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August 2010

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Electrical Stimulation
Sacral Nerve Neuromodulation/Stimulation for Pelvic Floor Dysfunction
Sacral nerve stimulation may be now considered medically necessary for the treatment of chronic fecal incontinence in patients who have failed conservative therapy and meet the following criteria:

a) Chronic fecal incontinence of greater than 2 incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; and

b) Documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously); and

c) The patient is an appropriate surgical candidate; and

d) A successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; and

e) Condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease; and

f) Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.

Sacral nerve neuromodulation in the treatment of chronic constipation or chronic pelvic pain remains investigational and is not covered.

Treatment of Tinnitus
Tinnitus describes the perception of any sound in the ear in the absence of an external stimulus and presents a malfunction in the processing of auditory signals. 

Treatment of tinnitus with electrical stimulation, transcutaneous electrical stimulation, or transcranial magnetic stimulation is considered investigational and is not covered.

Outpatient Therapies
Cognitive Rehabilitation

Cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) may be considered medically necessary in the rehabilitation of patients with traumatic brain injury.

For services to be considered medically necessary, they must meet the following conditions:

a) The services must be provided by a qualified licensed professional;

b) The services must be prescribed by the attending physician as part of the written care plan;

c) There must be a potential for improvement (based on pre-injury function); and

d) Patients must be able to actively participate in the program.

Ongoing services are considered necessary only when there is demonstrated continued objective improvement in function.

Cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) is considered investigational and is not covered for all other applications, including, but not limited to stroke, post-encephalitic or post-encephalopathy patients, and the aging population, including Alzheimer’s patients.

Transplants
Kidney Transplants
The policy is being updated with the following criteria language to assist in appropriate patient selection:

Candidates for kidney transplant should meet the following criteria:
 
a) Adequate cardiopulmonary status,

b) Absence of significant infection that could be exacerbated by immunsuppressive therapy (e.g., human immunodeficiency virus (HIV)),

c) No history of malignancy within 5 years of transplantation, excluding nonmelanomatous skin cancer, AND

d) Documentation of compliance with medical management.

Kidney Specific

a) Indications for renal transplant include a creatinine level of greater than 8 mg/dL, or greater than 6 mg/dL in symptomatic diabetic patients.  However, consideration for listing for renal transplant may start well before the creatinine level reaches this point, based on the anticipated time that a patient may spend on the waiting list.

Prosthetics/Orthotics 
Interventions for Progressive Scoliosis
Orthotic bracing attempts to slow curve progression and reduce the need for fusion surgery in patients with progressive scoliosis.  A cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent patients at high-risk of progression which meets the following criteria:
 
1) Idiopathic spinal curve angle between 25° and 40°; and

2) Spinal growth has not been completed (Risser grade 0-3; no more than 1 year post-menarche in females)
OR
3) Idiopathic spinal curve angle greater than 20°; and

4) There is documented increase in the curve angle; and

5) At least 2 years growth remain (Risser grade 0 or 1; pre-menarche in females)

Use of an orthosis for the treatment of scoliosis that does not meet the criteria above is considered investigational and is not covered.

Genetic Testing
Tyrosine Kinase Mutations in Myeloproliferative Neoplasms
JAK2 tyrosine kinase and MPL mutation testing may be considered medically necessary in the diagnosis of patients presenting with clinical, laboratory, or pathological findings suggesting classic forms of myeloproliferative neoplasms (MPN), that is, polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF).

JAK2 tyrosine kinase and MPL mutation testing may be considered investigational in all other circumstances including, but not limited to, the following situations:
a) Diagnosis of nonclassic forms of MPNs

b) Molecular phenotyping of patients with MPNs

c) Monitoring, management, or selecting treatment in patients with MPNs

d) Diagnosis or selection of treatment in patients with Down syndrome and acute lymphoblastic leukemia
Patients suspected to have polycythemia vera (PV) should first be tested for the most common finding JAK2V617F.  If testing is negative, further testing to detect other JAK2 tyrosine kinase mutations, e.g., in exon 12, is warranted.
Patients suspected to have essential thrombocythemia (ET) or primary myelofibrosis (PMF) should first be tested for JAK2 mutations, as noted.  If testing is negative, further testing to detect MPL mutations is warranted.

Chondral Defects of the Knee 
Autologous Chondrocyte Implantation and Other Cell-based Treatments of Focal Articular Cartilage Lesions

Meniscal Allografts and Collagen Meniscus Transplants

Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

The policy has been renamed from Osteoarticular Transfer System (OATS)/Autologous Chondrocyte Transplant (ACT) to Chondral Defects of the Knee.
Medical necessity criteria for ACT and OATS have been updated and policy language regarding Meniscal Allografts and Collagen Meniscus Transplants moved to the policy.

Cryosurgical Ablation and Radiofrequency Ablation (RFA)
Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors
Coverage will be provided for radiofrequency ablation for the following indications:

1. To palliate pain in patients with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids.

2. To treat osteoid osteomas that cannot be managed successfully with medical treatment.

3. To treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria are met:

a) Preservation of kidney function is necessary (i.e., the patient has one kidney or renal insufficiency defined by a glomerular filtration rate (GFR) of < 60 mL/min/m2) and standard surgical approaches would compromise kidney function; or

b) Patient is not considered a surgical candidate due to co-morbid disease.

Radiofrequency ablation as a technique for ablation of tumors of the breast, lung, renal cell cancer not meeting criteria above, and all other tumors outside the liver including, but not limited to, the head and neck, adrenal gland, ovary, and pelvic/abdominal metastases of unspecified origin is considered investigational and is not covered.

Radiofrequency ablation as a technique for the treatment of osteoid osteomas that can be managed with medical treatment or for the initial treatment of painful bony metastases is considered investigational and is not covered.

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

Experimental/Investigational Services Radiology
Thermography
The use of all forms of thermography is considered investigational and is not covered.
 
Experimental/Investigational Services Medicine
Interventions for Progressive Scoliosis
Fusionless surgical procedures (e.g., vertebral body stapling and implantation of vertical titanium growing rods) have been evaluated as alternatives to bracing to slow or correct curve progression in pediatric patients with scoliosis.  These are considered investigational and are not covered.

Diagnosis and Management of Idiopathic Environmental Intolerance (i.e., Clinical Ecology)
Laboratory tests designed to affirm the diagnosis of idiopathic environmental intolerance are considered investigational and are not covered.

Nutritional assessments, including intracellular analysis of micronutrients in both asymptomatic and patients with symptoms suggestive of idiopathic environmental intolerance are considered investigational and are not covered.

Treatment of idiopathic environmental illness with IVIG, neutralizing therapy of chemical and food extracts, avoidance therapy, elimination diets, and oral nystatin (to treat candida) is considered investigational and is not covered.

Experimental/Investigational Services Therapy
Iontophoresis and Phonophoresis as a Transdermal Technique for Drug Delivery
Iontophoresis is considered investigational and not covered as a transdermal drug delivery technique for medical indications except:

1) To administer local anesthesia prior to a venipuncture or dermatologic procedure, OR

2)  For the short-term (i.e., less than 24 hours) management of acute postoperative pain in adult patients requiring opioid analgesia in a monitored facility (e.g., inpatient hospital, outpatient hospital, ambulatory surgical center).

Phonophoresis alone or in combination with iontophoresis as a transdermal drug delivery technique for any medical condition is considered investigational and not covered.

Cellular Immunotherapy for Prostate Cancer
Sipuleucel-T (Provenge®, Dendreon Corp.) is a new class of therapeutic agent, sometimes referred to as a vaccine, used in the treatment of metastatic prostate cancer.  Cellular immunotherapy is considered medically necessary for the FDA-approved indication in treatment of asymptomatic or minimally symptomatic, metastatic, androgen-independent prostate cancer.  Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to, treatment of hormone-responsive prostate cancer and treatment of those with moderate to severe symptomatic metastatic prostate cancer.

Treatment of Tinnitus
Treatment of tinnitus with tinnitus maskers, transmeatal laser irradiation, electromagnetic energy, tinnitus-retraining therapy, tinnitus-coping therapy, or botulinum toxin A injections is considered investigational and is not covered.