Lexology January 5, 2023
On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP).
First, OIG encourages CMS to “actively review current [ASP] guidance” in relation to nine topics to determine if additional guidance would ensure more accurate and consistent ASP calculations. OIG noted that previous audit efforts faced challenges in identifying noncompliance because of “broad regulations” allowing manufacturers to make “reasonable assumptions in the absence of specific guidance.” Nothing in the reports suggests that the “reasonable assumption” concept should be revisited.
Second, OIG believes CMS could bolster its oversight of ASP submissions, due to gaps in the same that resulted in inaccurate data...
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