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
Continuing a feature that I introduced on May 21, here are four more cases released today by the OIG at HHS. Ordinarily I would pick a favorite based upon the audaciousness of the scheme or the staggering financial implications, but these four are all interesting in their own way:
Fortune's team of Maria Aspan and Erika Fry have focused their analytical lens on the growth of health care firms in their recent article, "Companies like CVS and UnitedHealth are now some of the world’s biggest businesses. Is that healthy for the rest of us?" (May 24, 2023). It's a good read.
Let's start some context. Despite a recent minor dip, health care is the largest single sector that contributes to our Gross Domestic Product, the equal of defense and education (at all levels) combined.
Although this number -- whether expressed in absolute dollars, as a percentage of GDP, or as expenditures per capita -- is vastly larger than the expenditures of every other developed country in the world. And by almost any measure, the results -- in terms of life span, infant and maternal mortality, etc. -- pale in comparison to the same countries and many developing countries, as well. Much has been written about this conundrum. After all, we are a rich country and if we want to spend a lot of our wealth on health care, well, why not? The counter-argument is multifaceted. Are we as a society making smart decisions about those health care expenditures? Are there better strategies than "throw a ton of money at what ails you and hope that something works"? Are we doing all we reasonably can to root out waste and fraud? As COVID vividly and catastrophically demonstrated, expenditures for health care goods and services are not equitably distributed to racial and ethnic minorities, economically disadvantaged individuals and households, or the under- and uninsured, a group that persists despites the reforms of Obamacare.
This is Aspan and Fry's concern, too. They are looking at the rapid and extensive increase in firm size and the consolidation of disparate providers (hospitals, pharmacies, clinics, physician practices) into behemoths of unimaginable market power see at least a correlative relationship with GDP. Much of the merger activity in the health care sector is fueled by debt and venture capital, all of which demands cash flow to service. In other words, relentless growth in net revenues, year over year and quarter over quarter. Where's the incentive to keep patients healthy and out of hospital beds or to provide the most cost-effective care?
Granted, providers prosper by delivering more goods and services. And insurers prosper by paying for less care. As the authors point out, there is a conflict of interest at a fundamental level of this business model. Meanwhile, it's the wild, west out there, and the big firms seem to be doing just fine, at least for now. Whether that translates into better health outcomes for the rest of us is still very much in doubt.
If there's one indisputable legal and business trend in the health care industry over the past 10-20 years, it's the move toward greater consolidation of health care providers. Some observers praise consolidation on efficiency grounds (cutting duplication and waste --> lower costs --> lower prices for patients), while others decry consolidation because it concentrates market power and lessens competition, which leads to higher prices for patients.
The mechanism for resolving these claims in connection with large proposed mergers is the statute known as Hart-Scott-Rodino (H-S-R), along with its numerous FTC, DOJ, and SCOTUS interpretations. But according to Daniel Sokol and Dick Pierce, the times they are a-changin', though where federal policy is headed is anyone's guess.
In his Jotwell essay (May 25, 2023), Pierce argues that two articles by Sokol "are required reading for anyone who is interested in antitrust law, administrative law, government regulation, or corporate law." That's just about everyone in the legal profession, but I'll throw in health care law for good measure.
The catalyst for change is Lina Khan, the Biden Administration's chair of the FTC. As described by Pierce,
Khan has made it clear that she disagrees with virtually every characteristic of the [FTC/DOJ merger] guidelines, including the guidelines’ goals. She rejects the goal of maximizing consumer welfare, which the Justice Department and the FTC have pursued for the last 50 years. Instead, she has emphasized the need to protect competitors from large firms that charge low prices—a goal that the enforcement agencies and the Supreme Court disavowed 50 years ago. Khan cannot further her stated goals by applying the 2010 guidelines.
The Pierce essay is a quick and easy read. The implications of Chair Khan's views on mergers portends an era that will be messy and uncertain.
This would be a good fact pattern for a 1L Legislation-Regulation final exam. The question posed by the Board in its request is "Whether the Texas Board of Chiropractic Examiners has discretion to suspend or revoke a chiropractor’s license under Texas Occupations Code section 201.5065 if the chiropractor is convicted of certain offenses." The language in this section makes suspension or revocation of a license mandatory upon conviction of certain offenses. Other language sprinkled around the Occupations code provides for discretionary suspension or revocation for other offenses. Apparently the Board wants clarification as to the effect of mandatory authority on these discretionary provisions. Nice little statutory interpretation problem, eh? I think the answer should be clear: the Board has both types of authority absent a clear indication that the legislature intended to negate the discretionary provisions. I'll get back to you when the AG's opinions staff gives us their answer . . .
As with banks and bank robbers, health care is where the money is. And for some so-called health care providers, the temptation to rob, steal, and cheat is apparently irresistable. Starting today I will highlight some of the more audacious schemes drawn from the week's health fraud indictments, settlements, and verdicts.
We begin this series with the settlement of a civil fraud case in the Southern District of New York. A Bronx nursing home allegedly made cash payments to a hospital supervisor in return for patient referrals. Okay: big yawn. But the second fraud scheme is the frosting with sprinkles on top of the boring cake. The nursing home allegedly switched residents out of the lower-paying Medicare Advantage plan and into the relatively higher-paying Original Medicare plan without the consent of their residents. The parties paid $3.46 million to the United States to settle the claims.
I am not saying health insurers are evil. Or that their policies are evil. But their claims-handling practices are very often ill-advised, are calculated to maximize corporate revenues at the expense of the health of their insureds, and too often produce results that are, well, evil.
One of the defining characteristics of "managed care" -- which used to be this funky little thing over in the corner of our system of healthcare finance and delivery and now is everywhere -- is the notion of preauthorization by your insurance company before you can get almost anything: a visit to a specialist, hospitalization, a prescription drug, etc. The craziness that sometimes marks this process is hard to fathom (other than the aforementioned profit motive). Dr. Amy Faith Ho has taken this on over on Twitter and her posts are well worth following.
First, "innovation and access" is and always will be an important health law and policy topic. The testimony on May 10 covered Alzheimer's, cancer, FDA regulatory issues, Big Pharma R&D, and NIH research support. Important stuff.
Second, the blog post consists of summaries of testimony that were generated, in whole or in part, by ChatGPT. 'Nuff said? I could have waded through the testimony and written my own summaries or paid a research assistant to do the same. And I would certainly read the testimony if I were citing it, relying on it, etc. I am guess, though, that these summaries are serviceable enough as background reading (and a way of determining whether the testimony appears interesting enough to invest more of my time reading it).
This was posted recently by a wonderful German attorney and former Bioethics student of mine, Christine Gärtner. It appears to be part of an interview with Justice Ginsburg, and I am not sure of the source, but it sure looks like her crystal ball was firing on all cylinders. Of course, lots of others were making the same prediction, though she cut to the policy question that, honestly, can have only one answer:
The NEJM editorial summarizes the board's reasoning this way:
By abolishing longstanding legal protections, the U.S. Supreme Court’s reversal of Roe v. Wade serves American families poorly, putting their health, safety, finances, and futures at risk. In view of these predictable consequences, the editors of the New England Journal of Medicine strongly condemn the U.S. Supreme Court’s decision.
The full editorial, "Lawmakers v. The Scientific Realities of Human Reproduction,"is available here.
Justice Breyer's dissenting opinion on behalf of himself and Justices Sotomayor and Kagan lays out the costs in clear and vivid terms:
Today, the Court discards that balance. It says that from the very moment of fertilization, a woman has no rights to speak of. A State can force her to bring a pregnancy to term, even at the steepest personal and familial costs. An abortion restriction, the majority holds, is permissible whenever rational, the lowest level of scrutiny known to the law. And because, as the Court has often stated, protecting fetal life is rational, States will feel free to enact all manner of restrictions. The Mississippi law at issue here bars abortions after the 15th week of pregnancy. Under the majority’s ruling, though, another State’s law could do so after ten weeks, or five or three or one—or, again, from the moment of fertilization. States have already passed such laws, in anticipation of today’s ruling. More will follow. Some States have enacted laws extending to all forms of abortion procedure, including taking medication in one’s own home. They have passed laws without any exceptions for when the woman is the victim of rape or incest. Under those laws, a woman will have to bear her rapist’s child or a young girl her father’s—no matter if doing so will destroy her life. So too, after today’s ruling, some States may compel women to carry to term a fetus with severe physical anomalies—for example, one afflicted with Tay-Sachs disease, sure to die Cite as: 597 U. S. ____ (2022) BREYER, SOTOMAYOR, and KAGAN, JJ., dissenting 3 within a few years of birth. States may even argue that a prohibition on abortion need make no provision for protecting a woman from risk of death or physical harm. Across a vast array of circumstances, a State will be able to impose its moral choice on a woman and coerce her to give birth to a child.
So much has already been written on the leaked draft majority opinion by Justice Alito in the Mississippi abortion case, it's time to look back and forward -- back to understand the deep vein of misogyny that has driven much abortion policy in the past century, and forward to see where abortion policy is headed and what can be done to preserve what the Supreme Court has understood to be a fundamental right for 49+ years: the decision, as Justice Brennan so delicately phrased it in his 1972 majority opinion in Eisentstadt v. Baird, "whether to bear or beget a child."
There are lots of pathways back to pre-Roe misogyny. To state the obvious, that's not to say misogyny ended with Roe, but there is a specific version of it that is recognizable today and therefore still important to understand going forward. One way back is an essay by Adrienne Rich in the New York Review of Books, which recently posted the essay (without a paywall) on its website with these words:
In the Review’s October 2, 1975, issue, Adrienne Rich wrote about “The Theft of Childbirth,” tracing the patriarchal history of obstetrics—and “the technology of childbirth”—and finding that “the value of a woman’s life would appear to be contingent on her being pregnant or newly delivered. Women who refuse to become mothers are not merely emotionally suspect, they are dangerous.”
The path forward (assuming, as seems reasonable, that the Alito draft is fairly close to the final version that we will see later this Term) is littered with legal questions and controversies. I am working on a short piece for the SMU Law Review "Forum" on state restrictions on medical abortions, something I described in March as a legislative "pincer movement" intended to end all abortions in Texas and elsewhere without enacting an outright ban (though Texas and at least 12 other states have so-called "trigger" laws at the ready for the inevitable demise of Roe [NY Times, May 4; Politico, May 3 (23 states have pre-Roe prohibitions or trigger laws]). More on that topic in a subsequent post.
A "pincer movement" is defined as "a military maneuver in which forces simultaneously attack both flanks (sides) of an enemy formation. This classic maneuver holds an important foothold throughout the history of warfare" (Wikipedia), now including the Texas legislature's intentional and cruel war on women's health and their constitutional rights.
I've previously posted on Texas's restrictive, blatantly unconstitutional prohibition of abortions after approximately 6 weeks of pregnancy, i.e., before many if not most women even know they are pregnant, here, here, and here. The well-documented effect of SB 8 has been staff cutbacks and closings of abortion clinics in Texas and women scrambling to find out-of-state providers even for emergency terminations (NPR, 3-1-22; The Guardian, 3-3-22).
Mindful that they had succeeded in drastically cutting back on the availability of surgical abortions (which are far, far safer -- 14 times less likely to cause death -- compared to carrying a fetus to term), the legislature then turned its attention to shutting down access to medical abortions. In the 2nd Special Session last summer, the legislature passed SB 4, which became effective last September 17th. SB 4 makes it a state jail felony to provide an abortion-inducing drug, including the Mifeprex regimen, misoprostol (Cytotec), and methotrexate. Physicians are exempt if they follow a detailed protocol and then only if the drugs are provided within the first 7 weeks of pregnancy. SB 4 also provides: "A manufacturer, supplier, physician, or any other person may not provide to a patient any abortion-inducing drug by courier, delivery, or mail service."
I am reliably informed that some pharmacists in Texas are reluctant to fill prescriptions for these drugs and, even more worrisome, that drug manufacturers are expressing concerns that shipping these drugs into Texas will expose them to criminal liability.
I have four granddaughters, from 3 to 14 years of age. I care about their health, including their physical and mental health as well as their reproductive health. The effect of all but eliminating access to surgical and medical abortions, if successful, amounts to an intentionally cruel pincer movement that intensifies the Texas legislature's war against not only abortion but the health, safety, and welfare of Texas women, including my granddaughters. This war has to stop, but I am having a hard time imagining how or when.
The litigation history of Texas's abortion statute (SB 8) is a sorry tangle of "hot potato" from federal courts to state supreme court and from trial court to the U.S. Supreme Court, but one thing is unmistakable: The misnamed "heartbeat" law is unconstitutional under current federal law. Full stop. As long as Roe and Casey are good law -- and they may be seriously threatened by a supermajority of conservative justices on the Supreme Court, but for the time being those cases are still the law of the land -- a previability prohibition of abortions violates that law.
SB 8 prohibits abortions after about six weeks and provides for private parties to enforce the prohibition through civil litigation against anyone who "aids or abets the performance or inducement of an abortion" in violation of SB 8's prohibition. To be clear: an "aider" or "abettor" is a person who "assists someone in committing or encourages someone to commit a crime." Even under SB 8, a violation of its prohibition is not a crime, and Texas officials are barred from enforcing its provisions whether civilly or criminally. Private enforcement was intended to insulate the law from constitutional review (no state actors = no state action, et voila!: no constitutional violation!). If this is upheld, any state that isn't happy with a decision of the Supreme Court can pass a law in violation, provide for exclusively private enforcement, and shield the state law from federal constitutional review.
All of this -- the litigation tangle, the constitutional analysis, and the implications for the future -- are admirably addressed in a brief opinion piece by Glenn Cohen, Rebecca Reingold, and Larry Gostin in the Journal of the American Medical Association, on-line and free. It's worth a read.
Yep. That's the title of an op-ed in today's Washington Post. That we have this "partial holiday" at all is contemptible. That it occurs the same week as the federal MLK holiday is even worse. C'mon folks! In the past legislative session, there were 3 bills introduced in the House to eliminate this official state holiday (HB 36, HB 219, and HB 2067) and one bill in the Senate (SB 128), and none of them went anywhere. . . {sigh}. The op-ed doesn't mince words: "The South lost. It’s good to bring down Confederate monuments. But it’s also time for Texas to stop giving symbolic shelter to enslavers and rapists and traitors — and relegate Confederate Heroes Day to the ash heap of history, where it belongs."
These are the messages from Ed Yong's latest piece in The Atlantic: "It’s a Terrible Idea to Deny Medical Care to Unvaccinated People." To which I'd add:
4. Tort law will not support your decision. My first-year Torts students read a case in which the Tennessee Supreme Court reversed a trial court decision to allow the jury to compare the degree of fault of a hospital and two employees (whose provision respiratory support left the patient with permanent brain damage) with the degree of fault of the plaintiff (who had been driving with a blood alcohol level of .20% at the time of the accident). The American Law Institute's Third Restatement of Torts supports the rule that a patient's prior conduct (whether tortious or criminal) -- conduct that necessitate the medical treatment in issue -- does not diminish a health care provider's duty to treat or the duty to meet a professional standard of care. Restatement (Third) of Torts, Apportionment of Liability § 7, cmt. m (2000).
Yong concedes that this "debate" is theoretical:
Health-care workers are not denying care to unvaccinated patients, even though, ironically, many told me they’ve been accused of doing so by not prescribing ivermectin or hydroxychloroquine, which are ineffective against COVID but are often wrongly billed as lifesavers. Still, I ran this argument past several ethicists, clinicians, and public-health practitioners. Many of them sympathized with the exasperation and fear behind the sentiment. But all of them said that it was an awful idea—unethical, impractical, and founded on a shallow understanding of why some people remain unvaccinated.
1. Not particularly well, except in the few cases where they do.
2. Talking is an essential, and often overlooked, aspect of advance care planning. In my talks to community groups, my advice is this: If you were forced to choose between executing the documents (e.g., living will, medical power of attorney) and discussing your values and preferences with family and physicians, you should choose the latter. Checking off a few boxes and affixing your signature to a document is seldom the panacea we think it will be. Of course, it's a false choice and you can do both.
3. Essential reading: (a) An essay in the Jan. 3 New York Times by physician Daniela Lamas. (2) A balanced and fair piece in Kaiser Health News this morning (reprinted with permission):
A New Paradigm Is Needed: Top Experts Question the Value of Advance Care Planning
Judith Graham
For decades, Americans have been urged to fill out documents specifying their end-of-life wishes before becoming terminally ill — living wills, do-not-resuscitate orders, and other written materials expressing treatment preferences.
Now, a group of prominent experts is saying those efforts should stop because they haven’t improved end-of-life care.
“Decades of research demonstrate advance care planning doesn’t work. We need a new paradigm,” said Dr. R. Sean Morrison, chair of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai in New York and a co-author of a recent opinion piece advancing this argument in JAMA.
“A great deal of time, effort, money, blood, sweat and tears have gone into increasing the prevalence of advance care planning, but the evidence is clear: It doesn’t achieve the results that we hoped it would,” said Dr. Diane Meier, founder of the Center to Advance Palliative Care, a professor at Mount Sinai and co-author of the opinion piece. Notably, advance care planning has not been shown to ensure that people receive care consistent with their stated preferences — a major objective.
“We’re saying stop trying to anticipate the care you might want in hypothetical future scenarios,” said Dr. James Tulsky, who is chair of the department of psychosocial oncology and palliative care at the Dana-Farber Cancer Institute in Boston and collaborated on the article. “Many highly educated people think documents prepared years in advance will protect them if they become incapacitated. They won’t.”
The reasons are varied and documented in dozens of research studies: People’s preferences change as their health status shifts; forms offer vague and sometimes conflicting goals for end-of-life care; families, surrogates and clinicians often disagree with a patient’s stated preferences; documents aren’t readily available when decisions need to be made; and services that could support a patient’s wishes — such as receiving treatment at home — simply aren’t available.
But this critique of advance care planning is highly controversial and has received considerable pushback.
Advance care planning has evolved significantly in the past decade and the focus today is on conversations between patients and clinicians about patients’ goals and values, not about completing documents, said Dr. Rebecca Sudore, a professor of geriatrics and director of the Innovation and Implementation Center in Aging and Palliative Care at the University of California-San Francisco. This progress shouldn’t be discounted, she said.
Also, anticipating what people want at the end of their lives is no longer the primary objective. Instead, helping people make complicated decisions when they become seriously ill has become an increasingly important priority.
When people with serious illnesses have conversations of this kind, “our research shows they experience less anxiety, more control over their care, are better prepared for the future, and are better able to communicate with their families and clinicians,” said Dr. Jo Paladino, associate director of research and implementation for the Serious Illness Care Program at Ariadne Labs, a research partnership between Harvard and Brigham and Women’s Hospital in Boston.
Advance care planning “may not be helpful for making specific treatment decisions or guiding future care for most of us, but it can bring us peace of mind and help prepare us for making those decisions when the time comes,” said Dr. J. Randall Curtis, 61, director of the Cambia Palliative Care Center of Excellence at the University of Washington.
Curtis and I communicated by email because he can no longer speak easily after being diagnosed with amyotrophic lateral sclerosis, an incurable neurologic condition, early in 2021. Since his diagnosis, Curtis has had numerous conversations about his goals, values and wishes for the future with his wife and palliative care specialists.
“I have not made very many specific decisions yet, but I feel like these discussions bring me comfort and prepare me for making decisions later,” he told me. Assessments of advance care planning’s effectiveness should take into account these deeply meaningful “unmeasurable benefits,” Curtis wrote recently in JAMA in a piece about his experiences.
The emphasis on documenting end-of-life wishes dates to a seminal legal case, Cruzan v. Director, Missouri Department of Health, decided by the Supreme Court in June 1990. Nancy Cruzan was 25 when her car skidded off a highway and she sustained a severe brain injury that left her permanently unconscious. After several years, her parents petitioned to have her feeding tube removed. The hospital refused. In a 5-4 decision, the Supreme Court upheld the hospital’s right to do so, citing the need for “clear and convincing evidence” of an incapacitated person’s wishes.
Later that year, Congress passed the Patient Self-Determination Act, which requires hospitals, nursing homes, home health agencies, health maintenance organizations and hospices to ask whether a person has a written “advance directive” and, if so, to follow those directives to the extent possible. These documents are meant to go into effect when someone is terminally ill and has lost the capacity to make decisions.
But too often this became a “check-box” exercise, unaccompanied by in-depth discussions about a patient’s prognosis, the ways that future medical decisions might affect a patient’s quality of life, and without a realistic plan for implementing a patient’s wishes, said Meier, of Mount Sinai.
She noted that only 37% of adults have completed written advance directives — in her view, a sign of uncertainty about their value.
Other problems can compromise the usefulness of these documents. A patient’s preferences may be inconsistent or difficult to apply in real-life situations, leaving medical providers without clear guidance, said Dr. Scott Halpern, a professor at the University of Pennsylvania Perelman School of Medicine who studies end-of-life and palliative care.
For instance, an older woman may indicate she wants to live as long as possible and yet also avoid pain and suffering. Or an older man may state a clear preference for refusing mechanical ventilation but leave open the question of whether other types of breathing support are acceptable.
“Rather than asking patients to make decisions about hypothetical scenarios in the future, we should be focused on helping them make difficult decisions in the moment,” when actual medical circumstances require attention, said Morrison, of Mount Sinai.
Also, determining when the end of life is at hand and when treatment might postpone that eventuality can be difficult.
Morrison spoke of his alarm early in the pandemic when older adults with covid-19 would go to emergency rooms and medical providers would implement their advance directives (for instance, no CPR or mechanical ventilation) because of an assumption that the virus was “universally fatal” to seniors. He said he and his colleagues witnessed this happen repeatedly.
“What didn’t happen was an informed conversation about the likely outcome of developing covid and the possibilities of recovery,” even though most older adults ended up surviving, he said.
For all the controversy over written directives, there is strong support among experts for another component of advance care planning — naming a health care surrogate or proxy to make decisions on your behalf should you become incapacitated. Typically, this involves filling out a health care power-of-attorney form.
“This won’t always be your spouse or your child or another family member: It should be someone you trust to do the right thing for you in difficult circumstances,” said Tulsky, who co-chairs a roundtable on care for people with serious illnesses for the National Academies of Sciences, Engineering and Medicine.
“Talk to your surrogate about what matters most to you,” he urged, and update that person whenever your circumstances or preferences change.
Most people want their surrogates to be able to respond to unforeseen circumstances and have leeway in decision-making while respecting their core goals and values, Sudore said.
The Centers for Disease Control and Prevention also has a comprehensive list of resources.
We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.
A story in the Dallas Morning News (Dec. 6) by reporters Marin Wolf and Lauren McGaughy provides extremely useful details and context for the decision to shutter the Genecis ("Gender Education and Care, Interdisciplinary Support") program that was jointly run by UT-Southwestern Medical Center and Children's Health. Transgender and gender-diverse minors will now have a harder time than ever getting "health care, including mental health counseling and hormone therapy":
Last month, the hospitals said they would no longer be taking on new patients for hormone or puberty suppression therapy. They also removed all online references to the program, saying the care previously provided through the program will now be managed and coordinated through different specialty departments at the two hospitals.
According to the DMN article, the Genecis clinic was "the only program specifically for transgender children living in Texas and its surrounding states."
UT-Southwestern hasn't commented on the decision to shutter Genecis, but others haven't been so reticent. The article quotes Steve Rosenthal, medical director of the child and adolescent gender center for the University of California, San Francisco Benioff Children’s Hospitals: “It almost goes without saying that this seems inequitable and flatly wrong. Where are these patients going to go? And what’s the reason you’re not going to do it anymore?”
SCOTUS holds oral argument this morning in the Mississippi case that involves a law that bans abortions after 15 weeks of pregnancy, and the Court has granted review of SB 8, the Texas law that effectively bans abortions after 6 weeks. Prof. Michele Goodwin's guest essay in yesterday's New York Times is an apparently much-needed reminder just how stunted, myopic, and lacking in moral imagination is the world view of legislators in states like Michigan and Texas. Prof. Goodwin describes being 12 years old and pregnant after her father's repeated sexual assaults. She says the abortion she obtained saved her life. And for the record, SB 8 contains no exception for rape or incest.
It's a health-law-heavy docket this year over at SCOTUS. Next up for oral argument (Nov. 29) is Becerra v. Empire Health Foundation (No. 20-1312; SCOTUSBlog summary). The case involves the somewhat mind-numbing question of how to calculate the "Medicare fraction," one of two ratios that, when combined, determine whether a hospital is entitled to supplemental Medicare reimbursement adjustments as a Disproportionate Share Hospital (DSH) -- that is, a hospital that provides care to a large number of low-income patients. A 2004 change in the calculation of the Medicare fraction resulted in higher DSH payments to some hospitals and lower payments to others. The other fraction is the "Medicaid fraction."
This is a statutory-interpretation question: do the phrases “entitled to benefits under [Medicare] part A” [42 U.S.C. § 1395ww(d)(5)(f )(vi)(I)] and "eligible for medical assistance under [Medicaid]" [42 U.S.C. § 1395ww(d)(5)(f)(vi)(II)]. Professor Alison K. Hoffman does a nice job unpacking the issues over at the Commonwealth Fund's blog.
HHS's merits brief makes a strong pitch for Chevron deference. With the conservatives on the Court grousing about Chevron for the past decade or two, it will be interesting to see how far the government is pushed on that point during oral argument.
From SCOTUSBlog (with additional cites and links):
Ruan and Kahn
In Ruan v. United States (20-1410; opinion below) and Kahn v. United States (21-5261; opinion below) the justices agreed to decide whether a doctor who has the authority to prescribe controlled substances can be convicted for unlawful distribution of those drugs when he reasonably believed that his prescriptions fell within professional norms. The question came to the court in April in the case of Xiulu Ruan, an Alabama doctor who specialized in pain management. The government contended that the doctor had prescribed medicine outside the standard of care – for example, prescribing opioids when physical therapy or a detox facility would have been more appropriate. Ruan countered that he had always acted in good faith, making individual assessments of what each patient needed.
The second case came to the court in July. The doctor in that case, Shakeel Kahn, argued that he did not know that his patients were abusing or selling the medicine that he prescribed for them — primarily opioids. He was sentenced to 25 years in prison. The justices granted both cases and consolidated them for one hour of oral argument.
The justices also will weigh in on a dispute filed by DaVita, the country’s largest dialysis provider, over the interpretation of the Medicare Secondary Payer Act, which bars health plans from considering whether an individual is eligible for Medicare benefits because they suffer from kidney failure. A health plan also cannot provide different benefits to such individuals than they provide to others covered by the plan. After the U.S. Court of Appeals for the 6th Circuit ruled that the Marietta Memorial Hospital health plan discriminates against patients with kidney failure by providing less coverage for dialysis, the plan came to the Supreme Court, which granted its petition for review on Friday.
Prof. Wendy Parmet had an excellent guest column in the NY Times on 10/31 concerning religious exemptions from vaccination mandates during a pandemic. She points out that the Supreme Court has been pretty consistent since 1905 that medical exemptions -- based upon legitimate medical evaluations -- are legitimate (and may be required by the Constitution -- I think they are), but that until the past year, the Court was clear that religious exemptions are not required by the Constitution. A handful of cases from the Court's "shadow docket" suggest majority support for religious exemptions. As a public-health scholar, Parmet sees this trend as not only worrying but potentially deadly.
Friday's decision to allow Maine's vaccination mandate to remain in effect was not as hopeful a sign as one might expect. Parmet explained that three justices supported a religious exemption as a First Amendment requirement, which turns a century of public-health rulings on their head. Two other conservatives voted with the liberals on process grounds (another shadow docket decision), which suggests there might be five votes for a constitutionally required religious exemption from vaccination mandates.
The consulting firm McKinsey & Co. has a new report (full, executive summary) that identifies the sorts of administrative simplification that together could save the health care system $265 billion annually. As illustrated by a Perspectives piece in the October 20 issue of JAMA, that sum "would be more than 3 times the combined 2019 budgets of the National Institutes of Health ($39 billion), the Health Resources and Services Administration ($12 billion), the Substance Abuse and Mental Health Services Administration ($6 billion), and the Centers for Disease Control and Prevention ($12 billon)." As Everett Dirksen and Charlie Halleck might have said back in the day, a quarter-trillion here and a quarter-trillion there, and pretty soon you're talking about real money.
So, if administrative simplification is such a good idea and the benefits are so patently obvious, why has it not happened already? McKinsey identifies the types of changes that would need to be made. Some are changes that could happen within individual organizations (assuming regulators and private accreditation agencies were on-board). Other changes would need to be implemented between organizations (same assumptions and assuming public and private antitrust enforcement would permit it). And, finally, there are market failures that will require "seismic" interventions at the industry level -- "including the necessary decision-makers and influencers from both the public and private sectors for a given intervention" (emphasis added).
By comparison, the interventions introduced by the Affordable Care Act look downright modest. But the question remains: Can we really afford to continue to pay one trillion dollars every four years for nonbeneficial administrative waste?
In yesterday's N.Y. Times, columnist Michelle Goldberg has a powerful up-ed describing the situation created by SB 8 -- Texas's so-called "heartbeat bill" -- for pregnant minors in Texas who seek an abortion. The situation is beyond grim.
On top of totally unconstitutional legal and practical barriers that all Texas women face (until a federal judge enters a TRO, hopefully soon): imagine being 16, finding out you're pregnant, and then (unless your parents are on-board) needing to deal with the mechanics of a judicial-bypass process while the clock is ticking, all before detection of a so-called fetal (not really a fetus) heartbeat (not really a heartbeat, more like electrical signals from the precursor to the heart). Hard to imagine. But let's face it, moral imagination is not a strong suit for the GOP legislators (and AG and Governor) who dreamed up this scheme.
It's not surprising, but it is still staggering. As reported by Health Affairs: "A surge in COVID-19 hospitalizations among people who have not been vaccinated in August is adding billions of dollars in preventable costs to the nation’s health-care system. The analysis estimates that the preventable costs of treating unvaccinated patients in the hospitals now stand at an estimated $5.7 billion." The full Peterson-KFF report is here.
Paul Krugman's N.Y. Times newsletter today (not posted yet, but it should be soon) has two altogether unsurprising but very revealing graphs that neatly summarize where we are with the latest surge in COVID-related deaths:
The delta variant is everywhere, but not every country is experiencing the surge that we are. Something other than infectivity is at work here. As Krugman points out, "the systematic refusal to get vaccinated, refusal to wear masks, etc., is very clearly tied to the unique way that common-sense public health measures have been caught up in the culture war. . . . According to a recent NBC poll, 91 percent of Biden voters have been vaccinated but only 50 percent of Trump voters. Or look at death tolls: Blue states look more like Canada or Germany than like Florida or Texas".
Can anyone seriously doubt that the non-policies of Govs. DeSantis and Abbott are unnecessarily killing people in their states?
This is today's dispatch from Steve Love, the CEO of the Dallas-Fort Worth Hospital Council:
We have 1,126 COVID-19 patients in our hospitals in TSA-E which is an increase from 1046 yesterday and we are sorry to see this number spike over 1,100 COVID-19 hospitalized patients. This represents 8.28 percent of bed capacity and 23.91 percent of adult ICU patients which means we are approaching one in four of our adult ICU patients has COVID-19. Tarrant county has 401, Dallas 336, Collin 162, Denton 53, Hunt 28, Grayson 30 and Rockwall 35. As we have said before, the majority of the patients are not vaccinated. As a point of reference, we had 387 COVID-19 patients in the hospitals on June 25 so as you can tell, our hospitalizations have increased significantly in 30 days. Currently, we have 118 available adult staffed ICU beds . We have 135 adults on ventilators.
As nearly as anyone can tell, with the exception of a relative handful of "breakthrough" infections among the fully vaccinated (to be expected, because no vaccine is 100% effective), this increase is almost entirely among the unvaccinated population.
I am not inclined to be judgmental when it comes to choices people make for themselves, but refusing vaccination puts family and loved ones and the rest of the community at increased risk, and as the above numbers indicate, stress the critical care capacity to the detriment of other patients who also need treatment. Without a truly compelling reason (e.g., a validated medical reason) to skip vaccinations, failing to be vaccinated at this point is simply incomprehensible. And compelling reasons do not include cost (it's free), inconvenience (shots are available everywhere), or doubts about efficacy and safety (both of which have been amply demonstrated by the millions of individuals who have been vaccinated after the FDA granted emergency approval).
The gory details are contained in a report of the Inspector General released this month. Becker's Hospital CFO Report has a summary (emphasis added):
HHS' watchdog agency, the Office of Inspector General, recovered $3.1 billion in false and fraudulent claims in 2020, according to a July report.
OIG won or negotiated more than $1.8 billion in judgments and settlements in 2020, which, combined with efforts from previous years, led to 2020's $3.1 billion recovery. Of the $3.1 billion, $2.1 billion was transferred to the Medicare Trust Fund, and $128.2 million in Medicaid funds was transferred to the Treasury.
A total of 440 people were convicted of healthcare fraud and related crimes in 2020, the OIG said. The Department of Justice opened 1,148 healthcare fraud investigations in 2020, according to the report.
Even after teaching health law (including fraud and abuse) for 33 years, I am still gobsmacked by the amount of thievery and other forms of law-breaking that goes on in the healthcare industry. I am reminded of Willie Sutton's reported response to a reporter's question why he robbed banks: "Because that's where the money is." The health care sector represents 18% of GDP, more than defense and all levels of education combined. Yep, that's where the money is all right.
Good news for fans of Atul Gawande (books: Amazon author's page) who will be pleased to know Pres. Biden has nominated the author/surgeon/health policy wonk to be assistant administrator of the United States Agency for International Development's Bureau for Global Health. One of the hottest pandemic-related issues confronting the developed world is how to meet the need for vaccines and vaccination resources (human and otherwise) in the 90% of the world that is less than 10% immunized. It's an enormous challenge and one that falls squarely within Dr. Gawande's portfolio (assuming Senate confirmation).
Thad Pope has a useful post on this subject. There are direct medical costs (estimated at $2,700/day (Ottawa study) to $4,000/day (UCLA study)), but equally if not more concerning "may be (a) the opportunity cost when other patients are denied ICU care, (b) moral distress of the nursing staff, and (c) suffering inflicted on the patient."
None of this seems to matter to the legislators in Texas who try, every legislative session, to gut the provisions of the Texas Advance Directives Act that were added in 1999 to deal with disputes over medically inappropriate treatment. The provisions are at Tex. Health & Safety Code § 166.046. The purpose of the law was to provide a nonjudicial mechanism for resolving these disputes. The key provision is in subsection (d), which -- after reasonable efforts over a 10-day period to find a provider willing to provide the treatment requested by the surrogate decision-maker fail to identify a provider willing to accept transfer of the patient -- permits the disputed treatment to be withheld or withdrawn.
The objectors in the legislature want to replace that 10-day process with a provision that requires the health care providers to "treat until transfer." This benign-sounding idea would mean that, in the vast majority of cases in which no transferee provider can be found, medically inappropriate treatment must be provided until death occurs, which may be months or even years later. A current example is the Tinslee Lewis case in Fort Worth, which has been in litigation for over two years. According to a motion filed by defendant Cook Children's Hospital,
a review of Tinslee’s case was initiated by third-party administrator Aetna’s Special Investigative Unit, which has requested all of Tinslee’s records. The Special Investigative Unit’s mandate under Medicaid regulations is to investigate “waste, abuse, and fraud,” the motion says.
“In Cook Children’s experience, such reviews are often precursors to efforts to deny payment or even claw back funds previously paid,” the motion said.
Today (July 5th) is the day of the federal holiday celebrating the Second Continental Congress's adoption of the text of the Declaration of Independence on July 4th, which set out the argument for independence from "the state of Great Britain," which independence was actually declared by vote of the same Congress on July 2nd with the adoption of the Lee Resolution (a/k/a the Resolution of Independence) with New York abstaining. My best friend from law school, Frank, insists that July 2 is or at least ought to be the true Independence Day, and in that belief he is joined by many others, not least of whom was John Adams, who wrote to his wife Abigail on July 3: "The second day of July, 1776, will be the most memorable epoch in the history of America. I am apt to believe that it will be celebrated by succeeding generations as the great anniversary festival."
For 32 years, NPR staff (news readers, correspondents, commentators) have read the Declaration of Independence during the Morning Edition show closest to the 4th of July. Pretty much in Frank's honor (and out of respect to John Adams), this year the date for the reading fell on Friday, the 2nd of July. For many years, the readers included Bob Edwards, Red Barber, and "Kim Williams of Missoula, Montana," whose distinctive voices and personalities were represented long after their departure from NPR (Bob) and the land of the living (Red and Kim).
This year was a little different, with a disclaimer that noted the hypocrisy of drafters and signers: "It famously declares 'that all men are created equal' even though women, enslaved people and Indigenous Americans were not held as equal at the time." So the Declaration remains an aspirational document for a country this is still reckoning with the long-term effects of its past.
It remains, for all its limitations, the founding document that added philosophy and history to the political message of the Lee Resolution. It provided an outline for large parts of the original Constitution and the Bill of Rights. And for all sorts of reasons it is well worth reading at least once a year to remind us not only of the founders who "mutually pledge[d] to each other [their] Lives, [their] Fortunes and [their] sacred Honor" but also of the work left to be done to achieve its goals.
There is one scholar whose knowledge and understanding of the PPACA is second to none: Tim Jost. His book review of Jonathan Cohn's The Ten-Year War in the June 2021 issue of Health Affairs has sent me directly to the bookstore to buy my copy. Here are two key excerpts:
One of the main messages of The Ten Year War, Jonathan Cohn’s excellent history of the Affordable Care Act (ACA), appears in the final chapter: “The Affordable Care Act is a highly flawed, distressingly compromised, woefully incomplete attempt to establish a basic right that already exists in every other developed nation. It is also the most ambitious and significant piece of domestic legislation to pass in half a century—a big step in the direction of a more perfect union and a more humane one as well.”
Cohn has produced the most readable and comprehensive history of the ACA yet available—a must-read for anyone who wants to understand this history.
Looking forward to reading (and reviewing) this book!
The 2021 Term will be a lively one for health lawyers in light of yesterday's grant of four petitions for review (two Medicare cases, one Medicaid case, and a PPACA case that doesn't involve a challenge to the constitutionality of the law):
American Hospital Association v. Becerra, No. 20-1114, a challenge to a Department of Health and Human Services rule that cut Medicare reimbursement rates for prescription drugs for hospitals that participate in a program for underserved communities. The U.S. Court of Appeals for the District of Columbia Circuit ruled that the reimbursement cut was a reasonable interpretation of the Medicare statute; the justices on Friday agreed to weigh in on whether that deference is appropriate in this case. The court also asked both sides to discuss whether the challenge is barred by a provision of federal law that limits judicial review of certain Medicare-related calculations.
Gallardo v. Marstiller, No. 20-1263, in which the court will decide whether a state Medicaid program can get reimbursed for past medical expenses that it has paid by taking money from a settlement or jury award that is intended to compensate for future expenses.
Becerra v. Empire Health Foundation, No. 20-1312, a dispute over how to calculate additional payments under the federal Medicare program for hospitals with a large number of low-income patients.
CVS Pharmacy v. Doe, No. 20-1374, in which the court will consider whether the Rehabilitation Act, which bars discrimination on the basis of disability by any program or activity receiving federal funding, and the Affordable Care Act allow plaintiffs to bring claims alleging that a policy or practice disproportionately affects people with disabilities.
Surprise medical bills are horrific events for patients and their families, throw insurance underwriting into disarray, and create or reinforce barriers to entry into the medical-industrial complex. The federal No Surprises Act (a relatively small part (32 pages) of H.R. 133, the 2,124-page Omnibus Reconciliation Act of 2021) was supposed to address the problem, but the new law needed a regulation to implement it. That rule -- in the form of a 411-page "interim final rule" with a request for comments -- dropped today. CMS has provided a reasonably helpful fact sheet if you don't have time to wade through the rule's preamble. The rule is supposed to have an effective date of January 1, 2022, but don't be surprised if that date gets bumped. This rule will undoubtedly attract a ton of comments. The comment period closes 60 days after publication of the interim final rule in the Federal Register.
As reported by The NY Times, The Associated Press, KHOU-TV, the Houston Chronicle, and Forbes, Dr. Hasan Gokal will not be indicted by the Harris County grand jury on charges that he stole vials of COVID-19 vaccine for family and friends. His defense consisted of the following:
The doses were about to be destroyed due to nonuse and aging.
It was his duty as a physician -- and one employed by the Harris County health department -- to maximize health and protect life.
Allowing the doses to be destroyed would have been a violation of his professional duties and sacred oath.
In short: "In an interview with The Associated Press, Gokal, 48, said when he was confronted with the possibility that a life saving vaccine could be lost, he made the decision to find eligible people late at night who could be given the expiring doses."
Although Harris County Public Health fired Gokal over the incident, the defense worked with the Texas Medical Board, which dismissed charges against him, as well as with a Harris County Court-at-Law Judge, who dismissed the theft charges against him. Prosecutors then turned to the grand jury, which rejected the case on June 30.
I'm searching for the right analogy to capture what was wrong with the prosecutor's case. Is this an "inverse Jean Valjean" situation, where the loaf of bread (vials of vaccine) would have been stolen not to feed Gokal's family (though his wife did get one of the doses) but the family of others?
It's difficult to criticize Gokal's action if [1] the vaccine was going to be destroyed unless he acted, [2] noöne would be harmed if he did act (so this is not a variation on The Trolley Problem), [3] 9 otherwise at-risk individuals acquired some protection from infection at a time (late December 2020) when COVID-19 was still running rampant, and [4] Gokal himself wasn't responsible for creating the dilemma in the first place.
