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
 
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.