1.1 	A bill for an act
1.2 	relating to medical assistance; providing coverage for routine patient costs that 
1.3 	are incurred in the course of a clinical trial if the medical assistance program would 
1.4 	provide coverage for the same routine patient costs not incurred in a clinical trial; 
1.5 	amending Minnesota Statutes 2018, section 256B.0625, subdivision 64.
1.6 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.7 	Section 1. Minnesota Statutes 2018, section 256B.0625, subdivision 64, is amended to 
1.8 	read:
1.9 		Subd. 64.Investigational drugs, biological products, and devices. (a) Medical 
1.10 	assistance and the early periodic screening, diagnosis, and treatment (EPSDT) program do 
1.11 	not cover the costs of any services that are incidental to, associated with, or resulting from 
1.12 	the use of investigational drugs, biological products, or devices as defined in section 151.375
1.13 	or any other treatment that is part of an approved clinical trial as defined in section 62Q.526. 
1.14 	Participation of an enrollee in an approved clinical trial does not preclude coverage of 
1.15 	medically necessary services covered under this chapter that are not related to the approved 
1.16 	clinical trial.
1.17 	(b) Notwithstanding paragraph (a), stiripentol may be covered by the EPSDT program 
1.18 	if all the following conditions are met:
1.19 	(1) the use of stiripentol is determined to be medically necessary;
1.20 	(2) the enrollee has a documented diagnosis of Dravet syndrome, regardless of whether 
1.21 	an SCN1A genetic mutation is found, or the enrollee is a child with malignant migrating 
1.22 	partial epilepsy in infancy due to an SCN2A genetic mutation;
2.1 	(3) all other available covered prescription medications that are medically necessary for 
2.2 	the enrollee have been tried without successful outcomes; and
2.3 	(4) the United States Food and Drug Administration has approved the treating physician's 
2.4 	individual patient investigational new drug application (IND) for the use of stiripentol for 
2.5 	treatment.
2.6 	This paragraph does not apply to MinnesotaCare coverage under chapter 256L.