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.