MDNews - San Antonio

++++++++++++ + +++ +LEGAL U +++ ++++++++++++ The Sunshine Act FinalPhysicians Rule: Implications for By Cassia M. Ysaguirre Y OU MAY WANT to think twice before accepting anything of value from a manufacturer1 of drugs, devices, biologics, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) issued the much-anticipated final rule implementing the federal Physician Payment Sunshine Act. Enacted in 2009, the Sunshine Act requires medical supply and drug manufacturers to annually report certain payments or transfers of va lue. The Sunshine Act f ur ther requires manufacturers and applicable g roup pu rch a sing org a n i z at ions (including physician-owned distributorships) to report physician ownership or investment interests on an annual basis. CMS has the authority to impose penalties of up to $10,000 for each payment or other transfer of value not reported timely, accurately, or completely, up to a per annual report cap of $150,000. 18 | San Antonio MD NEWS I MDNEWS.COM Public Disclosure The final rule requires medical supply and drug manufacturers to start collecting data on August 1, 2013, and to submit their first annual reports to CMS by March 31, 2014. CMS will publish most of the reported information on a public website by September 30, 2013. This website will subject physicians to increased scrutiny not only from their patients, but also from state and federal enforcement authorities. The f ina l r ule commenta r y emphasizes that compliance with the repor ting requirements does not exempt manufacturers, physicians or others from any potential liability associated with payments or other transfers of value, or ownership or investments interests (e.g., potential liabilit y under t he federa l A ntiKickback Statute or False Claims Act). Applicability and Content + Manufacturers must report the following information for each payment or other transfer of value: + Physician name, address, specialty, national provider identifier (NPI) and state license number(s) + Date and amount of payment + Form of payment (e.g., cash, in-kind items/services, ownership interest, dividend/profit) + Nature of payment (e.g., consulting or speaker fee, honoraria, gift, entertainment, food/beverage, travel/lodging, education, research, royalty/license, charitable contribution, grant) + Name of related covered drugs, devices, biologicals or medical supplies + Whether the payment or other transfer of value was provided to a third party (e.g., a charity) at the request of or designated on behalf of a physician + Whether the payment or other transfer of value was provided to a physician or the immediate family of the physician

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