Ultragenyx to Pay $6 Million To Settle False Claims Act Case

Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). 

Ultragenyx manufactures a drug called Crysvita, which is a US Food and Drug Administration (FDA)-approved drug for the treatment of X-linked hypophosphatemia (XLH). XLH is a rare, inherited disorder that is often definitively diagnosed via genetic testing. Individuals with XLH have low levels of phosphate in their blood, weakened bones, and may experience bowed or bent legs, short stature, bone pain, fractures, and dental abscesses. According to the qui tam action, Ultragenyx allegedly paid kickbacks in exchange for referrals for Crysvita in violation of the Anti-Kickback Statute and the FCA.

As part of the settlement, Ultragenyx admitted that it understood a positive genetic test for XLH was sometimes required for insurers, including Medicare and Medicaid, to reimburse for Crysvita and for some health care providers to definitively diagnose XLH and prescribe Crysvita. Ultragenyx admitted to paying a genetic testing laboratory to conduct genetic testing at no expense to patients or health care providers, and the test results were then provided to the health care provider. 

Ultragenyx also paid the genetic testing laboratory for the results, which did not include patient names, but included the name of the health care provider who ordered the test, a de-identified patient ID number, the date the test was ordered, and the test result. Ultragenyx used the test results to identify potential Crysvita patients and their health care providers and market Crysvita to them.

The qui tam case is United States ex rel. Ruggiero v. Ultragenyx Pharmaceutical, Inc., Case No. 1:21-cv-11176-ADB (D. Mass.). Read the Settlement Agreement here.

Thomas Girardi Found Fit to Face Fraud Allegations

Former high-profile plaintiff’s lawyer Tom Girardi, 84, ex-husband of Real Housewives of Beverly Hills star Erika Jane, was found competent to face trial for allegedly stealing millions of dollars from his clients. 

Girardi was first accused in December 2020 of stealing millions from settlement funds of victims of the 2018 Boeing 737 MAX Lion Air plane crash in Indonesia. Girardi was charged on February 1, 2022, by prosecutors in Chicago and Los Angeles for allegedly taking over $15 million in funds belonging to clients of his firm, Girardi Keese. Girardi pleaded not guilty to five counts of wire fraud in Los Angeles and eight counts of wire fraud and four counts of criminal contempt in Chicago. He has since been disbarred in California.

Girardi’s lawyers claimed that he suffers from dementia, brain atrophy, and memory loss and is unaware that he is disbarred or has not paid his clients. Competency hearings were held in August and September, after which US District Judge Josephine Staton determined that Girardi is “competent to stand trial” in his California criminal case.

The CA case is United States v. Girardi, Case No. 2:23-cr-00047 (C.D. Cal.).

Cancer Research Hospital Pays Over $19 Million for Improper Billing

A non-profit cancer research center, H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. (Moffitt) of Tampa, Florida, has agreed to a settlement with the government for over $19 million dollars for alleged improper claim submission under the FCA. The settlement resolves Moffitt’s civil liability for allegedly improper claims it submitted to Medicare and other federal healthcare programs from 2014 to 2020. The government asserted that Moffitt billed for items and services as part of a clinical research trial which were not eligible for reimbursement; the claims, according to the government, should have been billed to non-government trial sponsors.

Upon learning of these issues, Moffitt initiated an independent investigation and compliance review, subsequently providing the government with a written disclosure of findings. Moffitt fully cooperated with the government’s investigation and implemented compliance and remedial measures as a result. For its cooperation, Moffitt received credit under the Department of Justice’s guidelines for taking disclosure, cooperation, and remediation into account in FCA cases. The government’s share of the settlement is approximately $18.2 million and state Medicaid share is approximately $1.3 million.

Read the settlement here.