Print Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure

Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure

 

DESCRIPTION

It is estimated that 20%-30% of patients with heart failure (CHF) have intraventricular conduction disorders resulting in a discoordinated contraction pattern and a wide QRS interval on the electrocardiogram (EKG). This abnormality appears to be associated with increased morbidity and mortality. Biventricular pacemakers using three leads (one in the right atrium and one in each ventricle) have been investigated as a technique to coordinate the contraction of the ventricles, thus improving the hemodynamic status of the patients. Two strategies are being explored: incorporating biventricular pacing into automatic implantable cardiac defibrillators and the development of stand-alone biventricular pacemakers. 

One stand-alone biventricular pacemaker (InSync® Biventricular Pacing System, Medtronic) has received approval by the U.S. Food and Drug Administration (FDA) for the treatment of patients with New York Heart Association (NYHA) Class III or IV heart failure, on a stable pharmacologic regimen, who also have a QRS duration of >130 msec and a left ventricular ejection fraction of <35%. Biventricular pacemakers have also been combined with automatic implantable cardiacdefibrillators (AICDs). Both Guidant (CONTAK CD ® CRT-D System) and Medtronic (InSync ®ICD Model 7272) have received FDA approval for combined cardiac resynchronization therapy defibrillators for patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have NYHA Class III or IV heart failure with left ventricular ejection fraction of <35%, QRS duration >130ms (>120ms for the Guidant device) and remain symptomatic despite a stable, optimal heart failure drug therapy. See the Automatic Implantable Cardioverter Defibrillator (AICD) medical policy.

In September 2010, the FDA expanded the indications for CRT to include patients with class I and II heart failure. In addition to NYHA class I/II heart failure, indications for CRT in mild heart failure include a left ventricular (LV) ejection fraction of less than 30% and a QRS duration of 130 msec or greater.

In 2005, the InSync Sentry system received FDA approval through the supplemental premarket approval (PMA) process.  This combined biventricular pacemaker/AICD is additionally equipped to monitor intrathoracic fluid levels using bioimpedance technology, referred to as OptiVol Fluid Status monitoring.  Bioimpedance measures, defined as the electrical resistance of tissue to flow of current, are performed many times per day using a vector from the right ventricular coil on the lead in the right side of the heart to the implanted pacemaker devices; changes in bioimpedance reflect intrathoracic fluid status and are evaluated based on a computer algorithm.  For example, changes in a patient's daily average of intrathoracic bioimpedance can be monitored; differences in the daily average compared to a baseline are reported as the OptiVol Fluid Index.  It has been proposed that these data may be used as an early warning system of cardiac decompensation, or provide additional feedback enabling a physician to further tailor medical therapy.

 

POLICY

Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary as a treatment of heart failure in patients who meet all of the following criteria:

NYHA Class III or IV

  • Left ventricular ejection fraction <35%
  • Sinus rhythm
  • QRS duration of >120 - 130* msec
  • Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotension-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker digoxin, and/or diuretics.

NYHA class II

  • Left ventricular ejection fraction ≤30%
  • Sinus rhythm
  • QRS duration of ≥120–130* msec, and
  • Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker digoxin, and/or diuretics

*The FDA-labeled indication for the InSync® device is limited to patients with a QRS duration of  >130 msec, while the FDA-labeled indication for the CONTAK CD®  CRT-D System is limited to patients with QRS >120 msec.

The New York Heart Association (NYHA) functional class is a widely used rating system that quantifies the degree of symptom severity. Each class indicates a value that is reflective of the cardiac functional status. The different functional stages are as follows:

New York Heart Association (NYHA) Functional Class

Class

Description 

I

No limitations; Ordinary physical activity does not cause symptoms

II

Slight limitations; Comfortable at rest. Ordinary physical activity causes symptoms

III

Marked limitations; Less than ordinary activity causes symptoms

IV

Class IV Inability to carry out any physical activity; symptoms present at rest

Andreoli et al., 1993

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) are considered investigational as a treatment of NYHA class I heart failure.

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD), are considered investigational as a treatment for heart failure in patients with atrial fibrillation.

An intrathoracic fluid monitoring sensor is considered investigational as a component of a biventricular pacemaker.

Triple-site (triventricular) CRT, using an additional pacing lead, is considered investigational.

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

2/2000: Approved by Medical Policy Advisory Committee (MPAC)

2/8/2002: Investigational definition added

4/18/2002: Type of Service and Place of Service deleted

8/2002: Reviewed by MPAC; investigational status changed to medically necessary

12/16/2002: New York Heart Association (NYHA) functional class added, Code Reference section updated, CPT code 33224, 33225, 33226, 33999 added, ICD-9 diagnosis code 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 428.0, 428.9 added

3/4/2003: CPT code 33215 added

8/29/2003: "Description" section updated to be consistent with BCBSA

8/9/2005: Code Reference section updated, CPT code 33215, 33999 deleted, ICD-9 procedure code 00.52 added

9/13/2006:  Coding revised.  ICD9 2006 revisions added to policy

12/13/2006: Policy reviewed, intrathoracic fluid monitoring noted to be investigational

2/19/2008: Policy reviewed, no changes

01/14/2010:  Description section updated, Policy Statement was updated to include that biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary based on indications.  Also corrected typographic error, changed QRS duration from >20 msec to >120 msec. Added that biventricular pacemakers with or without an accompanying implantable cardiac defibrillator are considered investigational as a treatment of NYHA class I or II heart failure.  Coding Section updated to add the following verbiage: "*Some covered procedure codes may have multiple descriptions.  Coverage will only be made for covered codes when used for services outlined within the policy statement section." removed ICD-9 Procedure code 00.52 and added "unspecified" to ICD-9 diagnosis codes 428.0 and 428.9 description.

04/28/2010:  Policy description updated to add link to related medical policy. Clarified the policy statement regarding biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator; intent unchanged. Deleted outdated references from the Sources section. 

08/03/2011:  Policy statement revised to add specific coverage criteria for NYHA class II heart failure. Deleted "congestive" from the policy title and statement.

07/12/2012:  Added Cardiac Resynchronization Therapy to the policy title. Deleted "(or angiotensin receptor blocker)" from the fourth bullet after beta blocker in both of the NYHA criteria lists. Added "sinus rhythm" to the class III or IV statement for clarity purposes.

09/25/2012:  Added the following investigational policy statement:  Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD), are considered investigational as a treatment for heart failure in patients with atrial fibrillation.

05/06/2013: Added the following investigational policy statement:  Triple-site (triventricular) CRT, using an additional pacing lead, is considered investigational.

 

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.10

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Covered Codes

Code Number

Description

CPT-4

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) (effective 1-1-2003) (added 12-16-2002)

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) Use 33225 in conjunction with 33206, 33207, 33208, 33212, 33213, 33214, 33216, 33217, 33222, 33233, 33234, 33235, 33240, 33249)

33226

Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or replacement of generator)

ICD-9 Procedure

 

 

ICD-9 Diagnosis

402.01

Malignant hypertensive heart disease with congestive heart failure

402.11

Benign hypertensive heart disease with congestive heart failure

402.91

Unspecified hypertensive heart disease with congestive heart failure

404.01

Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified. (Description revised 10-1-2006)

404.03

Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease.   (Description revised 10-1-2006)

404.11

Hypertensive heart and chronic kidney disease, benign, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified. (Description revised 10-1-2006)

404.13

Hypertensive heart and chronic kidney disease, benign, with heart failure and with chronic kidney disease stage V or end stage renal disease.   (Description revised 10-1-2006)

404.91

Hypertensive heart and chronic kidney disease, unspecified, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified. (Description revised 10-1-2006)

404.93

Hypertensive heart and chronic kidney disease, unspecified, with heart failure and with chronic kidney disease stage V or end stage renal disease.   (Description revised 10-1-2006)

428.0

Congestive heart failure, unspecified

428.9

Unspecified heart failure, unspecified

HCPCS

 

 

 

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