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.
The amicus briefs challenge the method in which HHS collected data to establish market-based Medicare prices and found flaws in a district court decision dismissing the case.
CAP will work with the CDC and others to develop, publish, and encourage adoption of technical solutions for cancer and biomarker electronic reporting.
The association says a provision requiring MACs to independently review LCDs from other jurisdictions before adoption is critical to the legislation.
Changes to the checklist included restructuring requirements related to analyte-specific reagents and laboratory-developed tests to reduce redundancy.
Proposals from ACLA, CAP, and others included statistical sampling to collect hard-to-capture lab pricing data from across the industry.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.