Proposed Tri-Agency Rules Expand Preventive Care Under the ACA

In our previous issue, we discussed guidance impacting health plans and issuers pertaining to preventive care benefits announced by the U.S. Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments). On October 21, 2024, the Departments proposed new rules affecting plans and issuers, similarly expanding coverage requirements of certain preventive care without cost-sharing, including contraceptive care. These proposed regulations implement the Public Health Service Act and corresponding provisions of ERISA and the Internal Revenue Code, as amended by the Affordable Care Act (ACA). 

Of particular note, these proposed rules would require, for the first time, that most group health plans and issuers (non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage) cover over-the-counter (OTC) contraceptives without cost-sharing and without a prescription. The proposed rules also require these plans and issuers to cover all recommended contraceptive drugs and drug-led combination products, unless a therapeutic equivalent is already covered without cost-sharing. The proposed effective date for these requirements is plan/policy years beginning on or after January 1, 2026. 

Additionally, the proposed rules require these plans and issuers to provide "an easily accessible, transparent, and sufficiently expedient exceptions process" for "medical management techniques," allowing for coverage without cost-sharing for a preventive service deemed medically necessary. Medical management techniques are used by plans and issuers "to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service," to the extent not otherwise specified in a relevant recommendation or guideline. See 26 CFR § 54.9815-2713T(a)(4); 29 CFR § 2590.715-2713(a)(4); 45 CFR § 147.130(a)(4). The proposed effective date for the exceptions process requirement is the effective date of the final rules. 

Lastly, the proposed rules would require plans and issuers to provide information related to contraceptive coverage and cost-sharing requirements, including that OTC contraceptives are covered without cost-sharing, in their Transparency in Coverage self-service tool or, if requested by the individual, on paper. This informational requirement would be effective for plan/policy years beginning on or after January 1, 2026. 

These proposed rules would not alter federal conscience protections pertaining to contraceptive coverage. The comment period ends on December 27, 2024. 

Both Parties in Becerra v. Braidwood Ask Supreme Court to Hear ACA Appointments Clause Dispute 

The U.S. Supreme Court may soon take up Becerra v. Braidwood Management Inc., a closely watched case we previously reported on impacting the ACA's preventive services mandate. To briefly recap, on June 21, 2024, a unanimous Fifth Circuit panel affirmed in part and reversed in part a Texas district court's injunction and vacatur of the preventive care recommendations of the U.S. Preventive Services Task Force (PSTF) on the grounds that the appointment of task force members was constitutionally defective because PSTF members are principal officers who have not been appointed by the president with the advice and consent of the Senate. The Fifth Circuit agreed with the district court and the plaintiffs who filed the case that the PSTF members were not properly appointed, but it reversed the national vacatur and injunction, limiting relief to the named plaintiffs. 

On September 19, 2024, the U.S. government filed a petition for certiorari, arguing that the Fifth Circuit erred in holding that the PSTF violates the Appointments Clause and in declining to sever the statutory provision that the court found to protect the PSTF from the HHS Secretary's supervision. On October 24, 2024, the respondents (the original plaintiffs in the case) filed their brief also in support of certiorari, favoring a ruling that the appointment of the PSTF members is unconstitutional. The district court case was stayed pending appeal to the Supreme Court. 

If certiorari is granted, the outcome of the case should provide much needed clarification regarding the fate of the PSTF, perhaps necessitating Congress to act to amend the statutory framework governing the PSTF and the other bodies involved in recommending preventive services to be covered without cost-sharing under the ACA's mandate. See 42 U.S.C. 300gg-13. 

Upcoming Speaking Engagements and Events

Joanne will speak at the American Bar Association 18th Annual Labor and Employment Law Conference on November 16.

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