S 154 — An act relating to health insurance coverage for biomarker testing

Biomarker testing includes single-analyte tests, multiplex panel tests, protein expression analysis, and whole exome, whole genome, and whole transcriptome sequencing.

(3) “Consensus statements” means 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 the statements are based on the best available evidence for the purpose of optimizing the outcomes of clinical care.

(4) “Nationally recognized clinical practice guidelines” means 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.

BILL AS INTRODUCED AND PASSED BY SENATE S.154 Page 5 of 8 (b) The Agency of Human Services shall provide Medicaid coverage for the services of biomarker testing for the purposes of diagnosis, treatment, appropriate management, and ongoing monitoring of a patient’s disease or condition when the test is supported by medical and scientific evidence, including:

(1) labeled indications for a test approved or cleared by the U.S.

Food and Drug Administration (FDA);

(2) indicated tests for an FDA-approved drug;

(3) warnings and precautions on FDA-approved drug labels;

(4) Centers for Medicare and Medicaid Services national coverage determinations or Medicare Administrative Contractor local coverage determinations;

or (5) nationally recognized clinical practice guidelines and consensus statements.

(c) The Agency of Human Services shall ensure that the Medicaid coverage required in subsection (b) of this section is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.

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3.

MEDICAID STATE PLAN AMENDMENT The Agency of Human Services shall request approval from the Centers for Medicare and Medicaid Services to amend Vermont’s Medicaid state plan if BILL AS INTRODUCED AND PASSED BY SENATE S.154 Page 6 of 8 necessary to provide coverage for biomarker testing as set forth in Sec.

2 of this act.

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EFFECTIVE DATES (a) Sec.

1 (8 V.S.A.

§ 4088n) shall take effect on January 1, 2026 and shall apply to all health insurance plans issued on and after January 1, 2026 on such date as a health insurer offers, issues, or renews the health insurance plan, but in no event later than January 1, 2027.

(b) Sec.

2 (33 V.S.A.

§ 1901n) shall take effect on the later of January 1, 2026 or upon approval by the Centers for Medicare and Medicaid Services of the amendment to Vermont’s Medicaid state plan as directed in Sec.

3, if an amendment is necessary.

(c) Sec.

3 (Medicaid state plan amendment) and this section shall take effect on passage.

Sec.

1.

BILL AS INTRODUCED AND PASSED BY SENATE S.154 Page 7 of 8 (3) “Consensus statements” means 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 the VT LEG #388281 v.1 AS PASSED BY SENATE S.154 Page 2 of 4 statements are based on the best available evidence for the purpose of optimizing the outcomes of clinical care.

(4) “Nationally recognized clinical practice guidelines” means evidence-evidence-based 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.

VT LEG #388281 v.1 AS PASSED BY SENATE S.154 Page 3 of 4 (4) Centers for Medicare and Medicaid Services national coverage determinations or Medicare Administrative Contractor local coverage determinations;

§§ 155.170 155.170 and for premium increases in the State Employees’ Health Benefit Plan.

BILL AS INTRODUCED AND PASSED BY SENATE S.154 Page 8 of 8 (2) On or before January 15, 2027, the Agency of Human Services shall report to the House Committee on Health Care and the Senate Committee on Health and Welfare regarding the approvals that would be needed from the Centers for Medicare and Medicaid in order for Vermont Medicaid to cover biomarker testing as set forth in subsection (b) of this section and the costs to the Medicaid program if Vermont were to enact legislation requiring that coverage.

VT LEG #388281 v.1 AS PASSED BY SENATE S.154 Page 4 of 4 Sec.

VT LEG #388281 v.1