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Integrating
a CMS Reimbursement Strategy
into Your
FDA Planning Process
Recorded
Thursday, August 11, 2005
Background
Planning
for reimbursement by CMS is as important as planning for clearance by FDA.
Medical device firms may now have to satisfy CMS in structuring their
clinical trials, conducting their post-approval studies and implementing their
product launch strategies. To learn about FDA and CMS requirements, register for
“Integrating a CMS Reimbursement Strategy into Your FDA Planning
Process.”
What
You Will Learn
·
What CMS is and how it works
·
The type of evidence CMS expects from device firms
·
The steps required for getting your product covered and reimbursed
·
In what areas CMS and FDA coordinate their activities
·
How you should plan your clinical trials to satisfy the reviewers in both
agencies
·
How regulatory professionals should approach this process
What
You Will Get:
·
Organizational charts with the key players
·
Flow chart on how the process works
·
Handouts with key definitions
Faculty:
·
Carol Kelly, Director, Office of Policy, in CMS Administrator’s Office
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Ron Milhorn, former Senior Policy Analyst with CMS’s Coverage &
Analysis Group
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Phil Phillips, former Dep.
Dir. For Science and Regulatory Policy at CDRH’s ODE
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Stephanie Mensh, Senior Reimbursement Advisor, with King & Spalding
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Ron Geigle, of Polidais, a
Washington
policy analysis and public affairs firm
·
Nancy Singer, president of
Compliance-Alliance
Order
the Audio CD -- $95
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