COVID-19 Vaccine Fraud: The Worst of the Worst?

Here's the case summary from USDOJ (Office of Public Affairs, June 17, 2024):

A New York woman pleaded guilty today to fraudulently destroying over 2,600 COVID-19 vaccines and issuing a corresponding number of fraudulent COVID-19 vaccination record cards.

According to court documents, Kathleen Breault, 66, of Cambridge, a midwife at Sage-Femme Midwifery PLLC (Safe-Femme), an authorized COVID-19 vaccine administration site in Albany, New York, conspired to obstruct the government’s distribution of COVID-19 vaccines by providing COVID-19 vaccination record cards to individuals who were not vaccinated, including to minors who were at the time ineligible to be vaccinated and to Canadian citizens who were not present in the United States when they were purportedly vaccinated. In addition to destroying COVID-19 vaccines and issuing fraudulent vaccination record cards, Breault and her co-conspirators made over 2,600 false entries into a New York State database that tracked COVID-19 vaccine distribution. Breault agreed to pay more than $37,000 in restitution for the destroyed vaccines.    

Breault pleaded guilty to conspiring to defraud the United States and its departments and agencies. She is scheduled to be sentenced on Sept. 18 and faces a maximum penalty of five years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. 

The worst of the worst? It's up there. 

Most health care fraud is about money -- ill-gotten gains obtained by billing for services that were never rendered or that were not medically necessary and appropriate. Individual patients are sometimes harmed in these schemes (denied care they actually needed or exposed to treatment risks that were unnecessary), and then there are the addiction cases that -- in addition to the risk of death or serious injury -- often harm not only individuals but also families and contribute to the harm to whole communities. Even "pure financial fraud" harms insurance programs by taking away funds that could otherwise pay for the provision of medical care to patients in need of it.

This case adds another dimension to fraud-based community harms: public health and safety. Falsely documenting vaccinations and diverting thousands of doses of vaccine to the trash is doubly harmful. It allows unvaccinated individuals to work and play within communities that depended on the widest possible rate of vaccination. And many communities at times throughout the worst of the pandemic experienced vaccine shortages. This case isn't only about money. It's about a kind of depraved indifference to communal well-being that is hard to fathom.

The Bump Stock Case: Is SCOTUS a Public Health Menace (Part II)?

The latest blockbuster decision from SCOTUS is "the bump stock case," Garland v. Cargill, U.S. No. 22-976 (June 14). There isn't much to add to the voluminous media coverage of this case, in which the six conservatives on the Court struck down a 2018 BATF regulation that banned bump stocks because they turned semiautomatic rifles into machineguns, which Congress severely restricted in 1934 (see definition of machinegun in National Firearms Act of 1934, 26 U. S. C. §5845(b)). The majority (in a highly technical and narrow decision by Justice Thomas*) disagreed with BATF and held that bump-stock-equipped rifles are not machineguns. To be fair, the Obama administration came to the same conclusion when it decided against a regulation that would have classified bump-stock-equipped rifles as machineguns. 

Writing for the three liberal justices in dissent, Justice Sotomayor wrote:

A machinegun does not fire itself.  The important question under the statute is how a person can fire it.  A weapon is a “machinegun” when a shooter can (1) “by a single function of the trigger,” (2) shoot “automatically more than one shot, without manually reloading.”  26 U. S. C. §5845(b).  The plain language of that definition refers most obviously to a rifle like an M16, where a single pull of the trigger provides continuous fire as long as the shooter maintains backward pressure on the trigger.  The definition of “machinegun” also includes “any part designed and intended . . . for use in converting a weapon into a machinegun.”  Ibid.  That language naturally covers devices like bump stocks, which “conver[t]” semiautomatic rifles so that a single pull of the trigger provides continuous fire as long as the shooter maintains forward pressure on the gun. 

This is not a hard case.  All of the textual evidence points to the same interpretation.  A bump-stock-equipped semiautomatic rifle is a machinegun because (1) with a single pull of the trigger, a shooter can (2) fire continuous shots without any human input beyond maintaining forward pressure.  The majority looks to the internal mechanism that initiates fire, rather than the human act of the shooter’s initial pull, to hold that a “single function of the trigger” means a reset of the trigger mechanism.  Its interpretation requires six diagrams and an animation to decipher the meaning of the statutory text.  Then, shifting focus from the internal mechanism of the gun to the perspective of the shooter, the majority holds that continuous forward pressure is too much human input for bump-stock-enabled continuous fire to be “automatic.” [emphasis added]

Justice Sotomayor rejects the majority's technical analysis with her customary flair:

Today, the Court puts bump stocks back in civilian hands.  To do so, it casts aside Congress’s definition of “machinegun” and seizes upon one that is inconsistent with the ordinary meaning of the statutory text and unsupported by context or purpose.  When I see a bird that walks like a duck, swims like a duck, and quacks like a duck, I call that bird a duck.  A bump-stock-equipped semiautomatic rifle fires “automatically more than one shot, without manual reloading, by a single function of the trigger.”  §5845(b).  Because I, like Congress, call that a machinegun, I respectfully dissent. 

At a minimum, doesn't the 6-3 split in this case suggest that it's plausible -- even reasonable --  to define bump-stock-enhanced rifles as machineguns, even if there is a plausible -- even reasonable -- contrary argument? Given the room for argument, isn't this just the sort of case in which generalist judges, with or without technical drawings and a video, should defer to the expertise of the agency (with or without Chevron)?

Last Father's Day, I posted about the Supreme Court's obstinate Second Amendment jurisprudence ("2nd Amendment thoughts -- The Constitution is not a suicide pact (or is it?)" (June 18, 2023).) Breaking no new ground whatsoever, I wrote that gun violence is not only a criminal-justice matter, it's also a matter of public health law. The statistics are stunning. So far this year, there have been 225 mass shootings in this country. Granted, few if any involved a bump-stock-equipped rifle, but the 2017 shooting at a Las Vegas music festival (in which 58 people were killed and over 500 injured by a shooter using weapons enhanced by bump stocks) demonstrates the lethality of bump stocks. And with over 700,000 of these things already in circulation (ABC News (June 14, 2024)), to build on Justice Sotomayor's analogy, we are all sitting ducks. 

So this Father's Day, I revisit the issue of gun violence and ask last year's question one more time: Don't we owe more to our children (and their children) than a world in which assault rifles are legal in 40 states and anyone with a driver's license can turn their assault rifle into a machinegun?

____________________

* There is a random connection between machineguns (especially the Thompson machinegun) and Dallas. The father of the late Cary Maguire -- Dallas oilman and philanthropist par excellence -- supplied Allied forces with the Tommy gun during WWII:

NY Times, Nov. 11, 1966 (obituary, J. Russell Maguire, (behind a paywall)).

NEWS FLASH: Telehealth Fraud is Health Fraud. Full Stop.

Here's the headline from DOJ, along with excepts from the news release announcing the arraignment of two principals of a telehealth company in California:

Founder/CEO and Clinical President of Digital Health Company Arrested
for $100M Adderall Distribution and Health Care Fraud Scheme

The founder and CEO (He) of a California-based digital health company and its clinical president (Brody) were arrested today in connection with their alleged participation in a scheme to distribute Adderall over the internet, conspire to commit health care fraud in connection with the submission of false and fraudulent claims for reimbursement for Adderall and other stimulants, and obstruct justice. . . .

“The individuals charged today allegedly disregarded the first rule of medical care—do no harm—in order to maximize profits, and there is no place for such fraud in our healthcare system,” said Secretary of Homeland Security Alejandro N. Mayorkas. . . . 

“As alleged in the indictment, the defendants provided easy access to Adderall and other stimulants by exploiting telemedicine and spending millions on deceptive advertisements on social media. They generated over $100 million in revenue by arranging for the prescription of over 40 million pills,” said Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division. “These charges are the Justice Department’s first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company. As these charges make clear, corporate executives who put profit over the health and safety of patients—including by using technological innovation—will be held to account.”

According to court documents, He and Brody allegedly conspired with others to provide easy access to  Adderall and other stimulants in exchange for payment of a monthly subscription fee. The indictment alleges that the conspiracy’s purpose was for the defendants to unlawfully enrich themselves by, among other things, by increasing monthly subscription revenue and thus increasing the value of the company. Done allegedly arranged for the prescription of over 40 million pills of Adderall and other stimulants, and obtained over $100 million in revenue. 

He and Brody allegedly obtained subscribers by targeting drug seekers and spending tens of millions of dollars on deceptive advertisements on social media networks. They also allegedly intentionally structured the Done platform to facilitate access to Adderall and other stimulants, including by limiting the information available to Done prescribers, instructing Done prescribers to prescribe Adderall and other stimulants even if the Done member did not qualify, and mandating that initial encounters would be under 30 minutes. To maximize profits, He allegedly put in a place an “auto-refill” function that allowed Done subscribers to elect to have a message requesting a refill be auto-generated every month. He wrote that Done sought to “use the comp structure to dis-encourage follow-up” medical care by refusing to pay Done prescribers for any medical visits, telemedicine consultation, or time spent caring for patients after an initial consultation, and instead paying solely based on the number of patients who received prescriptions.

“The defendants in this case operated Done Global Inc., an online telehealth website that prescribed Adderall and other highly addictive medications to patients who bought a monthly subscription. The defendants allegedly preyed on Americans and put profits over patients by exploiting telemedicine rules that facilitated access to medications during the unprecedented COVID-19 public health emergency,” said DEA Administrator Anne Milgram. “Instead of properly addressing medical needs, the defendants allegedly made millions of dollars by pushing addictive medications. In many cases, Done Global prescribed ADHD medications when they were not medically necessary. In 2022 the FDA issued a notice of shortages in prescription stimulants, including Adderall. Any diversion of Adderall and other prescription stimulant pills to persons who have no medical need only exacerbates this shortage and hurts any American with a legitimate medical need for these drugs. The DEA will continue to hold accountable anyone, including company executives, that uses telehealth platforms to put profit above patient safety”. . . .

He and Brody allegedly persisted in the conspiracy even after being made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, and that Done members had overdosed and died. They also allegedly concealed and disguised the conspiracy by making fraudulent representations to media outlets to forestall government investigations and action and induce third parties to continue doing business with Done. . . .

This isn't just about money. It's about enabling addiction and about killing patients. I am amazed at the sociopathic conduct alleged here, and even more amazed that a digital company thought it could (allegedly) engage in massive on-line health fraud without leaving a digital trail  that would lead directly back to the company and its leaders. Hubris? Stupidity? Both?

SCOTUS: Mifepristone Remains Available Despite 5th Circuit Ruling

A unanimous Supreme Court today reversed a Fifth Circuit opinion that held that various actions taken by the FDA with respect to its regulation of mifepristone were arbitrary and capricious.

The court's opinion -- which all nine justices joined -- found that the plaintiffs lacked Article III standing to press their claim that the FDA acted unlawfully when it approved, and then loosened, restrictions on the way the abortion drug may be prescribed. I usually feel that the Court uses (and misuses) standing doctrine to avoid deciding questions it would rather not decide. In this case, though, the plaintiffs' standing theories were pretty farfetched and the Court wasn't buying any of them.

The basic problem with this case was that the doctors couldn't point to any harm, injury, or hardship the FDA's approval imposed on them:

[T]he plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain.  Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue. [emphasis in original]

On the merits (which the Court did not address), I think the FDA's handling of the demonstrably safe and effective mifepristone was unassailable, but a win is a win.

The next question is: If these plaintiffs don't have standing to challenge the FDA's actions, who does? The answer might well be noöne:

For starters, it is not clear that no one else would have standing to challenge FDA’s relaxed regulation of mifepristone.  But even if no one would have standing, this Court has long rejected that kind of “if not us, who?” argument as a basis for standing. The “assumption” that if these plaintiffs lack “standing to sue, no one would have standing, is not a reason to find standing.” Rather, some issues may be left to the political and democratic processes: The Framers of the Constitution did not “set up something in the nature of an Athenian democracy or a New England town meeting to oversee the conduct of the National Government by means of lawsuits in federal courts.” [citations omitted]

That said, three states have intervened in this case, which is pending in federal district court in Amarillo. Why Amarillo? Because conservative plaintiffs know they have a judge there who will lend a sympathetic ear to their cause. See Texas Tribune, April 11, 2024. 

As reported by Bloomberg News:

Missouri, Idaho, and Kansas have already intervened in the case before the district court, alleging their own unique harms. The states claim their residents are suffering serious medical complications that require emergency care after taking mifepristone that they’ve obtained through the mail and the states are having to pay for much of that care through Medicaid.

Stay tuned . . . .

"Private Equity and the Practice of Medicine"

Harvard Magazine has published a useful summary of the quality issues that appear to arise when private equity firms invest in health care facilities:

According to associate professor of health care policy and medicine Zirui Song and other Harvard researchers, patients in hospitals owned by private equity firms suffered significantly more hospital-acquired adverse events than those being cared for in similar hospitals with no such investor participation. [Song] analyzed more than 4.8 million Medicare claims tied to hospital stays between 2009 and 2019. Patients in the hospitals acquired by private equity firms experienced 25.4 percent more hospital-acquired conditions. Underlying that alarming overall difference was a 37.7 percent increase in central-line associated bloodstream infections and a 27.3 percent increase in falls, compared to peer hospitals with no private equity involvement.

The problem is particularly acute when the private equity firm employs a leveraged buy-out to acquire the facility. The investor funds the acquisition with debt that goes onto the facility's books. The equity partners typically do quite well with their investment, but servicing that debt often requires cuts in services and staff. And some facilities don't survive, removing a health care provider from the community. The closures haven't discouraged private equity investors from seeking profits from health care providers, with "investors taking a $1-trillion stake during the past decade in everything from nursing homes and rehabilitation facilities to physicians’ practices and hospitals. According to the nonprofit Private Equity Stakeholder Project, approximately 460 U.S. hospitals are currently owned by private equity firms, representing eight percent of all private hospitals and 22 percent of all proprietary for-profit hospitals."

Song and his colleagues have a few suggestions for reform:

• "[S]tates could better enforce existing regulations designed to prevent commercial exploitation of physicians, though most states have broad exceptions to these “corporate practice of medicine” laws."
• "States might also grant their attorneys general more authority to block private equity healthcare deals they deem harmful to patients or to competition. Federal policymakers and legal scholars have put forth similar views."
• "Critics also suggest lowering the threshold for mandatory reporting of private equity deals to the Securities and Exchange Commission, established by the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Currently, that ceiling, which changes yearly, stands at $119.5 million. Song notes, 'Most private equity acquisitions, especially of physician practices, are well below that threshold, so they never get reported."

A similar concern with quality after private equity comes on the scene was expressed by Edward P. Hoffer, "Private Equity and Medicine: A Marriage Made in Hell," 137 Am. J. Med. 5 (Jan. 2024) (may be behind a paywall).

Health Care Fraud: The Beat Goes On (and On and On)

 

More enforcement news from the HHS Office of Inspector General:

• Queens And Brooklyn-Based Eye Doctor Settles Health Care Fraud Claims For More Than $2.4 Million (June 6, 2024; U.S. Attorney's Office, Eastern District of New York)
• Five Individuals Arrested For Defrauding Medicare Of Over $15M Through Sham Hospices And Money Laundering (June 7, 2024; US DOJ)
• Former Fresno Sleep Clinic Owner Sentenced To 46 Months In Prison For Submitting Over $1.5 Million In Fraudulent Claims For Sleep Studies To Medicare And Medi-Cal (June 6, 2024; U.S. Attorney's Office, Eastern District of California)
• Chronic Disease Health Care Provider To Pay Florida Medicaid Nearly $600,000 For False Claims Act Violations (June 5, 2024; State of Florida)

These aren't huge amounts of money, as far as health care fraud goes in this country. What impresses (and depresses) me is the steady drumbeat of criminal activity in this sector. With all the money sloshing around in the industry that counts for the largest percentage of our GDP, the lure of easy money is apparently irresistible. 

SCOTUS (5-4) Rules in Favor of Indian Nations in Health Care Funding Dispute

Feb 28, 2023Feb 28, 2023 

The Supreme Court today decided a statutory interpretation case in which millions of dollars were at stake. Without getting too far into the weeds, the issue was whether the federal government is obligated to pay the costs incurred by Indian tribes to administer health programs funded by Medicare, Medicaid, and private insurers. The majority ruled that the statute in question -- the  Indian Self-Determination and Education Assistance Act ("ISEA"), 25 U. S. C. §5301 et seq. -- requires (unambiguously, apparently) the U.S. to reimburse the tribes for those administrative costs.

The Court's analysis (written by Chief Justice Roberts) invoked the text of the statute, the policy Congress sought to further when it passed the ISEA, and the history of the statutory provisions in question. The analysis is pretty mainstream for the Court, although originalists often abjure policy and legislative history as too squishy to be relied upon.

As the Court's opinion points out, there is an interpretive tool called "the Indian canon," which calls for statutory language that is ambiguous to be construed in favor of Indian tribes. One of the courts of appeals relied on the Indian canon to rule against the federal government. The other lower court produced three opinions in which one of the judges in the majority found the statute to be ambiguous and subject to the Indian canon, while the other judge in the majority thought the provision unambiguously supported the tribe. 

The SCOTUS majority, after mentioning the Indian canon in its description of the rulings below, never went back to it. Maybe the Court found the statute's meaning to be unambiguous. And maybe the Chief decided to skip the canon in order to keep Justice Kavanaugh as the all-important fifth vote. 

Canons of statutory interpretation are getting increased scrutiny at the Court, as evidenced by a recent concurring opinion by Justice Kavanaugh (Rudisill v. Secretary, Dep't of Veterans Affairs, April 16, 2024; see also Daniel Harawa, Justices lean toward narrow reading of aggravated identity theft, SCOTUSBlog, Feb 28, 2023 ("In many ways, Monday’s oral argument in Dubin v. United States felt like a legislation class in law school, with various canons of statutory construction being bandied about"; the defendant prevailed in this identity-fraud case in a 9-0 opinion by Justice Sotomayor that Professor Harawa described as "a tutorial in statutory interpretation"). 

Is a free-for-all over competing interpretive canons evidence that canons are alive and well? Or that interpretive canons are seen as makeweights with little more than rhetorical value?

More Healthcare Fraud Enforcement Actions: The Beat Goes On

  It's hard to know who is winning the battle against healthcare fraud -- the fraudsters or the enforcers. The list of enforcement outcomes (charges, verdicts, sentencing) is pretty darned impressive, both for the brazenness of the crimes and the success of the prosecutors. 

The HHS Office of Inspector General has a useful website that list 9,232 enforcement actions over the past decade. For my purposes, it's over-inclusive, because it lists "[c]riminal, civil or administrative legal actions relating to fraud and other alleged violations of law, initiated or investigated by OIG and its law enforcement partners" -- in other words, way more than only criminal prosecutions for health care fraud. The site does have some filters, but none are specific to health care. The listings for the past week alone, however, show the heavy concentration of health care fraud and the use of the criminal-justice system to punish wrongdoers:

• Florida Felon Sentenced to Prison for Role in Multi-Million Dollar Health Care Kickback Scheme After Pleading Guilty to COVID-19 Fraud and Unlawfully Possessing Firearm (May 30, 2024)
• Attorney General Ken Paxton Secures 84-Month Prison Sentence for Clinic Owner in $15 Million Medicare Fraud Scheme (May 30, 2024) (Note: Paxton's a terrible model of a public servant, but his fraud task force has done admirable work over the years going after healthcare fraudsters)
• Medical Device Manufacturer Innovasis Inc. and Two Top Executives Agree to Pay $12M to Settle Allegations of Improper Payments to Physicians (May 29, 2024) 
• Wisconsin Attorney Sentenced To Five And A Half Years In Federal Prison For $2.3 Million Fraud And Tax Evasion Schemes (May 28, 2024) 
• Penn Highlands Healthcare To Pay $735,000 To Settle False Claims Act Allegations (May 28, 2024) 
• Doctor Convicted Of $70M Medicare Fraud Scheme (May 24, 2024)
• Florida Businessman Daniel Hurt To Pay Over $27 Million For Medicare Fraud In Connection With Cancer Genomic Tests (May 24, 2024) 

Is it characteristic of fraudsters that, in their heart of hearts, they really believe they won't be found out by the authorities? Of do they take a (misguided) risk/reward calculation? 

JAMA: Texas Medical Board Dropped the Ball with its Abortion "Exceptions" Rule

The authors of an opinion piece in the Journal of the American Medical Association (published on-line today) offer their critique of the "non-guidance guidance" concerning emergency exceptions to the Texas ban on abortions. In a previous post, I expressed disappointment with the "cut-and-paste job" that offered nothing of value to guide physicians who need to decide whether a patient is experiencing the sort of medical crisis that would satisfy Texas's vague exception for an "emergency." 

As the JAMA authors point out, the rule does add onerous reporting requirements with potentially lethal consequences:

"Although labeled as mere documentation, each of these requirements potentially heightens the danger of criminal prosecution for clinicians working in already challenging circumstances. A patient’s condition might generally indicate a risk to her life. But pointing to this rule, a prosecutor or complainant before the Texas Board might argue that a physician did not exercise reasonable medical judgment, because they did not obtain a second opinion, attempt every alternative, or seek transfer. The Board’s proposal could invite—rather than ward off—second-guessing clinical decisions in legal proceedings."

The authors' conclusion seems unassailable: "Like other Texas institutions, the Texas Medical Board was unwilling to provide guidance to the medical profession. . . . With a sword of Damocles hanging over their heads, physicians hesitate to provide standard-of-care medicine, and the steady stream of patients denied care continues, and increases."

New Study Confirms Public Health Policy and Tools Were Weakened by Judicial Decisions During COVID Pandemic

Health Affairs has "pre-posted" the most detailed and insightful study I've seen that shows how court decisions -- including those from SCOTUS and various state supreme courts -- undermined traditional public-health policies and tools. The study was headed by Michelle M. Mello, David H. Jiang, and Wendy E. Parmet and deserves close study of the dismantling of a public-health regime that has, by and large, served this country well since its founding. Here's the authors' conclusion:

Our analysis of 112 COVID-19-era judicial decisions revealed areas of profound instability in how courts analyze challenges to exercises of public health legal powers. Based on our understanding of prepandemic case law, the decisions also represent surprising departures from how courts had previously analyzed similar claims, especially those concerning religious liberty and statutory authority.

Public officials come in for some of the criticism, particularly for their occasional failure to explain the rationale for their decisions, which left those decisions vulnerable to attack through litigation. The lesson is unmistakable: the courts, the regulators, and the rest of us need to do better the next time. And there will be a next time.

ECMO: A Clinical and Ethical Challenge for Our Time

The New Yorker has posted an excellent essay ("How ECMO is Redefining Death") on the history, current status, and ethical challenges of extracorporeal membrane oxygenation (a/k/a ECMO), an out-of-body device that bypasses the heart and lungs by taking carbon dioxide out of a patient's blood, oxygenating it, and returning the blood to the patient's circulatory system. Issues abound -- Under what circumstances should this procedure be started (i.e., for what medical purpose)? If it's started to keep a patient alive until a transplant organ becomes available, what happens if the patient's condition deteriorates until she is no longer a candidate for an organ? Who decides whether to stop ECMO? What are the standards for stopping? What if the patient wants to be kept alive on ECMO? (If you're not a subscriber, you can brush up on the ethical analysis of ECMO by reading an article on PubMed,) Or . . .

The piece is written by Clayton Dalton, identified as an ER physician in New Mexico. His personal website has links to other published essays, including a bunch of New Yorker articles. If you're not a subscriber to the magazine, he might have the ECMO piece posted on his website sometime soon.

Pharma Loses "Takings" Argument in NJ District Court

UPDATE to previous posts (here and here) on the Medicare Drug Price Negotiation Program in the Inflation Reduction Act. As reported by BioSpace, on April 29:

Judge Zahid Quraishi of the District of New Jersey issued summary judgment against J&J’s Janssen and BMS, dismissing their claim that the Medicare Drug Price Negotiation Program was an unconstitutional taking of their assets.

“In short, Defendants are not taking drugs from Plaintiffs,” Quraishi wrote in his 26-page ruling, according to multiple news outlets. “Selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make Defendants’ decision to participate any less voluntary.”

BMS has already appealed the ruling to the Third Circuit Court of Appeals, Endpoints News reported. 

The BioSpace piece has a nice summary of the various attempts by Big Pharma to mount challenges against the program. And a comprehensive discussion of the program was posted this morning in The Washington Post (possibly one-time free access). See also Reuters, 

The district court's opinion is here.

US Court of Appeals (4th Cir.): States Must Include Gender-Affirming Surgery in Health Plans

Otherwise, paying for the very same procedures for non-transgendered patients violates the Equal Protection Clause of the federal Constitution. Yes, they said it in a majority opinion released today. And yes, of course there were dissenting opinions (3 of 'em). The split on the court in this en banc case was 8-6. 

For just a flavor of the principal dissenting opinion, try this:

I respectfully dissent.  The Equal Protection Clause does not license judges to strike down any policy we disagree with.  It instead grants the states leeway to tailor policies to local circumstances, while providing a carefully calibrated remedy for truly illicit discrimination.  No such discrimination appears in these cases.  North Carolina and West Virginia do not target members of either sex or transgender individuals by excluding coverage for certain services from their policies.  They instead condition coverage on whether a patient has a qualifying diagnosis.  Anyone—regardless of their sex, gender identity, or combination thereof—can obtain coverage for these services if they have a qualifying diagnosis.  And no one—regardless of their sex, gender identity, or combination thereof—can obtain coverage if they lack one.  There is therefore nothing about these policies that discriminates on the basis of sex or transgender status.

This is truly "Alice Through the Looking Glass" stuff.

The real question is what the Supreme Court will do when it gets its hands on this issue. That is a question, right? And not a foregone conclusion?

Negotiating with Big Pharma Over Drug Prices for Medicare

You really can't blame Big Pharma for hating the new federal law that authorizes the Medicare program (for the first time in its 59-year existence) to stop buying drugs for the manufacturer's price but instead to negotiate for a reasonable price (the way the VA, state Medicaid agencies, the Defense Department, and most other countries do).

Medicare has been a predictably incredible cash cow for Big Pharma for generations, and that way of doing business is on its way out. 

The Medicare Drug Price Negotiation Program was authorized by Subtitle B (Prescription Drug Pricing Reform) of the bipartisan Inflation Reduction Act (once you're at the IRA, just do a search for "drug price"). As the Centers for Medicare & Medicaid Services (CMS) eases into this new role, it identified 10 drugs that cost the program the most (a function of price x frequency of Rx). 

Big Pharma's government-relations/lobby folks have all sorts of arguments against the program. Some question whether the government will save as much money as it predicts will be the case. Time will tell.

But one argument is more philosophical: This level of government intervention is inconsistent with the traditional "free market" system that has served patients so darned well.

There's an article in the April 25 issue of the New England Journal that refutes Big Pharma's assertion. The article is "The Myth of the Free Market for Pharmaceuticals" by Rena M. Conti, Ph.D., Richard G. Frank, Ph.D., and David M. Cutler, Ph.D. There's a "public link" that's available behind a "Share" button on the NEJM webpage. I don't know if it works for nonsubscribers, but here it is: https://www-nejm-org.foyer.swmed.edu/doi/pdf/10.1056/NEJMp2313400.

The article makes the point that the market for pharmaceutical products is not and never has been a "free market," at least not in the classic economic sense. The characteristics of a free market, the authors argue, are:

1. consumers are assumed to be fully informed, 
2. it is assumed that they choose products on the basis of their discernable benefits and costs, 
3. sellers can freely enter markets and make products similar or identical to others, and 
4. prices, set by firms seeking to maximize profits, are competitive with those of other sellers and unmodified by government intervention.

The authors conclude that "[t]he U.S. pharmaceutical market strays from all these features." The point is a basic one, and you don't need a Ph.D. to figure this out. The government issues patents that grant monopoly status to drugs, entry into the market with competing drugs depends upon FDA approval, consumers are woefully uninformed about benefits and costs (or highly dependent upon information provided by parties with very strong economic interests), and most purchasers are shielded from paying the true cost of drugs by third-party payers (insurers who may pick up 80% or more of the price).

Perhaps the more salient point to be made is that Big Pharma knows its business even better than I do, and its "free market" argument is not even intended to be technically correct. It's political speech, like the AMA's old argument against Medicare ("it's communistic" or "it's socialized medicine"). Not true, but it rings bells and sets off alarms. 

That said, "free market" is a technical phrase, and it deserves to be dispatched by reference to its technical meaning. This week's NEJM article does just that. 

America's Best Poetry Critic Has Died

Despite this blog's self-description up at the top of this page, I don't recall ever posting anything here about poetry over the past 21 years.

Until today.

And I'm not posting about poetry -- at least not only about poetry -- but also about poetry criticism -- and not about the work of all poetry critics, but about one in particular.

Professor Helen Vendler
(April 30, 1933 - April 23, 2024)

You could say that as a one-time, part-time poetry columnist for the Dallas Morning News from 1998-2003, I was once in the same line of work as Helen Vendler. That's about as accurate and helpful as saying a cockroach and a lion are the same because they both have legs.

Helen Vendler was a much-honored Harvard Professor of English and American Literature and Language. Her awards were many and her books even more so. I never read a Vendler piece without feeling glad that  I had. According to Wikipedia, "In 2006, The New York Times called Vendler 'the leading poetry critic in America,'" and even her critics would have been hard-pressed to disagree. She was a traditionalist, which made her controversial in some circles, and that probably appealed to my own taste in poetry. 

The death notices and appreciations are starting to pile up, though I fear most of these links are behind a firewall. Even better, check out a book by Vendler and dip in. It will be a great trip.

• The New York Times, Helen Vendler: An Appreciation (She devoted her life to showing us how and why.) Apr. 25.
• Washington Post, Helen Vendler, poetry critic both revered and feared, dies at 90 (Helen Vendler, a literary scholar and reviewer of poetry who was revered and feared in equal measures, whose scalpel-sharp critiques could...) Apr. 25.
• The Boston Globe, Helen Vendler, a towering presence in poetry criticism, has died (Struggling as a single mother in 1967 to raise a son on scant funds while teaching 10 college courses a year, Helen Vendler realized that...) Apr. 24.
• The New York Times, Helen Vendler, 'Colossus' of Poetry Criticism, Dies at 90 (Helen Vendler, one of the leading poetry critics in the United States, with a reputation-making power that derived from her fine-grained,...) Apr. 24.

Noncompete Clauses and the FTC's Ban (UPDATED 4/29/24)

UPDATE (4/29/2024, 5:15PM CDT):

The Chamber of Commerce filed a "coalition lawsuit" against the FTC on Wednesday, April 24 (news release; complaint). In addition to the points listed below, the CoC is also hanging its hat on the retroactive application of the new to rule to nearly all 30 million existing noncompete agreements (see Complaint, ¶¶ 8, 21, 59, 84, 104-05). Retroactivity is not per se illegal, but there generally must be clear authorization from Congress (Bowen v. Georgetown University Hospital (U.S. 1988)) or the agency must be writing on a clean slate with its retroactive rule (Smiley v. Citibank (U.S. 1996)), as seems to be the case here.

ORIGINAL POST (4/24/2024):

After 15 months of reviewing over 26,000 public comments on its proposed rule, the Federal Trade Commission voted 3-2 yesterday to adopt a final rule banning most noncompete agreements, including those involving health-care professionals and employees, effective 120 days after publication of the rule in the Federal Register. A 2-1/2-page fact sheet provides a helpful overview of the 570-page final rule. The majority claimed that "noncompetes are an unfair method of competition and therefore violate Section 5 of the Federal Trade Commission Act ('FTC Act')."

Highlights of the rule (from the fact sheet):

• The rule states that noncompetes are an unfair method of competition. As a result, the rule prohibits employers from entering into new noncompetes with workers, as of the effective date. 
• The rule prohibits employers from enforcing noncompetes with workers other than senior executives as of the effective date. 
• Less than 1% of workers are estimated to be senior executives under the final rule. 
• Specifically, the final rule defines the term “senior executive” as workers earning more than $151,164 who are in a “policy-making position.” 
• The rule requires employers to notify workers whose noncompetes are no longer enforceable that their noncompetes are no longer in effect and will not be enforced. The FTC provides model language that employers can use to notify employees. 
• The rule includes an exception that allows noncompetes between the seller and buyer of a business. 
• The final rule differs from the proposed rule in several respects. For example: 
• The rule does not ban existing noncompetes with senior executives. 
• The rule simplifies the notice and compliance requirements for employers. 
• The rule expands the sale of business exception.

Of particular interest to hospitals, Becker's Hospital Review (4/24/2024) observes:

• Though the FTC recognized that it does not have jurisdiction over nonprofit entities, it reserved the right to evaluate an entity's nonprofit status, which would include a significant portion of the 6,120 hospitals in the U.S. 
  
  
• Specifically, the agency said that "some portion of the 58% of hospitals that claim tax-exempt status as nonprofits and the 19% of hospitals that are identified as state or local government hospitals in the data cited by [American Hospital Association] likely fall under the commission's jurisdiction and the final rule's purview."

The American Hospital Association continued its rejection of the rule:

• The final rule would have significant implications for the healthcare industry and has been described by Federation of American Hospitals President and CEO Chip Kahn as a "double whammy" against hospitals. 
  
  
• "The ban makes it more difficult to recruit and retain caregivers to care for patients, while at the same time creating an anticompetitive, unlevel playing field between taxpaying and tax-exempt hospitals — a result the FTC rule precisely intended to prevent," Mr. Kahn said in a statement shared with Becker's. "In a time of constant healthcare workforce shortages, the FTC's vote today threatens access to high-quality care for millions of patients."

The AHA position seemingly concedes the point that noncompetes tend to lock employees into the current job, and once the constraint of a noncompete is removed, it will be just that much more difficult to retain workers in a job market that is already producing shortages at many hospitals.

The U.S. Chamber Commerce has already stated its intention to challenge the rule in the courts:

“The Federal Trade Commission’s decision to ban employer noncompete agreements across the economy is not only unlawful but also a blatant power grab that will undermine American businesses’ ability to remain competitive.  

“Since its inception over 100 years ago, the FTC has never been granted the constitutional and statutory authority to write its own competition rules. Noncompete agreements are either upheld or dismissed under well-established state laws governing their use. Yet, today, three unelected commissioners have unilaterally decided they have the authority to declare what’s a legitimate business decision and what’s not by moving to ban noncompete agreements in all sectors of the economy. 

“This decision sets a dangerous precedent for government micromanagement of business and can harm employers, workers, and our economy. 

“The Chamber will sue the FTC to block this unnecessary and unlawful rule and put other agencies on notice that such overreach will not go unchecked.”

For the record, the FTC sees the situation differently:

Noncompetes restrict the freedom of American workers and suppress wages.

• Noncompetes restrict workers’ fundamental freedom to leave for a better job or to start their own business.
• In many cases, noncompetes are take-it-or-leave-it contracts that exploit workers’ lack of bargaining power and coerce workers into staying in jobs they would rather leave, or force workers to leave a profession or even relocate.
• By restricting workers from moving freely, noncompetes prevent workers from accepting higher-paying jobs.
• Noncompetes even reduce the wages of workers who aren’t subject to noncompetes. Noncompetes stifle new businesses and new ideas. 

Noncompetes restrict the freedom of American workers and suppress wages. 

• Noncompetes prevent workers from starting their own firms and block new businesses from hiring qualified workers. 
• Noncompetes restrict the flow of knowledge between firms, and studies have found that noncompetes reduce innovation. This affects not just workers but also consumers by depriving consumers of better products and lower prices that result from competition and innovation. 

Noncompetes are widespread throughout the U.S. economy. 

• Roughly one in five Americans, totaling nearly 30 million people, are subject to noncompetes. 
• The Commission received over 26,000 comments, with thousands of workers describing how noncompetes blocked them from taking a better job, negotiating better pay, or starting their own business. 
• The Commission also heard from entrepreneurs and small businesses who said noncompetes prevented them from starting new ventures or hiring knowledgeable workers to help grow their businesses. 
• Over 25,000 commenters supported a categorical ban on noncompetes. 

By banning noncompetes, the FTC estimates that: 

• New business formation will grow by 2.7%, creating over 8,500 new businesses each year. 
• American workers’ earnings will increase by $400-$488 billion over the next decade, with workers’ earnings rising an estimated $524 a year on average. 
• Health care costs will be reduced by $74-$194 billion over the next decade in reduced spending on physician services. 
• Innovation will increase, with an average estimated increase of 17,000-29,000 more patents each year over the next decade. 

The Many Stories of Palliative Care

One of the newest medical specialties around, palliative care may also be one of the least understood. It is not not synonymous with either end-of-life care or with hospice care, though it often plays an important role in each. It is also not only about pain control through medications alone. I think of it as a holistic approach to all dimensions of suffering -- pain control when and as needed, as well as psychosocial, emotional, and spiritual care. As this list suggests, good palliative care is a multi-disciplinary team approach to suffering. 

Herein the sermon endeth.

If your eyes started to glaze over while you read that first paragraph, you're likely to be in good company. Understanding what palliative care is about, what it can and cannot accomplish, like most things worth doing in life, is best understood through the stories of patients, various health care professionals, families, administrators, etc.

Fortunately there is a book that does just that, bringing to life the practice of palliative care and in doing so bringing us to a deeper understanding of what palliative care seeks to accomplish and how. I am thinking of The Pursuit of Life: The Promise and Challenges of Palliative Care, a collection of essays edited by my SMU colleague (in Perkins School of Theology) Jack Levison and my long-time collaborator and friend, Bob Fine. You can read about it on the BMJ Supportive and Palliative Care blog and if you are moved to do as I did, you can purchase a copy over at Amazon.

Spike in ER Refusals of Pregnancy-Related Emergency Care After Dobbs Decision

A story from the Associated Press (AP, 4/19/24) reports that "more than two dozen complaints about emergency pregnancy care were lodged in the months after the Dobbs decision was unveiled. It is not known how many complaints were filed last year as the [AP's FOIA] request only asked for 2022 complaints and the information is not publicly available otherwise."

Individual refusals are stunningly heartless:

One woman miscarried in the lobby restroom of a Texas emergency room as front desk staff refused to check her in. Another woman learned that her fetus had no heartbeat at a Florida hospital, the day after a security guard turned her away from the facility. And in North Carolina, a woman gave birth in a car after an emergency room couldn’t offer an ultrasound. The baby later died. . . .

Consider what happened to a woman who was nine months pregnant and having contractions when she arrived at the Falls Community Hospital in Marlin, Texas, in July 2022, a week after the Supreme Court’s ruling on abortion. The doctor on duty refused to see her.

“The physician came to the triage desk and told the patient that we did not have obstetric services or capabilities,” hospital staff told federal investigators during interviews, according to documents. “The nursing staff informed the physician that we could test her for the presence of amniotic fluid. However, the physician adamantly recommended the patient drive to a Waco hospital.”

Ethics. “It is shocking, it’s absolutely shocking,” said Amelia Huntsberger, an OB/GYN in Oregon. “It is appalling that someone would show up to an emergency room and not receive care -- this is inconceivable.” Why is this happening? 

Pregnant patients have “become radioactive to emergency departments” in states with extreme abortion restrictions, said Sara Rosenbaum, a George Washington University health law and policy professor.

“They are so scared of a pregnant patient, that the emergency medicine staff won’t even look. They just want these people gone,” Rosenbaum said. 

Law. Aren't the refusals of pregnancy-related emergency care illegal? Well, the federal Emergency Medical Treatment and Active Pregnancy Act requires Medicare-contracted hospitals to stabilize the emergency medical condition when a woman comes to the emergency department in labor. It's a Condition of Participation in the Medicare program. It shouldn't be complicated, but it is.

On Wednesday, April 24, the Supreme Court will hear oral arguments in the case of Moyle v. United States, No. 23-726, in which the issue is "[w]hether 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." There are 45 amicus briefs in this case, an indication of the broad and strong interest in this case on both sides of the issue. (The district court's order in unpublished but can be found at pages 620-59 of Vol. 2 of the Joint Appendix filed in the Supreme Court matter.)

No, I am not "The Patient"

There's a good reflection piece posted (free) today on-line at JAMA: “The Patient” by Katie Thure. It starts:

Mrs T was a 58-year-old female admitted to the intensive care unit (ICU) for respiratory distress secondary to pneumonia. On her 10th day of hospitalization, she developed septic shock. Despite escalations in care, it became clear Mrs T would not survive. After a goals-of-care conversation with her husband, her 2 adult children, living outside of the state, were called to come to say their goodbyes. With both children at bedside, a woman wearing scrubs and a long white coat walked into the room and announced, “I’m Dr A, an ICU resident.” She explained the medical data and summarized to the family that “the patient has no chance of survival.” Although this statement was objectively correct, it failed to acknowledge that “the patient” was also a community advocate for equitable education, a wife of 40 years, a lover of mischief, and my mom. . . .

I was not surprised to hear about her poor prognosis. But I was surprised at Dr A’s choice to call my mom the patient. Is this how everyone is told their best friend was going to die? How could my mom be just the patient if her fingernails were still painted with Christmas trees and snowflakes?

There's more to savor and learn from this short essay. It's about the dehumanizing effect of the language of medical encounters. "Dr. Jones" becomes simply "the resident," and Dr. Smith is "the attending." "Mrs. Thure" is stripped of personhood and is "the patient." As the author writes: "When we choose not to use someone’s name, we are choosing to reduce them. We are indirectly saying, 'You are no more than the one-word descriptor I have given you.' The patient is not a human but just a pathology needing to be addressed." 

Ms. Thure (Class of 2024 in UCLA's medical school) doesn't oversimplify: 

Years later as a medical student, I was taught to think about patients both holistically and also to reduce them to a one-liner. There is clinical significance to having an accurate, concise depiction of a patient’s history and current medical needs. There is also equal clinical significance to remembering the person behind the one-liner.

What defines the distance between these two descriptions? Empathy. Or maybe simply circumstances:

Over the years, I have spent a fair amount of time trying to figure out how my mom became the patient. Maybe Dr A was at the end of a long and difficult shift, maybe that was not the first bad news she had delivered that evening, maybe she was never trained to be empathetic, maybe it is just the culture of medicine. Or maybe there was no reason at all.

Tomorrow is the last meeting of this semester's edition of "Law, Literature & Medicine." It's a seminar for 4th-year med students (UT-Southwestern) and 3rd-year law students (SMU/Dedman) that I have taught for decades, since 2017 with my valued friend and co-teacher, Dr. Reeni Abraham. I will propose that we email the class a PDF of Ms. Thure's essay and discuss whether it should be included in the first day's reading assignment when we offer the course again in 2025. The course is about the language we professionals use, identity (our patients' and clients' and our own), narratives, and empathy. And it's all here in this wonderful little essay.

Health Disparities: More Data from The Commonwealth Fund

Here is The Commonwealth Fund's introduction to the new report (released today):

Part of the Fund’s ongoing series examining state health system performance, Advancing Racial Equity in U.S. Health Care: The Commonwealth Fund 2024 State Health Disparities Report evaluates states on 25 measures of health care access, quality, service use, and health outcomes for Black, white, Hispanic, American Indian and Alaska Native (AIAN), and Asian American, Native Hawaiian, and Pacific Islander (AANHPI) populations. 

Among the key findings:

The health care divide is especially stark when it comes to premature deaths: American Indian and Black people die from preventable and treatable causes at substantially higher rates than other groups.

Disparities exist even in states that are otherwise considered high performing on health care.

Health care experiences for people of color vary widely across states. For example, health systems in South Dakota, North Dakota, and Alaska perform worst for American Indian people, while North Carolina’s health system performs best.

Find out where your state ranks, and how we can achieve more equitable health care systems in each state.