Departments Issue Proposed Rule Expanding Coverage of Birth Control and Other Preventive Services; Comments Due December 27

Published October 21, 2024

The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the departments) have released a proposed rule with guidance and frequently asked questions (FAQs) regarding implementation of certain provisions of the Affordable Care Act (ACA) and the Women’s Health and Cancer Rights Act (WHCRA).

The guidance is a fact sheet on the proposed rules that would expand access to coverage of recommended preventive services without cost sharing and focuses on reducing barriers to coverage of contraceptive services, including over-the-counter (OTC) contraceptives. A summary of the proposed rules, includes:

  • 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 over the counter (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 FAQs in Part 68 provide a series of examples to illustrate the guidance for both plans and issuers to educate network providers on the availability and proper usage of service codes and modifiers to denote when an item or service is furnished as, or integral to the furnishing of, a recommended preventive item or service. The Departments also encourage providers to take steps to ensure that all recommended preventive items or services, including items and services that are integral to the furnishing of a recommended preventive item or service, are appropriately identified as recommended preventive items or services on claims.

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.

Comments are requested by December 27, 2024.

Additional Resources:

News release

White House Fact Sheet

HHS Notice of Request for Public Comments on Draft Recommendations for the HRSA-Supported Women’s Preventive Services Guidelines Relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening