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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.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
The decision, issued by Medicare Administrative Contractor Palmetto GBA, is effective Dec. 10 and provides coverage of the test for about 25,000 Medicare patients.
Smaller multiplex molecular panels of five or fewer targets will be covered, while a determination of gastrointestinal panel coverage is expected soon.
Noridian GBA has issued the LCD for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low-risk prostate cancer.
The association says a provision requiring MACs to independently review LCDs from other jurisdictions before adoption is critical to the legislation.
The test is a targeted sequencing assay that detects mutations in the blood of non-small cell lung cancer patients to inform treatment selection.
Veracyte said that the draft policy is open to a 45-day comment period and could potentially go into effect in early 2019.
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.