L32813 BIVENTRICULAR PACING/CARDIAC RESYNCHRONIZATION THERAPY

 

 

01/01/2013

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• Medicare will consider cardiac resynchronization therapy, biventricular pacing (CRT-P), medically necessary when the following criteria are met (1 or 2):

o New York Heart Association (NYHA) classification of heart failure III or IV;

AND

o Sinus rhythm, or chronic atrial fibrillation (AF), or frequent dependence on ventricular pacing;

AND

o left ventricular ejection fraction (LVEF) less than or equal to 35 %;

AND

o QRS duration greater than or equal to 120 msec;

AND

o beneficiary is on a stable pharmacologic regimen before implantation, which may include any of the following, unless contraindicated:

 angiotensin-converting enzyme inhibitor,

 angiotensin receptor blocker,

 beta blocker, digoxin, or

 diuretics;

 and

 The device is approved by the Food and Drug Administration (FDA) for this indication.

AND

o The device is approved by the Food and Drug Administration (FDA) for this indication.

OR

o NYHA classification of heart failure II;

AND

o sinus rhythm;

AND

o no evidence of atrial arrhythmia;

AND

o left ventricular ejection fraction (LVEF) less than or equal to 30%;

AND

o left bundle branch block with QRS duration greater than or equal to 130 msec;

AND

o beneficiary is on a stable pharmacologic regimen before implantation, which may include any of the following, unless contraindicated: angiotensin-converting enzyme inhibitor, angiotensin receptor blocker; beta blocker; digoxin, or diuretics,

AND

o The device is FDA approved for this indication.

• Medicare will consider cardiac resynchronization therapy with implantable cardioverter defibrillator (ICD) system ( CRT-D) medically necessary for patients at high risk for life-threatening ventricular arrhythmia or sudden cardiac arrest when the following criteria are met:

o the aforementioned criteria for CRT-P are met (1 or 2);

AND

o The patient meets a covered indication in CMS’s National Coverage Determination Manual for Implantable automatic defibrillators (NCD 20.4). (Refer to the Medicare Coverage Database at http://www.cms.gov/medicare-coverage-database/);

AND

o The device is FDA approved for the indication.

 

 

Coding Information

 

Bill Type Codes

 

• 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.

 

11x Hospital Inpatient (Including Medicare Part A)

12x Hospital Inpatient (Medicare Part B only)

13x Hospital Outpatient

85x Critical Access Hospital

 

 

Revenue Codes

 

• 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.

 

0360 Operating Room Services - General Classification

0480 Cardiology - General Classification

0960 Professional Fees - General Classification

0975 Professional Fees - Operating Room

 

 

CPT/HCPCS Codes

 

33202 INSERTION OF EPICARDIAL ELECTRODE(S); OPEN INCISION (EG, THORACOTOMY, MEDIAN STERNOTOMY, SUBXIPHOID APPROACH)

33203 INSERTION OF EPICARDIAL ELECTRODE(S); ENDOSCOPIC APPROACH (EG, THORACOSCOPY, PERICARDIOSCOPY)

33206 INSERTION OF NEW OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); ATRIAL

33207 INSERTION OF NEW OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); VENTRICULAR

33208 INSERTION OF NEW OR REPLACEMENT OF PERMANENT PACEMAKER WITH TRANSVENOUS ELECTRODE(S); ATRIAL AND VENTRICULAR

33212 INSERTION OF PACEMAKER PULSE GENERATOR ONLY; WITH EXISTING SINGLE LEAD

33213 INSERTION OF PACEMAKER PULSE GENERATOR ONLY; WITH EXISTING DUAL LEADS

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)

33217 INSERTION OF 2 TRANSVENOUS ELECTRODES, PERMANENT PACEMAKER OR CARDIOVERTER-DEFIBRILLATOR

33221 INSERTION OF PACEMAKER PULSE GENERATOR ONLY; WITH EXISTING MULTIPLE LEADS

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 EXISTING 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 (EG, FOR UPGRADE TO DUAL CHAMBER SYSTEM) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

33226 REPOSITIONING OF PREVIOUSLY IMPLANTED CARDIAC VENOUS SYSTEM (LEFT VENTRICULAR) ELECTRODE (INCLUDING REMOVAL, INSERTION AND/OR REPLACEMENT OF EXISTING GENERATOR)

33230 INSERTION OF PACING CARDIOVERTER-DEFIBRILLATOR PULSE GENERATOR ONLY; WITH EXISTING DUAL LEADS

33231 INSERTION OF PACING CARDIOVERTER-DEFIBRILLATOR PULSE GENERATOR ONLY; WITH EXISTING MULTIPLE LEADS

33240 INSERTION OF PACING CARDIOVERTER-DEFIBRILLATOR PULSE GENERATOR ONLY; WITH EXISTING SINGLE LEAD

33249 INSERTION OR REPLACEMENT OF PERMANENT PACING CARDIOVERTER-DEFIBRILLATOR SYSTEM WITH TRANSVENOUS LEAD(S), SINGLE OR DUAL CHAMBER

 

 

ICD-9 Codes that Support Medical Necessity

 

For CPT codes 33224 and 33225:

398.91 RHEUMATIC HEART FAILURE (CONGESTIVE)

402.01 MALIGNANT HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.11 BENIGN HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.91 UNSPECIFIED HYPERTENSIVE HEART DISEASE WITH 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

404.03 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.11 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.91 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.93 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

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

 

 

Documentation Requirements

 

• The medical record must contain documentation that fully supports the medical necessity and justification of the procedure performed.

o The documentation must be made available to Medicare upon request.

o When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.

• A history and physical, discharge summary, physician progress notes and an operative report are typically in the hospital record for the procedures in this local coverage determination (LCD).

o Other relevant information addressing coverage criteria related to the patient’s episode of care prior to the hospitalization, should be included in the hospital record.

• Providers must be able to justify the medical necessity of devices other than single lead devices.

o This justification should follow standard guidelines for the appropriate use of biventricular pacing and must be available in the patient's medical record.

• Medical record documentation maintained by the physician must substantiate the medical need for CRT and must include the following:

o Office notes/hospital record, including history and physical by the attending/treating physician. [Myocardial Infarctions (MIs) must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction (as applicable)]

o Documentation of the history and duration of unsuccessful medical management

o Interpretation and reports for diagnostic studies (as applicable).[Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography]

o Complete operative report outlining operative approach used and all the components of the biventricular pacemaker insertion

• Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient.

o To meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives, and the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition).

o Lacking compelling arguments for an exception in the supporting documentation, the hospital and physician services can be denied.

o If in certain circumstances the patient does not meet all of the required criteria outlined in the LCD for a procedure, but the treating physician feels that the procedure is a covered procedure given the current standards of care, then the documentation must clearly outline the patient’s episode of care that supports the procedure and must clearly address the reason(s) for coverage.

o For example, if clinical findings (or lack of) for an indication are not consistent with the LCD criteria, it should be directly addressed in the pre-procedure documentation.

o Also, if certain conservative therapies are not necessary for a given patient, it should be directly noted in the pre-procedure documentation.

o The clinical judgment of the treating physician is always a consideration if clearly addressed in the pre-procedure record and if consistent with the episode of care for the patient as documented in patient’s records and claims history.

 

 

Treatment Logic

 

• Heart failure is common and rapidly increasing in incidence.

o It carries a poor prognosis, with an estimated 1-year mortality of 30–50% for patients with advanced disease.

o It is also associated with a high burden of illness, high resource utilization, and frequent hospitalizations.

o The current treatment for heart failure involves addressing the underlying cause(s), lifestyle modifications, and pharmacologic interventions.

o In the majority of cases, treatment is not curative but intended to ameliorate symptoms and improve function.

o Approximately 20–30% of patients with heart failure exhibit dyssynchronous contractions of the left and right ventricles due to conduction system disease.

o Dyssynchrony further depresses the already impaired pumping ability of the heart.

o The New York Heart Association (NYHA) classes for heart failure are defined as follows:

 Class I: Individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion.

 Class II: Individuals with cardiac disease resulting in a slight limitation of physical activity; they are comfortable at rest; ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

 Class III: Individuals with cardiac disease resulting in a marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.

 Class IV: Individuals with cardiac disease resulting in the inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

• Despite the combination of various therapies for heart failure, some patients remain refractory to full medical treatment.

o Of the various nonpharmacological approaches, biventricular pacing or Cardiac Resynchronization Therapy (CRT) [also called Cardiac Resynchronization Therapy Pacemaker (CRT-P)] has gained interest since its introduction in the early 1990’s.

o CRT is the term applied to reestablishing synchronous contraction between the left ventricular free wall and the ventricular septum in an attempt to improve left ventricular efficiency and, subsequently, to improve functional class.

o Generally, CRT has been used to describe biventricular pacing, but cardiac resynchronization can be achieved by left ventricular pacing only in some patients.

o Selected patients with moderate to severe heart failure may benefit from CRT or biventricular pacing.

o CRT, in combination with stable optimal medical therapy, may help the lower chambers of the heart beat together and improve the heart's ability to supply blood and oxygen to the body.

o CRT is designed to help the right (RV) and left ventricle (LV) beat at the same time in a normal sequence treating ventricular dyssynchrony.

• An implantable biventricular pacemaker is an advanced version of a standardized implantable pacemaker.

o The biventricular pacemaker is implanted in the muscle tissue of the chest, below the collarbone, or in the abdomen.

o Three leads or wires, one atrial lead [right atrium] and two ventricular leads [right and left ventricles], are transvenously connected from the pacemaker to both sides of the heart.

o Once the pacemaker is implanted, it is programmed so that both ventricles are stimulated to contract after atrial contraction with the goal of improving left ventricle function, reducing presystolic mitral regurgitation, and improving LV diastolic filling time.

o The most frequently reported complication of CRT is lead dislodgement, which occurs in approximately 9% of patients.

• Some individuals with heart failure are also at high risk for life-threatening heart rhythms.

o Patients with heart failure who are at high risk for ventricular tachycardia and ventricular fibrillation may require a CRT system that includes implantable cardioverter defibrillator (ICD) therapy.

o The CRT-P (biventricular pacemaker) plus implantable cardioverter defibrillator (ICD) system (CRT-D) is designed to help the two lower heart chambers, the right and left ventricles, beat at the same time in a normal sequence, treating ventricular dyssynchrony.

o Additionally, should an individual experience an episode of ventricular tachycardia or ventricular fibrillation, the CRT-D system will detect the life-threatening arrhythmia and automatically correct the heart's rhythm.

 

 

Sources of Information and Basis for Decision

 

Aetna Clinical Policy Bulletin: Biventricular Pacing (Cardiac Resynchronization Therapy)/ Combination Resynchronization-

Defibrillation Devices for Congestive Heart Failure, number 0610.

 

Alpert JS, Thygesen K, et. al. Myocardial redefined—a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J AM Coll Cardiol, 2001.

 

BlueCross BlueShield Association Technology Evaluation Center (TEC): Therapy for Mild Heart Failure, December 2011.

Retrieved from http://www.bcbs.com/blueresources/tec/vols/26/cardiac-resynchronization.html

 

BlueCross of Idaho: Biventricular Pacemakers for the Treatment of Heart Failure, issue 4:2011.

Retrieved from https://www.bcidaho.com/providers/medical_policies/med/mp_20210.asp

 

Boston Scientific: 2012 Billing and Coding Guide. Retrieved from http://www.bostonscientific.com/cardiac-rhythm-resources/assets/downloads/reimbursement/2012/2012_Billing_Coding_Guide.pdf

 

Burkhardt JD, MD and Wilkoff BL, MD. Circulation AHA Journals: Interventional Electrophysiology and Cardiac Resynchronization Therapy Delivering Electrical Therapies for Heart Failure, 2007. Retrieved from http://circ.ahajournals.org/content/115/16/2208.full

 

Cigna Medical Coverage Policy: Biventricular Pacing/Cardiac Resynchronization Therapy (CRT), number 0174.

 

Epstein AE, DiMarco JP, Ellenbogen KA, et. al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. American College of Cardiology/American Heart Association/Heart Rhythm Society Practice Guidelines, 2008. Retrieved from http://www.guidelines.gov/content.aspx?id=12590&search=cardiac+resynchronization+therapy

 

Hunt SA, Abraham WT, Chin MH, et. al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults [trunc]. J AM Coll Cardiol, 2009.

 

InterQual® 2011 Procedures Adult Criteria, Pacemaker Insertion, Biventricular. McKesson Corporation.

 

InterQual® 2012 Procedures Adult Criteria, Pacemaker Insertion, Biventricular +/- ICD Insertion. McKesson Corporation.

 

National Institute for Health and Clinical Excellence (NICE). Cardiac resynchronisation therapy for the treatment of heart failure. UK, 2007. Retrieved from http://guidelines.gov/content.aspx?id=10855

 

Seidl K, Rameken M, Vater M, et. al. Cardiac resynchronization therapy in patients with chronic heart failure: pathophysiology and current experience. AM J Cardiovascular Drugs, 2002. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/14727967

 

Vardas PE, Auricchio A, Blancc JJ, et. al. Guidelines for cardiac pacing and cardiac resynchronization therapy. Eur Heart J, 2007. Retrieved from http://www.guidelines.gov/content.aspx?id=15949&search=cardiac+resynchronization+therapy

 

01/01/2013

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

AMA CPT / ADA CDT Copyright Statement

 

CPT codes, descriptions and other data only are copyright 2012 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.

 

LCD Biventricular Pacing/Cardiac Resynchronization Therapy (L32813)