SB 1795

                                      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:
1Section A.  Chapters 208 and 376, RSMo, are amended by
2  adding thereto three new sections, to be known as sections
3  208.1450, 376.1194, and 376.1195, to read as follows:
1208.1450.  1.     The MO HealthNet program shall cover
2  biomarker testing for the purposes of diagnosis, treatment,
3  appropriate management, or ongoing monitoring of a
4  participant's disease or condition to guide treatment
5  decisions when the test provides clinical utility to the
6  patient as demonstrated by medical and scientific evidence,
7  including, but not limited to:
8(1)       Labeled indications for a test approved or cleared
9  by the U.S. Food and Drug Administration (FDA) or indicated
10  tests for an FDA approved drug;
11(2)       Centers for Medicare and Medicaid Services
12  national coverage determinations or Medicare administrative
13  contractor local coverage determinations; or
14(3)       Nationally recognized clinical practice guidelines.
152.     MO HealthNet managed care organizations contracted
16  to deliver services to participants shall provide biomarker
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17 testing at the same scope, duration, and frequency as MO
18 HealthNet otherwise provides to participants.
193.    Nothing in this section shall be construed to
20 require coverage of biomarker testing for screening purposes.
214.    As used in this section, the following terms shall
22 mean:
23(1)    "Biomarker", a defined characteristic that is
24 measured as an indicator of normal biological processes,
25 pathogenic processes, or responses to an exposure or
26 intervention, including therapeutic interventions.
27 Molecular, histologic, radiographic, or physiologic
28 characteristics are types of biomarkers.     A biomarker is not
29 an assessment of how a patient feels, functions, or survives;
30(2)    "Biomarker testing", the analysis of a patient's
31 tissue, blood, or other biospecimen for the presence of a
32 biomarker.     Biomarker testing includes, but is not limited
33 to, single-analyte tests and multi-plex panel tests
34 performed at a participating in-network laboratory facility
35 that is either CLIA certified or CLIA waived by the federal
36 Food and Drug Administration.
1376.1194.    For purposes of this section and section
2 376.1195, the following terms shall mean:
3(1)    "Biomarker", a defined characteristic that is
4 measured as an indicator of normal biological processes,
5 pathogenic processes, or responses to an exposure or
6 intervention, including therapeutic interventions.
7 Molecular, histologic, radiographic, or physiologic
8 characteristics are types of biomarkers.     A biomarker is not
9 an assessment of how a patient feels, functions, or survives;
10(2)    "Biomarker testing", the analysis of a patient's
11 tissue, blood, or other biospecimen for the presence of a
12 biomarker.     Biomarker testing includes, but is not limited
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13 to, single-analyte tests and multi-plex panel tests
14 performed at a participating in-network laboratory facility
15 that is either CLIA certified or CLIA waived by the U.S.
16 Food and Drug Administration;
17(3)    "Clinical utility", the test result provides
18 information that is used in the formulation of a treatment
19 or monitoring strategy that informs a patient's outcome and
20 impacts the clinical decision;
21(4)    "Nationally recognized clinical practice
22 guidelines", evidence-based clinical practice guidelines
23 developed by independent organizations or medical
24 professional societies utilizing a transparent methodology
25 and reporting structure and with a conflict of interest
26 policy.     Clinical practice guidelines establish standards of
27 care informed by a systematic review of evidence and an
28 assessment of the benefits and costs of alternative care
29 options and include recommendations intended to optimize
30 patient care.
1376.1195.    1.   Health insurers, nonprofit health
2 service plans, and health maintenance organizations issuing,
3 amending, delivering, or renewing a health insurance
4 contract on or after August 28, 2026, shall include coverage
5 for biomarker testing for the purposes of diagnosis,
6 treatment, appropriate management, or ongoing monitoring of
7 a covered person's disease or condition to guide treatment
8 decisions when the test provides clinical utility to the
9 patient as demonstrated by medical and scientific evidence,
10 including, but not limited to:
11(1)    Labeled indications for a test approved or cleared
12 by the U.S. Food and Drug Administration or indicated tests
13 for an FDA approved drug;
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14(2)    Centers for Medicare and Medicaid Services
15 national coverage determinations or Medicare administrative
16 contractor local coverage determinations; or
17(3)    Nationally recognized clinical practice guidelines.
182.    Such coverage shall be provided in a manner that
19 shall limit disruptions in care including the need for
20 multiple biopsies or biospecimen samples.
213.    The patient and prescribing practitioner shall have
22 access to a clear, readily accessible, and convenient
23 process to request an exception to a coverage policy
24 provided pursuant to the provisions of this section.        Such
25 process shall be made readily accessible on the health
26 insurer's, nonprofit health service plan's, or health
27 maintenance organization's website.
284.    Nothing in this section shall be construed to
29 require coverage of biomarker testing for screening purposes.
305.    The department of commerce and insurance shall
31 adopt rules as necessary to effectuate the provisions of
32 this section.     Any rule or portion of a rule, as that term
33 is defined in section 536.010, that is created under the
34 authority delegated in this section shall become effective
35 only if it complies with and is subject to all of the
36 provisions of chapter 536 and, if applicable, section
37 536.028.     This section and chapter 536 are nonseverable and
38 if any of the powers vested with the general assembly
39 pursuant to chapter 536 to review, to delay the effective
40 date, or to disapprove and annul a rule are subsequently
41 held unconstitutional, then the grant of rulemaking
42 authority and any rule proposed or adopted after August 28,
43 2026, shall be invalid and void.
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