procedure code and description



33240 – Insrt pulse gen w/singl lead  – average fee payment  – $430 – $440



33249 – Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber – average fee payment -$250 – $260


33241 – (Removal of pacing cardioverter defibrillator pulse generator only) when the code is billed with procedure 33243 (Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy) – average fee payment -$250 – $260


33243 – Remove eltrd/thoracotomy – average fee payment -$250 – $260


Effective for services furnished on or after January 1, 2012, the American Medical Association (AMA) changed the descriptor for procedure code 33249 to read “Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber.” This has necessitated the removal of HCPCS code C1882 (Cardioverter-defibrillator, other than single or dual chamber (implantable)) from the list of those device codes required to be billed with procedure code 33249 on the procedure-to-device edit list, since this link is no longer clinically appropriate. CMS is making this change retroactive to January 1, 2012.


 Implantable Automatic Defibrillators (Various Effective Dates Below)

A. General
  • The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.
  •  
B. Covered Indications
  1. Documented episode of cardiac arrest due to Ventricular Fibrillation (VF), not due to a transient or reversible cause (effective July 1, 1991).
  2. Documented sustained Ventricular Tachyarrhythmia (VT), either spontaneous or induced by an Electrophysiology (EP) study, not associated with an acute Myocardial Infarction (MI) and not due to a transient or reversible cause (effective July 1, 1999).
  3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy (effective July 1, 1999).


Additional indications effective for services performed on or after October 1, 2003:
  1. Coronary artery disease with a documented prior MI, a measured Left Ventricular Ejection Fraction (LVEF) ≤0.35 and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than four weeks after the qualifying MI.)
  2. Documented prior MI and a measured LVEF ≤0.30 and a QRS duration of > 120 milliseconds (the QRS restriction does not apply to services performed on or after January 27, 2005). Patients must not have:
    1. New York Heart Association (NYHA) classification IV.
    2. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm.
    3. Had a Coronary Artery Bypass Graft (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past three months.
    4. Had an enzyme-positive MI within the past month. (Effective for services on or after January 27, 2005, patients must not have an acute MI in the past 40 days.)
    5. Clinical symptoms or findings that would make them a candidate for coronary revascularization.
    6. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than one year.


Additional indications effective for services performed on or after January 27, 2005:
  1. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF ≤35%.
  2. Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF ≤35%.
  3. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure.


All indications must meet the following criteria:
a. Patients must not have irreversible brain damage from preexisting cerebral disease.
b. 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.
Indications 3–8 (primary prevention of sudden cardiac death) must also meet the following criteria:
    1. Patients must be able to give informed consent.
    2. Patients must not have:
      • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm.
      • Had a CABG or PTCA within the past three months.
      • Had an acute MI within the past 40 days.
      • Clinical symptoms or findings that would make them a candidate for coronary revascularization.
      • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than one year.
    3. Ejection fractions must be measured by angiography, radionuclide scanning or echocardiography.
    4. The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B Investigational Device Exemption (IDE) clinical trial (42 CFR Section 405.201), a trial under the CMS Clinical Trial Policy (NCD, Section 310.1) or a qualifying data collection system including approved clinical trials and registries. Initially, an Implantable Cardiac Defibrillator (ICD) database will be maintained using a data submission mechanism that is already in use by Medicare-participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC) – a Quality Improvement Organization (QIO) contractor – for determination of reasonableness and necessity and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via Quality Network Exchange (QNet) to the IFMC, which will collect and maintain the database. Additional stakeholder-developed data collection systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria:
      • Written protocol on file.
      • Institutional review board review and approval.
      • Scientific review and approval by two or more qualified individuals who are not part of the research team.
      • Certification that investigators have not been disqualified.
e. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.
f. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient’s medical record.
  1. Patients with NIDCM > three months, NYHA Class II or III heart failure and measured LVEF ≤ 35%, only if the following additional criteria are also met:

    1. Patients must be able to give informed consent.
    2. Patients must not have:
      • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm.
      • Had a CABG or PTCA within the past three months.
      • Had an acute MI within the past 40 days.
      • Clinical symptoms or findings that would make them a candidate for coronary revascularization.
      • Irreversible brain damage from preexisting cerebral disease.
      • Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year.
    1. Ejection fractions must be measured by angiography, radionuclide scanning or echocardiography.
    2. 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. 2)
    3. The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR Section 405.201), a trial under the CMS Clinical Trial Policy (NCD, Section 310.1) or a prospective data collection system meeting the following basic criteria:
      • Written protocol on file.
      • Institutional Review Board review and approval.
      • Scientific review and approval by two or more qualified individuals who are not part of the research team.
      • Certification that investigators have not been disqualified.
For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.
    1. Providers must be able to justify the medical necessity of devices other than single-lead devices. This justification should be available in the patient’s medical record.

Either one of the following criteria satisfies the diagnosis for an acute, evolving or recent MI:
1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
a. Ischemic symptoms.
b. Development of pathologic Q waves on the ECG.
c. ECG changes indicative of ischemia (ST segment elevation or depression).
Or,
d. Coronary artery intervention (e.g., coronary angioplasty).
2. Pathologic findings of an acute MI.
Criteria for Established MI
Any one of the following criteria satisfies the diagnosis for established MI:
1. Development of new pathologic Q waves on serial ECGs. The patient may or may not remember previous symptoms. Biochemical markers of myocardial necrosis may have normalized, depending on the length of time that has passed since the infarct developed.
  1. Pathologic findings of a healed or healing MI.



C. Other Indications
All other indications for implantable automatic defibrillators not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR Section 405.201) and the CMS Routine Clinical Trials Policy (NCD, Section 310.1).
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
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, 12X, 13X, 85X
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.
procedure/HCPCS Codes
33240©
Insert pulse generator
33241©
Remove pulse generator
33243©
Remove eltrd/thoracotomy
33244©
Remove eltrd, transven
33249©
Eltrd/insert pace-defib




Effective for services furnished on or after January 1, 2012, the American Medical Association (AMA) changed the descriptor for procedure  code 33249 to read “Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber.” This has necessitated the removal of HCPCS code C1882 (Cardioverter-defibrillator, other than single or dual chamber (implantable)) from the list of those device codes required to be billed with procedure  code 33249 on the procedure-to-device edit list, since this link is no longer clinically appropriate. CMS is making this change retroactive to January 1, 2012.


Q: Is prior authorization required?



A: Yes, procedure  codes 33230, 33231, 33240, 33249, 33262, 33263 and 33264 are included in the Cardiology Prior Authorization Program


Cardiac Resynchronization Therapy


Effective for services furnished on or after January 1, 2012, cardiac resynchronization therapy involving an implantable cardioverter defibrillator (CRT-D) will be recognized as a single, composite service combining implantable cardioverter defibrillator procedures (described by CPT code 33249 (Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator )) and pacing electrode insertion procedures (described by CPT code 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))) when performed on the same date of service. When these procedures appear on the same claim but with different dates of service, or appear on the claim without the other procedure, the standard APC assignment for each service will continue to be applied.


Medicare will make a single payment for those procedures that qualify for composite service payment, as well as any packaged services furnished on the same date of service. Because CPT codes 33225 and 33249 may be treated as a composite service for payment purposes, CMS is assigning them status indicator “Q3” (Codes that may be paid through a composite APC) in Addendum B.


Hospitals will continue to use the same CPT codes to report CRT-D procedures, and the I/OCE will evaluate every claim received to determine if payment as a composite service is appropriate. Specifically, the I/OCE will determine whether payment will be made through a single, composite payment when the procedures are done on the same date of service, or through the standard APC payment methodology when they are done on different dates of service.


CMS is also implementing claims processing edits that will return to providers incorrectly coded claims on which a pacing electrode insertion procedure described by CPT code 33225 is billed without one of the following CPT codes for insertion of an implantable cardioverter defibrillator or pacemaker:


o 33206 (Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial);


o 33207 (Insertion or replacement of permanent pacemaker with transvenous electrode(s); ventricular);


o 33208 (Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular);


o 33212 (Insertion or replacement of pacemaker pulse generator only; single chamber, atrial or ventricular);


o 33213 (Insertion or replacement of pacemaker pulse generator only; dual chamber, atrial or ventricular);


o 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));


o 33216 (Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator);


o 33217 (Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator);


o 33221(Insertion of pacemaker pulse generator only; with existing multiple leads);


o 33222 (Revision or relocation of skin pocket for pacemaker);


o 33230 (Insertion of pacing cardioverter-defibrillator pulse generator only; with existing dual leads);


o 33231 (Insertion of pacing cardioverter-defibrillator pulse generator only; with existing multiple leads)


o 33233 (Removal of permanent pacemaker pulse generator);


o 33234 (Removal of transvenous pacemaker electrode(s); single lead system, atrial or ventricular);


o 33235 (Removal of transvenous pacemaker electrode(s); dual lead system, atrial or ventricular);


o 33240 (Insertion of single or dual chamber pacing cardioverter-defibrillator pulse generator); or


o 33249 (Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator).




ICD-10 Codes that Support Medical Necessity
  
    For CPT codes 33224 and 33225:


    Group 1 Codes
    I09.81 Rheumatic heart failure
    I11.0 Hypertensive heart disease with heart failure
    I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease
    I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease
    I50.20 Unspecified systolic (congestive) heart failure
    I50.21 Acute systolic (congestive) heart failure
    I50.22 Chronic systolic (congestive) heart failure
    I50.23 Acute on chronic systolic (congestive) heart failure
    I50.30 Unspecified diastolic (congestive) heart failure
    I50.31 Acute diastolic (congestive) heart failure
    I50.32 Chronic diastolic (congestive) heart failure
    I50.33 Acute on chronic diastolic (congestive) heart failure
    I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
    I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure
    I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure
    I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

    I50.9 Heart failure, unspecified







ICD-9-CM Codes That Support Medical Necessity

The procedure/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified procedure/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for procedure/HCPCS codes 
33240, 33241, 33243, 33244 and 33249:
Covered for:
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
404.11
Hypertensive heart and chronic kidney disease, benign
404.13
Hypertensive heart and chronic kidney disease, benign
404.91
Hypertensive heart and chronic kidney disease, unspecified
404.93
Hypertensive heart and chronic kidney disease, unspecified
410.00–410.02
Acute myocardial infarction of anterolateral wall
410.10–410.12
Acute myocardial infarction of other anterior wall
410.20–410.22
Acute myocardial infarction of inferolateral wall
410.30–410.32
Acute myocardial infarction of inferoposterior wall
410.40–410.42
Acute myocardial infarction of other inferior wall
410.50–410.52
Acute myocardial infarction of other lateral wall
410.60–410.62
True posterior wall infarction
410.70–410.72
Subendocardial infarction
410.80–410.82
Acute myocardial infarction of other specified sites
410.90–410.92
Acute myocardial infarction of unspecified site
412
Old myocardial infarction
414.8
Other specified forms of chronic ischemic heart disease
425.1
Hypertrophic obstructive cardiomyopathy
425.4
Other primary cardiomyopathies
426.82
Long qt syndrome
427.1
Paroxysmal ventricular tachycardia
427.41–427.42
Ventricular fibrillation and flutter
427.5
Cardiac arrest
427.89
Other specified cardiac dysrhythmias
427.9
Cardiac dysrhythmia unspecified
428.0
Congestive heart failure unspecified
428.1
Left heart failure
428.20–428.23
Systolic heart failure
428.30–428.33
Diastolic heart failure
428.40–428.43
Combined systolic and diastolic heart failure
428.9
Heart failure unspecified
746.89
Other specified congenital anomalies of heart
996.04
Mechanical complication due to AICD
996.72
Other complications due to other cardiac device implant and graft
V12.53
Sudden cardiac arrest
V53.32
Fitting and adjustment of AICD
In addition to the limited coverage listed above, Medicare is establishing the following limited coverage forCPT/HCPCS codes 33241, 33243 and 33244:
Covered for:
996.61
Infection and inflammatory response due to internal cardiac device, implant and graft
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
Only one of the diagnoses listed above is required, but the criteria listed in the “Indications and Limitations of Coverage and/or Medical Necessity section must be fulfilled to bill Medicare. The medical record must specify explicitly how the criteria have been fulfilled.