1.1 	A bill for an act
1.2 	relating to health care; requiring medical assistance to cover rapid whole genome 
1.3 	sequencing (rWGS) testing;amending Minnesota Statutes 2020, section 256B.0625, 
1.4 	by adding a subdivision.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. Minnesota Statutes 2020, section 256B.0625, is amended by adding a subdivision 
1.7 	to read:
1.8 		Subd. 28c.Coverage for rapid whole genome sequencing (rWGS) testing. (a) Medical 
1.9 	assistance covers rapid whole genome sequencing (rWGS) testing if the testing is performed 
1.10 	on a critically ill infant who is one year of age of younger; has been admitted to an inpatient 
1.11 	intensive care unit, including but not limited to a neonatal or pediatric intensive care unit, 
1.12 	with a complex illness of unknown etiology; and all the following apply:
1.13 	(1) the infant's signs or symptoms suggest a rare genetic condition that cannot be 
1.14 	diagnosed by a standard clinical workup;
1.15 	(2) the infant's signs or symptoms suggest a broad, differential diagnosis that could 
1.16 	require multiple genetic tests if rWGS testing was not performed;
1.17 	(3) timely identification of a molecular diagnosis is necessary in order to guide clinical 
1.18 	decision-making, and the rWGS testing results will guide the treatment or management of 
1.19 	the infant's condition; and
1.20 	(4) at least one of the following clinical criteria apply to the infant:
1.21 	(i) multiple congenital anomalies;
1.22 	(ii) specific malformations highly suggestive of a genetic etiology;
2.1 	(iii) an abnormal laboratory test suggests the presence of a genetic disease or complex 
2.2 	metabolic phenotype;
2.3 	(iv) refractory or severe hypoglycemia;
2.4 	(v) abnormal response to therapy related to an underlying medical condition affecting 
2.5 	vital organs or bodily systems;
2.6 	(vi) severe hypotonia or refractory seizures;
2.7 	(vii) a high-risk stratification on evaluation for a brief resolved unexplained event (BRUE) 
2.8 	with any of the following features: recurrent events without respiratory infection, recurrent 
2.9 	witnessed seizure-like events, or required cardiopulmonary resuscitation (CPR);
2.10 	(viii) abnormal chemistry levels suggestive of inborn error of metabolism;
2.11 	(ix) abnormal cardiac diagnostic testing results suggestive of possible channelopathies, 
2.12 	arrhythmias, cardiomyopathies, myocarditis, or structural heart disease; or
2.13 	(x) family genetic history related to the infant's condition.
2.14 	(b) Testing must be ordered by the infant's treating physician, and prior to ordering the 
2.15 	testing the infant must be evaluated by a medical geneticist or other physician subspecialist 
2.16 	with expertise in the conditions or genetic disorder for which the testing is being considered. 
2.17 	The evaluation must be documented in the infant's medical record and if performed through 
2.18 	telehealth must meet all the telehealth requirements under this section.
2.19 	(c) The commissioner shall establish a separate payment methodology to reimburse 
2.20 	hospitals for the cost associated with rWGS testing when the test is provided in an inpatient 
2.21 	hospital setting prior to discharge, the clinical criteria described in this subdivision are met, 
2.22 	and prior authorization from the commissioner has been obtained. Managed care plans and 
2.23 	county-based purchasing plans are not responsible for the additional payment for rWGS 
2.24 	testing if performed on an enrollee of the plan. The commissioner shall reimburse the hospital 
2.25 	separately for rWGS testing for both fee-for-service and managed care enrollees. To obtain 
2.26 	reimbursement, a hospital must request prior authorization directly from the commissioner 
2.27 	and must submit reimbursement claims directly to the commissioner.

2.28 	EFFECTIVE DATE. This section is effective July 1, 2022, or upon federal approval 
2.29 	whichever occurs last. The commissioner of human services shall notify the revisor of 
2.30 	statutes when federal approval is obtained.