HB4896eng 96TH GENERAL ASSEMBLY

HB4896 Engrossed LRB096 16094 HLH 31343 b

AN ACT concerning State government.

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. 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 the diseases phenylketonuria, hypothyroidism, galactosemia and other metabolic diseases. 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 mental retardation resulting from the diseases.

(a-5) Beginning July 1, 2002, provide all newborns with expanded screening tests for the presence of genetic, endocrine, or other metabolic disorders, including phenylketonuria, galactosemia, hypothyroidism, congenital adrenal hyperplasia, biotinidase deficiency, and sickling disorders, as well as other amino acid disorders, organic acid disorders, fatty acid oxidation disorders, and other abnormalities detectable through the use of a tandem mass spectrometer. If by July 1, 2002, the Department is unable to provide expanded 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 expanded 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 subsection (e) of this Section.

(a-6) In accordance with the timetable specified in this subsection, provide all newborns with expanded screening tests for the presence of certain Lysosomal Storage Disorders known as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing shall begin within 6 months following the occurrence of all of the following:

(i) the registration with the federal Food and Drug Administration of the necessary reagents;

(ii) the availability of the necessary reagents from the Centers for Disease Control and Prevention;

(iii) the availability of quality assurance testing methodology for these processes; and

(iv) the acquisition and installment by the Department of the equipment necessary to implement the expanded screening tests.

It is the goal of this amendatory Act of the 95th General Assembly that the expanded screening for the specified Lysosomal Storage Disorders begins within 3 years after the effective date of this Act. The Department is authorized to implement an additional fee for the screening 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 the specified Lysosomal Storage Disorders.

(b) Maintain a registry of cases including information of importance for the purpose of follow-up services to prevent mental retardation.

(c) 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.

(d) Arrange for or provide public health nursing, nutrition and social services and clinical consultation as indicated.

(e) Require that all specimens collected pursuant to this Act or the rules and regulations promulgated hereunder be submitted for testing to the nearest Department of Public Health laboratory designated to perform such tests. The Department may develop a reasonable fee structure and may levy fees according to such structure to cover the cost of providing this testing service. Fees collected from the provision of this testing service shall be placed in a special fund in the State Treasury, hereafter known as 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 such Fund. Moneys shall be appropriated from such Fund to the Department of Public Health solely for the purposes of providing metabolic screening, follow-up and treatment programs. The Metabolic Screening and Treatment Fund is not subject to administrative charges, or charge-backs, including but not limited to those authorized under Section 8h of the State Finance Act. 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 (e) is guilty of a petty offense.

(Source: P.A. 95-695, eff. 11-5-07.)

Section 99. Effective date. This Act takes effect upon becoming law.