether developed by
a plan or issuer, or the Medicare Part D Coverage Determination form,
readily available, both in paper and electronically (such as on a
website). The Departments request comment on whether the Medicare Part
D Coverage Determination form, or another existing format, would be an
appropriate model for plans and issuers implementing a standardized
exceptions process under these proposed rules. Alternatively, the
Departments request comment on whether it would be beneficial to
interested parties if the Departments developed and made available a
new standard form for an exceptions process, what information should be
included in any such form, and whether use of such a standardized form
should be required or optional. The Departments anticipate that most,
if not all, plans and issuers have an existing exceptions process for
recommended preventive services, or a process for other services that
can be adapted to meet these requirements for recommended preventive
services at minimal cost. The Departments request comment on this
assumption and on all other aspects of this proposal.
---------------------------------------------------------------------------
\84\ FAQs Part 54, Q9 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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2. Coverage of Contraceptive Items
Section 2713(a)(4) of the PHS Act was enacted to ensure that plans
and issuers cover women's preventive health needs. Contraceptive
coverage is an essential component of women's health care, as
recognized by its inclusion in the HRSA-supported Guidelines, in part
because contraception is effective at reducing unintended pregnancies
and associated negative maternal-infant outcomes.\85\ Unintended
pregnancies, which account for approximately 42 percent of pregnancies
annually in the United States, are a major public health
concern.<SUP>86 87</SUP> Coverage requirements that promote equitable
access to medically appropriate contraceptive items and services are an
essential component of high-quality reproductive health care with wide-
ranging social and economic benefits.\88\ Research shows that many
women are not using their contraceptive of choice, for reasons that
include concerns about side effects, cost, lack of availability, or
inability to get a provider appointment.\89\ Coverage that allows
individuals to identify and obtain a medically necessary contraceptive
(accounting for variables such as hormonal properties, side effects,
and delivery mechanisms, among other factors) without cost sharing
could improve quality of life, reduce behaviors such as discontinuing
contraception, and result in more effective use of contraception to
prevent unintended pregnancy.\90\ As noted in the preamble to the 2023
proposed rules, increased contraceptive coverage can improve access to
care, and therefore also help to address racial inequities in
reproductive health care that contribute to lifelong disproportionate
health outcomes for women in underserved communities, including
disparate maternal health outcomes.\91\
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\85\ Nelson, H., Darney, B., Ahrens, K., Burgess, A., Jungbauer,
R., Cantor, A., Atchison, C., Eden, K., Goueth, R., Fu, R. (2002).
``Associations of Unintended Pregnancy With Maternal and Infant
Health Outcomes: A Systematic Review and Meta-analysis,'' JAMA,
available at <a href="https://jamanetwork.com/journals/jama/fullarticle/2797874">https://jamanetwork.com/journals/jama/fullarticle/2797874</a>.
\86\ See CDC, ``Reproductive Health, Unintended Pregnancy,''
available at <a href="https://www.cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html">https://www.cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html</a>.
\87\ See Bradford, K., Costanza, K., Fouladi, F., Hill, T.,
Nguyen, K., and Speer, K., NCSL (2023). ``Supporting Moms' Health in
the Postpartum Period,'' available at <a href="https://www.ncsl.org/health/supporting-moms-health-in-the-postpartum-period">https://www.ncsl.org/health/supporting-moms-health-in-the-postpartum-period</a>; Nelson, et al.,
supra fn. 75; Cruz-Bendez[uacute], A., Lovell, G. Roche, B.,
Perkins, M., Blake-Lamb, T., Taveras, E., and Simione M. (2020).
``Psychosocial status and prenatal care of unintended pregnancies
among low-income women,'' BMC Pregnancy and Childbirth, available at
<a href="https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-03302-2">https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-03302-2</a>; Blake, S., Kiely, Gard, C., El-Mohandes, A., El-
Khorazaty, M.N. (2007). ``Pregnancy Intentions and Happiness Among
Pregnant Black Women at High Risk for Adverse Infant Health
Outcomes,'' American Journal of Public Health, available at <a href="https://doi.org/10.1363/3919407">https://doi.org/10.1363/3919407</a>; Finer, L., and Zolna, M. (2014). ``Shifts
in intended and unintended pregnancies in the United States, 2001-
2008,'' American Journal of Public Health, available at <a href="https://pubmed.ncbi.nlm.nih.gov/24354819">https://pubmed.ncbi.nlm.nih.gov/24354819</a>.
\88\ Id., see also Sonfield, A., Hasstedt, K., Kavanaugh, M.,
and Anderson, R., (2013). ``The Social and Economic Benefits of
Women's Ability to Determine Whether and When to Have Children,''
Guttmacher Institute, available at <a href="https://www.guttmacher.org/sites/default/files/report_pdf/social-economic-benefits.pdf">https://www.guttmacher.org/sites/default/files/report_pdf/social-economic-benefits.pdf</a>.
\89\ Frederiksen, B., Ranji, U., Long, M., Diep, K., and
Salganicoff, A., KFF (2022). ``Contraception in the United States: A
Closer Look at Experiences, Preferences, and Coverage,'' available
at <a href="https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings">https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings</a>.
\90\ Steinberg, J., Marthey, D., Xie, L., Boudreaux, M. (2021).
``Contraceptive method type and satisfaction, confidence in use, and
switching intentions,'' Contraception, available at <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286312">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286312</a>.
\91\ See 88 FR 7236, 7241 (Feb. 2, 2023), citing Sutton, M. Y.,
Anachebe, N. F., and Skanes H. (2021). ``Racial and Ethnic
Disparities in Reproductive Health Services and Outcomes, 2020,''
Obstetrics and Gynecology, available at <a href="https://doi.org/10.1097/AOG.0000000000004224">https://doi.org/10.1097/AOG.0000000000004224</a>; White House Blueprint for Addressing the
Maternal Health Crisis (2022), available at <a href="https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf</a>.
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Additionally, there has been significant activity related to
coverage of contraceptive services and several new developments,
including legal developments, that have affected women's needs
regarding access to affordable contraception since the publication of
the July 2010 interim final rules. The Departments continue to receive
complaints and are aware of other reports documenting plans' and
issuers' failure to provide coverage of the full range of contraceptive
services. Coverage issues leading to lack of access to contraception
were also substantiated in comments received in response to the OTC
Preventive Products RFI. Other developments have included the Dobbs
decision and subsequent State-level restrictions on access to abortion
and emergency contraception, which have made it more challenging for
women in some States to obtain contraception and quality family
planning care, including because health care providers have been forced
to close or chosen to relocate to
[[Page 85763]]
a different State; \92\ Executive Orders related to reproductive health
care; and FDA approval of the first daily OTC oral contraceptive. As a
result, the Departments have determined that it is necessary to propose
amendments to the regulations governing how plans and issuers cover
contraception and, as discussed in section II.B of this preamble, how
they communicate information about this coverage to participants,
beneficiaries, and enrollees.
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\92\ See, e.g., Murphy, C., Shin, P., Jacobs, F., and Johnson,
K. (2024). ``In States with Abortion Bans, Community Health Center
Patients Face Challenges Getting Reproductive Health Care,''
Commonwealth Fund, available at <a href="https://www.commonwealthfund.org/blog/2024/states-abortion-bans-community-health-center-patients-face-challenges-getting">https://www.commonwealthfund.org/blog/2024/states-abortion-bans-community-health-center-patients-face-challenges-getting</a>; Harper, C., Brown, K., and Arora, K.
(2024). ``Contraceptive Access in the US Post-Dobbs,'' JAMA Internal
Medicine, available at <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682">https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682</a>; Qato, D., Myerson, R.,
Shooshtari, A., Guadamuz, J., Alexander, G.C., (2024). ``Use of Oral
and Emergency Contraceptives After the US Supreme Court's Dobbs
Decision,'' available at <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370</a>.
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The Departments are interested in minimizing barriers to coverage
and expanding the scope of coverage without cost sharing for all
recommended preventive services, in alignment with section 2713 of the
PHS Act. The Departments also recognize that the proposals described in
this section II.A.2 of this preamble, if finalized, could require
significant changes to current plan and issuer operations. Therefore,
the Departments propose an incremental approach in this rulemaking with
respect to the types of recommended services addressed that is focused
initially on expanding coverage of contraception. This incremental
approach would facilitate implementation for plans, issuers, and other
interested parties and allow the Departments to gather additional
feedback on challenges and benefits of adopting these proposed policies
before considering whether and how to propose similar requirements with
respect to other recommended preventive services. Focusing first on
contraceptive items is appropriate due to ongoing and widely reported
concerns regarding challenges faced by consumers in accessing
contraceptive items and services without cost sharing, as well as
recent developments affecting access to reproductive health care.\93\
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\93\ See, e.g., Adler, A., Biggs, A.M., Kaller, S., Schroeder,
R., Ralph, L. (2023). ``Changes in the Frequency and Type of
Barriers to Reproductive Health Care from 2017 to 2021,'' JAMA
Network Open, available at <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087056">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087056</a>; Qato, D., Myerson, R., Shooshtari, A.,
Guadamuz, J., Alexander, G.C., (2024). ``Use of Oral and Emergency
Contraceptives After the US Supreme Court's Dobbs Decision,''
available at <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370</a>; Harper, C., Brown, K., and Arora, K. (2024).
``Contraceptive Access in the US Post-Dobbs,'' JAMA Internal
Medicine, available at <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682">https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682</a>; Kavanaugh, M. and
Friedrich-Karnik, A. (2024). ``Has the Fall of Roe changed
contraceptive access and use? New research from four US states
offers critical insights,'' Health Affairs Scholar, available at
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10986283">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10986283</a>; and American
Academy of Pediatrics, (updated July 2023) ``The Importance of
Access to Contraception--Barriers to accessing contraception'',
available at <a href="https://www.aap.org/en/patient-care/adolescent-sexual-health/equitable-access-to-sexual-and-reproductive-health-care-for-all-youth/the-importance-of-access-to-contraception">https://www.aap.org/en/patient-care/adolescent-sexual-health/equitable-access-to-sexual-and-reproductive-health-care-for-all-youth/the-importance-of-access-to-contraception</a>.
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As described in FAQs Part 51, Q9, FAQs Part 54, Q8, and sections
I.B and II.A.2 of this preamble, the Departments continue to receive
complaints and are aware of other credible reports that some plans and
issuers frequently restrict access to contraceptive items and services
that should be covered without cost sharing. For instance, in addition
to widespread denials of exceptions process requests as described in
section II.A.1 of this preamble, the October 2022 Oversight Committee
report identified at least 34 different contraceptive items that were
commonly excluded from coverage or for which cost-sharing requirements
often were applied.\94\ Additionally, a recent investigation by the
Vermont Department of Financial Regulation, the agency responsible for
regulating issuers in that State, found that three issuers in Vermont
violated State and Federal law by failing to provide coverage of
contraceptive services without cost sharing. The investigation found
that between 2017 and 2021, the issuers inappropriately charged
patients $1.5 million for contraceptive items and services that should
have been provided free of any out-of-pocket costs, resulting in a
finding that 9,000 people were entitled to receive restitution for cost
sharing that was incorrectly applied for contraceptive services.\95\
The investigation prompted a Congressional request to the Government
Accountability Office for an investigation into plan and issuer
compliance with ACA requirements to cover contraceptive items without
cost sharing.\96\ In addition, the Centers for Medicare & Medicaid
Services, as part of targeted market conduct examinations conducted on
behalf of HHS, has identified multiple violations of the requirements
of section 2713(a)(1) of the PHS Act and implementing regulations
related to contraceptive coverage and continues to investigate
additional complaints alleging violations.\97\ Additional reports of
noncompliance documented by members of Congress, advocacy
organizations, and media reports were cited by the Secretaries in their
June 27, 2022 letter to group health plan sponsors and issuers.\98\
Given these reported instances of continued obstacles for women in
accessing contraception, and within the context of several States'
efforts to restrict access to reproductive health care following the
Dobbs decision, the Departments have determined it is appropriate for
these proposed rules to begin with addressing barriers to contraceptive
services.
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\94\ U.S. House of Representatives Committee on Oversight and
Reform, ``Barriers to Birth Control: An Analysis of Contraceptive
Coverage and Costs for Patients with Private Insurance'' (Oct. 25,
2022), available at <a href="https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf">https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf</a>.
\95\ State of Vermont Department of Financial Regulation (Nov.
13, 2023). ``Contraceptive Services Claims Restitution
Information,'' available at <a href="https://dfr.vermont.gov/contraceptive-services-claims-restitution-information">https://dfr.vermont.gov/contraceptive-services-claims-restitution-information</a>.
\96\ Sen. Bernie Sanders (June 17, 2024). Letter to Hon. Gene
Dodaro, Comptroller General of the United States, available at
<a href="https://www.documentcloud.org/documents/24764790-61724-gao-aca-contraception-coverage-letter">https://www.documentcloud.org/documents/24764790-61724-gao-aca-contraception-coverage-letter</a>.
\97\ CMS, ``Compliance and Enforcement, Federal Market Conduct
Examination Final Reports,'' available at <a href="https://www.cms.gov/marketplace/private-health-insurance/consumer-protections-enforcement">https://www.cms.gov/marketplace/private-health-insurance/consumer-protections-enforcement</a>.
\98\ See, e.g., Secretaries Becerra, Yellen, and Walsh (June 27,
2022). Letter on the ACA contraceptive coverage requirement,
available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/letter-from-secretaries-becerra-yellen-and-walsh-on-the-aca-contraceptive-coverage-requirement.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/letter-from-secretaries-becerra-yellen-and-walsh-on-the-aca-contraceptive-coverage-requirement.pdf</a> (highlighting reports of
noncompliance documented by Members of the U.S. House of
Representatives (in 2021 and 2022) and the U.S. Senate (in 2021 and
2022), the National Women's Law Center, other nonprofit
organizations, and media reports).
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Furthermore, focusing on contraception is consistent with recent
Executive Orders. As described in section I.C of this preamble,
President Biden issued E.O. 14101, which directed the Secretaries to
consider actions that would, to the greatest extent permitted by law,
ensure coverage of comprehensive contraceptive care, including all
contraceptives approved, cleared, or granted by the FDA, without cost
sharing for participants, beneficiaries, and enrollees; and streamline
the process for patients and health care providers to request coverage,
without cost sharing, of medically necessary contraception. Further,
section 2(b) of E.O. 14101 instructed the Secretaries to consider
actions that would promote increased access to affordable OTC
[[Page 85764]]
contraception.\99\ Consistent with E.O. 14101, and in consideration of
the availability of OTC oral contraceptives, these proposed rules would
promote coverage and streamline access to all medically necessary
contraception, including the newly FDA-approved OTC daily oral
contraceptive, by removing prescription and cost barriers for
consumers.
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\99\ 88 FR 41815 at 41816 (June 23, 2023).
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The Departments acknowledge the possibility that increasing
coverage without cost sharing for recommended preventive services, as
discussed in this section II.A.2 of this preamble, could lead to
greater demand for those services and potentially higher prices charged
by providers. These increased costs could result in higher costs to
consumers, both in the form of higher premiums for people with
insurance and in the form of higher out-of-pocket costs for people who
do not use insurance coverage to obtain OTC contraceptive products. The
potential increases in cost further justify the incremental approach
taken in these proposed rules. In addition, comments in response to the
OTC Preventive Products RFI suggested that requiring coverage of all
OTC preventive products may be challenging for some types of preventive
care. For these reasons, the Departments propose to amend the
preventive services regulations with respect to only contraceptive
items \100\ at this time by inserting a new paragraph (a)(6) at 26 CFR
54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130. The
Departments' issuance of these proposals implementing section 2713 of
the PHS Act is authorized by section 9833 of the Code, section 734 of
ERISA, and section 2792 of the PHS Act.
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\100\ See section II.A.2 of the preamble to these proposed rules
for comment solicitation regarding whether to expand the proposed
coverage requirements to other recommended preventive services.
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First, the Departments propose to define the terms ``drug-led
combination product'' \101\ in proposed new paragraph (a)(6)(i)(A) and
``therapeutic equivalent'' in proposed new paragraph (a)(6)(i)(B) for
purposes of the proposed new paragraph (a)(6). Second, the Departments
propose in proposed new paragraph (a)(6)(ii) to require that plans and
issuers cover, without requiring a prescription and without imposing
cost-sharing requirements, recommended contraceptive items that are
available OTC and for which the applicable recommendation or guideline
does not require a prescription. Third, the Departments propose in
proposed new paragraph (a)(6)(iii) that, in order for medical
management techniques to be considered reasonable, plans and issuers
would be required to utilize a therapeutic equivalence approach for
recommended contraceptive drugs and drug-led combination products.
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\101\ The Departments are proposing to define the term ``drug-
led combination products'' in these proposed rules instead of the
term ``drug-led devices'' used in FAQs Part 64 to align these
proposed rules with existing definitions at 21 CFR 3.2(e). The
change in terminology should not be interpreted to suggest that the
terms are interchangeable, as the term ``drug-led combination
products'' encompasses ``drug-led devices'' as well as other drug-
led combination products for which the FDA evaluates therapeutic
equivalence.
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The Departments request comment on whether to finalize these
policies only with respect to contraception as proposed, or to instead
finalize these policies with respect to all preventive services, or
with respect to a larger subset of preventive services. In particular,
the Departments request comment on issues related to coverage of
additional specific OTC preventive products without a prescription (for
example, tobacco cessation items) in addition to OTC contraceptive
items, or all OTC preventive products without a prescription. The
Departments also request comment on the experiences (particularly with
respect to administrative challenges, consumer experiences, and costs)
of any plans and issuers that currently provide coverage for any OTC
preventive products without requiring a prescription, and how those
experiences could inform the implementation of these proposed rules, if
finalized. The Departments further request comment on whether and to
what extent these proposals could affect the ability of plans and
issuers to negotiate or otherwise limit costs for contraceptive items,
including OTC contraceptive items and contraceptive drugs and drug-led
combination products, and what additional rulemaking or guidance would
be necessary to ensure that plans and issuers retain the ability to do
so.
Along with the incremental approach proposed in this rulemaking
focused on contraception, the Departments anticipate issuing another
notice of proposed rulemaking in the near future to address additional
issues related to coverage of preventive services more generally.
a. Coverage of OTC Contraceptive Items Without Cost Sharing
As discussed in section I.B of this preamble, the Departments'
previously issued guidance provides that preventive health care items
generally available OTC to patients (such as folic acid and certain
contraceptive products, including contraceptive sponges, spermicides,
and emergency contraception (levonorgestrel)) must be covered without
cost sharing under section 2713 of the PHS Act only when prescribed by
a health care provider.\102\ This approach reflected the traditional
role of health coverage in providing benefits for health care items and
services for which there is provider involvement. However, the FDA's
approval of a daily OTC oral contraceptive without a prescription, in
combination with the reasons outlined earlier in this preamble, have
prompted the Departments to revisit this approach. As commenters to the
OTC Preventive Products RFI noted, neither section 2713 of the PHS Act
and its implementing regulations nor the current HRSA-supported
Guidelines require a prescription as a condition of coverage without
cost sharing for recommended preventive services that are available
OTC, except to the extent a particular recommendation or guideline
requires that an individual is prescribed an item or service.
Therefore, with respect to contraceptive items that can be lawfully
obtained \103\ by a participant, beneficiary, or enrollee without a
prescription and for which the applicable recommendation or guideline
does not require a prescription, the Departments propose in new
paragraph (a)(6)(ii) that a plan or issuer would not be considered to
comply with 26 CFR 54.9815-2713(a)(1), 29 CFR 2590.715-2713(a)(1), and
45 CFR 147.130(a)(1), unless the plan or issuer provides coverage for
the contraceptive item without requiring a prescription and without
imposing any cost-sharing requirements. As noted by many commenters to
the OTC Preventive Products RFI, out-of-pocket costs and prescription
requirements make it more difficult for women to access contraception,
including contraceptive items that are available without a
prescription, such as oral contraceptives recently approved by the FDA
for OTC sale. The Departments agree with commenters that these
[[Page 85765]]
obstacles present greater challenges to women in underserved
communities, including those with lower incomes and who are members of
underserved racial and ethnic groups, reinforcing structural barriers
to health care and contributing to reproductive health disparities.
Although some plans and issuers have voluntarily, or as required by
State law,\104\ provided coverage of OTC contraceptive items without a
prescription and without cost-sharing requirements or with limits on
cost sharing, the Departments understand that many women lack such
coverage. In response to a specific question regarding how commonly
plans and issuers provide coverage for OTC preventive products without
requiring a prescription, many commenters asserted that most plans and
issuers cover OTC preventive products only when they are prescribed.
The Departments have determined, therefore, that requiring (rather than
encouraging) coverage of OTC contraceptive items without cost sharing
and without a prescription, as proposed in these rules, is critical to
ensuring that coverage requirements provide women with access to
contraceptives as required under section 2713 of the PHS Act and the
applicable HRSA-supported Guidelines, and to realizing the goal of
promoting access to reproductive health care.
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\102\ See FAQs Part XII, Q4 and Q15 (Feb. 20, 2013), available
at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>;
FAQs Part 54, Q5-6 (July 28, 2022), available at https://
www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/
resource-center/faqs/aca-part-54.pdf and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\103\ The Departments intend for this proposal to apply only to
contraceptive items that are legally sold without a prescription.
Nothing in this proposal would require a plan or issuer to provide
coverage without cost sharing for a contraceptive item for which the
FDA requires a prescription, if a participant, beneficiary, or
enrollee acquires the item without a prescription.
\104\ CA, CO, MD, NM, NJ, NY, and WA require some coverage of
OTC contraceptive items. See KFF (Updated March 2024). ``State
Private Insurance Coverage Requirements for OTC Contraception
Without a Prescription,'' available at <a href="https://www.kff.org/other/state-indicator/state-private-insurance-coverage-requirements-for-otc-contraception-without-a-prescription">https://www.kff.org/other/state-indicator/state-private-insurance-coverage-requirements-for-otc-contraception-without-a-prescription</a>. See, e.g., Cal. Health &
Saf. Code section 1367.25(b)(1)(A) (barring prescription
requirements for OTC FDA-approved contraceptive drugs, devices, and
products and requiring point-of-sale coverage of OTC contraception
at in-network pharmacies); Md. Code, Ins. section 15-826.1
(requiring coverage without a prescription for all FDA-approved
contraceptive drugs available OTC and limiting cost-sharing for OTC
contraceptive drugs to the amount that would apply to the same drug
dispensed under a prescription).
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Under this proposal, the requirement to cover OTC contraceptive
items would be subject to the specific coverage requirements applicable
to all recommended preventive services in 26 CFR 54.9815-2713, 29 CFR
2590.715-2713, and 45 CFR 147.130. However, the Departments recognize
that the provision and coverage of OTC contraceptive items present
unique issues that plans and issuers may not encounter when covering
other recommended services. Therefore, the following sections of this
preamble discuss how plans and issuers would be expected to comply with
certain existing requirements with respect to coverage of OTC
contraceptive items.\105\
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\105\ The requirements regarding office visits would not be
relevant with respect to coverage of OTC contraceptive items, and
the requirements regarding timing do not raise unique issues with
respect to OTC contraceptive items.
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(1) In-Network and Out-of-Network Coverage of OTC Contraceptive Items
Under section 2713 of the PHS Act and its implementing regulations
at 26 CFR 54.9815-2713(a)(3)(i) and (ii), 29 CFR 2590.715-2713(a)(3)(i)
and (ii), and 45 CFR 147.130(a)(3)(i) and (ii), a plan or issuer is not
required to provide coverage for recommended preventive services
delivered by an out-of-network provider if the plan or issuer has a
network of providers. Similarly, nothing precludes a plan or issuer
that has a network of providers from imposing cost-sharing requirements
on recommended preventive services delivered by an out-of-network
provider. However, if a plan or issuer does not have a provider in its
network who can provide a recommended preventive service, the plan or
issuer must cover the recommended preventive service, without cost
sharing, when furnished by an out-of-network provider.\106\ Nothing
under section 2713 of the PHS Act nor its implementing regulations
requires a plan or issuer to establish a provider network.
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\106\ See FAQs Part XXII, Q3 (Feb. 20, 2013), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12</a>.
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The Departments are not proposing to amend these requirements with
respect to OTC contraceptive items. Therefore, a plan or issuer that
has a network of providers that can provide OTC contraceptive items
would not be required to provide coverage, or waive cost sharing, for
OTC contraceptive items that are provided by an out-of-network
provider. For example, if a plan or issuer has a network of pharmacies
(including mail-order pharmacies) that can provide OTC contraceptive
items without a prescription, the plan or issuer would not be required
to provide coverage (nor waive cost sharing) if a participant,
beneficiary, or enrollee obtains a covered OTC contraceptive item at an
out-of-network pharmacy or other retailer.\107\
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\107\ Nothing in the statute or preventive services regulations
prevents a plan or issuer from providing coverage without cost
sharing for out-of-network recommended preventive services, and the
Departments encourage plans and issuers to do so.
---------------------------------------------------------------------------
The Departments understand, based on responses to the OTC
Preventive Products RFI and communications with plans and issuers
regarding coverage of OTC COVID-19 diagnostic tests during and after
the COVID-19 PHE, that network contracts between plans and issuers and
pharmacies that are located in a retail store typically include only
the pharmacies as the in-network providers. The retail stores at which
the pharmacies are located are treated as separate entities. In these
cases, the pharmacy point of sale would be considered an in-network
provider at which an OTC contraceptive would be covered without cost
sharing, but a non-pharmacy point of sale (for example, a cash
register, self-check-out, or vending machine in the front of a retail
store, unaffiliated with the pharmacy department) would not be
considered an in-network provider. Although participants,
beneficiaries, and enrollees would typically be able to purchase OTC
contraceptives from the front of the retail store, these proposed rules
would not require a plan or issuer with a network of pharmacies to also
cover without cost sharing OTC contraceptive items that are purchased
at a retail store that is co-located with an in-network pharmacy. If
the plan or issuer has a network of pharmacies that provide coverage
for OTC contraceptive items without cost sharing, that plan or issuer
would be considered to have a network of providers to provide benefits
for OTC contraceptive items and therefore would not be required to
cover OTC contraceptive items purchased at a retail store that is not
part of its network. For example, emergency contraception could be
available in multiple locations in the same retail store: behind the
pharmacy counter through an in-network pharmacy where a consumer
typically provides health coverage information to allow the pharmacy to
process a claim for coverage; and ``off the shelf'' in a non-pharmacy
section of the same store. This could result in a participant,
beneficiary, or enrollee being able to access an OTC contraceptive item
at an in-network pharmacy without paying any out-of-pocket costs at the
pharmacy counter point of sale, while being liable for the full cost of
the identical OTC contraceptive item if it was purchased at a non-
pharmacy point of sale. The Departments request comment on the
potential impact on consumers, pharmacies, and retail stores with this
proposed approach.
The Departments would expect that in-network coverage for OTC
contraceptive items and services would be provided in a manner that is
comparable to coverage for other recommended preventive services. For
example, the Departments would expect
[[Page 85766]]
that a plan or issuer that does not preference the use of a mail-order
pharmacy for coverage of prescription-only recommended preventive
services would not preference the use of a mail-order pharmacy for
coverage of OTC contraceptives. As another example, a plan or issuer
should not impose shipping costs on an OTC contraceptive item that is
furnished via mail order if the plan or issuer would not impose
shipping costs on a comparable prescription product. Likewise, to the
extent that a plan or issuer generally covers a recommended preventive
service that requires a prescription without cost sharing at the in-
network pharmacy point of sale, without requiring consumers to pursue
post-purchase reimbursement, the Departments would expect that the plan
or issuer would generally cover OTC contraceptive items at the in-
network pharmacy point of sale in the same manner. Plans and issuers
that require participants, beneficiaries, or enrollees to present
information, such as an insurance card, to allow an in-network pharmacy
to process a claim for a prescription-only recommended preventive
service may require similar information to process a claim for an OTC
contraceptive item. The Departments request comment on the appropriate
approach for coverage in a scenario in which a plan's or issuer's
preferred OTC contraceptive item is out of stock at an in-network
pharmacy, while a non-preferred version is available. Specifically, the
Departments request comment on whether plans or issuers should be
required to cover the non-preferred version without cost-sharing
requirements at the in-network pharmacy, without requiring the consumer
to pursue an exceptions process when a preferred version is unavailable
at an in-network pharmacy. The Departments also request comment on
whether and how plans and issuers should document the unavailability of
a preferred OTC contraceptive for coverage purposes.
As noted earlier, plans and issuers are not required to establish a
provider network in order to provide coverage of recommended preventive
services and would not be required to contract with providers for the
purpose of providing in-network coverage of OTC contraceptive items if
these proposed rules are finalized. Under 26 CFR 54.9815-
2713(a)(3)(ii), 29 CFR 2590.715-2713(a)(3)(ii), and 45 CFR
147.130(a)(3)(ii), a plan or issuer that lacks an in-network provider
who can provide an OTC contraceptive item would be obligated to cover
the OTC contraceptive item when provided by an out-of-network provider
without imposing cost sharing.
In the absence of a provider network, the Departments encourage
plans and issuers to establish processes to ensure that participants,
beneficiaries, and enrollees can obtain OTC contraceptive items from
out-of-network providers without incurring out-of-pocket costs and
without encountering significant barriers to access.\108\ The
Departments are not proposing to specify in these proposed rules how a
plan or issuer would do so, but would encourage plans and issuers to
establish a robust approach with multiple entry points to ensure that
participants, beneficiaries, and enrollees can access out-of-network
OTC contraceptive items with no out-of-pocket costs and without
friction at the point of sale. The Departments request comment on what
additional standards or guidance would be helpful to ensure that
participants, beneficiaries, and enrollees can use their health
coverage to access OTC contraceptive items from out-of-network
providers without cost sharing, while allowing plans and issuers
flexibility to effectively implement the requirement to cover OTC
contraceptive items, if finalized.
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\108\ The Departments note that plans and issuers would not be
required to reimburse the cost of OTC contraceptive items that have
already been reimbursed by an account-based plan, such as a health
flexible spending arrangement (FSA) or health reimbursement
arrangement (HRA). As of January 2020, section 3702 of the CARES Act
amended the definition of qualifying medical expenses so that the
expenses for certain OTC medications purchased without a
prescription are eligible for reimbursement under certain
arrangements, such as health savings accounts (HSAs), HRAs, and
health FSAs. An individual generally may not submit claims to
multiple sources of coverage to be reimbursed more than once for the
same medical expense. Therefore, the cost (or the portion of the
cost) of OTC contraception that has already been paid or reimbursed
by a plan or issuer cannot also be reimbursed by an HSA, HRA, or
health FSA.
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If these requirements are finalized, plans and issuers should
ensure that processes that require participants, beneficiaries, or
enrollees to pay out-of-pocket for OTC contraceptive items and pursue
reimbursement do not present unreasonable barriers to accessing OTC
contraceptive items provided by either an in-network or out-of-network
provider. A traditional post-purchase reimbursement process might
require consumers to bear the upfront cost of an OTC contraceptive item
as well as the administrative burden of requesting reimbursement,
providing documentation either on paper or electronically, and
absorbing the financial impact of a delayed reimbursement while a
reimbursement request is being reviewed and processed by the plan or
issuer. For example, while it would be reasonable for a plan or issuer
to require a form and receipt or other proof of purchase, post-purchase
reimbursement programs that require an individual to submit multiple
documents or involve numerous steps that unduly delay an individual's
reimbursement for an OTC contraceptive item would not be reasonable
under these proposed rules.
Further, the Departments would strongly encourage plans and issuers
to consider implementing additional methods for providing coverage of
OTC contraceptive items without cost sharing, in addition to or in lieu
of a traditional post-purchase reimbursement process. For example,
plans and issuers could consider providing access to pre-paid accounts
that are programmed to cover upfront costs associated with OTC
contraceptive items at the point of sale, either by issuing physical
debit or credit cards or providing access to a linked smartphone
application or QR code to participants, beneficiaries, or enrollees,
provided funds were sufficient to cover costs associated with OTC
contraceptive items, the mechanism for delivery was programmed with
sufficient guardrails to prevent funds from being applied to items that
were not covered, and the method of access was otherwise implemented
consistent with applicable law. Subject to the requirements for
utilizing reasonable medical management techniques \109\ and consistent
with previously issued guidance \110\ (including providing access to an
easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome on the individual, a provider, or
other authorized representative),\111\ plans and issuers would be able
to utilize reasonable medical management techniques to contain costs
and promote efficient delivery of care, and could consider how to do so
within the
[[Page 85767]]
context of such an approach for out-of-network coverage of OTC
contraceptive items. For example, a plan or issuer would be able to
program a debit or credit card or linked account to limit reimbursement
to a set amount within a specified period of time, provided such
limitations do not unreasonably limit coverage of covered OTC
contraceptive items.
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\109\ 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and
45 CFR 147.130(a)(4).
\110\ See, e.g., FAQs Part XII, Q14 (Feb. 20, 2013), available
at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>;
FAQs Part XXVI (May 11, 2015), available at https://www.dol.gov/
sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/
faqs/aca-part-xxvi.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>.
\111\ See section II.A of the preamble to these proposed rules
for a description of existing guidance regarding the use of an
exceptions process and the proposal in these proposed rules to
require plans and issuers to provide an exceptions process when
utilizing reasonable medical management for recommended preventive
services.
---------------------------------------------------------------------------
The Departments are aware that some OTC contraceptive items, such
as software applications granted marketing authorization by the FDA for
use as contraception, are typically not furnished by in-network
providers (for example, because consumers purchase them directly from a
manufacturer or vendor website). As with other recommended preventive
services for which a plan or issuer does not have an in-network
provider who can provide the item or service, the plan or issuer would
be required to cover the item or service when delivered by an out-of-
network provider and could not impose cost sharing with respect to the
item or service. The Departments request comment on whether additional
guidance is necessary to ensure that individuals would be able to use
their health coverage to obtain OTC contraceptive items that are
typically obtained outside of the traditional system of network
providers with zero cost sharing and without unnecessarily burdensome
reimbursement requirements, while permitting plans and issuers to
utilize reasonable medical management techniques.
The Departments request comment on how plans and issuers would
likely operationalize out-of-network coverage and whether the
Departments should adopt specific standards for out-of-network coverage
with respect to OTC contraceptive items. In addition, participants,
beneficiaries, and enrollees would benefit if plans and issuers provide
access to a broad network of providers with the capacity to provide the
full range of OTC contraceptive items, and the Departments request
comment on how to support and incentivize plans and issuers to develop
such networks.
(2) Reasonable Medical Management Techniques for OTC Contraceptive
Services
As discussed in section II.A.1 of this preamble, to the extent not
specified in the applicable recommendation or guideline, plans and
issuers may rely on the relevant clinical evidence base and established
reasonable medical management techniques to determine the frequency,
method, treatment, or setting for coverage of a recommended preventive
health service.\112\ In prior guidance, the Departments have stated
that if a plan or issuer utilizes medical management techniques within
a specified category of contraception (or, with respect to
contraceptive categories not specifically described in the HRSA-
supported Guidelines, a group of substantially similar services or
products), the use of those techniques will not be considered
reasonable unless the plan or issuer has an easily accessible,
transparent, and sufficiently expedient exceptions process that is not
unduly burdensome on the individual or their attending provider (or
other individual acting as the individual's authorized representative)
allowing such individual to obtain coverage for a service or FDA-
approved, -cleared, or -granted product determined to be medically
necessary, as determined by the individual's attending provider.\113\
The Departments are not proposing amendments to the medical management
provisions specific to OTC contraceptive items. Therefore, these
standards, as well as the new standards proposed in these rules,\114\
would apply to a plan's or issuer's use of medical management
techniques with respect to OTC contraceptive items in the same manner
and to the same extent as they would apply to other recommended
preventive services.
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\112\ 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and
45 CFR 147.130(a)(4).
\113\ See FAQs Part 54, Q3 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a>.
\114\ See sections II.A.1 (for discussion of proposal to amend
the general requirements related to reasonable medical management)
and II.A.2.b (for discussion of proposed amendment regarding
reasonable medical management for contraceptive drugs and drug-led
combination products, including OTC contraceptive items) of the
preamble to these proposed rules.
---------------------------------------------------------------------------
The Departments recognize that plans and issuers may encounter
unique issues related to medical management if the Departments finalize
the proposed requirements to cover OTC contraceptive items. In the OTC
Preventive Products RFI, the Departments requested comment on what
types of reasonable medical management techniques plans and issuers
would consider implementing if recommended OTC preventive products were
required to be covered without cost sharing. In response, some
commenters suggested plans and issuers could limit the number of
products an individual could obtain during a given period as a
guardrail for OTC contraceptive services. One commenter stated that
quantity limits would help prevent inequitable distribution and
stockpiling for resale of OTC contraceptive services. Another commenter
urged the Departments to allow plans and issuers to limit the initial
purchase of OTC contraceptive services until there is more
understanding of the cost implications and distribution channels for
OTC preventive services. Other commenters discouraged the use of
quantity limits as a medical management technique out of concern that
such limits would discourage continuation of use, by creating new
access barriers for individuals that already face challenges engaging
with the health care system, in particular individuals that are members
of underserved communities. In addition, a commenter expressed concern
about the difficulty in predicting the need for emergency
contraception.
Some commenters advocated for 12-month quantity limits for monthly
OTC contraceptive services in order to balance the health equity
concerns of individuals with the implementation challenges that may
arise for retailers and plans and issuers transitioning to covering OTC
contraceptive services without a prescription and without cost sharing.
Some commenters noted that there is already ample precedent for
requiring coverage of extended supplies of contraceptives, with at
least 25 States and the District of Columbia requiring Medicaid and
private payers to cover the dispensing of an extended (usually 12-
month) supply of prescription contraceptives.\115\ One commenter to the
OTC Preventive Products RFI stated that purchasing contraceptive items
in larger dispensing quantities may create opportunities for plans and
issuers to negotiate pricing discounts that will decrease per-unit
costs for plans and issuers as well as suppliers and distributors. The
Departments note that when the OTC oral contraceptive became available
in March 2024 for sale online and in stores under the brand name
Opill[supreg], the manufacturer's suggested retail price for a 6-month
supply was cheaper (per-month) than
[[Page 85768]]
the manufacturer's suggested retail price for a 1-month supply.\116\
---------------------------------------------------------------------------
\115\ In States that have implemented a 12-month prescription
limitation, plans and issuers are required to cover without cost
sharing a supply of up to 12 months when indicated by the
prescribing provider. See Power to Decide (August 2023), ``Coverage
for an Extended Supply of Contraception,'' available at <a href="https://powertodecide.org/sites/default/files/2023-08/Extended%20Supply%20of%20Contraception.pdf">https://powertodecide.org/sites/default/files/2023-08/Extended%20Supply%20of%20Contraception.pdf</a>. Since the comment
submission period for the OTC Preventive Products RFI closed,
additional States have enacted coverage requirements related to
extended contraceptive supplies. See NCSL, ``State Contraception
Policies,'' available at <a href="https://www.ncsl.org/health/state-contraception-policies">https://www.ncsl.org/health/state-contraception-policies</a>.
\116\ Lupkin, S., NPR (March 18, 2024). ``First over-the-counter
birth control pill now for sale online,'' available at <a href="https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-counter-birth-control-pill-contraceptive-shop">https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-counter-birth-control-pill-contraceptive-shop</a>.
---------------------------------------------------------------------------
Literature on contraception shows that dispensing a multi-month
supply of prescription oral contraceptive pills at one time during the
plan year is generally associated with increased continuation of
contraception use, decreased occurrence of unintended pregnancy, and
greater cost savings, but also more pill waste, compared to dispensing
a single month's supply.<SUP>117 118</SUP> Research also shows that
advance provision of emergency contraception significantly increases
its use without adversely affecting the use of routine
contraception,\119\ which suggests that it may be beneficial for women
to receive more than one unit of emergency contraception at a time, in
order to realize the benefits of advance provision for future use.
Limitations on the supply of OTC contraception dispensed at one time
should take into account the clinical evidence base regarding benefits
to consumers, including as described in this section II.a.2.
---------------------------------------------------------------------------
\117\ See Steenland, M., Rodriguez, M., Marchbanks, P., and
Curtis, K. (2013). ``How does the number of oral contraceptive pill
packs dispensed or prescribed affect continuation and other measures
of consistent and correct use? A systematic review,'' Contraception,
available at <a href="https://www.sciencedirect.com/science/article/pii/S0010782412007317?via%3Dihub">https://www.sciencedirect.com/science/article/pii/S0010782412007317?via%3Dihub</a>.
\118\ See Judge-Golden, C. P., Smith, K. J., Mor, M. K., and
Borrero, S. (2019). ``Financial Implications of 12-Month Dispensing
of Oral Contraceptive Pills in the Veterans Affairs Health Care
System,'' JAMA Internal Medicine, available at <a href="https://doi.org/10.1001/jamainternmed2019.1678">https://doi.org/10.1001/jamainternmed2019.1678</a> (study of the Veterans Affairs health
care system finding that a 12-month supply better supports
continuous usage of contraceptive items than a 3-month supply and
decreases the risk of unwanted pregnancies, and concluding that a
12-month dispensing option would likely result in a $2 million
dollar annual cost-savings for the Veterans Affairs health care
system).
\119\ See Kripke, C. (2000). ``Advance Provision for Emergency
Oral Contraception,'' American Family Physician, available at
<a href="https://www.aafp.org/pubs/afp/issues/2007/0901/p654.html">https://www.aafp.org/pubs/afp/issues/2007/0901/p654.html</a>; Jackson
R.A., Bimla Schwarz, E., Freedman L, Darney P. (2003). ``Advance
supply of emergency contraception: effect on use and usual
contraception--a randomized trial,'' Obstetrics and Gynecology,
available at <a href="https://pubmed.ncbi.nlm.nih.gov/12850599">https://pubmed.ncbi.nlm.nih.gov/12850599</a>.
---------------------------------------------------------------------------
Given the evidence regarding benefits to consumers of a multi-month
supply of prescription oral contraceptive pills, the Departments would
generally not consider coverage limitations that only allow for a 1-
month supply of an OTC oral contraception per instance of dispensing to
be reasonable or consistent with the requirement to cover recommended
preventive services under 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-
2713(a)(4), and 45 CFR 147.130(a)(4) if there is no clinical basis for
limiting the quantity to be dispensed at one time. The Departments seek
comment, with respect to all forms of OTC contraceptives, on whether
other quantity limits (such as a 6-month limit on OTC oral
contraception or a 3-unit limit on OTC emergency contraception per
instance of dispensing) should be considered reasonable or
unreasonable, and what additional facts and circumstances should be
considered when determining the reasonableness of a particular quantity
limit with respect to OTC contraception, such as initial success with a
shorter supply of OTC contraception. The Departments also request
comment on the circumstances under which participants, beneficiaries,
and enrollees who receive an initial extended quantity of OTC
contraception could access a different form of contraception without
incurring cost sharing before finishing the initial extended quantity
(for example, before a 6-month supply is exhausted).
Some commenters to the OTC Preventive Products RFI suggested
individuals should be required to submit evidence to a plan or issuer
that a particular form of prescription birth control is inappropriate
before receiving coverage for an OTC contraceptive service. The
Departments previously issued guidance that it is not a reasonable
medical management technique to require individuals to fail first using
numerous other services or FDA-approved, -cleared, or -granted
contraceptive products before the plan or issuer will approve coverage
for the service or FDA-approved, -cleared, or -granted contraceptive
product that is medically necessary for the individual, as determined
by the individual's attending provider.\120\ Within the context of
medical management of OTC contraceptive items, the Departments would
not consider it reasonable either to impose a prescription requirement
for OTC contraception as a form of medical management, including
requiring an individual to fail first using a prescription-only
contraceptive item before providing coverage of an OTC contraceptive
item without cost sharing, or to require an individual to fail first
with numerous prescription or OTC contraceptive items before the plan
or issuer will approve coverage for a medically necessary OTC
contraceptive item.
---------------------------------------------------------------------------
\120\ See FAQs Part 54, Q8 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
---------------------------------------------------------------------------
Other commenters suggested that a plan or issuer could consider
implementing age-based limitations or gender-based requirements instead
of offering benefits to all individuals with reproductive capacity. The
Departments would not consider age- and gender-based medical management
with respect to OTC contraceptive services to be reasonable unless the
medical management technique relies on a clinical rationale for
limiting access to individuals of a certain age or gender and is
consistent with FDA approvals of any particular OTC contraceptive
product. The Departments have stated in previous guidance that imposing
an age limit on contraceptive coverage instead of providing these
benefits to all women would not be considered a reasonable medical
management technique.\121\
---------------------------------------------------------------------------
\121\ Id.
---------------------------------------------------------------------------
A commenter suggested that implementing prior authorization
requirements with respect to certain OTC items would not be an
unreasonable medical management technique. However, such medical
management techniques create barriers for consumers accessing
contraceptive services with a prescription \122\ and would create
similar barriers for consumers accessing contraceptives services
without a prescription, with the added challenge that consumers seeking
to obtain OTC contraceptive items are likely navigating such
requirements without the assistance of a provider. Such requirements
could be used as a means of circumventing the requirement to provide
coverage of contraception without cost sharing and without a
prescription. Therefore, under these proposed rules, coverage
requirements that, in practice, operate as substitutes for a
prescription coverage requirement by requiring the involvement of a
provider (such as prior authorization processes that require provider
involvement or other clinical expertise or a requirement that
individuals receive counseling from a pharmacist prior to accessing an
OTC contraceptive item) would not be considered reasonable medical
management techniques with respect to OTC contraceptive items.
---------------------------------------------------------------------------
\122\ See U.S. House of Representatives Committee on Oversight
and Reform (Oct. 25, 2022). ``Barriers to Birth Control: An Analysis
of Contraceptive Coverage and Costs for Patients with Private
Insurance,'' available at <a href="https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf">https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf</a>.
---------------------------------------------------------------------------
[[Page 85769]]
Under these proposed rules, plans and issuers generally could adopt
medical management techniques with respect to OTC contraceptive items
that are not described as unreasonable in this preamble as long as they
are otherwise consistent with proposed 26 CFR 54.9815-2713(a)(4), 29
CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4) and existing guidance
and the plan or issuer makes available an exceptions process as
described in these proposed rules. The Departments request comment on
what other medical management techniques plans and issuers would
consider applying to OTC contraceptive items, including whether such
techniques should be considered reasonable or unreasonable. The
Departments request comment on the proposed interpretation of
reasonable medical management requirements with respect to OTC
contraceptive items, including whether any final regulations should
specify or use examples to illustrate in the regulatory text the
Departments' interpretation of reasonable medical management for OTC
contraceptive items.
(3) Other Considerations
The Departments acknowledge the concerns raised by commenters to
the OTC Preventive Products RFI, such as risks to patient privacy, of
overconsumption, and of fraud, waste, or abuse, that some commenters
believe could be exacerbated with increased coverage with no cost
sharing of OTC contraceptive items. These concerns could be heightened
with respect to OTC items and services that do not require the input of
a provider in the form of a prescription and may be further increased
within the context of out-of-network providers with whom plans and
issuers do not have contractual relationships. For example, plans and
issuers may wish to ensure that individuals are obtaining OTC
contraceptive items to prevent pregnancy rather than solely to address
another underlying condition (such as to treat anemia or manage
premenstrual symptoms) or to ensure that an individual is obtaining
condoms for the use of a woman covered under the plan, rather than for
use by another individual. Several commenters to the OTC Preventive
Products RFI highlighted concerns that coverage of OTC preventive
products without cost sharing could incentivize overconsumption or
waste of such products. Additionally, OTC contraceptive items may
present particular challenges with respect to patient privacy, given
the deeply personal nature of reproductive health care and the dynamic
nature of State laws governing access to reproductive health care.
The Departments anticipate that plans and issuers with a network of
providers would mitigate these risks by using existing claims
processing systems with respect to in-network coverage, but acknowledge
that coverage through pathways other than an in-network pharmacy may
present privacy challenges (for example, because non-provider retailers
are not required to implement the same privacy and security safeguards
as they are with respect to back-pharmacy transactions). The
Departments request comment on how best to encourage plans and issuers
to develop mechanisms that promote access to OTC contraceptive items in
accordance with these proposed regulations, if finalized, while
protecting patient privacy and allowing plans and issuers to identify
and address risks including waste, fraud, and abuse.
The Departments further request comment on how the proposed
exceptions process requirement should apply with respect to OTC
contraceptives items, for which no provider involvement is generally
required. The proposed exceptions process requirement described in
section II.A.1 of this preamble refers to the determination of an
individual's attending provider. Thus, the Departments request comment
on what information individuals should be required to provide to seek
an exception to access coverage for an OTC contraceptive item that is
not typically covered, including how plans and issuers could determine
whether an OTC contraceptive item is medically necessary, and whether
any additional changes are necessary for an exceptions process when
used to seek coverage, without cost sharing, for an OTC contraceptive
item.
The Departments also request comment on whether it would be
beneficial to define a new term to refer to contraception that would be
subject to the proposed amendments to 26 CFR 54.9815-2713(a)(6), 29 CFR
2590.715-2713(a)(6), and 45 CFR 147.130(a)(6); and if so, request
feedback on the appropriate term and scope of the definition. For
example, the Departments request comment on whether to define
``contraceptive item,'' ``contraceptive product,'' or ``contraceptive
items and services'' within the context of these proposed rules; and
whether the term would refer to all contraceptive items and services
recommended under the HRSA-supported Guidelines, all contraceptive
items and services recommended under 26 CFR 54.9815-2713(a)(1), 29 CFR
2590.715-2713(a)(1), and 45 CFR 147.130(a)(1); or another subset of
recommended preventive services.
b. Therapeutic Equivalence Approach to Reasonable Medical Management
for Contraceptive Drugs and Drug-Led Combination Products
As discussed in section II.A.2 of this preamble, despite repeated
clarification in guidance, the Departments have continued to receive
complaints and reports that participants, beneficiaries, and enrollees
are being denied coverage for contraceptives that their attending
providers have prescribed, in some cases due to the application of
medical management techniques that are not reasonable based on all the
relevant facts and circumstances.\123\ The Departments are also aware
of investigations and other credible reports that have documented plans
and issuers using potentially unreasonable medical management
techniques.\124\ In response to these reports, the Departments issued
FAQs Part 64 on January 22, 2024, which set forth a therapeutic
equivalence approach that plans and issuers can, but are not required
to, use (in combination with an easily accessible, transparent, and
sufficiently expedient exceptions process) to comply with PHS Act
section 2713 and its implementing regulations with respect to FDA-
approved contraceptive drugs and drug-led devices, as an alternative to
standards that had been set forth in previous guidance and described in
section II.A.1 of this preamble.\125\ The Departments have determined
that it is necessary to require the therapeutic equivalence approach to
ensure coverage of the full range of FDA-approved contraceptive items
that are drugs and drug-led combination products. The proposed
therapeutic equivalence approach would serve as a guardrail against the
widespread use of narrow drug formularies, which the Departments
[[Page 85770]]
understand plans and issuers use to limit costs, but can have the
effect of limiting access to medically appropriate contraceptive drugs
and drug-led combination products.\126\ This proposed regulation would
limit the use of such techniques with respect to recommended
contraceptive drugs and drug-led combination products.
---------------------------------------------------------------------------
\123\ See also FAQs Part 54, Q8 (July 28, 2022), available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\124\ See U.S. House of Representatives Committee on Oversight
and Reform (Oct. 25, 2022). ``Barriers to Birth Control: An Analysis
of Contraceptive Coverage and Costs for Patients with Private
Insurance,'' available at <a href="https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf">https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf</a>.
\125\ FAQs Part 64 (Jan. 22, 2024), available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
\126\ See Dieguez, G., Sawhney, T., and Mirchandani, H.,
Milliman (2016). ``Evolution of the Use of Restrictions in
Commercial Formularies,'' available at <a href="https://www.milliman.com/-/media/milliman/importedfiles/uploadedfiles/insight/2016/evolution-restrictions-commercial-formularies.ashx">https://www.milliman.com/-/media/milliman/importedfiles/uploadedfiles/insight/2016/evolution-restrictions-commercial-formularies.ashx</a>; Rucker, J., Benfield, M.,
Jenkins, N., Enright, D., Henderson, R., Chambers, J. (2023).
``Commercial Coverage of Specialty Drugs, 2017-2021'' Health Affairs
Scholar, available at <a href="https://academic.oup.com/healthaffairsscholar/article/1/2/qxad030/7236995">https://academic.oup.com/healthaffairsscholar/article/1/2/qxad030/7236995</a>.
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Therefore, the Departments propose to amend 26 CFR 54.9815-2713, 29
CFR 2590.715-2713, and 45 CFR 147.130 to add a new paragraph
(a)(6)(iii) that would specify that a plan's or issuer's medical
management techniques are not considered to be reasonable unless the
plan or issuer provides coverage for recommended preventive services
that are contraceptive drugs and drug-led combination products, other
than those items for which there is at least one therapeutic equivalent
drug or drug-led combination product, as applicable, for which the plan
or issuer provides coverage without imposing any cost-sharing
requirements, consistent with the therapeutic equivalence approach
described in FAQs Part 64. The Departments also propose to define
``therapeutic equivalent'' for purposes of this proposed provision as
having the meaning given the term ``therapeutic equivalents'' in 21 CFR
314.3(b), which defines ``therapeutic equivalents'' as ``approved drug
products that are pharmaceutical equivalents for which bioequivalence
has been demonstrated, and that can be expected to have the same
clinical effect and safety profile when administered to patients under
the conditions specified in the labeling.''
Under this proposal, consistent with FAQs Part 64, a therapeutic
equivalent drug or drug-led combination product would be one that is
designated with a code with the first letter ``A'' in the FDA's
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange
Book).\127\ If the Orange Book does not identify a therapeutic
equivalent for a given drug or drug-led combination product, that drug
or drug-led combination product would have no therapeutic equivalent
for purposes of these proposed rules, and a plan or issuer would not be
permitted to use medical management techniques to deny coverage of (or
impose cost sharing on) that drug or drug-led combination product. For
example, assume that there are six oral contraceptives (Pill A, Pill B,
Pill W, Pill X, Pill Y, and Pill Z) listed in the Orange Book that are
within the HRSA-supported Guidelines category of contraceptives known
as ``oral contraceptives (combined pill).'' If the Orange Book does not
identify a therapeutic equivalent for either Pill A or Pill B, but
identifies the latter four (Pill W, Pill X, Pill Y, and Pill Z) as
therapeutic equivalents of each other, then under these proposed rules,
the plan would be required to cover without cost sharing Pill A and
Pill B, for which there are no therapeutic equivalents. The plan could
utilize reasonable medical management techniques that result in it
covering only one of Pill W, Pill X, Pill Y, or Pill Z without cost
sharing because all four are therapeutically equivalent to each other
(provided the plan has an exceptions process that ensures an individual
can receive coverage, without cost sharing, for any of Pill W, Pill X,
Pill Y, or Pill Z, in the circumstances discussed in more detail in
section II.A.1 of this preamble).
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\127\ FAQs Part 64, Q2 (Jan. 22, 2024), available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64</a> and <a href="https://www.cms.gov/files/document/faqs-part-64.pdf">https://www.cms.gov/files/document/faqs-part-64.pdf</a>.
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In the Orange Book, the FDA evaluates only multisource prescription
drug products for therapeutic equivalence.\128\ Therefore, the FDA does
not evaluate therapeutic equivalence for OTC drugs or OTC drug-led
combination products and the Orange Book does not categorize such
products as a ``therapeutic equivalent'' of any other drug or drug-led
combination product. As described in section II.A.2, the Departments
are proposing to require plans and issuers to provide coverage of OTC
contraceptives without cost sharing and without requiring a
prescription. If both the therapeutic equivalence proposal described in
this preamble section and the OTC contraceptive coverage proposal are
finalized, plans and issuers would be required to cover all OTC
contraceptive items that are drugs and drug-led combination products
without cost sharing. The Departments request comment on the potential
impacts to interested parties, including participants, beneficiaries,
and enrollees and plans and issuers, if both proposals are finalized.
The Departments further request comment on whether an alternative
approach to therapeutic equivalence would be appropriate for OTC
contraceptive drugs and drug-led combination products. If so, the
Departments request comment on what medical management techniques would
be appropriate and reasonable while balancing the goals of increasing
consumer access to OTC contraceptive drugs and drug-led combination
products and containing costs. For example, the Departments seek
comment on whether plans and issuers should be permitted to provide
coverage without cost-sharing or prescription requirements of a
preferred generic version of an OTC contraceptive, while only covering
the brand version without cost-sharing or prescription requirements
subject to an exceptions process.
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\128\ FDA, ``Orange Book Preface,'' available at <a href="https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface">https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface</a>.
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In addition to satisfying the therapeutic equivalence approach, the
Departments would not consider a plan's or issuer's medical management
techniques with respect to recommended contraceptive services to be
reasonable unless the plan or issuer meets existing standards under
applicable regulations and guidance, to the extent not superseded by
the other proposals in these proposed rules. For example, as described
in FAQs Part 54, Q8, a plan's or issuer's medical management techniques
would generally be considered reasonable only if the plan or issuer
utilizes reasonable medical management techniques within a specified
category described in the HRSA-supported Guidelines (or group of
substantially similar products that are not included in a specified
category).<SUP>129 130</SUP> Therefore, if a plan or
[[Page 85771]]
issuer provided coverage consistent with the proposed therapeutic
equivalence approach, but used medical management techniques to deny
coverage or impose cost sharing for all contraceptives in another
category (or other groups of substantially similar products), such as
the category for sterilization surgery for women, the plan's or
issuer's medical management techniques would not be considered to be
reasonable. Similarly, consistent with FAQs Part 54, Q8, the
Departments would not consider a plan's or issuer's medical management
techniques to be reasonable if the plan or issuer requires an
individual to fail first using numerous contraceptives within a
category prior to providing coverage consistent with the proposed
therapeutic equivalence approach.
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\129\ FAQs Part 54, Q8 (July 28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\130\ The Departments acknowledge that the proposed therapeutic
equivalence standard would require plans and issuers to cover more
contraceptive drugs and drug-led combination products than under
FAQs Part XXVI, Q2, which specified that a plan or issuer must cover
at least one form of contraception in each method that is identified
by the FDA. The Departments have determined that this approach is
necessary to ensure coverage of the full range FDA-approved
contraceptive drugs and drug-led combination products, as required
under section 2713 of the PHS Act, while still permitting plans and
issuers to contain costs by not requiring plans and issuers to cover
items for which there is at least one therapeutic equivalent drug or
drug-led combination product, as applicable, for which the plan or
issuer provides coverage without imposing any cost-sharing
requirements. The FDA defines ``therapeutic equivalents'' at 21 CFR
314.3(b) as approved drug products that are pharmaceutical
equivalents (meaning, in general, that they contain identical
amounts of the identical active drug ingredient in the identical
dosage form and route of administration) and bioequivalents
(meaning, in general, that the rate and extent of the active
ingredient at the site of action are the same), and that can be
expected to have the same clinical effect and safety profile when
administered to patients under the conditions specified in the
labeling. The contraceptives described in the HRSA-supported
Guidelines do not refer to therapeutic equivalence, and as a result,
there may be multiple drugs or drug-led combination products within
a category that are not therapeutically equivalent to each other.
For example, within the ``oral contrac
[…truncated; see source link]Indexed from Federal Register on October 28, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.