NEWBORN METABOLIC SCREENING

Full Bill Text

SB3049 Enrolled LRB104 16764 BDA 32796 b 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 as follows: 6 (410 ILCS 240/2) (from Ch. 111 1/2, par. 4904) 7 Sec. 2. General provisions. The Department of Public 8 Health shall administer the provisions of this Act and shall: 9 (a) Institute and carry on an intensive educational 10 program among physicians, hospitals, public health nurses , and 11 the 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: SB3049 Enrolled - 2 - LRB104 16764 BDA 32796 b 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 8 prior to the beginning of testing for a new genetic, 9 metabolic, or congenital disorder. Fees collected from the 10 provision of this testing service shall be placed in the 11 Metabolic Screening and Treatment Fund. Other State and 12 federal funds for expenses related to metabolic screening, 13 follow-up, and treatment programs may also be placed in 14 the Fund. 15 (2) Moneys shall be appropriated from the Fund to the 16 Department solely for the purposes of providing newborn 17 screening, follow-up, and treatment programs. Nothing in 18 this Act shall be construed to prohibit any licensed 19 medical facility from collecting additional specimens for 20 testing for metabolic or neonatal diseases or any other 21 diseases or conditions, as it deems fit. Any person 22 violating the provisions of this subsection (a-5.1) is 23 guilty of a petty offense. 24 (3) If the Department is unable to provide the 25 screening using the State Laboratory, it shall temporarily 26 provide such screening through an accredited laboratory SB3049 Enrolled - 3 - LRB104 16764 BDA 32796 b 1 selected by the Department until the Department has the 2 capacity to provide screening through the State 3 Laboratory. If screening is provided on a temporary basis 4 through an accredited laboratory, the Department shall 5 substitute the fee charged by the accredited laboratory, 6 plus a 5% surcharge for documentation and handling, for 7 the fee authorized in this subsection (a-5.1). 8 (a-5.2) Maintain a registry of cases, including 9 information of importance for the purpose of follow-up 10 services to assess long-term outcomes. 11 (a-5.3) Supply the necessary metabolic treatment formulas 12 where practicable for diagnosed cases of amino acid metabolism 13 disorders, including phenylketonuria, organic acid disorders, 14 and fatty acid oxidation disorders for as long as medically 15 indicated, when the product is not available through other 16 State agencies. 17 (a-5.4) Arrange for or provide public health nursing, 18 nutrition, and social services and clinical consultation as 19 indicated. 20 (a-5.5) Utilize the Universal Newborn Screening Genetic 21 and Metabolic Diseases Advisory Committee established under 22 the Genetic and Metabolic Diseases Advisory Committee Act to 23 provide guidance and recommendations to the Department's 24 newborn screening program. The Universal Newborn Screening 25 Genetic and Metabolic Diseases Advisory Committee shall review 26 the feasibility and advisability of including additional SB3049 Enrolled - 4 - LRB104 16764 BDA 32796 b 1 metabolic, genetic, and congenital disorders in the newborn 2 screening panel, according to a review protocol applied to 3 each suggested addition to the screening panel. Beginning 4 January 1, 2027, the Universal Newborn Screening Advisory 5 Committee shall review all new conditions added to the federal 6 Recommended Uniform Screening Panel within 12 months of the 7 condition being added to the Recommended Uniform Screening 8 Panel, as long as the condition meets the requirements of this 9 Section. If the Recommended Uniform Screening Panel includes 10 conditions not screened by the State on the effective date of 11 this amendatory Act of the 104th General Assembly, the 12 Universal Newborn Screening Advisory Committee shall begin 13 review of the condition no later than one year after the 14 effective date of this amendatory Act of the 104th General 15 Assembly. Nothing in this Section shall be construed to 16 prevent the review and recommendation of additional conditions 17 not on the Recommended Uniform Screening Panel on the 18 effective date of this amendatory Act of the 104th General 19 Assembly, as long as they meet the requirements for review. 20 The Department shall consider the recommendations of the 21 Universal Newborn Screening Genetic and Metabolic Diseases 22 Advisory Committee in determining whether to include an 23 additional disorder in the screening panel prior to proposing 24 an administrative rule concerning inclusion of an additional 25 disorder in the newborn screening panel. Notwithstanding any 26 other provision of law, no new screening may begin prior to the SB3049 Enrolled - 5 - LRB104 16764 BDA 32796 b 1 occurrence of all the following: 2 (1) the establishment and verification of relevant and 3 appropriate performance specifications as defined under 4 the federal Clinical Laboratory Improvement Amendments and 5 regulations thereunder for U.S. Food and Drug 6 Administration-cleared or in-house developed methods, 7 performed under an institutional review board-approved 8 protocol, if required; 9 (2) the availability of quality assurance testing 10 methodology for the processes set forth in item (1) of 11 this subsection (a-5.5); 12 (3) the acquisition and installment by the Department 13 of the equipment necessary to implement the screening 14 tests; 15 (4) the establishment of precise threshold values 16 ensuring defined disorder identification for each 17 screening test; 18 (5) the authentication of pilot testing achieving each 19 milestone described in items (1) through (4) of this 20 subsection (a-5.5) for each disorder screening test; and 21 (6) the authentication of achieving the potential of 22 high throughput standards for statewide volume of each 23 disorder screening test concomitant with each milestone 24 described in items (1) through (4) of this subsection 25 (a-5.5). 26 (a-6) (Blank). SB3049 Enrolled - 6 - LRB104 16764 BDA 32796 b 1 (a-7) (Blank). 2 (a-8) (Blank). 3 (b) (Blank). 4 (c) (Blank). 5 (d) (Blank). 6 (e) (Blank). 7 (Source: P.A. 98-440, eff. 8-16-13; 98-756, eff. 7-16-14; 8 99-403, eff. 8-19-15.) 9 Section 10. The Genetic and Metabolic Diseases Advisory 10 Committee Act is amended by changing Section 5 as follows: 11 (410 ILCS 265/5) 12 Sec. 5. Universal Newborn Screening Genetic and Metabolic 13 Diseases Advisory Committee. 14 (a) The Director of Public Health shall create the 15 Universal Newborn Screening Genetic and Metabolic Diseases 16 Advisory Committee to advise the Department of Public Health 17 regarding issues relevant to newborn screenings of metabolic 18 diseases. 19 (b) The Universal Newborn Screening Advisory Committee 20 shall purposes of Metabolic Diseases Advisory Committee are 21 all of the following : 22 (1) Conduct reviews of any condition added to the 23 federal Recommended Uniform Screening Panel pursuant to 24 Section 2 of the Newborn Metabolic Screening Act within SB3049 Enrolled - 7 - LRB104 16764 BDA 32796 b 1 one year of addition to the Recommended Uniform Screening 2 Panel. 3 (2) Conduct reviews within one year of any condition 4 that meets the following criteria once both criteria have 5 been met: 6 (A) there is a newborn screening assay available 7 for the condition; and 8 (B) there is a therapeutic intervention or 9 treatment approved by the United States Food and Drug 10 Administration for the condition. 11 (3) Following review of each condition, make a formal 12 recommendation to the Department of Public Health on 13 whether to add the condition to the newborn screening 14 panel. If the Department approves the addition of the 15 condition, the Department must inform the State Laboratory 16 within 60 days of receiving the recommendation. The State 17 Laboratory shall implement newborn screening for the 18 approved conditions within 2 years. If the Department does 19 not approve the condition, the Department must provide 20 information as to why the decision was made and what gaps 21 of information are needed for reconsideration. 22 (4) Submit to the Governor's Office and the General 23 Assembly by December 31, 2027 and each year thereafter, a 24 list of the conditions the Committee reviewed, the 25 Committee's recommendations, the Department of Public 26 Health's decisions, and the status of implementation in SB3049 Enrolled - 8 - LRB104 16764 BDA 32796 b 1 the lab. Any recommendations not to add a condition shall 2 include information from the Committee as to why the 3 decision was made, what gaps of information need to be met 4 for reconsideration along with processes to initiate 5 reconsideration. 6 (5) (1) Advise the Department regarding issues 7 relevant to its Genetics Program. 8 (6) (2) Advise the Department regarding optimal 9 laboratory methodologies for screening of the targeted 10 conditions. 11 (7) (3) Recommend to the Department consultants who 12 are qualified to diagnose a condition detected by 13 screening, provide management of care, and genetic 14 counseling for the family. 15 (8) (4) Monitor the incidence of each condition for 16 which newborn screening is done, evaluate the effects of 17 treatment and genetic counseling, and provide advice on 18 disorders to be included in newborn screening panel. 19 (9) (5) Advise the Department on educational programs 20 for professionals and the general public. 21 (10) (6) Advise the Department on new developments and 22 areas of interest in relation to the Genetics Program. 23 (11) (7) Address any other matters Any other matter 24 deemed appropriate by the Committee and the Director. 25 (b-5) Nothing in this Section shall be construed to 26 prevent the review and recommendation of additional conditions SB3049 Enrolled - 9 - LRB104 16764 BDA 32796 b 1 not currently on the Recommended Uniform Screening Panel. 2 (c) The Committee shall consist of 20 members appointed by 3 the Director of Public Health. Membership shall include 4 physicians, geneticists, nurses, nutritionists, and other 5 allied health professionals, as well as patients and parents. 6 Ex officio Ex-officio members may be appointed, but shall not 7 have voting privileges. 8 (d) Members of the Committee may receive compensation for 9 necessary expenses incurred in the performance of their 10 duties. 11 (Source: P.A. 98-440, eff. 8-16-13.) 12 Section 99. Effective date. This Act takes effect upon 13 becoming law.