Sunshine Act Promises Public Transparency in 2014

Starting in September 2014, members of the public will be able to access a searchable database containing information about gifts and payments that pharmaceutical companies have given to physicians. The American Medical Association’s website adds:

The long-awaited final rule for the implementation of the Physician Payment Sunshine Act — a 2010 law requiring financial ties between manufacturers and medicine to be disclosed — was released on Feb. 1. The Centers for Medicare & Medicaid Services addressed several issues pertaining to the reporting of fees, meals, travel expenses and other transfers of value. Those issues were raised by the American Medical Association and other organized medicine groups over an earlier proposed version of the rule. For instance, CMS will allow doctors additional time to resolve disputes over any inaccurate data and will not require certain indirect payments from continued medical education programs to be reported on the database.

The release of the final regulations has arrived after more than 13 months of proposals, which included input from more than hundreds of interested parties like medical organizations, healthcare professionals, industry members, and even consumers. Forbes released this statement from Scott Liebman, a principal at Porzio, Bromberg & Newman and Vice President at Porzio Life Sciences:

“At its essence, the Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to CMS information regarding payments, ownership, investment interests and other transfers of value to physicians and teaching hospitals. The intent of this law is to bring potential conflicts of interest to light with the goal of driving down healthcare costs.”

Pharmaceutical manufacturers will need to make sure they are compliant with the new regulation or they will be subject to hefty fines—CMS can levy $10,000 for failing to report gifts, and the penalty increases to $100,000 if a manufacturer is found to have knowingly omitted payment information. The amount of effort that will need to go into complying with the new law is staggering; it is estimated that approximately 450,000 thousand physicians have financial relationships with pharmaceutical companies or device manufacturers. Additionally, CMS “projects that half of those physicians and their staffs actually will review their reports compiled by the companies before publication of the first year of data — causing a total administrative burden to doctors valued at roughly $59 million.”

Around the Web

Public Can See Pharma Payments to Doctors Starting in 2014 [American Medical Association]

The Sunshine Act Is Finally Final [Forbes]