FDA Cleared or Approved Companion Diagnostic Testing (for Pennsylvania Only)
State-specific UnitedHealthcare Community Plan medical policy governing coverage of FDA-cleared or -approved companion diagnostic molecular oncology tests (tissue and liquid biopsy) used to inform targeted therapeutic product selection in Pennsylvania; includes named CDx tests and indication/drug pairings, criteria for other FDA-cleared/approved CDx, concurrent testing rules, and documentation expectations.
Policy language revised to indicate the policy applies to tests that have been granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests.
Explicit listings added for multiple CDx tests and their proven indication/drug pairings (e.g., Guardant360 CDx, MI Cancer Seek, Oncomine Dx Express/Target, oncoReveal CDx, TruSight Oncology Comprehensive, xT CDx).
Guardant360 CDx is proven and medically necessary when used to inform management of specified indication/drug pairings (breast cancer, NSCLC indications with specified drugs).
MI Cancer Seek is proven and medically necessary for listed indication/drug pairings (breast, colorectal, melanoma, NSCLC, solid tumors with specific drugs).
Oncomine Dx Express Test and Oncomine Dx Target Test added as proven and medically necessary for specified NSCLC and other tumor/drug pairings.
Added oncoReveal CDx, TruSight Oncology Comprehensive, and xT CDx as proven and medically necessary for specific indication/drug pairings.
Added CPT codes 0211U and 0523U to applicable codes and removed multiple CPT codes (0179U, 81445, 81449, 81450, 81451, 81455, 81456, 81599).
Concurrent tissue and liquid biopsy CDx testing is considered proven and medically necessary for advanced/metastatic (stage IV) breast cancer and stage IV NSCLC when CDx criteria are met.
Subsequent use of an FDA cleared or approved CDx test on a new specimen is considered proven and medically necessary when disease recurrence or progression/nonresponse to most recent systemic therapy is present.
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