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The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.
The organization continues to support direct access genetic testing for healthcare decision making, while remaining neutral on recreational, novelty, lifestyle, and ancestry genetic testing.
The guidelines provide recommendations for what CYP2C9 variant alleles should be included in clinical pharmacogenomic tests assessing that gene.
A draft bill provides for a major expansion of eligible material, a move the ACLU and AMP said threatens to reduce competition in genetic testing.
At issue are updates to CMS' guidance instructing labs to report single HCPCS/CPT codes even in cases where a procedure produces multiple reportable results.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The authors of CAP's practical framework for NGS testing of inherited disorders see it as a baseline for future efforts to standardize NGS testing.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.