evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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)
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
-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);
(Medicare National Coverage Determinations Manual)
 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.
(Medicare National Coverage Determinations Manual)
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.