Orthofix International N.V. (Orthofix) has reported that a federal False Claims Act, or qui tam, complaint filed on March 23, 2005 against the primary manufacturers of bone growth stimulators in the US, including the company, has been unsealed by the US District Court for the District of Massachusetts. The complaint against these manufacturers emerges to focus on alleged reimbursement-related false claims associated with the sale versus the rental of those devices.
The civil qui tam action unsealing is a routine procedure and enables the individual plaintiff involved to pursue civil claims in federal court. The company indicated that this week it has received what it believes is a related subpoena from the Department of Justice (DOJ) requesting documentation for a period from 1995 to 2009. The company thinks the DOJ is requesting information primarily related to claims for reimbursement for the sale of stimulation devices.
In the beginning of April 2009, Orthofix has reported that its subsidiary, Orthofix Inc., had been approved for accreditation by the Accreditation Commission for Health Care, Inc., (ACHC) for the provision of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) services. Obtaining accreditation is currently a voluntary activity where healthcare organizations submit their internal policies, processes and patient care delivery systems for peer review against national standards. Meeting and maintaining such accreditation status indicates the company’s compliance with ACHC’s standards and its commitment to quality in the provision of DMEPOS services.
Orthofix is a Netherlands Antilles-based medical device company.