The Physician Payment Sunshine Act will require manufacturers of medical devices and prescription drugs covered by Medicare and Medicaid to report all grants, consulting fees, and travel reimbursements they provide to physicians and teaching hospitals.
Under the proposed rule, companies would receive a $150,000 fine for not reporting any gifts or payments totaling more than $10. Information on those payments would be posted on a public website where affected companies and individuals would be able to review the data before it is made public. Information found to be inaccurate could be contested and corrected.
Charles Rosen, MD, co-founder of the Association for Medical Ethics, said the PPSA is designed to "rein in undue and harmful influence of money on medicine." Olsen and four other physicians sent a Jan. 15 letter to White House Chief of Staff Jacob Lew requesting that "the administration implement the PPSA without any further delay." The letter also suggested that "the final rules are being held up at the White House Office of Management and Budget."
The Sunshine Act has run into some opposition. Some organizations and manufacturers have raised issues ranging from the $10 threshold for reporting payments to suggestions that the proposed payment reporting process is too complex and could discourage physicians and hospitals from participating in research projects.
In a statement delivered at a September 2012 Senate hearing to consider implementation of the PPSA, the Association of Clinical Research Organizations (ACRO) outlined several concerns about its potential impact. They included confusion about how payments and transfers of value to physicians and hospitals will be reported and concerns that data provided to the CMS "has great potential to be misrepresented."