Industry Responds to the Physician Payment Sunshine Act
BY CHARLES CAO, APRIL 15, 2008
The medical device industry has been closely following progress on the Physician Payment Sunshine Act (S. 2029), which is currently under review in Congress and intends to increase transparency in the relationship between physicians and manufactures. This bill was first introduced by Senators Grassley, Kohl, Kennedy, Klobuchar, McCaskill and Schumer on September 6, 2007.
To summarize, S. 2029 requires drug and device manufacturers with annual revenues greater than $100 million to disclose to the Secretary of Health and Human Services (HHS), on a quarterly basis, anything of value (greater than $25) given to physicians. The disclosure must include the physician's name, the value and date of the payment or gift, its purpose, and what, if anything, was received in exchange. The bill then requires HHS to make the information available to the public through a searchable website.
AdvaMed has voiced their support and recommendations for the bill. One recommendation is to make the new legislation preempt any state disclosure law, simplifying the compliance process and reducing patient confusion. Another recommendation suggests changing the exemption floor of $100 million in revenue to $250,000 in reportable physician payment and not allowing exemption when a physician has both an equity interest in the company and influence over purchasing. Finally, it was stressed that companies should have opportunities to provide context for the information released to the public, in an effort to limit misconceptions about the nature of the payments to the physicians.
GPO Premier has also endorsed the bill and provided recommendations. One recommendation calls for restricting the application of the bill to only practicing and research physicians. Another recommendation calls for expanding the detail of disclosure to include physician’s license number, name of the affiliated entity, and the medical issue addressed by the transaction. Finally, Premier advocates the bill be applied to all companies, regardless of sales or revenue.
MDMA has said they are working with Congressional staff to ensure the bill provides transparency without being unnecessarily burdensome to small manufacturers.
The bill is currently under review by the Senate Finance committee. No date has been publicized for a vote, though there has been significant media attention and ongoing hearings on the bill.