Ultragenyx to Pay $6 M for Allegedly Paying Kickbacks to Induce Claims for Drug

 Pharmaceutical company Ultragenyx Pharmaceutical Inc. (Ultragenyx) 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.

Ultragenyx separately paid the Laboratory to provide the test results to Ultragenyx, including the name of the HCP who ordered the test, a de-identified patient ID number, the date the test was ordered and — once ready — the test result itself (collectively, Results Reports). Ultragenyx used the Results Reports, in part, for marketing purposes to find potential Crysvita patients and their HCPs. Until April 2022, Ultragenyx received Results Reports and disseminated this information to its sales force with instructions to make sales calls for Crysvita to HCPs who ordered a test or, in particular, who had a patient with a positive test result. Ultragenyx’s sales force followed up with HCPs regarding test results. The United States contends that, as a result of these actions, Ultragenyx caused the submission of false claims to Medicare and Medicaid by paying kickbacks 1) to beneficiaries in the form of free genetic tests to induce their purchase of Medicare or Medicaid-reimbursed Crysvita and 2) to the Laboratory for the Results Reports to induce the referral to Ultragenyx of HCPs to whom Ultragenyx could market Crysvita.

As part of the settlement, Ultragenyx admitted and accepted responsibility for certain facts providing the basis of the settlement.

https://www.justice.gov/opa/pr/pharmaceutical-company-ultragenyx-agrees-pay-6-million-allegedly-paying-kickbacks-induce