On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and device, biological, or medical supply manufacturers to physicians or teaching hospitals, and disclosure of certain ownership and investment interests in manufacturers and group purchasing organizations (GPOs). Its goal is to implement a national, Internet-based disclosure program for Payments and ownership and investment interests, to promote transparency and decrease the potential for conflicts of interest. The first reports from mandated reporters are due to CMS by March 31, 2014, and must reflect payments made on or after August 1, 2013, through December 31, 2013. Note that registration by mandated reporters is required prior to reporting (within 90 days of the end of the reporting period).
The regulations contain detailed guidance related to who must report and what must be reported, along with guidance on the mechanisms of reporting, including Payment classification and attribution rules. We have listed below in summary fashion some of the key features of the Sunshine Act's payment reporting provisions applicable to manufacturers, together with our suggested responses.
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Topics: CMS, Covered Products, Disclosure Requirements, Manufacturers, Medicaid, Medical Devices, Medical Supplies, Medicare, Reporting Requirements, Sunshine Act
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