One component of the Affordable Care Act that is of particular interest to medical device and pharmaceutical companies is the Physician Payment Sunshine Act (the Sunshine Act). For those who need a refresher, the act requires all manufacturers of drugs and medical devices to annually report any payments or other “transfers of value” to physicians and teaching hospitals—consulting fees, grants, clinical research, royalties, samples, and even food. This information will then be posted on a public website so that consumers can see exactly how much is being paid to their physician by pharmaceutical and med device companies.
There is only one way to describe 2012 as it relates to the Sunshine Act: hurry up and wait. One year ago, CMS announced it would collect feedback on the rule before issuing its final guidance. At that point I don’t think anyone thought that one year later we’d be sitting in almost the exact same position, wondering what it all means for pharmaceutical and medical device manufacturers.
Back in May, after collecting over 300 comments from manufacturers, associations, and other industry-related organizations, CMS announced a delay in collecting aggregate spend data until 2013 (exact date undeclared). CMS also promised its final guidance at the end of the year. That meant more waiting, although manufacturers breathed a collective sigh of relief knowing they had a brief reprieve before data collection and reporting would commence.
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Shortly thereafter, in June, the Supreme Court upheld the Affordable Care Act (ACA), ensuring that the Sunshine Act would live to see another day. But then we had to wait for the outcome of the 2012 presidential election. The election’s outcome could have radically changed the future of the ACA. But President Obama‘s win removed any doubt that the ACA or Sunshine Act might be repealed. Yet still we waited for the final CMS rule.
On November 27, 2012, CMS finally sent its final rule to the Office of Management and Budget (OMB), but—surprise, surprise—we’re still left waiting. The OMB has 30 days to review the final rule, but it could take longer since they are a bit back-logged. Once feedback is received from OMB, then CMS has 90 days to issue the final rule. And that, folks, puts us into late February 2013.
And so we wait.
