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Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Friday, November 29, 2024
Two New Enforcement Actions from Texas Attorney General
U.K. Moves Toward Medical Assistance in Dying/Assisted Suicide
The bill will now go through a process of amendment and then on to the House of Lords for final approval.
Monday, November 18, 2024
West Virginia's Constitutional Amendment Prohibiting Physician-Assisted Suicide
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.
Thursday, November 14, 2024
Health Affairs: "The Impact Of The Election On Health Policy And The Courts"
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)
Friday, November 08, 2024
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
(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.
Thursday, November 07, 2024
Tax-Exempt Hospitals & Charity Care: A Mixed Bag
- 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)
- 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.
- 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.
- 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.
- 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.
Wednesday, November 06, 2024
Washington Physicians Seek Supreme Court Injunction, Claiming 1st Amendment Right to Spread Vax Misinformation
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.
- 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")
Tuesday, November 05, 2024
SCOTUS Oral Argument Today
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.
Monday, November 04, 2024
SCOTUS Watch Update: Oral Arguments for the Coming 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.
Saturday, November 02, 2024
Reprise: Does EMTALA Pre-Empt Restrictive State Abortion Laws?
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].
Friday, November 01, 2024
SCOTUS Update: Health-Related Cases on the Docket for the October 2024 Term
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.