US Market Access & Reimbursement : Medical Devices

Why Should You Attend:

This course specifically focuses on getting your Medical Device [whether new or existing] used by physicians and hospitals instead of being de-selected, because other choices are available that are reimbursable by insurance, thereby being lower cost to the patient. This course focuses on a practical approach to help you understand your current status to be reimbursed and then what options you might have to have your device added to existing reimbursable codes or when other steps might be necessary to secure a reimbursable status.

Managed by the U.S. Medicare System, the system is extremely complex to understand. Different codes, payment mechanisms and different payors all add to a confusing system. The Course will walk you through the steps of defining a Winning Reimbursement Strategy, including what options might be available and what are the chances of success with each.

Webinar Agenda / Areas Covered:

• Defining the Opportunity
• U.S. Medical Device / IVD Reimbursement Market: Segments, Key Profile Plans
• Definitions Used
• Developing a Winning Reimbursement Strategy
• Common U.S. Payors
• Different Codes & Payment Mechanisms
• Impact of Care Setting: Outpatient vs. Hospital vs. Self Administration
• Reimbursement for U.S. Decision Makers
• Conclusions

Who will Benefit:

• U.S. and ex-U.S. Manufacturers looking to enter the U.S. Market
• Global Business Development personnel responsible for entering new markets and having their devices selected by medical staff
• Any sales or general management employee requiring an understanding of how to grow new markets for medical devices
• Regulatory personnel whose responsibilities require knowledge of U.S. reimbursement mechanisms
• Medical Device commercial or project managers who can build this into their development plans early-on
• QA / QC Personnel
• Global Supply Chain personnel

Robert J Russell
President, RJR Consulting, Inc

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 22 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.

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