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Article | Insider

FAQs issued on ACA required contraceptive drug coverage

By Maureen Gammon and Kathleen Rosenow | February 16, 2024

Recent guidance gives a new alternative path to compliance with the ACA requirement that health plans provide preventive care coverage of certain contraceptives without cost sharing.
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The departments of Labor, Health and Human Services (HHS), and the Treasury have issued Affordable Care Act (ACA) FAQs Part 64 on preventive care coverage of contraceptives and family planning counseling without cost sharing. The guidance restates the law under the ACA dealing with coverage of preventive services and gives non-grandfathered employer-sponsored group health plans and health insurance issuers a new alternative path — the “therapeutic equivalence approach” — to compliance, specifically related to contraceptives.

FAQs Part 64 do not change the timing of the ACA preventive care mandate for contraceptives (which includes the contraceptive coverage requirement). Note: The mandate continues to be challenged in a federal district court in Texas, with no word on when the court may issue its opinion.

ACA preventive care requirements

The ACA requires non-grandfathered employer-sponsored group health plans and health insurance issuers to provide certain preventive care services with no deductibles or copays. In part, the ACA guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling. At least one form of contraception in each Food and Drug Administration (FDA)-identified contraceptive category must be covered without cost sharing. Any FDA-approved, ‑cleared or -granted contraceptive product that is deemed medically appropriate by the patient and the patient’s physician must also be covered without cost sharing.[1]

FAQs Part 64 guidance

The departments have released FAQs Part 64 in response to reports that many plans and issuers have not been using “reasonable” medical management techniques as required under the ACA. For example, many reportedly “continue to impose barriers to contraceptive coverage, such as requiring patients to satisfy step therapy protocols, imposing unduly burdensome administrative requirements, or requiring cost-sharing for services that are integral to the application of the preventive service provided.”

To address these concerns, the new guidance:

  • Reiterates what is considered to be a “reasonable” medical management technique under the ACA
  • Provides an alternative “therapeutic equivalence approach” to compliance

‘Reasonable’ medical management

With regard to the ACA contraceptive mandate, whether it is “reasonable” depends on all the relevant facts and circumstances. The FAQs reiterate that a reasonable medical management technique is one that is “an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or their provider (or other individual acting as the individual’s authorized representative)” and that “covers without cost sharing a contraceptive service or FDA-approved, ‑cleared, or ‑granted contraceptive product determined to be medically necessary with respect to an individual as determined by the individual’s attending provider.”

New alternative therapeutic equivalence approach

General approach

Under the alternative therapeutic equivalence approach, a plan’s or issuer’s medical management technique with respect to FDA-approved contraceptive drugs and drug-led devices within a specified category — as described in the Health Resources and Services Administration-supported guidelines (or group of substantially similar products that are not included in a specified category) — generally will be considered reasonable if the plan or issuer:

  • Covers the contraceptives 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
  • Provides an exceptions process that allows an individual to access without cost sharing the specific contraceptive that is determined by the attending provider to be medically necessary for the individual

What is a therapeutically equivalent drug or device?

A therapeutically equivalent drug or device is one that is identified as a therapeutic equivalent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The FAQs provide an example of a reasonable medical management technique under the therapeutically equivalent drug/device approach.

The departments note that the new approach would not apply to forms of contraception that are not FDA-approved drugs or drug-led devices (which are not listed in the Orange Book).

Going forward

Employer plan sponsors should:

  • Review their group health plan provisions with their third-party administrators (TPAs) and insurance carriers to determine if they are providing the appropriate ACA preventive care services and supplies with no cost sharing, including services and supplies for reproductive care
  • Work with their TPAs and carriers to ensure their medical management techniques are “reasonable” in light of previous guidance as well as these new FAQs
  • Consult with their TPAs and carriers to consider whether to utilize the therapeutic equivalence approach to compliance with the ACA’s contraceptive coverage mandate as an alternative to using the departments' current implementing guidance


  1. For more information on previous guidance regarding birth control and contraceptive counseling under the ACA preventive care mandate, see “ACA FAQs clarify reproductive preventive care coverage requirements,” Insider, August 2022. Return to article

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