Frequently Asked Questions

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Is a distributor for an applicable manufacturer responsible for reporting to CMS payments or other transfers of value to health care professionals?

If a distributor holds title to any covered drug, device, biological, or medical supply, the distributor meets the definition of an applicable manufacturer as defined at 42 C.F.R. ยง 403.902, and is subject to Open Payments reporting requirements. A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and possesses the right to re-sell the inventory of the products that it has purchased. Applicable manufacturers that have products with titles held by distributors do not need to report payments or other transfers of value made by the distributor to covered recipients. The distributor that holds title will be subject to the same reporting requirements as applicable manufacturers, and thus will be responsible for reporting the transfer of value.

Key words: Open Payments, Sunshine Act

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