Medicare National Coverage Determinations Manual

=== Page 1 === # Medicare National Coverage Determinations Manual ## Chapter 1, Part 1 (Sections 10 – 80.12) ## Coverage Determinations **Table of Contents** ## Transmittals for Chapter 1, Part 1 Foreword - Purpose for National Coverage Determinations (NCD) Manual 10 - Anesthesia and Pain Management - 10.1 - Use of Visual Tests Prior to and General Anesthesia During Cataract Surgery - 10.2 - Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain - 10.3 - Inpatient Hospital Pain Rehabilitation Programs - 10.4 - Outpatient Hospital Pain Rehabilitation Programs - 10.5 - Autogenous Epidural Blood Graft - 10.6 - Anesthesia in Cardiac Pacemaker Surgery 20 - Cardiovascular System - 20.1 - Vertebral Artery Surgery - 20.2 - Extracranial - Intracranial (EC-IC) Arterial Bypass Surgery - 20.3 - Thoracic Duct Drainage (TDD) in Renal Transplants - 20.4 - Implantable Cardioverter Defibrillators (ICDs) - 20.5 - Extracorporeal Immunoadsorption (ECI) Using Protein A Columns (RETIRED) - 20.6 - Transmyocardial Revascularization (TMR) - 20.7 - Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates Below) - 20.8 - Cardiac Pacemakers (Various Effective Dates Below) - 20.8.1 - Cardiac Pacemaker Evaluation Services - 20.8.1.1 - Transtelephonic Monitoring of Cardiac Pacemakers - 20.8.2 - Self-Contained Pacemaker Monitors - 20.8.3 - Single Chamber and Dual Chamber Permanent Cardiac Pacemakers - 20.8.4 - Leadless Pacemakers - 20.9 - Artificial Hearts And Related Devices (RETIRED) === Page 2 === 20.9.1 - Ventricular Assist Devices (Various Effective Dates Below) 20.10 - Cardiac Rehabilitation Programs (RETIRED) 20.10.1 - Cardiac Rehabilitation Programs for Chronic Heart Failure 20.11 - Intraoperative Ventricular Mapping 20.12 - Diagnostic Endocardial Electrical Stimulation (Pacing) 20.13 - HIS Bundle Study 20.14 - Plethysmography 20.15 - Electrocardiographic Services 20.16 - Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB) – Various Effective Dates Below 20.17 - Noninvasive Tests of Carotid Function 20.18 - Carotid Body Resection/Carotid Body Denervation 20.19 - Ambulatory Blood Pressure Monitoring 20.20 - External Counterpulsation (ECP) Therapy for Severe Angina (Effective March 20, 2006) 20.21 - Chelation Therapy for Treatment of Atherosclerosis 20.22 - Ethylenediamine-Tetra-Acetic (EDTA) Chelation Therapy for Treatment of Atherosclerosis 20.23 - Fabric Wrapping of Abdominal Aneurysms 20.24 - Displacement Cardiography 20.25 - Cardiac Catheterization Performed in Other Than a Hospital Setting (RETIRED) 20.26 - Partial Ventricullectomy 20.27 - Cardiointegram (CIG) as an Alternative to Stress Test or Thallium Stress Test 20.28 - Therapeutic Embolization 20.29 - Hyperbaric Oxygen Therapy 20.30 - Microvolt T-Wave Alternans (MTWA) 20.31 - Intensive Cardiac Rehabilitation (ICR) Programs 20.31.1 - Pritikin Program (Effective August 12, 2010) 20.31.2 - Ornish Program for Reversing Heart Disease (Effective August 12, 2010) 20.31.3 - Benson-Henry Institute Cardiac Wellness Program (Effective May 6, 2014) 20.32 - Transcatheter Aortic Valve Replacement (TAVR) 20.33 - Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation 20.34 - Percutaneous Left Atrial Appendage Closure (LAAC) 20.35 - Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) === Page 3 === 30 - Complementary and Alternative Medicine 30.1 - Biofeedback Therapy 30.1.1 - Biofeedback Therapy for the Treatment of Urinary Incontinence 30.2 - Thermogenic Therapy 30.3 - Acupuncture 30.3.1 - Acupuncture for Fibromyalgia 30.3.2 - Acupuncture for Osteoarthritis 30.3.3 - Acupuncture for Chronic Lower Back Pain (cLBP) 30.4 - Electrosleep Therapy (RETIRED) 30.5 - Transcendental Meditation 30.6 - Intravenous Histamine Therapy 30.7 - Laetrile and Related Substances 30.8 - Cellular Therapy 30.9 - Transillumination Light Scanning, or Diaphanography 40 - Endocrine System and Metabolism 40.1 - Diabetes Outpatient Self-Management Training 40.2 - Home Blood Glucose Monitors 40.3 - Closed-Loop Blood Glucose Control Device (CBGCD) 40.4 - Insulin Syringe 40.5 - Treatment of Obesity 40.7 - Outpatient Intravenous Insulin Treatment (Effective December 23, 2009) 50 - Ear, Nose and Throat (ENT) 50.1 - Speech Generating Devices 50.2 - Electronic Speech Aids 50.3 - Cochlear Implantation (Effective April 4, 2005) 50.4 - Tracheostomy Speaking Valve 50.5 - Oxygen Treatment of Inner Ear/Carbon Therapy 50.6 - Tinnitus Masking (RETIRED) 50.7 - Cochleostomy With Neurovascular Transplant for Meniere's Disease 50.8 - Ultrasonic Surgery 60 - Emergency Medicine 70 - Evaluation and Management of Patients - Office/hospital/home 70.1 - Consultations With a Beneficiary's Family and Associates 70.2 - Consultation Services Rendered by a Podiatrist in a Skilled Nursing Facility 70.3 - Physician's Office Within an Institution - Coverage of Services and Supplies Incident to a Physician's Services 70.4 - Pronouncement of Death 70.5 - Hospital and Skilled Nursing Facility Admission Diagnostic Procedures === Page 4 === 80 - Eye 80.1 - Hydrophilic Contact Lens for Corneal Bandage 80.2 - Photodynamic Therapy 80.2.1 - Ocular Photodynamic Therapy (OPT) - Effective April 3, 2013 80.3 - Photosensitive Drugs 80.3.1 - Verteporfin - Effective April 3, 2013 80.4 - Hydrophilic Contact Lenses 80.5 - Scleral Shell 80.6 - Intraocular Photography 80.7 - Refractive Keratoplasty 80.7.1 - Keratoplasty 80.8 - Endothelial Cell Photography 80.9 - Computer Enhanced Perimetry 80.10 - Phaco-Emulsification Procedure - Cataract Extraction 80.11 - Vitrectomy 80.12 - Intraocular Lenses (IOLs) === Page 5 === # Foreword - Purpose for National Coverage Determinations (NCD) Manual (Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10) ## A. Purpose The statutory and policy framework within which National Coverage Determinations (NCDs) are made may be found in title XVIII of the Social Security Act (the Act), and in Medicare regulations and rulings. The NCD Manual describes whether specific medical items, services, treatment procedures, or technologies can be paid for under Medicare. NCDs have been made on the items addressed in this manual. Decisions that items/services are not covered are generally based on §1862(a)(1) of the Act (the “not reasonable and necessary” exclusion) unless otherwise specifically noted. Where another statutory authority for denial is indicated, that is the authority for denial. Where an item/service is stated to be covered, but such coverage is explicitly limited to specified indications or specified circumstances, all limitations on coverage of the items/services because they do not meet those specified indications or circumstances are based on §1862(a)(1) of the Act. Where coverage of an item/service is provided for specified indications or circumstances but is not explicitly excluded for others, or where the item/service is not mentioned at all in the Centers for Medicare & Medicaid Services (CMS) NCD Manual the Medicare Administrative Contractor (MAC) has the discretion to make the coverage decision, in consultation with its medical staff, and with CMS when appropriate, based on the law, regulations, rulings, and general program instructions The coverage determinations in the manual will be revised based on the most recent medical and other scientific and technical evidence available to CMS. Other manuals in this system in which coverage-related instructions may be found are: - Pub 100-02 (Benefit Policy); - Pub 100-04 (Claims Processing); - Pub 100-05 (Medicare Secondary Payer); and - Pub 100-08 (Program Integrity) These manuals usually contain more general coverage descriptions and/or claims processing instructions. There should be no inconsistencies among the instructions in any of these manuals and the NCD Manual pertaining to coverage. If any such inconsistencies are found, bring them to the attention of CMS, Center for Clinical Standards and Quality, Coverage and Analysis Group, Division of Operations and Information Management. ## B. Organization The NCD Manual is organized by categories, e.g., medical procedures, supplies, diagnostic services. A table of contents is provided at the beginning of the manual === Page 6 === designating coverage determination categories. Each subject discussed within the category is listed and identified by a number. The revision transmittal sheet identifies new material and summarizes the principal changes. When a change in policy or procedure is involved, the background and effective date for the change is provided. If, at a later date, the reader wishes to refer to the background explanation given on a transmittal sheet, the reader can identify the transmittal by its number which appears on each manual page. ## C. CMS Coverage Web site The CMS Coverage Web page http://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html?redirect=/center/coverage.asp contains information about pending NCDs and also provides access to a database of NCDs, National Coverage Analyses, and Local Medical review Policies. ## 10 - Anesthesia and Pain Management (Rev. 1, 10-03-03) ## 10.1 - Use of Visual Tests Prior to and General Anesthesia During Cataract Surgery ### A. Pre-Surgery Evaluations Cataract surgery with an intraocular lens (IOL) implant is a high volume Medicare procedure. Along with the surgery, a substantial number of preoperative tests are available to the surgeon. In most cases, a comprehensive eye examination (ocular history and ocular examination) and a single scan to determine the appropriate pseudophakic power of the IOL are sufficient. In most cases involving a simple cataract, a diagnostic ultrasound A-scan is used. For patients with a dense cataract, an ultrasound B-scan may be used. Accordingly, where the only diagnosis is cataract(s), Medicare does not ro

Use of visual tests prior to and general anesthesia during cataract surgery is covered. Transcutaneous Electrical Nerve Stimulation (TENS) is covered for acute post-operative pain management. Inpatient and outpatient hospital pain rehabilitation programs are covered. Surgery for symptomatic vertebral artery stenosis. Indicated for patients requiring revascularization of the brain. Implantation of ICDs is covered for patients with a high risk of sudden cardiac arrest. Cardiac rehabilitation programs for chronic heart failure are covered. External counterpulsation therapy is covered for severe angina. Cardiac catheterization procedures are necessary for diagnosis or treatment of heart conditions. Therapeutic embolization is indicated for specific vascular lesions. Microvolt T-Wave Alternans testing is covered for patients at risk of cardiac events. Biofeedback therapy is indicated for the treatment of urinary incontinence. Acupuncture is indicated for fibromyalgia, osteoarthritis, and chronic lower back pain. Diabetes outpatient self-management training is covered for managing diabetes effectively. Coverage for cochlear implantation as medically necessary for severe to profound hearing loss Indications for speech generating devices for individuals with severe speech impairment Covered for hydrophilic contact lens for corneal bandage. Ocular photodynamic therapy is medically necessary for specific eye conditions. Provided for specified indications or circumstances as determined by the Medicare Administrative Contractor. Use of visual tests prior to and general anesthesia during cataract surgery. Cataract surgery is covered when accompanied by a comprehensive eye examination and a scan to determine IOL power. Diagnostic ultrasound A-scan is generally sufficient for simple cataracts, while dense cataracts may require an ultrasound B-scan. Coverage is provided for one comprehensive eye examination or a combination of a brief/intermediate examination and an A-scan or a B-scan if medically justified. Use of TENS for relief of acute post-operative pain is covered under Medicare. TENS may be used as an adjunct or alternative to drugs in treating acute pain resulting from surgery. TENS devices may be used to treat acute post-operative pain. They are covered as hospital supplies for inpatients under Part A or as supplies incident to a physician's service for outpatients under Part B. Pain rehabilitation programs are covered for patients with intractable pain. Goals include providing patients with tools to manage pain and improve independent functioning. Coverage for multidisciplinary pain rehabilitation programs that address physiological, psychological, and social aspects of pain. Programs must include diagnostic testing, skilled nursing, psychotherapy, physical therapy, and occupational therapy. Pain rehabilitation programs are covered for patients with physical disabilities to maximize mobility and endurance. Pain rehabilitation programs eligible if they require inpatient hospital care Diagnostic tests covered when related to the patient's condition and not duplicative Inpatient program of 4 weeks' duration is required to modify pain behavior. Outpatient rehabilitation services may be provided following the inpatient program. Inpatient program is reasonable and necessary for the treatment of the patient's condition. Covered for patients with chronic pain attributable to a physical cause where usual treatments have failed. Inclusion of psychological treatment is appropriate as part of a multi-disciplinary approach. Pain rehabilitation programs are covered for outpatient treatment of mental conditions when provided in accordance with each patient’s individualized plan. Coverage is available if the patient's pain is due to a physical cause, usual treatments are ineffective, and there is a significant loss of independent function. Covered for severe headaches after spinal anesthesia, spinal taps, or myelograms. General or monitored anesthesia during transvenous cardiac pacemaker surgery is covered if adequate documentation of medical necessity is provided. The thoracic method of implantation for pacemaker surgery always requires general anesthesia. Obstructions causing vertigo, visual or speech defects, ataxia, mental confusion, or stroke due to reduced blood flow in the vertebral artery. Vertebral artery endarterectomy is necessary for symptomatic vertebral artery obstruction. Subclavian artery resection is medically necessary if symptoms of obstruction exist and other causes are ruled out. Angiograms documenting a valid obstruction should include the aortic arch and vessels off the arch, as well as neck and head vessels. Sequential views are necessary to diagnose conditions such as 'subclavian steal' due to subclavian artery obstruction. Symptoms due to vertebral artery obstruction documented by angiography. Differential diagnosis should include various degenerative disorders of the brain, orthostatic hypotension, acoustic neuroma, labyrinthitis, diabetes mellitus, and hypoglycemia-related disorders. Coverage for intravascular obstructions due to arteriosclerotic lesions within the vertebral artery. Coverage for extravascular obstructions affecting the vertebral artery. Indications include bony tissue or osteophytes affecting the cervical vertebral area along the course of the vertebral artery. Surgical correction is indicated in rare cases where vertebral artery abnormalities cause symptoms of obstruction. Vertebral artery surgery is covered when performed to remove specific obstructions impacting blood flow. Claims for vertebral artery surgery should identify the exact obstruction and surgical procedure utilized. Surgery is covered if it is necessary to remove or relieve an obstruction to vertebral artery flow. Covered for kidney transplant recipients or individuals approved for transplantation in an approved hospital. Applicable whether performed pre- or post-transplant. Covered when used to treat life-threatening ventricular tachyarrhythmias. Patients with a personal history of sustained ventricular tachyarrhythmia (VT) not associated with acute myocardial infarction (MI). Patients who have experienced cardiac arrest due to ventricular fibrillation (VF) not related to a transient or reversible cause. Patients with a prior myocardial infarction (MI) and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Patients with severe ischemic dilated cardiomyopathy and NYHA Class II or III heart failure, LVEF ≤ 35%. Patients with severe, non-ischemic, dilated cardiomyopathy, NYHA Class II or III heart failure, LVEF ≤ 35%, and on optimal medical therapy for at least 3 months. Patients must have a formal shared decision-making encounter prior to initial ICD implantation. Patients with documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias, including long QT syndrome and hypertrophic cardiomyopathy. Patients identified in B5 must have a formal shared decision-making encounter with a physician or qualified non-physician practitioner before initial ICD implantation. Patients with an existing ICD may receive a replacement due to end of battery life, elective replacement indicator (ERI), or device/lead malfunction. Patients must be clinically stable, not in shock. LVEF must be measured by echocardiography, radionuclide imaging, cardiac MRI, or catheter angiography. Patients who meet CMS coverage requirements for cardiac pacemakers may receive combined devices in one procedure when clinically indicated. Patients with an existing ICD may receive a replacement if it is due to end of battery life, ERI, or device/lead malfunction. Coverage of ICDs as a bridge-to-transplant for patients on the UNOS transplant list awaiting a donor heart is determined by local Medicare Administrative Contractors. All other indications for ICDs not currently covered may be covered under Category B investigational device exemption (IDE) trials. Transmyocardial revascularization (TMR) is covered for patients with severe angina due to ischemic heart disease when direct coronary interventions are not feasible. Patients with severe angina (Class III or IV) who have not found relief from other medical therapies. Coverage for services that assist individuals in performing normal activities of daily living. Coverage for TMR is provided for patients with severe angina (Canada Cardiovascular Society Classes III or IV) that is refractory to standard medical therapy. Patients with an ejection fraction of 25 percent or greater meeting the criteria for laser treatment. Patients with areas of viable ischemic myocardium not amenable to surgical therapies. Procedure coverage is limited to trained physicians. Providers must have dedicated cardiac care units with necessary support services. PTA is covered for the treatment of atherosclerotic and other vascular stenoses. PTA is indicated for improving blood flow through narrowed or occluded blood vessels. Treatment of atherosclerotic obstructive lesions in the lower extremities (iliac, femoral, and popliteal arteries). Treatment of obstructive lesions in a single coronary artery for patients with angina refractory to optimal medical management, objective evidence of myocardial ischemia, and lesions amenable to angioplasty. Treatment of renal artery lesions in patients with inadequate response to medical management where surgery is a likely alternative. Treatment of arteriovenous dialysis fistulas and grafts performed through either a venous or arterial approach. PTA of the carotid artery concurrent with carotid stent placement is covered when performed in FDA-approved Category B IDE clinical trials. PTA is considered reasonable and necessary for carotid artery dilation concurrent with carotid stent placement during such trials. Patients with symptomatic carotid artery stenosis of 50% or greater. Patients with asymptomatic carotid artery stenosis of 70% or greater are covered. Coverage includes carotid endarterectomy (CEA) for symptomatic patients with 70-99% stenosis. Transcarotid artery revascularization (TCAR) is medically necessary for high-risk patients with carotid artery stenosis. Facilities must have a program to grant carotid stent privileges based on outcome monitoring. Medicare covers PTA and stenting of intracranial arteries for patients with cerebral artery stenosis ≥50% due to intracranial atherosclerotic disease in FDA-approved Category B IDE clinical trials. PTA of the carotid artery concurrent with stenting may be covered when determined reasonable and necessary by Medicare Administrative Contractors. Persistent, symptomatic second-degree atrioventricular (AV) block. Persistent, symptomatic third-degree atrioventricular (AV) block. Symptomatic sinus bradycardia. Cardiac pacemakers are covered as prosthetic devices under the Medicare program if deemed reasonable and necessary for the treatment of the condition. Permanent cardiac pacing is medically necessary when other diagnostic or therapeutic modalities have been undertaken. Permanent cardiac pacing is indicated for patients with symptomatic bradycardia. Cardiac pacing may be medically necessary for patients with certain arrhythmias such as complete heart block. Single-chamber pacemaker claims may be covered without further claims development under specified medical conditions. Dual-chamber pacemaker claims may be covered without further claims development under specified medical conditions. Single-Chamber Cardiac Pacemakers are covered for patients with medically necessary conditions justifying cardiac pacing. Cardiac pacing is considered medically necessary for chronic or recurrent conditions not due to transient causes like acute myocardial infarction or drug toxicity. A single episode of symptoms such as syncope or seizure is adequate to establish medical necessity for chronic or recurrent rhythm disturbances. Acquired complete AV heart block. Congenital complete heart block with severe bradycardia, significant physiological deficits, or significant symptoms. Second-degree AV heart block Type II with no progressive P-R interval prolongation prior to blocked beats. Second-degree AV heart block Type I with significant symptoms due to hemodynamic instability. Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, CHF) must have documented correlation with bradycardia. Substantial sinus bradycardia (heart rate less than 50) with dizziness or confusion requires documentation linking symptoms to bradycardia. Sinus bradycardia due to long-term necessary medication with significant symptoms (e.g., syncope, seizures, CHF) must show correlation to be covered. Bradycardia symptoms must be attributed to the condition rather than other causes. Sinus node dysfunction is covered if accompanied by significant symptoms like syncope or confusion. Coverage extends to sinus node dysfunction with life-threatening ventricular arrhythmias secondary to bradycardia. Bradycardia associated with supraventricular tachycardia and significant symptoms unresponsive to pharmacological management. Hypersensitive carotid sinus syndrome with syncope due to bradycardia unresponsive to medical measures. Bifascicular or trifascicular block with syncope attributed to transient complete heart block after exclusion of other causes. Prophylactic pacemaker use post-recovery from acute myocardial infarction with temporary complete or Mobitz Type II AV block. Overdrive pacing is indicated for patients with recurrent and refractory ventricular tachycardia. Pacing is also indicated for patients with second-degree AV heart block of Type I with prolonged QRS complexes. Coverage is not provided for syncope of undetermined cause. Asymptomatic second-degree AV block of Type I is not covered unless the QRS complexes are prolonged. Asymptomatic bradycardia in post-MI patients initiating long-term beta-blocker therapy is indicated for cardiac pacing. Single-chamber cardiac pacing is necessary if ventricular pacing causes a drop in blood pressure, retrograde conduction, or discomfort. Patients who have experienced significant symptoms of pacemaker syndrome (atrioventricular asynchrony) with a pacemaker that is being replaced. Patients with congestive heart failure (CHF) who would experience improvement in quality of life from even a small increase in cardiac efficiency, despite adequate other medical measures. Young and active patients who may anticipate future pacemaker syndrome. Dual-chamber pacemakers may be covered if medical necessity is justified through adequate claims development. Frequent or persistent supraventricular tachycardias that do not require pacing for the control of the tachycardia. Clinical conditions requiring intermittent and brief pacing, not associated with prolonged pacing needs. Prophylactic use of pacemaker after recovery from acute myocardial infarction with third-degree or Type II second-degree AV block. Covered for Category B IDE clinical trials. Routine costs of dual-chamber cardiac pacing associated with clinical trials are covered. Medicare covers services for the post-implant follow-up and evaluation of implanted cardiac pacemakers. Coverage is limited to lithium battery-powered pacemakers. Dual-chamber pacemakers are used for patients needing both atrial and ventricular pacing. Single-chamber pacemakers are indicated for pacing only the ventricles. Pacemaker monitoring frequency is determined by the patient's physician and may vary based on individual patient circumstances. Transtelephonic monitoring is covered for patients with implanted cardiac pacemakers. Medically necessary for identifying early signs of pacemaker failure. Indicated for detecting battery depletion and internal electronic problems in pacemakers, especially dual-chamber devices. Transtelephonic monitoring services are covered when consisting of a minimum 30-second readable strip of the pacemaker in free-running and magnetic modes, along with a minimum 30 seconds of readable ECG strip. Covered when transtelephonic monitoring is deemed medically necessary based on the patient's condition. More frequent monitorings may be allowed for pacemakers with unexpected defects or premature failure. Pacemaker systems meeting ICHD standards for longevity and output voltage decay are covered. Patients may require monitoring for pacemaker adjustments based on overall condition changes. Reprogramming of dual-chamber pacemakers may necessitate monitoring guideline adjustments. Single-chamber pacemakers are indicated for patients needing monitoring every 2 weeks in the first month, then at specified intervals through failure. Dual-chamber pacemakers are indicated for patients needing monitoring every 2 weeks in the first month, followed by a regular schedule until failure. Pacemaker monitoring covered when performed by pacemaker clinics. Clinic visits may be done concurrently with transtelephonic monitoring. Monitoring of single-chamber pacemakers is indicated twice in the first 6 months after implantation, then once every 12 months. Monitoring of dual-chamber pacemakers is indicated twice in the first 6 months after implantation, then once every 6 months. Covered when the device is used to provide instantaneous digital readout of the pacemaker pulse rate. Patient may use a self-contained pacemaker monitor at home to evaluate pacemaker functionality. Patients should contact their physician upon detecting any significant change in pacemaker rate. Medically necessary for patients requiring permanent cardiac pacing due to bradycardia. Covered when the patient's heart does not respond adequately to natural pacing mechanisms. Implanted permanent cardiac pacemakers are covered for non-reversible symptomatic bradycardia due to sinus node dysfunction. Coverage extends to second and/or third degree atrioventricular block. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block. Reversible causes of bradycardia such as electrolyte abnormalities, medications, or drugs, and hypothermia do not warrant treatment. Asymptomatic first degree atrioventricular block is not covered. Asymptomatic sinus bradycardia is excluded from coverage. Asymptomatic sino-atrial block or sinus arrest do not meet criteria for intervention. Ineffective atrial contractions without symptomatic bradycardia are not covered. Asymptomatic second degree atrioventricular block of Mobitz Type I is covered only when QRS complexes are prolonged. Syncope of undetermined cause needs additional investigation for coverage. Bradycardia occurring during sleep is not considered medically necessary. Right bundle branch block with left axis deviation without symptoms does not qualify for treatment. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia. A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged. Implantation and use of single chamber or dual chamber cardiac pacemakers may be covered based on coverage determinations by A/B MACs. Medically necessary for patients requiring ventricular pacing without the complications associated with traditional pacing systems. Leadless pacemakers are covered when procedures are performed in FDA approved studies. Leadless pacemakers used in accordance with FDA approved label are covered if they are part of an ongoing or completed FDA post-approval study. The study tests if the item or service meaningfully improves health outcomes of affected beneficiaries. The study must comply with applicable federal regulations protecting human subjects. Meaningful informed consent must be obtained from patients involved in the study. Studies are covered when they aim to address life-threatening conditions and no viable treatment options are available. The study must include subpopulations traditionally underrepresented in clinical studies. Clinical research studies addressing pertinent beneficiary subpopulations are supported. All clinical research study protocols must be reviewed and approved by CMS. VADs are covered post-cardiotomy when approved by the FDA and used per FDA labeling instructions. LVADs are covered for heart failure patients with NYHA Class IV heart failure, LVEF ≤ 25%, and who are inotrope dependent. Alternately, LVADs are indicated for patients with a Cardiac Index < 2.2 L/min/m² who are on optimal medical management for at least 45 days and failing to respond, or who have advanced heart failure for at least 14 days while depending on an IABP or similar support for at least 7 days. Beneficiaries receiving a VAD must be managed by a multidisciplinary team. Coverage is provided for patients undergoing placement of a Ventricular Assist Device (VAD) when managed by a qualified team. Use of Ventricular Assist Devices (VADs) in the context of Category B investigational device exemption clinical trials. Destination therapy for patients requiring mechanical cardiac support with FDA-approved VADs. Patients with chronic end-stage heart failure (NYHA Class IV) who are not candidates for heart transplantation. Patients must have failed optimal medical management for 45 of the last 60 days, be balloon pump-dependent for 7 days, or IV inotrope-dependent for 14 days. Patients must have a left ventricular ejection fraction (LVEF) <25%. Facilities credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities. Beneficiaries receiving VADs for DT must be managed by a cohesive multidisciplinary team. The team must ensure patients and caregivers are informed for shared decision-making and consent. Coverage is provided when at least one physician with cardiothoracic surgery privileges has experience implanting at least 10 durable, intracorporeal left ventricular assist devices (VADs) as bridge to transplant (BTT) or destination therapy (DT) in the past 36 months and has been active in the last year. At least one cardiologist trained in advanced heart failure is required to manage patients before and after heart transplant. Covered when used in investigational device exemption clinical trials as per Category B guidelines. Coverage for cardiac rehabilitation programs under Medicare Part B for beneficiaries with specified cardiac conditions. Acute myocardial infarction within the preceding 12 months Coronary artery bypass surgery Current stable angina pectoris Heart valve repair or replacement Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting Heart or heart-lung transplant Other cardiac conditions as specified through a national coverage determination Coverage is expanded for cardiac rehabilitation services for beneficiaries with stable, chronic heart failure, defined as left ventricular ejection fraction of 35% or less and NYHA class II to IV symptoms despite optimal therapy for at least six weeks. Stable patients are those without recent or planned major cardiovascular hospitalizations or procedures within the defined time frames. Intraoperative ventricular mapping is covered when it is performed to guide cardiac surgery by recording electrical activity directly from the heart. Covered for localizing accessory pathways associated with Wolff-Parkinson-White and other preexcitation syndromes. Covered for mapping the sequence of atrial and ventricular activation for drug-resistant supraventricular tachycardias. Covered for delineating the anatomical course of His bundle and/or bundle branches during corrective cardiac surgery for congenital heart diseases. Covered for directing surgical treatment of patients with refractory ventricular tachyarrhythmias. Covered when used for patients with severe cardiac arrhythmias. Medically necessary for studying arrhythmias and abnormalities of the heart's conduction system. Used to investigate mechanisms, site of origin, and pathways of cardiac arrhythmias. Indicated for diagnosing and treating sustained ventricular tachycardia. Provides value in managing complex arrhythmias, conduction defects, and post-cardiac arrest. Patients with complex ongoing acute arrhythmias. Patients with intermittent or permanent heart block when considering pacemaker implantation. Patients who have recently developed heart block due to myocardial infarction. Covered for diagnostic, preoperative, and postoperative evaluation of peripheral artery disease. Useful for preoperative evaluation of diabetic patients or those with intermittent claudication indicative of peripheral vascular disease. Considered a reasonable and necessary procedure for the diagnostic evaluation of suspected peripheral arterial disease in the hospital vascular laboratory. Procedures listed in Category I are covered for accepted medical indications. Services for segmental plethysmography are covered. Ultrasonic measurement of blood flow is useful for evaluating peripheral vascular disease. Electrocardiograms (EKGs) are used to diagnose a wide range of heart disease and conditions manifested by abnormal cardiac electrical activity. EKG services are covered when there are documented signs and symptoms or other clinical indications. Coverage includes the review and interpretation of EKGs by a physician. Used to evaluate symptoms correlated with intermittent cardiac arrhythmias, such as syncope, dizziness, chest pain, palpitations, or shortness of breath. Utilized to assess patient response to arrhythmic drug therapy. Covered when demonstrated by clinical studies to improve patient management and health outcomes in the Medicare population. Includes superior detection of serious or life-threatening arrhythmias compared to currently described devices. Holter monitors are covered for recording EKG over a 24-hour period to detect transient arrhythmias. Event monitors are covered for intermittently recording cardiac arrhythmic events activated by the patient. Patient-activated event monitors are covered when patients initiate recording during symptoms as instructed by a physician. Self-sensing monitors are covered when they automatically record EKG data upon detecting arrhythmias. Covered when using cardiac event monitors with transtelephonic capabilities that transmit EKG data to a central reception center or IDTF. Coverage for cardiac event monitors when medically necessary to capture electrical activity potentially indicative of cardiac issues. Indicated for patients requiring monitoring of complex EKG tracings with multiple electrodes. Coverage for the Pre-symptom Memory Loop Recorder (MLR) when symptoms are detected. Usage of the Implantable Loop Recorder (ILR) is warranted when cardiac-related syncope occurs infrequently enough that it cannot be detected by traditional monitors. Coverage for cardiac event recorder use is provided for patients experiencing symptoms for which an EKG is deemed necessary. Computer analysis of EKGs covered when performed under the necessary circumstances for other EKG services. EKG services from IDTFs are covered, including physician review and interpretation, unless the physician is not the patient's attending or consulting physician. Emergency EKGs are covered when performed by a portable x-ray supplier with physician attendance during or immediately after the service. Home EKG services are covered with documented medical necessity. Diagnostic service for specified indications when performed with compliant equipment. Detect, characterize, and document symptomatic transient arrhythmias. Initiate, revise, or discontinue arrhythmic drug therapy. Carry out early post-hospital monitoring of patients discharged after myocardial infarction (MI) with 24-hour coverage. 24-hour attended coverage is covered when there is an EKG technician or non-physician at a monitoring site with immediate access to a physician. Ambulatory EKG monitoring is covered when operated in a time-sampling mode. Ambulatory cardiac monitoring is covered if performed with a marketed, FDA-approved device and can be categorized according to the specified framework. 24-hour attended coverage is utilized for patients discharged after a myocardial infarction (MI) unless other provisions are made. TEB is covered for non-invasive diagnosis or monitoring of hemodynamics in patients with suspected or known cardiovascular disease. TEB is covered for patient management based on sufficient clinical literature and guidance. Differentiation of cardiogenic from pulmonary causes of acute dyspnea when insufficient information is available from medical history and standard assessment tools. Optimization of A/V interval for patients with A/V sequential cardiac pacemakers when standard assessment tools do not provide necessary information. Monitoring continuous inotropic therapy for patients with terminal congestive heart failure who are choosing comfort at home or are awaiting heart transplant. Evaluation for rejection in patients with a heart transplant as an alternative to a myocardial biopsy when deemed necessary. Fluid management optimization in congestive heart failure when standard assessment tools are insufficient, requiring TEB hemodynamic data. Use of TEB for the management of drug-resistant hypertension is considered reasonable and necessary. Drug-resistant hypertension is defined as failure to achieve goal blood pressure in patients adhering to a full dose of an appropriate 3-drug regimen including a diuretic. Direct tests examine the anatomy and physiology of the carotid artery. Indirect tests evaluate hemodynamic changes in the distal beds of the carotid artery. Carotid body resection is accepted when there is evidence of a mass in the carotid body indicating the need for surgery to remove a carotid body tumor. Denervation of a carotid sinus may be considered reasonable and necessary for patients with hypersensitive carotid sinus reflex experiencing symptoms such as dizziness or syncope due to hypotension and slowed heart rate. Surgery is indicated when there is a failure of medical therapy and continued deterioration in the patient's condition. ABPM is covered for patients with suspected white coat hypertension, defined as office blood pressure > 140/90 mm Hg on at least three visits with two measurements each. Additional criteria include at least two documented out-of-office measurements < 140/90 mm Hg and no evidence of end-organ damage. ABPM is necessary for determining appropriate management of the patient. Patients with ABPM demonstrating blood pressure >135/85 may need antihypertensive therapy. ECP is covered for treatment of stable angina pectoris that is refractory to medical and/or surgical therapy. Coverage for ECP is provided for patients diagnosed with Class III or Class IV disabling angina who are not candidates for surgical interventions. Patients must have coronary conditions deemed inoperable or at high risk of complications, incompatible coronary anatomy, or co-morbid conditions that elevate surgical risks. Covered for patients requiring full course therapy consisting of 35 one-hour treatments. Indicated for patients whose lower trunk and lower extremities are treated with compressive air cuffs. Medically necessary for patients requiring enhancement of venous return and reduction of ventricular workload. Patients experiencing increased time until onset of ischemia. Increased exercise tolerance and reduction in the number and severity of anginal episodes. EDTA Chelation Therapy is covered for the treatment of atherosclerosis in patients who meet specific clinical criteria. Cardiokymography is covered for evaluating coronary artery disease for services rendered on or after October 12, 1988. For male patients, atypical angina pectoris or nonischemic chest pain. For female patients, angina, either typical or atypical. Therapeutic embolization is covered for hemorrhage and for other conditions when reasonable and necessary. Renal embolization for renal adenocarcinoma is covered to reduce tumor vascularity preoperatively, reduce tumor bulk in inoperable cases, or palliate specific symptoms. Hyperbaric oxygen therapy is covered for specified conditions under Medicare guidelines. Covered for specified medical conditions that require hyperbaric oxygen therapy. HBO therapy is indicated for acute carbon monoxide intoxication and cyanide poisoning. Use as an adjunctive treatment for decompression illness and gas embolism. Indicated for crush injuries and suturing of severed limbs when loss of function, limb, or life is threatened. HBO therapy is appropriate for progressive necrotizing infections, acute traumatic peripheral ischemia, chronic refractory osteomyelitis, and preparation of compromised skin grafts. Actinomycosis is covered only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment. Patients with type I or type II diabetes who have a lower extremity wound due to diabetes. Wounds classified as Wagner grade III or higher. HBO therapy is covered as adjunctive therapy after 30 days of standard wound therapy with no measurable signs of healing. Coverage for chronic non-healing wounds may be determined by Medicare Administrative Contractors (MACs) within their respective jurisdictions. MTWA testing is indicated for patients at risk for sudden cardiac death (SCD) from ventricular arrhythmias. A negative MTWA test may identify low-risk patients unlikely to benefit from implantable cardioverter defibrillator (ICD) placement. MTWA diagnostic testing is covered for the evaluation of patients at risk for sudden cardiac death (SCD) when the Spectral Analysis (SA) method is used. MTWA diagnostic testing is covered for patients at risk for sudden cardiac death (SCD). ICR programs are covered when they demonstrate positive effects on the progression of coronary heart disease. Covered when ICR reduces the need for coronary bypass surgery or percutaneous coronary interventions. Must show a statistically significant reduction in five or more specified health measures post-rehabilitation. Medications for managing cholesterol levels, blood pressure, and diabetes are covered when medically necessary. Coverage for participation in the Pritikin Program when medically necessary for weight management, management of diabetes, or lowering cholesterol. The Pritikin Program meets the intensive cardiac rehabilitation program requirements. Eligible for the Ornish Program when medically necessary for reversing heart disease. Eligible for coverage if enrolled in the Ornish Program for Reversing Heart Disease as it meets Intensive Cardiac Rehabilitation requirements. Medically necessary for individuals at high cardiovascular risk who will benefit from a multi-component intervention program that includes supervised exercise, behavioral interventions, and counseling. The Benson-Henry Institute Cardiac Wellness Program is covered as it meets the ICR program requirements established by Medicare. Used in the treatment of aortic stenosis. Indicated for patients who are not candidates for traditional surgical aortic valve replacement. TAVR is covered for the treatment of symptomatic aortic valve stenosis when performed with an FDA-approved aortic valve and implantation system. TAVR must be done with the care of a heart team comprising multi-disciplinary medical professionals. Indications for TAVR include patients with symptomatic aortic stenosis assessed by a cardiac surgeon and interventional cardiologist. TAVR is suitable for patients deemed high-risk or when surgical aortic valve replacement is unsuitable. Heart valve surgery covered for patients eligible for TAVR. Eligibility for TAVR program requires the hospital to have performed ≥ 50 open heart surgeries in the previous year. A minimum of ≥ 20 aortic valve related procedures must be conducted in the 2 years prior to TAVR program initiation. Candidates for TAVR must have ≥ 50 aortic valve replacements (AVRs) per year, including ≥ 20 TAVR procedures in the prior year. Candidates must have ≥ 100 AVRs every 2 years, including ≥ 40 TAVR procedures in the prior 2 years. The facility must have ≥ 2 physicians with cardiac surgery privileges and ≥ 1 physician with interventional cardiology privileges. A minimum of ≥ 300 percutaneous coronary interventions (PCIs) must be performed per year. Coverage for patients facing all-cause mortality risks. Coverage for patients experiencing Transient Ischemic Attacks (TIAs). Coverage for patients who have suffered major vascular events. Coverage for patients with acute kidney injury. Coverage for repeat aortic valve procedures. Coverage for new permanent pacemaker implantation. Coverage focusing on improvements in Quality of Life (QoL). Transcatheter aortic valve replacement (TAVR) is covered for uses not expressly listed as FDA-approved indications when performed within a qualified clinical study. Study is to test health outcome improvements for affected beneficiaries. Study rationale supported by scientific and medical evidence. Eligible studies must include life-threatening conditions with no viable treatment options. Public release of study outcomes within 12 months of primary completion date is required. Beneficiary subpopulations affected by the item or service should be discussed, particularly underrepresented groups. Coverage for TAVR is supported when clinical research studies meet the required standards. TEER is covered for the treatment of mitral regurgitation. Covered for the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation when the patient is symptomatic despite maximally tolerated guideline-directed medical therapy plus cardiac resynchronization therapy. Covered for significant symptomatic degenerative mitral regurgitation when furnished according to an FDA-approved indication. Patient must be under the care of a heart team, a cohesive multidisciplinary team of medical professionals. Cardiac surgical procedures must be performed by a surgeon with at least 20 mitral valve surgeries per year or 40 over two years, with at least 50% being mitral valve repairs. Interventional cardiologists must have experience in at least 50 career structural heart disease procedures, including participation in at least 20 trans-septal interventions. Interventional echocardiographer must have experience with ≥ 10 trans-septal guidance procedures and ≥ 30 structural heart procedures. Heart failure cardiologist required for advanced heart failure patients with functional MR. Patients with functional MR must have persistent symptoms despite maximally tolerated GDMT and cardiac resynchronization therapy. Each patient's suitability for surgical mitral valve repair or TEER must be evaluated by the heart team. Patients with degenerative mitral regurgitation must be evaluated by both a heart team interventional cardiologist and a cardiac surgeon. Mitral valve TEER procedures must be performed by an interventional cardiologist or cardiac surgeon from the heart team. Transesophageal echocardiography must be performed by an interventional echocardiographer from the heart team. Covered for patients requiring on-site heart valve surgery and interventional cardiology with the specified hospital and physician requirements. Eligibility for TEER patients enrolled in a national registry that tracks specific clinical outcomes. TEER procedures are indicated for reporting outcomes and adverse events compared to pivotal clinical studies. Mitral valve TEER is covered when performed within a clinical study that meets specified criteria. Indications for Transcatheter Edge-to-Edge Repair (TEER) include patients with symptomatic mitral regurgitation despite optimal medical therapy. Patients who are at increased surgical risk for mitral valve surgery may be candidates for TEER. Item or service improves health outcomes of affected beneficiaries as supported by study results. The study must comply with Federal regulations concerning the protection of human subjects. Coverage provided for research studies that aim to treat life-threatening conditions when no other viable treatment options exist. Study protocols must include discussions on underrepresented beneficiary populations affected by the item or service under investigation. Coverage for percutaneous left atrial appendage closure (LAAC) is for patients with non-valvular atrial fibrillation (NVAF). The LAAC device must have received FDA Premarket Approval for its indicated use. Coverage is indicated for individuals with a CHADS2 score ≥ 2. Coverage is also indicated for individuals with a CHA2DS2-VASc score ≥ 3. Patients with non-valvular atrial fibrillation (NVAF) who are suitable for short-term warfarin but unable to take long-term oral anticoagulation. Patients undergoing LAAC must have a documented shared decision-making interaction with an independent physician using an evidence-based decision tool. LAAC is covered for patients whose operators have received manufacturer-prescribed training and performed ≥ 25 interventional cardiac procedures involving transeptal puncture. The patient must be enrolled in a national audited registry that tracks specified outcomes for at least 4 years. Device effectiveness must be evaluated for short-term (≤12 months) and long-term (≥4 years) durability. Coverage includes monitoring of device-specific complications, including any thromboses. LAAC is covered for NVAF patients in FDA-approved randomized controlled trials. Clinical research studies must address CMS research questions and meet the criteria outlined in the decision. Item or service must meaningfully improve health outcomes for Medicare beneficiaries. Research studies are covered if they have a methodologically appropriate design. Studies must have a sufficient anticipated number of enrolled subjects to answer the research questions. The study has a written protocol demonstrating adherence to Medicare requirements. Clinical research studies are applicable when testing involved conditions are life-threatening and no viable treatment options exist. LAAC is covered for NVAF treatment when furnished under Coverage with Evidence Development (CED) according to specified criteria. Supervised exercise therapy (SET) is covered for patients with symptomatic peripheral artery disease (PAD) experiencing intermittent claudication. SET is considered effective in alleviating claudication symptoms and may prevent the progression of PAD. Coverage for supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) related to symptomatic peripheral artery disease (PAD). Beneficiaries must have a face-to-face visit with the physician responsible for PAD treatment to obtain referral for supervised exercise therapy (SET). Patients must receive information regarding cardiovascular disease and PAD risk factor reduction during the visit. Biofeedback therapy is covered if medically necessary. SET (specific therapy) may be covered beyond 36 sessions for clinical indications with a second referral. Biofeedback therapy is indicated for alleviating abnormal bodily conditions by allowing voluntary control over body functions. Coverage includes therapy that utilizes devices to provide feedback on heart rate, blood pressure, skin temperature, and muscle tone. Biofeedback therapy is covered when necessary for muscle re-education of specific muscle groups or treating pathological muscle abnormalities such as spasticity, muscle spasm, or weakness. Coverage applies only when more conventional treatments (heat, cold, massage, exercise, support) have not been successful. Biofeedback therapy is covered for treating urinary incontinence when provided by a qualified practitioner. Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients after failing a trial of pelvic muscle exercises. Acupuncture for the selection and manipulation of specific acupuncture points using needling and non-needling techniques. Acupuncture is covered for chronic low back pain under section 1862(a)(1)(A) of the Social Security Act. Acupuncture is covered for Medicare patients with chronic Lower Back Pain (cLBP), effective from January 21, 2020. Up to 12 visits in 90 days are covered for patients meeting the criteria. Coverage for acupuncture is provided for chronic low back pain lasting 12 weeks or longer, nonspecific, not associated with surgery or pregnancy. An additional 8 sessions of acupuncture may be covered for patients demonstrating improvement. Physician assistants, nurse practitioners, and auxiliary personnel may furnish acupuncture if they hold a master's or doctoral level degree in acupuncture or Oriental Medicine and have an active state license. Medically prescribed Transcendental Meditation for treatment of mild hypertension. Adjunctive therapy for essential hypertension. Sole or adjunctive treatment of anxiety and other psychological stress-related disorders. Diagnostic tests to assess the ability of the stomach to secrete acid. Assessment of the integrity of peripheral sensory nerves. Evaluation of circulatory competency in limb extremities. Diagnosis of pheochromocytoma. Blood glucose monitors using reflectance meters specifically designed for home use by diabetic patients may be covered as durable medical equipment. Home blood glucose monitors are covered for patients who require frequent checking of blood glucose levels to control their diabetes. Patient has been diagnosed with diabetes. The physician confirms the patient or a responsible individual can be trained to use the device. The device is intended for home use. Covered when the patient meets the conditions for standard home blood glucose monitors. The physician certifies that the patient has a visual impairment requiring use of the special monitoring system. Covered when special systems provide higher reimbursement for blood glucose monitoring. For short-term management of patients with insulin-dependent diabetes mellitus (Type I) during periods of stress such as trauma, labor and delivery, and surgery. Used for stabilizing Type I diabetics with wide fluctuations in blood sugar levels. Short-term management of insulin-dependent diabetics in crisis situations in a hospital inpatient setting. Use is covered only under the direction of specially trained medical personnel. Insulin syringes are covered when used by a physician or under direct supervision during emergency situations such as diabetic coma. Outpatient intravenous insulin therapy is indicated when guided by measurements of respiratory quotient, urine urea nitrogen, arterial, venous, or capillary glucose, or potassium concentration. Intravenous insulin therapy is indicated for ongoing diabetic management in patients. Adjunctive therapy to a patient's existing diabetes treatment regimen may include periodic insulin administration. Individual components of OIVIT may have medical uses in conventional treatment regimens for diabetes and other conditions. Coverage for other uses may be determined by other Medicare determinations. Coverage is provided for patients with severe speech impairments who require devices for functional speech needs. Coverage for devices providing digitized audible/verbal speech output. Coverage for synthesized speech output with multiple access methods for message formulation. Coverage for speech generating devices used by individuals with severe speech impairment to meet functional speaking needs. Covered under Part B as prosthetic devices for patients who have had a laryngectomy or have a permanently inoperative larynx. Cochlear implants are covered for individuals who are moderately to profoundly hearing impaired and require the device for awareness and identification of sounds. Cochlear implantation is covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss. Patients must demonstrate limited benefit from amplification, defined as test scores of 60% or less in open-set sentence recognition under best-aided conditions. Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from hearing aids. Cognitive ability to use auditory clues and a willingness to undergo a program of rehabilitation. Freedom from middle ear infection and other anatomical contraindications to surgery. Coverage may be provided for cochlear implants in FDA-approved category B investigational device exemption clinical trials. Tracheostomy speaking valve is considered medically necessary as an accessory to enhance the function of a trachea tube. Reimbursement made for ultrasonic surgery in treating severe and recurrent vertigo due to Meniere's syndrome. Physician may contact relatives and close associates for background information to assist in diagnosis and treatment planning when a patient is withdrawn and uncommunicative due to a mental disorder or is comatose. Covered when family counseling is primarily for treatment of the patient's condition. Applicable when observing patient interaction with family members is necessary. Consultation services provided by a podiatrist in a skilled nursing facility are covered as part of the physician’s personal services to the patient. Consultation services by a podiatrist in a skilled nursing facility are covered if deemed reasonable and necessary. Services are covered if they are related to specific symptoms that suggest the need for covered services, regardless of resultant diagnosis. Diagnosis and treatment of diabetic sensory neuropathy. Coverage includes patients with diabetes experiencing peripheral neuropathy. Foot exams for individuals with diabetic sensory neuropathy with loss of protective sensation (LOPS) are reasonable and necessary for early intervention in complications. Covered for individuals with a documented diagnosis of diabetic sensory neuropathy and loss of protective sensation (LOPS). Evaluations are covered no more than every six months, provided the beneficiary has not seen a foot care specialist for another reason in the interim. Diagnosis of peripheral neuropathy requires absence of sensation at two or more sites out of five tested on either foot. Foot examination including history and physical inspection is necessary for patients with conditions impacting foot health. Local care of superficial wounds is covered as part of treatment. Foot care services covered for patients with a diagnosis of diabetic sensory neuropathy with loss of protective sensation (LOPS). Assessment of other causes of peripheral neuropathy must be documented by the primary care physician prior to foot care services. Services and supplies in a physician's office within a nursing home are covered if they comply with the 'incident to a physician’s professional service' provision. Covered services must be commonly furnished in physician offices. Reimbursement is contingent on the services not falling outside the physician's office scope. Physician's services are considered for coverage when deemed reasonable and necessary. Medical services rendered up to and including the pronouncement of death by a legally authorized person, usually a physician, are covered. Diagnostic procedures are covered when specifically ordered by the admitting physician. Procedures are considered reasonable and necessary if performed as part of the admitting process. The test is medically necessary for the diagnosis or treatment of the individual patient's condition. The test does not unnecessarily duplicate the same test performed on an outpatient basis. Covered for treatment of acute or chronic corneal pathology including bulbous keratopathy, dry eyes, corneal ulcers, and erosion. Also indicated for keratitis, corneal edema, descemetocele, corneal ectasis, Mooren's ulcer, anterior corneal dystrophy, and neurotrophic keratoconjunctivitis. Payment is made for hydrophilic contact lenses approved by the FDA used as a supply incident to a physician's service. Photodynamic therapy is indicated for patients with specific types of diseased tissue. Ocular Photodynamic Therapy (OPT) is covered for the treatment of ophthalmologic diseases when used in conjunction with verteporfin. OPT is covered for classic subfoveal choroidal neovascular lesions with a diagnosis of neovascular age-related macular degeneration where classic CNV occupies ≥50% of the lesion area. Coverage is also provided based on fluorescein angiogram results during the initial visit. Opt with verteporfin is covered for treatment of age-related macular degeneration (AMD). OPT may be eligible for coverage at the discretion of individual A/B MAC for certain other ocular indications. OPT with verteporfin is approved for diagnosis of neovascular AMD with predominately classic subfoveal CNV lesions if the area of classic CNV occupies ≥50% of the lesion area. Non-coverage of OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by an FA. OPT with verteporfin is approved for neovascular AMD with predominantly classic subfoveal CNV lesions. There are no requirements regarding visual acuity, lesion size, or number of re-treatments for predominantly classic lesions. Subfoveal occult with no classic CNV associated with AMD. Subfoveal minimally classic CNV where classic CNV occupies <50% of the lesion associated with AMD. OPT with verteporfin is covered for age-related macular degeneration (AMD) when other specified indications are met. Additional ocular indications such as pathologic myopia or presumed ocular histoplasmosis syndrome are subject to local coverage determinations. Photosensitive drugs are indicated for the treatment of diseased tissue in photodynamic therapy. Coverage for verteporfin is limited to patients diagnosed with neovascular age-related macular degeneration (AMD) having predominantly classic subfoveal choroidal neovascular (CNV) lesions, where the classic CNV occupies ≥50% of the lesion area. Initial diagnosis must be confirmed by fluorescein angiogram (FA). Coverage is provided for indications specifically related to AMD. OPT with verteporfin is eligible for coverage in non-AMD conditions at the discretion of the A/B MAC. Covered for patients diagnosed with neovascular age-related macular degeneration (AMD). Predominantly classic subfoveal choroidal neovascularization (CNV) lesions where the area of classic CNV occupies ≥50% of the area of the entire lesion. Subfoveal minimally classic CNV associated with AMD, where the area of classic CNV occupies <50% of the area of the entire lesion. Lesions must be small (4 disk areas or less) at initial treatment or within 3 months prior. Lesions must show evidence of progression within 3 months prior to treatment, documented by visual acuity deterioration or lesion growth. OPT with verteporfin for AMD is covered for approved indications not specified as non-covered. Eligible for local coverage determinations for other ocular indications like pathologic myopia. Payment may be made for hydrophilic contact lenses when prescribed for an aphakic patient. Covered when a scleral shell is used for patients whose eye has been rendered sightless and shrunken by inflammatory disease. Scleral shells are covered as a prosthetic device in the treatment of dry eye when used in combination with artificial tears. Covered for diagnosis of macular degeneration, retinal neoplasms, choroid disturbances, diabetic retinopathy, glaucoma, multiple sclerosis, and central nervous system abnormalities when deemed reasonable and necessary by an ophthalmologist. Refractive keratoplasty procedures are indicated for the correction of myopia and hyperopia. Keratoplasty that treats specific lesions of the cornea, such as phototherapeutic keratectomy that removes scar tissue from the visual field, may be covered. Covered when reasonable and necessary for patients who meet one or more specified criteria. Used as a predictor of success for ocular surgery or certain other ocular procedures. Have slit lamp evidence of endothelial dystrophy (cornea guttata). Have slit lamp evidence of corneal edema (unilateral or bilateral). Are about to undergo a secondary intraocular lens implantation. Have had previous intraocular surgery and require cataract surgery. Are about to undergo a surgical procedure associated with a higher risk to corneal endothelium, such as phacoemulsification or refractive surgery. With evidence of posterior polymorphous dystrophy of the cornea or iridocorneal-endothelium syndrome. Are about to be fitted with extended wear contact lenses after intraocular surgery. Endothelial cell photography is covered as part of the presurgical comprehensive eye examination for cataract surgery when the only visual problem is cataracts. Computer enhanced perimetry is covered for assessing visual fields in patients with glaucoma or neuropathologic defects. Phaco-emulsification for cataract extraction is an accepted procedure for cataract removal. Vitrectomy may be considered reasonable and necessary for vitreous loss incident to cataract surgery. Indicated for vitreous opacities due to vitreous hemorrhage or other causes. Applicable in cases of retinal detachments secondary to vitreous strands. Covered for proliferative retinopathy. Indicated for vitreous retraction. Intraocular lens implantation is covered when deemed reasonable and necessary following cataract surgery. Services may include medical assessments like preimplantation ultrasound for eye measurement. Percutaneous transluminal angioplasty (PTA) of the carotid artery is covered for patients with symptomatic carotid stenosis. It is also covered for asymptomatic patients with severe carotid stenosis who meet specific criteria. Covered for patients who meet specific criteria as outlined in NCD 20.4. Medically necessary for patients with a history of life-threatening arrhythmias. Microvolt T-wave alternans testing is covered for patients at risk of sudden cardiac death, specifically those with a history of myocardial infarction. Covered for patients with classic subfoveal choroidal neovascularization due to age-related macular degeneration. Cochlear implantation is covered for individuals with severe to profound sensorineural hearing loss.

Coverage is not provided for non-approved indications. Limitations on frequency of TENS usage may apply. Extracranial-intracranial bypass surgery is not covered for asymptomatic patients. Certain procedures may have effective dates that impact coverage. Not covered if there are contraindications to surgery. Coverage for cardiac rehabilitation programs may be limited based on previous cardiac events. External counterpulsation is not covered for conditions other than severe angina. Not covered if performed in a non-hospital setting without sufficient justification. Limited to patients meeting specific clinical criteria for each procedure. Electrosleep therapy is retired and no longer covered. Intravenous histamine therapy and Laetrile are not covered under this policy. Limitations on coverage for cochlear implantation include pre-operative assessment requirements Not covered if the individual has no potential for auditory benefit from the device Certain procedures may be excluded based on patient age or specific conditions. Refractive keratoplasty may not be covered for purely cosmetic reasons. Items/services may be considered not reasonable and necessary under §1862(a)(1) of the Act. Coverage limitations may apply when conditions or indications are not specifically met. Decisions may be made at the discretion of the Medicare Administrative Contractor for items/services not explicitly excluded or mentioned. Additional tests are not covered for cataracts unless there is an additional diagnosis and the medical necessity is fully documented. Cataract surgery is elective, and an additional examination may be needed if performed by a physician other than the diagnosing physician. Use of TENS for acute pain is expected to be necessary for 30 days or less. If TENS is used for chronic pain beyond the specified period, coverage as durable medical equipment must be evaluated. Non-covered if the program atmosphere supports pain behavior. Services and devices such as acupuncture and dorsal column stimulators are excluded from coverage Family counseling services are not covered Inpatient care beyond 4 weeks requires documentation to substantiate reasonableness and necessity. Discharge occurs if the patient cannot adjust to the program within the first 7-10 days. Not covered when pain does not result in a significant loss of ability to function independently. Treatment is not covered if symptoms result from a physical cause rather than a mental condition. Vocational counseling, meals for outpatients, and acupuncture are excluded from coverage. Coverage may be denied if the pain rehabilitation program is deemed not reasonable and necessary for specific patients. Coverage is determined on a case-by-case basis, requiring advice from medical consultants for documentation adequacy. Procedures are not covered if there are contraindications such as coexistent obstructions of multiple cerebral vessels. Procedures are not indicated without radiographic evidence of vertebral artery obstruction. Coverage is not provided for anatomical variations such as anomalous locations or congenital abnormalities of the vertebral artery. Fibrous tissue alterations due to neck manipulation or related injuries are excluded from coverage. Surgical intervention is not performed in the absence of symptoms of vertebral artery obstruction. Abnormalities like tortuosity and kinks are generally considered insignificant without symptoms. Coverage for vertebral artery procedures must be determined on a case-by-case basis. General phrases used to describe the surgery may lead to claim denials due to lack of specific detail. Coverage is only valid if the four specific conditions noted in the policy are met. Procedures cannot be considered reasonable and necessary for reimbursement under the program. EC-IC arterial bypass surgery is not covered for ischemic cerebrovascular disease of the carotid or middle cerebral arteries. The procedure has not been demonstrated to be more effective than no surgical intervention for preventing strokes. Not covered for patients not admitted for treatment related to kidney transplantation. Not applicable for patients with New York Heart Association (NYHA) classification IV heart failure. Not applicable for patients who have undergone coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) with angioplasty and/or stenting within the past 3 months. Not applicable for patients who have had an MI within the past 40 days. Not applicable for patients with clinical symptoms that indicate a candidate for coronary revascularization. Not covered if the patient has had CABG or PCI within the past 3 months. Not covered if the patient has had an MI within the past 40 days. Not covered if clinical symptoms suggest candidacy for coronary revascularization. Patients who have had CABG or PCI within the past 3 months are not eligible. Patients with a myocardial infarction within the past 40 days or those exhibiting clinical symptoms suitable for coronary revascularization are excluded. Implantation requires a formal shared decision-making encounter with a physician or qualified non-physician practitioner using an evidence-based decision tool. Patients must not have significant irreversible brain damage. Patients with diseases associated with a likelihood of survival less than 1 year are not covered. Supraventricular tachycardia with poorly controlled ventricular rate excludes patients. No national coverage determination (NCD) is appropriate for Extracorporeal Immunoadsorption (ECI) Using Protein A Columns. Coverage determinations will be made by Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act. Procedure is considered experimental due to uncertain efficacy mechanisms. Coverage is limited to cases where other revascularization options have been exhausted. The technique does not provide increased life expectancy. It does not affect the underlying cause of angina. TMR is considered a last resort treatment option and is only covered after all standard therapies have been tried at maximum tolerated dosages. Coverage is limited to FDA-approved uses of the laser for the specified indications. Patients must have maximally stabilized acute conditions such as severe ventricular arrhythmias. Coverage is limited to providers demonstrating proper training for all personnel involved in the procedure. Providers must conform to laser safety standards set by the American National Standards Institute (ANSIZ1363). Coverage is limited to procedures concurrent with stenting using FDA-approved devices. Procedures must adhere to FDA-approved protocols governing post-approval studies. Formal shared decision-making must occur before furnishing carotid artery stenting. Non-invasive imaging must confirm the degree of stenosis before invasive procedures. Not covered if patient has 0-49% carotid artery stenosis. Procedures without adherence to established institutional and physician standards will not be reimbursed. Physicians must meet minimum case volumes to maintain privileges, subject to institutional risk adjustment thresholds. Coverage is limited to procedures conducted under FDA-approved protocols governing Category B IDE clinical trials. Not covered for patients who do not meet the criteria for FDA-approved clinical trials. All other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries remain non-covered. All indications for PTA without stenting not specifically indicated for coverage by CMS remain non-covered. Clinical goals of cardiac pacing must be established due to the variability in conditions requiring pacing, necessitating expertise and judgment. Pacemaker use is not justified for dubious medical conditions or where clinical benefit is marginal. Significant complications and adverse side effects associated with pacemaker use must be considered. Not covered for temporary or non-implanted pacemakers. Coverage may be limited based on individual patient circumstances and additional evaluations. Claims for single-chamber pacemakers may be denied unless further claims development shows coverage criteria are met. Claims for dual-chamber pacemakers may be denied unless further claims development shows they meet covered categories or special medical circumstances exist. Not covered when pacemaker implantation is deemed routine and not medically justified. Not covered for conditions that are transient. Single-chamber pacemakers are not covered for conditions unsupported by adequate evidence of benefit. A/B MACs should review claims for unsupported indications for further claims development prior to denial. Claims may be denied for sinus bradycardia without significant symptoms. Prolonged P-R intervals with atrial fibrillation or bradycardia during sleep are not medically necessary. Single-chamber cardiac pacing is nationally non-covered for indications not specifically listed by CMS, except for investigational clinical trials per section 310.1. Not covered for patients with ineffective atrial contractions, such as those with chronic atrial fibrillation or flutter, or a giant left atrium. Not covered when pacing is only intermittently needed and does not have a reasonable likelihood of prolonged pacing requirements. Non-covered for all other indications not specified by CMS. Guidelines are not applicable to mercury-zinc battery-powered pacemakers, which are no longer manufactured. Claims for monitoring mercury-zinc units must follow guidelines published in 1980 until they are replaced. Dual-chamber units programmed solely for ventricular pacing should be treated as a single-chamber unit for screening guidelines. Monitoring by entities other than the patient's physician requires a physician's prescription that should be renewed at least annually. Monitoring is not covered if there are no indications of cardiac arrhythmias. Not covered if monitoring does not detect subclinical pacemaker failure. Excluded when the monitoring method does not meet established standards for efficacy. The transmitting device furnished to the patient is not covered as durable medical equipment. Payment may only be made for monitorings within a specified maximum frequency. Claims may require written justification for any frequency exceeding the established maximum. Pacemaker systems not meeting ICHD standards are not covered. Guideline II applies only to systems with sufficient long-term clinical information. Changes in monitoring frequency should be based on individual patient conditions and not standardized. Monitoring frequency is limited to specified intervals based on the time since implantation. Services rendered by a pacemaker clinic are more extensive than those possible by telephone. Concurrent use of different monitoring types is permitted. No specific limitations outlined in the document. Use of this device does not involve professional services until certain conditions are met. Regular outpatient evaluations are necessary if the pacemaker monitor is utilized. No professional services are involved until an alteration in monitoring signals occurs. Not covered for patients who do not exhibit symptomatic bradycardia. Devices are excluded for those with conditions where pacing may not provide clinical benefit. Not covered for patients who are asymptomatic. No coverage if bradycardia is treated without clear clinical necessity. Coverage is not guaranteed for indications not addressed in this national coverage. Not covered for patients who do not need ventricular pacing. Coverage is limited to procedures conducted in studies approved by CMS. Studies must address specific research questions regarding complications, long-term outcomes, and patient characteristics. Studies primarily testing toxicity or disease pathophysiology in healthy individuals are not covered unless they meet certain regulatory requirements. Inclusion and exclusion criteria must be clearly defined to ensure diverse enrollment. Studies not addressing recruitment or retention of underrepresented populations may be limited. The principal investigator must identify relevant CMS research questions that will be addressed. Leadless pacemakers are non-covered when furnished outside of a CMS approved CED study. VADs are not covered if not FDA approved for post-cardiotomy use. Not covered if the team lacks required members including a seasoned physician with cardiothoracic surgery privileges. All other indications for VADs not explicitly listed are non-covered. VADs are not covered unless defined within investigational clinical trial protocols. Not covered for right ventricular support, biventricular support, or in beneficiaries under 18. Not covered for complex congenital heart disease or acute heart failure without chronic heart failure history. Coverage is not applicable to patients who are candidates for heart transplantation. Excludes patients who do not meet specified medical and functional criteria. Facilities must comply with specific criteria as determined by a credentialing organization by the transition period's conclusion. Not covered for right ventricular support, biventricular support, patients under 18, patients with complex congenital heart disease or acute heart failure without a history of chronic heart failure. Coverage decisions for these situations will be made by local A/B MACs. Maximum number of program sessions is defined by Medicare regulations. Any cardiac indication not specifically covered in 42 CFR § 410.49(b)(1)(vii) is considered non-covered. Intraoperative ventricular mapping may not be covered for procedures that do not require direct mapping of cardiac electrical activity. No separate charge will be recognized for the His Bundle cardiogram. Only one catheterization will be covered when performed simultaneously with the HIS Bundle Study. No separate charge will be recognized for the His bundle study if obtained as part of a diagnostic endocardial electrical stimulation. Unsuitable for routine use in the physician's office. Procedures in Category II are considered experimental and are not covered. Claims will be denied for noncovered procedures or lack of medical indication for plethysmographic evaluation. Inductance Plethysmography is considered experimental and does not provide reproducible results. Capacitance Plethysmography is considered experimental and does not provide reproducible results. Mechanical Oscillometry is nonstandardized and offers poor sensitivity, not superior to peripheral blood pressure measurements. Photoelectric Plethysmography only determines pulse presence and does not provide reproducible measurements of blood flow. Not covered when quantitative measurements of blood flow are not made. Conditions under which this test does not meet the definition of plethysmography are unclear. Reimbursement for studies done by techniques other than venous occlusive pneumoplethysmography should be denied until additional data becomes available. No coverage for EKG services when rendered as a screening test or during routine examinations. EKGs are only covered when performed as part of the one-time 'Welcome to Medicare' preventive physical examination. Monitoring longer than 24 hours requires documentation of medical necessity. The recording device is not covered as durable medical equipment separate from the diagnostic service. Not covered if the services are conducted without physician oversight. 24-hour attended monitoring services are required for transmitted EKG data review. Time sampling mode of operation is not covered under ambulatory EKG monitoring technology. Devices requiring patient to dial a number for transmission of EKG data must have this capability to be considered covered. Not covered when devices are used inappropriately or without medical necessity. Excluded for routine monitoring without clinical indications. Not covered for conditions unrelated to cardiac syncope. Exclusion of coverage for the use of loop recorders in patients without symptomatic events. Not covered for devices that do not include a memory loop. Coverage duration is limited to 30 days. Separate physician services for EKGs are not covered unless they are the patient's attending or consulting physician. Not covered when the emergency EKG does not involve physician attendance. Coverage is limited to amounts payable with respect to the physician's service. Certain uses outside specified indications may only be covered if deemed medically necessary by the local A/B MAC. Devices must meet specified criteria for transmitting EKG Leads to be covered. This coverage is not provided for taping devices as a substitute for an EKG technician. Indications are nationally non-covered unless otherwise specified. Services provided by a portable x-ray supplier are not covered without a physician in attendance at the time of service or immediately thereafter. Home EKG services are not covered without documentation of medical necessity. Separate physician services are not typically covered unless rendered by the patient's attending or consulting physician. Coverage is subject to local A/B MAC discretion if no specific NCD exists for the device or service. Marketed FDA-approved ambulatory cardiac monitoring devices not fitting into the framework are not covered. The use of TEB was deemed not medically necessary under reconsideration. TEB is non-covered for patients with severe aortic regurgitation. TEB is non-covered for patients with minute ventilation sensor function pacemakers. TEB is non-covered during cardiac bypass surgery. TEB is non-covered for managing all forms of hypertension, except for drug-resistant hypertension. All other uses of TEB not otherwise specified remain non-covered. The names of tests are not standardized, and local medical consultants should make determinations. The provided list of tests is not inclusive. All carotid body resections to relieve pulmonary symptoms, including asthma, are considered investigational and not reasonable and necessary. No reimbursement will be made for carotid body resections performed for pulmonary symptom relief. Denervation of the carotid sinus is rarely performed and should be carefully evaluated on a case-by-case basis. ABPM is not covered for patients without suspected white coat hypertension. Coverage is contingent upon all specified criteria being met. ABPM is not covered for any uses other than determining appropriate management. Subsequent ABPM tests require the same qualifying criteria to be met. Not covered for treatments of cardiac conditions other than stable angina pectoris. Non-coverage of hydraulic versions of ECP devices remains in force. Not covered for treatments not conforming to the specified 35 one-hour sessions. Not covered if therapy is not synchronized with the patient's cardiac cycle. Not covered for conditions where vascular compression is not indicated or effective. All other cardiac conditions not otherwise specified for the use of ECP remain nationally non-covered. EDTA chelation therapy for the treatment or prevention of atherosclerosis is considered experimental and is not covered. Claims referring to alternative diagnoses related to atherosclerosis will also be denied. EDTA Chelation Therapy is not covered for indications outside of atherosclerosis or when not medically necessary. The use of EDTA as a chelating agent to treat atherosclerosis, arteriosclerosis, calcinosis, or similar conditions not listed by the FDA is not covered and considered experimental. Fabric wrapping of abdominal aneurysms is not covered. Fabric wrapping of abdominal aneurysms is not covered as it has not been shown to prevent eventual rupture. External wall reinforcement is not covered unless excision of the aneurysm and reconstruction with synthetic materials is not viable. Photokymography remains excluded from coverage. Not covered. Partial ventriculectomy is not covered by Medicare due to high mortality rates and lack of scientific evidence to support its necessity. Not covered due to being considered investigational pending additional data on clinical efficacy and value as a diagnostic tool. Reimbursement limited to therapy administered in a chamber, including single-person units. Not covered for conditions not listed in the specified indications. Not indicated for primary management of wounds. HBO therapy should only be used in conjunction with standard therapeutic measures. Patient must have failed an adequate course of standard wound therapy. HBO therapy is not covered if measurable signs of healing occur during treatment. Wounds must be evaluated every 30 days during HBO therapy. Healing has not been demonstrated within any 30-day period of treatment. No coverage for HBO in the treatment of cutaneous, decubitus, and stasis ulcers. No coverage for chronic peripheral vascular insufficiency. No coverage for anaerobic septicemia and infections other than clostridial. No coverage for skin burns (thermal). No coverage for senility. No coverage for myocardial infarction. No coverage for cardiogenic shock. No coverage for sickle cell anemia. No coverage for acute thermal and chemical pulmonary damage. No coverage for acute or chronic cerebral vascular insufficiency. No coverage for hepatic necrosis. No coverage for aerobic septicemia. No coverage for nonvascular causes of chronic brain syndrome (e.g., Pick's, Alzheimer's, Korsakoff diseases). No coverage for tetanus. No coverage for systemic aerobic infection. No coverage for organ transplantation and organ storage. Topical application of oxygen is not covered as per previous NCD criteria. Prior determinations of coverage for specific conditions may vary by MAC. Coverage determination is at the discretion of A/B MACs within their jurisdictions. Services must be peer-reviewed in published research to be covered. Not covered if the program does not demonstrate expected outcomes as defined by the legislation. Medications must be approved through the national coverage determination process. Not covered for patients who are not medically cleared for the program. Limitations on frequency and duration based on individual patient assessments. Non-covered if the specific ICR program is not included on the list of approved Medicare programs. Specific ICR programs not included on the list as a Medicare-approved ICR program are non-covered. Specific ICR programs not included on the approved list are not covered. Not covered for patients with specific contraindications for the procedure. Excluded for patients with severe comorbidities that significantly increase risks. TAVR is only covered when the procedure adheres to FDA-approved indications. Patients must be evaluated by the heart team's interventional cardiologist and cardiac surgeon. TAVR is limited to hospitals with appropriate infrastructure for the procedure. Not covered if the hospital lacks appropriate procedures for post-procedure intensive care. TAVR programs must maintain a minimum of ≥ 2 physicians with cardiac surgery privileges. Only hospitals with appropriate personnel qualifications, including the presence of specific trained physicians, will be eligible. Coverage is contingent on participation in a national audit registry that tracks patient outcomes including stroke for at least one year. The registry must comply with regulations related to the protection of human research subjects. Coverage may be contingent upon outcomes compared to pivotal clinical studies when performed outside a controlled clinical study. Long-term outcomes must be assessed to determine continued coverage. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR. Study results must not duplicate existing knowledge. Design must be methodologically appropriate with sufficient subjects. Results must be reported, including negative outcomes or early termination. Protocols must justify inclusion and exclusion criteria that may negatively impact recruitment of underrepresented populations. Coverage is limited to approved studies identified on the CMS website. TAVR is not covered for patients with existing co-morbidities that preclude the expected benefit from correction of aortic stenosis. Procedure must use a mitral valve TEER system that has received FDA premarket approval. Not applicable to non-board-certified providers without advanced training. Other physicians and advanced practitioners may participate but have limited roles. Patient evaluations must be documented and made available to heart team members. The heart team heart failure cardiologist may evaluate the patient through medical record review if a relationship with an experienced cardiologist is established. The interventional echocardiographer may not furnish anesthesiology during the same procedure. All participating physicians must have device-specific training as required by the manufacturer. Hospital must maintain at least 20 mitral valve surgical procedures for severe MR per year or at least 40 over two years. At least 10 (or 20 over two years) must be mitral valve repairs. Must have ≥ 2 physicians with cardiac surgery privileges experienced in valvular surgery. Must have ≥ 1 physician with interventional cardiology privileges. Must perform ≥ 300 percutaneous coronary interventions (PCIs) per year. Outcomes must be tracked for at least one year, including all-cause mortality and major vascular events. Outcomes and adverse events must be compared to pivotal clinical studies when performed outside of controlled clinical studies. An interventional echocardiographer cannot provide anesthesiology during the procedure. TEER is not covered for patients who are not symptomatic or have mild mitral regurgitation. Procedures for patients with contraindications to anticoagulation therapy are not covered. Studies designed exclusively to test toxicity or disease pathophysiology in healthy individuals are not covered unless meeting specific criteria. Protocols must justify any inclusion and exclusion criteria that may negatively affect the recruitment or retention of underrepresented populations. Not covered for patients with existing co-morbidities that preclude expected benefit from a mitral valve TEER procedure. Not covered in patients with untreated severe aortic stenosis. LAAC is not covered unless all specified conditions are met. Patients must not have contraindications to LAAC. LAAC is only covered as a second-line therapy to oral anticoagulants. The procedure must be performed in hospitals with a structural heart disease or electrophysiology program. Not covered if the operator has performed less than 25 interventional cardiac procedures involving transeptal puncture. Not covered outside the specified national registry participation and outcomes tracking. Registry documentation must be approved by CMS for data collection. Claims must include the registry's national clinical trial number. Coverage is limited to patients included in approved clinical research studies. FDA-approved RCTs must be reviewed and approved by CMS. Study results should not unjustifiably duplicate existing knowledge. Not covered if the study does not comply with Federal regulations regarding human subject protection. Studies must be conducted according to appropriate standards of scientific integrity. Studies that only test toxicity or pathophysiology in healthy individuals do not meet the criteria. Nationally non-covered indications are specified based on the study protocol. LAAC is non-covered for the treatment of NVAF when not furnished under CED. SET is limited to up to 36 sessions over a 12-week period. Sessions must last between 30-60 minutes and be conducted in a physician's office. SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician. Coverage for SET beyond 36 sessions requires Medicare Administrative Contractor discretion and a second referral. No coverage for therapeutic sessions exceeding the limits without proper approval. Biofeedback therapy is not covered for the treatment of ordinary muscle tension states. Not covered for psychosomatic conditions. Coverage is limited to therapy rendered in an office or other facility setting. Services performed by non-practitioners are not covered. Home use of biofeedback therapy is not covered. Contractors may decide whether to cover biofeedback as an initial treatment modality. Thermogenic therapy is not reasonable and necessary for the treatment of any illness or injury. Payment will not be excluded for inpatient stay where other covered services are needed, despite non-coverage for thermogenic therapy. All indications for acupuncture outside of NCD section 30.3.3 remain non-covered. Medicare reimbursement for acupuncture as an anesthetic, analgesic, or for other therapeutic purposes is not provided unless a specific indication is excepted. Acupuncture is not considered reasonable and necessary for the treatment of fibromyalgia. There is no convincing evidence for the use of acupuncture for pain relief in patients with fibromyalgia. N/A for acupuncture for osteoarthritis. Acupuncture is not covered for pain relief in patients with osteoarthritis. There is no convincing evidence supporting acupuncture's efficacy for improving health outcomes in this context. Coverage is limited to services performed on or after January 21, 2020. No more than 12 acupuncture visits in a 90-day period are covered. No more than 20 acupuncture treatments may be administered annually. Acupuncture treatment must be discontinued if the patient is not improving or is regressing. All types of acupuncture including dry needling are non-covered by Medicare for any condition other than chronic lower back pain (cLBP). Electrosleep Therapy has no national coverage determination and will be covered by contractors under specific conditions if applicable. Transcendental Meditation is not covered. Coverage is not established due to incomplete evidence demonstrating medical efficacy. Professional skill is not required for training patients in Transcendental Meditation techniques. Histamine is not covered for treatment; only for diagnostic purposes. No coverage for training patients in the use of TM related to hypertension and anxiety. Histamine therapy is not covered due to lack of scientific evidence supporting its effectiveness. Laetrile and related substances are not covered as they are primarily used for cancer treatment without established effectiveness. Use of laetrile is not covered as it is not recognized as safe or effective for therapeutic use. Hospital stays solely for the administration of laetrile are not covered. Laetrile use during an otherwise covered hospital stay is also not covered. Cellular therapy is not considered reasonable and necessary due to lack of scientific evidence and safety concerns. Transillumination light scanning, or diaphanography, for breast cancer detection is not covered due to insufficient evidence of its usefulness. Further studies are required to determine the role of this technology in breast cancer diagnosis. Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for home use due to the need for frequent professional re-calibration. Lancets, reagent strips, and other supplies are covered only for patients for whom the device is indicated and used properly. Cost and supply limitations restrict coverage to patients who must use these devices regularly. Coverage is limited to devices designed for home use only. Claims for special devices must be separately identified for reimbursement. Not covered for long-term management or outpatient use. Not indicated for patients without insulin-dependent diabetes mellitus. Use of the CBGCD is generally limited to a 24- to 48-hour period due to potential complications. Requires continuous observation by specially trained medical personnel. Insulin syringes used by diabetics themselves are not covered under Medicare. Not specified. OIVIT is not reasonable and necessary for any indication under section 1862(a)(1)(A) of the Social Security Act. Services comprising an OIVIT regimen are nationally non-covered under Medicare when furnished pursuant to an OIVIT regimen. Coverage does not pertain to OIVIT uses outside specified Medicare guidelines. Consult specific sections of the NCD Manual and Claims Processing Manual for related guidelines. Devices are not covered if primarily for use with audible/verbal speech output. Computers and tablets are not considered DME as they are useful in the absence of illness or injury. Internet or phone services to modify a patient's home for speech generating device use are not covered. Features not necessary for generating audible/verbal speech, including non-medical functions like creating documents or playing games, are excluded from coverage. Features of speech generating devices are not covered under Medicare, and costs are the responsibility of the beneficiary. Coverage discretion lies with A/B MACs based on their reasonable and necessary determinations. Patients not meeting all coverage criteria are not eligible for Medicare coverage. Non-covered indications include any failure to satisfy criteria for cochlear implantation. Cochlear implants are not covered for beneficiaries not meeting other specified criteria outside approved trials. Oxygen and carbon dioxide inhalation therapy for inner ear disease is not covered as it is not deemed reasonable and necessary. Cochleostomy with neurovascular transplant is not covered for treatment of Meniere’s disease due to lack of scientific evidence supporting its safety and effectiveness. Procedure generally done under local anesthesia and requires skilled personnel. Not covered when treatment is not for severe and recurrent episodes of vertigo. Part B reimbursement for consultations with relatives is subject to special limitations on payments for services related to mental, psychoneurotic, and personality disorders when the beneficiary is not an inpatient. Counseling focused solely on the effects of the patient's condition on the individual being interviewed is not covered. Services may only be covered when they relate primarily to the management of the patient's problems. Payment for the treatment of flat foot conditions, subluxations of the foot, and routine foot care is excluded per Section 1862(a)(13). Routine consultations for screening purposes not associated with specific foot ailments are generally not covered. Excludes payment for routine physical checkups. Services are not covered more frequently than every six months. LOPS must be diagnosed through sensory testing with the 5.07 monofilament. Services performed outside the designated office area are subject to different coverage rules applicable to services outside the office setting. Services provided in a facility owned by the physician are not covered if they are not part of common office practices. Reimbursement is denied for auxiliary medical personnel unless they are members of the physician's practice. Claims may be denied if the services do not meet the requirements set forth by the Social Security Act. Not covered when the test is performed under standing orders of a physician for his patients. Consult with Quality Improvement Organizations (QIOs) if prior admissions justifying the necessity of the test are not documented. Payment for the lens is included in the payment for the physician's service to which the lens is incident. A/B MACs are authorized to accept an FDA letter of approval as evidence of FDA approval. OPT is not covered unless used with verteporfin. OPT is not covered for patients with occult subfoveal CNV lesions in the context of age-related macular degeneration. Use of OPT with verteporfin for minimally classic CNV lesions, atrophic, or dry AMD is non-covered. OPT with verteporfin is not covered for pathologic myopia or presumed ocular histoplasmosis syndrome, unless specified by individual A/B MAC. CMS has determined that OPT with verteporfin for these patients remains non-covered. Lesions must be small (4 disk areas or less) at the time of initial treatment or within the 3 months prior. Evident progression within the 3 months prior to treatment must be documented. Use of OPT with verteporfin for juxtafoveal or extrafoveal CNV lesions, inability to obtain a fluorescein angiogram, and atrophic or 'dry' AMD is non-covered. Treatment is not covered if the drugs are not used in accordance with specified protocols. Subsequent follow-up visits require documentation of treatment response through either optical coherence tomography or FA. Verteporfin is not covered for indications other than the specified type of neovascular AMD. Will remain non-covered for all other indications related to AMD. Verteporfin is not covered unless used in conjunction with ocular photodynamic therapy (OPT). No requirements regarding visual acuity, lesion size, and number of retreatments when treating predominantly classic lesions. Nationally non-covered indications were stated but not elaborated. Non-covered uses include juxtafoveal or extrafoveal CNV lesions, inability to obtain an FA, or atrophic 'dry' AMD. Hydrophilic contact lenses are not covered for non-diseased eyes with spherical ametropia, refractive astigmatism, or corneal astigmatism. Hydrophilic contact lenses are excluded under §1862(a)(7) of the Social Security Act. Payment is made under §1861(s)(8) of the Act only in specific cases. Not covered for cosmetic purposes or in eyes that are not rendered sightless. Coverage is limited to rare cases of dry eye where tears are rapidly depleted due to lacrimal gland failure. Refractive keratoplasty is not covered under this policy. Correction of common refractive errors by eyeglasses, contact lenses or other prosthetic devices is specifically excluded from coverage. The use of radial keratotomy is also limited. Radial keratotomy and keratoplasty to treat refractive defects are not covered as they are considered alternatives to glasses or contacts and may be seen as cosmetic surgery. Procedures deemed cosmetic are excluded under the Act. Coverage restricted to practitioners who have completed an approved training program in ophthalmologic surgery. Endothelial cell photography is not covered as an additional service if performed in conjunction with the presurgical examination. Not covered if the patient does not meet the clinical indications for treatment. Limitation on the frequency of procedure based on clinical necessity. Not covered for patients without a documented history of arrhythmias. Usage is limited to specific patient populations as detailed in the NCD. Not covered for patients who are not at risk of sudden cardiac death. Testing is not covered when performed for non-medically necessary reasons. Not covered for patients with occult choroidal neovascularization without classic component. Exclusions apply for patients with macular edema secondary to diabetic retinopathy. Cochlear implantation is not covered for individuals who have contraindications for the procedure.

Clinical documentation must support the medical necessity of procedures performed. Prior authorization may be required for specific pain management programs. Clinical documentation supporting necessity for surgery. Preoperative and postoperative evaluations must be included. Clinical documentation that shows medical necessity for services provided. Prior authorization may be required before service initiation. Clinical documentation supporting the medical necessity of the procedure. Evidence of prior treatment failure for non-invasive therapies when applicable. Prior authorization required with clinical documentation supporting device necessity Medical records must include audiological evaluations and treatment plans Documentation supporting medical necessity for procedures. Clinical notes detailing prior treatments and patient history. Preoperative tests include a comprehensive eye examination and scan results. Medical necessity for additional tests must be fully documented. Documentation of patient participation in the coordinated pain rehabilitation program. Clinical notes detailing the treatment modalities used. Ongoing assessment of patient condition and response is required. Clinical evidence supporting the necessity for a hospital level of care Documentation to confirm that diagnostic tests are not duplicative Documentation to determine the necessity of extended inpatient care. Clinical evaluation results from the initial evaluation period. Adequate documentation of medical necessity must be provided. Radiographic evidence of vertebral artery obstruction must be provided. Clinical evidence ruling out other causes of symptoms must be documented. Claims must include specific identification of the obstruction in question. Details regarding the surgical procedure performed are required for coverage evaluation. Clinical documentation supporting admission for TDD. Approval confirmation for kidney transplantation. Formal shared decision making encounter must occur between the patient and a physician or qualified non-physician practitioner. Use of an evidence-based decision tool on ICDs prior to initial ICD implantation. Evidence of a formal shared decision-making encounter with a qualified practitioner. Clinical documentation supporting the indication of ICD implantation. Documentation of the shared decision-making encounter must be provided. Evidence of shared decision making using an evidence-based decision tool on ICDs prior to initial implantation. Clinical documentation confirming patient stability and LVEF measurement. Clinical documentation demonstrating failure of conventional treatment options. Patient history indicating severe angina symptoms. Diagnostic studies demonstrating viable ischemic myocardium. Clinical documentation supporting the ejection fraction and stabilization of conditions. Documentation of training for all personnel including physicians and nurses is required. Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after CAS. Duplex ultrasound must be performed as the first-line evaluation. Clinical documentation of patient comorbidities and concomitant treatments must be provided. Patient's personal preferences and clinical considerations must be documented. Documentation of physician qualifications using published standards from specialty societies. Documentation of participation in FDA-approved protocols for Category B IDE clinical trials is required. Clinical notes demonstrating the need for permanent cardiac pacing. Evidence of symptomatic bradycardia or arrhythmias outlined in indications. Documentation must establish a correlation between symptoms and bradycardia or attribute symptoms to bradycardia rather than other causes. Documentation of bradycardia symptoms is required. Medical necessity must be sufficiently justified through adequate claims development. Frequency data must be included for both clinic visits and transtelephonic monitoring. Clinical documentation showing the need for monitoring due to arrhythmia. Clinical notes supporting the necessity of transtelephonic monitoring. Evidence of prior pacemaker issues requiring monitoring. Written justification from the patient's physician for more frequent monitorings. Documentation from any involved monitoring service. Clinical information demonstrating compliance with ICHD longevity and decay standards. Documentation of any changes in the patient's monitoring prescription. A physician must prescribe self-contained pacemaker monitors to qualify for rental or purchase payment. Documentation of medical necessity for pacemaker evaluation in an outpatient setting. Clinical documentation must support the need for cardiac pacing. Records of previous treatment and test results related to patient's heart condition are required. Clinical evaluation indicating bradycardia is symptomatic if treatment is proposed. Test results showing the nature of bradycardia before coverage approval. Clinical documentation supporting the need for a leadless pacemaker. Each study must be fully described in a written protocol. A written protocol demonstrating adherence to Medicare requirements. Evidence of compliance with standards of scientific integrity. Research studies and registries must be registered on ClinicalTrials.gov and AHRQ's Registry prior to subject enrollment. Public release of prespecified outcomes within 12 months of study completion Results must include number of participants, summary results, statistical analyses, and adverse events A plan for retention and reporting of underrepresented populations in the trial. Protocol must discuss generalizability to affected beneficiary subpopulations. Complete study protocol submission required for review. Must include a statement on scientific integrity standards. Documentation must confirm the participation of all required team members, including experience in managing VAD patients. Clinical documentation showing failure to respond to optimal medical management. Test results confirming LVEF and peak oxygen consumption levels. All team members must have experience working with patients before and after VAD placement. Documentation must align with the standards set forth in 42CFR410.49 regarding physician supervision. Documentation of the specific cardiac surgery being performed and the clinical indication for the use of intraoperative ventricular mapping. Intracardiac electrode catheters and recordings must be documented. Documentation of medical necessity for monitoring longer than 24 hours. Clinical notes indicating the use of event monitor technology and symptoms. Documentation of any telephonic transmission or monitoring conducted. Documentation of EKG data must be retained and reviewed by the receiving center. Clinical justification for the use of the cardiac event monitor. Evidence of patient-specific criteria for device programming. Clinical evidence demonstrating the need for an MLR or an ILR based on symptom frequency. Medical records must include EKG data supporting the use of the chosen recording device. Documentation of symptoms prompting EKG recording. Evidence that no other monitoring options are viable. Documentation of medical necessity is required for home EKG services. Document that an EKG technician is present and has access to a physician. Include emergency contact procedures for assisting patients in emergencies. Medical necessity must be documented should a biopsy be performed after TEB. Clinical assessments and hemodynamic data must be provided for adequate patient management. Clinical documentation of office and out-of-office blood pressure measurements. Records must demonstrate compliance with the defined criteria for suspected white coat hypertension. Documentation by a cardiologist or cardiothoracic surgeon stating the patient's surgical candidacy status. Clinical notes detailing patient eligibility for therapy. Documentation of treatment frequency and duration. Procedure must be performed under the direct supervision of a physician. Clinical documentation supporting the diagnosis of atherosclerosis and the appropriateness of EDTA therapy. Documentation of lack of measurable healing after 30 days of standard wound care. Evaluation notes at least every 30 days during HBO therapy. Documented evidence from peer-reviewed research supporting program efficacy. Clinical data showing pre- and post-rehabilitation health measures. Necessary documentation demonstrating medical necessity for the medications. Medical records indicating patient's medical conditions requiring dietary intervention. Progress notes showing prior attempts at weight loss or dietary modification. Clinical documentation supporting the diagnosis of aortic stenosis. Assessment results confirming the patient’s suitability for TAVR. Documentation of the complete aortic valve and implantation system that received FDA premarket approval. Evidence of a cohesive multi-disciplinary heart team involved in patient care. Documentation must include a face-to-face evaluation by a cardiac surgeon and an interventional cardiologist. Rationale for clinical judgment must be recorded and accessible to the heart team. Documentation of personnel experience in managing open-heart valve procedures. Documentation of the number of surgeries performed by the facility in the past year must be maintained. Records confirming the qualifications and training of the heart team members are required. Documentation of participation in relevant national auditing registries. Clinical data necessary to track patient outcomes as stipulated by the requirements of the registry. A written executable analysis plan must address defined CED questions. Data collection on long-term durability and adverse events is required. The clinical research study must critically evaluate each patient's quality of life pre- and post-TAVR for a minimum of 1 year. Results of the study must be documented and supported. Sponsorship by capable organization or individual is required. Must provide and obtain meaningful informed consent from patients regarding risks associated with the study and data disposition. Study must have a written protocol demonstrating adherence to Medicare requirements. Registration of studies on ClinicalTrials.gov before enrollment. Study results must include number started/completed, summary results for primary and secondary outcomes, statistical analyses, and adverse events. Discussion of how results are expected to be generalizable to affected beneficiary subpopulations. Complete study protocol must be submitted. Statement addressing satisfaction of the standards of scientific integrity. Proof of the cardiac surgeon's surgical experience and board certification. Proof of the interventional cardiologist's procedural experience and board certification. Clinical documentation confirming professional experience and training. Documentation of evaluations by the heart team interventional cardiologist and heart team heart failure cardiologist is required. Evaluation must include a face-to-face examination and relevant medical record information. Documentation of hospital volume requirements for mitral valve surgical procedures. Clinical credentials of physicians involved in the procedures. Compliance with 45 CFR Part 46 and 21 CFR Parts 50 & 56 regarding human research subjects. Design documentation permitting identification and analysis of patient and practitioner variables. Reports on outcomes, adverse events, and demographics of registry patients must be provided. The clinical research trial protocol must evaluate specific questions with 12 months or longer follow-up. Clinical documentation demonstrating symptomatic mitral regurgitation must be provided. Records indicating previous treatments and their outcomes must be submitted. Must provide meaningful informed consent from patients regarding risks and data use. Written protocol demonstrating adherence to Medicare requirements is required. Research studies must be registered on www.ClinicalTrials.gov prior to participant enrollment. Results must be made public within 12 months of study's primary completion date. Results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Protocols must discuss generalizability of results to affected beneficiary subpopulations, including those eligible for Medicare due to age, disability, or Medicaid eligibility. Complete study protocol submission as per specified standards Identification of relevant CMS research questions addressed by the study Documentation of the shared decision-making interaction in the medical record. Care must be coordinated by a multidisciplinary team preoperatively and postoperatively. Clinical documentation of LAAC procedure and participation in the national registry. Annual outcome tracking for each patient for a minimum of 4 years. Registry documentation including the written executable analysis plan and auditing plan must be submitted for CMS approval. Medicare claims must include the national clinical trial number. RCT protocol must include endpoints measuring incidence of ischemic stroke and systemic embolism. The principal investigator must submit the complete study protocol and identify the relevant CMS research question(s). Analysis plan addressing scientific integrity standards. Investigator's contact information must be provided. Informed consent must be obtained from patients regarding risks associated with study items and services. Documentation must demonstrate compliance with applicable Federal regulations. Clinical research studies and registries must be registered on www.ClinicalTrials.gov before subject enrollment. Study protocol must discuss beneficiary subpopulations affected by the item or service. Details on inclusion and exclusion criteria affecting recruitment must be provided. Discussion on generalizability of results to beneficiary subpopulations is required. Documentation of participation in a SET program comprising qualified personnel and physician supervision. Refer to clinical notes confirming the face-to-face visit with the physician. Referral documentation for additional SET sessions. Documented trial of pelvic muscle exercise training showing no clinically significant improvement in urinary incontinence after four weeks. Documentation of the patient's improvement must be provided to continue treatment. Documentation must demonstrate compliance with state requirements and supervision is required for auxiliary personnel. Documentation of the patient's diabetes management plan and clinical need for blood glucose monitoring devices. Documentation from the patient's physician confirming the diagnosis and training capability. Physician certification of visual impairment. Clinical documentation indicating the need for short-term use. Records of blood glucose monitoring and patient condition during hospitalization. Specialized training for interpretation of the CBGCD's diagnostic and therapeutic contribution is required. Documentation must include evidence of the emergency situation necessitating the use of insulin. Clinical records of patient’s routine diabetic management. Documentation of the frequency and method of insulin administration. Suppliers are encouraged to provide a voluntary Advance Beneficiary Notice (ABN) to inform beneficiaries that certain features are not covered. Documentation must support participation in designated clinical trials as per regulations. Clinical documentation detailing the severity of vertigo episodes. Evidence that previous treatments were unsuccessful. Interviews and communications with a patient's relatives must be documented as physician's services. Documentation of the diagnosis of diabetic sensory neuropathy. Sensory testing results using the 5.07 monofilament at five sites on each foot. Documentation of sensation testing results using the 5.07 Semmes-Weinstein monofilament. Patient history and physical examination documentation required. Diagnosis of diabetic sensory neuropathy with LOPS must be established and documented. Documentation must show that supervision of auxiliary personnel entails a personal professional service to the patient. Claims must include documentation demonstrating the necessity of services rendered. An FDA letter of approval or other FDA published material. Fluorescein angiogram results for initial visit. Optical coherence tomography or fluorescein angiogram required for subsequent follow-ups to assess treatment response. Fluorescein angiogram (FA) must confirm presence of classic CNV lesions. Initial diagnosis confirmed by fluorescein angiography (FA) or optical coherence tomography (OCT) for treatment response assessment. Evidence of deterioration of visual acuity (at least 5 letters on standard eye chart). Documentation of lesion growth (increase of at least 1 disk area) or appearance of blood associated with the lesion. Clinical documentation must demonstrate the appropriateness of photodynamic therapy for the treatment of the diagnosed condition. Clinical documentation supporting neovascular AMD diagnosis. Fluorescein angiogram or other imaging results to assess treatment response. Clinical documentation of diagnosis and procedure performed. Fluorescein angiogram (FA) to confirm diagnosis at initial visit. Follow-up visits require either optical coherence tomography or FA to assess treatment response. Documentation of visual acuity change and lesion progression. A/B MACs may accept FDA approval letters or other FDA-published material as evidence of approval. Clinical documentation supporting the need for PTA and stenting. Pre-operative imaging and risk assessments must be included. Clinical documentation must support the diagnosis of arrhythmias. Prior authorization may be required based on patient condition. Clinical documentation confirming the patient's history of myocardial infarction. Prior authorization is required to verify test necessity. Clinical documentation must show diagnosis of age-related macular degeneration. Pre-treatment visual acuity and neovascularization characteristics must be recorded. Clinical evaluation must include audiologic assessment and medical examination results.