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    Coverage with Evidence Development

    Medicare paradigm conditioning coverage on participation in approved clinical studies or registries.

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

    Definition

    Under CED, CMS provides coverage for promising items or services on the condition that beneficiaries are enrolled in an approved study or data collection effort that addresses outstanding questions.

    What this means in practice

    CED is common for novel devices with developing evidence (e.g., TAVR, leadless pacemakers historically). Registry participation requirements influence hospital adoption and total cost of evidence generation.

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    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    CMS·1AMA·1AdvaMed·1
    1. 1
      CMS CED
      Verified
      CMScms.gov
    2. 2
      AMA CPT Resources
      Bot-blocked
      AMAama-assn.org
    3. 3
      AdvaMed - Payment & Coverage
      Verified
      AdvaMedadvamed.org

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