Public Act 099-0403

HB2790 Enrolled LRB099 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.