FDA Approves First Non-Prescription Daily Oral Contraceptive

HIGHLIGHTS

• The FDA has approved the first over-the-counter birth control pill, called Opill.
• Opill is expected to become available in stores and online in early 2024.
• The ACA requires most health plans and issuers to cover FDA-approved contraceptives without cost sharing when prescribed by a health care provider. This coverage mandate does not apply to nonprescription birth control pills.
• However, consumers may be able to use their HSAs, health FSAs and HRAs to pay for over-the-counter medicines, including contraceptives.

On July 13, 2023, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter daily oral contraceptive to prevent pregnancy. Approval of this drug, named Opill, will allow consumers to purchase non-prescription oral contraceptive medicine without needing to see a health care provider first.

According to the FDA, nearly half of the 6.1 million pregnancies in the United States each year are unintended. The availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.

Opill was originally approved for prescription use by the FDA in 1973. It is expected to become available to consumers without a prescription from stores and online retailers in early 2024. Other FDA-approved oral contraceptives will remain available with a prescription.

Insurance Coverage for Contraceptives

The out-of-pocket costs to consumers for nonprescription oral contraceptives depend on the drug manufacturer’s pricing and availability of insurance coverage.

The Affordable Care Act (ACA) requires most group health plans and health insurance issuers to provide coverage of certain specified preventive services for women, including all FDA-approved contraceptives, as prescribed by a health care provider. This coverage cannot be subject to any cost-sharing requirements, such as a copayment, coinsurance or deductible, when items or services are provided by an in-network provider.

The ACA’s contraceptive coverage mandate does not cover over-the-counter oral contraceptives that are obtained without a prescription. It is possible that the Biden administration or Congress will take action to expand insurance coverage of over-the-counter oral contraceptives. In the meantime, employers should review the terms of their health coverage to determine the scope of their plan’s coverage of contraceptives.

HSAs, Health FSAs and HRAs

Due to a law change made by the Coronavirus Aid, Relief and Economic Security Act (CARES Act), individuals can now pay for over-the-counter medicines, including contraceptives, using their health savings accounts (HSAs). The CARES Act also allows health flexible spending accounts (FSAs) and health reimbursement arrangements (HRAs) to be designed to reimburse all over-the-counter drugs. Thus, although the ACA does not require health plans to cover nonprescription oral contraceptives without cost sharing, consumers may be able to use their HSAs, health FSAs or HRAs to pay for this medication.