Biomarker Testing Access

SECTION 1. DEFINITIONS 

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, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes, 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, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. 

3. “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. 

4. “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 risks of alternative care options and include recommendations intended to optimize patient care.  

 
  
SECTION 2. HEALTH INSURER REQUIREMENTS 

1. Health insurers, nonprofit health service plans, [health carrier, health benefit plan, etc.] and health maintenance organizations issuing, amending, delivering or renewing a health insurance contract on or after [DATE] shall include coverage for biomarker testing as defined in Section 1, pursuant to criteria established under Subsection 2(b). 

2. Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test is supported by medical and scientific evidence, including, but not limited to: 

1. Labeled indications for an FDA-approved or -cleared test;  

2. Indicated tests for an FDA-approved drug;  

3. Warnings and precautions on FDA-approved drug labels; 

4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or 

5. Nationally recognized clinical practice guidelines and consensus statements. 

3. Health insurers, nonprofit health service plans [health carrier, health benefit plan, etc.] and health maintenance organizations must ensure 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. 

 
[If no existing state statute establishes timeline for prior authorization review or if existing statutory timelines are too long] 
If utilization review (including but not limited to prior authorization) is required, the health insurer, nonprofit health service plan, health maintenance organization, utilization review entity or any third party acting on behalf of an organization or entity subject to this Section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider, and any entity requesting authorization of the service within 72 hours for non-urgent requests or within 24 hours for urgent requests. 
 
If there is an existing statute for exceptions review, timeline may be adjusted to match that statute. 

4. The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination of a health insurer, nonprofit health service plan, and health maintenance organization.  The process shall be made readily accessible on the health insurer’s, nonprofit health service plan’s, or health maintenance organization’s website. 

 
SECTION 3. MEDICAID COVERAGE REQUIREMENTS 

1. The State Medical Assistance Program (Medicaid Program) shall cover biomarker testing as defined in section (1) in accordance with requirements outlined in this section. 

2. Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test is supported by medical and scientific evidence, including, but not limited to: 

1. Labeled indications for an FDA-approved or -cleared test; 

2. Indicated tests for an FDA-approved drug; 

3. Warnings and precautions on FDA-approved drug labels; 

4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or 

5. Nationally recognized clinical practice guidelines and consensus statements. 

3. Risk-bearing entities contracted to the Medical Assistance Program (Medicaid Program) to deliver services to beneficiaries shall provide biomarker testing as defined by Section (1) at the same scope, duration and frequency as the Medicaid program otherwise provides to enrollees. 

5. [If no existing state statute establishes timeline for prior auth review] If utilization review (including but not limited to prior authorization) is required, the health insurer, nonprofit health service plan, health maintenance organization, utilization review entity or any third party acting on behalf of an organization or entity subject to this Section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider, and any entity requesting authorization of the service within 72 hours for non-urgent requests or within 24 hours for urgent requests. 

 
If there is an existing statute for exceptions review, timeline may be adjusted to match that statute. 

4. The enrollee and participating provider shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy of the Medical Assistance Program (Medicaid Program) or by risk-bearing entities contracted to the Medical Assistance Program (Medicaid Program).  The process shall be made readily accessible to all participating providers and enrollees online.