There’s evidence that a cancer drug can cut deaths from lung cancer by as much as 50% when pathology testing indicates the patient has the EGFR mutation
Results from a decade-long clinical trial indicate that lung cancer patients with the epidermal growth factor receptor (EGFR) mutation have significantly better survival rates when treated with the drug osimertinib. This is a positive step forward for precision medicine and will give clinical laboratories an opportunity to deliver more value to physicians and patients.
The study known as ADAURA was led by scientists at Yale University and funded by British pharmaceutical/biotechnology company AstraZeneca. The researchers recently found that taking the cancer drug osimertinib (brand name Tagrisso) reduces by half the number of deaths among patients who had undergone surgery for EGFR–mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), according to NBC News.
Lung cancer has been one of the toughest types of cancers to diagnose early. When finally diagnosed, many patients do not have a good prognosis. Thus, the results of this multi-national study—and the connection involving patients with the EGFR gene—is a welcome development that promises better outcomes for cancer patients.
At the same time, this increases the value of EGFR as a biomarker for clinical laboratories and pathology groups that offer EGFR testing. It could become a companion diagnostic test—part of a clinical guideline for diagnosing lung cancer—that helps identify appropriate anti-cancer drugs for specific patients.
“Adjuvant osimertinib is currently the only EGFR tyrosine kinase inhibitor to translate a statistically significant and practice-changing disease-free survival benefit into a significant [overall survival] benefit in a phase 3 trial, supporting osimertinib as the standard of care for patients in this setting,” said Roy Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center, who led the Yale study, at the 2023 ASCO Annual Meeting, according to an ASCO news release. (Photo copyright: Yale School of Medicine.)
Identifying Best Candidates for Specific Cancer Drugs
The results of the Yale-led study of the cancer drug osimertinib suggest that testing for a mutation in the EGFR gene could become part of the standard-of-care for NSCLC. Researchers found that NSCLC patients with the mutation showed improved survival rates and reduced risk of recurrence when taking the drug following surgery. EGFR tests could thus become companion diagnostics to determine whether patients are good candidates for the drug.
“We have been using one-size-fits-all adjuvant chemotherapy for every patient with lung cancer despite a decade of advances in targeted treatments for select groups of patients that result in dramatically better outcomes,” Nathan Pennell, MD, PhD, Vice Chair of Clinical Research and Director, Lung Cancer Medical Oncology Program Cleveland Clinic Taussig Cancer Institute, told the ASCO Post.
Pennell, who was not involved in the Yale research, described the finding as “a first for the lung cancer field,” and said adjuvant osimertinib “should be the new standard of care” for patients with EGFR-mutated NSCLC.
‘Practice-changing’ Cancer Drug
The study was led by Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Assistant Dean for Translational Research at Yale School of Medicine. Herbst is the principal investigator for the ADAURA global multi-site clinical trial which enrolled 682 patients with stage IB-IIIA NSCLC, in an effort to determine the efficacy of the cancer drug osimertinib, a pill taken once a day, which, according to NBC News, has fewer major side effects than chemotherapy.
The FDA approved the drug in 2015 for patients with advanced lung cancer. In 2020, the agency approved its use at earlier stages of the disease.
The ADAURA study included patients from 26 countries across Europe, North America, South America, and the Asia-Pacific region. About half of the patients took the pill each day for three years following surgery. The other half received a placebo.
According to a Yale news release, the researchers reported that 88% of patients treated with the drug were still alive five years later, compared with 78% of patients who received the placebo.
Earlier research demonstrated that the drug prevented recurrence of tumors and kept the disease from spreading to other organs, NBC News reported. “However, what we are seeing now is that patients will also live longer,” said oncologist Charu Aggarwal, MD, MPH, of the University of Pennsylvania’s Perelman School of Medicine, who was not involved in the study.
Herbst described the drug as “practice-changing” in the Yale news story.
An EGFR ‘Off Switch’
Non-small cell lung cancer is the most common form of lung cancer, The Guardian reported, adding that the EGFR mutation “is found in about a quarter of global lung cancer cases, and accounts for as many as 40% of cases in Asia. An EGFR mutation is more common in women than men and in people who have never smoked or have been light smokers.”
The mutation can cause cells to “excessively divide and multiply, which may cause cancer,” NBC News explained. Herbst described osimertinib as an “off” switch for the mutation.
“I think we’re curing some patients,” he said at the ASCO annual meeting, NBC News reported. “We’re really showing progress in lung cancer like never before,” he noted, adding that the results were “about twice as good as we expected.
“Overall survival has historically been considered the gold standard efficacy endpoint for randomized adjuvant clinical trials. The results of the ADAURA trial will broaden treatment access for patients with EGFR-mutated NSCLC,” Herbst told ASCO Post. “Together with the practice-changing disease-free survival data from our primary analysis, the overall survival benefit instills confidence that adjuvant osimertinib is the standard of care for patients with resected EGFR-mutated stage IB to IIIA NSCLC.”
Side effects of the pill include skin rashes and mild diarrhea, but in general the drug is “quite well tolerated,” Herbst said.
Impact on Labs
In Herbst’s view, the results of the Yale study demonstrate that patients diagnosed with lung cancer should be tested for the EGFR mutation, which is not always the case, The Guardian reported. “This further reinforces the need to identify these patients with available biomarkers at the time of diagnosis and before treatment begins,” he said.
Aggarwal agreed, telling NBC News that data from the study could be a “call to action” for more EGFR screening.
In light of the results, clinical laboratories and anatomic pathology groups should expect that EGFR screening may soon become a companion diagnostic test as part of a precision medicine clinical guideline for early diagnosing of lung cancer.
This research indicates consumers could increase their demand for clinical laboratory testing for genetic risk factors associated with addiction
Rutgers University researchers recently published a study of hundreds of college students that suggests there could be high future consumer demand for genetic testing related to addiction risk. What is significant is that the college students surveyed are members of Generation Z, people born between the mid-1990s and early 2010s.
Zoomers grew up knowing about the human genome, and they are likely aware of new genetic insights, new gene therapies, and new clinical laboratory tests that analyze genomic data to diagnose disease and/or identify the individual’s predisposition to certain genetic conditions.
Thus, consumer demand among Gen Z for clinical laboratories to provide such tests in the future could drive a new class of diagnostic testing that would generate a new revenue stream for clinical laboratories, while also enabling labs to deliver a value-added service to healthcare consumers and their physicians.
“Overall, the [study] results strongly encourage the notion that real genetic risk scores may prove helpful in preventing and treating alcohol addiction,” Danielle Dick, PhD, Director of the Rutgers Addiction Research Center and lead author of the study, told Neuroscience News. The results of the Rutgers study could lead to increased demand for clinical laboratory tests to determine addiction risk. (Photo copyright: Rutgers University.)
Methodology Used in Rutgers Study
To complete their study, the Rutgers researchers surveyed 325 college students and asked how they would react to learning about genetic test results indicating their risk for alcohol use disorder. The researchers found that despite the complexity of the genetic factors underlying addiction, respondents understood the connection between genetic risk and the likelihood of developing alcoholism. And most respondents indicated they would take precautions if they learned that they were at high risk.
The research “paves the way for studies using real genetic data and for integrating genetic information into prevention and intervention efforts,” the study’s lead author, Danielle Dick, PhD, Director of the Rutgers Addiction Research Center (RARC), Greg Brown Endowed Chair in Neuroscience, and Professor, Robert Wood Johnson Medical School/Psychiatry, told Neuroscience News.
The story notes that most genes associated with addiction have only been discovered recently. Commercial genetic testing services do not provide information about addiction risk, “so very few people have ever received genuine information about their genetic tendency toward addiction,” Neuroscience News noted.
The researchers obtained their data as part of a trial that sought to evaluate “the efficacy of educational information on understanding of polygenic risk scores for alcohol use disorder,” they wrote in the American Journal of Medical Genetics.
After recruiting the study participants, the researchers randomly assigned them to one of three groups:
A control group of 109 students that received no educational information.
A group of 105 students who were directed to a website with educational information about alcohol use disorder, “including a definition, consequences, and ways to reduce risk,” the researchers wrote.
A group of 111 students who were directed to a website with the same information about alcoholism, in addition to information about the role of genetics in addiction risk. This included information about “genetic variation, risk variants, how polygenic scores are created, and how they can be interpreted,” the researchers noted.
In all three groups, the survey asked respondents to imagine three hypothetical scenarios: that they had 1) a below-average genetic risk of developing alcoholism, 2) an average risk, and 3) an above-average risk.
For each level of risk, they answered a series of questions “that assessed psychological distress, perceived chance of developing alcohol use disorder, and intentions related to seeking additional information, talking to a healthcare provider, and drinking behavior,” the researchers wrote.
Results of the Rutgers Study of Genetic Risk for Alcohol Use Disorder
The researchers found that exposure to educational information had a minimal impact on the responses, which were generally consistent across all three groups.
With higher levels of risk for alcohol use disorder, respondents were more likely to indicate psychological distress, more likely to seek additional information, more likely to talk to a healthcare provider, and more likely to change drinking behaviors.
And “as the level of genetic risk increased, the perceived chance of developing alcohol use disorder significantly increased,” the researchers wrote.
Does Learning of Risk Alter Behavior?
Citing previous research, Dick said that addiction risk is roughly half determined by genetic factors, “but there’s no single addiction gene that’s either present or absent,” Dick told Neuroscience News. “Instead, there are thousands of interacting genes, so each person’s genetic risk falls somewhere on a continuum.”
The risk is distributed on a bell curve, she said, and most people fall in the middle. But despite this complexity, “study participants formed relatively accurate impressions of the risk for addiction associated with various genetic results.”
The researchers appeared to be most encouraged that the respondents indicated a willingness to take precautionary measures if they learned they had a high genetic risk of developing alcoholism.
“There was a hope that compelling information about elevated genetic risk would get people to change behavior, but we haven’t seen that happen for other aspects of health,” Dick said. “Initial studies suggest that receiving genetic feedback for heart disease, lung cancer, and diabetes does not get people to change their behavior. Getting people to alter their behavior is hard.”
Future Rutgers studies will investigate understanding of risk scores in other populations, Neuroscience News reported.
Research shows face-to-face genetics counseling overcomes barriers to proceeding with genetic testing and increases chances of catching cancer early
Research funded by the Prostate Cancer Foundation (PCF) has found that when patients receive in-person genetics counseling instead of virtual telehealth consultation, they are more likely to complete full germline genetic testing.
Clinical laboratory professionals have long been aware, at least anecdotally, that when physicians hand medical laboratory test orders to patients, a high percentage do not follow through and provide blood specimens for testing.
According to a PCF press release, with an on-site genetics counseling program “genetic testing occurs at the time of the consult,” whereas “with the telegenetics model, testing kits are mailed to the veteran’s home to be completed later, which can be a significant barrier, particularly for veterans with unstable housing. Researchers also explain that a face-to-face interaction with a trusted healthcare provider may be a better forum for having psychosocially complex genetic counseling discussions than telemedicine.”
This insight may be useful for genetic testing labs that can arrange for personal counseling of patients whose physician has recommended a complete full germline genetic test. Those labs would likely see a higher proportion of genetic test referrals convert into actual tests because more patients would decide to proceed.
“Without a doubt, telemedicine has many benefits, but this research shows that when it comes to genetic counseling and testing, in-person consults are most impactful,” Howard R. Soule, PhD, PCF Executive Vice President and Chief Science Officer, said in the press release.
Prostate Cancer Foundation Executive Vice President and Chief Science Officer Howard R. Soule, PhD said in-person counseling for genetic testing is more effective than a telehealth consult. Clinical laboratories are familiar with the problem of patients not following through on doctors’ orders for lab testing. (Photo copyright: Prostate Cancer Foundation.)
Germline genetic testing identifies inherited mutations that may be linked to cancer. In at-risk individuals, it plays a role in secondary screening, and it is also an element in treating prostate and other cancers.
The patients in the study were referred for cancer genetics services between October 1, 2020, and February 28, 2022, the JCO Oncology Practice paper noted. About two-thirds (65%) were referred due to a personal history of cancer and 26% due to family history of cancer. More than half self-identified as Black.
Among the 238 patients, 130 received telehealth genetic counseling compared with 108 who were counseled onsite. A total of 117 patients in the study underwent the genetic testing.
The researchers found that among all patients in the study, those who received on-site counseling had a 3.2-fold higher likelihood of completing the genetic testing compared with the telehealth service. Among the patients who self-identified as Black, the likelihood was 4.8-fold higher. The study also found that those who received on-site counseling were less likely to miss follow-up care.
The study noted some demographic differences between the two groups: Veterans seen onsite had a median age of 71 and 92% were male. Among those who received telegenetics counselling, the median age was 57 and 58% were male.
Barriers to Genetic Testing
“Barriers to genetic testing—such as lack of access to cancer genetic services and an overall shortage of genetics service providers, both within and outside of the VA—translate to missed opportunities to diagnose cancer earlier, identify at risk family members, and offer precision oncology treatment,” the press release states.
Citing previous studies, the researchers noted that barriers to completion of genetic testing “have been magnified among racial minorities, even in cases for which there is a clear indication for testing, or if the testing is provided free of cost.”
One goal of the study, the researchers wrote, was to determine if on-site consultation could help overcome those barriers.
These consultations “can be complex encounters, and for patients with active cancer, they occur during a stressful period of their care,” the researchers wrote. The consults should include “the benefits and limitations of testing, different types of test results, and the risk of psychological impact of test results.”
Possible Explanations for Genetic Test Completion Rates
The researchers pointed to several possible explanations for the differences in testing rates. The on-site genetics nurse “has flexibility to see patients in the same physical space as their oncology follow-up or treatment visits.” The study found that this led to better attendance at appointments.
In addition, those patients received testing during the consultation. However, patients who underwent genetics counselling received their testing kits by mail. “This time delay allows for multiple intervening factors that could affect the completion of genetic testing,” the researchers wrote.
The researchers also suggested that patients may be more inclined to trust providers with whom they have face-to-face interactions.
“Our findings suggest that the presence of an on-site genetics service can potentially mitigate [racial] disparities, while effectively increasing the proportion of completed [genetic tests] for patients regardless of racial or ethnic background,” they wrote.
“Although telegenetics has greatly expanded access to genetics evaluations, it is possible that a face-to-face interaction with a provider onsite may be a better method for delivery of genetics consultations, given the inherent complexity in these encounters, particularly in the veteran population,” the researchers noted in JCO Oncology Practice. “It is imperative to optimize these interactions and facilitate genetics services follow-up, as the ultimate results from testing—if indicated—have profound implications on matters that are important to patients.”
Though the PCF study is confined to genetic testing and does not encompass all clinical laboratory testing, those with experience in medical laboratories know a high percentage of patients do not complete doctor-ordered lab tests.
“Going as far back as the 1990s, there has been recognition among pathologists and clinical laboratory managers that, as a rule of thumb, for every 100 lab test orders a doctor hands to patients, only 60% of those patients come in and provide a blood specimen,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “To my knowledge, there’s never been a published study about this aspect of clinical laboratory testing that has appeared in a peer-reviewed medical journal.
“Over the years, fear of needles was believed to be one reason why some patients accept a lab test order from their physician but do not take the next step of providing a specimen to a clinical lab,” Michel added. “Today, with high-deductible health plans and expensive genetic tests, cost would be another reason why patients might decline to go forward with lab tests ordered by their physicians.”
Provider groups and members of Congress say the rules favor payers, federal judge agrees, but path forward in how providers bill patients remains unclear
Groups representing healthcare providers—including pathologists—are challenging the Biden administration’s implementation of the No Surprises Act, a bill passed in 2020 that aims to protect patients from surprise medical bills.
This will be of particular interest to pathologists who—as a study from the Health Care Cost Institute (HCCI) found—were second only to emergency room physicians among providers with the highest percentage of out-of-network billing.
The College of American Pathologists (CAP) and American Society for Clinical Pathology (ASCP), both of which supported the No Surprises Act, are now among numerous provider groups claiming that the bill’s rules for resolving payment disputes unfairly favor payers.
These groups have bipartisan support in Congress, Bloomberg Law reported, noting that some legislators are urging Health and Human Services (HHS) Secretary Xavier Becerra to change the rules. The lawmakers may seek to amend the law or turn to the courts if Becerra does not follow through on their requests.
“Either we legislate, we go to court, whatever it takes,” Rep. Brad Wenstrup (R-Ohio) told Bloomberg. Meanwhile, a federal district court judge has sided with the Texas Medical Association (TMA) in two lawsuits over the rules, Healthcare Dive reported.
“We need to make sure that the administration is implementing what we passed consistent with the legislative intent,” Sen. Michael Bennet (D-Colorado) told Bloomberg Law regarding the No Surprises Act. “We had a very complicated coalition of people to come together to support this legislation.” (Photo copyright: Senate.gov.)
Details of No Surprises Act
The No Surprises Act aims to protect patients from “balance billing,” in which they receive surprise bills for out-of-network medical services even when they use in-network providers. The bill was signed into law in December 2020, with most provisions taking effect on Jan. 1, 2022.
As Dark Daily reported in “ASCP and CAP Support New Legislation That Bars Surprise Medical Billing,” following passage of the bill, patients who unknowingly receive services from out-of-network providers are liable only for costs they would have incurred for in-network care. Providers and payers then have 30 days to negotiate a payment. If they can’t agree, an arbiter determines the payment as part of a federal independent dispute resolution (IDR) process.
Passage of the bill required the federal Department of Health and Human Services (HHS), Department of Treasury, and Department of Labor to craft regulations and guidance to implement the law—including the IDR process—according to the American Hospital Association (AHA).
Legal Pushback to Arbitration Rule
One contention was an interim rule that instructed arbiters to use the “qualifying payment amount” (QPA) as the primary basis for ruling in favor of either insurers or providers in payment disputes.
Writing in MedPage Today, pediatric radiologist Richard Heller, MD, National Subspecialty Lead for Pediatric Radiology at Radiology Partners in Chicago, and Radiological Society of North America (RSNA) Board Liaison for Public Information and Corporate Relations, described the QPA as “the insurer’s median in-network rate.”
Heller wrote that “the calculation methodology does not result in real world, market-based rates. Further, insurers calculate their own QPA, and may do so in a non-transparent fashion, raising questions about QPA integrity.”
He added, “The departments have repeatedly tried to establish the QPA as the primary factor arbiters should use in their decision making. These attempts have twice been rejected by a federal court. Recent guidance issued by the administration as a result of the second Texas Medical Association lawsuit more closely reflects the balance that Congress intended.”
In its first lawsuit, the TMA characterized the QPA as “an opaque and flawed insurer-calculated amount” that would result in reduced payments to providers. The lawsuit claimed that Congress, instead, intended for the dispute resolution process to look at “a range of factors.”
Federal Judge Jeremy Kernodle ruled in the TMA’s favor and ordered HHS to change the rule. He also sided with the TMA in another lawsuit, which alleged that a final rule issued in August 2022, while “formally abandoning the QPA rebuttable presumption,” unduly restricted use of non-QPA factors, according to a litigation update for certified IDR entities from Sidley Austin LLP.
The final rule “nevertheless continues to place a thumb on the scale for the QPA by requiring arbitrators to begin with the QPA and then imposing restrictions on the non-QPA factors that appear nowhere in the statute,” the judge stated in his ruling, the American Medical Association (AMA) reported.
In its latest lawsuit, the TMA is challenging a big hike in administrative fees for dispute resolution, which went from $50 initially to $350 beginning last January.
Another issue with the law has been the sheer volume of arbitration cases. The administration originally estimated that payers and providers would submit about 17,000 claims per year, but between April 15 and Sept. 30, 2022, about 90,000 disputes were initiated, according to a government report cited by RevCycleIntelligence.
The No Surprises Act reflected lawmaker compromises about arbitration, Sen. Michael Bennet (D-Colorado) told Bloomberg Law. Bennet indicated to the news outlet that he is not happy with the current arbitration process.
Pathology Groups Weigh In
The CAP and ASCP joined other physician organizations in raising early objections to the Biden Administration’s plans to implement the independent dispute process.
“The skewed IDR process outlined within the IFC [Interim Final Rule with Comment Period] will remove a critical incentive for insurers to negotiate reasonable contracts with physicians by establishing the QPA as a reasonable out-of-network payment,” the ASCP stated in a Dec. 6, 2021, letter to administration officials.
On Dec. 23, 2021, the CAP filed an amicus brief in a lawsuit brought by the AMA and AHA challenging an interim rule issued that September. The regulations “must support an equitable and balanced system for resolving out-of-network payment disputes,” said CAP President Emily Volk, MD, FCAP in a statement accompanying the filing. “As of today, the rules heavily favor the insurers when their power is already too great.”
The AMA and AHA later withdrew the lawsuit after the Biden administration revised the rule, Healthcare Finance News reported. However, the groups still contend that the rule favors payers.
High Stakes for Pathologists
When the law passed Congress, it appeared likely it would have a disproportionate impact on medical laboratories and pathology groups. The HCCI report ranked pathology number two among six specialties responsible for the highest percentage of out-of-network bills. And when the interim final rule was published in the Federal Register, the HCCI data was cited in an accompanying commentary.
However, the CAP told The Dark Report that the statistics about pathologists, though accurate, were “presented in a somewhat misleading manner.”
The No Surprises Act does permit balance billing when patients have given prior consent, but pathologists were among a group of specialties barred entirely from the practice, Dark Daily previously reported.
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.
