HF 3330

1st Engrossment - 93rd Legislature (2023 - 2024) Posted on 03/20/2024 12:43pm

A bill for an act
relating to insurance; requiring coverage for rapid whole genome sequencing;
amending Minnesota Statutes 2022, section 256B.0625, by adding a subdivision;
proposing coding for new law in Minnesota Statutes, chapter 62A.

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

Section 1.

new text begin [62A.3098] RAPID WHOLE GENOME SEQUENCING; COVERAGE.
new text end

new text begin Subdivision 1. new text end

new text begin Definition. new text end

new text begin For purposes of this section, "rapid whole genome sequencing"
or "rWGS" means an investigation of the entire human genome, including coding and
noncoding regions and mitochondrial deoxyribonucleic acid, to identify disease-causing
genetic changes that returns the final results in 14 days. Rapid whole genome sequencing
includes patient-only whole genome sequencing and duo and trio whole genome sequencing
of the patient and the patient's biological parent or parents.
new text end

new text begin Subd. 2. new text end

new text begin Required coverage. new text end

new text begin A health plan that provides coverage to Minnesota residents
must cover rWGS testing if the enrollee:
new text end

new text begin (1) is 21 years of age or younger;
new text end

new text begin (2) has a complex or acute illness of unknown etiology that is not confirmed to have
been caused by an environmental exposure, toxic ingestion, an infection with a normal
response to therapy, or trauma; and
new text end

new text begin (3) is receiving inpatient hospital services in an intensive care unit or a neonatal or high
acuity pediatric care unit.
new text end

new text begin Subd. 3. new text end

new text begin Coverage criteria. new text end

new text begin Coverage may be based on the following medical necessity
criteria:
new text end

new text begin (1) the enrollee has symptoms that suggest a broad differential diagnosis that would
require an evaluation by multiple genetic tests if rWGS testing is not performed;
new text end

new text begin (2) timely identification of a molecular diagnosis is necessary in order to guide clinical
decision making, and the rWGS testing may aid in guiding the treatment or management
of the enrollee's condition; and
new text end

new text begin (3) the enrollee's complex or acute illness of unknown etiology includes at least one of
the following conditions:
new text end

new text begin (i) congenital anomalies involving at least two organ systems, or complex or multiple
congenital anomalies in one organ system;
new text end

new text begin (ii) specific organ malformations that are highly suggestive of a genetic etiology;
new text end

new text begin (iii) abnormal laboratory tests or abnormal chemistry profiles suggesting the presence
of a genetic disease, complex metabolic disorder, or inborn error of metabolism;
new text end

new text begin (iv) refractory or severe hypoglycemia or hyperglycemia;
new text end

new text begin (v) abnormal response to therapy related to an underlying medical condition affecting
vital organs or bodily systems;
new text end

new text begin (vi) severe muscle weakness, rigidity, or spasticity;
new text end

new text begin (vii) refractory seizures;
new text end

new text begin (viii) a high-risk stratification on evaluation for a brief resolved unexplained event with
any of the following features:
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new text begin (A) a recurrent event without respiratory infection;
new text end

new text begin (B) a recurrent seizure-like event; or
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new text begin (C) a recurrent cardiopulmonary resuscitation;
new text end

new text begin (ix) abnormal cardiac diagnostic testing results that are suggestive of possible
channelopathies, arrhythmias, cardiomyopathies, myocarditis, or structural heart disease;
new text end

new text begin (x) abnormal diagnostic imaging studies that are suggestive of underlying genetic
condition;
new text end

new text begin (xi) abnormal physiologic function studies that are suggestive of an underlying genetic
etiology; or
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new text begin (xii) family genetic history related to the patient's condition.
new text end

new text begin Subd. 4. new text end

new text begin Cost sharing. new text end

new text begin Coverage provided in this section is subject to the enrollee's
health plan cost-sharing requirements, including any deductibles, co-payments, or coinsurance
requirements that apply to diagnostic testing services.
new text end

new text begin Subd. 5. new text end

new text begin Reimbursement. new text end

new text begin If the enrollee's health plan uses a capitated or bundled
payment arrangement to reimburse a provider for services provided in an inpatient setting,
reimbursement for services covered under this section must be paid separately and in addition
to any reimbursement otherwise payable to the provider under the capitated or bundled
payment arrangement, unless the health carrier and the provider have negotiated an increased
capitated or bundled payment rate that includes the services covered under this section.
new text end

new text begin Subd. 6. new text end

new text begin Genetic data. new text end

new text begin Genetic data generated as a result of performing rWGS and
covered under this section: (1) must be used for the primary purpose of assisting the ordering
provider and treating care team to diagnose and treat the patient; (2) is protected health
information as set forth under the Health Information Portability and Accountability Act
(HIPAA), the Health Information Technology for Economic and Clinical Health Act, and
any promulgated regulations, including but not limited to the HIPAA Privacy Rule under
Code of Federal Regulations, title 45, parts 160 and 164, subparts A and E; and (3) is a
protected health record under the Minnesota Health Records Act under section 144.291.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025, and applies to a health
plan offered, issued, or sold 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. 72. new text end

new text begin Rapid whole genome sequencing. new text end

new text begin Medical assistance covers rapid whole
genome sequencing (rWGS) testing. Coverage and eligibility for rWGS testing, and the use
of genetic data, must meet the requirements specified in section 62A.3098, subdivisions 1
to 3 and 6.
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