Bill Text: HI SB969 | 2025 | Regular Session | Introduced
Bill Title: Relating To Insurance.
Spectrum: Partisan Bill (Democrat 3-0)
Status: (Introduced) 2025-01-23 - Referred to HHS, CPN/WAM. [SB969 Detail]
Download: Hawaii-2025-SB969-Introduced.html
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THE SENATE |
S.B. NO. |
969 |
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THIRTY-THIRD LEGISLATURE, 2025 |
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STATE OF HAWAII |
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A BILL FOR AN ACT
relating to insurance.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
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.
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INTRODUCED BY: |
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Report Title:
Health
Insurance; Mutual Benefit Societies; Health Maintenance Organizations;
Medicaid; Biomarker Testing; Mandatory Coverage
Description:
Beginning
1/1/2026, requires health insurers, mutual benefit societies, health
maintenance organizations, and health plans under the State's Medicaid managed
care program to provide coverage for biomarker testing.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.
