Why OIG Did This Review. Medicare and its enrollees spend nearly $40 billion annually to cover a limited number of Part B outpatient prescription drugs and biologicals. (Part B drugs are generally drugs that are injected or infused in physicians’ offices or hospital outpatient settings.) The Centers for Medicare & Medicaid Services (CMS) uses manufacturer-reported average sales prices (ASPs) - which are based on manufacturers’ actual quarterly drug sales - to calculate provider payment amounts for these drugs. When drug manufacturers’ data are not accurate, Medicare and its enrollees may make inappropriate payments for these drugs. The Consolidated Appropriations Act, 2021, directed OIG to review manufacturer-reported ASP data. We conducted this evaluation to provide insight into CMS’s oversight of ASP data, including assessing their accuracy before using them to calculate Medicare Part B payment amounts. How OIG Did This Review. To determine how CMS oversees the accuracy of manufacturer-submitted ASP data, we (1) collected and reviewed CMS’s standard operating procedures for oversight of ASP data; and (2) interviewed CMS staff regarding CMS’s oversight processes and challenges to conducting effective oversight. We reviewed 5 years of Medicare Part B ASP and drug payment data from the first quarter of 2016 to the fourth quarter of 2020. We determined the number of drug codes for which CMS calculated a payment amount using a payment methodology other than ASP because the ASP data were either unavailable or invalid (i.e., the ASP data were equal to or less than zero). We also identified the number of drugs that CMS categorized as having data values missing.
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