SB 3049

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Full Text of SB3049
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	SB3049 - 104th General Assembly
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			Senate Amendment 001
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		SB3049 Enrolled		LRB104 16764 BDA 32796 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 as follows:
6    (410 ILCS 240/2)  (from Ch. 111 1/2, par. 4904)
7    Sec. 2. General provisions. The Department of Public
8Health shall administer the provisions of this Act and shall:
9    (a) Institute and carry on an intensive educational
10program among physicians, hospitals, public health nurses, and
11the public 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:
		SB3049 Enrolled	- 2 -	LRB104 16764 BDA 32796 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
8    prior to the beginning of testing for a new genetic,
9    metabolic, or congenital disorder. Fees collected from the
10    provision of this testing service shall be placed in the
11    Metabolic Screening and Treatment Fund. Other State and
12    federal funds for expenses related to metabolic screening,
13    follow-up, and treatment programs may also be placed in
14    the Fund.
15        (2) Moneys shall be appropriated from the Fund to the
16    Department solely for the purposes of providing newborn
17    screening, follow-up, and treatment programs. Nothing in
18    this Act shall be construed to prohibit any licensed
19    medical facility from collecting additional specimens for
20    testing for metabolic or neonatal diseases or any other
21    diseases or conditions, as it deems fit. Any person
22    violating the provisions of this subsection (a-5.1) is
23    guilty of a petty offense.
24        (3) If the Department is unable to provide the
25    screening using the State Laboratory, it shall temporarily
26    provide such screening through an accredited laboratory
		SB3049 Enrolled	- 3 -	LRB104 16764 BDA 32796 b
1    selected by the Department until the Department has the
2    capacity to provide screening through the State
3    Laboratory. If screening is provided on a temporary basis
4    through an accredited laboratory, the Department shall
5    substitute the fee charged by the accredited laboratory,
6    plus a 5% surcharge for documentation and handling, for
7    the fee authorized in this subsection (a-5.1).
8    (a-5.2) Maintain a registry of cases, including
9information of importance for the purpose of follow-up
10services to assess long-term outcomes.
11    (a-5.3) Supply the necessary metabolic treatment formulas
12where practicable for diagnosed cases of amino acid metabolism
13disorders, including phenylketonuria, organic acid disorders,
14and fatty acid oxidation disorders for as long as medically
15indicated, when the product is not available through other
16State agencies.
17    (a-5.4) Arrange for or provide public health nursing,
18nutrition, and social services and clinical consultation as
19indicated.
20    (a-5.5) Utilize the Universal Newborn Screening [Genetic ]
21[and Metabolic Diseases] Advisory Committee established under
22the Genetic and Metabolic Diseases Advisory Committee Act to
23provide guidance and recommendations to the Department's
24newborn screening program. The Universal Newborn Screening
25[Genetic and Metabolic Diseases] Advisory Committee shall review
26the feasibility and advisability of including additional
		SB3049 Enrolled	- 4 -	LRB104 16764 BDA 32796 b
1metabolic, genetic, and congenital disorders in the newborn
2screening panel, according to a review protocol applied to
3each suggested addition to the screening panel. Beginning 
4January 1, 2027, the Universal Newborn Screening Advisory 
5Committee shall review all new conditions added to the federal 
6Recommended Uniform Screening Panel within 12 months of the 
7condition being added to the Recommended Uniform Screening 
8Panel, as long as the condition meets the requirements of this 
9Section. If the Recommended Uniform Screening Panel includes 
10conditions not screened by the State on the effective date of 
11this amendatory Act of the 104th General Assembly, the 
12Universal Newborn Screening Advisory Committee shall begin 
13review of the condition no later than one year after the 
14effective date of this amendatory Act of the 104th General 
15Assembly. Nothing in this Section shall be construed to 
16prevent the review and recommendation of additional conditions 
17not on the Recommended Uniform Screening Panel on the 
18effective date of this amendatory Act of the 104th General 
19Assembly, as long as they meet the requirements for review.
20The Department shall consider the recommendations of the
21Universal Newborn Screening [Genetic and Metabolic Diseases]
22Advisory Committee in determining whether to include an
23additional disorder in the screening panel prior to proposing
24an administrative rule concerning inclusion of an additional
25disorder in the newborn screening panel. Notwithstanding any
26other provision of law, no new screening may begin prior to the
		SB3049 Enrolled	- 5 -	LRB104 16764 BDA 32796 b
1occurrence of all the following:
2        (1) the establishment and verification of relevant and
3    appropriate performance specifications as defined under
4    the federal Clinical Laboratory Improvement Amendments and
5    regulations thereunder for U.S. Food and Drug
6    Administration-cleared or in-house developed methods,
7    performed under an institutional review board-approved
8    protocol, if required;
9        (2) the availability of quality assurance testing
10    methodology for the processes set forth in item (1) of
11    this subsection (a-5.5);
12        (3) the acquisition and installment by the Department
13    of the equipment necessary to implement the screening
14    tests;
15        (4) the establishment of precise threshold values
16    ensuring defined disorder identification for each
17    screening test;
18        (5) the authentication of pilot testing achieving each
19    milestone described in items (1) through (4) of this
20    subsection (a-5.5) for each disorder screening test; and
21        (6) the authentication of achieving the potential of
22    high throughput standards for statewide volume of each
23    disorder screening test concomitant with each milestone
24    described in items (1) through (4) of this subsection
25    (a-5.5).
26    (a-6) (Blank).
		SB3049 Enrolled	- 6 -	LRB104 16764 BDA 32796 b
1    (a-7) (Blank).
2    (a-8) (Blank).
3    (b) (Blank).
4    (c) (Blank).
5    (d) (Blank).
6    (e) (Blank).
7(Source: P.A. 98-440, eff. 8-16-13; 98-756, eff. 7-16-14;
899-403, eff. 8-19-15.)
9    Section 10. The Genetic and Metabolic Diseases Advisory
10Committee Act is amended by changing Section 5 as follows:
11    (410 ILCS 265/5)
12    Sec. 5. Universal Newborn Screening [Genetic and Metabolic ]
13[Diseases] Advisory Committee.
14    (a) The Director of Public Health shall create the
15Universal Newborn Screening [Genetic and Metabolic Diseases]
16Advisory Committee to advise the Department of Public Health
17regarding issues relevant to newborn screenings of metabolic
18diseases.
19    (b) The Universal Newborn Screening Advisory Committee 
20shall [purposes of Metabolic Diseases Advisory Committee are ]
21[all of the following]:
22        (1) Conduct reviews of any condition added to the 
23    federal Recommended Uniform Screening Panel pursuant to 
24    Section 2 of the Newborn Metabolic Screening Act within 
		SB3049 Enrolled	- 7 -	LRB104 16764 BDA 32796 b
1    one year of addition to the Recommended Uniform Screening 
2    Panel.
3        (2) Conduct reviews within one year of any condition 
4    that meets the following criteria once both criteria have 
5    been met:
6            (A) there is a newborn screening assay available 
7        for the condition; and
8            (B) there is a therapeutic intervention or 
9        treatment approved by the United States Food and Drug 
10        Administration for the condition.
11        (3) Following review of each condition, make a formal 
12    recommendation to the Department of Public Health on 
13    whether to add the condition to the newborn screening 
14    panel. If the Department approves the addition of the 
15    condition, the Department must inform the State Laboratory 
16    within 60 days of receiving the recommendation. The State 
17    Laboratory shall implement newborn screening for the 
18    approved conditions within 2 years. If the Department does 
19    not approve the condition, the Department must provide 
20    information as to why the decision was made and what gaps 
21    of information are needed for reconsideration.
22        (4) Submit to the Governor's Office and the General 
23    Assembly by December 31, 2027 and each year thereafter, a 
24    list of the conditions the Committee reviewed, the 
25    Committee's recommendations, the Department of Public 
26    Health's decisions, and the status of implementation in 
		SB3049 Enrolled	- 8 -	LRB104 16764 BDA 32796 b
1    the lab. Any recommendations not to add a condition shall 
2    include information from the Committee as to why the 
3    decision was made, what gaps of information need to be met 
4    for reconsideration along with processes to initiate 
5    reconsideration.
6        (5) [(1)] Advise the Department regarding issues
7    relevant to its Genetics Program.
8        (6) [(2)] Advise the Department regarding optimal
9    laboratory methodologies for screening of the targeted
10    conditions.
11        (7) [(3)] Recommend to the Department consultants who
12    are qualified to diagnose a condition detected by
13    screening, provide management of care, and genetic
14    counseling for the family.
15        (8) [(4)] Monitor the incidence of each condition for
16    which newborn screening is done, evaluate the effects of
17    treatment and genetic counseling, and provide advice on
18    disorders to be included in newborn screening panel.
19        (9) [(5)] Advise the Department on educational programs
20    for professionals and the general public.
21        (10) [(6)] Advise the Department on new developments and
22    areas of interest in relation to the Genetics Program.
23        (11) [(7)] Address any other matters [Any other matter]
24    deemed appropriate by the Committee and the Director.
25    (b-5) Nothing in this Section shall be construed to 
26prevent the review and recommendation of additional conditions 
		SB3049 Enrolled	- 9 -	LRB104 16764 BDA 32796 b
1not currently on the Recommended Uniform Screening Panel.
2    (c) The Committee shall consist of 20 members appointed by
3the Director of Public Health. Membership shall include
4physicians, geneticists, nurses, nutritionists, and other
5allied health professionals, as well as patients and parents.
6Ex officio [Ex-officio] members may be appointed, but shall not
7have voting privileges.
8    (d) Members of the Committee may receive compensation for
9necessary expenses incurred in the performance of their
10duties.
11(Source: P.A. 98-440, eff. 8-16-13.)
12    Section 99. Effective date. This Act takes effect upon
13becoming law.