FDA/CMS Announce Long Delayed Ruling on Sunshine Act

As some of you may know, the FDA/CMS (Centers for Medicare and Medical Services) have been (very) late in issuing their final ruling as to when physician Sunshine Act reporting will begin. Those of you who follow me via Twitter and on the i3 Community site know that I’ve been posting updates about the Sunshine Act compliance deadlines and extensions communicated by the FDA and CMS since December of 2011 (http://i3.infinityinfo.com/blogs/tags/tag/sunshine-act).

Well, they finally made their decision today and released the details the life science industry has anxiously been awaiting – http://www.modernhealthcare.com/article/20130201/NEWS/302019903?AllowView=VW8xUmo5Q21TcWJOb1gzb0tNN3RLZ0h0MWg5SVgra3NZRzROR3l0WWRMWGJWdjBBRWxiNUtpQzMyWmVwNTMwWUpieWk=.

In a rare act of kindness, the CMS has provided manufacturers and GPO?s a bit of extra time to get things in order. By law, manufacturers and GPO’s were only required to provide a 3 month notification of when data collection should begin, however, they have now given 6 months notice.

Starting August 1, 2013, drug and device companies will be required to collect data about payments, gifts and other transfers of value given to physicians and teaching hospitals (greater than $10). This final ruling also requires manufacturers and GPOs to report the first round of data collection to the CMS by March 31, 2014. Data must be submitted annually by the 90th day of each calendar year thereafter.

What does this mean? Companies that have not yet implemented a solution for meeting the reporting requirements of the law now have a bit of breathing room, although not much. Microsoft Dynamics CRM provides an excellent platform for adding functionality that will allow companies to more easily meet these requirements – Infinity would love to show you how!

If you have any questions or would like to discuss further, please don’t hesitate to reach out to me at mhammons@infinityinfo.com.