Rep. Laura Fine

Filed: 3/23/2015





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2    AMENDMENT NO. ______. Amend House Bill 2790 by replacing
3everything after the enacting clause with the following:
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



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1presence of certain genetic, metabolic, and congenital
2anomalies as determined by the Department, by rule.
3    (a-5.1) Require that all blood and biological specimens
4collected pursuant to this Act or the rules adopted under this
5Act be submitted for testing to the nearest Department
6laboratory designated to perform such tests. The following
7provisions shall apply concerning testing:
8        (1) Beginning July 1, 2015, the base fee for newborn
9    screening services shall be $118. The Department may
10    develop a reasonable fee structure and may levy additional
11    fees according to such structure to cover the cost of
12    providing this testing service and for the follow-up of
13    infants with an abnormal screening test. Fees collected
14    from the provision of this testing service shall be placed
15    in the Metabolic Screening and Treatment Fund. Other State
16    and federal funds for expenses related to metabolic
17    screening, follow-up, and treatment programs may also be
18    placed in the Fund.
19        (2) Moneys shall be appropriated from the Fund to the
20    Department solely for the purposes of providing newborn
21    screening, follow-up, and treatment programs. Nothing in
22    this Act shall be construed to prohibit any licensed
23    medical facility from collecting additional specimens for
24    testing for metabolic or neonatal diseases or any other
25    diseases or conditions, as it deems fit. Any person
26    violating the provisions of this subsection (a-5.1) is



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1    guilty of a petty offense.
2        (3) If the Department is unable to provide the
3    screening using the State Laboratory, it shall temporarily
4    provide such screening through an accredited laboratory
5    selected by the Department until the Department has the
6    capacity to provide screening through the State
7    Laboratory. If screening is provided on a temporary basis
8    through an accredited laboratory, the Department shall
9    substitute the fee charged by the accredited laboratory,
10    plus a 5% surcharge for documentation and handling, for the
11    fee authorized in this subsection (a-5.1).
12    (a-5.2) Maintain a registry of cases, including
13information of importance for the purpose of follow-up services
14to assess long-term outcomes.
15    (a-5.3) Supply the necessary metabolic treatment formulas
16where practicable for diagnosed cases of amino acid metabolism
17disorders, including phenylketonuria, organic acid disorders,
18and fatty acid oxidation disorders for as long as medically
19indicated, when the product is not available through other
20State agencies.
21    (a-5.4) Arrange for or provide public health nursing,
22nutrition, and social services and clinical consultation as
24    (a-5.5) Utilize the Genetic and Metabolic Diseases
25Advisory Committee established under the Genetic and Metabolic
26Diseases Advisory Committee Act to provide guidance and



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1recommendations to the Department's newborn screening program.
2The Genetic and Metabolic Diseases Advisory Committee shall
3review the feasibility and advisability of including
4additional metabolic, genetic, and congenital disorders in the
5newborn screening panel, according to a review protocol applied
6to each suggested addition to the screening panel. The
7Department shall consider the recommendations of the Genetic
8and Metabolic Diseases Advisory Committee in determining
9whether to include an additional disorder in the screening
10panel prior to proposing an administrative rule concerning
11inclusion of an additional disorder in the newborn screening
12panel. Notwithstanding any other provision of law, no new
13screening may begin prior to the occurrence of all the
15        (1) the establishment and verification of relevant and
16    appropriate performance specifications as defined under
17    the federal Clinical Laboratory Improvement Amendments and
18    regulations thereunder for U.S. Food and Drug
19    Administration-cleared or in-house developed methods,
20    performed under an institutional review board-approved
21    protocol, if required;
22        (2) the availability of quality assurance testing
23    methodology for the processes set forth in item (1) of this
24    subsection (a-5.5);
25        (3) the acquisition and installment by the Department
26    of the equipment necessary to implement the screening



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1    tests;
2        (4) the establishment of precise threshold values
3    ensuring defined disorder identification for each
4    screening test;
5        (5) the authentication of pilot testing achieving each
6    milestone described in items (1) through (4) of this
7    subsection (a-5.5) for each disorder screening test; and
8        (6) the authentication of achieving the potential of
9    high throughput standards for statewide volume of each
10    disorder screening test concomitant with each milestone
11    described in items (1) through (4) of this subsection
12    (a-5.5).
13    (a-6) (Blank).
14    (a-7) (Blank).
15    (a-8) (Blank).
16    (b) (Blank).
17    (c) (Blank).
18    (d) (Blank).
19    (e) (Blank).
20(Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11;
2197-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff.
23    (410 ILCS 240/3.4 new)
24    Sec. 3.4. Adrenoleukodystrophy. In accordance with the
25timetable specified in this Section, the Department shall



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



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1    Section for ALD; and
2        (8) the authentication of achieving the potential of
3    high throughput standards for statewide volume of ALD
4    concomitant with each milestone described in items (1)
5    through (6) of this Section.
6    The Department is authorized to implement an additional fee
7for the screening prior to beginning the testing in order to
8accumulate the resources for start-up and other costs
9associated with implementation of the screening and thereafter
10to support the costs associated with screening and follow-up
11programs for adrenoleukodystrophy.
12    Section 99. Effective date. This Act takes effect July 1,