Pharmaceutical and medical device manufacturers take note: In the recently issued calendar year (CY) 2022 Medicare Physician Fee Schedule Final Rule (Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized a number of important updates to the federal Physician Payment Sunshine Act (Sunshine Act) regulations and related Open Payments reporting system available on the CMS website. These revisions demonstrate CMS’ ongoing interest in enhancing both the integrity of the Sunshine Act reporting regime and the agency’s ability to engage in vigorous oversight of financial relationships between manufacturers and covered recipients. The stakes have never been higher, as CMS is updating the reporting rules against the backdrop of a new wave of enforcement in this area by the Department of Justice (as discussed here). Continue reading

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