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1 New Subdivision; Managed Care Law; Biomarker Testing. Amend RSA 420-J by inserting after section 19 the following new subdivision:
Biomarker Testing
420-J:20 Definitions. In this subdivision:
I. "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.
II. "Biomarker testing" means 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.
III. "Clinical utility" means a biomarker test result that provides information used in the formulation of a treatment or monitoring strategy that informs a covered person's outcomes and impacts the treating provider's clinical decisions. 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.
IV. "Consensus statements" mean 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.
V. "Nationally recognized clinical practice guidelines" mean 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.
420-J: 21 Biomarker Testing; Health Benefit Plan Coverage Requirements.
I. Each health carrier issuing, amending, delivering or renewing a health benefit plan on or after January 1, 2026 shall include coverage for biomarker testing as defined in RSA 420-J:20, II, pursuant to the criteria established in this section.
II. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the test provides clinical utility and is demonstrated by the following medical and scientific evidence, including but not limited to any of the following:
(a) Labeled indications for an FDA-approved or -cleared test;
(b) Indicated tests for an FDA-approved drug;
(c) Warnings and precautions on FDA-approved drug labels;
(d) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or
(e) Nationally recognized clinical practice guidelines and consensus statements.
III. A health carrier shall ensure that coverage as defined in paragraph II is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.
IV. If utilization review, including but not limited to prior authorization, is required, the health carrier, utilization review entity, or any third party acting on behalf of an organization or entity subject to this subdivision shall 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 14 days for non-urgent requests or within 72 hours for urgent requests.
V. The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy or an adverse utilization review determination of a health carrier. The process shall be made readily accessible on the health carrier's website.
2 New Section; Medicaid Coverage of Biomarker Testing. Amend RSA 167 by inserting after section 4-f the following new section:
167:4-g Biomarker Testing; Medicaid Coverage Requirements.
I. The state Medicaid plan shall cover biomarker testing as defined in RSA 420-J:20, II, in accordance with the requirements of this section.
II. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the department of health and human services determines that the test provides clinical utility, as defined in RSA 420-J:20, III and is demonstrated by the following medical and scientific evidence, including but not limited to any of the following:
(a) Labeled indications for an FDA-approved or -cleared test;
(b) Indicated tests for an FDA-approved drug;
(c) Warnings and precautions on FDA-approved drug labels;
(d) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or
(e) Nationally recognized clinical practice guidelines and consensus statements.
III. Risk-bearing entities contracted under the state Medicaid plan to deliver services to beneficiaries shall provide biomarker testing at the same scope, duration and frequency as the Medicaid program otherwise provides to enrollees.
IV. The state Medicaid plan shall ensure coverage as defined in paragraph II is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.
V. If utilization review, including but not limited to prior authorization, is required, the state Medicaid plan, utilization review entity, or any third party acting on behalf of an organization or entity subject to this section shall 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 14 days for non-urgent requests or within 72 hours for urgent requests.
VI. The enrollee and participating provider shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy of the state Medicaid plan or by risk-bearing entities contracted to the program. The process shall be made readily accessible to all participating providers and enrollees online.
VII. The department of health and human services shall submit to the Centers for Medicare and Medicaid Services any amendment to the state Medicaid plan required to provide coverage for biomarker testing in accordance with this section.
3 Effective Date. This act shall take effect July 1, 2025.
Text to be added highlighted in green.
1 New Subdivision; Managed Care Law; Biomarker Testing. Amend RSA 420-J by inserting after section 19 the following new subdivision:
Biomarker Testing
420-J:20 Definitions. In this subdivision:
I. "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.
II. "Biomarker testing" means 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.
III. "Clinical utility" means a biomarker test result that provides information used in the formulation of a treatment or monitoring strategy that informs a covered person's outcomes and impacts the treating provider's clinical decisions. 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.
IV. "Consensus statements" mean 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.
V. "Nationally recognized clinical practice guidelines" mean 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.
420-J: 21 Biomarker Testing; Health Benefit Plan Coverage Requirements.
I. Each health carrier issuing, amending, delivering or renewing a health benefit plan on or after January 1, 2026 shall include coverage for biomarker testing as defined in RSA 420-J:20, II, pursuant to the criteria established in this section.
II. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the test provides clinical utility and is demonstrated by the following medical and scientific evidence, including but not limited to any of the following:
(a) Labeled indications for an FDA-approved or -cleared test;
(b) Indicated tests for an FDA-approved drug;
(c) Warnings and precautions on FDA-approved drug labels;
(d) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or
(e) Nationally recognized clinical practice guidelines and consensus statements.
III. A health carrier shall ensure that coverage as defined in paragraph II is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.
IV. If utilization review, including but not limited to prior authorization, is required, the health carrier, utilization review entity, or any third party acting on behalf of an organization or entity subject to this subdivision shall 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 14 days for non-urgent requests or within 72 hours for urgent requests.
V. The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy or an adverse utilization review determination of a health carrier. The process shall be made readily accessible on the health carrier's website.
2 New Section; Medicaid Coverage of Biomarker Testing. Amend RSA 167 by inserting after section 4-f the following new section:
167:4-g Biomarker Testing; Medicaid Coverage Requirements.
I. The state Medicaid plan shall cover biomarker testing as defined in RSA 420-J:20, II, in accordance with the requirements of this section.
II. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the department of health and human services determines that the test provides clinical utility, as defined in RSA 420-J:20, III and is demonstrated by the following medical and scientific evidence, including but not limited to any of the following:
(a) Labeled indications for an FDA-approved or -cleared test;
(b) Indicated tests for an FDA-approved drug;
(c) Warnings and precautions on FDA-approved drug labels;
(d) Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations; or
(e) Nationally recognized clinical practice guidelines and consensus statements.
III. Risk-bearing entities contracted under the state Medicaid plan to deliver services to beneficiaries shall provide biomarker testing at the same scope, duration and frequency as the Medicaid program otherwise provides to enrollees.
IV. The state Medicaid plan shall ensure coverage as defined in paragraph II is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.
V. If utilization review, including but not limited to prior authorization, is required, the state Medicaid plan, utilization review entity, or any third party acting on behalf of an organization or entity subject to this section shall 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 14 days for non-urgent requests or within 72 hours for urgent requests.
VI. The enrollee and participating provider shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy of the state Medicaid plan or by risk-bearing entities contracted to the program. The process shall be made readily accessible to all participating providers and enrollees online.
VII. The department of health and human services shall submit to the Centers for Medicare and Medicaid Services any amendment to the state Medicaid plan required to provide coverage for biomarker testing in accordance with this section.
3 Effective Date. This act shall take effect July 1, 2025.