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July 2010

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Cardiac Rhythm Devices
Biventricular Pacemakers for the Treatment of Congestive Heart Failure
Implantable Cardioverter Defibrillator (AICD)
Wearable Cardioverter-Defibrillators

A new policy was created to incorporate biventricular pacemakers, implantable and wearable cardioverter-defibrillators into one policy and to capture all applications of these devices. 

Coverage is provided for automatic implantable cardioverter-defibrillators, wearable cardioverter-defibrillators, and biventricular pacemakers when meeting medically necessity criteria specified in the policy.

Use of wearable cardioverter-defibrillators for the prevention of sudden cardiac death is considered investigational for all other indications, including use immediately (i.e., less than 40 days) following an acute myocardial infarction and are not covered.

Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) as a treatment of congestive heart failure in patients who do not meet specific criteria are considered not medically necessary and are not covered.

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) are considered investigational as a treatment for patients with NYHA class I/II congestive heart failure and are not covered.

No coverage is provided for an intrathoracic fluid monitoring sensor as a component of a biventricular pacemaker as this is considered investigational.

Scanning Computerized Ophthalmic Diagnostic Imaging
Corneal Topography/Computer-Assisted Corneal Topography/Photokeratoscopy
No coverage will be provided computer-assisted corneal topography to detect or monitor diseases of the cornea as this is considered not medically necessary.

Transplants
Hematopoetic Stem-Cell Transplantation in the Treatment of Germ-Cell Tumors
Tandem or sequential auto-HSCT may now be considered medically necessary for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease. The following are considered medically necessary:

Single autologous hematopoietic stem-cell transplantation as salvage therapy for germ-cell tumors in the following situations:

  1. In patients with favorable prognostic factors that have failed a previous course of conventional-dose salvage chemotherapy; or
  2. In patients with unfavorable prognostic factors as initial treatment of first relapse (i.e., without a course of conventional-dose salvage chemotherapy) and in patients with platinum-refractory disease.

Tandem or sequential autologous hematopoietic stem-cell transplantation for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease.

The following are considered investigational and are not covered:

  • Autologous hematopoietic stem-cell transplantation as a component of first-line treatment for germ-cell tumors;
  • Except as noted above for treatment of certain testicular tumors, tandem or sequential autologous hematopoietic stem-cell to treat germ-cell tumors of any stage;
  • Allogeneic hematopoietic stem-cell transplantation to treat germ-cell tumors, including, but not limited to its use as therapy after prior failed autologous hematopoietic stem-cell transplantation.

Sleep Disorder Services
Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome
Uvulopalatopharyngoplasty (UPPP), hyoid suspension, and adenotonsillectomy may be medically necessary under certain criteria.  Minimally-invasive procedures, such as radiofrequency volumetric tissue reduction of the tongue or palatal tissues, Laser-assisted palatoplasty (LAUP), palatal stiffening procedures, or tongue base suspension for the sole or adjunctive treatment of obstructive sleep apnea (OSA) or upper airway resistance syndrome are considered investigational and are not covered.  Interventions for snoring alone are considered not medically necessary and are not covered.

Brachytherapy
Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas or Metastasis to the Brain
No coverage will be provided for intracavitary balloon catheter brain brachytherapy alone or as a part of multi-modality treatment regimen, for primary or recurrent malignant brain tumors as this is considered investigational.

No coverage will be provided for intracavitary balloon catheter brain brachytherapy alone or as part of a multi-modality treatment regimen, for metastasis to the brain from primary solid tumors outside the brain since this is considered investigational.

Genetic Testing
Cytochrome p450 Genotyping
CYP450 genotyping for CYP2C19 *2 and *3 alleles may be considered medically necessary in patients with cardiovascular disease undergoing treatment with clopidogrel (Plavix) in order to identify those who are poor metabolizers of the drug (patients with CYP2C19*2/2,*3/3, and *2/3 genotypes) and who are therefore likely to exhibit poor response to the drug.

Aside from the use with clopidogrel treatment noted above and the separate applications noted below, genotyping to determine specific cytochrome p450 (CYP450) genetic polymorphisms for the purpose of aiding in the choice of drug or dose to increase efficacy and/or avoid toxicity is considered investigational and is not covered.  This includes, but is not limited to, CYP450 genotyping for the following applications:

  1. Selection or dose of selective serotonin reuptake inhibitor (SSRI);
  2. Selection or dose of antipsychotics;
  3. Deciding whether to prescribe codeine for nursing mothers;
  4. Determining risk of atherothrombotic events in patients treated with clopidogrel after an acute coronary syndrome or percutaneous coronary intervention;
  5. Dose of atomoxetine HCl (approved for treatment of attention-deficit/hyperactivity disorder);
  6. Dose of efavirenz (common component of highly active antiretroviral therapy for HIV infection);
  7. Dose of immunosuppressant for organ transplantation; and
  8. Selection or dose of beta blockers (e.g., metoprolol).

Use of Common Genetic Variants to Predict Risk of Non-familial Breast Cancer
No coverage will be provided for testing for one of more single nucleotide polymorphisms (SNPs) to predict an individual’s risk of breast cancer (i.e., the deCODE BreastCancer test™) as this is considered investigational.

Bariatric Surgery
The requirement that the screening be performed by a licensed psychologist or psychiatrist only has been expanded to include licensed clinical social workers.  Patients must be screened by a licensed psychologist, psychiatrist, or licensed clinical social worker familiar with the requirements of Bariatric Surgery looking for psychopathology (schizophrenia, obsessive-compulsive disorder, borderline personality disorder, bipolar disorder, severe depression, alcoholism, substance abuse, etc.) that would interfere with their ability to comply with the rigorous pre-and post-operative regimens required for success.

The following procedures are considered experimental/investigational and members are responsible for any charges for treatment for:

Experimental/Investigational Services Pathology/Laboratory  
Proteomics-based Testing for the Evaluation of Ovarian (Adnexal) Masses
Except as an aid to further assess the likelihood that malignancy is present when the physician’s (other than gynecological oncologist) independent clinical and radiological pre-operative evaluations do not indicate malignancy in a patient with an ovarian (adnexal) mass, all other uses of the proteomics-based OVA1TM test are investigational and not covered including but not limited to:

  1. screening for ovarian cancer, or
  2. selecting patients for surgery for an adnexal mass, or
  3. evaluation of patients with clinical or radiologic evidence of malignancy, or
  4. evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy.

Systems Pathology for Predicting Risk of Recurrence in Prostate Cancer
Use of tests utilizing “Systems Pathology” (i.e. Prostate PX+ and Post-op PX tests) that use cellular and biologic features of a tumor, including use in predicting risk of recurrence in patients with prostate cancer are considered investigational and not covered.

Experimental/Investigational Services Medicine
In vitro chemoresistance assays, including, but not limited to extreme drug resistance assays are considered investigational and not covered.

In vitro chemosensitivity assays, including, but not limited to, the histoculture drug response assay or a fluorescent cytoprint assay are considered investigational and is not covered.

Experimental/Investigational Services Therapy
Manipulation under Anesthesia for Treatment of Chronic Spinal or Pelvic Pain

Spinal manipulation (and manipulation of other joints, e.g., hip joint, performed during the procedure) with the patient under anesthesia, spinal manipulation under joint anesthesia, and spinal manipulation after epidural anesthesia and corticosteroid injection for treatment of chronic spinal (cranial, cervical, thoracic, lumbar) pain and chronic sacroiliac and pelvic pain is considered investigational and not covered.

Orthopedic Applications of Stem Cell Therapy
Mesenchymal stem cell therapy for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue is considered investigational and is not covered.

Serum Tumor Markers
No coverage will be provided for the HE4 (Human epididymis protein 4) enzymeimmunometric assay for the quantitative determination of HE4 in human serum as this is considered investigational.