pharmaceutical litigation legal team

Impact of the Physician Payment Sunshine Act on State Regulations: Where Federal Overrules State

By on May 30, 2013 - Comments off

The Physician Payment Sunshine Act (PPSA) was not established to replace state laws, but to build on them and remove redundancies. The PPSA requires “applicable manufacturers,” defined as “a manufacturer of a covered drug, device, biological, or medical supply,” to disclose payments and additional transfers of value to physicians or teaching hospitals. The Act defines “physician” as a doctor of medicine, a podiatrist, a dentist, a chiropractor or an optometrist.

In addition to disclosing all payments and transfers of value to physicians, the PPSA also requires that manufacturers report aggregate marketing expenses by state. Since several states and the District of Columbia have established their own laws related to disclosure of payments/gifts to physicians, the PPSA includes a preemption clause that overrules state laws that require disclosure of the same types of payments, or transfers of value. Aside from this, nearly all existing state regulations are kept intact. As a result, however, manufacturers may be required to report payments to the U.S. Department of Health and Human Services as well as state health care authorities.

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