Brief background

The proposed rules are the most recent in a series of guidance regarding coverage of recommended preventive services required under the ACA, which requires non-grandfathered group health plans to provide coverage for certain recommended preventive services without imposing any cost-sharing requirements, such as a copayment, coinsurance or deductible. These preventive services include:

• Certain evidence-based items or services recommended by the United States Preventive Services Task Force
• Immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
• Preventive care and screenings for infants, children and adolescents recommended by the Health Resources and Services Administration (HRSA)
• Preventive care and screenings for women as provided for in comprehensive guidelines supported by HRSA

Key changes under the proposed rules

The proposed rules, which were published in the Federal Register on October 28, 2024, would require plans to:

• Establish an easily accessible, transparent, and sufficiently expedient exceptions process.
• Cover certain recommended OTC contraceptive items without a prescription.
• Cover certain contraceptive drugs and drug-led combination products.
• Include disclosure on coverage and cost-sharing for OTC contraceptives in their internet-based self-service transparency tools.
  
  

Exceptions process for all recommended ACA preventive services

In the absence of a specified recommendation or guideline, current regulations permit plans and insurers to use reasonable medical-management techniques to determine the frequency, method, treatment or setting for coverage of a recommended preventive service. The Departments previously stated that medical management techniques with respect to recommended preventive services are not considered to be reasonable absent the availability of an exceptions process.

Under the proposed rules, a plan using reasonable medical-management techniques in connection with a preventive service would be required to have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider. The plan would be required to cover without cost sharing the recommended preventive service according to the frequency, method, treatment or setting determined to be medically necessary with respect to the individual, as determined by the individual’s healthcare provider.

Coverage of contraceptive items

In response to consumer complaints that plans have failed to provide coverage of the full range of contraceptive services, the Departments propose the following new rules governing how plans cover contraception and how they communicate information about this coverage to participants:

Coverage of OTC contraceptive items without cost sharing

For contraceptive items that can be lawfully obtained by a participant or enrollee without a prescription and for which the applicable recommendation or guideline does not require a prescription, the proposed rules would require plans to provide coverage for the contraceptive item without requiring a prescription and without imposing any cost-sharing requirements.

Reasonable medical-management techniques for OTC contraceptive services

The proposed rules would allow a plan to adopt reasonable medical-management techniques with respect to OTC contraceptive items, provided the plan makes the required exceptions process available and complies with the therapeutic-equivalence approach described in previous guidance, which we discussed in our February 5, 2024 insight, “New Guidance on How Plans Should Cover Contraceptives.” This would require that the plan cover all FDA-approved contraceptive items, other than those items for which there is at least one therapeutic equivalent drug or drug-led combination product for which the plan or issuer provides coverage without imposing any cost-sharing requirements.

Communicating OTC contraceptive coverage requirements

Plans already must disclose an estimate of the cost-sharing liability for all covered items or services furnished by a provider or providers using an internet-based self-service tool. Under current rules, for contraceptive items that are only covered by the plan or coverage for preventive purposes the self-service tool is required only to reflect a zero-dollar cost-sharing liability.

To ensure individuals are aware that OTC contraceptive items are covered consistent with the proposed rules, the Departments would require plans to make an additional cost-sharing information disclosure to participants and enrollees. Specifically, if a participant, beneficiary or enrollee requests cost-sharing information for any covered contraceptive item or service through a self-service tool, the proposed rules would require the response through the self-service tool to include with the information a statement explaining that OTC contraceptive items are covered without cost sharing and without a prescription. This statement would be required to include a phone number and internet link that a participant or enrollee could use to learn more information about the plan’s contraception coverage.

Implications for group health plan sponsors

If made final as proposed, the rules could require significant changes to current plan and insurer operations. For example, plan sponsors would have to revise their current exceptions process for all ACA preventive services to comply with the proposed new standards for being easily accessible, transparent, sufficiently expedient, and not unduly burdensome. Additionally, plans will have to implement procedures for covering non-prescription OTC contraceptives at point-of-service without cost-sharing that are comparable to the procedures in place for other ACA preventive services.

Most challenging may be the establishment of reasonable medical-management techniques that comply with the proposed rules and the guidance set forth in its preamble. This includes the requirement to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost‑sharing requirements, unless at least one therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing.

The Departments welcome comments on all aspects of the proposed rules, including whether any additional guidance is needed. As noted above, the comment deadline is December 28, 2024.