Pharmaceutical company Schwarz Pharma, headquartered in Chicago, has agreed to pay $22 million to resolve allegations that it had failed to advise the Centers for Medicare and Medicaid Services that two of its drugs — Deponit and Hyoscyamine Sulfate Extended Release — did not quality for coverage under the federal healthcare programs, according to a Department of Justice news release.
Deponit, a skin patch used to prevent angina, and Hyoscyamine Sulfate ER, a medication used to treat various stomach, intestinal and urinary tract disorders, contain active ingredients that were determined by the Food and Drug Administration to be ineligible for reimbursement by federal healthcare programs.
Schwarz allegedly failed to tell CMS that the drugs did not quality for coverage under federal healthcare programs, which led Schwarz to allegedly submit false claims to the programs for the unapproved drugs. It was also accused of submitting false quarterly reports to the government that allegedly misrepresented the drugs' regulatory status.
A portion of the government's recovery from Schwarz' settlement will be paid back to the whistleblowers who filed the False Claims Act lawsuits. State Medicaid programs, such as Kentucky, will also share in some of the settlement money.
Read the DOJ news release about Schwarz Pharma's settlement.
Read other coverage about pharmaceutical company settlements.
- Pharmaceutical Company AstraZeneca Settlement Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud
Deponit, a skin patch used to prevent angina, and Hyoscyamine Sulfate ER, a medication used to treat various stomach, intestinal and urinary tract disorders, contain active ingredients that were determined by the Food and Drug Administration to be ineligible for reimbursement by federal healthcare programs.
Schwarz allegedly failed to tell CMS that the drugs did not quality for coverage under federal healthcare programs, which led Schwarz to allegedly submit false claims to the programs for the unapproved drugs. It was also accused of submitting false quarterly reports to the government that allegedly misrepresented the drugs' regulatory status.
A portion of the government's recovery from Schwarz' settlement will be paid back to the whistleblowers who filed the False Claims Act lawsuits. State Medicaid programs, such as Kentucky, will also share in some of the settlement money.
Read the DOJ news release about Schwarz Pharma's settlement.
Read other coverage about pharmaceutical company settlements.
- Pharmaceutical Company AstraZeneca Settlement Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud