Full Text of HB2790 99th General Assembly
HB2790ham001 99TH GENERAL ASSEMBLY | Rep. Laura Fine Filed: 3/23/2015
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| 1 | | AMENDMENT TO HOUSE BILL 2790
| 2 | | AMENDMENT NO. ______. Amend House Bill 2790 by replacing | 3 | | everything after the enacting clause with the following:
| 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 |
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| 1 | | presence of certain genetic, metabolic, and congenital | 2 | | anomalies as determined by the Department, by rule. | 3 | | (a-5.1) Require that all blood and biological specimens | 4 | | collected pursuant to this Act or the rules adopted under this | 5 | | Act be submitted for testing to the nearest Department | 6 | | laboratory designated to perform such tests. The following | 7 | | provisions shall apply concerning testing: | 8 | | (1) Beginning July 1, 2015, the base fee for newborn | 9 | | screening services shall be $118. The Department may | 10 | | develop a reasonable fee structure and may levy additional | 11 | | fees according to such structure to cover the cost of | 12 | | providing this testing service and for the follow-up of | 13 | | infants with an abnormal screening test. Fees collected | 14 | | from the provision of this testing service shall be placed | 15 | | in the Metabolic Screening and Treatment Fund. Other State | 16 | | and federal funds for expenses related to metabolic | 17 | | screening, follow-up, and treatment programs may also be | 18 | | placed in the Fund. | 19 | | (2) Moneys shall be appropriated from the Fund to the | 20 | | Department solely for the purposes of providing newborn | 21 | | screening, follow-up, and treatment programs. Nothing in | 22 | | this Act shall be construed to prohibit any licensed | 23 | | medical facility from collecting additional specimens for | 24 | | testing for metabolic or neonatal diseases or any other | 25 | | diseases or conditions, as it deems fit. Any person | 26 | | violating the provisions of this subsection (a-5.1) is |
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| 1 | | guilty of a petty offense. | 2 | | (3) If the Department is unable to provide the | 3 | | screening using the
State Laboratory, it shall temporarily | 4 | | provide such screening
through an accredited laboratory | 5 | | selected by the Department until the
Department has the | 6 | | capacity to provide screening through the State
| 7 | | Laboratory. If screening is provided on a temporary basis
| 8 | | through an accredited laboratory, the Department shall | 9 | | substitute the fee
charged by the accredited laboratory, | 10 | | plus a 5% surcharge for
documentation and handling, for the | 11 | | fee authorized in this subsection (a-5.1). | 12 | | (a-5.2) Maintain a registry of cases, including | 13 | | information of importance for the purpose of follow-up services | 14 | | to assess long-term outcomes. | 15 | | (a-5.3) Supply the necessary metabolic treatment formulas | 16 | | where practicable for diagnosed cases of amino acid metabolism | 17 | | disorders, including phenylketonuria, organic acid disorders, | 18 | | and fatty acid oxidation disorders for as long as medically | 19 | | indicated, when the product is not available through other | 20 | | State agencies. | 21 | | (a-5.4) Arrange for or provide public health nursing, | 22 | | nutrition, and social services and clinical consultation as | 23 | | indicated. | 24 | | (a-5.5) Utilize the Genetic and Metabolic Diseases | 25 | | Advisory Committee established under the Genetic and Metabolic | 26 | | Diseases Advisory Committee Act to provide guidance and |
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| 1 | | recommendations to the Department's newborn screening program. | 2 | | The Genetic and Metabolic Diseases Advisory Committee shall | 3 | | review the feasibility and advisability of including | 4 | | additional metabolic, genetic, and congenital disorders in the | 5 | | newborn screening panel, according to a review protocol applied | 6 | | to each suggested addition to the screening panel. The | 7 | | Department shall consider the recommendations of the Genetic | 8 | | and Metabolic Diseases Advisory Committee in determining | 9 | | whether to include an additional disorder in the screening | 10 | | panel prior to proposing an administrative rule concerning | 11 | | inclusion of an additional disorder in the newborn screening | 12 | | panel. Notwithstanding any other provision of law, no new | 13 | | screening may begin prior to the occurrence of all the | 14 | | following: | 15 | | (1) the establishment and verification of relevant and
| 16 | | appropriate performance specifications as defined under
| 17 | | the federal Clinical Laboratory Improvement Amendments and
| 18 | | regulations thereunder for U.S. Food and Drug
| 19 | | Administration-cleared or in-house developed methods,
| 20 | | performed under an institutional review board-approved
| 21 | | protocol, if required; | 22 | | (2) the availability of quality assurance testing
| 23 | | methodology for the processes set forth in item (1) of this | 24 | | subsection (a-5.5); | 25 | | (3) the acquisition and installment by the Department
| 26 | | of the equipment necessary to implement the screening
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| 1 | | tests; | 2 | | (4) the establishment of precise threshold values | 3 | | ensuring
defined disorder identification for each | 4 | | screening test; | 5 | | (5) the authentication of pilot testing achieving each
| 6 | | milestone described in items (1) through (4) of this
| 7 | | subsection (a-5.5) for each disorder screening test; and | 8 | | (6) the authentication of achieving the potential of | 9 | | high
throughput standards for statewide volume of each | 10 | | disorder
screening test concomitant with each milestone | 11 | | described
in items (1) through (4) of this subsection | 12 | | (a-5.5).
| 13 | | (a-6) (Blank). | 14 | | (a-7) (Blank). | 15 | | (a-8) (Blank). | 16 | | (b) (Blank).
| 17 | | (c) (Blank).
| 18 | | (d) (Blank).
| 19 | | (e) (Blank).
| 20 | | (Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; | 21 | | 97-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff. | 22 | | 7-16-14.)
| 23 | | (410 ILCS 240/3.4 new) | 24 | | Sec. 3.4. Adrenoleukodystrophy. In accordance with the | 25 | | timetable specified in this Section, the Department shall |
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| 1 | | provide all newborns with screening tests for the presence of | 2 | | adrenoleukodystrophy (ALD). The testing shall begin within 18 | 3 | | months following the occurrence of all of the following: | 4 | | (1) the development and validation of a reliable | 5 | | methodology for screening newborns for ALD using dried | 6 | | blood spots and quality assurance testing methodology for | 7 | | such test or the approval of a test for ALD using dried | 8 | | blood spots by the federal Food and Drug Administration; | 9 | | (2) the availability of any necessary reagents for such | 10 | | test; | 11 | | (3) the establishment and verification of relevant and | 12 | | appropriate performance specifications as defined under | 13 | | the federal Clinical Laboratory Improvement Amendments and | 14 | | regulations thereunder for Federal Drug | 15 | | Administration-cleared or in-house developed methods, | 16 | | performed under an institutional review board approved | 17 | | protocol, if required; | 18 | | (4) the availability of quality assurance testing and | 19 | | comparative threshold values for ALD; | 20 | | (5) the acquisition and installment by the Department | 21 | | of the equipment necessary to implement the initial pilot | 22 | | and statewide volume of screening tests for ALD; | 23 | | (6) the establishment of precise threshold values | 24 | | ensuring defined disorder identification for ALD; | 25 | | (7) the authentication of pilot testing achieving each | 26 | | milestone described in items (1) through (6) of this |
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| 1 | | Section for ALD; and | 2 | | (8) the authentication of achieving the potential of | 3 | | high throughput standards for statewide volume of ALD | 4 | | concomitant with each milestone described in items (1) | 5 | | through (6) of this Section. | 6 | | The Department is authorized to implement an additional fee | 7 | | for the screening prior to beginning the testing in order to | 8 | | accumulate the resources for start-up and other costs | 9 | | associated with implementation of the screening and thereafter | 10 | | to support the costs associated with screening and follow-up | 11 | | programs for adrenoleukodystrophy.
| 12 | | Section 99. Effective date. This Act takes effect July 1, | 13 | | 2015.".
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