Full Text of HB2790 99th General Assembly
HB2790enr 99TH GENERAL ASSEMBLY |
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| 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 ; however, | 7 | | additional fees may be levied no sooner than 6 months prior | 8 | | to the beginning of testing for a new genetic, metabolic, | 9 | | or congenital disorder . Fees collected from the provision | 10 | | of this testing service shall be placed in the Metabolic | 11 | | Screening and Treatment Fund. Other State and federal funds | 12 | | for expenses related to metabolic screening, follow-up, | 13 | | and treatment programs may also be placed in the Fund. | 14 | | (2) Moneys shall be appropriated from the Fund to the | 15 | | Department solely for the purposes of providing newborn | 16 | | screening, follow-up, and treatment programs. Nothing in | 17 | | this Act shall be construed to prohibit any licensed | 18 | | medical facility from collecting additional specimens for | 19 | | testing for metabolic or neonatal diseases or any other | 20 | | diseases or conditions, as it deems fit. Any person | 21 | | violating the provisions of this subsection (a-5.1) is | 22 | | guilty of a petty offense. | 23 | | (3) If the Department is unable to provide the | 24 | | screening using the
State Laboratory, it shall temporarily | 25 | | provide such screening
through an accredited laboratory | 26 | | selected by the Department until the
Department has the |
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| 1 | | capacity to provide screening through the State
| 2 | | Laboratory. If screening is provided on a temporary basis
| 3 | | through an accredited laboratory, the Department shall | 4 | | substitute the fee
charged by the accredited laboratory, | 5 | | plus a 5% surcharge for
documentation and handling, for the | 6 | | fee authorized in this subsection (a-5.1). | 7 | | (a-5.2) Maintain a registry of cases, including | 8 | | information of importance for the purpose of follow-up services | 9 | | to assess long-term outcomes. | 10 | | (a-5.3) Supply the necessary metabolic treatment formulas | 11 | | where practicable for diagnosed cases of amino acid metabolism | 12 | | disorders, including phenylketonuria, organic acid disorders, | 13 | | and fatty acid oxidation disorders for as long as medically | 14 | | indicated, when the product is not available through other | 15 | | State agencies. | 16 | | (a-5.4) Arrange for or provide public health nursing, | 17 | | nutrition, and social services and clinical consultation as | 18 | | indicated. | 19 | | (a-5.5) Utilize the Genetic and Metabolic Diseases | 20 | | Advisory Committee established under the Genetic and Metabolic | 21 | | Diseases Advisory Committee Act to provide guidance and | 22 | | recommendations to the Department's newborn screening program. | 23 | | The Genetic and Metabolic Diseases Advisory Committee shall | 24 | | review the feasibility and advisability of including | 25 | | additional metabolic, genetic, and congenital disorders in the | 26 | | newborn screening panel, according to a review protocol applied |
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| 1 | | to each suggested addition to the screening panel. The | 2 | | Department shall consider the recommendations of the Genetic | 3 | | and Metabolic Diseases Advisory Committee in determining | 4 | | whether to include an additional disorder in the screening | 5 | | panel prior to proposing an administrative rule concerning | 6 | | inclusion of an additional disorder in the newborn screening | 7 | | panel. Notwithstanding any other provision of law, no new | 8 | | screening may begin prior to the occurrence of all the | 9 | | following: | 10 | | (1) the establishment and verification of relevant and
| 11 | | appropriate performance specifications as defined under
| 12 | | the federal Clinical Laboratory Improvement Amendments and
| 13 | | regulations thereunder for U.S. Food and Drug
| 14 | | Administration-cleared or in-house developed methods,
| 15 | | performed under an institutional review board-approved
| 16 | | protocol, if required; | 17 | | (2) the availability of quality assurance testing
| 18 | | methodology for the processes set forth in item (1) of this | 19 | | subsection (a-5.5); | 20 | | (3) the acquisition and installment by the Department
| 21 | | of the equipment necessary to implement the screening
| 22 | | tests; | 23 | | (4) the establishment of precise threshold values | 24 | | ensuring
defined disorder identification for each | 25 | | screening test; | 26 | | (5) the authentication of pilot testing achieving each
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| 1 | | milestone described in items (1) through (4) of this
| 2 | | subsection (a-5.5) for each disorder screening test; and | 3 | | (6) the authentication of achieving the potential of | 4 | | high
throughput standards for statewide volume of each | 5 | | disorder
screening test concomitant with each milestone | 6 | | described
in items (1) through (4) of this subsection | 7 | | (a-5.5).
| 8 | | (a-6) (Blank). | 9 | | (a-7) (Blank). | 10 | | (a-8) (Blank). | 11 | | (b) (Blank).
| 12 | | (c) (Blank).
| 13 | | (d) (Blank).
| 14 | | (e) (Blank).
| 15 | | (Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; | 16 | | 97-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff. | 17 | | 7-16-14.)
| 18 | | (410 ILCS 240/3.4 new) | 19 | | Sec. 3.4. Adrenoleukodystrophy. In accordance with the | 20 | | timetable specified in this Section, the Department shall | 21 | | provide all newborns with screening tests for the presence of | 22 | | adrenoleukodystrophy (ALD). The testing shall begin within 18 | 23 | | months following the occurrence of all of the following: | 24 | | (1) the development and validation of a reliable | 25 | | methodology for screening newborns for ALD using dried |
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| 1 | | blood spots and quality assurance testing methodology for | 2 | | such test or the approval of a test for ALD using dried | 3 | | blood spots by the federal Food and Drug Administration; | 4 | | (2) the availability of any necessary reagents for such | 5 | | test; | 6 | | (3) the establishment and verification of relevant and | 7 | | appropriate performance specifications as defined under | 8 | | the federal Clinical Laboratory Improvement Amendments and | 9 | | regulations thereunder for Federal Drug | 10 | | Administration-cleared or in-house developed methods, | 11 | | performed under an institutional review board approved | 12 | | protocol, if required; | 13 | | (4) the availability of quality assurance testing and | 14 | | comparative threshold values for ALD; | 15 | | (5) the acquisition and installment by the Department | 16 | | of the equipment necessary to implement the initial pilot | 17 | | and statewide volume of screening tests for ALD; | 18 | | (6) the establishment of precise threshold values | 19 | | ensuring defined disorder identification for ALD; | 20 | | (7) the authentication of pilot testing achieving each | 21 | | milestone described in items (1) through (6) of this | 22 | | Section for ALD; and | 23 | | (8) the authentication of achieving the potential of | 24 | | high throughput standards for statewide volume of ALD | 25 | | concomitant with each milestone described in items (1) | 26 | | through (6) of this Section. |
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| 1 | | The Department is authorized to implement an additional fee | 2 | | for the screening no sooner than 6 months prior to beginning | 3 | | the testing in order to accumulate the resources for start-up | 4 | | and other costs associated with implementation of the screening | 5 | | and thereafter to support the costs associated with screening | 6 | | and follow-up programs for adrenoleukodystrophy.
| 7 | | Section 99. Effective date. This Act takes effect July 1, | 8 | | 2015.
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