The Sunshine Act Final Rule

Why Should You Attend:

Are you aware of changes made between the Proposed Rule and the Final Rule for the Physician Payment Sunshine Act? Are you prepared to track and report gifts and payments made to physicians and teaching hospitals? Is your CEO, CFO or CCO prepared to certify your prospective submission in March of 2014? Are you prepared to report physician ownership? Penalties for non-compliance are substantial.

This 120-minute training will review the Final Rule, walk you through real world examples, and provide an opportunity for you to ask questions. We will discuss reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS. This training is important for companies impacted by the Sunshine Act.

Learning Objectives:

The goal of this training is for the participant to walk away with the knowledge of the impact the Final Rule will have on them along with ideas on how to prepare for it. Tracking starts August 1st-roughly 5 months away! The time to prepare is now. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS. We will discuss the law and the Final Rule. We will start with the basics and then get granular.

Areas Covered in the Webinar:

• Sunshine Act & the Final Rule
• Terminology used and how it applies to your company
• Considerations to make when putting an SOP in place
• Tracking and reporting requirements
• Customer considerations
• Exceptions that apply to reporting
• Deadlines

Who Will Benefit:

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

• Compliance Professionals
• Executive management (remember, the CEO, CFO, or CCO will be required to certify the report made to CMS)
• Attorneys and in-house counsel
• Regulatory affairs Professionals
• Finance Professionals

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, dietary supplement, drug, biotech, and food industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, FDA enforcement actions and aggregate spend. 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 is also an adjunct professor at Hamline University School of Law where he teaches food and drug law and serves as a health law regulatory and compliance competition coach. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group. He is the Chairman of the Minnesota State Bar Association Food, Drug and Device Law Section. He serves as a steering committee member of the Minnesota Medical Device Alliance. He is a member of the Medtech Resource Alliance. Gardner speaks and writes on issues that impact FDA regulated products.

Topic Background:

The Final Rule for the Physician Payment Sunshine Act (Sunshine Act) is out! New federal legislation governs relationships between physicians and medical device, drug, and biotech manufacturers. The Sunshine Act requires detailed reporting in 2014 of ''transfers of value'' made in 2012 to physicians and teaching hospitals as well as physician ownership in companies. The information reported will be made public by CMS.

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