Two Jacksonville Compounding Pharmacies And Their Owner Agree To Pay At Least $7.4 Million To Resolve False Claims Act Allegations (June 15, 2023; U.S. Department of Justice) Three Defendants Plead Guilty In Personal Care Attendant Fraud Cases (June 15, 2023; Massachusetts Attorney General) Attorney General Josh Stein Announces $4.7 Million Health Care Conviction (June 14, 2023; North Carolina Attorney General) Carr: Hart County Man Indicted For Elder Exploitation (June 14, 2023; Georgia Attorney General) Office Of The Attorney General’s Medicaid Fraud Control Unit Sends Owner Of Home Health Company To Prison For 57 Months For $1.4 Million Fraud Scheme (June 13, 2023; Texas Attorney General) Attorney General Alan Wilson Announces Arrest Of Kershaw Co. Man For Exploitation Of A Vulnerable Adult (June 13, 2023; South Carolina Attorney General) TennCare Fraud Investigation Leads To Arrest In Memphis(June 9, 2023; Tennessee Attorney General) |
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
Tuesday, June 20, 2023
Hellacious Health Care Fraud Cases of the Week (III)
Monday, June 19, 2023
Classic case of negligent infliction of emotional distress? Maybe not.
There are, however, some torts where one or more of those elements is presumed without an evidentiary showing. One of them is NIED under circumstances that courts regard as sufficiently vexing and extreme that extreme emotional distress may be presumed. Erroneously telling a family that a close family member has died is one of those types of cases.
That is exactly what happened on June 13, when Zuckerberg San Francisco General Hospital called the wrong family about a patient's death. The family was informed that their son had died at the hospital. The family, as it happened, had a 30-year-old son. But before traveling to San Francisco, the family asked for further identifying information, and the hospital described a decedent who was 4 inches taller and 50 pounds heavier than their son. The decedent inexplicably had the couple's son's identification, though, and the hospital has a policy -- one that sounds reasonable to me -- that calls for prompt notification of parents when a family member has died. It's hard to know what more the hospital could have done to avoid calling the family, who alone knew the height and weight of their actual son.
So was there a breach of the hospital's standard of care? It may take further factual investigation and even expert testimony to know for sure. The case does highlight the difficulty hospitals and other health care providers face when they are charged with a duty to do the right thing, particularly in the context of the many highly charged situations they deal with on a daily basis.
Source: Becker's Hospital Review (June 16); NBC Bay Area (June 15).
Sunday, June 18, 2023
2nd Amendment thoughts -- The Constitution is not a suicide pact (or is it?)
Some random thoughts on Father's Day about gun violence in the United States.
According to the authoritative Gun Violence Archive website, there were 125 shootings on Father's Day (July 18) resulting in 149 victim injuries and 49 victim deaths. Six shootings involved 4 or more victims being injured or killed (the commonly accepted criterion for a "mass shooting"), including 22 injured and 1 killed in a shooting at a Juneteenth celebration in Willowbrook, Illinois, and 9 injured and 1 killed in St. Louis. Today.
All gun deaths are horrible, but surely it is worth noting that it seems a disproportionate number of victims appear to be young people, the age of our kids (or, in my case, my grandkids).
As parents, it is our responsibility to try to make the world reasonably safe for our kids. We try to protect them from the consequences of choices and conduct that could kill or maim them. It is admittedly impossible to eliminate all risk from the world, but we do our best to manage that risk. Except when it comes to guns.
I am writing this in HealthLawBlog because gun violence is not only a criminal-law issue but also a public-health issue. As the American Public Health Association (APHA) has written:
Gun violence is a leading cause of premature death in the U.S. Guns kill more than 38,000 people and cause nearly 85,000 injuries each year. As a longtime advocate for violence prevention policies, APHA recognizes a comprehensive public health approach to addressing this growing crisis is necessary.
The biggest obstacle is the number of politicians who are beholden to the gun lobby for secure and well-financed primaries. There are plenty of voters who have been sold an absolutist interpretation of the Second Amendment, and politicians are scared of alienating them, too.
The question posed in the title of this post deserves an answer.
My SMU Law colleague Eric Ruben argues persuasively that Second Amendment absolutism is based upon a serious -- dare I say fatal? -- misreading of that amendment (click here for links to most of his writings; click here for his latest article, forthcoming in the Yale Law Journal). His work is well worth reading. Suffice it to say that gun-rights absolutists base their position on an ahistorical reading of the Second Amendment, an error that is compounded in the Court's most recent Second Amendment decision by what Ruben and his co-author, Joseph Blocher, in their Yale piece call "originalism-by-analogy," a unique version of originalism, seemingly invented to produce a particularly virulent reading of the Second Amendment.
Justice Robert Jackson wrote in his dissent in Terminiello v. City of Chicago:
There is danger that, if the Court does not temper its doctrinaire logic with a little practical wisdom, it will convert the constitutional Bill of Rights into a suicide pact.
The current Court would do well to heed the wise words of Justice Jackson.
Saturday, June 17, 2023
CMS estimates national health expenditures to increase to 19.6% of GDP in 10 years
From Health Affairs (online, June 14):
New estimates released today from the Office of the Actuary (OACT) at the Centers for Medicare and Medicaid Services (CMS) and published online today in Health Affairs project a rate of national health spending growth of 4.3 percent for 2022, with expenditures projected to have reached $4.4 trillion. Health spending over the course of 2022–31 is expected to grow 5.4 percent per year on average.
This study will also appear in the July 2023 issue of Health Affairs. The link to the full study, once the embargo lifts, will be https://health-policy.healthaffairs.org/keehan/july2023issue/aop.
Economic growth is expected to have outpaced growth in national health spending in 2022, causing ta decrease in the projected health spending share of gross domestic product (GDP) from 18.3 percent in 2021 to 17.4 percent in 2022. However, over the course of the 2022–31 period, nominal GDP is expected to grow 4.6 percent annually—0.8 percentage point lower than average growth in national health expenditures—resulting in health spending accounting for 19.6 percent of GDP by 2031 (emphasis added).
Wednesday, June 14, 2023
Yesterday (June 13), Gov. Greg Abbott signed into law HB 1998 -- closing what has been dubbed the "Dr. Death loophole" -- with an effective date of September 1, 2023. The "loopholes" are gaps in the reporting system known as the DHHS National Practitioner Data Bank, which was designed to encourage reporting by state medical boards and hospitals when adverse actions (e.g., restrictions or revocations of medical license or medical staff privileges, medical malpractice awards) were taken against a physician. As stated in the NPDB Guidebook:
Congress enacted legislation leading to the creation of the NPDB because it perceived that the increasing occurrence of medical malpractice litigation and the need to improve the quality of medical care had become nationwide problems that warranted greater efforts than could be undertaken by any individual state. Congress also identified the need to restrict the ability of incompetent physicians and dentists to move from state to state without disclosure or discovery of the physician's previous damaging or incompetent performance. Congress felt that the threat of private money damages liability under federal laws, including treble damages liability under federal antitrust law, unreasonably discouraged physicians and dentists from participating in effective professional peer review. Therefore, Congress sought to provide incentives and protection for physicians and dentists engaging in effective professional peer review.
Title IV led to the establishment of the NPDB, an information clearinghouse, to collect and release certain information related to the professional competence and conduct of physicians, dentists, and, in some cases, other health care practitioners. The creation of the NPDB represented an important step by the U.S. government to enhance professional review efforts by making available to eligible entities and individuals certain information concerning medical malpractice payments and adverse actions.
HB 1998 contains a few measures designed to prompt actions when the NPDB might not require reporting, including:
equipping the Texas Medical Board with necessary tools to protect patients from dangerous physicians while also maintaining transparency about physician disciplinary records.
Here's what else the new law provides:
- Lying on medical license applications will be a Class A misdemeanor.
- Physicians who have been convicted of a felony or misdemeanor related to moral turpitude may be denied a license to practice medicine in Texas.
- The Medical Board is required to conduct a criminal background check in connection with license renewals.
- Monthly monitoring of physicians will be required using the National Practitioner Data Bank.
- The Texas Medical Board must update physician profiles on its website within 10 days of being notified about any disciplinary action against a physician.
(Source: Becker's Hospital Review)
Probably no system is fool-proof, but this new law tightens things up considerably. Even before HB 1998 was passed, though, I wondered if our law ties the hands of the Medical Board too much. For example, Section 155.003(e), Occupations Code provides that "An applicant is not eligible for a license if: (1) the applicant holds a medical license that is currently restricted for cause, canceled for cause, or suspended for cause or revoked by a state, a province of Canada, or a uniformed service of the United States." But not all revocations, restrictions, and suspensions are created equal. For example, many are related to substance abuse, and Texas physicians who successfully complete a rehab program and stay clean are often allowed to return to practice. It's hard to justify a more draconian result when a Texas physician is disciplined for similar reasons by another state's licensing board.
Tuesday, June 13, 2023
My first publication for AHLA (actually, it was for NHLA, one of the merger partners that produced the AHLA) was “State Illegal Remuneration and Self-Referral Laws” (1996). Searching out every relevant state statute led to free-standing prohibitions, prohibitions inside professional licensing laws, and -- in one memorable instance -- a prohibition against paying for referrals that was buried in the Massachusetts motor vehicle insurance statute.
It looks like AHLA rounded up health lawyers from each jurisdiction to research their own state's laws. Smart. Very smart.
Members and non-members alike can order a copy here.
Sunday, June 11, 2023
New study endorses harvesting hearts after declaration of cardiopulmonary death
- moving the patient to the operating room (usually from an ICU);
- stopping all life-supporting measures;
- waiting for a fixed period of time for the heart to stop beating (usually 60-90 minutes);
- if the heart stops, waiting another period of time (usually 5 minutes) to see if the heart will autoresuscitate;
- if autoresuscitation doesn't occur, death is declared and organ harvesting (usually kidneys, liver, and pancreas).
Now doctors can remove those hearts and put them in a machine [a "heart-in-a-box" device invented by TransMedics, the sponsor of the study] that “reanimates” them, pumping through blood and nutrients as they’re transported –- and demonstrating if they work OK before the planned transplant.
Friday, June 09, 2023
Allina Health Suspends Policy to Deny Care to Patients with Unpaid Bills
Today, the Star Tribune reported that Allina has suspended its policy, presumably in no small part because the Minnesota AG was inviting patients to submit reports of denials to his office as he considers launching an investigation into the policy.
Hellacious Health Care Fraud of the Week (II)
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:
- Chief Compliance Officer Convicted of $50M Medicare Fraud Scheme (June 8, 2023; U.S. Department of Justice)
- Lavaca Man Sentenced In $134 Million COVID-19 Health Care Fraud And Money Laundering Scheme (June 8, 2023; U.S. Attorney's Office, Western District of Arkansas)
- Battle Creek Couple Sentenced On Fraud Charges (June 6, 2023; U.S. Attorney's Office, Western District of Michigan)
- Stacey Hayes Convicted Of Felony Theft Of Medicaid Funds (June 2, 2023; New Hampshire Attorney General)
Saturday, May 27, 2023
More on Consolidation within the Health Care Industry
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.
Thursday, May 25, 2023
Merger Chaos at the FTC?
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.
Texas Chiropractic Board Requests AG Opinion
Sunday, May 21, 2023
Hellacious Health Care Fraud of the Week (I)
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.
Friday, May 19, 2023
"Preauthorization" and why your insurer is out to get you
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.
ChatGPT Summary of Congressional Testimony on “Innovation and Patient Access”
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).
Sunday, July 17, 2022
RBG on the Overturning of Roe v. Wade
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:
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.