Whither Insurance Coverage for Preventive Health Services? District Court Decision Striking Down Affordable Care Act’s Preventive Care Coverage Requirements Temporarily Stayed by the Fifth Circuit

On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for preventive health services like cancer screenings and pre-exposure medications for people at high risk of getting HIV remain intact . . . for now.

The Fifth Circuit’s action comes one month after the federal government attempted to clarify the status of health insurance coverage for preventive health services in the wake of a district-court ruling barring enforcement of many of the ACA’s prevention-related coverage requirements. In a FAQ document co-issued by the U.S. Departments of Health & Human Services (HHS), Treasury, and Labor, as well as the Office of Personnel Management, the agencies provided initial guidance to the industry following the U.S. District Court for the Northern District of Texas decision in Braidwood Management Inc. v. Becerra (Braidwood).¹

This post summarizes the ACA’s preventive health services requirements, the Braidwood decision striking certain of them down and preventing their enforcement, the agencies’ post-Braidwood FAQ guidance, the Fifth Circuit’s temporary stay of the Braidwood ruling, and implications for patients, providers, and insurers. 

ACA’s Preventive Services Coverage Provisions

The ACA added Section 2713 to the Public Health Service Act (PHSA).² Section 2713 and its implementing regulations³ require non-grandfathered private health plans to cover preventive health services recommended by expert health agencies without any cost-sharing (such as co-pays, deductibles, or co-insurance). Those covered services and the agencies recommending them are: 

• (a)(1) Evidence-based items or services that have a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (PSTF) for the individual involved; 
• (a)(2) Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention for the individual involved;
• (a)(3) [For] infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration (HRSA); and 
• (a)(4) [For] women, such additional preventive care and screenings not described in section 2713(a)(1) as provided for in comprehensive guidelines supported by HRSA.

These benefits are now widespread and widely enjoyed. HHS estimates that as of 2020, over 150 million Americans (including 37 million children) were enrolled in non-grandfathered private health insurance plans covering preventive services with no-cost sharing. And according to an analysis by the independent, nongovernmental entity the Kaiser Family Foundation (KFF), roughly 100 million Americans (or six out of ten privately insured Americans and seven out of ten privately insured children) received preventive health services without cost-sharing in 2018.

Braidwood

On March 30, 2023, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas vacated all agency action taken to implement or enforce the preventive care coverage requirements in response to an “A” or “B” recommendation by the PSTF on or after March 23, 2010, and enjoined the federal government from enforcing the preventive services coverage mandate in response to an “A” or “B” rating from the PSTF in the future. 

The district court’s nationwide remedy decision followed its September 2022 ruling that section 2713(a)(1)’s authorization of the PSTF to issue recommendations carrying the force of law violates the Appointments Clause of the U.S. Constitution. The Appointments Clause requires that Officers of the United States be appointed by the President and confirmed by the Senate. PSTF members are independent, volunteer national experts in disease prevention and evidence-based medicine who are appointed by an agency within HHS. The district court concluded that the ACA’s elevation of the PSTF to issue recommendations carrying the force of law transformed PSTF members into Officers of the United States requiring presidential appointment and Senate confirmation. Hence, preventive service coverage requirements based on the PSTF’s recommendations after enactment of the ACA (March 23, 2010) were held unlawful. The court did not vacate coverage requirements based on PSTF recommendations issued before March 23, 2010, because the ACA carried those existing recommendations into law. The court also kept intact Sections 2713(a)(2)-(4) of the PHSA—ACA preventive service coverage requirements based on recommendations by ACIP and HRSA—because unlike PSTF recommendations, which are made without input from the political branches of government, ACIP and HRSA actions are “ratified by” the HHS Secretary, who is an Officer of the United States. 

This was not the first time Judge O’Connor struck down key parts of the ACA. Most notably, in 2018, he held the entire ACA unconstitutional after Congress zeroed out the penalty for individuals who did not purchase health insurance. That decision was ultimately reversed by the U.S. Supreme Court.⁴

The federal government appealed O’Connor’s preventive services ruling to the U.S. Court of Appeals for the Fifth Circuit and sought a stay of the nationwide remedy pending appeal.⁵  

FAQ Document

On April 13, 2023—after Judge O’Connor’s Braidwood ruling but before the Fifth Circuit issued the temporary stay—the federal agencies with jurisdiction over the ACA’s preventive services coverage requirements published an FAQ document. Among other things, the FAQ addressed which preventive service coverage requirements were affected by Braidwood, whether Braidwood prevented states from enacting their own coverage requirements, and whether insurers were obligated to continue to cover such services after the district-court rulings.
**IMPORTANT NOTE: All of the FAQ guidance is now on pause given the Fifth Circuit’s subsequent temporary stay.**

Which Preventive Health Services Were Affected By Braidwood?

The FAQ reinforced that the Braidwood decision applies to items and services required to be covered by non-grandfathered private plans and issuers without cost sharing in response to an ‘A’ or ‘B’ recommendation by the PSTF on or after March 23, 2010. 

The Braidwood decision does not address:

• items and services recommended with an “A” or “B” rating by the USPSTF before March 23, 2010; 
• the requirements under PHS Act section 2713(a)(2)-(4) to provide coverage without cost sharing for immunizations recommended by ACIP or preventive care and screenings for infants, children, and adolescents, as well as for women as provided for in comprehensive guidelines supported by HRSA. 

The PSTF maintains a list of its A and B recommendations and the release date of the current recommendation. KFF also published a table of major additions and revisions to PSTF recommendations made on or after March 23, 2010. According to KFF, statins to prevent heart disease, lung cancer screening, PrEP to prevent HIV, and medications to lower the risk of breast cancer for high-risk women (e.g., tamoxifen) are among the services which may no longer be required to be covered without cost-sharing on a federal level should Braidwood be upheld.

Did Braidwood Affect State Preventive Health Service Coverage Requirements?

The FAQ made clear that states can continue to require coverage of services recommended by PSTF on or after March 23, 2010 and that Braidwood does not affect any such state laws.
 
Must Plans Continue to Cover Preventive Services Affected By Braidwood?

The agencies stated:

Although the Braidwood decision prevents the Departments from implementing and enforcing PHS Act section 2713(a)(1)’s coverage requirements for items and services recommended with an “A” or “B” rating by the USPSTF on or after March 23, 2010, plans and issuers are not required to make any changes to coverage or cost sharing as a result of the Braidwood decision, and the Departments strongly encourage plans and issuers to continue to cover, without cost sharing, items and services affected by the court’s decision. Plans and issuers should consider other provisions of applicable federal and state law when determining whether changes to the terms of the plan or coverage may be made during a plan or policy year. Further, plans and issuers, including self-insured plans, may still be required to cover the full scope of recommended preventive services under other legal and contractual requirements.

The Fifth Circuit Stay

On May 15, 2023, a motions panel of the Fifth Circuit ordered an administrative stay of the nationwide remedy and “carried with the case” the federal government’s motion for a stay pending appeal. As a result, Judge O’Connor’s ruling is temporarily paused.

The Fifth Circuit panel judging the merits of the appeal will now also consider the government’s motion for an extended stay pending the appeal. Although many observers believed that the merits panel would allow the administrative stay to continue for the duration of its consideration of the merits—making the administrative stay a stay pending appeal in practice—the merits panel will in fact consider the government’s motion for a stay pending appeal before the merits. On May 19, 2023, the Fifth Circuit issued a clarifying order scheduling oral argument on the government’s stay motion for June. Briefing on the merits will follow later in the Summer.
 
Implications

After all that, the ACA’s preventive services coverage requirements are right back where they started before the Braidwood lawsuit was filed: They are intact pending further Fifth Circuit proceedings. Non-grandfathered private health plans must continue to cover preventive health services recommended by ACIP, HRSA, and PSTF under PHSA Section 2713 without cost-sharing, regardless of the date of recommendation.

But the stay may prove a temporary reprieve for patients who rely on these benefits. We’ll be monitoring the Fifth Circuit appeal (and any subsequent appeal to the U.S. Supreme Court) to see whether the district court’s ruling will be affirmed, reversed, or altered. This appeal very well could be destined to follow Judge O’Connor’s prior ACA decision—on its way to the Supreme Court.

Should the government’s motion for a stay pending appeal be denied, or the district court’s ruling be upheld in its entirety, the agencies’ existing FAQ document will provide immediately actionable guidance to patients and industry. Check back in this space for future updates.

¹ Civil Action No. 4:20-cv-00283-O (N.D. Tex. Mar. 30, 2023). 
² 42 U.S.C. § 300gg–13.
³ 26 C.F.R. § 54.9815-2713; 29 § C.F.R. 2590.715-2713; 45 C.F.R. § 147.130.
⁴ See California v. Texas, 141 S. Ct. 2104 (2021). In the Supreme Court and the Fifth Circuit, Zuckerman Spaeder LLP represented amici opposing O’Connor’s interpretation of the law, including various state hospital associations and nonprofit organizations.
⁵ No. 23-10326 (5th Cir.).