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January 2012

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Genetic Testing
Quantitative Assay for Measurement of HER2 Total Protein Expression and HER2 Dimers

Coverage will not be provided for the assessment of HER2 status by quantitative total HER2 protein expression and HER2 homodimer measurement (i.e. HERmark Breast Cancer Assay) as this is considered investigational.

BRAF Gene Mutation Testing To Select Melanoma Patients for BRAF Inhibitor Therapy
Coverage will be provided for testing for the BRAFV600 gene mutation when medically necessary.

1.   Testing for the BRAFV600 mutation in tumor tissue of patients with stage IIIC or IV melanoma may be considered medically necessary to select patients for treatment with vemurafenib.

2.   Testing for the BRAFV600 mutation for all other indications, including but not limited to, use in patients with lesser stage melanoma, is considered investigational and not covered.

In Vitro Companion Diagnostic Devices
Coverage will be provided for In Vitro Companion Diagnostic Devices (IVD) when medically necessary.

1.   IVD, e.g. diagnostic molecular tests may be considered medically necessary when all of the following criteria are met:

a)   The IVD was approved through the FDA In Vitro Companion Diagnostic Devices process; and

b)   The Associated Therapeutic Product (ATP), e.g. pharmaceutical or biologic treatment, would be considered medically necessary for the diagnosis and specific clinical situation under review; and

c)   The IVD is being used to determine whether the associated ATP would be a medically necessary therapy.

2.   The use of an IVD not meeting above criteria is considered investigational and not covered.

Cardiac Event Monitors
Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry

Coverage will be provided for ambulatory event monitors when medically necessary.

1.   The use of patient-activated or auto-activated external ambulatory event monitors may be considered medically necessary as a diagnostic alternative to Holter monitoring in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope).

2.   The use of auto-activated external ambulatory event monitors may be considered medically necessaryin patients treated for atrial fibrillation to monitor for asymptomatic episodes in order to evaluate treatment response.

3.   The use of implantable ambulatory event monitors, either patient activated or auto-activated, may be considered medically necessary only in the small subset of patients who experience recurrent symptoms so infrequently that a prior trial of Holter monitor and other external ambulatory event monitors has been unsuccessful.

4.   Other uses of ambulatory event monitors are considered investigational and not covered, including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes.

Experimental/Investigative Services Pathology/Laboratory
Intraepidermal Nerve Fiber Density Testing

Coverage will be provided for skin biopsy with epidermal nerve fiber density measurement for the diagnosis of small-fiber neuropathy when medically necessary.

1.   Skin biopsy with epidermal nerve fiber density measurement for the diagnosis of small-fiber neuropathy may be considered medically necessarywhen all of the following conditions are met:

a)       Individual presents with symptoms of painful sensory neuropathy; AND

b)       There is no history of a disorder known to predispose to painful neuropathy (e.g., diabetic neuropathy, toxic neuropathy, HIV neuropathy, celiac neuropathy, inherited neuropathy); AND

c)       Physical examination shows no evidence of findings consistent with large-fiber neuropathy, such as reduced or absent muscle-stretch reflexes or reduced proprioception and vibration sensation; AND

d)   Electromyography and nerve-conduction studies are normal and show no evidence of large-fiber neuropathy.

2.   Skin biopsy with epidermal nerve fiber density measurement is considered investigationaland not coveredfor all other conditions, including, but not limited to, the monitoring of disease progression or response to treatment.

Miscellaneous Services
No coverage will be provided for the Avise PG test to monitor a patient’s therapeutic response to methotrexate as this is considered investigational.

Experimental/Investigative Services Ophthalmologic
Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions

Coverage will be provided for anti-vascular endothelial growth factor therapies when medically necessary.

1.   Anti-vascular endothelial growth factor therapies (anti-VEGF), i.e., pegaptanib (Macugen®*), ranibizumab (Lucentis™*), and bevacizumab (Avastin™), may be considered medically necessaryas a treatment of neovascular (wet) age-related macular degeneration.

2.   Anti-vascular endothelial growth factor therapies (anti-VEGF) may be considered medically necessaryfor the treatment of choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, presumed ocular histoplasmosis syndrome, and uveitis.

3.   Anti-vascular endothelial growth factor therapies (anti-VEGF) are considered investigational and not covered for the treatment of chorioretinal scars.

Experimental/Investigative Services Medicine
Cytoreductive Surgery and Perioperative Intraperitoneal Chemotherapy for the Treatment of Pseudomyxoma Peritonei, Peritoneal Carcinomatosis of Gastrointestinal Origin, and Peritoneal Mesothelioma

Coverage will be provided for cytoreductive surgery and perioperative intraperitoneal chemotherapy when medically necessary.

1.       Cytoreductive surgery and perioperative intraperitoneal chemotherapy for the treatment of pseudomyxoma peritonei may be considered medically necessary.

2.       Cytoreductive surgery and perioperative intraperitoneal chemotherapy for the treatment of diffuse malignant peritoneal mesothelioma may be considered medically necessary.

3.       Cytoreductive surgery and perioperative intraperitoneal chemotherapy is considered investigational and not covered for peritoneal carcinomatosis from colorectal cancer.

Transcatheter Closure of Patent Ductus Arteriosus
Coverage will be provided for transcatheter closure of patent ductus arteriosus when medically necessary.

1.   Transcatheter closure of a patent ductus arteriosus using an FDA-approved device may be considered medically necessary.

2.   Transcatheter closure of a patent ductus arteriosus using other non–FDA-approved devices is considered investigational and not covered.

Experimental/Investigative Services Surgery
Periurethral Bulking Agents for the Treatment of Urinary Incontinence

Coverage will be provided for periurethral bulking agents for the treatment of urinary incontinence when medically necessary.

1.       The use of cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy.

a)       Patients should have had inadequate response to conservative therapy or therapies; in general, these treatments should have been used for at least 3 months.

b)       Conservative therapy for stress incontinence includes pelvic floor muscle exercises and behavioral changes, such as fluid management and moderation of physical activities that provoke incontinence.

c)       Additional options include intravaginal estrogen therapy, use of a pessary, and treatment of other underlying causes of incontinence in patients amenable to these treatments.

d)       When the above criteria have not been met, the use of periurethral bulking agents for the treatment of urinary incontinence is considered not medically necessary and is not covered.

Power Mobility Devices
Power Mobility Devices includes power operated vehicles and power wheelchairs.

Power Mobility Devices may be considered medically necessary when all policy criteria have been met. To ensure coverage, the provider should review the medical policy criteria/guidelines prior to providing the equipment to the member.

Contrast Enhanced Cardiac Computed Tomography Angiography (CTA) for Coronary Artery Evaluation
Contrast-Enhanced Computed Tomography Angiography (CTA) for Coronary Artery Evaluation

Contrast enhanced cardiac computer tomography angiography (CTA) may be considered medically necessary for the emergency evaluation of patients without known coronary artery disease and acute chest pain.