HB2790 Engrossed LRB099 03689 JLK 23700 b
1		AN ACT concerning health.
2		Be it enacted by the People of the State of Illinois,
3		represented in the General Assembly:
4		Section 5. The Newborn Metabolic Screening Act is amended
5		by 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
8		shall administer the provisions of this Act and shall:
9		(a) Institute and carry on an intensive educational program
10		among physicians, hospitals, public health nurses and the
11		public concerning disorders included in newborn screening.
12		This educational program shall include information about the
13		nature of the diseases and examinations for the detection of
14		the diseases in early infancy in order that measures may be
15		taken to prevent the disabilities resulting from the diseases.
16		(a-5) Require that all newborns be screened for the
17		presence of certain genetic, metabolic, and congenital
18		anomalies as determined by the Department, by rule.
19		(a-5.1) Require that all blood and biological specimens
20		collected pursuant to this Act or the rules adopted under this
21		Act be submitted for testing to the nearest Department
22		laboratory designated to perform such tests. The following
23		provisions 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
6		information of importance for the purpose of follow-up services
7		to assess long-term outcomes.
8		(a-5.3) Supply the necessary metabolic treatment formulas
9		where practicable for diagnosed cases of amino acid metabolism
10		disorders, including phenylketonuria, organic acid disorders,
11		and fatty acid oxidation disorders for as long as medically
12		indicated, when the product is not available through other
13		State agencies.
14		(a-5.4) Arrange for or provide public health nursing,
15		nutrition, and social services and clinical consultation as
16		indicated.
17		(a-5.5) Utilize the Genetic and Metabolic Diseases
18		Advisory Committee established under the Genetic and Metabolic
19		Diseases Advisory Committee Act to provide guidance and
20		recommendations to the Department's newborn screening program.
21		The Genetic and Metabolic Diseases Advisory Committee shall
22		review the feasibility and advisability of including
23		additional metabolic, genetic, and congenital disorders in the
24		newborn screening panel, according to a review protocol applied
25		to each suggested addition to the screening panel. The
26		Department shall consider the recommendations of the Genetic

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1		and Metabolic Diseases Advisory Committee in determining
2		whether to include an additional disorder in the screening
3		panel prior to proposing an administrative rule concerning
4		inclusion of an additional disorder in the newborn screening
5		panel. Notwithstanding any other provision of law, no new
6		screening may begin prior to the occurrence of all the
7		following:
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;
14		97-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff.
15		7-16-14.)
16		(410 ILCS 240/3.4 new)
17		Sec. 3.4. Adrenoleukodystrophy. In accordance with the
18		timetable specified in this Section, the Department shall
19		provide all newborns with screening tests for the presence of
20		adrenoleukodystrophy (ALD). The testing shall begin within 18
21		months 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
26		for the screening prior to beginning the testing in order to

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1		accumulate the resources for start-up and other costs
2		associated with implementation of the screening and thereafter
3		to support the costs associated with screening and follow-up
4		programs for adrenoleukodystrophy.
5		Section 99. Effective date. This Act takes effect July 1,
6		2015.