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Drug Price Reporting

In each CMP case resolved through a settlement agreement, the settling party has contested the OIG's allegations and denied any liability. No CMP judgment or finding of liability has been made against the settling party.

2015

05-08-2015 OIG Enforcement Case
Kansas Pharmaceutical Company Settles Case Involving Drug Price Reporting
On May 8, 2015, B.F. Ascher & Company, Inc. (B.F. Ascher), a Kansas pharmaceutical manufacturer, entered into a $178,000 settlement agreement with OIG. The settlement agreement resolves allegations that B.F. Ascher 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 from 2012 to 2014. 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.
05-06-2015 OIG Enforcement Case
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.
03-11-2015 OIG Enforcement Case
New Jersey Pharmaceutical Company Settles Case Involving Misrepresenting Drug Pricing Data to Medicare
On March 11, 2015, Sandoz, Inc. (Sandoz), a New Jersey generic pharmaceutical manufacturer, entered into a $12,640,000 settlement agreement with OIG. The settlement agreement resolves allegations that Sandoz misrepresented drug pricing data to the Medicare program. Federal law requires drug makers to report both accurate and timely "Average Sales Price" information to the Centers for Medicare & Medicaid Services (CMS). CMS uses this information to set payment amounts for most drugs covered under Medicare Part B. Inaccurate pricing information can cause Medicare to overpay for these drugs. Senior Counsels Geeta W. Kaveti and Nicole Caucci represented OIG.

News Release

2011

12-16-2011
Sandoz, Inc., New Jersey, agreed to pay $230,000 to resolve Civil Monetary Penalties liability under the Medicaid Drug Rebate Program. Sandoz, Inc. failed to timely submit required drug pricing information.
08-23-2011
Savient Pharmaceuticals, Inc. (Savient), New Jersey, agreed to pay $100,000 to resolve Civil Monetary Penalties liability under the Medicaid Drug Rebate Program. Savient failed to timely submit required drug pricing information.

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Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201