Chronic Myelogenous Leukemia
BCR-ABL1 qualitative testing for the presence of the fusion gene may be considered medically necessary for the diagnosis of chronic myeloid leukemia (see Policy Guidelines section).
BCR-ABL1 testing for messenger RNA transcript levels by quantitative real-time reverse transcription-polymerase chain reaction at baseline before initiation of treatment and at appropriate intervals (see Policy Guidelines section) may be considered medically necessary for monitoring of chronic myeloid leukemia treatment response and remission.
Evaluation of ABL kinase domain (KD) single nucleotide variants to assess individuals for tyrosine kinase inhibitor resistance may be considered medically necessary when there is an inadequate initial response to treatment or any sign of loss of response (see Policy Guidelines section); and/or when there is a progression of the disease to the accelerated or blast phase.
Evaluation of ABL KD single nucleotide variants is considered investigational for monitoring in advance of signs of treatment failure or disease progression.
Acute Lymphoblastic Leukemia
BCR-ABL1 testing for messenger RNA transcript levels by quantitative real-time reverse transcription-polymerase chain reaction at baseline before initiation of treatment and at appropriate intervals during therapy (see Policy Guidelines section) may be considered medically necessary for monitoring of Philadelphia chromosome-positive acute lymphoblastic leukemia treatment response and remission.
Evaluation of ABL KD single nucleotide variants to assess individuals for tyrosine kinase inhibitor resistance may be considered medically necessary when there is an inadequate initial response to treatment or any sign of loss of response.
Evaluation of ABL KD single nucleotide variants is considered investigational for monitoring in advance of signs of treatment failure or disease progression.
