local coverage determination

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 agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.

The test is designed to determine which early-stage, estrogen receptor-positive breast cancer patients are likely to benefit from extended endocrine therapy.

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 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 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.