Having delivered draft regulations—late—for the aggregate spending rules of the 2010 Affordable Care Act in December 2011, CMS said at the time that it hoped to have final rules issued “as soon as possible” during the current year, with the possibility of requiring data collection to begin during this year. Now, in a blog post on May 3, CMS said that it still “intends to release the final rule later this year,” but “will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013.”
When the Sunshine Act was passed, it was possible that data collection of payments and “transfers of value” between pharma manufacturers and healthcare providers could have started in January this year, and some pharma companies began building out the IT systems necessary to meet this deadline. Now, with a second delay, and with the Supreme Court contemplating a repeal of the entire Affordable Care Act, it’s conceivable that the entire program will go away. But that’s highly doubtful, according to Animesh Gandhi, director of information management at Alliance Life Sciences Consulting Group (Somerset, NJ). He points out that the Sunshine Act was passed with bipartisan support; that multiple states (including CA, VT, MN, WVA and MA) have some form of aggregate spend reporting on their books now (and many more states were contemplating legislative action until the Affordable Care Act was passed); and this type of regulatory requirement is now law in France and other countries. “The recent episode of WalMart allegedly involved in illegal payoffs in Mexico has put the Foreign Corrupt Practices Act high on corporate compliance concerns; the Sunshine Act provides protection for life sciences companies worried about this.”
Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) issued a letter stating that the delay is “disappointing,” and that “Given all the extra time, CMS will have no further excuses for not accomplishing these goals.”
CMS noted that it had received over 300 comments after the draft rules were published in December; its latest communication also cites “operational and implementation issues,” and the “ability to ensure the accuracy of the data that is collected” as reasons for delaying.