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As Reported by the House Health Committee
136th
General Assembly
Regular
Session
Am. H. B. No. 8
2025-2026
Representative White, A.
Cosponsors: Representatives Schmidt,
Somani
A
BILL
To
enact sections 3902.65 and 5164.13 of the Revised Code
to
require health benefit plan and Medicaid program coverage of
biomarker testing.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section
1.
That
sections
3902.65
and
5164.13 of the Revised Code be enacted to read as follows:
Sec.
3902.65.
(A)
As used in this section, "biomarker," "biomarker
testing," and "nationally recognized clinical practice
guidelines" have the same meanings as in section 5164.13 of the
Revised Code.
(B)
Notwithstanding section 3901.71 of the Revised Code, a health benefit
plan issued, renewed, or modified in this state on or after the
effective date of this section shall cover biomarker testing for any
of the following purposes:
(1)
Diagnosis;
(2)
Treatment and appropriate management of a disease or condition;
(3)
Ongoing monitoring of a disease or condition.
(C)
A health benefit plan shall cover biomarker testing ordered and
deemed medically necessary by
a
qualified
treating health care provider working within the provider's scope of
practice for the purposes included in division (B) of this section
when the test is supported by medical or scientific evidence, as
defined by section 3922.01 of the Revised Code, including at least
one of the following:
(1)
Labeled indications for a United States food and drug administration
approved or cleared test;
(2)
Indicated tests for a drug approved by the United States food and
drug administration;
(3)
Warnings and precautions for United States food and drug
administration approved drug labels;
(4)
National coverage determinations made by the United States centers
for medicare and medicaid services;
(5)
Medicare administrative contractor local coverage determinations;
(6)
Nationally recognized clinical practice guidelines;
(7)
Nationally recognized and peer reviewed studies indicating that the
test materially improves health outcomes.
(D)
If
there are multiple available biomarker tests that offer comparable
information, include all needed biomarkers, and are supported by
medical or scientific evidence as required by division (C) of this
section, a health benefit plan required to provide coverage under
division (B) of this section shall cover at least one such test at
the appropriate scope, duration, and frequency for the purposes
described in that division. A provider ordering the biomarker test
may request a coverage exception for any reason, including time
necessary to analyze a sample.
(E)
A
health plan issuer shall ensure coverage as required in division (B)
of this section in a manner that limits disruptions in care,
including the need for multiple biopsies or biospecimen samples.
(F)
Any
appeal of a biomarker testing coverage determination shall be handled
in accordance with the health plan issuer's appeal policy and any
other relevant provision of law, including section 1751.82 or Chapter
3922. of the Revised Code. The appeal process shall be made readily
accessible to all participating providers and recipients in writing
and online.
(G)
Nothing
in this section shall be construed to require coverage of biomarker
testing for screening purposes.
(G)(1)
Within ninety days after the effective date of this section, again
not later than February 1, 2027, and not later than the first day of
February of each year thereafter, the superintendent of insurance
shall submit to the standing committees of both the house of
representatives and of the senate with primary responsibility for
insurance legislation a report on health benefit plan provider
reimbursement rates for biomarker testing provided in this state by
health benefit plans during the previous year.
(2)
The report shall include the following statewide aggregate
information for both calendar year 2024 and the calendar year
immediately preceding the year the report is submitted:
(a)
The total number of insured patients who received biomarker testing;
(b)
The number of prior authorization requests for biomarker testing that
were approved by the health plan issuer;
(c)
The number of prior authorization requests for biomarker testing that
were denied by the health plan issuer;
(d)
The average and median amounts billed by providers per biomarker test
and the average and median amounts reimbursed to providers by health
benefit plans per biomarker test;
(e)
The ten most common conditions for which or reasons why biomarker
testing was ordered;
(f)
The number of patients who switched or avoided certain treatments as
a result of biomarker testing results;
(g)
Cost savings as a result of covering biomarker testing under health
benefit plans in this state.
(3)
If any of the above data is not available, the report shall indicate
why the data is unavailable.
(4)
The report also shall provide recommendations on future reporting and
cost considerations for the committee.
Sec.
5164.13.
(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
specific therapeutic intervention, including known gene-drug
interactions for drugs being considered for use or already available
for use. Biomarkers include, but are not limited to, gene mutations,
characteristics of genes, or protein expression.
(2)
"Biomarker testing" means the analysis of tissue, blood, or
another biospecimen for the presence of a biomarker, and includes,
but is not limited to, single-analyte tests, multiplex panel tests,
protein expression, and whole exome, whole genome, and whole
transcriptome sequencing.
(3)
"Nationally recognized clinical practice guidelines" are
evidence-based clinical practice guidelines establishing standards of
care informed by a systematic review and assessment of benefits and
risks of alternative care options and include recommendations
intended to optimize patient care, developed by independent
organizations or medical professional societies utilizing a
transparent methodology and reporting structure and with a conflict
of interest policy.
(B)
The medicaid program shall cover biomarker testing, subject to
division (C) of this section, for any of the following purposes:
(1)
Diagnosis;
(2)
Treatment and appropriate management of a disease or condition;
(3)
Ongoing monitoring of a disease or condition.
(C)
The medicaid program shall cover biomarker testing ordered and deemed
medically necessary by
a
qualified
treating health care provider working within the provider's scope of
practice for the purposes included in division (B) of this section
when the test is supported by medical or scientific evidence, as
defined by section 3922.01 of the Revised Code, including at least
one of the following:
(1)
Labeled indications for a United States food and drug administration
approved or cleared test;
(2)
Indicated tests for a drug approved by the United States food and
drug administration;
(3)
Warnings and precautions for United States food and drug
administration approved drug labels;
(4)
National coverage determinations made by the United States centers
for medicare and medicaid services;
(5)
Medicare administrative contractor local coverage determinations;
(6)
Nationally recognized clinical practice guidelines;
(7)
Nationally recognized and peer reviewed studies indicating that the
test materially improves health outcomes.
(D)
If
there are multiple available biomarker tests that offer comparable
information, include all needed biomarkers, and are supported by
medical or scientific evidence as required by division (C) of this
section, the medicaid program shall cover at least one such test at
the appropriate scope, duration, and frequency for the purposes
described in division (B) of this section. A provider ordering the
test may request a coverage exception for any reason, including time
necessary to analyze a sample.
(E)
The
Medicaid program shall ensure coverage as required in division (B) of
this section in a manner that limits disruptions in care, including
the need for multiple biopsies or biospecimen samples.
(F)
Any
appeal of a biomarker testing coverage policy shall be handled in
accordance with section 5160.31 of the Revised Code. The appeal
process shall be made readily accessible to all participating
providers and recipients in writing and online.
(G)
Nothing
in this section shall be construed to require coverage of biomarker
testing for screening purposes.
(G)(1)
Within ninety days of the effective date of this section, again not
later than February 1, 2027, and not later than the first day of
February of each year thereafter, the medicaid director shall submit
to the standing committees of both the house of representatives and
of the senate with primary responsibility for insurance legislation a
report on provider reimbursement rates for biomarker testing provided
under the medicaid program in this state during the previous year.
(2)
The report shall include the following statewide aggregate
information for both calendar year 2024 and the calendar year
immediately preceding the year the report is submitted:
(a)
The total number of patients who received biomarker testing under the
medicaid program;
(b)
The number of prior authorization requests for biomarker testing that
were approved under the medicaid program;
(c)
The number of prior authorization requests for biomarker testing that
were denied under the medicaid program;
(d)
The average and median amounts billed by medicaid providers per
biomarker test and the average and median amounts reimbursed by the
medicaid program to medicaid providers for biomarker testing, along
with the average medicare provider reimbursement for biomarker
testing;
(e)
The ten most common conditions for which or reasons why biomarker
testing was ordered;
(f)
The number of patients who switched or avoided certain treatments as
a result of biomarker testing results;
(g)
Cost savings as a result of covering biomarker testing under the
medicaid program during the applicable calendar year.
(3)
If any of the above data is not available, the report shall indicate
why the data is unavailable.
(4)
The report also shall provide recommendations on future reporting and
cost considerations for the committee.
Section
2.
It
is the intent of the General Assembly to ensure coverage for
appropriate biomarker testing supported by medical or scientific
evidence, as defined by section 3922.01 of the Revised Code, with the
goal of producing long-term healthcare cost savings and improving
health outcomes for Ohioans covered under this act. The General
Assembly does not intend to create a landscape which allows
manufacturers and administrators of biomarker tests to substantially
increase pricing for existing and new biomarker tests as a result of
the coverage requirements for certain health insurance markets under
this act.