SB2658 103RD GENERAL ASSEMBLY

LRB103 35285 JAG 65318 b

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.

A BILL FOR

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 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. 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.

Section 99. Effective date. This Act takes effect upon becoming law.