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:
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, poetry, and other things that matter
Sunday, July 17, 2022
Friday, June 24, 2022
Editors of New England Journal of Medicine Condemn SCOTUS's Decision to Overrule Roe
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.
Thursday, May 26, 2022
Sherry Colb on Samuel Alito's Draft Opinion in Dobbs
Sherry Colb's essay at Dorf on Law makes a powerful case against the theocratic basis for overruling Roe. It is well worth reading.
Thursday, May 05, 2022
The End of Roe (and Privacy as Well)
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.
Friday, March 04, 2022
The Intentional Cruelty of the Texas Legislature
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.
Monday, January 31, 2022
Excellent analysis of SB 8 online at JAMA
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.
Thursday, January 20, 2022
"It’s time for Texas to abolish Confederate Heroes Day"
Don't Deny COVID Care to the Unvaccinated
1. It's bad policy.
2. It's not feasible.
3. It's unethical.
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.
Thursday, January 06, 2022
Advance Directives: 1. Do They Work? 2. Is There Something Better?
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
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.
Among tools that can help patients and families are Sudore’s Prepare for Your Care program; materials from the Conversation Project, Respecting Choices and Caring Conversations; and videos about health care decisions at ACP Decisions.
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.
Subscribe to KHN's free Morning Briefing.
Tuesday, December 07, 2021
Bad news for transgender kids: Genecis program is no more
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?”
Wednesday, December 01, 2021
Texas and Mississippi Abortion Laws: A "Lack of Empathy and Hubris"
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.
Wednesday, November 24, 2021
Billions (and Chevron?) at Stake in SCOTUS's Medicaid Case
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.
Saturday, November 06, 2021
SCOTUS Grants Cert. in Three Health Law Cases
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.
Marietta Memorial Hospital (20-1641; opinion below)
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.
Monday, November 01, 2021
Vaccines and Religious Exemptions
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.
Sunday, October 24, 2021
How to Save a Quarter-Trillion Dollars a Year in Health Care (Hint: It's Not as Easy as It Sounds)
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?
Wednesday, September 15, 2021
Teenaged and pregnant in Texas after SB8
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.
Unvaccinated patients added $5.7 billion to June-August healthcare expenditures
Tuesday, September 07, 2021
The latest surge: It's real and it was avoidable
Sunday, July 25, 2021
DFW's COVID-19 Hospitalizations Have Tripled in the Past Month
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).
Friday, July 16, 2021
Massive HHS settlements & judgments in 2020 for false and fraudulent claims
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.
Wednesday, July 14, 2021
Atul Gawande Nominated for Global Health Role at USAID
Tuesday, July 13, 2021
The High Costs of Non-Beneficial Treatments in the ICU
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.
Monday, July 05, 2021
Happy Independence Day (almost)
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.
Saturday, July 03, 2021
New Book: A political history of the Affordable Care Act
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!
Friday, July 02, 2021
SCOTUS grants review in 4 health law cases
- 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.
Thursday, July 01, 2021
CMS Proposes Final Interim Rule to Implement the No Surprises Act
Grand Jury Declines to Indict Houston Doctor Accused of Stealing COVID Vaccine
- 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.
Tuesday, June 29, 2021
Hospitals Now Employ 50% of all U.S. Physicians
Once upon a time, it was a virtually universal no-no for a corporation or other lay entity or person to own, or even have an ownership interest in, a physician's practice. There were various rationales for the so-called "corporate practice prohibition," including:
- only natural persons could meet the requirements for medical licensure,which ruled out corporations, trusts, partnerships, etc.
- a corporate or other lay owner created at least the potential for dual loyalties, putting doctors in the impossible position of choosing between his or her patient and corporate overlords; and
- allowing non-physicians to get in on a medical practice's action represented an unseemly commercialization of medical practice.
Thursday, June 17, 2021
SCOTUS Rejects Red States' Challenge to ACA
In a 7-2 decision (majority opinion by Justice Breyer, dissent by Justice Alito), the Supreme Court today tossed out the suit filed by Texas plus other states and two individuals, not on the merits but for lack of standing.
Basic standing analysis requires a direct harm to the plaintiff that is  traceable to an unlawful action or provision of law and is  redressable if a court were to give the plaintiff the relief it seeks. The majority opinion concluded that -- even if it agreed that the individual mandate lost its constitutional moorings when in 2017 Congress zeroed out the tax for noncompliance -- the only burdens (i.e., "harms") the plaintiffs could point to were the costs of complying with the presumptively lawful parts of the ACA that remained on the books. It is hard to see how future plaintiffs would be able to overcome the standing hurdle created by this opinion.
As the dissent points out,
Today’s decision is the third installment in our epic Affordable Care Act trilogy, and it follows the same pattern as installments one and two. In all three episodes, with the Affordable Care Act facing a serious threat, the Court has pulled off an improbable rescue.
None of this is to say that challenges to the ACA on other grounds can't or won't be brought, but opponents are running out of constitutional theories. Indeed, the Court has already granted cert. in two ACA cases for the 2021 Term (Nos. 20-429 and 20-539), and there are 6 more ACA cases listed for the Court's next conference. See Nos. 20-219, 20-1162, 20-1200, 20-1374, 20-1432, and 20-1536. All 8 cases are statutory-interpretation cases and none challenge the constitutionality of the ACA or any part of it.
Wednesday, June 16, 2021
Surprise billing: It's still a thing
From the Kaiser Family Foundation's news service:
In Alleged Health Care ‘Money Grab,’ Nation’s Largest Hospital Chain Cashes In on Trauma Centers
After falling from a ladder and cutting his arm, Ed Knight said, he found himself at Richmond, Virginia’s Chippenham Hospital surrounded by nearly a dozen doctors, nurses and technicians — its crack “trauma team” charged with saving the most badly hurt victims of accidents and assaults. But Knight’s wound, while requiring about 30 stitches, wasn’t life-threatening. Hospital records called it “mild.” Nevertheless, Chippenham, owned by for-profit chain HCA Healthcare, included a $17,000 trauma team “activation” fee on Knight’s bill, which totaled $52,238 and included three CT scans billed at $14,000. His care should have cost closer to $3,500 total, according to a claims consultant which analyzed the charges for KHN. (KHN, Richmond Times-Dispatch)
The federal No Surprises Act (signed Dec. 27, 2020) was supposed to curb billing abuses. The KHN link has an exhaustive analysis of the problem, but it doesn't say whether Mr. Knight's trip to the ER was before or after the effective date of the new law. (And the Richmond Times-Dispatch link didn't work for me; I've included it here in case it works for you.)
Monday, June 14, 2021
Public Health: The Neglected Infrastructure Crisis
Dr. Anne Schuchat's June 10th NY Times op-ed is a must-read for any and all who want to understand the importance of investment in public health resources as part of our renewed interest in rebuilding the nation's infrastructure. Published upon the eve of her retirement as second-in-command at the CDC after 33 years of public service. It's a great essay that celebrates public service as a career path. It's also a scary-as-hell depiction of the sorry state of public health in this country. Here's an example:
The Covid-19 pandemic is not the first time the U.S. public health system has had to surge well beyond its capacity, but with the worst pandemic in a century and, initially, a heavily partisan political context, the virus collided with a system suffering from decades of underinvestment. A recent report from the National Academy of Medicine revealed that state and local public health departments have lost an estimated 66,000 jobs since around 2008. [emphasis added]
We cannot count on a once-in-a-century cycle of pandemics. There is every reason to believe that all countries -- the more economically developed chief among them -- are susceptible to increasingly frequent outbreaks.
It's time to wake up and get prepared for when not if.
Wednesday, May 26, 2021
SCOTUS still has to decide a big ACA case
I have a hard time believing the Court will affirm the Fifth Circuit and the District Court and toss out the entire ACA on the specious ground that Congress wouldn't want the ACA to survive without the individual mandate. The premise -- that there is no longer an individual mandate -- flies in the face of the fact that the ACA still contains the individual mandate. The penalty for not purchasing health-insurance coverage was reduced to $0 in the 2017 tax reform law, which renders the mandate a somewhat toothless requirement, But even before 2017, the IRS's collection tools under the ACA were quite limited, which rendered the individual mandate one of the most under-enforced requirements in the United States Code.
Even if the Court agrees that the individual mandate is no more, however, the idea that the Court would go along with tossing out the entire ACA is mind-boggling. That would mean:
- no more prohibition against pre-existing condition exclusions
- no more prohibition against arbitrary and discriminatory rescissions
- no more family coverage for children up to age 26
- the reintroduction of annual and lifetime caps on coverage
- no more Medicaid expansion funds (raising a serious question about the status of funds for the 39 states that have expanded eligibility based on a promise of a generous (read: massive) federal subsidy)
- the elimination of federal insurance exchanges and possibly state exchanges, too
- the elimination of premium tax credits for low-income households
- the elimination of subsidies for out-of-pocket expenditures
- the elimination of what amounts to a cap on the amount insurers can spend on items other than health-care claims (accompanied by a premium rebate when non-health-care expenditures exceed the permitted amount)
- and on and on and on.
Tuesday, May 25, 2021
COVID-19 at the Intersection of Criminal Justice Reform and Public Health
As jails and prisons remain leading sites of COVID-19 outbreaks, mass incarceration poses ongoing health risks for communities. We investigate whether short-term jailing of individuals prior to release may drive COVID-19 spread. We find that cycling individuals through Cook County Jail in March 2020 alone can account for 13% of all COVID-19 cases and 21% of racial COVID-19 disparities in Chicago as of early August. We conclude that detention for alleged offenses that can be safely managed without incarceration is likely harming public safety and driving racial health disparities. These findings reinforce consensus among public health experts that large-scale decarceration should be implemented to protect incarcerated people, mitigate disease spread and racial disparities, and improve biosecurity and pandemic preparedness.
The full article is well worth a close read.