CMS Fully Accepts ICDs

The Centers for Medicare & Medicaid Services (CMS) recently announced a change to the 20.4 National Coverage Decision (NCD)  regarding implantable cardioverter defibrillators (ICDs), which the agency says are now “reasonable and necessary for the treatment of illness or injury.”

 ICD Update First Since 2005

The 77-page decision includes the following changes to Coverage indications the NCD’s Analysis section:
Covered Indications

1. Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated:

• An episode of sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction and not due to a transient or reversible cause; or
• An episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible

2. Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Patients must not have:

• New York Heart Association (NYHA) classification IV heart failure;
• Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
• Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.
The shared decision making encounter may occur at a separate visit.

3. Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%. Additionally, patients must not have:
   • Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
   • Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.
The shared decision making encounter may occur at a separate visit.

4. Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF)

≤ 35%, been on optimal medical therapy (OMT) for at least 3 months. Additionally, patients must not have:

• Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
• Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.
The shared decision making encounter may occur at a separate visit.

5. Patients with documented familial, or genetic disorders with a high risk of life-threatening tachyarrhytmias (sustained ventricular tachycardia or ventricular fibrillation), to include, but not limited to, long QT syndrome or hypertrophic

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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.
The shared decision making encounter may occur at a separate visit.

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

For each of these groups listed above, the following additional criteria must also be met:

1. Patients must be clinically stable (e.g., not in shock, from any etiology);
2. Left ventricular ejection fraction (LVEF) must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter angiography;
3. 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 1 year; or
   • Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.
     1. 1. Exceptions to waiting periods for patients that have had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months, or had a myocardial infarction within the past 40 days:Other Indications:

        Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers and who meet the criteria in this national coverage determination for an ICD may receive the combined device in one procedure at the time the pacemaker is clinically indicated;
        Replacement of ICDs: Patients with an existing ICD may receive a ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction.

   • For patients who 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).All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B IDE trials (42 CFR 405.

ICD Patient and Waiting Changes

• Patient Criteria
  • Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF);
  • Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months;
  • Require a patient shared decision making (SDM) interaction prior to ICD implantation for certain

• Additional Patient Criteria
  • Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT).

• Exceptions to Waiting Periods
  • Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
  • Add an exception for patients with an existing ICD and qualifying

• Registry Requirement
  • End the data collection

• Author
• Recent Posts

Brad Ericson

Director of Publishing at AAPC

Brad Ericson, MPC, CPC, COSC, is a seasoned healthcare writer and editor.He directed publishing at AAPC for nearly 12 years and worked at Ingenix for 13 years and Aetna Health Plans prior to that. He has been writing and publishing about healthcare since 1979. He received his Bachelor's in Journalism from Idaho State University and his Master's of Professional Communication degree from Westminster College of Salt Lake City.

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