Bird Flu: It May Be Worse Than We Suspect

The Kaiser Family Foundation (KFF) just published a report on the bird flu with a pretty scary title: "How America Lost Control of the Bird Flu, Setting the Stage for Another Pandemic." What?!?

A few salient quotes:

• "Nearly a year into the first outbreak of the bird flu among cattle, the virus shows no sign of slowing. The U.S. government failed to eliminate the virus on dairy farms when it was confined to a handful of states, by quickly identifying infected cows and taking measures to keep their infections from spreading. Now at least 875 herds across 16 states have tested positive."
• "Experts say they have lost faith in the government’s ability to contain the outbreak. 'We are in a terrible situation and going into a worse situation,' said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. 'I don’t know if the bird flu will become a pandemic, but if it does, we are screwed.'"
• "To understand how the bird flu got out of hand, KFF Health News interviewed nearly 70 government officials, farmers and farmworkers, and researchers with expertise in virology, pandemics, veterinary medicine, and more. . . . Together with emails obtained from local health departments through public records requests, this investigation revealed key problems, including deference to the farm industry, eroded public health budgets, neglect for the safety of agriculture workers, and the sluggish pace of federal interventions."
• "Far more bird flu damage is inevitable, but the extent of it will be left to the Trump administration and Mother Nature." No comment.
• "[T]the outbreak poses the threat of a pandemic. More than 60 people in the U.S. have been infected, mainly by cows or poultry, but cases could skyrocket if the virus evolves to spread efficiently from person to person. And the recent news of a person critically ill in Louisiana with the bird flu shows that the virus can be dangerous. . . . Just a few mutations could allow the bird flu to spread between people. Because viruses mutate within human and animal bodies, each infection is like a pull of a slot machine lever.
• “Even if there’s only a 5% chance of a bird flu pandemic happening, we’re talking about a pandemic that probably looks like 2020 or worse,” said Tom Peacock, a bird flu researcher at the Pirbright Institute in the United Kingdom, referring to covid. “The U.S. knows the risk but hasn’t done anything to slow this down,” he added.

SCOTUS Adds Medicaid Exclusion of Planned Parenthood to its Docket

Add another case to my SCOTUS "roundup" (Dec. 1).

SCOTUSBlog notes that the Supreme Court has granted review of the 4th Circuit Court of Appeals's decision in Kerr v. Planned Parenthood, which involves "a dispute over whether a South Carolina woman can bring a lawsuit challenging that state’s decision to end Planned Parenthood’s participation in its Medicaid program. . . ." Amy Howe, Court adds Medicaid lawsuit to docket, SCOTUSblog (Dec. 18, 2024, 12:57 PM). It's a safe bet that the required four votes to grant the petition for review came from the 6-member conservative group of Justices, so this is an ominous development for Planned Parenthood (and the women who depend upon PP for a variety of healthcare needs). The note continues:

Under federal law, Medicaid funds cannot generally be used to provide abortions. But Planned Parenthood provides other medical services to women, including gynecological and contraceptive care but also screenings for cancer, high blood pressure, and cholesterol.

At two clinics in Charleston and Columbia, Planned Parenthood has tried to make it easier to lower-income patients, many of whom are covered by Medicaid, to use its services – by, for example, offering same-day appointments and extended clinic hours. One of those Medicaid patients is Julie Edwards, who suffers from diabetes. She went to Planned Parenthood for birth control but says she wants to return to receive other care in the future.

In 2018, South Carolina Governor Henry McMaster ordered the state’s Department of Health and Human Services to bar abortion clinics from participating in the Medicaid program. McMaster explained that the “payment of taxpayer funds to abortion clinics, for any purpose, results in the subsidy of abortion and the denial of the right to life.”

Edwards and Planned Parenthood went to federal court in South Carolina. They argued that McMaster’s order violated a provision of the Medicaid Act that allows any patient who is eligible for Medicaid to seek health care from any “qualified” provider.

A federal appeals court agreed with Edwards and Planned Parenthood and blocked the state from excluding Planned Parenthood from its Medicaid program. That decision prompted the state – represented by the conservative Alliance Defending Freedom – to come to the Supreme Court this summer, asking the justices to decide whether Edwards and Planned Parenthood have a legal right to sue to enforce the Medicaid Act.

The state told the justices that five federal courts of appeals “have wrongly subjected states to private lawsuits Congress never intended.” Moreover, it added, with 70 million Americans receiving Medicaid benefits and tens of thousands of health-care providers participating in the program, the question at the center of the case is “of great national importance.”

But Planned Parenthood and Edwards countered that the question does not come up very often these days. And most of the cases in which it did arise, they continued, “were efforts by states to target Planned Parenthood in ways courts have recognized are unwarranted and politically motivated.” But in any event, they concluded, as all three judges on the court of appeals agreed in this case, the Medicaid law is “clear and unambiguous in conferring a privately enforceable right.”

The justices considered the state’s petition at nine consecutive conferences before finally granting review on Wednesday. The case will likely be slated for argument in either March or April, with a decision to follow by summer.

A number of states have removed Planned Parenthood from their Medicaid programs, including Texas. Beyond that, the Texas Attorney General has sued PP for$1.8 billion in an attempt to bankrupt the organization. Details are here.

Two-week nationwide law enforcement action produces criminal charges for submission of over $2.75 billion in alleged false billings

The announcement from the U.S. Attorney's Office for Montana was pretty bland: "Whitefish doctor sentenced for defrauding Medicare and other federal health programs." But the devil, as they say, is in the details:

A Whitefish doctor who admitted defrauding Medicare and other federal government health programs through a telemedicine conspiracy that resulted in more than $31 million in false billing was sentenced today to six months in prison, to be followed by six months of home confinement, fined $100,000 and ordered to pay $780,509 restitution, the U.S. Attorney’s Office said.

The defendant, Ronald David Dean, 64, pleaded guilty in July to conspiracy to commit wire fraud. . . .

The government alleged in court documents that Dean, a licensed physician, was paid by a telemedicine company to sign orders for durable medical equipment that patients did not need. Dean then fraudulently charged Medicare, CHAMPVA and the Railroad Retirement Board programs for telemedicine office visits that did not occur.  The telemedicine company also used Dean’s information to prescribe unneeded and unnecessary covid tests to patients.  The conspiracy ran from about January 2022 until July 2023. The total amount billed to Medicare, the VA and the Railroad Retirement Board based on orders Dean signed was $31,432,001, and the total amount paid from those programs was $13,785,724.

As part of the scheme, Dean relied on information provided by people he did not know, with an unknown amount of training or experience, to prescribe braces for beneficiaries he did not see or evaluate himself. Dean frequently did not even talk to the beneficiaries, and when he did it was merely to tell them the braces were approved. Dean had no idea if those people who received braces actually needed them. With the covid tests, Dean provided blanket authorization for the telemedicine company to send out tests to anyone and bill Medicare for as many covid tests as the company desired.

The case was part of a strategically coordinated, two-week nationwide law enforcement action that resulted in criminal charges against 193 defendants for their alleged participation in health care fraud and opioid abuse schemes that resulted in the submission of over $2.75 billion in alleged false billings. The defendants allegedly defrauded programs entrusted for the care of the elderly and disabled to line their own pockets, and the Government, in connection with the enforcement action, seized over $231 million in cash, luxury vehicles, gold, and other assets.

Fear and greed are classic human motivators. This time, as I suspect in most such cases of health care fraud, greed overcame any fear of being caught. Six months in the pokey seems awfully light, but I assume the sentence falls within a range permitted by the Federal Sentencing Guidelines. A month for every million paid by the government would have had a nice ring to it.

FTC Withdraws 2000 Antitrust Guidelines for Collaborations Among Competitors

On Dec. 11, the Federal Trade Commission and the Justice Department’s Antitrust Division (DOJ) jointly announced the withdrawal of the Antitrust Guidelines for Collaborations Among Competitors (Collaboration Guidelines):

The Collaboration Guidelines, issued in April 2000, no longer provide reliable guidance about how enforcers assess the legality of collaborations involving competitors, according to the FTC and DOJ’s joint withdrawal statement. Businesses considering collaborating with competitors are encouraged to review the relevant statutes and caselaw to assess whether a collaboration would violate the law.

The FTC and DOJ are committed to vigorous antitrust enforcement on a case-by-case basis in the area of competitor collaborations because such collaborations can harm competition and subvert the competitive process, according to the withdrawal statement.

 It was a 3-2 vote. In addition to the withdrawal statement (link above), three commissioners issued statements (including two dissenting statements:

• Statement of Commissioner Alvaro M. Bedoya Regarding the Withdrawal of the Antitrust Guidelines for Collaborations Among Competitors
• Dissenting Statement of Commissioner Andrew N. Ferguson Regarding the Withdrawal of the Antitrust Guidelines for Collaborations Among Competitors
• Dissenting Statement of Commissioner Melissa Holyoak Regarding Withdrawal of 2000 Antitrust Guidelines for Collaboration Among Competitors

This most recent withdrawal is part of a broader program of withdrawing guidelines and policy statements deemed to be out of date. E.g.,  Press Release, Department of Justice, Office of Public Affairs, Justice Department Withdraws Outdated Enforcement Policy Statements (Feb. 3, 2023), https://www.justice.gov/opa/pr/justicedepartment-withdraws-outdated-enforcement-policy-statements; Press Release, Federal Trade Commission, Federal Trade Commission Withdraws Health Care Enforcement Policy Statements (July 14, 2023), https://www.ftc.gov/news-events/news/press-releases/2023/07/federal-trade-commission-withdraws-health-careenforcement-policy-statements. 

As Commissioner Holyoak observed in her dissenting statement, the Commission has withdrawn its 2000 guidance without providing updated guidance, leaving competitors who are in or are contemplating collaborations in the dark.

77 Nobel Laureates Oppose RFKJr's Nomination to Head DHHS

For the reportedly first time ever, 77 Nobel Prize Laureates have written a letter (also: here) to the members of the U.S. Senate in which they urge rejection of the Trump Secretary-designate Robert F. Kennedy, Jr. to head the $1.8 trillion/year Department of Health and Human Services. DHHS is the mother ship for operating divisions that administer over 100 health and safety programs. The divisions include:  

• Agency for Healthcare Research and Quality
• Agency for Toxic Substances and Disease Registry
• Administration on Aging
• Centers for Disease Control and Prevention
• Centers for Medicare & Medicaid Services (formerly Health Care Finance Administration)
• Office of Child Support Enforcement 
• Office of Child Support Services 
• Administration for Children and Families 
• Office of Family Assistance
• Food and Drug Administration
• Health Resources and Services Administration
• Indian Health Service
• Inspector General Office, Health and Human Services Department
• National Institutes of Health
• National Library of Medicine
• Program Support Center
• Public Health Service
• Office of Refugee Resettlement 
• Substance Abuse and Mental Health Services Administration
• Community Living Administration
• Strategic Preparedness and Response Administration

The laureates's bill of particulars is as familiar as it is damning: 

In addition to his lack of credentials or relevant experience in medicine, science, public health, or administration, Mr. Kennedy has been an opponent of many health-protecting and life-saving vaccines, such as those that prevent measles and polio; a critic of the well-established positive effects of fluoridation of drinking water; a promoter of conspiracy theories about remarkably successful treatments for AIDS and other diseases; and a belligerent critic of respected agencies (especially the Food and Drug Administration, the Centers for Disease Control, and the National Institutes of Health). The leader of DHHS should continue to nurture and improve---not threaten---these important and highly respected institutions and their employees.

In conclusion:  

In view of his record, placing Mr. Kennedy in charge of DHHS would put the public's health in jeopardy and undermine America's global leadership in the health sciences, in both the public and commercial sectors.

If there is a Senate vote on Mr. Kennedy's nomination -- which is still a matter of some doubt -- we will find out if the Senator -- and Senate Republicans in particular -- share Trump's and Kennedy's disdain for science and medicine and expertise earned over lifetimes of work in these fields. 

HHS OIG and DOJ Publish 2023 Report on Fraud and Abuse Enforcement

Unlike the proposed, scammy Department of Government Efficiency, whose billionaire leaders seem focused on slashing budgets and trimming enforcement efforts in numerous federal agencies regarded as part of the "deep state," DOJ and HHS have actually been working hard to root out skullduggery and outright theft in the health care industry. This report is quite revealing. It also begs the question whether we will see another report like this from the next administration. 

Here's an overview:

In FY 2023, civil health care fraud settlements and judgments under the False Claims Act exceeded $1.8 billion, in addition to other health care administrative impositions won or negotiated by the Federal Government. Due to these efforts, as well as those of preceding years, more than $3.4 billion was returned to the Federal Government or paid to private persons in FY 2023. Of this $3.4 billion, the Medicare Trust Funds received transfers of approximately $974 million during this period, in addition to $257.2 million in Federal Medicaid money that was transferred separately to the Centers for Medicare & Medicaid Services.

One gets the feeling that $1.8 billion is the tip of the fraud-and-abuse iceberg. First, the report shows just how thoroughly fraud permeates most aspects of the health care system. The report discusses major areas of enforcement efforts (past, present, and future) and should be read by any healthcare lawyer who advises any individual or institutional providers on this list:

• Ambulances 
• Clinics (e.g., pain clinics, ophthalmology services and related ambulatory surgical centers)
• COVID-19 Related Enforcement 
• Diagnostic Testing (huge)
• Durable Medical Equipment (DME) (an oldie but a goodie, still huge)
• Electronic Health Records 
• EMTALA Violations
• Genetic Testing/RPP (Respiratory Pathogens Panel )Testing 
• Home Health Providers 
• Hospice Care
• Hospitals and Health Systems (see below for the details of one especially notable enforcement action against a renowned hospital and health system)
• Laboratory Testing 
• Managed Care 
• Medical Devices 
• Pharmacies 
• Physical Therapy 
• Physician and Other Practitioners 
• Prescription Drugs and Opioids 
• Psychiatric and Psychological Testing and Services
• Substance Use Treatment Centers 
• Telemedicine Exploitation and Fraud

More detail on the "Hospitals and Health Systems" item. 

In February 2023, the University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), and a cardiothoracic surgeon agreed to pay $8.5 million, submit to a year-long audit, and implement a corrective action plan to resolve civil FCA allegations that UPMC (an integrated health care system and teaching hospital based in Pittsburgh), UPP (UPMC’s physician practice group), and the surgeon (a teaching physician and longtime chair of UPMC’s department of cardiothoracic surgery) violated the Teaching Physician Regulations, 42 C.F.R. §§ 415.190 and 415.192, by performing as many as three complex surgeries at the same time, failing to participate in all of the key and critical portions of those surgeries, unnecessarily inflating anesthesia times during those surgeries, and billing Medicare and other government Health Benefit Programs for those surgeries and services.  In its September 2021 Complaint-in-Partial-Intervention, the government alleged that, from 2015-2021, UPMC, UPP and the surgeon submitted false claims for payment related to: (1) doubly- and triply-concurrent surgeries, during which the surgeon left a first surgery before the key and critical portions of that surgery were complete, participated in as many two other simultaneous surgeries in separate operating rooms, and caused delays and complications in some of those surgeries; (2) surgeries where the surgeon did not participate in the timeout at the outset of the procedure; (3) surgeries where the surgeon was outside the hospital facility, unlocatable for significant stretches, or otherwise not immediately available throughout the procedure; (4) unduly prolonged anesthesia services associated with the surgeon’s concurrent surgeries and absences; and (5) procedures, services, and care related to otherwise avoidable complications caused by the concurrent surgeries. 

This is far from an isolated incident. Massachusetts General Hospital, one of the Harvard teaching hospitals, was cited for the same activity and paid out three settlements that totaled $32.7 million to settle three claims of multiple simultaneous surgeries between 2019 and 2022 (Boston Globe, Feb. 18, 2022 - paywall; law firm blurb based on the story). In June 2024 I wrote on the issue when it involved a major Houston hospital.

The report has some additional intriguing details:

In FY 2023, the Department of Justice (DOJ) opened more than 802 new criminal health care fraud investigations.  Federal prosecutors filed criminal charges in over 346 cases involving at least 530 defendants.  More than 476 defendants were convicted of health care fraud related crimes during the year.  Also, in FY 2023, DOJ opened more than 770 new civil health care fraud investigations and had over 1,147 civil health care fraud matters pending at the end of the fiscal year.  Federal Bureau of Investigation (FBI) investigative efforts resulted in over 620 operational disruptions of criminal fraud organizations and the dismantlement of more than 127 health care fraud criminal enterprises. 

In FY 2023, investigations conducted by HHS’s Office of Inspector General (HHS-OIG) resulted in 651 criminal actions against individuals or entities that engaged in crimes related to Medicare and Medicaid, and 733 civil actions, which include false claims, unjust-enrichment lawsuits filed in Federal district court, and civil monetary penalty (CMP) settlements.  HHS-OIG excluded 2,112 individuals and entities from participation in Medicare, Medicaid, and other Federal health care programs.  Among these were exclusions based on criminal convictions for crimes related to Medicare and Medicaid (871) or to other health care programs (314), for beneficiary abuse or neglect (203), and as a result of state health care licensure revocations (531).  

There's no denying it's been another busy year for the enforcers, but there seems to be no stopping health care providers (real or fake) with larceny in their heart. 

CDC Reports on Intimate-Partner Violence

The full title of the CDC's report gives an accurate picture of the report's focus on intimate-partner violence "(IPV"): Intimate Partner Violence and Pregnancy and Infant Health Outcomes — Pregnancy Risk Assessment Monitoring System, Nine U.S. Jurisdictions, 2016–2022 (Dec. 5, 2025). 

The implications of IPV for public health, maternal health, and infant health are far-reaching, complex, and difficult to solve. Here's a snapshot of this important report:

Summary

What is already known about this topic?

Intimate partner violence (IPV) during pregnancy is a preventable cause of injury and death with negative short- and long-term impacts for pregnant women, infants, and families.

What is added by this report?

During 2016–2022, among women with a live birth in nine jurisdictions, 5.4% experienced IPV during pregnancy. Emotional IPV (5.2%) was more common than physical (1.5%) and sexual (1.0%) IPV. All IPV types were associated with delayed or no prenatal care, depression and substance use during pregnancy, and low infant birth weight.

What are the implications for public health practice?

Addressing multiple IPV types through comprehensive prevention efforts is critical to supporting maternal and infant health.

Abstract

Intimate partner violence (IPV) can include emotional, physical, or sexual violence. IPV during pregnancy is a preventable cause of injury and death with negative short- and long-term impacts for pregnant women, infants, and families. Using data from the 2016–2022 Pregnancy Risk Assessment Monitoring System in nine U.S. jurisdictions, CDC examined associations between IPV during pregnancy among women with a recent live birth and the following outcomes: prenatal care initiation, health conditions during pregnancy (gestational diabetes, pregnancy-related hypertension, and depression), substance use during pregnancy, and infant birth outcomes. Overall, 5.4% of women reported IPV during pregnancy. Emotional IPV was most prevalent (5.2%), followed by physical (1.5%) and sexual (1.0%) IPV. All types were associated with delayed or no prenatal care; depression during pregnancy; cigarette smoking, alcohol use, marijuana or illicit substance use during pregnancy; and having an infant with low birth weight. Physical, sexual, and any IPV were associated with having a preterm birth. Physical IPV was associated with pregnancy-related hypertension. Evidence-based prevention and intervention strategies that address multiple types of IPV are important for supporting healthy parents and families because they might reduce pregnancy complications, depression and substance use during pregnancy, and adverse infant outcomes.

As a side note, this report is an example of the sort of data collection and dissemination that may be at risk in the Trump administration. It appears that the president-elect's advisors, as well as members of Congress, are looking to cut the CDC's budget and scale back some of its public-health activities. I hope cooler heads will prevail, but "Hope is that thing with feathers." 

SCOTUS Watch: Week of Dec. 2

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

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

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

 

Two New Enforcement Actions from Texas Attorney General

As easy as it is to dislike Ken Paxton for his extravagantly disruptive policies on abortion and gender-affirming care for minors, his office does a good job in its enforcement program against health fraud. Two recent examples:

Attorney General Ken Paxton’s Investigation Results In 10-Year Prison Sentence And Over $34 Million Restitution For North Texas Doctor (November 25, 2024; State of Texas) Attorney General Ken Paxton’s Medicaid Fraud Control Unit Plays Key Role In Largest Ever Criminal Enforcement Action Targeting Opioid Distributors (November 25, 2024; State of Texas)

U.K. Moves Toward Medical Assistance in Dying/Assisted Suicide

A bill to legalize physician-assisted suicide passed in the House of Commons today. In the U.S., where 10 states and D.C. have legalized PAS (also known as Medical Aid in Dying ("MAiD")), state laws have largely followed the law in Oregon, the first state to legalize PAS. The British bill does the same, adding additional safeguards such as a mandatory physician's second-opinion and required court approval.

The bill will now go through a process of amendment and then on to the House of Lords for final approval.

West Virginia's Constitutional Amendment Prohibiting Physician-Assisted Suicide

Prof. Austin Sarat (Amherst College) has posted an excellent op-ed on the website of The Hill that describes and decries the autonomy-crushing West Virginia constitutional amendment that voters passed last week by a 1% margin (50.5% yes-49.5% no). In the 40 states where physician-assisted suicide (a/k/a Medical Aid-in-Dying) is illegal, the prohibitions are statutory. As Sarat points out, by embedding a ban in its constitution West Virginia has made it exponentially more difficult to reverse course in future years. 

Major arguments for and against the ballot measure are summarized by Ballotpedia:

In opposition:

Death with Dignity: "While Death with Dignity is already illegal under current West Virginia law, this constitutional amendment would mark the first time any state amended its constitution to explicitly prohibit aid in dying. Never before has a legislature in this country mobilized an attack like this on terminally ill patients. And to make matters worse, proponents of the ban are on a press tour spreading malicious lies about how Death with Dignity works in states where it’s legal." 

Eli Baumwell, interim executive director for ACLU West Virginia: "'Mountaineers are always free' is a promise that the ACLU of West Virginia works every day to ensure is kept. Amendment One runs counter to that promise by enshrining a prohibition into the state constitution designed to take away the last free choice Mountaineers can make. West Virginians, like most Americans, do not believe that the government should interfere in personal medical decisions. As shown by the Legislature going zero for four last year in seeking permission from the people to modify our Constitution, they do not represent the will of the people. Instead, they represent a dangerous and out of touch minority: lawmakers who want to take the last medical decision you can ever make about yourself." 

In support:

State Del. Pat McGeehan (R-1): "There’s this phenomenon of nihilism that’s sort of spreading across the country, and I think it’s an important issue we need to address. To the best of my knowledge, we’ll be the first to place this and take a stand in the state constitution." 

State Del. Pat McGeehan (R): "That’s why it is vital to vote for Amendment One this November. It secures our state from medically-assisted suicide and the culture of indifference and carelessness it promotes. It affirms the goodness of suicide prevention. And it sends a clear and confident message that West Virginia is not a place of fear and despair, but a state of courage and hope." 

Mary Tillman, legislative coordinator for the West Virginia alliance for Ethical Health Care: "If there is a fear of pain at the end of life, good palliative care and hospice care are ways to provide comfort and care until a person’s life ends naturally. A vote FOR Amendment One will protect all West Virginians from physician-assisted suicide. This November, please vote to keep West Virginia a state where all lives are valued and protected." 

Ms. Tillman's point about "good palliative care and hospice care" is only half right. Palliation and hospice care are designed to provide relief from suffering, but relief is far from inevitable. In a pioneering article in the New England Journal of Medicine, Dr. Tim Quill (coincidentally, a graduate of Amherst College, Class of 1971) wrote about the last days of his patient, Diane, who was dying of leukemia:

Bone pain, weakness, fatigue, and fevers began to dominate her life. Although the hospice workers, family members, and I tried our best to minimize the suffering and promote comfort, it was clear that the end was approaching. Diane's immediate future held what she feared the most — increasing discomfort, dependence, and hard choices between pain and sedation. . . .

Although I know we have measures to help control pain and lessen suffering, to think that people do not suffer in the process of dying is an illusion. Prolonged dying can occasionally be peaceful, but more often the role of the physician and family is limited to lessening but not eliminating severe suffering. [italics added]

"Death and Dignity — A Case of Individualized Decision Making," N Engl J Med 1991;324:691-694 (March 7, 1991). Any argument that ignores this harsh reality lacks scientific, medical, and moral authority.

Finally, I want to end with the point that Prof. Sarat makes at the outset of his op-ed:

Donald Trump’s surprisingly decisive electoral victory was a serious blow to those who value freedom and human dignity. . . .

His version of freedom does not include respecting the choices that individuals make about their own bodies. . . .

And while our attention was focused on those assaults on bodily autonomy, voters in West Virginia, where the MAGA ethos reigns supreme, passed a ballot measure amending their state constitution to prohibit people from participating in “the practice of medically assisted suicide, euthanasia, or mercy killing of a person.”   

Passage of West Virginia's ballot measure represents a victory for MAGA-types and MAGA-adjacent pro-life absolutists like the National Right to Life Committee and its various state affiliates. They added end-of-life decision-making to their traditional focus on reproductive decision-making three decades ago and have advocated relentlessly and quite successfully to curtail patient rights ever since.

Health Affairs: "The Impact Of The Election On Health Policy And The Courts"

The nonpartisan and highly respected journal, Health Affairs, today posted an analysis of some of the more conspicuous (and worrying) changes to the health care scene we might expect to see once Donald Trump's administration is in place. It is, as usual, well worth reading in whole.

The areas that are discussed include:

• the Affordable Care Act (ACA) (primary concern: allowing premium tax credit enhancements to expire entirely after 2025, which could result in 4 million people losing their health insurance coverage; also -- whether by statute, agency regulation, or executive order -- any number of the ACA's protections are at risk)
• Medicaid (during the campaign Trump vowed to leave Social Security and Medicare alone; "experts noted that Medicaid was conspicuously absent from the conversation")
• reproductive health care (abortion, LGBTQ nondiscrimination, reviving the Comstock Act, changing the Administration's position in state and federal lawsuits)
• nondiscrimination and health equity ("Health care is a civil rights issue. . . . Anti-discrimination protections in health are also likely to suffer major blows going forward."
• Medicare Drug Negotiation Program (hard to believe that a program that will save the government and citizens billions will be watered down, but Big Pharma has hated this law from the beginning and it has some attentive allies in the new administration)
• public health (RFK, Jr. -- need I say more? He was named as Trump's nominee for Secretary of HHS; the mind reels)
• the courts (Yup. From the Supreme Court on down, expect change)

The end. (Take that any way you want.)

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

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

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

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

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

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

"Read the Full Report"

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

From the Centers for Medicare and Medicaid Services:

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

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

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

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

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

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

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

The full article is well worth the time to read.

Texas Tax-Exempt Hospitals & Charity Care: Surprisingly Progressive

In 1985 -- one year before Congress added EMTALA to Medicare's Conditions of Participation -- Texas became the first state in the country to enact a prohibition against patient-dumping, the practice of for-profit hospitals to transfer unfunded emergency patients to local public hospitals. See Tex. Health & Safety Code § 311.022. When a patient needs emergency medical treatment, the consequences of transfer-related delays could be dire, including death. See this 1985 N.Y. Times story:

(click image to enlarge)

This isn't the only progressive healthcare law in Texas. For decades now, we have also required nonprofit hospitals to provide a certain minimum amount of charity care, both to maintain its nonprofit status (Tex. Health & Safety Code, ch. 311(D)) and to qualify for tax-exempt status (Tex. Tax Code § 11.1801). If a nonprofit hospital meets any one of three measures of required charity care, it gets its exemption:

(A)  charity care and government-sponsored indigent health care (e.g., Medicaid] are provided at a level which is reasonable in relation to the community needs, as determined through the community needs assessment, the available resources of the hospital or hospital system, and the tax-exempt benefits received by the hospital or hospital system; 

(B)  charity care and government-sponsored indigent health care are provided in an amount equal to at least 100 percent of the hospital's or hospital system's tax-exempt benefits, excluding federal income tax;  or 

(C)  charity care and community benefits are provided in a combined amount equal to at least five percent of the hospital's or hospital system's net patient revenue, provided that charity care and government-sponsored indigent health care are provided in an amount equal to at least four percent of net patient revenue. 

The statutes aren't perfect. They are written so that, with enough uncompensated care provided to Medicaid patients, a hospital (in theory) could meet any of the three standards with no charity care whatsoever. In addition,  with careful planning most nonprofit community hospitals can meet one of these standards, and both statutes provide for fairly generous exceptions to the three measures. For example, a recent study concluded that nonprofit hospitals in Texas provide charity care at a level approximately equal to 60% of the value of their tax exemption. Part of the problem is the extremely limited enforcement procedures and budget. And the root of the entire problem is that very few health systems have the level of excess income to do more than put a dent in their community's need for charity care. Medicaid meets some of that need, but most state Medicaid programs are underfunded.

Tax-Exempt Hospitals & Charity Care: A Mixed Bag

Health Affairs just published (and re-published) a few articles on this topic. Their titles pretty much tell the whole story (but here are links so you can read them yourself):

• US Nonprofit Hospitals Have Widely Varying Criteria To Decide Who Qualifies For Free And Discounted Charity Care, Luke Messac et al. (current issue)
• Nonprofit Hospitals: Profits And Cash Reserves Grow, Charity Care Does Not, Derek Jenkins and Vivian Ho (June 2023)
• Analysis Suggests Government And Nonprofit Hospitals’ Charity Care Is Not Aligned With Their Favorable Tax Treatment, Ge Bai et al. (April 2021)
• In California, Not-For-Profit Hospitals Spent More Operating Expenses On Charity Care Than For-Profit Hospitals Spent, Erica Valdovinos et al. (August 2015)

Although some commentators insist that the provision of charity care is a requirement for obtaining and maintaining federal tax-exempt status, I think that's a serious misreading of § 501(r) of the Internal Revenue Code, which was added to the Code by the Affordable Care Act in 2010. Yes, the Code now requires tax-exempt hospitals to formulate, adopt, and widely publicize a financial assistance policy ("FAP"). But the minimum requirements for the FAP merely include the following: "Eligibility criteria for financial assistance, and whether such assistance includes free or discounted care" (emphasis added). 

1. It is at technically correct that an FAP may not provide for free or discounted care. A wise hospital administrator should probably avoid this option, but it is available. Charity care is still an audit item, even if it is not required, and it's an important part of a hospital's connection to the community it serves.
2. The FAP's eligibility criteria my be written in such a manner that little or no financial assistance is actually provided. Failure to meet the community need for health care requires an explanation, but it does not appear to be a basis for the revocation of tax-exempt status.
3. Discounted care alone would also satisfy the requirements of the FAP. So, presumably, would be a low- or no-interest loan program. Again, § 501(r) does not require the provision of any level of charity care; prudence does, but not the IRC. 
4. The IRS's 63-page final rule to implement the ACA's Community Health Needs Assessment mention charity care in exactly one paragraph of the rule's preamble, and it's in the discussion of the administrative burden on hospitals that have to implement the final rule's requirements. 

None of this is to say that the governing legal standard for federal tax-exempt status ("community benefit") doesn't include charity care. It does; it's just not required. The requisite level of "community benefit" can be satisfied without it, as long as other forms of community benefit (education, training, research, etc.) are deemed to be adequate. 

Many if not most communities in this country have some level of need for charity care. Section 501(r) requires that the level of need be documented along with an exempt hospital's efforts to meet that need. Unfortunately, reporting does not mean the same as providing. Maybe someday it will, but not yet.

Washington Physicians Seek Supreme Court Injunction, Claiming 1st Amendment Right to Spread Vax Misinformation

Three physicians licensed in Washington State have disciplinary proceedings pending against them based upon their unfounded public statements about the PCR test for COVID-19 ("inaccurate"), the risk of injury or death from the COVID vaccine, the efficacy of ivermectin and hydroxychloroquine, and the transmissibility of COVID-19 from children.

The physicians have sued the state Attorney General (who represents the Washington Medical Commission) and the chair of the Commission in federal district court, claiming the pending investigations violate their protect speech and due-process rights under the First, Fifth, and Fourteenth Amendments. Their suit is joined by a nonphysician who claims a constitutional right to read and listen to the physicians' misinformation.

District Judge Thomas O. Rice denied the plaintiffs' request for an injunction against the state's enforcement proceedings and granted the state's motion to dismiss the suit for failure to state a claim upon which relief could be granted (Fed. R. Civ. P. 12(b)(6)). See Stockton et al v. Ferguson et al, No. 2:2024cv00071 (E.D. Wash., May 22 2024). The judge ruled that, because the state had not (yet) taken any action against the physician plaintiffs, "Plaintiffs have not shown that they are impeded from otherwise accessing this information, or that Drs. Eggleston and Siler’s speech has been or will likely be chilled by the Commission’s actions." Because the plaintiffs they had not (yet) suffered and were not likely to suffer any harm to a claimed constitutional right, their case was not ripe for judicial consideration. More than that, the judge found  plaintiffs' challenge to the Commission's ability to be completely wrong-headed. The judge ruled that "medical board disciplinary proceedings clearly implicate an important state interest in ensuring adequate healthcare."

On appeal to the Ninth Circuit Court of Appeals, plaintiffs asked for an injunction against the state's enforcement proceedings while their appeal was pending. The Court denied their motion, and on Monday the plaintiffs (represented by, among others, Robert F. Kennedy Jr.) filed an application with the Circuit Justice for the Ninth Circuit, Justice Elena Kagan, against seeking an injunction against the state. Significantly, they asked Justice Kagan not to decide their application but instead to circulate it to the entire court. Stockton et al. v. Ferguson et al., No. 24a440 (filed Oct. 30, 2024), Application at 1.

The plaintiffs' position is clear: "Public speech does not lose its constitutional protection from government action simply because it is uttered by a healthcare professional, even if it is at odds with medical orthodoxy." Id. at 4. The district court's opinion, however, has the better argument:

[T]he Commission may fully regulate professional conduct of physicians licensed to practice in this state.  States may regulate professional conduct, even though that conduct incidentally involves speech.Tingley v. Ferguson, 47 F.4th 1055, 1074 (9th Cir. 2022).  “[C]onduct may indicate unfitness to practice medicine if it raises reasonable concerns that the individual may abuse the status of being a physician in such a way as to harm members of the public, or if it lowers the standing of the medical profession in the public's eyes.”  Haley v. Med. Disciplinary Bd., 117 Wash. 2d 720, 733 (1991).  The Commission’s regulation of medical professionals does not violate the First Amendment.  Accordingly, Plaintiffs’ First Amendment facial challenges or as applied challenges to the Commission’s authority must fail.

COVID-19 misinformation constitutes a clear and present threat to public health and safety. You can read more about it here:

• U.S. Surgeon General: "Health Misinformation" (“Health misinformation is a serious threat to public health. It can cause confusion, sow mistrust, harm people’s health, and undermine public health efforts.”)
• Mayo Clinic, "Debunking COVID-19 myths" (comprehensive collection of myths and why they are wrong)
• Frank Otto, Penn Medicine News, "COVID-19 Misinformation: The Flip Side of ‘Knowledge is Power’" ("An early study estimated that one rumor, which had to do with drinking highly-concentrated alcohol-based cleaning products as a 'cure' for COVID-19, led to more than 5,800 people being hospitalized (with 800 dying) from January through March of 2020 alone")

More later. Meanwhile, Kelsey Reichmann at the Courthouse News Service is doing a good job of following the Stockton case and explaining what's going on.

SCOTUS Oral Argument Today

Just a quick addendum to my Friday listing of healthcare-related cases on the current SCOTUS docket. This morning the Justices heard oral argument in Advocate Christ Medical Center v. Becerra, No. 23-715. The question presented (and accepted by the Court as defining the scope of their review) is a dry-sounding issue of statutory interpretation: "Does the phrase 'entitled . . . to benefits,' used twice in the same sentence of the Medicare Act, mean the same thing for Medicare part A and SSI, such that it includes all who meet basic program-eligibility criteria, whether or not benefits are actually received."

Is this technical issue worth more than a minute of our time? Well, yes, it is. I point you to an excellent article in Axios by Maya Goldman. A few key points from her piece:

• Over 200 hospitals joined this case as petitioners. This is probably not a record number of parites joining together to seek review, but it's still a lot!
• Why does issue mean so much to so many hospitals? Because an answer to the question that favors the hospitals will increase their Disproportionate Share payments -- a reimbursement bump to reflect the higher average cost of treating low-income patients -- by about $1.5 billion.

As Sen. Everett Dirksen (probably never) famously said (though it is often misattributed to him*): "A billion here, a billion there, and pretty soon you're talking about real money." Enough to get the attention of nine Justices of the Supreme Court for an hour on Election Day. Oral argument audio should be posted later today.

_________________________________________________

* https://en.wikiquote.org/wiki/Everett_Dirksen. The New Yale Book of Quotations (2021) cites to a quotation from the Jan. 19, 1938 New York Times "Topics of the Times" column: "Well, now, about this new budget. It's a billion here and a billion there, and by and by it begins to mount up into money."

SCOTUS Watch Update: Oral Arguments for the Coming Week

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

• Monday, 12/2: E-cigarettes and the FDA.
  The Court will consider "[w]hether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious." Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, reviewing the en banc decision of the 5th Circuit Court of Appeals, which vacated the FDA's orders as arbitrary and capricious.  
  
  
• Wednesday, 12/4: Gender-affirming care for minors.
  The Court will consider "[w]hether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow 'a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex' or to treat 'purported discomfort or distress from a discordance between the minor’s sex and asserted identity,' violates the equal protection clause of the 14th Amendment." United States v. Skrmetti, No. 23-477, reviewing the decision of the 6th Circuit Court of Appeals, which reversed the preliminary injunctions issued by the district courts and remanded them for further proceedings.

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

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

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

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

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

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

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

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

SCOTUS Update: Health-Related Cases on the Docket for the October 2024 Term

Here are a handful of cases of potential significance (case name links to SCOTUSBlog; case numbers link to Supreme Court's docket):

Firearm Regulation

Garland v. VanDerStok, No. 23-852 [Argued: 10.8.2024]
Issue(s): (1) Whether “a weapon parts kit that is designed to or may readily be completed, assembled, restored, or otherwise converted to expel a projectile by the action of an explosive” under 27 C.F.R. § 478.11 is a “firearm” regulated by the Gun Control Act of 1968; and (2) whether “a partially complete, disassembled, or nonfunctional frame or receiver” that is “designed to or may readily be completed, assembled, restored, or otherwise converted to function as a frame or receiver” under 27 C.F.R. § 478.12(c) is a “frame or receiver” regulated by the act.

Smith & Wesson Brands v. Estados Unidos Mexicanos, No. 23-1141 [No argument date yet]
Issue(s): (1) Whether the production and sale of firearms in the United States is the proximate cause of alleged injuries to the Mexican government stemming from violence committed by drug cartels in Mexico; and (2) whether the production and sale of firearms in the United States amounts to “aiding and abetting” illegal firearms trafficking because firearms companies allegedly know that some of their products are unlawfully trafficked.

Medicare

Advocate Christ Medical Center v. Becerra, No. 23-715 [Argued: 11.5.2024]
Issue(s): Whether the phrase “entitled ... to benefits,” used twice in the same sentence of the Medicare Act, means the same thing for Medicare part A and Supplemental Social Security benefits, such that it includes all who meet basic program eligibility criteria, whether or not benefits are actually received.

Medicare Part D: See Mulready case, below

Medicaid, Affordable Care Act

See Crouch case, below (Transgender Health Care)

FDA: E-cigarettes

Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038 [Set for argument: 12.2.2024]
Issue(s): Whether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious.

Transgender Health Care

U.S. v. Skrmetti, No. 23-477 [Set for argument: 12.4.2024]
Issue(s): Whether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow “a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex” or to treat “purported discomfort or distress from a discordance between the minor’s sex and asserted identity,” violates the equal protection clause of the 14th Amendment.

Cert. petition pending: Crouch v. Anderson, No. 24-90
Issues: (1) Whether West Virginia violated the equal protection clause of the 14th Amendment by declining to cover surgical treatments for gender dysphoria; and (2) whether West Virginia violated the Medicaid Act and the Affordable Care Act by declining to cover surgical treatments for gender dysphoria.

Disability Discrimination/ADA

Stanley v. City of Sanford, Florida, No. 23-997 [Set for argument: 1.13.2025]
Issue(s): Whether, under the Americans with Disabilities Act, a former employee — who was qualified to perform her job and who earned post-employment benefits while employed — loses her right to sue over discrimination with respect to those benefits solely because she no longer holds her job.

ERISA

Cunningham v. Cornell University, No. 23-1007 [Set for argument: 1.22.2025]
Issue(s): Whether a plaintiff can state a claim by alleging that a plan fiduciary engaged in a transaction constituting a furnishing of goods, services, or facilities between the plan and a party in interest, as proscribed by 29 U.S.C. § 1106(a)(1)(C), or whether a plaintiff must plead and prove additional elements and facts not contained in the provision’s text. Note: This case involves a retirement plan, not a health-insurance plan. I've included it here because the case is based upon an alleged violation of a plan fiduciary's statutory duty and is equally applicable to pension plans and health plans.

Cert. petition pending: Mulready v. Pharmaceutical Care Management Association, No. 23-1213
Issues: (1) Whether the Employee Retirement Income Security Act preempts state laws that regulate pharmacy benefit managers (PBMs) by preventing them from cutting off rural patients’ access, steering patients to PBM-favored pharmacies, excluding pharmacies willing to accept their terms from preferred networks, and overriding state discipline of pharmacists; and (2) whether Medicare Part D preempts state laws that limit the conditions PBMs may place on pharmacies’ participation in their preferred networks. Note: The Court has requested a brief from the Solicitor General.

Abortion/First Amendment

Cert. petition pending: Turco v. City of Englewood, New Jersey, No. 23-1189
Issues: (1) Whether the City of Englewood’s speech-free buffer zones, including zones outside an abortion clinic, violate the First Amendment; and (2) whether the court should overrule Hill v. Colorado. Distributed for the third time for Conference of 11/8/2024.

Note: The Court has denied review in a Texas case that raised the issue whether the state's restrictive abortion law violates federal EMTALA law. Xavier Becerra, Secretary of Health and Human Services v. Texas,, No. 23-10246. Late in the October 2023 Term, the Court declined to review two cases out of Idaho that raised the same issue. Moyle v. United States, No. 23-726; Idaho v. United States, No. 23-727.