Medicare Claims Processing Manual

=== Page 1 === # Medicare Claims Processing Manual ## Chapter 32 – Billing Requirements for Special Services Table of Contents ## Transmittals for Chapter 32 10- Diagnostic Blood Pressure Monitoring 10.1 - Ambulatory Blood Pressure Monitoring (ABPM) Billing Requirements 11 - Wound Treatments 11.1 – Electrical Stimulation 11.2 – Electromagnetic Therapy 11.3 – Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds 11.3.1 – Policy 11.3.2 – Healthcare Common Procedure Coding System (HCPCS) Codes and Diagnosis Coding 11.3.3 – Types of Bill (TOB) 11.3.5 – Place of Service (POS) for Professional Claims 11.3.6 – Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs) and Group Codes 12 - Counseling to Prevent Tobacco Use 12.1 – Counseling to Prevent Tobacco Use HCPCS and Diagnosis Coding 12.2 – Counseling to Prevent Tobacco Use A/B MAC (B) Billing Requirements 12.3 – A/B MAC (A) Billing Requirements 12.4 – Remittance Advice (RA) Notices 12.5 – Medicare Summary Notices (MSNs) 12.6 – Post-Payment Review for Counseling To Prevent Tobacco Use Services 12.7 – Common Working File (CWF) Inquiry 12.8 – Provider Access to Counseling To Prevent Tobacco Use Services Eligibility Data 20 – Billing Requirements for Coverage of Kidney Disease Patient Education Services 20.1 – Additional Billing Requirements Applicable to Claims Submitted to Fiscal Intermediaries (FIs) 20.2 – Healthcare Common Procedure Coding System (HCPCS) Procedure Codes and Applicable Diagnosis Codes 20.3 – Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes (CARCs) 20.4 – Advance Beneficiary Notice (ABN) Information 30 – Hyperbaric Oxygen (HBO) Therapy 30.1 – Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities === Page 2 === 30.2 Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen) 40 – Sacral Nerve Stimulation 40.1 – Coverage Requirements 40.2 – Billing Requirements 40.2.1 – Healthcare Common Procedural Coding System (HCPCS) 40.2.3 – Payment Requirements for Device Codes A4290, E0752 and E0756 40.2.4 – Payment Requirements for Codes C1767, C1778, C1820, C1883 and C1897 40.3 – Bill Types 40.4 – Revenue Codes 40.5 – Claims Editing 50 – Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease 50.1 – Coverage Requirements 50.2 – Billing Requirements 50.2.1 – Part A Intermediary Billing Procedures 50.3 – Payment Requirements 50.3.1 – Part A Payment Methods 50.3.2 – Bill Types 50.3.3 – Revenue Codes 50.4 – Allowable Codes 50.4.1 – Allowable Covered Diagnosis Codes 50.4.2 – Allowable Covered Procedure Codes 50.4.3 – Healthcare Common Procedure Coding System (HCPCS) 50.5 – Ambulatory Surgical Centers 50.6 – Claims Editing for Intermediaries 50.7 – Remittance Advice Notice for A/B MACs (A) 50.8 – Medicare Summary Notices (MSN) Messages for Intermediaries 50.9 – Provider Notification 60 – Coverage and Billing for Home Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management 60.1 – Coverage Requirements 60.2 – Intermediary Payment Requirements 60.2.1 – Part A Payment Methods 60.3 – Intermediary Billing Procedures 60.3.1 – Bill Types 60.3.2 – Revenue Codes 60.4 – Intermediary Allowable Codes 60.4.1 – Allowable Covered Diagnosis Codes 60.4.2 – Healthcare Common Procedure Coding System (HCPCS) for Intermediaries 60.5 – Carrier Billing Instructions 60.5.1 – HCPCS for Carriers 60.5.2 – Applicable Diagnosis Codes for A/B MACs (B) 60.6 – Carrier Claims Requirements === Page 3 === 60.7 – Carrier Payment Requirements 60.8 – Carrier and Intermediary General Claims Processing Instructions 60.12 – Coverage for PET Scans for Dementia and Neurodegenerative Diseases 60.8.1 – Remittance Advice Notices 60.8.2 – Medicare Summary Notice (MSN) Messages 66 – National Coverage Determination (NCDs) services that are considered a significant cost for Medicare Advantage. 66.1 – Institutional Billing for National Coverage Determination (NCDs) services that are considered a significant cost for Medicare Advantage 66.2 – Services Identified as having Significant Cost for Medicare Advantage 67 – No Cost Claims 67.1 – Practitioner Billing for No Cost Items 67.2 – Institutional Billing for No Cost Items 67.2.1 – Billing No Cost Items Due to Recall, Replacement, or Free Sample 68 – Investigational Device Exemption (IDE) Studies 68.1 – Billing Requirements for Providers Billing for Routine Care Items and Services in Category A IDE Studie 68.2 – Billing Requirements for Providers Billing for Category B IDE Devices and Routine Care Items and Services in Category B IDE Studies 68.4 – Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category B IDE 69 – Qualifying Clinical Trials 69.1 – General 69.2 – Payment for Qualifying Clinical Trial Services 69.3 – Medical Records Documentation Requirements 69.4 – Local Medical Review Policy 69.5 – Billing Requirements – General 69.6 – Requirements for Billing Routine Costs of Clinical Trials 69.7 – Reserved for Future Use 69.8 – Handling Erroneous Denials of Qualifying Clinical Trial Services 69.9 – Billing and Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees 69.10 – CWF Editing Of Clinical Trial Claims For Managed Care Enrollees 69.11 – Resolution of CWF UR 5232 Rejects 70 – Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial 70.1 – Healthcare Common Procedure Coding System (HCPCS) Codes for Carriers 70.2 – Applicable Modifier for Islet Cell Transplant Claims for Carriers 70.3 – Special Billing and Payment Requirements for Carriers 70.4 – Special Billing and Payment Requirements for A/B MACs (A) 70.5 – Special Billing and Payment Requirements Medicare Advantage (MA) Beneficiaries 80 – Billing of the Diagnosis and Treatment of Peripheral Neuropathy with Loss of Protective Sensation in People with Diabetes 80.1 – General Billing Requirements 80.2 – Applicable HCPCS Codes 80.3 – Diagnosis Codes === Page 4 === 80.4 - Payment 80.5 - Applicable Revenue Codes 80.6 - Editing Instructions for A/B MACs (A) 80.7 - CWF General Information 80.8 - CWF Utilization Edits ## 90 - Stem Cell Transplantation ### 90.1 - General ### 90.2 - HCPCS and Diagnosis Coding - ICD-9-CM Applicable #### 90.2.1 - HCPCS and Diagnosis Coding for Stem Cell Transplantation - ICD-10-CM Applicable ### 90.3 - Non-Covered Conditions ### 90.4 - Edits ### 90.5 - Suggested MSN and RA Messages ### 90.6 - Clinical Trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS) ## 100 - Billing Requirements for Expanded Coverage of Cochlear Implantation ### 100.1 - A/B MACs (Part A) Billing Procedures #### 100.1.1 - Applicable Bill Types #### 100.1.2 - Special Billing Requirements for A/B MACs (A) for Inpatient Billing ### 100.2 - A/B MACs (Part A) Payment Requirements ### 100.3 - A/B MACs (Part B) Billing Procedures ### 100.4 - Healthcare Common Procedural Coding System (HCPCS) ### 100.5 - Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages ## 110 - Coverage and Billing for Ultrasound Stimulation for Nonunion Fracture Healing ### 110.1 - Coverage Requirements ### 110.2 - Intermediary Billing Requirements ### 110.3 - Bill Types ### 110.4 - Carrier and Intermediary Billing Instructions ### 110.5 - DMERC Billing Instructions ## 120 - Presbyopia-Correcting (P-C IOLS) and Astigmatism-Correcting Intraocular Lenses (A-C IOLs) (General Policy Information) ### 120.1 - Payment for Services and Supplies ### 120.2 - Coding and General Billing Requirements ### 120.3 - Provider Notification Requirements ### 120.4 - Beneficiary Liability ## 130 - External Counterpulsation (ECP) Therapy ### 130.1 - Billing and Payment Requirements ### 130.2 - Special Intermediary Billing and Payment Requirements #### 140 140 - Cardiac Rehabilitation (CR) Programs, Intensive Cardiac Rehabilitation (ICR) Programs, and Pulmonary Rehabilitation (PR) Programs On or After January 1, 2024 ### 140.1 - CR Program Services Furnished On or Before Dec. 31, 2009 === Page 5 === 140.1.1 - Coding Requirements for CR Services Furnished On or Before Dec. 31, 2009 140.2 - CR Program Services Effective for Dates of Service On or After January 1, 2024 140.2.1 - Coding Requirements for CR Services Furnished On or After January 1, 2010 140.2.2 - Claims Processing Requirements for Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Services Furnished On or After January 1, 2010 140.2.2.1 - Correct Place of Service (POS) Codes for CR and ICR Services on Professional Claims 140.2.2.2 - Requirements for CR and ICR Services on Institutional Claims 140.2.2.3 - Frequency Edits for CR and ICR Claims 140.2.2.4 - Edits for CR Services Exceeding 36 Sessions 140.2.2.5 - Edits for ICR Services Exceeding 126 Days and 72 Sessions 140.2.2.6 - Supplier Specialty Code 31 Requirements for ICR Claims 140.3 - ICR Program Services Effective for Dates of Service On or After January 1, 2024 140.3.1 - Coding Requirements for ICR Services Furnished On or After January 1, 2010 140.4 - PR Program Services Effective for Dates of Service On or After January 1, 2024 140.4.1 - Coding Requirements for PR Services Furnished On or After January 1, 2010 140.4.2 - Claims Processing Requirements for Pulmonary Rehabilitation (PR) Services Furnished On or After January 1, 2010 140.4.2.1 - Correct Place of Service (POS) Codes for PR Services on Professional Claims 140.4.2.2 - Requirements for PR Services on Institutional Claims 140.4.2.3 - Daily Frequency Edits for PR Claims 140.4.2.4 - Edits for PR Services Exceeding 36 Sessions 140.4.2.5

Ambulatory Blood Pressure Monitoring (ABPM) is covered for patients with suspected white coat hypertension or resistant hypertension. Electrical stimulation is medically necessary for wound healing in patients with chronic non-healing wounds. Counseling is covered for individuals who use tobacco products and have a health condition affected by tobacco use. HBO Therapy is covered for the treatment of diabetic wounds of the lower extremities. Home PT/INR monitoring is covered for patients on anticoagulation therapy requiring monitoring. Coverage for PET scans is provided for patients with suspected dementia or neurodegenerative diseases. PET imaging is medically necessary for differential diagnosis when standard evaluations are inconclusive. Billing for providers involved in Category A IDE studies for routine care items and services. Billing for providers involved in Category B IDE studies, including routine costs associated with clinical trials. Coverage for services rendered in a qualifying clinical trial as defined by Medicare criteria. Medically necessary services for the treatment of patients enrolled in qualifying clinical trials. Islet cell transplantation for beneficiaries participating in a National Institutes of Health (NIH) Clinical Trial. Diagnosis and treatment of peripheral neuropathy with loss of protective sensation in people with diabetes. Ultrasound stimulation is covered when used for the treatment of nonunion fractures. Coverage requires documentation of failed previous treatment options. Cardiac rehabilitation services are covered for patients with a history of heart attack, heart surgery, or significant cardiac conditions. Intensive cardiac rehabilitation is covered under similar conditions as traditional cardiac rehabilitation. Cardiac Rehabilitation (CR) services are covered for patients post-cardiac event or surgery. Intensive Cardiac Rehabilitation (ICR) services are covered for patients with specific criteria outlined in the policy. Pulmonary Rehabilitation (PR) services are covered when medically necessary for patients with chronic respiratory diseases. ICD codes applicable for patients with BMI ≥ 35 for bariatric surgery eligibility. ICD codes for Type II Diabetes Mellitus complications as indicators for bariatric surgery. Carotid artery stenting (CAS) is indicated for patients meeting specific criteria related to carotid artery disease. Intracranial PTA with stenting is covered under certain medical conditions as specified in the guidelines. ICD-9 diagnosis codes for Vagus Nerve Stimulation are covered since dates of service on and after July 1, 1999. Coverage provided for CPAP when medically necessary for patients diagnosed with obstructive sleep apnea. Billing instructions for when surgical procedures are performed incorrectly on patients or sites. Implantable automatic defibrillators are covered when medically necessary for patients at risk for sudden cardiac arrest. Indications include prior cardiac arrest, life-threatening ventricular dysfunction, and specific arrhythmias. Transesophageal Doppler is covered for cardiac monitoring in specific conditions. Medically necessary for assessing hemodynamic status in critically ill patients. Transesophageal Doppler monitoring is covered for patients who meet specific clinical criteria. Artificial Hearts and related devices are indicated for patients who are candidates for heart transplantation or those with end-stage heart failure. Coverage for emergency services rendered by nonparticipating providers is provided under specific conditions. Emergency hospital services are covered when medically necessary. Coverage for services rendered in Canada or Mexico when medically necessary. Claims for foreign services will be processed according to contractor guidelines. Payment is covered for services received in nonparticipating facilities under certain conditions. Emergency services from nonparticipating providers will be considered for reimbursement. Microvolt T-wave alternans testing may be covered for patients with a history of unexplained syncope and/or those at high risk for sudden cardiac death. Acupuncture is covered for chronic low back pain when other treatments have failed. Monoclonal antibodies are covered for the treatment of Alzheimer's disease. Implantable pulmonary artery pressure sensors are indicated for heart failure management. Medicare coverage for ABPM is allowed for beneficiaries with suspected 'white coat hypertension' (WCH). WCH is defined by clinic/office blood pressure >140/90 mm Hg on at least three separate visits and at least two documented measurements outside the clinic <140/90 mm Hg. ABPM must be performed for at least 24 hours for coverage. ABPM is covered for patients requiring 24 hours or longer monitoring. ICD-10-CM code R03.0 is applicable for elevated blood pressure reading without a diagnosis of hypertension. ABPM services billed on specific types of bills 13X and 23X are payable under the Outpatient Prospective Payment System (OPPS). Non-OPPS hospitals can bill based on reasonable cost for ABPM services. RHCs and FQHCs can receive reimbursement for ABPM services provided they bill using the correct type of bill (71x for RHCs, 73x for FQHCs) with revenue code 052x. ABPM services are covered under the all-inclusive rate for FQHCs. ABPM services are covered when billed with ICD-10-CM diagnosis code R03.0 for patients who meet the criteria. Coverage is provided for electrical stimulation in the treatment of chronic Stage III or Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers. Electrical stimulation is covered only after standard wound care has been attempted for at least 30 days with no measurable signs of healing. Electrical stimulation is covered when used in unattended settings for chronic Stage III wounds. Coverage for stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan. Coverage for electrical stimulation services provided under supervision in healthcare facilities. Payments made under all-inclusive rate for therapy services at RHCs and FQHCs. Critical Access Hospitals (CAHs) receive payment on a reasonable cost basis. Coverage includes services related to Physical Therapy and Occupational Therapy provided under specified revenue codes. Covered for Electrical Stimulation services billed with HCPCS code G0281. Coverage for electromagnetic therapy is allowed for chronic Stage III or Stage IV pressure ulcers. Coverage extends to arterial ulcers, diabetic ulcers, and venous stasis ulcers. Electromagnetic therapy is covered after at least 30 days of standard wound care with no measurable signs of healing. Coverage for electromagnetic therapy is provided for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers that do not show measurable signs of healing after 30 days of conventional care. Medicare will cover the service of electromagnetic therapy for the treatment of wounds. Covered for electromagnetic therapy services when provided under the Medicare Physician Fee Schedule. Covers services under revenue codes for physical therapy and occupational therapy. Payments for services provided in Federal Qualified Health Centers and Rural Health Centers. Electromagnetic therapy is covered when billed using HCPCS code G0329. Coverage for autologous platelet-rich plasma (PRP) is for the treatment of chronic non-healing diabetic wounds. PRP is covered for a duration of 20 weeks when prepared by FDA-cleared devices for managing exuding cutaneous wounds. Coverage for autologous PRP treatment of chronic non-healing wounds (non-diabetic) determined by local MACs. PRP is covered for treatment of chronic non-healing diabetic wounds when billed with specific ICD-10 codes. Covered when the ulcer is chronic and shows no signs of healing despite conservative management for at least 30 days. Medically necessary for patients with underlying conditions that impair healing, such as diabetes or peripheral vascular disease. Coverage for non-pressure chronic ulcers of the right thigh with various severities, including breakdown of skin, fat layer exposure, muscle involvement, and necrosis. Coverage for non-pressure chronic ulcers of the left thigh with similar severity classifications as the right thigh. Coverage applies for non-pressure chronic ulcers of the left thigh and right calf, with varying severity and involvement of skin, fat, muscle, or bone. Coverage for chronic ulcers of the left calf with bone necrosis (L97.224). Coverage for chronic ulcers of the left calf with muscle involvement without necrosis (L97.225). Coverage for chronic ulcers of the left calf with bone involvement without necrosis (L97.226). Coverage for chronic ulcers of the left calf with other specified severity (L97.228). Coverage for chronic ulcers of the right ankle with muscle involvement without necrosis (L97.315). Coverage for chronic ulcers of the right ankle with bone involvement without necrosis (L97.316). Coverage for chronic ulcers of the right ankle with other specified severity (L97.318). Coverage for chronic ulcers of the left ankle limited to breakdown of skin (L97.321). Coverage for chronic ulcers of the left ankle with fat layer exposed (L97.322). Coverage for chronic ulcers of the left ankle with muscle necrosis (L97.323). Coverage for chronic ulcers of the left ankle with bone necrosis (L97.324). Coverage for non-pressure chronic ulcers of the left ankle that involve muscle without necrosis. Coverage for non-pressure chronic ulcers of the left ankle with bone involvement without necrosis. Coverage for non-pressure chronic ulcers of the left ankle of other specified severity. Coverage for non-pressure chronic ulcers of the right heel and midfoot limited to breakdown of skin. Coverage for non-pressure chronic ulcers of the right heel and midfoot with fat layer exposed. Coverage for non-pressure chronic ulcers of the right heel and midfoot with muscle necrosis. Coverage for non-pressure chronic ulcers of the right heel and midfoot with bone necrosis. Coverage for non-pressure chronic ulcers with specific characteristics such as bone involvement, muscle involvement, or necrosis as specified in the included ICD-10 codes. Coverage for treatment of non-pressure chronic ulcers of the buttock with various severities, including fat layer exposed, muscle necrosis, and bone involvement. Coverage for treatment of non-pressure chronic ulcers of the back with similar severity classifications. Coverage for PRP services is available for chronic non-healing diabetic wounds. PRP services can be covered for a maximum of 20 weeks beginning with the first week of treatment. PRP services are covered for chronic non-healing non-diabetic wounds. Payment for PRP services in hospital outpatient departments (TOBs 12X and 13X) under the Outpatient Prospective Payment System. Payment for skilled nursing facility services (TOBs 22X and 23X) under the Medicare Physician Fee Schedule (MPFS). PRP services are covered when provided in designated places of service (POS) codes 11, 19, 22, and 49. PRP services for chronic non-healing diabetic wounds are covered when performed within 20 weeks of the first PRP service. PRP services for the treatment of chronic non-healing diabetic wounds are covered when appropriate diagnosis codes are provided. Coverage is determined based on Local Coverage Determination (LCD) guidelines. Claims may be appealed using information provided by a doctor. Covered for smoking and tobacco-use cessation counseling services. Counseling services for smoking and tobacco-use cessation. Payment is allowed for a medically necessary E/M service when clinically appropriate on the same day as counseling to prevent tobacco use. Counseling for the prevention of tobacco use services with an appropriate diagnosis code. Coverage for diagnosis of non-dependent tobacco use disorder (305.1) and toxic effects of tobacco (989.84). ICD-10 codes relevant for nicotine dependence, including complications and remissions. Coverage for nicotine dependence related to other tobacco products, including uncomplicated and withdrawal cases. Coverage for medical treatment related to toxic effects of chewing tobacco, intentional and unintentional. Coverage for medical treatment related to toxic effects of tobacco cigarettes, intentional and unintentional. Covers the toxic effect of other tobacco and nicotine due to assault, initial encounter. Covers the toxic effect of other tobacco and nicotine with an undetermined cause, initial encounter. Counseling services billed under codes G0436 and G0437 are covered for dates of service from August 25, 2010, through September 30, 2016. Counseling services billed with codes G0436 and G0437 are covered for dates of service from August 25, 2010, through September 30, 2016. Counseling services are covered for the prevention of tobacco use. Coverage for skilled nursing facility services is medically necessary for patients requiring rehabilitation after hospitalization. Patients with significant medical needs such as chronic illnesses that require daily skilled nursing interventions. Home health services are covered for skilled patients under Part A PPS. Critical Access Hospitals provide technical services paid at 101% of reasonable cost. Counseling to prevent tobacco use services may be offered prior to the effective date of August 25, 2010. Counseling services for tobacco use are covered under certain circumstances specified by Medicare. Counseling services for smoking and tobacco-use cessation are covered when provided according to Medicare's coverage instructions. Counseling services are covered for Medicare beneficiaries to assist them in quitting smoking and using tobacco products. Kidney disease patient education services are covered for patients with stage IV chronic kidney disease (CKD). KDE services are provided as medically necessary. KDE services provided to individuals needing kidney management, in groups of 2 to 20. Services must be furnished upon the referral of a physician managing the kidney condition. KDE services are covered when rendered in a rural area. Claims with specific Type of Bill (TOB) codes are covered when received from section 401 hospitals. Covered when provided to patients with stage IV chronic kidney disease. KDE services are covered for patients with chronic kidney disease Stage IV (severe). KDE services are covered when rendered by a hospital listed on the section 401 list. KDE services are covered when the claim is submitted on TOB 85X. HBO therapy may be covered for the treatment of diabetic wounds of the lower extremities. Coverage for Hyperbaric Oxygen Therapy is allowed for the treatment of diabetic wounds of the lower extremities. Medically necessary for conditions that benefit from hyperbaric oxygen therapy as dictated by standards. HBO therapy is covered for diabetic wounds of the lower extremities when performed as a physician service in a hospital outpatient setting and for inpatient services. Services are covered when provided by Critical Access Hospitals under cost reimbursement. Covered for the treatment of diabetic wounds of the lower extremities when medical necessity is established. Topical oxygen therapy is covered for the treatment of chronic wounds. Covered for the treatment of urinary urge incontinence. Covered for urgency-frequency syndrome. Covered for urinary retention. Patients must demonstrate a 50% or greater improvement through test stimulation before permanent implantation. Patient must have had a successful test stimulation to support subsequent implantation. Covered for patients requiring sacral nerve stimulation. Medically necessary for improvement in chronic pelvic pain management. Payment is made on a reasonable cost basis when devices A4290, E0752, and E0756 are implanted in a Critical Access Hospital (CAH). Technical component for provider-based RHC/FQHC is furnished by the provider and billed using appropriate bill types. DBS is covered for patients with essential tremor. DBS is medically necessary for Parkinson's disease when other therapies are ineffective. Symptomatic relief of essential tremor in patients who do not respond to or cannot tolerate first-line medications like beta-adrenergic blockers and anticonvulsants. Coverage for unilateral or bilateral thalamic VIM DBS for the treatment of essential tremor (ET) and/or Parkinsonian tremor. Coverage for unilateral or bilateral STN or GPi DBS for the treatment of Parkinson's disease (PD). Diagnosis of essential tremor (ET) based on postural or kinetic tremors of hand(s) without other neurologic signs. Diagnosis of idiopathic Parkinson's Disease (PD) with at least 2 cardinal features of tremor, rigidity, or bradykinesia, specifically of a tremor-dominant form. Marked disabling tremor at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale, causing significant limitation in daily activities despite optimal medical therapy. Willingness and ability to cooperate during conscious operative procedure and post-surgical evaluations. Diagnosis of Parkinson's Disease (PD) based on presence of at least 2 cardinal features: tremor, rigidity, or bradykinesia. Advanced idiopathic PD as determined by Hoehn and Yahr stage or UPDRS part III motor subscale. L-dopa responsive with clearly defined 'on' periods. Persistent disabling symptoms or drug side effects despite optimal medical therapy. Willingness and ability to cooperate during operative procedure and post-surgical evaluations. DBS is indicated for patients with non-idiopathic Parkinson’s disease or 'Parkinson’s Plus' syndromes. DBS lead implantation is reasonable and necessary under specific conditions outlined. Coverage includes DBS therapy for patients with movement disorders. Indications for DBS therapy require involvement from physicians specializing in movement disorders for patient selection and post-procedure care. Procedure is indicated when brain imaging equipment is available for pre-operative stereotactic localization. Stereotactic surgery requires necessary operating room equipment and patient support services. Implantation of electrodes is covered when performed in a hospital inpatient setting. Implantation of the pulse generator is covered when performed in an outpatient department. Deep Brain Stimulation is covered under certain inpatient and outpatient procedures. Deep Brain Stimulation is covered for patients diagnosed with Parkinson's disease, with or without dyskinesia. Coverage for essential tremor (ICD-10-CM G25.0) diagnoses. Coverage for other specified forms of tremor (ICD-10-CM G25.2) diagnoses. Coverage for insertion of neurostimulator lead into brain or cerebral ventricle when medically necessary. Removal of neurostimulator lead from brain or cerebral ventricle is covered when clinically indicated. Placement of cranial neurostimulator for conditions requiring deep brain stimulation. Functional mapping of brain structures utilizing electrode stimulation. Used for functional cortical and subcortical mapping to provoke seizures or identify vital brain structures. Applicable for electronic analysis of implanted neurostimulator pulse generator system. Covered for electronic analysis of implanted neurostimulator pulse generator system. Coverage for the electronic analysis of implanted neurostimulator pulse generator/transmitter when performed by a physician or other qualified health care professional. Covered when electronic analysis is performed by a physician or qualified healthcare professional. Incision and subcutaneous placement of cranial neurostimulator pulse generator or receiver is covered when performed in an Ambulatory Surgical Center. Revision or removal of cranial neurostimulator pulse generator or receiver is covered in an Ambulatory Surgical Center. Prothrombin time (PT) testing is covered for patients on anticoagulation therapy to monitor warfarin effectiveness. Coverage for home INR monitoring for patients with mechanical heart valves on warfarin who have been anticoagulated for at least 3 months. Coverage for home PT/INR monitoring is for patients with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism on warfarin. Patients must have been anticoagulated for at least 3 months prior to using the home INR device. Coverage for patients with activated protein C resistance, prothrombin gene mutation, and other primary thrombophilia. Patients diagnosed with antiphospholipid syndrome or lupus anticoagulant syndrome are also covered. Coverage for multiple subsegmental pulmonary emboli without acute cor pulmonale (I26.94). Coverage for chronic thromboembolic pulmonary hypertension (I27.24). Coverage for acute embolism and thrombosis of various veins including femoral and iliac veins (I82.411, I82.412). Coverage for acute embolism and thrombosis of popliteal vein, tibial vein, peroneal vein, calf muscular vein, and other specified deep veins. Coverage for chronic embolism and thrombosis of femoral vein, iliac vein, and other specified deep veins. Covers diagnosis and management of chronic embolism and thrombosis of deep veins of upper extremities. Covers acute embolism and thrombosis of selected veins as specified by ICD codes. Home INR monitoring is covered for patients with mechanical heart valves who meet Medicare criteria. Provision of test materials and equipment for home INR monitoring is covered for patients with mechanical heart valve(s) who meet Medicare coverage criteria. Demonstration of home INR monitoring is covered for patients with mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meet Medicare coverage criteria. Home INR monitoring for patients with mechanical heart valves. Home INR monitoring for patients with chronic atrial fibrillation. Home INR monitoring for patients with venous thromboembolism. Home INR monitoring demonstration is covered for patients with mechanical heart valves who meet Medicare coverage criteria. Provision of test materials for home INR monitoring is covered for eligible patients. Physician review and interpretation of home INR testing results is covered for patients with mechanical heart valves and other coverage criteria. Home INR monitoring for patients with mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meet Medicare coverage criteria. Covered for patients with mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meet Medicare coverage criteria. Coverage for diagnoses including activated protein C resistance and prothrombin gene mutation. Coverage includes chronic thromboembolic pulmonary hypertension (I27.24). Coverage includes chronic pulmonary embolism (I27.82). Coverage for various types of atrial fibrillation including paroxysmal (I48.0) and permanent (I48.21) forms. Coverage for acute embolism and thrombosis of specified veins in the lower and upper extremities. Coverage for acute and chronic embolism and thrombosis of upper extremity veins and jugular veins. Coverage includes diagnoses such as cerebral venous thrombosis in the puerperium and long-term use of anticoagulants. PT/INR testing is covered under the physician fee schedule. Payment denial based on a National Coverage Determination (NCD). Not deemed a medical necessity by the payer for services furnished after July 1, 2002. Medicare covers FDG PET scans for a differential diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease. Coverage is also provided for its use in CMS-approved practical clinical trials focused on dementing neurodegenerative diseases. PET scans are covered for the differential diagnosis of fronto-temporal dementia and Alzheimer’s disease. Claims submitted must include an appropriate CPT code from section 60.3.1. Coverage is applicable for patients diagnosed with mild cognitive impairment or dementia after thorough clinical evaluation. Conditions under consideration include normal aging and various stages of dementia (mild, moderate, or severe). Coverage for Positron Emission Tomography (PET) beta amyloid imaging is allowed under evidence development (CED). Coverage requires reporting of CD-10 diagnosis code Z00.6 in either primary or secondary position. At least one additional diagnosis code from the provided table is required alongside Z00.6. Coverage applies for unspecified dementia without behavioral disturbance. Coverage applies for unspecified dementia with behavioral disturbance. Coverage applies for vascular dementia without behavioral disturbance. Coverage applies for vascular dementia with behavioral disturbance. Coverage applies for dementia in other diseases classified elsewhere without behavioral disturbance. Coverage applies for dementia in other diseases classified elsewhere with behavioral disturbance. Coverage applies for Pick's disease. Coverage applies for other frontotemporal dementia. Coverage applies for corticobasal degeneration. Coverage applies for dementia with Lewy bodies. Coverage applies for mild cognitive impairment. Coverage applies for anterograde amnesia. Coverage applies for retrograde amnesia. Coverage applies for other amnesia. Services considered a significant cost for Medicare Advantage Plans. Original fee-for-service Medicare coverage applies for certain disallowed services. Services eligible for Medicare payment include significant cost services for MA plan beneficiaries. Services necessary to diagnose a condition covered by the NCD or legislative changes in benefits. Most services furnished as follow up care to the NCD services. Any services that are already a Medicare-covered service under the annual M+C capitation rate. Costs of NCD services that the M+C organization is obligated to cover as an additional benefit. Condition Code 78 is covered when certain services are disallowed on Medicare Advantage plans that are significant costs under section 422.109(a)(2). Services disallowed on Medicare Advantage plans that are considered a significant cost under section 422.109(a)(2) are covered. Covered for patients receiving CAR-T therapy. No cost items can be received by providers but should not be billed for reimbursement. Providers must report no cost items for specific claims under OPPS due to processing edits. Billing the corresponding drug administration charge when administering drugs. Claims for no cost items provided to patients are covered when proper documentation is submitted. No cost items are payable when billed accurately and in conjunction with related procedures. Institutional providers may bill device HCPCS codes for no cost or full credit items with token charges. Modifier -FB indicates that an item used in a procedure was furnished without cost to the provider. Product replacement is covered within the product lifecycle if needed. Replacement of a product is covered when the manufacturer or FDA has identified it for recall. Medical devices provided at no cost or with full credit due to warranty or recall are covered. Applicable to inpatient or outpatient institutional claims that include a no cost/full credit replacement device when warranty or recall conditions are met. Used to identify and track medical devices provided by a manufacturer at no cost due to clinical trials. Replacement of a product earlier than the anticipated lifecycle. Replacement due to manufacturer or FDA recall. Initial placement of a medical device in a clinical trial or as a free sample. Providers must report condition codes for medical devices provided at no cost due to warranty, recall, or free sample. Items and services in Category A and B IDE studies are covered under Medicare. Routine care items and services in Category A IDE device studies approved by CMS are eligible for claims submission. Claims for routine care items and services in Category A IDE studies are covered when approved by CMS. Claims for items/services provided in clinical trials must report a clinical trial number. Services under Coverage with Evidence Development (CED) require the same reporting. ICD-9 diagnosis code V70.7 or ICD-10 diagnosis code Z00.6 in primary/secondary positions. Services provided as routine care in a Medicare qualifying clinical trial using appropriate modifiers. Coverage for Category B IDE devices when used for FDA-approved clinical trials. Routine care items and services in Category B IDE studies approved by CMS. Claims for routine care items and services in Category B IDE studies must be submitted by institutional providers. Category B IDE devices are covered when billed appropriately with the corresponding HCPCS modifiers. Claims for routine care items and services in Category B IDE studies approved by CMS must be submitted. Services must be billed according to clinical trial billing instructions. Investigational clinical service provided in a clinical research study that is in an approved clinical research study. Category B devices are covered when used in FDA approved clinical trials and the IDE number is validated. Claims for items/services provided in clinical trials/studies/registries must report a valid clinical trial number. ICD-9 diagnosis code V70.7 or ICD-10 diagnosis code Z00.6 must be in either primary or secondary positions for coverage. Claims must include HCPCS modifier Q0 or Q1 as appropriate for clinical trial services. Routine costs of clinical trials involving Category B IDE devices are covered when conditions specified by the contractor are met. Category B IDE devices and related routine costs are eligible for payment under Medicare. Routine costs of clinical trials involving Category B IDE devices are covered. Claims with dates of service on or after January 1, 2008, may use the Q0 modifier. Claims with dates of service prior to January 1, 2008, may use the QA modifier. Claims for clinical trials involving Category B IDE devices must include a clinical trial number. Routine costs of clinical trials are covered if billed per clinical trial billing instructions. Claims must include a clinical trial number. Practitioners must bill Category B IDE devices with a QA modifier for dates of service on or before December 31, 2007. For dates of service on or after January 1, 2008, practitioners will bill with a Q0 modifier. Claims are covered when submitted with the valid IDE number and modifier Q0. Claims must include at least one Remark Code. Claims lacking required information may be rejected. Coverage is provided for routine costs of qualifying clinical trial services that meet necessary criteria. Coverage extends to reasonable and necessary items and services for diagnosing and treating complications from participation in clinical trials. Covered services furnished to beneficiaries participating in qualifying clinical trials. Items/services provided in clinical trials must report a clinical trial number. Clinical trial services that meet the requirements of the NCD are considered reasonable and necessary. Services must be billed separately for clinical trials and non-clinical trials. Providers are instructed to submit charges for non-covered services as non-covered at the time of entry. Reporting a token charge for a 'no cost' item when required by claims processing edits. CMS covers routine costs of healthy volunteers in a qualified clinical trial. Trials must have therapeutic intent to be covered. Therapeutic trials must enroll patients with diagnosed diseases. Claims must include a valid ICD-10-CM code Z00.6 or ICD-9-CM code V70.7 when applicable. Claims for items/services provided in clinical trials/studies/registries or under CED must report a clinical trial number. For applicable ICD-9-CM, include diagnosis code V70.7; for ICD-10-CM, include Z00.6. Claims submitted for institutional clinical trial services. Claims for items/services provided in clinical trials/studies/registries, or under Coverage with Evidence Development (CED) must report an 8-digit clinical trial number. Items and services that constitute medically necessary routine patient care in Medicare-covered clinical trials are covered. Covered for patients participating in a qualifying clinical trial. Institutional providers must report ICD-9 code V70.7 or ICD-10 code Z006 for clinical trial services. Report ICD-9 diagnosis code V70.7 when ICD-9-CM is applicable. Report ICD-10 diagnosis code Z00.6 when ICD-10-CM is applicable. Clinical trial services are covered for beneficiaries enrolled in managed care plans. Payment for clinical trial services is covered for beneficiaries enrolled in managed care plans. Covered outpatient services related to clinical trials. Clinical trial services must be billed separately from non-clinical trial services. Clinical trial services are covered for managed care enrollees when coded as such. Claims for clinical trial services will be processed without applying the Part B deductible. Islet cell transplantation for beneficiaries enrolled in a National Institutes of Health (NIH) clinical trial. Coverage for islet cell transplantation is available for patients with Type I diabetes participating in an NIH sponsored clinical trial. Laparoscopy for islet cell transplant including portal vein catheterization and infusion. Laparotomy for islet cell transplant including portal vein catheterization and infusion. Coverage for islet cell transplants when medically necessary as per the MPFS. Covered for patients requiring pancreatic islet cell transplantation due to diabetes. Medically necessary for patients who do not have adequate control of blood glucose levels. Coverage for Type 1 diabetes mellitus with various complications including nephropathy, hyperglycemia, and retinopathy with and without edema. Coverage for Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema in right, left, or bilateral eyes. Coverage for Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema in right, left, or bilateral eyes. Coverage for Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema in right, left, or bilateral eyes. Coverage includes Type 1 diabetes mellitus with moderate to severe nonproliferative diabetic retinopathy. Indications with or without macular edema in one or both eyes are included. Coverage for Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema in the left eye. Coverage for Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema in both eyes. Coverage for Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment, whether involving the macula or not, in one or both eyes. Coverage for Type 1 diabetes with proliferative diabetic retinopathy with associated retinal detachments in either eye or both. Type 1 diabetes with stable proliferative diabetic retinopathy is covered for right, left, or bilateral conditions. Proliferative diabetic retinopathy without macular edema in either eye is covered. Coverage for diabetic retinopathy and related eye conditions associated with Type 1 diabetes mellitus. Treatment for diabetic neuropathy and other neurological complications resulting from Type 1 diabetes. Coverage for Type 1 diabetes mellitus with various diabetic complications including neuropathic arthropathy, peripheral angiopathy with or without gangrene, and skin complications. Indications include diabetic foot ulcers and other skin ulcers associated with diabetes. Coverage for clinical trials involving Type 1 diabetes mellitus with hypoglycemia without coma (ICD-10 E10.649). Coverage for clinical trials involving Type 1 diabetes mellitus with unspecified complications (ICD-10 E10.8). Islet isolation services are covered for inpatient hospitals participating in this trial. Two add-on payments for islet cell isolation are allowed if two infusions occur during the same hospital stay. Islet cell transplantation follow-up care is covered when performed in an outpatient department of a hospital after a transplant done in conjunction with an NIH-sponsored clinical trial. Routine costs of pancreatic islet cell transplants for MA beneficiaries participating in an NIH-sponsored clinical trial are covered. Coverage is applicable for individuals with diabetes diagnosed with peripheral neuropathy leading to loss of protective sensation. Medically necessary for individuals who exhibit symptoms like inability to feel minor trauma due to peripheral nerve damage. Foot exams are covered for patients with diabetic peripheral neuropathy with loss of protective sensation (LOPS) to allow for early intervention in complications. Coverage for foot examination every 6 months for individuals with documented diabetic sensory neuropathy and loss of protective sensation (LOPS). Absence of sensation at two or more sites out of five tested on either foot using the 5.07 Semmes-Weinstein monofilament is required to diagnose peripheral neuropathy with loss of protective sensation. Initial physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS). Follow-up physician evaluation and management for diabetic patients with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS). Routine foot care for diabetic patients with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS). Covered when ICD-10-CM diagnosis codes are reported in conjunction with the benefit. Coverage is indicated for patients diagnosed with various forms of diabetes mellitus who show neurological complications. Conditions such as diabetic neuropathy and diabetic polyneuropathy are medically necessary for coverage. Coverage for diabetic neuropathy with loss of protective sensation (LOPs) is medically necessary. Services provided to patients of Comprehensive Outpatient Rehabilitation Facilities (CORFs) are covered when billed by the physician. Services rendered in a Rural Health Clinic (RHC) or Federally Qualified Health Center (FQHC) by a physician or non-physician are considered RHC/FQHC services. Procedures can be performed in various revenue centers like clinics for hospitals. Payment allowed for LOPS codes G0245, G0246, and G0247 when submitted with specified ICD-10-CM diagnosis codes. Coverage for patients with diabetes mellitus suffering from various forms of diabetic neuropathy. Indications include diabetic neuropathy linked to underlying conditions or drug/chemical-induced diabetes. Services are covered if appropriate diagnoses are submitted. Claims for G0245 or G0246 are payable when submitted not less than 6 months apart for the same beneficiary. Claims will be processed if G0245 or G0246 has been submitted and accepted as payable on the same date of service. Medicare covers routine foot care when a beneficiary's condition progresses to necessitate this service. Stem cell transplantation is covered when performed under specified circumstances. Covered under Medicare for specific diagnoses as stated in Pub. 100-03, section 110.23. Transfusion of allogeneic related bone marrow is covered when medically necessary. Transfusion of allogeneic unrelated hematopoietic stem cells is covered when clinically indicated. Transfusion of allogeneic related or unrelated bone marrow and hematopoietic stem cells into the central vein is considered medically necessary. Indications must align with established clinical criteria for the treatment of relevant conditions. Treatment of leukemia, including leukemia in remission Coverage for acute lymphoblastic leukemia, chronic lymphocytic leukemia, prolymphocytic leukemia, and adult T-cell lymphoma/leukemia in various remission statuses. Coverage is provided for myeloid leukemia diagnoses, including those in remission, relapse, or not achieving remission. Coverage for treatment of aplastic anemia per specified ICD-10-CM codes. Coverage for various types of aplastic anemia including D60.0 to D61.3. Coverage for certain acute lymphoblastic leukemia diagnoses such as D62.0 to D62.10. Treatment of severe combined immunodeficiency disease (SCID) for specified ICD-10-CM codes. Treatment of Wiskott-Aldrich syndrome (ICD-10-CM code D82.0). Treatment of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence Development (CED) for specified ICD-10-CM codes. Coverage for allogeneic HSCT for multiple myeloma is limited to beneficiaries with Durie-Salmon Stage II or III, or ISS Stage II or III, participating in an approved prospective clinical study. Coverage for allogeneic HSCT for myelofibrosis is limited to beneficiaries with DIPSSplus intermediate-2 or high primary or secondary MF, participating in an approved prospective clinical study. Coverage is for beneficiaries with severe, symptomatic sickle cell disease (SCD) who participate in an unspecified clinical protocol. Transfusion of autologous hematopoietic stem cells is covered for patients undergoing specified treatment protocols. Transfusion of autologous bone marrow is medically necessary for specific indications as outlined in treatment guidelines. Covered for acute leukemia in remission without trial. Covered for resistant non-Hodgkin's lymphomas. Covered for recurrent/refractory neuroblastoma. Covered for advanced Hodgkin's disease on or after 4/28/89. Covered for Durie-Salmon stage II/III responsive multiple myeloma and responsive relapse on or after 10/1/00. Covered for primary amyloid light chain (AL) amyloidosis on or after 3/15/05 combined with high dose melphalan (HDMI) without trial. Nodular lymphocyte predominant Hodgkin lymphoma covered in various lymph node locations. Nodular sclerosis Hodgkin lymphoma covered in various lymph node locations. Mixed cellularity Hodgkin lymphoma covered in various lymph node locations. Coverage is provided for patients diagnosed with mixed cellularity Hodgkin lymphoma affecting various lymph node locations. Coverage is provided for patients diagnosed with lymphocyte depleted and lymphocyte-rich Hodgkin lymphoma depending on specified lymph node involvement. Coverage includes various types of Hodgkin lymphoma affecting different lymph nodes. Follicular lymphoma in specified lymph node regions is also covered. Diagnosis of follicular lymphoma grade III or diffuse follicle center lymphoma of specified lymph node regions is covered. Coverage for various types of follicle center lymphoma as specified in the coding section. Indications include diffuse and cutaneous lymphoma affecting lymph nodes in various sites and stages. Coverage provided for various types of lymphomas including follicular, small cell B-cell, mantle cell, diffuse large B-cell, and lymphoblastic lymphomas affecting various lymph node regions. Coverage for lymphoblastic lymphoma affecting various lymph nodes and solid organ sites. Inclusion of Burkitt lymphoma and other non-follicular lymphoma types in covered conditions. Coverage for mycosis fungoides affecting various lymph node regions including intrathoracic, intra-abdominal, axilla, lower limb, and multiple sites. Sezary disease coverage extends to lymph nodes of the head, neck, and multiple sites. Peripheral T-cell lymphoma coverage includes various lymph nodes of the head, thorax, abdomen, and more. Coverage is provided for diagnoses of anaplastic large cell lymphoma, ALK-positive and ALK-negative in various lymph node sites. Coverage includes mature T/NK-cell lymphomas diagnosed in specified lymph node regions. Covered for patients diagnosed with cutaneous T-cell lymphoma at unspecified intra-abdominal or other specified lymph node sites. Covered for patients diagnosed with unspecified and mature B-cell lymphomas at various lymph node sites. Coverage includes specific types of non-Hodgkin lymphoma involving various lymph nodes and organ sites. Coverage for extranodal NK/T-cell lymphoma (C86.0), hepatosplenic T-cell lymphoma (C86.1), various other T-cell lymphomas, and multiple myeloma (C90.00, C90.01, C90.02) depending on clinical presentation. Indications include acute lymphoblastic leukemia (C91.01), chronic lymphocytic leukemia (C91.11), and other lymphoid leukemias as outlined by specific ICD codes. Coverage for acute and chronic leukemias in remission. Coverage includes polycythemia vera and various forms of amyloidosis. Acute leukemia in remission who have a high probability of relapse and who have no HLA-matched donors. Resistant non-Hodgkin's lymphomas or those with poor prognostic features following an initial response. Single AuSCT is covered for Durie-Salmon Stage II or III multiple myeloma patients with specific ICD-10-CM codes. Newly diagnosed or responsive multiple myeloma, including those previously untreated or with a partial response to chemotherapy. Medicare beneficiaries with primary AL amyloidosis, amyloid deposition in 2 or fewer organs, and left ventricular ejection fraction greater than 45%. Light chain (AL) amyloidosis is covered when diagnosis is confirmed. Claims for amyloidosis are subject to prepayment reviews when using ICD-10-CM codes E85.4, E85.81, E85.9, and E85.89. Acute leukemia not in remission prior to October 1, 2000, with ICD-10-CM codes C91.00, C92.00, C93.00, C94.00, and C95.00. Chronic granulocytic leukemia prior to October 1, 2000, with ICD-10-CM code C92.10. Solid tumors (excluding neuroblastoma) prior to October 1, 2000, with ICD-10-CM codes C00.0 – C80.2 and D00.0 – D09.9. Multiple myeloma prior to October 1, 2000, with ICD-10-CM codes C90.00, C90.01, C90.02 and D47.Z9. Tandem transplantation on or after October 1, 2000, with ICD-10-CM codes C90.00, C90.01, C90.02, and D47.Z9. Non-primary amyloidosis on or after October 1, 2000, for all Medicare beneficiaries. Primary AL amyloidosis effective from October 1, 2000, to March 14, 2005, for Medicare beneficiaries age 64. Covered for Myelodysplastic Syndrome (MDS), Multiple Myeloma, Myelofibrosis (MF), and Sickle Cell Disease (SCD) within clinical trials. Allogeneic HSCT for the treatment of Myelodysplastic Syndromes (MDS) in a Medicare-approved, prospective clinical study after August 4, 2010. Allogeneic HSCT for the treatment of multiple myeloma, myelofibrosis (MF), and sickle cell disease (SCD) in a Medicare-approved, prospective clinical study after January 27, 2016. Covered for allogeneic HSCT for myelodysplastic syndromes (MDS) when provided pursuant to a Medicare-approved clinical study. Coverage for stem cell acquisition as per Medicare-approved clinical trial coding conventions. Allogeneic HSCT is covered for multiple myeloma when provided under a Medicare-approved clinical study. Allogeneic HSCT is covered for myelofibrosis when provided under a Medicare-approved clinical study. Allogeneic HSCT is covered for sickle cell disease when provided under a Medicare-approved clinical study. Coverage for specific ICD-10-CM diagnosis codes indicating hematologic malignancies and other related conditions. Coverage for ICD-10-PCS codes related to stem cell procedures in approved clinical trials. Professional claims are covered when submitted with place of service codes 19, 21, or 22. Coverage is provided for allogeneic stem cell transplantation when it meets the criteria outlined in the National Coverage Determination. Allogeneic stem cell transplantation is covered for recipients with inherited or acquired hematopoietic deficiencies. Autologous stem cell transplantation is covered for certain specified diagnoses for services rendered on or after April 28, 1989. Treatment of leukemia or leukemia in remission with appropriate ICD-10 codes. Treatment of aplastic anemia with appropriate ICD-10 codes. Treatment of severe combined immunodeficiency disease with appropriate ICD-10 codes. Treatment of Wiskott-Aldrich syndrome with ICD-10-CM code D82.0. Treatment of patients with acute leukemia in remission who have a high probability of relapse and no HLA matched. Treatment of resistant non-Hodgkin’s lymphomas with poor prognostic features after initial response. Treatment of recurrent or refractory neuroblastoma. Treatment of advanced Hodgkin’s disease for patients who failed conventional therapy and have no HLA matched donor. Covered for treatment of multiple myeloma for beneficiaries under age 78 with Durie-Salmon stage II or III newly diagnosed or responsive multiple myeloma and adequate cardiac, renal, pulmonary and hepatic functioning. Covered for treatment of recurrent or refractory neuroblastoma. High-dose melphalan with autologous stem cell transplantation is reasonable and necessary for treatment of primary AL amyloidosis in patients with amyloid deposition in 2 or fewer organs and cardiac left ventricular ejection fraction greater than 45%. Acute lymphoblastic leukemia not having achieved remission (ICD-10 C91.00) Acute lymphoblastic leukemia in remission (ICD-10 C91.01) Acute lymphoblastic leukemia in relapse (ICD-10 C91.02) Chronic lymphocytic leukemia of B-cell type not having achieved remission (ICD-10 C91.10) Chronic lymphocytic leukemia of B-cell type in remission (ICD-10 C91.11) Chronic lymphocytic leukemia of B-cell type in relapse (ICD-10 C91.12) Coverage for treatment of prolymphocytic leukemia of B-cell and T-cell types, both in remission and relapse. Coverage applies for acute and chronic myeloid leukemias, including variations with specific genetic markers. Coverage for various types of leukemia based on individual conditions such as remission and relapse status. Covered for the treatment of aplastic anemia as per the ICD-10-CM codes listed in the policy. Coverage for chronic acquired pure red cell aplasia (D60.0). Coverage for transient acquired pure red cell aplasia (D60.1). Coverage for constitutional (pure) red blood cell aplasia (D61.01). Coverage for drug-induced aplastic anemia (D61.1). Coverage for idiopathic aplastic anemia (D61.3). Covered for resistant non-Hodgkin's lymphomas with ICD-10-CM codes C82.01-C85.29, C85.81-C86.6, C96.4, and C96.Z-C96.9. Tandem transplantation for patients with multiple myeloma with ICD-10-CM codes C90.00, C90.01, C90.02, and D47.Z9. Acute leukemia not in remission prior to October 1, 2000 (ICD-10-CM codes C91.00, C92.00, C93.00, C94.00, and C95.00). Chronic granulocytic leukemia prior to October 1, 2000 (ICD-10-CM code C92.10). Solid tumors prior to October 1, 2000 (other than neuroblastoma) (ICD-10-CM codes C00.0 – C80.2 and D00.0 – D09.9). Multiple myeloma prior to October 1, 2000 (ICD-10-CM codes C90.00, C90.01, C90.02 and D47.Z9). Tandem transplantation on or after October 1, 2000 (ICD-10-CM codes C90.00, C90.01, C90.02, and D47.Z9). Primary AL amyloidosis effective October 1, 2000, through March 14, 2005, for Medicare beneficiaries age 64 (ICD-10-CM codes E85.4, E85.81, E85.9, and E85.89). Medically necessary for patients diagnosed with Myelodysplastic Syndrome (MDS) to receive appropriate treatment. Allogeneic HSCT for MDS is covered when provided under a Medicare-approved clinical study. Coverage is granted under the Coverage with Evidence Development (CED) provisions. Claims for hematopoietic stem cell transplant (HSCT) for myelodysplastic syndromes (MDS) are covered if provided under a Medicare-approved clinical study. Coverage includes procedures related to Medicare-approved clinical trials as specified in Pub. 100-04. Stem cell acquisition for approved cases as detailed in Medicare Claims Processing Manual. Services are covered only when provided in place of service codes 21 or 22. Coverage for cochlear implantation is provided when part of a qualifying clinical trial or study. Coverage for bilateral cochlear implantation for individuals with pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss. Patients must have hearing test scores of 60% or less in the best aided condition and demonstrate limited benefit from amplification. Coverage for FDA-approved category B IDE clinical trials. Routine costs associated with clinical trials under CMS clinical trial policy. The second or subsequent diagnosis code must be ICD-10-CM Z00.6 for claims processing to recognize it as a clinical trial. Routine costs associated with FDA-approved category B IDE clinical trials require the -Q1 modifier. Cochlear implantation devices and services are covered for beneficiaries meeting the criteria in Publication 100-03, Chapter 1, section 50.3. Claims for cochlear implantation devices are accepted for beneficiaries participating in an FDA-approved category B IDE clinical trial when billed with the -Q0 modifier. Routine costs for beneficiaries participating in clinical trials may be covered. Evaluation and therapeutic services related to cochlear implantation Routine clinical services provided in an approved clinical research study Coverage for cochlear devices includes all internal and external components. Replacement of cochlear implant external speech processors and controllers is covered. Treatment of speech, language, voice, communication, and auditory processing disorders is included. Cochlear implantation devices and services are covered for beneficiaries with moderate-to-profound hearing loss who have hearing test scores ≤ 40% through 9/25/22. Effective 9/26/22, cochlear implantation services are covered for beneficiaries with hearing test scores ≤ 60%. Claims processed using LCDs determine what is covered. Ultrasound stimulation is used for healing nonunion fractures. Ultrasonic osteogenic stimulators are covered for the treatment of nonunion bone fractures prior to surgical intervention. Ultrasonic Osteogenic Stimulators are covered when billed on specific type of bills (TOBs) 32X, 33X, 34X. Payment is allowed for ultrasonic osteogenic stimulators used to aid bone healing. Low intensity ultrasound stimulation is indicated for noninvasive and nonoperative treatments. A presbyopia-correcting IOL is indicated for primary implantation in the capsular bag of the eye following cataract extraction intended to provide near, intermediate, and distance vision. Coverage for insertion of an A-C IOL for patients with regular astigmatism. Payment for intraocular lens (IOL) insertion following cataract removal in a hospital setting or Medicare-approved ambulatory surgical center. Payment for the IOL is packaged into the payment for the surgical cataract extraction/lens replacement procedure. Covered for removal of a cataract with insertion of a conventional IOL. Covered when a P-C or A-C IOL is inserted following cataract removal. Facility charges for treatments, services, and supplies related to monitoring beneficiaries after P-C or A-C IOL insertion are not covered. Conventional IOL insertion is covered for medically necessary cataract surgery. Payment for conventional IOL insertion is included in the surgical facility payment. No Medicare benefit for physician charges related to the insertion of P-C or A-C IOL following cataract removal. Covered for complex cataract removal requiring advanced techniques or devices. Coverage includes extracapsular and intracapsular cataract procedures with intraocular lens prosthesis. Insertion of intraocular lens prosthesis (secondary implant) not associated with concurrent cataract extraction. Exchange of intraocular lens is medically necessary. Physicians, hospitals, and ASCs may bill for non-covered charges related to the P-C function of the IOL using HCPCS code V2788 effective January 1, 2006. From January 22, 2007 to January 1, 2008, HCPCS code V2788 can be used for non-covered charges related to the A-C function of the IOL. CPT codes can be used to bill for evaluation and management services following cataract extraction surgery. Coverage for conventional IOL insertion following removal of a cataract. Access to P-C or A-C IOL insertion is requested by the beneficiary after cataract removal. Cataract extraction with insertion of a P-C or A-C IOL is performed when beneficiary requests this service. Inclusion of additional work and resources for P-C or A-C IOL insertion and monitoring. Covered for patients with stable angina (Class III or IV) not amenable to surgical intervention. Patients must be evaluated by a cardiologist or cardiothoracic surgeon for candidacy. External Counterpulsation (ECP) services are covered when provided per session as indicated by the use of HCPCS code G0166. Evaluation and management services must be justified with adequate documentation of the medical necessity of the visit. Payment is made to hospitals for the facility costs incurred under Part B on a reasonable cost basis. Payment is made to PPS-exempt hospitals for facility costs incurred on a reasonable cost basis. Cardiac rehabilitation is covered when prescribed by a physician or nonphysician practitioner. Intensive cardiac rehabilitation is covered when it demonstrates improvement in cardiovascular disease through specific outcome measurements. Coverage for pulmonary rehabilitation is provided for patients with chronic obstructive pulmonary disease (COPD) and certain other chronic respiratory diseases when criteria are met. Coverage is dependent on the program being physician or nonphysician practitioner supervised. Documented diagnosis of acute myocardial infarction (MI) within the preceding 12 months. History of coronary bypass surgery. Stable angina pectoris. Heart valve repair/replacement. Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting. Heart or heart-lung transplant. Considered reasonable and necessary for up to 36 sessions of cardiac rehabilitation (CR) for patients post-cardiac event. Patients generally receive 2 to 3 sessions per week for 12 to 18 weeks. Coverage provided for outpatient cardiac rehabilitation services. Medicare Part B covers cardiac rehabilitation for beneficiaries who have had certain qualifying cardiac events as specified at 42 CFR 410.49. Acute myocardial infarction (MI) within the preceding 12 months. Coronary artery bypass surgery. Current stable angina pectoris. Heart valve repair or replacement. Stable chronic heart failure defined as left ventricular ejection fraction of 35% or less with NYHA class II to IV symptoms despite optimal heart failure therapy for at least 6 weeks. Other cardiac conditions specified through national coverage determination (NCD). Cardiac rehabilitation must include physician prescribed exercise and risk factor modification tailored to individual needs. A psychosocial assessment and outcomes assessment are required as part of the cardiac rehabilitation process. Medicare Part B covers cardiac rehabilitation in a physician's office or a hospital outpatient setting. Eligible nonphysician practitioners can supervise cardiac rehabilitation effective January 1, 2024. Physician or qualified health care professional services for outpatient cardiac rehabilitation. Cardiac rehabilitation (CR) sessions are covered when treatment duration is at least 31 minutes for one session or 91 minutes for two sessions reported in a single day. Covered for patients who have coronary artery disease, heart failure, or post heart surgery. Cardiac rehabilitation sessions are covered when the total duration exceeds 90 minutes in a day. Two sessions per day may be reported, regardless of total duration. Coverage for cardiac rehabilitation services is provided for patients who meet medical necessity criteria established by CMS. Intensive cardiac rehabilitation services are covered for patients who have experienced a qualifying cardiac event. Beneficiaries may participate in a series of up to 36 sessions of cardiac rehabilitation (CR) following a myocardial infarction (MI) within 12 months. Beneficiaries experiencing stable angina can also participate in one series of cardiac rehabilitation sessions up to 36 sessions. Eligibility for coverage of more CR or ICR requires experience of another indication. Coverage for up to 72 sessions of CR with documentation verifying the need beyond 36 sessions. Beneficiaries switching from ICR to CR may be eligible for a combined total of 72 sessions. CR and ICR services must use place of service code 11 for physician's office and code 22 for hospital outpatient settings. All other POS codes will lead to claim denials. Coverage is limited to certain settings as specified by Medicare guidelines. Payment is allowed for CR and ICR services submitted on Types of Bill (TOBs) 13X and 85X. CR claims (professional and institutional) are covered when they do not exceed 2 units per date of service. ICR claims are covered when they do not exceed 6 units per date of service. ICR claims (G0422 and G0423) are covered when they do not exceed 72 sessions. Claims are payable when all billed sessions are provided within 126 days from the date of the first session and a KX modifier is included. ICR services are covered when submitted by providers enrolled as specialty code 31. Medicare Part B covers ICR for beneficiaries who have experienced one or more specified conditions as outlined in 42 CFR 410.49. Acute myocardial infarction within the preceding 12 months. Stable chronic heart failure with left ventricular ejection fraction of 35% or less and NYHA class II to IV symptoms despite optimal heart failure therapy for at least 6 weeks from February 9, 2018. Other cardiac conditions as specified through an NCD. Medically necessary exercise prescribed by a physician for cardiac rehabilitation. Psychosocial assessment and individualized treatment plans required for patient treatment. Positively affected the progression of coronary heart disease. Reduced the need for coronary bypass surgery. Reduced the need for percutaneous coronary interventions. ICR program must demonstrate a statistically significant reduction in LDL and four other measures after CR services. ICR is covered in a physician's office or hospital outpatient setting with appropriate supervision. Eligible nonphysician practitioners may supervise ICR effective January 1, 2024. Hospitals and practitioners may report up to 6 1-hour sessions of ICR per day. A session can be reported if the treatment duration is at least 31 minutes. ICR sessions are reported by total duration, with specific thresholds determining the number of units billed. Coverage for pulmonary rehabilitation is provided for beneficiaries with moderate to very severe COPD (GOLD classification II, III, and IV) when referred by the physician treating the chronic respiratory disease. Coverage is also available for beneficiaries who have had confirmed or suspected COVID-19 and experience persistent respiratory dysfunction symptoms for at least four weeks. Covered when physician prescribes exercise during each pulmonary rehabilitation session. Education or training tailored to individual needs, including respiratory problem management and brief smoking cessation counseling. Covered when pulmonary rehabilitation is provided in a physician’s office or hospital outpatient setting with required medical supervision. Pulmonary rehabilitation (PR) services are medically necessary for patients requiring structured exercise interventions. Outpatient pulmonary rehabilitation services are covered without continuous oximetry monitoring per session. Outpatient pulmonary rehabilitation services are covered with continuous oximetry monitoring per session. Eligible patients may receive a maximum of 2 one-hour sessions of pulmonary rehabilitation (PR) per day, with each session lasting a minimum of 31 minutes. Coverage for pulmonary rehabilitation is provided when combined total of therapy sessions exceeds 90 minutes in a day. Services are considered medically necessary when provided to patients with chronic respiratory conditions. Pulmonary rehabilitation services are covered when provided according to the specified coding for up to two sessions per day. Pulmonary rehabilitation services are covered when performed in a physician's office (POS 11) or hospital outpatient setting (POS 22). PR services are covered when submitted on a type of bill (TOB) 13X and 85X along with revenue code 0948. Claims for PR services are covered when they do not exceed two units on the same date of service. Coverage for physical rehabilitation services is medically necessary when billed within the approved session limits. Bariatric surgery is covered for the treatment of morbid obesity as long as it meets the defined medical necessity criteria. Bariatric surgery is covered for patients with a body-mass index (BMI) ≥ 35 and at least one co-morbidity related to obesity. Patients must have been previously unsuccessful with medical treatment for obesity. Bariatric surgery is covered when performed on patients with Type 2 diabetes mellitus as a co-morbidity. Services for various bariatric procedures are covered when medically necessary. Open biliopancreatic diversion with duodenal switch (BPD/DS) is covered. Laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) is covered. Laparoscopic sleeve gastrectomy (LSG) is covered at MAC discretion. Covered for bariatric surgery procedures like gastric bypass and other restrictive procedures to treat morbid obesity. Surgical procedures include laparoscopy with gastric bypass and various gastric restrictive techniques. Covered for laparoscopic vertical banded gastroplasty. Covered for open sleeve gastrectomy. Bariatric surgery is covered for treatment of co-morbid conditions related to morbid obesity. Indicated for patients requiring bypass surgery using autologous, synthetic, or non-autologous tissue substitutes. Coverage based on medical necessity for specific gastrointestinal bypass procedures. Medically necessary for patients requiring bypass of stomach to jejunum using non-autologous tissue substitute. Indicated for patients requiring bypass of stomach to ileum with non-autologous tissue substitute. Coverage for various surgical bypass procedures involving the stomach and intestine. Covered for bypass surgeries involving the stomach and various segments of the intestines. Medically necessary for patients who meet specific clinical criteria for surgical intervention. Covers endoscopic bypass procedures when performed for appropriate clinical indications. Coverage for endoscopic bypass of the stomach to the transverse colon, duodenum, jejunum, and ileum. Medically necessary when performed in accordance with defined surgical guidelines. Covered for excision of the stomach via natural or artificial opening. Covered for excision of the small intestine and duodenum when performed with appropriate indications. Medically necessary for bypass procedures from duodenum to jejunum, ileum, or duodenum as specified. Indicated for patients requiring a bypass of the duodenum due to conditions affecting normal digestive function. Bypass surgery of the duodenum using autologous, synthetic, or non-autologous tissue substitutes for clinically indicated conditions. Covered for patients requiring bypass procedures from the duodenum to the jejunum or ileum using non-autologous tissue substitutes via percutaneous endoscopic approaches. Indicated for patients requiring duodenal bypass for severe gastrointestinal obstruction. Covered for surgical bypass procedures involving duodenum, jejunum, or ileum, via natural or artificial openings. Covered for jejeunostomy procedures involving bypass with autologous, synthetic, or non-autologous tissue substitutes. Medically necessary for patients requiring rerouting of intestinal flow to treat conditions like obstructions or malabsorption. Covered when performing bypass procedures from jejunum to ileum or jejunum to jejunum with appropriate substitution technique. Indicated for patients requiring surgical intervention for gastrointestinal conditions. Surgical intervention for bypassing ileum is medically necessary when traditional methods are inadequate. ICD-10 procedure code 0DB64Z3 is covered for bariatric surgery at contractor discretion. Bariatric surgery is covered for Medicare beneficiaries with a BMI ≥35 and type 2 diabetes mellitus as a comorbid condition. Claims must include ICD code E66.01 as primary diagnosis and associated codes for T2DM and BMI ≥35. Covered for patients with Body Mass Index (BMI) 39.0-39.9, 40.0-44.9, 45.0-49.9, 50.0-59.9, 60.0-69.9, and 70.0 and over who have Type II Diabetes Mellitus. Coverage is provided for Type 2 diabetes mellitus with or without complications as specified by associated ICD-10 codes. Services are payable for diabetic conditions including hyperglycemia, ketoacidosis, hypoglycemia, diabetic nephropathy, and diabetic retinopathy. Coverage for Type 2 diabetes mellitus with specified diabetic retinopathy conditions, including mild, moderate, severe, and proliferative classifications. Diabetes-related retinal diagnoses including proliferative diabetic retinopathy with or without macular edema are covered. Claims are payable for other specified diabetes mellitus with various stages of diabetic retinopathy. Coverage is provided for various diabetic retinopathy diagnoses with associated conditions such as macular edema and traction retinal detachment. Specific codes E11.39 and E11.65 together do not require coverage; each can justify the service individually. Coverage for Type 2 diabetes related complications including diabetic neuropathy, angiopathy, and skin complications. Medically necessary for conditions resolved following treatment like diabetic macular edema. Diagnosis of other specified diabetes mellitus with hypoglycemia without coma (E13.649). Diagnosis of other specified diabetes mellitus with hyperglycemia (E13.65). Diagnosis of other specified diabetes mellitus with other specified complication (E13.69). Diagnosis of other specified diabetes mellitus with unspecified complications (E13.8). Diagnosis of type 2 diabetes mellitus with unspecified complications (E11.8). Bariatric surgery is covered for treatment of co-morbid conditions related to morbid obesity when diagnosed with ICD-10 code E66.01. Bariatric surgery is covered when the beneficiary has a BMI ≥35 and at least one obesity-related co-morbidity. Bariatric surgery procedures are covered for patients with the ICD-10 diagnosis code E66.01 when the procedure code is present. Bariatric surgery may be covered for patients who meet specific criteria related to obesity and associated comorbidities. Bariatric surgery is covered when performed in Indian Health Services inpatient hospitals and other inpatient hospitals under specific billing requirements. Bariatric surgery is covered when performed in an approved facility. Physician must ensure beneficiaries are informed about financial liability for unapproved facilities. Medicare covers percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement when performed according to FDA protocols governing Category B IDE studies. Coverage requires billing of a six-digit IDE Number beginning with 'G'. Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent and embolic protection device for FDA-approved indications when furnished according to FDA protocols. Covers patients participating in FDA-approved post-approval studies and extension studies. Patients participating in FDA-approved post-approval studies are included in the covered population. Reimbursement for procedures performed as part of a carotid artery stenting post-approval study. Extension studies reviewed and acknowledged by the FDA are covered by Medicare. Coverage for procedures performed in FDA-approved post-approval extension studies following submission of required documentation. Cerebral infarction due to thrombosis of carotid arteries Cerebral infarction due to embolism of carotid arteries Cerebral infarction due to occlusion or stenosis of carotid arteries Medically necessary for dilation of intracranial arteries with drug-eluting intraluminal devices for patients meeting specific clinical criteria. Indicated for cases requiring percutaneous or percutaneous endoscopic approaches. Dilation of intracranial artery with four or more intraluminal devices, percutaneous endoscopic approach. Dilation of right common carotid artery with drug-eluting or intraluminal devices via percutaneous approach. Dilation of left common carotid artery with drug-eluting or intraluminal devices via percutaneous approach. Dilation of the left or right common carotid arteries with drug-eluting or intraluminal devices. Dilation with two, three, or four or more devices in both common and internal carotid arteries. Dilation of the carotid arteries is indicated in cases of significant stenosis causing ischemic symptoms. Percutaneous approaches are medically necessary when traditional surgical methods pose higher risks. Dilation of the left external carotid artery using intraluminal devices via percutaneous approach is covered. Use of drug-eluting devices is indicated for patients requiring advanced intervention in artery dilation. CAS is covered for patients with symptomatic carotid artery stenosis who have a minimum 70% stenosis. CAS is also indicated for asymptomatic patients with 80% or greater carotid artery stenosis. Coverage for PTA of the carotid artery concurrent with stenting for Medicare beneficiaries with symptomatic carotid artery stenosis ≥ 50%. Coverage for PTA of the carotid artery concurrent with stenting for asymptomatic carotid artery stenosis ≥ 70%. Patients with symptomatic carotid artery stenosis of 50% or greater. Patients with asymptomatic carotid artery stenosis of 70% or greater. Covered for patients undergoing PTA of the carotid artery concurrent with placement of an FDA-approved carotid stent with embolic protection. Coverage requires use of FDA-approved CAS systems and approved embolic protection devices. CAS with embolic protection is reasonable and necessary for high-risk patients when performed in competent facilities. Intracranial PTA with stenting is covered when performed in accordance with FDA-approved protocols for Category B IDE clinical trials. Intracranial PTA and stenting covered for patients with cerebral atherosclerosis (I67.2) when appropriate procedure and diagnosis codes are billed. ICD-10-PCS procedure codes are required for billing intracranial PTA under Part A. Dilation procedures for intracranial arteries with drug-eluting intraluminal devices are covered when medically necessary. Dilation of the right common carotid artery using intraluminal devices is covered. Dilation of the left common carotid artery using intraluminal devices is covered. Dilation of the carotid artery with intraluminal devices is covered when medically necessary for symptomatic carotid artery disease. Use of drug-eluting devices for internal carotid artery dilation is medically necessary for patients with specific clinical indications. Dilation of carotid arteries with drug-eluting intraluminal devices is indicated for patients with symptomatic carotid artery stenosis. Procedures using multiple drug-eluting devices are indicated for severe stenosis requiring advanced intervention. Dilation of the left external carotid artery with one or more intraluminal devices is covered when clinically indicated. Use of drug-eluting intraluminal devices for dilation is covered when medically warranted. LADR with lumbar artificial discs is not covered for Medicare beneficiaries over 60 years of age. LADR with the Charite™ lumbar artificial disc is covered for Medicare beneficiaries over 60 years of age. Total disc arthroplasty is covered for lumbar interspace replacement after discectomy when medically necessary. LADR is covered when approved under the IDE/clinical trial criteria. Services performed on TOB 11X in CAHs are payable at 101% of reasonable cost. Services performed on TOB 11X in IHS inpatient hospitals are based on the inpatient prospective payment system (IPPS) based on the DRG. Cryosurgery for the treatment of prostate cancer is covered when medically necessary. Coverage for primary treatment of clinically localized prostate cancer, Stages T1 – T3 (ICD-10 code 185). Salvage therapy for recurrent, localized prostate cancer in patients who failed radiation therapy and meet specific criteria. Cryosurgery for localized prostate cancer, stages T1-T3, is covered. Cryosurgery claims must include the appropriate ICD-9-CM or ICD-10-CM diagnosis codes. Payment for outpatient claims must include postoperative irrigations and aspiration of sloughing tissue. Covered for primary treatment of clinically localized prostate cancer, Stages T1 – T3. Cryosurgery performed as salvage therapy is covered under specified conditions. Inpatient services in Critical Access Hospitals (CAH) are covered at 101% of reasonable cost, minus applicable deductible and coinsurance. Inpatient services in short-term acute care hospitals are covered at DRG payment minus applicable deductible and coinsurance. Outpatient services in hospitals subject to Outpatient PPS are covered at assigned APC minus applicable deductible and coinsurance. Outpatient services in exempt hospitals are covered at reasonable cost, minus applicable deductible and coinsurance. Payment is made for outpatient services in Indian Health Service hospitals using TOBs 13x and 83x. Inpatient services performed at hospitals exempt from inpatient acute care PPS are covered. Coverage for alcohol misuse screening with HCPCS code G0442 and counseling with HCPCS code G0443 when billed with another encounter on the same date of service. Medically necessary behavioral counseling for alcohol misuse indicated by code G0443. Screening for alcohol misuse is covered once in a 12-month period using HCPCS code G0442. Alcohol misuse counseling sessions are covered up to four times in a 12-month period using HCPCS code G0443. Alcohol misuse counseling session HCPCS code G0443 is covered if there is a prior claim for screening service HCPCS code G0442 in the last 12 months. Covered when an alcohol misuse screening (G0442) is performed and paid for, with frequency limits applied. G0443 PROF services are covered when billed in conjunction with G0442 PROF services. Counseling sessions for G0443 are limited to four sessions within a 12-month period based on prior G0442 service. G0442 is covered for beneficiaries meeting eligibility criteria. G0443 is covered only if G0442 has been paid for the same beneficiary. Alcohol misuse screening is covered once every 11 months with code G0442. Alcohol misuse brief behavioral counseling is covered up to 4 times in a 12-month period with code G0443. G0442 screening is covered when performed on the same date of service as G0443 counseling. Extracorporeal photopheresis is covered for patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppressive drug treatment. Extracorporeal photopheresis is covered for patients with chronic graft versus host disease whose disease is refractory to standard immunosuppressive drug treatment. Extracorporeal photopheresis is covered for the treatment of bronchiolitis obliterans syndrome (BOS) after lung allograft transplantation when provided under a clinical research study. Coverage for extracorporeal photopheresis is applicable for patients with oncological and autoimmune disorders. Extracorporeal photopheresis is medically necessary for treating bronchiolitis obliterans syndrome (BOS) following lung allograft transplantation when provided under a clinical research study. Coverage for Mycosis fungoides affecting specific lymph nodes including the head, face, neck, intrathoracic, intra-abdominal, axilla, inguinal region, pelvic lymph nodes, spleen, and multiple/extranodal sites. Coverage for Sézary disease affecting specific lymph nodes including the same regions as Mycosis fungoides. Covered for cutaneous T-cell lymphoma, unspecified, in various anatomic sites including lymph nodes of the head, face, neck, and other regions. Coverage for acute cardiac allograft rejection and related graft-versus-host diseases. Conditions include chronic graft-versus-host disease, acute on chronic graft-versus-host disease, and unspecified graft-versus-host disease. Covered for patients with chronic bronchitis and chronic obstructive pulmonary disease. Applicable for codes J42, J44.0, J44.1, J44.81, J44.9, T86.810, T86.811, T86.812, T86.818, T86.819, Z94.2, and Z00.6. Coverage for extracorporeal photopheresis is medically necessary for bronchiolitis obliterans syndrome (BOS) in inpatient or outpatient hospital settings. Service is covered when deemed reasonable and necessary under 1862(a)(1)(A) of the Act. Coverage of Vagus Nerve Stimulation (VNS) when provided under specific conditions as outlined in hospital guidelines. Vagal nerve stimulation is covered for the treatment of refractory epilepsy in patients who have not responded to at least two antiepileptic medications. Vagus Nerve Stimulation is covered when the appropriate ICD-10 diagnosis codes are reported. Covered for localization-related (focal) idiopathic epilepsy and epileptic syndromes with localized onset seizures, intractable. Coverage for Dravet syndrome with intractable epilepsy is applicable when the patient experiences status epilepticus. Coverage for Dravet syndrome without status epilepticus is also medically necessary. Covered for Lafora progressive myoclonus epilepsy patients with intractable seizures without status epilepticus. Vagus nerve stimulation is covered for epilepsy and recurrent seizures. Claims submitted for vagus nerve stimulation are accepted for services performed on or after July 1, 1999. Claims submitted for vagus nerve stimulation for epilepsy and recurrent seizures are accepted. Vagus nerve stimulation is considered medically necessary for epilepsy patients whose seizures are not controlled by other treatments. Medicare will cover Vagus Nerve Stimulation procedures when it's reasonable and necessary for specific seizure disorders or resistant depression. Covers billing for wrong surgical or other invasive procedures performed on a patient. Covers billing for procedures performed on the wrong body part. Hospitals must bill a covered claim for services unrelated to a surgical error. Non-covered claims must be reported for procedures related to the erroneous surgery on specific codes. Claims related to surgical errors must utilize applicable HCPCS modifiers. Surgeries deemed erroneous will be denied. Providers must issue an Advance Beneficiary Notice of Non-coverage (ABN) when a service is believed to be denied by Medicare. Hospital Issued Notices of Non-coverage (HINNs) must also be issued under similar circumstances. Services related to follow-up care for non-covered surgical errors may be covered if delivered a proper notice. Claims for beneficiaries with transgender, ambiguous genitalia, and hermaphrodite issues may be covered when billed properly. Services for transgender, ambiguous genitalia, and hermaphrodite beneficiaries are covered when modifier KX is used. Claims may proceed with normal processing when a gender/procedure or gender/diagnosis conflict edit occurs using the KX modifier. Billing of the KX modifier is required for procedure codes specific to transgender, ambiguous genitalia, and hermaphrodite beneficiaries. Pharmacogenomic testing for warfarin responsiveness is covered for candidates for anticoagulation therapy with warfarin who have not been previously tested for CYP2C9 or VKORC1 alleles. Testing is covered when the patient has received fewer than five days of warfarin in the anticoagulation regimen. Claims for pharmacogenomic testing for warfarin response must include ICD-10 diagnosis codes Z79.01 (primary) and Z00.6 (secondary). Practitioner clinical trial claims for pharmacogenomic testing for warfarin response are eligible when all required elements are present. Use of ICD-10 diagnosis codes Z79.01 and Z00.6 is covered in relevant clinical trial settings. HCPCS code G9143 is covered for applicable claims with dates of service on or after August 3, 2009. Covered when pharmacogenomic testing for warfarin response is medically necessary. Pharmacogenomic testing for warfarin response is covered when billed with HCPCS modifier Q0 and ICD-10-CM Z00.6 as a secondary diagnosis. Coverage requires a valid ICD-10-CM Z00.6 diagnosis code when reporting HCPCS G9143 with Q0 modifier. Coverage for treatments for facial lipodystrophy syndrome is provided for HIV-infected Medicare beneficiaries experiencing severe facial abnormalities due to HIV or highly active antiretroviral therapy. Dermal injections for facial LDS are covered in HIV-infected beneficiaries manifesting depression secondary to the physical stigmata of HIV treatment. Covered when LIDOS is performed on or after March 23, 2010. Coverage for ICD-10-CM diagnosis codes B20 (Human Immunodeficiency Virus disease) and E88.1 (Lipodystrophy, not elsewhere classified). Facial LDS claims are to be covered when billed with the required temporary HCPCS code. Covered for patients with Human Immunodeficiency Virus [HIV] disease (ICD-10-CM code B20) and Lipodystrophy (ICD-10-CM code E88.1). A diagnosis code for comorbidity of depression may be required for coverage determinations. Covered for treatment of facial lichen sclerosus (LDS) when billed correctly. Covered for patients with a diagnosis of HIV (ICD-10-CM B20) and lipodystrophy (ICD-10-CM E88.1) on or after March 23, 2010. Treatment is applicable when using HCPCS code G0429. ICD-9-CM procedure code 86.99 or ICD-10-PCS procedure code 3E00XGC is applicable. ICD-9 diagnosis codes 042 and 272.6, or ICD-10-CM diagnosis codes B20 and E88.1 are relevant. A diagnosis code for comorbidity of depression may be required based on individual contractor's policy. Dermal injections for the treatment of facial LIDOS are covered when performed in a non-facility setting. Coverage for HIV disease (ICD-10-CM code B20) and lipodystrophy (ICD-10-CM code E88.1) requires both diagnosis codes on the claim. A diagnosis code for the comorbidity of depression may be required based on the individual Medicare contractor's policy. Dermal injections for treatment of facial LDS are covered after March 23, 2010. Covered for treatment of facial LDS in patients with comorbidities of HIV and lipodystrophy. Covered for Medicare beneficiaries who meet comorbidity requirements, including HIV and lipodystrophy. Implantable automatic defibrillator is covered for treating life-threatening tachyarrhythmias. Removal of single or dual chamber pacing cardioverter-defibrillator electrodes by transvenous extraction. Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator. Insertion of defibrillator generator into abdomen subcutaneous tissue and fascia, open approach. Insertion of defibrillator generator into abdomen subcutaneous tissue and fascia, percutaneous approach. Insertion of defibrillator lead into right atrium, left atrium, or left ventricle is indicated for patients who require cardiac resynchronization therapy. Percutaneous approaches to defibrillator lead insertion are covered for patients meeting necessary clinical criteria. Covered for removal of cardiac rhythm related devices under specific circumstances. Insertion of defibrillator lead into the right atrium is medically necessary for patients requiring cardiac pacing. Insertion of defibrillator lead into the left atrium is indicated for certain arrhythmias. Patients receiving a defibrillator for primary prevention of sudden cardiac arrest must be enrolled in a qualifying data collection system. Covered for secondary prevention patient or replacement implantations due to recalled devices. Includes ICD-9-CM codes for significant cardiac issues such as ventricular tachycardia, cardiac arrest, and mechanical complications of cardiac devices. Coverage for ventricular tachycardia diagnoses including unspecified and specific types such as Torsades De Pointes. Coverage for cardiac arrest due to underlying cardiac conditions or unspecified causes. Displacement of cardiac electrode, pulse generator, and other electronic devices during initial encounter. Personal history of sudden cardiac arrest. Coverage of sipuleucel-T (PROVENGE®) is provided for patients with asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone refractory) prostate cancer. PROVENGE® treatment is covered when using HCPCS code C9273 for Sipuleucel-T, which includes leukapheresis and all preparatory procedures. On-label indication of asymptomatic or minimally symptomatic metastatic, castrate-resistant prostate cancer. Coverage for secondary malignant neoplasm of intrathoracic lymph nodes. Coverage for secondary malignant neoplasm of intra-abdominal lymph nodes. Coverage for secondary malignant neoplasm of lymph nodes of the inguinal region and lower limb. Coverage for secondary malignant neoplasm of intrapelvic lymph nodes. Coverage for secondary malignant neoplasm of lymph nodes of multiple sites. Coverage for secondary malignant neoplasm of unspecified lymph node site. Coverage for secondary malignant neoplasm of lung. Coverage for secondary malignant neoplasm of liver. Coverage for secondary malignant neoplasm of kidney. Diagnosis of secondary malignant neoplasm of the urinary organs. Secondary malignant neoplasm originating in the bone and bone marrow. PROVENGE® used off-label for the treatment of prostate cancer. Malignant neoplasm of prostate (C61) is covered for on-label or off-label indications. Carcinoma in situ of prostate (D075) is covered for off-label indications only. Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes (C77.1) is a covered indication. Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes (C77.2) is a covered indication. Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes (C77.4) is a covered indication. Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes (C77.5) is a covered indication. Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions (C77.8) is a covered indication. Coverage for the diagnosis of secondary and unspecified malignant neoplasms in lymph nodes. Treatment coverage for secondary malignant neoplasms located in various organs including lung, liver, kidney, urinary organs, and bone. PROVENGE® is covered for use in specified institutional claims with applicable Types of Bill. Payment for PROVENGE® is covered when billed with ICD-9-CM diagnosis code 185 and at least one other diagnosis code from defined ICD-9 table. Coverage for PROVENGE® is limited to three services in a patient's lifetime. Transcatheter aortic valve replacement (TAVR) is indicated for patients with aortic stenosis. Coverage is contingent upon the criteria set by the heart team and the hospital. Transcatheter Aortic Valve Replacement (TAVR) is covered for patients with severe aortic stenosis. Covered for patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement. Indicated when the patient meets the criteria established for successful transcatheter delivery. TAVR is indicated for patients with severe aortic stenosis who are at high risk for surgery. Procedure is covered when performed using appropriate techniques and approaches. TAVR services are covered when performed in place of service code 21. TAVR claim lines are covered when billed with diagnosis code V70.7 (ICD-10 Z00.6). TAVR claims are payable with the appropriate clinicaltrials.gov identifier number. TAVR services are covered when performed in accordance with FDA-approved clinical trial protocols. TAVR procedures are covered for inpatient hospital discharges when billed with a 11X TOB. Inpatient hospital discharges for TAVR are medically necessary when billed with ICD-10 Z00.6 for dates of service on or after October 1, 2015. Inpatient hospital discharges for TAVR are also covered when accompanied by an 8-digit clinicaltrials.gov identifier number. Covered when services are provided as part of a qualifying trial/study. Ocular Photodynamic Therapy (OPT) is covered for the treatment of age-related macular degeneration (AMD). OPT with Verteporfin is covered when billed with applicable ICD-10-CM codes. Covered for patients with exudative age-related macular degeneration affecting the right eye. Covered when diagnosis specifies stage or presence of choroidal neovascularization or scar in either eye. ICD-10 Codes for OPT with Verteporfin are eligible for local coverage determinations through individual contractor discretion. Covered for unspecified macular degeneration. Applicable to various stages of nonexudative age-related macular degeneration in right and left eyes. Covered for diagnoses related to Exudative Age-related Macular Degeneration. Covered for ventilated patients in the ICU. Covered for operative patients needing intra-operative fluid optimization. Transesophageal Doppler cardiac monitoring is indicated for ventilated patients in the ICU or for operative patients needing intra-operative fluid optimization. Intra-operative fluid optimization procedures when performed in an Ambulatory Surgical Center (ASC) setting. Transesophageal Doppler cardiac monitoring is covered for patients in specific clinical scenarios that require hemodynamic assessment. Transesophageal Doppler (HCPCS G9157) is covered for cardiac monitoring of ventilated patients in the ICU or for operative patients needing intra-operative fluid optimization. Transesophageal Doppler cardiac monitoring is covered when provided at Place of Service (POS) 21. Coverage determinations for artificial hearts and related devices shall be made by Medicare Administrative Contractors. Use of artificial hearts is covered when beneficiaries are enrolled in a clinical study that meets specified criteria. Artificial hearts in the context of an approved clinical study for a Category A IDE. Rheumatic heart failure (I09.81) covered for appropriate management. Hypertensive heart disease with heart failure (I11.0) is covered. Chronic kidney disease stages 1-4 with heart failure (I13.0) is covered. End stage renal disease with heart failure (I13.2) is covered. Unstable angina (I20.0) eligible for coverage. ST elevation myocardial infarctions (STEMI) involving various coronary arteries (I21.01-I21.29) are covered. Non-ST elevation myocardial infarction (NSTEMI) (I21.4) is covered. Subsequent myocardial infarctions (I22.0-I22.2) qualify for coverage. Coverage for subsequent ST elevation myocardial infarction of other sites and unspecified sites. Coverage for acute coronary thrombosis not resulting in myocardial infarction. Coverage for ischemic cardiomyopathy. Atherosclerosis of native coronary artery of transplanted heart is covered with various forms of angina pectoris. Nonrheumatic mitral and aortic valve conditions are covered under specific diagnostic codes. Coverage for cardiomyopathies including eosinophilic disease, endocardial fibroelastosis, alcoholic cardiomyopathy, among others. Treatment for various arrhythmias including atrial fibrillation, ventricular tachycardia, and sick sinus syndrome is covered. Coverage for postprocedural heart failure following cardiac surgery and other surgical procedures. Indications include complications from congenital heart defects and intraoperative cardiac disturbances. Coverage for congenital heart conditions requires specific ICD-10 codes listed in the document. Covered for aftercare following heart transplant. Covered for aftercare following heart-lung transplant. Covered for patients with heart transplant status. Coverage for cardiac allograft vasculopathy (T86.290) and other complications of heart transplant. Coverage for encounters following heart transplant (Z48.21) and heart-lung transplant (Z48.280). Medicare may cover a Ventricular Assist Device (VAD) for patients with a damaged or weakened native heart. A VAD is used to assist or augment the heart's ability to pump blood, potentially allowing for device removal. Ventricular assist devices (VADs) are covered for post-cardiotomy use if FDA-approved and used according to FDA labeling instructions. Left ventricular assist devices (LVADs) are covered for short-term and long-term mechanical circulatory support for heart failure patients meeting specific clinical criteria. VADs are covered in the context of Category B investigational device exemption clinical trials. Covered for patients diagnosed with rheumatic heart failure. Covered for hypertensive heart disease with heart failure. Coverage includes chronic kidney disease stages 1-4 associated with hypertensive heart disease and heart failure. Includes patients with stage 5 chronic kidney disease or end-stage renal disease linked to hypertensive heart disease and heart failure. Covered for patients with unstable angina. Coverage for ST elevation (STEMI) myocardial infarction involving the left main coronary artery. Coverage is provided for various ST elevation myocardial infarctions including those involving the anterior, inferior, and right coronary arteries. Subsequent myocardial infarctions are also covered under specific codes. Acute coronary thrombosis not resulting in myocardial infarction is a covered indication. Coverage for patients with unstable angina pectoris as indicated by ICD-10 code I25.110. Patients with atherosclerotic heart disease and documented spasm are covered under ICD-10 code I25.111. Refractory angina pectoris is covered when diagnosed according to ICD-10 code I25.112. Coverage is indicated for atherosclerosis of autologous and nonautologous arteries related to coronary artery bypass graft(s) with specified types of angina pectoris. Conditions are categorized based on the type of angina (unstable, documented spasm, or unspecified). Coverage for chronic ischemic heart diseases such as atherosclerosis with and without angina pectoris. Coverage for nonrheumatic valve disorders affecting mitral, aortic, tricuspid, and pulmonary valves. Coverage for endocarditis and heart valve disorders. Coverage for various types of cardiomyopathy including dilated and hypertrophic. Coverage for cardiac arrhythmias including sick sinus syndrome and unspecified cardiac arrhythmia. Coverage for various types of heart failure, including acute and chronic systolic, diastolic, and combined heart failure. Postprocedural heart failure following cardiac surgery or other surgery. Other postprocedural cardiac functional disturbances following cardiac surgery or other surgery. Intraoperative cardiac arrest during cardiac surgery or other surgery. Other intraoperative cardiac functional disturbances during cardiac surgery or other surgery. Complications related to biological heart valve grafts, artificial hearts, infusion catheters, and other cardiac devices. Heart transplant and heart-lung transplant complications such as rejection, infection, and failure. Claims for replacement of accessories and supplies for VADs are payable for patients who are now eligible for coverage under Medicare Part B. Coverage for replacement of supplies and accessories for external VADs in rare instances. Coverage for emergency back-up controllers for external VADs may be necessary. Covered for use with an external ventricular assist device. Covered for use with an implanted ventricular assist device. Covered for replacement of specific components of pneumatic and electric ventricular assist devices. Power pack base, emergency power sources, and related components are covered for replacement use with electric or pneumatic ventricular assist devices. Replacement of holsters, belts, bags, filters, and mobility carts specifically designed for use with electric or electric/pneumatic ventricular assist devices. Replacement of batteries and power adapters for pneumatic ventricular assist devices. Dressings used with vascular access devices (VADs) are covered when determined to be medically necessary. Percutaneous Image-guided Lumbar Decompression (PILD) is covered for patients with Lumbar Spinal Stenosis (LSS) who have not responded to conservative management. Percutaneous Image-guided Lumbar Decompression (PILD) is covered for symptomatic lumbar spinal stenosis (LSS) unresponsive to conservative therapy. Percutaneous image-guided lumbar decompression (PILD) is covered when billed as part of a clinical trial approved by CMS. PILD procedure code G0276 is covered when also billed in connection with a blinded procedure for lumbar stenosis as part of an approved clinical trial. Covered for beneficiaries with lumbar spinal stenosis (LSS) enrolled in a CMS-approved prospective longitudinal study for PILD procedures. Coverage requires the use of an FDA-approved/cleared device that is part of a CMS-approved randomized controlled clinical trial. PILD is covered for ICD-9 diagnosis codes 724.01-724.03 or ICD-10 codes M48.05-M48.07, specifically billed in places of service 22 or 24. Payment for PILD claims with procedure code G0276 and 8-digit clinical trial identifier number. PILD is covered for LSS claims only when billed in place of service 22 or 24. PILD claims for LSS are only payable when billed with modifier Q0. PILD claims for LSS are payable only when billed with ICD-9 codes 724.01-724.03 or ICD-10 codes M48.05-M48.07. PILD claims are payable when billed with ICD-9 diagnosis of V70.7 or ICD-10 diagnosis of Z00.6 in either primary or secondary positions. Coverage for PILD is provided for beneficiaries with lumbar spinal stenosis (LSS) enrolled in a CMS-approved prospective longitudinal study using an FDA-approved device. Coverage is provided for hospital outpatient procedures for PILD when performed in conjunction with ICD-10 Z00.6 and Condition Code 30. Procedures must also include Modifier Q0 and a valid clinical trial identifier. Claims are covered only when billed by hospitals participating in the clinical trial/registry. Used in the treatment of mitral regurgitation (MR). Coverage for mitral valve TEER procedures for the treatment of functional mitral regurgitation (MR). Coverage for TEER for the treatment of degenerative MR through coverage with evidence development (CED) and mandatory registry participation. TMVR for significant, symptomatic degenerative mitral regurgitation when furnished according to an FDA-approved indication and all CMS coverage criteria are met. TMVR for MR uses not expressly listed as FDA-approved indications within the context of an FDA-approved, randomized clinical trial that meets all CMS coverage criteria. TMVR is covered under Coverage with Evidence Development (CED). Transcatheter mitral valve repair is covered when performed via percutaneous approach including transseptal puncture. Nonrheumatic mitral valve insufficiency (I34.0) Nonrheumatic mitral valve prolapse (I34.1) Encounter for examination for normal comparison and control in clinical research program (Z00.6) Coverage is limited to specific clinical settings as indicated in the Medicare Summary Notice. Claims for Mitral Valve TEER procedures must include a mandatory National Clinical Trial Number. Covered for inpatient hospital discharges for mitral valve TEER when billed using specific clinical trial coding. Mitral Valve TEER services are covered for eligible Medicare Advantage participants. Mitral valve transcatheter edge-to-edge repair (TEER) services are covered for Medicare Advantage (MA) plan participants. Emergency services furnished in a foreign country under specific conditions outlined in 42 CFR 424.120-127. Payment is made for Part A inpatient and Part B outpatient services in a nonparticipating U.S. hospital necessary to prevent death or serious impairment of health. Services may be reimbursed if the hospital is defined as an emergency hospital and the services are emergency services. Emergency inpatient hospital services covered if the emergency occurred while the beneficiary was in the United States or in Canada while traveling without reasonable delay. Emergency or nonemergency inpatient hospital services covered if the hospital is closer or more accessible than the nearest participating U.S. hospital capable of treatment. Payment for physician and ambulance services during a covered foreign hospitalization. Services provided aboard a ship are covered only when in United States waters. Service must be provided by a doctor licensed to practice in the United States. Inpatient hospital services are covered for qualified Railroad Retirement beneficiaries in Canadian hospitals. Services for individuals with religious nonmedical health care status may be covered if criteria are met. Emergency services are covered when necessary to prevent death or serious impairment. Emergency diagnosis or treatment is deemed necessary based on physician evaluation upon patient arrival to the hospital. Claim substantiation for emergency hospitalization may require evaluation from the attending physician who ordered hospitalization. Emergency services are covered when medical necessity is documented. Subsequent payment requests for extended emergency situations must be substantiated with adequate physician statements. Nonparticipating hospitals that meet legal definitions and full-time nursing services. Hospitals primarily engaged in providing services under the supervision of medical doctors. Emergency services received by Medicare beneficiaries in foreign hospitals. Emergency services are covered if the foreign hospital is closer or substantially more accessible than the nearest adequately equipped U.S. hospital. Coverage applies if the individual was physically present in the U.S. at the time of the emergency and departed specifically to obtain treatment at the foreign hospital. Emergency benefits are payable if the emergency occurred while traveling without unreasonable delay between Alaska and another state. Coverage applies if the beneficiary was enroute by the shortest practicable route or while making a necessary stopover. Route involving less travel in Canada is considered the 'shortest practicable route'. Greater travel may be justified due to factors like road conditions, age, health, or need for accommodations. Coverage is provided for inpatient hospital services in a foreign hospital if it is closer or more accessible than the nearest U.S. hospital equipped for the condition. Applicable regardless of whether an emergency existed and regardless of where the illness or injury occurred. Services provided in hospitals accredited by standards equivalent to Joint Commission must be covered. Claims for services at Canadian hospitals accredited by the CCHA meet qualifying requirements. Services may be covered if provided in an emergency situation, determined by medical necessity. Claims for services may be approved based on accessibility to a foreign hospital near the beneficiary's U.S. residence. Claims may be covered if evidence suggests the beneficiary was not aware of their non-coverage status. Necessary physician and ambulance services furnished in connection with a covered foreign hospitalization. Physicians' services are covered on the day of inpatient admission for the same condition being treated. Ambulance services are covered for the trip to the hospital when necessary for inpatient admission. Coverage includes services furnished by foreign licensed practitioners when provided outside the U.S. Beneficiaries may file for Part B benefits through properly licensed foreign physicians or ambulance companies. Covered hospital services for qualified railroad retirement beneficiaries (QRRBs) in Canadian hospitals. Part B services related to hospitalization in Canada are processed by the RRB. Claims for inpatient hospital services in Mexico related to QRRB beneficiaries. Laboratory services are covered if furnished during an emergency inpatient service at a hospital-leased laboratory that does not meet participation conditions. Nonemergency services to Medicare beneficiaries may be paid if the coverage requirements for the services are met. Part B medical and other health services furnished by a U.S. nonparticipating hospital may be covered on a nonemergency basis. Coverage for diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests, provided the hospital meets applicable conditions of participation. Coverage for x-ray, radium, and radioactive isotope therapy, including associated materials and technician services, contingent upon hospital meeting applicable conditions of participation. Services of residents, interns, nurses, therapists, etc. related to diagnostic tests. Prosthetic devices replacing internal organs or their functions. Braces and artificial limbs for physical condition changes. Emergency outpatient hospital services when emergency requirements are met. Services under 'incident to' physicians' services rendered to outpatients. Payment for diagnostic laboratory tests by an emergency hospital is allowed if the hospital meets conditions of participation for hospital laboratories. Payment for radiology services by an emergency hospital is allowed if it meets conditions of participation for radiology departments. Emergency inpatient services are covered when provided by nonparticipating hospitals. Emergency outpatient services are covered when provided by nonparticipating hospitals. Beneficiaries can file claims if the hospital does not submit a billing election. Foreign hospitals must agree to bill for all covered services for the calendar year. Beneficiaries may claim payment if the hospital does not bill. Emergency claims may be submitted for payment evaluation by the appropriate MAC. Claims submitted by hospitals that have filed an election to bill the program will be processed. Beneficiary claims will be processed if the hospital has made a billing election. Emergency services provided by U.S. hospitals may be covered under specific circumstances outlined in Medicare guidelines. Payment for physician and independent ambulance services is covered if all requirements are met, even if Part A benefits are exhausted. Claims for foreign physician and ambulance services must be attached to the corresponding Part A claim. Claims for physicians' and ambulance services furnished in connection with a covered foreign hospital stay are eligible for processing. Part B services are covered when furnished in connection with covered foreign inpatient hospital services. Inpatient hospital stay must be established for foreign physician or ambulance service to be covered. Medicare will cover services rendered in Canada at the lower of the allowed U.S. amount or the Canadian Provincial fee. Services rendered in Mexico are covered up to the Medicare allowed amount for similar services in the U.S. Emergency services are covered when necessary for immediate medical care. Claims for services in foreign religious non-medical health care institutions are considered under certain conditions. Coverage is provided when a participating hospital is closer to the site of an emergency than a nonparticipating hospital. Coverage is provided if the participating hospital is within fifteen miles farther from the emergency site than the nonparticipating hospital. Services are presumed available in a participating hospital in urban and suburban areas when both participating and nonparticipating hospitals are nearby. Admission to a nonparticipating hospital is covered only if extenuating circumstances necessitate it. Claims will be reviewed if the nearest participating hospital is 15 or fewer miles away from the emergency location. The accessibility requirement is deemed met if the admitting foreign hospital is closer to the beneficiary's residence than the nearest participating U.S. hospital. The accessibility requirement is met if evidence shows practical necessity for admission to a farther admitting foreign hospital. Reimbursement is permitted for emergency inpatient hospital services during periods of a health or life-endangering emergency that requires immediate hospital care. Diagnosis is considered an emergency when it threatens the life and health of the patient. Emergency conditions such as myocardial infarction and acute appendicitis require immediate inpatient hospital services. Conditions that unanticipatedly deteriorate a beneficiary's health, impacting chances of survival or regaining health status, are covered. Further documentation required if diagnosis is 'coronary' without additional details regarding treatment. No further documentation may be necessary for diagnoses indicative of medical emergencies, provided treatment aligns with the diagnosis. Emergency services may be covered if an emergency existed at the time of admission. Claims for emergency services are permissible if the period of coverage is reasonable. Claims are payable when an injury, disease, or acute change poses an immediate threat to life or health. Emergency services are justified when the patient's medical condition contraindicates arranging alternative transportation. Emergency services are covered when developed subsequent to a non-emergency admission based on the physician's assessment at arrival. Emergency services coverage applies when a patient enters a nonparticipating hospital under an emergency situation. Coverage continues for other injuries, diseases, or disorders that pose an immediate threat to life or health. Claims for emergency services must be supported by an Attending Physician's Statement certifying that the services were necessary due to an emergency. Emergency services are determined necessary if an emergency occurred while traveling between Alaska and another State as per the most direct route without unreasonable delay. Requests and claims for payment for emergency hospital services are covered. Claims for hospital services outside the U.S. related to emergency situations are also covered. Emergency services are covered until the patient has received a reasonable period of medical care related to the emergency condition. Emergency medical care for stroke patients may be necessary if impairment is prolonged or deteriorating. Emergency services are covered if the claim period does not exceed 3 to 5 days after substantial improvement in the patient's condition. Coverage for acute urinary retention due to prostatic hypertrophy. Coverage for mental illness with suicidal and/or homicidal tendencies. Medicare payment is not made for services rendered to alien beneficiaries not lawfully present in the United States at the time of service. Claims are covered when the beneficiary is lawfully present in the U.S. on the date of service. Claims must be denied when the patient has not met required eligibility requirements. Medicare payment may not be made for services when the patient was not lawfully present in the United States on the date of service. Services covered for beneficiaries lawfully present in the United States. Payment may be made for services furnished to a non-qualified alien who is lawfully present in the United States and authorized to be employed with respect to wages counted for Medicare eligibility. Payment for emergency services received from nonparticipating providers in accordance with 42 CFR 424.100-109. Payment for inpatient claims to Federal hospitals furnishing emergency services to entitled individuals. Medicare will pay for the inpatient deductible charged by VA hospitals for emergency services furnished to veterans. Medicare can cover emergency outpatient claims for eligible veterans. Hospital-based ambulance services may be covered and paid on a non-emergency basis. Emergency inpatient services are covered based on payment computation rules. Emergency outpatient services are covered after applying the Part B deductible. Part B medical services furnished by nonparticipating hospitals may be covered and paid on a non-emergency basis. Coverage for inpatient hospital services as described in the policy. Medicare pays for room and board during hospitalization. Coverage applies for certain nonroutine hospital services. Payment made for items listed on accompanying form. Payment is available for emergency services provided in foreign hospitals under specific conditions. Claims filed by hospitals must meet defined payment regulations to be considered. Coverage applies to foreign hospitals billing Medicare when they submit an itemized bill for customary charges. Ambulance services covered when provided in connection with a Medicare-covered hospital stay. Emergency services can be billed for Medicare beneficiaries. Hospitals may bill Medicare for emergency services if they elect to participate in the program. Beneficiaries may apply for reimbursement by submitting an itemized bill if the hospital does not elect to bill. Payment for hospital services in a nonparticipating hospital is covered in emergency situations. Emergency services furnished to Medicare beneficiaries. Nonparticipating hospitals may elect to bill Medicare for emergency services. Hospitals may bill for emergency services under certain conditions. Beneficiaries may apply for reimbursement by submitting an itemized bill if a hospital does not elect to bill. Emergency services rendered to a Medicare beneficiary admitted to a nonparticipating hospital are covered. Emergency services are covered when provided by a nonparticipating hospital if the facility elects to bill Medicare. Services covered for beneficiaries in emergency situations as determined by medical necessity. Care necessary to prevent death or serious impairment of health. Emergency care when brought to the nearest hospital with beds available. Hospital admission is necessary when a medical emergency exists. Emergency care is covered when it is necessary to prevent death or serious impairment to health. Emergency services must be provided at the nearest available hospital equipped to handle the emergency. Medical necessity for emergency hospitalization during an emergency condition. Medically necessary shipboard services are covered when specific criteria are met. Services must be furnished while the ship is within U.S. territorial waters. Services are only covered for individuals entitled to Part B benefits. Services must be in connection with covered inpatient hospital services. Services on the ship must relate to the condition that necessitated inpatient admission. Physician must be legally authorized to practice in the location where services are provided. Medicare may pay for services rendered in a foreign hospital under specific limited circumstances. Medicare will cover services if a medical emergency occurs in a foreign hospital closer than the nearest U.S. hospital. Coverage applies when traveling through Canada without unreasonable delay to an emergency service that is closer than a U.S. facility. Medicare will cover services in a foreign hospital if it is closer to a U.S. resident's home than the nearest U.S. hospital for their medical condition. Covered for patients at risk for sudden cardiac death (SCD) from ventricular arrhythmias. Coverage applicable for patients who may be candidates for the placement of an implantable cardiac defibrillator (ICD). Covered when using the SA method of analysis for MTWA diagnostic testing for evaluation of patients at risk for sudden cardiac death (SCD). Coverage determination for other methods of analysis is at the discretion of MACs with necessary documentation. Evaluation of patients at risk for sudden cardiac death using the SA analysis method Coverage includes ST elevation myocardial infarction involving left main coronary artery. Coverage includes ST elevation myocardial infarction involving left anterior descending coronary artery. Coverage includes ST elevation myocardial infarction involving other coronary artery of anterior wall. Coverage includes ST elevation myocardial infarction involving right coronary artery. Covered for ST elevation (STEMI) myocardial infarction involving various coronary arteries. Covered for subsequent myocardial infarctions post initial event. Leadless pacemakers are covered through Coverage with Evidence Development (CED) for procedures performed in CMS-approved CED studies. Covered for programming device evaluation in person with iterative adjustment of the implantable device. Covered for peri-procedural device evaluation and programming of device system parameters before or after surgery. Leadless pacemakers are covered when placed in specific facilities. Use of modifier Q0 for investigational clinical services provided in approved clinical research studies. Leadless pacemakers are covered when appropriate place of service (POS) code is included in claims. Coverage for supervised exercise therapy (SET) is for beneficiaries with intermittent claudication (IC) due to symptomatic peripheral artery disease (PAD). Up to 36 sessions over a 12-week period are covered if all components of a SET program are met. Supervised Exercise Therapy (SET) is covered for patients with Peripheral Artery Disease (PAD) who have claudication. Covered for beneficiaries without absolute contraindications to exercise as determined by their primary attending physician. Covered for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic Peripheral Arterial Disease (PAD) with a physician referral. ICD-10 codes I70.211 to I70.212 are covered for right and left leg arterial disease. Bilateral leg conditions are covered under codes I70.213. Beneficiary entitlement status and claims history are considered in the determination of remaining SET sessions. Remaining SET sessions will include any changes to beneficiary master or claims data. Coverage determination based on the National Coverage Determination (NCD) for specific items or services. Coverage is for patients undergoing Chimeric Antigen Receptor (CAR) T-cell therapy for specific cancers. CAR T-cells must be genetically altered to improve efficacy against abnormal cells. Covered for T-cell treatment for cancer when used for an FDA-approved indication. Also covered when used for off-label purposes if supported by CMS-approved compendia. Indicated for certain hematological malignancies. May be used in patients who have exhausted other treatment options. Payment for administration of autologous treatment for cancer with T-cells expressing at least one CAR. Applicable to diagnoses under NCD 310.1 for patients enrolled in clinical trials. Billing codes for inpatient and outpatient CAR T-cell therapy services are structured under specific revenue codes. Coverage for outpatient CAR T-cell therapy services. Administration of CAR T-cells under physician or NPP supervision. Coverage for CAR T-cell products is designated at specific places of service including Office and Independent Clinic. Coverage for CAR T-cell therapy is applicable for specific ICD-10-CM diagnoses. Covered for use in clinical trials FDA-approved under NCD 310.1 with CAR T-cell therapy obtaining FDA approval and lacking a specific PCS code. Yescarta® therapy is medically necessary for patients with certain types of refractory large B-cell lymphoma. Kymriah® therapy is indicated for patients with relapsed or refractory acute lymphoblastic leukemia. ABECMA® is covered for patients with multiple myeloma who have had at least 4 prior therapies. Tecartus™ therapy is indicated for mantle cell lymphoma after at least one prior therapy. Breyanzi® immunotherapy is covered when introduced into the peripheral vein or central vein via percutaneous approach. Yescarta®, ABECMA®, Kymriah® immunotherapy is covered when administered into the peripheral vein or central vein via percutaneous approach for dates of service prior to October 1, 2021. Tecartus™ immunotherapy is covered when transfused into the peripheral vein via percutaneous approach. Transfusion of Brexucabtagene Autoleucel Immunotherapy into Central Vein is covered. Transfusion of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein is covered. Transfusion of Lisocabtagene Maraleucel Immunotherapy into Central Vein is covered. Coverage for autologous CAR T-cell therapy is applicable in clinical trials, requiring specific ICD-10-PCS codes billed with the NCT number. CAR T-cell therapy is covered when administered at a healthcare facility that is enrolled in the REMS program as a REMS participating site. CAR T-cell therapy services are covered when billed with a -LU modifier indicating fractionation, along with a -KX modifier. Coverage for CAR T-cell products when administered within the allowed dosage limits. Billing for exceeded dosage using HCPCS J3490, J3590, or J9999, specifying the product and exceeded dosage. Allowable for CAR T-cell therapy under specific billing conditions. Services must be submitted on TOB 11X. Covered when CAR T-cell therapy services are performed in hospital outpatient departments using TOB 13X or inpatient ancillary TOB 12X. Services in CAH OPDs are covered based on reasonable cost. Services under CAH Method II with specific revenue codes are covered based on lesser actual charge or Medicare Physician Fee Schedule. CAR-T drug administration in the Hospital Outpatient Department (HOPD) setting. CAR-T dosing and preparation services are covered when the T-cells are administered in the HOPD setting. Services leading to CAR-T drug administration are covered. CAR T-cell preparation services may be covered when initiated in the HOPD setting while the CAR T-cells are administered in the inpatient setting. CAR T-cell therapy is covered when administered in a hospital inpatient setting. Services are payable when billed on Form CMS-1500 or electronic 837P for administration in a physician office or non-hospital clinic. Administration of CAR-T drug in physician office or non-hospital clinic setting enrolled in REMS program. CAR-T services are indicated for collection and preparation of genetically modified T-cells. CAR T-cell therapy is covered when performed in inpatient hospitals and Critical Access Hospitals as per billing requirements. CAR T-cell therapy is covered when services are submitted on TOBs 13X and 85X. CAR T-cell dosing and preparation services are covered when administered in hospital outpatient departments (HOPDs). Services related to viable CAR T-cells are payable when tracked appropriately in the outpatient setting. Administration of CAR T-cell products in the Hospital Outpatient Department (HOPD) setting. Medicare will not separately reimburse for the collection and preparation steps of CAR T-cells. CAR T-cell preparation services are covered when initiated or performed in the HOPD facility, even if viable T-cells are not administered. CAR T-cell preparation services are covered when initiated in the HOPD setting. CAR T-cell therapy products are covered when submitted in places of service 11 or 49. Covered when CAR T-cells are administered in a physician office or non-hospital clinic enrolled in the REMS program. CAR T-cell product service is indicated when genetically modified T-cells are administered. CAR T-cell product administration is indicated when viable T-cells are prepared and administered. CAR T-cells treatment covered when administered in an inpatient setting using appropriate revenue codes. CART-cell preparation services are covered when initiated and furnished in a physician office setting. CAR T-cell preparation services are covered when initiated in a physician office or non-hospital clinic. Viable T-cells must be administered in the hospital inpatient setting. CAR T-cell therapy is covered when administered through healthcare facilities enrolled in the FDA REMS requirements. Covered when performed in place of service 11 or 49. CAR T-cell therapy is covered under the conditions specified in NCD 110.24. Claims for CAR T-cell therapy are covered when billed under clinical trials with the appropriate NCT number. Coverage for CAR T-cell therapy for cancer is required when the criteria outlined in NCD 110.24 are met. Coverage for acupuncture is provided for chronic low back pain (cLBP) as per established guidelines. Coverage for acupuncture is provided for chronic low back pain (cLBP) lasting 12 weeks or longer. cLBP must be nonspecific, with no identifiable systemic cause, and not associated with surgery or pregnancy. Up to 20 acupuncture treatments may be administered annually for patients demonstrating improvement. Acupuncture for chronic low back pain (cLBP) services reported with specific CPT codes. Acupuncture for chronic low back pain (cLBP) services is covered when reported on institutional claims. Acupuncture for chronic low back pain (cLBP) services reported on institutional claims. Acupuncture for chronic low back pain (cLBP) is covered for up to 20 sessions per annum. Acupuncture is covered for chronic low back pain (cLBP) as per the specified guidelines. Coverage is determined based on the application of the Local Coverage Determination (LCD). Acupuncture is covered for chronic low back pain (cLBP) when specific criteria are met. Acupuncture for chronic low back pain (cLBP) is covered when medically necessary. Acupuncture is covered for chronic low back pain (cLBP) when specific HCPCS codes are used. Covers professional services for home infusion therapy, including nursing services and training. Includes remote monitoring for patients receiving home infusion drugs. Infusion therapy services are covered for beneficiaries receiving certain drugs and biologicals through a covered DME. Beneficiaries must have an established plan of care by a physician, nurse practitioner, or physician’s assistant. Home infusion therapy services are covered for the administration of certain home infusion drugs. Services related to the administration of parenteral drugs or biologicals are covered when provided in the individual's home through an infusion pump. Home infusion drugs payable under specific HCPCS J-code payment categories. Coverage includes intravenous antifungals, antivirals, long-term infusions, pain management, inotropic, and chelation drugs. Coverage for drugs that require infusion therapy in a physician’s office. Covered for patients requiring intravenous acyclovir administration. Indicated for patients needing antifungal treatment with amphotericin B. Injection of amphotericin b cholesteryl sulfate complex is covered. Injection of amphotericin b liposome is covered. Injection of deferoxamine mesylate is covered. Injection of hydromorphone is covered. Injection of dobutamine hydrochloride is covered. Injection of dopamine HCl is covered. Home infusion drugs administered through durable medical equipment (DME) may be covered under specific circumstances. Intravenous anti-infective, pain management, chelation, or pulmonary hypertension treatment. Subcutaneous immunotherapy for allergy management. Chemotherapy and other complex intravenous drug administration. Medications covered when medically necessary for treatment of specific conditions as per prescribing physician's determination. Coverage for specific injectable medications listed in the policy. Home infusion therapy services are covered for eligible home infusion therapy suppliers. Eligible for home infusion therapy services billed with applicable G-codes and J-codes. Home infusion therapy services are covered when associated with a home infusion drug J-code. Payment is contingent upon billing for the appropriate drug administered during the visit. Home infusion therapy suppliers may bill one of the initial visit G-codes for new patients who had their last infusion service more than 60 days prior. Coverage applies for units based on specified time ranges. Home infusion therapy is covered for patients requiring complex drug administration. G-codes are used to categorize home infusion therapy based on therapy type. Covered for intravenous anti-infective agents, pain management using intravenous and other specified infusion drugs. Covered for subcutaneous immunotherapy and certain subcutaneous infusion drugs. Covered for chemotherapy and specific highly complex intravenous drugs. Professional services for the administration of intravenous infusion drugs for anti-infective, pain management, chelation, pulmonary hypertension, inotropic agents, or other biologicals in the individual's home, each 15 minutes. Professional services for the administration of subcutaneous immunotherapy or other subcutaneous infusion drugs in the individual's home, each 15 minutes. Covered for administration of intravenous chemotherapy or other highly complex drug infusion in the home setting. Covered for the administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusions (excluding chemotherapy) in the home. Medically necessary for the administration of intravenous chemotherapy or other highly complex infusion drugs in a home setting. Edit created for multiple HCPCS codes G0068, G0069, G0070, G0088, G0089, or G0090 on the same Date of Service. Claims for identified J-codes are payable when there is no DME claim in history for 30 days prior to the date of service. Part B claims with G-codes are recycled up to three times for a total of 15 days if previous claims with allowable drug J-codes are not received. Claims for codes G0088, G0089, or G0090 are subject to processing rules when within 60 days of prior DME or Part B Professional claims. Coverage for monoclonal antibodies directed against amyloid in treatment of Alzheimer's Disease. Coverage for FDA-approved monoclonal antibodies directed against amyloid for treatment of Alzheimer's Disease (AD) is provided for patients with a clinical diagnosis of mild cognitive impairment. Coverage is provided for patients with mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD dementia with confirmed amyloid beta pathology. Coverage for ICD-10 diagnosis code Z00.6 with one of the specified additional diagnosis codes G30.0, G30.1, G30.8, G30.9, G31.84, and the Q0 or Q1 modifier. Coverage includes HCPCS code J0174 for Injection, lecanemab-irmb, 1 mg (Leqembi®). Applicable when any FDA-approved therapy covered under NCD 200.3 is used. Monoclonal antibodies are covered for the treatment of Alzheimer's Disease (AD) when billed with an appropriate HCPCS code and a diagnosis code from Section 412.1. Monoclonal antibody treatments are covered when associated with specified diagnosis codes. Use of an implantable PA pressure sensor (IPAPS) is indicated for patients with heart failure to enable early detection of changes in blood flow. IPAPS is utilized to manage medications and adjust lifestyle to prevent acute decompensated heart failure episodes. Coverage for implantable pulmonary artery pressure sensor(s) is provided for heart failure management under Coverage with Evidence Development (CED). Services must meet FDA market-authorized indications and all conditions specified in NCD 20.36. Transcatheter implantation of wireless pulmonary artery pressure sensor for long term hemodynamic monitoring. ICD-10-PCS codes 02HQ30Z and 02HR30Z are covered on type of bill 11X. Implantable pulmonary artery pressure sensors are covered for heart failure management when specific clinical criteria are met. Patients must meet the necessary diagnostic requirements for heart failure as outlined in the coverage criteria. Monoclonal antibodies directed against amyloid are covered for the treatment of Alzheimer’s Disease in patients meeting specific clinical criteria. Coverage for Cochlear Implantation under NCD 50.3. Updates on coding revisions to the NCDs for the specified dates. Covered for patients with chronic, non-healing wounds. Medically necessary when other treatments have failed. Stem cell transplantation for multiple myeloma, myelofibrosis, sickle cell disease, and myelodysplastic syndromes. Percutaneous Image-guided Lumbar Decompression (PILD) is covered for lumbar spinal stenosis. TMVR is covered for patients with symptomatic mitral valve disease. Procedure must meet patient selection criteria defined in guidelines. Coverage for patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement. Medically necessary for patients who meet specific anatomical and clinical criteria outlined in the NCD. Laparoscopic Sleeve Gastrectomy (LSG) is covered for patients with a BMI ≥ 40 or a BMI ≥ 35 with obesity-related comorbid conditions. Autologous cellular immunotherapy is indicated for patients with metastatic prostate cancer. Updates related to outpatient services covered under the Hospital Outpatient Prospective Payment System. Routine foot care is covered for patients with loss of protective sensation. Reimbursement adjustments for inpatient services involving replaced devices that are provided at no cost or with a credit. Ultrasound stimulation is covered for the treatment of nonunion fractures. Cochlear implantation is covered for individuals with profound sensorineural hearing loss. Device is medically necessary when hearing aids provide inadequate sound amplification.

Not covered for conditions that are not chronic or do not meet specific criteria for healing. ABPM is not covered if performed for routine monitoring without medical necessity. Counseling is not covered for individuals under the age of 18. Counseling services must be provided by qualified healthcare professionals. Not covered for non-diabetic wounds. Treatment duration must not exceed 30 sessions within a 12-week period. Not covered for patients without a diagnosis requiring anticoagulation management. Coverage is not provided for routine health screening or asymptomatic patients. PET scans are not covered if performed for non-medically necessary reasons. Not all expenses related to clinical trials may be covered under routine costs. Coverage for Category B IDE devices may have specific restrictions and require additional criteria. Routine costs associated with clinical trials will not be covered unless they meet specific Medicare criteria. Non-covered services include investigational items or services not approved by Medicare. Islet cell transplantation is not covered outside of approved clinical trials. Peripheral neuropathy treatments not covered if the loss of protective sensation is not documented. Certain conditions are explicitly not covered under this policy, including conditions related to stem cell transplantation. Ultrasound stimulation is not covered for fractures that are classified as acute. Treatment is limited to a certain number of sessions within a defined period. Services are not covered when furnished after December 31, 2009, unless specifically noted otherwise. Patients must meet specific eligibility criteria based on their heart conditions to receive coverage. CR services are limited to a maximum of 36 sessions. ICR services are limited to a maximum of 72 sessions within 126 days. PR services are not covered beyond 36 sessions unless specifically authorized. Services exceeding 72 sessions will not be covered. Procedures are not covered without proper indication code submission. Coverage specifically excludes cases that do not meet the defined BMI thresholds. Coverage is limited to specific post-approval studies and approved devices. Procedures may not be covered if they do not meet Medicare requirements. Not covered when CPAP is used for conditions other than OSA. Not covered for surgical procedures deemed incorrect due to provider error. Not covered for patients with terminal conditions or limited life expectancy. Coverage is limited based on medical necessity criteria as defined in the policy. Not covered for routine use in the absence of critical medical need. Will not cover assessments performed outside of clinical guidelines. Transesophageal Doppler monitoring is not covered for non-specific cases without clinical justification. Artificial hearts may not be covered for patients who do not meet the medical necessity criteria. Services rendered outside of the U.S. may have specific restrictions based on location. Claims for nonemergency Part B medical services are not covered. Claims related to services that are not medically necessary will not be covered. Procedures performed outside of Medicare-approved settings may be excluded. Claims for Medicare services provided to alien beneficiaries who are not lawfully present in the United States will be denied. Emergency services provided outside the United States may be subject to time limitations for reimbursement. Services are not covered if the claim is filed incorrectly by nonparticipating providers. Claims for services from foreign hospitals may be subjected to stricter documentation requirements. MTWA testing is not covered when performed in conjunction with other non-invasive cardiac assessments. Not covered for acute low back pain. Limited to a maximum of 12 treatments in 12 weeks. Not covered if the patient does not meet the clinical criteria for Alzheimer's treatment. Implantable sensors are not covered for patients without a diagnosis of heart failure. ABPM is not covered for any other uses beyond the criteria for white coat hypertension. Coverage is contingent on having no evidence of end-organ damage. Payment is not allowed for institutionalized beneficiaries, such as those receiving Medicare-covered skilled nursing. If ABPM needs to be performed more than once, the same qualifying criteria must be met for each test. Type of bill 14X is not applicable for ABPM services. Maryland Hospitals are paid based on a percentage of cost. Separate payment for the professional component of ABPM services is not allowed outside the all-inclusive rate. RHCs are not mandated to use ABPM HCPCS codes for professional services covered under the all-inclusive rate. Separate payment to a FQHC for the professional component of ABPM services is not allowed. FQHCs are not required to use ABPM HCPCS codes for professional services covered under the all-inclusive rate. Coinsurance and deductible apply to ABPM services billed to the A/B MACs except for FQHCs, where only coinsurance applies. Independent and free-standing RHC/FQHC practitioners are only reimbursed for ABPM technical components when billed according to A/B MAC (B) instructions. Electrical stimulation will not be covered as an initial treatment modality. All other uses of electrical stimulation for wound treatment are not covered by Medicare. Continued electrical stimulation is not covered if measurable signs of healing are not demonstrated within any 30-day treatment period. Electrical stimulation must be discontinued when the wound has a 100% epithelialized wound bed. Wounds must be evaluated no less than every 30 days by a treating physician. Coverage is limited to unattended electrical stimulation only. The device for electrical stimulation is not covered by Medicare. Unsupervised home use of electrical stimulation will not be covered. Only one payment will be made per visit for therapy services. RHCs and FQHCs no longer required to report HCPCS codes for billing as of April 1, 2005. Services provided under revenue codes 520, 521 are limited to Federally Qualified Health Centers and Rural Health Centers. Critical Access Hospital professional services are limited to method II only. RHCs/FQHCs are no longer required to report HCPCS codes when billing for therapy services. Coinsurance and deductible apply for therapy services, except for FQHCs where only coinsurance applies. Electromagnetic therapy is not covered for any other types of wounds. It will not be covered as an initial treatment modality. Continued treatment is not covered if there are no measurable signs of healing within any 30-day treatment period. Electromagnetic therapy must be discontinued upon achieving a 100% epithelialized wound bed. The device used for electromagnetic therapy will not be covered. Unsupervised home use of electromagnetic therapy will not be covered. Not covered for services billed by RHCs/FQHCs requiring HCPCS codes after April 1, 2005. Only one payment will be made for the therapy service visit at RHCs/FQHCs. Covered services must be provided in accordance with established guidelines and regulations. Critical Access Hospital services are limited to professional services only under method II. Coinsurance and deductible apply to electromagnetic therapy services, except for FQHCs, where only coinsurance applies. PRP services performed more than 20 weeks after the date of the first PRP service are subject to review by the local Medicare Administrative Contractor (MAC). PRP services for diabetic wounds must meet specific conditions as outlined in NCD Manual Section 270.3. Non-covered for any wounds that do not meet the chronic non-healing definition. Both ICD-10 codes for diabetes mellitus and chronic ulcers must be reported for coverage. Not covered for ulcers that have not been present for at least 30 days. Will not cover treatments deemed to be experimental or not recognized as standard care. Not covered for ulcers not meeting the stated criteria. Specific severity levels and involvement of underlying tissues must be documented. PRP services performed after 20 weeks require the -KX modifier to be reported on the claim. Coverage is limited to the conditions specified in the policy. Contractors have discretion to determine the frequency of PRP services. PRP services for hospitals in Maryland under the jurisdiction of the Health Services Cost Review Commission are limited to outpatient basis with TOB 13X. Payments based on all-inclusive rates for certain types of facilities (TOB 71X and TOB 77X) may have specific criteria. Claims for PRP services will be denied when provided on other than TOBs 12X, 13X, 22X, 23X, 71X, 75X, 77X, and 85X. PRP services are only covered in certain settings as outlined by Medicare regulations. Treatment is not covered when rendered in an inappropriate or invalid place of service. Service/procedure not covered when performed in this place of service. Claims for PRP services will be rejected if performed more than 20 weeks after the first service without the --KX modifier. Services will be denied if benefits are exhausted. PRP services are non-covered when not deemed a 'medical necessity' by the payer. Claims will be denied if appropriate diagnosis codes are not included. Coverage is based on the specific policies indicated and may vary. Claims will be reviewed based on NCD 270.3 and LCD decision framework. Coverage for smoking and tobacco-use cessation counseling services was deleted for Medicare Part A and Part B effective September 30, 2016. Only 8 counseling to prevent tobacco use sessions are covered in a 12-month period. Beneficiaries may receive an additional 8 sessions only after 11 full months have passed since the previous covered session. Minimal cessation counseling (3 minutes or less) is covered as part of Evaluation and Management (E/M) visits and is not separately billable. Not covered for conditions related to tobacco use that are not specified. Claims where assignment was not taken are subject to the Medicare limiting charge, which means that charges to the beneficiary may be no more than 115% of the allowed amount. Deductible and coinsurance are waived for covered services. Deductible and coinsurance are waived for counseling to prevent tobacco use services. Services billed with G0436 and G0437 will not be covered after September 30, 2016. Type of bill 14X is no longer applicable for these services. Outpatient services provided by clinical nurse specialists in RHC/FQHC settings are not billable as visits. Services are not covered if the patient does not meet criteria for skilled nursing level of care. Not covered for custodial care or services that do not require skilled nursing. Maryland Hospitals payments are based on HSCRC guidelines, covering only 94% of submitted charges. Payment is not allowed for inpatients whose primary diagnosis is counseling to prevent tobacco use. Claims for counseling services that do not meet coverage criteria will be denied. Counseling services may be denied if performed prior to the effective date of coverage. Coverage criteria must be met for services to be covered by Medicare. Claims for counseling services are denied if the dates of service exceed the maximum benefit allowed. Medicare may conduct post-payment reviews to ensure that services align with coverage instructions. Providers must maintain patient records for claims submitted for counseling services. Eligibility data is limited to the number of counseling sessions rendered, as maintained by the Common Working File (CWF). No more than 6 sessions of KDE services are provided in a lifetime. Sessions must be at least 31 minutes in duration to be billed. Renal dialysis facilities (Type of Bill 72x) are precluded from providing KDE services. Services can only be provided by qualified healthcare personnel or facilities located in rural areas. Hospices must report KDE services on a separate claim, and claims containing other services will be returned. Hospital outpatient departments are not required to report revenue code 0942. KDE services are not covered when submitted on TOB 72X. Claims with HCPCS codes G0420 or G0421 cannot be billed with ICD-9 or ICD-10 codes for the same service date. Claims for KDE services will be denied if billed without diagnosis code 585.4. Claims for KDE services when submitted for more than 6 sessions will be denied. Claims for KDE services when both professional and institutional claims are billed on the same service date will be denied. KDE services rendered in an urban area will be denied unless specific criteria are met. Claims submitted on TOB 72X will be denied for KDE services. Not covered if the service is performed, referred or ordered by a non-participating provider. Payment is denied when performed or billed by this type of provider in this type of facility. Topical application of oxygen does not meet the definition of Hyperbaric Oxygen Therapy and is not covered. No Medicare reimbursement is available for the topical application of oxygen due to unestablished clinical efficacy. Code G0277 is not available for use outside of a hospital outpatient department. In skilled nursing facilities, HBO therapy is included in the SNF PPS payment. Claims with invalid diagnosis codes will be denied as not medically necessary. Payment is not covered under Method I for CAHs unless specifically documented. Not covered when services are not rendered in compliance with Medicare guidelines. Professional component billed under where not covered under the Physician Fee Schedule. Claims may be denied if the condition does not meet coverage requirements. Not covered if the claim review determines that the service is not medically necessary. Payment for HBO therapy is denied if it does not meet the specific medical necessity criteria. No coverage for any separate or additional physician's professional services related to topical oxygen therapy. Coverage is determined by local Medicare contractors. No coverage for any separate or additional physician’s professional services related to the procedure. Patient must be refractory to conventional therapy (documented behavioral, pharmacologic and/or surgical therapy). Patient must be an appropriate surgical candidate for implantation with anesthesia. Patients with stress incontinence, urinary obstruction, and specific neurologic diseases are excluded. Not covered for patients without evidence of appropriate clinical criteria. Exclusions apply for experimental or investigational use. C codes C1897, E0752, and E0756 are only applicable under the hospital outpatient prospective payment system (OPPS). Deductible and coinsurance apply to services covered under this policy. Only hospital outpatient departments report these codes. Payment is made under OPPS. RHC/FQHC services are not covered under this policy and must use outpatient provider numbers for billing. Claims processing edits for pre or post payment review of sacral nerve stimulation are not required at this time. DBS is not covered for patients with untreated psychiatric illness. DBS is not covered for patients with neurological disorders that are not specified. Not covered for patients who do not have medically refractory essential tremor. DBS devices must be FDA approved or used in accordance with FDA approved protocols for IDE clinical trials. DBS is not covered for essential tremor (ET). DBS is not covered for PD patients with disabling symptoms that are manageable with optimal medical therapy. DBS is not indicated for patients with cognitive impairment, dementia, or depression that would impair their ability to benefit from the procedure. Patients with current psychosis or substance abuse (alcohol or drugs) are contraindicated for DBS. Structural lesions such as a basal ganglionic stroke, tumor, or vascular malformation as the etiology of movement disorder exclude eligibility for DBS. Previous movement disorder surgery within the affected basal ganglion is a contraindication. Significant co-morbidities that contraindicate DBS surgery or stimulation will also exclude patients from eligibility. ACLS should be performed cautiously in patients with cardiac pacemakers or other electronically controlled implants. Not covered if the neurosurgeon lacks proper training and experience with DBS therapy. Limitation exists if the operative team doesn't have adequate training in DBS systems and related techniques. Payment methods vary for inpatient and outpatient procedures based on hospital type. Certain claims must adhere to specific bill types and revenue codes. Procedures are not covered when deemed not medically necessary. Frequency of procedures may be limited based on clinical criteria. Procedure not covered for patients who are not candidates for surgical intervention. Coverage is limited to patients with specific medical conditions requiring electrical stimulation. Implantation of electrodes is not payable in an Ambulatory Surgical Center. Claims for DBS performed prior to April 1, 2003, are not covered. Service not covered by Medicare when received. Home INR monitoring is not covered when conducted more frequently than medically necessary. Self-testing frequency is limited to once per week. Home INR device must be prescribed by a physician. Self-testing with the device should not occur more frequently than once a week. Coverage requires a face-to-face educational program for the patient on anticoagulation management. Home INR monitoring for patients with porcine valves is not covered under this NCD unless specified by local Medicare contractors. Not covered for patients without a confirmed diagnosis of a listed condition. Limitations apply to idiopathic conditions that do not meet specified diagnostic criteria. Not covered for conditions not listed in the specified codes. Exclusions apply to services deemed not medically necessary. Not covered for conditions not explicitly listed in the coding section. Limitations may apply based on clinical criteria not detailed in the document. Not covered for conditions not specified in listed ICD codes. Coverage is not available for related conditions unless explicitly indicated. Provision of equipment is limited to once a week. Not covered if criteria for home INR monitoring are not met. Coverage is limited to patients with mechanical heart valves. Services do not require face-to-face interactions with the physician. Provisions and physician reviews are not covered more frequently than once a week. Not covered for conditions not specified in the coverage indications. Conditions not covered where medical necessity is not demonstrated. Not covered if clinical documentation does not meet stated criteria. Exclusions for conditions not specified in the recognized codes. Non-coverage for instances of thrombosis not related to acute or chronic embolism as per listed codes. No limitations specified in the provided document. This test is not covered as durable medical equipment. Claims submitted to DMERCs will not be paid. Billing for G0249 and G0250 should not exceed once every 4 weeks. Services will not be covered if determined not medically necessary. Coverage is limited to services on or after September 15, 2004. Specific coverage conditions and clinical trial requirements must be followed as outlined in Pub. 100-03, NCD Manual. Claims must include appropriate diagnosis codes. Not covered without accompanying diagnosis codes listed. Claims will be denied if a diagnosis code outside the specified range is used. Claims must have applicable diagnosis codes or an Advanced Beneficiary Notice must be issued. Not covered if necessary conditions as outlined in the NCD Manual, section 220.6.13, are not met. Coverage is not applicable for patients lacking sufficient neuropsychological or imaging evidence. Claims for PET Aβ imaging will be unprocessable if they do not include condition code 30 and value code D4. Modifier Q0 must be used as appropriate for claims through CED during clinical trials. Claims for PET Aβ imaging are denied if a previous claim for the same procedure code has been paid. Coverage for PET Aβ is limited to a lifetime benefit maximum, meaning it is only covered once per patient. Service not covered if provided more than once in a lifetime. Claims with GA modifier will receive a PR group code. Claims with GZ modifier will receive a CO group code. Services or benefits not paid by CMS A/B MACs become the responsibility of the M+C organization. Institutional inpatient billing for services that are considered a significant cost for Medicare Advantage. Current editing must be updated to allow Condition Code 78 unless previous instructions exclude certain conditions. Condition Code 78 is applicable only for outpatient institutional claims. Claims will not be covered if previous instructions exclude certain conditions. Coverage is limited to services incurred between 08/07/2019 and 12/31/2020. Providers are not to seek reimbursement for no cost items as they are considered non-covered. Practitioners must report Category A IDE devices received at no cost on claims but will not receive payment. Drug administration charges cannot be billed without a covered drug charge on the claim. No cost items must be reported with a token charge of less than $1.01. Claims for no cost items must include the appropriate HCPCS modifier. Claims may be denied if they do not properly reflect services provided. Providers must ensure patients are not liable for charges associated with no cost items. Charges for items indicated with modifier -FB are not billed to Medicare or the beneficiary. Condition codes 49 and 50 are only for devices provided at no cost or with full credit for warranty malfunctions. Coverage is limited to devices specifically identified by condition codes for warranty or recall situations. Modifier –FB must be appended to the procedure code for implanting no cost/full credit devices. Claims processing edits may require specific devices to be billed with their associated procedures. OPPS hospitals are not required to append modifier –FB for no cost/full credit devices in certain claims instances. Refer to Pub. 100-02 for complete Medicare coverage requirements and any specific limitations that may apply. Category A IDE devices are not eligible for payment under Medicare. Claims must adhere to specific billing instructions outlined in §69.6. Category A IDE devices are not eligible for payment under Medicare and shall not be reported on practitioner claims. Claims without a valid clinical trial number will not be processed. Providers must use the specified fields on CMS-1500 or 837 P forms to report clinical trial numbers. Claims submitted without a clinical trial number shall be returned as unprocessable. Claims submitted without valid Investigational Device Exemption (IDE) numbers will be considered unprocessable. Practitioners must use a Q0 modifier instead of QV for services on or after January 1, 2008. Payment for the device cannot exceed the Medicare-approved amount for a comparable FDA-approved device. Claims with an invalid IDE number will be returned. Claims must be submitted according to clinical trial billing instructions. Hospital inpatient providers may not bill for the Category B IDE device if it was received free-of-charge. Claims must be billed according to the clinical trial billing instructions specified in the policy. Not covered if the Category B IDE device is provided at no cost unless billed with a token charge. Specific HCPCS modifiers must be used depending on the date of service. Category B IDE device must be billed with a QA modifier for services on or before December 31, 2007. Claims after January 1, 2008, may have different billing requirements not specified in this excerpt. Claims with an invalid IDE number will be returned with specific messages regarding missing or incorrect information. Claims without a clinical trial number will not be covered. The trial number must be preceded by 'CT' on paper forms, and not used on electronic claims. Claims submitted without a valid clinical trial number will be returned as unprocessable. Investigational Device Exemption number must be provided for FDA-approved clinical trial services. Claims for Category B IDE devices must not be submitted until the contractor has confirmed that all required information has been furnished. Payment for the Category B IDE device may not exceed the Medicare-approved amount for a comparable FDA-approved device. Hospital inpatient providers should not bill for the Category B IDE device if the device is received free-of-charge. Institutional providers must submit claims according to specific billing instructions. Only costs incurred for Category B IDE devices are eligible for billing. For claims prior to January 1, 2014, if the Category B IDE device is provided at no cost, a token charge must be reported. Claims for no-cost Category B IDE devices must report a token charge with condition code '53' and Value Code 'FD'. Not covered for services/items outside the scope of clinical trials or studies. Claims lacking required information for adjudication will be unprocessable. Clinical trial services must include a valid Investigational Device Exemption number. Approval for billing with QA modifier is limited to services rendered on or before December 31, 2007. Billing with Q0 modifier is mandated for services starting January 1, 2008. Claims with an invalid IDE number will be returned to the provider. Claims submitted without the Q0 modifier will also be returned. Claims missing procedure modifier(s) will not be covered. Qualifying clinical trials must meet specific enrollment and protocol criteria to be eligible. Applicable deductibles and coinsurance rules apply to clinical trial items and services, except for managed care enrollees. Part A and Part B deductibles are assumed to be met for managed care enrollees if billed on a fee service basis. Do not develop new or revised LMRPs for clinical trial services. Items and services provided free-of-charge by research sponsors may not be billed. Certificate of Medical Necessity (CMN) is required for certain services. Providers cannot hold beneficiaries liable for charges related to non-covered services. Claims with no cost items must include an applicable HCPCS modifier (modifier –FB). Mandatory reporting of a clinical trial number for claims related to items/services in clinical trials/studies/registries or under CED. Claims must include HCPCS modifier 'Q1'. For ICD-9-CM, ICD-9 diagnosis code V70.7 must be reported as the secondary diagnosis. For ICD-10-CM, ICD-10 diagnosis code Z00.6 must be used. Trials designed exclusively to test toxicity or pathophysiology are not covered. Diagnostic intervention trials may enroll healthy volunteers only for control groups. Claims will be rejected if they lack necessary diagnosis codes or clinical trial numbers. Reporting of clinical trial numbers is voluntary until December 31, 2013. Claims must not use 'CT' in the electronic claim format. Claims require a valid Investigational Device Exemption number for FDA-approved clinical trials. Claims submitted with incomplete or invalid information are unprocessable and will not be eligible for appeal. Claims submitted without a clinical trial number shall be returned to providers after January 1, 2014. Items and services provided solely for data collection and analysis purposes are not covered. Services not covered by Medicare due to statutory exclusions or lack of a benefit category may not be billed with the Q1 modifier. HCPCS codes are not reported on inpatient claims; therefore, related HCPCS modifier requirements do not apply. Investigational items/services require HCPCS modifier Q0 for dates of service on or after 1/1/08. Routine services require HCPCS modifier Q1 for dates of service on or after 1/1/08. Providers must be enrolled with Medicare to bill for covered clinical trial services. Beneficiaries are not responsible for Part A or Part B deductibles. Managed care enrollees must pay applicable coinsurance amounts for services. Providers must not bill outpatient clinical trial services and non-clinical trial services on the same claim. Claims must be submitted with all services specifically coded for clinical trials. Date(s) of service must be on or after September 19, 2000. Claims including both clinical and non-clinical trial services will be rejected. Non-clinical trial services must be processed separately as standard fee-for-service claims. All other uses for islet cell services not involving NIH trials are non-covered. Claims must use the QR modifier for services provided as part of a Medicare-specified study. Routine follow-up care for islet cell transplantation may have specific billing instructions. Deductibles and coinsurance apply for fee-for-service beneficiaries. Not covered for patients who have a contraindication to islet cell transplantation. Excluded for patients who are not compliant with medical treatment protocols. Not covered if the condition does not meet specified guidelines. Treatment may be limited by frequency or specific clinical outcomes. Not covered for conditions not specified in the indications. Exclusions apply to treatments that are not necessary for managing diabetic complications. Secondary diagnosis of ICD-10 CM code Z00.6 must be present for clinical trial coverage. Deductible and coinsurance apply for fee-for-service beneficiaries. Add-on payments for isolation of islet cells are limited to two per hospital stay. Charges for organ acquisition related to islet transplants must be reported using specific revenue codes. Normal inpatient billing practices apply; the QR modifier is only accepted for specific outpatient billing types (13X or 85X). MA organizations will not be liable for payment for routine costs of this new clinical trial until MA payments can be appropriately adjusted. Beneficiaries are not responsible for Part A and Part B deductibles, but may be liable for any applicable coinsurance amounts established by MA organizations. Not covered for individuals without documented loss of protective sensation or peripheral neuropathy. Exclusions apply when foot lesions are not present. The beneficiary must not have seen a foot care specialist for other reasons during the interim period. Code G0247 must be billed on the same date of service with either G0245 or G0246 to be considered for payment. Coverage may not be applicable if diagnoses do not meet specified criteria. Excluded situations may include those unrelated to the diabetic conditions outlined. Payment is subject to settings such as hospital outpatient departments and critical access hospitals. CORFs do not bill for services; they must be billed by the physician on a professional claim. Payment is subject to the Part B deductible and co-insurance calculations. Payment will not be made unless the claim contains a related visit revenue code (520 or 521). Applicable revenue code is 940, except for hospitals. Applicable revenue code for hospitals is not specified in detail. Specific revenue codes may not apply uniformly across all hospital settings. Not all forms of diabetes mellitus with neurological complications are covered; specific codes must apply. Limitations may apply based on additional patient circumstances or condition severity. G0247 will be denied if not submitted on the same claim as G0245 or G0246. Services not covered under certain circumstances as indicated by Medicare. Claims for Rural Health Clinics and Federally Qualified Health Centers will reject as duplicates when billing parameters match. G0245 and G0246 can only be billed once every 6 months for a particular beneficiary regardless of the provider. CWF will reject claims for G0245 or G0246 if submitted within 6 months of a paid claim for the same code. Service is denied if it has not been 6 months since the last examination of this kind. Claim will be denied due to non-covered charges if payment was previously made for the same/similar procedure within the set time frame. Payment for LOPS evaluation and management services is not made once routine foot care is covered. Not covered when the service is billed under circumstances outside of specified conditions. Conditions for coverage are specified in the National Coverage Determinations Manual, with certain diagnoses being excluded. Not covered for procedures that do not follow medical necessity guidelines. Limitations on frequency of transfusions may apply based on clinical criteria. Transfusion procedures are not covered when performed for non-medically necessary reasons. Specific age restrictions or frequency limits may apply to certain transfusion procedures. Coverage may not apply if the diagnosis does not meet specific medical necessity criteria. No specific limitations provided. Not covered for beneficiaries without severe, symptomatic SCD. Not covered for experimental procedures not recognized in standard treatment guidelines. Transfusions are not reimbursed if performed outside of approved clinical protocols. Not covered for conditions not included within the specified ICD codes. Exclusions apply for treatments not meeting established medical necessity criteria based on the type of Hodgkin lymphoma. Not covered for non-specified lymphoid tissue or other conditions outside this classification. Coverage may be limited to specified types of lymphoma with documented diagnoses. Conditions not specified in the coding list may not be covered under this policy. Specific subtypes and locations of lymphomas must be confirmed for coverage. Not covered if lymphoma diagnosis does not match specified ICD codes. Conditions not specified in the list of ICD-10 codes are not covered. Experimental treatments for lymphoma are excluded from coverage. Not covered for lymphomas not fitting the specified types or classifications. Exclusions apply to lymphomas outside of defined categories. Limitations may apply based on specific subtypes and sites of lymphoma. Services may not be covered if not medically necessary or not in line with established treatment guidelines. Not covered for any lymphoma types not listed in the specified ICD-10 codes. Coverage may not extend to unverified or unapproved treatment methods. Non-Hodgkin lymphoma diagnoses are not covered when unspecified or not meeting criteria for specified types. Coverage is not available for conditions not explicitly listed or for any non-malignant hyperproliferative diseases. Limitations exist regarding treatment modalities and may vary by specific health plans or clinical scenarios. Specific exclusions related to non-covered leukemias are not provided. Single AuSCT is not covered for patients who do not meet the specified Durie-Salmon staging criteria. Not covered for patients with advanced Hodgkin's disease who have an HLA-matched donor. Not covered if amyloid deposition is in more than 2 organs. Not covered if left ventricular ejection fraction is 45% or below. Not covered for patients without laboratory confirmation of light chain amyloidosis. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is not covered for multiple myeloma (ICD-10-CM codes C90.00, C90.01, C90.02, and D47.Z9) for claims from May 24, 1996, through January 27, 2016. Autologous Stem Cell Transplantation (AuSCT) is not considered reasonable or necessary and is not covered under Medicare. All other indications for stem cell transplantation not otherwise noted are at the discretion of the local Medicare Administrative Contractor. Claims with ICD-10-CM codes E85.4, E85.81, E85.9, and E85.89 must be reviewed to determine payment appropriateness. Not covered for non-clinical trial situations. Payment adjusted if information submitted does not support the level of service. Services must be provided only in the inpatient setting, outpatient Part B, or in Method II critical access hospitals. Claims for these services are not covered outside of the specified settings. Services are only payable in the inpatient setting, inpatient Type of Bill (TOB) 11X, outpatient Part B (TOB 13X), and in Method II critical access hospitals (TOB 85X). Not covered unless the procedure is part of an approved Medicare clinical trial. Certain ICD-10-CM diagnosis codes are only covered under specific circumstances. Claims will be denied if services are not provided in accordance with CED. Claims deemed non-medical necessity will be denied with CARC 50. Not covered if the service/item was not provided as part of a qualifying trial/study. Not covered when non-qualifying policies such as NCD 110.23 are applied. Expenses incurred by a donor are covered for the recipient but not paid separately, except for physician services. Autologous stem cell transplantation coverage is limited to specified diagnoses. Not covered if criteria regarding age, stage of disease, or organ function are not met. Treatment is not covered if leukemia is documented as having achieved remission without further relapse. Evidence of clinical need must be substantiated; treatment solely for convenience is excluded. Exclusions are not specified in the provided document. Not covered for conditions not explicitly listed in coding criteria. Exclusions apply to non-compliant or incomplete documentation. Not covered for acute leukemia not in remission. Not covered for chronic granulocytic leukemia. Not covered for solid tumors, except neuroblastoma. All forms of amyloidosis in beneficiaries age 64 or older are not covered. Non-primary amyloidosis is also not covered. Autologous stem cell transplantation is not covered for specific conditions. Coverage for conditions not specifically designated as covered will be at the discretion of the individual A/B MAC (B). Appropriate diagnosis to procedure code edits should be implemented for non-covered conditions. Payment adjusted if the information submitted does not support the need for the service as indicated by MSN - 15.4. Claims may be denied if the payer deems the submitted information does not support the service level, indicated by CARC - 150. Allogeneic HSCT for MDS is not reasonable and necessary under §1862(a)(1)(A) of the Act. Non-coverage applies outside of approved clinical studies. Payment is only applicable for services rendered in the inpatient setting (TOB 11X), outpatient Part B (TOB 13X), or Method II critical access hospitals (TOB 85X). Codes are applicable only for inpatient settings and Medicare-approved trials. Claims failing to meet the specified criteria will be denied. Claims will be denied if the services are deemed not medically necessary. Coverage is not applicable to beneficiaries not meeting criteria unless specific additional criteria are satisfied. Specific limitations may apply as detailed in Publication 100-03, Chapter 1, Section 50.3. Surgical procedures are not acceptable on 12X bill types. No special payment methods are available; existing methods shall apply. Claims not meeting coverage criteria in Publication 100-03, Chapter 1, section 50.3 are subject to certain conditions. Coverage is limited to services provided in specified studies as defined by the -Q0 modifier. Claims will not be accepted for beneficiaries not meeting the coverage criteria specified under Publication 100-03, Chapter 1, Section 50.3. Services must be billed on an approved electronic claim form or paper CMS Form 1500. Repairs of prosthetic devices only cover minor parts. Specific evaluations for speech fluency and sound production are necessary for claims. Claims may be denied for cochlear implantation devices and services based on specific CARCs and RARCs. No payment will be made for claims not meeting the hearing test score criteria. Non-covered services because not deemed a 'medical necessity' by the payer. Services submitted without specific criteria or diagnostic codes are excluded from coverage. Services related to cochlear implantation are not covered when submitted with a type of bill other than 11X, 12X (except surgical procedures), 13X, or 85X. Services submitted without a diagnostic code Z00.6 will be denied. Not covered under contractual obligation by the provider. Claims for evaluation and therapeutic services related to cochlear implantation are denied. Ultrasonic stimulators cannot be used concurrently with other non-invasive osteogenic devices. Coverage requires evidence of nonunion fracture demonstrated by a minimum of 2 sets of radiographs, separated by at least 90 days. Hospitals cannot bill for Ultrasonic Osteogenic Stimulators. Ultrasonic Osteogenic Stimulators must be included in the patient's home health plan of care if billed on TOBs 32X or 33X. No covered services for Ultrasonic Osteogenic Stimulation for which hospitals can receive payment from the fiscal intermediaries. The use of ultrasonic osteogenic stimulators is subject to date of service limitations; coverage applies only from April 27, 2005, and onward. Beneficiaries are responsible for any additional charges associated with the insertion of a P-C IOL. Charges for A-C IOL are not covered by Medicare as they fall outside Medicare benefit categories. A-C IOL is intended to replace both a conventional IOL and the cost of corrective eyewear, which are also not covered. Medicare does not make separate payment for an IOL inserted subsequent to extraction of a cataract. Civil money penalties may apply for improper billing of IOL during or after cataract surgery under the ASC fee schedule. Use of V2788 for additional charges for P-C IOL or A-C IOL insertion ended after January 1, 2008. V2787 must be used after January 1, 2008, for additional charges for A-C IOL. Facility charges for services required to insert and adjust a P-C or A-C IOL are not covered. Coverage is limited to conventional IOL insertion and adjustment charges only. There is no Medicare benefit category for facility charges exceeding those for monitoring after cataract surgery with a conventional IOL. No Medicare coverage for P-C or A-C IOL insertion fees exceeding those of conventional IOLs. No coverage for subsequent monitoring or examination fees for P-C or A-C IOLs that exceed those for conventional IOLs. Physician charges for services and supplies to insert P-C or A-C IOL are not covered. Payment for P-C or A-C IOL services is not separate when performed in a hospital setting. Not covered if the procedure does not meet complexity criteria. Services performed during the amblyogenic development stage may face additional scrutiny. Insertion of P-C IOL or A-C IOL in an office setting must follow Medicare's pricing for reasonable costs. The type of service indicator for the non-covered billed charges is Q, applied by the Medicare carrier. Effective January 1, 2008, V2787 should be used instead of V2788 for reporting additional charges related to A-C IOL insertion services. Non-payable charges with codes V2787 or V2788 are not covered. Claims for conditional IOLs must be paid under current methodologies. Medicare will not cover services specific to the P-C or A-C functionalities of the IOL. An Advanced Beneficiary Notice is not required for beneficiaries requesting P-C or A-C IOL. Beneficiary is responsible for payment of facility and physician charges specifically for the P-C or A-C functionality. Charges cannot be levied for cataract extraction with insertion of a P-C or A-C IOL unless requested by the beneficiary. Beneficiaries cannot be mandated to request a P-C or A-C IOL to receive cataract extraction. Not covered for patients who are operable or have low risk for operative complications. Procedures must not be appropriate based on coronary anatomy or existing co-morbidities. Evaluation and management services cannot be billed on the same day as ECP treatments unless they occur in a different clinical setting. Deductible and coinsurance apply. Applicable bill types are 12X, 13X, 83X or 85X. Nonphysician practitioners must be defined as per section 1861(aa)(5)(A) of the Social Security Act. Not covered unless specific criteria are met by the Medicare beneficiary and the setting in which it is administered. Nonphysician practitioners must be defined as physician assistants, nurse practitioners, or clinical nurse specialists. Coverage must not exceed a total of 72 sessions within a 36-week period. CR must be performed incident to the services of a physician in outpatient settings. Only one session may be billed per day if the total CR time is less than 60 minutes. Sessions must last a minimum of 60 minutes each to bill more than one unit. The individualized treatment plan must be reviewed and signed by a physician every 30 days. Number of cardiac rehabilitation sessions is limited to a maximum of 2 one-hour sessions per day for up to 36 sessions over 36 weeks. An additional 36 sessions may be approved by the Medicare Administrative Contractor. Only a maximum of 2 one-hour sessions may be reported per day. If total CR service provided in a day is less than 31 minutes, no sessions may be reported. Not covered if services exceed 36 sessions in total. Not covered for patients with unstable angina or significant arrhythmias. Not covered beyond 36 total cardiac rehabilitation sessions post-switch to ICR. The KX modifier is required for claims involving more than 36 sessions. Services are not covered for patients who do not meet Medicare's medical necessity criteria. Rehabilitation services are limited to a certain number of sessions as specified in Medicare policy. Beneficiaries are limited to a one-time switch from intensive cardiac rehabilitation (ICR) to cardiac rehabilitation (CR). Once a beneficiary switches from ICR to CR, they will only have the remaining sessions of CR available, with a maximum of 36 overall sessions. Further sessions exceeding 72 within 126 days must meet medical necessity criteria. Sessions beyond 126 days from the first session are not covered. Claims with POS codes other than 11 and 22 will be denied. Payment is denied when services are performed by unallowed providers in specified facilities. Certain procedures are not covered when performed in non-designated places of service. Claims submitted on TOBs other than 13X and 85X will be denied. Services not covered when performed in settings not specified in the policy. Claims exceeding the unit limits will be denied by the contractors. All claims dated January 1, 2010, or later must adhere to these frequency limits. Claims exceeding 36 CR sessions without a -KX modifier will be denied. Contractors shall not adjust claims for ICR (HCPCS G0422 and G0423) exceeding 6 units processed before edit implementation. Services are not considered medically necessary. Benefit maximum for this period or occurrence has been reached. Frequency limits exceeded without support documentation. Claims exceeding 72 sessions will be rejected. Claims with dates of service exceeding 126 days from the first session will be rejected unless accompanied by a KX modifier. Claims cannot exceed 72 sessions. Billed sessions must occur within 126 days from the date of the first session. Claims for ICR services paid for more than 72 sessions are not subject to adjustment. Claims billed after 126 days from the date of the first session are not subject to adjustment. Procedure code is inconsistent with the provider type/specialty. This provider type may not bill this service. The service is not covered when performed or ordered by the specified provider. Coverage may not be supported by clinical evidence as determined by the NCD process. Non-coverage of certain cardiac conditions if not clinically warranted. Programs must demonstrate efficacy through peer-reviewed research and be listed by CMS. Individualized treatment plans must be reviewed and signed by a physician every 30 days. ICR is limited to 72 one-hour sessions, with a maximum of 6 sessions per day over 18 weeks. ICR sessions must be reported in 1-hour increments; additional sessions require at least 31 minutes beyond the hour increment. If total service time is less than 31 minutes in a day, no sessions of ICR can be reported. Billing for ICR sessions is limited by the total duration, with specific thresholds of 90 minutes and 150 minutes for units. Additional medical indications for coverage may be established through an NCD, and not all indications are covered automatically. Recommendations and treatment plans must be reviewed and signed by a physician every 30 days. Requires a physician or nonphysician practitioner to be immediately accessible for emergencies. Effective January 1, 2024, nonphysician practitioners may supervise pulmonary rehabilitation. PR sessions are limited to 2 one-hour sessions per day, for a maximum of 36 sessions over 36 weeks. An additional 36 sessions may be approved by the MACs on a case-by-case basis. If the total treatment time is less than 31 minutes, no PR session may be reported. Total treatment time for two sessions must be at least 91 minutes, with the first session accounting for 60 minutes and the second for at least 31 minutes. Not covered if the total duration of pulmonary rehabilitation services does not exceed 90 minutes in a day. Excluded for patients not meeting the clinical criteria for chronic respiratory conditions. A maximum of two sessions may be reported per day, regardless of the total duration of services provided. Claims from places of service other than POS 11 and POS 22 will be denied. PR services performed in unauthorized POS will receive a denial message CARC 96 and RARC N428. This service is only covered in certain settings as determined by Medicare. Claims with any other type of bill (TOB) shall be denied. Medicare does not cover PR services when performed in settings outside of specified TOBs. All PR claims exceeding two units on the same date of service will be denied. Claims with a GZ modifier indicating no signed ABN will hold financial liability to the provider. Services exceeding 36 sessions are subject to additional review. Benefits not payable if maximum service limits are reached. Claims exceeding 36 PR sessions will be denied if the KX modifier is not included. Medicare will not cover services deemed not medically necessary, as indicated by denial messages. Claims with Patient Responsibility (PR) that exceed 72 sessions will be rejected. Claims will be denied regardless of the presence of a KX modifier. Services will not be covered if the number of sessions exceeds 72 unless a -KX modifier is submitted. Claims may be denied if benefits are exhausted at the time of service. The procedure must be performed at an approved facility. Documentation of the patient's medical information must be in the medical record. Requests for bariatric surgery must meet Medicare's medical necessity criteria. Facilities no longer need to be certified for performing bariatric surgery for covered conditions. Procedures are non-covered if performed for convenience, cosmetic reasons, or if criteria for surgical candidacy are not met. Certain HCPCS codes are non-covered for bariatric surgery services after February 21, 2006. Non-covered instances include laparoscopic sleeve gastrectomy. Non-covered instances include open adjustable gastric banding. Coverage is limited to specific ICD-10 procedure codes effective for services on or after October 1, 2015. Not covered for procedures not medically necessary or not meeting established guidelines. Not covered for procedures without clinical justification. Excluded if performed using methods not aligned with current medical standards. Procedures may not be covered if performed for non-medical reasons. Specific techniques may have restrictions based on patient health status. Not covered for procedures not meeting clinical indications or guidelines. Exclusions may apply based on the patient's health status or previous surgical history. Not covered for procedures performed without medical necessity or outside of approved indications. Not covered for procedures not conforming to established surgical criteria. Coverage is limited to specific indicated procedures listed. Not covered when procedures are performed for convenience or without medical necessity. Excision codes must be used in accordance with the provided coding guidelines. Not covered for procedures lacking medical necessity. Not covered if the procedure is performed for convenience rather than medical necessity. Procedures are not covered if performed without medical necessity. Not covered if other surgical options are available. Not covered for procedures that do not meet the specified medical necessity criteria. Not covered for patients with contraindications to surgery. Excluded if performed for non-medical reasons. Not covered for procedures lacking medical necessity or appropriate indications. Not covered for procedures performed without medical necessity or solely for convenience. Exclusions may apply for patients with contraindications to the use of the specified substitutes. Not covered for patients who do not meet criteria for surgical intervention. Exclusion applies to procedures that are performed for cosmetic reasons. Procedures may not be covered if performed for non-medically necessary reasons. Not covered for patients with contraindications to surgical procedures. There is no distinction between open and laparoscopic BPD with DS or GRDS for the inpatient setting; one code from each of the specified groups must appear on the claim for coverage. Coverage is contingent upon meeting specific BMI and comorbidity criteria. Claims must provide specific ICD codes to support coverage. Not covered if the patient does not have a diagnosis of Type II Diabetes Mellitus. Not all codes require combination for coverage; individual codes justify the service. Services are excluded when diabetes complications do not present as per condition criteria. Not covered for diabetes-related conditions not specified in the policy. Claims for conditions not specified in the ICD-10 codes listed will not be covered. Non-covered conditions include diabetic retinopathy that is not classified under the specified codes. Conditions without proper evidence of diabetic complications are not covered. Services may not be covered if criteria for specific diabetic eye complications are not met. Not covered if diabetes-related complications are excluded or not listed in policy. Combination of E11.40 with E11.65 is not required for coverage. Combination of E11.69 with E11.65 is not required for coverage. Facility certification validation is required for all bariatric surgery claims on a pre-pay basis for dates of service up to and including September 23, 2013. Claims are not covered if ICD-10 diagnosis code E66.01 is present without a corresponding covered procedure code. Claims are not covered if the procedure is performed in an unapproved facility. Claims may be denied if there is an absence of covered procedure codes in conjunction with ICD-10 diagnosis code E66.01. Services rendered in an inappropriate or invalid place of service will not be covered. Medicare does not pay for this item or service. Services are considered non-covered because they are not deemed 'medically necessary' by the payer. The service or item is not covered as the information provided does not support its necessity. Diagnosis codes associated with this service are not covered. Services are not covered unless submitted on type of bill 11X. Payment for services in Indian Health Services critical access hospitals is based on facility specific per diem rate only. Not covered when surgery is performed in an unapproved facility without proper notification. Claims for PTA in an FDA-approved clinical study must be reviewed for payment approval by contractors. Institutional providers must bill the IDE Number on a 0624 Revenue Code line. Practitioners must bill the IDE Number with a Q0 modifier. Coverage is only applicable to patients in post-approval studies and not to other situations. Extensions of post-approval studies are not subject to FDA approval. Individual Post-Market Approval (PMA) numbers cannot be issued for extension studies. An individual PMA number cannot be assigned to each extension study. Providers must submit the FDA acknowledgement letter and CMS coverage letter to contractors. Claims must be billed using the most current ICD-10-CM applicable to indications for PTA of the Carotid Artery Concurrent with Stenting. Not covered for procedures without medical necessity evidenced by clinical documentation. Excluded if the procedure is performed solely for convenience or outside established clinical guidelines. Not covered for procedures involving fewer than two intraluminal devices. Will not cover when performed for convenience or without medical necessity. Procedures are not covered for indications outside of specified arterial dilation. Services will not be covered if performed during the same session as another unrelated procedure. Not covered in asymptomatic patients with minimal stenosis. Procedures performed solely for convenience are excluded from coverage. Procedures are not covered for patients with a documented history of surgical complications from previous arterial interventions. Frequency limits may apply based on individual patient assessments and medical history. CAS is not covered for patients who are not candidates for carotid endarterectomy. CAS should not be performed in patients with an active infection or significant comorbidities. Facilities that perform CAS procedures are no longer required to be approved by CMS. Additional reasonable and necessary determinations are at the discretion of MACs. Beneficiaries are no longer required to be enrolled in a clinical trial for this service. Not covered if the deployment of the embolic protection device (EPD) is not technically possible. Coverage limited to procedures performed up to October 10, 2023. Facilities must meet minimum CMS standards to receive coverage for CAS procedures. Facilities are required to recertify every 2 years to maintain coverage. Intracranial PTA with stenting remains non-covered for all other indications. Coverage is limited to situations where providers meet Category B IDE billing requirements. Payment is contingent on billing both the correct procedure and diagnosis codes for the date of service. Procedures using more than four devices per dilation are subject to additional documentation and review. Non-covered when performed for convenience rather than medical necessity. Procedures are not covered if performed without appropriate clinical indications. Not covered for patients with contraindications to the procedure. Procedures are not covered when performed solely for non-medical reasons or convenience. Repeated dilation procedures within a specified timeframe may not be covered. Not covered for asymptomatic patients with mild stenosis. Procedures are not covered if they do not meet established clinical guidelines. Procedures are not covered when performed for experimental or investigational purposes. Limitations may apply based on patient age or comorbid conditions. Lumbar artificial disc replacement (LADR) with the Charite™ lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age. LADR with lumbar artificial discs has no national coverage determination for beneficiaries 60 years and younger; coverage is determined by local contractors. Claims submitted with specific Category III Codes for Medicare beneficiaries over 60 years of age shall be denied. Claims for LADR surgery will be denied for Medicare beneficiaries over 60 years of age (on or after their 61st birthday). Coverage is limited to a single interspace or the second interspace. Coverage is limited to claims submitted with ICD-9-CM procedure code 84.65. Claims must include condition code 30 and ICD-9-CM diagnosis code V70.7. Coverage applies only for the type of bill (TOB) 11X during the effective period from May 16, 2006, to August 13, 2007. ICD-9-CM procedure code 84.65 is not payable for beneficiaries over 60 years of age with the Charite™ lumbar artificial disc. If a different manufacturer’s disc is used, condition code 30 and ICD-9-CM diagnosis code V70.7 must be included on the claim for payment. LADR is non-covered for Medicare beneficiaries over 60 years of age. Claims with ICD-9-CM procedure code 84.65 for beneficiaries over 60 will be denied. This service is not covered for patients over age 60. Providers are liable for charges if lumbar artificial disc replacement is used without informing the beneficiary. Salvage therapy is not covered for patients with Gleason score 9 or above or PSA levels 8 ng/ml or greater. Claims must be submitted on ASC X12 837 or a hard copy Form CMS – 1450 in exceptional circumstances. This service is only covered in inpatient or outpatient hospital settings. Inpatient claims must use specified ICD codes for procedure classification. Ultrasonic guidance is not separately compensated but bundled within cryosurgical payment. Payment for the procedure may vary based on the type of facility and setting. Payment for inpatient or outpatient services in hospitals in Maryland is determined according to the State Cost Containment system. Payment is on a reasonable cost basis, minus any applicable deductible and coinsurance. Claims that do not meet the above criteria are subject to denial. Claims for HCPCS code G0442 and G0443 denied if submitted on TOB other than 13X, 71X, 77X, and 85X. Claims with an inconsistent procedure code or bill type are denied based on the place of service. Claims for more than one counseling session (G0443) on the same date of service will be denied. Payment will not cover services if deemed excessive based on the provided documentation. Claims are denied if not submitted from the appropriate provider specialties. Financial liability falls on the provider if a claim is received with a GZ modifier indicating no signed ABN on file. The item or service is not covered when performed or ordered by this provider. Claim adjustments may occur if the rendering provider is not eligible to perform the billed service. Claims may be denied if submitted without the appropriate Place of Service (POS) code. Not covered when the service is rendered in an inappropriate or invalid place of service. Claim denied for services provided in locations not recognized by Medicare. Claims for alcohol misuse screening (HCPCS G0442) will be denied if billed more than once in a 12-month period. Claims for alcohol misuse counseling (HCPCS G0443) will be denied if billed more than four times in the same 12-month period. Claims for HCPCS code G0443 will be denied if there is no prior claim for HCPCS code G0442 in the previous 12 months. Medicare does not pay for services related to unapproved procedures. Service/procedure requires a qualifying service/procedure to be received and covered. Claims without a signed Advance Beneficiary Notice (ABN) may assign financial responsibility to the provider. Claims for G0443 will be rejected if four G0443 services have been billed within a 12-month period. Claims for G0442 and G0443 billed on the same day will be rejected with specific error codes for time-of-billing classifications. G0443 claims may be rejected if a corresponding G0442 claim is canceled within the 12-month period. No coverage for G0443 services if billed after the limit of four sessions has been reached. No next eligible date calculation if G0442 is not paid. Beneficiary master data changes may affect eligibility dates. Subsequent payment for G0442 cannot occur until 11 full months have elapsed since the last screening visit. A maximum of 4 counseling sessions (G0443) is allowed within the same 12-month period counted from the last G0442 screening. Claims for facility fees identified with TOB 13X, 85X are covered unless revenue code is 096X, 097X, or 098X. RHCs and FQHCs are excluded from this coverage policy. Coverage is limited to claims with dates of service on or after April 30, 2012. Extracorporeal photopheresis must be part of a clinical research study that meets specific requirements. Payment for extracorporeal photopheresis is conditional upon an appropriate oncological or autoimmune disorder diagnosis. Coverage for extracorporeal photopheresis is limited to claims with dates of service on or after October 1, 2015. Extracorporeal photopheresis is not covered outside of a clinical research study. Coverage limited to specific types of cutaneous T-cell lymphoma as listed. Coverage is subject to clinical trial conditions (BOS CED/TRIAL ONLY). Claims for extracorporeal photopheresis for BOS will be denied if the service is rendered outside of inpatient or outpatient hospital settings. Extracorporeal photopheresis is not covered for other diagnoses such as chronic graft versus host disease in non-hospital settings. Not covered when performed in this location/facility. Payment is denied when performed/billed by this type of provider in this type of facility. Claims are unprocessable if missing diagnosis code Z00.6, condition code 30, clinical trial modifier Q0/Q1, or value code D4 with an 8-digit clinical trial identifier number. Contractors will hold physicians and hospitals liable for charges unless the beneficiary signs an Advance Beneficiary Notice before the service. Service falls outside the scope of the revised NCD found in Pub. 100-03, chapter 1, section 110.4. Services provided to hospital inpatients for reasons unrelated to the admission are not covered unless specific documentation is signed. Not covered for patients whose epilepsy is adequately controlled with medication. Coverage is limited to patients over the age of 12. The service is not covered unless billed specifically for Vagus Nerve Stimulation. Not reasonable and necessary for all types of refractory seizures when surgery is not recommended or has failed. Claims for vagus nerve stimulation for resistant depression are denied. Vagus nerve stimulation is not reasonable and necessary for all other types of seizures that are refractory. Claims for vagus nerve stimulation for resistant depression will be rejected. Non-covered services because these are not deemed a medical necessity by the payer. Not covered when items or services are not reasonable and necessary or constitute custodial care. Medicare will not pay for VNS procedures unless an appropriate advance beneficiary notice (ABN) is issued. Physicians are liable for non-covered VNS procedures unless they provide an ABN. Thermal Intradiscal Procedures (TIPs) are not reasonable and necessary for the treatment of low back pain and are therefore non-covered. Claims with these non-covered codes submitted on or after September 29, 2008, will be denied. TIP services used in surgery are non-covered unless the beneficiary signed an ABN acknowledging financial responsibility. Charges are not covered if the service was not covered by Medicare at the time it was received. Does not cover situations where the procedure was performed on the wrong patient. Claims for non-covered services must use Type of Bill 110 and match the Statement Covers Period. For discharges prior to October 1, 2009, specific codes must be entered for erroneous surgeries. Specific ICD codes E876.5, E876.6, E876.7, Y65.51, Y65.52, and Y65.53 must be reported in diagnosis position 2-9 for non-covered TOB 110. The specified codes shall not be reported in the External Cause of Injury (E-code) field. Services related to surgical errors are not considered medically necessary and will not be covered by Medicare. These are non-covered services because this is not deemed a ‘medical necessity’ by the payer. Providers cannot shift financial liability for non-covered services to beneficiaries unless ABN or HINN criteria are satisfied. Surgical errors and related services will not be covered under NCD criteria. An ABN or HINN cannot be validly delivered prior to non-covered services. Claims may be denied due to sex-related edits unless condition code 45 is used. Claims related to transgender, ambiguous genitalia, or hermaphrodite issues must report condition code 45. The KX modifier is only to be billed on the detail line with procedure codes indicated. Testing is only covered in the context of a prospective, randomized, controlled clinical study that meets specific criteria. Not covered for patients who have been previously tested for CYP2C9 or VKORC1 alleles. Institutional clinical trial claims must have Value Code D4 and an 8-digit clinical trial number if present. Outpatient claims require HCPCS modifier Q0. Coverage does not extend to identifying CYP2C9 or VKORC1 alleles for purposes other than warfarin responsiveness. Decisions regarding other alleles for predicting warfarin responsiveness are determined at the local MAC level. Not covered if the beneficiary has received the test in their lifetime due to the one-time limit on the test. These services are deemed non-medically necessary by the payer. Service/item is not covered after exceeding the lifetime limit. Days or units of service exceed acceptable maximum. Claims for pharmacogenomic testing will be returned as unprocessable if not billed with HCPCS modifier Q0. Claims will be unprocessable if ICD-10-CM Z00.6 is not present as a secondary diagnosis. Claim will not be covered if it lacks information for adjudication, such as missing ICD-10 code or Q0 modifier. Service/item not covered if not provided as part of a qualifying trial/study. Not covered for patients who do not exhibit severe facial abnormalities or are not HIV-infected. Coverage may be limited if patients exhibit psychosocial issues unrelated to the condition. Dermal injections are only reasonable and necessary if using FDA-approved dermal fillers. Claims must have the line item date of service on or after March 23, 2010. Claims must include a discharge date on or after March 23, 2010. Only specific HCPCS codes are billable until further updates are issued, restricting the use of previously accepted codes. Claims must include HCPCS codes Q2026 or Q2027 with a Line Item Date of service on or after March 23, 2010. Claims for facial LDS must include the temporary HCPCS code C9800 instead of G0429 when billed for outpatient services during the specified timeframe. Services not provided for disorders outside the specified ICD-10-CM diagnosis codes. Claims must include a line with HCPCS codes Q2026 or Q2027 (replaced with Q2028 effective 1/1/14) with a LIDOS date on or after March 23, 2010. Claims must also include a line with HCPCS code G0429 with a LIDOS date on or after March 23, 2010. Claims for services rendered before Medicare coverage will not be processed. Services received prior to March 23, 2010, are not covered. Billing for services not meeting comorbidity coverage requirements will be denied. Not covered for patients without the specified comorbidities. Denials based on 'medical necessity' as deemed by the payer. Not covered for beneficiaries who do not meet the required comorbidities. Claims may be denied with the message indicating lack of information supporting the need for service. Coverage is subject to specific indications listed in the Medicare National Coverage Determinations Manual. For inpatient hospitals claims, applicable ICD codes must be used. More than one ICD-10-PCS code (a cluster) is required for claims. Not covered for patients who do not meet specified clinical indications for defibrillator lead insertion. Exclusions apply for experimental techniques not supported by current evidence. Not covered for procedures performed without medical necessity. Procedures are not covered if there is no documented need for pacing. Insertion in patients without prior arrhythmia diagnoses may be excluded. No specific limitations mentioned in the document. Specific codes may have age restrictions or other clinical criteria that must be met. Certain conditions may not be covered if associated with other diagnoses that are not included. Conditions of Medicare Part A and Medicare Part B coverage for sipuleucel-T are specified in the Medicare NCD Manual, Publication 100-03, section 110.22. Use of J3490 (Unclassified Drugs) and J3590 (Unclassified Biologics) does not constitute coverage for PROVENGE®. Must be billed with ICD-9 code 185 for the malignant neoplasm of prostate. Not covered for indications outside of the specified diagnosis codes. Not covered for cancer originating from primary tumors not specified. Exclusions apply for neoplasms not documented or inaccurately coded. Claims for off-label treatment must use specific ICD-9 or ICD-10 codes. Not covered if not billed with appropriate ICD code(s) and HCPCS Q2043. Coverage is limited to secondary malignant neoplasms as specified in the policy document. Certain secondary neoplasm conditions may be excluded based on individual assessment. Payment is limited based on specific Types of Bill and revenue codes. Claims with TOB 85X are paid based on reasonable cost and may have specific conditions. Routine costs associated with PROVENGE® are not covered separately, except for the cost of administration. Medicare will not pay for claims submitted without the required ICD-9 codes. Medicare cannot pay for PROVENGE® submitted without ICD-9-CM diagnosis code 233.4. Claims will be denied for the off-label indication. Claims for PROVENGE® exceeding three services in a patient's lifetime will be denied. Claims may be denied if benefits are exhausted. Coverage is limited to claims with dates of service on and after June 21, 2019. Exclusions apply based on trial outcomes and registry questions/criteria as specified in Publication 100-03, National Coverage Determination Manual Part 1, section 20.32. TAVR is not covered for patients deemed low surgical risk. Procedures performed without the appropriate clinical trial reporting will not be reimbursed. Not covered for patients who are not deemed suitable candidates for transcatheter aortic valve replacement. Exclusions apply to cases where there are contraindications for the procedure. Not covered for patients with moderate or mild aortic stenosis. Exclusion for patients with contraindications to anticoagulation. TAVR claims will be denied if performed in any other place of service. Services are not covered when rendered in an inappropriate or invalid place of service. Claims billed without modifier -62 shall be returned as unprocessable. Claims billed without modifier -62 will be returned as unprocessable. Claims containing incomplete or invalid information will not have appeal rights afforded. Claims billed without modifier -Q0 will be returned as unprocessable. Claims billed without diagnosis code V70.7 (ICD-10 Z00.6) shall be returned as unprocessable. Claims billed without diagnosis code V70.7 (ICD-10 Z00.6) will be returned as unprocessable. Claims not covered if not part of a qualifying clinical trial or study. Claims returned as unprocessable must contain valid ICD-10 diagnosis Z00.6. Claims without an 8-digit clinicaltrials.gov identifier number will be unprocessable. Claims will not be processed if the Investigational Device Exemption number is missing, incomplete, or invalid. Claims billed by hospitals not participating in the trial/registry are non-covered services. Claims will be rejected with a CARC 50 message indicating these services are not deemed a 'medical necessity' by the payer. Not covered when the service/item was not provided as part of a qualifying trial/study. TAVR services are not covered under section 310.1 of the NCD Manual. OPT coverage is limited to ophthalmologic diseases specified in the NCD Manual. Limitations unspecified in the document. Not covered for forms of macular degeneration other than specified in the indications. Limitations may apply based on clinical severity or staging. Coverage is denied when billed with Nationally Non-Covered ICD-10-CM codes. The fluorescein angiogram or optical coherence tomography is not required to be submitted on the claim for OPT services and can be maintained in the patient's file for audit purposes. Medicare cannot pay for this service for diagnoses not listed on the claim. Treatment may be deemed inappropriate or invalid if rendered in an inappropriate place of service. Not covered for routine monitoring in patients without specific clinical indications. Frequency limits may apply based on clinical necessity. Services must be provided in POS 21 to qualify for reimbursement. HCPCS G9157 will be denied when billed at any POS other than 21 for ventilated patients in the ICU or operative patients needing intra-operative fluid optimization. Treatment deemed rendered in an inappropriate or invalid place of service will not be covered. Artificial hearts are not covered for discharges before May 1, 2008, nor as a permanent replacement or temporary life-support system outside of clinical studies. Exclusions for conditions not documented as part of acute ischemic heart disease. Not covered for unspecified forms of angiographic procedures. Certain forms of atherosclerosis without angina pectoris may have limited coverage. Not medically necessary if condition does not meet established diagnostic criteria. Not covered for unspecified cardiac conditions without documented justification. Coverage does not extend to conditions excluded from this list or those not medically necessary. Not covered for complications that are unrelated to the surgical procedure performed. Exclusions may apply for pre-existing conditions that do not result from the surgery. Not covered for complications unrelated to heart transplant. Exclusions apply to pre-existing conditions prior to transplant. Limitations may apply to procedures based on clinical necessity and patient condition. Not covered for complications arising from non-medically necessary transplants. VADs are not covered if not FDA-approved for the intended purpose. Coverage for LVADs is contingent upon meeting the clinical criteria outlined in NCD 20.9.1. All other indications for the use of VADs not listed remain non-covered. Non-covered uses of VADs include those not part of clinical trials. No indications provided for limitations or exclusions in this document. Services related to unspecified angina pectoris under ICD-10 code I25.119 may not be covered. Conditions such as silent myocardial ischemia under ICD-10 code I25.6 are subject to additional pre-authorization. No coverage if the condition is not clearly specified or falls outside the mentioned classifications. Addressing issues not included under defined criteria may lead to non-coverage. Exclusions for unspecified chronic ischemic heart disease conditions. Non-coverage for conditions that do not meet medical necessity standards. Not covered for conditions outside specified ICD-10 codes. Limitations on treatment for unspecified cardiac conditions. Services not covered for heart conditions without a clear clinical diagnosis. Experimental treatments for heart diseases are not included. Not covered for conditions not related to operative procedures. Will not cover complications that do not fall under specified postprocedural scenarios. Not covered for complications not associated with the specified cardiac devices. Excluded situations that do not meet medical necessity criteria. VADs for right ventricular support not covered. Biventricular support and use in beneficiaries under 18 not covered. Use in beneficiaries with complex congenital heart disease not covered. Use in beneficiaries with acute heart failure without a history of chronic heart failure is not covered. Claims will be manually reviewed. Replacement supplies and accessories are not covered if the patient was not eligible for coverage under Medicare Part A at the time of device implantation. Claims for replacement supplies or accessories must meet specific HCPCS code criteria to be covered. Claims should be billed to the appropriate MACs depending on the provider type. Not covered if payment was already made under Medicare Part A for the implanted ventricular assist device. Replacement coding is designated for specific components and does not cover any additional upgrades or modifications. Components are only covered for replacement and not for initial installations. Items are not covered if they are not replacements for existing devices. No coverage for equipment that does not meet specific design requirements for ventricular assist devices. Procedure is not covered if the patient has not undergone conservative treatment. Not covered when the procedure is not performed under indirect image guidance. Exclusions may apply based on patient condition and specific clinical criteria. Not covered outside of approved clinical trials. PILD is not covered outside approved CED clinical trials. Claims must include an 8-digit clinical trial identifier number. Claims for PILD billed without an 8-digit clinical trial identifier number shall be returned as unprocessable. Claims adjustment reason code 16 applies for claims lacking necessary information for adjudication. Claims for PILD not billed in place of service 22 or 24 shall be returned as unprocessable. Coverage is only applicable when the service is performed as part of a clinical trial. Claims billed without modifier Q0 will be returned as unprocessable. Claims with inconsistent procedure codes and missing required modifiers will be denied. Claims not billed with the covered diagnosis will be returned unprocessable. Claims Adjustment Reason Code B22 indicates payment adjustment based on diagnosis. Claims without the clinical trial diagnosis are unprocessable. Claims may be adjusted based on the provided diagnosis. Medicare will only cover PILD under CED for those enrolled in a CMS-approved study that completed a CMS-approved randomized controlled trial. Hospital outpatient procedures for PILD will be rejected when billed without ICD-10 Z00.6 and Condition Code 30. Claims lacking Modifier Q0 will also be denied. Claims billed by hospitals not participating in the trial will be rejected as non-covered services. Services/items not provided as part of a qualifying trial/study are not covered. Maintains coverage only with registry participation. Changes to heart team, hospital, registry questions, and trial requirements apply. TMVR is non-covered outside of Coverage with Evidence Development (CED). TMVR is not covered for non-mitral regurgitation indications. This coverage is limited to specific criteria under the related CED. Not covered if not performed with appropriate clinical indications. Claims for mitral valve TEER services will be denied if not billed using POS code 21. All other POS codes for mitral valve TEER claims shall be denied. Services may be denied if provided in an inappropriate or invalid place of service. Treatment is not covered if a signed Advance Beneficiary Notice (ABN) is not on file. Claims for mitral valve TEER billed without modifier -Q0 shall be returned as unprocessable. Claim lines will be denied if the procedure code is inconsistent with the modifier used. Claims for mitral valve TEERs without ICD-10 codes I34.0, I34.1, or Z00.6 will be denied as non-covered services. Effective 01/01/25, ICD-10 codes I34.0 or I34.1 will no longer need to be primary with Z00.6 as secondary. Claims billed without an 8-digit NCT number will be returned as unprocessable. The 'CT' prefix is required on paper claims but not on electronic claims. Claims for mitral valve TEER services are unprocessable without an 8-digit NCT number. Claims may lack information needed for adjudication, including a Remark Code. Inpatient claims for mitral valve TEER will be denied if they do not include the required ICD-10 codes and clinical trial coding. Services are deemed non-covered if not considered 'medical necessity' by the payer. Services are subject to standard claims processing requirements. Additional limitations may be specified by the contractor. Medicare coverage for mitral valve TEER is not included under section 310.1 of the NCD Manual (Routine Costs in Clinical Trials). Services furnished outside the U.S. are generally excluded from payment as per 42 CFR 411.9. Payment exclusions apply to services furnished on board a ship as described in 42 CFR 411.9(a)(2). The hospital must be substantially more accessible than the nearest participating hospital to qualify for reimbursement. Only specified emergency services will be covered. Services furnished outside the U.S. are generally excluded from coverage. Exclusions apply to services rendered on board a ship. No payment for other Part B medical services, including outpatient services outside the United States. Services rendered outside of United States territorial waters are not covered. Payment may not be made for items provided or delivered outside the United States. Physician and ambulance services are not covered by the Railroad Retirement Act. Election for religious nonmedical health care institution revocation applies if hospital services are utilized. Claims for emergency services must include a physician's statement describing the emergency. A statement of emergency existence is insufficient without documentation of when the emergency ceased. Exclusions may apply if documentation fails to substantiate the need for emergency services. Unaccompanied statements that an emergency continues are not acceptable for coverage. Services may not be deemed emergency if proper documentation is not provided. The hospital must not be primarily engaged in providing skilled nursing care. The hospital must meet the definition of an emergency hospital and be licensed or approved by the appropriate agency in its country. Services are not covered if departure from the U.S. was part of a trip abroad, unless the foreign hospital was more accessible due to an inability to return to the U.S. hospital. Similar limitations apply to emergencies occurring in Canada without specific criteria being met. Benefits are not payable if the emergency occurred while the beneficiary was on vacation. Emergencies within the Canadian inland waterway between Washington and Alaska are considered to have occurred in Canada. Deviation from the 'shortest practicable route' occurs when travel is for sightseeing or vacationing. Claims for services in countries other than Canada or Mexico will be processed under specific MAC jurisdiction. Coverage for emergency services is limited to accredited facilities recognized by appropriate authorities. Claims may be denied if services are determined not to be medically reasonable and necessary. Custodial care is excluded from coverage under §§1862(a)(1) and (9). Foreign hospitals not participating with Medicare are not obligated to provide written notice of non-coverage. Finding that a beneficiary had knowledge of non-coverage is rare. Limitations on liability information must be referenced from Pub 100-04, chapter 30. Return trips from a foreign hospital are not covered. Foreign hospitalization must meet emergency service criteria to be considered covered. Normal deductible and coinsurance requirements apply to physician and ambulance services. The assignment method cannot be used for requests involving foreign services. Physician and ambulance services are not covered under the Railroad Retirement Act. Payment for Part B services requires compliance with specific requirements outlined in the policy. Medicare payments are reduced by the amount paid by the Canadian Provincial Health Insurance Plan for services furnished in Canada. No payments are made for healthcare services furnished in Mexico or any other foreign country besides Canada. Claims may be denied if the requirements in §350.6.A are not met. Part B claims will be held until MAC determines Part A service coverage. Services are not covered if the laboratory does not meet hospital conditions of participation. Claims from the laboratory must be identified as 'Emergency Lead' by the MAC. Services are not covered as Part A emergency inpatient services. Claims may be disallowed if no emergency is alleged. Outpatient physical therapy and speech-language pathology are not covered under nonemergency provisions. Payment for 'incident to' services is only applicable under emergency provisions. Payments for diagnostic laboratory tests by nonparticipating hospitals are allowed only if the laboratory meets conditions of coverage for independent laboratories. Payments for radiology services by nonparticipating hospitals are limited to when the facility meets conditions for radiology departments. Claims may be returned if services are determined not covered under nonemergency provisions. Electing hospitals must file claims for services provided to all Medicare beneficiaries. Beneficiaries cannot be billed for covered services beyond deductibles, coinsurance, and noncovered services in a calendar year. Hospitals must refund incorrect collections and cannot file an election for the year if covered services were charged. The MAC will only send letters to non-participating hospitals once a year during November. Hospitals cannot bill beneficiaries for amounts other than deductible, coinsurance, and charges for non-covered services. Beneficiaries must be refunded for any incorrect payments collected by the hospital. Hospitals cannot file an election if they have charged beneficiaries for covered services during the calendar year. Claims will be denied if the hospital has not filed a billing election. Claims may be subject to technical denial based on the Medicare secondary payer provisions. Claims denied if the residence requirement is not met. Claims denied if the hospital does not meet Joint Commission accreditation requirements. Claims denied if accessibility requirements are not met. Claims denied for Canadian travel when requirements are not met. Claims denied if the hospital does not meet the definition of an emergency hospital. Claims denied if the beneficiary is not entitled to benefits. Claims denied if Part A benefits are exhausted without involvement of Part B claims. Part A or Part B emergency services may be denied. Part B payment may only be possible for services specified in Medicare manuals. Part B claims will be denied if the Part A claim is denied due to accessibility of medical emergency. Claims are not covered unless the medical emergency is approved for the specified period. The geographic location of the foreign hospitals must meet the requirements in §350.6 for inpatient services. Claims will be rejected if there is no evidence of covered services. Processing is limited to beneficiaries residing in areas for which contractors are responsible. Foreign physician or ambulance services are not covered unless furnished in connection with a covered inpatient stay. Claims without hospitalization evidence will be denied. Coverage is limited to the maximum charge determined by the designated Medicare Administrative Contractor (MAC). Services must be deemed medically necessary and adhere to Medicare's coverage guidelines. Coverage determinations depend on the relative distances to participating hospitals. Nonparticipating hospitals may be accessed only when a participating hospital is not available within a safe transportation distance. Selection of a hospital based on personal preferences of the individual or physician is not considered in the determination. Not covered if the distance to the participating hospital exceeds sixteen miles farther than the nonparticipating hospital. Claims are denied if the accessibility requirement is not met for reasons other than the nature of the emergency. Transportation to a participating hospital must not cause undue hazard to the patient. The accessibility requirement is not met if the admitting foreign hospital is farther from the beneficiary's residence than the nearest participating U.S. hospital, unless evidence of practical necessity is provided. Accessibility determination does not consider personal preference of the beneficiary or physician. Type of accommodations or nonavailability of staff privileges are not criteria for hospital selection. The existence of an emergency must be substantiated by sufficient medical information; failure to do so results in denied claims. Death of the patient does not establish the existence of a medical emergency in cases of chronic illnesses. Transportation to a participating hospital does not constitute a reason for emergency hospital admission without an immediate threat to life. Conditions developing after a non-emergency admission are not classified as emergencies. Hospital must verify medical documentation for internal consistencies upon admission. Coverage is contingent on the need for immediate medical or surgical procedures. Documentation must detail intensive care or specific procedures performed if the diagnosis is vague. Claims are denied if death occurs from elective surgery or due to chronic illness without showing an emergency. Claims are denied if the attending physician lacks staff privileges at a participating hospital. Claim is denied if the beneficiary chooses to be admitted to a non-participating hospital when a bed is available in a participating hospital and is accessible. Claims will be denied if there is no immediate threat to life or health and transportation could have been arranged. Lack of transportation alone does not justify emergency services. Payment cannot be made for emergency services rendered by a nonparticipating hospital following a non-emergency admission. Emergency services coverage ends when it is medically safe to transfer the patient to a participating institution or discharge them. Claims will not be approved if the statement only includes a declaration of an emergency without accompanying clinical documentation. Denial letters will be sent for non-covered foreign related claims. Nonemergency services furnished by a domestic nonparticipating hospital are not covered. No payment will be made for emergency services rendered after a reasonable period of care. Coverage may not be available for nonparticipating hospitals under Part B. Emergency care coverage does not include the entire hospital stay if care extends beyond major diagnostic evaluation. Claims for periods exceeding 3 to 5 days after substantial improvement are denied. Short stay emergency hospitalization cases where the patient is discharged or transferred within a reasonable time after substantial improvement will be screened out. Medicare does not cover items or services for alien beneficiaries who are unlawfully present when service is provided. Claims must be denied for items and services provided to beneficiaries not lawfully present in the U.S. on the date of service. Claims will be denied if error code MSN Message 5.7 is triggered. Payment is not made for items or services provided during periods of unlawful presence. Federal public benefits including Medicare are not available to aliens who are not 'qualified aliens' as per Section 401 of the PRWORA. Payments are only applicable to those who are classified as lawfully present in the United States according to 8 CFR 1.3. Non-participating providers do not have standing to file an appeal for individual claims. Claims submitted by non-participating providers cannot be appealed by the provider. Non-participating providers have specific appeal rights under 42 CFR Part 498. Claims must be filed using Form CMS-1450 or its electronic equivalent. Payment rate is based on the lower of actual charges from the hospital or rates published for Federal hospitals. Adjustment for any deductible and coinsurance amounts for which the beneficiary is responsible. Medicare will not pay federal hospitals for emergency items or services provided to veterans or military personnel. If a Part A claim is denied, a notice will be forwarded to the beneficiary from the MAC. Not covered for services that are not related to hospital-based ambulance transports. Coverage is limited to the Part B deductible and coinsurance rate applications. Noncovered accommodation charges will be subtracted from total accommodation charges. Remaining inpatient deductibles and coinsurances affect the total covered amount. Coverage is only applicable after any Part B deductible has been deducted from total covered charges. Payment applies at an 80 percent rate after the deductible. Medicare does not cover the first $______ of charges or the first three pints of blood. Charges exceed Medicare coverage after the 60th day of stay in a benefit period. Payment not provided for non-itemized hospital bills beyond specified percentage. Reconsiderations may only be requested for incorrect determinations. Room and board, along with certain other services, are not covered by medical insurance. Payment cannot be made under hospital insurance for these services. Payments are subject to applicable deductible and coinsurance amounts. Payments depend on the official exchange rate on the discharge date. Nonparticipating hospitals must file a statement of election each calendar year to receive payments. Claims for ambulance services furnished in Canada and Mexico are processed only for beneficiaries residing in the designated states/areas. Payment is subject to the Medicare Part B deductible. Payment for emergency services is not made to nonparticipating hospitals unless they elect to receive reimbursement from Medicare for all such services in a calendar year. An election to bill cannot be withdrawn during the year. If no statement is received by December 31, the hospital will be assumed to not wish to bill. Services are only covered if the hospital meets specific conditions set by law. Payment will only be made if the hospital elects to bill Medicare for all emergency services in a calendar year. The election to bill cannot be withdrawn during the year. Coverage is contingent upon participation as a provider in the Medicare program. Hospital benefits are ordinarily paid only for care in participating hospitals. Nonparticipating hospitals must meet specific conditions for emergency services to be covered. Reimbursement for emergency services is only available if the hospital has not charged the Medicare beneficiary for services rendered during the calendar year. The election to bill Medicare cannot be withdrawn during the year. Not covered if claims are submitted for services rendered after patient is legally pronounced dead. Emergency services must meet established medical necessity criteria to be covered. Payment is not made for services in nonparticipating hospitals unless it is for emergency care. Services do not qualify as emergency care if not necessary to prevent serious health risks. Not covered if medical emergency was not present at the time of admission. Admission delay to a participating Medicare hospital is not justified. Payment for emergency services stops when the emergency ends. Transfer to a participating hospital or discharge is permissible from a medical standpoint. Coverage ends when the emergency condition is resolved. Transfer to a Medicare-participating hospital is required once stabilized. Medical services provided by a federal hospital to retired members of the armed services or their eligible dependents are not covered under the Medicare program. Medical services provided on cruise ships are generally not covered unless all requirements are fulfilled. Services are not covered outside of U.S. territorial waters. Services are not covered if the individual is not entitled to Part B benefits. Payment cannot be made for items and services furnished outside the United States except in certain situations. Medicare does not cover foreign hospital services in situations not specified by law. Medicare only pays for services that are Medicare-covered when provided in a foreign hospital. Coverage determination for MTWA testing performed using methods other than spectral analysis (SA) is at the discretion of Medicare Administrative Contractors (MACs). Non-covered when methods of analysis other than SA are used without documentation. All other methods of analysis for MTWA are non-covered unless specific criteria are met. A/B MACs may have additional covered diagnosis codes where deemed reasonable and necessary. Not covered for myocardial infarction events without clinical justification. Exclusions may apply based on the necessity of interventions. Not covered for evaluations not performed in person. Exclusions apply to diagnoses not specifically listed in the policy. Claims for leadless pacemakers will only be paid if services are provided in designated places of service. Services must be performed in POS 06, 21, 22, or 26. Clinical trial identifier must be included in item 23 of the CMS-1500 form for billing. Claims for leadless pacemakers without an appropriate POS code will be denied. This policy is based on a National Coverage Determination and applies to all related services. Service is denied as Medicare only covers it in certain settings. Claims with certain procedure codes must be billed without modifier Q0. Claims billed with the Q0 modifier must include an 8-digit clinical trial identifier or will be returned as unprocessable. Coverage is contingent upon completion of specific components of the SET program. Claims without necessary information for adjudication may be denied. The program must consist of therapy sessions lasting 30-60 minutes and must be conducted under the direct supervision of a qualified healthcare professional. Coverage requires a face-to-face visit with the physician responsible for PAD treatment to obtain a referral. SET is non-covered for beneficiaries with absolute contraindications to exercise. MACs have discretion to cover more than 36 sessions over 12 weeks for SET. Claims for additional sessions must include a KX modifier as attestation that documentation is available. Codes I70.218, I70.311, I70.312, and similar for 'other extremity' may be excluded from coverage. Fatal conditions occurring before diagnosis are not covered. Claims will be rejected if a beneficiary has reached 36 SET sessions within 84 days without the KX modifier. SET sessions are not covered after 84 days from the first session without the KX modifier. Claims for SET will be denied when services are not provided on TOBs 13X and 85X. Services deemed inappropriate or invalid at the place of service will not be covered. Diagnosis is not covered as specified in CARC 167. Financial liability is assigned to the beneficiary if a GA modifier is present. Financial liability is assigned to the provider if a GZ modifier is present. Claims exceeding 36 sessions within 84 days are rejected if KX modifier is not included. Any sessions after 84 days from the first session will be rejected if KX modifier is not included. Claims with a GZ modifier indicating no signed ABN is on file are subject to financial liability allocation. Benefit maximum for this time period or occurrence has been reached. This decision was based on a National Coverage Determination (NCD). Coverage is not provided for patients without a signed ABN when applicable codes are not present. Certain cancer types or stages may not be covered under this policy. Procedure must be performed at healthcare facilities enrolled in FDA REMS. Not covered if performed outside the designated REMS facilities. The use of allogenic T-cells from healthy donors is not covered as autologous CAR T-cell treatments. Claims for clinical trials do not require the NCD 110.24 -KX modifier and must include the NCT number and -Q0 modifier. Contractors shall not require REMS facility and diagnosis codes for CAR T-cell therapy in clinical trials. Valid type of bills include specific inpatient and outpatient hospital types only. The procedure to administer CAR T-cells is not paid separately under OPPS/MPFS. Professional claims for CAR T-cell administration must utilize covered POS. Limitations are guided by the applicable ICD-10-CM diagnosis codes. Not covered for patients with a history of certain autoimmune diseases. Therapies not covered if administered outside of a certified treatment center. Not covered if the patient has an active infection at the time of treatment. Allogenic T-cells are not covered under the autologous CAR T-cell procedure codes. NCD 110.24 REMS facility and diagnosis codes are not required for Part A inpatient claims. Services must only be submitted by or performed in an FDA REMS approved facility. Submission of the service requires a -KX modifier to indicate compliance with FDA REMS approval. Total units for CAR T-cell therapy services must not exceed 1 unit. Multiple claims for fractionated units on the same date of service must be properly adjudicated. The provider must bill in 0.1 unit fractions, totaling 10 fractional units to reach the Medicare allowed payment amount. Contractors will only pay for up to 1 unit; any additional units must be denied. Billing for CAR T-cell products exceeding allowed dosage must utilize specific HCPCS codes. Off label use if the maximum number of cells exceeds HCPCS code descriptors. Duplicate denials may occur if not correctly billed with -76 modifier. Services performed in inpatient hospitals are subject to the MS-DRG payment system. Payment for services at Critical Access Hospitals is based on 101% of reasonable cost. Reporting of items and services related to CAR-T is subject to specific scenarios outlined in the policy. Drug codes will be denied as a Part A service even if billed with the administration. Charges for CAR T-cell collection and preparation may be rejected on the HOPD claim. Costs may need to be included in the charge reported for the biological. Preparation services are not covered if the CAR-T drug is not administered. Medicare will reject billing for drug Q codes if T-cells are not administered during the HOPD visit. The hospital cannot report the drug Q code for T-cells administered in the inpatient setting when preparation occurs in HOPD. Charges for the various steps to collect and prepare CAR T-cells must be reported separately using revenue codes. Not covered for services billed improperly outside the specified forms. Inpatient providers must report the date of CAR-T administration, not the cell collection date. Not covered if administration occurs outside a REMS participating site. Practitioners must code the CAR-T product service based on the administration date, not the collection date. CAR-T drug code cannot be reported if the drug is not administered, only the preparation services are performed. Payment for inpatient services is based on the Medicare Severity-Diagnosis Related Group (MS-DRG) and must be submitted under TOB 11X. Coverage is dependent on the facility type and setting. No coverage specified for other types of billing. Payment for CAH Method II services is based on the lesser of actual charge or 115% of the Medicare Physician Fee Schedule. Use of specific HCPCS codes (Q2041, Q2042, Q2053, etc.) based on the effective date for reporting purposes. Unclassified drug codes must be used when specific codes are not available. Charges for collection and preparation of CAR T-cells must be included in the charge reported for the biological product. Claims for collection and preparation of CAR T-cells submitted separately will be rejected. CAR T-cell product HCPCS code will not be reported if viable T-cells are not administered. The HCPCS code for CAR T-cell product cannot be reported when the cells are administered in the inpatient setting. Charges for collection and preparation of CAR T-cells must be reported separately on inpatient claims. Inpatient providers must report the date of CAR T-cell administration, not the date cells were collected. Not covered unless performed in a REMS participating site. Medicare will deny billing for these services on the professional claim. Medicare will deny billing for these services as it does not pay separately. The CAR T-cell product HCPCS code cannot be reported if the CAR T-cells are administered in a hospital inpatient setting rather than in an outpatient setting. Charges must be reported separately when CAR T-cells are on inpatient claims. Not covered when the procedure is reported with incorrect revenue codes. CAR T-cell product HCPCS code is not reportable when administered in HOPD setting. Medicare will reject applicable CPT codes reported by the HOPD. The drug HCPCS code cannot be reported for T-cells administered in the inpatient setting if preparation occurred elsewhere. Charges for preparation steps may be reported separately by the hospital or included in the biological claim. Claims will be denied when the service is not administered in accordance with Medicare coverage criteria for CAR T-cell therapy. Service cannot be paid when provided in this location/facility. Non-covered services when appropriate ICD-10 coding is not used. Claims may be denied if determined not to be a 'medical necessity' by the payer. Not covered when claims are rendered in an inappropriate or invalid place of service. Claims for CAR T-cell therapy procedures may be denied if they do not contain the new modifier - LU. Claims for allogeneic CAR T-cell therapy ICD-10-PCS codes XW033G7 and XW043G7, and autologous CAR T-cell therapy ICD-10-PCS codes XW033C7 and XW043C7 are rejected if not billed for clinical trials under NCD 310.1. Claims may be denied if fractional units exceed 1 unit, as deemed unsupported by the payer. Procedure/treatment/drug is deemed experimental/investigational by the payer. Service/item was not covered because it was not provided as part of a qualifying trial/study. Coverage for CAR T-cell therapy for cancer is only applicable to services from August 7, 2019 for the benefit years 2019 and 2020. Plans must incorporate CAR T-cell therapy costs in their 2021 bids. Acupuncture for conditions other than chronic low back pain is not covered. Up to 12 acupuncture visits are covered within a 90-day period. Treatment is not covered for acute low back pain or for pain related to systemic causes. All types of acupuncture, including dry needling for conditions other than chronic low back pain (cLBP), are non-covered by Medicare. A minimum of 11 months must pass after the first service before eligibility for new sessions begins. Covered services are limited to no more than 20 times per annum. The 1st through 12th service do not require the -KX modifier. If the 1st service is performed on a given date, the next service cannot be performed until 11 full months later. Claims must use specific types of bill (TOBs) such as 12X, 13X, 71X, 77X, and 85X. Acupuncture services reported under Revenue Code 096X, 097X, and 098X are not covered. Claims that do not contain the appropriate diagnosis/procedure coding will be denied as non-covered services. Claims for acupuncture services without the -KX modifier will be considered unprocessable. All denied parties have appeal rights. Claims for acupuncture for cLBP are denied if more than 20 claims are submitted per annum. Charges will not be covered beyond the allowed frequency within the given time period. Claims not meeting the criteria outlined in the LCD may be denied. The policy applies to specific CPT/HCPCS codes as defined by the LCD. Payment for acupuncture claims for cLBP is limited to 20 treatments per annum. Coverage is restricted to claims with a date of service on or after January 21, 2020, and received on or after October 5, 2020. Coverage is limited to 11 full months following the first acupuncture for cLBP service. No coverage for acupuncture services more than once every month within the coverage period. Coverage is limited to 20 acupuncture sessions for cLBP unless the -KX modifier is included for sessions 13 through 20. Claims will be rejected for sessions exceeding 20 without the appropriate modifier. Not covered if the provided services are not in accordance with the patient's plan of care. Coverage limited to services provided in the individual's home. Payment is only made to suppliers enrolled in Medicare as qualified home infusion therapy suppliers. Services not provided by certified qualified home infusion therapy suppliers are not covered. Does not include insulin pump systems or self-administered drugs on a self-administered drug exclusion list. Not covered for infusion drugs not assigned to a designated payment category. Exclusions apply to certain subcutaneous infusion drugs not specified in the policy. Payment amounts are limited to the equivalent of 5 hours of infusion therapy. Not covered for patients who can receive oral alternatives. No coverage for exceedance of recommended dosing limits. Coverage is subject to the contractor's determination for new home infusion drugs using not-otherwise-classified (NOC) codes. Not covered for experimental or unproven uses. Limitations apply based on specific medication indications and patient criteria. Not covered for drugs not specified in the code listings. Certain injections may have specific quantity limits. Home infusion drugs added to the LCD will be determined by the contractor. Not covered for drugs classified as not otherwise classified under home infusion therapy. Claims for home infusion therapy services are not payable to DME suppliers. Only one G-code per line item date of service is billable for drugs in the same category. Home infusion therapy suppliers must bill for the drug no more than 30 days prior to the visit. Only one visit can be billed per service date, with payment equal to the highest payment category if multiple visits occur. Initial visit billed G-codes can only be reported once per new patient scenario. Not covered for time units outside the defined ranges. Payment categories apply only to specific G-code designations. Not covered for therapies or drugs not detailed in the payment categories. Not covered for services outside of the home setting. Conditions must be met for home administration to be deemed necessary. Claims will be denied if a new G-code is received for the same date of service as a previous paid claim for the same line item. Adjustment should be submitted to receive a higher payment on rejected claims. The benefit for this service is included in the payment/allowance for another service/procedure that has already been adjudicated. Claims will be denied if the service was previously billed and adjudicated. Claims will be denied if there is a lack of information or billing errors after three recycling attempts. Claims for services G0088, G0089, or G0090 will be denied if billed more than once within a 60-day period. Charges may be deemed non-covered if at least one Remark Code is not provided. Claims will be rejected if multiple specified HCPCS codes are submitted for the same Date of Service. Claims are rejected if there is a Part B claim history for the same date of service with one of the identified G-codes. Override capability at the claim detail line may be applied. Claims will be rejected if the allowed DME or Part B Professional claim has Dates of Service prior to 01/01/2021. Claims from DME with G0068, G0069, or G0070 codes prior to 01/01/2021 are subjected to edit if within 60 days of an incoming claim. Coverage only for claims with specific G codes related to prior treatment claims. Not covered if prior claims do not match specified G codes within 60 days. Coverage is limited to cases where FDA-approved monoclonal antibodies are furnished under coverage with evidence development (CED). Claims must include condition code 30 for institutional claims only. A National Clinical Trial (NCT) number is required, or a default NCT number 99999999 must be provided. Claims must include condition code 30 for institutional claims. Claims lacking an NCT number will be returned as unprocessable. Claims without the specified diagnosis codes will be denied. Claims for monoclonal antibodies submitted without the specified modifiers will be returned as unprocessable. Claims that lack required information or have submission errors will not be covered. Claims will be denied for any bill type other than those listed. Denial messages apply when required information for payment is incorrect. Not covered for patients without a confirmed diagnosis of heart failure. Usage of IPAPS does not guarantee prevention of hospitalization in all cases. ICD-10-PCS codes 02HQ30Z and 02HR30Z are only reported on institutional claims. Modifier Q0 is for investigational clinical services and is not for routine clinical use. Claims must be for dates of service on or after January 13, 2025. IPAPS implantation is limited to once in a beneficiary’s lifetime. Not covered for patients not meeting the established diagnosis for heart failure. Coverage is limited to specific patient populations and clinical settings. Coverage is limited to patients with a confirmed diagnosis of Alzheimer’s Disease who meet the approved clinical criteria. Not covered for patients with other types of dementia. Updates may include removal of certain existing coverage determinations. Coverage limitations may apply based on patient criteria outlined in specific NCDs. Not covered for wounds that do not meet chronic criteria. Does not cover treatments for conditions not specified in the criteria. Coverages are rescinded and replaced by updated transmittals for specified therapies such as PILD. Limitations may apply based on individual clinical scenarios and may not cover updates. Coverage is limited to approved clinical settings. Not covered for patients with severe mitral regurgitation not meeting specific criteria. Not covered if the patient is not an appropriate candidate for TAVR according to established criteria. Exclusions apply for patients who have undergone certain other cardiac procedures. Not covered for patients who do not meet the aforementioned BMI criteria. Excludes procedures performed on individuals who are under age 18. Not covered when the treatment does not meet the criteria set forth in the latest transmittal. Does not cover services that do not meet Medicare's medical necessity criteria. Only applicable to services provided in hospital outpatient settings. Foot care is not covered when payment ceases for loss of protective sensation. Not covered when the device is not approved or does not meet reimbursement criteria set forth by CMS. Not covered for fractures that are less than three months old. Will not cover if the patient has previously received two or more types of non-surgical treatment. Cochlear implants are not covered for individuals with variable hearing loss or with contraindications. Procedure is not reimbursed for those with a history of non-compliance with previous hearing aids.

Clinical notes documenting the necessity for each therapy. Test results and patient history must be provided for ABPM. Clinical documentation must include patient's tobacco use history and health condition. Documentation confirming the need for counseling services. Clinical documentation of the diabetic wound and the treatment plan. Evidence of prior conservative management before HBO Therapy initiation. Clinical documentation justifying the need for home monitoring. Clinical notes detailing the necessity of the PET scan. Results of standard assessments conducted prior to the PET scan. Claim submissions must include appropriate documentation verifying routine care items and services. Providers must maintain comprehensive records of all services provided under the IDE. Complete medical records supporting patient enrollment in a qualifying clinical trial. Documentation of all services and procedures performed as part of the trial. Documentation of clinical trial participation for islet cell transplantation. Medical records supporting the diagnosis and treatment of peripheral neuropathy. Medical records must include clinical notes detailing previous treatments and their outcomes. Prior authorization is required before beginning treatment with ultrasound stimulation. Clinical documentation must support the medical necessity for cardiac rehabilitation services. Prior authorization is required for intensive cardiac rehabilitation programs. Documentation must include appropriate medical history and test results. Prior authorization is required for ICR claims. Clinical documentation supporting the necessity of PR services is required. Physician authorization is necessary to exceed standard session limits. Submission of appropriate ICD codes as evidence for claims. Medical records must include documentation of weight-related comorbidities. Documented evidence of medical necessity including outcomes from prior authorization processes. Required documentation must include clinical justification and any imaging studies performed. Documentation consistent with coverage indications. Clinical documentation supporting the diagnosis of obstructive sleep apnea. Clinical documentation supporting the procedure performed must accompany claims. Clinical documentation supporting the need for an implantable automatic defibrillator. Prior authorization documentation as required by the payer policy. Clinical documentation must support medical necessity for use. Test results and physician notes are required for coverage. Clinical documentation should support the need for transesophageal Doppler monitoring. Medical records must detail the patient's condition and eligibility for artificial heart devices. Documentation of emergency medical necessity is required. Claims must include proof of service from foreign hospitals if applicable. Documentation proving medical necessity for out-of-country services is required. Complete medical records must be provided to support the claim. Attending Physician's Statement and documentation of the emergency situation must be submitted. Full documentation of services rendered is required to process claims. Clinical notes must detail the patient's history and the rationale for testing. Test results and interpretation must be included in the medical record. Clinical documentation supporting prior treatments attempted. Records showing the patient's response to acupuncture treatments. Clinical documentation supporting the diagnosis of Alzheimer's disease for monoclonal antibody therapy. Documentation of heart failure diagnosis and treatment plans for implantable sensor coverage. Documentation of blood pressure measurements from clinic visits detailing the required thresholds. Interpretation of 24-hour ABPM results by a physician. Follow general billing instructions as specified in Chapter 25 of the manual. Periodic evaluations of wounds by the treating physician. Claims must be billed on Form CMS-1500 or electronic equivalent. Wounds must be evaluated by the treating physician no less than every 30 days. Follow general billing instructions as outlined in Chapter 25 of the manual. Claims must be billed using ASC X12 837 professional claim format or Form CMS-1500. Diagnosis must include an ICD-10 code for diabetes mellitus and an ICD-10 code for chronic ulcers. Clinical notes demonstrating conservative management attempts. Photographic documentation of the ulcer's condition at initial assessment and follow-ups. Clinical documentation demonstrating the presence and severity of the chronic ulcer. Evidence to support the degree of tissue involvement must be submitted. Claims must include the --KX modifier when applicable. Diagnosis codes must be documented. Documentation from the doctor required for appeals. Claims must include an appropriate diagnosis code. Clinical notes indicating toxic effects and medical necessity. Claims for counseling to prevent tobacco use services should be submitted using the ASC X12 837 institutional claim format or Form CMS-1450. Clinical documentation demonstrating the need for skilled nursing services. Patient history and assessment reports indicating the level of care required. Documentation supporting that counseling services were provided. Proper documentation must be provided to support the necessity of counseling services. Patient records must include sufficient history and standard information to verify compliance with coverage instructions. Providers must reference the beneficiary's Medicare beneficiary identifier to access session data. Documentation must include physician referral for kidney condition management. Clinical notes confirming eligibility for KDE services. Revenue code 0942 should be reported for KDE services in SNFs, HHAs, CORFs, hospices, and CAHs. Hospices must report value code 61 or G8 when billing for KDE services. ICD diagnosis code is required: ICD-9-CM 585.4 or ICD-10-CM N18.4 for chronic kidney disease Stage IV. A signed Advance Beneficiary Notice (ABN) is necessary for liability determination. Claims for HBO therapy should be submitted using the ASC X12 837 institutional claim format or Form CMS-1450. Applicable hospital bill types include 11X, 13X, and 85X. Documentation must include valid diagnosis codes for HBO therapy. Claims should be submitted using the ASC X12 837 professional claim format or Form CMS-1500. Clinical documentation supporting the medical necessity of HBO therapy. Claims must be submitted using the ASC X12 837 institutional claim format or Form CMS-1450. Patient must adequately record voiding diary data for clinical evaluation of the implant procedure. Clinical documentation supporting the need for neurostimulation. Prior authorization forms may be required. Claims must be submitted using the ASC X12 837 professional claim format or Form CMS-1500. Clinical evaluation reports prior to surgery. Psychiatric evaluations confirming absence of untreated mental illness. Clinical documentation demonstrating inadequate response or intolerance to initial therapies. Patient history and clinical diagnosis of movement disorder. Psychological evaluation to assess cognitive status. Documentation of prior treatment responses and current functional status. Documentation must show neurosurgeon training and experience in managing movement disorders. Records must indicate involvement of specialty physicians in patient selection and care post-procedure. Documentation of availability of brain imaging equipment and operating room capabilities. Support services documentation for potential complications during and post procedure. Claims must be submitted using specified institutional bill types. Clinical notes supporting the necessity of the procedure. Prior authorization documentation may be required. Clinical notes demonstrating medical necessity for the procedure. Results of prior imaging studies indicating the need for neurostimulation. Documentation must support the need for PT/INR testing based on the patient's anticoagulation therapy. Patient must complete an educational program on anticoagulation management and the use of the device. Documentation of physician prescription for the monitor and device. Evidence of educational program completion and correct device use demonstration. Clinical documentation confirming diagnosis of thrombophilia. Evidence of testing results for relevant conditions. Medical records indicating diagnosis as per listed ICD codes. Clinical documentation supporting the necessity of procedures or treatments. Clinical documentation supporting the diagnosis of embolism and thrombosis. Test results confirming the presence of acute or chronic conditions. Clinical documentation supporting the diagnosis of venous thrombosis. Any prior history of venous thromboembolism must be provided. Documentation demonstrating the patient's ability to use the INR monitor and report test results. Documentation of patient ability to perform testing prior to its use. Physician-directed instructions for reporting home INR test results. Reporting of test results to physician. Provision of materials for use in the home. Documentation of patient's ability to perform testing. Reporting of test results to the physician is required. Instructions for reporting home INR test results. Documentation of home INR monitoring use and physician verification. Clinical documentation supporting the diagnosis. Test results confirming the thrombophilia status. Clinical notes detailing diagnosis and treatment history. Test results confirming diagnosis of indicated conditions. Clinical documentation of diagnosis confirming embolism or thrombosis. Medical history and test results supporting necessity for treatment. Documentation of diagnosis to support the medical necessity of treatment. Refer to Pub. 100-03, NCD Manual, section 220.6.13 for documentation requirements. Claims must present one of the specified ICD-10 codes for coverage. Provider documentation is required with the PET Scan claim. Maintain records of the date of onset of symptoms. Document diagnosis of clinical syndrome, MMSE or equivalent test scores, and results from structural imaging. Include any performed neuropsychological testing and relevant laboratory results. Claims must include the specified condition and value codes. Applicable drug HCPCS code must be reported with appropriate units. Must include the appropriate drug administration CPT or HCPCS code in billing. Complete and accurate reflection of all services provided to the patient. Communication to the contractor that payment is not sought for the no cost item. Providers must document the use of condition codes to identify devices replaced due to warranty or recall. Condition codes must be reported to explain if the device was provided free of cost due to warranty or recall. Condition codes must be reported on inpatient or outpatient claims involving no cost/full credit replacement devices. Follow documentation requirements as outlined in Pub. 100-02 for Category A and B IDE studies. Claims must follow clinical trial billing instructions as specified. Claims must be submitted according to the clinical trial billing instructions found in §69.6. Clinical trial number assigned by the National Library of Medicine must be included in claims. Verification of the trial/study/registry can be done through CMS’s Coverage Website. At least one Remark Code must be provided for adjudication. Proper completion of claims to avoid unprocessable status. IDE numbers must be provided in claims for clinical trial services. Valid IDE number must be submitted with claims. Compliance with §69.6 of the clinical trial billing instructions. Documentation must support incurred costs for Category B IDE devices. Claims must include applicable HCPCS modifiers. Token charge is required when billing for devices provided at no cost. Follow clinical trial billing instructions in section 69.6 for submitting claims. Billing with Q0 modifier along with the IDE number. Claims must include modifier Q0 along with the IDE number for adjudication. Include the clinical trial number in claims submissions. Consult CMS's Coverage Website for trial validity verification. Clinical trial number must be included in claims submissions. You must provide at least one Remark Code for adjudication. Providers must notify their contractor of the IDE device trial before billing. Claims must be billed according to clinical trial billing instructions. Claims must include the Category B IDE device HCPCS code if applicable. Claims should include appropriate HCPCS modifiers Q0 or Q1 for relevant dates of service. Applicable HCPCS modifier (e.g., modifier -FB) must be appended to the procedure code for billing no-cost items. Must include clinical trial number on claims for items/services in clinical trials. Follow clinical trial billing instructions as outlined in section 69.6. Clinical trial number must be reported in either primary or secondary positions. IDE number must be included on claims. Valid IDE number must be validated upon claim submission. Claims submission must provide appropriate supporting documentation. Clinical trial number from the National Library of Medicine is required. Value code 'D4' must be mapped to the 837 institutional claim format. The billing provider must include the trial name, sponsor, and sponsor-assigned protocol number in the beneficiary's medical record. Complete Certificate of Medical Necessity (CMN) for covered items. Providers must provide documentation of items and services provided free-of-charge to receive payment for covered routine costs. Claims must include relevant diagnosis codes. Ensure compliance with clinical trial requirements. At least one Remark Code must be included for claims adjudication. Include clinical trial number in Loop 2300 REF02 (REF01=P4) for 837 professional claims. In CMS-1500 paper forms, place clinical trial number in Field 19 preceded by 'CT'. The 8-digit clinical trial number must be reported using value code 'D4' with the value code amount equal to the clinical trial number. Provider's attestation that the service was furnished to a beneficiary participating in a qualifying clinical trial. Providers must contact their local Medicare carrier for enrollment application if not enrolled. Claims for clinical trial services must be submitted as fee-for-service. Routine follow-up care documentation is necessary for each trial patient. Claim documentation must include details of the procedure performed. Medical records supporting the islet cell transplant must be available. Clinical documentation supporting the need for islet cell transplantation. Prior authorization forms required before the procedure. Clinical notes confirming the diagnosis of diabetes and related complications. Documentation of treatment protocol and outcomes for diabetic eye and neurological conditions. Clinical documentation demonstrating the presence of diabetic complications. Medical record documentation specifying the nature and severity of the patient’s diabetes. Claims must include condition code 30 indicating the patient is part of a qualifying clinical trial. Inpatient hospitals must report charges for organ acquisition in Revenue Code 0810, 0811, 0812, 0813, or 0819. Clinical documentation must confirm diagnosis of peripheral neuropathy and accompanying loss of protective sensation. Medical records should include evaluations showing decreased sensory function. Diagnosis of LOPS must be confirmed through sensory testing with the 5.07 monofilament at five randomly selected sites on the plantar surface of each foot. Documented test results showing the absence of sensation. The diagnosis of Loss of Protective Sensation (LOPS). A patient history. Patient history and physical examination including detailed evaluations of foot structure, sensation, and vascular status. Clinical documentation confirming diabetic sensory neuropathy and the presence of LOPS. Clinical documentation supporting the diagnosis of diabetes and related neurological conditions. Medical record evidence of complications resulting from diabetes must be provided. Claims must include a visit revenue code in order to be processed. Hospitals must report procedures under the correct revenue center where they are performed. Clinical documentation must support the diagnosis of diabetes with neurological complications. Records of relevant testing and treatments must be maintained. Service assignment must reference the appropriate diagnosis. Relevant claim adjustment reason codes must be used. Billing must be done using routine foot care codes as specified in Pub 100-02, Chapter 15, §290. Clinical notes documenting the necessity of the transfusion. Test results supporting the diagnosis and need for treatment. Clinical documentation must support the medical necessity of the transfusion. Clinical documentation needed to substantiate diagnosis and treatment. Clinical documentation supporting the diagnosis and treatment plan. Prior authorization may be required for specific treatment protocols. Clinical documentation supporting the diagnosis of Hodgkin lymphoma. Medical records indicating the specific lymph node involvement as per ICD codes. Clinical documentation confirming diagnosis of follicular lymphoma or diffuse follicle center lymphoma. Clinical documentation corroborating the diagnosis of lymphoma. Detailed medical records supporting the necessity of treatment for each case. Clinical documentation confirming the lymphoma diagnosis and its location. Pathology reports supporting the diagnosis of lymphoma. Medical records must confirm the diagnosis of the lymphoma type. Clinical notes supporting the medical necessity for treatment must be provided. Clinical documentation confirming diagnosis of specific lymphoma types. Prior authorization documentation may be required for coverage. Clinical documentation supporting the diagnosis of lymphoma. Clinical documentation confirming diagnosis of lymphoma based on ICD-10 codes listed. Medical records must support the necessity of treatment for covered indications. Clinical documentation supporting diagnosis with specific ICD codes. Required documentation may include laboratory test results, imaging studies, and treatment history. Clinical documentation confirming the diagnosis of leukemia or related neoplasms is required. Clinical documentation demonstrating the patient's eligibility based on staging. Prior authorization may be required depending on specific criteria. Clinical evidence of amyloid deposition and organ involvement. Cardiac function test results indicating left ventricular ejection fraction. Clinical documentation confirming diagnosis based on biopsy results. Adherence to Coverage with Evidence Development (CED) requirements. Documentation of the Medicare-approved clinical study participation is required to process claims. Clinical documentation supporting the use of stem cell acquisition. Must adhere to inpatient billing requirements as outlined in Medicare Claims Processing Manual. Providers must issue a hospital issued notice of non-coverage (HINN) or advance beneficiary notice (ABN) to the beneficiary. Clinical documentation must include results of relevant laboratory tests and patient history. Prior authorization may be required based on specific treatment protocols. Documentation of the diagnosis status (remission, relapse, etc.) for the different leukemia types. Laboratory results supporting the presence of indicated conditions. Clinical study documentation must be provided to support coverage. Follow requirements as specified in Pub. 100-03 and Pub. 100-04. Providers must issue a hospital issued notice of non-coverage (HINN) or advance beneficiary notice (ABN) if services do not meet criteria. Hearing test results documenting the specified scores. Clinical evidence supporting limited benefit from conventional amplification. Send information from your doctor if you think it could change the decision. Each radiograph set must include multiple views of the fracture site accompanied by a physician's written interpretation indicating no significant evidence of healing. There should be documentation that Ultrasonic Osteogenic Stimulators are part of the patient's home health plan of care. Documentation must be included with the claim specifying the use of modifiers for HCPCS codes. Documentation of the procedure and medical necessity for lens implantation. Proper billing with applicable CPT codes for related services. Beneficiary must be informed about lack of Medicare coverage for P-C or A-C IOL insertion. Notice of Exclusion from Medicare Benefits is encouraged to be issued. Documentation of the patient's condition and evaluation by a cardiology specialist. Adequate documentation of medical necessity for evaluation and management services. Follow policies for services incident to physician's services as applicable in each setting. Documentation of physician prescribed exercise and individualized treatment plan. Document total minutes of CR service to support billing. Clinical notes documenting the medical necessity of the rehabilitation program. Evidence of prior authorization if required. Clinical documentation must support the patient's need for cardiac rehabilitation. Prior authorization may be required for certain rehabilitation services. Documentation must be on file attesting to the medical necessity for exceeding session limits. A signed Advance Beneficiary Notice (ABN) must be on file if applicable. Claims must indicate the appropriate modifiers if an ABN is present. Support documentation required for claims exceeding allowed sessions. Documentation must include a signed ABN for claims submitted with the GA modifier. Claims submitted with the GZ modifier must show that no signed ABN is on file. Individualized treatment plan established, reviewed, and signed by a physician. Psychosocial assessment documentation. Peer-reviewed published research showing improvement in specific clinical measures. Individualized treatment plan detailing components utilized for each patient. Psychosocial assessment and outcomes assessment required. Documentation of necessary cardio-pulmonary and life-saving equipment must be maintained. Clinical documentation must support the need for pulmonary rehabilitation services. Clinical documentation supporting the patient's need for pulmonary rehabilitation services. Medical record must reflect the total time of rehabilitation sessions. A signed ABN must be on file if a GA modifier is indicated on the claim. Claims must include the KX modifier for PR sessions exceeding 36. Claim must include a signed ABN when applicable. Medical record must document the patient's BMI and co-morbid conditions. Evidence of previous unsuccessful medical treatment for obesity is required. Clinical documentation demonstrating the medical necessity of bariatric surgery. Evidence of co-morbid conditions such as Type 2 diabetes. Clinical documentation supporting the necessity for bypass surgery. Prior authorization may be required for specific procedures. Clinical notes supporting the medical necessity of the procedure. Surgical documentation detailing the approach and materials used. Pre-authorization may be required. Comprehensive medical records documenting need for procedure. Clinical documentation supporting the need for surgical intervention. Prior authorization may be required based on specific payer guidelines. Clinical documentation must support the necessity of the procedure. Clinical documentation confirming surgical necessity. Pre-operative assessment reports must be included with claims. Clinical documentation justifying the medical necessity of the procedure. Operative reports and consent forms are required for coverage. Clinical notes supporting the need for the specific bypass procedure. Clinical documentation supporting the necessity of the surgery and the indication for bypass. Clinical documentation supporting the need for bypass surgery. Operative reports detailing the type of tissue substitute used. Clinical documentation justifying the need for the specific bypass procedure. Pre-operative assessments and imaging studies are required. Clinical documentation justifying the need for surgical bypass. Required pre-operative assessments and imaging results. Prior authorization must be obtained before the procedure. Clinical documentation must support medical necessity and indication for surgery. Clinical documentation supporting the need for bypass procedures. Pre-operative assessments must be included. Clinical documentation indicating both comorbid T2DM and BMI ≥35. Clinical documentation confirming diagnosis of Type II Diabetes Mellitus. Medical records must document the specific diabetes diagnosis indicated by the relevant ICD-10 code. Clinical documentation supporting diagnosis of diabetic retinopathy. Documentation must include clinical notes and test results confirmatory of the diabetic retinopathy diagnosis. Prior authorization may be required based on specific billing codes. Clinical notes detailing the type and status of diabetic retinopathy. Results from relevant eye examinations and tests are required. Clinical documentation supporting the diagnosis of diabetes mellitus and related conditions. Evidence of treatment for diabetic complications as specified. Documentation must confirm the beneficiary's BMI ≥35 and evidence of at least one obesity-related co-morbidity. Clinical documentation must support the medical necessity of the surgical procedure. Advance Beneficiary Notice (ABN) must be signed by the beneficiary if the procedure is performed in an unapproved facility. HINN model language must be adapted and issued appropriately. Contractors must provide provider education information to assist with billing for this service. Providers must bill the Pre-Market Approval (PMA) number assigned to the stent system by the FDA. Include the FDA-issued PMA number on each claim to indicate participation in a specific study. FDA acknowledgement letter confirming scientific validity and clinically relevant data. CMS letter to the study sponsor indicating coverage. FDA acknowledgement letter CMS letter providing coverage for the extension study Any other materials required by the contractors for FDA-approved post-approval studies Clinical notes detailing necessity for dilation procedure. Approval for prior authorization as per payer requirements. Clinical documentation supporting the medical necessity of the procedure. Detailed records of the intraluminal device used during the procedure. Clinical documentation supporting the necessity for dilation procedures. Records of prior treatment attempts and their outcomes. Written documentation of symptoms and diagnostic results supporting the need for dilation. Clinical records should include details on previous treatment attempts and their outcomes. Clinical documentation supporting the need for dilation of the left external carotid artery. Prior authorization forms when required. Documentation must include imaging studies confirming stenosis severity. Clinical notes that justify the medical necessity for CAS. Neurological assessments must be documented. Imaging and shared decision-making must be documented. Documentation of facility competency in evaluation, procedure, and follow-up is required. Providers must submit the appropriate documentation as per Category B IDE billing requirements. Clinical notes supporting the necessity for dilation with intraluminal devices. Prior authorization documentation may be required for specific cases. Pre-authorization may be required for certain cases. Clinical notes supporting the medical necessity of dilation procedures. Pre-authorization may be required prior to performing carotid dilation. Clinical notes justifying the procedure based on symptomatology. Required pre-authorization documentation for multi-device interventions. Clinical notes detailing the medical necessity of the procedure. Documentation of previous treatment attempts and their outcomes. Providers should have beneficiaries sign an Advance Beneficiary Notice (ABN) to avoid liability. Providers must issue a Hospital Issued Notice of Noncoverage (HINN) if beneficiaries are to be financially responsible. Claims must have diagnosis codes C61 (ICD-10-CM) or 185 (ICD-9-CM). Claims must include relevant codes and encounter details. No signed ABN document required for claims with GZ modifier. Refer to the 835 Healthcare Policy Identification Segment for additional details. Contractors must review prior G0442 claims when processing G0443 claims to verify eligibility. Claims history and Part B entitlement status must support eligibility calculations. Clinical documentation demonstrating the medical necessity related to the patient's condition. Documentation of clinical research study participation is required for coverage. Claims must include primary/secondary diagnosis code Z00.6 for institutional claims. Condition code 30 is required for institutional claims. Advance Beneficiary Notice must be signed prior to service. A Hospital Issued Notice of Noncoverage letter must be signed by the beneficiary prior to service. Medical records must show failure of at least two antiepileptic medications. Prior authorization is required to verify medical necessity. Documentation to prove reasonableness and necessity of services. Include appropriate language in the ABN stating the reason for non-coverage. The provider must have the beneficiary sign an ABN prior to the procedure to avoid liability. Claims must indicate applicable erroneous surgery codes in the Remarks field of Form CMS1450. Modifiers PA, PB, or PC must be appended to claims involving surgical errors. The ABN must describe the item or service expected to be denied and include a cost estimate. HINNs must detail the item or service expected to be denied and adhere to specific instructions outlined in the Claims Processing Manual. Documentation must include notices delivered prior to services related to non-covered surgical errors. Institutional providers must use condition code 45 to identify claims with a gender/procedure or gender/diagnosis conflict. Clinical study documentation must meet the criteria outlined in Pub 100-03, section 90.1 of the NCD Manual. Claims must reference Transmittal 310 and 1418 instructions for proper billing. 8-digit clinical trial number must be included when present on the claim. Use of HCPCS modifier Q0 is required. Clinical documentation supporting the diagnosis of facial lipodystrophy syndrome. Evidence of psychological distress linked to facial abnormalities must be documented. Claim must include required elements for outpatient claims. Claims must contain all required elements as per the policy. Clinical documentation justifying the treatment must be maintained. Required elements must be present on the claim for coverage. Claims must include all required elements for dermal injections related to facial LDS treatment. Documentation requirements may include the clinical justification for the need based on comorbidities. Clinical documentation must support the necessity of the dermal injections. Documentation must support the medical necessity of the procedure. Clinical notes supporting the medical necessity for lead insertion. Evidence of previous efforts to manage the condition without an implantable device. Clinical documentation must support the need for device removal. Clinical documentation supporting the necessity of lead insertion is required. Prior authorization forms indicating patient eligibility for procedures must be submitted. Providers must use modifier Q0 to identify patients whose data is being submitted to a data collection system. Documentation must include relevant diagnosis codes indicating non-primary prevention needs. Clinical notes supporting the diagnosis and necessity of procedures related to the covered indications. Test results documenting the necessity for monitoring or intervention in cases of arrhythmias. Clinical documentation supporting diagnosis of secondary malignant neoplasm. Pathology reports confirming malignancy and site of origin. Documentation of the clinical rationale for off-label use. Appropriate records must include billed ICD codes. Clinical diagnosis documentation confirming the presence of secondary malignant neoplasms. Medical record that supports the treatment plan for the indicated conditions. Claims must include appropriate TOBs and revenue code 0636 - drugs requiring detailed coding. Claims must include ICD-9-CM diagnosis code 185. Clinical trial number reporting is required for TAVR. Medical records must support the medical necessity for TAVR. Documentation of severity of aortic stenosis as indicated by echocardiogram. Clinical notes justifying the medical necessity of TAVR over surgical options. Clinical documentation supporting the diagnosis of severe aortic stenosis. Prior authorization required before procedure. Results of pre-operative testing must be included. Complete documentation including orders, notes, summary, and chart is required for claims processing. Claims must include appropriate documentation/orders/notes. An 8-digit clinicaltrials.gov identifier number must be included in the claim submission. Complete and correct claim information must be submitted, including the clinicaltrials.gov identifier for TAVR. Refer to Section 69 of this chapter for further guidance on billing under CED. Providers must include ICD-10 Z00.6 and Condition Code 30 on claims for TAVR. An 8-digit clinicaltrials.gov identifier number must be listed on claims. Medical record documentation to support the necessity for OPT treatment. Claims must adhere to documenting the OPT with Verteporfin service provided. Clinical documentation of diagnosis including ICD-10 codes. Test results supporting the diagnosis must be included. Correct Medicare contractor billing by the provider. Documentation of clinical indications for monitoring must be included in the medical record. Documentation of enrollment in an approved clinical study is required. Clinical notes indicating diagnosis of myocardial infarction or ischemic heart disease. Additional documentation may be required for specific billing codes. Clinical documentation supporting diagnosis of cardiovascular conditions. Test results must be available to verify the specific type of heart disease. Clinical notes documenting the diagnosis with ICD-10 code linkage. Any prior authorization documentation as required by the payer. Clinical documentation supporting the diagnosis of postprocedural complications. Medical records must include details of the surgical procedure and subsequent cardiac status. Clinical documentation of transplant surgery. Follow-up evaluations and monitoring reports required. Clinical documentation supporting the transplant status and complications. Medical records detailing specific complications and treatments. Clinical documentation supporting the diagnosis of myocardial infarction or coronary artery disease. Clinical documentation supporting the diagnosis of unstable angina pectoris or other specified conditions. Evidence of a previous cardiac evaluation must be included in medical records. Clinical documentation supporting the diagnosis of atherosclerosis. Medical records must detail the patient's angina pectoris types. Clinical documentation supporting the diagnosis of indicated conditions. Clinical documentation supporting diagnosis of listed cardiac conditions. Clinical notes demonstrating the necessity for treatment. Test results supporting the diagnosis of cardiac conditions. Clinical documentation confirming the surgical procedure performed. Medical records demonstrating the occurrence of the complications listed. Clinical records detailing the nature of complications or aftercare following heart transplants. Documentation must demonstrate eligibility for replacement supplies and accessories under Medicare Part B. Claims for replacement supplies should include relevant details as determined by the contractor. Documentation must clearly support medical necessity for the dressings used with the VAD. Clinical documentation supporting lack of response to conservative treatment. Medical records detailing diagnosis of LSS and treatment history. Clinical documentation must establish unresponsiveness to conservative therapy. Documentation that indicates participation in an approved clinical trial. Claims must include the clinical trial identifier number. 8-digit clinical trial identifier number must be included in Field 19 of paper Form CMS-1500 or in electronic 837P. A valid Investigational Device Exemption number or Clinical Trial number must be provided for coverage. Claims must include appropriate diagnosis codes. Documentation of enrollment in the approved study and clinical outcomes from the trial. An 8-digit clinical trial identifier number must be included. Documentation must reflect the use of ICD-10 Z00.6 and Condition Code 30. An 8-digit clinical trial identifier number is required. Participation in the mandatory registry for TEER procedures. Clinical documentation supporting the need for transcatheter mitral valve repair. 8-digit NCT number must be included in Field 19 of paper Form CMS-1500. NCT number must be entered without the 'CT' prefix in electronic 837P claims. Provide a valid Investigational Device Exemption number for FDA-approved clinical trial services. Ensure ABN is signed and on file if GZ modifier is present. Claims must include secondary ICD-10 diagnosis code Z00.6. Condition Code 30 and Value code D4 with the clinical trial identifier number must be included. Specific documentation as outlined in NCD 20.33. Documentation to establish requirements for inpatient services. Proof of physician and/or ambulance service connection to inpatient services. Physician's statement required. Documentation of the date when the emergency ceased in addition to the physician's evaluation. Physician's statement on CMS-1771 or beneficiary's medical records is required for medical necessity. Additional supporting information may be requested from the physician, hospital, or others at the scene. Documentation must support medical necessity and the appropriateness of services provided. Medical records must show if the beneficiary was advised on their non-coverage status. Medical necessity must be documented for services rendered on the day of admission. Beneficiaries must provide an unpaid bill for any claims filed by deceased individuals. Foreign physicians or ambulance companies must accept MACs reasonable charge determination. Documentation must demonstrate compliance with inpatient service requirements as specified in the policy sections. Claims must show that physician and/or ambulance services were furnished in connection with covered hospital services. Documentation regarding Part A coverage determination. Claims must show that emergency services were rendered within the emergency period. Beneficiaries may request information from the hospital or the MAC. Foreign hospitals must submit a statement to the appropriate MAC regarding billing intentions. Emergency documentation must include Form CMS-1771, Attending Physician's Statement, and medical records substantiating the emergency. Documentation to determine eligibility for billing must be submitted by the hospital. Claims must be retained for appeal by the beneficiary. The hospital must forward any Part B claim for foreign services to the MAC along with the corresponding Part A claim. Evidence of furnished services in the context of foreign inpatient hospital services. Notification of Medicare Determination should specify the nature of the foreign service. Documentation of the accessibility requirement must be provided in cases where the hospital selection is made. Clinical justification for admission to a nonparticipating hospital under extenuating circumstances. Documentation of the emergency nature indicating immediate transportation needs. Evidence that a closer participating U.S. hospital was impractical due to non-availability of beds, needed equipment or personnel, or lack of transportation. Sufficient medical information from the physician or hospital must be provided. Clinical corroboration of the emergency allegation is required. Medical documentation showing signs and symptoms upon admission. Notations concerning changes in a pre-existing condition. Physician statement must clearly relate to the diagnosis. Admitting and discharge diagnoses must be consistent with the treatment provided. Physician's supporting statement to document medical necessity. Provide an Attending Physician's Statement and Documentation of Medicare Emergency, Form CMS-1771, or equivalent. Hospital records must include history, physical and admission notes, medical record admission sheet, nurses' notes, doctors' orders, discharge summary, and all progress notes. Beneficiary's statement must support the occurrence of an emergency during travel. Denial letters and MSN notifications must be sent as per claims related requirements. Medical records must support the duration of emergency services claimed. Refer to CWF documentation for error code MSN Message 5.7. Appeals can be made based on proof of lawful presence in the U.S. on the date of service. Documentation of actual charges from the hospital. The VA or Department of Defense hospital must file a statement of election for each calendar year to receive direct payment from Medicare. Documentation supporting the need for ambulance service. Evidence of cost calculation that includes deductible and coinsurance. Claims must include the applicable Part B deductible information. Itemized hospital bill must be provided for coverage verification. Notice must accompany any in-person requests for clarification. Claim must comply with the regulations outlined in 42 CFR 424.100-109. An itemized bill must be submitted with each claim. Attending Physician’s Statement using Form CMS-1771. A signed statement from an authorized official of the hospital electing to bill Medicare. An authorized official must sign a statement electing to bill Medicare. Itemized bill must be submitted for reimbursement if the hospital does not bill. An authorized hospital official must sign a statement electing to bill Medicare for emergency services. Documentation supporting the medical necessity of emergency services must accompany claims. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is requested Specific date(s) of service Signature of the beneficiary or authorized representative Medical admission facts and condition at the time of admission. Beneficiary name and Medicare beneficiary identifier for redetermination requests. Specific service and/or item(s) for which a redetermination is being requested Signature of the beneficiary or the beneficiary’s authorized or appointed representative Claims must include documentation of the patient's entitlement to Part B benefits. Clinical documentation linking the services on the ship to the inpatient condition. Specific service and/or item(s) for redetermination Signature of the beneficiary or the beneficiary’s authorized or appointed representative. The -KX modifier must be used to attest that documentation verifying the performed MTWA is on file. Clinical documentation supporting the diagnosis of myocardial infarction. Required evidence from diagnostic tests confirming the acute condition. Documentation of the device evaluation process is required. Analysis and report of device functionality must be maintained. Include the 8-digit clinical trial identifier in the claim form. At least one Remark Code must be provided with claims. Claims must provide relevant information for adjudication. Documentation must include evidence of the SET program components. Must provide a valid Investigational Device Exemption number or Clinical Trial number if applicable. Beneficiaries must receive educational information regarding cardiovascular disease and PAD risk factor reduction during the face-to-face visit. Documentation of contraindications by the primary attending physician. Documentation verifying that further treatment beyond the standard 36 sessions meets medical policy requirements. Claims must include the KX modifier when applicable. Documentation of the number of SET sessions provided and dates of service. Documentation must include clinical justification for services rendered. Documentation of the patient's diagnosis must be provided. Clinical notes supporting the necessity of CAR T-cell therapy are required. Documentation of FDA-approved indication or compendia support for off-label use. Claims must include the Z00.6 clinical trial diagnosis code. NCT number for the specific trial and appropriate clinical trial modifiers must be included. Clinical notes must confirm diagnosis and previous treatment history. Prior authorization is required along with supporting medical documentation. Clinical trial must be identified by the NCT number and include condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code. The -KX modifier must be appended to the line item for CAR T-cell therapy services. Include CAR T-cell product name and exceeded dosage in Block 19 of the claim form. Appropriate documentation to support billing requirements must be provided. Refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual for billing unclassified drug codes. Documentation must indicate the initiation of CAR-T preparation services. Billing must clearly reflect the date of CAR-T administration. Documentation supporting the steps of collecting and preparing CAR T-cells during inpatient claims. Clinical documentation supporting the necessity of CAR-T therapy must be maintained. Prior authorization forms may be required for coverage. Refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual for detailed billing instructions. Refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual for instructions on unclassified drug codes. Inpatient claims must use revenue code 0871 to report preparation charges. Services must be submitted on the Form CMS-1500 or electronic 837P. Documentation of enrollment in the REMS program. Documentation must reflect the date of CAR T-cells administration. Date of CAR T-cell administration must be documented when administered in the hospital. Report the date of CAR T-cell administration instead of the date cells were collected. Refer to the 835 Healthcare Policy Identification Segment for specifics. Claims must include condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code. Clinical documentation supporting the diagnosis of chronic low back pain is required. ICD-10 diagnosis codes must be reported for acupuncture services. Appropriate documentation must confirm medical necessity as justified in the medical record. Claims must contain appropriate diagnosis/procedure coding as specified. Claims must include the appropriate modifier for the services rendered. Documentation must support the medical necessity of acupuncture treatments. At least one Remark Code must be provided to support claim denial reasons. Provide supporting information from your doctor during an appeal. Documentation must include clinical notes confirming cLBP diagnosis and treatment rationale. Prior authorization may be required for acupuncture services. Plan of care must be documented and followed. Clinical documentation supporting the necessity of home infusion therapy. A physician-established plan of care that prescribes the type, amount, and duration of infusion therapy services is required. Documentation of the specific infusion drug and its corresponding payment category. Clinical notes justifying the necessity of the administered infusion. Clinical documentation supporting the need for injectable therapy. Prior authorization forms if specified dosing exceeds standard limits. Clinical documentation justifying the use of injected medications. Prior authorization may be required for some J-codes. Clinical documentation supporting medical necessity for the injection. Prior authorization documentation may be required for specific injections. Documentation proving eligibility of home infusion therapy suppliers is required. Documentation must support the medical necessity of the home infusion therapy service. Suppliers must report visit length in 15-minute increments. Clinical documentation supporting the need for home infusion services. Prior authorization may be required for specific drug administrations. At least one Remark Code must be provided for claim resubmission. Claims must document the Date of Service for the submitted HCPCS codes. Claims must include relevant J-codes submitted within specified time frames. Must provide history of Part B Professional claims with relevant G codes. NCT number must be included with claims. Investigational Device Exemption number or Clinical Trial number must be specified. Medical records indicating the patient's chronic heart failure diagnosis. Records of previous heart failure-related hospitalizations and treatment adjustments. Documentation must demonstrate compliance with FDA indications for coverage. Include 8 digit clinical trial number reported as Value Code D4. Documentation must include the required diagnosis codes for claims. Obtain a copy of the LCD for appeal from www.cms.gov/medicare-coverage-database. Clinical documentation supporting the diagnosis of heart failure must be provided. Prior authorization may be required with specific documentation. Clinical documentation of Alzheimer’s Disease diagnosis. Evidence supporting the medical necessity for the treatment. Clinical documentation to support medical necessity based on coding updates. Relevant test results and prior authorization forms may be required. Medical records demonstrating chronic, non-healing wounds. Evidence of failed prior treatment attempts. Clinical documentation supporting the medical necessity of transplantations and decompression procedures is required. Clinical documentation must support the diagnosis of mitral valve disease. Prior authorization is required before procedure. Clinical documentation must support indication for TAVR, including echocardiogram results. Pre-procedure assessments and interdisciplinary evaluations are required. Patient medical history and records must support the diagnosis of morbid obesity. Prior authorization is required for coverage approval. Clinical documentation supporting the need for the therapy. Claims must include necessary documentation to support service coverage under the OPPS. Documentation of loss of protective sensation evaluation and management is required. Medical records indicating the nature of the device replacement and compliance with coverage criteria. Clinical documentation supporting the diagnosis of nonunion fracture. Medical records indicating previous treatment attempts. Clinical evaluation documenting degree of hearing loss. Trial with hearing aids must be documented and show insufficient benefit.