CMS announced today the proposed final rule for increasing transparency in health care. The Sunshine rule as stipulated in the Patient Protection and Affordable Care Act (PPACA) was initially to be finalized by Oct. 1st and we’ve seen a fair amount of hand wringing by sponsors of the original legislation and industry stakeholders gearing up to meet the Sunshine deadlines.
The proposed rule requires “manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS payments or other transfers of value they make to physicians and teaching hospitals. The proposed rule would also require manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.” CMS estimates that approximately 1,150 manufacturers and 420 GPOs will be required to disclose interaction data on almost 700,000 physicians as well as teaching hospitals.
The original timeline for collecting aggregate spend data was set for January 1, 2012. In issuing this proposed rule, CMS is calling for a comment period lasting until Feb. 17, 2012 and is recommending that the collection be delayed to a currently unspecified date. While the delay may help some smaller life science companies, many are already publicly disclosing provider interactions as a result of state regulations, corporate integrity agreements or company policy.
A special Senate Aging committee hearing on this subject has been postponed from Thursday Dec. 15th . A press release by the committee quoted Senator Grassley as saying, “The completion of the guidance is good news. It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS. It shows Congress has a responsibility not just to make laws but also to see that they’re carried out as intended. Companies need this guidance to do their part." The senators plan to review the proposed rule and reschedule the hearing for early next year.