Bill Text: IL HB0595 | 2019-2020 | 101st General Assembly | Engrossed


Bill Title: Amends the Newborn Metabolic Screening Act. Provides that the Department of Public Health shall provide all newborns with a screening test for guanidinoacetate methyltransferase deficiency using a method that determines the presence or absence of the deficiency, beginning on the earlier of July 1, 2021 or within 6 months following the occurrence of specified milestones. Authorizes the Department to adopt emergency rules to implement the amendatory Act. Amends the Illinois Administrative Procedure Act. Makes a conforming change.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Engrossed - Dead) 2019-05-10 - Rule 3-9(a) / Re-referred to Assignments [HB0595 Detail]

Download: Illinois-2019-HB0595-Engrossed.html



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1 AN ACT concerning health.
2 Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4 Section 5. The Illinois Administrative Procedure Act is
5amended by changing Section 5-45 as follows:
6 (5 ILCS 100/5-45) (from Ch. 127, par. 1005-45)
7 Sec. 5-45. Emergency rulemaking.
8 (a) "Emergency" means the existence of any situation that
9any agency finds reasonably constitutes a threat to the public
10interest, safety, or welfare.
11 (b) If any agency finds that an emergency exists that
12requires adoption of a rule upon fewer days than is required by
13Section 5-40 and states in writing its reasons for that
14finding, the agency may adopt an emergency rule without prior
15notice or hearing upon filing a notice of emergency rulemaking
16with the Secretary of State under Section 5-70. The notice
17shall include the text of the emergency rule and shall be
18published in the Illinois Register. Consent orders or other
19court orders adopting settlements negotiated by an agency may
20be adopted under this Section. Subject to applicable
21constitutional or statutory provisions, an emergency rule
22becomes effective immediately upon filing under Section 5-65 or
23at a stated date less than 10 days thereafter. The agency's

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1finding and a statement of the specific reasons for the finding
2shall be filed with the rule. The agency shall take reasonable
3and appropriate measures to make emergency rules known to the
4persons who may be affected by them.
5 (c) An emergency rule may be effective for a period of not
6longer than 150 days, but the agency's authority to adopt an
7identical rule under Section 5-40 is not precluded. No
8emergency rule may be adopted more than once in any 24-month
9period, except that this limitation on the number of emergency
10rules that may be adopted in a 24-month period does not apply
11to (i) emergency rules that make additions to and deletions
12from the Drug Manual under Section 5-5.16 of the Illinois
13Public Aid Code or the generic drug formulary under Section
143.14 of the Illinois Food, Drug and Cosmetic Act, (ii)
15emergency rules adopted by the Pollution Control Board before
16July 1, 1997 to implement portions of the Livestock Management
17Facilities Act, (iii) emergency rules adopted by the Illinois
18Department of Public Health under subsections (a) through (i)
19of Section 2 of the Department of Public Health Act when
20necessary to protect the public's health, (iv) emergency rules
21adopted pursuant to subsection (n) of this Section, (v)
22emergency rules adopted pursuant to subsection (o) of this
23Section, or (vi) emergency rules adopted pursuant to subsection
24(c-5) of this Section. Two or more emergency rules having
25substantially the same purpose and effect shall be deemed to be
26a single rule for purposes of this Section.

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1 (c-5) To facilitate the maintenance of the program of group
2health benefits provided to annuitants, survivors, and retired
3employees under the State Employees Group Insurance Act of
41971, rules to alter the contributions to be paid by the State,
5annuitants, survivors, retired employees, or any combination
6of those entities, for that program of group health benefits,
7shall be adopted as emergency rules. The adoption of those
8rules shall be considered an emergency and necessary for the
9public interest, safety, and welfare.
10 (d) In order to provide for the expeditious and timely
11implementation of the State's fiscal year 1999 budget,
12emergency rules to implement any provision of Public Act 90-587
13or 90-588 or any other budget initiative for fiscal year 1999
14may be adopted in accordance with this Section by the agency
15charged with administering that provision or initiative,
16except that the 24-month limitation on the adoption of
17emergency rules and the provisions of Sections 5-115 and 5-125
18do not apply to rules adopted under this subsection (d). The
19adoption of emergency rules authorized by this subsection (d)
20shall be deemed to be necessary for the public interest,
21safety, and welfare.
22 (e) In order to provide for the expeditious and timely
23implementation of the State's fiscal year 2000 budget,
24emergency rules to implement any provision of Public Act 91-24
25or any other budget initiative for fiscal year 2000 may be
26adopted in accordance with this Section by the agency charged

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1with administering that provision or initiative, except that
2the 24-month limitation on the adoption of emergency rules and
3the provisions of Sections 5-115 and 5-125 do not apply to
4rules adopted under this subsection (e). The adoption of
5emergency rules authorized by this subsection (e) shall be
6deemed to be necessary for the public interest, safety, and
7welfare.
8 (f) In order to provide for the expeditious and timely
9implementation of the State's fiscal year 2001 budget,
10emergency rules to implement any provision of Public Act 91-712
11or any other budget initiative for fiscal year 2001 may be
12adopted in accordance with this Section by the agency charged
13with administering that provision or initiative, except that
14the 24-month limitation on the adoption of emergency rules and
15the provisions of Sections 5-115 and 5-125 do not apply to
16rules adopted under this subsection (f). The adoption of
17emergency rules authorized by this subsection (f) shall be
18deemed to be necessary for the public interest, safety, and
19welfare.
20 (g) In order to provide for the expeditious and timely
21implementation of the State's fiscal year 2002 budget,
22emergency rules to implement any provision of Public Act 92-10
23or any other budget initiative for fiscal year 2002 may be
24adopted in accordance with this Section by the agency charged
25with administering that provision or initiative, except that
26the 24-month limitation on the adoption of emergency rules and

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1the provisions of Sections 5-115 and 5-125 do not apply to
2rules adopted under this subsection (g). The adoption of
3emergency rules authorized by this subsection (g) shall be
4deemed to be necessary for the public interest, safety, and
5welfare.
6 (h) In order to provide for the expeditious and timely
7implementation of the State's fiscal year 2003 budget,
8emergency rules to implement any provision of Public Act 92-597
9or any other budget initiative for fiscal year 2003 may be
10adopted in accordance with this Section by the agency charged
11with administering that provision or initiative, except that
12the 24-month limitation on the adoption of emergency rules and
13the provisions of Sections 5-115 and 5-125 do not apply to
14rules adopted under this subsection (h). The adoption of
15emergency rules authorized by this subsection (h) shall be
16deemed to be necessary for the public interest, safety, and
17welfare.
18 (i) In order to provide for the expeditious and timely
19implementation of the State's fiscal year 2004 budget,
20emergency rules to implement any provision of Public Act 93-20
21or any other budget initiative for fiscal year 2004 may be
22adopted in accordance with this Section by the agency charged
23with administering that provision or initiative, except that
24the 24-month limitation on the adoption of emergency rules and
25the provisions of Sections 5-115 and 5-125 do not apply to
26rules adopted under this subsection (i). The adoption of

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1emergency rules authorized by this subsection (i) shall be
2deemed to be necessary for the public interest, safety, and
3welfare.
4 (j) In order to provide for the expeditious and timely
5implementation of the provisions of the State's fiscal year
62005 budget as provided under the Fiscal Year 2005 Budget
7Implementation (Human Services) Act, emergency rules to
8implement any provision of the Fiscal Year 2005 Budget
9Implementation (Human Services) Act may be adopted in
10accordance with this Section by the agency charged with
11administering that provision, except that the 24-month
12limitation on the adoption of emergency rules and the
13provisions of Sections 5-115 and 5-125 do not apply to rules
14adopted under this subsection (j). The Department of Public Aid
15may also adopt rules under this subsection (j) necessary to
16administer the Illinois Public Aid Code and the Children's
17Health Insurance Program Act. The adoption of emergency rules
18authorized by this subsection (j) shall be deemed to be
19necessary for the public interest, safety, and welfare.
20 (k) In order to provide for the expeditious and timely
21implementation of the provisions of the State's fiscal year
222006 budget, emergency rules to implement any provision of
23Public Act 94-48 or any other budget initiative for fiscal year
242006 may be adopted in accordance with this Section by the
25agency charged with administering that provision or
26initiative, except that the 24-month limitation on the adoption

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1of emergency rules and the provisions of Sections 5-115 and
25-125 do not apply to rules adopted under this subsection (k).
3The Department of Healthcare and Family Services may also adopt
4rules under this subsection (k) necessary to administer the
5Illinois Public Aid Code, the Senior Citizens and Persons with
6Disabilities Property Tax Relief Act, the Senior Citizens and
7Disabled Persons Prescription Drug Discount Program Act (now
8the Illinois Prescription Drug Discount Program Act), and the
9Children's Health Insurance Program Act. The adoption of
10emergency rules authorized by this subsection (k) shall be
11deemed to be necessary for the public interest, safety, and
12welfare.
13 (l) In order to provide for the expeditious and timely
14implementation of the provisions of the State's fiscal year
152007 budget, the Department of Healthcare and Family Services
16may adopt emergency rules during fiscal year 2007, including
17rules effective July 1, 2007, in accordance with this
18subsection to the extent necessary to administer the
19Department's responsibilities with respect to amendments to
20the State plans and Illinois waivers approved by the federal
21Centers for Medicare and Medicaid Services necessitated by the
22requirements of Title XIX and Title XXI of the federal Social
23Security Act. The adoption of emergency rules authorized by
24this subsection (l) shall be deemed to be necessary for the
25public interest, safety, and welfare.
26 (m) In order to provide for the expeditious and timely

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1implementation of the provisions of the State's fiscal year
22008 budget, the Department of Healthcare and Family Services
3may adopt emergency rules during fiscal year 2008, including
4rules effective July 1, 2008, in accordance with this
5subsection to the extent necessary to administer the
6Department's responsibilities with respect to amendments to
7the State plans and Illinois waivers approved by the federal
8Centers for Medicare and Medicaid Services necessitated by the
9requirements of Title XIX and Title XXI of the federal Social
10Security Act. The adoption of emergency rules authorized by
11this subsection (m) shall be deemed to be necessary for the
12public interest, safety, and welfare.
13 (n) In order to provide for the expeditious and timely
14implementation of the provisions of the State's fiscal year
152010 budget, emergency rules to implement any provision of
16Public Act 96-45 or any other budget initiative authorized by
17the 96th General Assembly for fiscal year 2010 may be adopted
18in accordance with this Section by the agency charged with
19administering that provision or initiative. The adoption of
20emergency rules authorized by this subsection (n) shall be
21deemed to be necessary for the public interest, safety, and
22welfare. The rulemaking authority granted in this subsection
23(n) shall apply only to rules promulgated during Fiscal Year
242010.
25 (o) In order to provide for the expeditious and timely
26implementation of the provisions of the State's fiscal year

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12011 budget, emergency rules to implement any provision of
2Public Act 96-958 or any other budget initiative authorized by
3the 96th General Assembly for fiscal year 2011 may be adopted
4in accordance with this Section by the agency charged with
5administering that provision or initiative. The adoption of
6emergency rules authorized by this subsection (o) is deemed to
7be necessary for the public interest, safety, and welfare. The
8rulemaking authority granted in this subsection (o) applies
9only to rules promulgated on or after July 1, 2010 (the
10effective date of Public Act 96-958) through June 30, 2011.
11 (p) In order to provide for the expeditious and timely
12implementation of the provisions of Public Act 97-689,
13emergency rules to implement any provision of Public Act 97-689
14may be adopted in accordance with this subsection (p) by the
15agency charged with administering that provision or
16initiative. The 150-day limitation of the effective period of
17emergency rules does not apply to rules adopted under this
18subsection (p), and the effective period may continue through
19June 30, 2013. The 24-month limitation on the adoption of
20emergency rules does not apply to rules adopted under this
21subsection (p). The adoption of emergency rules authorized by
22this subsection (p) is deemed to be necessary for the public
23interest, safety, and welfare.
24 (q) In order to provide for the expeditious and timely
25implementation of the provisions of Articles 7, 8, 9, 11, and
2612 of Public Act 98-104, emergency rules to implement any

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1provision of Articles 7, 8, 9, 11, and 12 of Public Act 98-104
2may be adopted in accordance with this subsection (q) by the
3agency charged with administering that provision or
4initiative. The 24-month limitation on the adoption of
5emergency rules does not apply to rules adopted under this
6subsection (q). The adoption of emergency rules authorized by
7this subsection (q) is deemed to be necessary for the public
8interest, safety, and welfare.
9 (r) In order to provide for the expeditious and timely
10implementation of the provisions of Public Act 98-651,
11emergency rules to implement Public Act 98-651 may be adopted
12in accordance with this subsection (r) by the Department of
13Healthcare and Family Services. The 24-month limitation on the
14adoption of emergency rules does not apply to rules adopted
15under this subsection (r). The adoption of emergency rules
16authorized by this subsection (r) is deemed to be necessary for
17the public interest, safety, and welfare.
18 (s) In order to provide for the expeditious and timely
19implementation of the provisions of Sections 5-5b.1 and 5A-2 of
20the Illinois Public Aid Code, emergency rules to implement any
21provision of Section 5-5b.1 or Section 5A-2 of the Illinois
22Public Aid Code may be adopted in accordance with this
23subsection (s) by the Department of Healthcare and Family
24Services. The rulemaking authority granted in this subsection
25(s) shall apply only to those rules adopted prior to July 1,
262015. Notwithstanding any other provision of this Section, any

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1emergency rule adopted under this subsection (s) shall only
2apply to payments made for State fiscal year 2015. The adoption
3of emergency rules authorized by this subsection (s) is deemed
4to be necessary for the public interest, safety, and welfare.
5 (t) In order to provide for the expeditious and timely
6implementation of the provisions of Article II of Public Act
799-6, emergency rules to implement the changes made by Article
8II of Public Act 99-6 to the Emergency Telephone System Act may
9be adopted in accordance with this subsection (t) by the
10Department of State Police. The rulemaking authority granted in
11this subsection (t) shall apply only to those rules adopted
12prior to July 1, 2016. The 24-month limitation on the adoption
13of emergency rules does not apply to rules adopted under this
14subsection (t). The adoption of emergency rules authorized by
15this subsection (t) is deemed to be necessary for the public
16interest, safety, and welfare.
17 (u) In order to provide for the expeditious and timely
18implementation of the provisions of the Burn Victims Relief
19Act, emergency rules to implement any provision of the Act may
20be adopted in accordance with this subsection (u) by the
21Department of Insurance. The rulemaking authority granted in
22this subsection (u) shall apply only to those rules adopted
23prior to December 31, 2015. The adoption of emergency rules
24authorized by this subsection (u) is deemed to be necessary for
25the public interest, safety, and welfare.
26 (v) In order to provide for the expeditious and timely

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1implementation of the provisions of Public Act 99-516,
2emergency rules to implement Public Act 99-516 may be adopted
3in accordance with this subsection (v) by the Department of
4Healthcare and Family Services. The 24-month limitation on the
5adoption of emergency rules does not apply to rules adopted
6under this subsection (v). The adoption of emergency rules
7authorized by this subsection (v) is deemed to be necessary for
8the public interest, safety, and welfare.
9 (w) In order to provide for the expeditious and timely
10implementation of the provisions of Public Act 99-796,
11emergency rules to implement the changes made by Public Act
1299-796 may be adopted in accordance with this subsection (w) by
13the Adjutant General. The adoption of emergency rules
14authorized by this subsection (w) is deemed to be necessary for
15the public interest, safety, and welfare.
16 (x) In order to provide for the expeditious and timely
17implementation of the provisions of Public Act 99-906,
18emergency rules to implement subsection (i) of Section 16-115D,
19subsection (g) of Section 16-128A, and subsection (a) of
20Section 16-128B of the Public Utilities Act may be adopted in
21accordance with this subsection (x) by the Illinois Commerce
22Commission. The rulemaking authority granted in this
23subsection (x) shall apply only to those rules adopted within
24180 days after June 1, 2017 (the effective date of Public Act
2599-906). The adoption of emergency rules authorized by this
26subsection (x) is deemed to be necessary for the public

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1interest, safety, and welfare.
2 (y) In order to provide for the expeditious and timely
3implementation of the provisions of Public Act 100-23,
4emergency rules to implement the changes made by Public Act
5100-23 to Section 4.02 of the Illinois Act on the Aging,
6Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code,
7Section 55-30 of the Alcoholism and Other Drug Abuse and
8Dependency Act, and Sections 74 and 75 of the Mental Health and
9Developmental Disabilities Administrative Act may be adopted
10in accordance with this subsection (y) by the respective
11Department. The adoption of emergency rules authorized by this
12subsection (y) is deemed to be necessary for the public
13interest, safety, and welfare.
14 (z) In order to provide for the expeditious and timely
15implementation of the provisions of Public Act 100-554,
16emergency rules to implement the changes made by Public Act
17100-554 to Section 4.7 of the Lobbyist Registration Act may be
18adopted in accordance with this subsection (z) by the Secretary
19of State. The adoption of emergency rules authorized by this
20subsection (z) is deemed to be necessary for the public
21interest, safety, and welfare.
22 (aa) In order to provide for the expeditious and timely
23initial implementation of the changes made to Articles 5, 5A,
2412, and 14 of the Illinois Public Aid Code under the provisions
25of Public Act 100-581, the Department of Healthcare and Family
26Services may adopt emergency rules in accordance with this

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1subsection (aa). The 24-month limitation on the adoption of
2emergency rules does not apply to rules to initially implement
3the changes made to Articles 5, 5A, 12, and 14 of the Illinois
4Public Aid Code adopted under this subsection (aa). The
5adoption of emergency rules authorized by this subsection (aa)
6is deemed to be necessary for the public interest, safety, and
7welfare.
8 (bb) In order to provide for the expeditious and timely
9implementation of the provisions of Public Act 100-587,
10emergency rules to implement the changes made by Public Act
11100-587 to Section 4.02 of the Illinois Act on the Aging,
12Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code,
13subsection (b) of Section 55-30 of the Alcoholism and Other
14Drug Abuse and Dependency Act, Section 5-104 of the Specialized
15Mental Health Rehabilitation Act of 2013, and Section 75 and
16subsection (b) of Section 74 of the Mental Health and
17Developmental Disabilities Administrative Act may be adopted
18in accordance with this subsection (bb) by the respective
19Department. The adoption of emergency rules authorized by this
20subsection (bb) is deemed to be necessary for the public
21interest, safety, and welfare.
22 (cc) In order to provide for the expeditious and timely
23implementation of the provisions of Public Act 100-587,
24emergency rules may be adopted in accordance with this
25subsection (cc) to implement the changes made by Public Act
26100-587 to: Sections 14-147.5 and 14-147.6 of the Illinois

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1Pension Code by the Board created under Article 14 of the Code;
2Sections 15-185.5 and 15-185.6 of the Illinois Pension Code by
3the Board created under Article 15 of the Code; and Sections
416-190.5 and 16-190.6 of the Illinois Pension Code by the Board
5created under Article 16 of the Code. The adoption of emergency
6rules authorized by this subsection (cc) is deemed to be
7necessary for the public interest, safety, and welfare.
8 (dd) In order to provide for the expeditious and timely
9implementation of the provisions of Public Act 100-864,
10emergency rules to implement the changes made by Public Act
11100-864 to Section 3.35 of the Newborn Metabolic Screening Act
12may be adopted in accordance with this subsection (dd) by the
13Secretary of State. The adoption of emergency rules authorized
14by this subsection (dd) is deemed to be necessary for the
15public interest, safety, and welfare.
16 (ee) In order to provide for the expeditious and timely
17implementation of the provisions of this amendatory Act of the
18100th General Assembly, emergency rules implementing the
19Illinois Underground Natural Gas Storage Safety Act may be
20adopted in accordance with this subsection by the Department of
21Natural Resources. The adoption of emergency rules authorized
22by this subsection is deemed to be necessary for the public
23interest, safety, and welfare.
24 (ff) In order to provide for the expeditious and timely
25implementation of the provisions of this amendatory Act of the
26101st General Assembly, emergency rules may be adopted by the

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1Department of Labor in accordance with this subsection (ff) to
2implement the changes made by this amendatory Act of the 101st
3General Assembly to the Minimum Wage Law. The adoption of
4emergency rules authorized by this subsection (ff) is deemed to
5be necessary for the public interest, safety, and welfare.
6 (gg) In order to provide for the expeditious and timely
7implementation of the provisions of this amendatory Act of the
8101st General Assembly, emergency rules to implement the
9changes made by this amendatory Act of the 101st General
10Assembly to the Newborn Metabolic Screening Act may be adopted
11in accordance with this subsection (gg) by the Department of
12Public Health. The adoption of emergency rules authorized by
13this subsection (gg) is deemed to be necessary for the public
14interest, safety, and welfare.
15(Source: P.A. 100-23, eff. 7-6-17; 100-554, eff. 11-16-17;
16100-581, eff. 3-12-18; 100-587, Article 95, Section 95-5, eff.
176-4-18; 100-587, Article 110, Section 110-5, eff. 6-4-18;
18100-864, eff. 8-14-18; 100-1172, eff. 1-4-19; 101-1, eff.
192-19-19.)
20 Section 10. The Newborn Metabolic Screening Act is amended
21by adding Section 3.40 as follows:
22 (410 ILCS 240/3.40 new)
23 Sec. 3.40. Guanidinoacetate methyltransferase deficiency.
24In accordance with the timetable specified in this Section, the

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1Department shall provide all newborns with a screening test for
2guanidinoacetate methyltransferase deficiency using a method
3that determines the presence or absence of guanidinoacetate
4methyltransferase deficiency, beginning on the earlier of the
5following:
6 (1) July 1, 2021; or
7 (2) within 6 months following the occurrence of all of
8 the following:
9 (A) the establishment and verification of relevant
10 and appropriate performance specifications as defined
11 under the federal Clinical Laboratory Improvement
12 Amendments and regulations thereunder for federal Food
13 and Drug Administration-cleared or in-house developed
14 methods, performed under an institutional review board
15 approved protocol, if required;
16 (B) the availability of quality assurance
17 materials and comparative threshold values to
18 determine the presence or absence of guanidinoacetate
19 methyltransferase deficiency;
20 (C) the procurement and installation by the
21 Department of the equipment necessary to implement the
22 initial pilot and statewide volume of screening tests
23 for guanidinoacetate methyltransferase deficiency;
24 (D) the establishment of precise threshold values
25 ensuring defined disease identification for
26 guanidinoacetate methyltransferase deficiency;

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1 (E) the development and validation of a reliable
2 methodology for screening newborns for
3 guanidinoacetate methyltransferase deficiency using
4 dried blood spots and quality assurance testing
5 methodology for such test or the approval and
6 procurement of a test for guanidinoacetate
7 methyltransferase deficiency using dried blood spots
8 by the federal Food and Drug Administration;
9 (F) the authentication of pilot testing achieving
10 each milestone described in subparagraphs (A) through
11 (E) of this paragraph for guanidinoacetate
12 methyltransferase deficiency; and
13 (G) the authentication of achieving the potential
14 of high throughput standards for statewide volume of
15 guanidinoacetate methyltransferase deficiency
16 concomitant with each milestone described in
17 subparagraphs (A) through (E) of this paragraph.
18 The Department is authorized to implement an additional fee
19for the screening upon the effective date of this amendatory
20Act of the 101st General Assembly in order to accumulate the
21resources for start-up and other costs associated with the
22implementation of the screening and thereafter to support the
23costs associated with screening. If the Department has not
24implemented statewide screening for guanidinoacetate
25methyltransferase deficiency under this Section within 36
26months after the effective date of this amendatory Act of the

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1101st General Assembly, then the Department shall cease
2collecting any additional fees related to the screening. The
3Department may adopt emergency rules in accordance with Section
45-45 of the Illinois Administrative Procedure Act to implement
5this Section.
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