Implantable cardioverter defibrillator (ICD) CMS coverage requirements
Implantable cardioverter defibrillator (ICD) Medicare defines the requirements for coverage of an implantable cardioverter defibrillator (ICD) insertion under the National Coverage Determination (NCD) 20.4, Implantable Automatic Defibrillators.
The coverage falls into two major categories:
- Primary prevention of sudden cardiac death and
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.
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.
- Secondary prevention of sudden cardiac death.
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.
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:
- 5Ischemic 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);
- 0Dilated 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 (I42.1Obstructive 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:
- 0Re-entry ventricular arrhythmia
- 2Ventricular tachycardia
- 3Ventricular premature depolarization
- 01Ventricular fibrillation
- 02Ventricular flutter
- 2Cardiac arrest due to underlying cardiac condition
- 8Cardiac arrest due to other underlying condition
- 9Cardiac arrest, cause unspecified
- 9Cardiac arrhythmia, unspecified
- 110ABreakdown (mechanical) of cardiac electrode, initial encounter
- 111ABreakdown (mechanical) of cardiac pulse generator (battery), initial encounter
- 118ABreakdown (mechanical) of other cardiac electronic device, initial encounter
- 119ABreakdown (mechanical) of unspecified cardiac electronic device, initial encounter
- 120ADisplacement of cardiac electrode, initial encounter
- 121ADisplacement of cardiac pulse generator (battery), initial encounter
- 128ADisplacement of other cardiac electronic device, initial encounter
- 129ADisplacement of unspecified cardiac electronic device, initial encounter
- 190AOther mechanical complication of cardiac electrode, initial encounter
- 191AOther mechanical complication of cardiac pulse generator (battery), initial encounter
- 198AOther mechanical complication of other cardiac electronic device, initial encounter
- 199AOther mechanical complication of unspecified cardiac device, initial encounter
- 74Personal history of sudden cardiac arrest
- 02Encounter for adjustment and management of automatic implantable cardiac defibrillator
Meeting Coverage Criteria for:
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(R) 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.
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 Q1Routine clinical service provided in a clinical research study that is an approved clinical research studyas 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).