The Physician Payments Sunshine Act of 2009: Better or worse than the 2008 bill?

Medical society executives and presidents are wondering how the recently introduced bill, S. 301: Physician Payments Sunshine Act of 2009, would impact their physician members.

Introduced on January 22, 2009, by Senators Charles E. Grassley (R-IA) and Herb Kohl (D-WI) the Sunshine Act would require pharmaceutical and medical device manufacturers to report a wide range of payments or other transfers of value to physicians and physician-owned entities to the Secretary of Health and Human Services (HHS). Grassley and Kohl drafted a similar bill introduced in 2007 and modified by the House in 2008 but never acted on by Congress.

Comparisons between 2008 & 2009

Direct CME payments must be reported
Under the 2007 and 2008 versions, manufacturers were required to report payments made to physicians for “participation in a medical conference, continuing medical education, or other educational or informational program or seminar.” In other words indirect payments were included – payments made by medical societies, for example, using manufacturers’ sponsorship support. The 2009 bill omits this requirement and instead calls for a direct payment reporting system. It reads:

“In the case where an applicable manufacturer provides a payment or other transfer of value to an entity or individual at the request or designated on behalf of a covered recipient, the applicable manufacturer shall disclose that payment or other transfer of value under the name of the covered recipient.”

While it isn’t clear how HHS would interpret and formulate a rule based on this section of the bill, on first blush it looks as if manufacturers will not need to report medical education sponsorships paid to medical societies. But, payments made from the manufacturer directly to a physician for “…serving as a faculty member or as a speaker for a continuing medical education program” must be reported.

Reporting threshold changed – to $100

Cumulative payments valued at $100 or more must be reported. The 2007 bill originally called for reporting of payments as low as $25, an amount later raised, in 2008, to $500. The bill’s definition of payments or transfers of value encompasses 14 items but allows the HHS Secretary to define more.

Stricter state laws would apply

The 2009 bill preempts state sunshine laws except those where requirements are stricter.

What do you think?

American Academy of Family Physician President Ted Epperly, MD, welcomes transparency and agrees with the overall intent of the bill but worries that it “…could discourage physicians from participating in CME.” He considers this version overly onerous, saddling physicians with an inordinate amount of paperwork. Epperly wants a return to the 2008 version, which he considered the “right thing to do” but less restrictive.

Tell us what you think!

For additional information & commentary:

• Text of bill
• Track the bill
• Policy and Medicine: Physician Payment Sunshine Act 2009 Introduced
• AdvaMed Statement on Physician Payments Sunshine Act of 2009
• AAFP Expresses Concerns About Revised Physician Sunshine Act
• Statement of NLARx Director Sharon Treat on the "Physician Payments Sunshine Act"
• Statement from The Prescription Project, regarding the revised Physician Payments Sunshine Act