GUIDELINE NOTE 173, INTERVENTIONS THAT ARE …



CPT 81518 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapyLast reviewed at VbBS in November 2018. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. 81518 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapySimilar codes are on line 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER81519 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence scoreThis code is used for Oncotype Dx81520 Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk scoreThis code is used for Prosigna81521 Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk of distant metastasisThis code is used for MammaprintBreast cancer algorithmic tests were reviewed in an HTAS coverage guidance in May 2018. CPT 81518 appears to represent a test called the Breast Cancer Index. The Breast Cancer Index test analyzes the activity of seven genes to help predict the risk of node-negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis. The test is designed to help women and their doctors decide if extending hormonal therapy 5 more years (for a total of 10 years of hormonal therapy) would be beneficial. The 7 genes listed by the industry website for Breast Cancer Index indicate that these 7 genes are “content” genes; no mention is made of housekeeping genes. The coverage guidance recommended that the Breast Cancer Index not be covered (weak recommendation).HERC staff recommendation:Add CPT 81518 (Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapy) to line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS Add the entry shown below to GN173 and modify the existing entry Edit Guideline Note 148 as shown belowGUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONSLine 660The following Interventions are prioritized on Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS:Procedure CodeIntervention DescriptionRationaleLast Review81518Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapyInsufficient evidence of effectivenessNovember 2018Coverage Guidance May 2018Breast Cancer Gene Expression tests billed with nonspecific codes (e.g. 81479, 81599, 84999, S3854)MammostratOncotype DX Breast DCIS ScoreBreast Cancer IndexIHC4Unproven interventionMay 2018 Coverage Guidance Blog ................
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