On November 27, the Centers for Medicare & Medicaid Services (CMS) sent its final rule implementing the “Sunshine Act” to the Office of Management and Budget (OMB) for review. OMB review and approval is the final step before the regulation is released and published in the Federal Register.
CMS published a proposed rule in December 2011 implementing Section 6002 of the Affordable Care Act, known as the Physician Payments Sunshine Act. Section 6002 requires manufacturers of drugs, devices, biologics, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) to disclose payments or other transfers of value made to physicians or teaching hospitals. As set forth in the statute, data collection was to begin on January 1, 2012, and initial reports were to be submitted to CMS by March 31, 2013.
CMS acknowledged in the proposed rule that a final rule would not be published in time for companies to begin collecting information on January 1. The agency indicated that it was therefore considering a preparation period of 90 days after publication of the final rule to allow manufacturers time to implement the requirements of the final rule. On May 3, CMS posted on its website a notice announcing that manufacturers will not be required to collect data before January 1, 2013.
More than 300 individuals and entities submitted comments on CMS’s proposed rule. Many of the comments focused on several key issues, including CMS’s definition of “applicable manufacturer,” the agency’s proposal for reporting research payments, its treatment of indirect payments where the manufacturer does not know the identity of the recipient, the methodology for allocating the costs of meals, and the process for resolving disputes regarding disclosures.
Many companies are already tracking and disclosing information about payments to physicians and other recipients, either voluntarily or as required by corporate integrity agreements. Other companies will need to implement policies, procedures, and information technology systems to begin collecting data in accordance with the requirements of the final rule.