SCOTUS Watch: Week of Dec. 2

The Court will hear arguments in two important health-law-related case this week:

• Monday, 12/2: E-cigarettes and the FDA. The Court will consider "[w]hether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious." Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, reviewing the en banc decision of the 5th Circuit Court of Appeals, which vacated the FDA's orders as arbitrary and capricious.  

• Wednesday, 12/4: Gender-affirm care for minors.
  The Court will consider "[w]hether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow 'a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex' or to treat 'purported discomfort or distress from a discordance between the minor’s sex and asserted identity,' violates the equal protection clause of the 14th Amendment." United States v. Skrmetti, No. 23-477, reviewing the decision of the 6th Circuit Court of Appeals, which reversed the preliminary injunctions issued by the district courts and remanded them for further proceedings.

 

Hospital Price Transparency Rule & No Surprises Act: Two Updates (One Surprising, the Other Not So Much)

I. HHS OIG Report -- Disappointing But Not So Surprising

"Not All Selected Hospitals Complied With the Hospital Price Transparency Rule (A-07-22-06108)

"Not all of the selected hospitals made their standard charges available to the public as required by Federal law. 

[Note: This is one of the most basic, and hotly contested (and resisted), requirements of the ACA, which added § 2718 to the the Public Health Service Act. In 2019 CMS promulgated the final version of its Hospital Transparency Rule with this introduction: "This final rule establishes requirements for hospitals operating in the United States to establish, update, and make public a list of their standard charges for the items and services that they provide. These actions are necessary to promote price transparency in health care and public access to hospital standard charges".] 

Of the 100 hospitals in our stratified random sample, 63 complied with the Hospital Price Transparency (HPT) rule requirements. Thirty-seven did not fully comply with one or both of the following criteria: 34 hospitals failed to meet one or more requirements for publishing comprehensive machine-readable files, and 14 hospitals did not display shoppable services in a consumer-friendly manner. Based on these sample results, we estimate that 46 percent of the 5,879 hospitals required to comply with the HPT rule did not make information about their standard charges publicly available. [emphasis added]

"Read the Full Report"

II. Fifth Circuit Sides with the Administration For Once -- Surprising

From the Centers for Medicare and Medicaid Services:

On October 30, 2024, the United States Court of Appeals for the Fifth Circuit (Fifth Circuit) issued an opinion in Texas Medical Association, et al. v. United States Department of Health and Human Services et al., Case No. 23-40605 __ (TMA III). The Fifth Circuit partially reversed a decision of the U.S. District Court for the Eastern District of Texas (the District Court). The Fifth [C]ircuit partially reversed the District Court’s holding that vacated certain provisions of the regulations and guidance under the No Surprises Act related to the methodology for calculating the qualifying payment amount (QPA). [Rules and Fact Sheets; statute] It also affirmed the District Court’s vacatur of certain deadline provisions and affirmed the District Court’s holding as to the disclosure requirements. The Departments and OPM are reviewing the Fifth Circuit’s decision and intend to issue further enforcement guidance in the near future.  [hyperlinks added]

For more litigation-related context, Zachary Baron writes for Health Affairs' "Forefront": 

Years after the bipartisan enactment of the No Surprises Act (NSA) in late December 2020 to protect consumers from the most pervasive out-of-network surprise medical bills and constrain overall health care costs, ongoing litigation continues to shape the implementation of the NSA. 

Much of the litigation has focused on the manner in which the Administration sought to implement aspects of the law’s arbitration process related to disputes between providers and insurers over certain out-of-network payments. Data from arbitration under the law shows providers have continued to win most of the disputes, with filings heavily dominated by a few provider groups (backed by private equity) in a few states.

But other cases reach beyond the arbitration process, including how the qualifying payment amount (QPA) is calculated under the law. While important in the arbitration process, the QPA also has a direct connection to patient cost-sharing because it is the basis for determining what individuals might owe for items and services covered by the law’s balance-billing protections.

On October 30, 2024, a Fifth Circuit panel unanimously reversed a ruling by a Texas district court judge to vacate certain regulatory provisions related to the NSA’s QPA methodology. The decision also touched on other regulations implementing the NSA, upholding one victory secured by providers.

This article will examine the Fifth Circuit panel’s decision in detail, including insights into how courts approach disputed statutory provisions after the Supreme Court’s decision in Loper Bright overruling the Chevron doctrine. While the appeal concerned litigation brought by the Texas Medical Association (TMA) and certain air-ambulance providers, this article will call the case TMA III to distinguish it from earlier litigation brought by TMA and air-ambulance providers challenging previous regulations under the NSA. [emphasis added]

The full article is well worth the time to read.

Reprise: Does EMTALA Pre-Empt Restrictive State Abortion Laws?

Back in June I discussed the applicability of the federal Emergency Medical Treatment and Labor Act to pregnant persons who come to hospital emergency departments with pregnancy-related emergency conditions for whom an abortion is the accepted standard of emergency medical treatment. Common sense should tell us that a federal statute that requires that emergency conditions be stabilized supersede state laws that provide otherwise. A passing familiarity with the Constitution's Supremacy Clause confirms common sense. And -- as stated in an article in the Journal of the American Medical Association ("JAMA") -- "[a contrary] argument [is] particularly absurd in that it turns the rule of law on its head—ignoring more than 200 years of well-settled legal principles that date back to the nation’s founding—namely, that federal law preempts contrary state law.

As this foundational constitutional principle applies to emergency abortion cases, the article observes that "[s]ince the George W. Bush administration, the Department of Health and Human Services (HHS) has interpreted EMTALA to require pregnancy termination if it represents the stabilizing care necessary to save the pregnant patient’s life or prevent grave harm to health."

The federal district court in Idaho followed this precedent, history, and the statutory text and held that EMTALA applies when state law prohibits abortions in response to pregnancy-related emergencies, Moyle v. United States (Idaho), and entered an injunction against enforcement of the restrictive Idaho abortion law. The 9th Circuit Court of Appeals, sitting en banc, refused to stay the district court opinion, which left the district court's injunction in place. The Supreme Court granted review and then decided certiorari was improvidently granted and sent the case back the the 9th Circuit for further development, presumably for a full hearing and decision on the merits. For the time being, the district court's injunction remains effective, providing a small measure of sanity to apply in Idaho.

Not so much in the 5th Circuit, which includes Texas, Mississippi, and Louisiana, where EMTALA and the Supremacy Clause were brushed aside in Texas v, Becerra (5th Cir. 2024). The case involved a challenge to guidance from the U.S, Department of Health & Human Services, which advised in 2022 (within a couple of weeks of the Supreme Court's decision in Dobbs), that EMTALA supersedes state-level abortion bans and restrictions. The 5th Circuit's opinion is limited to its affirmance of the lower court's injunction prohibiting Texas officials from following the HHS guidance, but there is no doubt that a similar challenge to the HHS guidance by Mississippi or Louisiana would be equally successful.

The JAMA article makes a couple of key points that bear repeating here:

• "The idea of a pregnant person being turned away from an emergency department because they are not near enough to death betrays every core principle of medical ethics: beneficence, nonmaleficence, autonomy, and justice."
• "Maternal mortality and morbidity rates in states with abortion bans are so high that they surpass those of every high-income country. High rates of infant mortality and morbidity are now the norm in states with the strictest abortion bans. Indeed, research now confirms the troubling increase in infant deaths after the abortion ban in Texas. If abortion bans are supposed to protect pregnant persons and infants, as proponents of the laws suggest, they are failing miserably" [footnote omitted].

For the time being, the Supreme Court's docket for the Fall 2024 Term doesn't include a pregnancy/EMTALA case. As I noted yesterday, he Court has denied review in a Texas case that raised the issue whether the state's restrictive abortion law violates federal EMTALA law. Xavier Becerra, Secretary of Health and Human Services v. Texas, No. 23-10246. Similar challenges are likely to meet the same fate, so we will have to wait for the 9th Circuit to deliver a decision on the merits of the EMTALA issue. It's entirely likely that there will be four votes to grant certiorari to resolve a split among the circuits. I don't know whether to look forward to or to fear such a decision from the Court.