Some genetic testing services are not covered and a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state mandate, R.I.G.L. §27-19-81. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Refer to the Biomarker Testing Mandate policy for more details.

Newly developed policies:

The following new policies were created and will be effective January 1, 2024. Please review the full text of these policies in the Provider section of BCBSRI.com under the Medical Policy heading.

• Biomarker Testing Mandate
• Blood Product Molecular Antigen Typing
• Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer
• Genetic Testing for Duchenne and Becker Muscular Dystrophy 
• Genetic Testing for Epilepsy 
• Genetic Testing for Mitochondrial Disorders 
• Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer 
• Identification of Microorganisms Using Nucleic Acid Probes
• Invasive Prenatal (Fetal) Diagnostic Testing
• Laboratory Testing Investigational Services  
• Mass Spectrometry (MS) Testing in Monoclonal Gammopathy 
• Multicancer Early Detection
• Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis
• Next-Generation Sequencing for Solid Tumors
• Preimplantation Genetic Testing
• Prognostic and Predictive Molecular Classifiers for Bladder Cancer
• Proteomic Testing for Targeted Therapy in Non-Small-Cell Lung Cancer
• Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders

Policies with changes:

The following policies will be updated with changes due to implementation of the Rhode Island Biomarker Testing Mandate.

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer                                                                                                

For commercial products, CPT code 0153U will be removed from this policy and will change from not medically necessary to prior authorization using the criteria found in the online authorization tool, which will be reflected in the policy Proprietary Laboratory Analyses (PLA). CPT code 0045U will change from not medically necessary to prior authorization using the medical necessity criteria found in this policy.

For Medicare Advantage plans, CPT code 0153U will be removed from this policy but will continue to require prior authorization using the medical criteria found in the policy, medical necessity, which will be reflected in policy Proprietary Laboratory Analyses (PLA). There will be no changes for CPT code 0045U. For additional details related to this policy, please click here. 

Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)                                                                                                                

For commercial products, CPT code 0091U will be added to this policy but will remain not medically necessary.

For Medicare Advantage plans, CPT code 0091U will be added to this policy and will change from prior authorization using the criteria found in the policy, medical necessity, to not covered in this policy. For additional details related to this policy, please click here.  

Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies              

For Medicare Advantage plans and commercial products, CPT codes 0006M, 0019U, 0036U, 0174U, 0211U will be included in this policy and will be not covered for Medicare Advantage plans and not medically necessary for commercial products. For additional details related to this policy, please click here.  

Envisia for Idiopathic Pulmonary Fibrosis                                                            

CPT code 81554 will change from not medically necessary to priorauthorization for commercial products following the medical necessity criteria in this policy. There will be no changes for Medicare Advantage plans. For additional details related to this policy, please click here.  

Evaluation of Biomarkers for Alzheimer's Disease                                                           

For Medicare Advantage plans and commercial products, CPT code 0361U will be included in this policy and will be subject to the medically necessary ICD-10-CM diagnoses currently utilized in the policy. For additional details related to this policy, please click here.

Gene Expression Profiling for Cutaneous Melanoma                                                       

For commercial products, CPT codes 81529, 0089U and 0090U will change from not medically necessary to prior authorization following the medical necessity criteria in this policy. There will be no changes for Medicare Advantage plans. For additional details related to this policy, please click here.  

Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management 

For commercial products, CPT codes 81479 (Oncotype DX AR-V7 Nuclear Detect), 81541, 81542, and 0047U will change from not medically necessary to prior authorization using the criteria found in the policy. There will be no changes for Medicare Advantage plans. For additional details related to this policy, please click here.  

Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer                                                                                                                   

For commercial products, CPT codes 81313, 81539, 81551, 0005U, 0113U, and 0339U will change from not medically necessary to prior authorization using the criteria found in the policy. CPT code 86316 will be added to the policy and will be considered not medically necessary when filed with one of the non-covered ICD-10-CM codes listed in the policy.

For Medicare Advantage plans, CPT code 0113U will change from not covered to prior authorization using the criteria found in the policy. CPT code 86316 will be added to the policy and will be considered not covered when filed with one of the non-covered ICD-10-CM codes listed in the policy. For additional details related to this policy, please click here.  

Genetic Testing for Diagnosis and Management of Mental Health Conditions             

Effective January 1, 2024, CPT code 81479 will continue to require prior authorization and will be covered for Medicare Advantage Plans and Commercial Products when used for the Psychotropic Pharmacogenomics Gene Panel (Mayo Clinic). CPT code 0345U will change from requiring prior authorization to covered for Medicare Advantage Plans and will change from not medically necessary to covered for Commercial Products. CPT codes 0173U, 0175U, 0331U, and 0392U will be added to this policy and will change from requiring prior authorization to not covered for Medicare Advantage Plans and will continue to be not medically necessary for Commercial Products. For additional details related to this policy, please click here. 

Genetic Testing Services                                                                                                       

Several CPT codes were re-evaluated due to the state biomarker testing mandate and may have different coverage as of January 1, 2024. Select Pathology and Laboratory CPT codes will be included in the Genetic Testing Services policy due to consideration as biomarkers. Additionally, Multianalyte Assays with Algorithmic Analyses (MAAA) CPT codes will be moved from the Genetic Testing Services policy and will be included in the Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA) policy. Language related to genetic testing panels will be updated to be in alignment with the state mandate. Also, the criteria used to determine medical necessity for CPT codes 81236, 81237 and 81357 will change from BCBSRI policy to InterQual content. For additional details related to this policy, please click here.

Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms         

CPT code 0250U will be included in this policy. Commercial products will change from not medically necessary to prior authorization following the medical necessity criteria in this policy. Medicare Advantage plans will continue to require prior authorization but will follow the medical necessity criteria in this policy. For additional details related to this policy, please click here.  

Laboratory Tests Post Transplant and for Heart Failure                                                

For commercial products, CPT code 81595 will be considered medically necessary when the criteria found in the online authorization tool has been met. CPT codes 0018M, 0087U and 0088U will be included in this policy and are not covered for Medicare Advantage plans and not medically necessary for commercial products. Additionally, the test QSant™, with CPT code 81599, will require prior authorization for both Medicare Advantage plans and commercial products using the criteria found in the policy. For additional details related to this policy, please click here.  

Minimal Residual Disease Testing for Cancer                                                                   

Policy will include test Guardant Response, filed with unlisted CPT code 81479. The test will need prior authorization and will follow the medical necessity criteria in the policy for Medicare Advantage plans and commercial products. For additional details related to this policy, please click here.  

Molecular Markers in Fine Needle Aspiration of the Thyroid                                        

CPT code 0204U will change from not covered for Medicare Advantage plans and not medically necessary for commercial products to prior authorization using the criteria found in the policy. For additional details related to this policy, please click here.  

Molecular Testing for the Management of Pancreatic Cysts, Barrett Esophagus, and Solid Pancreaticobiliary Lesions                                                                                                   

For commercial products, PathfinderTG Molecular Testing (CPT codes 84999 or 81479) will continue prior authorization but will change from not medically necessary to covered when the criteria found in the policy is met. There will be no changes for Medicare Advantage plans. For additional details related to this policy, please click here.    

Molecular Testing in the Management of Pulmonary Nodules                                       

For commercial products, Percepta® Bronchial Genomic Classifier (CPT code 81479) will continue prior authorization but will change from not medically necessary to covered when the criteria found in the policy is met. CPT code 0360U will be added to this policy but will remain not medically necessary.

For Medicare Advantage plans CPT codes 0080U, 0092U and 0360U will change from prior authorization using the criteria found in the policy, medical necessity, to not covered in this policy. For additional details related to this policy, please click here.

Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease Cancer                                                                                                                     

For Medicare Advantage plans and commercial products, CPT codes 0002M, 0003M and 81596 will be included in this policy and will be subject to the medically necessary ICD-10-CM diagnoses currently utilized in the policy. CPT codes 0014M and 0166U will also be included in this policy and will be not covered for Medicare Advantage plans and not medically necessary for commercial products. For additional details related to this policy, please click here.

Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease 

For commercial products, CPT codes 83700, 83701 and 83704 will change from not medically necessary to covered when filed with a covered ICD-10-CM code. This policy is not applicable to Medicare Advantage plans. For additional details related to this policy, please click here.

Nutrient/Nutrition Panel Testing                                                                                        

For Medicare Advantage plans and commercial products, CPT code 81479 will be removed from the policy as it is not applicable to the testing described in this policy. CPT code 84999 will remain in the policy, will continue to require prior authorization and will be not covered for Medicare Advantage plans and not medically necessary for commercial products. For additional details related to this policy, please click here.  

Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)                                                                                                                        

The Proprietary Laboratory Analyses (PLA) policy title has been changed to: Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA). Several CPT codes were re-evaluated due to the state biomarker testing mandate and may have different coverage as of January 1, 2024. Additionally, Multianalyte Assays with Algorithmic Analyses (MAAA) CPT codes will be moved from the Genetic Testing Services policy and will be included in the Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA) policy. Language related to genetic testing panels will be added to the policy to be in alignment with the state mandate. Also, the criteria used to determine medical necessity for CPT code 0414U will change from BCBSRI policy to InterQual content. For additional details related to this policy, please click here.

Serum Tumor Markers for Breast and Gastrointestinal Malignancies                          

For commercial products, CPT code 86316 will change from not medically necessary to not medically necessary when filed with one of the non-covered ICD-10-CM codes listed in the policy. CPT code 86316 will now be addressed for Medicare Advantage plans and will change from covered to not covered when filed with one of the non-covered ICD-10-CM codes listed in the policy. For additional details related to this policy, please click here.

Tumor-Informed Circulating Tumor DNA Testing for Cancer Management               

CPT code 0340U will change from not covered for Medicare Advantage plans and not medically necessary for commercial products to prior authorization using the criteria found in the online authorization tool. As a result, this policy will be archived effective January 1, 2024. For additional details related to this policy, please click here.

Urinary Biomarkers for Cancer Screening, Diagnosis and Surveillance                        

For commercial products, CPT code 86316 will be added to the policy and will be considered not medically necessary when filed with one of the non-covered ICD-10-CM codes listed in the policy. CPT codes 88120 and 88121 will be removed from the policy and will change from not medically necessary to prior authorization using the criteria found in the online authorization tool, and the codes will be reflected in the policy, Genetic Testing Services.

For Medicare Advantage plans, CPT code 86316 will be added to the policy and will be considered not covered when filed with one of the non-covered ICD-10-CM codes listed in the policy. CPT codes 88120 and 88121 will be removed from the policy and will change from not covered to prior authorization using the criteria found in the online authorization tool, and the codes will be reflected in the policy, Genetic Testing Services. CPT code 0363U will change from prior authorization using the criteria found in the policy, medical necessity, to not covered. For additional details related to this policy, please click here.

The following policies were updated only with language to address that some services will not be covered and will be a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state biomarker mandate. 

• CA-125
• Fecal Calprotectin Testing
• Genomic Sequence Analysis in the Treatment of Hematolymphoid Diseases
• Homocysteine Testing in the Screening, Diagnosis, and Management of Cardiovascular Disease
• Immune Cell Function Assay
• In Vitro Chemoresistance and Chemosensitivity Assays 
• Lung Liquid Biopsy
• Measurement of Lipoprotein-Associated Phospholipase A2 in the Assessment of Cardiovascular Risk
• Measurement of Serum Antibodies to be Selected Biologic Agents
• Multimarker Serum Testing Related to Ovarian Cancer
• Proteogenomic Testing for Patients with Cancer
• Salivary Estriol as Risk Predictor Factor Preterm Labor and Management of Menopause and/or Aging
• Serologic Genetic and Molecular Screening for Colorectal Cancer
• Serum Biomarker Human Epididymis Protein 4