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    RWE for Reimbursement

    Real-world evidence used to support coverage and payment decisions.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Real-world evidence - from registries, claims data, and EHRs - increasingly supports CMS coverage decisions, NICE technology appraisals, and EU JCA dossiers, particularly for technologies where RCTs are infeasible or have completed.

    What this means in practice

    Registry-based evidence (TVT, NCDR, ACC/STS) underpins coverage for structural heart and EP devices. Manufacturers must invest in registry strategy alongside trial strategy.

    Primary references

    3 sources
    Link health: 3 needs review· last checked 2026-05-09
    1. 1
      FDA/CMS parallel review
      Needs review
      CMScms.gov
    2. 2
      CMS - Coverage
      Needs review
      CMScms.gov
    3. 3
      CMS - Coding
      Needs review
      CMScms.gov

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