How to Integrate FDA Device Approval and Reimbursement - Webinar CD/Transcript
How to Integrate FDA Device Approval and Reimbursement
For medical device manufacturers trying to get reimbursed is hard enough. Add in the fact that every year Medicare changes payments for hospitals, doctors, clinical lab tests and ambulatory surgical centers and it gets even harder.
What are the critical reimbursement questions you should be asking? How do you decide what data is needed to get maximum reimbursement?
Integrating FDA decisions with reimbursement needs, coverage and payment can improve decision-making on FDA regulatory pathways and support long-term product marketing success.
Join Steve Terman — Principal Attorney, Olson Frank Weeda Terman Matz — and Gordon Schatz — President, Schatz Reimbursement Strategies — on Feb. 22 when they’ll explain how to strategically blend reimbursement with FDA regulatory issues and identify the need for outcomes data, comparative evidence, professional society guidelines and how to meet Medicare and managed care reimbursement standards.
After this 90-minute webinar you’ll understand:
- How to evaluate the 510(k)/PMA options in terms of maximizing reimbursement
- What are key reimbursement questions that must be asked in advance of selecting the FDA approval pathway
- How to decide what data is needed to support both a favorable FDA outcome and obtain the desired reimbursement
- How to comply with FDA labeling requirements and assess its impact on reimbursement.
- When to apply for a new code or when to seek coding confirmation
- What you can say at launch about reimbursement
- The 7 steps to reimbursement success
- The most important websites to access national and local reimbursement policies
Register today — if you plan to start the FDA regulatory process or launch your product this year or next, reimbursement planning is essential.