What is in this article?:
The final provisions for the The Sunshine Act, which requires pharmaceutical and medical device manufacturers to track and publicly report what they spend on physicians at their meetings, were released February 1. Here’s a rundown of how the rule will affect—and why some continuing education providers are breathing a qualified sigh of relief.
The Centers for Medicare and Medicaid Services released the long-awaited final rule on the Sunshine Act provisions of the Affordable Care Act on February 1. Pharmaceutical meeting managers and continuing medical education providers are reacting with a mixture of cautious optimism, relief, and resignation.
The transparency bill, passed as the “National Physician Payment Transparency Program: Open Payments,” details how pharmaceutical and medical device manufacturers covered by Medicare, Medicaid, or the Children’s Health Insurance Program will be required to collect data annually on “all payments or transfers of value” of more than $10 to physicians and teaching hospitals. Group purchasing organizations also must follow the final rule’s requirements.
Under the final rule, companies and GPOs will be required to begin collecting this data on August 1, 2013. The 2013 data collected from August through December 2013 is due to CMS by March 31, 2014; it will be posted publicly on the CMS Web site by September 30, 2014. Docs and teaching hospitals will be allowed 45 days to review and correct the data before it is made public, according to CMS. Those who fail to report can look forward to civil penalties of up to $150,000 per year. Violators found to have a “knowing failure to report” could be fined up to $1 million, and CMS and the Office of the Inspector General of the Health and Human Services “reserve the right to audit, evaluate, or inspect applicable manufacturers and applicable GPOs for their compliance with the reporting requirements.”
The Pharmaceutical Research and Manufacturers of America, or PhRMA, said in a statement that it “remains committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information.” The Medical Imaging & Technology Alliance issued a statement saying, “We appreciate that CMS has given device manufacturers 180 days after publication to implement the final regulations, so that our members have sufficient time to successfully implement the law.”
But many pharmaceutical and medical device meeting managers may not need the extra time—several of the larger pharma companies have been required to collect the data under corporate integrity agreements for some time. Many others, expecting that this was coming, had been preparing to meet the original January 1, 2012, deadline, which then was pushed back to January 2013, and now to August. In a December 2011 survey of participants at the West Coast Pharmaceutical Meeting Management Forum, co-organized by and the Center for Business Intelligence, 88 percent said they had a system in place to track their spend on physicians and other healthcare professionals. Seventy-six percent said they were either already testing their system or that their system was ready to roll as of a year ago.