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.

Medicare Cognitive Assessments: Yet Another Example of Mental Health's Second-Class Status

A new GAO report -- "Medicare Cognitive Assessments: Utilization Tripled between 2018 and 2022, but Challenges Remain" (Dec. 11) -- is a good-news/bad-news sort of thing. 

First, the (somewhat) good news: “Cognitive assessment and care plan services” is a service available to Medicare beneficiaries in which providers diagnose and develop a plan to manage cognitive impairments, such as Alzheimer's disease. . . . GAO found that use of the service in traditional fee-for-service Medicare tripled from 2018 through 2022." Demand undoubtedly increased, due in part to the stresses and challenges of COVID. 

And it's possible that utilization of this Medicare service also increased because of increased availability and awareness.

But the bad news suggests otherwise: "[A] relatively small number of Medicare beneficiaries diagnosed with a cognitive impairment received the service. GAO calculated that, at most, in 2021, about 2.4 percent of traditional Medicare beneficiaries with a diagnosis of Alzheimer's disease or a related disorder may have received the service." 

Possible explanations for this low level of service within the population of the elderly cognitively impaired include: "various challenges faced by providers delivering the cognitive assessment service and beneficiaries trying to access the service. Provider challenges include (1) the time needed [60 minutes of face-to-face interaction], particularly for providers who typically schedule 15-20-minute visits; (2) billing limitations that prevent providers working in teams to collaborate on the service visit; and (3) limited training for primary care providers [who provide more than 80% of Medicare cognitive assessments]."

But wait -- there's more: 

"Some stakeholder groups reported that the stigma of being assessed for, or being diagnosed with, a cognitive impairment is a challenge for beneficiaries. Research we reviewed found that individuals aged 40 and older have stigmas or negative thoughts and perceptions regarding cognitive impairments and potentially being diagnosed with these conditions. Both beneficiary advocacy groups and the policy group we interviewed noted that such stigmas can make beneficiaries hesitant to access the cognitive assessment service. According to one primary care provider group, the very act of performing a cognitive assessment implies to a beneficiary that a cognitive impairment exists. Additionally, five stakeholder groups noted that beneficiaries’ understanding of cognitive impairments and the services available to them may be related to perceptions of stigma, or negative thoughts and perceptions about their conditions. Further, research has found that stigma, including worry, fear, and shame, is known to interfere with and delay seeking important medical care for cognitive impairments." [footnotes omitted]

Despite repeated legislative attempts over the decades, mental health impairments continue to be under-diagnosed and under-treated. As this report illustrates, the problems are both structural and behavioral. La plus ça change . . . .

Ruth Marcus: Calling Out the Texas Supreme Court for its Opinion in the Kate Cox Case

Ruth Marcus is one of the most acute observers of political cultural and political life in this country. Now add legal commentary to her toolkit (she's a 1984 graduate of Harvard Law School). There's no better example than her column in the Washington Post eviscerating the Texas Supreme Court's opinion in the Kate Cox case. There's a paywall, but there may also be a quota of free articles that non-subscribers can tap into. If not, here are a few highlights:

• "Women of Texas, now you know: The state’s abortion law will not protect you in the case of a medical emergency. Not only will the state’s attorney general come after you, the all-Republican, Texas Supreme Court will contort itself to find that your situation doesn’t constitute an emergency that would allow an abortion to proceed. Never mind what your doctors say — courts know best, even as they purport to be deferring to medical judgment."
• "The court’s brief ruling — seven pages almost entirely devoid of legal reasoning — is a masterpiece of intellectual dishonesty masquerading as judicial deference."
• "[T]he craft of judging is about applying the law to specific facts, and here is where the Texas justices fell woefully short. The court’s opinion never explains why it is not a reasonable medical judgment that abortion is advisable in this situation, in which Cox would otherwise be forced to continue with a doomed pregnancy and incur the risk of a repeat C-section or uterine rupture from vaginal delivery. It acts as if Cox’s obstetrician hadn’t determined that an abortion would be in her best medical interest, when in fact she had found just that. It all but writes the provision about impairment of a major bodily function out of the law."
• "Theoretical exceptions are cold comfort to real women in excruciating circumstances, and without hope of getting the care they desperately need."

Harsh but fair. 

Kaiser: Who Decides When a Patient Qualifies for an Abortion Ban Exception? Doctors vs. the Courts

 Here's a thoughtful brief from the Kaiser Family Foundation on abortion-ban exceptions around the country.

It starts with a quick summary of the Texas Supreme Court's opinion in the Kate Cox case and follows with some observations that somehow escaped the attention of Texas's high court:

• "The case in Texas highlights the impossible situation that many doctors and patients find themselves in when faced with a pregnancy that may qualify for an exception."
• "[I]f doctors are prosecuted for providing abortions under an exception, the courts will nonetheless end up determining whether the abortions qualified for an exception and physicians will still be vulnerable to having their judgment second-guessed by judges and juries. Unable to get a determination from a court ahead of providing care, yet vulnerable to prosecution after providing care, doctors and their patients caught in a 'Catch-22.' In this case, Ms. Cox was reportedly able to leave the state to receive the abortion care her doctor believed she needed, but others may not have the resources to travel out of state to get medically-indicated care."
• "All 20 states with abortion and gestation bans currently in effect contain exceptions to 'prevent the death' or 'preserve the life' of the pregnant person. Like Texas, these exceptions are not clear how much risk of death or how close to death a pregnant patient may need to be for the exception to apply, and the determination is not explicitly up to the physician treating the pregnant patient."
• "The Texas abortion ban specifies that the physician must determine that the abortion is necessary based on their 'reasonable medical judgement.' This standard leaves physicians in a legally vulnerable situation and understandably reluctant to certify a pregnancy as qualifying for a life or health exception. This reluctance stems from the concern of being found guilty of violating the law if the court relies on the testimony of other medical experts that say that the treating physician didn’t meet the standard for “'reasonable medical judgement.'"

The brief includes an interactive that shows the exceptions for life, health, rape/incest, and fatal fetal anomalies in states that have them:

Texas Supreme Court Puts an Exclamation Point on Kate Cox's Doomed Quest for Reproductive Health Care in Texas

Late yesterday (12/11) the Supreme Court of Texas issued a seven-page per curiam opinion that reversed the trial court's order in the action Kate Cox brought against the State of Texas. 

The trial court enjoined state officials from enforcing statutory abortion prohibitions based upon the "good faith belief" of Ms. Cox's physician that "continuing the pregnancy puts her at high risk for severe complications threatening her life and future fertility, including uterine rupture and hysterectomy" [Complaint ¶ 1]. A reasonable interpretation of this language would conclude that Ms. Cox's pregnancy "places [her] at risk of death or poses a serious risk of substantial impairment of a major bodily function unless the abortion is performed or induced," the statutory exception to Texas's abortion prohibition., TEX. HEALTH & SAFETY CODE § 170A.002(b)(2). That is not the Supreme Court's interpretation.

Ms. Cox's physician's "good faith belief" is presumably based upon two subsidiary considerations: [1] a medical conclusion based upon reasonable medical judgment combined with [2] uncertainty as to the scope of the vague language of the statutory exception. There is no other way to read ¶¶ 138-139 of the Complaint:

138. Dr. Karsan has met Ms. Cox, reviewed her medical records, and believes in good faith, exercising her best medical judgment, that a D&E abortion is medically recommended for Ms. Cox. 

139. It is also Dr. Karsan’s good faith belief and medical recommendation that the Emergent Medical Condition Exception to Texas’s abortion bans and laws permits an abortion in Ms. Cox’s circumstances, as Ms. Cox has a life-threatening physical condition aggravated by, caused by, or arising from her current pregnancy that places her at risk of death or poses a serious risk of substantial impairment of her reproductive functions if a D&E abortion is not performed. 

[emphasis added]

This was not good enough for the Supreme Court, though:

Dr. Karsan did not assert that Ms. Cox has a “life-threatening physical condition” or that, in Dr. Karsan’s reasonable medical judgment, an abortion is necessary because Ms. Cox has the type of condition the exception requires. . . .  The exception requires a doctor to decide whether Ms. Cox’s difficulties pose such risks [i.e., to the pregnant woman's life or substantial bodily function].  Dr. Karsan asked a court to pre-authorize the abortion yet she could not, or at least did not, attest to the court that Ms. Cox’s condition poses the risks the exception requires.    

Does the outcome in this case really turn on a physician's attestation that she exercised reasonable medical judgment? If the verified petition in this case doesn't meet that standard, does the Court require three "magic words" to establish a woman's right to necessary medical care? Is there a difference between "best medical judgment" and "reasonable medical judgment"? The Court writes that "[a]  pregnant woman does not need a court order" to get an abortion in Texas. But if the scope of the statutory exception is uncertain, does the Court seriously expect physicians to risk a 99-year prison sentence and a $100,000 fine without first obtaining a court's authorization? 

And on the vagueness argument, the Court concludes:

The Texas Medical Board, however, can do more to provide guidance in response to any confusion that currently prevails.  Each of the three branches of government has a distinct role, and while the judiciary cannot compel executive branch entities to do their part, it is obvious that the legal process works more smoothly when they do.

The Legislature pretty clearly intended the in terrorem effect that SB 8 and post-Dobbs enactments have produced. And in terrorem effects work best when the law is vague, its application is potentially broad, and the penalties for being wrong are draconian. Unfortunately, the Court's opinion in the Cox case -- whether wittingly or not -- plays into this cynical strategy. 

Kate Cox Leaves Texas to Obtain an Abortion

I put up a series of posts last week to illustrate the tortuous path taken by Kate Cox in order to terminate a pregnancy that posed a threat to her health and future reproductive prospects. By the end of the week, the Texas Attorney General was threatening civil and criminal action against her doctor and any hospital that allowed the procedure to be performed there AND the Texas Supreme Court stayed the order of a Texas trial judge that was based on the judge's conclusion that Ms. Cox fell within the statutory exception to Texas's abortion ban.

As reported this afternoon by the Washington Post, the New York Times, NBC, ABC, and the Guardian, Ms. Cox has left the state to obtain the abortion that has so far been denied her in her home state: 

“Kate desperately wanted to be able to get care where she lives and recover at home surrounded by family,” Nancy Northup, the chief executive for the Center for Reproductive Rights, which was representing Ms. Cox in her case, said in a statement on X. “While Kate had the ability to leave the state, most people do not, and a situation like this could be a death sentence.”

Ms. Cox describes last week's legal developments as "hellish." It's a fit description of a society that meets a very human loss such as hers with motions, briefs, opinions, orders, and sabre-rattling by an indicted Attorney General. It reminds me of Grant Gilmore's great quote from The Ages of American Law (1977):

Law reflects, but in no sense determines the moral worth of a society…. The better the society, the less law there will be. In Heaven, there will be no law, and the lion will lie down with the lamb…. The worse the society, the more law there will be. In Hell, there will be nothing but law, and due process will be meticulously observed.

Unfortunately, last week was Kate Cox's introduction to hell. 

Blog Post #1,000: Celebrating Emily Dickinson's 193rd Birthday

Taking a break from Health Care Law for this special blog post. But do read on for the health care tie-in. Promise.

From Day 1 -- 20 years ago -- the description for HealthLawBlog has included "poetry and other things that matter." So it's entirely fitting that my 1,000th blog post should fall on Emily Dickinson's 193rd birthday. 

The "Belle of Amherst" was born in Amherst, Massachusetts in 1830, and after 10 months of study at the Mount Holyoke Female Seminary, now Mount Holyoke College, lived out the rest of her 38 years back in her hometown. The home where she spent most days is now the Emily Dickinson Museum, a great place to visit and a website that is full of resources.

Emily Dickinson published 11 poems in her lifetime. Her 1,755 poems stand alongside the poetry of her contemporary, Walt Whitman, as the beginning of modern American poetry. She was obsessed with "Death," and her poems are an indispensable guide -- and challenge -- for health care providers who rely on the humanities to develop their professional chops.

This is why her poetry is included in my course, older than HealthLawBlog itself, "Law, Literature & Medicine." Ten 4th-year medical students from UT-Southwestern Medical School and ten 3rd-year Dedman Law students join together every spring semester to explore common issues in professional identity formation. Big shout-out to my collaborator UTSW prof (and law school adjunct) Reeni Abraham, M.D.! 

Poetry is a big part of the readings, and Emily is always on the list. 

Happy birthday, Em!

Hospital Discharge Planning: It Takes a SYSTEM

On Thursday (Dec. 7), I posted about a Catholic hospital system in California that has taken to suing patients for trespass when they refuse to leave the hospital after a discharge order has been written. I don't know how the suits will turn out (settled, is my guess), but there are factual disputes as to whether safe discharge locations (such as home, nursing home, intermediate care facilities) are available for patients who leave their hospital settings. The hospitals undoubtedly believe there are safe alternatives, so if there is no settlement, there will need to be a trial to resolve the factual disagreements. In short, it's a mess.

Another side of the same coin was highlighted by a different kind of story later in the week. Coming a $2.3 billion operating loss in 2022, Massachusetts General Hospital reported a $95 million operating revenue surplus for 2023 (Boston Globe, Dec. 8; paywall likely). Major contributors to the one-year turn-around: the last of the one-time COVID relief money and "a robust investment portfolio." In other words, this year's net revenue was not necessarily directly related to higher volumes and greater efficiencies in providing patient care, though the hospital did report an nearly $1 billion increase in revenue from patient activities year-over-year.

The financial picture could have been even better. According the the Globe story, "The system is treating fewer people than it would like to, largely because there is less capacity at nursing homes and rehabilitation facilities that would normally take discharged patients recovering from hospitalization" (emphasis added). The hyperlink is to a (June 12, 2023) report that over 1,000 patients in the Bay State remain "stuck" in hospitals because of the shortage of nursing homes and rehab facilities. But the main point of the Dec. 8 story is that hospitalizations are being limited at the front end at MGH, which means care is being delayed and even denied for lack of appropriate discharge options. 

We refer incessantly to the "American health care system," but this is another reminder that the "system" is less than that. It's an agglomeration of disparate parts -- some public, some private, some for-profit, others nonprofit -- the locations and even existence of which are largely market-driven, which is often not the same as need-driven. The big players are in a fairly decent position to protect themselves, as the 2023 MGH numbers illustrate. But there are lots of smaller and rural providers that lack the resources and resiliency to weather large losses year after year. The outlook for them is grimmer than ever. 

The Affordable Care Act was premised (correctly, IMHO) on the proposition that the private health insurance market could not operate in the public interest without a large dose of regulatory correction. Even the advances of the ACA -- as desirable and necessary as they were and are -- were delayed and reduced bu its opponents. From my Dec. 4 blog post:

As Abbe Gluck and two co-authors wrote in the Georgetown Law Journal in 2020, "[t]he ACA is the most challenged statute in American history." The authors cite more than 2,000 legal attacks, more than 70 GOP-led attempts in Congress to repeal or strip down the Act, and seven trips to the Supreme Court. Add to the story that "the statute has been rebelled against by the states charged with implementing it, sabotaged by the second President to administer it, and financially starved by Congress," and the story becomes one of "unprecedented statutory resilience."

Private health insurance is just one piece of the puzzle -- a very significant piece, but only a part of the story. If this country tried to get serious about organizing health care into a true system, the opposition would dwarf anything we saw from 2010-2020.  

Texas Supreme Court Stays Trial Court's Abortion Order

The court entered an "administrative stay" pending review of the TxAG's request for mandamus in the Cox case. In almost any other case, this would be a routine, even benign, development. In this case, though, it's far from routine or benign.

• Kate Cox is entering her 21st week of pregnancy. She's not far from her third trimester, when  termination of a pregnancy will be considered a "late term" abortion and nearly impossible to obtain.
  
  
• Every delay increases the risk to Kate Cox's health, including her ability to have a child in the future. There is no such thing as "maintaining the status quo" in this case.
  
  
• This case vividly illustrated the human cost of a GOP-dominated legislature and Republican AG torning abortion into a political football. One can only hope that the all-GOP Supreme Court sees this case as the trial judge did . . . and without delay.

A Further Comment on the Texas AG's Threat to Hospitals, Doctors, and Anyone Else

As noted earlier today, on Thursday the Texas AG's office responded immediately to the TRO enjoining the state from suing or prosecuting the parents, their doctor, or the doctor's staff pursuant to the Texas's abortion laws. AG Paxton's response was a letter to three hospitals where the doctor has medical staff privileges. As summarized on the AG's website, the letter stated:

The Temporary Restraining Order (“TRO”) granted by the Travis County district judge purporting to allow an abortion to proceed will not insulate hospitals, doctors, or anyone else, from civil and criminal liability for violating Texas’ abortion laws. This includes first degree felony prosecutions, Tex. Health & Safety Code § 170A.004, and civil penalties of not less than $100,000 for each violation, Tex. Health & Safety Code §§ 170A.005, 171.207-211. And, while the TRO purports to temporarily enjoin actions brought by the OAG and TMB against Dr. Karsan and her staff, it does not enjoin actions brought by private citizens. Tex. Health & Safety Code § ¬¬171.207. Nor does it prohibit a district or county attorney from enforcing Texas’ pre-Roe abortion laws against Dr. Karsan or anyone else. The TRO will expire long before the statute of limitations for violating Texas’ abortion laws expires.

Prof. Steve Vladeck (UT-Austin) made this excellent point on "X": 

Those defending ambiguous medical exceptions in abortion bans regularly suggest that the problem is not the ambiguities, but doctors narrowly construing them.

And yet, here’s Texas AG Ken Paxton threatening doctors with civil and criminal liability for FOLLOWING A COURT ORDER.

Vladeck's post underscores the irony of the state's argument in November before the Texas Supreme Court  in defense of the medical exception in Texas's abortion ban that allows for an abortion in cases of "a life-threatening condition or risk of substantial bodily harm." The AG's office argued that the problem wasn't with ambiguous statutory language but instead with timid doctors who unreasonably refuse to follow the standard of care in such cases: "Beth Klusmann, a lawyer for the state, argued . . . that the women did not have the standing to sue, suggesting that the women should have instead sued their doctors for medical malpractice" (CBS, Nov. 28). Oral arguments in the Supreme Court are here.

The case is Zurawski v. State of Texas, and developments in the case can be followed on the website of the Center for Reproductive Rights, which represents the plaintiffs. 

DFW Woman Obtains Court Order Allowing an Abortion, A First Since Dobbs and SB 8

The story is all over the news, so for now I will provide a few links to the news coverage and to some of the key documents in the case:

• News coverage:
• CNN
• NPR
• WaPo (possible firewall)
• NY Times (firewall)
• Yahoo News
  
  
• SB 8 (Tex. Leg., 2021): the so-called "heartbeat law," which provides that "a physician may not knowingly perform or induce an abortion on a pregnant woman if the physician detected a fetal heartbeat for the unborn child . . .  or failed to perform a test to detect a fetal heartbeat."
  
  
• Complaint (filed Dec. 5, 2023) -- the complaint alleges that "[o]n November 28, 2023, Ms. Kate Cox received the results of an amniocentesis which confirmed prior prenatal testing—her third pregnancy has full trisomy 18, meaning her pregnancy may not survive to birth, and, if it does, her baby would be stillborn or survive for only minutes, hours, or days."
  
  
• Trisomy 18 (from the National Library of Medicine) -- "Due to the presence of several life-threatening medical problems, many individuals with trisomy 18 die before birth or within their first month."
  
  
• Cleveland Clinic: At least 95% of fetuses with the condition don’t survive to full term, meaning pregnancies end in miscarriage or babies are stillborn. Infants born with trisomy 18 have many birth defects, which can cause life-threatening consequences. Almost 40% don’t survive labor, and less than 10% live past their first year.
  
  
• Trial Court's Order Granting TRO Against State Officials to Permit Abortion (Dec. 7, 2023, 10:21am)
  
  
• Letter from Attorney General Ken Paxton (Dec. 7, 2023, 1:49pm) -- posted to Twitter (now "X") -- sent to three Houston hospitals and addressed "To Whom It May Concern" -- 
  
  
  
  
  
  

  
• 
  
SB 8 was the first outrage. Requiring a pregnant person in Ms. Cox's circumstance to go to court for an order to preserve her health, including her future ability to have another child, continues the outrage. And the AG's letter to hospitals where Ms. Cox's physician has medical staff privileges is about what we've come to expect from that office.

What Is a Hospital to Do When a Patient Refuses a Discharge?

Here's the scenario: A patient is admitted to the hospital for treatment. Treatment goes well, and the patient can safely be discharged to home. But the patient refuses to leave the hospital. If the patient lacks decision-making ability, the surrogate decision-maker may be refusing on the patient's behalf. Either way, a patient who no longer needs hospital-level care continues to consume hospital resources -- a bed, nursing time and attention, housekeeping, dietary, etc. -- without a discernible medical advantage.

There are lots of ways to respond to the refusal to leave, mostly involving a sensitive exploration of the social, familial, financial, emotional or other reasons for the refusal. Sometimes it is possible to make arrangements that can address the patient's (or surrogate's) concerns.

As reported in the Los Angeles Times (and reprinted by KFF News (Nov. 15)), San Francisco-based Dignity Health, a tax-exempt organization Catholic hospital system with $9.5 billion in revenue, is trying another approach: sue the patients for trespass. In three cases, Dignity Health has invoked a California law intended to prevent anti-abortion demonstrators from obstructing entry to healthcare facilities, accusing the patients of "commercial blockage" for "unreasonably and unlawfully" refusing to be discharged once they were deemed medically and legally eligible. Dignity claims the actions hindered its ability to care for other patients during COVID-19 surges. 

Unsurprisingly, the patients claim a right to be discharged to a facility that offered appropriate care and that they could afford, not simply sent home without the ability to take care of themselves. As described by California Disability Rights, state and federal law (Medicare's Conditions of Participation) provide significant protections against hospital discharges that aren't safe, so the outcome in these cases is likely to turn on very fact-specific considerations.

One of the cases is scheduled to go to trial on November 15. More later . . . .

Latest Fraud Enfocement Actions include $148 Million Scheme

Here's the latest rundown from USDOJ, with some details on a couple of the most notable actions:

Lab Owner Pleads Guilty To $1.7 Million COVID-19 Test Fraud Scheme (December 1, 2023; U.S. Attorney's Office, Northern District of Texas)

Physician Sentenced For $1.2M Pill Mill Scheme (November 30 2023; U.S. Department of Justice)

Philadelphia Pharmacy Pleads Guilty To More Than $500,000 In Fraudulent Insurance Claims As Part Of Prescription Medication Scam (November 28, 2023; Pennsylvania Attorney General)

▶︎Man Charged In $148M Medicare And Medicaid Fraud Scheme (November 30 2023; U.S. Department of Justice)

A federal grand jury in Baton Rouge, Louisiana, returned an indictment today charging a Louisiana man for his role in a scheme to defraud Medicare and Medicaid of over $148 million in medically unnecessary definitive urine drug testing services.   

According to court documents, Brad Paul Schaeffer, 48, of Zachary, was a co-owner and chief executive officer of MedComp Sciences LLC (MedComp), a diagnostic laboratory located in Zachary. From approximately January 2013 through approximately August 2022, MedComp, at the direction of Schaeffer, allegedly billed Medicare and Medicaid for definitive testing of at least 15 substances in urine specimens it received, regardless of the patient’s treatment plan and history, or the request of the referring provider. 

To perpetuate the fraud, Schaeffer, through MedComp, allegedly took several actions, among them, writing off patient co-pays, directing MedComp staff to fill out and submit order forms on providers’ “behalf,” concealing the true nature, permissibility, and extent of testing from providers, orchestrating a pass-through billing scheme using hospitals, and paying kickbacks to physicians disguised as laboratory ownership interests. Schaeffer then allegedly used the fraudulent proceeds for his own benefit, including spending thousands of dollars to renovate a pool and on a pool house in his backyard, and to restore a truck. 

▶︎Caretaker Charged With Involuntary Manslaughter, Neglect For Failure To Renew Patient’s Medications Which Led To Fatal Seizure Episode (November 29, 2023; Pennsylvania Attorney General)

Kelly Gonzales, 48, was the administrator at ARC of Lawrence County, a personal care home in New Castle, when she failed to renew a prescription for the patient’s anti-seizure medication. Gonzalez then altered medical records to indicate that a health care provider discontinued the medication — which was not true.

As the administrator of the personal care home, Gonzales was responsible for the administration and management of the home, including the health, safety, and well-being of the residents. This included ensuring the residents’ paperwork was complete, that they attended all medical appointments, and received their prescribed medication in a timely manner.

According to the complaint, the resident was diagnosed with a seizure disorder and was prescribed anti-seizure medication to control his seizures. He died at the care home on Dec. 2, 2021 after not receiving his medication for over 10 days. Upon autopsy, it was discovered that the seizure disorder caused his death and that the levels of anti-seizure medication in his system were well below therapeutic levels.

Gonzales was charged Tuesday with felony counts of neglect of a care dependent person and tampering with records, and misdemeanor involuntary manslaughter. Gonzales surrendered Tuesday, was arraigned and released on her own recognizance.

What's the Test for Causation in a False Claims Act Suit Based Upon the Anti-Kickback Act?

This is an issue only a lawyer could love, but there's already a circuit split, and two federal judges in the Massachusetts District have reached opposite conclusions, with one of them asking for a resolution by the First Circuit, which will either deepen the split or (if it comes up with a third approach) broaden it. Considering the large number of qui tam actions for AKB violations that are litigated each year, this is an important issue that cries out for resolution by SCOTUS. 

How much do lawyers love this issue? Here is a collection of law firms' commentary on the issue in the last couple of months --

• Haynes and Boone, Another Win for Defendants on the Issue of Causation in AKS-Based FCA Cases (Oct. 5) (extensive analysis)
• Sidley: District of Massachusetts Adopts But-For Causation Test for FCA Claims Premised on AKS Violations (Oct. 3)
• WilmerHale: Government Setback “Resulting From” Another Court Adopting the “But For” Causation Standard for False Claims Act Cases Furthering Court Split (Oct. 19)
• DLA Piper: Massachusetts District Judge rules that government must clear high causation bar in False Claims Act cases (Oct. 10)
• ArentFox: Federal Judge Rules Government Must Demonstrate “But-For” Causation for Anti-Kickback Statute Claims (Oct. 6)
• Goodwin Procter: “Greenfield Fraught with Problems”: District of Massachusetts Holds But-For Causation Required in False Claims Act Cases Based on Kickbacks (Oct. 5)
• Bradley: District of Massachusetts Split on Causation Standard in Kickback FCA Cases (Oct. 30)
• Mintz: Courts Continue to Grapple with the Causation Standard for False Claims Act Suits Based on Alleged Kickback Schemes, While the Supreme Court Stays on the Sidelines (Oct. 5)
• Squire Patton Boggs: Federal Courts Continue to Grapple with Causation in Anti-Kickback-Based False Claims Act Cases (Nov. 29)
• Bass Berry & Sims: District Courts Wrestle with Causation in Kickback Cases While Circuit Courts Remain Divided (Oct. 5)
• Weiner Brodsky Kider: Mass. Federal Court Adopts More-Stringent Causation Standard for FCA Claims Based on Alleged Unlawful Kickbacks (Oct. 12)
• McGuireWoods: The Growing Causal Divide: But-For Causation in AKS/FCA Actions (Dec. 4) (citations and some hyperlinks to opinions)
• Akerman: Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim (Aug. 10)
• Hogan Lovells: Anti-kickback causation in FCA suits: text or purpose? (undated, but apparently written before the D. Mass. split)
• Ropes & Gray: Sixth Circuit Requires But-For Causation and Narrowly Defines Remuneration under AKS (April 4) (before the D. Mass. split)
• Arnold & Porter: More Disagreement About the Causation Standard for AKS Cases Under the FCA (July 21) (before the Regeneron case created a split within the Mass. District)

For a very brief introduction to the laws involved in this split, you can start with the HHS OIG website.

DeSantis Pledges to Supersede ACA

As reported in Becker's Hospital Review (Dec. 4), Ron DeSantis regards the ACA as a failure and has vowed to "repeal and supersede" the Act with a shinier and better alternative. Taking a page out of the Trump playbook in 2016, DeSantis has no plan of his own to offer, but he assured viewers of "Meet the Press" yesterday that his plan will "reduce healthcare costs to ensure affordability for individuals, protect those with preexisting conditions, and scrutinize 'big institutions that are causing prices to be high: big pharma, big insurance and big government.'" 

Right. 

As Abbe Gluck and two co-authors wrote in the Georgetown Law Journal in 2020, "[t]he ACA is the most challenged statute in American history." The authors cite more than 2,000 legal attacks, more than 70 GOP-led attempts in Congress to repeal or strip down the Act, and seven trips to the Supreme Court. Add to the story that "the statute has been rebelled against by the states charged with implementing it, sabotaged by the second President to administer it, and financially starved by Congress," and the story becomes one of "unprecedented statutory resilience."

According to a recent Statista study, tens of thousands of lives have been saved by the ACA, and 40 million of us are enrolled in ACA-related health plans. The same study points out that the ACA was flawed in some ways and -- due in part to the intransigence of twelve states that still haven't expanded Medicaid eligibility -- 19.5 million Americans are still uninsured. 

So the results have been mixed, though we will never know what the original Act would have accomplished, because of significant changes from Congress and SCOTUS before it was even implemented.  

The empty rhetoric and even emptier promises of DeSantis and Trump are recent illustrations of the wisdom of H.L. Mencken: "There is always an easy solution to every human problem -- neat, plausible, and wrong." A less well-knowm but perhaps even more apt Mencken quote is this: "The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, all of them imaginary."

When Your "Free" Annual Check-up Isn't Free

A good reminder from the Kaiser Family Foundation (and broadcast on NPR's "Morning Edition" today: The ACA requires that insurers pay for an annual physical with no out-of-pocket payment by the insured patient, but that doesn't cover "extra" services that are offered during the same visit.

What's "extra." Like so much in health care, it depends.

One patient, Christine Rogers, answered her doctor's screening questionnaire honestly when it asked about depression. Her mother had unexpectedly died in a nursing home 13 hours away, and she answered the questionnaire with "It was a horrible year. I lost my mom." That triggered a 5-minute conversation about depression and an additional charge - not covered by her insurer - of $76.06.

Ms. Rogers felt a bit betrayed by a screening process that depends upon honest answers to questions about a patient's physical and emotional condition and then adds to her bill at the rate of $912.72 an hour.

The hospital and physician group stood behind the charge but -- perhaps to avoid being highlighted by KFF and NPR -- wrote off the extra charge.

The take-away: The ACA guarantees you one free physical per year, but what's included in that free service may vary from provider to provider, with precious little guidance to constrain billing practices.

Caveat emptor, indeed.

Abortion: Legislative Update

We* had our 36th Annual Conference of the Professions here in Dallas yesterday. The official title was "Governmental conflict with standards and professional judgment: Case studies in Texas." Our keynote speaker -- Prof. David Orentlicher, M.D., J.D. -- was great, as were our panelists from the clergy, law, and medicine -- Dr. Charles Brown, TAMU School of Medicine; Shelly Skeen, JD – Southern Regional Director, Lambda Legal; and Rev. Danielle Ayers, Pastor of Justice, Friendship-west -- and our panel moderator, Rev. George Mason, pastor emeritus of Wilshire Baptist Church & founder of Faith Commons.

It didn't take a lot of imagination to read our open-ended title and conclude that abortion and gender-affirming care would figure prominently in the discussion. We did cover a number of other subjects, but these two topics dominated the discussion.

Coincidentally, today's Washington Post ran an article on the abortion bans around the country, with a focus on the vague language state legislatures use to describe exceptions to the ban, e.g.:

(Click on images to enlarge.)

Predictably, that vague language leaves physicians and hospital guessing about whether any particular patient's condition qualifies for termination of her pregnancy. The Conference explored this effect in some detail yesterday. If you missed it, this article is a very good guide to the issue.

_____________________
*The organizers of the Conference are:  SMU Dedman School of Law, the Dallas County Medical Society, the Dallas Bar Association, the SMU Perkins School of Theology, The University of Texas Southwestern Medical Center at Dallas, Faith Commons, and SMU’s Maguire Center for Ethics and Public Responsibility.

J.D. Degree is a Lousy Way to Get to a Health Care C-Suite

Becker's CEO Report had an article on Tuesday about "The most common degrees for healthcare CEOs," based upon a report by C-suite consulting firm Crist|Kolder. Lawyers are well represented in the ranks of CEO at universities, nonproft organizations, and for-profits, but within healthcare organizations? Not so much:

Fifty percent of healthcare CEOs have a MBA and did not study beyond it, compared to a cross-industry average of 43 percent, according to the report. Another 21.2 percent received only a bachelor's degree. 

More healthcare CEOs hold a MD or PhD than chief executives of any other industries; over 15 percent can call themselves "doctor." 

In addition, 4.5 percent have their JD, and 9.1 percent hold a Master's in any field. 

Hospice Director Sentenced in $150+ Million Fraud Scheme

A hospice medical director was sentenced yesterday to 50 months in prison for his role in a scheme that involved the submission of over $150 million in false and fraudulent claims to Medicare for hospice and other health care services. According to DOJ's press release: 

According to court documents, from 2009 to 2018, Jesus Virlar-Cadena, 52, served as the medical director of the Merida Group, a large health care company that operated dozens of locations throughout Texas. Evidence at the trial of co-defendants Rodney Mesquias, Henry McInnis, and Francisco Pena, showed that the Merida Group marketed their hospice programs through a group of companies known as the Merida Group. They enrolled patients with long-term incurable diseases, such as Alzheimer’s and dementia, as well as patients with limited mental capacity who lived at group homes, nursing homes, and in housing projects. In some instances, Merida Group marketers falsely told patients they had less than six months to live. They also sent chaplains to the patients based on the false pretense they were near death. [emphasis added]

In order to bill Medicare for these services, the Merida Group hired Virlar and other medical directors, but made payment of their medical director fees contingent upon an agreement to certify unqualified patients for hospice. In addition to regular medical director payments, Virlar received luxury trips, bottle service at exclusive nightclubs, and other perks in exchange for his certification of unnecessary hospice patients. In exchange for these illegal kickbacks, Virlar himself certified over $18 million in unnecessary hospice services as part of the over $150 million conspiracy.   

Putting aside the financial crime involved in this case. Lying to these patients that they have a terminal illness is a gross violation of the interests of a vulnerable population. 

Tennessee Physician Sentenced in $1.88 Million Health Fraud Case

A Tennessee doctor will have 7 years in federal prison to contemplate his crimes against the Medicare program and his patients. 

He was convicted on a 36-count indictment in the following scheme, as described by the U.S. Attorney for the Middle District of Tennessee:

The defendant, through his medical clinic in Clarksville, billed federal health insurance programs for hundreds of medically unnecessary services, including unnecessary office visits and steroid injections. The evidence at trial showed that he required Medicare beneficiaries and other patients to visit his clinic as many as six times each month and to undergo unnecessary steroid injections in order to obtain their prescriptions. The evidence also showed that the defendant altered progress visit notes in his patients’ medical records to justify higher billing rates.

The physician was ordered to pay over $1 million in restitution and serve three years of supervised release.  He was also fined $195,000 and must forfeit previously seized assets worth approximately $900,000.

This isn't the physician's first encounter with the legal system. In 2022 the Administrator of DEA revoked his authorization to prescribe controlled substances, based upon findings that he indiscriminately and dangerously prescribed large amounts of oxycodone and other controlled substances. See Fed. Reg., Jan. 19, 2022, at 2986. 

Health care fraud is as health care fraud does.

Chamber of Commerce Is Denied an Injunction to Halt Medicare Drug Price Negotiations

Happy to do the bidding of Big Pharma, the US Chamber of Commerce sued the Biden Administration to stop the Drug Price Negotiation Program created by the federal Inflation Reduction Act,  42  U.S.C.  §§ 1320(f), et  seq in its tracks on the theory that this program violates due process. The Chamber was joined by a handful of affiliates -- along with AbbVie, Inc., manufacturer of the lucrative Imbruvica (used to treat Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)) and is one of eight such suits filed around the country.

On Friday a Trump appointee in the Southern District of Ohio denied the Chamber's motion for a preliminary injunction, as well as the government's motion to dismiss. The opinion is a Civil Procedure teacher's dreams, covering such juicy first-years topics as:

• subject-matter jurisdiction
• standing, especially associational standing
• ripeness
• the standards for a preliminary injunction, especially irreparable harm if denied and likelihood of prevailing on the merits.

Dayton Area Chamber of Commerce v. Becerra, S.D. Ohio, September 29, 2023, No. 323cv00156SDOh/5.

It's hard to say how long this victory for HHS will last. Plaintiffs were ordered to file an amended complaint by October 13, and HHS will have until October 27 to respond, so it will be at least November before there's another ruling. Meanwhile, discovery will continue.

AHLA Podcast on Tax-Exempt Joint Ventures

AHLA has a nice, 19-minute podcast that offers a useful overview of the types of issues that arise when a tax-exempt entity enters into a joint venture (mostly ancillary jv's rather than whole-hospital jv's) with a for-profit entity. The participants include the indefatigable Gerry Griffith, Partner, Jones Day (Detroit), as well as Jennifer Noel, Corporate Director of Tax, Christiana Care Health System, and Robert Friz, Partner, PricewaterhouseCoopers. Nerd that I am, I love these tax issues and look forward to teaching them in my Health Law course each year. 

This podcast is actually a teaser for AHLA’s upcoming "Tax Issues for Health Care Organizations" program in Washington, DC on October 23-24. The program and faculty all look great.

Disclaimer: AHLA didn't ask me to post this plug for the program.