All PlansPrior AuthHigh impact
Circulating Tumor DNA and Circulating Tumor Cells for Management (Liquid Biopsy) of Solid Tumor Cancers
Regence BlueShield·Oncology, Hematology, Pathology·Prior Authorization
Effective date
Jul 1, 2026
We identified it
Jul 7, 2026
Summary
New policy (LAB46) effective July 1, 2026 establishes coverage criteria for liquid biopsy testing (circulating tumor DNA and circulating tumor cells) in solid tumor cancers. Coverage is limited to two scenarios: (1) advanced/metastatic ER-positive, HER2-negative breast cancer, or (2) cases where tissue testing is impossible AND the test includes genes with FDA-approved targeted therapies. All other liquid biopsy uses (MRD testing, cancer screening, urine tests) are classified as investigational and not covered. Prior authorization is required.
Action Required
By June 15, 2026: (1) Billing team must implement prior authorization requirement for all liquid biopsy tests in billing system and EMR encounter templates. (2) Create decision tree in billing workflow: Route claims to prior auth only if they meet Criterion I (advanced/metastatic ER+/HER2- breast cancer OR tissue testing impossible + FDA-approved gene present). (3) Providers must document in medical records: cancer type, indication for testing, reason tissue biopsy cannot be performed, specific genes tested, and corresponding FDA-approved medications under consideration. (4) Update claim submission templates to require this documentation before processing. (5) Flag and deny claims for investigational uses (MRD monitoring, cancer screening, urine-based tests, plasma PIK3CA/ESR1 for breast cancer, blood EGFR for NSCLC, HPV testing). (6) Train billing and clinical staff on new coverage criteria. Failure to obtain prior auth or submit required documentation will result in claim denials and member balance billing.