SCOTUS and Health Agencies (Part 2)

The totally excellent health-policy journal, Health Affairs, posted an analysis of the likely impact of the death of the Chevron doctrine on some hotly (or at least frequently) litigated federal health-law issues: "Supreme Court Overrules Chevron Doctrine: Ripple Effects Across Health Care," by Zachary Baron et al. (I have no idea if this article is available only to subscribers (like me) or is free to the public. The latter, I hope.)

The authors start with Chevron itself, a useful three-paragraph introduction especially for anyone -- lawyers and non-lawyers alike -- with limited or no familiarity with Chevron deference.

After that, the authors focus on six areas of possible impact as a result of the Court's decision in the Loper Bright Enterprises case (discussed by this blog on July 7):

1. Nondiscrimination Protections. This includes "the battle over the meaning of 'sex' under Section 1557 [of the Affordable Care Act], which prohibits discrimination in health care on the basis of race, color, national origin, disability, age, and sex."
2. Medicare Reimbursement. An early test might be a case currently pending before the Supreme Court for its 2024 Term: Advocate Christ Medical Center v. Becerra. As the authors point out, there are few statutes that rival the Medicare statute in complexity, and lower courts often decide these reimbursement disputes by relying on Chevron: If the statutory provision is unclear (which is often the case), the courts defer to any reasonable interpretation by HHS/CMS. That was the case in Advocate Christ Medical Center. If I had to guess, this case might be remanded for reconsideration in light of Loper Bright, but there will be others!
3. Medicare Advantage. Noting that "federal agencies often face hurdles to accomplishing their regulatory goals separate and aside from Chevron, . . . the path forward for litigation over the MA program following Chevron being overruled is not clear." Not necessarily good news for "more than half, or 51 percent, of the eligible Medicare population."
4. Medicare Drug Negotiation. BigPharma has been fighting this program since before its enactment, bringing "a slew of constitutional, statutory, and agency authority claims against the negotiation program, [and] industry has lost on the substance of all their legal arguments." Will Loper Bright help the drug makers in future court challenges to the program. The authors think not.
5. Private Health Insurance. In the more than 2,000 legal challenges to the Affordable Care Act and its volumes of regulations, Chevron has played a role in the final rulings of many cases but far from all. The authors look at a couple of cases involving the No Surprises Act that are currently pending before the Fifth Circuit. The authors conclude: "Now, the Administration and health care providers are sparring about the fallout from the Loper Bright decision and how it will impact the pending Fifth Circuit decisions. Yet with the current Fifth Circuit taking such a strict approach to statutory interpretation even when Chevron remained on the books, the Administration faces a challenging environment there."
6. FDA. Chevron deference has been "critical to allow FDA to use its expertise to administer very complex and technical programs that widely touch industry and health care consumers alike. . . . Overturning Chevron could open the floodgates to challenges of a wide variety of FDA regulations." 

The authors conclude:

This revised legal regulatory landscape opens up new opportunities to challenge regulations and other agency actions by future administrations. These challenges may affect the implementation of agency regulations addressing consumer protections, access to health care services, women’s rights, and other measures that impact health care costs. . . . The level of disruption remains uncertain, and may be felt unevenly, but the trend line remains clear: Courts more than ever will have the final say on complex policy decisions that affect the health of millions of Americans."

Oh, happy day. {sigh} 

Does EMTALA Require Medically-Appropriate Abortion Even in the Absence of a State Exception for Emergency Medical Conditions? [Updated June 27]

One of the most eagerly awaited opinions yet to be released by SCOTUS is -- or was (see below) -- Moyle v. United States, Docket No. 23-726. The question presented is "Whether the Supreme Court should stay the order by the U.S. District Court for the District of Idaho enjoining the enforcement of Idaho’s Defense of Life Act, which prohibits abortions unless necessary to save the life of the mother, on the ground that the Emergency Medical Treatment and Labor Act preempts it."

The federal district court for Idaho ruled that EMTALA pre-empts state law and requires hospitals to provide stabilizing medical care for emergency conditions, which federal law defines more broadly than life-threatening conditions.The U.S. Court of Appeals for the Ninth Circuit declined to stay the lower-court injunction against enforcement of Idaho's law pending appeal from the district court's ruling. 

This set up the appeal to SCOTUS. Merits briefs were filed and the case was argued in April. With the Supreme Court's term winding down, Moyle was one of the most anticipated cases left on the Court's docket, especially after a Fifth Circuit decision that rejected the EMTALA pre-emption argument (Texas v, Becerra, No. 23-10246, 5th Cir., Jan. 2, 2024).

SCOTUSBlog (free access) reports that Bloomberg (possible paywall) reports that earlier today, inadvertently and only briefly, SCOTUS posted an opinion in Moyle that dismisses the case on the ground that review was improvidently granted. Assuming no change after the premature release, this will keep the 9th Circuit's refusal to stay the district court's injunction pending appeal. 

Update: On Thursday, June 27, SCOTUS released the official order and concurring and dissenting opinions:

A. The effect of this order is to allow the district court's injunction against enforcement of the restrictive Idaho law, which means doctors and hospitals may provide EMTALA-mandated stabilizing treatment -- including abortions, as needed -- when continuing the pregnancy represents a threat to the pregnant person's health. Eventually the 9th Circuit will decide this case on the merits (assuming there's no problem with standing), the losing party will ask SCOTUS to review, and SCOTUS will decide in its discretion whether to grant the request.

B. A majority of the Court is unlikely to say this, but it's obvious that they view the Court's January actions to be a mistake. Which actions? All of them:

• Entering a stay that had the effect of negating EMTALA and allowing the restrictive Idaho law to be enforced;
• Skipping over the usual order of things, which would typically allow the Court of Appeals to rule on the merits before deciding whether to grant review; and
• Treating the petitioner's request for a stay as the equivalent of a petition for certiorari and then granting the "petition."

C. Some of the Justices weren't shy about calling out other Justices, either for entering a stay in the first place or for now changing their minds about the stay. There were lots of opinions, and they don't conform to the usual 6-3 lineup along party lines:

1. Opinion per curiam. 
2. Kagan, J., filed a concurring opinion, in which Sotomayor, J., joined, and in which Jackson, J., joined as to Part II. 
3. Barrett, J., filed a concurring opinion, in which Roberts, C. J., and Kavanaugh, J., joined. 
4. Jackson, J., filed an opinion concurring in part and dissenting in part. 
5. Alito, J., filed a dissenting opinion, in which Thomas, J., joined, and Gorsuch, J., joined as to Parts I and II.

How Much Does the Fifth Circuit Care About Public Health?

The 5th Circuit Court of Appeals has handed down a couple of decisions this week that surprised me a lot (except that this 5th Circuit is the most conservative federal appellate court in the country):

1. Abortion. The Texas Tribune has a good story on the history of this litigation and Tuesday's ruling (State of Texas et al. v. Becerra, No. 23-10246  (Jan. 2, 2024). The court upheld a permanent injunction against an HHS injunction against DHHS's post-Dobbs guidance that the Emergency Medicine & Active Labor Act (EMTALA) requires Medicare providers to perform an abortion when that is necessary to stabilize a pregnant woman's emergency (life- or limb-threatening) condition. The court concluded that Congress did not intend for the statute to require performance of a procedure that was forbidden by state law. The court went on, asserting that Texas law provides plenty of protection for procedures, including abortion, when continuing the pregnancy poses a threat to the pregnant woman's life or a major bodily function. This is the same line taken by the Texas Supreme Court in its opinion that denied Kate Cox's bid for an abortion under the same exception to the state's abortion ban. 

Meanwhile, according to Kate Riga at TalkingPointsMemo.com, the same issue is in front of the 9th Circuit Court of Appeals. Depending on the outcome of that case, the issue may land at SCOTUS's doorstep soon.

2. E-cigarettes. The case is Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, No. 21-60766 (Jan. 3, 2024). This was an en banc proceeding of the Court of Appeals, with a majority opinion by Judge Oldham (and joined by nine others) and a dissenting opinion by Judge Haynes (joined by four others). The result of the case is that the FDA is ordered to review over 1 million pre-market tobacco applications (PMTAs) against the backdrop of clear and convincing evidence that e-cigs represent a serious health threat, especially to minors, with no countervailing health benefits. 

This is Judge Haynes' take on the majority opinion (emphasis added):

It is against this backdrop that the FDA reviewed the PMTAs of Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia LLC (“Vapetasia”) (collectively, “Petitioners”) and issued marketing denial orders (“MDOs”) to Petitioners.  The FDA denied Petitioners’ PMTAs because they did not contain any reliable evidence suggesting the benefits of Petitioners’ flavored products outweighed the significant risks to youth—an outcome that aligned with both the guidance the FDA had given to applicants and its statutory mandate under the TCA.  But the majority opinion erroneously concludes that the FDA changed the evidentiary standards applied to Petitioners’ PMTAs and wholly ignored Petitioners’ marketing plans, and thus acted in an arbitrary and capricious manner.  Unfortunately, based on a misreading of the law and a misconstruing of the relevant facts, the majority opinion supersedes the FDA’s work by remanding instead of denying the petition, which cuts the FDA’s legs out from under it in the middle of a dangerous and constantly evolving public health crisis.  

In so doing, the majority opinion also departs from all but one of our sister circuits that have addressed the same issue.  See, e.g., Magellan Tech., Inc. v. FDA, 70 F.4th 622 (2d Cir. 2023) (unanimous denial); Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022) (unanimous denial); Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022) (unanimous denial), cert. denied, No. 22-1112, 2023 WL 6558399 (U.S. Oct. 10, 2023); Gripum, LLC v. FDA, 47 F.4th 553 (7th Cir. 2022) (unanimous denial), cert. denied, 143 S. Ct. 2458 (2023); Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657 (9th Cir. 2023) (unanimous denial); Prohibition Juice, 45 F.4th 8 (unanimous denial); see also Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021) (denying motion for stay), app. for stay denied, 142 S. Ct. 638 (2021).  The only circuit that granted a petition for review in a comparable context did so on much narrower grounds than the majority opinion embraces today.  See Bidi Vapor, 47 F.4th at 1195 (remanding based on the FDA’s failure to consider marketing and sales-access-restriction plans); but see id. at 1208–18 (Rosenbaum, J., dissenting).  Despite the Eleventh Circuit’s opinion, however, it is telling that the Supreme Court recently denied certiorari for two cases in which other circuits considered similar facts to those before us and denied the petition for review.  See Gripum, LLC v. FDA, 143 S. Ct. 2458 (2023) (mem.); Avail Vapor, LLC v. FDA, No. 22-1112, 2023 WL 6558399 (U.S. Oct. 10, 2023) (mem.); see also Breeze Smoke, LLC v. FDA, 142 S. Ct. 638 (2021) (mem.) (denying application for stay of FDA’s denial, without any recorded dissent). 

Reevaluating this case en banc, I would reach the same determination that the merits panel did and deny the petitions for review before us.

I concur.