Medicare Advantage

Medical Policy

Title:

Leadless Pacemakers

Policy #:

MA05.067f

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.

LEADLESS PACEMAKERS

EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, leadless pacemakers are considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development (CED).

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Leadless pacemakers will be covered under Medicare's Coverage with Evidence Development (CED) when individuals are enrolled in a clinical study that fulfills ALL of the requirements as stated in the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Leadless Pacemakers (20.8.4).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Claims for leadless pacemakers for individuals enrolled in a CED clinical study should be submitted to the Medicare Advantage plan.

Providers must report Modifier Q0 with procedure codes 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, 0804T, 0823T, 0824T, 0825T, 0826T, 33274, 33275, C1605 to represent investigational clinical service provided in a CMS-approved clinical research study.

Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, leadless pacemakers are covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development (CED) listed in this medical policy are met.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

A list of approved CED studies for leadless pacemakers are listed and maintained on the CMS website at:
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Medtronic

Micra™

Transcatheter Pacemaker System was approved by the FDA on April 6, 2016, and is indicated for use in individuals who have experienced one or more of the following conditions:

Symptomatic paroxysmal or permanent high-grade atrioventricular (AV) block in the presence of atrial fibrillation (AF).
Symptomatic paroxysmal or permanent high-grade AV block in the absence of AF as an alternative to dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.
Symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses) as an alternative to atrial or dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.

Aveir™ VR Leadless Pacemaker System was approved by the FDA on March 31, 2022, and is indicated for use in individuals with bradycardia and:

• Normal sinus rhythm with only rare episodes of AV block or sinus arrest

• Chronic AF

• Severe physical disability

Aveir™ DR Leadless Pacemaker System was approved by the FDA on June 29, 2023, and is indicated for management of one or more of the following permanent conditions:

Syncope
Pre-syncope
Fatigue
Disorientation

Description

Leadless pacemakers are intended to treat bradycardia in individuals who require single-chamber ventricular pacing. The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead, which are integral elements of traditional pacing systems. The removal of these elements eliminates an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart; they function similarly to other transvenous single-chamber ventricular pacemakers.

References

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Leadless Pacemakers (20.8.4). 01/18/2017. [CMS website]. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=370&ncdver=1&bc=AAAAgAAAAAAAAA==&. Accessed February 20, 2025.

Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374(6):533-541.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket approval letter. Medtronic Micra™ Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software Model SW022 version 1.1). [FDA Web site]. 04/06/16. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150033A.pdf. Accessed February 20, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket approval letter. Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link Module . [FDA Web site]. 03/31/2022. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150035A.pdf. Accessed February 20, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket approval letter. Aveir™ DR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Leadless Pacemaker (Right aTRIAL), Aveir™ Delivery System Catheter, Aveir™ Link Module. [FDA Web site]. 06/29/2023. Available at: Correspondence Generator (CorGen) (fda.gov). Accessed February 20, 2025.

Coding

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT LEADLESS PACEMAKERS WHICH ARE EXPERIMENTAL AND INVESTIGATIONAL AND NOT COVERED EXCEPT WHEN UNDER MEDICARE'S COVERAGE WITH EVIDENCE DEVELOPMENT

0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, 0804T, 0823T, 0824T, 0825T, 0826T, 33274, 33275

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Z00.6 Encounter for examination for normal comparison and control in clinical research program

HCPCS Level II Code Number(s)

C1605 Pacemaker, leadless, dual chamber (right atrial and right ventricular implantable components), rate-responsive, including all necessary components for implantation

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub
Modifiers

THE FOLLOWING MODIFIER MUST BE APPENDED TO 33274 IN ORDER TO BE CONSIDERED FOR REIMBURSEMENT:

Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA05.067f:

04/01/2026	This policy has been reisued in accordance with the Company's annual review process.
04/02/2025	This policy has been reviewed and reissued to communicate the Company's continuing position on leadless pacemakers.
07/01/2024	This policy has been identified for the annual HCPCS code update effective 07/01/2024. Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. The following HCPCS code has been added to this policy: C1605 Pacemaker, leadless, dual chamber (right atrial and right ventricular implantable components), rate-responsive, including all necessary components for implantation

04/01/2026

This policy has been reisued in accordance with the Company's annual review process.

04/02/2025

This policy has been reviewed and reissued to communicate the Company's continuing position on leadless pacemakers.

07/01/2024

This policy has been identified for the annual HCPCS code update effective 07/01/2024.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS code has been added to this policy:

C1605 Pacemaker, leadless, dual chamber (right atrial and right ventricular implantable components), rate-responsive, including all necessary components for implantation

Revisions From MA05.067e:

04/01/2024

This version of the policy will become effective 04/01/2024.

The intent of this policy has not changed, although it has been modified to incorporate US Food and Drug Administration (FDA) status of the Aveir™ DR Leadless Pacemaker System.

In addition, a billing requirement regarding Modifer Q0 has been revised to include CPT codes that represent the removal of leadless pacemakers.

The Company's coverage position has changed from Medically Necessary to Experimental and Investigational and Not Covered except when under Medicare's Coverage with Evidence Development for the following CPT codes:

0798T, 0799T, 0800T, 0824T, 33275

Revisions From MA05.067d:

01/02/2024

This policy has been identified for the annual CPT code update effective 01/02/2024.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following CPT codes have been added to this policy:

0823T, 0824T, 0825T, 0826T

Revisions From MA05.067c:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
07/01/2023	This policy has been identified for the annual HCPCS code update effective 07/01/2023. Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. The following CPT codes have been added to this policy: 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, 0804T

Revisions From MA05.067b:

02/08/2023	This policy has been reissued in accordance with the Company's annual review process.
05/18/2022	This policy has been reissued in accordance with the Company's annual review process.
02/10/2021	This policy has been reissued in accordance with the Company's annual review process.
02/26/2020	This policy has been reissued in accordance with the Company's annual review process.
01/01/2020	This policy has been identified for the annual HCPCS code update effective 01/01/2020. The following CPT code narrative has been revised in this policy 33275

Revisions From MA05.067a:

02/13/2019	This policy has been reissued in accordance with the Company's annual review process.
01/01/2019	This policy has been identified for the CPT code update effective 01/01/2019. The following CPT codes have been termed from this policy: 0387T, 0388T, 0389T, 0390T, 0391T. The following CPT codes have been added to this policy: 33274, 33275.

Revisions From MA05.067:

08/15/2018	This policy has been reissued in accordance with the Company's annual review process.
11/03/2017	This version of the policy will become effective 11/03/2017. The following new policy has been developed to communicate the Company’s coverage criteria for leadless pacemakers.

Version Effective Date:

7/1/2024

Version Issued Date: