Prevention is at the heart of the Affordable Care Act (ACA). The word prevention appears 233 times in the law; the word preventive 108 times. Section 2713, a key insurance reform provision, requires that all nongrandfathered health insurance and group health plans cover certain preventive services (such as flu shots and diabetes screening) without cost sharing. Studies have shown an increase in the use of preventive services since the law was enacted and a reduction in racial and ethnic disparities in the use of preventive care. Section 2713 is now being challenged by lawsuits, claiming it is unconstitutional. This post analyzes these claims.

Defining Preventive Services

In drafting the ACA, Congress sought to ensure that enrollees would be covered for preventive care. Congress also recognized that it would need expert assistance to scientifically identify effective preventive services. It turned to three entities with a proven track record. First, it asked the U.S. Preventive Services Task Force (PSFT), a congressionally established private body of experts, which has been in existence for nearly 40 years, to identify highly rated “evidence-based” preventive services. Second, it designated the Advisory Committee on Immunization Practices (ACIP), another private entity with more than a half century’s experience, to identify appropriate vaccines, subject to approval by the Centers of Disease Control and Prevention (CDC). Lastly, it chose the Health Resources and Services Administration (HRSA) to recommend preventive services and screenings for children and women.

The Constitutional Challenges

The constitutionality of Section 2713 is being attacked by plaintiffs who oppose the coverage of contraceptives and preexposure prophylaxis (a medication that prevents HIV) on religious or other grounds. In Leal v. Becerra, a federal district court rejected a claim by the plaintiffs that 2713 unconstitutionally delegates to HRSA the power to adopt legal requirements binding on private parties, a power the Constitution vests in Congress. The plaintiffs have appealed this decision to the Fifth Circuit. In Kelley v. Becerra, a different federal court refused to dismiss similar claims that Section 2713 unconstitutionally delegates legislative authority to the PSTF, ACIP, and HRSA. Kelley also refused to dismiss claims that 2713 unconstitutionally gives decision-making power to officials not appointed by either the president or the heads of federal departments without Senate confirmation.

The Nondelegation Doctrine

Article I of the Constitution vests all legislative authority in Congress. But Congress lacks the scientific expertise and resources to make all the detailed regulatory decisions of the federal government. The Supreme Court has long held, therefore, that Congress may delegate authority if it provides an “intelligible principle” to guide discretion. The Court has interpreted this requirement liberally, and for more than 85 years has not invalidated a statute for not meeting it. A recent dissenting opinion by three justices, and another separate opinion by Judge Kavanaugh in another case have indicated, however, that some justices are seeking to limit Congress’s ability to confer policy discretion on administrative agencies.

Section 2713 should readily survive a nondelegation challenge under either long-standing case law or any revised test the Supreme Court might develop. It specifies the entities that must identify preventive services, the target population for the services, the nature of the services, and the methodology for developing recommendations. Congress was familiar with and endorsed the agencies’ methodologies. Congress made the major policy decision — to cover evidence-based preventive services without cost sharing — with the agencies filling in the details.

The Appointments Clause

Article II of the Constitution vests the executive authority of the United States in the president but allows executive authority to be exercised by officers nominated by the president and confirmed by the Senate or by other “inferior officers,” as designated by law to be appointed by the president or heads of departments. This is known as the “Appointments Clause.”

Some commentators believe that the preventive services mandate may violate the Appointments Clause. However, the director of HRSA is appointed by the president, as is the director of the CDC, which must approve immunization recommendations made by ACIP. The members of ACIP are appointed by the Secretary of Health and Human Services (HHS); and the PSTF is convened by the Agency for Healthcare Research and Quality. Neither the directors of HRSA nor the CDC nor the members of ACIP or the PSTF must be confirmed by the Senate. As such, they are “inferior” officers whose work must be “directed and supervised at some level” by nominated and confirmed officers.

None of these entities directly require the coverage of particular services; instead, that obligation is imposed by the Secretary of HHS or other Senate-confirmed officials. In considering a challenge to the authority of HHS (and other agencies) to craft religious exemptions, the Supreme Court endorsed the government’s argument that the role of the departments of HHS, Treasury, and Labor “as the administering agencies permits them to guide HRSA by defining the scope of permissible exemptions and accommodations for such guidelines.” The authority of the Secretary to instruct HRSA should resolve any Appointments Clause difficulty. The same logic also would apply to ACIP and the PSTF, which are appointed by the Secretary or officials answerable to the HHS Secretary.

Moreover, are the members of ACIP and the PSTF federal “officers”? An officer must be “invested by legal authority with a portion of the sovereign powers of the federal government.” ACIP and the PSTF do not exercise federal sovereign powers. Rather, they make recommendations based on scientific evidence, which are implemented and enforced by nominated and confirmed officers. If their standards are unconstitutional, so arguably are thousands of other scientific standards formulated by other private entities and adopted into federal law.

The importance of 2713’s dynamic and flexible approach is reinforced by our current COVID experience. When Congress adopted Section 3203 of the CARES Act in 2020 to ensure rapid coverage without cost sharing of COVID-related preventive services and vaccines then under development, it turned to ACIP and the PSTF for assistance, building on the foundation of 2713. If the Leal and Kelley challenges succeed, all preventive services coverage, including those for COVID, are at risk. Many other regulatory requirements where the law depends on technical or scientific standards would be as well.