Ultragenyx agrees to pay $6M to resolve DOJ allegations of false claims

The U.S. Department of Justice said that Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, in violation of the False Claims Act, by paying for free genetic tests, plus a separate fee to receive test result information for marketing purposes, to collectively induce prescriptions of its drug Crysvita and referrals of health care providers (HCPs) to Ultragenyx for the furnishing or arranging for the furnishing of Crysvita. Ultragenyx is a pharmaceutical manufacturer with a principal place of business in California that manufactures Crysvita. Crysvita is an FDA-approved drug to treat X-linked hypophosphatemia (XLH) in adult and pediatric patients six months of age and older. XLH is a rare inherited disorder characterized by low levels of phosphate in the blood, which can lead to weak bones and, in many instances, may require a genetic test to definitively diagnose. Ultragenyx understood that, in some cases, a positive genetic test for a genetic mutation consistent with XLH would be required for an insurer (including Medicare or Medicaid) to pay for a patient’s prescription for Crysvita, or for a healthcare provider (HCP) to make a definitive diagnosis of XLH and prescribe Crysvita. Thus, Ultragenyx entered into an arrangement with a genetic testing laboratory (Laboratory), whereby Ultragenyx paid the Laboratory to conduct genetic tests – at no cost to HCPs or patients – and provide the results to the HCP. Ultragenyx referred to this program as its “sponsored” XLH testing program and Ultragenyx sales personnel discussed the XLH testing program with HCPs and delivered order forms for the tests to HCP offices. As part of the settlement, Ultragenyx admitted and accepted responsibility for certain facts providing the basis of the settlement.