Establish Medical Necessity for Implantable Cardioverter-defibrillators
Be sure documentation proves the device is necessary, and determine the proper diagnosis code.
Medicare defines the requirements for coverage of an implantable cardioverter-defibrillator (ICD) insertion in National Coverage Determination (NCD) 20.4, Implantable Automatic Defibrillators. The coverage falls into two major categories: primary prevention of sudden cardiac death and secondary prevention of sudden cardiac death.
Primary prevention ICD implantation is to prevent sudden death in a patient who has poor cardiac function and potentially abnormal heart rhythm that could lead to cardiac arrest. Secondary prevention ICD implantation is due to the patient already experiencing abnormal heart rhythm or cardiac arrest. Secondary prevention is covered if there are no contraindications, as described in the NCD. Primary prevention is only covered if data is submitted to a U.S. Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial, a trial under the Centers for Medicare & Medicaid Services (CMS) Clinical Trial Policy, or a qualifying data collection system, including approved clinical trials and registries.
Medical Necessity Indicators for Primary Prevention
Primary prevention indicators are listed as numbers 3-8 in NCD 20.4. The indicators require one of the following combinations of conditions (and corresponding ICD-10-CM codes) be documented to demonstrate medical necessity for ICD placements for primary prevention of sudden cardiac death:
- I25.5 Ischemic cardiomyopathy; I50.1-I50.9, New York class II-III heart failure; I25.2 Old myocardial infarction, (greater than 40 days prior to implant); plus documentation of left ventricular ejection fraction of 35 percent or less (no code);
- I42.0 Dilated cardiomyopathy; I50.1-I50.9, heart failure; I25.2; plus documentation of left ventricular ejection fraction of 35 percent or less;
- Familial or inherited conditions with high risk of life-threatening ventricular tachycardia, such as:
- hypertrophic cardiomyopathy (I42.1 Obstructive hypertrophic cardiomyopathy, I42.2 Other hypertrophic cardiomyopathy), Z82.41 Family history of sudden cardiac death, R55 Syncope and collapse, or I45.81 Long QT syndrome; or
- Documented prior myocardial infarction (MI) (I25.2) and left ventricular ejection fraction of 30 percent or less (no code).
Medical Necessity Indicators
for Non-primary ICD Placement
Non-primary (secondary prevention) indicators are listed as numbers 1-2 in NCD 20.4. These conditions/codes are indicators for secondary prevention of sudden cardiac death or replacement of a previously placed ICD device or lead:
I47.0 Re-entry ventricular arrhythmia
I47.2 Ventricular tachycardia
I49.3 Ventricular premature depolarization
I49.01 Ventricular fibrillation
I49.02 Ventricular flutter
I46.2 Cardiac arrest due to underlying cardiac condition
I46.8 Cardiac arrest due to other underlying condition
I46.9 Cardiac arrest, cause unspecified
I49.9 Cardiac arrhythmia, unspecified
T82.110A Breakdown (mechanical) of cardiac electrode, initial encounter
T82.111A Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter
T82.118A Breakdown (mechanical) of other cardiac electronic device, initial encounter
T82.119A Breakdown (mechanical) of unspecified cardiac electronic device, initial encounter
T82.120A Displacement of cardiac electrode, initial encounter
T82.121A Displacement of cardiac pulse generator (battery), initial encounter
T82.128A Displacement of other cardiac electronic device, initial encounter
T82.129A Displacement of unspecified cardiac electronic device, initial encounter
T82.190A Other mechanical complication of cardiac electrode, initial encounter
T82.191A Other mechanical complication of cardiac pulse generator (battery), initial encounter
T82.198A Other mechanical complication of other cardiac electronic device, initial encounter
T82.199A Other mechanical complication of unspecified cardiac device, initial encounter
Z86.74 Personal history of sudden cardiac arrest
Z45.02 Encounter for adjustment and management of automatic implantable cardiac defibrillator
Several conditions are noted in NCD 20.4 to contraindicate placement of an ICD, even if qualifying diagnoses are provided. Ask Medicare patients to sign an Advanced Beneficiary Notice (ABN) prior to performing the ICD procedure if any of the following conditions are documented:
- New York class IV heart failure (I50.1-I50.9). Note: Heart failure codes do not distinguish between classes I-IV;
- R57.0 Cardiogenic shock;
- Symptomatic hypotension while in a stable rhythm (I95.9 Hypotension, unspecified);
- Coronary artery bypass graft (Z95.1 Presence of aortocoronary bypass graft) or angioplasty (Z95.5 Presence of coronary angioplasty implant and graft, Z98.61 Coronary angioplasty status) in preceding 3 months;
- Acute MI (I21.01-I21.4, I22.0-I22.8) within preceding 40 days;
- Any condition with a life expectancy of less than 1 year;
- Irreversible brain damage from cerebrovascular disease (including, but not limited to G93.1 Anoxic brain damage, not elsewhere classified, G93.9 Disorder of brain, unspecified (brain damage), G93.82 Brain death); or
- Inability of the patient to give informed consent (no code).
Meeting Coverage Criteria for
Primary Prevention of Sudden Death
Although Medicare’s NCD provides coverage criteria for primary and secondary prevention of sudden death, the coverage of the two indications is not the same.
Secondary prevention of sudden death is covered, as long as there are no contraindications. Medicare only covers ICDs placed for the primary prevention of sudden cardiac death if data is submitted to an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a qualifying data collection system, including approved clinical trials and registries. CMS selected the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR) ICD Registry as the mandated national registry for ICDs in October 2005. The ClinicalTrials.gov identifier for this data repository is NCT01999140.
When an ICD is implanted in the outpatient setting, providers notify Medicare that data is being submitted to the ACC-NCDR, as required in the NCD, by appending modifier Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study to the CPT® code for the implantation procedure. If the performed procedure is for primary prevention of sudden death, and modifier Q0 is not appended, there is no coverage for the ICD implantation.
Modifier Q0 is required only when the ICD is implanted for primary prevention of sudden death. Modifier Q0 may be appended to claims for secondary prevention indications (those meeting non-restricted coverage requirements due to clinical indications) when data is being submitted to a data collection system.
Although the ACC-NCDR may not meet the expected definition of a clinical trial, the use of modifier Q0 categorizes the procedure as part of a clinical study. When a clinical study is performed, ICD-10-CM Z00.6 Encounter for examination for normal comparison and control in clinical research program typically is required in either the primary or secondary position on the claim.
The following items are required when billing for ICDs implanted for primary prevention of sudden death:
For hospital outpatient billing, clinical trial registry number 1999140 in the electronic claim equivalent, 837I (Loop 2300 REF02 (REF01=P4) for an 837I claim when a clinical trial claim includes:
- Condition code 30;
- ICD-10 dx code Z00.6 (in either the primary/secondary positions); and
- Modifier Q0 and/or Q1 Routine clinical service provided in a clinical research study that is an approved clinical research study as appropriate (outpatient claims only).
For physician billing, clinical trial registry number 1999140 preceded by the two alpha characters “CT” placed in Field 19 of the paper Form CMS-1500; or the electronic claim equivalent 837P in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:
- ICD-10 diagnosis code Z00.6 (in either the primary/secondary positions); and
- Modifier Q0 and/or Q1 as appropriate (outpatient claims only).
Example of Primary Prevention
Implantation of ICD Generator
Clinical indications: This is a 65-year-old gentleman who was recommended to undergo ICD placement for primary prevention due to his class 2 congestive heart failure, severe ischemic cardiomyopathy, ejection fraction of 30 to 35 percent, and history of MI two years earlier.
Description of procedure: Written informed consent was obtained after risks, benefits, and alternatives were discussed with the patient. The patient was taken to the cath lab and placed in the supine position. Left chest area was prepped and draped in sterile fashion. The left AC groove area was anesthetized with 1% lidocaine with epinephrine. A 4 cm incision was made in the left AC groove area. Blunt dissection was carried out. A pocket was created. The cephalic vein was identified and isolated. It was cannulated using an 0.014 wire, which was advanced through the cephalic vein. Using modified Seldinger technique, an 8 French sheath was advanced into the subclavian vein. Then the right ventricular lead was advanced to the right ventricular apex. Good position was seen with excellent threshold and diaphragmatic stimulation at 10 volts. The sheath was peeled away. The lead was tied down using 0 Ethibond. The pocket was irrigated with antibiotic solution. The lead was connected to the generator and placed into the pocket and tied down. At this point, DFT testing was performed. The device appropriately detected the ventricular fibrillation and successfully cardioverted the patient to sinus rhythm using 18 joules. The pocket was closed with one layer of 2-0 Vicryl and two layers of 3-0 Vicryl. Steri-Strips were applied. A sterile dressing was applied. The patient tolerated the procedure well with no complication.
Conclusion: Successful placement of single chamber ICD and defibrillator threshold testing.
33249–Q0 Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber
93641 Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator pulse generator
I50.9 Heart failure, unspecified
The patient had the ICD placed for primary prevention of sudden cardiac death. The patient’s information must be submitted to the registry for Medicare to cover the implantation for this clinical indication.
Ruth Broek, MBA, CIRCC, COC, CCS, RTR, CHC, vice president of ZHealth Publishing, is responsible for all support functions, including researching coverage issues, maintaining coding policies, keeping the reference library updated, and maintaining website information. She also performs chargemaster reviews and revenue cycle process improvement for facilities across the country. Broek is a member of the Murfreesboro, Tenn., local chapter.
Sara Wolf, BA, COC, CCS, CPMA, executive director of ZHealth, is involved in providing medical necessity audits, E/M reviews, ICD-10 coding, diagnosis-related group audits, revenue cycle process improvement for facilities, and live ICD-10 seminars. Wolf is an ICD-10 approved trainer for AAPC and AHIMA, and is the lead author of the ICD-10 Coding Companion for Interventional Radiology Coding Reference. Wolf is a member of the Murfreesboro, Tenn., local chapter.
Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Sections 10-80.12, Coverage Determinations, 20.4 – Implantable Automatic Defibrillators
CMS ICD Registry
ACC-NCDR, ClinicalTrials.gov Identifier Repository NCT01999140