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June 28, 2024
Health Law Weekly

Fifth Circuit Ends Nationwide Injunction of ACA Preventative Services Coverage Requirements for Now

  • June 28, 2024

Certain preventative services coverage requirements under the Affordable Care Act (ACA), including cancer and diabetes screenings and the so-called PrEP (pre-exposure prophylaxis) drugs to prevent HIV, remain in effect for now after the Fifth Circuit found a lower court abused its discretion in by enjoying the federal government from enforcing the mandates nationwide.

The appeals court, however, largely sided with plaintiffs who challenged the mandates, finding that the United States Preventative Services Task Force (PSTF), which issued the disputed coverage recommendations, was unconstitutionally appointed. While upholding the injunction as to the specific challengers, the Fifth Circuit found the district court went too far in vacating the task force’s recommendations and issuing a nationwide injunction because the plaintiffs had not raised a claim under the Administrative Procedure Act (APA) or met the narrow circumstances for granting such broad relief.

Notably, the Fifth Circuit also cast doubt on the preventative service recommendations of two other administrative bodies—the Advisory Committee on Immunization Practices (ACIP) and the Health Resources and Services Administration (HRSA). The lower court had left preventative coverage requirements flowing from ACIP and HRSA in place after determining the Department of Health and Human Services (HHS) Secretary sufficiently ratified their recommendations. But the Fifth Circuit said the district court failed to consider the plaintiffs’ arguments that the ratification was defective under the APA and remanded for further consideration on that issue.

Preventative Coverage Requirements

The ACA requires group health plans and health insurance issuers to provide coverage without cost sharing for four categories of preventative care. The ACA empowers three agencies affiliated with HHS to determine what items and services fall within those four categories: PSTF, ACIP, and HRSA.

PSTF recommended that PrEP drugs to prevent HIV infection be covered under the ACA mandate, as well as a host of other services, including cancer and diabetes screenings.

Christian for-profit corporation Braidwood, which provides health insurance to its roughly 70 employees through a self-insured plan, and other plaintiffs objected to the PrEP drug mandates arguing that compulsory coverage of these services required them to violate their religious beliefs.

Plaintiffs also contended the three agencies were unconstitutional because they violated the Appointments Clause, which requires “principal officers” to be nominated by the President and confirmed by the Senate.

District Court Ruling

The U.S. District Court for the Northern District of Texas rejected plaintiffs’ argument as to the ACIP and HRSA holding their recommendations for preventative services were ratified by the HHS Secretary. The court also found, however, that the Secretary lacked authority to ratify the PSTF’s recommendations. Braidwood Mgmt. Inc. v. Becerra, No. 4:20-cv-00283-O (N.D. Tex. Sept. 7, 2022).

In a follow-up decision on the appropriate remedy, the court enjoined the PSTF-recommended preventative services coverage requirements nationwide. Braidwood Mgmt. Inc. v. Becerra, No. 4:20-cv-00283-O (N.D. Tex. Mar. 30, 2023). The court also determined that the ACA mandate requiring private health insurance to cover drugs to prevent HIV violated the Religious Freedom Restoration Act as to Braidwood. This aspect of the district court’s rulings was not before the Fifth Circuit.

The Fifth Circuit initially issued an administrative stay of the nationwide injunction, and the parties subsequently agreed that the government would not seek statutory penalties or pursue enforcement action against plaintiffs for any violations of the ACA preventative services requirements between the date of the stipulation and the appeals court’s decision. In return, plaintiffs agreed not to challenge the administrative stay of the nationwide injunction.

Fifth Circuit Decision

The appeals court held that the 16-members of the PSTF are “principal officers” of the United States who must be nominated by the President and confirmed by the Senate.

While HHS technically can remove PSTF members at will, the Fifth Circuit concluded that the Secretary lacked statutory authority to oversee the task force’s work, which tipped the scale in favor of finding they were principal, rather than inferior, officers for purposes of the Appointments Clause.

The statutory scheme contemplates that the PSTF operates independently without political pressure. “In our view, the Task Force cannot be ‘independent’ and free from ‘political pressure’ on the one hand, and at the same time be supervised by the HHS Secretary, a political appointee, on the other,” the appeals court concluded.

The appeals court also held the Secretary’s subsequent ratification of the PSTF’s recommendations could not remedy the Appointments Clause defect since he lacked statutory authority to review or revise the task force's work in the first place.

The Fifth Circuit, however, found the district court improperly granted plaintiffs vacatur under the APA and the related universal injunction. Plaintiffs did not assert an APA claim, the appeals court observed. “We do read our precedent . . . to say that one of the minimal requirements to be entitled to this ‘default’ APA remedy is, perhaps unsurprisingly, an APA claim.”

Without a basis to seek vacatur of final agency actions taken to enforce the preventative care mandates, there was no grounds for granting a universal injunction to plaintiffs already provided complete relief, the appeals court determined.

Finally, the appeals court remanded to the district court to consider whether the HHS Secretary properly ratified ACIP and HRSA preventive care mandates. While acknowledging that the Secretary has supervisory authority over ACIP and HRSA, the Fifth Circuit was not convinced the ratification of their recommendations cured the Appointments Clause defects for those two administrative bodies.

“[P]laintiffs put forward compelling and essentially unrebutted arguments that there are serious APA problems with the Secretary’s ratification,” including failing to follow notice-and-comment rulemaking, failure to explain his reasoning, and as improperly retroactive. Those arguments should be considered by the district court in the first instance, the Fifth Circuit concluded.

Braidwood Mgmt., Inc. v. Becerra, No. 23-10326 (5th Cir. June 21, 2024).