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June 2013

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Transplant
Total Artificial Hearts and Implantable Ventricular Assist Devices

Ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions, may be considered medically necessary and covered as a bridge to heart transplantation in children 16 years old or younger who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation.

Electrical/Neuromuscular Stimulator
Functional Neuromuscular Electrical Stimulation

No coverage will be provided for neuromuscular stimulation as a technique to restore function following nerve damage or nerve injury, as this is considered investigational.  This includes its use in the following situations:

  1. As a technique to provide ambulation in patients with spinal cord injury; or
  2. To provide upper extremity function in patients with nerve damage (e.g., spinal cord injury or post-stroke); or
  3. To improve ambulation in patients with foot drop caused by congenital disorders (e.g., cerebral palsy) or nerve damage (e.g., post-stroke or in those with multiple sclerosis).

Peripheral Subcutaneous Field Stimulation
No coverage will be provided for peripheral subcutaneous field stimulation as this is considered investigational.

Genetic Testing
BCR-ABL1 Testing for Diagnosis, Monitoring, and Drug Resistance Mutation Detection in Chronic Myelogenous Leukemia
Coverage will be provided for BCR/ABL1 qualitative testing for the presence of the fusion gene as this is considered medically necessary for diagnosis of chronic myeloid leukemia.

Coverage will be provided for BCR/ABL1 testing for messenger RNA transcript levels by quantitative real-time reverse transcription-polymerase chain reaction at baseline prior to initiation of treatment and at appropriate intervals during therapy as this is considered medically necessary for monitoring of chronic myeloid leukemia treatment response and remission.

Coverage will be provided for evaluation of ABL kinase domain point mutations to evaluate patients for tyrosine kinase inhibitor resistance as this is considered medically necessary when there is inadequate initial response to treatment or any sign of loss of response; and/or when there is progression of the disease to the accelerated or blast phase.

Coverage will not be provided for the evaluation of ABL kinase domain point mutations 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. For monitoring in advance of signs of treatment failure or disease progression.
  2. All other indications not identified above as medically necessary.

PTEN Hamartoma Tumor Syndrome
Coverage will be provided for genetic testing for a PTEN mutation when medically necessary:

  1. To confirm the diagnosis when a patient has clinical signs of a PTEN hamartoma tumor syndrome.
  2. In a first -degree relative of a proband with a known PTEN mutation.

Coverage will not be provided for genetic testing for a PTEN mutation 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. Prenatal testing.
  2. All other indications not identified above as medically necessary.

Genetic Testing for Duchenne and Becker Muscular Dystrophy
Coverage will be provided for genetic testing for Duchenne muscular dystrophy (DMD) gene mutations when medically necessary:

  1. In a male with signs and symptoms of a dystrophinopathy in order to confirm the diagnosis and direct treatment.
  2. For at-risk female relatives to confirm or exclude the need for cardiac surveillance.

No coverage will be provided for genetic testing for DMD gene mutations for all other conditions as this is considered not medically necessary.

Stereotactic Radiosurgery and Charged-Particle Radiation Therapy
Charged-Particle (Proton or Helium Ion) Radiation Therapy

Coverage will be provided for charged-particle irradiation with proton or helium ion beams when medically necessary.

  1. Charged-particle irradiation with proton or helium ion beams may be considered medically necessaryin the following clinical situations:
    • Primary therapy for melanoma of the uveal tract (iris, choroid, or ciliary body), with no evidence of metastasis or extrascleral extension, and with tumors up to 24 mm in largest diameter and 14 mm in height;
    • Postoperative therapy (with or without conventional high-energy x-rays) in patients who have undergone biopsy or partial resection of chordoma or low-grade (I or II) chondrosarcoma of the basisphenoid region (skull-base chordoma or chondrosarcoma) or cervical spine. Patients eligible for this treatment have residual localized tumor without evidence of metastasis.
    • In the treatment of pediatric (<21 yrs of age) central nervous system tumors.
  2. Charged-particle irradiation with proton beams using standard treatment doses is considered not medically necessary in patients with clinically localized prostate cancer.

Coverage will not be provided for charged-particle irradiation 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. Use of proton beam therapy for non-small-cell lung cancer (NSCLC) at any stage or for recurrence.
  2. Pediatric non-central nervous system tumors.
  3. Tumors of the head and neck (other than skull-based chordoma or chondrosarcoma).
  4. All other indications not identified above as medically necessary.

Transcatheter Embolization
Radioembolization for Primary and Metastatic Tumors of the Liver

Coverage will not be provided for radioembolization to treat primary intrahepatic cholangiocarcinoma as it is considered investigational.

Experimental/Investigative Services Ophthalmologic
Eyelid Thermal Pulsation for the Treatment of Dry Eye Syndrome

Coverage will not be provided for eyelid thermal pulsation therapy to treat dry eye syndrome as this is considered investigational.

Intraocular Radiation Therapy for Age-Related Macular Degeneration
Coverage will not be provided for intraocular proton beam therapy for the treatment of choroidal neovascularization as this is considered investigational.

Experimental/Investigative Services Surgery
Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Coverage will not be provided for the use of perianal bulking agents to treat fecal incontinence as this is considered investigational.

Ablation Services
MRI-Guided Focused Ultrasound (MRgFUS)

Coverage will not be provided for MRI-guided high-intensity ultrasound ablation as this is considered investigational.  This includes, but is not limited to, its use in the following situations:

  1. Treatment of uterine fibroids.
  2. Pain palliation for patients with metastatic bone cancer.
  3. Treatment of other tumors e.g., brain cancer, prostate cancer and breast cancer.