Friday, May 02, 2025

Krugman: MAGA's War on Science

My last final exam is finally ready for prime time (Mon., May 5, at 1:30: Legislation and Regulation, a required 1L course; I wish my students good luck on the exam).

Grading will begin Tuesday morning.

So this is a perfect time to blog a little something, which I haven't done since February. After my grades are in, I will be on sabbatical for a year, followed by retirement on May 31, 2026. This year I'll be finishing a student treatise on health law regulation and compliance (state and federal), public health law, bioethics, and medical malpractice. Not sure whether blogging fits into that task, at least until September when my draft is due to the publisher.

If it hadn't been for an eye-catching email from Paul Krugman this morning, I probably wouldn't be blogging this afternoon, but his thoughts are compelling for anyone who cares about scientific research in general or medical research in particular. I republishing his email below in the hope that he won't find out won't mind, because his email starts with this: "Forwarded this email? Subscribe here for more." In lieu of literally forwarding his email to you (impossible to do), I'm forwarding in the best way available to me. But definitely subscribe. In my perennially overstuffed Inbox, his messages are among the handful that I genuinely look forward to reading.

So much for the prelude. Now comes Krugman, unvarnished.

Many of us have long noted the growing hostility of the G.O.P. to science. But my experience was that many people viewed those raising the alarm — like Chris Mooney, who wrote a 2005 book titled The Republican War on Science — as over the top scaremongers.

But at this point, can we acknowledge that MAGA is indeed waging war on science? Not just “woke” stuff, but science in general.

Nature tells us that National Science Foundation funds have been frozen, and that even if some money eventually flows again, funding will be heavily politicized:

Staff members at the US National Science Foundation (NSF) were told on 30 April to “stop awarding all funding actions until further notice,” according to an email seen by Nature.

The policy prevents the NSF, one of the world’s biggest supporters of basic research, from awarding new research grants and from supplying allotted funds for existing grants, such as those that receive yearly increments of money. The email does not provide a reason for the freeze and says that it will last “until further notice”.

Earlier this week, NSF leadership also introduced a new policy directing staff members to screen grant proposals for “topics or activities that may not be in alignment with agency priorities”. Proposals judged not “in alignment” must be returned to the applicants by NSF employees. The policy has not been made public but was described in documents seen by Nature.

In effect, NSF, if it supports research at all, will only support research that tells MAGA what it wants to hear. Add in RFK Jr.’s savage cuts at the National Institutes of Health, budget cuts at the National Oceanic and Atmospheric Administration and the Trump administration’s attacks on research universities, and we’re looking at a near-collapse of U.S. science. I don’t mean a hypothetical collapse a few years down the road, but the destruction of large parts of the American scientific enterprise — the envy of the world just a few months ago — this year.

Why should those who aren’t scientists care? In the 21st century, science isn’t some esoteric intellectual affair. It’s the foundation of social and economic progress. And no, we can’t expect the private sector to fill the gap left by loss of government support. Basic research is a public good: it generates real benefits, but those benefits can’t be monetized because everyone can make use of the knowledge gained. So government support is the only way to sustain science. And that support is being rapidly ended.

But why do our new rulers want to destroy science in America? Sadly, the answer is obvious: Science has a tendency to tell you things you may not want to hear. Medical research may tell you that vaccines work and don’t cause autism. Energy research may tell wind power works and doesn’t massacre birds.

And one thing we know about MAGA types is that they are determined to hold on to their prejudices. If science conflicts with those prejudices, they don’t want to know, and they don’t want anyone else to know either. So they really want to destroy science.

Again, this isn’t hyperbole, and it’s not about the long run. American science is being gutted as you read this.

Monday, February 03, 2025

I Really Didn't Plan to Post Anything Until My Next Sabbatical, But It's Time to Get Real (Part II)

The new administration is systematically undoing years and decades of support for the sorts of health- and medicine-related web posts and publications, as I described  in yesterday's blog post. A few concrete examples to illustrate the author's claims:

-- ABC News: Multiple Health Agency Websites On HIV, Contraception Taken Down To Comply With Executive Orders (KFF News, 2/3/2025):

Government agency webpages about HIV, LGBTQ+ people and multiple other public health topics were down as of Friday evening due to President Donald Trump's executive orders aimed at gender ideology and diversity, equity and inclusion. Some of the terms being flagged for removal include pregnant people, chestfeeding, diversity, DEI and references to vaccines, health and gender equity, according to officials at the Centers for Disease Control and Prevention who spoke to ABC News on the condition of anonymity. Entire databases have also been temporarily removed. (Wang, Portnoy, Haslett, Brownstein and Benadjaoud, 1/31)

-- One day after the inauguration, OMB instructed staff at agencies inside the Department of Health and Human Services to stop all external communications. The affected agencies included the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health. As reported by the Washington Post, "The pause on communications includes scientific reports issued by the CDC, known as the Morbidity and Mortality Weekly Report (MMWR); advisories sent out to clinicians on CDC’s health alert network about public health incidents; data updates to the CDC website; and public health data releases from the National Center for Health Statistics, which tracks myriad health trends, including drug overdose deaths."

Sunday, February 02, 2025

I Really Didn't Plan to Post Anything Until My Next Sabbatical, But It's Time to Get Real (Part I)

A niece of a retired law-school colleague is a Clinical Professor of Emergency Medicine at UCLA Medical School. She reposted a message from a colleague that deserves to be heard far and wide. Please read carefully:

Shared from a colleague (Sunny Smith):

For those who may not be a physician or aren’t in physician communities - yes, it’s true, it’s actually true.  

The United States government has required our leading health agencies to remove basic information on guidelines and best practices used every day for medical care and public health.   For treatment and prevention.   Every day clinical care.  

This has to be one of the most surreal (and terrifying) times in modern history. 

They have taken down information on antibiotics, antivirals, sexually transmitted infections, contraception, vaccines, and gender related issues.  

Physicians are outraged and alarmed.   

Physicians are banding together to obtain and share the information they need to treat patients.     They are literally saying “i have the guidelines for this, does anyone have guidelines for that”.  

Emergency physicians. Pediatricians.  OB Gyns.  Primary care.  

Real physicians.  Real conversations.  

This is not a dress rehearsal.  

We won't keep quiet and many are screaming from the rooftops.  

If you are not alarmed, you should be.  

11 days into this administration and by 5pm Friday our nation's health organizations have been forced to take down crucial health information. 

This is “Defending women from gender ideology” ?!?!?!!!!!!!! 

Let’s be very very very clear - this is NOT defending women.  

Do not be gaslit for one second that any of this is to protect women.   

That is the absolute antithesis of what this does to women.  And the whole population. 

This Executive Order alongside DEI EOs and blaming DEI for plane crashes. 

DO. NOT. BELIEVE. THESE. LIES.  

DEI did not cause plane crashes. 

Helping physicians treat infections or prevent pregnancies is not bad. 

The shock and awe and overwhelm and division and othering and inciting fear is intentional. 

Please speak up.  Anywhere and everywhere.   The compound effect of real people talking to other real people matters.  

You are not powerless.  They just want you to think you are.  Who wins when you think that? 

They can not paralyze over 300 milllion people.   

The way out of learned helplessness is to take small actions over and over again.  To take control anywhere within your own locus of control.   

And - Even if you were on the fence before or voted for him or are in a red state - PLEASE - consider having a tiny bit more opennness to start to question what is happening right now.  Look at data.  (May we all become increasingly aware of and question our own internalized bias, implicit or explicit bias, assumptions, racism, misogyny).

If you trust your LIFE to physicians, during any truly imminently life-threatening emergency for you or your loved ones, please listen when we say this is NOT okay.

Edited to add (after a physician colleague shared this immediately)  ->  Feel free to share.

In Part II I will provide some links to the Executive Orders and missing web pages. 

Saturday, December 28, 2024

Rural Health Care and the Tenuous Connection to Urban Tertiary Care Centers

Today's on-line post (possibly free, at least for awhile) from the New England Journal of Medicine is by a physician in the Northern Navajo Medical Center, Shiprock, NM, an unincorporated community on the Navajo reservation in San Juan County, New Mexico, population 7,718 people. It's located in what we city-folk call "the middle of nowhere," and that's a problem. Actually, it's the problem if you live in Shiprock and have a complex kidney-stone problem that requires specialty care in a tertiary-care hospital. That was Ms. C's situation. 

Two options were a facility 7 hours away that was booked nearly a year out and another that was 4 hours away and booked 6 months out. But a familiar sequence of events saved the day for Ms. C:

I emailed a urologist in Boston who’d volunteered at my hospital years earlier. He called a colleague in California, who recommended a former trainee in Tucson. The Tucson team recognized the complexity of Ms. C.’s medical case and her geography. They admitted her and removed her right stone, monitoring for complications before releasing her. They had her come back, when she was ready, for the left.

Calling a friend who knows a friend who knows a friend is not unique to rural settings. I regularly receive pleas from friends around the country whose relative needs a specialist's care and do I know someone who knows someone who can call in a favor and secure an appointment in San Antonio, Austin, Fort Worth, Dallas, etc. 

Physician shortages in lots of urban settings lead to long waits for an appointment, but the problem is orders of magnitudes worse in rural areas, including Texas. Here's some sobering homework reading:

Sunday, December 22, 2024

Latest Report on National Health-Related Spending in 2023

From Health Affairs on-line today:

In an ahead-of-print article published [Dec. 18], Anne B. Martin and colleagues at the Centers for Medicare and Medicaid Services (CMS) released their 2023 health care spending report.

Key takeaways from the report include:

  • Health care spending in the US continues to climb, with private insurance and Medicare leading the charge.
  • The insured share of the population reached a high of 92.5% in 2023.
  • Medicaid spending growth slowed as pandemic-related funding waned.
  • State and local governments accounted for a larger share of health spending, while federal contributions declined.

And some tidbits from the article's Abstract:

  • Health care spending in the US reached $4.9 trillion and increased 7.5 percent in 2023 [compared to our overall rate of inflation of 4.1%], growing from a rate of 4.6 percent in 2022. 
  • In 2023, the insured share of the population reached 92.5 percent, as enrollment in private health insurance increased at a strong rate for the second year in a row, and both private health insurance and Medicare spending grew faster than in 2022. 
  • For Medicaid, spending and enrollment growth slowed as the COVID-19 public health emergency ended. 
  • The health sector’s share of the economy in 2023 was 17.6 percent, which was similar to its share of 17.4 percent in 2022 but lower than in 2020 [19.7%] and 2021 [18.3%], during the height of the COVID-19 pandemic. 
  • State and local governments accounted for a higher share of spending in 2023 than in 2022, while the federal government share was lower as COVID-19-related funding declined and federal Medicaid spending growth slowed. 

Friday, December 20, 2024

Bird Flu: It May Be Worse Than We Suspect

The Kaiser Family Foundation (KFF) just published a report on the bird flu with a pretty scary title: "How America Lost Control of the Bird Flu, Setting the Stage for Another Pandemic." What?!?

A few salient quotes:

  • "Nearly a year into the first outbreak of the bird flu among cattle, the virus shows no sign of slowing. The U.S. government failed to eliminate the virus on dairy farms when it was confined to a handful of states, by quickly identifying infected cows and taking measures to keep their infections from spreading. Now at least 875 herds across 16 states have tested positive."
  • "Experts say they have lost faith in the government’s ability to contain the outbreak. 'We are in a terrible situation and going into a worse situation,' said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. 'I don’t know if the bird flu will become a pandemic, but if it does, we are screwed.'"
  • "To understand how the bird flu got out of hand, KFF Health News interviewed nearly 70 government officials, farmers and farmworkers, and researchers with expertise in virology, pandemics, veterinary medicine, and more. . . . Together with emails obtained from local health departments through public records requests, this investigation revealed key problems, including deference to the farm industry, eroded public health budgets, neglect for the safety of agriculture workers, and the sluggish pace of federal interventions."
  • "Far more bird flu damage is inevitable, but the extent of it will be left to the Trump administration and Mother Nature." No comment.
  • "[T]the outbreak poses the threat of a pandemic. More than 60 people in the U.S. have been infected, mainly by cows or poultry, but cases could skyrocket if the virus evolves to spread efficiently from person to person. And the recent news of a person critically ill in Louisiana with the bird flu shows that the virus can be dangerous. . . . Just a few mutations could allow the bird flu to spread between people. Because viruses mutate within human and animal bodies, each infection is like a pull of a slot machine lever.
  • “Even if there’s only a 5% chance of a bird flu pandemic happening, we’re talking about a pandemic that probably looks like 2020 or worse,” said Tom Peacock, a bird flu researcher at the Pirbright Institute in the United Kingdom, referring to covid. “The U.S. knows the risk but hasn’t done anything to slow this down,” he added.


Thursday, December 19, 2024

SCOTUS Adds Medicaid Exclusion of Planned Parenthood to its Docket

Add another case to my SCOTUS "roundup" (Dec. 1).

SCOTUSBlog notes that the Supreme Court has granted review of the 4th Circuit Court of Appeals's decision in Kerr v. Planned Parenthood, which involves "a dispute over whether a South Carolina woman can bring a lawsuit challenging that state’s decision to end Planned Parenthood’s participation in its Medicaid program. . . ." Amy Howe, Court adds Medicaid lawsuit to docket, SCOTUSblog (Dec. 18, 2024, 12:57 PM). It's a safe bet that the required four votes to grant the petition for review came from the 6-member conservative group of Justices, so this is an ominous development for Planned Parenthood (and the women who depend upon PP for a variety of healthcare needs). The note continues:

Under federal law, Medicaid funds cannot generally be used to provide abortions. But Planned Parenthood provides other medical services to women, including gynecological and contraceptive care but also screenings for cancer, high blood pressure, and cholesterol.

At two clinics in Charleston and Columbia, Planned Parenthood has tried to make it easier to lower-income patients, many of whom are covered by Medicaid, to use its services – by, for example, offering same-day appointments and extended clinic hours. One of those Medicaid patients is Julie Edwards, who suffers from diabetes. She went to Planned Parenthood for birth control but says she wants to return to receive other care in the future.

In 2018, South Carolina Governor Henry McMaster ordered the state’s Department of Health and Human Services to bar abortion clinics from participating in the Medicaid program. McMaster explained that the “payment of taxpayer funds to abortion clinics, for any purpose, results in the subsidy of abortion and the denial of the right to life.”

Edwards and Planned Parenthood went to federal court in South Carolina. They argued that McMaster’s order violated a provision of the Medicaid Act that allows any patient who is eligible for Medicaid to seek health care from any “qualified” provider.

A federal appeals court agreed with Edwards and Planned Parenthood and blocked the state from excluding Planned Parenthood from its Medicaid program. That decision prompted the state – represented by the conservative Alliance Defending Freedom – to come to the Supreme Court this summer, asking the justices to decide whether Edwards and Planned Parenthood have a legal right to sue to enforce the Medicaid Act.

The state told the justices that five federal courts of appeals “have wrongly subjected states to private lawsuits Congress never intended.” Moreover, it added, with 70 million Americans receiving Medicaid benefits and tens of thousands of health-care providers participating in the program, the question at the center of the case is “of great national importance.”

But Planned Parenthood and Edwards countered that the question does not come up very often these days. And most of the cases in which it did arise, they continued, “were efforts by states to target Planned Parenthood in ways courts have recognized are unwarranted and politically motivated.” But in any event, they concluded, as all three judges on the court of appeals agreed in this case, the Medicaid law is “clear and unambiguous in conferring a privately enforceable right.”

The justices considered the state’s petition at nine consecutive conferences before finally granting review on Wednesday. The case will likely be slated for argument in either March or April, with a decision to follow by summer.

A number of states have removed Planned Parenthood from their Medicaid programs, including Texas. Beyond that, the Texas Attorney General has sued PP for$1.8 billion in an attempt to bankrupt the organization. Details are here.

Wednesday, December 18, 2024

Two-week nationwide law enforcement action produces criminal charges for submission of over $2.75 billion in alleged false billings

The announcement from the U.S. Attorney's Office for Montana was pretty bland: "Whitefish doctor sentenced for defrauding Medicare and other federal health programs." But the devil, as they say, is in the details:

A Whitefish doctor who admitted defrauding Medicare and other federal government health programs through a telemedicine conspiracy that resulted in more than $31 million in false billing was sentenced today to six months in prison, to be followed by six months of home confinement, fined $100,000 and ordered to pay $780,509 restitution, the U.S. Attorney’s Office said.

The defendant, Ronald David Dean, 64, pleaded guilty in July to conspiracy to commit wire fraud. . . .

The government alleged in court documents that Dean, a licensed physician, was paid by a telemedicine company to sign orders for durable medical equipment that patients did not need. Dean then fraudulently charged Medicare, CHAMPVA and the Railroad Retirement Board programs for telemedicine office visits that did not occur.  The telemedicine company also used Dean’s information to prescribe unneeded and unnecessary covid tests to patients.  The conspiracy ran from about January 2022 until July 2023. The total amount billed to Medicare, the VA and the Railroad Retirement Board based on orders Dean signed was $31,432,001, and the total amount paid from those programs was $13,785,724.

As part of the scheme, Dean relied on information provided by people he did not know, with an unknown amount of training or experience, to prescribe braces for beneficiaries he did not see or evaluate himself. Dean frequently did not even talk to the beneficiaries, and when he did it was merely to tell them the braces were approved. Dean had no idea if those people who received braces actually needed them. With the covid tests, Dean provided blanket authorization for the telemedicine company to send out tests to anyone and bill Medicare for as many covid tests as the company desired.

The case was part of a strategically coordinated, two-week nationwide law enforcement action that resulted in criminal charges against 193 defendants for their alleged participation in health care fraud and opioid abuse schemes that resulted in the submission of over $2.75 billion in alleged false billings. The defendants allegedly defrauded programs entrusted for the care of the elderly and disabled to line their own pockets, and the Government, in connection with the enforcement action, seized over $231 million in cash, luxury vehicles, gold, and other assets.

Fear and greed are classic human motivators. This time, as I suspect in most such cases of health care fraud, greed overcame any fear of being caught. Six months in the pokey seems awfully light, but I assume the sentence falls within a range permitted by the Federal Sentencing Guidelines. A month for every million paid by the government would have had a nice ring to it.

Tuesday, December 17, 2024

FTC Withdraws 2000 Antitrust Guidelines for Collaborations Among Competitors

On Dec. 11, the Federal Trade Commission and the Justice Department’s Antitrust Division (DOJ) jointly announced the withdrawal of the Antitrust Guidelines for Collaborations Among Competitors (Collaboration Guidelines):
The Collaboration Guidelines, issued in April 2000, no longer provide reliable guidance about how enforcers assess the legality of collaborations involving competitors, according to the FTC and DOJ’s joint withdrawal statement. Businesses considering collaborating with competitors are encouraged to review the relevant statutes and caselaw to assess whether a collaboration would violate the law.

The FTC and DOJ are committed to vigorous antitrust enforcement on a case-by-case basis in the area of competitor collaborations because such collaborations can harm competition and subvert the competitive process, according to the withdrawal statement.

 It was a 3-2 vote. In addition to the withdrawal statement (link above), three commissioners issued statements (including two dissenting statements:

  • Statement of Commissioner Alvaro M. Bedoya Regarding the Withdrawal of the Antitrust Guidelines for Collaborations Among Competitors
  • Dissenting Statement of Commissioner Andrew N. Ferguson Regarding the Withdrawal of the Antitrust Guidelines for Collaborations Among Competitors
  • Dissenting Statement of Commissioner Melissa Holyoak Regarding Withdrawal of 2000 Antitrust Guidelines for Collaboration Among Competitors
This most recent withdrawal is part of a broader program of withdrawing guidelines and policy statements deemed to be out of date. E.g.,  Press Release, Department of Justice, Office of Public Affairs, Justice Department Withdraws Outdated Enforcement Policy Statements (Feb. 3, 2023), https://www.justice.gov/opa/pr/justicedepartment-withdraws-outdated-enforcement-policy-statements; Press Release, Federal Trade Commission, Federal Trade Commission Withdraws Health Care Enforcement Policy Statements (July 14, 2023), https://www.ftc.gov/news-events/news/press-releases/2023/07/federal-trade-commission-withdraws-health-careenforcement-policy-statements

As Commissioner Holyoak observed in her dissenting statement, the Commission has withdrawn its 2000 guidance without providing updated guidance, leaving competitors who are in or are contemplating collaborations in the dark.

Tuesday, December 10, 2024

77 Nobel Laureates Oppose RFKJr's Nomination to Head DHHS

For the reportedly first time ever, 77 Nobel Prize Laureates have written a letter (also: here) to the members of the U.S. Senate in which they urge rejection of the Trump Secretary-designate Robert F. Kennedy, Jr. to head the $1.8 trillion/year Department of Health and Human Services. DHHS is the mother ship for operating divisions that administer over 100 health and safety programs. The divisions include:  

  • Agency for Healthcare Research and Quality
  • Agency for Toxic Substances and Disease Registry
  • Administration on Aging
  • Centers for Disease Control and Prevention
  • Centers for Medicare & Medicaid Services (formerly Health Care Finance Administration)
  • Office of Child Support Enforcement 
  • Office of Child Support Services 
  • Administration for Children and Families 
  • Office of Family Assistance
  • Food and Drug Administration
  • Health Resources and Services Administration
  • Indian Health Service
  • Inspector General Office, Health and Human Services Department
  • National Institutes of Health
  • National Library of Medicine
  • Program Support Center
  • Public Health Service
  • Office of Refugee Resettlement 
  • Substance Abuse and Mental Health Services Administration
  • Community Living Administration
  • Strategic Preparedness and Response Administration
The laureates's bill of particulars is as familiar as it is damning: 
In addition to his lack of credentials or relevant experience in medicine, science, public health, or administration, Mr. Kennedy has been an opponent of many health-protecting and life-saving vaccines, such as those that prevent measles and polio; a critic of the well-established positive effects of fluoridation of drinking water; a promoter of conspiracy theories about remarkably successful treatments for AIDS and other diseases; and a belligerent critic of respected agencies (especially the Food and Drug Administration, the Centers for Disease Control, and the National Institutes of Health). The leader of DHHS should continue to nurture and improve---not threaten---these important and highly respected institutions and their employees.

In conclusion:  

In view of his record, placing Mr. Kennedy in charge of DHHS would put the public's health in jeopardy and undermine America's global leadership in the health sciences, in both the public and commercial sectors.

If there is a Senate vote on Mr. Kennedy's nomination -- which is still a matter of some doubt -- we will find out if the Senator -- and Senate Republicans in particular -- share Trump's and Kennedy's disdain for science and medicine and expertise earned over lifetimes of work in these fields. 

Saturday, December 07, 2024

HHS OIG and DOJ Publish 2023 Report on Fraud and Abuse Enforcement

Unlike the proposed, scammy Department of Government Efficiency, whose billionaire leaders seem focused on slashing budgets and trimming enforcement efforts in numerous federal agencies regarded as part of the "deep state," DOJ and HHS have actually been working hard to root out skullduggery and outright theft in the health care industry. This report is quite revealing. It also begs the question whether we will see another report like this from the next administration. 
Here's an overview:

In FY 2023, civil health care fraud settlements and judgments under the False Claims Act exceeded $1.8 billion, in addition to other health care administrative impositions won or negotiated by the Federal Government. Due to these efforts, as well as those of preceding years, more than $3.4 billion was returned to the Federal Government or paid to private persons in FY 2023. Of this $3.4 billion, the Medicare Trust Funds received transfers of approximately $974 million during this period, in addition to $257.2 million in Federal Medicaid money that was transferred separately to the Centers for Medicare & Medicaid Services.

One gets the feeling that $1.8 billion is the tip of the fraud-and-abuse iceberg. First, the report shows just how thoroughly fraud permeates most aspects of the health care system. The report discusses major areas of enforcement efforts (past, present, and future) and should be read by any healthcare lawyer who advises any individual or institutional providers on this list:

  • Ambulances 
  • Clinics (e.g., pain clinics, ophthalmology services and related ambulatory surgical centers)
  • COVID-19 Related Enforcement 
  • Diagnostic Testing (huge)
  • Durable Medical Equipment (DME) (an oldie but a goodie, still huge)
  • Electronic Health Records 
  • EMTALA Violations
  • Genetic Testing/RPP (Respiratory Pathogens Panel )Testing 
  • Home Health Providers 
  • Hospice Care
  • Hospitals and Health Systems (see below for the details of one especially notable enforcement action against a renowned hospital and health system)
  • Laboratory Testing 
  • Managed Care 
  • Medical Devices 
  • Pharmacies 
  • Physical Therapy 
  • Physician and Other Practitioners 
  • Prescription Drugs and Opioids 
  • Psychiatric and Psychological Testing and Services
  • Substance Use Treatment Centers 
  • Telemedicine Exploitation and Fraud

More detail on the "Hospitals and Health Systems" item. 

In February 2023, the University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), and a cardiothoracic surgeon agreed to pay $8.5 million, submit to a year-long audit, and implement a corrective action plan to resolve civil FCA allegations that UPMC (an integrated health care system and teaching hospital based in Pittsburgh), UPP (UPMC’s physician practice group), and the surgeon (a teaching physician and longtime chair of UPMC’s department of cardiothoracic surgery) violated the Teaching Physician Regulations, 42 C.F.R. §§ 415.190 and 415.192, by performing as many as three complex surgeries at the same time, failing to participate in all of the key and critical portions of those surgeries, unnecessarily inflating anesthesia times during those surgeries, and billing Medicare and other government Health Benefit Programs for those surgeries and services.  In its September 2021 Complaint-in-Partial-Intervention, the government alleged that, from 2015-2021, UPMC, UPP and the surgeon submitted false claims for payment related to: (1) doubly- and triply-concurrent surgeries, during which the surgeon left a first surgery before the key and critical portions of that surgery were complete, participated in as many two other simultaneous surgeries in separate operating rooms, and caused delays and complications in some of those surgeries; (2) surgeries where the surgeon did not participate in the timeout at the outset of the procedure; (3) surgeries where the surgeon was outside the hospital facility, unlocatable for significant stretches, or otherwise not immediately available throughout the procedure; (4) unduly prolonged anesthesia services associated with the surgeon’s concurrent surgeries and absences; and (5) procedures, services, and care related to otherwise avoidable complications caused by the concurrent surgeries. 

This is far from an isolated incident. Massachusetts General Hospital, one of the Harvard teaching hospitals, was cited for the same activity and paid out three settlements that totaled $32.7 million to settle three claims of multiple simultaneous surgeries between 2019 and 2022 (Boston Globe, Feb. 18, 2022 - paywall; law firm blurb based on the story). In June 2024 I wrote on the issue when it involved a major Houston hospital.

The report has some additional intriguing details:

In FY 2023, the Department of Justice (DOJ) opened more than 802 new criminal health care fraud investigations.  Federal prosecutors filed criminal charges in over 346 cases involving at least 530 defendants.  More than 476 defendants were convicted of health care fraud related crimes during the year.  Also, in FY 2023, DOJ opened more than 770 new civil health care fraud investigations and had over 1,147 civil health care fraud matters pending at the end of the fiscal year.  Federal Bureau of Investigation (FBI) investigative efforts resulted in over 620 operational disruptions of criminal fraud organizations and the dismantlement of more than 127 health care fraud criminal enterprises. 

In FY 2023, investigations conducted by HHS’s Office of Inspector General (HHS-OIG) resulted in 651 criminal actions against individuals or entities that engaged in crimes related to Medicare and Medicaid, and 733 civil actions, which include false claims, unjust-enrichment lawsuits filed in Federal district court, and civil monetary penalty (CMP) settlements.  HHS-OIG excluded 2,112 individuals and entities from participation in Medicare, Medicaid, and other Federal health care programs.  Among these were exclusions based on criminal convictions for crimes related to Medicare and Medicaid (871) or to other health care programs (314), for beneficiary abuse or neglect (203), and as a result of state health care licensure revocations (531).  

There's no denying it's been another busy year for the enforcers, but there seems to be no stopping health care providers (real or fake) with larceny in their heart. 

Thursday, December 05, 2024

CDC Reports on Intimate-Partner Violence

The full title of the CDC's report gives an accurate picture of the report's focus on intimate-partner violence "(IPV"): Intimate Partner Violence and Pregnancy and Infant Health Outcomes — Pregnancy Risk Assessment Monitoring System, Nine U.S. Jurisdictions, 2016–2022 (Dec. 5, 2025)

The implications of IPV for public health, maternal health, and infant health are far-reaching, complex, and difficult to solve. Here's a snapshot of this important report:

Summary

What is already known about this topic?

Intimate partner violence (IPV) during pregnancy is a preventable cause of injury and death with negative short- and long-term impacts for pregnant women, infants, and families.

What is added by this report?

During 2016–2022, among women with a live birth in nine jurisdictions, 5.4% experienced IPV during pregnancy. Emotional IPV (5.2%) was more common than physical (1.5%) and sexual (1.0%) IPV. All IPV types were associated with delayed or no prenatal care, depression and substance use during pregnancy, and low infant birth weight.

What are the implications for public health practice?

Addressing multiple IPV types through comprehensive prevention efforts is critical to supporting maternal and infant health.

Abstract

Intimate partner violence (IPV) can include emotional, physical, or sexual violence. IPV during pregnancy is a preventable cause of injury and death with negative short- and long-term impacts for pregnant women, infants, and families. Using data from the 2016–2022 Pregnancy Risk Assessment Monitoring System in nine U.S. jurisdictions, CDC examined associations between IPV during pregnancy among women with a recent live birth and the following outcomes: prenatal care initiation, health conditions during pregnancy (gestational diabetes, pregnancy-related hypertension, and depression), substance use during pregnancy, and infant birth outcomes. Overall, 5.4% of women reported IPV during pregnancy. Emotional IPV was most prevalent (5.2%), followed by physical (1.5%) and sexual (1.0%) IPV. All types were associated with delayed or no prenatal care; depression during pregnancy; cigarette smoking, alcohol use, marijuana or illicit substance use during pregnancy; and having an infant with low birth weight. Physical, sexual, and any IPV were associated with having a preterm birth. Physical IPV was associated with pregnancy-related hypertension. Evidence-based prevention and intervention strategies that address multiple types of IPV are important for supporting healthy parents and families because they might reduce pregnancy complications, depression and substance use during pregnancy, and adverse infant outcomes.

As a side note, this report is an example of the sort of data collection and dissemination that may be at risk in the Trump administration. It appears that the president-elect's advisors, as well as members of Congress, are looking to cut the CDC's budget and scale back some of its public-health activities. I hope cooler heads will prevail, but "Hope is that thing with feathers." 

Sunday, December 01, 2024

SCOTUS Watch: Week of Dec. 2

The Court will hear arguments in two important health-law-related case this week:

  • Monday, 12/2: E-cigarettes and the FDA. The Court will consider "[w]hether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious." Food and Drug Administration v. Wages and White Lion Investments, LLCNo. 23-1038, reviewing the en banc decision of the 5th Circuit Court of Appeals, which vacated the FDA's orders as arbitrary and capricious.  
  • Wednesday, 12/4: Gender-affirm care for minors.
    The Court will consider "[w]hether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow 'a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex' or to treat 'purported discomfort or distress from a discordance between the minor’s sex and asserted identity,' violates the equal protection clause of the 14th Amendment." United States v. SkrmettiNo. 23-477, reviewing the decision of the 6th Circuit Court of Appeals, which reversed the preliminary injunctions issued by the district courts and remanded them for further proceedings.

 

Friday, November 29, 2024

Two New Enforcement Actions from Texas Attorney General

As easy as it is to dislike Ken Paxton for his extravagantly disruptive policies on abortion and gender-affirming care for minors, his office does a good job in its enforcement program against health fraud. Two recent examples:

U.K. Moves Toward Medical Assistance in Dying/Assisted Suicide

A bill to legalize physician-assisted suicide passed in the House of Commons today. In the U.S., where 10 states and D.C. have legalized PAS (also known as Medical Aid in Dying ("MAiD")), state laws have largely followed the law in Oregon, the first state to legalize PAS. The British bill does the same, adding additional safeguards such as a mandatory physician's second-opinion and required court approval.

The bill will now go through a process of amendment and then on to the House of Lords for final approval.

Monday, November 18, 2024

West Virginia's Constitutional Amendment Prohibiting Physician-Assisted Suicide

Prof. Austin Sarat (Amherst College) has posted an excellent op-ed on the website of The Hill that describes and decries the autonomy-crushing West Virginia constitutional amendment that voters passed last week by a 1% margin (50.5% yes-49.5% no). In the 40 states where physician-assisted suicide (a/k/a Medical Aid-in-Dying) is illegal, the prohibitions are statutory. As Sarat points out, by embedding a ban in its constitution West Virginia has made it exponentially more difficult to reverse course in future years. 

Major arguments for and against the ballot measure are summarized by Ballotpedia:

In opposition:

Death with Dignity: "While Death with Dignity is already illegal under current West Virginia law, this constitutional amendment would mark the first time any state amended its constitution to explicitly prohibit aid in dying. Never before has a legislature in this country mobilized an attack like this on terminally ill patients. And to make matters worse, proponents of the ban are on a press tour spreading malicious lies about how Death with Dignity works in states where it’s legal." 

Eli Baumwell, interim executive director for ACLU West Virginia: "'Mountaineers are always free' is a promise that the ACLU of West Virginia works every day to ensure is kept. Amendment One runs counter to that promise by enshrining a prohibition into the state constitution designed to take away the last free choice Mountaineers can make. West Virginians, like most Americans, do not believe that the government should interfere in personal medical decisions. As shown by the Legislature going zero for four last year in seeking permission from the people to modify our Constitution, they do not represent the will of the people. Instead, they represent a dangerous and out of touch minority: lawmakers who want to take the last medical decision you can ever make about yourself." 

In support:

State Del. Pat McGeehan (R-1): "There’s this phenomenon of nihilism that’s sort of spreading across the country, and I think it’s an important issue we need to address. To the best of my knowledge, we’ll be the first to place this and take a stand in the state constitution." 

State Del. Pat McGeehan (R): "That’s why it is vital to vote for Amendment One this November. It secures our state from medically-assisted suicide and the culture of indifference and carelessness it promotes. It affirms the goodness of suicide prevention. And it sends a clear and confident message that West Virginia is not a place of fear and despair, but a state of courage and hope." 

Mary Tillman, legislative coordinator for the West Virginia alliance for Ethical Health Care: "If there is a fear of pain at the end of life, good palliative care and hospice care are ways to provide comfort and care until a person’s life ends naturally. A vote FOR Amendment One will protect all West Virginians from physician-assisted suicide. This November, please vote to keep West Virginia a state where all lives are valued and protected." 

Ms. Tillman's point about "good palliative care and hospice care" is only half right. Palliation and hospice care are designed to provide relief from suffering, but relief is far from inevitable. In a pioneering article in the New England Journal of Medicine, Dr. Tim Quill (coincidentally, a graduate of Amherst College, Class of 1971) wrote about the last days of his patient, Diane, who was dying of leukemia:

Bone pain, weakness, fatigue, and fevers began to dominate her life. Although the hospice workers, family members, and I tried our best to minimize the suffering and promote comfort, it was clear that the end was approaching. Diane's immediate future held what she feared the most — increasing discomfort, dependence, and hard choices between pain and sedation. . . .

Although I know we have measures to help control pain and lessen suffering, to think that people do not suffer in the process of dying is an illusion. Prolonged dying can occasionally be peaceful, but more often the role of the physician and family is limited to lessening but not eliminating severe suffering. [italics added]

"Death and Dignity — A Case of Individualized Decision Making," N Engl J Med 1991;324:691-694 (March 7, 1991). Any argument that ignores this harsh reality lacks scientific, medical, and moral authority.

Finally, I want to end with the point that Prof. Sarat makes at the outset of his op-ed:

Donald Trump’s surprisingly decisive electoral victory was a serious blow to those who value freedom and human dignity. . . .

His version of freedom does not include respecting the choices that individuals make about their own bodies. . . .

And while our attention was focused on those assaults on bodily autonomy, voters in West Virginia, where the MAGA ethos reigns supreme, passed a ballot measure amending their state constitution to prohibit people from participating in “the practice of medically assisted suicide, euthanasia, or mercy killing of a person.”   

Passage of West Virginia's ballot measure represents a victory for MAGA-types and MAGA-adjacent pro-life absolutists like the National Right to Life Committee and its various state affiliates. They added end-of-life decision-making to their traditional focus on reproductive decision-making three decades ago and have advocated relentlessly and quite successfully to curtail patient rights ever since.

Thursday, November 14, 2024

Health Affairs: "The Impact Of The Election On Health Policy And The Courts"

The nonpartisan and highly respected journal, Health Affairs, today posted an analysis of some of the more conspicuous (and worrying) changes to the health care scene we might expect to see once Donald Trump's administration is in place. It is, as usual, well worth reading in whole.

The areas that are discussed include:

  • the Affordable Care Act (ACA) (primary concern: allowing premium tax credit enhancements to expire entirely after 2025, which could result in 4 million people losing their health insurance coverage; also -- whether by statute, agency regulation, or executive order -- any number of the ACA's protections are at risk)
  • Medicaid (during the campaign Trump vowed to leave Social Security and Medicare alone; "experts noted that Medicaid was conspicuously absent from the conversation")
  • reproductive health care (abortion, LGBTQ nondiscrimination, reviving the Comstock Act, changing the Administration's position in state and federal lawsuits)
  • nondiscrimination and health equity ("Health care is a civil rights issue. . . . Anti-discrimination protections in health are also likely to suffer major blows going forward."
  • Medicare Drug Negotiation Program (hard to believe that a program that will save the government and citizens billions will be watered down, but Big Pharma has hated this law from the beginning and it has some attentive allies in the new administration)
  • public health (RFK, Jr. -- need I say more? He was named as Trump's nominee for Secretary of HHS; the mind reels)
  • the courts (Yup. From the Supreme Court on down, expect change)
The end. (Take that any way you want.)

Friday, November 08, 2024

Hospital Price Transparency Rule & No Surprises Act: Two Updates (One Surprising, the Other Not So Much)

I. HHS OIG Report -- Disappointing But Not So Surprising

"Not All Selected Hospitals Complied With the Hospital Price Transparency Rule (A-07-22-06108)

"Not all of the selected hospitals made their standard charges available to the public as required by Federal law. 

[Note: This is one of the most basic, and hotly contested (and resisted), requirements of the ACA, which added § 2718 to the the Public Health Service Act. In 2019 CMS promulgated the final version of its Hospital Transparency Rule with this introduction: "This final rule establishes requirements for hospitals operating in the United States to establish, update, and make public a list of their standard charges for the items and services that they provide. These actions are necessary to promote price transparency in health care and public access to hospital standard charges".] 

Of the 100 hospitals in our stratified random sample, 63 complied with the Hospital Price Transparency (HPT) rule requirements. Thirty-seven did not fully comply with one or both of the following criteria: 34 hospitals failed to meet one or more requirements for publishing comprehensive machine-readable files, and 14 hospitals did not display shoppable services in a consumer-friendly manner. Based on these sample results, we estimate that 46 percent of the 5,879 hospitals required to comply with the HPT rule did not make information about their standard charges publicly available. [emphasis added]

"Read the Full Report"

II. Fifth Circuit Sides with the Administration For Once -- Surprising

From the Centers for Medicare and Medicaid Services:

On October 30, 2024, the United States Court of Appeals for the Fifth Circuit (Fifth Circuit) issued an opinion in Texas Medical Association, et al. v. United States Department of Health and Human Services et al., Case No. 23-40605 __ (TMA III). The Fifth Circuit partially reversed a decision of the U.S. District Court for the Eastern District of Texas (the District Court). The Fifth [C]ircuit partially reversed the District Court’s holding that vacated certain provisions of the regulations and guidance under the No Surprises Act related to the methodology for calculating the qualifying payment amount (QPA). [Rules and Fact Sheets; statute] It also affirmed the District Court’s vacatur of certain deadline provisions and affirmed the District Court’s holding as to the disclosure requirements. The Departments and OPM are reviewing the Fifth Circuit’s decision and intend to issue further enforcement guidance in the near future.  [hyperlinks added]

For more litigation-related context, Zachary Baron writes for Health Affairs' "Forefront"

Years after the bipartisan enactment of the No Surprises Act (NSA) in late December 2020 to protect consumers from the most pervasive out-of-network surprise medical bills and constrain overall health care costs, ongoing litigation continues to shape the implementation of the NSA. 

Much of the litigation has focused on the manner in which the Administration sought to implement aspects of the law’s arbitration process related to disputes between providers and insurers over certain out-of-network payments. Data from arbitration under the law shows providers have continued to win most of the disputes, with filings heavily dominated by a few provider groups (backed by private equity) in a few states.

But other cases reach beyond the arbitration process, including how the qualifying payment amount (QPA) is calculated under the law. While important in the arbitration process, the QPA also has a direct connection to patient cost-sharing because it is the basis for determining what individuals might owe for items and services covered by the law’s balance-billing protections.

On October 30, 2024, a Fifth Circuit panel unanimously reversed a ruling by a Texas district court judge to vacate certain regulatory provisions related to the NSA’s QPA methodology. The decision also touched on other regulations implementing the NSA, upholding one victory secured by providers.

This article will examine the Fifth Circuit panel’s decision in detail, including insights into how courts approach disputed statutory provisions after the Supreme Court’s decision in Loper Bright overruling the Chevron doctrine. While the appeal concerned litigation brought by the Texas Medical Association (TMA) and certain air-ambulance providers, this article will call the case TMA III to distinguish it from earlier litigation brought by TMA and air-ambulance providers challenging previous regulations under the NSA. [emphasis added]

The full article is well worth the time to read.

Texas Tax-Exempt Hospitals & Charity Care: Surprisingly Progressive

In 1985 -- one year before Congress added EMTALA to Medicare's Conditions of Participation -- Texas became the first state in the country to enact a prohibition against patient-dumping, the practice of for-profit hospitals to transfer unfunded emergency patients to local public hospitals. See Tex. Health & Safety Code § 311.022. When a patient needs emergency medical treatment, the consequences of transfer-related delays could be dire, including death. See this 1985 N.Y. Times story:


(click image to enlarge)

This isn't the only progressive healthcare law in Texas. For decades now, we have also required nonprofit hospitals to provide a certain minimum amount of charity care, both to maintain its nonprofit status (Tex. Health & Safety Code, ch. 311(D)) and to qualify for tax-exempt status (Tex. Tax Code § 11.1801). If a nonprofit hospital meets any one of three measures of required charity care, it gets its exemption:
(A)  charity care and government-sponsored indigent health care (e.g., Medicaid] are provided at a level which is reasonable in relation to the community needs, as determined through the community needs assessment, the available resources of the hospital or hospital system, and the tax-exempt benefits received by the hospital or hospital system; 
(B)  charity care and government-sponsored indigent health care are provided in an amount equal to at least 100 percent of the hospital's or hospital system's tax-exempt benefits, excluding federal income tax;  or 
(C)  charity care and community benefits are provided in a combined amount equal to at least five percent of the hospital's or hospital system's net patient revenue, provided that charity care and government-sponsored indigent health care are provided in an amount equal to at least four percent of net patient revenue. 
The statutes aren't perfect. They are written so that, with enough uncompensated care provided to Medicaid patients, a hospital (in theory) could meet any of the three standards with no charity care whatsoever. In addition,  with careful planning most nonprofit community hospitals can meet one of these standards, and both statutes provide for fairly generous exceptions to the three measures. For example, a recent study concluded that nonprofit hospitals in Texas provide charity care at a level approximately equal to 60% of the value of their tax exemption. Part of the problem is the extremely limited enforcement procedures and budget. And the root of the entire problem is that very few health systems have the level of excess income to do more than put a dent in their community's need for charity care. Medicaid meets some of that need, but most state Medicaid programs are underfunded.

Thursday, November 07, 2024

Tax-Exempt Hospitals & Charity Care: A Mixed Bag

Health Affairs just published (and re-published) a few articles on this topic. Their titles pretty much tell the whole story (but here are links so you can read them yourself):

Although some commentators insist that the provision of charity care is a requirement for obtaining and maintaining federal tax-exempt status, I think that's a serious misreading of § 501(r) of the Internal Revenue Code, which was added to the Code by the Affordable Care Act in 2010. Yes, the Code now requires tax-exempt hospitals to formulate, adopt, and widely publicize a financial assistance policy ("FAP"). But the minimum requirements for the FAP merely include the following: "Eligibility criteria for financial assistance, and whether such assistance includes free or discounted care" (emphasis added). 

  1. It is at technically correct that an FAP may not provide for free or discounted care. A wise hospital administrator should probably avoid this option, but it is available. Charity care is still an audit item, even if it is not required, and it's an important part of a hospital's connection to the community it serves.
  2. The FAP's eligibility criteria my be written in such a manner that little or no financial assistance is actually provided. Failure to meet the community need for health care requires an explanation, but it does not appear to be a basis for the revocation of tax-exempt status.
  3. Discounted care alone would also satisfy the requirements of the FAP. So, presumably, would be a low- or no-interest loan program. Again, § 501(r) does not require the provision of any level of charity care; prudence does, but not the IRC. 
  4. The IRS's 63-page final rule to implement the ACA's Community Health Needs Assessment mention charity care in exactly one paragraph of the rule's preamble, and it's in the discussion of the administrative burden on hospitals that have to implement the final rule's requirements. 
None of this is to say that the governing legal standard for federal tax-exempt status ("community benefit") doesn't include charity care. It does; it's just not required. The requisite level of "community benefit" can be satisfied without it, as long as other forms of community benefit (education, training, research, etc.) are deemed to be adequate. 

Many if not most communities in this country have some level of need for charity care. Section 501(r) requires that the level of need be documented along with an exempt hospital's efforts to meet that need. Unfortunately, reporting does not mean the same as providing. Maybe someday it will, but not yet.