Plan sponsors may wish to provide comments on implementation, administration and health equity issues related to providing these OTC services. Comments must be received by 5 pm (ET) on December 4, 2023.

Background

The ACA requires non-grandfathered group health plans to offer the following preventive services in-network without any cost sharing:

• Evidence-based items or services that have a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (USPSTF)
• Immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
• Preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration (HRSA)

While most of these recommended preventive services require a healthcare provider to either provide a prescription for an item or service or to directly furnish a service, several ACA preventive services, such as certain types of tobacco-cessation pharmacotherapy, folic acid supplements, breastfeeding supplies and certain contraceptives recommended by HRSA, are available to consumers without the involvement of a provider or a prescription. In previous guidance issued in 2013 and 2022, the Departments had interpreted the statutory and regulatory requirements to require a prescription for ACA OTC preventive services.

Preventive services recommended by the USPSTF are presently the subject of litigation. For more information see our July 15, 2023 insight, “Court Reinstates ACA’s Preventive Services Mandate.”

Recent developments

Over the last two years, the President Biden has issued four Executive Orders that together direct the Departments to improve access to and affordability of reproductive health services and increase access to OTC contraceptives. Additionally, on July 13, 2023, the FDA announced that it had approved Opill^® (norgestrel), a progestin-only birth control pill, for use in the U.S. as the first daily oral contraceptive available without a prescription.

Challenges with access and costs are among the most common reasons cited by women for not using contraception or having gaps in contraceptive use. Therefore, the availability of a daily OTC oral contraceptive without a prescription by a healthcare provider may improve access and use if the product is affordable and/or covered by insurance without cost sharing.

The Departments state that they are of the view that requiring plans and issuers to cover ACA OTC preventive products without a prescription by a healthcare provider is an important option to consider for expanding access to contraceptive care.

The Departments seek comments

The Departments are interested in input on the benefits, operational challenges or burdens to plans, insurers, third-party administrators, pharmacy benefit managers and retailers if plans and insurers are required to cover, without imposing cost-sharing requirements on the consumer, OTC preventive products purchased without a prescription. The Departments recognize that most plans do not cover ACA OTC preventive products without a prescription at this time. 

The Departments ask about the following specific areas:

• Access to and utilization of OTC preventive products
• Implementation issues
• Health equity
• Economic impacts

The Departments are also interested in lessons learned from providing coverage for and facilitating the provision of OTC COVID-19 diagnostic tests without a prescription during the COVID-19 Public Health Emergency. (For more information, see our February 8, 2022 insight, “New Guidance on Covering Over-the-Counter COVID-19 Tests.”)

As noted above, comments must be received by 5 pm (ET) on December 4, 2023.

Implications for group health plans

Non-grandfathered group health plans must cover without cost sharing any contraceptive services and FDA-approved, cleared or granted contraceptive products that an individual and their attending provider have determined to be medically appropriate for the individual. Coverage must be provided without cost-sharing for at least one form of contraception in each category identified in the current FDA Birth Control Guide. A plan may use medical management techniques within a specified category of contraception, but only if it has an easily accessible, transparent and sufficiently expedient exceptions process that covers a product determined to be medically necessary for an individual. Under current guidance, OTC contraceptive products are generally only required to be covered without cost-sharing if they are FDA-approved and prescribed by a healthcare provider.

Group health plan sponsors should request information from their PBM about how OTC contraceptives, like Opill, are currently covered under the plan. They should also ensure that their PBM has an exceptions process to address medical necessity exceptions.

Plan sponsors may wish to comment on the RFI, particularly with respect to the operational considerations associated with covering an ACA OTC drug with no prescription. Issues could include increased administrative costs in setting up direct coverage of OTC ACA services as well as additional claims procedures for reimbursement. As with the coverage of OTC COVID-19 tests, group health plans would need the ability to take reasonable steps to assure medical management and prevent, detect, and address fraud and abuse. Plan sponsors may also wish to seek a better understanding of which ACA OTC services would be payable without a prescription and how to address when new items are made available. Further information about covering other OTC contraceptive methods may also be helpful.

Plan administrators also would need to coordinate plan coverage of the OTC ACA services with any coverage under flexible spending arrangements (health FSAs) and health reimbursement arrangements (HRAs) to make sure that the ACA OTC products covered under the plan are not also reimbursed under the FSA, HRA or HSA.

Plan sponsors should review all contraceptive coverage generally to assure that it meets ACA requirements. For additional information, see our July 19, 2023 insight, “Executive Order Strengthens Access to Contraception.”