US Department of Justice sends a strong message that it will continue to root out fraud involving clinical laboratory owners and operators
Arkansas clinical laboratory owner/operator Billy Joe Taylor has been sentenced to 15 years in federal prison and ordered to pay nearly $30 million in restitution, according to a June 8 press release from the US Attorney’s Office for the Western District of Arkansas.
Taylor pleaded guilty in October of 2022 to conspiracy to commit fraud and money laundering. He and his accomplices submitted $134 million in false or fraudulent claims to Medicare before and during the COVID-19 pandemic.
The claims came from five laboratory companies owned and operated by Taylor and his co-conspirators. All claims centered around respiratory illness tests or urine drug tests that were either not medically necessary or not ordered by medical providers, the DOJ’s press release states.
Taylor’s 15-year sentence in federal prison and huge restitution reinforces the fact that the federal Department of Justice (DOJ) will indict—and convict—owners and managers of clinical laboratory companies accused of healthcare fraud.
Billy Joe Taylor, owner/operator of five clinical laboratories in four states, was sentenced in June to 15 years in prison and ordered to repay nearly $30 million in fraudulent test claims made to Medicare prior to and during the COVID-19 pandemic. This conviction is part of an ongoing campaign against healthcare fraud being conducted by the US Department of Justice. (Photo copyright: Arkansas Democrat-Gazette.)
Details of Taylor Fraud Case
Taylor allegedly obtained private personal and medical data from Medicare beneficiaries and then used that information to submit and resubmit claims to Medicare for diagnostic tests. More than $38 million was received from Medicare on those fraudulent claims, the DOJ noted.
In 2021, Taylor claimed innocence and told Arkansas Business that the accusations were “sensationalism-type claims from the government that were completely erroneous and false.”
As a young man, Taylor planned to go into the clinical laboratory field when he was still in high school. He got started by volunteering at his hometown hospital in Stigler, Oklahoma, the Free Library reported. Eventually hired by the hospital to draw blood, run tests, and keep quality control and inspection data, Taylor later moved to other hospitals before partnering in 2009 to start Advanced Laboratory Services (ALS) of Oklahoma City, Oklahoma.
A pulmonary embolism and stroke forced Taylor to sell his share in ALS, and not long after returning as a consultant, his business partner sold the lab company. Taylor joined two people from a Tulsa laboratory to start a new company, acquiring Medtest Laboratories LLC of Hurricane, West Virginia, and Vitas laboratory LLC in 2017. He hoped to compete with national laboratories, earning up to $2 million per month, the Free Library reported.
Other Clinical Laboratory Testing Fraud Schemes
The DOJ’s aggressive efforts to crack down on healthcare fraud over the past years have produced multiple court cases against clinical laboratory owners, managers, and the doctors who conspire with them. Dark Daily has covered such fraud cases in numerous ebriefings over the years.
In 2021, the DOJ’s Healthcare Fraud Unit brought “criminal charges against 14 defendants, including 11 newly-charged defendants and three who were charged in superseding indictments, in seven federal districts across the United States for their alleged participation in various healthcare fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings,” a DOJ press release announced.
In a statement to the press, Deputy Attorney General Lisa O. Monaco said, “The multiple healthcare fraud schemes charged today describe theft from American taxpayers through the exploitation of the national emergency … These medical professionals, corporate executives, and others allegedly took advantage of the COVID-19 pandemic to line their own pockets instead of providing needed healthcare services during this unprecedented time in our country.
“We are committed to protecting the American people and the critical healthcare benefits programs created to assist them during this national emergency, and we are determined to hold those who exploit such programs accountable to the fullest extent of the law,” she added.
Monaco’s statement emphasizes the DOJ’s expanding focus on healthcare fraud. The DOJ formed the Health Care Fraud Strike Force in 2007 to handle cases like Taylor’s. The program is composed of 15 teams operating out of 25 federal districts. During the 15 plus years the Strike Force has been active, the DOJ has charged more than 5,000 defendants who collectively billed over $24 billion to both private insurers and federal healthcare programs.
Therefore, it behooves clinical laboratory managers to ensure all lab operations are well-within the bounds of legality. The DOJ is taking its hunt for healthcare fraudsters quite seriously.
Federal prosecutors build the new healthcare-related fraud cases on previous nationwide enforcement actions from 2022
Federal charges have once again been brought against a number of physicians and clinical laboratory owners in what the US Department of Justice described as the “largest ever” coordinated nationwide law enforcement effort against COVID-19 pandemic-related healthcare fraud.
In total, the DOJ filed criminal charges against 18 defendants in five states plus the territory of Puerto Rico, according to an April 20 press release.
The highest dollar amount of these frauds involved ENT physician Anthony Hao Dinh, DO, who allegedly defrauded the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program for millions of dollars, and Lourdes Navarro, owner of Matias Clinical Laboratory, for allegedly “submitting over $358 million in false and fraudulent claims to Medicare, HRSA, and a private insurance company for laboratory testing” while performing “COVID-19 screening testing for nursing homes and other facilities with vulnerable elderly populations, as well as primary and secondary schools,” the press release states. Both court cases are being conducted in Southern California courtrooms.
The DOJ’s filing of charges came rather speedily, compared to other cases involving fraudulent clinical laboratory testing schemes pre-pandemic. The amount of money each defendant managed to generate in reimbursement from the fraud represents tens of thousands of patients. If feds were paying $100 per COVID-19 test, then the $153 million represents 153,000 patients, in just 18 to 24 months.
“Today’s announcement marks the largest-ever coordinated law enforcement action in the United States targeting healthcare fraud schemes that exploit the COVID-19 pandemic,” said Assistant Attorney General Kenneth A. Polite, Jr. (above), in an April 20 DOJ press release. “The Criminal Division’s Health Care Fraud Unit and our partners are committed to rooting out pandemic-related fraud and holding accountable anyone seeking to profit from a public health emergency.” Clinical laboratory managers may want to pay close attention to the DOJ’s prosecution of these newest cases of alleged COVID-19 fraud. (Photo copyright: Department of Justice.)
Prosecutors allege that Navarro and her husband, Imran Shams, who operated Matias—also known as Health Care Providers Laboratory—perpetrated a scheme to perform medically unnecessary respiratory pathogen panel (RPP) tests on specimens collected for COVID-19 testing, even though physicians had not ordered the RPP tests and the specimens were collected from asymptomatic individuals.
In some cases, the indictment alleges, Navarro and Shams paid kickbacks and bribes to obtain the samples.
The indictment notes that reimbursement for RPP and other respiratory pathogen tests is generally “several times higher” than reimbursement for COVID-19 testing. Claims for the tests were submitted to Medicare and an unidentified private insurer, as well as the HRSA COVID-19 Uninsured Program, which provided support for COVID-19 testing and treatment for uninsured patients.
Claims to the HRSA falsely represented that “the tested individuals had been diagnosed with COVID-19, when in truth and in fact, the individuals had not been diagnosed with COVID-19 and the tests were for screening purposes only,” the First Superseding Indictment states.
The indictment further states that both Navarro and Shams had previously been barred from participating in Medicare and other federal healthcare programs due to past fraud convictions. Navarro, the indictment alleges, was reinstated in December 2018 after submitting a “false and fraudulent” application to the HHS Office of Inspector General.
It also alleges that Navarro and Shams concealed their ownership role in Matias so the lab could maintain billing privileges.
More Alleged Abuse of HRSA Uninsured Program
In a separate case, Federal prosecutors alleged that Anthony Hao Dinh, DO, an ear, nose, and throat physician in Orange County, California, engaged in a scheme to defraud the HRSA COVID-19 Uninsured Program as well.
Dinh, prosecutors allege, “submitted fraudulent claims for treatment of patients who were insured, billed for services that were not rendered, and billed for services that were not medically necessary.”
The criminal complaint, filed on April 10, alleges that Dinh submitted claims for approximately $230 million, enough to make him the program’s second-highest biller. He was paid more than $153 million, prosecutors allege, and “used fraud proceeds for high-risk options trading, losing over $100 million from November 2020 through February 2022,” states the US Attorney’s Office, Central District of California press release.
Dinh was also charged for allegedly attempting to defraud the federal Paycheck Protection Program (PPP) and Economic Injury Disaster Loan (EIDL) program. He faces a maximum sentence of 50 years in federal prison, the press release states.
Dinh’s sister, Hang Trinh Dinh, 64, of Lake Forest, California, and Matthew Hoang Ho, 65, of Melbourne, Florida, are also charged in the complaint, the Los Angeles Times reported.
Both of these cases are notable because of the size of the fraud each defendant pulled off involving COVID-19 lab testing. Clinical laboratory managers may want to review the original court indictments. The documents show the brazenness of these fraudsters and detail how they may have induced other doctors to refer them testing specimens.
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Insurers from three states claim pandemic start-up medical lab company charged as much as $979 for SARS-CoV-2 PCR test
In an unprecedented move, Blue Cross insurers in three states are suing a clinical laboratory company in Nebraska for test price gouging during the COVID-19 pandemic. The lawsuit claims that the lab company charged as much as 10 times more than other labs for similar tests.
The interesting twist to the pricing aspect of this story is that the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) requires insurers to pay the full publicly-posted cost of COVID-19 testing. This means that, in many cases, the insurers may have no choice but to pay.
Is GS Labs, which was formed by an investment firm in the early months of the COVID-19 pandemic, yet another example of unscrupulous clinical laboratory operators taking advantage of the demand for COVID-19 testing during the early years of the coronavirus pandemic? GS Labs says no. The courts will decide.
Taken from the Premera Blue Cross court documents, the chart above shows GS Labs’ test prices compared with Medicare reimbursement rates. “As demonstrated by the following chart, the prices GS Labs charges insurers for COVID-19 testing well exceed the reimbursement rates set by Medicare Administrative Contractors, and in some cases are nearly ten times Medicare rates,” Premera states in the documents. Nevertheless, the federal CARES Act requires insurers to pay any COVID-19 test price a clinical laboratory posts publicly on its website. (Graphic copyright: Premera Blue Cross.)
Responding to Nationwide Demand for COVID-19 Testing
In October 2020, GS Labs began offering COVID-19 tests to provide Omaha residents with “convenient and quick testing options with same-day appointments and same-day results,” according to the company’s website. In response to nationwide demand, GS Labs quickly opened more than 20 testing COVID-19 testing sites across multiple states in its first three months of operations.
Today, GS Labs operates 14 rapid COVID testing locations in Iowa (1), Minnesota (6), Nebraska (1), Oregon (1) and Washington (5), but is under fire in several states for alleged price gouging.
Blue Cross Blue Shield of Kansas City was the first insurer to file suit in July 2021, alleging unreasonable reimbursement rates. The Kansas City Business Journal reported that GS Labs responded with a counter suit a month later accusing Blue KC of a “reckless disregard for the law” and attempting to bully its way out of paying for $9.7 million in COVID-19 testing fees.
The CARES Act states that, in the absence of a contractual payment agreement, insurers are required to pay the “cash prices” testing providers post on their public websites.
Christopher Erickson, a GS Labs Partner, told The New York Times (NYT), the law is on GS Labs’ side. “Insurers are obligated to pay cash price, unless we come to a negotiated rate,” he said.
In the fall of 2021, Premera Blue Cross also filed suit in Washington state alleging the lab routinely uses deceptive practices to run multiple unnecessary COVID tests on patients at an inflated cost. “In the words of one former employee, it ‘manipulates people into thinking they need all three COVID [sic] test’ that GS Labs offers, such that ‘[p]atients are being lied to just so th[e] company can make a profit,’” court documents state.
Premera also alleges in its lawsuit that GS Labs failed to report test results in a timely manner and returned hundreds of tests that were “by its own admission, tainted by “deviat[ions] from applicable laboratory standards for testing facilities.”
“This is fraud, and it’s fraud against Premera, it’s fraud against the industry, and more importantly, it’s fraud against the customers,” Courtney Wallace, DNP, Premera’s Director of Strategic Communications, told Washington State Wire.
And earlier this year, Blue Cross Blue Shield of Minnesota sued GS Labs to recover more than $10 million in over payments made since the start of the pandemic. A BCBS of Minnesota new release states that GS Labs “consistently charged more than five times the median market rate for its most commonly administered COVID-19 diagnostic test.”
CMS Inspection Finds GS Labs Site Posed “Immediate Jeopardy”
APM Reports spent nearly a year investigating the startup lab. Its team of journalists interviewed more than 65 GS Labs customers, former employees, and public health professionals, and reviewed thousands of pages of public documents. It concluded the lab “at times delivered inaccurate results, faced backlogs, charged high prices, and pushed customers into unnecessary tests.”
The APM Reports investigators found:
The company was slow to inform public health officials in several states about positive cases and in a few instances reported negative results to patients who had COVID-19. Other patients never received test results or received someone else’s results.
Overwhelmed by the number of tests it was processing, GS Labs at one point had a month-long backlog of untested samples.
Health officials in three states found GS Labs’ work was slower and less reliable than other labs.
According to APM Reports, in an email to colleagues about flaws in GS Labs’ operation in Washington state, Melissa Pond, [then] Program Manager for Clark County Washington’s COVID-19 Response Team, wrote, “[It] makes me so angry that they brought their greed to our community. They just popped up to make money knowing they would fly under the radar as long as possible and close their doors when someone caught them!”
Providing COVID-19 Testing During a Time of Need
APM Reports noted GS Labs’ founders formed the company in the early days of the pandemic after their friends and family could not find tests following a COVID exposure.
GS Labs is a subsidiary of City+Ventures, an Omaha investment and development company. Its portfolio includes an aviation investment company, car wash chain, car dealerships, restaurants, and other businesses.
City+Ventures’ co-founders, Erickson and Danny White had no healthcare investments prior to 2020, APM Reports noted. But early that year, the two men had joined with Gabe Sullivan and Darin Jackson, MD, who currently owns Prestige Medical Laser Solutions in Omaha, to create a men’s health and anti-aging company called 88MED. During the pandemic, that company transitioned to COVID-19 testing and was renamed GS Labs.
It is worth noting that GS Labs responded at length and in detail to the questions raised by the APM Reports investigation. It is useful reading for clinical laboratory leaders who wish to be fully informed on both sides of the controversy.
In its rebuttal, the company pointed out it had processed more than 2.1 million tests nationwide with less than 1.5% of its results being called into question. It maintained “GS Labs’ policy has never been to ‘push’ tests on anyone” and stated its cash prices “were higher than some testing providers,” but “lower than others” and reflected the company’s significant start-up costs.
GS Labs wrote, “At a time when our communities desperately needed increased COVID testing capacity, GS Labs took action to deliver that testing, investing more than $150 million in a business whose prospective success and lifespan were extremely uncertain. By filling a critical gap in COVID testing, GS Labs literally saved lives, and we are extremely proud of the service that we have provided to the communities we serve.”
GS Labs also has countersued BCBS of Minnesota, denying all prior allegations made by the insurer and alleging 21 counter claims.
Sabrina Corlette, JD, Research Professor and Project Director at Georgetown University Center on Health Insurance Reforms, has studied coronavirus testing prices. She told the NYT, “This is not like neurosurgery where you might want to pay a premium for someone to have years of experience.” She pointed out the CARES Act may provide GS Labs with the legal grounds to charge above market prices.
“Whatever price the lab puts on their public-facing website, that is what has to be paid,” she said.
GS Labs may have found a legal loophole to justify its sky-high COVID-19 testing prices, but consumers may view this behavior by a clinical laboratory company as unethical and yet another reason to be disillusioned with America’s healthcare system.
No explanation for the delay was provided by court after nine weeks of testimony in the prosecution of the former clinical laboratory executive
Former Theranos president/chief operating officer Ramesh “Sunny” Balwani’s often-delayed fraud trial was scheduled to resume on May 27 with a full day of defense witness testimony. It will now be delayed until June 7.
According to NBC Bay Area, a court assistant announced the delay but did not provide a reason for the postponement. A copy of the clerk’s notice posted on Twitter by Law360 also provided no further details. Pathologists and clinical laboratory managers must now wait several more months to learn what may be next revealed in testimony during this trial.
It is also yet one more delay in Balwani’s trial. His original trial date was January 2022 before being rescheduled for February. The needs for COVID-19 pandemic protocols further delayed the start multiple times until opening arguments began March 22 in a federal court room in San Jose, Calif.
One part of the trial has concluded. On May 20, the government rested its case against Balwani, who faces 12 counts of wire fraud and conspiracy to commit wire fraud while serving as second in command at Theranos, the now defunct Silicon Valley medical laboratory startup.
Former Theranos president and COO Ramesh “Sunny” Balwani (above) faces 12 charges of wire fraud and conspiracy to commit wire fraud while serving as chief operating officer of Theranos, the company that boldly declared it would disrupt the clinical laboratory testing industry. His trial, which began in March in US District Court in San Jose, Calif., is now delayed until June 7, when his defense attorneys will begin their first full day of witness testimony. (Photo copyright: Stephen Lam/Reuters/The New York Times.)
According to The Wall Street Journal (WSJ), nine weeks of testimony in US District Court in San Jose, Calif., included testimony from 24 witnesses. Prosecutors aimed to convince jurors Balwani controlled much of the day-to-day decision-making at Theranos and was a full participant in the fraud scheme.
NBC Bay Area stated prosecutors worked to link Balwani to two key decisions:
The rollout of the failed Edison blood testing device in Walgreens, and
The company’s improper use of the Pfizer logo on a report to Walgreens executives that appeared to validate Theranos’ technology.
Before this latest postponement, Balwani’s attorneys had begun their client’s defense by putting a naturopathic physician from Arizona on the stand. The witness testified to sending more than 150 patients to Theranos and to using the company’s blood tests for herself, the WSJ reported.
Bloomberg reported that prosecutors followed the previous outline used to gain the conviction of Elizabeth Holmes, founder and former CEO of Theranos, with many of the same witnesses from her trial reappearing on the stand to testify in the Balwani trial.
Prosecutors primarily focused their case on the injury to investors, which has angered some former Theranos customers.
“I feel like I belong to a group of people who were on the receiving end of a crime,” said Erin Tompkins—a Theranos customer who testified against both Holmes and Balwani—outside the courthouse shortly after finishing her testimony in the Balwani case, Bloomberg reported.
According to CNBC, Tompkins testified she was misdiagnosed as having HIV after having her blood drawn from a Theranos device at a Walgreens in Arizona.
“Despite the dedication and support of prosecutors, patient witnesses have been treated as peripheral” compared to the investors, Tompkins told Bloomberg. “We were defrauded because we trusted them with our blood and however many dollars for the test. But we weren’t robbed of millions of dollars.”
Susanna Stefanek, editorial manager at Apple Inc. who served on the Holmes jury, told Bloomberg, “[The prosecution] didn’t really prove that these patients were persuaded to get these blood tests by something she said or did, or even the advertising. The connection between Elizabeth Holmes and the patients was not that strong to us.”
Proving Patient Fraud
Michael Weinstein, JD, a former federal prosecutor turned Chair of White-Collar Litigation and Government at Cole Schotz in New Jersey, told Bloomberg that to convict Balwani of patient fraud, prosecutors must prove Balwani knew what was going on inside Theranos and that his misrepresentations caused patients to suffer.
“The government wants to show there was an inconsistency between what he was learning internally versus what he was saying externally,” Weinstein said.
With the Balwani trial likely to conclude this month, clinical laboratory directors and pathologists who have closely followed Theranos’ rise and fall should prepare for the final chapter in the saga.
