The Sunshine Act is about transparency; it is on the minds of Pharmaceutical and Biotech Companies (drugs & devices) since they are required to report Physician Payments starting in 2013, however, Centers for Medicare and Medicaid (CMS) have not yet published a final rule. The purpose of the Act is to make public financial dealings between physicians and Life Science (manufacturers) companies. Another way of looking at the Act; ” The idea is that the more transparent the process, the more public scrutiny will steer all parties to better practices and will guard against questionable behavior” I am not an attorney but from my perspective the Physician Payments under scrutiny appears to be very broad, for example, the list below are some areas that need to be reported if the value (transfer) is more than $25.00 and if the manufacturer’s gross annual revenue is more than 100 million; I have found that these dollar amounts apparently are different depending on what/where/when information is read. Please be aware that this list is not a complete compilation and the dollar amount may be questionable.
Research funding or grants
Education, tuition for continuing-education
Direct Compensation for Serving as a Speaker for Medical Education Programs
Ownership or investment interests
stock or stock option grants
Any categories of information the secretary(of Health and Human Services) determines appropriate
There is an article in Applied Clinical Trials http://www.appledclinicaltrialsonline.com April issue title “Sunshine Act’s Impact” that is worth reviewing. The Sunshine Act is not new however drug and device companies are trying to decide how to implement the Act to obviously be compliant but not to negatively impact how the physician and key opinion leaders will interact with them; stay tuned for yet another final ruling as lawmakers work on making relationships and thus, financial transactions/disclosure initiatives more visible.