Billing and Coding: Leadless Pacemakers

Medicare covers initial placement or replacement of leadless pacemakers only when performed in CMS-approved Coverage with Evidence Development (CED) clinical studies under NCD 20.8.4 (effective 2017-01-18), and coverage applies to both Part A and Part B. Claims must include specific CED billing elements (ICD-10 Z00.6, modifier Q0, and an 8-digit CMS-approved clinical trial identifier plus condition/value codes for institutional claims); missing or incorrect elements may cause rejection or denial. Removal-only procedures and device programming/evaluation codes are not covered by this NCD guidance, and all services must still meet Medicare Reasonable and Necessary requirements.

"Leadless pacemaker procedures (initial placement or replacement) are covered only when performed in CMS-approved Coverage with Evidence Development (CED) clinical studies per NCD 20."

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