Manufacturers have been monitoring a circuitous regulatory process in preparing to comply with the Sunshine Act’s requirements. In December 2011, CMS issued a proposed rule, shortly before the data collection requirement was set to take effect on January 1, 2012 (Tom Crane, Karen Lovitch, and I discussed the proposed rule in an article published in BNA’s Health Care Fraud Report). CMS also postponed data collection until after promulgation of the Final Rule. On May 3, 2012, CMS again postponed the start of data collection until January 1, 2013 and said that “CMS intends to release the final rule later this year.” CMS sent the Final Rule to the Office of Management and Budget (“OMB“) for review on November 27, 2012.
Predicting the timing of publication is difficult. Executive Order 12866, “Regulatory Planning and Review,” requires OMB’s Office of Information and Regulatory Affairs to waive review or notify the agency in writing of the results of its review within 90 days after the agency submits the required information (which would be late February 2013 based upon CMS’s transmittal of the rule to OMB on November 27, 2012). However, HHS’s Regulatory Agenda, published in the Federal Register on January 8, 2013, lists “12/00/14” as the deadline for final action.
With the January 1, 2013 deadline to begin collecting data having passed without publication of the Final Rule, Manufacturers are anxiously awaiting final guidance. Manufacturers have invested substantial resources to prepare for compliance with the Sunshine Act. In the absence of the Final Rule, however, Manufacturers remain in the dark about many operational and implementation details, and they cannot fully implement processes to comply with the Sunshine Act’s data collection and reporting requirements.
We will continue to monitor the progress of the Final Rule and provide any updates.