S 154

 BILL AS INTRODUCED AND PASSED BY SENATE  S.154
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1S.154
2 Introduced by Senators Gulick, Brock, Major and Vyhovsky
3 Referred to Committee on Finance
4 Date: May 9, 2025
5 Subject: Health; health insurance; Medicaid; biomarker testing
6 Statement of purpose of bill as introduced: This bill proposes to require health
7 insurance and Medicaid coverage for biomarker testing.
8    An act relating to health insurance coverage for biomarker testing
9 It is hereby enacted by the General Assembly of the State of Vermont:
10 Sec. 1. 8 V.S.A. § 4088n is added to read:
11 § 4088n. COVERAGE FOR BIOMARKER TESTING
12    (a) As used in this section:
13(1) “Biomarker” means a characteristic that is objectively measured and
14 evaluated as an indicator of normal biological processes, pathogenic processes,
15 or pharmacologic responses to a specific therapeutic intervention, including
16 known gene-drug interactions for medications being considered for use or
17 already being administered. Biomarkers include gene mutations,
18 characteristics of genes, and protein expression.
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1(2) “Biomarker testing” means the analysis of a patient’s tissue, blood,
2 or other biospecimen for the presence of a biomarker. Biomarker testing
3 includes single-analyte tests, multiplex panel tests, protein expression analysis,
4 and whole exome, whole genome, and whole transcriptome sequencing.
5(3) “Consensus statements” means statements developed by an
6 independent, multidisciplinary panel of experts utilizing a transparent
7 methodology and reporting structure and with a conflict of interest policy.
8 These statements are aimed at specific clinical circumstances and the
9 statements are based on the best available evidence for the purpose of
10 optimizing the outcomes of clinical care.
11(4) “Health insurance plan” means any health insurance policy or health
12 benefit plan offered by a health insurer, as defined in 18 V.S.A. § 9402. The
13 term does not include policies or plans providing coverage for a specified
14 disease or other limited benefit coverage.
15(5) “Nationally recognized clinical practice guidelines” means evidence-
16 based clinical practice guidelines developed by independent organizations or
17 medical professional societies utilizing a transparent methodology and
18 reporting structure and with a conflict of interest policy. Clinical practice
19 guidelines establish standards of care informed by a systematic review of
20 evidence and an assessment of the benefits and risks of alternative care options
21 and include recommendations intended to optimize patient care.
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1    (b) A health insurance plan shall provide coverage for the services of
2 biomarker testing for the purposes of diagnosis, treatment, appropriate
3 management, and ongoing monitoring of a patient’s disease or condition when
4 the test is supported by medical and scientific evidence, including:
5(1) labeled indications for a test approved or cleared by the U.S. Food
6 and Drug Administration (FDA);
7(2) indicated tests for an FDA-approved drug;
8(3) warnings and precautions on FDA-approved drug labels;
9(4) Centers for Medicare and Medicaid Services national coverage
10 determinations or Medicare Administrative Contractor local coverage
11 determinations; or
12(5) nationally recognized clinical practice guidelines and consensus
13 statements.
14    (c) The coverage required in subsection (b) of this section shall be
15 provided in a manner that limits disruptions in care, including the need for
16 multiple biopsies or biospecimen samples.
17 Sec. 2. 33 V.S.A. § 1901n is added to read:
18 § 1901n. MEDICAID COVERAGE FOR BIOMARKER TESTING
19    (a) As used in this section:
20(1) “Biomarker” means a characteristic that is objectively measured and
21 evaluated as an indicator of normal biological processes, pathogenic processes,
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1 or pharmacologic responses to a specific therapeutic intervention, including
2 known gene-drug interactions for medications being considered for use or
3 already being administered. Biomarkers include gene mutations,
4 characteristics of genes, and protein expression.
5(2) “Biomarker testing” means the analysis of a patient’s tissue, blood,
6 or other biospecimen for the presence of a biomarker. Biomarker testing
7 includes single-analyte tests, multiplex panel tests, protein expression analysis,
8 and whole exome, whole genome, and whole transcriptome sequencing.
9(3) “Consensus statements” means statements developed by an
10 independent, multidisciplinary panel of experts utilizing a transparent
11 methodology and reporting structure and with a conflict of interest policy.
12 These statements are aimed at specific clinical circumstances and the
13 statements are based on the best available evidence for the purpose of
14 optimizing the outcomes of clinical care.
15(4) “Nationally recognized clinical practice guidelines” means evidence-
16 based clinical practice guidelines developed by independent organizations or
17 medical professional societies utilizing a transparent methodology and
18 reporting structure and with a conflict of interest policy. Clinical practice
19 guidelines establish standards of care informed by a systematic review of
20 evidence and an assessment of the benefits and risks of alternative care options
21 and include recommendations intended to optimize patient care.
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1    (b) The Agency of Human Services shall provide Medicaid coverage for
2 the services of biomarker testing for the purposes of diagnosis, treatment,
3 appropriate management, and ongoing monitoring of a patient’s disease or
4 condition when the test is supported by medical and scientific evidence,
5 including:
6(1) labeled indications for a test approved or cleared by the U.S. Food
7 and Drug Administration (FDA);
8(2) indicated tests for an FDA-approved drug;
9(3) warnings and precautions on FDA-approved drug labels;
10(4) Centers for Medicare and Medicaid Services national coverage
11 determinations or Medicare Administrative Contractor local coverage
12 determinations; or
13(5) nationally recognized clinical practice guidelines and consensus
14 statements.
15    (c) The Agency of Human Services shall ensure that the Medicaid
16 coverage required in subsection (b) of this section is provided in a manner that
17 limits disruptions in care, including the need for multiple biopsies or
18 biospecimen samples.
19 Sec. 3. MEDICAID STATE PLAN AMENDMENT
20    The Agency of Human Services shall request approval from the Centers for
21 Medicare and Medicaid Services to amend Vermont’s Medicaid state plan if
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1 necessary to provide coverage for biomarker testing as set forth in Sec. 2 of
2 this act.
3 Sec. 4. EFFECTIVE DATES
4    (a) Sec. 1 (8 V.S.A. § 4088n) shall take effect on January 1, 2026 and shall
5 apply to all health insurance plans issued on and after January 1, 2026 on such
6 date as a health insurer offers, issues, or renews the health insurance plan, but
7 in no event later than January 1, 2027.
8    (b) Sec. 2 (33 V.S.A. § 1901n) shall take effect on the later of January 1,
9 2026 or upon approval by the Centers for Medicare and Medicaid Services of
10 the amendment to Vermont’s Medicaid state plan as directed in Sec. 3, if an
11 amendment is necessary.
12    (c) Sec. 3 (Medicaid state plan amendment) and this section shall take
13 effect on passage.
 Sec. 1. HEALTH INSURANCE AND MEDICAID COVERAGE FOR
         BIOMARKER TESTING; DEPARTMENT OF FINANCIAL
         REGULATION; AGENCY OF HUMAN SERVICES; REPORTS
    (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,
 including known gene-drug interactions for medications being considered for
 use or already being administered. Biomarkers include gene mutations,
 characteristics of genes, and protein expression.
       (2) “Biomarker testing” means the analysis of a patient’s tissue, blood,
 or other biospecimen for the presence of a biomarker. Biomarker testing
 includes single-analyte tests; multiplex panel tests; protein expression
 analysis; and whole exome, whole genome, and whole transcriptome
 sequencing.
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  (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.
   (b) The Department of Financial Regulation and Agency of Human
Services shall analyze the costs associated with requiring health insurance
coverage and Medicaid coverage, respectively, for 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)(1) On or before January 15, 2027, the Department of Financial
Regulation shall report to the House Committee on Health Care and the Senate
Committees on Health and Welfare and on Finance on the estimated amount
that health insurance premiums would increase if Vermont were to enact
legislation requiring health insurance coverage of biomarker testing as set
forth in subsection (b) of this section, including the amounts of the State’s
financial obligations for defrayal of premium increases for qualified health
benefit plans pursuant to 45 C.F.R. § 155.170 and for premium increases in the
State Employees’ Health Benefit Plan.
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  (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.
Sec. 2. EFFECTIVE DATE
   This act shall take effect on passage.