December 19th, 2011- HealthCare Regulatory update

The Physician Payment Sunshine Act (PPSA) which requires pharmaceutical and device companies to report their payments to physicians and healthcare providers may shed even more light on payments to physicians than previously expected. According to recently unveiled proposed rules by the Centers for Medicare & Medicaid Services (CMS), Drug and device companies will, in fact, be required to report payments that flow directly or indirectly through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor The regulations recently released by CMS suggest that the agency has defined their purview quite broadly, such that payments from industry to third parties, who in turn provide payments or other transfers of value to physicians or teaching hospitals must now be reported.

The trend toward greater transparency is not unique to the U.S.

France is in the process of taking a more comprehensive approach. Legislation not only considers to increase transparency but also limit pharmaceutical marketing practices more broadly vis a vis medical professionals and institutions.  This legislation is so comprehensive in scope that it brings change to the way drugs are approved in France and the use of experts to assist in regulatory decisions and the way that company sales representatives go about their jobs.