MDIC 2019 ANNUAL REPORT
HEALTH ECONOMICS AND PATIENT VALUE MDIC’s Health Economics and Patient Value (HEPV) initiative, previously called Health Economics and Patient Access, was established in 2018. This initiative aims to create predictability and transparency of evidence requirements for coverage, speed patient access, and amplify the patient voice in the selection of treatment options. Building off successful projects in regulatory science, the MDIC Board identified an equally important need to create predictability within CMS and private payer evidentiary processes. HEPV is developing projects and focusing on tools to increase predictability of payer scientific and evidentiary requirements.
MDIC surveyed 34 medical device and diagnostic industry stakeholders on how their companies navigate the coverage process for innovative technologies with public and private payers. Within the survey responses, MDIC found that the major reimbursement challenges for industry fell in the following categories: • Lack of transparency in private payer evidentiary requirements • Lag between FDA approval and private payer coverage • Lag between CMS coverage decision and coding and/or payment decisions • Patient preference data included in regulatory decision-making is not considered for coverage MDIC also identified the following key factors impacting patient access:
Health Economics and Patient Value: 2019 Accomplishments
• FDA approval or clearance • Private payer coverage
Health Economics and Patient Value Member Survey
• Local coverage
Following initial meetings to define the objectives of the HEPV initiative, understand reimbursement challenges, and gather priority areas for engagement, the HEPV steering committee initiated a survey to further define “pain points” with both CMS and private payer coverage processes.
• National coverage These responses will help inform the HEPV committee on where to best collaborate on process improvements and enhancements to coverage decisionmaking methodologies.
Health Economics and Patient Value Member Survey Reimbursement Challenges Lack of transparency in private payer evidentiary requirements
Lag between CMS coverage decision and coding and/or payment decisions
Lag between FDA approval and private payer coverage
Patient preference data included in regulatory decision-making is not considered for coverage
PAGE 13
