Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) for Treating Life-threatening Ventricular Tachyarrhythmia
Policy #:MA05.027

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Subcutaneous implantable cardioverter defibrillator (S-ICD) for the treatment of life-threatening ventricular tachyarrhythmia in individuals who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing, is considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35 percent or less
  • Ischemic cardiomyopathy with NYHA functional class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30 percent or less
  • Nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35 percent or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined
  • Hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; one or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a professional provider experienced in the care of individuals with HCM.
  • History of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for S-ICD are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

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.
Policy Guidelines

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

NEW YORK HEART ASSOCIATION FUNCTIONAL CLASSIFICATION

ClassPatient Symptoms
Class I (Mild)No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II (Mild)Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III (Moderate)Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV (Severe)Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, S-ICD is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Cameron Health S-ICDŽ System was approved by the FDA on September 28, 2012 for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

Supplemental approvals for Emblem TM S-ICD System have since been issued by the FDA.

Description

A traditional implantable cardioverter defibrillator (ICD) is implanted under the skin with the generator positioned underneath the collar bone. The defibrillator lead is inserted through the veins in the chest that course to the heart, permitting direct attachment to right ventricle inside the heart. The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.

A subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed that does not employ transvenous leads, with the goal of reducing lead-related complications such as dislodgement, insulation breakage, and fractures leading to device replacement and surgical revision. The S-ICD device provides an electric shock to the heart (defibrillation) for the treatment of life-threatening heart arrhythmias that originate from the lower chambers of the heart (ventricular tachyarrhythmias). The most common types of ventricular tachyarrhythmias are ventricular tachycardia and ventricular fibrillation. Ventricular tachycardia is a heart rhythm faster than 100 beats per minute along with three or more consecutive irregular beats, and ventricular fibrillation is the uncoordinated contraction of the muscles of the ventricles, making them quiver rather than contract, thus the heart pumps less blood to the body. Ventricular tachyarrhythmias are usually diagnosed by a detailed history and physical including a 12-lead electrocardiogram (ECG), cardiac enzyme levels, and an echocardiogram to assess for structural heart disease.

The S-ICD device consists of a titanium case containing a battery and electronic circuitry that provides defibrillation therapy and pacing at a rate of 50 beats per minute up to 30 seconds after a shock. The subcutaneous electrode has a proximal and distal ring electrode on each side of a three-inch (eight-cm) defibrillation coil electrode. Accessories include an electrode insertion tool, programmer, telemetry wand, magnet, suture sleeve, torque wrench, and memory card. The S-ICD is programmable as a single or dual zone device which allows the professional provider to tailor the therapy for the individual. The S-ICD is implanted under the left breast, and the lead is placed under the skin along the left side of the breastbone. The lead does not course through the central veins in the chest, nor is it attached to the tissue within the heart chambers. There are currently two S-ICD devices manufactured by Boston Scientific, the Cameron Health S-ICDŽ System (first generation) and the Emblem TM S-ICD System (second generation).

In September 2012, the U.S. Food and Drug Administration (FDA) approved the first-generation Cameron Health S-ICDŽ System (Cameron Health, San Clemente, CA, acquired by Boston Scientific Corp., San Clemente, CA) to provide defibrillation therapy for the life-threatening ventricular tachyarrhythmias in individuals who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing (ATP). The FDA approval was based upon an Investigational Device Examination (IDE) study (Weiss et al.), a single-arm, prospective, non-randomized, multicenter clinical study reporting on the results of a 321-participant study in which 304 individuals were successfully implanted with the S-ICDŽ System. The safety endpoint was evaluated through the use of a 180-day S-ICD complication free rate. The effectiveness endpoint was evaluated using an induced ventricular fibrillation conversion efficacy rate. Spontaneous episodes and chronic conversion testing data were evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD. The S-ICDŽ System was successful at converting all abnormal heart rhythms that it detected, back to normal rhythms. Investigators followed these study participants for six months following implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 individuals. All arrhythmias were either successfully converted back to normal by the defibrillator or resolved on their own. Because the S-ICDŽ System memory stores data from only the 22 most recent arrhythmia episodes, there may have been other detected episodes that could not be analyzed by investigators. In March 2015, the FDA granted marketing approval through a PMA supplement for the Emblem TM S-ICD System, the second-generation system. Results from a pooled analysis of the IDE study and EFFORTLESS study (Lambiase et al.) reported by Burke 2015, where 889 individuals underwent implantation were followed for over a three-year period. Subcutaneous-ICD showed high shock efficacy for spontaneous ventricular arrhythmias and a decreasing incidence of inappropriate shocks. The complication-free rate and low mortality rate extended beyond the first year. The rate of inappropriate shocks and the risks of infection and total complications decreased as professional providers who performed the procedure gained more experience with the device. This data provided further support for the safety and efficacy of the S-ICD in individuals with primary and secondary indications without pacing indications over a three-year period. As part of the approval, FDA is requiring the manufacturing company to conduct a postmarket study to assess the long-term safety and performance of the device and to assess differences in effectiveness across genders. The study will follow 1,616 individuals for five years.

Subcutaneous-ICD is intended for individuals who do have standard indications for an ICD, but do not require pacing for bradycardia, or antitachycardia overdrive pacing for ventricular tachycardia. Individuals who have comorbid conditions that preclude access to the vasculature or heart may now benefit from defibrillation therapy with S-ICD, since S-ICD does not require access to the vasculature or heart, and it is reported to avoid some risks associated with transvenous leads such as venous occlusion, embolic vascular events, and lead failure from subclavian crush. It can be used for individuals with congenital heart disease, individuals lacking venous access, and individuals with indwelling catheters who are at high risk for infection, along with individuals who are immunocompromised, who are on dialysis, who need to preserve venous assess, and for younger individuals for whom lead longevity is a concern.

The Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS) 2014 has published a consensus statement on the recognition and management of arrhythmias in adult congenital heart disease which states that the S-ICD may be a reasonable option in adults with congenital heart disease in whom transvenous access is not possible or desirable and in whom bradycardia and ATP functions are not essential.

In June 2013, the HRS submitted a letter supporting coverage of the S-ICDŽ System as a medically reasonable option for individuals who meet criteria for a standard transvenous ICD for primary or secondary prevention of sudden cardiac death.

The National Institute for Health and Care Excellence (NICE) 2013 Guideline states that the current evidence on the efficacy of the insertion of an S-ICD for the prevention of sudden cardiac death is adequate in the short- and medium-term.
References

American College of Cardiology, American Heart Association Task Force, European Society of Cardiology Committee for Practice Guidelines (ACC/AHA/ESC). 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death). J Am Coll Cardiol. 2006;48(5):247-346.

American Heart Association (AHA). What is an implantable cardioverter defibrillator (ICD)?. [AHA Web site]. 12/09/2015. Available at:
http://www.heart.org/HEARTORG/Conditions/What-is-an-Implantable-Cardioverter-Defibrillator-ICD_UCM_430941_Article.jsp. Accesssed August 15, 2016.

Aziz S, Leon AR, El-Chami MF. The subcutaneous defibrillator. A review of literature. [American College of Cardiology Web site]. 01/14/2014. Available at:
http://ac.els-cdn.com/S0735109714003295/1-s2.0-S0735109714003295-main.pdf?_tid=508c5d0a-3482-11e5-8b4f-00000aacb360&acdnat=1438017180_19c88759a304f535068e2714fe9691b5 Accessed August 15, 2016.

Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363(1):36-44.

Burke MC, Gold MR, Knight BP, et al. Safety and efficacy of the totally subcutaneous implantable defibrillator. [Science Direct Web site]. 04/28/2015. Available at:
http://www.sciencedirect.com/science/article/pii/S0735109715007573. Accessed August 15, 2016.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Transmittal 1672. Pub 100-20: Coding Revisions to National Coverage Determinations (NCDs). [CMS Web site]. 06/03/2016. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1672OTN.pdf. Accessed August 15, 2016.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).20.4: Implantable Automatic Defibrillators. [CMS Web site]. 01/27/2005. Available at:
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110&ncdver=3&DocID=20.4&generalError=Thank+you+for+your+interest+in+the+Medicare+Coverage+Database.+You+may+only+view+the+page+you+attempted+to+access+via+normal+usage+of+the+Medicare+Coverage+Database.&bc=gAAAABAAAAAAAA%3d%3d& Accessed August 15, 2016.

Chang PM, Doshi R, Saxon LA. Subcutaneous implantable cardioverter-defibrillator. [American Heart Association Web site]. 06/10/2014. Available at:http://circ.ahajournals.org/content/129/23/e644.full. Accessed August 15, 2016.

ClinicalTrials.gov. S-ICDŽ emblSystem IDE Clinical Study. [Clinical Trials.gov Web site]. 10/08/12. Available at: https://clinicaltrials.gov/ct2/show/NCT01064076. Accessed August 15, 2016.

Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61(3):6-75.

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):359-366.

Groh CA, Sharma S, Pelchovitz DJ, et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11(8):1361-1366.

Heart Rhythm Society (HRS). Payment for the Subcutaneous Implantable Defibrillator (S-ICD™) System. [HRS Web site]. June 2013. Available at: http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CDAQFjAA&url=http%3A%2F%2Fwww.hrsonline.org%2Fcontent%2Fdownload%2F14546%2F647768%2Ffile%2FHRS%2520SICD%2520coverage%2520statement062013.pdf&ei=ORwkVLvYEYqvyATF2YKgBA&usg=AFQjCNGKCqEicRM5Qy8R3cOL7KL3iWK6yw. Accessed August 15, 2016

Khairy P, Van Hare GF, Balaji S, et al. Expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease. [Heart Rhythm Society Web site]. October 2014. Available at:
file:///C:/Users/c62pp00/Downloads/2014%20Recognition%20and%20Management%20of%20Arrhymias%20in%20Adult%20Congenital%20Heart%20Disease.pdf. Accessed August 15, 2016.

Kobe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm.2013;10(1):29-36.

Kooiman KM, Knops RE, Olde Nordkamp L, et al. Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: Implications for management. Heart Rhythm. 2014;11(3):426-434.

Lambiase PD, Srinivasan NT. Early experience with the subcutaneous ICD. Curr Cardiol Rep. 2014;16(8):516.

Lambiase PD, Theuns DAMJ, Barr C, et al. International experience with a subcutaneous ICD: preliminary results of the EFFORTLESS S-ICD Registry. Heart Rhythm. 2012; 9(suppl):S15.

National Institute for Health and Clinical Excellence (NICE). Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of sudden cardiac death. [NICE Web site]. April 2013. Available at: https://www.nice.org.uk/guidance/ipg454. Accessed August 15, 2016.

Raphael C, Briscoe C, Davies J, et al. Limitations of the New York Heart Association functional classification system and self‐reported walking distances in chronic heart failure. Heart. 2007;93(4): 476–482.

Russo AM, Stainback RF, Bailey SR, et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: 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. J Am Coll Cardiol. 2013;61(12):1318-1368.

Saxon LA. The subcutaneous implantable defibrillator: a new technology that raises an existential question for the implantable cardioverter-defibrillator. Circulation. 2013;128(9):938–940.

US Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Subcutaneous Implantable Defibrillator (S-ICD)Ž System. Premarket approval letter. [FDA Web site]. 09/28/12. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042a.pdf
Accessed August 15, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH).Subcutaneous Implantable Defibrillator (S-ICDŽ) System. Summary of safety and effectiveness. [FDA Web site]. 09/28/12 Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042b.pdf. Accessed August 15, 2016..

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). A patient guide. Living with your Subcutaneous Implantable Defibrillator (S-ICDŽ) System. Labeling. [FDA Web site]. 2012. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042c.pdf. Accessed Augusy 15, 2016.

Weiss R, Knight BP, Gold MR, et al . Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128(9):944–953.

Yaminisharif A, Nader S, Akbar S, et al. Generator and lead-related complications of implantable cardioverter defibrillators. Int Cardiovasc Res J. 2014;8(2): 66–70.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

33240, 33241, 33262, 33270, 33271, 33272, 33273, 93260, 93261, 93644


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

NOT AN ALL INCLUSIVE LIST

I47.1 Supraventricular tachycardia

I47.2 Ventricular tachycardia

I49.01 Ventricular fibrillation

T82.110A Breakdown (mechanical) of cardiac electrode, initial encounter

T82.110D Breakdown (mechanical) of cardiac electrode, subsequent encounter

T82.110S Breakdown (mechanical) of cardiac electrode, sequela

T82.111A Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter

T82.111D Breakdown (mechanical) of cardiac pulse generator (battery), subsequent encounter

T82.111S Breakdown (mechanical) of cardiac pulse generator (battery), sequela

T82.118A Breakdown (mechanical) of other cardiac electronic device, initial encounter

T82.118D Breakdown (mechanical) of other cardiac electronic device, subsequent encounter

T82.118S Breakdown (mechanical) of other cardiac electronic device, sequela

T82.119A Breakdown (mechanical) of unspecified cardiac electronic device, initial encounter

T82.119D Breakdown (mechanical) of unspecified cardiac electronic device, subsequent encounter

T82.119S Breakdown (mechanical) of unspecified cardiac electronic device, sequela

T82.6XXA Infection and inflammatory reaction due to cardiac valve prosthesis, initial encounter

T82.6XXD Infection and inflammatory reaction due to cardiac valve prosthesis, subsequent encounter

T82.6XXS Infection and inflammatory reaction due to cardiac valve prosthesis, sequela

T82.7XXA Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts, initial encounter

T82.7XXD Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts, subsequent encounter

T82.7XXS Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts, sequela

Z45.02 Encounter for adjustment and management of automatic implantable cardiac defibrillator




HCPCS Level II Code Number(s)

Healthcare Common Procedure Coding System (HCPCS) C Series Codes can only be reported for outpatient facility services. Professional providers should not report HCPCS C Series Codes for professional services regardless of where those services are performed:

C1722 Cardioverter-defibrillator, single chamber (implantable)

C1896 Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable)




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References




Policy History

MA05.027
11/20/2019This policy has been reissued in accordance with the Company's annual review process.
08/31/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on subcutaneous implantable cardioverter defibrillator (S-ICD) for treating life-threatening ventricular tachyarrhythmia.
10/01/2015The following new policy has been developed to communicate the Company’s coverage criteria for subcutaneous implantable cardioverter defibrillator (S-ICD) for treating life-threatening ventricular tachyarrhythmia.






Version Effective Date: 10/01/2015
Version Issued Date: 10/01/2015
Version Reissued Date: 11/21/2019