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New Jersey Pharmaceutical Company Settles Case Involving Drug Price Reporting

On May 6, 2015, Seton Pharmaceuticals (Seton), a Manasquan, New Jersey, specialty generic pharmaceutical company, entered into a $91,800 settlement agreement with OIG. The settlement agreement resolves allegations that Seton failed to timely submit certified monthly and quarterly Average Manufacturer's Price (AMP) data to the Centers for Medicare and Medicaid Services (CMS) for certain months and quarters in 2012 and 2013. The Medicaid Drug Rebate Program requires pharmaceutical companies to enter into and have in effect a national rebate agreement with the Secretary of Health and Human Services in order for Medicaid payments to be available for the pharmaceutical company's covered drugs. Companies with such rebate agreements are required to submit certain drug pricing information to CMS, including quarterly and monthly AMP data. Senior Counsels Geeta W. Kaveti and Nicole Caucci represented OIG.

Action Details

  • Date:May 6, 2015
  • Enforcement Types:
    • CMP and Affirmative Exclusions