Departments Issue FAQs Addressing Contraceptive Coverage

PDF

On January 22, 2024, the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) issued Frequently Asked Question (“FAQ”) guidance addressing group health plan coverage of contraceptives and contraceptive care under the Affordable Care Act’s (“ACA’s”) preventive services coverage mandate, pursuant to Public Health Services Act (PHSA) § 2713.

Background

PHSA § 2713 and its implementing regulations require non-grandfathered group health plans and insurers to provide certain preventive services without imposing any cost-sharing (aka, providing “first-dollar coverage”). As a result, deductibles, copays, coinsurance, or other cost-sharing may not be imposed on items and services that qualify as preventive. The following items and services qualify as preventive for this purpose:

• Evidence-based items or services with an “A” or “B” rating recommended by the U.S. Preventive Services Task Force (USPSTF);[1]
• Immunizations for routine use for children, adolescents, or adults recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC);
• With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA); and
• With respect to women, other evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by HRSA.

The HRSA-supported Women’s Preventive Services Guidelines recommend that adolescent and adult women have access to the full range of FDA-approved, cleared, or granted contraceptives, effective family planning practices, and sterilization procedures be available as part of contraceptive care, including  the 17 categories listed in the FDA’s Birth Control Guide: sterilization surgery; implantable rods; copper intrauterine devices; intrauterine devices with progestin; injectable contraceptives; oral contraceptives (combined pill); oral contraceptives (progestin only); oral contraceptives (extended or continuous use); the contraceptive patch; vaginal contraceptive rings; diaphragms; contraceptive sponges; cervical caps; condoms; spermicides; emergency contraception (levonorgestrel); and emergency contraception (ulipristal acetate).

The Departments have interpreted PHSA § 2713 and its implementing regulations as requiring plans and issuers to cover, without cost sharing: (1) at least one form of contraception in each of the categories listed in the HRSA-supported guidelines; and (2) any contraceptive services and FDA-approved, cleared, or granted products that individuals and their attending providers have determined are medically appropriate.

If the HRSA-supported guidelines do not specify the frequency, method, treatment, or setting for the provision of recommended preventive contraceptive services or products, then plans and issuers may use reasonable medical management techniques within a specified category of contraception. However, using such medical management techniques generally will not be considered reasonable unless the plan or issuer (1) has an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome; and (2) 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.

In prior FAQ guidance, the Departments described several examples of potentially unreasonable medical management techniques used by plans and issuers, including the use of step therapy (aka, fail-first) protocols, application of age-related restrictions, imposition of onerous documentation requirements that result in denials of coverage, and requiring cost-sharing for services that are integral to the provision of the contractive service (e.g., anesthesia or other pre- or post-operative items and services integral to the furnishing of sterilization surgeries).

Because of reports indicating that such unreasonable medical management techniques continue to be used with relative prevalence, causing continued barriers to accessing contraceptive coverage, the Departments issued new FAQ guidance outlining an alternative “therapeutic equivalence approach” to assessing the reasonableness of a plan's or issuer's medical management techniques.

Alternative Approach to Assessing the Reasonableness of Medical Management Techniques

To comply with the ACA’s preventive services coverage mandate with respect to the first-dollar coverage of contraceptives, plans and insurers can either continue to provide contraceptive coverage consistent with the Departments’ prior guidance or, alternatively, use the new “therapeutic equivalence approach” related to FDA-approved contraceptives only. Under the new approach, if a plan or issuer utilizes medical management techniques within a specified category described in the HRSA-supported guidelines, the Departments generally will consider such medical management techniques to be reasonable if the plan or issuer covers all FDA-approved contraceptives in that category without cost sharing, other than those for which there is at least one therapeutic equivalent drug that the plan or issuer covers without cost sharing. However, the plan or issuer still must provide an exceptions process that allows an individual to access, without cost sharing, the specific contraceptive drug (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.

The Departments will consider a contraceptive drug to be therapeutically equivalent to another drug if it is identified as a therapeutic equivalent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (aka, the “Orange Book”). The Departments will consider a drug for which the Orange Book has not identified any therapeutic equivalents to have no therapeutic equivalent.

Takeaways for Plan Sponsors

Plan sponsors of self-funded group health plans whose claims administrators are following prior Departmental guidance on the reasonableness of medical management techniques applied to contraceptive coverage should discuss with their claims administrators the need to carefully review the Departments’ previously issued FAQs and all current medical management techniques to ensure that such techniques are reasonable under either the prior approach or the new therapeutic equivalence approach. As a reminder, regardless of which approach used, plan sponsors must ensure that their plans offer an exceptions process, and that they properly communicate that exceptions process to plan participants.

_{[1] On March 30, 2023, a federal trial court held that the members of the USPSTF were unconstitutionally appointed and thus do not have the authority to determine the preventive services that must be covered by private health plans. The court ordered that USPSTF actions taken on or after March 23, 2010 be vacated as unlawful. However, a federal appellate court issued an order allowing the USPSTF preventive health services recommendations and the corresponding coverage mandate to remain in effect while the court decides the case}