MDMA Offers Insight into the Physician Payment Sunshine Act
BY LAUREN UZDIENSKI, FEBRUARY 12, 2009
On a members-only webinar this week, the MDMA provided detailed information on the Physician Payment Sunshine Act, from its origins to the nuances of compliance to a timeline for implementation.
The bill was first introduced in 2007 by Senators Grassley and Kohl, with a similar version introduced in the House in 2008. The latest version was introduced in January and will cover any transaction valued at $100 or more as well as require physician disclosure of any ownership stake in a manufacturer or GPO. The information will be made available on a searchable, "clear and understandable" website maintained by HHS.
There are a handful of exceptions to the disclosure rules. For pre-commercial companies, disclosure can be delayed until after the company receives FDA clearance or up to two years after the transaction is completed, whichever comes first. The MDMA has recommended that pre-commercial companies be exempt from the legislation. Per the current version of the bill, product samples, educational materials, discounts, donations-in-kind and dividends are among the items exempt from disclosure.
When will these regulations go into effect? Assuming the bill is passed, the first reporting period will begin on January 1, 2010, with March 31, 2011 marking the deadline for the first submission of disclosures. Disclosures will be due on March 31 of each year thereafter.
The bill has been referred to the Senate Committee on Finance.
