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Alnylam Pharmaceuticals Agreed to Pay $170,000 for Allegedly Violating the Civil Monetary Penalties Law by Failing to Submit Timely Pricing Data

On May 2, 2024, Alnylam Pharmaceuticals, Inc. (Alnylam), Cambridge, Massachusetts, entered into a $170,000 settlement agreement with OIG. The settlement agreement resolves allegations that Alnylam failed to submit timely certified monthly Average Manufacturer's Price (AMP) data to the Centers for Medicare and Medicaid Services (CMS) for certain months in 2021 and 2023, and also failed to submit timely quarterly Average Sales Price data to CMS for certain quarters in 2020, 2021, and 2023. The Medicaid Drug Rebate Program requires manufacturers 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 manufacturer's covered outpatient drugs. Companies with such rebate agreements are required to submit certain drug pricing information to CMS, including monthly AMP data and quarterly ASP data. Senior Counsel Gregory Becker, with the assistance of Program Analyst Mariel Filtz, represented OIG.

Action Details

  • Date:May 2, 2024
  • Enforcement Types:
    • CMP and Affirmative Exclusions