May 11, 2023

Under the ACA and implementing regulations, most group health plans are required to cover certain preventive services without cost-sharing to participants. These preventive services include those with an “A” or B” rating from the U.S. Preventive Services Task Force (USPSTF), as well as preventive services in the Health Resources and Services Administration’s (HRSA) Women’s Preventive Services Guidelines and immunizations recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).

The plaintiffs in Braidwood challenged the ACA’s preventive services coverage mandate on several grounds, including that (i) the appointment of the USPSTF, ACIP, and HRSA violated the Constitution’s “Appointments” clause and “Vesting” clause, (ii) these bodies’ recommendations impermissibly violated the “nondelegation doctrine,” and (iii) the specific requirement to cover preexposure prophylaxis (PrEP) for HIV prevention violated the plaintiffs’ rights under the Religious Freedom Restoration Act (RFRA).

On September 7, 2022, the U.S. District Court for the Northern District of Texas issued an initial ruling partly in favor of the plaintiffs and partly in favor of the federal government. The court dismissed the plaintiffs’ claims about the ACIP and HRSA, the constitutionality claims pertaining to the “Vesting” clause, and the nondelegation claims. However, the court held that the appointment of the USPSTF violated the “Appointments” clause of the Constitution because the members of the task force were not properly appointed. Business Group on Health reviewed this initial ruling during our September 2022 Regulatory & Compliance webinar.

On March 30, 2023, the district court judge issued an order for the remedy in Braidwood. The order immediately blocked the requirement nationwide that applicable plans and health insurance issuers cover preventive services recommended or updated by the USPSTF on or after March 23, 2010. The federal government has appealed this decision to the 5th Circuit Court of Appeals requesting a stay of the nationwide impact.

Following the district court’s order, the Business Group and other stakeholders sent a letter to the Department of the Treasury and Internal Revenue Service (Treasury/IRS) requesting guidance that would preserve high-deductible health plan (HDHP) status for plans that continued to cover preventive services on a pre-deductible basis. Treasury/IRS, in-turn, included such guidance, among others, in FAQ 59.

FAQs Part 59

The Departments issued FAQs Part 59 to answer stakeholder questions about the nationwide implications of the district court’s order, including relating to the HDHP considerations raised by the Business Group.

Coverage of USPSTF Recommended Services

Although the Departments note that the Braidwood order prevents the agencies from implementing and enforcing the coverage requirement for USPSTF “A” and “B” rated services on or after March 23, 2010, plans and issuers must continue to cover, without cost sharing, items and service recommended prior to March 23, 1010. The Departments note in FAQs Part 59 that the court’s order does not preclude plans and issuers from continuing to cover all “A” and “B” rated services without cost-sharing, and the Departments encourage the continuation of the full extent of preventive coverage. The FAQs also remind plans and issuers that HRSA and ACIP recommended services are not impacted by the Braidwood decision.

The Departments remind plans and issuers that the Braidwood decision does not require any changes to their preventive care coverage or cost-sharing, and that plans and issuers considering changes should consider other applicable federal and state laws, as well as other legal or contractual requirements (e.g., collective bargaining agreements).

The FAQs also remind plans and issuers that applicable notice requirements apply when making changes to the terms of coverage with respect to USPSTF recommended items and services, such as Summary of Benefits and Coverage (SBC), Summary of Material Modification (SMM), and/or Summary Plan Description (SPD) updates.

HDHP Safe Harbor for Preventive Care

As requested by the Business Group, FAQs Part 59 provides a temporary allowance for HDHP plans continuing to cover preventive care. The Departments confirm that a group health plan will not lose HDHP status because the plan covers USPSTF “A” and “B” rated preventive services prior to the satisfaction of the minimum annual deductible.

Coverage of COVID-19 Vaccines

The FAQs note that since the USPSTF does not recommend any qualifying coronavirus services as defined by Section 32023 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act and implementing regulations - these are recommended by the ACIP – the Braidwood decision has no impact on this requirement. Applicable plans and issuers must continue to cover COVID-19 vaccines and their administration at no cost to participants, in accordance with other guidance previously provided by the Departments in FAQs Part 58. For additional information about COVID-19-related services following the termination of the COVID-19 national emergency and public health emergency declarations, see our article FAQs Part 58.

Resources

• FAQs Part 59
• USPSTF: List of “A” and “B” Recommendations
• ACIP: Vaccine Recommendations and Guidelines
• HRSA: Women’s Preventive Services Guidelines
• Business Group on Health: Regulatory & Compliance Update, April 2023
• Business Group on Health: Regulatory & Compliance Update, September 2022

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Articles & Guides Affordable Care Act (ACA) Compliance