Bill Text: IL SB3049 | 2025-2026 | 104th General Assembly | Enrolled

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Bill Title: Amends the Genetic and Metabolic Diseases Advisory Committee Act. Changes the name of the Genetic and Metabolic Diseases Advisory Committee to the Universal Newborn Screening Advisory Committee. Adds duties for the Committee, including duties to hold quarterly meetings, review conditions, make recommendations, and prepare reports. Makes conforming changes in the short title of the Act, the Newborn Metabolic Screening Act, and the Rare Disease Commission Act. Effective immediately.

Sponsorship: Partisan Bill (Democrat 14)

Status: (Passed) 2026-08-21 - Public Act . . . . . . . . . 104-0843 [SB3049 Detail]

Download: Illinois-2025-SB3049-Enrolled.html

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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Newborn Metabolic Screening Act is amended
by changing Section 2 as follows:
(410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)
Sec. 2. General provisions. The Department of Public
Health shall administer the provisions of this Act and shall:
(a) Institute and carry on an intensive educational
program among physicians, hospitals, public health nurses, and
the public concerning disorders included in newborn screening.
This educational program shall include information about the
nature of the diseases and examinations for the detection of
the diseases in early infancy in order that measures may be
taken to prevent the disabilities resulting from the diseases.
(a-5) Require that all newborns be screened for the
presence of certain genetic, metabolic, and congenital
anomalies as determined by the Department, by rule.
(a-5.1) Require that all blood and biological specimens
collected pursuant to this Act or the rules adopted under this
Act be submitted for testing to the nearest Department
laboratory designated to perform such tests. The following
provisions shall apply concerning testing:

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(1) Beginning July 1, 2015, the base fee for newborn
screening services shall be $118. The Department may
develop a reasonable fee structure and may levy additional
fees according to such structure to cover the cost of
providing this testing service and for the follow-up of
infants with an abnormal screening test; however,
additional fees may be levied no sooner than 6 months
prior to the beginning of testing for a new genetic,
metabolic, or congenital disorder. Fees collected from the
provision of this testing service shall be placed in the
Metabolic Screening and Treatment Fund. Other State and
federal funds for expenses related to metabolic screening,
follow-up, and treatment programs may also be placed in
the Fund.
(2) Moneys shall be appropriated from the Fund to the
Department solely for the purposes of providing newborn
screening, follow-up, and treatment programs. Nothing in
this Act shall be construed to prohibit any licensed
medical facility from collecting additional specimens for
testing for metabolic or neonatal diseases or any other
diseases or conditions, as it deems fit. Any person
violating the provisions of this subsection (a-5.1) is
guilty of a petty offense.
(3) If the Department is unable to provide the
screening using the State Laboratory, it shall temporarily
provide such screening through an accredited laboratory

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selected by the Department until the Department has the
capacity to provide screening through the State
Laboratory. If screening is provided on a temporary basis
through an accredited laboratory, the Department shall
substitute the fee charged by the accredited laboratory,
plus a 5% surcharge for documentation and handling, for
the fee authorized in this subsection (a-5.1).
(a-5.2) Maintain a registry of cases, including
information of importance for the purpose of follow-up
services to assess long-term outcomes.
(a-5.3) Supply the necessary metabolic treatment formulas
where practicable for diagnosed cases of amino acid metabolism
disorders, including phenylketonuria, organic acid disorders,
and fatty acid oxidation disorders for as long as medically
indicated, when the product is not available through other
State agencies.
(a-5.4) Arrange for or provide public health nursing,
nutrition, and social services and clinical consultation as
indicated.
(a-5.5) Utilize the Universal Newborn Screening Genetic
and Metabolic Diseases Advisory Committee established under
the Genetic and Metabolic Diseases Advisory Committee Act to
provide guidance and recommendations to the Department's
newborn screening program. The Universal Newborn Screening
Genetic and Metabolic Diseases Advisory Committee shall review
the feasibility and advisability of including additional

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metabolic, genetic, and congenital disorders in the newborn
screening panel, according to a review protocol applied to
each suggested addition to the screening panel. Beginning
January 1, 2027, the Universal Newborn Screening Advisory
Committee shall review all new conditions added to the federal
Recommended Uniform Screening Panel within 12 months of the
condition being added to the Recommended Uniform Screening
Panel, as long as the condition meets the requirements of this
Section. If the Recommended Uniform Screening Panel includes
conditions not screened by the State on the effective date of
this amendatory Act of the 104th General Assembly, the
Universal Newborn Screening Advisory Committee shall begin
review of the condition no later than one year after the
effective date of this amendatory Act of the 104th General
Assembly. Nothing in this Section shall be construed to
prevent the review and recommendation of additional conditions
not on the Recommended Uniform Screening Panel on the
effective date of this amendatory Act of the 104th General
Assembly, as long as they meet the requirements for review.
The Department shall consider the recommendations of the
Universal Newborn Screening Genetic and Metabolic Diseases
Advisory Committee in determining whether to include an
additional disorder in the screening panel prior to proposing
an administrative rule concerning inclusion of an additional
disorder in the newborn screening panel. Notwithstanding any
other provision of law, no new screening may begin prior to the

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occurrence of all the following:
(1) the establishment and verification of relevant and
appropriate performance specifications as defined under
the federal Clinical Laboratory Improvement Amendments and
regulations thereunder for U.S. Food and Drug
Administration-cleared or in-house developed methods,
performed under an institutional review board-approved
protocol, if required;
(2) the availability of quality assurance testing
methodology for the processes set forth in item (1) of
this subsection (a-5.5);
(3) the acquisition and installment by the Department
of the equipment necessary to implement the screening
tests;
(4) the establishment of precise threshold values
ensuring defined disorder identification for each
screening test;
(5) the authentication of pilot testing achieving each
milestone described in items (1) through (4) of this
subsection (a-5.5) for each disorder screening test; and
(6) the authentication of achieving the potential of
high throughput standards for statewide volume of each
disorder screening test concomitant with each milestone
described in items (1) through (4) of this subsection
(a-5.5).
(a-6) (Blank).

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(a-7) (Blank).
(a-8) (Blank).
(b) (Blank).
(c) (Blank).
(d) (Blank).
(e) (Blank).
(Source: P.A. 98-440, eff. 8-16-13; 98-756, eff. 7-16-14;
99-403, eff. 8-19-15.)
Section 10. The Genetic and Metabolic Diseases Advisory
Committee Act is amended by changing Section 5 as follows:
(410 ILCS 265/5)
Sec. 5. Universal Newborn Screening Genetic and Metabolic
Diseases Advisory Committee.
(a) The Director of Public Health shall create the
Universal Newborn Screening Genetic and Metabolic Diseases
Advisory Committee to advise the Department of Public Health
regarding issues relevant to newborn screenings of metabolic
diseases.
(b) The Universal Newborn Screening Advisory Committee
shall purposes of Metabolic Diseases Advisory Committee are
all of the following:
(1) Conduct reviews of any condition added to the
federal Recommended Uniform Screening Panel pursuant to
Section 2 of the Newborn Metabolic Screening Act within

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one year of addition to the Recommended Uniform Screening
Panel.
(2) Conduct reviews within one year of any condition
that meets the following criteria once both criteria have
been met:
(A) there is a newborn screening assay available
for the condition; and
(B) there is a therapeutic intervention or
treatment approved by the United States Food and Drug
Administration for the condition.
(3) Following review of each condition, make a formal
recommendation to the Department of Public Health on
whether to add the condition to the newborn screening
panel. If the Department approves the addition of the
condition, the Department must inform the State Laboratory
within 60 days of receiving the recommendation. The State
Laboratory shall implement newborn screening for the
approved conditions within 2 years. If the Department does
not approve the condition, the Department must provide
information as to why the decision was made and what gaps
of information are needed for reconsideration.
(4) Submit to the Governor's Office and the General
Assembly by December 31, 2027 and each year thereafter, a
list of the conditions the Committee reviewed, the
Committee's recommendations, the Department of Public
Health's decisions, and the status of implementation in

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the lab. Any recommendations not to add a condition shall
include information from the Committee as to why the
decision was made, what gaps of information need to be met
for reconsideration along with processes to initiate
reconsideration.
(5) (1) Advise the Department regarding issues
relevant to its Genetics Program.
(6) (2) Advise the Department regarding optimal
laboratory methodologies for screening of the targeted
conditions.
(7) (3) Recommend to the Department consultants who
are qualified to diagnose a condition detected by
screening, provide management of care, and genetic
counseling for the family.
(8) (4) Monitor the incidence of each condition for
which newborn screening is done, evaluate the effects of
treatment and genetic counseling, and provide advice on
disorders to be included in newborn screening panel.
(9) (5) Advise the Department on educational programs
for professionals and the general public.
(10) (6) Advise the Department on new developments and
areas of interest in relation to the Genetics Program.
(11) (7) Address any other matters Any other matter
deemed appropriate by the Committee and the Director.
(b-5) Nothing in this Section shall be construed to
prevent the review and recommendation of additional conditions

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not currently on the Recommended Uniform Screening Panel.
(c) The Committee shall consist of 20 members appointed by
the Director of Public Health. Membership shall include
physicians, geneticists, nurses, nutritionists, and other
allied health professionals, as well as patients and parents.
Ex officio Ex-officio members may be appointed, but shall not
have voting privileges.
(d) Members of the Committee may receive compensation for
necessary expenses incurred in the performance of their
duties.
(Source: P.A. 98-440, eff. 8-16-13.)
Section 99. Effective date. This Act takes effect upon
becoming law.