Federal Agencies Withdraw Proposed Rule to Expand ACA’s Contraceptive Coverage Mandate

On January 14, 2025, the Departments of Health and Human Services, Labor and the Treasury (Departments) rescinded a proposed rule from October 2024 that would have expanded the Affordable Care Act’s (ACA) coverage mandate for contraceptives. Most notably, the proposed rule would have required most health plans and health insurance issuers to cover over-the-counter (OTC) contraceptives without imposing cost-sharing (e.g., deductibles, copayments or coinsurance) or requiring a prescription.

The Departments noted that they are withdrawing the proposed rule to focus on other matters at this time, such as a new transparency requirement for advanced explanation of benefits. However, new rules may be released in the future to address coverage of OTC contraceptives.

Contraceptive Coverage Mandate

The ACA requires non-grandfathered health plans and issuers to provide benefits for certain women’s preventive health services without imposing cost-sharing requirements. These preventive health services include contraceptive services and products approved, cleared or granted by the U.S. Food and Drug Administration (FDA) that a woman’s attending healthcare provider determines to be medically appropriate.

Currently, health plans and issuers are only required to cover OTC preventive products without cost sharing when they are prescribed by a healthcare provider. In July 2023, the FDA approved the first OTC daily oral contraceptive, which is now widely available across the country.

Proposed Changes (Rescinded)

The proposed rule, which has been rescinded, would have required health plans and issuers to:

• cover recommended OTC contraceptive items without requiring a prescription and without imposing cost-sharing;

• cover every FDA-approved contraceptive drug or drug-led combination product without cost sharing, unless the plan also covers a therapeutic equivalent of the drug or drug-led combination product without cost-sharing; and

• disclose to plan participants that OTC contraception is covered without a prescription and without cost sharing.

The above information does not constitute advice. Always contact your employee benefits broker or trusted adviser for insurance-related questions.