Of 27 BSL-4 labs assessed, Global Biolabs ranked only seven as having ‘good’ biosafety management
In a new report, a research firm assessed the conditions at the handful of laboratories across the world that handle the most dangerous pathogens. In the wake of the SARS-CoV-2 global pandemic, there is heightened awareness of the risks of a lab accident that might release such pathogens into the environment, putting humans at risk.
Medical laboratory scientists working in clinical laboratories worldwide understand the critical nature of biosafety laboratory (BSL) criteria. Nearly all clinical laboratories that test for infectious disease agents are biosafety level-1 and -2 (BSL-1, BSL-2).
Other high-containment laboratories (HCL) that handle deadly, highly transmissible pathogens are typically government-run or university-affiliated. HCL labs have BSL-3 and BSL-4 levels and require rigorous adherence to protocols that ensure worker safety and prevent escape of dangerous pathogens.
Thus, the new report from Global Biolabs, which is critical of biorisk management protocols at existing and planned BSL-4 laboratories—especially given the increasing construction of new HCL labs worldwide—will be of interest to medical technologists, pathologists, and clinical scientists working with highly infectious diseases.
The biosafety experts who make up the Global Biolabs research team conduct risk-assessments and “provide key policy recommendations for strengthening biorisk management in BSL-4 labs,” according to the organization’s website.
“The more labs and people working with dangerous pathogens, the risks go up,” biosecurity expert Filippa Lentzos, PhD (above), Associate Professor, Science and International Security, King’s College London, told Science magazine. Lentzos was part of the team that created the Global Biolabs mapping project two years ago. Clinical laboratory managers may want to review the findings in the Global Biolabs report. (Photo copyright: King’s College London.)
Only Seven Out of 27 Countries Get ‘Good’ Overall Score
“The boom in BSL-4 lab construction appears, so far, not to have been accompanied by strengthened biorisk management oversight,” according to the Global Biolabs 2023 report from the Global Biolabs Initiative. “Additionally, most planned BSL-4 labs will be in countries with relatively low scores for governance and stability,” the report’s authors wrote.
The report included a ranking of countries by total biorisk management score, the Daily Mail noted, adding:
Of 27 countries analyzed, seven ranked as good (above 70%) for biorisk policies,
15 scored medium (above 30%),
five scored below.
Those with the best biorisk management scores (maximum 48):
Canada scored 46 (96%),
US scored 42 (88%),
Australia and the United Kingdom each scored 40 (83%).
Notably, China “scored zero on modifying pathogen rules.” According to the Daily Mail, “China’s overall management score (33) was in the middle of the pack, 69%.”
Associate Professor in Science and International Security, King’s College London, and Gregory Koblentz, PhD, Associate Professor and Director Biodefense Graduate Program, George Mason University, Fairfax, Virginia. The organization tracks maximum containment labs worldwide, noting trends that raise biosafety and biosecurity concerns.
According to the Daily Mail, Lentzos noted “that a particular worrying aspect of the BSL-4 boom was those countries looking to open their first lab were the bottom scorers in terms of good biorisk management.
“Many of the countries building new labs, some for the first time, score poorly on biorisk management. However, there is still time to strengthen national laws and regulations on biosafety, biosecurity, and dual-use research [biological research that could cause harm] to bring them up to international standards,” the Global Biolabs researchers wrote in their report.
Global Mapping of BSL-4 Labs
There are 51 BSL-4 labs operating worldwide, and 18 are planned or under construction, according to Global BioLab’s report. Here’s where they are located:
Europe: 24
North America: 12
Asia: 9
Oceania: 4
Africa: 2
South America: 0
Also, BSL-3+ labs total 55:
Europe: 21
North America: 18
Asia: 10
South America: 3
Africa: 2
Oceania: 1
The report also noted:
Of the 18 BSL-4 labs under construction, 11 are planned to open in Asia.
About half of BSL-4 labs are “less than the size of a tennis court.”
“Eighty percent (of BSL-4 labs) are located in urban areas, which heightens concerns about accidents at these facilities,” Koblentz told the Daily Mail.
According to Science, the number of BSL-4 labs has doubled since 2013. Growth in BLS-4 labs began around the time of the 2001 anthrax attacks and picked up speed in 2003 following the SARS outbreak, University World News reported.
Biosecurity and Biosafety Analyzed
Global Biolabs’ analysis included countries’ biosecurity and biosafety scores. Just 12 out of 27 countries with BSL-4 labs scored high on biosecurity, nine scored medium, and six scored low.
A high score for biosecurity—which US and France received—reflects laws for biosecurity, a national list of dangerous pathogens, and whistleblower protection.
Out of 27 countries, 21 with BSL-4 labs scored high on biosafety. However, two countries scored medium, and four scored low. The two countries that earned the highest scores for biosafety—Canada and Australia—have physical/engineering controls, occupational health, and transportation safety, among other areas reviewed.
Opportunities for Improvement
Global Biolabs made the following recommendations in their report:
Nations with BSL-4 and BSL-3 labs need to have in place biorisk management systems including comprehensive laws, regulations, and institutions that require safety and security risk assessments of proposed research.
Strengthening of biorisk management is called for by the World Health Organization and Biological Weapons Convention.
Labs, of all biosafety levels, are advised to aim toward safety, security, and responsible research.
The effort by Global BioLabs to create a public record of how each BSL-4 and BSL-3 laboratory adheres to strict standards of safety and operations demonstrates that some degree of risk exists in the operation of these labs. Whether government and world health authorities make it a priority to address known deficiencies in those labs is a question yet to be answered.
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.
More than 10,000 doctors walked out for the second time in two months, further burdening an already overwhelmed NHS
On April 11, tens of thousands of junior doctors (similar to medical residents in the US) left their posts in British hospitals commencing a four-day walkout. The strike resulted in the cancellation of thousands of operations and appointments, as well as cancelling or delaying thousands of clinical laboratory tests and anatomic pathology readings associated with those healthcare visits and surgical procedures.
The walkout was spurred by pay concerns and working conditions and comes on the heels of a three-day strike last month. That strike had already weakened the UK’s frail National Health System (NHS), which has become inundated with appointment backlogs that predate the COVID-19 pandemic, and which has led to longer wait times to see a doctor, ABC News reported.
This latest strike was more perilous since the senior doctors who covered for their juniors during last month’s strike were previously on leave for a holiday weekend, United Press International (UPI) reported.
“These strikes are going to have a catastrophic impact on the capacity of the NHS to recover,” Matthew Taylor (above), Chief Executive of the NHS Confederation, told Sky News. “The health service has to meet high levels of demand at the same time as making inroads into that huge backlog … That’s a tough thing to do at the best of times—it’s impossible to do when strikes are continuing.” (Photo copyright: Wikimedia Commons.)
Junior Docs Cite Injustice
Junior doctors who walked out are calling for a 35% pay raise to right the wrongs of 15 years of below-inflation raises, but the government continues to argue it cannot afford to increase pay, UPI noted.
“There is nothing ‘junior’ about the work I have done as a doctor. For an hour of work that I might save a life, I can be paid 19£ [$23.65],” said Jennifer Barclay, MD, a surgical junior doctor in the UK’s North West electoral zone, in a British Medical Association (BMA) press release.
“My dad, an electrician, tells me to quit and retrain in his footsteps. I’d be earning more, have less stress, less responsibility, better hours, and a better work-life balance after three years,” she added. “Surely, this life, this training, responsibility, debt, and crushing workload is worth more than 19£ per hour? I’ll be on the picket line this week because doctors believe that it is.”
According to the BMA, newly qualified junior doctors earn just over 14£ ($17.43) per hour, ABC News reported, which added, “The doctors’ union has asked for a 35% pay rise to bring junior doctor pay back to 2008 levels.”
However, their pay demands come in the midst of a cost-of-living crisis in the UK. Inflation has risen above 10%. Paired with increases in heating costs and food prices mean that decreased wages leave many struggling to pay bills, ABC news reports.
A hard-hitting BMA advertising campaign designed to shine light on these disparities depicts three junior doctors (with one-, seven-, and 10-years’ experience) removing an appendix. The video shows that the total the three would be paid for the hour-long operation would be 66.55£ ($82.84):
Doctor with one year experience: 14.09£ ($17.54).
Doctor with two years’ experience: 24.46£ ($30.45).
Doctor with three years’ experience: 28£ ($34.85).
And this for performing a potentially life-saving procedure, the BMA stated.
In the press release, BMA Junior Doctors Committee co-chairs Robert Laurenson and Vivek Trivedi said, “It is appalling that this government feels that paying three junior doctors as little as 66.55£ between them for work of this value is justified. This is highly skilled work requiring years of study and intensive training in a high-pressure environment where the job can be a matter of life or death.”
Patient Care is Affected
Lower salaries also affect patient care levels and have led to recruitment issues, with many doctors leaving the profession, the BBC reported. “This is not a situation where we are fixed in our position. We’re looking for negotiations and Steve Barclay (UK’s Secretary of State for Health and Social Care) isn’t even willing to talk to us. He hasn’t put any offer at all on the table … there has to be two sides in the discussion,” Emma Runswick, MD, a junior doctor and deputy chairwoman of the BMA, told the BBC.
But while the junior doctors battle for wages, the government’s initial focus has been on patient wellbeing. “There will be risks to patient safety, risks to patient dignity, as we are not able to provide the kind of care we want to,” NHS Confederation Chief Executive Matthew Taylor told UPI prior to the walkout.
The timing of the walkout also caused consternation with the NHS. “Not only will walkouts risk patient safety, but they have been timed to maximize disruption after the Easter break,” Health Secretary Barclay told UPI as the walkout was announced.
Barclay also claimed the amount sought by doctors was “unreasonable” and would cause raises above $25,000 per year, UPI reported. “If the BMA is willing to move significantly from this position and cancel strikes, we can resume confidential talks and find a way forward as we have done with other unions,” he stated.
It is important to note that doctors would be pulled from picket lines if immediate danger were present due to trade union laws that say life-and-limb coverage must be provided, the BMA told the BBC.
Founder of now defunct clinical laboratory testing company was supposed to report to prison April 27, but a last-minute legal challenge has delayed that judge’s order
Anatomic pathologists and clinical laboratory leaders who are following the continuing saga of Theranos and Elizabeth Holmes may be interested to learn that the former CEO’s attorneys are making last-minute legal moves to delay her prison sentence while she appeals her guilty verdict. At the same time, Holmes appears to be on a mission to revamp her public image.
Apparently, the twists and turns in Holmes’ never-ending story are not yet over when it comes to Theranos, its maligned clinical laboratory technology, and the company’s convicted founder.
On May 7, The New York Times (NYT) profiled Holmes in a massive, 5,000-word story that attempted to portray her as a flawed businessperson who now prefers a simpler life with her partner and two young children.
“I made so many mistakes and there was so much I didn’t know and understand, and I feel like when you do it wrong, it’s like you really internalize it in a deep way,” disgraced Theranos founder Elizabeth Holmes recently told The New York Times. Anatomic pathologists and clinical laboratory directors impacted by the revelation that Theranos hide the fact that its blood testing technology was faulty may not sympathize with Holmes’ position. (Photo copyright: Stuart Isett/Fortune Global Forum.)
Legal Team Secures Last-Minute Delay in Holmes’ Surrender
Holmes admitted to the news outlet that the deep voice she used in public, along with her black turtleneck sweaters, were part of a character she created.
“I believed it would be how I would be good at business and taken seriously and not taken as a little girl or a girl who didn’t have good technical ideas,” Holmes told the NYT. “Maybe people picked up on that not being authentic, since it wasn’t.”
However, on April 26, the 9th Circuit Court of Appeals stayed her surrender date until that court rules on Holmes’ latest bid to stay free while she appeals her conviction, The Washington Post reported.
Just days earlier on April 10, a district court judge ruled that Holmes would not stay free while her appeal progresses. The 9th Circuit announcement curtailed the district court ruling. It is not known when the 9th Circuit will issue a decision in the matter.
New York Times Reports on Holmes’ Change in Personality
The somewhat odd New York Times profile of Holmes varied between reflections on her past crimes and on her current personal life, where she is known as “Liz.”
“In case you’re wondering, Holmes speaks in a soft, slightly low, but totally unremarkable voice—no hint of the throaty contralto she used while running her blood-testing startup Theranos, now defunct,” the NYT reported.
Holmes still lives in California with her partner, Billy Evans (whose parents own a luxury hotel chain), and their two children: a son who is almost two years old and a daughter born in February. She works at home for a rape-crisis hotline.
Balwani’s Role in Theranos Again Publicly Debated
In the NYT interview, Holmes talked about being raped while a student at Stanford University and about alleged abuse from her Theranos business partner and former lover, Ramesh “Sunny” Balwani.
Balwani, Theranos’ former President and Chief Operating Officer, began his 12-year, 11-month prison sentence on April 20 in a Southern California facility for his role in defrauding Theranos investors, KTVU TV reported. Balwani has also appealed his conviction on the 12 fraud charges.
Holmes reiterated to the NYT past statements she made in court that Balwani allegedly exerted social and sexual control over her when they both worked at Theranos and were in a romantic relationship.
“She lived by entrepreneurial tenets that she said Balwani told her she needed to follow in order to succeed,” the NYT reported. “These included not sleeping for more than five hours, going vegan, getting to the office daily by 5 a.m., no alcohol.”
“[I] deferred to [Balwani] in the areas he oversaw because I believed he knew better than I did,” including on clinical lab activities at Theranos, Holmes said.
Balwani’s attorneys dismissed Holmes’ allegations, as they have in the past.
Clinical laboratory professionals can reasonably make two broad observations from the continuing saga of Theranos and Elizabeth Holmes:
Justice for healthcare crimes is often deferred for those who have influence and money.
Holmes’ image overhaul may be a last-ditch effort to sway public opinion about her, in the event that she receives a new jury trial as a result of her appeal.
Dark Daily will continue to keep you updated on further developments in this case.
Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.
“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”
“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)
Arguments For and Against FDA LDT Regulation of LDTs
Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.
Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.
In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.
“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.
“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.
Actions Clinical Laboratory Managers Can Take
Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:
Contact their representatives in Congress.
Find out whether any trade associations they belong to have taken a position on the VALID Act.
Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.
Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs.
Novel scheme by medical laboratory company to induce patients to collect and return their own specimen for testing is central to a federal whistleblower case alleging violations of the Anti-Kickback Statute
Handing out gift cards only to patients who return a specimen to a clinical laboratory company for colorectal cancer screening is a unique approach that is now at the center of a federal qui tamcase filed by a retired Indiana pathologist.
The defendant in this whistleblower lawsuit is Exact Sciences Laboratories and its parent company Exact Sciences Corporation (NASDAQ:EXAS). Last month, a federal judge ruled the court case will proceed following attempts by the defendant’s attorneys to have the case dismissed.
The plaintiffs (United States of America ex rel. Niles Rosen, MD) allege Exact Sciences Laboratories violated the Federal Anti-Kickback Statute (AKS) and False Claims Act by offering $75 gift cards to induce patients to return self-collected fecal samples for the lab’s Cologuard at-home colon cancer screening kit through its Patient Compliance Program.
Exact Sciences refuted the allegations and moved to have the case dismissed claiming it “had a good faith belief that its [Patient Compliance Program] complied with the law and thus lacked the requisite intent for a violation of the AKS,” according to court documents. The court denied Exact Sciences’ motion to dismiss.
“We are grateful for the hard work and courage of those private citizens who bring evidence of fraud to the Department’s attention, often putting at risk their careers and reputations,” said Brian Boynton, JD (above), Principal Deputy Assistant Attorney General and head of the federal Department of Justice (DOJ) Civil Division in a February 7, 2023, DOJ statement. “Our ability to protect citizens and taxpayer funds continues to benefit greatly from their actions.” Clinical laboratory managers will want to follow this and other qui tam cases claiming violation of anti-kickback laws. (Photo copyright: Department of Justice.)
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Was Exact Sciences’ Patient Compliance Program a Kickback?
Cologuard is a non-invasive testing kit utilized by people to screen for colorectal cancer in the privacy of their own homes. It is intended for those over the age of 45 who are at low or average risk for the disease. Exact Sciences regularly runs television advertisements urging individuals to be screened for colorectal cancer using the Cologuard test.
Following a physician’s order, and after receiving the testing kit in the mail, individuals collect a stool sample using the specimen container in the kit and return the sample to Exact Sciences Laboratories (ESL) for analysis. The test works by looking for certain DNA markers and blood in the stool sample.
According to Report on Medicare Compliance from the Health Care Compliance Association (HCCA), in 2017, a gastroenterologist ordered the Cologuard kit for Rosen, the whistleblower, but Rosen chose not to return a stool sample to ESL. A few months later, ESL sent Rosen a letter offering him a $75 Visa gift card if he performed the at-home specimen collection and then returned it to ESL by March 22, 2018. Persuaded by the offer, Rosen collected a sample, returned it to ESL, and received the gift card.
As part of its Patient Compliance Program, ESL analyzed Rosen’s sample and received $499 from Medicare for performing the test. The complaint filed against Exact Sciences states Medicare paid Exact Sciences more than $160 million for a total of 334,424 Cologuard tests in 2018 while the company offered “unlawful cash equivalent inducements directly to Medicare beneficiaries,” COSMOS reported.
“It was a straight-up kickback,” Rosen’s attorney Marlan Wilbanks, JD, Senior Partner at Atlanta law firm Wilbanks and Gouinlock, told COSMOS. “You can’t offer cash or cash equivalents to anyone to induce them to use a government service.”
DOJ Elects to Not Intervene in Lawsuit
In February 2020, Exact Sciences received a civil investigation demand by the US Department of Justice (DOJ) regarding the gift card incentive. The DOJ later filed a notice that it had elected to decline intervention in the lawsuit. This action did not prevent Rosen from continuing with the lawsuit. Accordingly, in April of 2021, he filed an amended complaint against Exact Sciences alleging violations of the Federal Anti-Kickback Statute and False Claims Act.
Rosen is seeking a monetary award for himself, and on behalf of the US government, for civil penalties, treble damages, fees, and costs.
According to Report on Medicare Compliance, Exact Sciences “refuted the allegations and asserted, among other things, that the arrangement qualifies for the preventive care safe harbor to the anti-kickback statute (AKS) and that the complaint fails for many reasons.”
Exact Sciences also noted in its motion to dismiss that “encouraging a patient to have a medical service that was already ordered by a provider isn’t an inducement under the AKS.”
At this time, the case remains unresolved and continues in federal court.
DOJ Recovers Billions of Taxpayer Dollars from AKS Violations
A qui tam lawsuit or action is a method available for individuals to help the government circumvent fraud and recover money for taxpayers. Types of fraud included in these cases often pertain to Medicare and Medicaid services, defense contractor fraud, and procurement fraud.
According to the DOJ, over $1.9 billion was recovered as a result of qui tam lawsuits pursued by either the government or whistleblowers during fiscal year 2022. The number of these types of lawsuits has increased dramatically over the years with a total of 652 qui tam cases filed in 2022 alone.
Thus, clinical laboratory professionals should be aware that this type of novel scheme to generate more patients could possibly lead to legal issues. Dark Daily would like to credit Laboratory Economics for calling attention to this fascinating case of alleged illegal inducement involving a medical laboratory company.
