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FAQS ABOUT AFFORDABLE CARE ACT

IMPLEMENTATION PART 64

January 22, 2024

Set out below are Frequently Asked Questions (FAQ s) regarding implementation of certain

provisions of the Affordable Care Act (ACA). These FAQs have been prepared jointly by the

Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the

Departments). Like previously issued FAQs (available at

https://www.dol.gov/agencies/ebsa/

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require non-grandfathered group health plans and health

insurance issuers offering non-grandfathered group or individual health insurance coverage to

cover, without the imposition of any cost-sharing requirements, the following items or services:

• Evidence-based items or services that have in effect a rating of “A” or “B” in the current

recommendations of the United States Preventive Services Task Force (USPSTF) with

respect to the individual involved, except for the recommendations of the USPSTF

regarding breast cancer screening, mammography, and prevention issued in or around

November 2009;

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See 26 CFR 54.9815-2713; 29 CFR 2590.715-2713; and 45 CFR 147.130.

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The USPSTF published updated breast cancer screening recommendations in January 2016. However, section 223

of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and

prevention issued before 2009 remain in effect until January 1, 2025.

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On March 30, 2023, the United States District Court for the Northern District of Texas issued a final judgment in

holding that the USPSTF’s members served in violation of the Appointments Clause of Article II of the United

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

to the individual involved (1) an evidence-based item or service that has in effect a rating of “A” or “B” in the

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• With respect to infants, children, and adolescents, evidence-informed preventive care and

screenings provided for in comprehensive guidelines supported by the Health Resources

and Services Administration (HRSA); and

• With respect to women,

such additional preventive care and screenings not described in

If a recommendation or guideline does not specify the frequency, method, treatment, or setting

for the provision of a recommended preventive service, then the plan or issuer

reasonable medical management techniques to determine any such coverage limitations. To the

extent not specified in a recommendation or guideline, a plan or issuer may rely on the relevant

clinical evidence base and established reasonable medical management techniques to determine

the frequency, method, treatment, or setting for coverage of a recommended preventive item or

service.

as updated on December 30, 2021, recommend that adolescent and adult women have access to

the full range of contraceptives and contraceptive care to prevent unintended pregnancies and

improve birth outcomes.

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The HRSA-supported Guidelines also provide that contraceptive care

includes screening, education, counseling, and provision of contraceptives (including in the

immediate postpartum period). Contraceptive care also includes follow-up care (e.g.,

implantable rods, (3) copper intrauterine devices, (4) intrauterine devices with progestin (all

current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from ACIP

(regardless of whether the immunization is recommended for routine use). 85 FR 71142 (Nov. 6, 2020). See also

faqs/downloads/faqs-part-58.pdf.

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See 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).

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See 85 FR 71142, 71174 (Nov. 6, 2020) (discussing examples provided in Coverage of Certain Preventive Services

Under the Affordable Care Act (“2015 Final Regulations”), 80 FR 41318 (July 14, 2015)); see also 2015 Final

Regulations, 80 FR 41318, 41319 (July 14, 2015) (discussing previous guidance).

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Women’s Preventive Services Guidelines, available at https://www.hrsa.gov/womens-

guidelines#:~:text=Contraception.

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The Departments are committed to ensuring consumers have access to all contraceptive benefits

to which they are entitled under federal law. The President has issued several executive orders

directing the Secretaries of the Treasury, Labor, and HHS (the Secretaries) to take steps to

strengthen the implementation of the ACA and improve the accessibility, affordability, and

comprehensiveness of health care and health coverage.

Most recently, on June 23, 2023, the

President issued Executive Order 14101, “Strengthening Access to Affordable, High-Quality

contraception.

The Departments have interpreted PHS Act section 2713 and its implementing regulations, in

conjunction with the HRSA-supported Guidelines, to require plans and issuers to cover without

cost sharing any contraceptive services and FDA-approved, -cleared, or -granted contraceptive

products that an individual’s attending provider determined to be medically appropriate for the

individual.

issued FAQs that stated the Departments’ interpretation of the requirement to cover

contraceptives and contraceptive care.

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See FAQs Part 54.

See FAQs Part 54, Q3, Q8, and Q9.

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anesthesia, pregnancy tests needed before the provision of certain forms of

contraceptives, or other pre- and post-operative items and services integral to the

furnishing of sterilization surgeries including tubal ligation.

The Departments are also aware of investigations that have documented potentially unreasonable

medical management techniques used by plans and issuers. For instance, the U.S. House of

Representatives Committee on Oversight and Reform (Committee) published a report in October

2022 documenting the findings of its investigation into contraceptive coverage for individuals

enrolled in private health coverage.

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Insurer%20Report.pdf.

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In this guidance, a drug-led device refers 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

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ensure compliance with the requirement to cover the full-range of FDA-approved

contraceptive drugs and drug-led devices

interpreting the regulations implementing PHS Act section 2713 in regard to the coverage of

contraception. Plans and issuers may continue to meet the requirements of section 2713 and its

implementing regulations by implementing the standards described in prior guidance.

regulations with respect to FDA-approved contraceptive drugs and drug-led devices, a plan or

issuer may provide coverage consistent with the therapeutic equivalence approach outlined in

these FAQs.

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

is covered without cost sharing) that is determined to be medically necessary with respect to the

individual, as determined by the individual’s attending provider.

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Under PHS Act section 2713 and its implementing regulations, in conjunction with the HRSA-supported

-granted contraceptives. The Departments refer to only “FDA-approved” contraceptive drugs and drug-led devices

in these FAQs to reflect that the FDA approves, but does not “clear” or “grant,” contraceptive drugs and drug-le

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See FAQs Part 54, Q8.

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approved oral contraceptives (combined pill) products without cost sharing, other than those for

which there is a therapeutic equivalent that is covered without cost sharing. Specifically, the plan

covers Pill A, Pill B, and generic Pill D without cost sharing. Neither Pill A nor Pill B has a

therapeutic equivalent product according to the Orange Book. Pill W, Pill X, and Pill Y, as well

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21 CFR 314.3(b), 44 FR 2932 (January 12, 1979) and 45 FR 72582 (October 31, 1980). The Orange Book

identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug,

and Cosmetic Act and related patent and exclusivity information. In addition, the Orange Book contains therapeutic

equivalence evaluations for approved multisource prescription drug products. The FDA believes that drug products

identical dosage form and route of administration, and (b) meet compendial or other applicable standards of

strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential

bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or

without a prescription. The Departments are considering the comments received in response to the Request for

Information regarding the coverage of preventive products available over-the-counter without cost sharing and

without a prescription to determine if and what additional actions the Departments may take regarding such

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

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contraceptives (combined pill)” are generally reasonable. However, the plan’s medical

management techniques could be considered unreasonable if the plan imposes additional medical

management techniques that are problematic, such those highlighted earlier in these FAQs.

equivalent products described in Q1 and Q2 apply to all forms of contraception required to

be covered under PHS Act section 2713?

No. Forms of contraception that are not FDA-approved drugs or drug-led devices are not listed in

the Orange Book. Therefore, the therapeutic equivalence approach described in Q1 and Q2 does

reasonable absent the availability of an exceptions process. Therefore, all plans and issuers are

expected to have an exceptions process available to ensure that individuals can access coverage

without cost sharing for a contraceptive service or FDA-approved, -cleared, or -granted

contraceptive product (including another contraceptive drug or drug-led device for which there is

a covered therapeutic equivalent) that is medically necessary for the individual, as determined by

the individual’s attending provider, and that is otherwise not covered without cost sharing.

The availability of an exceptions process as described in prior guidance remains a critical

resource for individuals to have access to the full range of contraceptives and contraceptive care,

as recommended by the HRSA-supported Guidelines and as individuals are entitled to, without

cost sharing, under PHS Act section 2713 and its implementing regulations.

See FAQs Part 54, Q3, Q8, and Q9.

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exceptions process that is not unduly burdensome on the individual or their provider (or other

individual acting as the individual’s authorized representative). However, given reports of

continued barriers to accessing contraception, the Departments remain concerned that many

issuer could provide coverage consistent with the Departments’ prior guidance or, alternatively,

consistent with the therapeutic equivalence approach outlined in these FAQs to comply with the

plans and issuers are expected to have an exceptions process available to ensure that individuals

can access coverage without cost sharing for a contraceptive service or FDA-approved, -cleared,

approved contraceptive drugs and drug-led devices, if a plan or issuer utilizes medical

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. Even then, a plan’s or issuer’s medical management

techniques would generally be considered reasonable only if the plan or issuer provides an

exceptions process that allows an individual to access without cost sharing the specific

contraceptive drug or drug-led device (that is, a therapeutic equivalent to the product that is

covered without cost sharing) that is determined to be medically necessary with respect to the

individual, as determined by the individual’s attending provider.

To ensure consumers have access to all contraceptive benefits to which they are entitled to under

federal law, plans and issuers following the prior guidance should carefully review the

contraceptive products and services to ensure that they are reasonable.