Typical divisions of a clinical laboratory include hematology, cytology, bacteriology, histology, biochemistry, medical toxicology, and serology. (2) Any facility that examines materials from the human body for purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered clinical laboratories. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. He can be reached at or at 61.(1) A clinical laboratory is a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, human beings. Jeffrey Newman and his firm represent whistleblowers nationwide including in several cases involving laboratory testing Medicare and Medicaid fraud. Those payments will be capped at $26 million, creating a total potential liability of $43 million. The company will then enter a five-year “corporate integrity agreement” involving an outside review organization and additional federal compliance requirements.Īlso over the next five years, Genova will pay the government 13% of any net annual revenue above $100 million and 20% of any asset sales over $1 million. Genova will forfeit over $17 million in payments from Medicare and TRICARE, the civilian health benefit system for the U.S. The complaint claims that Genova then falsely accused Landis of “employment-related misconduct” and fired him. In response to his diligence, Landis alleges, Genova’s then-CEO Chris Smith disregarded his concerns as “overly conservative,” cut his department’s budget and repeatedly excluded him from meetings with company leadership. He is represented in this case by Womble Bond Dickenson LLP in Winston-Salem NC. However, over time, he raised concerns and warned Genova that clinical support for the tests was non-existent for the medical necessity and he also warned that the billing of Medicare and Medicaid was improper. a board-certified physician who was hired as Genova’s CMO tasked with developing medical necessity evidence for the tests. The whistleblower, in this case, is Daryl Landis, M.D. The Complaint states that there are no published, peer-reviewed studies or papers or high-quality clinical studies to assess, demonstrate, or establish clinical validity. It recommends and markets it for use in diagnosing irritable bowel syndrome, inflammatory bowel disease, diabetes, obesity, cardiovascular disease and autoimmune disorders. Goneva’s website said that the GI effects panel provides immediate actional clinical information for the management of gut health including celiac disease. One was a panel of fecal stool tests assessing 46 biomarkers of gastrointestinal function. Those tests, it was alleged were not medically necessary in accordance with Medicare and Medicaid regulations. According to the Complaint, Genova offers unconventional tests including test panels relating to hormones, food allergies and gastro-intestinal targets. The company also allegedly classified some of those tests under false billing codes to defraud Medicare and Medicaid. The complaint filed with the federal court in May 2018, Genova allegedly sought and received payment for fecal, blood and urine tests that have not been scientifically proven to diagnose any medical condition. Genova Diagnostics had agreed to pay up to $43 million to settle allegations that it had fraudulently billed the federal government for unnecessary lab services.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |