Medicare contractor Palmetto is proposing to expand coverage to ensure that more patients have access to genomic profiling when tissue-based testing is not possible.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
The LCD will enable coverage of Envisia in patients for whom imaging does not lead to a definitive diagnosis of idiopathic pulmonary fibrosis.
Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.
In a pair of recent studies, Crescendo put forth new clinical utility data and an age and adiposity-adjusted model for its Vectra DA rheumatoid arthritis test.
The test is a targeted sequencing assay that detects mutations in the blood of non-small cell lung cancer patients to inform treatment selection.
Palmetto proposes to cover the assay for prostate cancer patients who are at very low and low risk of negative outcomes with active surveillance by NCCN guidelines.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.