12th Annual Medical Device Coverage and Reimbursement Conference

July 18-19, 2016 | Alexandria, VA
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DAY TWO

8:00 REGISTRATION & MORNING COFFEE

8:20 CHAIRPERSON OPENING REMARKS

8:30 MAXIMIZING HEALTH ECONOMIC EFFORTS IN NON-US MARKETS – SOMETIMES LESS IS MORE
While some consistency exists with regard to regulatory pathways for devices in non-US markets, market access and adoption processes can vary significantly. To gain efficiencies with your OUS launch planning, it is helpful to leverage certain evidence across multiple markets. In this session we will discuss the most popular payer archetypes, review evidence requirements and discuss the role of health economics in the market access decision-making process.

  • Overview of payer archetypes
  • Review of decision-makers and drivers of adoption
  • Necessary clinical and health economic evidence

Meghan Gavaghan, Senior Consultant, GFK MARKET ACCESS

 

9:15 NEXT STEPS FOR MEDICAL DEVICE PARALLEL REVIEW: CMS, FDA & PRIVATE PAYERS
KEY TAKEAWAYS:

  • Payer Communication Task Force (PCTF)
  • Examples of shortened FDA approval/coverage timelines
  • Clinical studies that meet FDA and payer requirements
  • Collaborative input from FDA, CMS and commercial payers
  • Processes for enrolling in the parallel review program

Kelly Wilkicki, Policy Analyst, CDRH, FDA

Ken Skodacek, Scientific Reviewer, CDRH, FDA

Rochelle Fink, M.D., J.D., Senior Health Science Project Specialist, External Expertise and Partnerships
CDRH, FDA

Tamara Syrek-Jensen, J.D., Director, Coverage & Analysis Group, OCSQ
CENTERS FOR MEDICARE AND MEDICAID SERVICES

 

10:00 COFFEE & NETWORKING BREAK

 

10:30 EVOLVING TO A NEW NORMAL FOR MEDICARE COVERAGE: COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
In a commitment to increase transparency and provide the least burdensome approach to Medicare coverage, CMS created coverage evidence development (CED) with the goal of expanding access of medical technologies to beneficiaries. The guidance also broadens the use of CED and introduces potential interactions between CMS and FDA. 2 years on since the release of the final guidance, reimbursement executives are keen understand if CED is to be used more frequently in response to the changing nature of medical technologies, patient access demands and NCD requests.

  • Review CED initiatives since 2014
  • CMS/FDA parallel review
  • Establishing an NCD under CED

Tamara Syrek-Jensen, J.D., Director, Coverage & Analysis Group, OCSQ
CENTERS FOR MEDICARE AND MEDICAID SERVICES

 

11:15 FORMULATING A VALUE-BASED REIMBURSEMENT STRATEGY IN LIGHT OF MEDICARE PHYSICIAN QUALITY PROGRAMS
CMS is continuing implementation of initiatives such as the Physician Quality Reporting System (PQRS), Physician Value-Based Payment Modifier (VBPM) and Medicare Shared Savings Program; all of which will impact physician payment over the next several years. These specific quality-related programs were implemented with select providers in 2015 and will extend to all by 2017. With the application of these programs, Medicare physicians will be paid based on the cost and quality of care they provide, directly impacting reimbursement rates for medical device technologies.
KEY TAKEAWAYS:

  • CMS quality initiatives impacting device coverage
    • PQRS
    • VBPM
    • Medicare Shared Savings Program
  • Review data collected and savings thus far
  • Formulating a quality-based reimbursement strategy
  • Impact on providers and meeting needs

Steve Phillips, Senior Director, Global Health Policy, Worldwide Government Affairs and Policy
JOHNSON & JOHNSON

 

12:00 LUNCHEON FOR SPEAKERS, SPONSORS & ATTENDEES

 

1:00 SHARED PERSPECTIVES ON PROACTIVELY PREPARING FOR & MANAGING BUNDLED PAYMENTS
Participation in the Bundled Payments for Care Improvement (BPCI) Initiative continues to expand to healthcare providers across the country and as of January 2016, the BPCI initiative had 1573 participants nationwide. This expansion demonstrates Medicare’s transition from voluntary to mandatory payment reform as they push providers away from traditional fee-for-service to quality and value-based payment models. Though shared perspectives on how payers, providers and device manufactures and are managing bundled payments, attendees will gain varied insights on the expanding payment model.

Mitchell Sugarman, Vice President of Health Economics, Policy and Payment
MEDTRONIC

Erin Smith, JD, Vice President and Executive Director
POST-ACUTE CARE CENTER FOR RESEARCH
Former Director, Division of Technical Model Support, and Lead, Bundled Payments for Care Improvement (BPCI) Initiative, Center for Medicare and Medicaid Innovation
CENTERS FOR MEDICARE AND MEDICAID SERVICES

Kim D. Eason, Manager, Partner Contracting, Outcomes and Relationships    
HORIZON BLUE CROSS BLUE SHIELD OF NEW JERSEY

Steve Phillips, Senior Director, Global Health Policy, Worldwide Government Affairs and Policy
JOHNSON & JOHNSON

 

1:45 CLOSING REMARKS & CONFERENCE CONCLUSION

 

2:00 PANEL: EVOLVING ROLE OF MEDICAL ASSOCIATIONS & KOLS IN MEDICAL DEVICE COVERAGE
Adding to the plethora of market access stakeholders across the healthcare industry, some medical associations have begun publishing coverage recommendations as a way of protecting patients and supporting members by promoting evidence based coverage policies. Key opinion leaders alike have become more vocal in speaking out against reductions in reimbursement for innovative devices and procedures that affect patients. As associations and KOL’s play an emerging role in the clinical evidence and coverage conversation, medical device reimbursement executives are interested in exploring:

  • Medical associations currently issuing coverage recommendations
  • Payer response to coverage recommendations thus far
  • Working with associations and KOLs on coverage recommendations
  • Associations and KOLs advocating for coverage

Tim Hunter, VP Health Economics, Reimbursement and Public Policy, MCRA

Scott Kreiner, MD, Co-chair, Coverage Committee and Evidence-based Guidelines Development Committee, NORTH AMERICAN SPINE SOCIETY

 

2:45 PCORI OUTCOME STUDIES FOR MEDICAL DEVICES
KEY TAKEAWAYS:

  • PCORI in practice: Opportunities for the medical device industry
  • Review current comparative outcomes studies for medical devices
  • FDA and PCORI partnership: Goals and practices

Jean R. Slutsky, PA, MSPH, Chief Engagement and Dissemination Officer and Program Director for Communication and Dissemination Research
PCORI

 

3:30 CLOSING REMARKS AND CONFERENCE CONCLUSION

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