The Social Security Act requires the OIG to notify the HHS Secretary if the average sales price (ASP) for a particular drug exceeds the drug’s AMP or widely available market price (WAMP) by a threshold, currently set at 5%. If that threshold is met, the Secretary is authorized to disregard the drug’s ASP and substitute the lesser of the WAMP or 103% of AMP. The OIG has released a series of reports comparing Medicare Part B drug ASPs with AMPs. While CMS has made no price adjustments in response to these reports to date, CMS’s 2012 Medicare physician fee schedule rule specifies the circumstances under which AMP-based price substitutions will occur beginning January 2012 (CMS is not implementing a price substitution policy based on the comparison of WAMP to ASP for 2012 in light of complicated operational issues). According to a recent OIG report comparing second quarter 2011 ASPs and AMPs, under CMS’s price substitution policy, reimbursement for 7 drugs would have been reduced in the fourth quarter of 2011, saving an estimated $696,000 (the savings would have been higher if additional drugs with partial AMP data were included). Separately, the OIG has issued a report comparing ASPs to WAMPs for 14 drugs that have been identified in previous OIG reports as repeatedly exceeding the 5% ASP-AMP threshold. According to the OIG, “limitations and irregularities in the sales data provided by the distributors and manufacturers of the 14 drugs called into question the data’s accuracy and reliability, and prevented us from measuring AMPs against the threshold.” For instance, some sales data did not reflect discounts and rebates passed on to providers, and the reported total number of units sold differed substantially from the number reported through quarterly ASP submissions. To fulfill its statutory mandate, the OIG will consider alternative methodologies to conduct pricing comparisons, including directly surveying providers.