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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. Fees collected
7    from the provision of this testing service shall be placed
8    in the Metabolic Screening and Treatment Fund. Other State
9    and federal funds for expenses related to metabolic
10    screening, follow-up, and treatment programs may also be
11    placed in the Fund.
12        (2) Moneys shall be appropriated from the Fund to the
13    Department solely for the purposes of providing newborn
14    screening, follow-up, and treatment programs. Nothing in
15    this Act shall be construed to prohibit any licensed
16    medical facility from collecting additional specimens for
17    testing for metabolic or neonatal diseases or any other
18    diseases or conditions, as it deems fit. Any person
19    violating the provisions of this subsection (a-5.1) is
20    guilty of a petty offense.
21        (3) If the Department is unable to provide the
22    screening using the State Laboratory, it shall temporarily
23    provide such screening through an accredited laboratory
24    selected by the Department until the Department has the
25    capacity to provide screening through the State
26    Laboratory. If screening is provided on a temporary basis



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



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1and Metabolic Diseases Advisory Committee in determining
2whether to include an additional disorder in the screening
3panel prior to proposing an administrative rule concerning
4inclusion of an additional disorder in the newborn screening
5panel. Notwithstanding any other provision of law, no new
6screening may begin prior to the occurrence of all the
8        (1) the establishment and verification of relevant and
9    appropriate performance specifications as defined under
10    the federal Clinical Laboratory Improvement Amendments and
11    regulations thereunder for U.S. Food and Drug
12    Administration-cleared or in-house developed methods,
13    performed under an institutional review board-approved
14    protocol, if required;
15        (2) the availability of quality assurance testing
16    methodology for the processes set forth in item (1) of this
17    subsection (a-5.5);
18        (3) the acquisition and installment by the Department
19    of the equipment necessary to implement the screening
20    tests;
21        (4) the establishment of precise threshold values
22    ensuring defined disorder identification for each
23    screening test;
24        (5) the authentication of pilot testing achieving each
25    milestone described in items (1) through (4) of this
26    subsection (a-5.5) for each disorder screening test; and



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1        (6) the authentication of achieving the potential of
2    high throughput standards for statewide volume of each
3    disorder screening test concomitant with each milestone
4    described in items (1) through (4) of this subsection
5    (a-5.5).
6    (a-6) (Blank).
7    (a-7) (Blank).
8    (a-8) (Blank).
9    (b) (Blank).
10    (c) (Blank).
11    (d) (Blank).
12    (e) (Blank).
13(Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11;
1497-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff.
16    (410 ILCS 240/3.4 new)
17    Sec. 3.4. Adrenoleukodystrophy. In accordance with the
18timetable specified in this Section, the Department shall
19provide all newborns with screening tests for the presence of
20adrenoleukodystrophy (ALD). The testing shall begin within 18
21months following the occurrence of all of the following:
22        (1) the development and validation of a reliable
23    methodology for screening newborns for ALD using dried
24    blood spots and quality assurance testing methodology for
25    such test or the approval of a test for ALD using dried



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



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1accumulate the resources for start-up and other costs
2associated with implementation of the screening and thereafter
3to support the costs associated with screening and follow-up
4programs for adrenoleukodystrophy.
5    Section 99. Effective date. This Act takes effect July 1,