Medical Policy Update

Medical Policy:  V.58 Oncology Testing: Algorithmic Assay

Effective Date:  07/01/2025
Preauthorization Required:  Yes
Policy Statement:
Prostate Cancer Treatment and Prognostic Algorithmic Tests

1. The use of a prostate cancer treatment and prognostic algorithmic test (i.e., Genomic Prostate Score Test, Prolaris, Decipher, ArteraAI) is considered medically necessary when:
   1. The member has a life expectancy of 10 years or more, AND
   2. The member does not have either of the following: 
      1. Very low-risk prostate cancer, as defined by all of the following characteristics:
         1. cT1c
         2. Grade Group 1
         3. PSA less than 10 mg/nl and density less than 0.15 ng/mL/g
         4. Biopsy shows less than 3 positive cores/fragments and less than or equal to 50% cancer in each core/fragment, OR
      2. Very high-risk prostate cancer, as defined by all of the following characteristics:
         1. cT3-cT4
         2. PSA greater than 40 ng/mL
         3. Grade Group 4 or 5.
2. The use of a prostate cancer treatment and prognostic algorithmic test is considered investigational for all other indications.

Medical Policy:  Oncology Testing: Hematologic Malignancy Molecular Diagnostics

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

Red Blood Cell Genotyping in Multiple Myeloma

1. Red blood cell genotyping in individuals with multiple myeloma is considered medically necessary when:
   1. The member has a diagnosis of multiple myeloma, AND
   2. The member is currently being treated or will be treated with an anti-CD38 monoclonal antibody.

Hematologic Minimal Residual Disease (MRD) Testing

1. Measurable (minimal) residual disease (MRD) analysis in bone marrow or peripheral blood is considered medically necessary when:
   1. The member has a diagnosis of:
      1. Acute Lymphocytic Leukemia (ALL), OR
      2. Multiple Myeloma, OR
      3. Chronic Lymphocytic Leukemia (CLL), AND
         1. The member has completed treatment.

Medical Policy:  V.57 Oncology: Cancer Screening

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

Multi-Cancer Early Detection Screening Test

1. Multi-cancer early detection screening tests are considered investigational for all indications. 

New Medical Policy: Specialty Testing: Transplant

Effective Date: 7/1/2025
Preauthorization Required: Yes

Post Heart Transplant Gene Expression Panels for Rejection Risk via Peripheral Blood

1. The use of post heart transplant gene expression panels for rejection risk via peripheral blood to determine management of patients after heart transplantation is considered medically necessary when:
   1. The member is age 18 or older, AND
   2. The member has undergone heart transplant, AND
   3. The member is at low risk for organ rejection, AND
   4. The member’s heart transplant was performed at least 2 months ago and less than 5 years ago.
2. The use of post heart transplant gene expression panels for rejection risk via peripheral blood to determine management of patients after heart transplantation is considered investigational for all other indications.

Medical Policy: V.67-Genetic Testing: Gastroenterology (Non-Cancerous) 

New Title: Specialty Testing: Gastroenterology
Effective Date:  7/1/2025
Preauthorization Required: YES
 
Blood-based Noninvasive Liver Fibrosis Screening Tests

1. Blood-based noninvasive liver fibrosis screening tests (e.g., Fibrosis-4 index (FIB-4), NAFLD Fibrosis Score [NFS], AST to Platelet Ratio Index [APRI]) are considered medically necessary when:
   1. The member has at least one of the following:
      1. Signs/symptoms or a diagnosis of chronic liver disease, OR
      2. Abnormal liver chemistries, OR
      3. Hepatic steatosis on imaging, OR
      4. Prediabetes/type 2 diabetes mellitus, OR
      5. Features of metabolic syndrome (e.g. dyslipidemia, obesity), OR
      6. Significant alcohol consumption, OR
      7. A first-degree relative with metabolic associated steatohepatitis (MASH) (formerly, nonalcoholic steatohepatitis [NASH]) cirrhosis.
2. The use of blood-based noninvasive liver fibrosis screening tests (e.g., FIB-4, NFS, APRI) are considered investigational for all other indications.

Blood-based Noninvasive Liver Disease Algorithmic Tests

1. Blood-based noninvasive liver disease algorithmic tests are considered medically necessary when:
   1. The member does NOT have a confirmed diagnosis of liver fibrosis, AND
   2. This test has NOT been performed within the last year, AND
   3. The member meets BOTH 1 and 2:
      1. One of the following: 
         1. Untreated chronic hepatitis C virus (HCV) infection, OR
         2. Suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) (formerly, nonalcoholic fatty liver disease [NAFLD]), AND
            1. The member does NOT have chronic cholestatic liver disease, AND
      2. One of the following:
         1. An intermediate or high-risk Fibrosis-4 index (FIB-4) score (1.3 or greater for individuals younger than 65 years of age; 2.0 or greater for individuals 65 years of age or older), OR
         2. A low-risk Fibrosis-4 index (FIB-4) score (less than 1.3 for individuals younger than 65 years of age; less than 2.0 for individuals 65 years of age or older), AND
            1. Prediabetes/type 2 diabetes, OR 
            2. Two or more features of metabolic syndrome (e.g., abdominal obesity, high blood pressure, high triglyceride levels), OR
         3. An indeterminate or high-risk score on the NAFLD fibrosis score (NFS) (less than -1.455).
2. Blood-based non-invasive liver disease algorithmic tests to rule out liver fibrosis are considered investigational for all other indications, including but not limited to:
   1. Alcohol-associated steatotic liver disease (formerly, alcoholic fatty liver disease).
      
       

Medical Policy: V.66 Genetic Testing: Cardiac Disorders

New Title: Specialty Testing: Cardiovascular
Effective Date:  7/1/2025
Preauthorization Required: YES

Hypertrophic Cardiomyopathy Panels

1. Genetic testing for hypertrophic cardiomyopathy via a multigene panel is considered medically necessary when:
   1. The member has unexplained left ventricular hypertrophy (LVH), as defined by myocardial wall thickness of 15mm or greater (in adults), or a z-score of 2 or greater (in children) based on echocardiogram or cardiac MRI.
2. Genetic testing for hypertrophic cardiomyopathy via a multigene panel is considered investigational for all other indications.

Dilated Cardiomyopathy Panels

1. Genetic testing for dilated cardiomyopathy (DCM) via a multigene panel is considered medically necessary when:
   1. The member has findings characteristic of DCM including all of the following: 
      1. Left ventricular enlargement or biventricular dilatation based on echocardiogram or cardiac MRI, AND
      2. Systolic dysfunction (e.g., ejection fraction less than 50%) based on echocardiogram, cardiac MRI, or left ventricular angiogram, AND
      3. Non-genetic causes of DCM have been ruled out, such as prior myocardial infarction from coronary artery disease, valvular and congenital heart disease, toxins (most commonly, anthracyclines or other chemotherapeutic agents; various drugs with idiosyncratic reactions), thyroid disease, inflammatory or infectious conditions, severe long-standing hypertension, and radiation.
2. Genetic testing for dilated cardiomyopathy (DCM) via a multigene panel is considered investigational for all other indications.

Familial Thoracic Aortic Aneurysm and Dissection (TAAD) Multigene Panel

1. Familial thoracic aortic aneurysm and dissection (TAAD) multigene panel analysis to establish a genetic diagnosis for TAAD is considered medically necessary when:
   1. The member has a history of any of the following:
      1. Aortic root enlargement, OR
      2. Thoracic aneurysm, OR
      3. Type A aortic dissection or type B aortic dissection, AND
   2. The member does not otherwise meet diagnostic criteria for another connective tissue disorder, AND
   3. The member has a family history of dilation or dissection of the aortic root, consistent with autosomal dominant inheritance.
2. Thoracic aortic aneurysm and dissection (TAAD) multigene panel analysis to establish a genetic diagnosis for TAAD is considered investigational for all other indications.

Hereditary Hemorrhagic Telangiectasia Multigene Panel

1. Hereditary hemorrhagic telangiectasia (HHT) multigene panel analysis to establish or confirm a diagnosis of HHT is considered medically necessary when:
   1. The member has any of the following clinical features of HHT:
      1. Spontaneous and recurrent nosebleeds (epistaxis), OR
      2. Mucocutaneous telangiectases at characteristic sites, including lips, oral cavity, fingers, and nose, OR
      3. Visceral arteriovenous malformation (AVM) (either pulmonary, cerebral, spinal, gastrointestinal or pancreatic), AND
   2. The panel includes, at a minimum, the following genes: ACVRL1, ENG.
2. Hereditary hemorrhagic telangiectasia (HHT) multigene panel analysis to establish or confirm a diagnosis of HHT is considered investigational for all other indications.