On September 7, the US District Court for the Northern District of Texas issued a ruling in Braidwood Management Inc. v. Becerra (formerly Kelley v. Becerra), which challenged the legality of the Affordable Care Act’s (ACA) preventive services coverage mandate.

Under Section 2713 of the ACA, self-funded health plans and insurers offering non-grandfathered group or individual market health plans must cover services given an “A” or “B” rating from the US Preventive Services Task Force (USPSTF), Advisory Committee on Immunization Practices-recommended vaccines, Health Resources and Services Administration (HRSA)-recommended preventive care and screening recommendations for children, and HRSA Women’s Preventive Services Initiative (WPSI)-recommended services, including contraceptives.

The court ruled that self-funded health plans and insurers are not required to cover services recommended by the USPSTF because its members are not properly appointed under the Constitution’s Appointments Clause. The court also ruled that requiring employers to provide insurance that covers pre-exposure prophylaxis (PrEP) for HIV prevention violates the rights of employers under the Religious Freedom Restoration Act (RFRA).

The ruling will have important implications for coverage with $0 cost sharing for PrEP and other preventive services with an USPSTF “A” or “B” rating. Cancer screenings, behavioral health interventions, and other services not typically offered at routine provider visits may be particularly impacted.

The plaintiffs also challenged the legality of coverage mandates for services recommended by the ACIP and WPSI, but the court upheld the legality of these groups.

The ruling did not address the plaintiffs’ original objections to contraceptive coverage under RFRA. On September 16, the parties submitted a joint status report requesting that the court address the claims related to contraceptive coverage and rule on the scope of remedy. A ruling from the district court is expected in the coming months.

Considerations

As stakeholders evaluate the implications of the court’s ruling on $0 cost-sharing coverage of preventive services recommended by USPSTF, it will be important to assess the following potential policy actions and considerations.

Could the federal government or state governments act to maintain $0 cost sharing for preventive services?

Government entities could address the issue by enacting legislation or issuing regulations, either at the federal or state level.

Congress may consider legislation that requires plans to cover PrEP and other USPSTF-recommended services. For example, a bill currently under consideration by Congress, Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021, would authorize coverage of and payment for Food & Drug Administration-approved multi-cancer early detection screening tests and in turn promote the Biden administration’s Cancer Moonshot Initiative. Another legislative approach could include changes to the USPSTF’s membership appointment process to align with the court’s interpretation of the Constitution’s Appointments Clause.

Within the administration, the Centers for Medicare & Medicaid Services’ (CMS) Center for Consumer Information and Insurance Oversight or the Department of Labor’s Employee Benefits Security Administration could issue regulations requiring $0 cost sharing for USPSTF-recommended preventive services under affected plans.

What might the impact of the ruling be on other preventive services and products that could be met with religious objections?

The district court ruled that PrEP coverage requirements violate employers’ rights under the RFRA and is expected to rule on the legality of contraception coverage requirements in the coming weeks. Beyond PrEP and contraception coverage, the court’s decision has the potential to impact coverage for other services that reduce harms associated with behaviors that are perceived as counter to an employer’s religious beliefs (e.g., sexually transmitted infection screening, coverage of HPV vaccines).

How will elimination of $0 cost sharing for preventive services impact health disparities and inequities?

While cost-sharing requirements for preventive services would apply to all of a health plan’s enrollees, they may disproportionately impact access and uptake for certain populations. For example, research conducted by Avalere and the Community Oncology Alliance indicated that mean breast cancer screening rates decreased in April 2020 during the COVID-19 public health emergency across all payers, but recovery to pre-pandemic levels occurred at a slower rate among certain racial and ethnic minority groups. Additionally, the research found that differences in recovery rates by payer type showed a strong relationship between income level and screening utilization. Many USPSTF-recommended services, which are covered with $0 cost sharing, are particularly relevant for populations that already experience health disparities such as lower screening rates or screening for conditions like diabetes that have higher incidence rates among non-White populations. These services could be particularly affected if plans and employers reduce coverage of these services. Stakeholders may consider the impact of the court’s ruling on patient access and develop strategies to promote equitable uptake of preventive services.

In the absence of federal or state legislative action to protect $0 cost sharing for preventive services, inequities in access to screenings and preventive medicines across therapeutic areas could be exacerbated.

What happens next?

The Biden administration is expected to appeal the court’s decision to the US Court of Appeals for the Fifth Circuit, and—following the appellate court’s ruling—either party may petition to have the case heard by the Supreme Court. This process will likely be lengthy, and it could be several years before a final verdict is reached. Plans would likely continue to cover USPSTF-recommended services and PrEP with no cost sharing during pending litigation.

A lengthy appeals process may prolong litigation through the 2024 presidential election. A different presidential administration may choose to drop the appeal and not undertake further legislative or regulatory action to ensure $0 cost sharing for the affected preventive services.

To learn more about how Avalere can support you in understanding the implications of court rulings, legislative actions, and rulemaking on preventive services connect with us.