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. 

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. 

Health Care Fraud: Texas Style

On Oct. 15 a federal jury in Houston convicted the owner of a firm that operated 14 pharmacies, on fifteen counts including conspiracy to commit mail fraud, conspiracy to violate the anti-kickback statute, bribery concerning programs receiving federal funds, conspiracy to commit bribery, five counts of healthcare fraud, and six counts of money laundering, resulting in $160 million in fraudulent claims that were paid by Medicare. 

As described by the Office of the U.S. Attorney for the Southern District of Texas:

From 2014 through 2021, Mohamad Mokbel led a company called 4M Pharmaceuticals which operated 14 pharmacies with straw owners. The jury heard evidence that Mokbel illegally purchased thousands of Medicare beneficiaries, including their identification number, personal health and physician information. Mokbel targeted elderly diabetic patients who are dependent on diabetic testing supplies to manage their blood sugar levels. Mokbel paid $16 to $40 per Medicare beneficiary.  

To maximize reimbursements and without regard for medical necessity, Mokbel then directed 4M employees to use the Medicare beneficiaries’ patient data to run insurance claims to determine if Medicare or other insurance plans would cover and reimburse at a high rate for the topical creams, Omega-3 pills and other medications that Mokbel intended to sell through 4M pharmacies.

At Mokbel’s direction, 4M employees would then fax pre-filled prescription requests to the patients’ doctors appearing to be for diabetic testing supplies with topical creams added at the bottom. They also included false representations that the patient was requesting a 4M Pharmacy fill their medications. In reality, Mokbel had previously purchased the patient’s personal information, the patient had not selected a 4M Pharmacy and the patient was often unaware the request was being made on their behalf. 

Many doctors apparently took the representations in the fax at face value and did sign and send back the prefilled prescription requests to 4M. Mokbel’s call center in Houston and later in Egypt then contacted the patients and made false and misleading statements about the topical cream and their doctor’s order. Mokbel’s pharmacies then shipped out numerous topical creams, often on auto-refill, and excessively billed Medicare, Medicaid and private insurance plans. 

Mokbel made over $200 million as a result of the scheme. 

The money value of the fraud is considerably less than the record for Medicare fraud, but what caught my eye was the complexity of the scheme and the lineup of law-enforcement agencies involved in the case: Homeland Security Investigations (HSI) Houston, the FBI, IRS Criminal Investigation, the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, and the Texas Attorney General’s Medicaid Fraud Control Unit. This was a big, big deal for these investigators.

Cyber Attack on United Healthcare Division Was Unprecedented in Scope

If you've tried to fill a prescription or get preauthorization for a drug or procedure or -- if you're a health care provider -- tried to submit a bill electronically, you have experienced the widespread crippling of our healthcare infrastructure that resulted from an unprecedented cyberhack. 

As reported by KFF Health News (March 8), 

The American Hospital Association calls the suspected ransomware attack on Change Healthcare, a unit of insurance giant UnitedHealth Group’s Optum division, “the most significant and consequential incident of its kind against the U.S. health care system in history.” While doctors’ practices, hospital systems, and pharmacies struggle to find workarounds, the attack is exposing the health system’s broad vulnerability to hackers, as well as shortcomings in the Biden administration’s response.

Despite the centrality of digital record-keeping, billing, and payment systems, there turns out to be no meaningful governmental involvement in this arena.

To date, government has relied on more voluntary standards to protect the health care system’s networks, Beau Woods, a co-founder of the cyber advocacy group I Am The Cavalry, said. But “the purely optional, do-this-out-of-the-goodness-of-your-heart model clearly is not working,” he said. The federal government needs to devote greater funding, and more focus, to the problem, he said. [emphasis added]

Restoration of full operability after a cyber attack typically takes 30 days, according to Mr. Woods, which means we can all expect slower response times to virtually all requests for health-related services at least through March and probably into April. Meaningful federal action will take much, much longer.

 

Chicken Soup for COVID-19?

Earlier this week, NBC reported that the CDC is considering a substantial change to its isolation guidelines for individuals who are COVID+. Under the proposal, individuals with COVID would be allowed to re-enter society 24 hours after they are fever-free without medications. In essence, according to the report, CDC's recommendation would be to treat COVID like the flu.

Soon after the NBC story broke, an anonymous official at DHHS emphasized there is no change yet, meaning their 5-day isolation/10-day masking guideline is still in effect, at least until it isn't, pointing out that "discussions are at an early stage and no definitive decisions have been made."

Outside the Washington Beltway, support for the change seems to be building:

Dr. William Schaffner, an infectious diseases expert at Vanderbilt University Medical Center in Nashville, Tennessee, said he and his colleagues have privately encouraged the CDC to drop the five-day isolation period, in part because there’s little evidence it’s stopping the spread of Covid. 

The “rigorous recommendations that are currently in place do not reflect common practice,” Schaffner said. “It’s difficult to demonstrate that strict isolation has had a notable impact on transmission.” 

California and Oregon have already broken with the CDC, suggesting that people don't need to stay home if they've been fever-free for 24 hours without medication.

“With each day, the risk of communicability diminishes,” Schaffner said. “Public health recommendations have to be practical.” That is, people may stay home for a few days if they have a fever and feel achy and fatigued. After that, it’s back to business as usual.

Dr. David Margolius, the public health director for the city of Cleveland, said he was also in favor of easing isolation restrictions.

“For a couple years, people really associated public health with the elimination of Covid,” Margolius said. But “public health is about increasing life expectancy for our residents. It’s about improving quality of life. And that is more than just controlling one virus.”

Covid is still contagious, said Dr. Abraar Karan, an infectious disease physician at Stanford Medicine. “What the CDC and health departments are trying to say is that we need to have policies that people are going to actually follow,” Karan said.

As of this month, emergency room visits, hospitalizations and deaths from Covid are down, according to the latest CDC data.