Pending Federal Marketing Legislation and the Potential Impact for Healthcare Conventions

The federal Physician Payments Sunshine Act (PPSA) was reintroduced January 22, 2009, and this time it contains stronger provisions targeting healthcare industry interactions with healthcare professionals (the original version of the bill was introduced in September 2007, but there was little activity on it during 2008).  For example, the revised bill, introduced again by Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.), provides for penalties up to $1 million for knowingly failing to disclose payments or gifts worth $100 or more given to physicians.  An exception to the reporting requirement would be a gift to a covered recipient of educational materials “that directly benefit patients or are intended for patient use.”

The new bill also contains language that outlines to whom the law is intended to apply:  “any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient).”  “Covered recipient” is defined in the bill as follows:

(A) A physician.
(B) A physician medical practice.
(C) A physician group practice.

While there is no specific language that references “all healthcare professionals” in the bill, it does appear that the lawmakers are attempting to cast a wide net to include a variety of different healthcare professionals.  Also, the bill specifically mentions activities/transfers of value related to the marketing of “drug, device, biological, or medical supply,” making clear that both pharmaceuticals and medical devices are included in the scope of the bill.
 
In addition, the bill contains language that relates to the preemption of state marketing laws:
(A) IN GENERAL- Effective on January 1, 2010, subject to subparagraph (B), the provisions of this section shall preempt any law or regulation of a State or of a political subdivision of a State that requires an applicable manufacturer (as defined in subsection (g)) to disclose or report information (as described in subsection (a)) regarding a payment or other transfer of value provided by the applicable manufacturer to a covered recipient (as so described).

(B) NO PREEMPTION OF ADDITIONAL REQUIREMENTS- Subparagraph (A) shall not preempt any law or regulation of a State or of a political subdivision of a State that requires the disclosure or reporting of information not required to be disclosed or reported under this section.

What this means is that, if passed (and there are indications that it will likely pass in some form), it will preempt state laws with provisions that are similar, but it will not preempt state laws with provisions that are more restrictive than the scope of the PPSA.

View the full text of the PPSA.

Also potentially on the horizon is another possible new federal bill that would address disclosure of commercial support given to “physician groups” and “professional organizations” – this initiative would be separate from the PPSA.  It appears that whether or not this new legislation will be considered necessary may be linked a report from the Medicare Payment Advisory Commission (MedPAC) expected to be released in March, according to discussions HCEA staff had with Christopher Armstrong, Investigative Counsel, U.S. Senate, Committee on Finance.  MedPac is an independent Congressional agency established to advise the U.S. Congress on issues affecting the Medicare program.  Here’s a link to an outline that the March MedPac report is supposed to be based on. 

HCEA will continue to monitor the progress of the PPSA and the other potential new federal legislation governing healthcare industry interactions with physicians, and will keep members informed about the latest developments.