The Justice Department announced that Assertio Therapeutics Inc., formerly known as Depomed Inc., (Assertio), a pharmaceutical company headquartered in Lake Forest, Illinois, has agreed to pay $3.6 million to resolve claims that Assertio violated the False Claims Act (FCA) by causing the submission of false claims for the transmucosal immediate-release fentanyl (TIRF) drug Lazanda for individuals who did not have breakthrough cancer pain. Lazanda, a fentanyl nasal spray, is approved by the FDA solely for break-through cancer pain in patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The United States alleges that, between 2013 and 2017, Assertio, which was known as Depomed at the time, caused the submission of false claims to the Medicare and TRICARE programs by focusing its marketing on pain specialists who were prescribing high volumes of TIRF products, including those who were flagged for diversion or who were later indicted. The United States further alleges that Assertio placed high-volume TIRF prescribers on its speakers’ bureau and advisory boards and developed its “Signature Support Program” to ensure that Lazanda prescriptions would be approved by insurance companies, including Medicare Part D plans. The United States contends that Assertio’s marketing efforts caused prescribers to write Lazanda prescriptions for Medicare and TRICARE beneficiaries who did not have breakthrough cancer pain, resulting in the submission of false claims to Medicare and TRICARE from thirteen high-volume prescribers.