Coverage of Over-the-Counter Oral Contraceptives: Overview of Federal Programs
Over-the-counter (OTC) availability of a Food and Drug Administration (FDA)-approved oral contraceptive could be an important option for addressing logistical obstacles to contraceptive access and consistent use. However, for an OTC oral contraceptive to meet its potential, federal agencies must ensure that it is fully covered by health insurance plans, and that all OTC contraceptives (emergency contraception, condoms, FDA-approved oral contraceptive pills, etc.) are covered without cost-sharing and without the need for a prescription.
Recommendations for OTC Contraceptive Coverage
Because health coverage in the United States falls under a wide array of regulatory regimes, multiple federal agencies will need to exercise their respective authorities to ensure that people under various plans have coverage for OTC contraceptives. Doing so would be in line with President Biden’s June 2023 executive order that directed the Secretaries of Labor, Health and Human Services, and the Treasury to consider actions “to promote increased access to affordable over-the-counter contraception.” Specifically, agencies may need to take one or more discrete steps to:
Cover a newly approved OTC oral contraceptive (for example, adding it to a coverage requirement and/or a formulary);
Eliminate any otherwise-required cost-sharing for OTC contraceptives, including an OTC oral contraceptive;
Eliminate any prescription requirement for OTC contraceptive coverage, including an OTC oral contraceptive;
Work with stakeholders such as providers, pharmacy chains, and health plans to make OTC coverage work as smoothly as possible at pharmacies and via mail order; and
Provide notice to beneficiaries, providers, and other stakeholders about any changes to coverage, as well as information about how to navigate and facilitate coverage of OTC contraceptives without prescription.
The table below summarizes the wide range of federally regulated health plans and the regulatory authorities that federal agencies will need to exercise to require or expand OTC contraceptive coverage. The table also includes links to resources from the Contraceptive Access Initiative (CAI) with additional details on specific programs and recommended federal actions. These resources include a white paper detailing necessary updates to the Affordable Care Act’s contraceptive coverage requirements and a series of short papers addressing six additional federal health coverage programs that are not subject to the ACA requirement.
In a couple of cases, federal agencies may not have the authority to actually require coverage of OTC contraceptives, but federal agencies can still encourage and facilitate it.
Federal Authority Beyond Health Coverage
This summary and the resources attached focus on health coverage. However, two of the programs described (run by the Department of Defense and the Department of Veterans Affairs) also include a direct services component, under which federal facilities provide health care, including contraception, to eligible recipients. For these programs, the papers also include recommendations about stocking and dispensing OTC contraceptives at these facilities.
The CAI resources do not address federal programs that are primarily or exclusively about the direct provision of health services (such as the Indian Health Service or health facilities run by federal prisons and detention centers), or federal programs that support non-federal facilities (such as the Title X family planning program or the Section 330 Health Centers program). These types of direct services programs are important for ensuring access to OTC contraceptives and other critical services, especially for people without health coverage or with limited coverage.
The Administration should also consider establishing a new program to ensure coverage or access for uninsured and underinsured people. For example, the proposed Individual Contraceptive Arrangement (a part of proposed rules from February 2023 on the ACA’s contraceptive coverage requirement) could be expanded to include anyone without comprehensive contraceptive coverage (as suggested by numerous expert organizations, including CAI).
