On Dec. 14, 2011, the U.S. Department of Health and Human Services (HHS) announced a proposed rule pursuant to § 6002 of the Patient Protection and Affordable Care Act (PPACA), which is commonly known as the Physician Payments Sunshine Act (Sunshine Act). The proposed rule provides details on the process and requirements for the reporting of physician payments and financial relationships as required by the Sunshine Act provisions. The proposed rule will be published in the Federal Register on Dec. 19, 2011.
Most significantly, the proposed rule includes an announcement that HHS will not require applicable manufacturers and GPOs to begin collecting information required for disclosure on Jan. 1, 2012, as required by the Sunshine Act. Rather, such collection will be required only after HHS publishes a final rule. The Sunshine Act imposed a deadline of Oct. 1, 2011, for the government to issue regulations. This deadline was intended to allow reporting entities time to adapt before Jan. 1, 2012, when such entities were required to commence data collection. However, much to the chagrin of Senators Herb Kohl, D-Wis., and Charles Grassley, R-Iowa, and industry, the government missed its deadline. In the proposed rule, HHS provides “[w]e hope to finalize this rule as soon as possible during calendar year (CY) 2012.”
After HHS reviews comments it will publish a final rule. HHS is seeking comments on how much time reporting entities will need, following publication of the final rule, to begin complying with the data collection requirements of the Sunshine Act. Comments are due by Feb. 17, 2012.
A detailed summary of this rule is now available online.
McGuireWoods is available to assist clients with drafting and submitting comments to HHS regarding the proposed rule. McGuireWoods advises medical device and pharmaceutical manufacturers on compliance with state marketing and transparency laws and on preparing for compliance with the Sunshine Act. If you would like to discuss your company’s compliance with these statutes and regulations, please contact the authors.