The Physician Sunshine Act: Are You Ready to Report & React?
Santa Ana, CA
Thursday March 20th, 2014
Tracking for the Physician Payment Sunshine Act (the “Sunshine Act”) started August 1, 2013. How is your company dealing with it? The Sunshine Act will have a long lasting impact on the way drug and device companies market products to doctors. Don’t underestimate the complexity of this law and the many granular and specific interpretations it requires for your organization. Depending on company size, CMS estimates companies will have to spend tens of thousands or even hundreds of thousands each year to comply with the new law. Those in industry know those are very conservative numbers. Although the law has many critics, it is here to stay. Marketers and CEOs are trying to decide whether to pivot, or keep doing business the way they have always done. The demands of the complying with the new law will be expensive and time consuming and require a level of transparency not seen before. This seminar will help you understand the law, the current implementation interpretations and challenges and will help you prepare for a CMS audit.
There are many reasons to consider changes to marketing behavior now. For example, keeping track of what may seem like de minimis payments (anything $10 or greater or $100 or greater in aggregate per year) requires complex systems and personnel to make sure the requirements of the law are being fulfilled.
From a marketing perspective, many physicians are unhappy about the law. They do not want their personal information made public. You need to be prepared for the impact this new law will have upon your customers and determine what to communicate to them. Physicians will be upset with industry if/when mistakes are made. If a physician disputes the data, and the matter cannot be resolved, then two sets of data will be reported abd published by CMS. If you send in the wrong data, CMS will publish it anyway, unless you correct it in time. Do not let this happen to you.
Government auditing is a major issue as well. Did you know CMS uses the word “audit” twenty times in the Final Rule of the Sunshine Act? They reserve the right to audit companies for compliance. Undoubtedly, government litigators will be trolling the CMS database containing all payment information disclosed, which will be made public, for unsavory payments and other information about companies. Fines are $1000-$100,000 per violation. Companies must ascertain how and what they will report and when they can lawfully avoid reporting. This 1-day interactive seminar in Chicago on will focus solely on the Sunshine Act. The course is taught by Mark Gardner, J.D., M.B.A., a national expert on the Sunshine Act. Mark has helped over 75 drug, biologic, and device companies, ranging in size from Fortune 500 to start-ups, get compliant with the Sunshine Act. Mark worked in the medical device industry in sales and marketing for 10-years before becoming an attorney specializing in representing FDA-regulated companies with DuVal & Associates, P.A. He will walk you through countless real-world examples. Come prepared with your questions. Marc Ussini, Director at Vector Health, will provide insights on how organizations have implemented web-based solutions to help organize and report their information in a compliant and more time and cost efficient manner.
UNDERSTANDING THE LAW AND REGULATIONS
The 1st-half of the program will be devoted to a detailed review of the final regulation and how it applies to your company. Attendees will learn the basics of the Sunshine Act. Topics include: collection of data, registering your company, reporting (and the exceptions), certification/attestation of data, verification of data with customers, correction of data, creation of an “assumptions” document, among other things. Importantly, there are many exceptions you need to know about. Not knowing the exceptions, and how they apply, will put you at a competitive disadvantage in the marketplace.
STRATEGICALLY APPLYING THE LAW TO YOUR SITUATION
The 2nd-half of the program will focus on strategic matters. Marketing needs to understand how this may change the face of the sales/marketing interface with physicians. They need to understand collateral impacts on customers (e.g., how the fraud and abuse laws play a role), and will include an interactive workshop on how to operationally get up to speed quickly. Internal policy and procedure development, implementation and training will be a focus. Vector Health’s Marc Ussini will provide insights into how they developed a system to assist companies in reporting.
COURSE OBJECTIVES AND QUESTIONS
The course is critical for companies of all types (drug, device, biologic) impacted by the Sunshine Act.
• Walk in with a basic knowledge, leave with a firm grasp on the Sunshine Act
and learn the terminology
• Find out what is important about the law and what you can discard
• Determine how the rule applies (or doesn’t) to your company
• Learn the reporting exceptions
• Figure out the easiest way to roll-out tracking program at your company
• How to develop an SOP
• Get a grip on tracking and reporting mechanisms
• Address critical customer issues
• Learn the corrections process, what the assumptions document entails, how to
register, certification/attestation, etc.
The course will provide answers to these questions and more:
• What are the common mistakes companies are making when they try to be
compliant with the Sunshine Act?
• What do I have to report? What can I avoid reporting? What are the reporting exceptions?
• How do I report? When do I have to report by? How the does the review
process work? What if a physician disagrees with my information? How do I
prepare an assumptions document?
• Do these rules apply to my company? What about my parent company? What about our distributors?
• Do all meals and gifts have to be tracked? What if I am working on a joint
venture? Who reports then?
• How the False Claims Act and Anti-kickback Statute play a role in the Sunshine Act?
• What state laws (e.g., Massachusetts, Vermont, Minnesota, West Virginia, D.C.) do I have to follow
now that the Sunshine Act is in effect?
• What sort of policies and procedures do I need in place?
• How do I train employees and management on the Sunshine Act?
• What tools should I use to record the data?
• What are emerging as best practices?
• What indirect payments must be reported and which ones can I avoid reporting?
• What are the nuances for drug companies? What about device companies?
• What is the latest guidance from CMS?
• How do I register with CMS?
• Detail of the regulation
• Covered and exempted payments
• Reporting general payments, clinical payments, and investment interests
• How to write policies and procedures for the Sunshine Act
• Strategic considerations—consider the business impact
• Tracking and reporting requirements
• Customer considerations
• State laws