The OIG has issued a report entitled "Average Sales Prices: Manufacturer Reporting and CMS Oversight." According to the OIG, for each quarter under review, over 40% of manufacturers submitted average sales prices (ASP) late, but most submitted the data within 10 days after the deadline. The OIG observes that current CMS methods for recording ASP data, including the use of manual processes, "may inhibit efficiency and result in potential errors." In addition, almost one-fifth of labeler codes with ASP submissions were associated with manufacturers that were not actually required to provide these prices, and in some cases Medicare payment amounts were based solely on submissions from manufacturers that did not have rebate agreements in effect. According to the OIG, if these manufacturers chose not to report ASPs, CMS would be unable to calculate ASP-based Medicare payment amounts for these drugs. In the report, the OIG recommends that CMS (1) develop an automated system for collecting ASP data, and (2) seek a legislative change to require all manufacturers of Part B-covered drugs to submit ASPs. CMS concurred with the first recommendation, but did not agree to seek a such legislative change at this time. In a separate report, “Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2008," the OIG noted that in 2008, the ASP for 80 HCPCS codes exceeded average manufacturer prices (AMP) by at least 5% in one or more quarters. If reimbursement amounts for these 80 codes had been lowered to 103% of the AMP, as is authorized by the statute, it would have reduced Medicare expenditures by almost $22 million. The OIG recommends that CMS develop a process to adjust payment amounts based on the results of OIG’s pricing comparisons (CMS concurred), and that CMS lower Medicare reimbursement amounts for drugs that meet the 5% threshold (CMS did not agree). CMS also outlined steps it is taking to address a third OIG recommendation – that CMS ensure that drug manufacturers are submitting the required AMP data in a timely manner.