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OLR Bill Analysis
sSB 307 (File 317, as amended by Senate "A")
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 the DSS commissioner to ensure this
coverage is medically necessary under existing state law applicable to
Medicaid services (see BACKGROUND).
The bill requires the commissioner to analyze relevant information
and use applicable clinical guidelines to inform her medical necessity
determination for the testing, including medical and scientific evidence
that demonstrates that a test provides clinical utility (e.g., FDA approval
or recommendations or other coverage determinations).
Under existing law, clinical policies, medical policies, clinical criteria,
and any other generally accepted clinical practice guidelines that DSS
uses to evaluate a service’s medical necessity are only used as guidelines
and are not the basis for DSS’s final determination. The bill specifies that
its provisions do not change these medical necessity provisions in
existing law. The bill further specifies that its provisions do not limit
DSS’s ability to require prior authorization to ensure that requested
testing meets the standards described above.
The bill requires the DSS commissioner to ensure that Medicaid
coverage of biomarker testing is provided in a way that limits
disruptions in care. The bill allows anyone adversely affected by DSS’s
decisions on this testing to request a fair hearing from the department
under a process established in existing law (CGS § 17b-60).
*Senate Amendment “A” (1) requires DSS to ensure coverage is 2024SB-00307-R01-BA.DOCX
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medically necessary under existing law rather than conditioning
coverage on certain evidence to determine medical necessity, (2)
requires evidence to demonstrate clinical utility and defines this term,
and (3) adds provisions on limiting disruptions in care and fair hearings.
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.
MEDICAL AND SCIENTI FIC EVIDENCE TO SUPP ORT TEST
COVERAGE
Under the bill, DSS must use applicable clinical guidelines to inform
its medical necessity determination for biomarker testing, including
medical and scientific evidence that demonstrates that a test provides
clinical utility. Under the bill, a test result has “clinical utility” if it
provides information used to make a treatment or monitoring strategy
that informs a patient’s outcome and impacts the clinical decision, and
it may include both information that is actionable and information that
cannot be immediately used to make a clinical decision.
Under the bill, this medical and scientific evidence may include one
or more of the following:
1. FDA approval of the test or FDA drug label recommendations to
conduct the test;
2. the federal Centers for Medicare and Medicaid Services’ national
or local coverage determinations for Medicare Administrative
Contractors; 2024SB-00307-R01-BA.DOCX
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3. nationally recognized clinical practice guidelines, which are (a)
evidence-based guidelines that set standards of care informed by
a systemic evidence review and cost-benefit analysis of
alternative care options and (b) developed by independent
organizations or medical professional societies; or
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.
Both the clinical practice guidelines and the consensus statements
described above must be developed using transparent methodologies,
reporting structures, and conflict of interest policies.
BACKGROUND
Related Bill
sHB 5367 (File 282), favorably reported by the Appropriations and
Human Services committees, 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
convenience; 2024SB-00307-R01-BA.DOCX
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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)