JAMA On-line: Scorn for Approach of Texas Supreme Court and AG in Cases Involving Exceptions to Abortion Ban

In an excellent on-line (and free) commentary in JAMA (Jan. 22, 2024), three Harvard authors ask the question: "Whose Responsibility Is It to Define Exceptions in Abortion Bans?" (Disclosure: One of the authors, Louise King, M.D., J.D., is a friend and former colleague.)

The context for this question is not surprising:

Two Texas court cases were filed in late 2023 requesting clarification of the scope of the life exception. In the first case, In re State of Texas, the Texas Supreme Court indicated that clinicians or the Texas Medical Board have responsibility for defining that exception. In the second case, State [of Texas] v Zurawski, the Texas attorney general suggested during oral arguments that the scope would be defined through medical malpractice litigation.

In short, both the Texas Supreme Court and the AG punted on the essential and inescapable issue of the scope of "life exception" to Texas's abortion ban.

Is that a problem?

At first glance, the Texas Supreme Court and attorney general may seem to defer to the expertise of clinicians and the medical system for when abortions are necessary to save a patient’s life. But upon closer analysis, these proposed ways to define the exception’s scope are neither workable nor constitutional. Putting the burden of defining a crime on the person who may commit it violates the US Constitution. Demanding that patients be injured and sue for malpractice to clarify a criminal statute is beyond draconian.

Legislating medical care means clinicians could risk prosecution if they act according to their ethics and training and follow the standard of care. But if they decline to provide care out of fear of legal consequences, they risk injuring a patient and facing a potential malpractice claim. It is for these very reasons that professional societies like the American College of Obstetricians and Gynecologists and the American Medical Association argue strongly against all legislation that interferes with the patient-clinician relationship.2 Texas and other states that criminalize abortion should consider the tremendously harmful effect that comes from interfering in clinical decision-making. 

This short but compelling commentary is worth reading in its entirety. It offers a fine illustration of the hall of mirrors created by the Texas legislature, Supreme Court, and Attorney General. 

 

JAMA: Increased Depression & Anxiety in Trigger States After Dobbs Decision

In a free article in the Journal of the American Medical Association (JAMA. 2024;331(4):294-301. doi:10.1001/jama.2023.25599) (PDF), researcher report that "[l]iving in states with trigger abortion bans compared with living in states without such bans was associated with a small but significantly greater increase in anxiety and depression symptoms after the Dobbs abortion opinion." The authors conclude:

The findings provide new evidence about the relationship between the changing abortion policy landscape and mental health following the Dobbs opinion. Although there were increases in symptoms of anxiety and depression for the general population after the opinion, changes in symptoms of anxiety and depression were greater among those living in states with trigger abortion bans, and in particular, among females within the age range generally used to compute lifetime abortion incidence. This finding could be related to many factors, including fear about the imminent risk of abortion denial; uncertainty around future limitations on abortion and other related rights, such as contraception; worry over the ability to receive lifesaving medical care during pregnancy; and a general sense of violation and powerlessness related to loss of the right to reproductive autonomy.

Donald Trump and the Perils of Practicing Medicine Without a License

Hydrochloroquine for COVID? Remember when that was a thing?

From The Messenger (Jan. 4):

In a study published this week in the journal Biomedicine & Pharmacotherapy, French researchers found that 17,000 people died across six countries because they depended on [the] drug. Researchers say this is because the drug was used in lieu of more effective treatments, and the potential cardiovascular issues it can cause as a side effect.

That number includes 12,000 deaths in the U.S. alone. Politico adds: "In fact, they say the figure may be far higher given the study only concerns six countries from March to July 2020, when the drug was prescribed much more widely."

You may recall that hydrochloroquine was then-President Trump's treatment of choice (along with household bleach). Here's the history reminder from The Messenger:

It was quickly shown to be ineffective. However, in a situation The Lancet describes as a “comedy of errors”, many political figures continued to endorse the drug as a legitimate COVID treatment. According to one report, Donald Trump, who was president at the time, was among the most prominent advocates of the medication as a treatment for COVID, mentioning it on Twitter and in press briefings.

“What do you have to lose? Take it,” Trump said during a White House briefing in 2020. “I really think they should take it. But it’s their choice. And it’s their doctor’s choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you’d like.”

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. 

Four New Advisory Opinions from HHS-OIG

On Jan. 3, HHS's Office of Inspector-General (OIG) released four new Advisory Opinions, all apparently finalized at the end of December:

Advisory Opinion 23-12: This favorable opinion regards a one-time, voluntary redemption offer to physician partners reaching age 67 to have their partnership units repurchased by a partnership over a 2-year period, contingent upon the physician partners’ agreement to retire from the practice of medicine.  

Advisory Opinion 23-13: This favorable opinion regards the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay. 

Advisory Opinion 23-14: This favorable opinion regards the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.  

Advisory Opinion 23-15: This favorable opinion regards a physician consulting company’s proposal to offer physician practices that are current customers of the company certain gift cards for referring potential new physician practice customers.

 

Physician Acquitted in $15M Healthcare Fraud Prosecution

A federal jury in Maryland convicted the physician on five counts of healthcare fraud in connection with his billing practices for level 4 CPT codes for evaluation and management services (E/M) for Covid patients. According to Becker's Hospital Review:

Ron Elfenbein, MD, 49, owned First Call Medical Center and Chesapeake ERgent Care, which operated multiple drive-thru COVID-19 testing sites. He instructed employees, in addition to billing for COVID-19 tests, to bill for high-level evaluation and management visits, according to an Aug. 4 Justice Department news release. Dr. Elfenbein ordered the high-level visits to be billed for all patients, including those who were asymptomatic, getting tested for their employment requirements or being tested so that they could travel, according to the release. Dr. Elfenbein was accused of submitting false claims for tens of thousands of high-level visits that were ineligible for reimbursement. 

As analyzed by Husch Blackwell:

[U]nlike some CPT codes, E/M CPT codes are imprecise. There is purpose in E/M CPT codes’ imprecision in that it allows physicians flexibility to exercise their best judgment given the multitude of factors that go into medical decision-making.

But that imprecision in E/M CPT codes makes for difficult federal prosecutions. As the court held in overturning Dr. Elfenbein’s convictions, CPT codes’ “imprecision does not necessarily integrate well with the clear notice and due process guarantees of our criminal law” and “where the relevant CPT codes and related definitions are ambiguous and subject to multiple interpretations, problems clearly arise.” 

Does this mean DOJ can't win ambiguous-CPT code cases? Not at all (from Husch):

The court was careful to make clear that it is possible for the Justice Department to successfully prosecute defendants who take advantage of ambiguous CPT codes, but that such prosecutions must show objective falsity in a way the prosecutors failed to do in Dr. Elfenbein’s trial. The “Government sails in shallow waters when it prosecutes a case of this type; these cases require careful navigation,” wrote the court.

To make its point, the court pointed to several cases in which the Justice Department was able to navigate ambiguous waters, including one E/M CPT case in which the prosecution’s expert testified the medical judgment was “not even close to being properly classified” at the code’s level. And so, while prosecutions based on ambiguous CPT codes are clearly an uphill battle for the Justice Department, they are not insurmountably uphill. 

The district court's 90-page opinion is here. 

UPDATED: Considerations on the Use of Neonatal and Pediatric Resuscitation Guidelines for Hospitalized Neonates and Infants

It's always a big deal when the American Academy of Pediatrics and the American Heart Association  publish an update on the use of resuscitation guidelines for neonates and infants. The latest dropped Dec. 18 (Volume 153, Issue 1. January 2024). The guidelines are different for the two groups, and deciding which guidelines to follow appears to be as much art as science. From the Conclusion: "The lack of robust scientific data makes it impossible to provide definitive recommendations on when to transition from neonatal to pediatric resuscitation guidelines for hospitalized neonates and infants." 

Also missing are a feature of the AHA Guidelines for resuscitation in adults: a section on decisions to withhold resuscitation based upon a futility determination.