When coverage criteria are not fully established in Medicare statute, regulation, NCD, or LCD, Carelon Medical Benefits Management 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, or at health plan request we use health plan medical policy/guidelines. According to 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 MBM Clinical Guidelines (or specific health plan policy/guidelines as applicable) 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)
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| The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:
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Computed Tomography (CT)
|
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
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:
|
Computed Tomography (CT)
|
| The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:
|
|
| The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:
|
Computed Tomography (CT)
|
| The following coverage determinations only address utility of the service and do not provide sufficient clinical criteria for determining clinical appropriateness:
|
Computed Tomography (CT)
|
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
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:
|
Computed Tomography (CT)
|
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
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:
|
Computed Tomography (CT)
|
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
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:
|
Transthoracic Echocardiography (TTE) and (Transesophageal Echocardiography (TEE) |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determination has no clinical criteria for determining appropriateness:
|
SPECT/SPECT CT Imaging |
| The following coverage determination has no clinical criteria for determining appropriateness:
|
Arterial Ultrasound
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| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness:
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Arterial Ultrasound
|
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness:
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Arterial Ultrasound
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| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness:
|
Diagnostic Coronary Angiography |
| 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:
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Percutaneous Coronary Intervention (PCI) |
| 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:
|
Cardiac Resynchronization Therapy (CRT) |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determinations have clinical criteria for ICD but no clinical criteria for determining appropriateness for CRT:
|
Subcutaneous Cardiac Rhythm Monitor |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determination includes an electrocardiographic services framework to determine if a service is eligible for coverage and indicates that determination of medical necessity is according to local MAC discretion. The document itself does not provide the medical necessity clinical coverage criteria.
|
Mobile Cardiac Telemetry |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determination includes an electrocardiographic services framework to determine if a service is eligible for coverage and indicates that determination of medical necessity is according to local MAC discretion. The document itself does not provide the medical necessity clinical coverage criteria.
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Vascular Embolization or Occlusion |
| The following coverage determination does not provide a comprehensive list of conditions amenable to the procedure nor does it supply the necessary criteria to determine clinical appropriateness.
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Intravascular Lithotripsy |
| Coverage criteria is not fully established as it does not provide the necessary clinical specificity for this specific clinical indication
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Neurostimulators
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| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness:
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Neurostimulators
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| The following coverage guidance has clinical criteria that is not fully established for all clinical scenarios and does not allow for consistent clinical appropriateness decisions:
The following coverage determinations have no clinical criteria for determining appropriateness:
|
Neurostimulators
|
| Coverage criteria is fully established by the following coverage determinations for the indication of urinary incontinence and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage criteria is fully established for the indication of fecal incontinence and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage criteria is not fully established for the indication of fecal incontinence and the use of internal clinical coverage criteria is necessary to consistently determine medical necessity:
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Neurostimulators
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| The following coverage determinations have no clinical criteria for determining appropriateness in the use of gastric neurostimulators:
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Neurostimulators
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| The following coverage guidance has clinical criteria that is not fully established for all clinical scenarios and does not allow for consistent clinical appropriateness decisions:
The following coverage determinations have no clinical criteria for determining appropriateness:
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Dermabrasion |
| The following coverage criteria is fully established for actinic keratosis and no internal coverage criteria will be used in any jurisdiction when this procedure is used for this diagnosis:
The following coverage guidance has clinical criteria for cosmetic and reconstructive indications. They do not provide sufficient clinical criteria to determine clinical appropriateness for scenarios outside of these indications:
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Suction Assisted Lipectomy |
| Coverage criteria for cosmetic indications is fully established by the following coverage determinations and so no internal coverage criteria is used for these indications in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness when used in the treatment of hyperhidrosis:
|
Osseointegrated Skull Implant |
| The applicable CMS guidance provides language indicating the service may be medically necessary and payable but does not provide sufficient clinical criteria to determine clinical appropriateness:
|
Genioplasty Mandibular Body/Angle Augmentation |
| Coverage criteria for cosmetic indications is fully established by the following coverage determinations and so no internal coverage criteria is used for these indications in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness when used in the treatment of non-cosmetic indications:
|
Lefort I Midface Reconstruction Mandible Osteotomy |
| Coverage criteria for cosmetic indications is fully established by the following coverage determinations and so no internal coverage criteria is used for these indications in the jurisdictions where these apply:
Coverage criteria for Obstructive Sleep Apnea is fully established by the following coverage determinations and so no internal coverage criteria is used for these indications in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness when used in the treatment of non-cosmetic indications:
|
Mandibular Rami Reconstruction |
| Coverage criteria for cosmetic indications is fully established by the following coverage determinations and so no internal coverage criteria is used for these indications in the jurisdictions where these apply:
The following coverage determinations have no clinical criteria for determining appropriateness when used in the treatment of non-cosmetic indications:
|
Repair of Nasal Valve Collapse with Implants |
| Coverage criteria is fully established for this procedure by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage document only addresses this procedure for cosmetic indications but does not provide clinical criteria for any other indications:
|
Soft Palate Implants |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage documents only address this procedure for cosmetic indications but do not provide clinical criteria for other non-cosmetic indications:
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Ocular Telescope Prosthesis Insertion |
| Coverage criteria is fully established by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The following coverage criteria indicate that the service is payable but do not contain the necessary clinical criteria to determine appropriateness:
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Cellular and Tissue Based Products
Amniotic/Placental Derived Products for Musculoskeletal Injections |
| Coverage criteria is fully established for Lower Extremity Wound indications by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
Coverage criteria is fully established for non-wound musculoskeletal indications by the following coverage determinations and so no internal coverage criteria is used in the jurisdictions where these apply:
The coverage determinations listed above have no clinical criteria for determining appropriateness for indications outside of lower extremity wound and non-wound musculoskeletal indications. |