CurrentBlue Cross Blue Shield - IowaPolicy N/A

Cardiac Contractility Modulation (CCM) Device Components and Ancillary Services

Supplemental coverage policy governing Cardiac Contractility Modulation components and ancillary services (CPT 0410T-0418T, 0948T-0949T; HCPCS C1824, K1030). It clarifies that CCM components and ancillary services are considered investigational for all indications because the primary implantation/replacement procedure (0408T) is investigational per the applicable EviCore guideline.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyCardiac Contractility Modulation (CCM) Device Components and Ancillary Services

Policy CodePolicy N/A

Change TypePolicy Revised (Jun & Nov 2025)

Effective DateJan 1, 2016

Next Review DateNov 30, 2025

Key ActionProviders must refer to the Wellmark Authorization Table for prior approval requirements and the applicable EviCore Evidence-based Guideline regarding implantation or replacement of cardiac contractility modulation (0408T).

POLICY UPDATE CHANGES

Policy Revised in June 2025 and November 2025 per policy history entries.

13Listed CPT/HCPCS codes addressed

2HCPCS device/accessory codes

1Primary implantation code referenced (0408T)

2019/2021Regulatory note: FDA Breakthrough & labeling change

Coverage Summary

This supplemental coverage policy addresses Cardiac Contractility Modulation (CCM) components and ancillary services and clarifies that these items are considered investigational. It is not an evidence review for implantation or replacement of the primary CCM device (CPT 0408T) and therefore defers to the applicable EviCore evidence-based guideline for decisions about implantation or replacement. The OPTIMIZER Smart System received FDA Breakthrough Device designation in 2019 and had a labeling modification in 2021. Policy effective date is 2016-01-01, last review 2025-11-01, and next review 2025-11-30.

Key Facts

SubjectCardiac Contractility Modulation (CCM) Device Components and Ancillary Services

Coverage stanceInvestigational / Not Covered for components & ancillary services

Primary implantation code referenced0408T

Regulatory noteOPTIMIZER Smart System received FDA Breakthrough Device designation (March 2019) and labeling modification approved Oct 26, 2021

Effective date2016-01-01

Last review2025-11-01

Next review2025-11-30

Coverage Determination / Medical Necessity

Coverage Determination

Coverage for CCM components and ancillary services is governed by the investigational status of the primary procedure:

ALL of the following

Cardiac Contractility Modulation components and ancillary services (CPT 0410T-0418T, 0948T-0949T; HCPCS C1824 & K1030) are considered investigational for all indications, including but not limited to heart failure.
The primary procedure of implantation or replacement of cardiac contractility modulation (0408T) is considered investigational per the applicable EviCore evidence-based guideline; therefore supplemental components and services are investigational.
This policy is not an evidence review for implantation or replacement (0408T); it is a supplemental coverage policy for components and ancillary services.
Refer to Wellmark Authorization Table for prior approval requirements and the applicable EviCore Evidence-based Guideline regarding implantation/replacement of CCM (0408T).

Codes (CPT, HCPCS, Service/Place)

Investigational / Not Covered (CCM components & ancillary services)CPTNot Covered

0410T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; atrial electrode only.
0411T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; ventricular electrode only.
0412T	Removal of permanent cardiac contractility modulation system; pulse generator only.
0413T	Removal of permanent cardiac contractility modulation system; transvenous electrode (atrial or ventricular).
0414T	Removal and replacement of permanent cardiac contractility modulation system pulse generator only.
0415T	Repositioning of previously implanted cardiac contractility modulation transvenous electrode, (atrial or ventricular lead).
0416T	Relocation of skin pocket for implanted cardiac contractility modulation pulse generator.
0417T	Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, including review and report, implantable cardiac contractility modulation system.
0418T	Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter; implantable cardiac contractility modulation system.
0948T	Interrogation device evaluation (remote), up to 90 days, cardiac contractility modulation system with interim analysis, review and report(s) by a physician or other qualified health care professional.

1–10 of 11

1/2

Investigational / Not Covered (HCPCS device & accessory)HCPCSNot Covered

C1824	Generator, cardiac contractility modulation (implantable).
K1030	External recharging system for battery (internal) for use with implanted cardiac contractility modulation generator, replacement only.

Service/Place of Servicemixed

Cardiology	Type of Service
Inpatient/Outpatient	Place of Service

Provider Actions & Billing Impact

Documentation Required

Refer to Authorization Table and EviCore Guideline

Providers must refer to the Wellmark Authorization Table for prior approval requirements and the applicable EviCore Evidence-based Guideline regarding implantation or replacement of cardiac contractility modulation (0408T).

Affected code: 0408T
See Wellmark Authorization Table and the applicable EviCore Evidence-based Guideline for implantation/replacement of CCM (0408T).

Denial Risk

Claims for CCM components/services considered investigational

Claims for components and ancillary services are considered investigational for all indications and may be denied on that basis.

Background

Cardiac Contractility Modulation (CCM) is a device therapy that delivers electrical signals to the ventricles during the ventricular absolute refractory period intended to improve functional status in chronic moderate-to-severe heart failure. The OPTIMIZER® Smart Implantable Pulse Generator (Impulse Dynamics) was granted FDA Breakthrough Device exemption in March 2019 for use in certain patients with chronic, moderate-to-severe heart failure and had a labeling modification approved on October 26, 2021 removing the normal sinus rhythm requirement from its indications. This policy is supplemental and focuses on CCM components and ancillary services (CPT 0410T-0418T, 0948T-0949T; HCPCS C1824 & K1030) and defers to EviCore and the Wellmark Authorization Table for coverage and prior approval requirements regarding implantation or replacement of the primary device (CPT 0408T).

Definitions

Thresholds / Notes

Revision History

June 2025Policy Revised

Policy Revised in June 2025 per policy history entry; interim review noted in June 2025.

November 2025Policy RevisedLatest

Policy Revised in November 2025 per policy history entry; listed as an interim review with action 'Policy Revised'.