954 Form

1

Medical Policy
Carelon Genetic Testing Management Program
Policy Number: 954 BCBSA Reference Number: N/A NCD/LCD: N/A Effective Date: January 1, 2019 Related Policies
• Carelon Genetic Testing Management Program CPT and HCPCS Codes, #957
• Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer, #336
• Cardiovascular Risk Panels, #664 • Preimplantation Genetic Testing, #088 • Medicare Advantage Management, #132 Table of Contents Overview ................................................................................................................................................................ 1 Policy and Coverage Criteria for Commercial and Medicare Advantage Products: .............................................. 2 Requesting Prior Authorization Information through Carelon Medical Benefits Management .............................. 2 Requesting Prior Authorization Information through BCBSMA ............................................................................. 3 List of Retired BCBSMA Genetic Testing Medical Policies: .................................................................................. 3 Disclaimer: ............................................................................................................................................................. 5 References: ........................................................................................................................................................... 6

Overview:
Commercial Products Effective January 1, 2019, BCBSMA has delegated utilization management of molecular genetic testing to Carelon Medical Benefits Management for Commercial products only.

The Genetic Testing Management Program requires prior authorization for molecular genetic tests per the medical necessity criteria reflected in the Carelon Medical Benefits Management Clinical Guidelines for Commercial products effective January 1, 2019.

Medicare Advantage Products Effective January 1, 2025, BCBSMA has delegated utilization management of molecular genetic testing to Carelon Medical Benefits Management for Medicare Advantage products.

The Genetic Testing Management Program requires prior authorization for molecular genetic tests per the medical necessity criteria reflected in the Carelon Medical Benefits Management Clinical Guidelines for Medicare Advantage products effective January 1, 2025.

The Carelon Medical Benefits Management Clinical Guidelines are based on peer-reviewed literature and recommendations from evidence-based research centers such as (but not limited to): The American College of

2

Medical Genetics (ACMG), The American College of Obstetrics and Gynecologists (ACOG), the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN).

Policy and Coverage Criteria for Commercial and Medicare Advantage Products: The Carelon Medical Benefits Management Clinical Guidelines include medical necessity criteria for genetic tests in the following categories:

Genetic Testing for Hereditary Cancer Susceptibility https://guidelines.carelonmedicalbenefitsmanagement.com/

Genetic Testing for Hereditary Cardiac Disease https://guidelines.carelonmedicalbenefitsmanagement.com/

Genetic Testing for Pharmacogenetic and Thrombophilia https://guidelines.carelonmedicalbenefitsmanagement.com/

Genetic Testing for Reproductive Carrier Screening and Prenatal Diagnosis https://guidelines.carelonmedicalbenefitsmanagement.com/

Genetic Testing for Single-Gene and Multifactorial Conditions https://guidelines.carelonmedicalbenefitsmanagement.com/

Genetic Testing for Whole Exome and Genome Sequencing https://guidelines.carelonmedicalbenefitsmanagement.com/

Molecular Testing of Solid and Hematologic Tumors and Malignancies https://guidelines.carelonmedicalbenefitsmanagement.com/

The following BCBSMA medical policy is used instead of the Carelon guideline on reproductive carrier screening and prenatal diagnosis: • BCBSMA Medical Policy #088 Preimplantation Genetic Testing (including preimplantation genetic diagnosis). The policy is only available on the BCBSMA medical policy website. • Prior authorization is required through BCBSMA. See instructions below.

The utilization management of molecular genetic testing through Carelon Medical Benefits Management does not include the following: • Cytogenetics
• Human Leukocyte Antigen (HLA) testing
• Human Platelet Antigen (HPA) testing.

For a list of specific tests, CPT codes, and HCPCS codes that require prior authorization, see Carelon Genetic Testing Management Program CPT and HCPCS Codes, #957.

CPT codes and HCPCS that apply to BCBSMA Medical Policy #088 are found on the policy. Do not use BCBSMA Policy #957 to look up codes for Preimplantation Genetic Testing.

Molecular genetic/genomic testing that does not meet coverage criteria listed in these clinical guidelines may be considered experimental/investigational or not medically necessary, and therefore not covered.

Genetic testing is covered only when the patient meets coverage criteria outlined in the corresponding guideline or in the BCBSMA Medical Policy. Carelon guidelines are available at Guidelines.carelonmedicalbenefitsmanagement.com.

Requesting Prior Authorization Information through Carelon Medical Benefits Management: To request prior authorization for the following products, please see instructions below.

3

• Commercial Managed Care (HMO and POS) and Commercial PPO/EPO (PA requirement in effect since 1/1/2019) • Medicare HMO Blue and Medicare PPO Blue (PA requirement effective 1/1/2025)

1. Through the Blue Cross Blue Shield of Massachusetts website: • Log in to your Blue Cross Blue Shield of Massachusetts Provider Central account at www.bluecrossma.com/provider. • Click eTools> and then to Carelon Medical Benefits Management • Click Go Now

2. Going directly to Carelon ProviderPortal (registration is required) • Go to www.providerportal.com • Or calling 1-866-745-1783 (when applicable).

   Requesting Prior Authorization Information through BCBSMA: This only applies to Medical Policy #088 Preimplantation Genetic Testing.

   To request prior authorization for the following products: Commercial Managed Care (HMO and POS) and Commercial PPO and Indemnity and Medicare HMO Blue and Medicare PPO Blue, please see instructions below.

   Through the Blue Cross Blue Shield of Massachusetts website: • Log in to your Blue Cross Blue Shield of Massachusetts Provider Central account at www.bluecrossma.com/provider. • Prior authorization is required for the following biopsy codes only:
   o 89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos o 89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos • No additional authorization is required for genetic testing when the biopsy has been approved.

   List of Retired BCBSMA Genetic Testing Medical Policies: The following BCBSMA Genetic Testing Medical Policies will be retired effective January 1, 2019. For the list of impacted CPT and HCPCS codes, see Carelon Genetic Testing Management Program CPT and HCPCS Codes, #957. Note: These policies will no longer be available on the BCBSMA website as of this date. For medically necessary indications, see the Carelon Medical Benefits Management Clinical Guidelines for non- oncologic and oncologic conditions.

   Medical Policy Title Policy Number Cardiology

   Gene Expression Testing in the Evaluation of Patients with Stable Ischemic Heart Disease 349 Genetic Testing for Congenital Long QT Syndrome 082 Genetic Testing for Dilated Cardiomyopathy 601 Genetic Testing for Marfan Syndrome, Thoracic Aortic Aneurysms and Dissections, and Related Disorders
   729 Genetic Testing for Predisposition to Inherited Hypertrophic Cardiomyopathy 909 Genotyping for 9p21 Genetic Polymorphisms to Predict Cardiovascular Disease Risk 340 General Genetics

   DNA-Based Testing for Adolescent Idiopathic Scoliosis 545 General Approach to Evaluating the Utility of Genetic Panels 734 General Approach to Genetic Testing 735 Genetic Testing for Alpha Thalassemia 520 Genetic Testing for Alpha-1 Antitrypsin Deficiency 906 Genetic Testing for CHARGE Syndrome 540 Genetic Testing for Facioscapulohumeral Muscular Dystrophy 535 Genetic Testing for Familial Alzheimer’s Disease 580 Genetic Testing for Helicobacter Pylori Treatment 288

4

Genetic Testing for Hereditary Hemochromatosis 908 Genetic Testing for Hereditary Pancreatitis 516 Genetic Testing for Heterozygous Familial Hypercholesterolemia 796 Genetic Testing for Inherited Thrombophilia 802 Genetic Testing for Lactase Insufficiency 565 Genetic Testing for Macular Degeneration 665 Genetic Testing for Muscular Dystrophies 828 Genetic Testing of CADASIL Syndrome 357 Human Leukocyte Antigen Testing for Celiac Disease 567 Miscellaneous Genetic and Molecular Diagnostic Tests 712 Whole Exome Sequencing 457 Hereditary Cancer

Genetic Cancer Susceptibility Panels Using Next Generation Sequencing 574 Genetic Testing for Cutaneous Malignant Melanoma 300 Genetic Testing for Fanconi Anemia 714 Genetic Testing for Hereditary Breast and Ovarian Cancer 245 Genetic Testing for Inherited Susceptibility to Colon Cancer, Including Microsatellite Instability Testing 226 Genetic Testing for Li-Fraumeni Syndrome 684 Genetic Testing for PTEN Hamartoma Tumor Syndrome 615 Use of Common Genetic Variants (Single Nucleotide Variants) to Predict Risk of Nonfamilial Breast Cancer 252 Musculoskeletal

Genetic Testing for Limb-Girdle Muscular Dystrophies 738 Genetic Testing for Mitochondrial Disorders 685 Neurology/Psychiatry

Genetic Testing for Developmental Delay/Intellectual Disability, Autism Spectrum Disorder and Congenital Anomalies 228 Genetic Testing for Epilepsy 668 Genetic Testing for FMR1 mutations (including Fragile X Syndrome) 907 Genetic Testing for Mental Health Conditions 669 Genetic Testing for Neurofibromatosis 793 Genetic Testing for Nonsyndromic Hearing Loss 452 Genetic Testing for Rett Syndrome 803 Genetic Testing for the Diagnosis of Inherited Peripheral Neuropathies 569 Oncology

Analysis of MGMT Promoter Methylation in Malignant Gliomas
587 Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer
055 BCR-ABL1 Testing in Chronic Myelogenous Leukemia and Acute Lymphoblastic Leukemia
612 Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) – Retired effective 1.4.2021 797 BRAF Gene Mutation Testing to Select Melanoma Patients for BRAF Inhibitor Targeted Therapy 398 Detection of Circulating Tumor Cells in the Management of Patients with Cancer 265 Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies 790 Gene Expression Based Assays for Cancers of Unknown Primary 614 Gene Expression Profiling for Cutaneous Melanoma 056 Gene Expression Profiling for Uveal Melanoma 683 Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer: TMPRSS Fusion Genes in Prostate Cancer (using PCR); Mitochondrial DNA Mutation Testing (eg, Prostate Core Mitomics Test™); Candidate Gene Panels; Gene Hypermethylation Testing (eg, ConfirmMDx®) 333 Genetic Testing for CHEK2 Mutations for Breast Cancer 741 Genetic Testing for FLT3 and NPM1 Mutations in Acute Myeloid Leukemia 693

5

Genetic Testing for Germline Mutations of the RET Proto-Oncogene in Medullary Carcinoma of the Thyroid 564 KIT (c-KIT) Mutation Analysis
829 KRAS and BRAF Mutation Analysis in Metastatic Colorectal Cancer
104 Microarray-based Gene Expression Analysis for Prostate Cancer Management
670 Microarray-Based Gene Expression Profile Testing for Multiple Myeloma Risk Stratification 477 Moderate Penetrance Variants Associated with Breast Cancer in Individuals at High Breast Cancer Risk
722 Molecular Analysis for Targeted Therapy of Non-Small-Cell Lung Cancer
563 Molecular Markers in Fine Needle Aspirates of the Thyroid 913 Molecular Testing for the Management of Pancreatic Cysts or Barrett Esophagus
566 Multigene Expression Assay for Predicting Recurrence in Colon Cancer 239 Non-BRCA Breast Cancer Risk Assessment - e.g., OncoVue
188 Proteogenomic Testing for Patients with Cancer (GPS Cancer Test) 838 Pharmacogenetics

Cytochrome p450 Genotyping 256 Genetic Testing for Lipoprotein(a) Variant(s) as a Decision Aid for Aspirin Treatment
339 Genetic Testing for Statin-Induced Myopathy 575 Genetic Testing for Tamoxifen Treatment 067 Genetic Testing for Warfarin Dose 214 KIF6 Genotyping for Predicting Cardiovascular Risk and or Effectiveness of Statin Therapy
129 Laboratory and Genetic for Use of 5-Fluorouracil in Patients with Cancer 318 Pharmacogenetic Testing for Pain Management 724 Pharmacogenomic and Metabolite Markers for Patients Treated with Thiopurines 096 Reproductive

Carrier Screening for Genetic Diseases 666 Chromosomal Microarray Testing for the Evaluation of Pregnancy Loss 686 Invasive Prenatal (Fetal) Diagnostic Testing 708 Noninvasive Fetal RHD Genotyping Using Cell-Free Fetal DNA
667 Noninvasive Prenatal Screening for Fetal Aneuploidies and Microdeletions Using Cell-Free Fetal DNA 628

Policy History
Date Action 1/2025 Policy revised. Carelon Genetic Testing Management Program document MP #954 updated to include that prior authorization is required for Medicare Advantage through Carelon. Effective 1/2025.

Note: Prior to 1/2025, prior authorization through Carelon was not required for Medicare Advantage products. Medicare NCDs and LCDs through the CMS website for genetic testing guidelines were followed for Medicare Advantage. 3/2023 AIM Specialty Health changed its name to Carelon Medical Benefits Management. 10/2022 Policy #790 Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies is retired. AIM Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies will be used to determine coverage. Effective 9/4/2022. For medical necessity criteria, see Carelon Medical Benefits Management Clinical Guidelines.
1/2021 Policy #797 Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) is retired. For medical necessity criteria, see Carelon Medical Benefits Management Clinical Guidelines. Effective 1/4/2021.
1/2019 Policy issued 1/1/2019.

Disclaimer
Coverage is subject to applicable benefit contract. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

6

Member’s medical records must document that services are medically necessary for the care provided. BCBS MA maintains the right to audit the services provided to our members, regardless of the participation status of the provider. All documentation must be available upon request. Failure to produce the requested information may result in denial or retraction of payment.

References Carelon Medical Benefits Management Clinical Guidelines