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For Medicare beneficiaries enrolled in a Medicare Advantage plan

When coverage criteria are not fully established in Medicare statute, regulation, National Coverage Determination (NCD) or Local Coverage Determination (LCD), Carelon Medical Benefits Management (MBM) uses publicly accessible internal coverage criteria in the form of Carelon MBM Guidelines which are based on current evidence in widely used treatment guidelines and clinical literature. According to the Centers for Medicare & Medicaid Services (CMS), coverage criteria are not fully established when additional unspecified criteria are needed to interpret or supplement general provisions to consistently determine medical necessity.

The following list represents services where CMS coverage criteria are not fully established in one or more CMS jurisdictions and Carelon MBM Clinical Guidelines are used to provide the necessary clinical criteria to ensure consistent decision-making.

Modality

CMS Coverage Determination(s)

Reason Coverage Criteria

Not Fully Established

Computed Tomography (CT)

  • Breast
  • Upper Extremity
  • Lower Extremity
  • Thoracic Spine
  • Lumbar Spine
  • NCD: Computed Tomography (220.1)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)

Computed Tomography (CT)

  • Cerebral Perfusion Analysis
  • NCD: Computed Tomography (220.1)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38694)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38667)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38709)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38700)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38769)
  • LCD: Category III Codes (L35490)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38694)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38667)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38709)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38700)
  • LCD: Computed Tomography Cerebral Perfusion Analysis (CTP) (L38769)
  • LCD: Category III Codes (L35490)

For the remaining jurisdictions, the applicable coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)

Computed Tomography (CT)

  • Head/Brain
  • NCD: Computed Tomography (220.1)
  • LCD: MRI and CT Scans of the Head and Neck (L37373)
  • LCD: MRI and CT Scans of the Head and Neck (L35175)
  • LCD: CT of the Head (L34417)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)
  • LCD: MRI and CT Scans of the Head and Neck (L37373)
  • LCD: MRI and CT Scans of the Head and Neck (L35175)
  • LCD: CT of the Head (L34417)

Computed Tomography (CT)

  • Orbit/Sella/Ear
  • Maxillofacial Area (Sinus)
  • Neck (Soft Tissue)
  • Cervical Spine
  • Computed Tomography (220.1)
  • MRI and CT Scans of the Head and Neck (L37373)
  • MRI and CT Scans of the Head and Neck (L35175)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)
  • LCD: MRI and CT Scans of the Head and Neck (L37373)
  • LCD: MRI and CT Scans of the Head and Neck (L35175)

Computed Tomography (CT)

  • Thorax (Chest)
  • NCD: Computed Tomography (220.1)
  • LCD: Computerized Axial Tomography (CT), Thorax (L33459)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)
  • LCD: Computerized Axial Tomography (CT), Thorax (L33459)

Computed Tomography (CT)

  • Abdomen
  • Pelvis
  • Abdomen/Pelvis Combination
  • NCD: Computed Tomography (220.1)
  • LCD: CT of the Abdomen and Pelvis (L34415)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: CT of the Abdomen and Pelvis (L34415)

For the remaining jurisdictions, the applicable coverage determinations only address utility of the service and do not provide any clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)

Computed Tomography (CT)

  • Cardiac CT – Calcium Scoring
  • NCD: Computed Tomography (220.1)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33947)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33559)
  • LCD: Cardiac Computed Tomography & Angiography (CCTA) (L33423)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L35121)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33947)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33559)
  • LCD: Cardiac Computed Tomography & Angiography (CCTA) (L33423)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L35121)

For the remaining jurisdictions, the applicable coverage determinations only address utility of the service and do not provide any clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)

Computed Tomography (CT)

  • Cardiac CT – Structure/Morphology
  • NCD: Computed Tomography (220.1)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33947)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33559)
  • LCD: Cardiac Computed Tomography & Angiography (CCTA) (L33423)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L35121)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Cardiac Computed Tomography & Angiography (CCTA) (L33423)

For the remaining jurisdictions, the applicable coverage determinations only address utility of the service and do not provide any clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33947)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L33559)
  • LCD: Coronary Computed Tomography Angiography (CCTA) (L35121)

Computed Tomography (CT)

  • Diagnostic Virtual Colonography

  • NCD: Computed Tomography (220.1)
  • LCD: Virtual Colonoscopy (CT Colonography) (L34055)
  • LCD: Computed Tomographic (CT) Colonography for Diagnostic Uses (L33562)
  • LCD: Virtual Colonoscopy (CT Colonography) (L33452)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Virtual Colonoscopy (CT Colonography) (L34055)
  • LCD: Computed Tomographic (CT) Colonography for Diagnostic Uses (L33562)
  • LCD: Virtual Colonoscopy (CT Colonography) (L33452)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Computed Tomography (220.1)

Magnetic Resonance Imaging (MRI)

  • Functional MRI Brain
  • Chest
  • Abdomen
  • Elastography
  • MRCP
  • Pelvis
  • Upper Extremity
  • Lower Extremity
  • Thoracic Spine
  • Bone Marrow Blood Supply
  • Spectroscopy
  • NCD: Magnetic Resonance Imaging (220.2)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)

Magnetic Resonance Imaging (MRI)

  • Brain
  • Orbit, Face, Soft Tissue Neck
  • Temporomandibular Joints (TMJ)
  • Cervical Spine
  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: MRI and CT Scans of the Head and Neck (L37373)
  • LCD: MRI and CT Scans of the Head and Neck (L35175)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: MRI and CT Scans of the Head and Neck (L37373)
  • LCD: MRI and CT Scans of the Head and Neck (L35175)

Magnetic Resonance Imaging (MRI)

  • Breast
  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: Breast Imaging Mammography/Breast Echography (Sonography)/Breast MRI/Ductography (L33950)
  • LCD: Breast Imaging: Breast Echography (Sonography)/Breast MRI/Ductography (L33585)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Breast Imaging Mammography/Breast Echography (Sonography)/Breast MRI/Ductography (L33950)
  • LCD: Breast Imaging: Breast Echography (Sonography)/Breast MRI/Ductography (L33585)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)

Magnetic Resonance Imaging (MRI)

  • Lumbar Spine
  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: Lumbar MRI (L34220)
  • LCD: Lumbar MRI (L37281)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Lumbar MRI (L34220)
  • LCD: Lumbar MRI (L37281)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)

Magnetic Resonance Imaging (MRI)

  • Cardiac MRI
  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)

Magnetic Resonance Angiography (MRA)

  • Head
  • Neck
  • Chest
  • Abdomen
  • Pelvis
  • Upper Extremity
  • Lower Extremity
  • Spinal Canal
  • NCD: Magnetic Resonance Imaging (220.2)

The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:

  • NCD: Magnetic Resonance Imaging (220.2)

Cardiac Blood Pool Imaging (MUGA)

  • LCD: Cardiovascular Nuclear Medicine (L33960)
  • LCD: Cardiovascular Nuclear Medicine (L33560)
  • LCD: Cardiac Radionuclide Imaging (L33457)

The following coverage determinations only addresses this study for evaluation of shunts but does not provide clinical criteria for any other indications.

  • LCD: Cardiovascular Nuclear Medicine (L33960)
  • LCD: Cardiovascular Nuclear Medicine (L33560)
  • LCD: Cardiac Radionuclide Imaging (L33457)

Myocardial Perfusion Imaging and Infarct Imaging

  • NCD: Single Photon Emission Computed Tomography (SPECT) (220.12)
  • LCD: Cardiovascular Nuclear Medicine

(L33960)

  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiovascular Nuclear Medicine (L33560)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)
  • LCD: Cardiac Radionuclide Imaging (L33457)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Cardiovascular Nuclear Medicine

(L33960)

  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiovascular Nuclear Medicine (L33560)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)
  • LCD: Cardiac Radionuclide Imaging (L33457)

The following coverage determination has no clinical criteria for determining appropriateness:

  • NCD: Single Photon Emission Computed Tomography (SPECT) (220.12)

Cardiac Positron Emission Tomography (PET)

  • NCD: PET for Perfusion of the Heart (220.6.1)
  • NCD: FDG PET for Myocardial Viability (220.6.8)
  • LCD: Positron Emission Tomography (PET) Scan for Inflammation and Infection (L39521)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)
  • LCD: Cardiac Radionuclide Imaging (L33457)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Positron Emission Tomography (PET) Scan for Inflammation and Infection (L39521)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L38396)
  • LCD: Cardiology Non-emergent Outpatient Stress Testing (L35083)
  • LCD: Cardiac Radionuclide Imaging (L33457)

The following coverage determinations have no clinical criteria for determining appropriateness:

  • NCD: PET for Perfusion of the Heart (220.6.1)
  • NCD: FDG PET for Myocardial Viability (220.6.8)

Transthoracic Echocardiography (TTE) and Transesophageal Echocardiography (TEE)

  • NCD: Ultrasound Diagnostic Procedures (220.5)
  • LCD: Transthoracic Echocardiography (TTE) (L34338)
  • LCD: Transthoracic Echocardiography (TTE) (L33577)
  • LCD: Echocardiography (L37379)
  • Transesophageal Echocardiography (TEE) (L34337)
  • LCD: Transesophageal Echocardiogram (L33756)
  • LCD: Transesophageal Echocardiography (TEE) (L33579)
  • LCD: Transesophageal Echocardiography (TEE) (L35016)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Transthoracic Echocardiography (TTE) (L34338)
  • LCD: Transthoracic Echocardiography (TTE) (L33577)
  • LCD: Echocardiography (L37379)
  • Transesophageal Echocardiography (TEE) (L34337)
  • LCD: Transesophageal Echocardiogram (L33756)
  • LCD: Transesophageal Echocardiography (TEE) (L33579)
  • LCD: Transesophageal Echocardiography (TEE) (L35016)

The following coverage determination has no clinical criteria for determining appropriateness:

  • NCD: Ultrasound Diagnostic Procedures (220.5)

SPECT/SPECT CT Imaging

  • NCD: Single Photon Emission Computed Tomography (SPECT) (220.12)

The following coverage determination has no clinical criteria for determining appropriateness:

  • NCD: Single Photon Emission Computed Tomography (SPECT) (220.12)

Arterial Ultrasound

  • Carotid Vertebrobasilar
  • NCD: Ultrasound Diagnostic Procedures (220.5)
  • LCD: Non-Invasive Extracranial Arterial Studies (L33695)
  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Cerebrovascular Studies (L35753)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Non-Invasive Extracranial Arterial Studies (L33695)
  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Cerebrovascular Studies (L35753)

The following coverage determinations have no clinical criteria for determining appropriateness:

  • NCD: Ultrasound Diagnostic Procedures (220.5)

Arterial Ultrasound

  • Abdominal Vessels
  • NCD: Ultrasound Diagnostic Procedures (220.5)
  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Duplex Scanning (L33674)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Abdominal / Visceral Vascular Studies (L35755)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Duplex Scanning (L33674)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Abdominal / Visceral Vascular Studies (L35755)

The following coverage determinations have no clinical criteria for determining appropriateness:

  • NCD: Ultrasound Diagnostic Procedures (220.5)

Arterial Ultrasound

  • Upper Extremity
  • Lower Extremity
  • Physiologic Study Extremity
  • NCD: Ultrasound Diagnostic Procedures (220.5)
  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Duplex Scan Of Lower Extremity Arteries (L33667)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Peripheral Arterial Vascular Studies (L35761)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Non-Invasive Vascular Studies (L34045)
  • LCD: Duplex Scan Of Lower Extremity Arteries (L33667)
  • LCD: Non-Invasive Vascular Studies (L33627)
  • LCD: Non-Invasive Peripheral Arterial Vascular Studies (L35761)

The following coverage determinations have no clinical criteria for determining appropriateness:

  • NCD: Ultrasound Diagnostic Procedures (220.5)

Diagnostic Coronary Angiography

  • LCD: Cardiac Catheterization and Coronary Angiography (L33959)
  • LCD: Cardiac Catheterization and Coronary Angiography (L33557)

The applicable coverage determinations provide a generalized list of indications where coronary angiography is utilized but does not provide sufficient clinical criteria to determine clinical appropriateness:

  • LCD: Cardiac Catheterization and Coronary Angiography (L33959)
  • LCD: Cardiac Catheterization and Coronary Angiography (L33557)

Percutaneous Coronary Intervention (PCI)

  • NCD: Percutaneous Transluminal Angioplasty (PTA) (20.7)
  • LCD: Percutaneous Coronary Intervention (L33623)
  • LCD: Percutaneous Coronary Interventions (L34761)

The applicable coverage determinations provide only limited coverage criteria for single vessel disease but are silent on other indications including multivessel disease. They do not provide sufficient clinical criteria to determine clinical appropriateness:

  • NCD: Percutaneous Transluminal Angioplasty (PTA) (20.7)
  • LCD: Percutaneous Coronary Intervention (L33623)
  • LCD: Percutaneous Coronary Interventions (L34761)

Cardiac Resynchronization Therapy (CRT)

  • NCD: Implantable Automatic Defibrillators (20.4)
  • LCD: Cardiac Resynchronization Therapy (CRT) (L39080)

Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:

  • LCD: Cardiac Resynchronization Therapy (CRT) (L39080)

The following coverage determinations have clinical criteria for ICD but no clinical criteria for determining appropriateness for CRT:

  • NCD: Implantable Automatic Defibrillators (20.4)

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