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Full Text of SB3509
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SB3509 - 104th General Assembly
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SB3509 Enrolled
LRB104 19966 BAB 33416 b
1
AN ACT concerning regulation.
2
Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:
4
Section 5.
The Illinois Insurance Code is amended by
5
changing Section 356z.46 as follows:
6
(215 ILCS 5/356z.46)
7
Sec. 356z.46.
Biomarker testing.
8
(a) As used in this Section:
9
"Biomarker" means a characteristic that is objectively
10
measured and evaluated as an indicator of normal biological
11
processes, pathogenic processes, or pharmacologic responses to
12
a specific therapeutic intervention
, including known gene-drug
13
interactions for medications being considered for use or
14
already being used
. "Biomarker" includes, but is not limited
15
to, gene mutations
, characteristics of genes,
or protein
16
expression.
17
"Biomarker testing" means the analysis of a patient's
18
tissue, blood, or
other
fluid
biospecimen for the presence of
19
a biomarker. "Biomarker testing" includes, but is not limited
20
to, single-analyte tests, multi-plex panel tests,
protein
21
expression whole exome,
and partial or
whole genome
, and whole
22
transcriptome sequencing and other genomic or molecular
23
sequencing.
SB3509 Enrolled
- 2 -
LRB104 19966 BAB 33416 b
1
"Consensus statement" means a statement developed by an
2
independent, multidisciplinary panel of experts using a
3
transparent methodology and reporting structure, with a
4
conflict of interest policy, that is aimed at specific
5
clinical circumstances, and the statement is based on the best
6
available evidence for the purpose of optimizing the outcomes
7
of clinical care.
8
"Nationally recognized clinical practice guidelines" means
9
evidence-based clinical practice guidelines developed by
10
independent organizations or medical professional societies
11
using a transparent methodology and reporting structure, with
12
a conflict of interest policy, that establish standards of
13
care informed by a systematic review of evidence and an
14
assessment of the benefits and risks of alternative care
15
options and that include recommendations intended to optimize
16
patient care.
17
(b) A group or individual policy of accident and health
18
insurance or managed care plan amended, delivered, issued, or
19
renewed on or after January 1, 2022 shall include coverage for
20
biomarker testing as defined in this Section pursuant to
21
criteria established under subsection (d).
22
(c) Biomarker testing shall be covered and conducted in an
23
efficient manner to provide the most complete range of results
24
to the patient's health care provider without requiring
25
multiple biopsies, biospecimen samples, or other delays or
26
disruptions in patient care.
SB3509 Enrolled
- 3 -
LRB104 19966 BAB 33416 b
1
(d) Biomarker testing must be covered for the purposes of
2
diagnosis, treatment, appropriate management, or ongoing
3
monitoring of an enrollee's disease or condition when the test
4
is supported by medical and scientific evidence, including,
5
but not limited to
, any one of the following
:
6
(1) labeled indications for an FDA-approved
or
7
FDA-cleared
test
;
or
8
(2)
indicated tests for an FDA-approved drug;
9
(3) warnings and precautions on FDA-approved drug
10
labels;
11
(4)
(2)
federal Centers for Medicare and Medicaid
12
Services National Coverage Determinations
or any Medicare
13
Administrative Contractor (MAC) Local Coverage
14
Determinations and associated Local Coverage Articles
;
or
15
(5) testing recommendations or considerations from:
16
(A)
(3)
nationally recognized clinical practice
17
guidelines;
or
18
(B) a consensus statement.
19
(4) consensus statements;
20
(5) professional society recommendations;
21
(6) peer-reviewed literature, biomedical compendia,
22
and other medical literature that meet the criteria of the
23
National Institutes of Health's National Library of
24
Medicine for indexing in Index Medicus, Excerpta Medicus,
25
Medline, and MEDLARS database of Health Services
26
Technology Assessment Research; and
SB3509 Enrolled
- 4 -
LRB104 19966 BAB 33416 b
1
(7) peer-reviewed scientific studies published in or
2
accepted for publication by medical journals that meet
3
nationally recognized requirements for scientific
4
manuscripts and that submit most of their published
5
articles for review by experts who are not part of the
6
editorial staff.
7
(e)
The requirements set forth in this Section are subject
8
to and shall operate in accordance with subsection (b) of
9
Section 20 of the Prior Authorization Reform Act and Section
10
45 of the Managed Care Reform and Patient Rights Act.
When
11
coverage of biomarker testing for the purpose of diagnosis,
12
treatment, or ongoing monitoring of any medical condition is
13
restricted for use by a group or individual policy of accident
14
and health insurance or managed care plan, the patient and
15
prescribing practitioner shall have access to a clear, readily
16
accessible, and convenient processes to request an exception.
17
The process shall be made readily accessible on the insurer's
18
website.
19
(f) The changes made to this Section by this amendatory
20
Act of the 104th General Assembly apply to policies,
21
contracts, and certificates of insurance amended, delivered,
22
issued, or renewed on or after January 1, 2028.
23
(Source: P.A. 102-203, eff. 1-1-22; 102-813, eff. 5-13-22.)
24
Section 99.
Effective date.
This Act takes effect January
25
1, 2028.
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