BLOOMBERG BNA WEBINAR EVENT: The Nuts and Bolts of the Sunshine Act and Enforcement Implications

Wednesday, February 27, 2013
1:00 PM - 2:30 PM ET

The Physician Payments Sunshine Act is one of the most closely watched regulations in the pharmaceutical and medical device industry. The Act’s just-released final rule, published in the February 8, 2013 Federal Register, will require manufacturers to start collecting data as of August 1, 2013 for annually reporting to the Centers for Medicare and Medicaid Services (CMS), which will be due on March 31, 2014, of all payments or transfers of value (including gifts, consulting fees, research activities, speaking fees, meals, and travel) made to physicians and teaching hospitals. The payment information will be posted on CMS’s website later in 2014 with data aggregated, downloadable and searchable. In an industry already under intense scrutiny, it is critical for companies to understand the type of information they need to disclose, how soon they will be required to start collecting data, ways to collect and report this information, and its possible uses by federal health officials and other enforcement agencies.

This program aims to help manufacturers and providers identify best practices for achieving compliance and highlight the Act’s implications for government enforcement activity. The faculty will review the Act’s reporting obligations; CMS guidelines for interactions between providers and manufacturers, key terms and exceptions; discuss key issues addressed in the regulation and remaining open questions; and identify practical compliance implementation issues.

Educational Objectives

Understand the legal framework of the Sunshine Act.
Review of key terms and exceptions.
Identify principal reporting obligations.
Review of key terms and exceptions.
Understand key issues in the regulation and open questions.
Learn practical compliance implementation problems.

Who would benefit most from attending the program?

Device and pharma compliance officers
Device and pharma in-house counsel
Community and academic medical center compliance officers
Community and academic medical center in-house counsel
Outside counsel

Program Level: Intermediate.

Credit Available: CLE. For more information, please click on the “CLE Credit” tab.