2015 MDMA Coverage, Reimbursement & Health Policy Conference Agenda

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Speakers will be added as confirmed

Wednesday, November 11, 2015

1:30pm - 5:00pm

An Introduction to Reimbursement

Questions about whether or how medical devices will be reimbursed, what it will take to establish reimbursement, and how long the process will take are prominent in conversations between medical device manufacturers and their multiple stakeholders. Manufacturers need to understand how reimbursement influences access, and how payers and providers evaluate clinical evidence, pricing, and payment before adopting technology. This session will introduce the foundation of medical device reimbursement (coverage, codes, and payment) as these processes intersect in the current and evolving healthcare environment, and will focus on creating an implementable strategy so a product can be commercialized.  At the end of the session, we will facility an idea exchange with participants to discuss product-specific reimbursement questions and issues to begin to put this information into practice.

     1:30pm - 3:00pm     Reimbursement 101

     3:00pm - 3:20pm     Networking Break

     3:20pm - 5:00pm     Idea Exchange

  • Judy Rosenbloom, Founder & President, JR Associates
  • Jo Ellen Slurzberg, Vice President, Global Health Policy/Reimbursement, JR Associates

5:00pm - 6:30pm

Networking Reception

Thursday, November 12, 2015

7:30am - 8:55am

Registration and Continental Breakfast

8:55am - 9:00am

Welcoming Remarks

  • Mark Leahey, President & CEO, MDMA

9:00am - 9:45am

Changing/Current Reimbursement Landscape

After decades of fee-for-service payments, the reimbursement landscape has begun to put a greater emphasis on quality and value. Earlier this year, the sustainable growth rate was repealed and replaced with a policy that changes the way Medicare pays physicians, moving to value-based and alternative payment models. Complementary efforts to reduce cost and improve care coordination and quality of healthcare delivery for Medicare beneficiaries are being made by the Centers for Medicare and Medicaid Services (CMS), with several pilots that tie reimbursement to the value of health care provided to Medicare beneficiaries.

Asd the reimbursement landscape transitions from fee-for service to a new pay-for-performance/quality paradigm, medical device manufacturers need to be aware of potential impacts this shift may have on industry. Learn about the current and changing reimbursement landscape, including changes in evidentiary requirements in quality and performance measurement, and what it could mean for you.

  • Elizabeth Halpern, Partner, Hogan Lovells
  • Ross Jaffe, M.D., Managing Director, Versant Ventures
  • Lindsey Tighe McCandless, Associate Director, ADVI
  • Marc Richmond, M.D., Regional Medical Director, Blue Shield of CA

9:45am - 10:30am

Developing the Right Clinical Data

The design of your clinical trial is often the "make or break" decision that impacts your ability to obtain adequate reimbursement. Learn the latest factors your team must consider to help ensure you are ready to confont the challenges in developing robust clinical evidence, and the nuances of developing data to seek Medical coverage versus commercial coverage.

  • Marc Richmond, M.D., Regional Medical Director, Blue Shield of CA
  • Sean Tunis, President, Center for Medical Technology Policy

10:30am - 10:45am

Networking Break

10:45am - 11:30am

Promoting Better Collaboration between Regulatory & Reimbursement

FDA approval is not a guarantee that a device will be reimbursed by Medicare or commercial payers, yet many device manufacturers fall into the trap of trying to use the same data to obtain regulatory approval and reimbursement. This session will review strategies to engage with the FDA and payers earlier and to facilitate collaboration between device manufacturers, regulatory authorities, and payers.

  • Murray Sheldon, M.D., Associate Director for Technology and Innovations, CDRH, FDA
  • Sean Tunis, President, Center for Medical Technology Policy

11:30am - 12:15pm

Working with Local MACS

When seeking Medicare coverage for devices, often times determinations are not made at the national level. Device manufacturers must then seek positive coverage from each of the local MACS. Learn strategies for meeting with MAC medical directors, how to demonstract value of the device, and what traps to avoid while working with local MACS.

  • Richard Baer, M.D., former Medical Director for NGS, Medical Director, Emerson Consultants
  • Barb Peterson, Founder, Emerson Consultants

12:15pm - 1:15pm


1:15pm - 2:00pm

Navigating the Current Procedural Terminology (CPT) Process

While the CPT process can be confusing and challenging, a former AMA CPT Director will help you understand what evidence you need to secure a CPT code and maximize your product's reimbursement.

  • Kenneth Brin, M.D., Chair, CPT Editorial Panel
  • Elizabeth Halpern, Parnter, Hogan Lovells
  • Marie Mindeman, Director CPT Coding and Regulatory Affairs, American Medical Association

2:00pm - 3:00pm

Key International Reimbursement Trends

International Reimbursement issues continue to change and present problems for medical device manufacturers. Learn about the status of China's procedure code and procurement policies, new changes in the German innovation payment, and the UK's web based formularies for devices and more.

  • Stephen Hull, Principal & Founder, Hull Associates

3:00pm - 3:15pm

Networking Break

3:15pm - 4:15pm

Demonstrating Value to Providers

As payers increasingly shift to paying providers for the value of care provided rather than the volume of services, providers are being held accountable for cost of care and are being moved into the driver's seat when choosing what product will give their patient the most "bang for the buck". This session will review what evidence you need to demonstrate value and how to speak providers' language when showing them the value of your product.

  • Judy Rosenbloom, Founder & President, JR Associates
  • Jo Ellen Slurzberg, Vice President, Global Health Policy/Reimbursement, JR Associates
  • Ning Tang, M.D., Senior Medical Director, Clinical Effectiveness & High Value Care, Clinical Associate Professor, Stanford Health Care



Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.