FDA Approves First Over-the-Counter Daily Oral Contraceptive
On July 13, 2023, the U.S. Food and Drug Administration (FDA) announced that it approved the first nonprescription daily oral contraceptive to prevent pregnancy. This drug is expected to become available to consumers without a prescription from stores and online retailers in early 2024.
Insurance Coverage
The Affordable Care Act (ACA) requires most group health plans and health insurance issuers to provide first-dollar coverage of certain specified preventive services for women, including all FDA-approved contraceptives, as prescribed by a health care 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
Individuals can pay for over-the-counter medicines, including contraceptives, using their health savings accounts (HSAs). Health flexible spending accounts (FSAs) and health reimbursement arrangements (HRAs) may 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.
Draft Forms for 2023 ACA Reporting Released
The IRS has released draft 2023 forms for reporting under Internal Revenue Code Sections 6055 and 6056. Draft instructions for these forms have not yet been released.
- 2023 draft Forms 1094-B and 1095-B are drafts of the forms used by providers of minimum essential coverage, including self-insured plan sponsors that are not applicable large employers (ALEs), to report under Section 6055.
- 2023 draft Forms 1094-C and 1095-C are drafts of forms ALEs use to report under Section 6056 and for combined Section 6055 and 6056 reporting by ALEs who sponsor self-insured plans.
No major substantive changes were made to the draft forms for 2023 reporting. However, certain changes may be made once these forms are finalized or when draft or final instructions are released.