Medical Policy Update

Updated Medical Policies

Medical Policy  V.60 Oncology Testing: Solid Tumor Molecular Diagnostics

Effective Date:  07/01/2025
Preauthorization Required: Yes

Evidence-Based Minimal Residual Disease (MRD) Testing by ctDNA for Bladder Cancer

1. Evidence-based minimal residual disease (MRD) tests performed via circulating tumor DNA (ctDNA) with sufficient evidence of clinical validity and utility in bladder cancer for monitoring of treatment response are considered medically necessary when:
   
   1. The member has a diagnosis of muscle-invasive bladder cancer (MIBC), AND
   2. The member’s tumor has all the following characteristics:
      1. Locally invasive (T2-4a), AND
      2. Node negative (N0), AND
      3. No metastasis (M0), AND
   3. All the following:
      1. The member has undergone cystectomy within the last 12 months, AND
      2. The member has no radiographic evidence of disease, AND
      3. The member is currently receiving or being considered for adjuvant chemotherapy.
2. Evidence-based minimal residual disease (MRD) tests performed via circulating tumor DNA (ctDNA) with insufficient evidence of clinical validity and utility in bladder cancer for monitoring of treatment response and/or recurrence are considered investigational for all other indications.

Evidence-Based Minimal Residual Disease (MRD) Testing by ctDNA for Colorectal Cancer

1. Evidence-based minimal residual disease (MRD) tests performed via circulating tumor DNA (ctDNA) with sufficient evidence of clinical validity and utility in colorectal cancer for monitoring of treatment response are considered medically necessary when:
   1. The member has a diagnosis of colorectal cancer, AND
      1. The member’s tumor has all the following characteristics:
         1. Stage II (T3-T4), AND
         2. Node negative (N0), AND
         3. No metastasis (M0), AND
      2. All the following:
         
         1. The member has undergone surgery within the last month, AND
         2. The member is being considered for adjuvant chemotherapy, AND
         3. The member has no radiographic evidence of disease.
2. Evidence-based minimal residual disease (MRD) tests performed via circulating tumor DNA (ctDNA) with insufficient evidence of clinical validity and utility in colorectal cancer for monitoring of treatment response and/or recurrence are considered investigational for all other indications.

NTRK Fusion Analysis Panel for Solid Tumors

1. NTRK 1/2/3 fusion analysis panel via fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC) in solid tumors is considered medically necessary when:
   1. The member is undergoing initial diagnostic workup for or has a diagnosis of: 
      1. Advanced, progressive, or metastatic solid tumor, OR
      2. Cancer for which surgical resection is not possible, OR
      3. Unknown primary cancers, OR
   2. The member has a diagnosis of any of the following cancers at any stage: 
      1. Anaplastic thyroid carcinoma, OR 
      2. Pediatric (diagnosed age 18 years or younger) diffuse high grade glioma.

Tumor Specific PIK3CA Variant Analysis

1. Tumor specific PIK3CA variant analysis in solid tumors is considered medically necessary when the member has a diagnosis of any of the following:
   1. Recurrent unresectable or stage IV, HR positive, HER2-negative invasive breast cancer, OR
   2. Stage II-III rectal cancer, OR
   3. Stage II-III colon cancer.

Medical Policy  V.62 Specialty Testing: Multisystem Genetic Conditions

Effective Date:  07/01/2025
Preauthorization Required: Yes

Chromosomal Microarray Analysis for Developmental Delay/Intellectual Disability, Autism Spectrum Disorder, or Congenital Anomalies

1. Chromosomal microarray analysis for developmental delay, intellectual disability, autism spectrum disorder, or congenital anomalies is considered medically necessary when:
   1. The member has global developmental delay and/or intellectual disability, OR
   2. The member has autism spectrum disorder, OR
   3. The member has multiple congenital anomalies not specific to a well-delineated genetic syndrome, OR
   4. The members have short stature. 
2. Chromosomal microarray analysis for developmental delay, intellectual disability, autism spectrum disorder, or congenital anomalies is considered investigational for all other indications.

Medical Policy  V.66 Specialty Testing: Cardiovascular

Effective Date:  07/01/2025
Preauthorization Required: YES

Qualitative Cardiac Troponin Tests

1. Qualitative cardiac troponin tests are considered investigational for all indications.

Conventional or High-Sensitivity Quantitative Cardiac Troponin Tests

1. Conventional or high-sensitivity quantitative cardiac troponin tests are considered medically necessary when:
   1. The member has signs or symptoms of acute coronary syndrome (ACS) or myocarditis, OR
   2. The member has undergone heart transplantation, OR
   3. The member has exposure to chemotherapy known to have cardiotoxic effects, OR
   4. The member has an autoimmune condition known to cause cardiomyopathy.
2. Conventional or high-sensitivity quantitative cardiac troponin tests are considered investigational for all other indications.