OIG Advisory Bulletin on Drug Manufacturer AMP/ASP Reporting Enforcement Initiative
On September 28, 2010, the HHS Office of Inspector General (OIG) issued an Advisory Bulletin that notifies drug manufacturers of an OIG enforcement initiative concerning the timely submission of data under the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, the Federal Upper Limit (FUL) Program, and the Medicare Part B outpatient prescription drug benefit. The Bulletin states that in light of OIG's findings that certain manufacturers have failed to submit required product and pricing data in a timely fashion, the OIG intends to pursue enforcement actions against noncompliant manufacturers as appropriate. The bulletin coincides with OIG release of a report, "Drug Manufacturers' Noncompliance With Average Manufacturer Price Reporting Requirements," which determined that in 2008, more than half of the drug manufacturers that were required to submit quarterly average manufacturer price (AMP) data to CMS failed to comply with reporting requirements in at least one quarter. In addition, more than three-quarters of manufacturers submitted late, incomplete, or no AMPs in at least 1 month of 2008. The OIG recommends that CMS take action against manufacturers that do not meet quarterly and monthly AMP data submission requirements. CMS concurred, and stated that it will begin referring manufacturers that submit incomplete quarterly and monthly data to OIG for civil money penalty consideration. The OIG "looks forward to expanding its collaboration with CMS regarding administrative remedies for noncompliance with AMP reporting requirements."
