CurrentKaiser PermanentePolicy N/A

Cardiac contractility modulation (Optimizer Smart System) — Clinical Review Criteria

Clinical review criteria for medical necessity and coverage stance on implantation and related services for the Optimizer Smart System (cardiac contractility modulation) for Kaiser Foundation Health Plan of Washington members; applies to Medicare and non‑Medicare with distinctions in rationale.

Policy Summary

PayerKaiser Permanente

PolicyCardiac contractility modulation (Optimizer Smart System) — Clinical Review Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting review, submit the last 6 months of clinical notes from the requesting provider and/or specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4trials reviewed

n=801sample size

25%–45%target LVEF

III–IVNYHA class

0408T–0418T, 0948T–0949T, C1824, K1030NMN codes listed

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Coverage Determination and Criteria

Coverage conclusion

Policy stance and evidence summary

Overall evidence conclusion: There is insufficient evidence that CCM (Optimizer Smart System) provides long-term clinical benefit (mortality, hospitalization) compared with optimal medical therapy; short-term improvements in quality of life and peak VO2 have been observed but long-term outcomes are unclear.

Based on 4 randomized trials (n=801): moderate-quality evidence for short-term symptomatic benefits; lack of mortality/hospitalization data and insufficient quantity/quality of evidence; committee determined evidence is insufficient and will await further trials including mortality data.

Insertion, replacement, removal, interrogation, programming, remote interrogation, and related device/charging supply services for the Optimizer Smart System (cardiac contractility modulation, CCM) are identified in this policy as Not Medically Necessary / experimental, investigational, or unproven. The policy lists the specific procedural and supply codes associated with these services and indicates they are not covered due to insufficient evidence of long‑term clinical benefit beyond short‑term symptomatic improvements.

Providers should note that the policy explicitly includes both in‑person device procedures (insertion, replacement, removal, repositioning, programming, interrogation) and remote device management services and supplies (remote interrogation/remote data acquisition, external recharging systems, and the implantable generator) in the non‑covered category. Use the plan’s pre‑authorization code check to verify any plan‑specific authorization requirements for these codes.

The following CPT and HCPCS codes for CCM device implantation and related services are listed in this policy as Not Medically Necessary / experimental, investigational, or unproven and therefore are considered non‑covered: CPT codes 0408T, 0409T, 0410T, 0411T, 0412T, 0413T, 0414T, 0415T, 0416T, 0417T, 0418T, 0948T, 0949T, and HCPCS codes C1824 and K1030. Note that the policy states the code lists may not be all‑inclusive and recommends verifying authorization requirements with the Pre‑authorization Code Check.

Billing Codes and Coding Guidance

Considered Not Medically Necessary / experimental procedural codesCPTNot Covered

0408T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; pulse generator with transvenous electrodes.
0409T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; pulse generator only.
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	0416T
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.

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Considered Not Medically Necessary / HCPCS codesHCPCSNot Covered

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

Provider Responsibilities and Prior Authorization

Prior Authorization

Prior Authorization / Code Verification

Listed CPT and HCPCS codes related to cardiac contractility modulation (CCM) are identified in this policy and may require prior authorization or verification before services are performed.

Verify prior authorization requirements via Pre-authorization Code Check for the specific member plan.
Codes listed in this policy may be updated; always confirm code status and plan-level rules before billing.

Note

Provider Action

Submit any required prior authorization requests and follow plan-specific billing guidelines. Contact the Kaiser Permanente provider line if you are unsure whether a service needs authorization.

Documentation Required

Clinical Background

Heart failure is a chronic, progressive condition most commonly resulting from ischemic heart disease, hypertension, or diabetes. Approximately half of heart failure cases are characterized by reduced left ventricular ejection fraction (HFrEF), and affected patients frequently remain symptomatic despite optimal medical therapy. Cardiac contractility modulation (CCM) with the Optimizer Smart System is an implanted, pacemaker‑sized, rechargeable device intended to deliver non‑excitatory electrical signals to the myocardium to increase ventricular contractility for selected patients with symptomatic heart failure (typically NYHA class III–IV) and an ejection fraction in the range discussed in the clinical literature. The policy committee reviewed randomized trials (total n≈801) and concluded that, while short‑term improvements in symptoms and exercise capacity have been reported, the evidence is insufficient to demonstrate sustained reductions in mortality or heart failure hospitalizations; therefore long‑term clinical benefit remains uncertain.

Device and Terminology

Optimizer Smart System / cardiac contractility modulation (CCM)

Device typePacemaker-sized, rechargeable implanted pulse generator (Optimizer Smart System).

Therapy deliveredCardiac contractility modulation (CCM): non-excitatory electrical signals delivered to the myocardium to increase ventricular contractile strength.

Intended patient populationPatients with heart failure NYHA class III–IV with left ventricular ejection fraction (LVEF) 25%–45% who remain symptomatic despite optimal medical therapy.

Mechanism of actionDelivers timed electrical pulses that modify myocardial contractility (non‑pacing, non‑exciting signals) to enhance ventricular contraction strength.

Implant and maintenanceImplanted transvenous system with pulse generator; device is rechargeable. Clinical use may require device programming, interrogation, and follow-up assessments.