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CMS final pricing for a number of CPT codes brings positive news for various gene sequencing procedures and multi-analyte algorithm assays.
The bill comes amid questions about the efficacy of Epigenomics' Epi proColon, the only blood-based cancer screening test approved in the US.
In a final policy on comprehensive genomic profiling, Palmetto said that approved registries will have to commit to sharing data, among other requirements.
The committee questioned stakeholders about the impact of FDA oversight of LDTs, and whether there was any consensus about how to move forward on a divisive topic.
The move follows the inclusion of Cologuard in the US Preventive Services Task Force's updated colorectal cancer screening recommendations.
The company hopes to simultaneously achieve premarket FDA approval and a national coverage determination from CMS for its NGS cancer panel.
CMS gave labs an additional year to gear up for the implementation of the Protecting Access to Medicare Act of 2014 and clarified key programmatic definitions.
Some of the proposed payment rates for 2017 are low, but diagnostics firms will likely try to negotiate higher pricing during the 30-day comment period.
The group hopes its proposed regulatory framework might strike a compromise between different industry stakeholders.
Originally published May 6.