How to Help Your Clients Comply With the Sunshine Provision

Published by American Health Lawyers Association

In October 2011, life sciences companies were expecting guidelines from the Centers for Medicare & Medicaid Services (CMS) regarding how they will report virtually any transfer of value or payment to physicians and/or teaching hospitals. This reporting requirement, established under Section 6002 of the Patient Protection and Affordable Care Act of 2010, is commonly referred to as the Physician Payment Sunshine Provision, or simply the Sunshine Provision.1 A major goal of the Sunshine Provision is to increase transparency by making information about certain payments to physicians available on a public, searchable website. In December 2011, CMS actually released its proposed rule for implementing the Sunshine Provision.2

The proposed rule establishes procedures for data collection and provides additional pertinent details. Most importantly, it clarifies that compliance with the law’s data collection and reporting requirements will not be required until ninety days following CMS’ issuance of the final rule. Other noteworthy information from the proposed rule reveals that the types of arrangements subject to the Sunshine Provision may be more expansive than originally thought. Specifically, the Sunshine Provision covers virtually any physician arrangement with a drug, device, biological, or medical supply manufacturer, direct and indirect. Comments on the proposed rule were due on February 17, 2012, and release of the final rule is expected in upcoming months.3

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