Supreme Court affirms constitutionality of U.S. Preventive Services Task Force

Case history and legal background

The USPSTF was formed in 1984 to provide the government with evidence-based recommendations regarding preventive healthcare services.² The Task Force reviews preventive services and grades their “effectiveness, appropriateness, and cost-effectiveness” on a letter-grade scale of “A” through “D,” with the USPSTF recommending the provision of services with an “A” or “B” grade.³ Before 2010, these grades were informational, but, with the passage of the ACA, non-grandfathered health insurers are required to provide coverage without cost-sharing for preventive services that receive an “A” or “B” grade.⁴ The USPSTF recommended grades are also important for the Medicare “additional preventive services” benefit, as a preventive service must receive an “A” or “B” grade for the service to qualify for Medicare coverage under this benefit.⁵

Braidwood Management and other plaintiffs challenged the USPSTF's ability to issue these binding recommendations under the ACA.⁶ They principally objected to the requirement that they provide coverage without cost-sharing for HIV pre-exposure prophylaxis (PrEP), to which the USPSTF has given an “A” grade.⁷ Although the plaintiffs attacked the USPSTF on various constitutional and statutory grounds, both the Fifth Circuit and Supreme Court focused on the plaintiffs' argument that the appointment of USPSTF members violated the Appointments Clause of the U.S. Constitution – which requires “principal officers” to be appointed by the President with advice and consent of the Senate but permits others, such as cabinet secretaries, to appoint “inferior officers.”⁸

USPSTF members are inferior officers

The Court held that USPSTF members are “inferior officers” that need not be nominated by the President and confirmed by the Senate because they are “directed and supervised” by a principal officer – namely, the Secretary.⁸ The Court's analysis hinged on two key conclusions about the scope of the Secretary's authority to direct and supervise Task Force Members.

First, the Court held that – although no statute explicitly grants the Secretary removal authority – the Secretary's authority to appoint USPSTF members comes with a “presumed” authority to remove Task Force members "at will".¹⁰ The Court further explained that "at will" removal power also gives the Secretary de facto ability to reject USPSTF recommendations, since the Secretary could delay the implementation of a USPSTF recommendation, reconstitute the USPSTF through at-will removal, and encourage the reconstituted board to withdraw a recommendation.¹¹

Second, the Court also held that the Secretary could review and approve or block USPSTF recommendations.¹² Although the Secretary has yet to establish such a formal approval process, the Court explained that various statutory mechanisms give the Secretary the ability to require prior Secretarial approval of all Task Force recommendations.¹³

Impact

The immediate implication of the Court's decision is that all non-grandfathered health insurers must continue providing no-cost coverage for preventive services receiving an “A” or “B” grade from the USPSTF. Further, though not directly at issue in the case, the continued viability of the USPSTF allows preventive services to continue to come within the Medicare additional preventive services benefit if they receive a sufficient grade. Likewise, though not at issue in the case, other legally binding effects of the USPSTF's recommendations will remain intact, such as flexibilities under the healthcare fraud and abuse laws afforded to providers of services identified in the USPSTF's Guide to Clinical Preventive Services.¹⁴

Although the decision preserves the use of USPSTF's recommendations to determine which services must be provided without out-of-pocket costs, it may further open the door to future political influence over those recommendations. As the Supreme Court itself noted, "at will" removal authority means that the Secretary could remove all USPSTF members and appoint new members who were willing to do as he instructs. In addition, the Secretary could move forward with adopting a formal process for requiring Secretarial pre-approval of all USPSTF recommendations – though, for the time being, USPSTF recommendations will continue to take effect automatically following a defined implementation period, unless and until the Secretary adopts such a process. With the Secretary having recently removed all of the members of the Advisory Committee on Immunization Practices (ACIP) and replaced them with individuals seemingly more aligned with the views of the Secretary, the blueprint for political influence over governmental committees was established prior to the Court's decision in Braidwood. The Court's decision nonetheless may embolden such action.

The Court's decision also has potential implications for healthcare companies beyond the USPSTF. As the Court's latest statement of Appointments Clause doctrine, the decision may indirectly affect ongoing litigation regarding the constitutionality of False Claims Act (FCA) qui tam enforcement mechanism. Three Justices have previously expressed skepticism regarding the constitutionality of the FCA's qui tam mechanism,¹⁵ and a Florida district court recently became the first to hold the FCA's qui tam mechanism unconstitutional under the Appointments Clause because a qui tam relator arguably wields executive power to enforce public law without close supervision of a department head.¹⁶ See our thoughts on these cases online here.

Conclusion

Hogan Lovells will continue to monitor developments in response to this decision and provide updates to clients. If you have any questions about this decision or the USPSTF, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you work.

Authored by James Huang, Stuart Langbein, Maura Calsyn, Victoria Wallace, Beth Halpern, Beth Roberts, Mike Dohmann, and Joe Liss.