The Physician Payment Sunshine Act, Section 6002 of the Patient Protection and Affordable Care Act, which will require pharmaceutical companies to track and publicly report what they spend on healthcare providers, is still in limbo as of the final days of 2012. The Centers for Medicare and Medicaid Services completed the final rule and submitted it to the Office of Management and Budget for review in late November. The Office of Information and Regulatory Affairs is evaluating the final rule’s potential effect on government and industry. Once its review is complete, the OMB could send it back to CMS for more tweaks, or it could become a final rule within 90 days.
According to Janna Sipes, president of BioPharma Consulting, this means that the law, which in its latest iteration has a January 1 deadline for companies to begin tracking physician spend data, likely won’t actually be implemented until February 25, which is at the tail end of the 90-day window. But, she said during her keynote at the West Coast Life Sciences Meeting Management Forum this month in San Diego, while it seems counterintuitive to start complying with reporting requirements of a law that’s not implemented yet, “I would stick with the January 1, 2013, date just to be on the safe side.” The West Coast Forum is co-organized by magazine and The Center for Business Intelligence.
Earlier this fall, the Senate Special Committee on Aging held a roundtable discussion to provide CMS with input, and to prod the agency to issue the final rule in a timely manner. Sunshine Act co-authors Senators Charles Grassley (R-Iowa) and Chairman of the Aging Committee Herb Kohl (D-Wis.) chided CMS for taking so long to issue the final rule. While the Sunshine Act will put the onus on pharmaceutical companies to track and report physician spending, continuing medical education providers also may have some skin in the game because the language of the interim rule doesn’t specifically exclude CME. At the roundtable, American Medical Association President Jeremy A. Lazarus, MD, made a case for exempting spending associated with certified CME from Sunshine Act reporting requirements because manufacturers have no control over the content or speakers.
In related news, Massachusetts’ amendments to its 2008 Pharmaceutical and Device Manufacturer Code of Conduct now will allow companies to provide “modest meals” for healthcare providers for product education (non-CME) outside of the office or hospital setting, along with other adjustments. The amendments, which were initially introduced as part of the 2013 state budget earlier in the year, were approved by the Massachusetts Public Health Council in late November.