Life Sciences Now Newsletter

CMS's Final "Sunshine" Rule: Implications for Research

By Robyn Shapiro and Julie Rusczek

With the “Physician Payment Sunshine Act” data collection requirement going into effect on August 1, we’re taking an in-depth look at the Final Rule, and its implications for research entities.  On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Sunshine Act.”  We discuss the changes and significant implications of the Final Rule for entities engaged in research.

French Sunshine Act Implemented…Awaiting Guidance 

By Julie Rusczek

As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations.  On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand.  The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012 , giving companies a mere 10 days to interpret the regulations and compile and report data.

CMS Issues Sunshine Act FAQs

By Jesse Witten

CMS recently issued an FAQ clarifying one of the most puzzling questions regarding implementation of the Sunshine Act reporting requirements:  whether manufacturers must report transfers of value (“TOVs”) to non-physician employees of teaching hospitals. This FAQ may substantially affect a company’s data collection and reporting activities. Entities that are subject to Sunshine Act reporting requirements should familiarize themselves with the CMS FAQs, which address many practical implementation issues raised by the final regulations.