The third-party consulting group used for the analysis recommended using a survey to set Medicare payment rates to reduce the reporting burden on laboratories.
The company has previously offered its liquid biopsy tests through an LDT model but sees the timing and the clinical niche as right for a regulatory bid in CSF testing.
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The firm will scale US-based testing capacity for its LiquidHallmark liquid biopsy assay, which uses amplicon-based technology to detect cancer-related mutations.
Amid increasing spending on genetic testing, there are more opportunities for bad actors to implement interstate, fraudulent billing schemes, according to OIG.
