LCO 1 of 3
General Assembly Substitute Bill No. 307
February Session, 2024
AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER
TESTING.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective July 1, 2024) (a) As used in this section: 1
(1) "Biomarker" means a characteristic, including, but not limited to, 2
a gene mutation or protein expression that can be objectively measured 3
and evaluated as an indicator of normal biological processes, pathogenic 4
processes or pharmacologic responses to a specific therapeutic 5
intervention for a disease or condition. 6
(2) "Biomarker testing" means the analysis of a patient's tissue, blood 7
or other biospecimen for the presence of a biomarker, including, but not 8
limited to, tests for a single substance, tests for multiple substances, 9
diseases or conditions, and whole genome sequencing. 10
(3) "Consensus statements" means statements developed by an 11
independent, multidisciplinary panel of experts utilizing a transparent 12
methodology and reporting structure and with a conflict-of-interest 13
policy that are (A) aimed at specific clinical circumstances, and (B) based 14
on the best available evidence for the purpose of optimizing clinical care 15
outcomes. 16
(4) "Nationally recognized clinical practice guidelines" means 17 Substitute Bill No. 307
LCO 2 of 3
evidence-based guidelines developed by independent organizations or 18
medical professional societies utilizing transparent methodologies and 19
reporting structures and conflict-of-interest policies that (A) establish 20
standards of care informed by a systematic review of evidence and 21
assessments of the benefits and costs of alternative care options, and (B) 22
include recommendations intended to optimize patient care. 23
(b) The Commissioner of Social Services, to the extent permissible 24
under federal law, shall provide coverage for biomarker testing for the 25
purpose of diagnosis, treatment, appropriate management or ongoing 26
monitoring of a Medicaid enrollee's disease or condition. The 27
commissioner shall condition such coverage on medical and scientific 28
evidence supporting such testing, including, but not limited to, (1) (A) 29
approval of such testing by the federal Food and Drug Administration, 30
or (B) recommendations provided on the labels of certain drugs 31
approved by the federal Food and Drug Administration that such 32
testing should be conducted prior to the use of such drugs, (2) national 33
coverage determinations or local coverage determinations for Medicare 34
Administrative Contractors by the Centers for Medicare and Medicaid 35
Services, (3) nationally recognized clinical practice guidelines and 36
consensus statements, or (4) any other sources for establishing medical 37
necessity in accordance with section 17b-259b of the general statutes. 38
(c) Nothing in this section shall be construed to limit the ability of the 39
Department of Social Services to require prior authorization to ensure 40
that a request for biomarker testing meets the standards under this 41
section. 42
This act shall take effect as follows and shall amend the following
sections:
Section 1 July 1, 2024 New section
Statement of Legislative Commissioners:
In Subsec. (b), "test" was changed to "testing" for consistency, Subsec.
(b)(1) was redrafted for clarity, and in Subsec. (c), "testing" was changed
to "biomarker testing" for consistency. Substitute Bill No. 307
LCO 3 of 3
HS Joint Favorable Subst.