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SECOND REGULAR SESSION
SENATE BILL NO. 1795
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR WEBBER.
7393S.01I KRISTINA MARTIN, Secretary
AN ACT
To amend chapters 208 and 376, RSMo, by adding thereto three new sections relating to biomarker
testing.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Chapters 208 and 376, RSMo, are amended by 1
adding thereto three new sections, to be known as sections 2
208.1450, 376.1194, and 376.1195, to read as follows:3
208.1450. 1. The MO HealthNet program shall cover 1
biomarker testing for the purposes of diagnosis, treatment, 2
appropriate management, or ongoing monitoring of a 3
participant's disease or condition to guide treatment 4
decisions when the test provides clinical utility to the 5
patient as demonstrated by medical and scientific evidence, 6
including, but not limited to: 7
(1) Labeled indications for a test approved or cleared 8
by the U.S. Food and Drug Administration (FDA) or indicated 9
tests for an FDA approved drug; 10
(2) Centers for Medicare and Medicaid Services 11
national coverage determinations or Medicare administrative 12
contractor local coverage determinations; or 13
(3) Nationally recognized clinical practice guidelines. 14
2. MO HealthNet managed care organizations contracted 15
to deliver services to participants shall provide biomarker 16
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testing at the same scope, duration, and frequency as MO 17
HealthNet otherwise provides to participants. 18
3. Nothing in this section shall be construed to 19
require coverage of biomarker testing for screening purposes. 20
4. As used in this section, the following terms shall 21
mean: 22
(1) "Biomarker", a defined characteristic that is 23
measured as an indicator of normal biological processes, 24
pathogenic processes, or responses to an exposure or 25
intervention, including therapeutic interventions. 26
Molecular, histologic, radiographic, or physiologic 27
characteristics are types of biomarkers. A biomarker is not 28
an assessment of how a patient feels, functions, or survives; 29
(2) "Biomarker testing", the analysis of a patient's 30
tissue, blood, or other biospecimen for the presence of a 31
biomarker. Biomarker testing includes, but is not limited 32
to, single-analyte tests and multi-plex panel tests 33
performed at a participating in-network laboratory facility 34
that is either CLIA certified or CLIA waived by the federal 35
Food and Drug Administration. 36
376.1194. For purposes of this section and section 1
376.1195, the following terms shall mean: 2
(1) "Biomarker", a defined characteristic that is 3
measured as an indicator of normal biological processes, 4
pathogenic processes, or responses to an exposure or 5
intervention, including therapeutic interventions. 6
Molecular, histologic, radiographic, or physiologic 7
characteristics are types of biomarkers. A biomarker is not 8
an assessment of how a patient feels, functions, or survives; 9
(2) "Biomarker testing", the analysis of a patient's 10
tissue, blood, or other biospecimen for the presence of a 11
biomarker. Biomarker testing includes, but is not limited 12
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to, single-analyte tests and multi-plex panel tests 13
performed at a participating in-network laboratory facility 14
that is either CLIA certified or CLIA waived by the U.S. 15
Food and Drug Administration; 16
(3) "Clinical utility", the test result provides 17
information that is used in the formulation of a treatment 18
or monitoring strategy that informs a patient's outcome and 19
impacts the clinical decision; 20
(4) "Nationally recognized clinical practice 21
guidelines", evidence-based clinical practice guidelines 22
developed by independent organizations or medical 23
professional societies utilizing a transparent methodology 24
and reporting structure and with a conflict of interest 25
policy. Clinical practice guidelines establish standards of 26
care informed by a systematic review of evidence and an 27
assessment of the benefits and costs of alternative care 28
options and include recommendations intended to optimize 29
patient care. 30
376.1195. 1. Health insurers, nonprofit health 1
service plans, and health maintenance organizations issuing, 2
amending, delivering, or renewing a health insurance 3
contract on or after August 28, 2026, shall include coverage 4
for biomarker testing for the purposes of diagnosis, 5
treatment, appropriate management, or ongoing monitoring of 6
a covered person's disease or condition to guide treatment 7
decisions when the test provides clinical utility to the 8
patient as demonstrated by medical and scientific evidence, 9
including, but not limited to: 10
(1) Labeled indications for a test approved or cleared 11
by the U.S. Food and Drug Administration or indicated tests 12
for an FDA approved drug; 13
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(2) Centers for Medicare and Medicaid Services 14
national coverage determinations or Medicare administrative 15
contractor local coverage determinations; or 16
(3) Nationally recognized clinical practice guidelines. 17
2. Such coverage shall be provided in a manner that 18
shall limit disruptions in care including the need for 19
multiple biopsies or biospecimen samples. 20
3. The patient and prescribing practitioner shall have 21
access to a clear, readily accessible, and convenient 22
process to request an exception to a coverage policy 23
provided pursuant to the provisions of this section. Such 24
process shall be made readily accessible on the health 25
insurer's, nonprofit health service plan's, or health 26
maintenance organization's website. 27
4. Nothing in this section shall be construed to 28
require coverage of biomarker testing for screening purposes. 29
5. The department of commerce and insurance shall 30
adopt rules as necessary to effectuate the provisions of 31
this section. Any rule or portion of a rule, as that term 32
is defined in section 536.010, that is created under the 33
authority delegated in this section shall become effective 34
only if it complies with and is subject to all of the 35
provisions of chapter 536 and, if applicable, section 36
536.028. This section and chapter 536 are nonseverable and 37
if any of the powers vested with the general assembly 38
pursuant to chapter 536 to review, to delay the effective 39
date, or to disapprove and annul a rule are subsequently 40
held unconstitutional, then the grant of rulemaking 41
authority and any rule proposed or adopted after August 28, 42
2026, shall be invalid and void. 43
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