Full Text of HB0595 101st General Assembly
HB0595eng 101ST GENERAL ASSEMBLY |
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| 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 Illinois Administrative Procedure Act is | 5 | | amended 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 | 9 | | any agency
finds reasonably constitutes a threat to the public | 10 | | interest, safety, or
welfare. | 11 | | (b) If any agency finds that an
emergency exists that | 12 | | requires adoption of a rule upon fewer days than
is required by | 13 | | Section 5-40 and states in writing its reasons for that
| 14 | | finding, the agency may adopt an emergency rule without prior | 15 | | notice or
hearing upon filing a notice of emergency rulemaking | 16 | | with the Secretary of
State under Section 5-70. The notice | 17 | | shall include the text of the
emergency rule and shall be | 18 | | published in the Illinois Register. Consent
orders or other | 19 | | court orders adopting settlements negotiated by an agency
may | 20 | | be adopted under this Section. Subject to applicable | 21 | | constitutional or
statutory provisions, an emergency rule | 22 | | becomes effective immediately upon
filing under Section 5-65 or | 23 | | at a stated date less than 10 days
thereafter. The agency's |
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| 1 | | finding and a statement of the specific reasons
for the finding | 2 | | shall be filed with the rule. The agency shall take
reasonable | 3 | | and appropriate measures to make emergency rules known to the
| 4 | | persons who may be affected by them. | 5 | | (c) An emergency rule may be effective for a period of not | 6 | | longer than
150 days, but the agency's authority to adopt an | 7 | | identical rule under Section
5-40 is not precluded. No | 8 | | emergency rule may be adopted more
than once in any 24-month | 9 | | period, except that this limitation on the number
of emergency | 10 | | rules that may be adopted in a 24-month period does not apply
| 11 | | to (i) emergency rules that make additions to and deletions | 12 | | from the Drug
Manual under Section 5-5.16 of the Illinois | 13 | | Public Aid Code or the
generic drug formulary under Section | 14 | | 3.14 of the Illinois Food, Drug
and Cosmetic Act, (ii) | 15 | | emergency rules adopted by the Pollution Control
Board before | 16 | | July 1, 1997 to implement portions of the Livestock Management
| 17 | | Facilities Act, (iii) emergency rules adopted by the Illinois | 18 | | Department of Public Health under subsections (a) through (i) | 19 | | of Section 2 of the Department of Public Health Act when | 20 | | necessary to protect the public's health, (iv) emergency rules | 21 | | adopted pursuant to subsection (n) of this Section, (v) | 22 | | emergency rules adopted pursuant to subsection (o) of this | 23 | | Section, or (vi) emergency rules adopted pursuant to subsection | 24 | | (c-5) of this Section. Two or more emergency rules having | 25 | | substantially the same
purpose and effect shall be deemed to be | 26 | | a single rule for purposes of this
Section. |
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| 1 | | (c-5) To facilitate the maintenance of the program of group | 2 | | health benefits provided to annuitants, survivors, and retired | 3 | | employees under the State Employees Group Insurance Act of | 4 | | 1971, rules to alter the contributions to be paid by the State, | 5 | | annuitants, survivors, retired employees, or any combination | 6 | | of those entities, for that program of group health benefits, | 7 | | shall be adopted as emergency rules. The adoption of those | 8 | | rules shall be considered an emergency and necessary for the | 9 | | public interest, safety, and welfare. | 10 | | (d) In order to provide for the expeditious and timely | 11 | | implementation
of the State's fiscal year 1999 budget, | 12 | | emergency rules to implement any
provision of Public Act 90-587 | 13 | | or 90-588
or any other budget initiative for fiscal year 1999 | 14 | | may be adopted in
accordance with this Section by the agency | 15 | | charged with administering that
provision or initiative, | 16 | | except that the 24-month limitation on the adoption
of | 17 | | emergency rules and the provisions of Sections 5-115 and 5-125 | 18 | | do not apply
to rules adopted under this subsection (d). The | 19 | | adoption of emergency rules
authorized by this subsection (d) | 20 | | shall be deemed to be necessary for the
public interest, | 21 | | safety, and welfare. | 22 | | (e) In order to provide for the expeditious and timely | 23 | | implementation
of the State's fiscal year 2000 budget, | 24 | | emergency rules to implement any
provision of Public Act 91-24
| 25 | | or any other budget initiative for fiscal year 2000 may be | 26 | | adopted in
accordance with this Section by the agency charged |
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| 1 | | with administering that
provision or initiative, except that | 2 | | the 24-month limitation on the adoption
of emergency rules and | 3 | | the provisions of Sections 5-115 and 5-125 do not apply
to | 4 | | rules adopted under this subsection (e). The adoption of | 5 | | emergency rules
authorized by this subsection (e) shall be | 6 | | deemed to be necessary for the
public interest, safety, and | 7 | | welfare. | 8 | | (f) In order to provide for the expeditious and timely | 9 | | implementation
of the State's fiscal year 2001 budget, | 10 | | emergency rules to implement any
provision of Public Act 91-712
| 11 | | or any other budget initiative for fiscal year 2001 may be | 12 | | adopted in
accordance with this Section by the agency charged | 13 | | with administering that
provision or initiative, except that | 14 | | the 24-month limitation on the adoption
of emergency rules and | 15 | | the provisions of Sections 5-115 and 5-125 do not apply
to | 16 | | rules adopted under this subsection (f). The adoption of | 17 | | emergency rules
authorized by this subsection (f) shall be | 18 | | deemed to be necessary for the
public interest, safety, and | 19 | | welfare. | 20 | | (g) In order to provide for the expeditious and timely | 21 | | implementation
of the State's fiscal year 2002 budget, | 22 | | emergency rules to implement any
provision of Public Act 92-10
| 23 | | or any other budget initiative for fiscal year 2002 may be | 24 | | adopted in
accordance with this Section by the agency charged | 25 | | with administering that
provision or initiative, except that | 26 | | the 24-month limitation on the adoption
of emergency rules and |
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| 1 | | the provisions of Sections 5-115 and 5-125 do not apply
to | 2 | | rules adopted under this subsection (g). The adoption of | 3 | | emergency rules
authorized by this subsection (g) shall be | 4 | | deemed to be necessary for the
public interest, safety, and | 5 | | welfare. | 6 | | (h) In order to provide for the expeditious and timely | 7 | | implementation
of the State's fiscal year 2003 budget, | 8 | | emergency rules to implement any
provision of Public Act 92-597
| 9 | | or any other budget initiative for fiscal year 2003 may be | 10 | | adopted in
accordance with this Section by the agency charged | 11 | | with administering that
provision or initiative, except that | 12 | | the 24-month limitation on the adoption
of emergency rules and | 13 | | the provisions of Sections 5-115 and 5-125 do not apply
to | 14 | | rules adopted under this subsection (h). The adoption of | 15 | | emergency rules
authorized by this subsection (h) shall be | 16 | | deemed to be necessary for the
public interest, safety, and | 17 | | welfare. | 18 | | (i) In order to provide for the expeditious and timely | 19 | | implementation
of the State's fiscal year 2004 budget, | 20 | | emergency rules to implement any
provision of Public Act 93-20
| 21 | | or any other budget initiative for fiscal year 2004 may be | 22 | | adopted in
accordance with this Section by the agency charged | 23 | | with administering that
provision or initiative, except that | 24 | | the 24-month limitation on the adoption
of emergency rules and | 25 | | the provisions of Sections 5-115 and 5-125 do not apply
to | 26 | | rules adopted under this subsection (i). The adoption of |
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| 1 | | emergency rules
authorized by this subsection (i) shall be | 2 | | deemed to be necessary for the
public interest, safety, and | 3 | | welfare. | 4 | | (j) In order to provide for the expeditious and timely | 5 | | implementation of the provisions of the State's fiscal year | 6 | | 2005 budget as provided under the Fiscal Year 2005 Budget | 7 | | Implementation (Human Services) Act, emergency rules to | 8 | | implement any provision of the Fiscal Year 2005 Budget | 9 | | Implementation (Human Services) Act may be adopted in | 10 | | accordance with this Section by the agency charged with | 11 | | administering that provision, except that the 24-month | 12 | | limitation on the adoption of emergency rules and the | 13 | | provisions of Sections 5-115 and 5-125 do not apply to rules | 14 | | adopted under this subsection (j). The Department of Public Aid | 15 | | may also adopt rules under this subsection (j) necessary to | 16 | | administer the Illinois Public Aid Code and the Children's | 17 | | Health Insurance Program Act. The adoption of emergency rules | 18 | | authorized by this subsection (j) shall be deemed to be | 19 | | necessary for the public interest, safety, and welfare.
| 20 | | (k) In order to provide for the expeditious and timely | 21 | | implementation of the provisions of the State's fiscal year | 22 | | 2006 budget, emergency rules to implement any provision of | 23 | | Public Act 94-48 or any other budget initiative for fiscal year | 24 | | 2006 may be adopted in accordance with this Section by the | 25 | | agency charged with administering that provision or | 26 | | initiative, except that the 24-month limitation on the adoption |
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| 1 | | of emergency rules and the provisions of Sections 5-115 and | 2 | | 5-125 do not apply to rules adopted under this subsection (k). | 3 | | The Department of Healthcare and Family Services may also adopt | 4 | | rules under this subsection (k) necessary to administer the | 5 | | Illinois Public Aid Code, the Senior Citizens and Persons with | 6 | | Disabilities Property Tax Relief Act, the Senior Citizens and | 7 | | Disabled Persons Prescription Drug Discount Program Act (now | 8 | | the Illinois Prescription Drug Discount Program Act), and the | 9 | | Children's Health Insurance Program Act. The adoption of | 10 | | emergency rules authorized by this subsection (k) shall be | 11 | | deemed to be necessary for the public interest, safety, and | 12 | | welfare.
| 13 | | (l) In order to provide for the expeditious and timely | 14 | | implementation of the provisions of the
State's fiscal year | 15 | | 2007 budget, the Department of Healthcare and Family Services | 16 | | may adopt emergency rules during fiscal year 2007, including | 17 | | rules effective July 1, 2007, in
accordance with this | 18 | | subsection to the extent necessary to administer the | 19 | | Department's responsibilities with respect to amendments to | 20 | | the State plans and Illinois waivers approved by the federal | 21 | | Centers for Medicare and Medicaid Services necessitated by the | 22 | | requirements of Title XIX and Title XXI of the federal Social | 23 | | Security Act. The adoption of emergency rules
authorized by | 24 | | this subsection (l) shall be deemed to be necessary for the | 25 | | public interest,
safety, and welfare.
| 26 | | (m) In order to provide for the expeditious and timely |
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| 1 | | implementation of the provisions of the
State's fiscal year | 2 | | 2008 budget, the Department of Healthcare and Family Services | 3 | | may adopt emergency rules during fiscal year 2008, including | 4 | | rules effective July 1, 2008, in
accordance with this | 5 | | subsection to the extent necessary to administer the | 6 | | Department's responsibilities with respect to amendments to | 7 | | the State plans and Illinois waivers approved by the federal | 8 | | Centers for Medicare and Medicaid Services necessitated by the | 9 | | requirements of Title XIX and Title XXI of the federal Social | 10 | | Security Act. The adoption of emergency rules
authorized by | 11 | | this subsection (m) shall be deemed to be necessary for the | 12 | | public interest,
safety, and welfare.
| 13 | | (n) In order to provide for the expeditious and timely | 14 | | implementation of the provisions of the State's fiscal year | 15 | | 2010 budget, emergency rules to implement any provision of | 16 | | Public Act 96-45 or any other budget initiative authorized by | 17 | | the 96th General Assembly for fiscal year 2010 may be adopted | 18 | | in accordance with this Section by the agency charged with | 19 | | administering that provision or initiative. The adoption of | 20 | | emergency rules authorized by this subsection (n) shall be | 21 | | deemed to be necessary for the public interest, safety, and | 22 | | welfare. The rulemaking authority granted in this subsection | 23 | | (n) shall apply only to rules promulgated during Fiscal Year | 24 | | 2010. | 25 | | (o) In order to provide for the expeditious and timely | 26 | | implementation of the provisions of the State's fiscal year |
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| 1 | | 2011 budget, emergency rules to implement any provision of | 2 | | Public Act 96-958 or any other budget initiative authorized by | 3 | | the 96th General Assembly for fiscal year 2011 may be adopted | 4 | | in accordance with this Section by the agency charged with | 5 | | administering that provision or initiative. The adoption of | 6 | | emergency rules authorized by this subsection (o) is deemed to | 7 | | be necessary for the public interest, safety, and welfare. The | 8 | | rulemaking authority granted in this subsection (o) applies | 9 | | only to rules promulgated on or after July 1, 2010 (the | 10 | | effective date of Public Act 96-958) through June 30, 2011. | 11 | | (p) In order to provide for the expeditious and timely | 12 | | implementation of the provisions of Public Act 97-689, | 13 | | emergency rules to implement any provision of Public Act 97-689 | 14 | | may be adopted in accordance with this subsection (p) by the | 15 | | agency charged with administering that provision or | 16 | | initiative. The 150-day limitation of the effective period of | 17 | | emergency rules does not apply to rules adopted under this | 18 | | subsection (p), and the effective period may continue through | 19 | | June 30, 2013. The 24-month limitation on the adoption of | 20 | | emergency rules does not apply to rules adopted under this | 21 | | subsection (p). The adoption of emergency rules authorized by | 22 | | this subsection (p) is deemed to be necessary for the public | 23 | | interest, safety, and welfare. | 24 | | (q) In order to provide for the expeditious and timely | 25 | | implementation of the provisions of Articles 7, 8, 9, 11, and | 26 | | 12 of Public Act 98-104, emergency rules to implement any |
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| 1 | | provision of Articles 7, 8, 9, 11, and 12 of Public Act 98-104 | 2 | | may be adopted in accordance with this subsection (q) by the | 3 | | agency charged with administering that provision or | 4 | | initiative. The 24-month limitation on the adoption of | 5 | | emergency rules does not apply to rules adopted under this | 6 | | subsection (q). The adoption of emergency rules authorized by | 7 | | this subsection (q) is deemed to be necessary for the public | 8 | | interest, safety, and welfare. | 9 | | (r) In order to provide for the expeditious and timely | 10 | | implementation of the provisions of Public Act 98-651, | 11 | | emergency rules to implement Public Act 98-651 may be adopted | 12 | | in accordance with this subsection (r) by the Department of | 13 | | Healthcare and Family Services. The 24-month limitation on the | 14 | | adoption of emergency rules does not apply to rules adopted | 15 | | under this subsection (r). The adoption of emergency rules | 16 | | authorized by this subsection (r) is deemed to be necessary for | 17 | | the public interest, safety, and welfare. | 18 | | (s) In order to provide for the expeditious and timely | 19 | | implementation of the provisions of Sections 5-5b.1 and 5A-2 of | 20 | | the Illinois Public Aid Code, emergency rules to implement any | 21 | | provision of Section 5-5b.1 or Section 5A-2 of the Illinois | 22 | | Public Aid Code may be adopted in accordance with this | 23 | | subsection (s) by the Department of Healthcare and Family | 24 | | Services. The rulemaking authority granted in this subsection | 25 | | (s) shall apply only to those rules adopted prior to July 1, | 26 | | 2015. Notwithstanding any other provision of this Section, any |
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| 1 | | emergency rule adopted under this subsection (s) shall only | 2 | | apply to payments made for State fiscal year 2015. The adoption | 3 | | of emergency rules authorized by this subsection (s) is deemed | 4 | | to be necessary for the public interest, safety, and welfare. | 5 | | (t) In order to provide for the expeditious and timely | 6 | | implementation of the provisions of Article II of Public Act | 7 | | 99-6, emergency rules to implement the changes made by Article | 8 | | II of Public Act 99-6 to the Emergency Telephone System Act may | 9 | | be adopted in accordance with this subsection (t) by the | 10 | | Department of State Police. The rulemaking authority granted in | 11 | | this subsection (t) shall apply only to those rules adopted | 12 | | prior to July 1, 2016. The 24-month limitation on the adoption | 13 | | of emergency rules does not apply to rules adopted under this | 14 | | subsection (t). The adoption of emergency rules authorized by | 15 | | this subsection (t) is deemed to be necessary for the public | 16 | | interest, safety, and welfare. | 17 | | (u) In order to provide for the expeditious and timely | 18 | | implementation of the provisions of the Burn Victims Relief | 19 | | Act, emergency rules to implement any provision of the Act may | 20 | | be adopted in accordance with this subsection (u) by the | 21 | | Department of Insurance. The rulemaking authority granted in | 22 | | this subsection (u) shall apply only to those rules adopted | 23 | | prior to December 31, 2015. The adoption of emergency rules | 24 | | authorized by this subsection (u) is deemed to be necessary for | 25 | | the public interest, safety, and welfare. | 26 | | (v) In order to provide for the expeditious and timely |
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| 1 | | implementation of the provisions of Public Act 99-516, | 2 | | emergency rules to implement Public Act 99-516 may be adopted | 3 | | in accordance with this subsection (v) by the Department of | 4 | | Healthcare and Family Services. The 24-month limitation on the | 5 | | adoption of emergency rules does not apply to rules adopted | 6 | | under this subsection (v). The adoption of emergency rules | 7 | | authorized by this subsection (v) is deemed to be necessary for | 8 | | the public interest, safety, and welfare. | 9 | | (w) In order to provide for the expeditious and timely | 10 | | implementation of the provisions of Public Act 99-796, | 11 | | emergency rules to implement the changes made by Public Act | 12 | | 99-796 may be adopted in accordance with this subsection (w) by | 13 | | the Adjutant General. The adoption of emergency rules | 14 | | authorized by this subsection (w) is deemed to be necessary for | 15 | | the public interest, safety, and welfare. | 16 | | (x) In order to provide for the expeditious and timely | 17 | | implementation of the provisions of Public Act 99-906, | 18 | | emergency rules to implement subsection (i) of Section 16-115D, | 19 | | subsection (g) of Section 16-128A, and subsection (a) of | 20 | | Section 16-128B of the Public Utilities Act may be adopted in | 21 | | accordance with this subsection (x) by the Illinois Commerce | 22 | | Commission. The rulemaking authority granted in this | 23 | | subsection (x) shall apply only to those rules adopted within | 24 | | 180 days after June 1, 2017 (the effective date of Public Act | 25 | | 99-906). The adoption of emergency rules authorized by this | 26 | | subsection (x) is deemed to be necessary for the public |
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| 1 | | interest, safety, and welfare. | 2 | | (y) In order to provide for the expeditious and timely | 3 | | implementation of the provisions of Public Act 100-23, | 4 | | emergency rules to implement the changes made by Public Act | 5 | | 100-23 to Section 4.02 of the Illinois Act on the Aging, | 6 | | Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code, | 7 | | Section 55-30 of the Alcoholism and Other Drug Abuse and | 8 | | Dependency Act, and Sections 74 and 75 of the Mental Health and | 9 | | Developmental Disabilities Administrative Act may be adopted | 10 | | in accordance with this subsection (y) by the respective | 11 | | Department. The adoption of emergency rules authorized by this | 12 | | subsection (y) is deemed to be necessary for the public | 13 | | interest, safety, and welfare. | 14 | | (z) In order to provide for the expeditious and timely | 15 | | implementation of the provisions of Public Act 100-554, | 16 | | emergency rules to implement the changes made by Public Act | 17 | | 100-554 to Section 4.7 of the Lobbyist Registration Act may be | 18 | | adopted in accordance with this subsection (z) by the Secretary | 19 | | of State. The adoption of emergency rules authorized by this | 20 | | subsection (z) is deemed to be necessary for the public | 21 | | interest, safety, and welfare. | 22 | | (aa) In order to provide for the expeditious and timely | 23 | | initial implementation of the changes made to Articles 5, 5A, | 24 | | 12, and 14 of the Illinois Public Aid Code under the provisions | 25 | | of Public Act 100-581, the Department of Healthcare and Family | 26 | | Services may adopt emergency rules in accordance with this |
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| 1 | | subsection (aa). The 24-month limitation on the adoption of | 2 | | emergency rules does not apply to rules to initially implement | 3 | | the changes made to Articles 5, 5A, 12, and 14 of the Illinois | 4 | | Public Aid Code adopted under this subsection (aa). The | 5 | | adoption of emergency rules authorized by this subsection (aa) | 6 | | is deemed to be necessary for the public interest, safety, and | 7 | | welfare. | 8 | | (bb) In order to provide for the expeditious and timely | 9 | | implementation of the provisions of Public Act 100-587, | 10 | | emergency rules to implement the changes made by Public Act | 11 | | 100-587 to Section 4.02 of the Illinois Act on the Aging, | 12 | | Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code, | 13 | | subsection (b) of Section 55-30 of the Alcoholism and Other | 14 | | Drug Abuse and Dependency Act, Section 5-104 of the Specialized | 15 | | Mental Health Rehabilitation Act of 2013, and Section 75 and | 16 | | subsection (b) of Section 74 of the Mental Health and | 17 | | Developmental Disabilities Administrative Act may be adopted | 18 | | in accordance with this subsection (bb) by the respective | 19 | | Department. The adoption of emergency rules authorized by this | 20 | | subsection (bb) is deemed to be necessary for the public | 21 | | interest, safety, and welfare. | 22 | | (cc) In order to provide for the expeditious and timely | 23 | | implementation of the provisions of Public Act 100-587, | 24 | | emergency rules may be adopted in accordance with this | 25 | | subsection (cc) to implement the changes made by Public Act | 26 | | 100-587 to: Sections 14-147.5 and 14-147.6 of the Illinois |
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| 1 | | Pension Code by the Board created under Article 14 of the Code; | 2 | | Sections 15-185.5 and 15-185.6 of the Illinois Pension Code by | 3 | | the Board created under Article 15 of the Code; and Sections | 4 | | 16-190.5 and 16-190.6 of the Illinois Pension Code by the Board | 5 | | created under Article 16 of the Code. The adoption of emergency | 6 | | rules authorized by this subsection (cc) is deemed to be | 7 | | necessary for the public interest, safety, and welfare. | 8 | | (dd) In order to provide for the expeditious and timely | 9 | | implementation of the provisions of Public Act 100-864, | 10 | | emergency rules to implement the changes made by Public Act | 11 | | 100-864 to Section 3.35 of the Newborn Metabolic Screening Act | 12 | | may be adopted in accordance with this subsection (dd) by the | 13 | | Secretary of State. The adoption of emergency rules authorized | 14 | | by this subsection (dd) is deemed to be necessary for the | 15 | | public interest, safety, and welfare. | 16 | | (ee) In order to provide for the expeditious and timely | 17 | | implementation of the provisions of this amendatory Act of the | 18 | | 100th General Assembly, emergency rules implementing the | 19 | | Illinois Underground Natural Gas Storage Safety Act may be | 20 | | adopted in accordance with this subsection by the Department of | 21 | | Natural Resources. The adoption of emergency rules authorized | 22 | | by this subsection is deemed to be necessary for the public | 23 | | interest, safety, and welfare. | 24 | | (ff) In order to provide for the expeditious and timely | 25 | | implementation of the provisions of this amendatory Act of the | 26 | | 101st General Assembly, emergency rules may be adopted by the |
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| 1 | | Department of Labor in accordance with this subsection (ff) to | 2 | | implement the changes made by this amendatory Act of the 101st | 3 | | General Assembly to the Minimum Wage Law. The adoption of | 4 | | emergency rules authorized by this subsection (ff) is deemed to | 5 | | be necessary for the public interest, safety, and welfare. | 6 | | (gg) In order to provide for the expeditious and timely | 7 | | implementation of the provisions of this amendatory Act of the | 8 | | 101st General Assembly, emergency rules to implement the | 9 | | changes made by this amendatory Act of the 101st General | 10 | | Assembly to the Newborn Metabolic Screening Act may be adopted | 11 | | in accordance with this subsection (gg) by the Department of | 12 | | Public Health. The adoption of emergency rules authorized by | 13 | | this subsection (gg) is deemed to be necessary for the public | 14 | | interest, safety, and welfare. | 15 | | (Source: P.A. 100-23, eff. 7-6-17; 100-554, eff. 11-16-17; | 16 | | 100-581, eff. 3-12-18; 100-587, Article 95, Section 95-5, eff. | 17 | | 6-4-18; 100-587, Article 110, Section 110-5, eff. 6-4-18; | 18 | | 100-864, eff. 8-14-18; 100-1172, eff. 1-4-19; 101-1, eff. | 19 | | 2-19-19.) | 20 | | Section 10. The Newborn Metabolic Screening Act is amended | 21 | | by adding Section 3.40 as follows: | 22 | | (410 ILCS 240/3.40 new) | 23 | | Sec. 3.40. Guanidinoacetate methyltransferase deficiency. | 24 | | In accordance with the timetable specified in this Section, the |
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| 1 | | Department shall provide all newborns with a screening test for | 2 | | guanidinoacetate methyltransferase deficiency using a method | 3 | | that determines the presence or absence of guanidinoacetate | 4 | | methyltransferase deficiency, beginning on the earlier of the | 5 | | following: | 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 | 19 | | for the screening upon the effective date of this amendatory | 20 | | Act of the 101st General Assembly in order to accumulate the | 21 | | resources for start-up and other costs associated with the | 22 | | implementation of the screening and thereafter to support the | 23 | | costs associated with screening. If the Department has not | 24 | | implemented statewide screening for guanidinoacetate | 25 | | methyltransferase deficiency under this Section within 36 | 26 | | months after the effective date of this amendatory Act of the |
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| 1 | | 101st General Assembly, then the Department shall cease | 2 | | collecting any additional fees related to the screening. The | 3 | | Department may adopt emergency rules in accordance with Section | 4 | | 5-45 of the Illinois Administrative Procedure Act to implement | 5 | | this Section.
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