SF 1948

1st Engrossment - 93rd Legislature (2023 - 2024) Posted on 06/29/2023 04:00pm

A bill for an act
relating to insurance; requiring health plans to provide coverage for biomarker
testing; amending Minnesota Statutes 2022, section 256B.0625, by adding a
subdivision; proposing coding for new law in Minnesota Statutes, chapter 62Q.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [62Q.473] BIOMARKER TESTING.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For the purposes of this section, the terms defined in this
subdivision have the meanings given.
new text end

new text begin (b) "Biomarker" means a characteristic that is objectively measured and evaluated as an
indicator of normal biological processes, pathogenic processes, or pharmacologic responses
to a specific therapeutic intervention, including but not limited to known gene-drug
interactions for medications being considered for use or already being administered.
Biomarkers include but are not limited to gene mutations, characteristics of genes, or protein
expression.
new text end

new text begin (c) "Biomarker testing" means the analysis of an individual's tissue, blood, or other
biospecimen for the presence of a biomarker. Biomarker testing includes but is not limited
to single-analyst tests; multiplex panel tests; protein expression; and whole exome, whole
genome, and whole transcriptome sequencing.
new text end

new text begin (d) "Clinical utility" means a test provides information that is used to formulate a
treatment or monitoring strategy that informs a patient's outcome and impacts the clinical
decision. The most appropriate test may include information that is actionable and some
information that cannot be immediately used to formulate a clinical decision.
new text end

new text begin (e) "Consensus statement" means a statement that (1) describes optimal clinical care
outcomes, based on the best available evidence, for a specific clinical circumstance; and
(2) is developed by an independent, multidisciplinary panel of experts that (i) uses a rigorous
and validated development process that includes a transparent methodology and reporting
structure, and (ii) strictly adheres to the panel's conflict of interest policy.
new text end

new text begin (f) "Nationally recognized clinical practice guideline" means an evidence-based clinical
practice guideline that (1) establishes a standard of care informed by (i) a systematic review
of evidence, and (ii) an assessment of the risks and benefits of alternative care options; and
(2) is developed by an independent organization or medical professional society that (i)
uses a transparent methodology and reporting structure, and (ii) adheres to a conflict of
interest policy. Nationally recognized clinical practice guideline includes recommendations
to optimize patient care.
new text end

new text begin Subd. 2. new text end

new text begin Biomarker testing; coverage required. new text end

new text begin (a) A health plan must provide coverage
for biomarker testing to diagnose, treat, manage, and monitor illness or disease if the test
provides clinical utility. For purposes of this section, a test's clinical utility may be
demonstrated by medical and scientific evidence, including but not limited to:
new text end

new text begin (1) nationally recognized clinical practice guidelines as defined in this section;
new text end

new text begin (2) consensus statements as defined in this section;
new text end

new text begin (3) labeled indications for a United States Food and Drug Administration (FDA)-approved
or FDA-cleared test, indicated tests for an FDA-approved drug, or adherence to warnings
and precautions on FDA-approved drug labels; or
new text end

new text begin (4) Centers for Medicare and Medicaid Services national coverage determinations or
Medicare Administrative Contractor local coverage determinations.
new text end

new text begin (b) Coverage under this section must be provided in a manner that limits disruption of
care, including the need for multiple biopsies or biospecimen samples.
new text end

new text begin (c) Nothing in this section prohibits a health plan company from requiring a prior
authorization or imposing other utilization controls when approving coverage for biomarker
testing.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025, and applies to health
plans offered, issued, or renewed on or after that date.
new text end

Sec. 2.

Minnesota Statutes 2022, section 256B.0625, is amended by adding a subdivision
to read:

new text begin Subd. 68. new text end

new text begin Biomarker testing. new text end

new text begin Medical assistance covers biomarker testing to diagnose,
treat, manage, and monitor illness or disease. Medical assistance coverage must meet the
requirements that would otherwise apply to a health plan under section 62Q.473.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025, or upon federal approval,
whichever is later.
new text end