SF 3230

as introduced - 92nd Legislature (2021 - 2022) Posted on 03/10/2022 04:25pm

A bill for an act
relating to health care; requiring medical assistance to cover rapid whole genome
sequencing (rWGS) testing; amending Minnesota Statutes 2020, section 256B.0625,
by adding a subdivision.

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

Section 1.

Minnesota Statutes 2020, section 256B.0625, is amended by adding a subdivision
to read:

new text begin Subd. 28c. new text end

new text begin Coverage for rapid whole genome sequencing (rWGS) testing. new text end

new text begin (a) Medical
assistance covers rapid whole genome sequencing (rWGS) testing if the testing is performed
on a critically ill infant who is one year of age of younger; has been admitted to an inpatient
intensive care unit, including but not limited to a neonatal or pediatric intensive care unit,
with a complex illness of unknown etiology; and all the following apply:
new text end

new text begin (1) the infant's signs or symptoms suggest a rare genetic condition that cannot be
diagnosed by a standard clinical workup;
new text end

new text begin (2) the infant's signs or symptoms suggest a broad, differential diagnosis that could
require multiple genetic tests if rWGS testing was not performed;
new text end

new text begin (3) timely identification of a molecular diagnosis is necessary in order to guide clinical
decision-making, and the rWGS testing results will guide the treatment or management of
the infant's condition; and
new text end

new text begin (4) at least one of the following clinical criteria apply to the infant:
new text end

new text begin (i) multiple congenital anomalies;
new text end

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

new text begin (iii) an abnormal laboratory test suggests the presence of a genetic disease or complex
metabolic phenotype;
new text end

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

new text begin (vii) a high-risk stratification on evaluation for a brief resolved unexplained event (BRUE)
with any of the following features: recurrent events without respiratory infection, recurrent
witnessed seizure-like events, or required cardiopulmonary resuscitation (CPR);
new text end

new text begin (viii) abnormal chemistry levels suggestive of inborn error of metabolism;
new text end

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

new text begin (x) family genetic history related to the infant's condition.
new text end

new text begin (b) Testing must be ordered by the infant's treating physician, and prior to ordering the
testing the infant must be evaluated by a medical geneticist or other physician subspecialist
with expertise in the conditions or genetic disorder for which the testing is being considered.
The evaluation must be documented in the infant's medical record and if performed through
telehealth must meet all the telehealth requirements under this section.
new text end

new text begin (c) The commissioner shall establish a separate payment methodology to reimburse
hospitals for the cost associated with rWGS testing when the test is provided in an inpatient
hospital setting prior to discharge, the clinical criteria described in this subdivision are met,
and prior authorization from the commissioner has been obtained. Managed care plans and
county-based purchasing plans are not responsible for the additional payment for rWGS
testing if performed on an enrollee of the plan. The commissioner shall reimburse the hospital
separately for rWGS testing for both fee-for-service and managed care enrollees. To obtain
reimbursement, a hospital must request prior authorization directly from the commissioner
and must submit reimbursement claims directly to the commissioner.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective July 1, 2022, or upon federal approval
whichever occurs last. The commissioner of human services shall notify the revisor of
statutes when federal approval is obtained.
new text end