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December 2013

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Stereotactic Radiosurgery and Charged-Particle Radiation Therapy
Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy

No coverage will be provided for SRS 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:

  • The treatment of seizures and functional disorders other than trigeminal neuralgia, including chronic pain, and the treatment of uveal melanoma. 

Genetic Testing
Genetic Testing for Nonsyndromic Hearing Loss

Coverage will be provided for genetic testing for nonsyndromic hearing loss (NSHL) when medically necessary.

NOTE: NSHL is defined as hearing loss that is not associated with other physical signs or symptoms.  For NSHL, it is more difficult to determine whether the etiology is hereditary or acquired, since by definition there are no other clinical manifestations.  Autosomal recessive patterns of inheritance predominate and account for 80% of congenital NSHL.  The majority of the remaining 20% of patients have an autosomal dominant inheritance pattern, with a small number having X-linked or mitochondrial inheritance.

  1. Genetic testing for NSHL mutations (GJB2, GJB6 and other NSHL-related mutations) may be considered medically necessary in individuals with NSHL to confirm the diagnosis of hereditary NSHL.
     
  2. Preconception genetic testing (carrier testing) for NSHL mutations (GJB2, GJB6 and other NSHL-related mutations) in parents may be considered medically necessarywhen at least one of the following conditions has been met:
    • Offspring with hereditary NSHL; OR
    • One or both parents with suspected NSHL; OR
    • First- or second-degree relative affected with hereditary NSHL; OR
    • First-degree relative with offspring who is affected with hereditary NSHL.
       
  3. Genetic testing for nonsyndromic hearing loss mutations is considered investigational for all other situations.

Whole Exome Sequencing
No coverage will be provided for whole exome sequencing as this is considered investigationalfor all indications

Genetic Testing for Familial Alzheimer’s Disease
No coverage will be provided for genetic testing for the diagnosis or risk assessment of Alzheimer’s disease as this is considered investigational.  Genetic testing includes, but is not limited to testing for the apolipoprotein E, epsilon 4 allele, presenilin genes or amyloid precursor gene, or TREM2.

Experimental/Investigative Services Pathology/Laboratory
Measurement of Serum Antibodies to Infliximab and Adalimumab
No coverage will be provided for measurement of antibodies to adalimumab in a patient receiving treatment with adalimumab, either alone or as a combination test which includes the measurement of serum adalimumab levels (e.g. Anser™ADA) as this is considered investigational.

Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease
No coverage will be provided for measurement of novel lipid and non-lipid risk factors (i.e., apolipoprotein B, apolipoprotein A-I, apolipoprotein E, cystatin C, leptin, LDL subclass, HDL subclass, lipoprotein[a]) as an adjunct to LDL cholesterol in the risk assessment and management of cardiovascular disease as this is considered investigational.

Experimental/Investigative Services Ophthalmologic
Aqueous Shunts and Stents for Glaucoma
No coverage will be provided for the use of a micro-stent, other than a single FDA-approved micro-stent which is implanted in conjunction with cataract surgery in patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication, as this is considered investigational.

Experimental/Investigative Services Medicine
Peroral Endoscopic Myotomy for Treatment of Esophageal Achalasia
No coverage will be provided for peroral endoscopic myotomy as a treatment for esophageal achalasia as this is considered investigational.

Bone Morphogenetic Protein
Bone Morphogenetic Protein
Coverage will be provided for bone morphogenetic protein when medically necessary.

  1. Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) may be considered medically necessaryin skeletally mature patients:
    • For anterior lumbar interbody fusion procedures when use of autograft is unfeasible.
    • For instrumented posterolateral intertransverse spinal fusion procedures when use of autograft is unfeasible.
       
  2. Use of recombinant human bone morphogenetic protein-7 (rhBMP-7, OP-1) may be considered medically necessary in skeletally mature patients:
    • For revision posterolateral intertransverse lumbar spinal fusion, when use of autograft is unfeasible.
    • For recalcitrant long-bone nonunions where use of autograft is unfeasible and alternative conservative treatments have failed.

Bone morphogenetic protein (rhBMP-2 or rhBMP-7) is considered not medically necessary for all other indications, including but not limited to spinal fusion when use of autograft is feasible.

NOTE:  Use of iliac crest bone graft (ICBG) may be considered unfeasible due to situations that may include, but are not limited to, prior harvesting of ICBG or need for a greater quantity of ICBG than available (e.g., for multi-level fusion).