Latest Review Date:   March 2024                

Category:  Surgical                                                                                                    

POLICY:

Cardiac Contractility Modulation is considered investigational for all indications, including but not limited to, heart failure.

DESCRIPTION OF PROCEDURE OR SERVICE:

The use of cardiac contractility modulation (CCM) therapy has been proposed as a treatment option for individuals with moderate-to-severe heart failure (HF) who are not candidates for cardiac resynchronization therapy.  CCM applies precisely time electrical stimulation to the heart to potentially reverse left ventricular (LV) remodeling and improve the heart’s contractility. 

The CCM device consists of a generator implanted in the subcutaneous tissue of the chest wall, with two leads implanted into the right ventricle of the heart.  Once the device is activated and programmed, it delivers CCM therapy to the myocardium in scheduled sessions throughout the day. 

KEY POINTS:

This policy has been updated with literature review performed through March 20, 2024.

Summary of Evidence

For individuals who receive cardiac contractility modulation for any indication, including heart failure, the evidence includes a meta-analysis, randomized controlled trials, prospective and retrospective studies.  Relevant outcomes are hospital admissions, functional outcomes, quality of life, and treatment related mortality and morbidity. A meta-analysis that included 641 participants with HF, found that CCM improved peak oxygen consumption and quality of life (measured by the Minnesota Living With Heart Failure Questionnaire).  However, when compared with placebo or usual care, the six minute walk test distance results were uncertain.  Trials that tested the efficacy of CCM showed minimal or no effect on all-cause mortality or on survival free of hospitalization. The evidence for CCM may show functional measure improvements, but high rates of complications and placebo effects have also been reported.  Additionally, further research is needed regarding the effect on long-term clinical outcomes with complication risk.  The evidence is insufficient to determine the effect of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Cardiology

In 2023, the ACC published Expert Consensus Decision Pathway on Management of Heart Failure with Preserved Ejection Fraction.  They state that “Other device interventions for HFpEF such as…. or cardiac contractility modulation are under evaluation; their benefits remain ambiguous.  Such procedures should be considered only within the context of clinical trials.”

American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA)

In 2022, the AHA/ACC/HFSA published a joint guideline for the management of heart failure.  CCM as a treatment for heart failure was included in a table for Evidence Gaps and Future Research Directions.

National Institute for Health and Care Excellence (NICE)

In June 2019, NICE published guidelines for cardiac contractility modulation device implantation for heart failure.  They state:

• “The evidence on cardiac contractility modulation device implantation for heart failure raises no major safety concerns. However, the evidence on efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.”
• “Further research should ideally be in the form of randomised controlled trials….”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cardiac Contractility Modulation, CCM, Device-based inotropic heart failure therapy, heart failure, Optimizer® Smart system

APPROVED BY GOVERNING BODIES:

In March 2019, the Optimizer Smart System was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process, indicated to improve 6 minute hall walk distance, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for Cardiac Resynchronization Therapy, and have a left ventricular ejection fraction ranging from 25% to 45%.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS:   Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. Abraham WT, Kuck KH, Goldsmith RL, et al. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail 2018; 6:874.
2. American College of Cardiology. 2023 ACC expert consensus decision pathway on management of heart failure with preserved ejection fraction. https://www.jacc.org/doi/pdf/10.1016/j.jacc.2023.03.393.
3. Anker SD, Borggrefe M, Neuser H, et al. Cardiac contractility modulation improves long-term survival and hospitalizations in heart failure with reduced ejection fraction. Eur J Heart Fail. 2019 Sep;21(9):1103-1113.
4. Colucci WS. Investigational therapies for management of heart failure. Up to Date. Available at: https://www.uptodate.com/contents/investigational-therapies-for-management-of-heart-failure?search=cardiac%20contractility%20modulation&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H3602588473.
5. FDA.  Premarket Approval (PMA) for Optimizer Smart System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180036A.pdf.
6. Giallauria F, Vigorito C, Piepoli MF, Stewart Coats AJ. Effects of cardiac contractility modulation by non-excitatory electrical stimulation on exercise capacity and quality of life: an individual patient's data meta-analysis of randomized controlled trials. Int J Cardiol 2014; 175:352.
7. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: A report of the American college of cardiology/American heart association joint committee on clinical practice guidelines. Circulation. 1 Apr 2022; 145:e895-e1032.
8. Impulse Dynamics.  An overview of CCM therapy for medical professionals.  Available at: https://impulse-dynamics.com/procedure-and-mode-of-action/.
9. Kuschyk J, Falk P, et al. Long-term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system. Eur J Heart Fail. 2021 May 17. doi: 10.1002/ejhf.2202.
10. Li Z, Liu Q, Zhou S, Xiao Y. Enhancing myocardial function with cardiac contractility  modulation: potential and challenges.  ESC Heart Fail. 2024 Feb;11(1):1-12. doi: 10.1002/ehf2.14575. Epub 2023 Nov 10.
11. Mando R, Goel A, et al. Outcomes of Cardiac Contractility Modulation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Cardiovasc Ther. 2019 Jun 17;2019:9769724.
12. Müller D, Remppis A, et al. Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left ventricular systolic dysfunction. Clin Res Cardiol. 2017 Nov;106(11):893-904.
13. National Institute for Health and Care Excellence (NICE). Cardiac contractility modulation device implantation for heart failure.  Available at: https://www.nice.org.uk/guidance/ipg655/chapter/2-The-condition-current-treatments-and-procedure.  Accessed March 2, 2023.
14. Wiegn P, Chan R, et al. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512.

POLICY HISTORY:

Medical Policy Group, March 2023 (4):  Adopted new policy from investigational listing.

Medical Policy Administration Committee: April 2023

Available for Comment: April 1, 2023 through May 15, 2023

Medical Policy Group, March 2024 (4): Updates to Key Points and References.  No change to policy statement. 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members.  Our decisions concern coverage only.  The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient.  The plan administers benefits based on the member's contract and corporate medical policies.  Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients.  Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. 

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.