Bill Text: HI HB2223 | 2024 | Regular Session | Amended
Bill Title: Relating To Insurance.
Spectrum: Partisan Bill (Democrat 8-0)
Status: (Introduced) 2024-02-08 - Passed Second Reading as amended in HD 1 and referred to the committee(s) on CPC with none voting aye with reservations; none voting no (0) and Representative(s) Nakashima, Nishimoto, Sayama, Ward excused (4). [HB2223 Detail]
Download: Hawaii-2024-HB2223-Amended.html
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HOUSE OF REPRESENTATIVES |
H.B. NO. |
2223 |
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THIRTY-SECOND LEGISLATURE, 2024 |
H.D. 1 |
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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:
"§431:10A- Biomarker testing; coverage. (a) Each individual or group policy
of accident and health or sickness insurance issued or renewed in this State on
or after January 1, 2025, shall provide coverage for the medically necessary services
of biomarker testing for the policyholder or any dependent of the policyholder
who is covered by the policy for the purposes of diagnosis, treatment,
appropriate management, or ongoing monitoring of an insured's disease or
condition to guide treatment decisions when supported by medical and scientific
evidence, including but not limited to:
(1) Labeled indications for an
FDA-approved or FDA-cleared test;
(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.
(b) Coverage under this section shall be provided
in a manner that limits disruptions in care, including the need for multiple
biopsies and consensus statements.
(c) When coverage under this section is
restricted for use by a policy, the patient and prescribing health care
provider shall have access to clear, readily accessible, and convenient
processes to request an exception. The
process shall be made readily accessible on the insurer's website.
(d) Coverage under this section may be subject to
copayment, deductible, and coinsurance provisions of a policy of accident and
health or sickness insurance that are no less favorable than the copayment,
deductible, and coinsurance provisions for other medical services covered by
the policy.
(e) Every insurer shall provide written notice to
its policyholders regarding the coverage required by this section. The notice shall be in writing and
prominently positioned in any literature or correspondence sent to
policyholders and shall be transmitted within calendar year 2025 when annual
information is made available to policyholders or in any other mailing to policyholders,
but in no case later than December 31, 2025.
(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" include but are not limited to gene mutations,
gene characteristics, or 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 but is not limited to
single-analyte tests, multi-plex panel tests, protein expression, whole exome,
and 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.
"Consensus
statements" means statements developed by an independent multidisciplinary
panel of experts utilizing a transparent methodology and reporting structure
and that include a conflict of interest policy, which are aimed at specific
clinical circumstances and based on the best available evidence for the purpose
of optimizing the outcomes of clinical care.
"FDA"
means the United States Food and Drug Administration.
"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 that include a conflict of interest policy."
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- Biomarker
testing; coverage. (a)
Every individual or group hospital or medical service plan
contract issued or renewed in this State on or after January 1, 2025, shall
provide coverage for the medically necessary services of biomarker testing for
the subscriber or member or any dependent of the subscriber or member who is
covered by the plan contract for the purposes of diagnosis, treatment,
appropriate management, or ongoing monitoring of a subscriber's or member's or
dependent's disease or condition to guide treatment decisions, when supported
by medical and scientific evidence, including but not limited to:
(1) Labeled
indications for an FDA-approved or FDA-cleared test;
(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.
(b) Coverage under this section shall be provided
in a manner that limits disruptions in care, including the need for multiple
biopsies and consensus statements.
(c) When coverage under this section is restricted
for use by a plan contract, the patient and prescribing health care provider
shall have access to clear, readily accessible, and convenient processes to
request an exception. The process shall
be made readily accessible on the mutual benefit society's website.
(d) Coverage under this section may be subject to
copayment, deductible, and coinsurance provisions of a plan contract that are
no less favorable than the copayment, deductible, and coinsurance provisions
for other medical services covered by the plan contract.
(e) Every mutual benefit society shall provide
written notice to its subscribers and members regarding the coverage required
by this section. The notice shall be in
writing and prominently positioned in any literature or correspondence sent to subscribers
and members and shall be transmitted within calendar year 2025 when annual
information is made available to subscribers or members or in any other mailing
to subscribers or members, but in no case later than December 31, 2025.
(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" include but are not
limited to gene mutations, gene characteristics, or 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 but is not limited to single-analyte tests, multi-plex
panel tests, protein expression, whole exome, and 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.
"Consensus statements"
means statements developed by an independent multidisciplinary panel of experts
utilizing a transparent methodology and reporting structure and that include a
conflict of interest policy, which are aimed at specific clinical circumstances
and based on the best available evidence for the purpose of optimizing the
outcomes of clinical care.
"FDA" means the United
States Food and Drug Administration.
"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 that include a conflict of interest policy."
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, 2025.
SECTION 5. (a) The reimbursement for medically necessary services of biomarker testing required under sections 1 and 2 of this Act shall apply to all health plans under the medicaid managed care program in the State.
(b) The department of human services shall submit the amendments to the Hawaii medicaid state plan to the Centers for Medicare and Medicaid Services no later than .
SECTION 6. Statutory material to be repealed is
bracketed and stricken. New statutory
material is underscored.
SECTION 7. This Act shall take effect on July 1, 3000; provided that section 5 shall take effect upon approval of the Hawaii medicaid state plan by the Centers for Medicare and Medicaid Services.
Report Title:
Health Insurance; Mutual Benefit Societies; Health Maintenance Organizations; Medicaid; Biomarker Testing; Mandatory Coverage
Description:
Beginning 1/1/2025, 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. Effective 7/1/3000. (HD1)
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.
