O F F I C E O F L E G I S L A T I V E R E S E A R C H
P U B L I C A C T S U M M A R Y
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PA 24-50—sSB 307
Human Services Committee
AN ACT CONCERNING ME DICAID COVERAGE OF B IOMARKER
TESTING
SUMMARY: This act 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 act
requires the DSS commissioner to ensure this coverage is medically necessary
under existing state law applicable to Medicaid services (see BACKGROUND).
The act 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).
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 act specifies that its provisions do not change these
medical necessity provisions in existing law. The act 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 act requires the DSS commissioner to ensure that Medicaid coverage of
biomarker testing is provided in a way that limits disruptions in care. The act 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).
EFFECTIVE DATE: July 1, 2024
BIOMARKER TESTING
The act’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 SCIENTIFIC EVIDENCE TO SUPPORT TEST COVERAGE
Under the act, DSS must use applicable clinical guidelines to inform its medical
necessity determination for biomarker testing, including medical and scientific O L R P U B L I C A C T S U M M A R Y
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evidence that demonstrates that a test provides clinical utility. Under the act, 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 act, this medical and scientific evidence may include one or more of
the following:
1. FDA approval of the test or recommendations on labels of FDA-approved
drugs to conduct the test;
2. the federal Centers for Medicare and Medicaid Services’ national or local
coverage determinations for Medicare Administrative Contractors;
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 and reporting structures
and conflict of interest policies.
BACKGROUND
Related Act
PA 24-130 requires DSS to provide medically necessary Medicaid coverage for
rapid whole genome testing for certain critically ill infants, within available
appropriations.
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;
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).