Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?

New federal legislation governs relationships between physicians and medical device, drug and biotech manufacturers. The Physician Payment Sunshine Act requires detailed reporting in 2013 of "transfers of value" made in 2012 to physicians and teaching hospitals. The information reported will be made public by CMS. Are you prepared to track and report gifts and payments made to physicians and teaching hospitals? Numerous states also require certain reporting of transactions and other requirements. Penalties for non-compliance are substantial.

This webinar will review the applicable laws, walk you through a case study and provide an opportunity for you to ask questions. This training is important for companies impacted by federal and state sunshine loss. The new federal law is now in effect but the proposed rule has not been finalized. This meeting will address many of the topics raised by the proposed rule.

In addition to the new federal law state sunshine laws have been on the books for sometime. These laws vary, however several require reporting of payments or gifts made to physicians. Others require annual certification and registration. Some require both. We will discuss these laws during this meeting.

Learning Objectives:

The goal of the meeting is for the participant to walk away with the knowledge of the new federal law and the existing state laws. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority. We will also discuss the proposed rule for the Physician Payment Sunshine Act in detail. We will start with the basics and then get granular.

Areas Covered:

• Physician Payment Sunshine Act
• State sunshine laws – for example, Vermont, Massachusetts, Connecticut, Nevada, California, Minnesota, West Virginia, DC, etc.
• The proposed rule for the Physician Payment Sunshine Act
• Terminology used in the new federal law and how it applies to your company
• Exceptions that apply to reporting under the federal and state laws
• Registration requirements
• Deadlines

Who Will Benefit:

The following personnel from medical device, drug, and biologics companies will benefit:

• Compliance Managers
• Attorneys and in-house counsel
• Regulatory Affairs
• Executive Management
• Finance

Instructor Profile:

Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, and FDA enforcement actions. Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

Gardner earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, double major, Finance and Economics from the University of Wisconsin-La Crosse. He is an Adjunct Professor at Hamline University School of Law. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group, as Vice Chairman for the Minnesota State Bar Association Food, Drug and Device Law Section and as an Advisory Committee Member for LifeScience Alley. Gardner speaks and writes often on issues that impact FDA regulated products.

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