Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders
Intrapulmonary percussive ventilation devices may be considered medically necessary only in the same situations as high-frequency chest wall compression i.e., for patients with cystic fibrosis or chronic bronchiectasis when there is a demonstrated need for airway clearance and documented failure of standard treatments or valid reasons why standard treatments cannot be performed.
- High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices in patients with cystic fibrosis or chronic bronchiectasis may be considered medically necessary when standard chest physiotherapy has failed or standard chest physiotherapy is unavailable or not tolerated.
- Use of the flutter valve or acapella device in patients with hypersecretory lung disease (i.e., produce excessive mucus) who have difficulty clearing secretions and recurrent disease exacerbations) may be considered medically necessary.
- Other applications of high frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in other lung diseases, such as Chronic Obstructive Pulmonary Disease (COPD) are considered experimental/investigational and are not covered.
-High frequency chest wall compression devices and intrapulmonary percussive ventilation devices as an alternative to chest physical therapy in patients with cystic fibrosis or chronic bronchiectasis in any other clinical situations remain not medically necessary and are not covered.
Home Apnea Monitoring
Home cardiorespiratory monitoring (pneumogram) is considered not medically necessary in infants with any siblings with a history of sudden infant death syndrome (SIDS) and is not covered.
Home cardiorespiratory monitoring (pneumogram) in all other conditions, including but not limited to the diagnosis of obstructive sleep apnea, is considered investigational and is not covered.
Genetic Testing for Hereditary Breast and/or Ovarian Cancer
Cancer of the fallopian tube and primary peritoneal cancer are added as additional cancers to consider in assessing risk. Testing for genomic rearrangements of the BRCA1 and BRCA2 genes is considered medically necessary in patients who meet the stated criteria when 1) there are 3 or more affected family members or 2) the risk of a BRCA mutation is at least 10%. Testing for CHEK2 mutations is investigational and is not covered.
Biomarker Genes for Detection of Lymph Node Metastases in Breast Cancer
No coverage is provided for evaluation of biomarker genes for detection of lymph node metastases in patients with breast cancer since this is considered investigational.
Myoelectric Prosthesis for the Upper Limb
Coverage is provided for myoelectric upper arm prosthetic components when the following conditions are met:
- The patient has an amputation or missing limb at the wrist or above (forearm, elbow, etc.); and
- Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; and
- The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; and
- The patient has demonstrated sufficient neurological and cognitive function to operate the prosthesis effectively; and
- The patient is free of comorbidities that could interfere with function of the prosthesis (neuromuscular disease, etc.); and
- Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (e.g., gripping, releasing, holding, and coordinating movement of the prosthesis) when performing activities of daily living. This evaluation should consider the patient’s needs for control, durability (maintenance), function (speed, work capability), and usability.
The policy was modified to include new medically necessary indications of Plasma exchange:
- Guillain-Barré syndrome (GBS) severity grades 1-2;
- ANCA-associated vasculitis with renal failure (serum Cr > 5.8 mg/dl).
Sleep Disorder Services
Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome (OSA)
Coverage is provided for a repeat supervised polysomnography performed in a sleep laboratory under the following circumstances:
- To initiate and titrate continuous positive airway pressure (CPAP) in adult patients with clinically significant OSA defined as those patients who have:
- An apnea/hypopnea index (AHI) of at least 15 per hour; or
- An AHI of at least 5 per hour in a patient with excessive daytime sleepiness or unexplained hypertension.
- Failure of resolution of symptoms or recurrence of symptoms during treatment; or
- To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices; or
- To reevaluate the diagnosis of obstructive sleep apnea and need for continued CPAP, e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.
Coverage is provided for auto-adjusting CPAP during a two week trial to initiate and titrate CPAP in adult patients with clinically significant obstructive sleep apnea.
Coverage is provided for CPAP in adult or pediatric patients with clinically significant obstructive sleep apnea.
No coverage is provided for multiple sleep latency testing in the diagnosis of obstructive sleep apnea except to exclude or confirm narcolepsy in the diagnostic workup of obstructive sleep apnea syndrome (OSAS).
Stereotactic Radiosurgery and Charged-Particle Radiation Therapy
Charged-Particle (Proton or Helium Ion) Radiation Therapy
Charged-particle irradiation with proton or helium ion beams may be considered medically necessary for the following indications:
- 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.
Other applications of charged-particle irradiation are considered investigational and are not covered.
Charged-particle irradiation with proton beams using standard treatment doses in patients with clinically localized prostate cancer is considered not medically necessary and is not covered.
Hematopoietic Stem-Cell Transplantation (HSCT) for Chronic Lymphocytic Leukemia and Small Cell Lymphocytic Lymphoma
Allogeneic HSCT may be considered medically necessary in cases of poor-risk (poor-prognosis) disease. Policy statements were updated to include current investigational and medically necessary applications.
Hematopoietic Stem-Cell Transplantation as a Treatment of Acute Lymphoblastic Leukemia (ALL)
Allogeneic HSCT may be considered medically necessary to treat ALL in first remission for any risk level. Policy statements were updated to include current investigational and medically necessary applications.
Hematopoietic Stem-Cell Transplantation for Multiple Myeloma
Use of allogeneic HSCT as salvage therapy is investigational and is not covered. Policy statements were updated to include current investigational and medically necessary applications.
The following procedures are considered experimental/investigational and members are responsible for any charges for treatment for:
Chiropractic Manipulative Treatment (CMT)
Decompression therapy is a non-surgical treatment for acute and chronic back pain. The treatment is performed through the application of traction. No coverage is provided for decompression therapy, e.g., VAX-D, DRX9000, Spine Med, Tru-Trac Traction Table since this is considered investigational.
Occipital Nerve Stimulation
Occipital nerve stimulation is being investigated as a method to prevent recurrent migraine and other types of headaches. The available evidence from small uncontrolled trials is insufficient to permit conclusions, and no implantable nerve stimulators have received FDA approval for this indication. This technology is considered investigational; language was added to the policy to indicate this: Occipital nerve stimulation for all applications is considered investigational.
Hyperbaric Oxygen (HBO) Therapy
Hyperbaric Oxygen Pressurization (HBO2)
The policy was updated based on new studies in autism spectrum disorders and early post-radiation therapy treatment; these are both considered investigational indications and are not covered. Hyperbaric oxygen pressurization in the treatment of acute carbon monoxide poisoning remains not medically necessary and is not covered. Topical hyperbaric oxygen therapy remains investigational and is not covered.
Percutaneous Vertebroplasty, Percutaneous Kyphoplasty
Information regarding the use of vertebroplasty or kyphoplasty for acute vertebral fractures has been added to the policy. Because the data is very limited, use for acute fractures due to osteoporosis or trauma is considered investigational and is not covered.
Percutaneous Kyphoplasty/Percutaneous Vertebroplasty are considered investigational for all other indications, including use in acute vertebral fractures and are not covered.
Policy was modified to include new investigational applications of Plasma exchange:
- Use in typical (diarrheal) forms of hemolytic uremic syndrome;
- Treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and Sydenham’s chorea.
Uterine Artery Embolization (UAE)
Occlusion of Uterine Arteries Using Transcatheter Embolization or Laparoscopic Occlusion to Treat Uterine Fibroids
The policy was updated to include investigational applications of transcatheter embolization and laparoscopic occlusion of uterine arteries:
- Repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization is considered investigational and is not covered;
- ? Laparoscopic occlusion of the uterine arteries using bipolar coagulation is considered investigational and is not covered.
Experimental/Investigational Services Path/Lab
Tyrosine Kinase Mutations in Myeloproliferative Neoplasms
The following investigational statements were added to the policy. Since they are investigational, these services are not covered:
- JAK2 tyrosine kinase and MPL mutation testing in the diagnosis of Acute Lymphoblastic Leukemia in patients with Down syndrome.
- JAK2 tyrosine kinase and MPL mutation testing for molecular profiling of MPNs (determining likely phenotype) and for determining disease prognosis.
- JAK2 tyrosine kinase and MPL mutation testing for predicting response to or monitoring either established or experimental (tyrosine kinase inhibitors) therapies.
Experimental/Investigational Services Medicine
Comprehensive gait analysis may be considered medically necessary for planning prior to lower
extremity surgery for patients with gait disorders associated with cerebral palsy. Gait analysis remains investigational for all other conditions. Language was revised to reflect the following:
- Comprehensive gait analysis for all other applications, except as an aid in surgical planning in patients with gait disorders associated with cerebral palsy is considered investigational and is not covered.
- Gait analysis that is not comprehensive is considered investigational and is not covered.
Experimental/Investigational Services Surgery
Endovascular Grafts for Abdominal Aortic Aneurysms
Endovascular grafts may be considered medically necessary for patients with ruptured abdominal aortic aneurysms when specific criteria as outlined in the policy are met.
Electromagnetic Navigation Bronchoscopy
Electromagnetic navigation bronchoscopy (ENB) is investigational for placement of fiducial markers and is not covered. Electromagnetic navigation bronchoscopy remains investigational for use with flexible bronchoscopy for the diagnosis of pulmonary lesions and mediastinal lymph nodes and is not covered.
MRI-Guided Focused Ultrasound (MRgFUS) for the Treatment of Uterine Fibroids and Other Tumors
The palliative treatment of bone metastases is an investigational treatment of MRI-guided high-intensity ultrasound ablation. MRI-guided high-intensity ultrasound ablation of uterine fibroids remains investigational and is not covered.
MRI-guided high-intensity ultrasound ablation of other tumors, including but not limited to, breast, brain, prostate cancer and palliative treatment of bone metastases is considered investigational and is not covered.