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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.Every fact on this page links to its source, starting with the official bill record.