Biomarkers Overview

This LCD covers germline genetic testing to establish a molecular diagnosis when the patient has clinical features, the result will directly affect treatment, and a definitive diagnosis is not achieved after standard evaluation; Factor II and Factor V testing are allowed for evaluation of venous thromboembolism. Somatic oncology biomarker testing is addressed under LCD L35396 and subject to that LCD's indications and frequency limits. Coverage requires demonstrated analytical and clinical validity and documentation (CLIA/CAP/NYSDOH/FDA records and clinical workup), while screening tests (including carrier and family studies) and tests lacking clinical utility or decision impact are excluded.

"Genetic (germline/hereditary) testing is medically necessary to establish a molecular diagnosis of an inheritable disease when (1) the beneficiary displays clinical features of the associated disea..."