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Drug Manufacturers’ Noncompliance with Average Manufacturer Price Reporting Requirements

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Topics: Prescription Drugs | Quality | Regulation

The U.S. Department of Health and Human Services’ (HHS) Office of the Inspector General’s (OIG) report found that over 75 percent of drug makers do not fully comply with federal average manufacturer price (AMP) reporting requirements.  The report noted that noncompliant companies did not submit any AMP information, filed their information late, or filed incomplete information. 

 

From the report:

 

The Social Security Act sets forth price reporting obligations for certain manufacturers, including the obligation to report AMP data to CMS. During 2008, AMP was generally defined by statute to be the average price paid to the manufacturer for the drug in the United States by wholesalers for drugs distributed to the retail pharmacy class of trade. Manufacturers must provide CMS with the AMP for each of their covered outpatient drugs within 30 days after the end of each month and each quarter.

Full Report: Drug Manufacturers’ Noncompliance with Average Manufacturer Price Reporting Requirements (PDF | 398 KB)  exit disclaimer small icon 

Department of Health and Human Services Office of the Inspector General. (2010). Drug manufacturers’ non compliance with average manufacturer price reporting requirements. Levinson, D.

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