Proposed Rules to Enhance Preventive Services Coverage Under the Affordable Care Act

On October 21, 2024, the Departments of Health and Human Services, Labor, and Treasury proposed new rules titled “Enhancing Coverage of Preventive Services Under the Affordable Care Act.” These rules aim to improve access to cost-free preventive services in the commercial market, focusing on reducing barriers to contraceptive coverage, including over-the-counter options.

Background

The Affordable Care Act (ACA) introduced section 2713 of the Public Health Service Act (PHS Act), requiring non-grandfathered group health plans and insurers to cover specific recommended preventive services without cost-sharing. These services include:

• Evidence-based items or services recommended by the United States Preventive Services Task Force.
• Immunizations recommended by the Advisory Committee on Immunization Practices of the CDC.
• Preventive care and screenings for infants, children, and adolescents are recommended by the Health Resources and Services Administration (HRSA).
• Preventive care and screenings for women are outlined in HRSA-supported guidelines.

The Departments’ regulations under PHS Act section 2713 allow plans and issuers to apply reasonable medical management techniques to determine the coverage of preventive services not specifically outlined in guidelines. They must cover, without cost sharing, essential items and services for recommended preventive services.

Since the ACA’s enactment in 2010, the Departments have received many complaints regarding coverage of certain preventive services. Currently, OTC preventive services are covered without cost-sharing only when prescribed by a healthcare provider. In October 2023, the Departments sought public input on requiring OTC preventive products, including contraception, to be covered without a prescription.

In response to RFI feedback, ongoing complaints, reports of inadequate contraceptive coverage, recent Executive Orders, and the FDA’s July 2023 approval of a prescription-free progestin-only oral contraceptive. Further, the Departments are proposing amendments to regulations on preventive service coverage and communication to participants and enrollees.

Summary of Proposed Rules

Exceptions Process for All Recommended Preventive Services

The Departments plan to formalize existing guidance on how plans and issuers can use reasonable medical management techniques. The proposed rules would require these plans to create a clear and easy exceptions process. This process would allow individuals to get coverage without cost sharing for preventive services that their healthcare provider determines are necessary. This applies even if the services are not typically included in their health plan’s coverage. This ensures that medical management does not create unfair barriers to accessing preventive services under section 2713 of the PHS Act.

Contraceptive Coverage and Disclosure

The proposed rules would require plans and issuers to cover recommended over-the-counter (OTC) contraceptive items without needing a prescription and without cost-sharing. Currently, the guidance states that OTC preventive health items, like folic acid and some contraceptives, must be covered without cost only when prescribed by a healthcare provider. However, section 2713 of the PHS Act and current HRSA-supported Guidelines do not require a prescription for OTC contraceptives to be covered without cost sharing. Should this proposal be implemented, coverage will comply with the law; prescription needs and out-of-pocket expenses will have been removed to increase access to contraceptives among women.

To facilitate implementation and to gather feedback on these policies, the Departments propose a staged approach for addressing recommended preventive service OTC medications, beginning with contraception. This focus responds to the ongoing debates regarding consumer out-of-pocket expenses for contraceptive items and services.

The proposed rules would require plans and issuers to cover certain recommended contraceptive drugs and drug-led combination products without cost-sharing unless at least one therapeutic equivalent is already covered without cost. The Departments will also define “therapeutic equivalent” and “drug-led combination” products according to FDA standards.

The proposed rules would require plans and issuers to include a disclosure in the results of any transparency in coverage self-service tool, stating that over-the-counter (OTC) contraceptive items are covered without a prescription and without cost sharing. This disclosure would also give out a phone number and a website link where participants can find out more about the contraception coverage in their plan.

Such rules would not alter the federal conscience protection of contraceptive coverage for employers, plans, or issuers. The Departments have asked for views on whether the contraceptive coverage proposals should apply to other preventive services as recommended. They intend to shortly float a new NPRM to specifically deal with other aspects of coverage of all preventive services.

Applicability Dates and Comment Period

The Departments propose that the requirement to provide an exception process for all recommended preventive services will take effect when the final rules are published. The specific proposals related to contraceptive coverage—including the OTC contraception coverage, therapeutic equivalence, and transparency in coverage disclosures—would apply to plan years (or policy years in the individual market) starting on or after January 1, 2026.

To be considered, written comments must be submitted within 60 days of the publication date in the Federal Register. For more information on the proposed rules, visit the Federal Register.