Medical Policy: 02.02.16
Original Effective Date: July 2013
Reviewed: October 2014
Revised: October 2014
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The automatic implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient's heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death.
Indications for ICD implantation can be broadly subdivided into 1) secondary prevention, i.e., their use in patients who have experienced a potentially life-threatening episode of ventricular tachyarrhythmia (VT) (near sudden cardiac death); and 2) primary prevention, i.e., their use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or ventricular fibrillation (VF).
A totally subcutaneous ICD (S-ICD®) has been developed. This device does not employ transvenous leads and thus avoids the need for venous access and complications associated with the venous leads. Rather, the S-ICD® uses a subcutaneous electrode that is implanted adjacent to the left sternum. The electrodes sense the cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall.
On September 28, 2012, the S-ICD® system by Cameron Health, Inc. was approved by the FDA "to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, continual (incessant) ventricular tachycardia, or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing".
The first study on outcomes of an entirely subcutaneous ICD was published in 2010. This study described the development and testing of the device, including empiric evidence for the optimal placement of the subcutaneous electrode.
National Institute for Health and Care Excellence (NICE) published guidance in April 2013 on the insertion of a subcutaneous implantable defibrillator with the following guidance: Current evidence on the efficacy of the insertion of a subcutaneous implantable cardioverter defibrillator (ICD) for the prevention of sudden cardiac death in the short and medium term is adequate. Evidence on its safety in the short term is adequate but there are uncertainties about long-term durability. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance published in 2013 regarding the subcutaneous ICD stated: further study is necessary to determine whether benefits might outweigh risks in patients who currently appear to derive little benefit from ICD therapy due to comorbidities and competing mortality risks.
The use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients.
At the present time, there is insufficient published data regarding the safety, efficacy and long-term outcomes from use of the S-ICD System, and further study is needed to confirm its usefulness as an alternative to conventional transvenous ICD devices.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 33270 Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed
- 33271 Insertion of subcutaneous implantable defibrillator electrode
- 33272 Removal of subcutaneous implantable defibrillator electrode
- 33273 Repositioning of previously implanted subcutaneous implantable defibrillator electrode
- 93260 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, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system
- 93261 Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system
- 93644 Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters)
Wellmark's policy is based on:
- Bardy GH, Smith WM, Hood MA et al. An entirely subcutaneous implantable cardioverter-defibrillator. N. Engl. J. Med. 2010; 363(1):36-44.
- Gold MR, Theuns DA, Knight BP et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J. Cardiovasc. Electrophysiol. 2012; 23(4):359-66.
- Jarman JW, Lascelles K, Wong T, Markides V, Clague JR, Till J: Clinical experience of entirely subcutaneous implantable cardioverter-defibrillators in children and adults: Cause for caution. Eur Heart J 2012;33:1351-1359
- Pedersen SS, Lambiase P, Boersma LV, Murgatroyd F, Johansen JB, Reeve H, Stuart AG, Adragao P, Theuns DA: Evaluation of factors impacting clinical outcome and cost effectiveness of the S-ICD: Design and rationale of the EFFORTLESS S-ICD Registry. Pacing Clin Electrophysiol 2012;35:574-579
- Blue Cross and Blue Shield Association Medical Policy Reference Manual Issue 5:2013. Accessed 6/18/13.
- Lambiase PD, Barr C, Theuns DA et al. Worldwide experience with totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD registry. Eur Heart J 2014;doi:10.1093/eurheartj/ehu112.
- Jarman JW, Todd DM. United Kingdom national experience of entirely subcutaneous implantablecardioverter-defibrillator technology: important lessons to learn. Europace 2013;15:1158-1165.
- NICE Interventional Procedures Guidance [IPG454}]. Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of sudden cardiac death. 24 April 2013.
Date Reason Action
July 2013 New Policy New Policy
December 2013 Annual review Policy renewed
October 2014 Annual review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.