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Proposed regulations: Amendments to coverage of certain preventive services under Affordable Care Act

Proposed rules would enhance coverage of preventive services, including contraceptive items.

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October 23, 2024

The U.S. Treasury Department and IRS, along with the Department of Labor (DOL) and Department of Health and Human Services (HHS), today released proposed regulations (REG-110878-24) that would amend the regulations regarding coverage of certain preventive services under the Affordable Care Act (ACA).

Specifically, the proposed regulations 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.

The proposed regulations also contain separate requirements that would apply to coverage of contraceptive items that are preventive services under the Public Health Service Act, as amended by the ACA. Specifically, the proposed regulations 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, the proposed regulations would 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.

Comments on the proposed regulations are due by December 27, 2024.

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