1.1 	A bill for an act
1.2 	relating to human services; exempting treatment from approved clinical trials from 
1.3 	coverage;amending Minnesota Statutes 2018, section 256B.0625, subdivision 64.
1.4 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

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