How to Integrate FDA Device Approval and Reimbursement - Webinar CD/Transcript

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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.

  • CEO, CFO, CMO, VP RA/QA, Marketing/Sales
  • Regulatory Affairs
  • Quality Assurance
  • Clinical and Medical Affairs
  • Marketing, Sales and Product management
  • Reimbursement
  • Market Access
  • Government Affairs

Meet Your Presenters

Steve Terman, Principal Attorney, Olson Frank Weeda Terman Matz
Steve Terman Esq. is one of the nation’s leading FDA lawyers who advise manufacturers on FDA medical device law, regulatory issues, and litigation matters. Steve heads up his law firm’s medical device practice. His expertise covers all areas of medical device law including: development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of regulatory filings; compliance with MDR requirements, employee education and system audits; classification and reclassification of medical devices;  labeling, advertising, and promotion of medical devices among others.

Gordon Schatz, President, Schatz Reimbursement Strategies
Gordon Schatz, JD, President of Schatz Reimbursement Strategies, is a nationally recognized expert in reimbursement for breakthrough medical device innovations and evolving device technologies. He has successfully obtained new product/procedure billing codes, expanded coverage, and increased payment from government and private commercial health payment programs, especially Medicare/Centers for Medicare and Medicaid Services.