Policy and Regulation

Roadmap to Affordability — CAI proposed federal action

Contraceptive Access Initiative has called on the Biden Administration and policymakers to advance over-the-counter insurance coverage for contraceptives. Our roadmap to affordability for over-the-counter (OTC) contraceptives includes making changes to private and public plans to ensure coverage, among other changes. 

The U.S. Supreme Court’s June 2022 decision overturning Roe v. Wade has highlighted the urgency for policymakers to not only defend abortion rights but also to defend and expand contraceptive rights and access. One major barrier to contraceptive access for many people in the U.S. has been the out-of-pocket cost of OTC contraceptives, including condoms and Plan B emergency contraception. This barrier is even more pronounced with Opill, the first ever daily oral contraceptive pill (often called the “mini-pill”), now available without a prescription in the U.S. 

The increased access that OTC coverage would provide is consistent with the intent of the Affordable Care Act (ACA) and related regulations, guidance and FAQs that the federal government has issued to implement the ACA. Broadly, under the ACA, plans and issuers are required to cover without cost-sharing the full range of FDA-approved, -cleared or -granted contraceptives. Unfortunately, this coverage requirement has long been interpreted as allowing private health plans to require a prescription, even for products that are sold OTC, in order for that product to be available to the patient without cost-sharing. As a result, tens of millions of U.S. residents who have otherwise comprehensive health insurance coverage for contraceptive care face a cost barrier for OTC contraception, simply because health insurance plans typically require enrollees to obtain a prescription even for contraceptives that are sold OTC. For OTC contraceptives to fully meet their potential, health insurance plans must cover them in full without red tape or requiring a prescription.

Multiple federal, state and private industry actions have advanced policies to cover OTC contraception, marking an emerging and positive trend toward full coverage.


For example:

  • In June 2023, the Biden-Harris White House issued an Executive Order to strengthen access to contraception, including specifically encouraging agencies to provide “guidance to support seamless coverage of over-the-counter contraception.”

  • On September 29, 2023, the U.S. Departments of Health and Human Services, Labor, and the Treasury issued a request for information (RFI) regarding insurance coverage for OTC products, with a public comment period that concluded on Dec. 4, 2023. 

“The goal of the RFI is to understand the potential challenges and benefits for various interested parties, including consumers, plans, issuers, pharmacies, and health care providers, to provide coverage at no cost for recommended OTC preventive products without requiring a prescription. The Departments are committed to ensuring that everyone is able to access affordable and critical preventive items and services, including OTC preventive products.”

  • In 2023, the Indian Health Service added Opill to its National Core Formulary, and in June 2024 ensured its availability through its distribution networks.

  • In July 2022, new ACA guidance urged insurance plans to cover emergency contraception without a prescription, stating: “Plans and issuers are also encouraged to cover OTC emergency contraceptive products with no cost sharing when they are purchased without a prescription.”

  • Already, policies in nine states require some OTC contraceptive coverage in state-regulated private insurance plans and/or Medicaid.

  • Some states have taken other steps to facilitate coverage of Opill with a prescription as “workarounds'' or interim solutions toward true OTC coverage. These actions include facilitating coverage of OTC contraceptives by issuing a state-wide prescription, known as a “standing order,” for specific products for people enrolled in private plans and/or Medicaid (see Massachusetts and Wisconsin as examples) or by granting pharmacists the authority to prescribe certain contraceptives.

The extension of insurance coverage to OTC contraception when obtained without a prescription is widely supported by state and federal policymakers and the medical community. For example:

  • In late-Oct. 2023, dozens of Democratic lawmakers, led by Washington Sen. Patty Murray, signed a letter urging the Biden-Harris administration to require private health insurance plans to fully cover the first over-the-counter birth control pill.

  • In Dec. 2023, Pro-Choice Caucus Contraception and Family Planning Task Force Chair Rep. Judy Chu and Democratic Women’s Caucus Chair Rep. Lois Frankel led 121 House Democrats in publishing a letter urging the Biden-Harris administration to further expand contraceptive access. The letter suggested requiring health insurance plans to fully cover over-the-counter contraceptives at zero cost to the patient and without a prescription. 

  • A Dec. 2023 letter from the Reproductive Freedom Alliance, a coalition of 23 governors, called on the U.S. Health and Human Services Secretary Xavier Becerra and his office to take additional steps to ensure coverage for over-the-counter contraception.

Medical groups such as ACOG, AMA, APHA and others support public and private coverage of over-the-counter contraceptives with no cost-sharing. Additionally, medical groups such as the ACOG, AMA, NFPRHA and more expressed their support for insurance coverage of OTC contraception in the FDA’s Request for Information in Dec. 2023.

The role of pharmacists in providing contraception and/or counseling — as a result of state laws allowing pharmacists to prescribe state-issued Rx “standing orders” for contraception or to provide counseling related to OTC contraception — is growing as additional pathways for contraceptive access and coverage are secured. In addition, as plans increase coverage of OTC contraception, either voluntarily or as the result of new coverage mandates, the pharmacy counter becomes an obvious location for consumers to obtain coverage of OTC contraception at the point of sale. These and other changes create an urgent need to address the role and challenges of pharmacists, pharmacy counters and pharmacy stores in the provision of contraception.


In Feb. 2024, the Contraceptive Access Initiative and the American Pharmacist Association hosted a convening, the "Accessible Consumer Choices: Shaping the Future of Contraceptive Care at Pharmacies Summit," attended by the Gender Policy Council and the Department of Health and Human Services, industry leaders, advocates and other stakeholders. The summit explored strategies to expand the role of pharmacies and pharmacists in promoting access to contraception and breaking down barriers for consumers. Read the report, published in Sept. 2024, that emerged from the summit.

Because of the fragmented nature of health insurance plans in the U.S., coverage requirements for various types of plans fall under a wide array of agencies and regulatory bodies. Multiple federal agencies will need to continue exercising their respective authorities to ensure that people under various plans have coverage for OTC contraceptives. As reflected in CAI’s comments to the Biden-Harris Administration’s RFI on coverage of OTC contraception, 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; 

  • 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.

See additional content from CAI’s White Paper on OTC Contraceptive Coverage here, as well as specific information on the following federal programs:

Additional information can be found here about implementing coverage of over-the-counter contraceptives