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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:



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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



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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
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



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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
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



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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.
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



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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.



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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,