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General Assembly Raised Bill No. 6628
January Session, 2023
LCO No. 3675
Referred to Committee on HUMAN SERVICES
Introduced by:
(HS)
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, 2023) (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, 4
pathogenic processes or pharmacologic responses to a specific 5
therapeutic intervention for a disease or condition. 6
(2) "Biomarker testing" means the analysis of a patient's tissue, 7
blood or other biospecimen for the presence of a biomarker, including, 8
but not limited to, tests for a single substance, tests for multiple 9
substances, 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 aimed at (A) specific clinical circumstances, and (B) 14
based on the best available evidence for the purpose of optimizing 15 Bill No. 6628
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clinical care outcomes. 16
(4) "Nationally recognized clinical practice guidelines" means 17
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 22
(B) 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 test, including, but not limited to (1) 29
approval of such test by the federal Food and Drug Administration or 30
recommendations on labels of drugs approved by the federal Food and 31
Drug Administration to conduct such test, (2) national coverage 32
determinations or local coverage determinations for Medicare 33
Administrative Contractors by the Centers for Medicare and Medicaid 34
Services, or (3) nationally recognized clinical practice guidelines and 35
consensus statements. 36
(c) The Commissioner of Social Services shall provide online access 37
to a Medicaid enrollee and a Medicaid provider to a clear, readily 38
accessible and convenient process to request an exception to a prior 39
authorization requirement or other coverage policy provision for 40
biomarker testing. 41
This act shall take effect as follows and shall amend the following
sections:
Section 1 July 1, 2023 New section
HS Joint Favorable C/R APP Bill No. 6628
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