September 26, 2022

Health Mettler Institute

Healthy LifeStyle & Education

Medical Technology Company President Convicted in $77 Million COVID-19 and Allergy Testing Scheme | OPA

A federal jury convicted the president of a Silicon Valley-based mostly clinical technological know-how company yesterday of collaborating in a plan to mislead traders, dedicate well being treatment fraud, and pay out illegal kickbacks in relationship with the submission of over $77 million in fake and fraudulent statements for COVID-19 and allergy tests.

Mark Schena, 59, of Los Altos, California, served as the president of Arrayit Corporation. According to court paperwork and evidence offered at demo, Schena engaged in a plan to defraud Arrayit’s traders by declaring that he experienced invented innovative technological innovation to exam for almost any illness using only a number of drops of blood. In conferences with buyers, Schena and his publicist claimed that Schena was the “father of microarray technology” and falsely stated that he was on the shortlist for the Nobel Prize. The evidence at trial showed that Schena also falsely represented to traders that Arrayit could be valued at $4.5 billion based on purported revenues of $80 million per year. 

In furtherance of the plan, the proof at trial showed that Schena, among other things, failed to launch Arrayit’s SEC-demanded financial disclosures and concealed that Arrayit was on the verge of bankruptcy. Schena lulled investors who ended up concerned that the organization was a “scam” by inviting them to private conferences and issuing fake press releases and tweets stating that Arrayit experienced entered into worthwhile partnerships with organizations, govt organizations, and community establishments, like a children’s hospital and a main California wellness treatment supplier. The tweets and push releases falsely claimed that these types of entities had agreed to use the Arrayit engineering, when in fact no this kind of agreements existed or have been of minimal worth. 

Schena also orchestrated an illegal kickback and overall health care fraud plan that involved submitting fraudulent promises to Medicare and personal insurance plan for unwanted allergy screening. Arrayit ran allergy screening exams on every affected person for 120 unique allergens (ranging from hornet stings to codfish) regardless of clinical necessity. In buy to obtain client blood specimens, Schena compensated kickbacks to entrepreneurs in violation of the Eradicating Kickbacks in Restoration Act and orchestrated a misleading marketing and advertising system that falsely claimed that the Arrayit take a look at was really accurate in diagnosing allergic reactions, when it was not, in point, a diagnostic exam. Arrayit billed extra for each affected person to Medicare for blood-dependent allergy tests than any other laboratory in the United States, the evidence at trial confirmed, and billed some professional insurers in excess of $10,000 for each examination.

In early 2020, Arrayit’s allergy screening business declined simply because the COVID-19 pandemic and stay-at-home orders lessened desire for allergy testing. Schena then falsely declared that Arrayit “had a check for COVID-19” based mostly on Arrayit’s blood testing technological innovation, ahead of establishing such a exam. Trying to find to capitalize on the nationwide lack of COVID-19 screening, Schena orchestrated a deceptive marketing and advertising scheme that falsely claimed that Dr. Anthony Fauci and other popular government officers experienced mandated testing for COVID-19 and allergy symptoms at the very same time and necessary that individuals receiving the Arrayit COVID-19 examination also be analyzed for allergy symptoms. Schena also falsely claimed that the Arrayit COVID-19 take a look at was much more accurate than a PCR check for diagnosing COVID-19 bacterial infections, while concealing from traders and clients taking the exam that the Meals and Drug Administration had informed him that the Arrayit take a look at was not precise ample to acquire an Crisis Use Authorization for use in the United States.

Schena was convicted of one depend of conspiracy to commit wellness care fraud and conspiracy to commit wire fraud, two counts of health care fraud, one rely of conspiracy to pay kickbacks, two counts of payment of kickbacks, and 3 counts of securities fraud. He is scheduled to be sentenced on Jan. 30, 2023 and faces a most penalty 20 a long time imprisonment for the conspiracy to commit health and fitness care fraud and conspiracy to commit wire fraud 10 yrs of imprisonment for each count of well being treatment fraud 5 yrs imprisonment for conspiracy to shell out kickbacks 10 yrs imprisonment for just about every depend of payment of kickbacks and 20 several years imprisonment for each and every count of securities fraud. U.S. District Judge Edward J. Davila will decide any sentence just after contemplating the U.S. Sentencing Rules and other statutory variables.

Assistant Lawyer Normal Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division U.S. Lawyer Stephanie M. Hinds for the Northern District of California Specific Agent in Demand Craig D. Fair of the FBI’s San Francisco Field Business Performing Specific Agent in Cost Steven J. Ryan of the U.S. Office of Well being and Human Solutions Place of work of Inspector Typical (HHS-OIG) Inspector in Charge Delany De Leon-Colon of the U.S. Postal Inspection Services (USPIS) – Legal Investigations Team Particular Agent in Cost Kim R. Lampkins of the Veterans Affairs Place of work of Inspector Normal (VA-OIG) and Exclusive Agent in Demand Bryan D. Denny of the Defense Legal Investigative Assistance (DCIS) Western Field Business office produced the announcement.

HHS-OIG’s San Francisco Regional Workplace and Detroit Regional Office, USPIS, the FBI, VA-OIG and DCIS investigated the circumstance.

Performing Principal Assistant Chief Jacob Foster and Demo Lawyer Laura Connelly of the Justice Department’s Fraud Portion and Assistant U.S. Legal professional Christina Liu for the Northern District of California are prosecuting the situation.

The Fraud Segment makes use of the Target Notification Process (VNS) to deliver victims with situation info and updates associated to this case. Victims with concerns could speak to the Fraud Section’s Target Help Device by contacting the Sufferer Help cell phone line at 1-888-549-3945 or by emailing [email protected] To learn much more about victims’ rights, please visit: https://www.justice.gov/prison-vns/victim-legal rights-derechos-de-las-v-ctimas. If you imagine you are a target who has invested in Arrayit, or you have taken a COVID-19 test geared up or promoted by Arrayit, remember to take a look at https://www.justice.gov/prison-vns/scenario/Arrayit.