Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) reintroduced the “Physician Payments Sunshine Act of 2009” on Thursday, January 22, 2009. This legislation will mandate pharmaceutical and medical device companies to publicly report all money or gifts (for example: consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel, education, research, charitable contributions, etc.) given to physicians exceeding a cumulative value of $100 per year.

The proposed legislation differs from the legislation introduced by these Senators in 2008 in some key areas. Eliminated from this bill is the right of physicians to review information prior to release for public view. Once this information is published, doctors will be allowed to contest the reports and the claims will be checked and validated by HHS staff.

Contrary to the MedPAC recommendations, Congress did not include product samples in the reporting.

The information will be available by the fall of 2011 on a searchable public website. The details of the public report will include the following:

• name of the recipient
• business address
• specialty
• value and nature of the payment
• date of the payment
• name of the drug or device (if applicable)

The website will be updated annually on June 30 of each year.

The bill proposes a delayed reporting for payment if there are product development agreements and clinical investigations related to a new drug, device or medical supply. This information will be reported after the date of approval/clearance by the FDA or two calendar years after the payment date, whichever occurs earlier.

The language will require the Secretary of HHS to produce an annual report to Congress and the states. Another change from the 2008 proposed legislation is how state disclosure laws will be affected. The original bill pre-empted all state requirements on disclosure, resulting in one uniform standard. The revised legislation will allow states to collect information not covered by federal law.

This proposed legislation does not include reporting of money given to medical societies contrary to the MedPAC recommendations. However, Senator Grassley is considering adding an amendment to this effect during the mark-up process.

The Heart Rhythm Society Staff  have been meeting with Capitol Hill Staff and will report on any updates.