| 47 | | - | SECTION 1. Chapter 431, Hawaii Revised Statutes, is amended by adding a new section to article 10A to be appropriately designated and to read as follows: "§431:10A- Biomarker testing; coverage. (a) Each individual or group policy of accident and health or sickness insurance issued or renewed in the State on or after January 1, 2026, shall provide coverage for biomarker testing for the policyholder, or any dependent of the policyholder who is covered by the policy, for purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an insured person's disease or condition, or to guide treatment decisions when supported by medical and scientific evidence, including: (1) Labeled indications for a test approved or cleared by the United States Food and Drug Administration; (2) Indicated tests for a drug approved by the United States Food and Drug Administration; (3) Warnings and precautions on the label of a drug approved by the United States Food and Drug Administration; (4) National coverage determinations from the Centers for Medicare and Medicaid Services or local coverage determinations from a medicare administrative contractor; or (5) Nationally recognized clinical practice guidelines and consensus statements. (b) Coverage under this section shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies. (c) If a policy of accident and health or sickness insurance restricts coverage under this section, the patient and prescribing health care provider shall be provided access to a clear, readily accessible, and convenient process for requesting an exception. The process for requesting an exception shall also be readily accessible on the insurer's website. (d) Coverage under this section may be subject to the copayment, deductible, and coinsurance provisions of a policy of accident and health or sickness insurance; provided that the terms shall be no less favorable than the copayment, deductible, and coinsurance provisions for other medical services covered by the policy. (e) Within calendar year 2026, and in no case later than December 31, 2026, each insurer shall provide written notice to its policyholders regarding the coverage required by this section. The notice shall be prominently featured in any literature or correspondence sent annually to policyholders. (f) This section shall not apply to limited benefit health insurance as provided in section 431:10A-607. (g) For the purposes of this section: "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" includes gene mutations, gene characteristics, and protein expression. "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; multi-plex panel tests; protein expression; and whole exome, whole genome, and whole transcriptome sequencing. "Clinical practice guidelines" means guidelines that establish standards of care informed by a systemic review of evidence and an assessment of the benefits and risks of alternative care options; that include recommendations intended to optimize patient care; and are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. "Consensus statements" means statements developed by an independent multidisciplinary panel of experts using a transparent methodology and reporting structure and with a conflict-of-interest policy and that are focused on specific clinical circumstances and are based on the best available evidence for the purpose of optimizing the outcomes of clinical care." SECTION 2. Chapter 432, Hawaii Revised Statutes, is amended by adding a new section to article 1 to be appropriately designated and to read as follows: "§432:1- Biomarker testing; coverage. (a) Each individual or group hospital or medical service plan contract issued or renewed in the State on or after January 1, 2026, shall provide coverage for biomarker testing for the subscriber or member, or any dependent of the subscriber or member who is covered by the plan contract, for purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a subscriber's, member's, or dependent's disease or condition, or to guide treatment decisions when supported by medical and scientific evidence, including: (1) Labeled indications for a test approved or cleared by the United States Food and Drug Administration; (2) Indicated tests for a drug approved by the United States Food and Drug Administration; (3) Warnings and precautions on the label of a drug approved by the United States Food and Drug Administration; (4) National coverage determinations from the Centers for Medicare and Medicaid Services or local coverage determinations from a medicare administrative contractor; or (5) Nationally recognized clinical practice guidelines and consensus statements. (b) Coverage under this section shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies. (c) If a plan contract restricts coverage under this section, the patient and prescribing health care provider shall be provided access to a clear, readily accessible, and convenient process for requesting an exception. The process for requesting an exception shall also be readily accessible on the mutual benefit society's website. (d) Coverage under this section may be subject to the copayment, deductible, and coinsurance provisions of a plan contract; provided that the terms shall be no less favorable than the copayment, deductible, and coinsurance provisions for other medical services covered by the plan contract. (e) Within calendar year 2026, and in no case later than December 31, 2026, each mutual benefit society shall provide written notice to its subscribers and members regarding the coverage required by this section. The notice shall be prominently featured in any literature or correspondence sent annually to subscribers and members. (f) For the purposes of this section: "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" includes gene mutations, gene characteristics, and protein expression. "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, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. "Clinical practice guidelines" means guidelines that establish standards of care informed by a systemic review of evidence and an assessment of the benefits and risks of alternative care options; that include recommendations intended to optimize patient care; and are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. "Consensus statements" means statements developed by an independent multidisciplinary panel of experts using a transparent methodology and reporting structure and with a conflict-of-interest policy and that are focused on specific clinical circumstances and are based on the best available evidence for the purpose of optimizing the outcomes of clinical care." SECTION 3. Section 432D:23, Hawaii Revised Statutes, is amended to read as follows: "§432D-23 Required provisions and benefits. Notwithstanding any provision of law to the contrary, each policy, contract, plan, or agreement issued in the State after January 1, 1995, by health maintenance organizations pursuant to this chapter, shall include benefits provided in sections 431:10-212, 431:10A-115, 431:10A-115.5, 431:10A-116, 431:10A‑116.2, 431:10A-116.5, 431:10A-116.6, 431:10A-119, 431:10A-120, 431:10A-121, 431:10A-122, 431:10A-125, 431:10A-126, 431:10A-132, 431:10A-133, 431:10A-134, 431:10A-140, and [431:10A-134,] 431:10A- , and chapter 431M." SECTION 4. The coverage and benefits to be provided by a health maintenance organization under section 3 of this Act shall take effect for all policies, contracts, plans, or agreements issued or renewed in the State on or after January 1, 2026. SECTION 5. (a) The reimbursement required by sections 1 and 2 of this Act for the medically necessary services of biomarker testing shall apply to all health plans under the State's medicaid managed care program. (b) The department of human services shall submit the necessary amendments to the Hawaii medicaid state plan to the Centers for Medicare and Medicaid Services no later than . SECTION 6. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun before its effective date. SECTION 7. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 8. This Act shall take effect on July 1, 3000; provided that section 5 shall take effect upon the approval of the Hawaii medicaid state plan by the Centers for Medicare and Medicaid Services. |
|---|
| 47 | + | SECTION 1. Chapter 431, Hawaii Revised Statutes, is amended by adding a new section to article 10A to be appropriately designated and to read as follows: "§431:10A- Biomarker testing; coverage. (a) Each individual or group policy of accident and health or sickness insurance issued or renewed in the State on or after January 1, 2026, shall provide coverage for biomarker testing for the policyholder, or any dependent of the policyholder who is covered by the policy, for purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an insured person's disease or condition, or to guide treatment decisions when supported by medical and scientific evidence, including: (1) Labeled indications for a test approved or cleared by the United States Food and Drug Administration; (2) Indicated tests for a drug approved by the United States Food and Drug Administration; (3) Warnings and precautions on the label of a drug approved by the United States Food and Drug Administration; (4) National coverage determinations from the Centers for Medicare and Medicaid Services or local coverage determinations from a medicare administrative contractor; or (5) Nationally recognized clinical practice guidelines and consensus statements. (b) Coverage under this section shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies. (c) If a policy restricts coverage under this section, the patient and prescribing health care provider shall be provided access to a clear, readily accessible, and convenient process for requesting an exception. The process for requesting an exception shall also be readily accessible on the insurer's website. (d) Coverage under this section may be subject to the copayment, deductible, and coinsurance provisions of a policy for accident and health or sickness insurance; provided that the terms shall be no less favorable than the copayment, deductible, and coinsurance provisions for other medical services covered by the policy. (e) Within calendar year 2026, and in no case later than December 31, 2026, each insurer shall provide written notice to its policyholders regarding the coverage required by this section. The notice shall be prominently featured in any literature or correspondence sent annually to policyholders. (f) This section shall not apply to limited benefit health insurance as provided in section 431:10A-607. (g) For the purposes of this section: "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 mediations being considered for use or already being administered. Biomarkers include gene mutations, gene characteristics, and protein expression. "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; multi-plex panel tests; protein expression; and whole exome, whole genome, and whole transcriptome sequencing. "Clinical practice guidelines" means guidelines that establish standards of care informed by a systemic review of evidence and an assessment of the benefits and risks of alternative care options and that include recommendations intended to optimize patient care. Clinical practice guidelines are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. "Consensus statements" means statements developed by an independent multidisciplinary panel of experts using a transparent methodology and reporting structure and with a conflict-of-interest policy. Consensus statements are focused on specific clinical circumstances and are based on the best available evidence for the purpose of optimizing the outcomes of clinical care." SECTION 2. Chapter 432, Hawaii Revised Statutes, is amended by adding a new section to article 1 to be appropriately designated and to read as follows: "§432:1- Biomarker testing; coverage. (a) Each individual or group hospital or medical service plan contract issued or renewed in the State on or after January 1, 2026, shall provide coverage for biomarker testing for the subscriber or member, or any dependent of the subscriber or member who is covered by the plan contract, for purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a subscriber, member, or dependent's disease or condition, or to guide treatment decisions when supported by medical and scientific evidence, including: (1) Labeled indications for a test approved or cleared by the United States Food and Drug Administration; (2) Indicated tests for a drug approved by the United States Food and Drug Administration; (3) Warnings and precautions on the label of a drug approved by the United States Food and Drug Administration; (4) National coverage determinations from the Centers for Medicare and Medicaid Services or local coverage determinations from a medicare administrative contractor; or (5) Nationally recognized clinical practice guidelines and consensus statements. (b) Coverage under this section shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies. (c) If a plan contract restricts coverage under this section, the patient and prescribing health care provider shall be provided access to a clear, readily accessible, and convenient process for requesting an exception. The process for requesting an exception shall also be readily accessible on the mutual benefit society's website. (d) Coverage under this section may be subject to the copayment, deductible, and coinsurance provisions of a plan contract; provided that the terms shall be no less favorable than the copayment, deductible, and coinsurance provisions for other medical services covered by the plan contract. (e) Within calendar year 2026, and in no case later than December 31, 2026, each mutual benefit society shall provide written notice to its subscribers and members regarding the coverage required by this section. The notice shall be prominently featured in any literature or correspondence sent annually to subscribers and members. (f) For the purposes of this section: "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 mediations being considered for use or already being administered. Biomarkers include gene mutations, gene characteristics, and protein expression. "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, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. "Clinical practice guidelines" means guidelines that establish standards of care informed by a systemic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care. Clinical practice guidelines are developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. "Consensus statements" means statements developed by an independent multidisciplinary panel of experts using a transparent methodology and reporting structure and with a conflict-of-interest policy. Consensus statements are focused on specific clinical circumstances and are based on the best available evidence for the purpose of optimizing the outcomes of clinical care." SECTION 3. Section 432D:23, Hawaii Revised Statutes, is amended to read as follows: "§432D-23 Required provisions and benefits. Notwithstanding any provision of law to the contrary, each policy, contract, plan, or agreement issued in the State after January 1, 1995, by health maintenance organizations pursuant to this chapter, shall include benefits provided in sections 431:10-212, 431:10A-115, 431:10A-115.5, 431:10A-116, 431:10A‑116.2, 431:10A-116.5, 431:10A-116.6, 431:10A-119, 431:10A-120, 431:10A-121, 431:10A-122, 431:10A-125, 431:10A-126, 431:10A-132, 431:10A-133, 431:10A-134, 431:10A-140, and [431:10A-134,] 431:10A- , and chapter 431M." SECTION 4. The coverage and benefits to be provided by a health maintenance organization under section 3 of this Act shall take effect for all policies, contracts, plans, or agreements issued or renewed in the State on or after January 1, 2026. SECTION 5. (a) The reimbursement required by sections 1 and 2 of this Act for the medically necessary services of biomarker testing shall apply to all health plans under the State's medicaid managed care program. (b) The department of human services shall submit the necessary amendments to the Hawaii medicaid state plan to the Centers for Medicare and Medicaid Services no later than . SECTION 6. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun before its effective date. SECTION 7. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 8. This Act shall take effect upon its approval; provided that section 5 shall take effect upon the approval of the Hawaii medicaid state plan by the Centers for Medicare and Medicaid Services. INTRODUCED BY: _____________________________ |
|---|