A settlement has been reached to resolve False Claims Act allegations against Paradigm Spine.
The allegations arose from a lawsuit that claimed Paradigm Spine caused health care providers to submit false claims to Medicare and other federal health care programs for spine surgeries by marketing the company’s coflex-F® device for surgical uses that were not approved by the U.S. Food and Drug Administration. Further, Paradigm caused false claims by giving false recommendations on how to code health claims for procedures involving the company’s coflex® device.
Paradigm Spine allegedly marketed coflex-F for surgical uses that were not approved by the FDA from 2011 to 2013 and allegedly provided health care providers with improper guidance on how to claim reimbursement for coflex from 2012 to 2015.
“A medical device manufacturer has a duty to be truthful about the approved uses of medical devices and the appropriate billing codes to use when seeking payment from the government,” said U.S. Attorney Rod J. Rosenstein.
The whistleblowers' share of the settlement will be approximately $105,300.
