CMS has at long last released the final regulations for the U.S. Sunshine Act, and other countries are enacting their own transparency laws. A recent study found that many manufacturers that should already be reporting (e.g., to Massachusetts or Vermont) were not. One of the primary reasons given is that senior stakeholders do not understand the requirements or are not aware of what happens when we don’t comply with them. In this practical Transparency Primer Webinar, we will give you:
- A brief overview of the U.S. and international transparency laws, Flowchart to determine if your company is subject to reporting Choosing a reporting solution: Quill and Abacus, or Ferrari?
- Communication best practices: over 50% of physicians have never heard of the Sunshine Act. Should you educate your physicians, and if so, how?
- It’s not ALL about the data: other compliance issues to address
- Finally, because we’ve been in your in-house shoes, we’d like to leave you with a practical road map of what you can do NOW to get ready to report. This webinar walks you through the basics and helps you kick-start your implementation efforts with a side-by-side comparison of changes made to Final Rule compared to the Proposed Final Rule first published by CMS.
Participants that will find this webinar most beneficial will be those involved in medical device, pharmaceutical, biotechnology, and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Compliance Directors & Managers
- Aggregate Spend Teams
- Legal Affairs
- General Counsel
- Corporate & Commercial Counsel
Former Director of Corporate Compliance
The Spectranetics Corporation
Life Compliance Solutions
Katie Norris, Former Director of Corporate Compliance, The Spectranetics Corporation
Katherine Norris is an independent compliance professional with significant CIA and Aggregate Spend experience in both the pharmaceutical and medical device manufacturing industries. Ms. Norris is the previous Director of Corporate Compliance at The Spectranetics Corporation, a small publicly traded medical device firm specializing in vascular intervention and cardiac lead removal technologies. At Spectranetics, Ms. Norris assumed significant responsibility for all aspects of the company’s compliance program, including management of aggregate spend initiatives and implementation of systems and technologies to support compliance with the transparency requirements of PPACA.
Kim Life, Principal, Life Compliance Solutions
Kim Life, Esq., is the principal of Life Compliance Solutions. Kim leads the life sciences practices, offering advice and counsel to companies grappling with compliance issues, including transparency and disclosure. With over eleven years of life sciences legal and compliance experience, both as in-house and outside counsel, Kim is recognized as a leader in developing and implementing comprehensive compliance programs, as well as compliant Aggregate Spend Solutions that conform to the way her clients do business. Kim earned her law degree from the Duke University School of Law. She is licensed to practice in California and the District of Columbia.