Federal District Court Ruling May Jeopardize Insurance Coverage of More Than 50 Recommended Procedures, Screenings, and Treatments

Regulatory Background

Under the Affordable Care Act, group health plans and health insurance issuers are required to provide health insurance coverage based on recommendations made by healthcare coverage professionals. The covered categories include: 

1. Evidence-based items or services that have a rating of “A” or “B” in the current recommendations of the USPSTF;
2. Immunizations that have a recommendation from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC);
3. Evidence-informed preventive care and screenings for infants, children, and adolescents, as provided for in comprehensive guidelines supported by the Health Resources and Services Administration (HRSA); and
4.  To the extent not already covered by the USPSTF recommendations in the first category, preventive care and screenings for women as provided for in comprehensive HRSA guidelines.

The USPSTF consists of independent volunteer members serving four-year terms who have expertise in making healthcare coverage recommendations. 42 U.S.C. § 300gg-13. By law, the USPSTF must be “independent and, to the extent practicable, not subject to political pressure.” Id. § 299b-4(a)(6). An official of the U.S. Department of Health and Human Services (HHS), the director of the Agency for Healthcare Research and Quality, has the power to convene the USPSTF, but neither the director nor the HHS secretary has the ability to revise the USPSTF’s recommendations.

ACIP is similarly an advisory body, but it reports to the CDC director and has no statutory mandate of independence. HRSA is an agency within HHS.

Case Background

The plaintiffs in the case consisted of two businesses and six individuals who were either responsible for providing health insurance coverage for others, or were looking to obtain coverage for themselves. The plaintiffs challenged three coverage requirements based on recommendations by the USPSTF, ACIP, and HRSA: (1) a mandate to cover PrEP for individuals with a high risk of contracting HIV, based on the USPSTF’s recommendation; (2) a mandate to cover the HPV vaccine for all children ages 11 to 12 (and catch-up doses for older populations), as recommended by ACIP; and (3) a mandate to cover contraception for all women with reproductive capacity, as recommended by HRSA.

Judge O’Connor ruled in the government’s favor on the challenges to ACIP and HRSA, upholding the HPV vaccine and contraceptive mandates. As to the USPSTF, however, Judge O’Connor ruled in favor of the plaintiffs, holding that the structure of the USPTSF violates the Appointments Clause of the Federal Constitution, because the USPSTF’s members exercise authority as “officers of the United States” but were not appointed under the constitutionally required process. Judge O’Connor reasoned that the USPSTF’s members are “officers” of the United States because (1) they have regular responsibilities — reviewing research, updating recommendations, and reporting to Congress and federal agencies; and (2) despite being called “recommendations,” the USPSTF’s guidelines have significant legal force, as they determine the scope of health insurance coverage. Judge O’Connor further reasoned that the USPSTF members are “principal” officers, who must be appointed by the President and confirmed by the Senate. But Judge O’Connor noted that even if the USPSTF members qualified as “inferior” officers, their method of appointment would still be impermissible. Finally, in light of the USPSTF’s political independence requirements, Judge O’Connor determined that the HHS secretary could not “fix” the Appointments Clause issue by ratifying the USPSTF’s recommendations after the fact, as the HHS secretary had done with the recommendations by ACIP and HRSA.

Separately, Judge O’Connor also held that the PrEP mandate substantially burdened the plaintiffs’ exercise of their religious beliefs, thus violating the Religious Freedom Restoration Act. He concluded that, whatever the overall benefits of PrEP, the government failed to show it had a “compelling interest in forcing private, religious corporations to cover PrEP drugs with no cost-sharing and no religious exemptions.”

Judge O’Connor has not yet decided what remedies are appropriate in light of his rulings on the USPSTF and PrEP. The parties are expected to file briefs on the impact on Judge O’Connor’s decision in the coming days.

What the Decision Means for Health Insurance Coverage and other USPSTF Decisions

It is not yet clear what impact Judge O’Connor’s ruling will have on the USPSTF and the PrEP mandate. The PrEP mandate will most likely be enjoined. As for the USPSTF, the government will likely argue for a remedy that leaves the USPSTF’s other recommendations intact. But given Judge O’Connor’s observations about the USPSTF’s political independence and the HHS Secretary’s limited authority with respect to the USPSTF, it is difficult to see a path forward where the USPSTF’s prior recommendations — and their impact on government or private healthcare coverage — are not cast into doubt.

Another significant area of authority for the USPSTF involves Medicare payment for preventive screening testing for which there is no existing Medicare benefit. More specifically, the Medicare Improvements for Patients and Providers Act of 2008 (P.L. 110-275) (commonly known as “MIPPA”) authorized the Medicare program — through its National Coverage Determination process — to cover preventive screening tests that do not fall under a Medicare benefit category, so long as three criteria are met: (a) the proposed preventive service is “reasonable and necessary for the prevention or early detection of an illness or disability (i.e., the Medicare coverage standard); (b) the proposed service is “appropriate” for Medicare beneficiaries; and (c) the proposed preventive service receives a grade “A” or “B” recommendation from the USPSTF. In addition to the other considerations raised in this Alert, it is also unclear whether Judge O’Connor’s decision will have any downstream implications on previous task force decisions that resulted in an “A” or “B” recommendation or that involved a decision to withhold such a recommendation.

The decision also may have implications for high deductible health plans (HDHPs). In order for an individual to be eligible to make tax-favored contributions to a health savings account (HSA), the IRS requires an individual to be covered by an HDHP. To qualify as an HDHP, a health plan is required by the IRS to have a minimum yearly deductible. Generally, an HDHP cannot provide any benefits to a member before the member has met his or her yearly deductible. Section 223(c)(2) of the Internal Revenue Code provides an exception to this limitation on HDHPs that allows “first-dollar coverage” for certain preventive care services, including evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force. Sponsors of HDHPs should evaluate the impact of the decision and any subsequent litigation on the provision of first-dollar coverage for items and services items and services based on United States Preventive Services Task Force ratings.

If Judge O’Connor issues a ruling effectively invalidating all of the USPSTF’s recommendations due to the PSTF’s members not being constitutionally appointed, such a ruling may have substantial consequences for the health insurance industry, for providers seeking coverage for preventive screening tests, and for makers of preventive screening tests. The USPSTF currently has more than 50 recommendations with a grade of “A” or “B,” covering conditions such as cancer, dental health, mental health, hypertension, and obesity. If Judge O’Connor enjoins HHS from enforcing the USPSTF’s recommendations — to the extent that the recommendations have a binding effect on insurers, Medicare, and Medicaid — it could have significant implications for coverage.

Judge O’Connor is unlikely to have the last word in this case. After he determines the appropriate remedy for the plaintiffs’ claims regarding the USPSTF and PrEP, both the federal government and the plaintiffs (to the extent they lost on their arguments regarding ACIP and HRSA) may appeal Judge O’Connor’s rulings to the U.S. Court of Appeals for the Fifth Circuit. The government may also seek a stay of Judge O’Connor’s remedies order pending appeal.