FAIRVIEW HEIGHTS – Utah-based Dolor Technologies, LLC (“Dolor) has entered into a settlement agreement with the United States to resolve Dolor’s civil liability relating to a device it sold and marketed to treat migraines, the Department of Justice announced today.
This resolution requires Dolor to make monetary payments to the U.S. based upon its ability to pay. The government alleges that, between July 2013 through July 2017, Dolor violated the False Claims Act (FCA) by causing medical providers to submit false claims to the Medicare Program for procedures using a device called the SphenoCath. The SphenoCath was intended to treat migraine headaches by administering nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves located deep in the midface of the skull.
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The government alleged the SphenoCath was not approved or authorized by the FDA for use in SPG nerve blocks for the treatment of headaches. The government also alleged Dolor instructed, coached, and encouraged medical providers to submit improper billing codes to Medicare for reimbursement of services using the SphenoCath device. “Device companies that evade the FDA approval process and improperly promote their products undermine the health of patients and the financial integrity of federal health care programs,” said U.S. Attorney Rachelle Aud Crowe for the Southern District of Illinois.
“This...
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