The Great Conundrum: FDA Approval and Medicare Coverage
St. Cloud State Series
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 9:30 am
As a medical products manufacturer, you have successfully helped your company receive FDA approval for your revolutionary device. However, you learn that Medicare is not covering or paying for its use. Your management team meets with the Centers for Medicare & Medicaid (CMS), who informs them that the product is interesting; however, they consider it investigational because there is insufficient clinical evidence to support coverage. But why is our data good enough to attain FDA approval, but not Medicare coverage or payment? What went wrong?
This session will help provide an understanding of the different perspectives of the FDA and CMS and will provide insight into how to design your clinical and regulatory strategies within the context of reimbursement. It will also provide an overview of the parallel review process initiated by the FDA and CMS.
- Provide a context of why CMS and FDA requirements differ
- Define the regulatory and reimbursement pathways
- Understand the perspectives of the agencies in regard to clinical trial design
- Provide an overview of the parallel review process outlined in the 2010 Memorandum of Understanding (MOU)
- Case studies
Judith M. Hickey, President, Princeton Reimbursement Group
Judith M. Hickey is co-founder and President of Princeton Reimbursement Group, a reimbursement consulting firm focused on (more)
The following topics will be addressed:
St. Cloud State University
Twin Cities Graduate Center
6401 Sycamore Court N.
Maple Grove, MN 55369