UN(PrEP)ARED: HOW BRAIDWOOD v. BECERRA COULD LEAVE PUBLIC HEALTH OFFICIALS SCRAMBLING

By: Tyler Blackmon, Volume 107 Staff Member

On September 7, 2022, a federal district court granted summary judgment to an employer who refused to cover an anti-HIV, pre-exposure prophylaxis drug (PrEP) because doing so would make that employer “complicit in facilitating homosexual behavior.”[1] The judge, Reed O’Connor (N.D. Tex.), previously tried to overturn the entire Affordable Care Act[2] and has developed a reputation as a judge whom conservative activists specifically seek out to overturn progressive policies.[3]

The court did so on two different grounds. First, because the relevant government agency who recommended PrEP be available free of charge consisted of officers of the United States who did not receive a constitutionally proper appointment nor confirmation. Second, because requiring employers to cover PrEP specifically violated the Religious Freedom Restoration Act (RFRA). Depending on which legal grounds, if any, survive appellate review, the impact on public health could be wide-ranging and swift.

I. BACKGROUND

Today, more than 1.2 million people in the United States are living with HIV, with 35,000 new infections occurring every single year, mostly among men who have sex with men.[4] But PrEP has been something close to a miracle drug: when taken as prescribed, PrEP reduces the chance of contracting HIV through sex by ninety-nine percent.[5] The public health data is clear: if insurers and providers charge for the drug, the incentive to take the drugs drops dramatically.[6] Therefore, it is in the government’s interest to require free preventive services now, such that they do not become much more expensive palliative and curative services later.

With those cost savings in mind, the Patient Protection and Affordable Care Act (ACA) requires most private health plans to cover certain types of preventive care without passing on part of the cost to the patient through cost-sharing.[7] Such a system has allowed employees covered under these plans to fill prescriptions for PrEP for free—a serious cost-savings for a drug that otherwise costs over $20,000 per year.[8] The ACA accomplishes this by deferring to the expertise of the U.S. Preventive Services Task Force (PSTF).[9] If that agency issues an “A” or “B” rating for the service, the Department of Health & Human Services will instruct private health insurers that they must cover the service at no cost to patients.[10] The PSTF has issued PrEP an “A” rating; thus, private insurers must offer it to patients without cost-sharing.[11]

The Plaintiff, Braidwood Management, Inc., provides health insurance to its employees but does not want to provide coverage for PrEP, arguing it would violate the owner’s religious beliefs.[12] Braidwood is owned by Republican activist Steve Hotze, who, among his several pet projects in the past, has campaigned against an anti-discrimination ordinance in Houston and supported a mayoral candidate who posited that the best method of combatting the HIV epidemic would be to “shoot the queers.”[13]

II. LEGAL ANALYSIS

Ultimately the court ruled for the Plaintiff on two separate grounds: the Appointments Clause, and RFRA.

A. Appointments Clause

First, the court ruled that PSTF members are officers of the United States and therefore act unconstitutionally without appointment by the President and confirmation by the Senate. The Appointments Clause of the Constitution allows two types of officers to make decisions in the federal government: “[Superior] Officers of the United States” must be nominated by the President and confirmed by the United States Senate.[14] “[I]nferior Officers,” on the other hand, need no nomination nor confirmation, and Congress may vest appointment power for such officers to the President, the courts, or to “Heads of Departments.”[15] To distinguish between the two, the court applies a two-part test: appointees are superior officers if they (1) occupy a “continuing and permanent” position by law and (2) exercise “significant authority pursuant to the laws of the United States.”[16]

Here, the court reasoned that members of the PSTF were superior officers.[17] First, the court found that PSTF members are “continuing and permanent” positions because they submit yearly reports to Congress, update their recommendations every five years, serve four-year terms, get reimbursements from the government for travel expenses, and occupy positions set indefinitely by statute.[18] Second, the court found the members wield significant authority primarily because their recommendations automatically trigger a requirement that private health insurers cover preventative care with no cost to the consumer and they are statutorily insulated from political pressure.[19] Because PSTF members are superior officers yet were not nominated by the President nor confirmed by the Senate, reasoned the court, they act unconstitutionally.

Still, the court’s argument stands on a pillar of shaky facts. PSTF members are unpaid, part-time volunteers who meet three times per year for two days in Washington, D.C.[20]—hardly “continuing and permanent” positions of the kind of caliber one might expect would require full-blown confirmation hearings and presidential appointments. Nor do their recommendations themselves have the force of law: PSTF members make their decisions based on scientific evidence about the effectiveness of preventive care.[21] It is Congress, not the PSTF, that has turned those recommendations into a regulatory requirement. Indeed, as Judge O’Connor himself admits, Congress regularly defers to outside organizations to take objective measurements.[22]

Nevertheless, should this theory stand, because the court questions the validity of the PSTF as a whole and not just its specific recommendation to cover PrEP, it could potentially invalidate every decision made by the organization for every preventive treatment currently required to be offered free of charge. Importantly, however, the court specifically reserved ruling on the particular fix for this constitutional issue and allowed the parties to submit supplemental briefing on the appropriate judicial remedy.[23]

B. Religious Freedom Restoration Act

Second, the court ruled that even if PSTF members were inferior officers, requiring employers to purchase health insurance that covered PrEP specifically imposes an impermissible substantial burden on employers’ religious beliefs under the Religious Freedom Restoration Act (RFRA).

By statute, RFRA guarantees that “Government shall not substantially burden a person’s exercise of religion even if the burden results from a rule of general applicability,” unless the government shows it has a “compelling governmental interest” and the policy “is the least restrictive means of furthering that compelling governmental interest.”[24]

In Braidwood, the court made three important findings. First, requiring Braidwood to cover PrEP would violate Hotze’s sincerely held religious beliefs because “providing coverage of PrEP drugs facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman, and . . . providing coverage of PrEP drugs in Braidwood’s self-insured plan would make him complicit in those behaviors.”[25] Second, requiring insurers to cover PrEP does not further a compelling government interest because—although HIV prevention is compelling generally—the Government did not show it had a specific compelling interest in compelling religious employers to cover PrEP.[26] Third, even if that interest were compelling, the PrEP mandate was not the least restrictive means of furthering that interest because the Government could have simply covered the cost of PrEP for anyone working for a religious employer that did not want to cover the drug.[27]

Taken together, these findings constitute a violation of RFRA. However, once again, the court reserved ruling on the appropriate remedy.[28]

III. IMPACT ON PUBLIC HEALTH

The impact on public health will depend on two different procedural next steps: the short-term remedy chosen by the federal district court, and the long-term claims the Fifth Circuit eventually allow to survive.

In the short-term, at the narrowest end of the spectrum, the court could cabin the remedy solely to the plaintiffs in this case. Doing so would allow them to purchase a health plan that did not cover PrEP and other services recommended by PSTF. But if the court opts for a broad remedy via a nationwide injunction, not only could every national health insurance plan suddenly drop coverage for PrEP (a drug that costs approximately $20,000 per year[29]), they could also drop coverage for any service receiving an “A” or “B” rating from PSTF. That list includes breast cancer screenings for women ages fifty to seventy-four, vision checks for children ages three to five, and screenings for diabetes and many sexually transmitted infections (STIs).[30] Presumably, this broad approach would inhibit PSTF’s ability to respond to future public health crises, as well.

How the Fifth Circuit responds will also determine which types of employers may begin dropping coverage for preventive care. While an appellate review that would allow the RFRA claim to stand seems likely to be narrowly applied to religious employers and narrowly applied to PrEP, a wholesale revocation of the authority of the PSTF would impact almost all workers and would allow almost all employers to drop the full list of services PSTF recommends.

Congress is not without remedy here, at least as it relates to the Appointments Clause challenge. For example, Congress could simply allow the Secretary of Health and Human Services moving forward to hire and fire PSTF members and veto any of their decisions, making it clearer that these are inferior rather than superior officers of the United States. But even if Congress could muster the votes for that now—over a decade since the original passage of the ACA, when Democrats enjoyed wide majorities in both chambers of Congress—removing these kinds of public health debates from the ebb and flow of federal politics was exactly the reason why the ACA deferred to the PSTF in the first place. Thrusting scientific decisions about the effectiveness of drugs like PrEP back into the hands of political actors who may share the same clear animus of plaintiffs in this case would imperil the very real progress this country has achieved over the last half century in combatting HIV—particularly among men who have sex with men.

For now, all the members of that community can do is wait. Their fate—and their health—is in the hands of Judge Reed O’Connor and the Fifth Circuit.

 

[1] Braidwood Mgmt. Inc. v. Becerra, No. 4:20-CV-00283-O, 2022 WL 4091215, at *3 (N.D. Tex. Sept. 7, 2022).

[2] Bob Bryan, Experts Think the Ruling That Declared Obamacare Unconstitutional Is ‘Insanity in Print’ and Will Likely be Overturned, Bus. Insider (Dec. 17, 2018), https://www.businessinsider.com/obamacare-repeal-lawsuit-supreme-court-overturn-odds-2018-12 [https://perma.cc/RQ7G-N2HE]; see also Nicholas Bagley, The Latest ACA Ruling Is Raw Judicial Activism and Impossible to Defend, Wash. Post (Dec. 15, 2018), https://www.washingtonpost.com/opinions/2018/12/15/latest-aca-ruling-is-raw-judicial-activism-impossible-defend [https://perma.cc/QYJ7-DZCZ] (accusing Judge O’Connor of being “blinded” by “his contempt of the ACA”).

[3] See Manny Fernandez, In Weaponized Courts, Judge Who Halted Affordable Care Act Is a Conservative Favorite, N.Y. Times (Dec. 15, 2018), https://www.nytimes.com/2018/12/15/us/judge-obamacare-reed-oconnor.html [https://perma.cc/9Z74-LC66] (“In the 11 years Judge Reed O’Connor has been on the federal bench, he has become a favorite of Republican leaders in Texas, reliably tossing out Democratic policies they have challenged.”).

[4] The HIV/AIDS Epidemic in the United States: The Basics, KFF (June 7, 2021), https://www.kff.org/hivaids/fact-sheet/the-hivaids-epidemic-in-the-united-states-the-basics [https://perma.cc/73JW-GJSF].

[5] How Effective is PrEP?, Ctrs. for Disease Control & Prevention (Oct. 24, 2022), https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html [https://perma.cc/8NSR-G2Q3].

[6] Benjamin Ryan, PrEP, the HIV Prevention Pill, Must Now Be Totally Free Under Almost All Insurance Plans, NBC News (July 20, 2021), https://www.nbcnews.com/nbc-out/out-health-and-wellness/prep-hiv-prevention-pill-must-now-totally-free-almost-insurance-plans-rcna1470 [https://perma.cc/R8A8-A67A] (“[I]f people can access PrEP at a lower cost or for free, they are more likely to take it.”).

[7] 42 U.S.C. § 300gg-13.

[8] How Much Does PrEP Cost?, PrEP Daily (Oct. 24, 2022) https://prepdaily.org/how-much-does-prep-cost [https://perma.cc/Q7EJ-ZXJ4] (“A prescription can add up to over $21,000 annually – as it costs $1,758.00 for a thirty-day supply if purchased without insurance or other payment programs.”).

[9] 42 U.S.C. § 300gg-13(a)(1).

[10] Id.

[11] A & B Recommendations, U.S. Preventive Servs. Task Force (Oct. 24, 2022), https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations [https://perma.cc/23WX-JWK8].

[12] Braidwood, 2022 WL 4091215, at *3.

[13] Tess Owen, The GOP Wellness Tycoon Bankrolling Election Fraud Vigilantism, VICE News (Dec. 16, 2020), https://www.vice.com/en/article/akd754/the-gop-wellness-tycoon-bankrolling-election-fraud-vigilantism [https://perma.cc/GU3Z-WWT3].

[14] U.S. Const. art. II, § 2, cl. 2.

[15] Id.

[16] Lucia v. S.E.C., 138 S. Ct. 2044, 2051 (2018).

[17] Braidwood, 2022 WL 4091215, at *9–12.

[18] Id. at *9–10.

[19] Id. at *10–11; 42 U.S.C. § 299b-4(a)(6) (“All members of the Task Force convened under this subsection, and any recommendations made by such members, shall be independent and, to the extent practicable, not subject to political pressure.”).

[20] Braidwood, 2022 WL 4091215, at *9.

[21] For an in-depth look at the PSTF’s scientific process, see generally Procedural Manual, U.S. Preventive Servs. Task Force, https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual [https://perma.cc/99GS-XNLD].

[22] See, e.g., 4 U.S.C. § 119(a)(2) (requiring electronic databases established by states to “be provided in a format approved by the American National Standards Institute’s Accredited Standards Committee X12”); 42 U.S.C. § 6293(b)(8) (requiring test procedures for water closets and urinals to comply with standards set by the American Society of Mechanical Engineers).

[23] Braidwood, 2022 WL 4091215, at *13.

[24] 42 U.S.C.A. § 2000bb-1.

[25] Braidwood, 2022 WL 4091215, at *18.

[26] Id. at *19.

[27] Id. at *20.

[28] Id.

[29] See How Much Does PrEP Cost?, supra note 8.

[30] A & B Recommendations, supra note 11.