The National Coverage Determination (NCD) 20.4, Implantable Automatic Defibrillators was revised with an effective date of February 15, 2018. The CMS A/B Medicare Administrative Contractors (MACs) have been instructed to implement the NCD at the local level. The following provides coding and billing instructions for the implementation of NCD 20.4. (CMS policy language is in italics.) The NCD “Item/Service Description” and “Indications and Limitations” are repeated here.
This article does not alter previous CMS A/B Medicare Administrative Contractors (MACs) instructions for coding and billing of NCD 20.8.3 (National Coverage Determination (NCD) for Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers) nor does it alter MAC Local Coverage for Cardiac Resynchronization Therapy.
Item/Service Description
A. General An ICD is an electronic device designed to diagnose and treat life-threatening ventricular tachyarrhythmias.
Indications and Limitations of Coverage
B. Nationally Covered Indications
Effective for services performed on or after February 15, 2018, CMS has determined that the evidence is sufficient to conclude that the use of ICDs, (also referred to as defibrillators) is reasonable and necessary:
1. Patients with a personal history of sustained Ventricular Tachyarrhythmia (VT) or cardiac arrest due to Ventricular Fibrillation (VF). Patients must have demonstrated:
- An episode of sustained 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; or
- An episode of cardiac arrest due to VF, not due to a transient or reversible cause.
ICD-10-CM codes which describe the above: I46.2, I46.9, I47.2, I49.01, I49.02, I49.3, I49.9, I5A, Z45.02 or Z86.74.
2. Patients with a prior MI and a measured Left Ventricular Ejection Fraction (LVEF) ≤ 0.30. Patients must not have:
- New York Heart Association (NYHA) classification IV heart failure; or,
- Had a Coronary Artery Bypass Graft (CABG), or Percutaneous Coronary Intervention (PCI) with angioplasty and/or stenting, within the past three (3) months; or,
- Had an MI within the past 40 days; or,
- Clinical symptoms and findings that would make them a candidate for coronary revascularization.
For these patients identified in B2, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Social Security Act (the Act)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision-making encounter may occur at a separate visit.
ICD-10-CM code I25.2 must be billed with one of the following ICD-10-CM codes which describe the above: I50.21, I50.22, I50.23, I50.41, I50.42 or I50.43.
3. Patients who have severe, ischemic, dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have NYHA Class II or III heart failure, LVEF ≤ 35%. Additionally, patients must not have:
- Had a CABG, or PCI with angioplasty and/or stenting, within the past three (3) months; or,
- Had an MI within the past 40 days; or,
- Clinical symptoms and findings that would make them a candidate for coronary revascularization.
For these patients identified in B3, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision-making encounter may occur at a separate visit.
ICD-10-CM code I25.5 must be billed with one of the following ICD-10-CM codes which describe the above: I50.21, I50.22, I50.23, I50.41, I50.42 or I50.43.
4. Patients who have severe, non-ischemic, dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, or cardiac arrest due to VF, and have NYHA Class II or III heart failure, LVEF ≤ 35%, been on optimal medical therapy for at least three (3) months. Additionally, patients must not have:
- Had a CABG or PCI with angioplasty and/or stenting, within the past three (3) months; or,
- Had an MI within the past 40 days; or,
- Clinical symptoms and findings that would make them a candidate for coronary revascularization.
For these patients identified in B4, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision-making encounter may occur at a separate visit.
ICD-10-CM codes I42.0, I42.6, I42.7 or I42.8 must be billed with one of the following ICD-10-CM codes which describe the above: I50.21, I50.22, I50.23, I50.41, I50.42 or I50.43.
5. Patients with documented, familial or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained VT or VF, to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy).
For these patients identified in B5, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared-decision making encounter may occur at a separate visit.
ICD-10-CM codes which describe the above: I42.1, I42.2, I45.6, I45.81 or I45.89.
6. Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, Elective Replacement Indicator (ERI), or device/lead malfunction.
For each of the six (6) covered indications above, the following additional criteria must also be met:
- Patients must be clinically stable (e.g., not in shock, from any etiology);
- LVEF must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac Magnetic Resonance Imaging (MRI), or catheter angiography;
- Patients must not have:
- Significant, irreversible brain damage; or,
- Any disease, other than cardiac disease (e.g., cancer, renal failure, liver failure) associated with a likelihood of survival less than one (1) year; or,
- Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.
Exceptions to waiting periods for patients that have had a CABG, or PCI with angioplasty and/or stenting, within the past three (3) months, or had an MI within the past 40 days:
Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in NCD 20.4 for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated;
Replacement of ICDs: Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, ERI, or device/lead malfunction.
ICD-10-CM codes which describe the above: T82.110A, T82.111A, T82.118A, T82.119A, T82.120A, T82.121A, T82.128A, T82.129A, T82.190A, T82.191A, T82.198A, T82.199A, T82.7XXA or Z45.02.
C. Nationally Non-Covered Indications
N/A
D. Other
For patients that are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor becomes available, is determined by the local Medicare Administrative Contractors (MACs).
ICD-10-CM code Z76.82 must be billed with ICD-10-CM code I50.84 which describes the above.
All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B Investigational Device Exemption (IDE) trials (42 CFR 405.201).
ICD-10-CM code which describes the above: Z00.6.
NOTE: Effective February 15, 2018, coverage policy is no longer contingent on participation in a trial/study/registry. Therefore, claims with DOS on an after February 15, 2018, no longer require trial-related coding unless they are associated with a Category B IDE trial, in which case Z00.6 must be appended to the claim.
The coding and billing guidelines apply to the following ICD-10-Procedure codes: insertion codes: 0JH608Z, 0JH609Z, 0JH638Z, 0JH639Z, 0JH808Z, 0JH809Z, 0JH838Z, 0JH839Z, 0JH60FZ, 0JH63FZ, 02H43KZ, 02H60KZ, 02H63KZ, 02H64KZ, 02H70KZ, 02H73KZ, 02H74KZ, 02HK0KZ, 02HK3KZ, 02HK4KZ, 02HL0KZ, 02HL3KZ, 02HL4KZ and removal codes: 0JPT0FZ, 0JPT3FZ, 0JPT0PZ, 0JPT3PZ, 02PA0MZ, 02PA3MZ, 02PA4MZ and 02PAXMZ.
The coding and billing guidelines also apply to the following CPT codes: 33202, 33203, 33223, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262, 33263, 33264, 33270, 33271, 33272, 33273, G0448, 33215, 33216, 33217, 33218, 33220, 33224, 33225, C7537, C7538, C7539 and C7540.
