Bill Text: IL SB2658 | 2023-2024 | 103rd General Assembly | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of Duchenne muscular dystrophy. Requires the testing to begin within 6 months following the occurrence of specified milestones. Allows the Department to require payment of an additional fee for the provision of Duchenne muscular dystrophy screening tests. Contains other provisions. Effective immediately.

Spectrum: Moderate Partisan Bill (Democrat 10-3)

Status: (Passed) 2024-08-09 - Public Act . . . . . . . . . 103-0909 [SB2658 Detail]

Download: Illinois-2023-SB2658-Introduced.html

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103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 SB2658 Introduced 1/10/2024, by Sen. Julie A. Morrison SYNOPSIS AS INTRODUCED:
410 ILCS 240/3.6 new
Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of Duchenne muscular dystrophy. Requires the testing to begin within 6 months following the occurrence of specified milestones. Allows the Department to require payment of an additional fee for the provision of Duchenne muscular dystrophy screening tests. Contains other provisions. Effective immediately.
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A BILL FOR
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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Newborn Metabolic Screening Act is amended
by adding Section 3.6 as follows:
(410 ILCS 240/3.6 new)
Sec. 3.6. Duchenne muscular dystrophy.
(a) The Department shall provide all newborns with
screening tests for the presence of Duchenne muscular
dystrophy. The testing shall begin within 6 months after the
occurrence of all of the following milestones:
(1) Unless the federal Food and Drug Administration
approves a screening test for Duchenne muscular dystrophy
using dried blood spots, the development and validation of
a reliable methodology for screening newborns for Duchenne
muscular dystrophy using dried blood spots and a
methodology for conducting quality assurance testing of
the screening test.
(2) The availability of any necessary reagent for a
Duchenne muscular dystrophy screening test.
(3) The establishment and verification of relevant and
appropriate performance specifications as defined under
the federal Clinical Laboratory Improvement Amendments and

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regulations thereunder for Federal Drug
Administration-cleared or in-house developed methods,
performed under an institutional review board approved
protocol, if required.
(4) The availability of quality assurance testing and
comparative threshold values for Duchenne muscular
dystrophy screening tests.
(5) The acquisition and installation by the Department
of equipment necessary to implement Duchenne muscular
dystrophy screening tests.
(6) The establishment of precise threshold values
ensuring defined disorder identification of Duchenne
muscular dystrophy.
(7) The authentication of pilot testing indicating
that each milestone described in paragraphs (1) through
(6) has been achieved.
(8) The authentication of achieving the potential of
high throughput standards for statewide volume of each
Duchenne muscular dystrophy screening test concomitant
with each milestone described in paragraphs (1) through
(4).
(b) To accumulate the resources for the costs, including
start-up costs, associated with Duchenne muscular dystrophy
screening tests and any follow-up programs, the Department may
require payment of an additional fee for administering a
Duchenne muscular dystrophy screening test under this Section.

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The Department may not require the payment of the additional
fee prior to 6 months before the Department administers
Duchenne muscular dystrophy screening tests under this
Section.