Introduction
On October 21, 2024, the Departments of Health and Human Services, Labor, and of the Treasury (collectively, the Departments) released proposed rules with comment period entitled “Enhancing Coverage of Preventive Services Under the Affordable Care Act.” These proposed rules would expand access to coverage of recommended preventive services without cost sharing in the commercial market, with a particular focus on reducing barriers to coverage of contraceptive services, including over-the-counter (OTC) contraceptives.
Background
The Affordable Care Act (ACA) added section 2713 of the Public Health Service Act (PHS Act), which requires non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage (plans and issuers) to provide coverage for certain recommended preventive services without imposing any cost-sharing requirements, such as a copayment, coinsurance, or deductible. These preventive services include (1) certain evidence-based items or services recommended by the United States Preventive Services Task Force; (2) immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention; (3) preventive care and screenings for infants, children, and adolescents recommended by the Health Resources and Services Administration (HRSA); and (4) preventive care and screenings for women as provided for in comprehensive guidelines supported by HRSA.
The Departments’ regulations and guidance under PHS Act section 2713 allow plans and issuers to use reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive service to the extent not specified in the relevant recommendation or guideline, and require plans and issuers subject to PHS Act section 2713 to cover, without cost sharing, items and services that are integral to the furnishing of a recommended preventive service.
Since the ACA was enacted in 2010, the Departments have received ongoing complaints and questions from interested parties regarding issues related to coverage of certain recommended preventive services. In addition, under the Departments’ current guidance, coverage of OTC preventive services without cost sharing is only required when prescribed by a health care provider. In October 2023, the Departments issued a Request for Information (OTC Preventive Products RFI) aimed at gathering input from the public regarding benefits and challenges that would be associated with requiring coverage of OTC preventive products, including contraception, without cost sharing and without a prescription from a provider.
In light of comments to the OTC Preventive Products RFI, ongoing complaints to the Departments and credible reports of widespread failure by plans and issuers to provide coverage of the full range of contraceptive services, as well as recent Executive Orders, and the FDA approval in July 2023 of a progestin-only oral contraceptive as the first daily oral contraceptive available without a prescription by a health care provider, the Departments are now proposing to amend the regulations governing how plans and issuers cover preventive services and how they communicate information about this coverage to participants, beneficiaries, and enrollees.
Summary of Proposed Rules
Exceptions Process for All Recommended Preventive Services
The Departments propose to codify previous guidance on the use of reasonable medical management techniques by plans and issuers. The proposed rules would provide that plans and issuers that utilize reasonable medical management techniques with respect to any recommended preventive services must provide an easily accessible, transparent, and sufficiently expedient exceptions process that allows an individual to receive coverage without cost sharing for the preventive service according to the frequency, method, treatment, or setting that is medically necessary for them, as determined by the individual’s attending provider, even if that service is not generally covered under their plan or coverage. The exceptions process would ensure that an individual can access coverage of medically necessary recommended preventive services without cost sharing and prevents medical management from functioning as an unreasonable barrier to coverage under section 2713 of the PHS Act.
Contraceptive Coverage and Disclosure
These proposed rules would also require plans and issuers to cover recommended OTC contraceptive items without requiring a prescription and without imposing cost-sharing requirements. The Departments’ previously issued guidance provides that OTC preventive health care items (such as folic acid and certain contraceptive products, including contraceptive sponges, spermicides, and emergency contraception) must be covered without cost sharing only when prescribed by a health care provider. However, neither section 2713 of the PHS Act, and its implementing regulations, nor the current HRSA-supported Guidelines require a prescription as a condition of coverage without cost sharing for recommended contraceptives that are available OTC. If finalized, this proposal would better align coverage requirements with the statute and remove barriers, such as prescription requirements and out-of-pocket costs, that make it more difficult for women to access contraception.
The Departments are proposing an incremental approach to OTC coverage of recommended preventive services in this rulemaking, in order to facilitate implementation for plans, issuers, and other interested parties, and allow the Departments to gather additional feedback on challenges and benefits of adopting these proposed policies before considering whether and how to propose similar requirements with respect to other recommended preventive services. The Departments have determined that focusing first on contraception is appropriate due to ongoing and widely reported concerns regarding challenges faced by consumers in accessing contraceptive items and services without cost sharing, as well as recent developments affecting access to reproductive health care.
In addition, the proposed rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost‑sharing requirements, unless at least one therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. For purposes of these proposed rules, the Departments also propose to define the terms “therapeutic equivalent” and “drug-led combination” product, consistent with FDA definitions of these terms.
Finally, these rules would require plans and issuers to add a disclosure to the results of any Transparency in Coverage self-service tool search, for covered contraceptives, that explains that OTC contraceptive items are covered without a prescription and without cost sharing and includes a phone number and internet link to where a participant, beneficiary, or enrollee can learn more information about the plan or policy’s contraception coverage.
These proposed rules would not modify federal conscience protections related to contraceptive coverage for employers, plans, or issuers.
The proposed rules include several comment solicitations aimed at gathering feedback from interested parties. Notably, the Departments seek comment on whether proposals related to coverage of recommended contraceptive items should be extended to other or all recommended preventive services. The Departments anticipate issuing another notice of proposed rulemaking in the near future to address additional issues related to coverage of all preventive services.
Applicability Dates and Comment Period
The Departments propose that the requirement to provide an exceptions process for all recommended preventive services would be applicable on the effective date of the final rules. The Departments propose that the proposals specific to contraceptive coverage (including the OTC contraception coverage proposal, therapeutic equivalence proposal, and transparency in coverage disclosure proposal related to OTC contraceptive coverage information) would be applicable for plan years (or, in the individual market, policy years) beginning on or after January 1, 2026.
Written comments must be received by 60 days after the publication date in the Federal Register to be considered.
To review or comment on the proposed rules during the 60-day public comment period, visit the Federal Register. To review the draft rule, visit CMS.gov.
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