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September 06, 2023

District Court Enjoins Agency Implementation of U.S. Preventive Services Task Force Recommendations, But Decision is Stayed Pending Appeal

Richard S. Siegel, Slevin & Hart, P.C.

On March 30, 2023, in Braidwood Management Inc. v. Becerra, the U.S. District Court for the Northern District of Texas blocked all agency actions to implement or enforce preventive care coverage requirements resulting from recommendations made by the U.S. Preventive Services Task Force (“USPSTF”) on or after March 23, 2010, and enjoined future agency action to implement or enforce USPSTF recommendations. However, the District Court’s nationwide injunction has been stayed pending appeal by the U.S. Court of Appeals for the Fifth Circuit. Additionally, prior to the Fifth Circuit staying the District Court’s nationwide injunction, the Departments of Labor, Health and Human Services (“HHS”) and Treasury (collectively, the “Departments”) published guidance to address open questions resulting from the Braidwood decision.

The Braidwood case was brought by individuals and businesses who challenged preventive care mandates implemented by the Affordable Care Act (“ACA”) as violating the U.S. Constitution and the Religious Freedom Restoration Act (“RFRA”). The plaintiffs argued that the recommendations issued by the USPSTF, as well as recommendations by the Health Resource and Services Administration (“HRSA”) and the Advisory Committee on Immunization Practices (“ACIP”), violated the Constitution’s Appointments Clause because their members were not appointed by the President with the advice and consent of the Senate. Certain plaintiffs also sued on religious grounds, objecting to being required to provide or pay for certain preventive coverage, including certain preexposure prophylaxis (“PrEP”) drugs that help reduce the risk of HIV infection. Other plaintiffs objected on non-religious grounds to being required to purchase health insurance for preventive care they claim to neither want nor need.

In September 2022, the District Court previously ruled that because USPSTF’s recommendations had the force and effect of law under the ACA but its members are appointed by the Director for the Agency for Healthcare Research and Quality, its appointment procedures violated the Constitution’s Appointments Clause. However, the District Court rejected challenges against HRSA and ACIP recommendations because, unlike USPSTF, the recommendations made by HRSA and ACIP were subject to ratification by the HHS Secretary, whose appointment complies with the Appointments Clause.

In its March 30, 2023, decision, the District Court concluded that, rather than severing the ACA’s provisions that were found to violate the Appointments Clause, the appropriate remedy was to vacate all agency actions implementing USPSTF’s recommendations issued on or after March 23, 2010 and enjoining agencies from implementing USPSTF recommendations in the future. In addition to PrEP drugs, USPSTF recommendations include a wide variety of preventive care treatment, including cancer, diabetes and heart disease screening.

In both its September 2022 and March 2023 rulings, the District Court also ruled that requiring religious objectors to pay for PrEP drugs violated the RFRA, concluding the government had not demonstrated a compelling interest in requiring religious objectors to pay for such coverage or that a mandate was the least restrictive means that the government could further a compelling interest.

On April 6, 2023, the government filed a notice of appeal of the District Court’s decision. On April 12, 2023, the government filed a motion asking the District Court to stay its nationwide injunction.

On April 13, 2023, the Departments answered a series of frequently asked questions resulting from the Braidwood decision. The FAQs make clear that the Braidwood decision does not affect USPSTF recommendations made prior to March 23, 2010. The FAQs further make clear that the Braidwood decision does not prevent plans from continuing to provide coverage for USPSTF recommendations made on or after March 23, 2010, and the Departments recommended that plans continue to do so. The FAQs provide that the Braidwood decision did not impact (a) recommendations made by HRSA and/or ACIP, (b) state laws requiring insurers to provide coverage for USPSTF recommendations (although such state laws would be preempted by ERISA for self-insured plans), and (c) whether high deductible health plans may continue to provide coverage for USPSTF recommendations, regardless of cost-sharing. Finally, the FAQs remind plans about their obligations to provide notice to participants and beneficiaries of any material reduction in covered services or benefits, including that if the removal of any USPSTF recommendations resulted in a discontinuation or change to cost-sharing to benefits described in a plan’s Summary of Benefits and Coverage, then 60-days’ advanced notice must be provided. The FAQs indicate that the Departments anticipated providing additional guidance with respect to USPSTF recommendations prior to March 23, 2010. To date, the Departments have not issued further guidance; it is unclear if they intend to do so in light of the stay of the court proceedings.

With its motion to stay in the District Court still pending, on April 27, 2023, the government filed a motion in the U.S. Court of Appeals for the Fifth Circuit to stay the District Court’s nationwide injunction pending appeal and for an administrative stay until the motion to stay could be decided on the merits. On May 15, 2023, the Fifth Circuit granted an administrative stay[2] and subsequently scheduled oral argument on the merits of the motion to stay for June 6, 2023, on which date argument was heard. However, before the motion to stay was decided, and with the administrative stay still in place, on June 12, 2023, the parties filed a stipulation resolving issues relating to enforcement while the appeal was pending, including agreeing to stay the nationwide injunction pending appeal. On June 13, 2023, the Fifth Circuit approved the stipulation and fully stayed the District Court’s nationwide injunction pending resolution of the appeal Briefing on the merits of the case in the Fifth Circuit has begun, including that the government and its supporting amici have already filed their opening briefs. Briefing on the appeal is scheduled to be completed by November 3, 2023.

    Richard S. Siegel

    Associate, Slevin & Hart

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