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November 2013

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Durable Medical Equipment (DME)
Tumor-Treating Fields Therapy for Glioblastoma

No coverage will be provided for tumor treatment fields therapy (The NovoTTF-100A™ System) to treat glioblastoma as this is considered investigational.

Genetic Testing
Genetic Testing for Alpha Thalassemia

Coverage will be provided for genetic testing for alpha thalassemia when medically necessary.

  1. Preconception (carrier) testing for alpha thalassemia in prospective parents may be considered medically necessarywhen both parents have evidence of alpha thalassemia based on biochemical testing.

a) Biochemical testing to determine whether alpha thalassemia is present should be the first step in evaluating the presence of the condition.

b) Biochemical testing consists of complete blood count, microscopic examination of the peripheral smear, and Hgb electrophoresis.

  1. Genetic testing to confirm a diagnosis of alpha thalassemia is considered not medically necessary.
  2. Genetic testing for alpha thalassemia in other clinical situations is considered investigational and not covered.

Genetic Testing for Facioscapulohumeral Muscular Dystrophy
Coverage will be provided for genetic testing for facioscapulohumeral muscular dystrophy (FSHD) when medically necessary.

  1. Genetic testing for facioscapulohumeral muscular dystrophy may be considered medically necessaryto confirm a diagnosis in a patient with clinical signs of the disease.

a) FSHD is typically suspected in an individual with the following:

  • weakness that predominantly involves the facial, scapular stabilizer, and foot dorsiflexor muscles without associated ocular or bulbar muscle weakness, and
  • age of onset usually by 20 years of age (although mildly affected individuals show signs at a later age and some remain asymptomatic).
  1. Genetic testing for facioscapulohumeral muscular dystrophy is considered investigationaland not coveredfor all other indications.

Genetic Testing for CHARGE Syndrome
Coverage will be provided for genetic testing for CHARGE Syndrome when medically necessary.

  1. Genetic testing for CHARGE syndrome may be considered medically necessaryto confirm a diagnosis in a patient with signs/symptoms of CHARGE syndrome when a definitive diagnosis cannot be made with clinical criteria.

a)     A diagnosis of definite CHARGE syndrome can be made clinically in individuals with all four major characteristics or three major and three minor characteristics.

  • Major characteristics include:  ocular coloboma, choanal atresia or stenosis, cranial nerve abnormality, ear anomalies/deafness.
  • Minor characteristics include:  genital hypoplasia, hypogonadotrophic hypogonadism, developmental delays, cardiac malformations, short stature, cleft lip and/or cleft palate, tracheoesophageal fistula, distinctive CHARGE facial appearance, consisting of a prominent forehead and a prominent nasal bridge. Other, less frequent manifestations include kidney malformations, immunodeficiency, various limb abnormalities, scoliosis, dental problems, omphalocele, brain malformations, attention deficit hyperactivity disorder (ADHD), and various behavioral problems.

b) In patients without the classical clinical criteria to diagnose CHARGE, in those with a milder phenotype, and/or in those with features that overlap with and cannot be distinguished from other syndromes, genetic testing may provide a definitive diagnosis.

  1. Mutation testing for CHARGE syndrome is considered investigational in all other situations and not covered.

Genetic Testing for Hereditary Pancreatitis
No coverage will be provided for genetic testing for hereditary pancreatitis as this is considered investigational.

Non-BRCA Breast Cancer Risk Assessment
No coverage will be provided for the OncoVue® and BREVAGen™ Breast Cancer Risk tests as a method of estimating individual patient risk for developing breast cancer as this is considered investigational.

Experimental/Investigative Services Surgery
Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins during Breast-Conserving Surgery
No coverage will be provided for handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery as this is considered investigational.

Surgical Deactivation of Headache Trigger Sites
No coverage will be provided for surgical deactivation of trigger sites for the treatment of migraine and non-migraine headache as this is considered investigational.

Capsule Endoscopy
Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon
No coverage will be provided for wireless capsule endoscopy for the following indications as they are considered investigational and, therefore, not covered because the safety and effectiveness of these services cannot be established by review of the available published peer-reviewed literature:

  1. Evaluation of the extent of involvement of known Crohn’s disease or ulcerative colitis.
  2. Evaluation of the esophagus in patients with gastroesophageal reflux (GERD) or other esophageal pathologies.
  3. Evaluation of other gastrointestinal diseases not presenting with GI bleeding including, but not limited to, celiac sprue, irritable bowel syndrome, Lynch syndrome  and small bowel neoplasm.
  4. Evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer.
  5. Initial evaluation of patients with acute upper GI bleeding.
  6. All other indications not identified above as medically necessary.

Hematopoietic Stem-Cell Transplantation (HSCT)
Hematopoietic Stem-Cell Transplantation for Plasma Cell Dyscrasias, Including Multiple Myeloma and POEMS Syndrome
Coverage will be provided for autologous or allogeneic hematopoietic stem-cell transplantation (HSCT) for the treatment of plasma cell dyscrasias, including multiple myeloma and POEMS Syndrome when medically necessary.

  1. Autologous hematopoietic stem-cell transplantation may be considered medically necessary and covered to treat disseminated POEMS syndrome.  NOTE:  Patients with disseminated POEMS syndrome may have diffuse sclerotic lesions or disseminated bone marrow involvement.
  2. No coverage will be provided for allogeneic and tandem hematopoietic stem-cell transplantation to treat POEMS syndrome as this is considered investigational.