The coverage decision limits the test to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue-based testing.
S.794 would require Medicare contractors to hold public meetings and disclose the rationale and evidence underlying an LCD at the start of the process.
The agency said it is giving labs 60 additional days to report private payor rates but is still expecting to launch the new clinical lab fee schedule in 2018.
ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.
Several MDx firms recently touted BCBS's Evidence Street opinions on their tests as milestones, and Palmetto GBA's MolDx may soon be using its assessments.
The firm said it expects that Noridian will similarly confirm its draft local coverage determination, bringing coverage for Percepta to around 35 million.
The coverage decision provides Humana's 13 million members with access to the test, which provides a numerical score to assess the risk of disease recurrence.
ConfirmMDx is an epigenetic tissue-based test for the early detection of prostate cancer, specifically aimed at addressing false-negative biopsy concerns.
EndoPredict is a kit-based RNA expression test that evaluates 12 genes to assess the aggressiveness of breast cancer on a molecular level, and is set to launch in the US this year.
Contractor Palmetto GBA issued a draft local coverage determination proposing ending coverage of the test based on factors including a recent critical study.
The Medicare contractor is proposing to not cover Vectra DA, but to extend coverage for Prolaris, Xpresys, and DecisionDx-UM under specific circumstances.
