Pharma Firm Pays $750,000 to Resolve Alleged Violations of the False Claims Act
Sentynl Therapeutics Inc., a Solana Beach, CA-based specialty pharmaceutical company, has agreed to pay a financial penalty of $750,000 to resolve allegations it violated the False Claims Act by causing the submission of claims for opioid medications, in violation of the federal Anti-Kickback Statute.
Between December 1, 2015, and August 31, 2016, Sentynl Therapeutics marketed and sold the prescription opioids, Abstral and Levorphanol Tartrate (Levorphanol). Abstral is a Transmucosal Immediate Release Fentanyl (TIRF) medication that is approved by the Food and Drug Administration for the treatment of breakthrough pain in opioid-tolerant cancer patients. Levorphanol is approved by the FDA for the treatment of pain severe enough to require an opioid analgesic when alternative treatments are inadequate.
During that time frame, Sentynl Therapeutics is alleged to have knowingly caused the submission of claims for Abstral and Levorphanol to Medicare after making indirect payments of kickbacks to a physician. Sentynl Therapeutics is alleged to have hired the girlfriend of a top prescriber of TIRF medications as a sales representative in the same region in South Florida where the physician practices, and paid her to induce the physician to prescribe its opioid medications. Sentynl Therapeutics paid the girlfriend a salary and bonus payments based on the number of prescriptions written by the physician, which violated the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b).
“Pharmaceutical companies are not exempt from their responsibilities to operate within the confines of the law,” said Special Agent in Charge Cheryl Ortiz of the Drug Enforcement Administration’s New Jersey Field Division. “We are glad our diversion investigators were able to assist efforts to bring this matter to a resolution.”
HHS OIG Exclusions List
What You Need To Know
Get The 6 Essentials Checklist For Compliance Officers
A link to your download will be sent to your email address
Your Privacy Respected
HIPAA Journal Privacy Policy
“Some violations of the Anti-Kickback Statute, like those alleged here, can induce physicians’ imprudent prescribing of controlled substances,” said Special Agent in Charge, Naomi Gruchacz, with the U.S. Department of Health and Human Services Office of Inspector General. “Individuals and entities that participate in the federal health care system are required to obey the laws meant to preserve the integrity of program funds and the provision of appropriate, quality services to patients.”
