2 Ways the Sunshine Act Proposal Affects the Device Industry

CMS has proposed updates to the Sunshine Act which requires applicable manufacturers and group purchasing organizations to report payments, transfers of value, ownerships or investment interests to CMS in efforts to induce greater transparency in the industry.

In addition to proposing to eliminate the CME exclusion, the proposal changes reporting requirements of other device manufacturers and medical suppliers.

Under the proposal, device manufacturers and medical suppliers would be required to report the marketed name for devices or supplies related to a particular payment. Currently, only drug and biologic manufacturers are required to report marketed names while device manufacturers and medical suppliers can report either the marketed name, the product category or the therapeutic area.

Additionally, the proposal would eliminate the "covered device" definition, as it suggest it is the same as and falls under the "covered drug, device, biological or medical supply" definition.

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Interactive CMS Tool Helps Hospitals Make Sense of Proposed MU Flexibility

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