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FDAnews Announces — How to Integrate FDA Device Approval and Reimbursement Webinar, Feb. 22, 2017

How to Integrate FDA Device Approval and Reimbursement
**An FDAnews Webinar**
Feb. 22, 2017 — 1:30 p.m. – 2:30 p.m. ET            

What are the critical reimbursement questions manufacturers should be asking before selecting an FDA approval pathway?

How should they evaluate the 510(k)/PMA options to get maximum reimbursement?

To have a successful medical device launch regulatory affairs and product management execs need to consider reimbursement requirements throughout the FDA process.

To make it even more complicated every year Medicare changes payments for hospitals, doctors, clinical lab tests and ambulatory surgical centers. The most recent reimbursement changes became effective Jan. 1, 2017. How do these changes affect devices?

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 attendees will 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 manfacturers can say at launch about reimbursement
  •     The 7 steps to reimbursement success
  •     The most important websites to access national and local reimbursement policies

Meet the 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.

Who Will Benefit:

  •     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

Webinar Details:
How to Integrate FDA Device Approval and Reimbursement
**An FDAnews Webinar**
Feb. 22, 2017 — 1:30 p.m. – 2:30 p.m. ET            

$287 per site

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at

Source: PRWeb
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