Biomarker Testing Mandate Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2024 POLICY LAST REVIEWED: 11|05|2025 OVERVIEW This is an administrative policy to document the state-mandated coverage guidelines for biomarker testing (§ 27-19-81 and §27-20-77, full text below). This policy is applicable to Commercial Products only. MEDICAL CRITERIA Medical criteria may vary based on the service being rendered. Please refer to the Related Policies section for services with recommended prior authorization. PRIOR AUTHORIZATION Prior authorization review may be recommended. Please refer to the Related Policies section. POLICY STATEMENT Commercial Products Biomarker testing may be considered medically necessary for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of a member’s disease or condition to guide treatment decisions, when the test provides clinical utility as demonstrated by medical and scientific evidence, including, but not limited to:
• Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-approved drug; • Centers for Medicare Services (CMS) National Coverage Determinations (NCD) or Medicare Administrative Contractor (MAC) Local Coverage Determinations (LCD); or • Nationally recognized clinical practice guidelines and consensus statements. Some genetic testing services are not medically necessary when: • there is insufficient clinical evidence or strength of recommendation, • results would not reasonably be used in management of a patient, • services are unlikely to impact therapeutic decision-making in the clinical management of the patient. 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 described below. For these groups, a list of which genetic testing services are covered with prior authorization, are not medically necessary or are not covered because they are a contract exclusion can be found in the Coding section of the Genetic Testing Services and Proprietary Laboratory Analyses policies. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Please refer to the list of Related Policies for more information. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for laboratory tests and applicable coverage/benefits. BACKGROUND §27-19-81 Nonprofit Hospital Service Corporations, Coverage for biomarker testing. §27-20-77 Nonprofit Medical Service Corporations, Coverage for biomarker testing. Medical Coverage Policy | Biomarker Testing Mandate d

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

(a) As used in this section:

(1) "Biomarker" means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. Biomarkers include, but are not limited to, gene mutations or protein expression.

(2) "Biomarker testing" is the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests, multi-plex panel tests, and whole genome sequencing.

(3) “Clinical utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient's outcome and impacts the clinical decision. The most appropriate test may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision.

(4) "Consensus statements" as used here are statements developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict of interest policy. These statements are aimed at specific clinical circumstances and base the statements on the best available evidence for the purpose of optimizing the outcomes of clinical care.

(5) "Nationally recognized clinical practice guidelines" as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy. Clinical practice guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options and include recommendations intended to optimize patient care.

(b) Every individual or group health insurance contract, or every individual or group hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state on or after January 1, 2024, shall provide coverage for the services of biomarker testing in accordance with each health insurer's respective principles and mechanisms of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition to guide treatment decisions, when the test provides clinical utility as demonstrated by medical and scientific evidence, including, but not limited to:

(1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA- approved drug;

(2) Centers for Medicare Services ("CMS") national coverage determinations or Medicare Administrative Contractor ("MAC") Local Coverage Determinations; or

(3) Nationally recognized clinical practice guidelines and consensus statements.

(c) Coverage as defined in subsection (b) is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(d) The patient and prescribing practitioner shall have access to clear, readily accessible and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit health service plan, and health maintenance organization. The process shall be made readily accessible on the health insurers’, nonprofit health service plans’, or health maintenance organizations’ website.

CODING Please refer to the Related Policies for coding information.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

RELATED POLICIES Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer Biomarker Testing in Risk Assessment and Management of Cardiovascular Disease
Blood Product Molecular Antigen Typing Bone Turnover Markers for Diagnosis and Management of Osteoporosis and Diseases Associates with High Bone Turnover CA-125 Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies Envisia for Idiopathic Pulmonary Fibrosis Evaluation of Biomarkers for Alzheimer’s Disease Fecal Calprotectin Testing Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management
Gene Expression Profiling for Cutaneous Melanoma Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer
Genetic Testing for Diagnosis and Management of Mental Health Conditions Genetic Testing for Duchenne and Becker Muscular Dystrophy Genetic Testing for Epilepsy Genetic Testing for Inherited Thrombophilia Genetic Testing for Mitochondrial Disorders Genetic Testing Services Genomic Sequence Analysis in the Treatment of Hematolymphoid Diseases Genomic Sequence Analysis in the Treatment of Solid Organ Neoplasms Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer Homocysteine Testing in the Screening, Diagnosis, and Management of Cardiovascular Disease Identification of Microorganisms Using Nucleic Acid Probes Immune Cell Function Assay In Vitro Chemoresistance and Chemosensitivity Assays Intracellular Micronutrient Analysis Invasive Prenatal (Fetal) Diagnostic Testing Laboratory Testing Investigational Services Laboratory Tests Post Transplant and for Heart Failure Lung Liquid Biopsy Lyme Disease Diagnosis and Treatment Mandate Mass Spectrometry (MS) Testing in Monoclonal Gammopathy Measurement of Serum Antibodies to Selected Biologic Agents Medicare Advantage Plans National and Local Coverage Determinations Minimal Residual Disease Testing for Cancer Molecular Markers in Fine Needle Aspiration of the Thyroid
Molecular Testing for the Management of Pancreatic Cysts, Barrett Esophagus, and Solid Pancreaticobiliary Lesions
Molecular Testing in the Management of Pulmonary Nodules Multicancer Early Detection Testing Multimarker Serum Testing Related to Ovarian Cancer Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis Next Generation Sequencing for Solid Tumors Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease Nutrient/Nutritional Panel Testing Preimplantation Genetic Testing Preventive Services for Commercial Members

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

Preventive Services for Medicare Advantage Plans Prognostic and Predictive Molecular Classifiers for Bladder Cancer Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA) Prostate Cancer Detection with IsoPSA Proteogenomic Testing for Patients with Cancer Proteomic Testing for Targeted Therapy in Non-Small-Cell Lung 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 Serum Tumor Markers for Breast and Gastrointestinal Malignancies Urinary Biomarkers for Cancer Screening, Diagnosis and Surveillance Vitamin D Testing Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders PUBLISHED Provider Update, January 2026 Provider Update, January 2025 Provider Update, October 2023

REFERENCES RIGL Mandate 27-20-77. Accessed on 11/12/2024. webserver.rilin.state.ri.us/Statutes/TITLE27/27-20/27- 20-77.htm

RIGL Mandate 27-19-81. Accessed on 11/12/2024. webserver.rilin.state.ri.us/Statutes/TITLE27/27-19/27- 19-81.htm

Centers for Medicare and Medicaid Services (CMS). Local Coverage Determination (LCD) Molecular Pathology Procedures L35000

Centers for Medicare and Medicaid Services (CMS). Local Coverage Article Billing and Coding: Molecular Pathology Procedures A56199

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This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS