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February 2012

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Genetic Testing
Genetic Testing for Hereditary Breast and/or Ovarian Cancer

Coverage will be provided for genetic testing for BRCA1 and BRCA2 mutations for members with inherited susceptibility for breast cancer or ovarian cancer when medically necessary. The policy statement has been amended based on new guidelines and further review of evidence that refines risk stratification for BRCA mutations.  The high-risk definitions in the Policy Guidelines were expanded to include both the U.S. Preventive Services Task Force (USPSTF) definition and adaptation of the National Comprehensive Cancer Network (NCCN) 2011 definition.

Genetic Testing for Inherited Susceptibility to Colon Cancer, Including Microsatellite Instability Testing
Genetic testing is available for both affected individuals, as well as those at risk, for various types of hereditary colon cancer.

Genetic testing for EPCAM mutations is considered medically necessary in the following patients:

a)   Patients with colorectal cancer, for the diagnosis of Lynch syndrome when:

  • Tumor tissue shows a high level of microsatellite instability
  • Tumor tissue shows lack of MSH2 expression by immunohistochemistry
  • Patient is negative for a germline mutation in MSH2

b)   At-risk relatives (primarily refers to first-degree relatives) of patients with Lynch syndrome with a known EPCAM mutation.

c)   Patients without colorectal cancer but with a family history meeting the Amsterdam or Revised Bethesda criteria (see below), when no affected family members have been tested for MMR mutations, and when sequencing for MMR mutations is negative.

NOTE:  For patients with colorectal cancer being evaluated for Lynch syndrome, either the microsatellite instability (MSI) test, or the immunohistochemistry (IHC) test with or without BRAF gene mutation testing, should be used as an initial evaluation of tumor tissue prior to MMR gene analysis. Both tests are not necessary. Consideration of proceeding to MMR gene sequencing would depend on results of MSI or IHC testing. IHC testing in particular may help direct which MMR gene likely contains a mutation, if any, and may also provide some additional information if MMR genetic testing is inconclusive.

Experimental/Investigative Services Pathology/Laboratory
Immune Cell Function Assay

Coverage will not be provided for use of the immune cell function assay under the following circumstances as this is considered investigational:

  • To monitor and predict immune function after solid organ transplantation;
  • For hematopoietic stem cell transplantation;
  • For all other indications

Experimental/Investigative Services Medicine
Tilt Table Testing

Coverage will be provided for tilt-table testing when medically necessary.

1.   Tilt table testing may be considered medically necessary in the following clinical settings:

a)   to evaluate recurrent episodes of syncope in the absence of organic heart disease, or in the presence of organic heart disease after cardiac causes of syncope have been excluded; or

b)   to evaluate an unexplained single syncopal episode in high risk settings (eg, occurrence or potential risk for physical injury).

2.   All other uses of tilt table testing are considered investigational and not covered.

Experimental/Investigative Services Surgery
Axial Lumbosacral Interbody

Coverage will not be provided for axial lumbosacral interbody fusion (axial LIF) as this is considered investigational.

Transcatheter Pulmonary Valve Implantation
Coverage will be provided for transcatheter pulmonary valve implantation when medically necessary.

1.   Transcatheter pulmonary valve implantation may be considered medically necessary for patients with prior repair of congenital heart disease and right ventricular outflow tract (RVOT) dysfunction, who are not good candidates for open repair due to one or more of the following conditions:

a)  High-risk for surgery based due to comcomitant medical commorbidities; or

b)  Poor surgical candidate due to multiple prior thoracotomies for open heart surgery.

2.   Transcatheter pulmonary valve implantation is considered investigationaland not coveredfor all other indications.

Bone Morphogenetic Protein
Coverage will not be provided for bone morphogenetic protein (rhBMP-2 or rhBMP-7) in cervical spinal fusion as this is considered investigational.

NOTE:  Due to emerging safety concerns, the risk/benefit ratio for use of rhBMP is uncertain, especially for patients who are at average risk for fusion failure. As a result, use of rhBMP should be restricted to cases where there is a high risk of fusion failure, pending the results of ongoing secondary analysis of the data on adverse effects. High risk for fusion failure can be defined by the presence of one or more of the following criteria:

  • one or more previous failed spinal fusion(s);
  • grade III or worse spondylolisthesis;
  • fusion to be performed at more than one level;
  • current tobacco use;
  • diabetes;
  • renal disease;
  • alcoholism;
  • steroid use.   

Experimental/Investigative Services Therapy
Manipulation Under Anesthesia

Coverage will be provided for manipulation under anesthesia (MUA) when medically necessary.

1.   MUA of the knee and shoulder may be considered medically necessary, only after an adequate trial of conservative measures (physical therapy and joint injections) have failed to restore range of motion and relieve pain, for the following conditions:

a)   Manipulation of the knee when performed to treat significant arthrofibrosis of the knee resulting from trauma or knee surgery;

b)   Manipulation of the shoulder when performed to treat capsulitis of the shoulder.

2.   Manipulation of the knee or shoulder when above criteria are not met is considered not medically necessary and not covered.

3.   MUA of the ankle, elbow, finger, hip, pelvic ring or wrist is considered not medically necessary and not covered.

Not Medically Necessary Services
H. pylori

Serology testing for H. pylori is considered not medically necessary and not covered.

Reduction Mammoplasty
Please note that this policy update refers only to those self-funded groups which cover reduction mammoplasty (fully-insured groups do not cover reduction mammoplasty).

No coverage will be provided for reduction mammoplasty when all of the policy criteria have not been met as this is considered cosmetic.