Sunday, July 25, 2021

DFW's COVID-19 Hospitalizations Have Tripled in the Past Month

This is today's dispatch from Steve Love, the CEO of the Dallas-Fort Worth Hospital Council:

We have 1,126 COVID-19 patients in our hospitals in TSA-E which is an increase from 1046 yesterday and we are sorry to see this number spike over 1,100 COVID-19 hospitalized patients. This represents 8.28 percent of bed capacity and 23.91 percent of adult ICU patients which means we are approaching one in four of our adult ICU patients has COVID-19. Tarrant county has 401, Dallas 336, Collin 162, Denton 53, Hunt 28, Grayson 30 and Rockwall 35. As we have said before, the majority of the patients are not vaccinated. As a point of reference, we had 387 COVID-19 patients in the hospitals on June 25 so as you can tell, our hospitalizations have increased significantly in 30 days. Currently, we have 118 available adult staffed ICU beds . We have 135 adults on ventilators.

As nearly as anyone can tell, with the exception of a relative handful of "breakthrough" infections among the fully vaccinated (to be expected, because no vaccine is 100% effective), this increase is almost entirely among the unvaccinated population. 

I am not inclined to be judgmental when it comes to choices people make for themselves, but refusing vaccination puts family and loved ones and the rest of the community at increased risk, and as the above numbers indicate, stress the critical care capacity to the detriment of other patients who also need treatment. Without a truly compelling reason (e.g., a validated medical reason) to skip vaccinations, failing to be vaccinated at this point is simply incomprehensible. And compelling reasons do not include cost (it's free), inconvenience (shots are available everywhere), or doubts about efficacy and safety (both of which have been amply demonstrated by the millions of individuals who have been vaccinated after the FDA granted emergency approval). 

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

Good news for fans of Atul Gawande (books: Amazon author's page) who will be pleased to know Pres. Biden has nominated the author/surgeon/health policy wonk to be  assistant administrator of the United States Agency for International Development's Bureau for Global Health. One of the hottest pandemic-related issues confronting the developed world is how to meet the need for vaccines and vaccination resources (human and otherwise) in the 90% of the world that is less than 10% immunized. It's an enormous challenge and one that falls squarely within Dr. Gawande's portfolio (assuming Senate confirmation).

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)

Today (July 5th) is the day of the federal holiday celebrating the Second Continental Congress's adoption of the text of the Declaration of Independence on July 4th, which set out the argument for independence from "the state of Great Britain," which independence was actually declared by vote of the same Congress on July 2nd with the adoption of  the Lee Resolution (a/k/a the Resolution of Independence) with New York abstaining. My best friend from law school, Frank, insists that July 2 is or at least ought to be the true Independence Day, and in that belief he is joined by many others, not least of whom was John Adams, who wrote to his wife Abigail on July 3: "The second day of July, 1776, will be the most memorable epoch in the history of America. I am apt to believe that it will be celebrated by succeeding generations as the great anniversary festival."

For 32 years, NPR staff (news readers, correspondents, commentators) have read the Declaration of Independence during the Morning Edition show closest to the 4th of July. Pretty much in Frank's honor (and out of respect to John Adams), this year the date for the reading fell on Friday, the 2nd of July. For many years, the readers included Bob Edwards, Red Barber, and "Kim Williams of Missoula, Montana," whose distinctive voices and personalities were represented long after their departure from NPR (Bob) and the land of the living (Red and Kim). 

This year was a little different, with a disclaimer that noted the hypocrisy of drafters and signers: "It famously declares 'that all men are created equal' even though women, enslaved people and Indigenous Americans were not held as equal at the time." So the Declaration remains an aspirational document for a country this is still reckoning with the long-term effects of its past. 

It remains, for all its limitations, the founding document that added philosophy and history to the political message of the Lee Resolution. It provided an outline for large parts of the original Constitution and the Bill of Rights. And for all sorts of reasons it is well worth reading at least once a year to remind us not only of the founders who "mutually pledge[d] to each other [their] Lives, [their] Fortunes and [their] sacred Honor" but also of the work left to be done to achieve its goals.


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

The 2021 Term will be a lively one for health lawyers in light of yesterday's grant of four petitions for review (two Medicare cases, one Medicaid case, and a PPACA case that doesn't involve a challenge to the constitutionality of the law):

  • American Hospital Association v. Becerra, No. 20-1114, a challenge to a Department of Health and Human Services rule that cut Medicare reimbursement rates for prescription drugs for hospitals that participate in a program for underserved communities. The U.S. Court of Appeals for the District of Columbia Circuit ruled that the reimbursement cut was a reasonable interpretation of the Medicare statute; the justices on Friday agreed to weigh in on whether that deference is appropriate in this case. The court also asked both sides to discuss whether the challenge is barred by a provision of federal law that limits judicial review of certain Medicare-related calculations.
  • Gallardo v. Marstiller, No. 20-1263, in which the court will decide whether a state Medicaid program can get reimbursed for past medical expenses that it has paid by taking money from a settlement or jury award that is intended to compensate for future expenses.
  • Becerra v. Empire Health Foundation, No. 20-1312, a dispute over how to calculate additional payments under the federal Medicare program for hospitals with a large number of low-income patients.
  • CVS Pharmacy v. Doe, No. 20-1374, in which the court will consider whether the Rehabilitation Act, which bars discrimination on the basis of disability by any program or activity receiving federal funding, and the Affordable Care Act allow plaintiffs to bring claims alleging that a policy or practice disproportionately affects people with disabilities.

Thursday, July 01, 2021

CMS Proposes Final Interim Rule to Implement the No Surprises Act

Surprise medical bills are horrific events for patients and their families, throw insurance underwriting into disarray, and create or reinforce barriers to entry into the medical-industrial complex. The federal No Surprises Act (a relatively small part (32 pages) of H.R. 133, the 2,124-page Omnibus Reconciliation Act of 2021) was supposed to address the problem, but the new law needed a regulation to implement it. That rule -- in the form of a 411-page "interim final rule" with a request for comments -- dropped today.  CMS has provided a reasonably helpful fact sheet if you don't have time to wade through the rule's preamble. The rule is supposed to have an effective date of January 1, 2022, but don't be surprised if that date gets bumped. This rule will undoubtedly attract a ton of comments. The comment period closes 60 days after publication of the interim final rule in the Federal Register.

Grand Jury Declines to Indict Houston Doctor Accused of Stealing COVID Vaccine

As reported by The NY TimesThe Associated PressKHOU-TV, the Houston Chronicle, and Forbes, Dr. Hasan Gokal will not be indicted by the Harris County grand jury on charges that he stole vials of COVID-19 vaccine for family and friends. His defense consisted of the following:

  1. The doses were about to be destroyed due to nonuse and aging.
  2. It was his duty as a physician -- and one employed by the Harris County health department -- to maximize health and protect life.
  3. Allowing the doses to be destroyed would have been a violation of his professional duties and sacred oath.
In short: "In an interview with The Associated Press, Gokal, 48, said when he was confronted with the possibility that a life saving vaccine could be lost, he made the decision to find eligible people late at night who could be given the expiring doses."

Although Harris County Public Health fired Gokal over the incident, the defense worked with the Texas Medical Board, which dismissed charges against him, as well as with a Harris County Court-at-Law Judge, who dismissed the theft charges against him. Prosecutors then turned to the grand jury, which rejected the case on June 30.

I'm searching for the right analogy to capture what was wrong with the prosecutor's case. Is this an "inverse Jean Valjean" situation, where the loaf of bread (vials of vaccine) would have been stolen not to feed Gokal's family (though his wife did get one of the doses) but the family of others? 

It's difficult to criticize Gokal's action if [1] the vaccine was going to be destroyed unless he acted, [2] noöne would be harmed if he did act (so this is not a variation on The Trolley Problem), [3] 9 otherwise at-risk individuals acquired some protection from infection at a time (late December 2020) when COVID-19 was still running rampant, and [4] Gokal himself wasn't responsible for creating the dilemma in the first place.