![]() ![]() At that time, the company regarded him as an expert in medical policy, research, and evidence-based care. Landis was hired in 2012 to be its chief medical officer and tasked with developing medical necessity evidence for its tests. In 2017, Genova’s Web site promoted the NutrEval Test FMV (First Morning Void) test as “an advanced diagnostic tool to guide nutritional therapies, often augmenting and speeding recovery of complex chronic conditions” the site claimed that the NutrEval Plasma test, would “reveal nutritional imbalances or inadequacies.” The site recommended both NutrEval Panels for individuals who suffer from mood disorders, fatigue, digestive complaints, chronic pain, inflammatory conditions, cardiovascular risk, and weight issues. These test over 100 organic acids, amino acids, fatty acids, micronutrients, and other elements in an individual’s blood and urine. It may also provide insight on intolerances, or nonimmune responses, to certain foods.” A food sensitivity test that “helps identify those with true IgE-mediated allergies as well as IgG-mediated food intolerances.” In 2017, Genova’s Web site claimed that the test was ideal for patients who may suffer from delayed reactions/sensitivities to specific foods. In 2017, Genova’s Web site claimed that the test provided “immediate, actionable clinical information for the management of gut health” and individuals with “leaky gut symptoms” celiac disease inflammatory bowel disease (IBD) diabetes obesity cardiovascular disease celiac and other malabsorption disorders mood disorders autism and autoimmune disorders and other conditions. A panel of fecal stool tests that assesses 46 different biomarkers of gastrointestinal function, including 24 commensal bacterial targets found in the gastrointestinal system. The lawsuit challenged three types of tests, which it described this way: Landis will receive roughly $6 million as part of the settlement. Among other things, the CIA requires Genova to establish and maintain a compliance program and engage an independent review organization. ![]() Genova also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. Under the settlement, Genova has agreed to pay approximately $17 million, through the surrender of claim funds held in suspension by Medicare and TRICARE, plus up to an additional $26 million if certain financial contingencies occur within the next five years, for a total potential payment of up to $43 million. Genova also made payments to three phlebotomy vendors that violated the Stark Law.During that time period, it also has submitted claims for payment for and received Medicaid reimbursements from the State of North Carolina for the Panels. From Jthrough June 30, 2017, Genova, with the knowledge or and at the direction of its owners, managers, and board of directors, has fraudulently submitted claims for payment for and received over $21 million in reimbursements from Medicare for the Panels.through Requisition Forms, the defendants knowingly forced physicians to order a large number of tests on each Panel which are not individualized for patients, which results in the ordering of and Genova’s billing of Medicare and Medicaid for tests that are medically unnecessary and not relevant to the diagnosis or treatment of patients.There is insufficient evidence that these are medically necessary and therefore eligible for Medicare or Medicaid payment.Genova markets a variety of unconventional laboratory tests to the functional medicine market, including test panels that relate to hormones, food allergies, nutrition, and gastrointestinal bacterial targets.Lauren Leichtman, Aaron Perlmutter, and Chris Smith. GNVA Holdings Inc, Levine Leichtman Capital Partners V, L.P. The suit was filed against Genova Diagnostics, Inc. Landis was represented by the law firm of Womble Bond Dickenson of Winston-Salem, North carolina. The alleged misconduct was brought to light by former Genova vice-president and chief medical officer Darryl Landis through the whistleblower provisions of the False Claims Act. The settlement resolved allegations that the company: (a) improperly submitted claims to Medicare, TRICARE, and the federal employee health program for tests that were not medically necessary, (b) engaged in improper billing techniques, and (c) violated the Stark law, which prohibits physicians from referring patients for certain designated health services paid for by Medicare to any entity in which they have a financial relationship. Genova Diagnostics Inc., a clinical laboratory services company based in Asheville, North Carolina, has agreed to pay up to approximately $43 million to resolve allegations that it violated the False Claims Act, including claims that it billed for medically unnecessary lab tests. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |