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OLR Bill Analysis
sSB 307
AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER
TESTING.
SUMMARY
This bill requires the Department of Social Services (DSS), to the
extent federal law allows, to provide coverage for biomarker testing to
diagnose, treat, manage, or monitor a Medicaid enrollee’s disease or
condition. The bill requires DSS to condition coverage on medical and
scientific evidence supporting the test, including the following:
1. FDA approval or FDA-approved drug label recommendations;
2. national or local coverage determinations for Medicare
Administrative Contractors by the federal Centers for Medicare
and Medicaid Services;
3. nationally recognized clinical practice guidelines, which are
evidence-based guidelines that set standards of care informed by
a systemic evidence review and cost-benefit analysis of
alternative care options, and are developed by independent
organizations or medical professional societies;
4. consensus statements, which are statements developed by an
independent, multidisciplinary expert panel, aimed at specific
clinical circumstances and based on the best available evidence
to optimize clinical care outcomes; or
5. any other sources for establishing medical necessity as defined in
existing state law (see BACKGROUND).
Both the clinical practice guidelines and the consensus statements
described above must be developed using transparent methodologies, 2024SB-00307-R000317-BA.DOCX
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reporting structures, and conflict of interest policies.
The bill specifies that its provisions do not limit DSS’s ability to
require prior authorization to ensure that requested testing meets the
standards described above.
EFFECTIVE DATE: July 1, 2024
BIOMARKER TESTING
The bill’s coverage requirements apply to biomarker testing, which is
the analysis of a patient’s tissue, blood, or other biospecimen for
biomarkers, which are characteristics, like 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. The testing includes tests for single or multiple
substances, diseases or conditions, and whole genome sequencing.
BACKGROUND
Related Bill
sHB 5367, favorably reported by the Human Services Committee,
requires DSS to provide medically necessary Medicaid coverage for
rapid whole genome sequencing for critically ill infants.
Medical Necessity
By law, for DSS’s medical assistance programs (e.g., Medicaid),
“medically necessary” means health services required to prevent,
identify, diagnose, treat, rehabilitate, or ameliorate a person’s medical
condition, or its effects, to attain or maintain achievable health and
independent functioning. Medically necessary services must be
1. consistent with generally accepted medical practice standards;
2. clinically appropriate in terms of type, frequency, timing, site,
extent, and duration and considered effective for the person’s
illness, injury, or disease;
3. not primarily for the person’s or the health care provider’s 2024SB-00307-R000317-BA.DOCX
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convenience;
4. not more costly than an alternative service that is at least as likely
to produce equivalent therapeutic or diagnostic results for the
person’s illness, injury, or disease; and
5. based on an assessment of the person and their medical condition
(CGS § 17b-259b).
COMMITTEE ACTION
Human Services Committee
Joint Favorable Substitute
Yea 22 Nay 0 (03/19/2024)