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What is a National Coverage Determination (NCD)?

Before deciding whether Medicare should cover a particular item (such as a brace or a hearing aid) or a service (such as therapy or screenings), the federal government conducts a comprehensive review process, and occasionally Congress may pass a law requiring coverage of a particular item or service. After coverage determinations or decisions are authorized, Medicare coverage is modified and Medicare carriers and other contractors (including Medicare Advantage organizations) coordinate their processes to fulfill these new coverage obligations. The formal name for these decisions which allow, limit, or exclude Medicare coverage is known as a National Coverage Determination (NCD). Coverage guidelines and effective dates are defined by Medicare or other rule making authority.

Below are changes that have occurred in the past year. It will be updated periodically. For more information, please contact Customer Service Monday through Friday from 8 a.m. to 8 p.m. at 541-768-4550 or toll free 800-832-4580. TTY users should call 800-735-2900.

NCD Change Description

Implantable Automatic Defibrillators (20.4) — 12/4/2018

Benefit Category

Prosthetic Devices 

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

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.
  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.
  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 Actor 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.
  4. Patients who have severe, non-ischemic, dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF < 35%,="" been="" 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.
  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.
  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:

  1. Patients must be clinically stable (e.g., not in shock, from any etiology);
  2. 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 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 this national coverage determination 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.

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).

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).

(This NCD last reviewed February 2018.)


Next Generation Sequencing (NGS) (90.2) — 12/6/2018

Item/Service Description

A. General

Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.

Patients with cancer can have recurrent, relapsed, refractory, metastatic, and/or advanced stages III or IV of cancer. Clinical studies show that genetic variations in a patient’s cancer can, in concert with clinical factors, predict how each individual responds to specific treatments.

In application, a report of results of a diagnostic laboratory test using NGS (i.e., information on the cancer’s genetic variations) can contribute to predicting a patient’s response to a given drug: good, bad, or none at all. Applications of NGS to predict a patient’s response to treatment occurs ideally prior to initiation of such treatment.

Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:

  1. Patient has:
    • either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and,
    • either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and,
    • decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
  2. The diagnostic laboratory test using NGS must have:
    • Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
    • an FDA-approved or -cleared indication for use in that patient’s cancer; and,
    • results provided to the treating physician for management of the patient using a report template to specify treatment options.

C. Nationally Non-Covered

Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1. above.

D. Other

Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of other NGS as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a treating physician, and the patient has:

  • either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,
  • either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test was performed only when a new primary cancer diagnosis is made by the treating physician; and,
  • decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

(This NCD last reviewed March 2018.)

H3811_MA4001-6_2019a, Page updated 2/3/2019