As Introduced
136th General Assembly
Regular Session H. B. No. 8
2025-2026
Representative White, A.
A B I LL
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.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17 H. B. No. 8 Page 2
As Introduced
(C) A health benefit plan shall cover biomarker testing
ordered and deemed medically necessary by the 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) 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.
(E) 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
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45 H. B. No. 8 Page 3
As Introduced
Code. The appeal process shall be made readily accessible to all
participating providers and recipients in writing and online.
(F) Nothing in this section shall be construed to require
coverage of biomarker testing for screening purposes.
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;
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74 H. B. No. 8 Page 4
As Introduced
(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 the 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) 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.
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101 H. B. No. 8 Page 5
As Introduced
(E) 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.
(F) Nothing in this section shall be construed to require
coverage of biomarker testing for screening purposes.
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.
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119