SF 3125

1st Engrossment - 91st Legislature (2019 - 2020) Posted on 06/02/2020 10:29am

A bill for an act
relating to medical assistance; providing coverage for routine patient costs that
are incurred in the course of a clinical trial if the medical assistance program would
provide coverage for the same routine patient costs not incurred in a clinical trial;
amending Minnesota Statutes 2018, section 256B.0625, subdivision 64.

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

Section 1.

Minnesota Statutes 2018, section 256B.0625, subdivision 64, is amended to
read:

Subd. 64.

Investigational drugs, biological products, and devices.

deleted text begin (a) deleted text end Medical
assistance and the early periodic screening, diagnosis, and treatment (EPSDT) program do
not cover new text begin the new text end costs new text begin of any services that are new text end incidental to, associated with, or resulting from
the use of investigational drugs, biological products, or devices as defined in section 151.375 new text begin
or any other treatment that is part of an approved clinical trial as defined in section 62Q.526.
Participation of an enrollee in an approved clinical trial does not preclude coverage of
medically necessary services covered under this chapter that are not related to the approved
clinical trial new text end .

deleted text begin (b) Notwithstanding paragraph (a), stiripentol may be covered by the EPSDT program
if all the following conditions are met:
deleted text end

deleted text begin (1) the use of stiripentol is determined to be medically necessary;
deleted text end

deleted text begin (2) the enrollee has a documented diagnosis of Dravet syndrome, regardless of whether
an SCN1A genetic mutation is found, or the enrollee is a child with malignant migrating
partial epilepsy in infancy due to an SCN2A genetic mutation;
deleted text end

deleted text begin (3) all other available covered prescription medications that are medically necessary for
the enrollee have been tried without successful outcomes; and
deleted text end

deleted text begin (4) the United States Food and Drug Administration has approved the treating physician's
individual patient investigational new drug application (IND) for the use of stiripentol for
treatment.
deleted text end

deleted text begin This paragraph does not apply to MinnesotaCare coverage under chapter 256L.
deleted text end