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Noridian Providing Limited Coverage for MDx Tests as Predictive Classifiers for NSCLC

NEW YORK – Medicare Administrative Contractor Noridian Health Solutions recently issued a final local coverage determination aligning its coverage with Palmetto's earlier decision to cover molecular diagnostic laboratory tests as predictive classifiers for non-small cell lung cancer.

Tests are considered reasonable and necessary if a patient has a non-squamous NSCLC with a tumor size of less than five centimeters and no positive lymph nodes. The patient must also be healthy enough to tolerate chemotherapy and adjuvant platinum-containing chemotherapy must be under consideration as treatment for the patient. The test must also be ordered by a clinician treating the patient for NSCLC to help decide whether to recommend adjuvant chemotherapy.

Their determination was based on studies of Razor Genomics' 14-gene lung cancer assay. Oncocyte acquired Razor Genomics last year and named the test DetermaRx.  

Noridian said that evidence shows molecular risk stratification with the Razor assay "enhances risk stratification among patients with tumors considered low risk," and noted it could accurately predict patients who will have disease recurrence or metastatic disease.

The LCD goes into effect Aug. 24. Last month, CGS Administrators also aligned its coverage with Palmetto's decision.