(Medicare National Coverage Determinations Manual)

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.   The precise workings of this technique are not certain.  The original theory upon which the technique was based, that the open channels would result in increased perfusion of the myocardium, does not appear to be the major or only action at work.  Several theories have been proposed, including partial denervation of  the myocardium, or the triggering of the cascade of biological reactions which encourage increased development of blood vessels.   However, research at several facilities indicates that, despite this uncertainty, the technique does offer relief of angina s ymptoms for a period of time in patients for whom no other medical treatment offering relief is available.  Studies indicate that both reduction in pain and reduction in hospitalizations are significant for most patients treated.  Consequently, CMS has concluded that, for patients with severe angina (Class III or IV, Canadian Cardiovascular Society, or similar classification system) for whom all other medical therapies have been tried or evaluated and found insufficient, such therapy offers sufficient evide nce of its medical effectiveness to treat the symptomatology.  It is important to note that this technique does not provide for increased life expectancy, nor is it proven to affect the underlying cause of the angina.  However, it appears effective in treating the symptoms of angina, and reducing hospitalizations and allowing patients to resume some of their normal activities of daily living.   The CMS therefore covers TMR as a late or last resort for patients with severe (Canadian Cardiovascular Society classification Classes III or IV) angina (stable or unstable) which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages.  In addition, the angina symptoms must be caused by areas of the heart not amenable to surgical therapies such as percutaneous transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass.   Coverage is further limited to those uses of the laser used in performing the procedure which have been approved by the Food and Drug Administration for the purpose for which they are being used.  Patients would have to meet all of the following additional selection guidelines:    An ejection fraction of 25 percent or greater;    Have areas of viable ischemic myo cardium (as demonstrated by diagnostic study) which are not capable of being revascularized by direct coronary intervention; and   Have been stabilized, or have had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmias, decompensated congestive heart failure or acute myocardial infarction.   Coverage is limited to physicians who have been properly trained in the procedure.  Providers of this service must also document that all ancillary personnel, including physicians, nurses, operating room personnel and technicians, are trained in the procedure and the proper use of the equipment involved.  Coverage is further limited to providers which have dedicated cardiac care units, including the diagnostic and support services necessary f or care of patients undergoing this therapy.  In addition, these providers must conform to the standards for laser safety set by the American National Standards Institute, ANSIZ1363.   20.7 - Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates Below)  (Rev. 212, Issued: 01- 19-19, Effective: 02 -19-19, Implementation: 02- 19-19)  The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiarys Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as  part of their processes.   A. General   This procedure involves inserting a balloon catheter into a narrow or occluded blood vessel to recanalize and dilate the vessel by inflating the balloon.  The objective of percutaneous transluminal angioplasty (PTA) i s to improve the blood flow through the diseased segment of a vessel so that vessel patency is increased and embolization is decreased.  With the development and use of balloon angioplasty for treatment of atherosclerotic and other vascular stenoses, PTA ( with and without the placement of a stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary arteries.   Indications and Limitations of Coverage   B. Nationally Covered Indications   The PTA is covered when used under the foll owing conditions:   1. Treatment of Atherosclerotic Obstructive Lesions   -In the lower extremities, i.e., the iliac, femoral, and popliteal arteries, or in the upper extremities, i.e., the innominate, subclavian, axillary, and brachial arteries. The upper extremities do not include head or neck vessels.   -Of a single coronary artery for patients for whom the likely alternative treatment is coronary bypass surgery and who exhibit the following characteristics:    Angina refractory to optimal medical managemen t;   Objective evidence of myocardial ischemia; and   Lesions amenable to angioplasty.   -Of the renal arteries for patients in whom there is an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. PTA for this group of patients is an alternative to surgery, not simply an addition to medical management.   -Of arteriovenous dialysis fistulas and grafts when performed through either a venous or arterial approach.   2. Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA) -Approved Category B Investigational Device Exemption (IDE) Clinical Trials   Effective July 1, 2001, Medicare covers PTA of the carotid artery concurrent with carotid stent placement when furnished in accordan ce with the FDA -approved protocols governing Category B IDE clinical trials. PTA of the carotid artery, when provided solely for the purpose of carotid artery dilation concurrent with carotid stent placement, is considered to be a reasonable and necessary service when provided in the context of such a clinical trial.   3. Concurrent with Carotid Stent Placement in FDA -Approved Post -Approval Studies   Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent and an FDA -approved or cleared embolic protection device (effective December 9, 2009) for an FDA -approved indication when furnished in accordance with FDA -approved protocols governing post -approval studies. The Centers for Medicare & Medicaid Services (CMS) determines that coverage of PTA of the carotid artery is reasonable and necessary in these circumstances.   4. Concurrent with Carotid Stent Placement in Patients at High Risk for Carotid Endarterectomy (CEA)   Effective March 17, 2 005, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent with embolic protection for the following:    Patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis 70%.  Coverage is limited to procedures performed using FDA -approved carotid artery stenting (CAS) systems and FDA -approved or - cleared (effective December 9, 2009) embolic protection devices.  If deployment of the embolic protection device is not technically poss ible, and not performed, then the procedure is not covered by Medicare (effective December 9, 2009);    Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare National Coverage Determination (NCD) Manual 310.1), or in accordance with the NCD on CAS post -approval studies (Medicare NCD Manual 20.7);    Patients who are at h igh risk for CEA and have asymptomatic carotid artery stenosis 80%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post -approval studies (Medicare NCD Manual 20.7).   Coverage is limited to procedures performed using an FDA -approved CAS, stents and FDA -approved or - cleared embolic protection devices.   The use of an FDA -approved or cleared embolic protection device is required. If deployment of the embolic protection device is not technically possible, and not performed, then the procedure is not covered by Medicare.   Patients at high risk for CEA are defined as having significant comorbidities and/or anatomi c risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA. Significant comorbid conditions include but are not limited to:    Congestive heart failure (CHF) class III/IV;   Left ventricular ejection fraction (LVEF) <30%;   Unstable angina;   Contralateral carotid occlusion;   Recent myocardial infarction (MI);   Previous CEA with recurrent stenosis;   Prior radiation treatment to the neck; and,   Other conditions that were used to determine p atients at high risk for CEA in the prior carotid artery stenting trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.   Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurological dys function persisting less than 24 hours), focal cerebral ischemia producing a non- disabling stroke (modified Rankin scale <3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). Patients who have had a disabling stroke ( modified Rankin scale 3) shall be excluded from coverage.  The determination that a patient is at high risk for CEA and the patients symptoms of carotid artery stenosis shall be available in the patient medical records prior to performing any procedure.  The degree of carotid artery stenosis shall be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patients medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis  must be confirmed by angiography at the start of the procedure. If the stenosis is determined to be <70% by angiography, then CAS should not proceed.  In addition, CMS has determined that CAS with embolic protection is reasonable and necessary only if per formed in facilities that have been determined to be competent in performing the evaluation, procedure and follow -up necessary to ensure optimal patient outcomes. Standards to determine competency include specific physician training standards, facility support requirements and data collection to evaluate outcomes during a required reevaluation.   The CMS has created a list of minimum standards modeled in part on professional society statements on competency. All facilities must at least meet CMSs standards in order to receive coverage for CAS for high- risk patients.    Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program. Specifically, high-quality x- ray imaging equipment is a critical component of any carotid interventional suite, such as high- resolution digital imaging systems with the capability of subtraction, magnification, road mapping, and orthogonal angulation.   Advanced physiologic monitoring must be available in t he interventional suite. This includes real time and archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, as well as support staff who are capable of interpreting the findings and responding appropriately.   Emergency management equipment and systems must be readily available in the interventional suite such as resuscitation equipment, a defibrillator, vasoactive and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia support.