LESS THAN ONE YEAR FROM NOW, onMarch 31, 2014, drug manufacturers will disclose to the government nearly all of the payments they will have made to physicians and teaching hospitals forthe five-month period ending on December 31, 2013. These voluntary disclosures of confidential commercial information will include a broad array of payments, encompassing everything from meals to consulting fees to research-related payments. The disclosures will not be made in response to a competitor’s document requests in civil litigation, nor to an inspector’s request to review records or an investigator’s subpoena or search warrant. And the disclosures will not remain confidential — the government will make them publicly available by posting them on the Internet no later than September 30, 2014. Drug manufacturers will make these disclosures less than a yearfrom now in orderto comply with the requirements of the Physician Payments Sunshine Act, enacted in 2010, and its implementing regulations, issued by the Centers for Medicare&Medicaid Services (“CMS”) attheU.S.Department of Health and Human Services (“HHS”) on February 1, 2013.
Sunshine Requirements Although similar “sunshine” disclosure requirements have been operative in a handful of states for several years, the new federaldisclosure requirements applynationwide.In2015 (and each year thereafter), drug manufacturers will be required to disclose to CMS the payments they made to physicians and teaching hospitals in the U.S. — fromAlaska to Florida — during the preceding calendar year.
Payment Disclosures: Under the law, drug manufacturers must report every “payment or other transfer of value” (including gifts, consulting fees, research activities, speaking fees, meals, and travel) provided to a physician or a teaching hospital. This requirement applies to manufacturers of drugs and biologics that are reimbursed by a federal healthcare program and entities under common ownership with such manufacturers. (It also applies to manufacturers of medical devices and supplies.) For each payment, the report must include: |