FDR's Four Freedoms on the 4th of July 2023

In his State of the Union speech on Jan. 6, 1941, FDR famously offered up "the Four Freedoms" to explain why the United States was at war abroad and on a war footing at home. He introduced the Four Freedoms with this eerily familiar list of goals for the country: 

[T]here is nothing mysterious about the foundations of a healthy and strong democracy. The basic things expected by our people of their political and economic systems are simple. They are:

Equality of opportunity for youth and for others.

Jobs for those who can work.

Security for those who need it.

The ending of special privilege for the few.

The preservation of civil liberties for all.

The enjoyment of the fruits of scientific progress in a wider and constantly rising standard of living.

These are the simple, basic things that must never be lost sight of in the turmoil and unbelievable complexity of our modern world. The inner and abiding strength of our economic and political systems is dependent upon the degree to which they fulfill these expectations.

Many subjects connected with our social economy call for immediate improvement.

As examples:

We should bring more citizens under the coverage of old-age pensions and unemployment insurance.

We should widen the opportunities for adequate medical care. [emphasis added -- this is a HealthLawBlog, after all]

We should plan a better system by which persons deserving or needing gainful employment may obtain it.

Then FDR got to the part of his speech that made it so enduring:

In the future days, which we seek to make secure, we look forward to a world founded upon four essential human freedoms.

The first is freedom of speech and expression--everywhere in the world.

The second is freedom of every person to worship God in his own way--everywhere in the world.

The third is freedom from want--which, translated into world terms, means economic understandings which will secure to every nation a healthy peacetime life for its inhabitants-everywhere in the world.

The fourth is freedom from fear--which, translated into world terms, means a world-wide reduction of armaments to such a point and in such a thorough fashion that no nation will be in a position to commit an act of physical aggression against any neighbor--anywhere in the world. 

As the Smithsonian has noted:

The public response? Crickets. Congress barely applauded. The next day most newspapers didn't even mention the “Four Freedoms.” Those who were still talking about the phrase in the weeks and months that followed did so to lambaste its “hollow, empty sound.” The government hired [E.B.] White and other A-list scribes to drum up some buzz, but White’s boss called his pamphlet “dull.” The “Four Freedoms,” in the words of one federal administrator, were a “flop.”

Ever the optimist, FDR concluded the list with this: "That is no vision of a distant millennium. It is a definite basis for a kind of world attainable in our own time and generation." Eighty-two years later the Four Freedoms are still aspirational, not real, for much of the world and for many of our fellow citizens. 

Teva & Gilead Prevail in $3.6 Billion "Pay for Delay" Suit

I haven't seen much discussion of this verdict handed down by a federal jury on Friday out in California that cleared the two pharmaceutical companies of antitrust liability. As reported by thepharmaletter's "Brief," consumers and other direct purchasers, including the Blue Cross and Blue Shield Association, filed the antitrust lawsuit in 2019 in which they alleged Gilead Sciences and Teva Pharmaceutical Industries entered into an illegal "pay for delay" patent deal that inflated prices for two HIV medications. The jury found that plaintiffs had not shown Gilead had market power or that it paid Teva to delay its generics, IP Law 360 reported.

The FTC has a good website on "Pay for Delay: When Drug Companies Agree Not to Compete." The policy against "pay to delay" seems sound. Usually to settle a private patent infringement suit between two drug manufacturers (which itself may or may not be hatched for this sole purpose), the practice amounts to extended patent protection for the original drug beyond what is contemplated by the Hatch-Waxman Act. That protection keeps a lower-cost generic off the market and allows the original patentee to reap what amounts to monopoly profits.

Good policy, but if the facts aren't there, the case will fail. It will be interesting to read the details surrounding this verdict in the days and weeks ahead.

Private Equity, Consolidation, and Prices of HC Goods and Services

Good article in the Washington Post on June 29. The case study concerns U.S. Anesthesia Partners, which has been on a buying spree. The business model is basic: Go into a market, purchase private anesthesia practices, and once they are under one roof, raise the prices these groups charge hospitals and surgery centers. One study, "based on six years of data, for example, found that when anesthesia companies backed by private-equity investors took over at a hospital outpatient or surgery center, they raised prices by an average of 26 percent more than facilities served by independent anesthesia practices."

The Federal Trade Commission is supposed to be watching out for mergers and acquisitions that produce enough market power to give the resulting entity the power to raise prices, According to the article, the FTC has given these consolidations of market share the equivalent of a raised eyebrow and nothing more. The Kaiser Family Foundation has published on this topic. Is anyone in government paying attention?

Health Affairs: Forefront articles from June

If I have any recommendations for "must-read" sources of insight into the world of health care policy and law they would be the Kaiser Family Foundation (KFF) Health News website/homepage and the policy journal Health Affairs. Today KFF recapped its most popular Forefront articles (June 2023). Here's a summary:

• Sara Rosenbaum, Tim Jost, and coauthors broke down the Supreme Court’s Talevski decision regarding Medicaid beneficiaries.
• Sean Tunis and Peter Neumann wrote about Medicare and Alzheimer’s drug coverage.
• Aletha Maybank and coauthors embrace creative tensions to advance health equity.
• Denver Health shares their experience with inclusive race and ethnicity data collection.
• Corwin Rhyan and George Miller share an early look at what drove 2022’s health care spending slowdown.

Also, we had many articles in our major Forefront series:

• In the Accountable Care for Population Health series, Gabriel Drapos and Michael Kopko argue that valued-based care fuels innovation, not consolidation.
• In our Medicare and Medicaid Integration series, Allison Rizer and Henry Claypool wrote two articles on the proposed Medicaid managed care rules. Here’s the first article.
• In our Provider Prices in the Commercial Sector series, Ann Kempski and Ge Bai write that the North Carolina Medicaid expansion puts employers and workers at risk for higher hospital prices.

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$2.5 billion in health fraud schemes charged against 78 suspects

I'm skipping my "Hellacious Health Care Fraud of the Week" feature to highlight DOJ's announcement of a massive health fraud enforcement action. Some of these schemes are old-fashioned wine (fraud) in new bottles (telemedicine, e.g.). Most, though, are audacious in concept if not execution. It seems never to have occurred to most of the accused individuals that the government also has computers!

NPR (among others) reports on a nationwide sweep by DOJ that resulted in 78 individuals being charged with various schemes to commit health care fraud at a value of $2.5 billion.

From the DOJ announcement: 

The defendants allegedly defrauded programs entrusted for the care of the elderly and disabled, and, in some cases, used the proceeds of the schemes to purchase luxury items, including exotic automobiles, jewelry, and yachts. In connection with the enforcement action, the Department seized or restrained millions of dollars in cash, automobiles, and real estate. 

“These enforcement actions, including against one of the largest health care fraud schemes ever prosecuted by the Justice Department, represent our intensified efforts to combat fraud and prosecute the individuals who profit from it,” said Attorney General Merrick B. Garland. . . .

Telemedicine Fraud

The enforcement action included charges against 11 defendants in connection with the submission of over $2 billion in fraudulent claims resulting from telemedicine schemes. In a case involving the alleged organizers of one of the largest health care fraud schemes ever prosecuted, an indictment in the Southern District of Florida alleges that the chief executive officer (CEO), former CEO, and Vice President of Business Development of purported software and services companies conspired to generate and sell templated doctors’ orders for orthotic braces and pain creams in exchange for kickbacks and bribes. The conspiracy allegedly resulted in the submission of $1.9 billion in false and fraudulent claims to Medicare and other government insurers for orthotic braces, prescription skin creams, and other items that were medically unnecessary and ineligible for Medicare reimbursement. 

As part of the alleged conspiracy, individuals in a massive telemarketing operation, located in the United States and abroad, targeted the elderly and disabled with direct mail, television advertisements, and other forms of advertising to induce them to contact offshore boiler-rooms staffed by individuals who “up-sold” the elderly and disabled on unnecessary medical equipment and prescriptions. According to the indictment, the software platform that the defendants allegedly operated was actually a conduit for these telemarketers to coordinate the payment of illegal kickbacks and bribes to telemedicine companies to obtain doctors’ orders for Medicare beneficiaries. The defendants allegedly programmed the software platform to generate false and fraudulent orders for telemedicine practitioners to sign and obstruct Medicare investigations by concealing that the interactions with beneficiaries had occurred remotely using telemedicine. The program-generated orders falsified certifications that the telemedicine doctors had examined the beneficiaries in person, and falsified diagnostic testing that Medicare required for brace orders. After the original CEO sold the company in a corporate acquisition, the new corporate leadership allegedly chose to continue the pre-existing fraud scheme.

In another telemedicine fraud case, in the Eastern District of Washington, a licensed physician was charged for signing more than 2800 fraudulent orders for orthotic braces, including for patients whose limbs had already been amputated. As alleged, the physician took less than 40 seconds to review and sign each order.

The cases announced today build on earlier telemedicine enforcement actions involving over $10.1 billion in fraud. The April 2019 Operation Brace Yourself Telemedicine and Durable Medical Equipment Takedown alone resulted in an estimated cost avoidance of more than $1.9 billion in the amount Medicare paid for orthotic braces in the 20 months following that enforcement action, preserving the Medicare trust fund for necessary medical care.

Pharmaceutical Fraud

The enforcement action also included charges against 10 defendants in connection with the submission of over $370 million in fraudulent claims submitted in connection with prescription drugs. In one case announced today, the owner and corporate officer of a pharmaceutical wholesale distribution company was charged for an alleged $150 million fraud scheme in which the company purchased illegally diverted prescription HIV medication, and then marketed and resold the medication by falsely representing that the company acquired it through legitimate channels. The defendant allegedly purchased the diverted medication at a substantial discount from individuals who obtained the drugs primarily through illegal “buyback” schemes in which they paid HIV patients cash for their expensive HIV medication and repackaged those pills for resale. To cover up their scheme, the defendant and others falsified labeling and product tracing documentation to make it appear legitimate. Pharmacies purchased the misbranded medications, dispensed them to patients, and billed them to health care benefit programs, all while the defendants reaped substantial illegal profits. 

In a related case, on June 15, an individual in the Southern District of Florida was sentenced to 15 years in prison for his role in this nationwide scheme. According to court documents, the defendant illegally acquired large quantities of prescription drugs from patients for whom the drugs had been prescribed but not yet consumed. The defendant and others then repackaged the drugs and sold them to wholesale companies. In some instances, the medication that the defendant sold contained the wrong medication, broken pills, and even pebbles, leading to complaints by pharmacies. The defendant used his share of the proceeds to purchase luxury goods, including a $280,000 Lamborghini, a $220,000 Mercedes, and three boats. 

Opioid Distribution and Other Types of Health Care Fraud

The charges also targeted over $150 million in false billings submitted in connection with other types of health care fraud, including the illegal distribution of opioids and clinical laboratory testing fraud. Today’s enforcement action includes charges against 24 physicians and other licensed medical professionals who lined their own pockets, including doctors who allegedly put their patients at risk by illegally providing them with opioids they did not need. The charges also include cases where healthcare companies, physicians, and other providers paid cash kickbacks to patient recruiters and beneficiaries in return for patient information, so that the providers could submit fraudulent bills for Medicare reimbursement. 

[Other] 

The Center for Program Integrity of the Centers for Medicare & Medicaid Services (CPI/CMS) separately announced today that it took adverse administrative actions in the last six months against 90 medical providers for their alleged involvement in health care fraud.

Hot Topics in Health Law from AHLA's Annual Meeting

The American Health Law Association (AHLA) wrapped up its annual meeting on June 28 with a presentation on hot topics. Speakers were from DHHS/OIG (Susan Edwards), DOJ (Kelley Hauser), and private practice (Scott Hasselman, Reed Smith).

Take-aways:

• According to Edwards, OIG plans to release a general Compliance Program Guidance (CPG) by the end of this year that will help providers develop and maintain an effective compliance program. OIG will then issue by the end of next year managed care and nursing facility CPGs, Edwards said.
• The informative session also covered fraud issues related to the end of the COVID-19 public health emergency. Hauser, noting that fraud enforcement always lags behind implementation of new reimbursement, assured the audience that more enforcement actions would be coming. Hauser also said that given the sensitivity of the emergency funds, DOJ would likely look harder at use of the funds and will pursue enforcement actions even if the recovery is not a big dollar amount.
• Edwards also mentioned the OIG final rule on information blocking that was released early on June 27 and noted that a separate rule that will apply to providers will list “disincentives” for information blocking.
• Hauser reviewed recent fraud case law, such as the SuperValu case on scienter—if there’s evidence that a defendant is questioning the accuracy of certain statements or billing, you’re probably going to hear from DOJ.
• The speakers also discussed the use of AI and questioned whether it could be used to create clinical notes. Hauser noted that the government is generally in favor of any technology that could improve accuracy and predicted that more widespread use of AI will likely lead to a certification process of some sort to ensure that such programs work as intended.
• Each speaker then chose an emerging topic to discuss. Hauser picked parallel criminal and civil investigations, highlighting that such investigations are advantageous to the government and he has seen a steady increase in them during his tenure at DOJ.
• Edwards talked about managed care oversight and its increasing importance amid explosive growth in managed care. And Hasselman highlighted the corporate practice of medicine doctrine (and here) and urged lawyers to be aware of it while structuring transactions.

Cryopreservation of whole organs may be a transplantation game-changer

Human organs, once removed from their owner's body, are very fragile things. As reported in Science (News, June 21, 2023), this poses a problem for transplant medicine:

The rapid decay of organs is one of the biggest problems bedeviling organ transplants for people. From the moment a human heart or lung is disconnected from a donor, doctors have 4 to 6 hours to get it hooked up to a new patient’s blood supply before it is irretrievably damaged. For a liver, the window is 8 to 12 hours. For a kidney it’s about 1 day.

The effort to cut the warm ischemic time between organ removal and successful implantation has transformed the legal landscape for organ transplantation. 

• It was one of the reasons for the development of "brain death" in 1968 -- waiting around for a patient with no brain function to lose all cardiopulmonary function often led to the loss of organs that start to deteriorate while still in the patient's body. It may not have been "a driving force" behind the 1968 recommendation of a Harvard Ad Hoc Committee, but it surely benefited the transplant industry and certainly escaped nobody's attention at the time. The 1968 recommendation was crucial to the development of the Uniform Determination of Death Act.
• It was the reason for widespread adoption of UNOS policy and hospital protocols for "Donation After Cardiac [or "Cardiopulmonary" or "Cardiac and Circulatory" or "Controlled Cardiocirculatory"] Death" ("DCD" or "DCCD"). Careful timing and choreography of the removal of life support, determination of death, and organ retrieval can reduce warm ischemic time dramatically. No new law was needed to make this legal, but DCD provoked a vigorous debate about a practice that involved inducing death, withholding life-saving and life-supporting measures, and deeming a patient to be dead while autoresuscitation might still be possible (multiple citations are available on PubMed; here's one).

The latest wrinkle in technology's advance to the frontiers of medicine and law was reported in a Science news report this past week (citation above). A team at the University of Minnesota took a kidney out of white lab rat, stuck it into a deep freeze (-150ºC), and then successfully transplanted the organ into a recipient rat. Within minutes, the once-frozen kidney began producing urine -- according to the young surgeon who produced this result, "First successful transplant of vitrified, nanowarmed rat kidney."

Although still a ways off, the implications of this breakthrough process are vast. Organs that cannot be used immediately -- say, after death has been declared but a donor match cannot be found -- can be frozen for future use. Stockpiling frozen organs could put a real dent in the waiting times experienced by potential recipients on the various organ waiting lists. 

The process won't be quite as straightforward with larger human organs, which take longer to freeze and are harder to squeeze water out of than tiny rat livers. But we now know that it can be done in small mammals, and you can be sure efforts are under way (or soon will be) to scale up to human organs. Stay tuned.

Texas abortion laws: A little bit of sanity (or at least clarity) enters from both stage left and stage right

When SB 8 was enacted in 2021, there was widespread concern that the state had made it a crime to treat a pregnant woman who  had experienced an ectopic pregnancy or previability rupture of her membranes. The artlessness of the language of SB 8, and the truly ugly legislative intent that undergirded the law, did not provide much comfort, despite the very clear standards of care for both life-threatening conditions for the woman and the nonsurvivability of such conditions by the fetus. (Multiple factors have a bearing on the health consequences for the pregnant woman and the fetus, but delays in fetal extraction is one of the risk factors. Sources: here (previability premature rupture of membranes) and here (ectopic pregnancy).)

Existing law -- Health & Safety Code § 245.002 -- provides: "An act is not an abortion if the act is done with the intent to: (A) save the life or preserve the health of an unborn child; (B) remove a dead, unborn child whose death was caused by spontaneous abortion; or (C) remove an ectopic pregnancy." This is actually not particularly helpful in reining in SB 8 for two reasons. First, it does not exclude previability rupture of membranes. Second, this exclusion is part of a definition of abortion that starts with this phrase: "In this chapter," and Chapter 245 is titled "Texas Abortion Facility Reporting and Licensing Act." It would be simple enough for an aggressive DA to argue that the exclusions apply only to abortion facilities and do not apply to a physician who is prosecuted under the provisions of SB 8.

In the most recent regular session, the legislature passed HB 3058, and Governor Abbott signed it into law on June 17. It's a relatively modest bill, but it's one of the only bills (I'm being generous; it is the only bill I know of) enacted this session that protects women's health and provides legal protection for physicians who provide treatment pursuant to reasonable medical judgment (an endangered concept in this state).

Here's a thumbnail sketch of HB 3058:

• The key to this bill is the addition of § 74.255 to the Texas Civil Practice & Remedies Code. The new provision creates an affirmative defense in a civil action brought against a physician or health care provider if "the physician or health care provider exercised reasonable medical judgment in providing medical treatment to a pregnant woman in response to: (1)  an ectopic pregnancy at any location; or (2) a previable premature rupture of membranes. The clear purpose of this language is to expand the exclusion if Chapter 245 beyond licensed abortion facilities to any setting in which treatment is provided, as well as to add treatment of previable premature ruptured membranes to the protection of the law.
• A pharmacist or pharmacy that "receives, processes, or dispenses a prescription drug or medication order written by a physician or health care provider to whom [the previous affirmative defense] applies is entitled to the affirmative defense provided by Subsection (a).
• Section 2 of HB 3058 prohibits licensing boards from pursuing disciplinary measure against health care provider whose actions are consistent with § 74.255.
• Section 3 of HB 3058 amends the Penal Code to extend the affirmative defense to criminal prosecutions of physicians and health care providers.

The text of the bill originated with the Texas Civil Justice League and was sheparded through the House by Rep. Ann Johnson (D-Houston) and in the Senate by Sen. Bryan Hughes (R-Tyler). Hughes is a reliable vote for Texas Right to Life, so his support was a bit of a surprise. Bipartisan sponsorship was certainly a big factor in getting this passed, and Sen. Hughes's name as Senate sponsor undoubtedly helped the Republicans decide it was safe to jump on board. TCJL's announcement heralded the success  of HB 3058, but provided this additional hopeful note:

The bill was drafted . . . to create a vehicle that could be amended later, once the necessary level of political consensus developed around the idea of doing something to ameliorate some of the unintended consequences of SB 8, the Dobbs decision, and the revival of Texas’ criminal penalties for performing an abortion. 

That is exactly how it played out in the two houses of the Legislature this past session. 

The very fact that Texas needed this clarification is an indication of how crazy and dangerous this state's abortion laws have become. Both medical conditions are relatively rare, but the potentially lethal consequences of not treating them and the utility of well-established standards of care should not have been placed under a legal cloud of doubt. And it's not just our legislature that's to blame. The U.S. Supreme Court's abandonment of women's reproductive health rights cleared the field for state improvisation, no matter how dangerous and ill-considered. (Linda Greenhouse wrote an op-ed in the N.Y. Times today (may require payment), the one-year anniversary of the Supreme Court's ruling in Dobbs). 

The next question is whether the new law will be "a vehicle that could be amended [in] later [legislative sessions] to do[] something to ameliorate" the changes in federal and state law that have stripped women of their right to make one of the most fundamental health decisions of their lives. 

Reducing mortality rates in hospitals: Good. Tying reductions to executive comp: Bad

Becker's Healthcare reports (June 21, 2023) that clinicians at various HCA facilities are pressured to refer patients to palliative care and hospice in order to move those patients' deaths off the hospital's books, thus lowering the mortality rate reported for that hospital. More on that below, where I analyze the ethics of the reported practice. But I don't want to bury the lede, so it's important to understand that executive compensation within the ranks of HCA, from the corporate CEO on down to hospital execs, is based in part upon lowering mortality rates. It is hard for me to see this linkage as anything but an invitation to distort and corrupt end-of-life care in these hospitals. HCA denies every aspect of the story.

[The story in Becker's is based upon an NBC News report. Having read both, I can say that the version in Becker's is a faithful rendition of the NBC News report. I've linked to both in this post because hyperlinks to stories don't last forever.]

Reducing hospital mortality rates

1. Reducing hospital mortality rates is an admirable goal. For decades hospitals have been enjoined to fight hospital-acquired infections, reduce rapid readmissions, and address various systemic weaknesses in the delivery of quality health care to reduce avoidable morbidity and mortality.
2. Palliative care is a valuable service. Study after study shows greater patient satisfaction with interactions with palliative staff than with with members of the treatment team. In my experience, a hospital's introduction of a palliative care service usually leads to an almost immediate and quite dramatic decrease in requests for consultations with the hospital's ethics committees. This "ethics prophylaxis" -- engaged listening and honest communication that addresses confusion, disagreements, and distress before there is a breakdown in patients' and families' trust in their treatment team -- contributes to the quality of care provided by the team. It's like dealing with small flare-ups before they turn into a conflagration. Ethics committees are often brought into the conversation too late to accomplish a break-through. (It's one reason among many that the model for ethics consultations is mediation, which seeks compromises that are limited in duration and scope.) Also, palliative care consultants are in a position to build a relationship with the patient and family over time. By contrast, ethics committee members walk into a consultation room without the benefit of that healthy relationship. (They also don't walk in with the burden of a bad relationship. Being a neutral has its advantages, though not all patients and families see the ethics team as neutral.) One final point: Palliative care isn't just about end-of-life care. It's appropriate anytime that a seriously ill patient might benefit from expert interactions that address the physical, psychological, or spiritual suffering the patient is experiencing. And with a common but often lethal diagnosis like metastatic cancer, on average it's been found to result in longer lives of higher quality. All of this is to say that a hospital or health care system that encourages appropriate referrals to the palliative care service is doing a good thing, not a bad thing.
3. Much the same can be said for hospice care. It's a valuable multidisciplinary service that addresses a similar set of needs as palliative care. It is also underutilized. Medicare covers 6 months (180 days) of hospice care based upon the reasonable judgment of a physician that the patient is likely to die within those 6 months. (This can be extended if the patient is still alive at the end of 6 months as long as the physician can reasonably determine that the patient is likely to die within the next 6 months.) The reality is that the average lifetime lengths of stay is about 3 months and for a single hospice stay about 50% of patients die or are discharged in less than 2.5 months (source). Encouraging earlier use of hospice is a good thing (as long as the referrals are appropriate) because of the integration of hospice and palliative care for the benefit of the dying patient.

Tying palliative care and hospice referrals to executive compensation is a really bad idea.

1. HCA's policy creates the impression that referrals to what is generally regarded as high quality end-of-life care are made for third-party financial gain and not the needs of the patient. Well, it's actually more than an impression, isn't it? That's exactly the situation that HCA's compensation scheme creates. 
2. Stories like this give the false impression that palliative care physicians and their staffs are inclined for their own reasons to push patients into end-of-life treatments prematurely. If the result is patient or family refusals to accept the referral, the result is often suboptimal care for the patient: the loss of an opportunity for higher quality care whether death is imminent or not.
3. The article illustrates how the pressure from above creates moral distress on the part of attending physicians and other clinical staff. Practicing medicine is hard enough in this day and age without creating yet another conflict of interest (or its appearance) to be negotiated or finessed.
4. Not to be petty, but the base pay of HCA's corporate CEO is already $35.3 million for the two years this incentive has been in place, of which the compensation incentive in question accounted for $305,400. And why? Because $17.8 million a year just isn't enough?

Another week of Hellacious Health Care Fraud Cases (IV)

Some serious violations with serious legal consequences. . . . $54 million bribery and kickback scheme , , , 30 years in prison . . . 25 years in prison . . . Opioid abuse resulting in 5 patient deaths. Every profession has its scoundrels whose hopes for riches overpower their judgment. You don't have to be an evil person to do an evil thing, but these cases do remind me of the opening to the old radio series, "The Shadow."

Man Convicted Of $54M Bribery And Kickback Scheme Involving Fraudulent Prescriptions (June 16, 2023; U.S. Department of Justice)

Lab Billing Company Settles False Claims Act Allegations Relating To Unnecessary Respiratory Panels Run On Seniors Receiving COVID-19 Tests (June 16, 2023; U.S. Department of Justice)

Rome Jury Finds Dr. Charles Adams And Full Circle Medical Center Liable For False Claims Act Violations (June 16, 2023; U.S. Attorney's Office, Northern District of Georgia)

Health Care Information Technology Contractor Agrees To Pay More Than $1.7 Million To Resolve False Claims Act Allegations For Charging Unallowable Costs To The National Institutes Of Health (June 16, 2023; U.S. Attorney's Office, District of Maryland)

Raleigh ENT Doctor Sentenced To 25 Years In Prison For Adulterating Surgical Devices, For Defrauding Medicare, And For Stealing Patient Identities (June 16, 2023; U.S. Attorney's Office, Eastern District of North Carolina)

Cambria County Woman Pleads Guilty To Conspiracy To Commit Health Care Fraud (June 16, 2023; U.S. Attorney's Office, Middle District of Pennsylvania)

Suburban Chicago Doctor Sentenced To Federal Prison And Fined $1 Million For Health Care Fraud (June 16, 2023; U.S. Attorney's Office, Northern District of Illinois)

Former Alaska Advanced Nurse Practitioner Sentenced To 30 Years For Illegally Prescribing Millions Of Opioids Causing Five Deaths (June 16, 2023; U.S. Attorney's Office, District of Alaska)

Covid-related Health Care Fraud

Like the medical consequences of "long-Covid," the legal repercussions for conduct during the emergency phase of the pandemic seem destined to remain with us for a long time. Case in point: It was announced today that an urgent-care chain settled a False Claims Act suit with DOJ for $1.6 million. The case arose out of whistle-blowers' allegations that the chain was illegally "upcoding" Evaluation and Management claims to Medicare for the testing and treatment of patients with suspected exposure to COVID-19 during the Coronavirus pandemic. 

There are admittedly some close judgment calls when it comes to coding claims for reimbursement, whether payment is sought from Medicare or from a private health insurer. And, as the announcement of the settlement recites, "The claims resolved by the settlement are allegations only, and there has been no determination of liability." The case for liability had to be pretty strong, though. DOJ gets to choose whether to get involved in qui tam suits brought by whistle-blowers, and the Department most often declines to take what it regards as weak cases, leaving the allegations to private litigation. 

Plastic surgeon to be sentenced after manslaughter conviction

It is rare, but not unheard of, for a physician to be prosecuted criminally for conduct that would otherwise be treated as medical malpractice and tried in a civil courtroom. Even egregious departures from the applicable professional standard of care will usually be treated as gross negligence or, rarely, an intentional tort (like assault), either of which may give rise to liability for punitive damages, usually multiples of the compensatory damage award. Again, even in most of these extreme-negligence/intentional-tort cases, prosecutors seldom seek criminal charges.

So when Beckers Hospital Report picked up a story from Colorado about a plastic surgeon who has been convicted of attempted reckless manslaughter and obstruction of telephone service (both felonies), a couple of questions occurred to me:

1. How bad was the surgeon's conduct to expose him to criminal liability?
2. "Obstruction of telephone service"? What on earth?

The surgeon was performing a breast augmentation procedure on an 18-year-old patient who, while under anesthesia, suffered a cardiac arrest and went into a coma. Staff members asked the surgeon for permission to call 911, and the surgeon said no. (Interference with telephone service?) 

Instead, the surgeon performed CPR himself and didn't allow a call to emergency responders until 5 hours after the cardiac arrest. The patient died 1 year later in a nursing home (NBC News, June 15, 2023).

More questions:

1. "Attempted" manslaughter? I am guessing the charge was negotiated down to attempt, despite the fact that the surgeon surely caused the patient's eventual death. The one-year delay before the patient died may have made it at least questionable that the state could prove causation in a manslaughter case. I'm not a Colorado attorney, but there also may be a statute or case law that bears on the issue of causation when there's a substantial delay between the injury and the death -- unlikely, but possible.
2. What were the clinic's staff thinking? That they might be fired if they disobeyed the surgeon's instruction not to call for help? I hate to be a Monday-morning quarterback, but this is really unconscionable.

The press version of legal cases often raise more questions than they answer and frequently get details wrong. But from what's available in NBC's reporting, this looks like a case that deserved to be scrutinized by the criminal justice system.

Hellacious Health Care Fraud Cases of the Week (III)

A fresh crop of miscreants -- some charged, some convicted, some sentenced. It's hard to quantify, but the continuing tidal wave of fraud enforcement actions leads me to question the deterrent effect claimed by criminal law theorists. Or it may be that criminal liability deters penny ante stuff but when the payoff is in the millions, the possibility of some time in jail may pale in comparison the the potential gain.

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)

Classic case of negligent infliction of emotional distress? Maybe not.

Negligent infliction of emotional distress (NIED) is exactly what it sounds like. As with most negligence torts, a plaintiff has to show duty, breach, causation (both factual and legal/proximate (don't ask)), injury (specifically extreme emotional distress), and damages. NIED also usually involves a fact pattern where the defendant's conduct put the plaintiff at immediate risk of physical injury.

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).

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. 

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).

The story of the lethal neurosurgeon's murderous rampage from one North Texas operating room to another to another is still pretty fresh. Reading the superb reporting of Laura Beil and then listening to the excellent podcast raised one large question over and over: How could these hospitals allow "Dr. Death" -- Dr. Christopher Duntsch -- to continue to mutilate and kill patients despite overwhelming evidence that he lacked the skills to perform these operations and allegedly performed surgery while he was impaired? He's serving a life sentence in prison so his doctoring days are over, but the question persists.

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.

AHLA's most recent 50-state survey looks great: Health Care Fraud Law: A 50 State Survey. The research required for such a project is back-breaking. 

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.

New study endorses harvesting hearts after declaration of cardiopulmonary death

There's an Associated Press article in this morning's Dallas Morning News describing a multicenter study involving the transplantation of hearts taken out of donors who were not brain dead but had been declared dead after irreversible cessation of cardiac and circulatory function (DCD/DCCD).

Certain solid organs have been transplanted after DCD for decades. The protocol for harvesting involves the following steps:

• 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).

The DCD procedure was designed to shorten the warm ischemic time from when cardiopulmonary function ceases and the harvested organ can be restored to function in the recipient's body. Even with that innovation, though, hearts were not considered for transplantation because of their extreme fragility.

As described by the AP, however, the results of a multicenter study over a number of years establishes that the six-month survival rate after DCD (94%) was slightly better that the survival rate for heart transplants after brain death (90%). So what has changed? As reported by the AP:

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.

I am all for increasing the supply of donor hearts, and this is a very interesting development.  I am wondering, however, how to square the transplantation of a viable heart with the cardiopulmonary criterion of death. The statutory standard of "irreversible cessation of all cardiopulmonary function" will  now need to be understood as “irreversible in the donor’s body but not necessarily in the body of the recipient of the heart.” That begs the question, which has applied to DCD from the beginning, why has cardiopulmonary ceased (because we took away the donor’s life support) and why is the cessation irreversible (because we didn’t try to reverse it). Once we actually try to restore cardiac function (“reanimating” the heart in a “heart-in-a-box” device), some hearts are restored and do at least as well in the recipient’s body as a heart from a brain-dead patient. 

Are we comfortable with this slightly altered version of "irreversible cessation"? Should we be? The so-called "dead donor rule" (DDR) forbids killing a patient for organs or removing organs needed to sustain life from a living patient. So far, we have avoided the slippery slope of removing organs from patients who are almost dead or "as good as dead." How certain are we that this new approach to DCD heart transplantation satisfies the DDR?