Relator Alleges Mitias Orthopaedics in New Albany, Mississippi Used and Billed for Non-Approved Injectable Devices

Bracker & Marcus LLC is pleased to announce that the United States Attorney for the Northern District of Mississippi has intervened in its False Claims Act case against provider Mitias Orthopaedics. Bracker & Marcus LLC represents the qui tam relator, a former orthopedic product salesman who in 2015 reported his concerns that Mitias was injecting a non-approved product into its patients.

Viscosupplements, such as Synvisc and Orthovisc, are injections approved by the Food and Drug Administration for the treatment of osteoarthritis pain in the knee. Mitias is alleged to have purchased and injected its patients with a viscosupplementation agent manufactured by a compound pharmacy. This is problematic for at least two reasons. First, because these are considered medical devices rather than drugs, most insurances (including Medicare) will only cover FDA-approved name brands (such as Synvisc or Orthovisc). A provider could not build its own knee-replacement device and expect Medicare to reimburse it. Second, this fact is reflected in the billing codes, as insurance pays different amounts for the different name brands. So by billing under the code for Synvisc, the provider is certifying that it injected the patient with Synvisc, not a generic product. Not only is there a safety concern of using non-FDA approved products, but a fraudulent billing component as well.

This is the second viscosupplementation case brought by the attorneys at Bracker & Marcus LLC. The first, filed against Tennessee Orthopaedic Clinics and Appalachian Orthopaedic Associates, alleged that the defendants reimported Synvisc from foreign countries, which essentially invalidated their FDA-approvals. The defendants in that action settled those claims for $1.85 million.

Bracker & Marcus LLC thank the U.S. Attorney’s Office for the Northern District of Mississippi for their dedication to preserving federally funded-healthcare programs and protecting its citizens from potentially harmful medical procedures.

From its press release: “Our office is committed to protect taxpayer dollars from waste, fraud, and abuse and ensure the integrity of our federal healthcare programs like Medicare, Medicaid, TRICARE and Railroad Medicare,” said U.S. Attorney William C. Lamar for the Northern District of Mississippi. “CMS/Medicare is ready, willing, and able to pay for high-quality products.  Any attempt to manipulate the reimbursement system drives up costs for everyone,” Lamar added.