New York-based Paradigm Spine agreed to pay the United States $585,000 to settle False Claims Act allegations, according to the United States Attorney's Office District of Maryland.
Here are five things to know:
1. Allegedly, Paradigm Spine marketed its coflex-F device for surgical uses not approved by the FDA, between 2011 and 2013.
2. Consequently, healthcare providers submitted false claims to Medicare and other federal programs for using the device in spine surgeries that weren't approved.
3. The allegations also include Paradigm Spine offering false recommendations on how to code claims for procedures using the device, from 2012 to 2015.
4. Thus, healthcare providers submitted false claims to federal programs for spine surgeries that were not eligible for reimbursement.
5. Paradigm Spine denies all allegations.