BlueCross BlueShield of Tennessee Medical Policy Manual

General Policy for Inherited Genetic Disorders

PURPOSE

To establish a basis for determining the medical necessity of genetic testing.

DESCRIPTION

Genetic testing involves the analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites. These tests are used to detect certain hereditary diseases. When used in clinical settings, these tests can be used to predict risk of disease, identify carriers, and formulate prenatal diagnosis/prognosis.

POLICY

• BlueCross BlueShield of Tennessee recognizes the need for consistency in the determination of medical appropriateness for genetic testing.

• Services will be considered medically appropriate only if they have met BlueCross BlueShield of Tennessee's technology evaluation criteria.

DIAGNOSTICS:

• Array Comparative Genomic Hybridization (aCGH) for the Genetic Evaluation of Individuals with Developmental Delay/Mental Retardation

• Cytochrome p450 Genotyping

• DNA-Based Testing for Adolescent Idiopathic Scoliosis (AIS)

• First-Trimester Detection of Down Syndrome Using Fetal Ultrasound Markers Combined with Maternal Serum Assessment

• Gene Expression Profiling Assays as a Technique to Determine Prognosis for Managing Breast Cancer Treatment

• Gene Expression Testing for Coronary Artery Disease

• Gene-based Tests for Screening, Detection, and/or Management of Prostate Cancer

• Genetic Testing: Alzheimer's Disease

• Genetic Testing: BRCA1, BRCA2 or CHEK2 for Breast or Ovarian Cancer

• Genetic Testing: Congenital Cardiac Channelopathies

• Genetic Testing: Cutaneous Malignant Melanoma

• Genetic Testing: Cystic Fibrosis

• Genetic Testing: Helicobacter pylori Treatment

• Genetic Testing: HER-2

• Genetic Testing: Inherited Susceptibility to Colon Cancer, including Microsatellite Instability Testing

• Genetic Testing: Medullary Thyroid Carcinoma

• Genetic Testing: Tamoxifen Treatment

• Genetic Testing: Warfarin Dose

• Genotyping for Chronic Hepatitis C

• KIF6 Genotyping for Predicting Cardiovascular Risk and/or Effectiveness of Statin Therapy

• Microarray-based Gene Expression Testing for Cancers of Unknown Primary

• Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer

• Non-BRCA Breast Cancer Risk Assessment

• NOTCH3 Genetic Testing for the Presence of Mutations Associated with CADASIL

• Use of Common Genetic Variants to Predict Risk of Nonfamilial Breast Cancer

THERAPEUTICS:

• Agalsidase Beta

• Alglucosidase Alfa

• Laronidase

ORIGINAL EFFECTIVE DATE:  11/18/1999

MOST RECENT REVIEW DATE:  2/2/2012

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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