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April 2012

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Durable Medical Equipment

Automated Ambulatory Blood Pressure Monitoring for the Diagnosis of Hypertension in Patients with Elevated Office Blood Pressure

Automated ambulatory blood pressure monitoring over a 24-hour period may be considered medically necessaryand coveredfor patients with elevated office BP, when performed one time to differentiate between ‘white coat’ hypertension and true hypertension, and when the following conditions are met:

a) Office blood pressure elevation is in the mild to moderate range (<180/110), not requiring immediate treatment with medications;

b) There is an absence of hypertensive end-organ damage on physical examination and laboratory testing.

All other uses of ambulatory blood pressure monitoring for patients with elevated office BP, including but not limited to repeated testing in patients with persistently elevated office BP, are considered investigational and not covered.

Surgically Implanted Hearing Devices

Implantable Bone-Conduction and Bone-Anchored Hearing Aids

Partially implantable bone conduction hearing systems using magnetic coupling for acoustic transmission are considered investigational and not covered.

Genetic Testing

Genetic Testing for Predisposition to Inherited Hypertrophic Cardiomyopathy

Genetic testing for predisposition to hypertrophic cardiomyopathy (HCM) may be considered medically necessaryand coveredfor individuals who are at risk for development of HCM, defined as having a first-degree relative with established HCM, when there is a known pathogenic gene mutation present in that affected relative.

Genetic testing for predisposition to HCM is considered not medically necessaryand not covered for patients with a family history of HCM in which a first-degree relative has tested negative for pathologic mutations.

Genetic testing for predisposition to HCM is considered investigationaland not coveredfor all other patient populations, including but not limited to individuals who have a first-degree relative with clinical HCM, but in whom genetic testing is unavailable.

Chromosomal Microarray (CMA) Analysis for the Genetic Evaluation of Patients with Developmental Delay/Intellectual Disability or Autism Spectrum Disorder

Coverage will be provided for chromosomal microarray analysis when medically necessary.

1. Chromosomal microarray analysis may be considered medically necessaryfor diagnosing a genetic abnormality in children with apparent nonsyndromic cognitive developmental delay/intellectual disability (DD/ID) or autism spectrum disorder (ASD) according to accepted Diagnostic and Statistical Manual of Mental Disorders-IV criteria when all of the following conditions are met:          

a) Any indicated biochemical tests for metabolic disease have been performed, and results are non-diagnostic, and

b) FMR1 gene analysis (for Fragile X), when clinically indicated, is negative, and

c) In addition to a diagnosis of nonsyndromic DD/ID or ASD, the child has one or more of the following:

  • two or more major malformations (see definitions), or
  • a single major malformation or multiple minor malformations, in an infant or child who is also small-for-dates, or
  • a single major malformation and multiple minor malformations, and

d) The results for the genetic testing have the potential to impact the clinical management of the patient, and

e) Testing is requested after the parent(s) have been engaged in face-to-face genetic counseling with a healthcare professional who has appropriate genetics training and experience.

2. Chromosomal microarray analysis is considered investigationalin all other cases of suspected genetic abnormality in children with developmental delay/intellectual disability or autism spectrum disorder.

3. Chromosomal microarray analysis to confirm the diagnosis of a disorder or syndrome that is routinely diagnosed based on clinical evaluation alone is considered not medically necessary.

4. Chromosomal microarray analysis is considered investigationalfor prenatal genetic testing.

Mutation Analysis in Fine Needle Aspirates of the Thyroid

No coverage will be provided for mutation analysis in fine-needle aspirates of the thyroid that are cytologically considered to be indeterminate, atypical or suspicious for malignancy as this is considered to be investigational.

Specimen Provenance Errors

No coverage will be provided for genetic testing for control and documentation of the handling of samples (i.e. The KnowError® Test, Specimen Provenance Assay) to decrease specimen provenance errors.

Wound Care

Negative Pressure Wound Therapy(NPWT) in the Outpatient Setting

According to the FDA, the safety and effectiveness of NPWT systems in newborns, infants and children has not been established; and there are no NPWT systems cleared for use in these populations.  Therefore, NPWT systems used in the treatment of children (from birth up to and including 12 years of age) is considered investigational and not covered.

Experimental/Investigative Services Pathology/Laboratory

Intravenous Antibiotic Therapy and Associated Diagnostic Testing for Lyme Disease

No coverage will be provided for other diagnostic testing including but not limited to C6 peptide ELISA or determination of levels of the B lymphocyte chemoattractant CXCL13 for diagnosis or monitoring treatment of Lyme disease as this is considered investigational.

Serologic Diagnosis of Celiac Disease

Serologic measurement of antigliadin antibodies may be considered medically necessary and covered in children less than 24 months of age with signs or symptoms suggestive of celiac disease.

Laboratory Studies for Diagnosing and Managing Inflammatory Bowel Disease

No coverage will be provided for determination of serological markers, anti-neutrophil cytoplasmic antibody (ANCA), anti-Saccharomyces cerevisiae antibody (ASCA), anti-outer membrane porin C (anti-OmpC) antibody, and anti-CBir1flaggellin (anti-CBir1) antibody in the work-up and monitoring of patients with inflammatory bowel disease as this is considered investigational.

No coverage will be provided for inflammatory bowel disease diagnostic testing combining serologic, genetic and inflammatory markers (eg, Prometheus IBD Sgi Diagnostic) as this is considered investigational.

Salivary Hormone Tests

No coverage will be provided for salivary tests of dehydroepiandrosterone (DHEA), estrogen, melatonin, progesterone, or testosterone for the screening, diagnosis, or monitoring of menopause as this is considered investigational.

Experimental/Investigative Services Medicine

Neural Therapy

No coverage will be provided for neural therapy (the injection of a local anesthetic into scars, trigger points, acupuncture points, tendon and ligament insertions, peripheral nerves, autonomic ganglia, the epidural space, and other tissues to treat chronic pain and illness) as it is considered investigational for all indications.

Ingestible pH and Pressure Capsule

No coverage will be provided for measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule for the evaluation of suspected gastroparesis, constipation or other gastrointestinal motility disorders as this is considered investigational.

Experimental/Investigative Services Surgery

Facet Joint Denervation

Radiofrequency denervation of cervical facet joints (C3-4 and below) and lumbar facet joints may be considered medically necessary and covered when all of the following criteria are met:

a) No prior spinal fusion surgery in the vertebral level being treated; and

b) Disabling low back (lumbosacral) or neck (cervical) pain, suggestive of facet joint origin as evidenced by absence of nerve root compression as documented in the medical record on history, physical and radiographic evaluations; and the pain is not radicular; and

c) Pain has failed to respond to three (3) months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program; and

d) There has been a successful trial of controlled diagnostic medial branch blocks. This consists of:
 

  • Two separate positive blocks on different days with local anesthetic only (no steroids or other drugs); or a placebo controlled series of blocks, under fluoroscopic guidance, that has resulted in at least a 50% reduction in pain for the duration of the local anesthetic used (e.g., 3 hours longer with bupivacaine than lidocaine);
  • No therapeutic intra-articular injections (i.e., steroids, saline, or other substances) should be administered for a period of at least 4 weeks prior to the diagnostic medial branch block;
  • The diagnostic blocks should involve the levels being considered for RF treatment and should not be conducted under intravenous sedation unless specifically indicated (e.g., the patient is unable to cooperate with the procedure);
  • These diagnostic blocks should be targeted to the likely pain generator;
  • Single level blocks lead to more precise diagnostic information, but multiple single level blocks require several visits and additional exposure to radiation.

e) If there has been a prior successful radiofrequency (RF) denervation, a minimum time of six (6) months has elapsed since prior RF treatment (per side, per anatomical level of the spine).

  • Radiofrequency denervation is considered investigationalfor the treatment of chronic spinal/back pain for all uses that do not meet the above criteria, including but not limited to treatment of thoracic facet or sacroiliac (SI) joint pain.
  • All other methods of denervation are considered investigational and not covered for the treatment of chronic spinal/back pain, including, but not limited to pulsed radiofrequency denervation, laser denervation, and cryodenervation.
  • Therapeutic medial branch blocks are considered investigational and not covered.
  •  If there has been a prior successful radiofrequency (RF) denervation, additional diagnostic medial branch blocks for the same level of the spine are not medically necessary and not covered.

Saturation Biopsy for Diagnosis and Staging of Prostate Cancer

No coverage will be provided for saturation biopsy, taking more than 20 core tissue samples at one time, in the diagnosis, staging, and management of prostate cancer as this is considered investigational.

Transcatheter Aortic-Valve Implantation for Aortic Stenosis

Transcatheter aortic valve replacement, performed via the transfemoral approach, is considered medically necessaryand coveredfor patients with aortic stenosis (AS) when all of the following conditions are present:

a) Severe aortic stenosis (defined by one or more of the following criteria) with a calcified aortic annulus; and

  • An aortic valve area of less than 0.8cm2
  • A mean aortic valve gradient greater than 40mmHg
  • A jet velocity greater than 4.0m/sec

b) NYHA heart failure Class II, III or IV symptoms; and

c) Patient is not an operable candidate for open surgery, as judged by at least two cardiovascular specialists (cardiologist and/or cardiac surgeon).

  • Transcatheter aortic valve replacement is considered investigational and not covered for all other indications, including but not limited to, patients at high risk for open surgery but who are operable candidates.

Automated Percutaneous and Endoscopic Discectomy

No coverage will be provided for automated percutaneous discectomy or endoscopic discectomy as a technique of intervertebral disc decompression in patients with back pain related to disc herniation in the lumbar, thoracic, or cervical spine as this is considered investigational.  
 

Ablation Services

Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

Radiofrequency ablation may be considered medically necessary in certain circumstances for the treatment of non-small cell lung cancer and metastatic pulmonary tumors.Patient selection criteria and treatment considerations were also included as follows:

  • Radiofrequency ablation may be considered medically necessary and covered to treat an isolated peripheral non-small cell lung cancer lesion that is no more than 3 cm in size when the following criteria are met:

a)  Surgical resection or radiation treatment with curative intent is considered appropriate based on stage of disease, however, medical co-morbidity renders the individual unfit for those interventions; AND

b)  Tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.

  • Radiofrequency ablation may be considered medically necessary and covered to treat malignant non-pulmonary tumor(s) metastatic to the lung that are no more than 3 cm in size when the following criteria are met:

c)  In order to preserve lung function when surgical resection or radiation treatment is likely to substantially worsen pulmonary status OR the patient is not considered a surgical candidate; AND

d)  There is no evidence of extrapulmonary metastases; AND the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.

e)  The following are additional criteria that have been developed by clinical judgment/consensus and existing guidelines for the use of RFA in metastatic tumors to the lung and include:

  • No more than 3 tumors per lung should be ablated;
  • Tumors should be amenable to complete ablation; AND
  • Twelve months should elapse before a repeat ablation is considered.

Microwave Tumor Ablation

No coverage will be provided for microwave ablation of primary and metastatic tumors as this is considered investigational.