Insurance coverage

Federal District Court Ruling May Impair Insurance Coverage for More Than 50 Recommended Procedures, Screenings and Treatments | Goodwin

Regulatory context

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

  1. Evidence-based items or services that have an “A” or “B” rating in current USPSTF guidelines;
  2. Vaccinations that have a recommendation from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC);
  3. Preventive care and evidence-based screenings for infants, children, and adolescents, as provided 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 in the comprehensive HRSA guidelines.

The USPSTF consists of four-year independent volunteer members who have expertise in making health care coverage recommendations. 42 USC § 300gg-13. By law, the USPSTF must be “independent and, to the extent possible, free from political pressure.” ID. § 299b-4(a)(6). A US Department of Health and Human Services (HHS) official, the director of the Agency for Health Care Research and Quality, has the authority to convene the USPSTF, but neither the director nor the secretary of the HHS does have the ability to review USPSTF recommendations.

ACIP is also an advisory body, but reports to the CDC Director and does not have a statutory mandate of independence. HRSA is an agency within HHS.

Background to the case

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

Justice O’Connor ruled in favor of the government on the ACIP and HRSA challenges, upholding the HPV vaccine and birth control mandates. With respect to the USPSTF, however, Judge O’Connor ruled in favor of the plaintiffs, finding that the USPTSF’s structure violates the Appointment Clause of the Federal Constitution, because USPSTF members wield authority as “officers of the United States” but were not appointed through the process required by the Constitution. Judge O’Connor held that members of the USPSTF are “officers” of the United States because (1) they have regular responsibilities: to review research, update recommendations, and report to Congress and federal agencies; and (2) although called “recommendations,” the USPSTF guidelines have significant legal force because they determine the scope of health insurance coverage. Justice O’Connor further explained that members of the USPSTF are “senior” officers, who must be appointed by the President and confirmed by the Senate. But Judge O’Connor noted that even if USPSTF members were labeled as “inferior” officers, their method of appointment would still be impermissible. Finally, in light of the USPSTF’s policy independence requirements, Judge O’Connor determined that the HHS Secretary could not “fix” the appointment clause problem by ratifying the USPSTF’s recommendations after suddenly, as the secretary of HHS had done with the recommendations of the ACIP and HRSA.

Separately, Judge O’Connor also found that the PrEP mandate significantly interfered with the plaintiffs’ exercise of their religious beliefs, thereby violating the Religious Freedom Restoration Act. He concluded that, regardless of the overall benefits of PrEP, the government has failed to show that it has “a compelling interest in forcing private religious corporations to cover PrEP drugs without cost-sharing or religious exemptions”.

Judge O’Connor has yet to decide which remedies are appropriate in light of his rulings on the USPSTF and PrEP. The parties are expected to file briefs on the impact on Justice O’Connor’s decision in the coming days.

What the ruling means for health insurance coverage and other USPSTF rulings

It is not yet clear what impact Judge O’Connor’s decision will have on the USPSTF and the PrEP mandate. The PrEP mandate will most likely be imposed. As for the USPSTF, the government will likely argue for a remedy that leaves the other USPSTF recommendations intact. But given Justice O’Connor’s observations on the USPSTF’s political independence and the HHS Secretary’s limited authority over the USPSTF, it’s hard to see a way forward where earlier recommendations of the USPSTF – and their impact on public or private health care coverage – are not in doubt.

Another important area of ​​authority for the USPSTF relates to Medicare payment for preventive screening tests for which there is no existing Medicare benefit. Specifically, the Medicare Improvement for Patients and Providers Act of 2008 (PL 110-275) (commonly referred to as “MIPPA”) authorized the Medicare program – through its determination process National Coverage – to cover preventive screening tests that do not fall under a Medicare benefit category, as long as three criteria are met: (a) the preventive service offered is “reasonable and necessary for the prevention or early detection illness or disability (i.e. the Medicare coverage standard); (b) the proposed service is “appropriate” for Medicare beneficiaries; and (c) the proposed preventative service receives a grade “A” or “B” recommendation from the USPSTF. In addition to other considerations raised in this alert, it is also unclear whether Judge O’Connor’s decision will have any downstream implications on the group’s previous decisions. work that resulted in an “A” or “B” recommendation or which involved a decision to suspend such a recommendation.

The decision may also have implications for high-deductible health plans (HDHPs). For an individual to be eligible to make tax-advantaged contributions to a Health Savings Account (HSA), the IRS requires that an individual be covered by an HDHP. To qualify as an HDHP, a health plan is required by the IRS to have a minimum annual deductible. Generally, an HDHP cannot provide any benefits to a member until the member has reached their annual 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 items or services based on evidence that indeed has an A or B grade in the current US Preventive Services Task Force recommendations. Sponsors of HDHPs should assess the impact of the decision and any subsequent litigation on the provision of first-dollar coverage for items and services based on assessments by the United States Preventive Services Task Force.

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

Judge O’Connor is unlikely to have the final say in this case. After determining the appropriate remedy for plaintiffs’ claims regarding USPSTF and PrEP, the federal government and plaintiffs (to the extent they have lost their cases regarding ACIP and HRSA) may appeal the judge’s decisions. O’Connor in the United States Court. Calls for the Fifth Circuit. The government can also seek a stay of Justice O’Connor’s appeal order pending appeal.

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