(Medicare National Coverage Determinations Manual)

Obstructions which can cause symptoms of blocked vertebral artery blood flow and which can be documented by an angiogram include:    Intravascular obstructions -  arteriosclerotic lesions within the vertebral artery or in other arteries.    Extravascular obstructions;   Bony tissue or osteophytes, located laterally in the C6 (C7) -C2 cervical vertebral area course of the vertebral artery, most commonly at C5 - C6;   Anatomical variations -  Anomalous location of the origin of the vertebral artery, a congenital aberra tion, and tortuosity and kinks of the vertebral artery; to   Fibrous tissue -  Tissue changed as a result of manipulation of the neck for neck pain or injury associated with hematoma; external bands, tendinous slings, and fibrous bands.  The most controversi al obstructions include vertebral artery tortuosity and kinks and connective tissue along the course of the vertebral artery, and variously called external bands, tendinous slings and fibrous bands.  In the absence of symptoms of vertebral artery obstructi on, vascular surgeons feel such abnormalities are insignificant.  Vascular surgery experts, however, agree that these abnormalities in very rare cases do cause symptoms of vertebral artery obstruction and do necessitate surgical correction.  Vertebral arte ry construction and vertebral artery surgery are phrases which most physicians interpret to include only surgical cleaning (endarterectomy) and bypass (resection) procedures.  However, some physicians who use these terms mean all operative manipulations which remove vertebral artery blood flow obstructions.  Also, some physicians use general terms of vascular surgery, such as endarterectomy, when vertebral artery related surgery is performed.  Use of the above terminology specifies neither the surgical proc edure performed nor its relationship to the vertebral artery.  Therefore, in developing claims for this type of procedure, require specific identification of the obstruction in question and the surgical procedure performed.  Also, in view of the specific coverage criteria given, develop all claims for vertebral artery surgery on a case-by-case basis.   Make payment for a surgical procedure listed above if: (1) it is reasonable and necessary for the individual patient to have the surgery performed to remove or relieve an obstruction to vertebral artery flow, and (2) the four conditions noted are met.  In all other cases, these procedures cannot be considered reasonable and necessary within the meaning of 1862( a)(1)  of the Act and are not reimbursable under the program.   20.2 - Extracranial - Intracranial (EC -IC) Arterial Bypass Surgery  (Rev. 1, 10- 03-03) CIM 35 -37  Extracranial -Intracranial (EC -IC) arterial bypass surgery is not a covered procedure when it is performed as a treatment for ischemic cerebrovascular disease of the carotid or middle cerebral arteries which includes the treatment or prevention of strokes.  The premise that this procedure which bypasses narrowed arterial segments, improves the blood supply to the brain and reduces the risk of having a stroke has not been demonstrated to be any more effective than no surgical intervention.  Accordingly, EC -IC arterial bypass surgery is not considered reasonable and necessary within the meaning of 1862(a)(1)  of the Act when it is performed as a treatment for ischemic cerebrov ascular disease of the carotid or middle cerebral arteries.   20.3 - Thoracic Duct Drainage (TDD) in Renal Transplants  (Rev. 1, 10- 03-03) CIM 35 -58  Thoracic duct drainage (TDD) is an immunosuppressive technique used in renal transplantation.  This procedur e which removes lymph from kidney transplant recipients as a means of achieving suppression of the immune mechanism, is currently being used both pre - and post -transplant in conjunction with more conventional immunotherapy.  TDD is performed on an inpatient basis, and the inpatient stay is covered for patients admitted for treatment in advance of a kidney transplant as well as for those receiving it post-transplant.  The TDD is a covered technique when furnished to a kidney transplant recipient or an indivi dual approved to receive kidney transplantation in a hospital approved to perform kidney transplantation.   20.4  Implantable Cardioverter Defibrillators (ICDs)  (Rev. 12112; Issued: 06- 29-23; Effective: 07 - 31-23; Implementation: 07- 31- 23)  A. General   An implantable cardioverter defibrillator (ICD) is an electronic device designed to diagnose and treat life -threatening ventricular tachyarrhythmias.    B. Nationally Covered Indications   Effective for services performed on or after February 15, 2 018 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 reversi ble 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 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 cl inical 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, dilate d 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 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 de cision 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 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 3 months.  Additionally, patients must not have:   Had a CABG or PCI with angioplasty and/or stenting, within the past 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 S ection 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 sep arate 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 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 ca theter 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 ta chycardia 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 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 clinical ly 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 unt il 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.)   20.5 - Extracorporeal Immunoadsorption (ECI) Using Protein A Columns  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that  no national coverage determination (NCD) is appropriate at this time for Extracorporeal Immunoadsorption (ECI) Using Protein A Columns. In the absence of an NCD, covera ge  determinations will be made by the Medicare Administrative Contractors under  1862(a)(1)(A) of the Social Security Act.   20.6 - Transmyocardial Revascularization (TMR)  (Rev. 1, 10- 03-03) CIM 35 -94  Transmyocardial revascularization (TMR) is a surgical technique which uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached by diseased or clogged arteries.  This technique is used as a late or last resort for relief of sympto ms of severe angina in patients with ischemic heart disease not amenable to direct coronary revascularization interventions, such as angioplasty, stenting or open coronary bypass.