Summary
This is a reissue with no substantive policy changes—Independence Blue Cross reconfirmed its existing position that leadless pacemakers remain experimental/investigational and are covered only through Medicare's Coverage with Evidence Development (CED) program when patients are enrolled in CMS-approved clinical studies. A new HCPCS code (C1605) was added to the policy effective 07/01/2024 to represent dual-chamber leadless pacemaker devices.
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What to do
Action · 6 steps
01By 07/01/2024: Billing team must ensure claims for leadless pacemaker procedures (CPT 0795T–0804T, 0823T–0826T, 33274, 33275; HCPCS C1605) submitted for Medicare Advantage members are only processed when the patient is enrolled in a CMS-approved CED clinical study.
02Verify CED enrollment status before claim submission by consulting the CMS CED study list at https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/.
03Append Modifier Q0 to all procedure codes to denote investigational clinical service in a CMS-approved study.
04Update billing software validation rules to reject claims lacking CED study enrollment documentation.
05Request and retain clinical trial enrollment documentation in the member's medical record.
06Claims submitted without CED enrollment documentation or without Modifier Q0 will be denied.
Codes mentioned
3327433275C1605Z00.6
Original notice
MA05.067f, Leadless Pacemakers
medpolicy.ibx.com · Always check the source before changing claims.
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