RETIRED LCD: Centers for Medicare & Medicaid Services

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Contractor Information

Contractor Name ^{back to top}

CIGNA Government Services
Contractor Number ^{back to top}
05440
Contractor Type ^{back to top}
Carrier

LCD Information

LCD ID Number ^{back to top}

L6853

LCD Title ^{back to top}
Resynchronization Therapy for Congestive Heart Failure (Biventricular Pacing)

Contractor's Determination Number ^{back to top}
2002-03-02

AMA CPT / ADA CDT Copyright Statement ^{back to top}
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy ^{back to top}
Section 1833(e) of Title XVIII of the Social Security Act. This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Section 1862(a)(1)(A) of Title XVIII of the Social Security Act. This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Section 1862(a)(7) of Title XVIII of the Social Security Act. This section excludes routine physical examinations. CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.4 Implantable Automatic Defibrillators, describes covered indications for implanted cardiac defibrillators. CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 310, describes coverage for qualified clinical trials.

Primary Geographic Jurisdiction ^{back to top}
Tennessee

Oversight Region ^{back to top}
Region IV

Original Determination Effective Date ^{back to top}
For services performed on or after 02/20/2003

Original Determination Ending Date ^{back to top}
08/28/2009

Revision Effective Date ^{back to top}
For services performed on or after 05/01/2007

Revision Ending Date ^{back to top}
08/28/2009

Indications and Limitations of Coverage and/or Medical Necessity ^{back to top}
Biventricular pacing or resynchronization therapy is a non-pharmacological treatment modality for patients with advanced heart failure. Its rationale is based on the observation that intraventricular conduction defects (IVCD) are associated with dysynchronization between the left and the right ventricle resulting in decreased cardiac performance. In biventricular pacing, the right and left ventricle are activated simultaneously. In addition to the right atrial and right ventricular leads, a dedicated lead is required to pace the left ventricle. The latter is positioned via the coronary sinus. Resynchronization therapy will be considered as medically reasonable and necessary if: 1) The patient is symptomatic despite optimal medical therapy with ACE (angiotensin converting enzyme) inhibitors and beta blockers as well as other appropriate pharmacologic measures, and 2) The patient has symptoms of moderate to severe congestive heart failure (NYHA Functional Class III or IV), and 3) The patient has a left ventricular ejection fraction of <35%, and 4) The QRS duration is ≥ 130 milliseconds. All four provisions must be met and documented. Although patients with a left ventricular end diastolic diameter (LVEDD) of 55 mm or greater are the group for which data suggests optimum clinical improvement, this will not be used as an exclusionary criterion when all the other requirements have been satisfied. As long as documented in the medical record, a patient’s intolerance or inability to take ACE inhibitors or beta blockers does not disqualify her/him for resynchronization therapy. For the initial implantation, a dedicated system must be used that is Food and Drug Administration (FDA) approved for this particular indication. Based on the individual patient situation, this carrier will consider the upgrade of previously implanted devices, as long as they are FDA approved. For the implantation of a biventricular pacing implantable cardiac defibrillator (ICD), all coverage criteria for the implantation of the ICD must be met first (CMS Manual System, Pub. 100-3, National Coverage Decisions, Ch. 1, section 20.4), in addition to all of the requirements for synchronized biventricular pacing. Documentation supporting this must be recorded in the medical record and available upon request. Resynchronization therapy is denied as not reasonable and necessary if these coverage criteria are not met.

Coding Information

Bill Type Codes: ^{back to top}

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes: ^{back to top}

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes ^{back to top}

33206	INSERTION OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); ATRIAL
33207	INSERTION OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); VENTRICULAR
33208	INSERTION OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); ATRIAL AND VENTRICULAR
33213	INSERTION OR REPLACEMENT OF PACEMAKER PULSE GENERATOR ONLY; DUAL CHAMBER
33214	UPGRADE OF IMPLANTED PACEMAKER SYSTEM, CONVERSION OF SINGLE CHAMBER SYSTEM TO DUAL CHAMBER SYSTEM (INCLUDES REMOVAL OF PREVIOUSLY PLACED PULSE GENERATOR, TESTING OF EXISTING LEAD, INSERTION OF NEW LEAD, INSERTION OF NEW PULSE GENERATOR)
33216	INSERTION OF A TRANSVENOUS ELECTRODE; SINGLE CHAMBER (ONE ELECTRODE) PERMANENT PACEMAKER OR SINGLE CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR
33217	INSERTION OF A TRANSVENOUS ELECTRODE; DUAL CHAMBER (TWO ELECTRODES) PERMANENT PACEMAKER OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR
33218	REPAIR OF SINGLE TRANSVENOUS ELECTRODE FOR A SINGLE CHAMBER, PERMANENT PACEMAKER OR SINGLE CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR
33220	REPAIR OF TWO TRANSVENOUS ELECTRODES FOR A DUAL CHAMBER PERMANENT PACEMAKER OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR
33222	REVISION OR RELOCATION OF SKIN POCKET FOR PACEMAKER
33223	REVISION OF SKIN POCKET FOR SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR
33224	INSERTION OF PACING ELECTRODE, CARDIAC VENOUS SYSTEM, FOR LEFT VENTRICULAR PACING, WITH ATTACHMENT TO PREVIOUSLY PLACED PACEMAKER OR PACING CARDIOVERTER-DEFIBRILLATOR PULSE GENERATOR (INCLUDING REVISION OF POCKET, REMOVAL, INSERTION, AND/OR REPLACEMENT OF GENERATOR)
33225	INSERTION OF PACING ELECTRODE, CARDIAC VENOUS SYSTEM, FOR LEFT VENTRICULAR PACING, AT TIME OF INSERTION OF PACING CARDIOVERTER-DEFIBRILLATOR OR PACEMAKER PULSE GENERATOR (INCLUDING UPGRADE TO DUAL CHAMBER SYSTEM) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
33233	REMOVAL OF PERMANENT PACEMAKER PULSE GENERATOR
33235	REMOVAL OF TRANSVENOUS PACEMAKER ELECTRODE(S); DUAL LEAD SYSTEM
33240	INSERTION OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR PULSE GENERATOR
33241	SUBCUTANEOUS REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER- DEFIBRILLATOR PULSE GENERATOR
33243	REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR ELECTRODE(S); BY THORACOTOMY
33244	REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR ELECTRODE(S); BY TRANSVENOUS EXTRACTION
33249	INSERTION OR REPOSITIONING OF ELECTRODE LEAD(S) FOR SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR AND INSERTION OF PULSE GENERATOR
71090	INSERTION PACEMAKER, FLUOROSCOPY AND RADIOGRAPHY, RADIOLOGICAL SUPERVISION AND INTERPRETATION
75860	VENOGRAPHY, VENOUS SINUS (EG, PETROSAL AND INFERIOR SAGITTAL) OR JUGULAR, CATHETER, RADIOLOGICAL SUPERVISION AND INTERPRETATION

ICD-9 Codes that Support Medical Necessity ^{back to top}

The primary ICD-9-CM codes must be accompanied by the secondary ICD-9-CM codes. The primary code indicates that the patient suffers from congestive heart failure, the secondary code attests to the intraventricular conduction defect.

Primary ICD-9-CM codes:

427.31	ATRIAL FIBRILLATION
428.0	CONGESTIVE HEART FAILURE UNSPECIFIED
428.1	LEFT HEART FAILURE
428.20	UNSPECIFIED SYSTOLIC HEART FAILURE
428.21	ACUTE SYSTOLIC HEART FAILURE
428.22	CHRONIC SYSTOLIC HEART FAILURE
428.23	ACUTE ON CHRONIC SYSTOLIC HEART FAILURE
428.30	UNSPECIFIED DIASTOLIC HEART FAILURE
428.31	ACUTE DIASTOLIC HEART FAILURE
428.32	CHRONIC DIASTOLIC HEART FAILURE
428.33	ACUTE ON CHRONIC DIASTOLIC HEART FAILURE
428.40	UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.41	ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.42	CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.43	ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.9	HEART FAILURE UNSPECIFIED

Secondary ICD-9-CM codes:

426.2 - 426.54 LEFT BUNDLE BRANCH HEMIBLOCK - TRIFASCICULAR BLOCK

Diagnoses that Support Medical Necessity ^{back to top}

Those listed in the "Indications and Limitations" section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity ^{back to top}

Any not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation ^{back to top}

Diagnoses that DO NOT Support Medical Necessity ^{back to top}

General Information

Documentation Requirements ^{back to top}

Each claim must be submitted with ICD-9-CM codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without ICD codes will be returned.

The operative note should reflect the indication for the procedure and its description with special attention to the placement of the coronary sinus lead, including any technical difficulties or complications. The type of equipment implanted must be recorded in the medical record.

A functional classification of the patient's heart failure, including appropriate diagnostic studies must be documented.

Documentation must be provided to Medicare upon request.

Appendices ^{back to top}

Utilization Guidelines ^{back to top}

Sources of Information and Basis for Decision ^{back to top}

. Saxon, Leslie, MD et al, "Devices in heart failure: Pacemakers", UpToDate®, Vol.9 No. 3

. Gerber, Thomas, MD et al "Left Ventricular and Biventricular Pacing in Congestive Heart Failure", Mayo Clin Proc. 2001; 76:803-812

. The Medtronic InSync® Cardiac Resynchronization System, statement

. Arrhythmia News, Continuum Heart Institute, St. Luke's-Roosevelt Hospital Center, Volume 7 Issue 2.

. Cazeau, Serge, MD et al, “Effects of Mulitisite Biventricular Pacing in Patients with Heart Failure and Intraventricular Conduction Delay”, New England Journal of Medicine, Vol. 344, No. 12, March 22, 2001, pp. 873-880.

. Results presented at the American College of Cardiology Meeting, March 21, 2001.

. Draft LMRP Empire Medicare Services – New York/New Jersey.

. MUSTIC Trial, NEJM 2001; 344; 873-80

Advisory Committee Meeting Notes ^{back to top}

This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which include representatives from cardiology and electrophysiology.

Start Date of Comment Period ^{back to top}

06/25/2002

End Date of Comment Period ^{back to top}

08/09/2002

Start Date of Notice Period ^{back to top}

01/02/2003

Revision History Number ^{back to top}

Revision History Explanation ^{back to top}

Revision 04
Effective Date: N/A
Revision Explanation: Secondary dx was inadvertently listed under primary dx section. Removed dx range 426.2-426.54 from primary dx.

Revision 03
Effective Date: May 1, 2007
Revision Explanation:
CMS NATIONAL COVERAGE POLICY:
NCDs 20.4 added.
INDICATIONS AND LIMITATIONS:
Acronyms written out and noncoverage statement added for clarity.
CPT/HCPCS CODES:
Statement about source of CPT codes removed.
ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:
Statements about basic ICD-9 code usage removed.
DIAGNOSES THAT SUPPORT MEDICAL NECESSITY:
Statement added.

Revision number: 02
Revision effective date: 11/01/2005
Revision explanation: added ICD-9's 426.2, 426.3, 426.4, 426.50, 426.51, 426.52, 426.53, 426.54, 427.31

Revision number: 01
Revision effective date: 01/01/2004
Explanation of revision: This policy revision reflects the ICD-9 and HCPCS Code updates for 2004. Only the changes that meet the medical necessity criteria of this policy were incorporated. Those may include:

1. Removal of ICD-9 "root" codes as a result of code expansions to additional digits.
2. Addition of new and deletion of outdated HCPCS Codes.
3. Changes in code descriptions.

Please note that changes to the ICD-9 coding system become effective on October 1, 2003 and have a grace period of 90 days.

New HCPCS codes and changes in code descriptions become effective immediately on January 1, 2004. Deleted codes have a grace period of 90 days.

This LCD was converted from an LMRP on 8/2/2004

11/07/2004 - The description for CPT/HCPCS code 33220 was changed in group 1

11/18/2006 - The description for CPT/HCPCS code 33224 was changed in group 1
11/18/2006 - The description for CPT/HCPCS code 33225 was changed in group 1

Changed date of retirement from 8/31/09 to 8/28/09 per CMS CR6436

Reason for Change ^{back to top}

Last Reviewed On Date ^{back to top}

09/17/2008

Medicare Coverage Database

LCD for Resynchronization Therapy for Congestive Heart Failure (Biventricular Pacing) (L6853)