HF 4899

as introduced - 92nd Legislature (2021 - 2022) Posted on 05/21/2022 11:45pm

A bill for an act
relating to insurance; requiring health plans to provide coverage for biomarker
testing; amending Minnesota Statutes 2020, 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. Biomarkers include but are not limited to gene
mutations 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, and whole genome sequencing.
new text end

new text begin (d) "Consensus statement" means a statement developed by an independent,
multidisciplinary panel of experts (1) using a transparent methodology and reporting structure,
and (2) with a conflict of interest policy. A statement must be applicable to specific clinical
circumstances and based on the best available evidence.
new text end

new text begin (e) "Nationally recognized clinical practice guideline" means an evidence-based clinical
practice guideline developed by an independent organization or medical professional society
(1) using a transparent methodology and reporting structure, and (2) with a conflict of
interest policy. A clinical practice guideline establishes a standard of care informed by a
systematic review of evidence and an assessment of the benefits and costs of alternative
care options, and 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 company must
provide coverage for biomarker testing to diagnose, treat, manage, and monitor illness or
disease.
new text end

new text begin (b) A health plan company is only required to provide coverage of biomarker testing
when the test is supported by medical evidence, including but not limited to:
new text end

new text begin (1) nationally recognized clinical practice guidelines;
new text end

new text begin (2) consensus statements;
new text end

new text begin (3) labeled indications for a United States Food and Drug Administration (FDA)-approved
or FDA-cleared test, or indicated tests for an FDA-approved drug; 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 (c) 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 EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2023, and applies to health
plans offered, issued, or renewed on or after that date.
new text end

Sec. 2.

Minnesota Statutes 2020, 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 company under section 62Q.473.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2023, or upon federal approval,
whichever is later.
new text end