Update on Medical Device Manufacturer Marketing Activities: State and Federal Restrictions and Reporting Requirements

This post was written by Elizabeth B. Carder-Thompson and Katie C. Pawlitz. States are increasingly imposing marketing restrictions on device manufacturers through laws that previously focused more specifically on pharmaceutical manufacturers. These laws affect compliance activities and relationships with providers, and create new reporting obligations. The impact is significant in that these state laws directly influence how companies conduct business and interact with customers, but implementation is complicated by the variations that exist between states. Most significantly, under the federal Patient Protection and Affordable Care Act ("ACA"), beginning March 31, 2013, and annually thereafter, device manufacturers must report payments to physicians and teaching hospitals during the preceding calendar year. This means manufacturers must be prepared to track payments in a comprehensive manner as of January 1, 2012. The Centers for Medicare & Medicaid Services ("CMS") is now in the early stages of developing specific provisions to implement the new ACA provisions, with publication of proposed regulations to occur not later than October 1, 2011. This Client Alert provides a brief overview of the existing state marketing laws that apply to device manufacturers, including recent changes to those laws, as well as federal reporting requirements under the ACA. Although the laws discussed may apply broadly to other entities, we refer in our Client Alert specifically to medical device manufacturers. To read the full Alert, click here.

Read more detail on Recent Administrative Law Posts –

Legal notice about the Update on Medical Device Manufacturer Marketing Activities: State and Federal Restrictions and Reporting Requirements rubric : Hukuki Net Legal News is not responsible for the privacy statements or other content from Web sites outside of the Hukuki.net site. Please refer the progenitor link to check the legal entity of this resource hereinabove.

Do you need High Quality Legal documents or forms related to Update on Medical Device Manufacturer Marketing Activities: State and Federal Restrictions and Reporting Requirements?

This entry was posted in Administrative law and tagged , , , , , , , , , , . Bookmark the permalink.

Leave a Reply