C1605, Pacemaker, leadless, dual chamber (right atrial and right ventricular
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- For Medicare, CMS covers leadless pacemakers only under Coverage with Evidence Development (CED) when procedures are performed in CMS‑approved prospective longitudinal FDA‑approved studies that use devices with either an associated ongoing FDA post‑approval study or a completed FDA post‑approval study; each CMS‑approved study must as part of its protocol address the listed peri‑procedural, long‑term outcome, and patient‑characteristic research questions.
- Documentation: Providers may be required to submit clinical documentation in support of a request for services.
- Documentation: Such documentation must accurately reflect the clinical situation at the time of the requested service, and sufficiently document the ordering provider’s clinical intent.
Key Coverage Criteria
- Micra VR or Aveir single‑chamber TPS considered medically necessary when BOTH: (1) high‑grade AV block in presence of atrial fibrillation or significant bradycardia with either normal sinus rhythm with episodes of 2nd/3rd degree AV block or sinus arrest, chronic atrial fibrillation, or severe physical disability; AND (2) significant contraindication to conventional single‑chamber ventricular pacemaker leads (history of endovascular/CIED infection or high infection risk; limited venous access inc [...]
- Micra AV single‑chamber TPS considered medically necessary when BOTH: (1) high‑grade AV block in presence of atrial fibrillation or significant bradycardia with either rare episodes of 2nd/3rd degree AV block or sinus arrest, chronic atrial fibrillation, severe physical disability, or indication for VDD pacing to maintain AV synchronous ventricular pacing; AND (2) significant contraindication to conventional single‑chamber ventricular pacemaker leads (history of endovascular/CIED infection or hi [...]
- Aveir DR dual‑chamber pacing system considered medically necessary when BOTH: (1) patient has an indication such as sick sinus syndrome, chronic symptomatic 2nd/3rd degree AV block, recurrent Adams‑Stokes syndrome, or symptomatic bilateral bundle branch block (after excluding tachyarrhythmia/other causes); AND (2) significant contraindication to conventional dual‑chamber pacing leads (history of endovascular/CIED infection or high infection risk; limited venous access including venous anomaly, a [...]
- Micra and Aveir single‑chamber and Aveir DR dual‑chamber systems may be considered medically necessary for individuals medically eligible for a conventional pacing system who have lifestyle or anatomic reasons directing use of leadless pacing.
- Micra VR or Aveir single‑chamber TPS considered medically necessary when BOTH: (1) high‑grade AV block in presence of atrial fibrillation or significant bradycardia with either normal sinus rhythm with episodes of 2nd/3rd degree AV block or sinus arrest, chronic atrial fibrillation, or severe physical disability; AND (2) significant contraindication to conventional single‑chamber ventricular pacemaker leads (history of endovascular/CIED infection or high infection risk; limited venous access inc [...]
- Micra AV single‑chamber TPS considered medically necessary when BOTH: (1) high‑grade AV block in presence of atrial fibrillation or significant bradycardia with either rare episodes of 2nd/3rd degree AV block or sinus arrest, chronic atrial fibrillation, severe physical disability, or indication for VDD pacing to maintain AV synchronous ventricular pacing; AND (2) significant contraindication to conventional single‑chamber ventricular pacemaker leads (history of endovascular/CIED infection or hi [...]
5 Active Policies
BCBSIL-SUR707.030, Leadless Cardiac Pacemakers
BCBSMT-SUR707.030, Leadless Cardiac Pacemakers
BCBSNM-SUR707.030, Leadless Cardiac Pacemakers
BCBSOK-SUR707.030, Leadless Cardiac Pacemakers
CARELON-permanent-implantable-pacemakers-2024-10-20, Permanent Implantable Pacemakers
Related Codes
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