Nonprofit Health Care Provider Agrees to Pay $750,000 to Resolve False Claims Act Allegations Involving Misbranded Contraceptives

SAN FRANCISCO - Salud Para La Gente, a nonprofit network of primary care clinics serving low-income individuals and families in Santa Cruz County and Monterey County, has agreed to pay a total of $750,000 to resolve allegations that it submitted false claims for payment to the Medicaid program in connection with its purchase and administration of misbranded contraceptives.

Among the services it provides, Salud offers contraceptive care, including etonogestrel marketed under the brand name Nexplanon, to Medicaid beneficiaries. Nexplanon is a thin rod that is inserted under the skin of a patient's upper arm that, once implanted, works to prevent pregnancy. The United States alleged that between May 17, 2017, and Sept. 11, 2020, Salud purchased misbranded Nexplanon from an unlicensed wholesaler and administered the misbranded Nexplanon to Medicaid patients. According to the United States, Salud knowingly submitted false claims for payment to Medicaid by using incorrect National Drug Code numbers, unique drug identifiers used by the FDA for reporting and patient safety purposes, for the misbranded Nexplanon and for its administration.

"Patient safety must be at the forefront of medical decision-making," said United States Attorney Craig H. Missakian. "Using misbranded drugs jeopardizes public health and constitutes a serious False Claims Act violation. We will continue to hold violators accountable."

"It's clearly dangerous and unethical for health care providers to administer misbranded drugs obtained from unlicensed sources to their patients," said Special Agent in Charge Robb R. Breeden of the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG). "Working with our law enforcement partners, HHS-OIG will continue to aggressively protect the health and well-being of patients and the integrity of federal health care programs."

Assistant U.S. Attorney Michelle Lo handled this matter. The resolution resulted from a coordinated effort between the U.S. Attorney's Office for the Northern District of California, HHS-OIG, and FDA's Office of Criminal Investigations.

The claims resolved by the settlement are allegations only, and there has been no determination of liability.