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Home » Braidwood v Becerra puts ACIP vaccine recommendations at risk

Braidwood v Becerra puts ACIP vaccine recommendations at risk


This article, about the recent Braidwood v Becerra appeals court decision, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law San Francisco, who is a frequent contributor to this and many other websites, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

In law journals, Professor Reiss writes extensively about vaccination’s social and legal policies. Reiss is also a member of the Parent Advisory Board of Voices for Vaccines. This parent-led organization supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On 21 June 2024, the Fifth Circuit published an opinion in the case of Braidwood v Becerra which could remove coverage for important preventive services and could put at risk past (and maybe future) ACIP vaccine recommendations without good reason. 

This post explains the issues behind the Braidwood v Becerra decision. 

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The Braidwood v Becerra case

Braidwood v Becerra focuses on the preventive services clause of the Affordable Care Act (ACA). The clause requires health insurance companies to provide coverage without cost sharing, so without cost to the patient, for four types of services: 

  1. Recommendations of the United States Preventive Services Task Force (hereinafter “the Task Force”) that have an A or B rating; 
  2. Immunizations recommended by the Advisory Committee on Immunization Practices (ACIP) for the individual in question; 
  3. Preventive services or screenings in guidelines by the Health Resources and Services Administration (HRSA)  for minors (babies to adolescents); 
  4. Preventive services or screenings in guidelines by the Health Resources and Services Administration (HRSA)  for women. 

Plaintiffs opposed providing coverage for some such services, including HPV vaccines, and contraceptives. They, as stated in the decision, 

…object to the preventive-care mandates on religious grounds and specifically allege that compulsory coverage of these services requires them to violate their religious beliefs “by making them complicit in facilitating homosexual behavior, drug use, and sexual activity outside of marriage between one man and one woman.”

The focus of the district court and the Fifth Circuit’s decisions, however, was not on the plaintiffs’ religious objections, but on their constitutional objections to the way the members of the bodies making the recommendations are appointed. The district court issued a preliminary injunction decision that found the plaintiffs were likely to succeed in challenging the Task Force’s constitutionality and issued a nationwide injunction against the preventive services provision for any of its recommendations; but it rejected the claim against ACIP and HRSA, finding their structure constitutional. The government appealed the finding for the Task Force, and the plaintiffs appealed the finding for ACIP and HRSA.

To understand these objections and the decisions, a short introduction to administrative law is needed. 

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Administrative law appointments: a mini primer

I cover appointments and removal in three lessons in my administrative law class, and it’s pretty complex. But for this discussion of Braidwood v Becerra, what people need to know is, hopefully, pretty straightforward. The Constitution directly addresses appointments. Article II, Section 2, clause 2 of the constitution says that the President  “shall nominate, and by and with the Advice and Consent of the Senate, shall appoint” “officers of the United States”, “but the Congress may by Law vest the Appointment of such inferior Officers, as they think proper, in the President alone, in the Courts of Law, or in the Heads of Departments.”

There is a lot to say about this clause, but for this discussion, “principal” officers of the United States, as they are called, need to be appointed by the President and confirmed by the Senate, but “inferior” officers can be appointed by someone else.

Principal officers are the most important ones, like the members of the cabinets, high officials, and other important officials. Another point to keep in mind is that increasing the number of principal officers will mean, in practice, that many positions may go unfilled because the Senate has limited time for confirmation and controversies may lead to non-confirmation. In studies, around 20% of principal officer positions in major agencies can be left unfilled at a time. So broadening that category makes it harder for the administrative state to function generally because more positions are left empty, without people to do the work. 

In this case, the members of the bodies in question were appointed by the Secretary of Health and Human Services (though usually underlings do most of the actual work of finding and recruiting people, the Secretary signs off on the appointments), so if they’re inferior officers, their appointment is fine, since the Secretary is a Head of Department, but if they’re principal officers, their appointment is invalid, since they were not nominated by the President and confirmed by the Senate.

So the line between principal and inferior officers is really, really important to this case. On this issue, the latest word from the Supreme Court was in a case called United States v. Arthrex from 2021. The question in that case was whether the Administrative Patent Judges in the Patent Trials and Appeals Board were principal officers or inferior officers.

The Supreme Court, simplifying previous jurisprudence, concluded that a federal officer is an “inferior officer” if they have a superior who is a principal officer. Part of the logic of the Court was that everyone in the administrative state needed to be controlled by the President, and the Court wanted the people deciding to have been put in place by the President (see pp. 6-8).

A superior must have meaningful control over the person in question. In Arthrex, the court found that the Director of the Patent Trials and Appeals Board – which is a principal officer nominated by the President with the consent of the Senate – did not have such control because although the Director could nominate the judge that would hear a specific case, and could reassign the case, the Director could not directly review the decisions of the Administrative Patent Judges. 

But the majority of the Court in the case also limited the decision by concluding that, although there was a statutory prohibition on review by the Director alone, the solution for them is to read that prohibition out of the statute and conclude that the director can review the decisions of these judges (pp. 20-21). This will become important later. This was probably done because the Court realized that trying to make the Senate appoint the many administrative patent judges would simply mean that they would not be appointed, and their important role would go unfilled. 

I will add that I find the Arthrex decision problematic. For decades, many officials with extensive power were seen as inferior officers, without direct control of their decisions. The Senate has limited time, and historically, it does not look as if it was expected that it will appoint that many officers, including some pretty important roles (CDC director is, until 2025, appointed only by the President, as an inferior officer). There are, after all, as the dissents in the case point out, other ways to control officers besides reviewing specific decisions – for example, removing them at will. There is quite a bit of scholarly commentary and discussion of the case. 

The bodies in question and the Fifth Circuit’s decision

The Affordable Care Act uses three expert bodies to set the services covered by the preventive services provision. The first is the Task Force for Preventive Health Services. Like ACIP (discussed below), the Task Force is essentially an advisory committee. As the site explains, it is

… made up of 16 volunteer members who are nationally recognized experts in prevention, evidence-based medicine, and primary care. Their fields of practice and expertise include behavioral health, family medicine, geriatrics, internal medicine, pediatrics, obstetrics and gynecology, and nursing. The panel is led by a chair and two vice chairs.

Task Force members are appointed by the Secretary of HHS to serve 4-year terms.

Their job is to make “…evidence-based recommendations about preventive services such as screenings, behavioral counseling, and preventive medications” that would guide professionals in providing care.

The Advisory Committee of Immunization Practices is another advisory committee, whose main job is to develop “recommendations for U.S. immunizations, including ages when vaccines should be given, number of doses, time between doses, and precautions and contraindications.” It, too, is made of volunteer experts, and consists of

…15 voting members responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination.

The Health Resources and Services Administration (HRSA) is different – it is, actually, an administrative unit in the Department of Health and Human Services, which provides direct health services to some people, but also has a role in supporting healthcare services.

One of its units – probably the relevant one here – is the Maternal and Child Health Bureau, which also does research and provides guidance on improving maternal and child health. HRSA has an administrator. The current administrator was either appointed by the Secretary of Health and Human Services, or by President Biden, but in either case, was not nominated by the President and confirmed by the Senate. 

Again, nomination by the Secretary – or the President – is fine for an inferior officer (or someone who is not an officer of the United States), but not fine for a principal officer. The plaintiffs claim all three bodies are made of principal officers, and the lack of supervision means that their decisions are void, since they were unconstitutionally appointed.

In other words, if they had their way, all the people in these advisory committees and pretty low unit in HHS would have to be nominated by the President and confirmed by the Senate – as will any equivalent people in the administrative state. You can imagine what that will do to the practical ability to fill these roles. 

The Fifth Circuit, in its ruling on Braidwood v Becerra, focused on the task force, the first of these, and concluded the members of this advisory committee were principal officers. The Fifth Circuit acknowledged that the task force members are removable by the Secretary at will, which creates a level of control over them. However, it concluded that there is no supervision of the task force’s decisions by a principal officer, in this case, the secretary.

The court drew on 42 U.S.C. §299b-4(a)(6), which says that “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.” Because Congress intended the members’ recommendations to be independent, the court concluded there could be no meaningful supervision by the secretary.

Therefore, the court concluded, the Task Force members are “principal officers” and need to be nominated by the President and confirmed by the Senate, and the only remedy is to declare that their recommendations are void, and therefore cannot be the basis for required insurance coverage under the act. Although Secretary Becerra wrote a memo ratifying the Task Force’s recommendations, the court concluded that since the Secretary does not have authority under the act to issue the recommendations himself, he does not have authority to ratify them, either. 

The court did, however, limit the remedy to “what is necessary to redress the plaintiffs’ injuries”, and made the injunction limited to prohibiting “the defendants from enforcing the preventive-care mandates against the plaintiffs” – not a more general remedy.  Note that this decision looked at the preliminary injunction; the Fifth Circuit decision essentially tells the district court to find the Task Force’s structure unconstitutional in its final decision too, and if it does that, the result will be that covering its recommendations cannot be enforced against any insurance company anywhere. 

What about the other two bodies? The Fifth Circuit discussion of them was very short. It said:

With respect to ACIP, its preventive-care recommendations must first be approved by the CDC Director before they can take effect. The CDC Director, in turn, derives his authority from the HHS Secretary, who can countermand the CDC Director’s decisions to approve ACIP’s vaccine recommendations. Similarly, with respect to HRSA, Secretary Becerra can exercise control over the guidelines it publishes by virtue of the transfer of power in HHS’s Reorganization Plan No. 3 of 1966. There, Congress authorized the Secretary to perform “all functions of the Public Health Service . . . and all functions of all agencies of or in the Public Health Service.” Thus, unlike his power vis-à-vis the Task Force, Secretary Becerra has fallback powers on which he can exercise supervisory authority over ACIP and HRSA—authority, in our view, that encompasses the prerogative to ratify their preventive-care recommendations and guidelines made pursuant to § 300gg-13(a).

You might think, reading this, that the Fifth Circuit agreed with the district court and rejected the challenge to ACIP and HRSA’s authority. After all, if the Secretary has the potential to control, these are inferior officers – whether or not the Secretary acted to control specific recommendations. 

But the Fifth Circuit went on and, strangely, said:

According to the Government, the Secretary has exercised this statutory prerogative and has effectively cured whatever Appointments Clause issues afflict ACIP and HRSA. Like it did with the Task Force, the Government points to Secretary Becerra’s memo of January 21, 2022, in which he purported to ratify all the recommendations and guidelines thus far issued by ACIP and HRSA. 

… we cannot accept the Secretary’s attempt to do so here—at least at this juncture. That is because the plaintiffs put forward compelling and essentially unrebutted arguments that there are serious APA problems with the Secretary’s ratification memo.

The Fifth Circuit then sent the case down for the lower court to decide whether plaintiffs’ arguments about the memo were valid. 

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What’s wrong with the Braidwood v Becerra decision?

To start with, the decision is bad on policy grounds – because it lets insurance companies not cover preventive services they don’t like, and it will, almost certainly, directly lead to deaths. It also undermines the administrative state by making filling relatively low-level positions incredibly cumbersome. 

But even more important, it is legally flawed. First, concerning ACIP and the Task Force, there is at least an argument that since they are issuing recommendations, their members are not “officers of the United States” at all. United States law does occasionally draw on private technical guidance, and in 1996, Congress expressly encouraged that.

There is a long-standing tradition of using expert guidance, and the makers of that guidance are not seen as officers of the United States. HRSA may be an agency, but both the Task Force and ACIP are advisory committees, and arguably, providing technical guidance should not turn them into officers – even if Congress decided to draw on that technical guidance in defining what are preventive services.

There is an argument that Dep’t of Transportation v. Association of American Railroads might suggest that guidance that has direct legal effects needs to be provided by appropriately appointed bodies, but it’s not clear – although the Amtrack Board was nominated by the President and confirmed by the Senate, the President was not. It is at least feasible to see Congress, not these bodies, as making the decision – that preventive services based on expert technical guidance be covered by insurance companies.

The decision is in direct tension with the Federal Advisory Committee Act and the role of advisory committees, which go back decades and have never been seen as constitutionally problematic by the courts. Undermining Congress’ will in this way is a very aggressive judicial move. 

Second, if we treat the recommending bodies as making the decision, the Task Force may run into Arthrex; but even then, the remedy should have been narrower. My colleague Richard Hughes VI, in a thorough post about the decision, said it well: 

“The pertinent Supreme Court severability precedent is fractured, but suggests the Fifth Circuit incorrectly decided the Appointments Clause question. In United States v. Arthrex, the Court overcame a federal board’s unreviewability problem by holding a Director could review their decisions, exercising “powers and duties” Congress had otherwise vested in him. Five of the conservative justices were in agreement that unreviewability was incompatible with the Secretary’s authority to appoint those same officers. This would suggest those same justices would take the same view of the Task Force’s insulation from supervision.

In Arthrex, seven of the justices were willing to depart from the statutory scheme intended by Congress by requiring the Director to hold the ultimate authority to review the board’s decisions. The justices diverged on whether the independence of the board was unconstitutional in the first place, which only strengthens support for severing the statute to resolve any unconstitutionality.”

In Arthrex, the Supreme Court simply read out a provision of the statute and gave the director power Congress clearly intended the director not to have. This could have just as easily been done here. In fact, Secretary Becerra has intended to go that route by writing his memo affirming the Task Force’s decisions.

Finally, and even more importantly, the Fifth Circuit’s decision about ACIP and HRSA makes no sense. In both those cases, as the court acknowledges, there is supervision, even if indirect, by a principal officer. For the CDC, the CDC director – who is appointed directly by the President, and since 2025 will require senate approval – is the one who makes the recommendations of the schedule, with the power to approve or reject the committee’s approvals. After 2025, that means the decision will be made by a principal officer; but even now, as the court acknowledges, the Secretary can overturn the decisions – the law says that the Secretary is acting through the director.

That means that the Secretary, who also appoints ACIP’s members, can and could overturn its decisions. The same is true of the administrator of HRSA, again, as the court acknowledged. That means that the Secretary of Health and Human Services has direct authority over both decision-making bodies – the Secretary does not have to exercise that authority all the time, just to have it. Since the court acknowledged that authority, there is no constitutional problem with the recommendations and guidance of those bodies, and the Secretary does not actually need to ratify them.

The Secretary’s ratification memo for them is nice as a statement of support but does not change the fact that the recommendations of these bodies stand by themselves. There is nothing to send back down on this, under the logic of the court’s decision, and appearing to send it back is strange. 

And yet, the Fifth Circuit did make this strange, illogical decision, which, as my colleague Richard Hughes points out, raises the risk that the lower court will overturn previous recommendations of ACIP and HRSA, leaving more people at unnecessary risk of harm.

Richard Hughes IV recently wrote:

While the parties may appeal the Fifth Circuit’s decision to the Supreme Court, it is unclear whether either side has an incentive to do so until further outcomes at the lower court level. The government would perhaps have a slight advantage on appeal—a plausible argument that the Fifth Circuit has misapplied its severability precedent. If successful, it could save the Task Force from its demise while simultaneously blocking the plaintiffs from gaining further advantages at the lower court.

The potential incentives for the plaintiffs to return to Judge O’Connor’s court are indeed great. They just garnered further support for their ACIP and HRSA claims, meaning they have a shot at a favorable decision on those two bodies. The Fifth Circuit has effectively invited the judge to go further. Moreover, the plaintiffs have a plausible path to amending their complaint in support of vacatur, invalidating the coverage requirement nationwide.

The only certainty in Braidwood is an uncertain future for the ACA’s preventive services coverage provision and the tremendous promise it has extended for nearly a decade and half.

Conclusion

The Fifth Circuit’s decision in Braidwood v Becerra is faulty even concerning the Task Force, by treating expert recommendations of an advisory committee as requiring the appointment of principal officers, and by providing a broad remedy, in contrast to the way the Supreme Court handled such cases. It’s even less founded concerning ACIP and HRSA, where the politically appointed Secretary of Health and Human Services has meaningful oversight of the decisions of the agencies. It is a legally problematic decision, and its policy implications could be even worse, since they could undermine coverage of preventive services and, literally, kill and disable people. 

Although the Fifth Circuit narrowed the injunction to cover only the plaintiffs, if the district court follows its instructions, the result may be striking down the preventive services provision, removing insurance coverage of preventive services for those not able to afford more expensive and comprehensive insurance or not knowledgeable enough to look for insurance that covers such services.

Dorit Rubinstein Reiss
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