Public Act 099-0403
 
HB2790 EnrolledLRB099 03689 JLK 23700 b

    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 and by adding Section 3.4 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:
        (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
    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 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 Genetic and Metabolic Diseases Advisory Committee shall
review the feasibility and advisability of including
additional metabolic, genetic, and congenital disorders in the
newborn screening panel, according to a review protocol applied
to each suggested addition to the screening panel. The
Department shall consider the recommendations of the 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 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).
    (a-7) (Blank).
    (a-8) (Blank).
    (b) (Blank).
    (c) (Blank).
    (d) (Blank).
    (e) (Blank).
(Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11;
97-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff.
7-16-14.)
 
    (410 ILCS 240/3.4 new)
    Sec. 3.4. Adrenoleukodystrophy. In accordance with the
timetable specified in this Section, the Department shall
provide all newborns with screening tests for the presence of
adrenoleukodystrophy (ALD). The testing shall begin within 18
months following the occurrence of all of the following:
        (1) the development and validation of a reliable
    methodology for screening newborns for ALD using dried
    blood spots and quality assurance testing methodology for
    such test or the approval of a test for ALD using dried
    blood spots by the federal Food and Drug Administration;
        (2) the availability of any necessary reagents for such
    test;
        (3) the establishment and verification of relevant and
    appropriate performance specifications as defined under
    the federal Clinical Laboratory Improvement Amendments and
    regulations thereunder for Federal Drug
    Administration-cleared or in-house developed methods,
    performed under an institutional review board approved
    protocol, if required;
        (4) the availability of quality assurance testing and
    comparative threshold values for ALD;
        (5) the acquisition and installment by the Department
    of the equipment necessary to implement the initial pilot
    and statewide volume of screening tests for ALD;
        (6) the establishment of precise threshold values
    ensuring defined disorder identification for ALD;
        (7) the authentication of pilot testing achieving each
    milestone described in items (1) through (6) of this
    Section for ALD; and
        (8) the authentication of achieving the potential of
    high throughput standards for statewide volume of ALD
    concomitant with each milestone described in items (1)
    through (6) of this Section.
    The Department is authorized to implement an additional fee
for the screening no sooner than 6 months prior to beginning
the testing in order to accumulate the resources for start-up
and other costs associated with implementation of the screening
and thereafter to support the costs associated with screening
and follow-up programs for adrenoleukodystrophy.
 
    Section 99. Effective date. This Act takes effect July 1,
2015.