Substitute Senate Bill No. 307
Public Act No. 24-50
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) "Biomarker" means a characteristic, including, but not limited to,
a gene mutation or protein expression that can be objectively measured
and evaluated as an indicator of normal biological processes, pathogenic
processes or pharmacologic responses to a specific therapeutic
intervention for a disease or condition.
(2) "Biomarker testing" means the analysis of a patient's tissue, blood
or other biospecimen for the presence of a biomarker, including, but not
limited to, tests for a single substance, tests for multiple substances,
diseases or conditions, and whole genome sequencing.
(3) "Clinical utility" means the test result provides information that is
used in the formulation of a treatment or monitoring strategy that
informs a patient's outcome and impacts the clinical decision. The most
appropriate test may include both information that is actionable and
some information that cannot be immediately used in the formulation
of a clinical decision. Substitute Senate Bill No. 307
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(4) "Consensus statements" means statements developed by an
independent, multidisciplinary panel of experts utilizing a transparent
methodology and reporting structure and with a conflict-of-interest
policy that are (A) aimed at specific clinical circumstances, and (B) based
on the best available evidence for the purpose of optimizing clinical care
outcomes.
(5) "Nationally recognized clinical practice guidelines" means
evidence-based guidelines developed by independent organizations or
medical professional societies utilizing transparent methodologies and
reporting structures and conflict-of-interest policies that (A) establish
standards of care informed by a systematic review of evidence and
assessments of the benefits and costs of alternative care options, and (B)
include recommendations intended to optimize patient care.
(b) The Commissioner of Social Services, to the extent permissible
under federal law, shall provide coverage for biomarker testing for the
purpose of diagnosis, treatment, appropriate management or ongoing
monitoring of a Medicaid enrollee's disease or condition. The
commissioner shall ensure that such coverage is medically necessary
pursuant to section 17b-259b of the general statutes and, to assist in such
determination of medical necessity, shall analyze relevant information
and use applicable clinical guidelines to help inform such
determination, including medical and scientific evidence supporting
such test when the test provides clinical utility as demonstrated by
medical and scientific evidence, including, but not limited to, one or
more of the following: (1) Approval of such test by the federal Food and
Drug Administration or recommendations on labels of drugs approved
by the federal Food and Drug Administration to conduct such test, (2)
national coverage determinations or local coverage determinations for
Medicare Administrative Contractors by the Centers for Medicare and
Medicaid Services, or (3) nationally recognized clinical practice
guidelines and consensus statements. Nothing in this section shall Substitute Senate Bill No. 307
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change the requirement in section 17b-259b of the general statutes that
policies, guidelines and similar information shall be used solely as
guidelines and shall not be the basis for a final determination of medical
necessity.
(c) Nothing herein shall restrict the ability of the Department of Social
Services to require prior authorization to assure that a request for testing
meets the standards under this section.
(d) Any Medicaid enrollee who is adversely affected by a decision of
the department under this section may request a hearing in accordance
with section 17b-60 of the general statutes.
(e) The Commissioner of Social Services shall ensure that the
coverage as defined in subsection (b) of this section is provided in a
manner that is designed to limit disruptions in care.