Tag: 2021 News

A strategically coordinated, six-week nationwide federal law enforcement action has resulted in criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals, in 31 federal districts across the United States for their alleged participation in various health care fraud schemes that resulted in approximately $1.4 billion in alleged losses.

The enforcement action includes criminal charges against four defendants in the Southern District of California, involving more than $129 million in intended losses.

Nationwide, this action includes more than $1.1 billion in fraud committed using telemedicine, more than $29 million in COVID-19 health care fraud, more than $133 million connected to substance abuse treatment facilities, or “sober homes,” and more than $160 million connected to other health care fraud and illegal opioid distribution schemes across the country

Telemedicine Fraud Cases – The largest amount of alleged fraud loss charged in connection with the announced  – over $1.1 billion in allegedly false and fraudulent claims submitted by more than 50 criminal defendants in 11 judicial districts nationwide – relates to schemes involving telemedicine: the use of telecommunications technology to provide health care services remotely.

COVID-19 Fraud Cases – Nine defendants are alleged to have engaged in various health care fraud schemes designed to exploit the COVID-19 pandemic, which resulted in the submission of over $29 million in false billings.

In the Southern District of California, Roselia Kubeck and Rosario Gonzalez pleaded guilty to having approached residents of senior complexes in El Centro and Calexico, California, who were Medicare beneficiaries, and offering COVID-19 screening tests for the residents. The defendants knew at the time that the tests would not actually test for COVID-19 but would be a general respiratory pathogens screening panel that tested for the presence of several kinds of respiratory pathogens. They also took urine samples from the Medicare beneficiaries without explaining that the urine samples were not necessary to conduct a COVID-19 test. The defendants then completed requisition forms for tests on the nasal swabs and urine samples, and inaccurately indicated on the forms that the beneficiaries needed the respiratory tests because they were suffering from acute respiratory infections and needed urine tests because the beneficiaries were long-term users of opiates or had urinary tract infections. The laboratories that performed the tests subsequently submitted inaccurate and medically unnecessary claims to Medicare based on the inaccurate diagnoses that the defendants put on the requisition forms.

Sober Homes Cases – The sober homes cases are announced on the one-year anniversary of the first ever national sober homes initiative in 2020, which included charges against more than a dozen criminal defendants in connection with more than $845 million of allegedly false and fraudulent claims for tests and treatments for vulnerable patients seeking treatment for drug and/or alcohol addiction. The over $133 million in false and fraudulent claims that are additionally alleged in cases just  announced reflect the continued effort by the National Rapid Response Strike Force and the Health Care Fraud Unit’s Los Angeles Strike Force, with the participation of the U.S. Attorney’s Offices for the Central District of California and the Southern District of Florida, to prosecute those who participated in illegal kickback and bribery schemes involving the referral of patients to substance abuse treatment facilities; those patients could be subjected to medically unnecessary drug testing – often billing thousands of dollars for a single test – and therapy sessions that frequently were not provided, and which resulted in millions of dollars of false and fraudulent claims being submitted to private insurers.

Cases Involving the Illegal Prescription and/or Distribution of Opioids and Cases Involving Traditional Health Care Fraud Schemes

In the Southern District of California, Ronald Charles Green Jr. and Melinda Elizabeth Green were charged with conspiring to defraud TRICARE and Medicare out of more than $129 million. In connection with a compounding pharmacy fraud, the defendants allegedly engaged in a scheme involving the submission of false and fraudulent claims to TRICARE for expensive and medically unnecessary pain creams, scar creams and multi-vitamins, which were billed through compound pharmacies. Thereafter, the defendants allegedly launched multiple durable medical equipment companies, and carried out a scheme to defraud Medicare through the submission of false and fraudulent claims for expensive durable medical equipment which were induced through a system of illegal kickbacks. Out of the $129 million in claims, Medicare paid the defendants’ companies more than $69 million.

Prior to the charges announced as part of the nationwide enforcement action and since its inception in March 2007, the Health Care Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,600 defendants who have collectively billed the Medicare program for approximately $23 billion.

The delta variant of the coronavirus roared into California midsummer, striking hard even in places where many people were vaccinated. Cases spiked. Hospitals again began to swell with patients. The daily death toll climbed into the triple digits for the first time in months.

But after a season in which the highly transmissible variant wreaked havoc on the nation, the Washington Post reports that California is reporting sustained progress against delta. And this is also good news for workers’ compensation claims in the state.

Earlier this week, California dropped from “high” to “substantial” virus spread, according to the Centers for Disease Control and Prevention. It later bounced back up, but total new cases per 100,000 residents are still lower than any other state. The change in CDC designation – a barometer of how well states are doing in combating the virus – was celebrated by public health officials, who suggested it was a signal that California could be close to a turning point.

An aggressive push for vaccines, coupled with masks mandates at the local level and a public largely willing to go along with them, appear to have helped flatten the state’s curve, experts said.

“California, as compared to many other states in the nation, took rapid steps to recognize the extent of the problem and to apply more covid control measures,” said Robert Kim-Farley, a infectious-disease expert at UCLA Fielding School of Public Health. “I think if California had not taken these steps to curb transmission, we could have ended up with much higher levels.”

The fight against delta is far from over in the Golden State, which still faces a host of challenges in containing cases. Though infections have dropped in California’s population hubs in recent weeks, they remain high in parts of the Central Valley and rural north. An influx of patients has overwhelmed some intensive care units in those regions.

Compounding the problem, California hospitals are facing staffing shortages. Medical workers have struggled with burnout, and surges in other states have created intense competition for nurses, said Bryan Bucklew, president and chief executive of Hospital Council of Northern & Central California, a nonprofit trade association.

“The numbers may be flattening, but the impact to the health-care system is extremely challenging,” he said. “We have a good handle on how to treat covid, with monoclonal antibodies, vaccines. We just have a lot less staff. It’s more of a workforce issue for us than a covid issue.”

Statewide, infections are still far higher than they were early in the summer, averaging about 9,300 new cases per day compared with 758 on July according to tracking by The Washington Post.

But they’re down from a summer peak of about 14,400 per day on average, the data shows. Hospitalizations have fallen statewide by about 10 percent over the past week. Positivity rates have also dropped recently, at a time when the state is administering more tests than at almost any point in the pandemic – another indicator that the spread is slowing.

At its worst point over the summer, cases per 100,000 people in California rose to about 35 per day on average, according to The Post’s analysis of state data. In Florida, where the governor has sought to ban public health mandates, per capita cases topped 100 during the peak of infections, and in Texas they’ve hovered around 60 for weeks, the data shows.

As of Thursday, California had 24 cases per 100,000 residents, less than half as many as Florida, with 55 per capita, and Texas with 59, according to The Post’s data.

John Swartzberg, an infectious-disease expert at the University of California at Berkeley, said California has benefited from a population that’s generally receptive to public health directives. He said the attitude was rooted in the public health response to the AIDS crisis in the early 1980s.

Back in 2019, Governor Gavin Newsom signed Assembly Bill 51 (Cal. Lab. Code §§ 432.6(a)–(c), 433; Cal. Gov’t Code § 12953), which effectively outlawed mandatory arbitration agreements with employees – a new version of a bill that prior Governor Jerry Brown had vetoed repeatedly while he was in office.

The law allows workers to pursue damages and attorneys’ fees and open criminal cases against employers who discriminate and retaliate against them for declining arbitration contracts.

The contentious bill bars employers from requiring applicants to waive their right to sue under state labor laws as a condition of employment. Going a step further, the bill sponsored by the California Labor Federation and Consumer Attorneys of California opened employers up to civil and criminal penalties for extreme violations.

A federal judge enjoined the state from enforcing Assembly Bill 51 last year, agreeing with the Chamber of Commerce and other employers that it was pre-empted by the Federal Arbitration Act. The decision was hailed by the coalition of business groups who accused California lawmakers of trying to weaken the common tool used to keep employment disputes out of the courts.

In the case of Chamber of Commerce v Rob Bonta, the Attorney General of the State of California, the Ninth Circuit panel ruled in a 2-1 decision, that the state can require all employment arbitration agreements be consensual and reversed the preliminary injunction. It found AB 51 doesn’t discriminate against arbitration agreements or nix their enforcement.

“In light of Congress’ clear purpose to ensure the validity and enforcement of consensual arbitration agreements according to their terms, it is difficult to see how [AB 51], which in no way affects the validity and enforceability of such agreements, could stand as an obstacle to the FAA,” U.S. Circuit Judge Carlos Lucero, a Bill Clinton appointee sitting by designation from the 10th Circuit, wrote for the majority.

U.S. Circuit Judge Sandra Segal Ikuta, a George W. Bush appointee, wrote a dissenting opinion. She commenced her dissent by claiming “Like a classic clown bop bag, no matter how many times California is smacked down for violating the Federal Arbitration Act (FAA), the state bounces back with even more creative methods to sidestep the FAA”.

“And today the majority abets California’s attempt to evade the FAA and the Supreme Court’s caselaw by upholding this anti-arbitration law on the pretext that it bars only nonconsensual agreements. The majority’s ruling conflicts with the Supreme Court’s clear guidance in Kindred Nursing Centers Ltd. Partnership v. Clark, 137 S. Ct. 1421, 1428–29 (2017), and creates a circuit split with the First and Fourth Circuits. Because AB 51 is a blatant attack on arbitration agreements, contrary to both the FAA and longstanding Supreme Court precedent, I dissent. “

According to a report in Courthouse News, the Chamber of Commerce signaled it could appeal.

“The majority decision is clearly wrong, violates U.S. Supreme Court precedent and runs contrary to decisions of many other courts,” said Daryl Joseffer, chief counsel for the chamber, in an email. “The U.S. Chamber will pursue further review of this flawed decision.”

Earlier this summer, the California Supreme Court declined to add a third exception to the Privette rule, and thus reversed the Court of Appeal n the case of Gonzalez v Mathis. A month later, it reviewed the rule once again, and reversed a multi-million dollar jury verdict against Qualcomm.

In this new case, Qualcomm planned to upgrade its onsite turbine generators at its San Diego campus in 2013. In order to accommodate this upgrade, Qualcomm hired TransPower Testing, Inc., an electrical engineering service company, to inspect and verify the amperage capacity of Qualcomm’s existing switchgear equipment.

Frank Sharghi, TransPower’s president, is a licensed electrical engineer and had worked on that switchgear at least monthly for nearly 20 years, since before Qualcomm acquired the campus.

After Sharghi was unable to locate some of the busbars in the “main cogen: circuit during one inspection, Sharghi hired Jose M Sandoval – an electrical parts supply and repair specialist with ROS Electrical Supply & Equipment – to accompany him at a second inspection.

For this second inspection, Qualcomm approved a scope of work authorizing TransPower to inspect the main cogen circuit from the front and back.On the morning of the second inspection, the team attended a safety briefing led by Qualcomm plant operator, and the team was reminded that some circuits in the switchgear would remain live.

At some point during this inspection, Sandoval walked away from the rest of the TransPower team. Sandoval would later recall that he was having trouble judging the size of some of the main cogen busbars from the front side of the cabinet, and he thought he might be able to get a better view from the back.

Sandoval asked a fellow worker to hold a flashlight as they both approached the back side of the cabinets. Sandoval was holding a metal tape measure which triggered an arc flash from the live, exposed circuit. The 4,160-volt arc flash – thousands of degrees in temperature – had set him aflame, and he suffered serious injury.

Sandoval filed suit against Qualcomm, TransPower, and ROS Electrical Supply, asserting claims for negligence and premises liability. Qualcomm moved for summary judgment on the basis that the presumption of delegation should shield it from liability here. Denying the motion, the trial court proceeded to trial, and a jury awarded Sandoval over $1 million in past and future medical expenses and $6 million in noneconomic damages. It apportioned the fault 46 percent to Qualcomm, 45 percent to TransPower, and 9 percent to Sandoval.

The Court of Appeal affirmed. However the California Supreme Court reversed in the case of Sandoval v Qualcomm.

“Strong public policy considerations readily acknowledged in our past decisions generally support a straightforward presumption about the responsibilities of hirers and contractors for worker injuries in situations like this: A person or entity hiring an independent contractor (a “hirer”) ordinarily delegates to that independent contractor all responsibility for the safety of the contractor’s workers.”

“This presumption is rooted in hirers’ reasons for employing contractors in the first place, and society’s need for clear rules about who’s responsible for avoiding harms to workers when contractors are hired.”

Thus the Supreme Court concluded “that defendant Qualcomm Incorporated, the hirer in this case, owed no tort duty to plaintiff Martin Sandoval, the parts specialist working for Qualcomm’s contractor, at the time of Sandoval’s injuries.”

The U.S. Food and Drug Administration’s announced that it had granted “full approval” to the Covid shots being offered by Pfizer.  But to be clear, what was actually given full approval was a separate Pfizer-BioNtech vaccine product which goes by the name Comirnaty. But Comirnaty is not currently available in the U.S.

The 13-page “approval letter” is addressed to BioNTech Manufacturing GmbH and Pfizer Inc. in New York City, and approves a biologics license application (BLA) for BioNTech Manufacturing GmbH in Mainz, Germany, for COMIRNATY.

Then a letter to Pfizer Inc. on the same date states: “FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.”

Footnote 8 reads: “The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

The “certain differences”are not specified, but it is perfectly clear that the two products are legally distinct.  An analysis by the Association of American Physicians and Surgeons notes these differences and concludes that “It appears that there are two legally distinct if otherwise mostly identical products. The remaining doses of the ‘Pfizer-BioNTech COVID-19 vaccine’ are still under an EUA and are not fully licensed.“

As of this date, the FDA has not approved the non Cominaty branded vaccine such as the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.

The FDA acknowledges that while Pfizer has insufficient supplies of the newly licensed Comirnaty vaccine actually available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine – which has been produced under Emergency Use Authorization (EUA) and will continue to be offered under the same EUA status.

EUA-licensed vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

Phizer’s Cominaty vaccine likely does not have that liability protection for Pfizer. The abundant U.S. supply of EUA authorized Pfizer-BioNtech vaccine product does protect Pfizer. Instead, the government has created a comparatively stingy compensation program, the Countermeasures Injury Compensation Program, – compared to tort law – to redress injuries from all EUA products.

For purposes of an informed consent, those choosing to take either vaccine should be advised that an unprecedented number of lethal or serious adverse effects have been reported to the Vaccine Adverse Events Reporting System (VAERS).

The FDA-approved package insert for Comirnaty reads: “13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.” It mentions one study in female rats. The package inserts warns of myocarditis, but omits mention of Guillain-Barré syndrome, thrombotic complications, and other serious events.

Now the thorny issues. Can an employer mandate that employee’s take a vaccine that is “legally distinct” from the approved Cominaty product made by Pfizer? And if they do, does that bring any potential side-effect related problem within the workers’ compensation system?

Federal Regulations provide that no one can force a human being to take an EUA drug. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” parties need to be informed of their “option to accept or refuse administration of the product.”  What is also not clear is if the employer’s vaccine mandate under threat of termination interferes with this right.