PPACA Incorporates Disclosure Requirements Under "Sunshine" Laws
By: Louis C. Szura
The new PPACA legislation includes a version of the previously proposed Physician Payment Sunshine Act, which requires drug, medical device, biological or medical supply manufacturers to disclose direct payments or transfers to physicians and teaching hospitals that are $10 or more (or total over $100 in a calendar year). It also requires those manufacturers to disclose any non-public ownership or investment interests of physicians and their immediate family members in the manufacturers. Those reporting requirements do not take effect until March 31, 2013 and the information will be available online to the public.
However, there are some significant limitations on these reporting requirements. First, there is no requirement to report payments made through third parties where the manufacturer does not known the identity of the physician. This means that typical survey and marketing research will not be covered. Second, certain transfers are not covered, including the loan of medical devices for under 90 days, product samples intended for patient use, discounts (including rebates) and other items. Third, in the case of payments made pursuant to product research or development of a new drug, technology or device in connection with a clinical investigation, the manufacture can delay reporting the payment for either four years or until the drug, device or technology is approved by the FDA. Overall, even with these limitations, the relationships between manufacturers and physicians will be clearer to the public. For additional information about these regulations, please contact Louis Szura.
