CAP

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.

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.

The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.