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.


LRB103 35285 JAG 65318 b

 

 

A BILL FOR

 

SB2658LRB103 35285 JAG 65318 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Newborn Metabolic Screening Act is amended
5by adding Section 3.6 as follows:
 
6    (410 ILCS 240/3.6 new)
7    Sec. 3.6. Duchenne muscular dystrophy.
8    (a) The Department shall provide all newborns with
9screening tests for the presence of Duchenne muscular
10dystrophy. The testing shall begin within 6 months after the
11occurrence of all of the following milestones:
12        (1) Unless the federal Food and Drug Administration
13    approves a screening test for Duchenne muscular dystrophy
14    using dried blood spots, the development and validation of
15    a reliable methodology for screening newborns for Duchenne
16    muscular dystrophy using dried blood spots and a
17    methodology for conducting quality assurance testing of
18    the screening test.
19        (2) The availability of any necessary reagent for a
20    Duchenne muscular dystrophy screening test.
21        (3) The establishment and verification of relevant and
22    appropriate performance specifications as defined under
23    the federal Clinical Laboratory Improvement Amendments and

 

 

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1    regulations thereunder for Federal Drug
2    Administration-cleared or in-house developed methods,
3    performed under an institutional review board approved
4    protocol, if required.
5        (4) The availability of quality assurance testing and
6    comparative threshold values for Duchenne muscular
7    dystrophy screening tests.
8        (5) The acquisition and installation by the Department
9    of equipment necessary to implement Duchenne muscular
10    dystrophy screening tests.
11        (6) The establishment of precise threshold values
12    ensuring defined disorder identification of Duchenne
13    muscular dystrophy.
14        (7) The authentication of pilot testing indicating
15    that each milestone described in paragraphs (1) through
16    (6) has been achieved.
17        (8) The authentication of achieving the potential of
18    high throughput standards for statewide volume of each
19    Duchenne muscular dystrophy screening test concomitant
20    with each milestone described in paragraphs (1) through
21    (4).
22    (b) To accumulate the resources for the costs, including
23start-up costs, associated with Duchenne muscular dystrophy
24screening tests and any follow-up programs, the Department may
25require payment of an additional fee for administering a
26Duchenne muscular dystrophy screening test under this Section.

 

 

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1The Department may not require the payment of the additional
2fee prior to 6 months before the Department administers
3Duchenne muscular dystrophy screening tests under this
4Section.
 
5    Section 99. Effective date. This Act takes effect upon
6becoming law.