HB2790 EnrolledLRB099 03689 JLK 23700 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 changing Section 2 and by adding Section 3.4 as follows:




6 (410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)



7 Sec. 2. General provisions. The Department of Public Health 
8shall administer the
provisions of this Act and shall:

9 (a) Institute and carry on an intensive educational program 
10among
physicians, hospitals, public health nurses and the 
11public concerning disorders included in newborn screening. 
12This
educational program shall include information about the 
13nature of the
diseases and examinations for the detection of 
14the diseases in early
infancy in order that measures may be 
15taken to prevent the disabilities resulting from the diseases.

16 (a-5) Require that all newborns be screened
for the 
17presence of certain genetic, metabolic, and congenital 
18anomalies as determined by the Department, by rule.
19 (a-5.1) Require that all blood and biological specimens 
20collected pursuant to this Act or the rules adopted under this 
21Act be submitted for testing to the nearest Department 
22laboratory designated to perform such tests. The following 
23provisions shall apply concerning testing:
 
 
HB2790 Enrolled- 2 -LRB099 03689 JLK 23700 b


1  (1) Beginning July 1, 2015, the base fee for newborn 
2 screening services shall be $118. The Department may 
3 develop a reasonable fee structure and may levy additional 
4 fees according to such structure to cover the cost of 
5 providing this testing service and for the follow-up of 
6 infants with an abnormal screening test; however, 
7 additional fees may be levied no sooner than 6 months prior 
8 to the beginning of testing for a new genetic, metabolic, 
9 or congenital disorder. Fees collected from the provision 
10 of this testing service shall be placed in the Metabolic 
11 Screening and Treatment Fund. Other State and federal funds 
12 for expenses related to metabolic screening, follow-up, 
13 and treatment programs may also be placed in the Fund.
14  (2) Moneys shall be appropriated from the Fund to the 
15 Department solely for the purposes of providing newborn 
16 screening, follow-up, and treatment programs. Nothing in 
17 this Act shall be construed to prohibit any licensed 
18 medical facility from collecting additional specimens for 
19 testing for metabolic or neonatal diseases or any other 
20 diseases or conditions, as it deems fit. Any person 
21 violating the provisions of this subsection (a-5.1) is 
22 guilty of a petty offense.
23  (3) If the Department is unable to provide the 
24 screening using the
State Laboratory, it shall temporarily 
25 provide such screening
through an accredited laboratory 
26 selected by the Department until the
Department has the 
 
 
HB2790 Enrolled- 3 -LRB099 03689 JLK 23700 b


1 capacity to provide screening through the State

2 Laboratory. If screening is provided on a temporary basis

3 through an accredited laboratory, the Department shall 
4 substitute the fee
charged by the accredited laboratory, 
5 plus a 5% surcharge for
documentation and handling, for the 
6 fee authorized in this subsection (a-5.1).
7 (a-5.2) Maintain a registry of cases, including 
8information of importance for the purpose of follow-up services 
9to assess long-term outcomes. 
10 (a-5.3) Supply the necessary metabolic treatment formulas 
11where practicable for diagnosed cases of amino acid metabolism 
12disorders, including phenylketonuria, organic acid disorders, 
13and fatty acid oxidation disorders for as long as medically 
14indicated, when the product is not available through other 
15State agencies.
16 (a-5.4) Arrange for or provide public health nursing, 
17nutrition, and social services and clinical consultation as 
18indicated.
19 (a-5.5) Utilize the Genetic and Metabolic Diseases 
20Advisory Committee established under the Genetic and Metabolic 
21Diseases Advisory Committee Act to provide guidance and 
22recommendations to the Department's newborn screening program. 
23The Genetic and Metabolic Diseases Advisory Committee shall 
24review the feasibility and advisability of including 
25additional metabolic, genetic, and congenital disorders in the 
26newborn screening panel, according to a review protocol applied 
 
 
HB2790 Enrolled- 4 -LRB099 03689 JLK 23700 b


1to each suggested addition to the screening panel. The 
2Department shall consider the recommendations of the Genetic 
3and Metabolic Diseases Advisory Committee in determining 
4whether to include an additional disorder in the screening 
5panel prior to proposing an administrative rule concerning 
6inclusion of an additional disorder in the newborn screening 
7panel. Notwithstanding any other provision of law, no new 
8screening may begin prior to the occurrence of all the 
9following:
10  (1) the establishment and verification of relevant and

11 appropriate performance specifications as defined under

12 the federal Clinical Laboratory Improvement Amendments and

13 regulations thereunder for U.S. Food and Drug

14 Administration-cleared or in-house developed methods,

15 performed under an institutional review board-approved

16 protocol, if required;
17  (2) the availability of quality assurance testing

18 methodology for the processes set forth in item (1) of this 
19 subsection (a-5.5);
20  (3) the acquisition and installment by the Department

21 of the equipment necessary to implement the screening

22 tests;
23  (4) the establishment of precise threshold values 
24 ensuring
defined disorder identification for each 
25 screening test;
26  (5) the authentication of pilot testing achieving each

 
 
HB2790 Enrolled- 5 -LRB099 03689 JLK 23700 b


1 milestone described in items (1) through (4) of this

2 subsection (a-5.5) for each disorder screening test; and
3  (6) the authentication of achieving the potential of 
4 high
throughput standards for statewide volume of each 
5 disorder
screening test concomitant with each milestone 
6 described
in items (1) through (4) of this subsection 
7 (a-5.5). 

8 (a-6) (Blank).
9 (a-7) (Blank).
10 (a-8) (Blank).
11 (b) (Blank).

12 (c) (Blank).

13 (d) (Blank).

14 (e) (Blank).

15(Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; 
1697-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff. 
177-16-14.)


18 (410 ILCS 240/3.4 new)
19 Sec. 3.4. Adrenoleukodystrophy. In accordance with the 
20timetable specified in this Section, the Department shall 
21provide all newborns with screening tests for the presence of 
22adrenoleukodystrophy (ALD). The testing shall begin within 18 
23months following the occurrence of all of the following:
24  (1) the development and validation of a reliable 
25 methodology for screening newborns for ALD using dried 
 
 
HB2790 Enrolled- 6 -LRB099 03689 JLK 23700 b


1 blood spots and quality assurance testing methodology for 
2 such test or the approval of a test for ALD using dried 
3 blood spots by the federal Food and Drug Administration;
4  (2) the availability of any necessary reagents for such 
5 test;
6  (3) the establishment and verification of relevant and 
7 appropriate performance specifications as defined under 
8 the federal Clinical Laboratory Improvement Amendments and 
9 regulations thereunder for Federal Drug 
10 Administration-cleared or in-house developed methods, 
11 performed under an institutional review board approved 
12 protocol, if required;
13  (4) the availability of quality assurance testing and 
14 comparative threshold values for ALD;
15  (5) the acquisition and installment by the Department 
16 of the equipment necessary to implement the initial pilot 
17 and statewide volume of screening tests for ALD;
18  (6) the establishment of precise threshold values 
19 ensuring defined disorder identification for ALD;
20  (7) the authentication of pilot testing achieving each 
21 milestone described in items (1) through (6) of this 
22 Section for ALD; and
23  (8) the authentication of achieving the potential of 
24 high throughput standards for statewide volume of ALD 
25 concomitant with each milestone described in items (1) 
26 through (6) of this Section.
 
 
HB2790 Enrolled- 7 -LRB099 03689 JLK 23700 b


1 The Department is authorized to implement an additional fee 
2for the screening no sooner than 6 months prior to beginning 
3the testing in order to accumulate the resources for start-up 
4and other costs associated with implementation of the screening 
5and thereafter to support the costs associated with screening 
6and follow-up programs for adrenoleukodystrophy. 


7 Section 99. Effective date. This Act takes effect July 1, 
82015.