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1 | AN ACT concerning regulation.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The State Employees Group Insurance Act of 1971 | ||||||||||||||||||||||||
5 | is amended by changing Section 6.11 as follows:
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6 | (5 ILCS 375/6.11)
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7 | Sec. 6.11. Required health benefits; Illinois Insurance | ||||||||||||||||||||||||
8 | Code
requirements. The program of health
benefits shall | ||||||||||||||||||||||||
9 | provide the post-mastectomy care benefits required to be | ||||||||||||||||||||||||
10 | covered
by a policy of accident and health insurance under | ||||||||||||||||||||||||
11 | Section 356t of the Illinois
Insurance Code. The program of | ||||||||||||||||||||||||
12 | health benefits shall provide the coverage
required under | ||||||||||||||||||||||||
13 | Sections 356g, 356g.5, 356g.5-1, 356m,
356u, 356w, 356x, | ||||||||||||||||||||||||
14 | 356z.2, 356z.4, 356z.4a, 356z.6, 356z.8, 356z.9, 356z.10, | ||||||||||||||||||||||||
15 | 356z.11, 356z.12, 356z.13, 356z.14, 356z.15, 356z.17, 356z.22, | ||||||||||||||||||||||||
16 | 356z.25, 356z.26, 356z.29, 356z.30a, 356z.32, 356z.33, | ||||||||||||||||||||||||
17 | 356z.36, and 356z.41 , and 356z.43 of the
Illinois Insurance | ||||||||||||||||||||||||
18 | Code.
The program of health benefits must comply with Sections | ||||||||||||||||||||||||
19 | 155.22a, 155.37, 355b, 356z.19, 370c, and 370c.1 and Article | ||||||||||||||||||||||||
20 | XXXIIB of the
Illinois Insurance Code. The Department of | ||||||||||||||||||||||||
21 | Insurance shall enforce the requirements of this Section with | ||||||||||||||||||||||||
22 | respect to Sections 370c and 370c.1 of the Illinois Insurance | ||||||||||||||||||||||||
23 | Code; all other requirements of this Section shall be enforced |
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| |||||||
1 | by the Department of Central Management Services.
| ||||||
2 | Rulemaking authority to implement Public Act 95-1045, if | ||||||
3 | any, is conditioned on the rules being adopted in accordance | ||||||
4 | with all provisions of the Illinois Administrative Procedure | ||||||
5 | Act and all rules and procedures of the Joint Committee on | ||||||
6 | Administrative Rules; any purported rule not so adopted, for | ||||||
7 | whatever reason, is unauthorized. | ||||||
8 | (Source: P.A. 100-24, eff. 7-18-17; 100-138, eff. 8-18-17; | ||||||
9 | 100-863, eff. 8-14-18; 100-1024, eff. 1-1-19; 100-1057, eff. | ||||||
10 | 1-1-19; 100-1102, eff. 1-1-19; 100-1170, eff. 6-1-19; 101-13, | ||||||
11 | eff. 6-12-19; 101-281, eff. 1-1-20; 101-393, eff. 1-1-20; | ||||||
12 | 101-452, eff. 1-1-20; 101-461, eff. 1-1-20; 101-625, eff. | ||||||
13 | 1-1-21 .) | ||||||
14 | Section 10. The Department of Public Health Powers and | ||||||
15 | Duties Law of the
Civil Administrative Code of Illinois is | ||||||
16 | amended by adding Section 2310-705 as follows: | ||||||
17 | (20 ILCS 2310/2310-705 new) | ||||||
18 | Sec. 2310-705. Contraceptive drugs and products; Director | ||||||
19 | standing order. | ||||||
20 | (a) As used in this Section: | ||||||
21 | "Hormonal contraceptive" means a prescribed | ||||||
22 | medically-acceptable oral drug, transdermal patch, or vaginal | ||||||
23 | ring that is approved by the United States Food and Drug | ||||||
24 | Administration to prevent pregnancy. |
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| |||||||
1 | "Standing order" has the meaning given to that term in the | ||||||
2 | Pharmacy Practice Act. | ||||||
3 | (b) If the Director of Public Health is a physician | ||||||
4 | licensed to practice medicine in all its branches in Illinois, | ||||||
5 | the Director shall establish a standing order complete with | ||||||
6 | the issuance of a prescription for a hormonal contraceptive in | ||||||
7 | accordance with this Section. If the Director is not a | ||||||
8 | physician licensed to practice medicine in all its branches in | ||||||
9 | Illinois, then the Medical Director of the Department of | ||||||
10 | Public Health shall establish a standing order in accordance | ||||||
11 | with this Section. | ||||||
12 | (c) The standing order, at a minimum, shall comply with | ||||||
13 | the following: | ||||||
14 | (1) A pharmacist may dispense a 12-month supply of | ||||||
15 | hormonal contraceptives to a patient. | ||||||
16 | (2) A pharmacist shall have the patient complete the | ||||||
17 | self-screening risk assessment tool. The self-screening | ||||||
18 | risk assessment tool is to be based on the most current | ||||||
19 | version of the United States Medical Eligibility Criteria | ||||||
20 | for Contraceptive Use published by the federal Centers for | ||||||
21 | Disease Control and Prevention. | ||||||
22 | (3) Based upon the results of the self-screening risk | ||||||
23 | assessment and the patient assessment, the pharmacist | ||||||
24 | shall use his or her professional and clinical judgment as | ||||||
25 | to when a patient should be referred to the patient's | ||||||
26 | physician or another health care provider. |
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| |||||||
1 | (4) The pharmacist shall provide, during the patient | ||||||
2 | assessment and consultation, counseling and education | ||||||
3 | about all methods of contraception, including methods not | ||||||
4 | covered under the standing order, and their proper use and | ||||||
5 | effectiveness. | ||||||
6 | (5) The patient consultation shall take place in a | ||||||
7 | private manner consistent with rules adopted by the | ||||||
8 | Department of Financial and Professional Regulation. | ||||||
9 | (6) The Department shall adopt rules under this | ||||||
10 | Section that require a pharmacist to: | ||||||
11 | (A) complete an educational training program | ||||||
12 | accredited by the Accreditation Council for Pharmacy | ||||||
13 | Education and approved by the Department that is | ||||||
14 | related to the patient self-screening risk assessment, | ||||||
15 | patient assessment, contraceptive counseling and | ||||||
16 | education, and dispensation of hormonal | ||||||
17 | contraceptives; and | ||||||
18 | (B) dispense the hormonal contraceptive to the | ||||||
19 | patient as soon as practicable after meeting the | ||||||
20 | requirements of paragraph (2). | ||||||
21 | (7) All State and federal laws governing insurance | ||||||
22 | coverage of contraceptive drugs shall apply to hormonal | ||||||
23 | contraceptives dispensed by a pharmacist under this | ||||||
24 | Section. | ||||||
25 | Section 15. The Counties Code is amended by changing |
| |||||||
| |||||||
1 | Section 5-1069.3 as follows: | ||||||
2 | (55 ILCS 5/5-1069.3)
| ||||||
3 | Sec. 5-1069.3. Required health benefits. If a county, | ||||||
4 | including a home
rule
county, is a self-insurer for purposes | ||||||
5 | of providing health insurance coverage
for its employees, the | ||||||
6 | coverage shall include coverage for the post-mastectomy
care | ||||||
7 | benefits required to be covered by a policy of accident and | ||||||
8 | health
insurance under Section 356t and the coverage required | ||||||
9 | under Sections 356g, 356g.5, 356g.5-1, 356u,
356w, 356x, | ||||||
10 | 356z.6, 356z.8, 356z.9, 356z.10, 356z.11, 356z.12, 356z.13, | ||||||
11 | 356z.14, 356z.15, 356z.22, 356z.25, 356z.26, 356z.29, | ||||||
12 | 356z.30a, 356z.32, 356z.33, 356z.36, and 356z.41 , and 356z.43 | ||||||
13 | of
the Illinois Insurance Code. The coverage shall comply with | ||||||
14 | Sections 155.22a, 355b, 356z.19, and 370c of
the Illinois | ||||||
15 | Insurance Code. The Department of Insurance shall enforce the | ||||||
16 | requirements of this Section. The requirement that health | ||||||
17 | benefits be covered
as provided in this Section is an
| ||||||
18 | exclusive power and function of the State and is a denial and | ||||||
19 | limitation under
Article VII, Section 6, subsection (h) of the | ||||||
20 | Illinois Constitution. A home
rule county to which this | ||||||
21 | Section applies must comply with every provision of
this | ||||||
22 | Section.
| ||||||
23 | Rulemaking authority to implement Public Act 95-1045, if | ||||||
24 | any, is conditioned on the rules being adopted in accordance | ||||||
25 | with all provisions of the Illinois Administrative Procedure |
| |||||||
| |||||||
1 | Act and all rules and procedures of the Joint Committee on | ||||||
2 | Administrative Rules; any purported rule not so adopted, for | ||||||
3 | whatever reason, is unauthorized. | ||||||
4 | (Source: P.A. 100-24, eff. 7-18-17; 100-138, eff. 8-18-17; | ||||||
5 | 100-863, eff. 8-14-18; 100-1024, eff. 1-1-19; 100-1057, eff. | ||||||
6 | 1-1-19; 100-1102, eff. 1-1-19; 101-81, eff. 7-12-19; 101-281, | ||||||
7 | eff. 1-1-20; 101-393, eff. 1-1-20; 101-461, eff. 1-1-20; | ||||||
8 | 101-625, eff. 1-1-21 .) | ||||||
9 | Section 20. The Illinois Municipal Code is amended by | ||||||
10 | changing Section 10-4-2.3 as follows: | ||||||
11 | (65 ILCS 5/10-4-2.3)
| ||||||
12 | Sec. 10-4-2.3. Required health benefits. If a | ||||||
13 | municipality, including a
home rule municipality, is a | ||||||
14 | self-insurer for purposes of providing health
insurance | ||||||
15 | coverage for its employees, the coverage shall include | ||||||
16 | coverage for
the post-mastectomy care benefits required to be | ||||||
17 | covered by a policy of
accident and health insurance under | ||||||
18 | Section 356t and the coverage required
under Sections 356g, | ||||||
19 | 356g.5, 356g.5-1, 356u, 356w, 356x, 356z.6, 356z.8, 356z.9, | ||||||
20 | 356z.10, 356z.11, 356z.12, 356z.13, 356z.14, 356z.15, 356z.22, | ||||||
21 | 356z.25, 356z.26, 356z.29, 356z.30a, 356z.32, 356z.33, | ||||||
22 | 356z.36, and 356z.41 , and 356z.43 of the Illinois
Insurance
| ||||||
23 | Code. The coverage shall comply with Sections 155.22a, 355b, | ||||||
24 | 356z.19, and 370c of
the Illinois Insurance Code. The |
| |||||||
| |||||||
1 | Department of Insurance shall enforce the requirements of this | ||||||
2 | Section. The requirement that health
benefits be covered as | ||||||
3 | provided in this is an exclusive power and function of
the | ||||||
4 | State and is a denial and limitation under Article VII, | ||||||
5 | Section 6,
subsection (h) of the Illinois Constitution. A home | ||||||
6 | rule municipality to which
this Section applies must comply | ||||||
7 | with every provision of this Section.
| ||||||
8 | Rulemaking authority to implement Public Act 95-1045, if | ||||||
9 | any, is conditioned on the rules being adopted in accordance | ||||||
10 | with all provisions of the Illinois Administrative Procedure | ||||||
11 | Act and all rules and procedures of the Joint Committee on | ||||||
12 | Administrative Rules; any purported rule not so adopted, for | ||||||
13 | whatever reason, is unauthorized. | ||||||
14 | (Source: P.A. 100-24, eff. 7-18-17; 100-138, eff. 8-18-17; | ||||||
15 | 100-863, eff. 8-14-18; 100-1024, eff. 1-1-19; 100-1057, eff. | ||||||
16 | 1-1-19; 100-1102, eff. 1-1-19; 101-81, eff. 7-12-19; 101-281, | ||||||
17 | eff. 1-1-20; 101-393, eff. 1-1-20; 101-461, eff. 1-1-20; | ||||||
18 | 101-625, eff. 1-1-21 .) | ||||||
19 | Section 25. The School Code is amended by changing Section | ||||||
20 | 10-22.3f as follows: | ||||||
21 | (105 ILCS 5/10-22.3f)
| ||||||
22 | Sec. 10-22.3f. Required health benefits. Insurance | ||||||
23 | protection and
benefits
for employees shall provide the | ||||||
24 | post-mastectomy care benefits required to be
covered by a |
| |||||||
| |||||||
1 | policy of accident and health insurance under Section 356t and | ||||||
2 | the
coverage required under Sections 356g, 356g.5, 356g.5-1, | ||||||
3 | 356u, 356w, 356x,
356z.6, 356z.8, 356z.9, 356z.11, 356z.12, | ||||||
4 | 356z.13, 356z.14, 356z.15, 356z.22, 356z.25, 356z.26, 356z.29, | ||||||
5 | 356z.30a, 356z.32, 356z.33, 356z.36, and 356z.41 , and 356z.43 | ||||||
6 | of
the
Illinois Insurance Code.
Insurance policies shall | ||||||
7 | comply with Section 356z.19 of the Illinois Insurance Code. | ||||||
8 | The coverage shall comply with Sections 155.22a, 355b, and | ||||||
9 | 370c of
the Illinois Insurance Code. The Department of | ||||||
10 | Insurance shall enforce the requirements of this Section.
| ||||||
11 | Rulemaking authority to implement Public Act 95-1045, if | ||||||
12 | any, is conditioned on the rules being adopted in accordance | ||||||
13 | with all provisions of the Illinois Administrative Procedure | ||||||
14 | Act and all rules and procedures of the Joint Committee on | ||||||
15 | Administrative Rules; any purported rule not so adopted, for | ||||||
16 | whatever reason, is unauthorized. | ||||||
17 | (Source: P.A. 100-24, eff. 7-18-17; 100-138, eff. 8-18-17; | ||||||
18 | 100-863, eff. 8-14-18; 100-1024, eff. 1-1-19; 100-1057, eff. | ||||||
19 | 1-1-19; 100-1102, eff. 1-1-19; 101-81, eff. 7-12-19; 101-281, | ||||||
20 | eff. 1-1-20; 101-393, eff. 1-1-20; 101-461, eff. 1-1-20; | ||||||
21 | 101-625, eff. 1-1-21 .) | ||||||
22 | Section 30. The Illinois Insurance Code is amended by | ||||||
23 | adding Section 356z.43 as follows: | ||||||
24 | (215 ILCS 5/356z.43 new) |
| |||||||
| |||||||
1 | Sec. 356z.43. Coverage for patient care services for | ||||||
2 | hormonal contraceptives provided by a pharmacist. A group or | ||||||
3 | individual policy of accident and health insurance or a | ||||||
4 | managed care plan that is amended, delivered, issued, or | ||||||
5 | renewed after the effective date of this amendatory Act of the | ||||||
6 | 102nd General Assembly shall provide coverage for patient care | ||||||
7 | services provided by a pharmacist for hormonal contraceptives | ||||||
8 | assessment and consultation. | ||||||
9 | Section 35. The Pharmacy Practice Act is amended by | ||||||
10 | changing Section 3 as follows:
| ||||||
11 | (225 ILCS 85/3)
| ||||||
12 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
13 | Sec. 3. Definitions. For the purpose of this Act, except | ||||||
14 | where otherwise
limited therein:
| ||||||
15 | (a) "Pharmacy" or "drugstore" means and includes every | ||||||
16 | store, shop,
pharmacy department, or other place where | ||||||
17 | pharmacist
care is
provided
by a pharmacist (1) where drugs, | ||||||
18 | medicines, or poisons are
dispensed, sold or
offered for sale | ||||||
19 | at retail, or displayed for sale at retail; or
(2)
where
| ||||||
20 | prescriptions of physicians, dentists, advanced practice | ||||||
21 | registered nurses, physician assistants, veterinarians, | ||||||
22 | podiatric physicians, or
optometrists, within the limits of | ||||||
23 | their
licenses, are
compounded, filled, or dispensed; or (3) | ||||||
24 | which has upon it or
displayed within
it, or affixed to or used |
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| |||||||
1 | in connection with it, a sign bearing the word or
words | ||||||
2 | "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical
Care", | ||||||
3 | "Apothecary", "Drugstore",
"Medicine Store", "Prescriptions", | ||||||
4 | "Drugs", "Dispensary", "Medicines", or any word
or words of | ||||||
5 | similar or like import, either in the English language
or any | ||||||
6 | other language; or (4) where the characteristic prescription
| ||||||
7 | sign (Rx) or similar design is exhibited; or (5) any store, or
| ||||||
8 | shop,
or other place with respect to which any of the above | ||||||
9 | words, objects,
signs or designs are used in any | ||||||
10 | advertisement.
| ||||||
11 | (b) "Drugs" means and includes (1) articles recognized
in | ||||||
12 | the official United States Pharmacopoeia/National Formulary | ||||||
13 | (USP/NF),
or any supplement thereto and being intended for and | ||||||
14 | having for their
main use the diagnosis, cure, mitigation, | ||||||
15 | treatment or prevention of
disease in man or other animals, as | ||||||
16 | approved by the United States Food and
Drug Administration, | ||||||
17 | but does not include devices or their components, parts,
or | ||||||
18 | accessories; and (2) all other articles intended
for and | ||||||
19 | having for their main use the diagnosis, cure, mitigation,
| ||||||
20 | treatment or prevention of disease in man or other animals, as | ||||||
21 | approved
by the United States Food and Drug Administration, | ||||||
22 | but does not include
devices or their components, parts, or | ||||||
23 | accessories; and (3) articles
(other than food) having for | ||||||
24 | their main use and intended
to affect the structure or any | ||||||
25 | function of the body of man or other
animals; and (4) articles | ||||||
26 | having for their main use and intended
for use as a component |
| |||||||
| |||||||
1 | or any articles specified in clause (1), (2)
or (3); but does | ||||||
2 | not include devices or their components, parts or
accessories.
| ||||||
3 | (c) "Medicines" means and includes all drugs intended for
| ||||||
4 | human or veterinary use approved by the United States Food and | ||||||
5 | Drug
Administration.
| ||||||
6 | (d) "Practice of pharmacy" means: | ||||||
7 | (1) the interpretation and the provision of assistance | ||||||
8 | in the monitoring, evaluation, and implementation of | ||||||
9 | prescription drug orders; | ||||||
10 | (2) the dispensing of prescription drug orders; | ||||||
11 | (3) participation in drug and device selection; | ||||||
12 | (4) drug administration limited to the administration | ||||||
13 | of oral, topical, injectable, and inhalation as follows: | ||||||
14 | (A) in the context of patient education on the | ||||||
15 | proper use or delivery of medications; | ||||||
16 | (B) vaccination of patients 14 years of age and | ||||||
17 | older pursuant to a valid prescription or standing | ||||||
18 | order, by a physician licensed to practice medicine in | ||||||
19 | all its branches, upon completion of appropriate | ||||||
20 | training, including how to address contraindications | ||||||
21 | and adverse reactions set forth by rule, with | ||||||
22 | notification to the patient's physician and | ||||||
23 | appropriate record retention, or pursuant to hospital | ||||||
24 | pharmacy and therapeutics committee policies and | ||||||
25 | procedures; | ||||||
26 | (B-5) following the initial administration of |
| |||||||
| |||||||
1 | long-acting or extended-release extended release form | ||||||
2 | opioid antagonists by a physician licensed to practice | ||||||
3 | medicine in all its branches, administration of | ||||||
4 | injections of long-acting or extended-release form | ||||||
5 | opioid antagonists for the treatment of substance use | ||||||
6 | disorder, pursuant to a valid prescription by a | ||||||
7 | physician licensed to practice medicine in all its | ||||||
8 | branches, upon completion of appropriate training, | ||||||
9 | including how to address contraindications and adverse | ||||||
10 | reactions, including, but not limited to, respiratory | ||||||
11 | depression and the performance of cardiopulmonary | ||||||
12 | resuscitation, set forth by rule, with notification to | ||||||
13 | the patient's physician and appropriate record | ||||||
14 | retention, or pursuant to hospital pharmacy and | ||||||
15 | therapeutics committee policies and procedures; | ||||||
16 | (C) administration of injections of | ||||||
17 | alpha-hydroxyprogesterone caproate, pursuant to a | ||||||
18 | valid prescription, by a physician licensed to | ||||||
19 | practice medicine in all its branches, upon completion | ||||||
20 | of appropriate training, including how to address | ||||||
21 | contraindications and adverse reactions set forth by | ||||||
22 | rule, with notification to the patient's physician and | ||||||
23 | appropriate record retention, or pursuant to hospital | ||||||
24 | pharmacy and therapeutics committee policies and | ||||||
25 | procedures; and | ||||||
26 | (D) administration of injections of long-term |
| |||||||
| |||||||
1 | antipsychotic medications pursuant to a valid | ||||||
2 | prescription by a physician licensed to practice | ||||||
3 | medicine in all its branches, upon completion of | ||||||
4 | appropriate training conducted by an Accreditation | ||||||
5 | Council of Pharmaceutical Education accredited | ||||||
6 | provider, including how to address contraindications | ||||||
7 | and adverse reactions set forth by rule, with | ||||||
8 | notification to the patient's physician and | ||||||
9 | appropriate record retention, or pursuant to hospital | ||||||
10 | pharmacy and therapeutics committee policies and | ||||||
11 | procedures. | ||||||
12 | (5) vaccination of patients ages 10 through 13 limited | ||||||
13 | to the Influenza (inactivated influenza vaccine and live | ||||||
14 | attenuated influenza intranasal vaccine) and Tdap (defined | ||||||
15 | as tetanus, diphtheria, acellular pertussis) vaccines, | ||||||
16 | pursuant to a valid prescription or standing order, by a | ||||||
17 | physician licensed to practice medicine in all its | ||||||
18 | branches, upon completion of appropriate training, | ||||||
19 | including how to address contraindications and adverse | ||||||
20 | reactions set forth by rule, with notification to the | ||||||
21 | patient's physician and appropriate record retention, or | ||||||
22 | pursuant to hospital pharmacy and therapeutics committee | ||||||
23 | policies and procedures; | ||||||
24 | (6) drug regimen review; | ||||||
25 | (7) drug or drug-related research; | ||||||
26 | (8) the provision of patient counseling; |
| |||||||
| |||||||
1 | (9) the practice of telepharmacy; | ||||||
2 | (10) the provision of those acts or services necessary | ||||||
3 | to provide pharmacist care; | ||||||
4 | (11) medication therapy management; and | ||||||
5 | (12) the responsibility for compounding and labeling | ||||||
6 | of drugs and devices (except labeling by a manufacturer, | ||||||
7 | repackager, or distributor of non-prescription drugs and | ||||||
8 | commercially packaged legend drugs and devices), proper | ||||||
9 | and safe storage of drugs and devices, and maintenance of | ||||||
10 | required records ; and . | ||||||
11 | (13) the assessment and consultation of patients and | ||||||
12 | dispensing of hormonal contraceptives pursuant to the | ||||||
13 | standing order under Section 2310-705 of the Department of | ||||||
14 | Public Health Powers and Duties Law of the Civil | ||||||
15 | Administrative Code of Illinois. | ||||||
16 | A pharmacist who performs any of the acts defined as the | ||||||
17 | practice of pharmacy in this State must be actively licensed | ||||||
18 | as a pharmacist under this Act.
| ||||||
19 | (e) "Prescription" means and includes any written, oral, | ||||||
20 | facsimile, or
electronically transmitted order for drugs
or | ||||||
21 | medical devices, issued by a physician licensed to practice | ||||||
22 | medicine in
all its branches, dentist, veterinarian, podiatric | ||||||
23 | physician, or
optometrist, within the
limits of his or her | ||||||
24 | license, by a physician assistant in accordance with
| ||||||
25 | subsection (f) of Section 4, or by an advanced practice | ||||||
26 | registered nurse in
accordance with subsection (g) of Section |
| |||||||
| |||||||
1 | 4, containing the
following: (1) name
of the patient; (2) date | ||||||
2 | when prescription was issued; (3) name
and strength of drug or | ||||||
3 | description of the medical device prescribed;
and (4) | ||||||
4 | quantity; (5) directions for use; (6) prescriber's name,
| ||||||
5 | address,
and signature; and (7) DEA registration number where | ||||||
6 | required, for controlled
substances.
The prescription may, but | ||||||
7 | is not required to, list the illness, disease, or condition | ||||||
8 | for which the drug or device is being prescribed. DEA | ||||||
9 | registration numbers shall not be required on inpatient drug | ||||||
10 | orders. A prescription for medication other than controlled | ||||||
11 | substances shall be valid for up to 15 months from the date | ||||||
12 | issued for the purpose of refills, unless the prescription | ||||||
13 | states otherwise.
| ||||||
14 | (f) "Person" means and includes a natural person, | ||||||
15 | partnership,
association, corporation, government entity, or | ||||||
16 | any other legal
entity.
| ||||||
17 | (g) "Department" means the Department of Financial and
| ||||||
18 | Professional Regulation.
| ||||||
19 | (h) "Board of Pharmacy" or "Board" means the State Board
| ||||||
20 | of Pharmacy of the Department of Financial and Professional | ||||||
21 | Regulation.
| ||||||
22 | (i) "Secretary"
means the Secretary
of Financial and | ||||||
23 | Professional Regulation.
| ||||||
24 | (j) "Drug product selection" means the interchange for a
| ||||||
25 | prescribed pharmaceutical product in accordance with Section | ||||||
26 | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and |
| |||||||
| |||||||
1 | Cosmetic Act.
| ||||||
2 | (k) "Inpatient drug order" means an order issued by an | ||||||
3 | authorized
prescriber for a resident or patient of a facility | ||||||
4 | licensed under the
Nursing Home Care Act, the ID/DD Community | ||||||
5 | Care Act, the MC/DD Act, the Specialized Mental Health | ||||||
6 | Rehabilitation Act of 2013, the Hospital Licensing Act, or the | ||||||
7 | University of Illinois Hospital Act, or a facility which is | ||||||
8 | operated by the Department of Human
Services (as successor to | ||||||
9 | the Department of Mental Health
and Developmental | ||||||
10 | Disabilities) or the Department of Corrections.
| ||||||
11 | (k-5) "Pharmacist" means an individual health care | ||||||
12 | professional and
provider currently licensed by this State to | ||||||
13 | engage in the practice of
pharmacy.
| ||||||
14 | (l) "Pharmacist in charge" means the licensed pharmacist | ||||||
15 | whose name appears
on a pharmacy license and who is | ||||||
16 | responsible for all aspects of the
operation related to the | ||||||
17 | practice of pharmacy.
| ||||||
18 | (m) "Dispense" or "dispensing" means the interpretation, | ||||||
19 | evaluation, and implementation of a prescription drug order, | ||||||
20 | including the preparation and delivery of a drug or device to a | ||||||
21 | patient or patient's agent in a suitable container | ||||||
22 | appropriately labeled for subsequent administration to or use | ||||||
23 | by a patient in accordance with applicable State and federal | ||||||
24 | laws and regulations.
"Dispense" or "dispensing" does not mean | ||||||
25 | the physical delivery to a patient or a
patient's | ||||||
26 | representative in a home or institution by a designee of a |
| |||||||
| |||||||
1 | pharmacist
or by common carrier. "Dispense" or "dispensing" | ||||||
2 | also does not mean the physical delivery
of a drug or medical | ||||||
3 | device to a patient or patient's representative by a
| ||||||
4 | pharmacist's designee within a pharmacy or drugstore while the | ||||||
5 | pharmacist is
on duty and the pharmacy is open.
| ||||||
6 | (n) "Nonresident pharmacy"
means a pharmacy that is | ||||||
7 | located in a state, commonwealth, or territory
of the United | ||||||
8 | States, other than Illinois, that delivers, dispenses, or
| ||||||
9 | distributes, through the United States Postal Service, | ||||||
10 | commercially acceptable parcel delivery service, or other | ||||||
11 | common
carrier, to Illinois residents, any substance which | ||||||
12 | requires a prescription.
| ||||||
13 | (o) "Compounding" means the preparation and mixing of | ||||||
14 | components, excluding flavorings, (1) as the result of a | ||||||
15 | prescriber's prescription drug order or initiative based on | ||||||
16 | the prescriber-patient-pharmacist relationship in the course | ||||||
17 | of professional practice or (2) for the purpose of, or | ||||||
18 | incident to, research, teaching, or chemical analysis and not | ||||||
19 | for sale or dispensing. "Compounding" includes the preparation | ||||||
20 | of drugs or devices in anticipation of receiving prescription | ||||||
21 | drug orders based on routine, regularly observed dispensing | ||||||
22 | patterns. Commercially available products may be compounded | ||||||
23 | for dispensing to individual patients only if all of the | ||||||
24 | following conditions are met: (i) the commercial product is | ||||||
25 | not reasonably available from normal distribution channels in | ||||||
26 | a timely manner to meet the patient's needs and (ii) the |
| |||||||
| |||||||
1 | prescribing practitioner has requested that the drug be | ||||||
2 | compounded.
| ||||||
3 | (p) (Blank).
| ||||||
4 | (q) (Blank).
| ||||||
5 | (r) "Patient counseling" means the communication between a | ||||||
6 | pharmacist or a student pharmacist under the supervision of a | ||||||
7 | pharmacist and a patient or the patient's representative about | ||||||
8 | the patient's medication or device for the purpose of | ||||||
9 | optimizing proper use of prescription medications or devices. | ||||||
10 | "Patient counseling" may include without limitation (1) | ||||||
11 | obtaining a medication history; (2) acquiring a patient's | ||||||
12 | allergies and health conditions; (3) facilitation of the | ||||||
13 | patient's understanding of the intended use of the medication; | ||||||
14 | (4) proper directions for use; (5) significant potential | ||||||
15 | adverse events; (6) potential food-drug interactions; and (7) | ||||||
16 | the need to be compliant with the medication therapy. A | ||||||
17 | pharmacy technician may only participate in the following | ||||||
18 | aspects of patient counseling under the supervision of a | ||||||
19 | pharmacist: (1) obtaining medication history; (2) providing | ||||||
20 | the offer for counseling by a pharmacist or student | ||||||
21 | pharmacist; and (3) acquiring a patient's allergies and health | ||||||
22 | conditions.
| ||||||
23 | (s) "Patient profiles" or "patient drug therapy record" | ||||||
24 | means the
obtaining, recording, and maintenance of patient | ||||||
25 | prescription
information, including prescriptions for | ||||||
26 | controlled substances, and
personal information.
|
| |||||||
| |||||||
1 | (t) (Blank).
| ||||||
2 | (u) "Medical device" or "device" means an instrument, | ||||||
3 | apparatus, implement, machine,
contrivance, implant, in vitro | ||||||
4 | reagent, or other similar or related article,
including any | ||||||
5 | component part or accessory, required under federal law to
| ||||||
6 | bear the label "Caution: Federal law requires dispensing by or | ||||||
7 | on the order
of a physician". A seller of goods and services | ||||||
8 | who, only for the purpose of
retail sales, compounds, sells, | ||||||
9 | rents, or leases medical devices shall not,
by reasons | ||||||
10 | thereof, be required to be a licensed pharmacy.
| ||||||
11 | (v) "Unique identifier" means an electronic signature, | ||||||
12 | handwritten
signature or initials, thumb print, or other | ||||||
13 | acceptable biometric
or electronic identification process as | ||||||
14 | approved by the Department.
| ||||||
15 | (w) "Current usual and customary retail price" means the | ||||||
16 | price that a pharmacy charges to a non-third-party payor.
| ||||||
17 | (x) "Automated pharmacy system" means a mechanical system | ||||||
18 | located within the confines of the pharmacy or remote location | ||||||
19 | that performs operations or activities, other than compounding | ||||||
20 | or administration, relative to storage, packaging, dispensing, | ||||||
21 | or distribution of medication, and which collects, controls, | ||||||
22 | and maintains all transaction information. | ||||||
23 | (y) "Drug regimen review" means and includes the | ||||||
24 | evaluation of prescription drug orders and patient records for | ||||||
25 | (1)
known allergies; (2) drug or potential therapy | ||||||
26 | contraindications;
(3) reasonable dose, duration of use, and |
| |||||||
| |||||||
1 | route of administration, taking into consideration factors | ||||||
2 | such as age, gender, and contraindications; (4) reasonable | ||||||
3 | directions for use; (5) potential or actual adverse drug | ||||||
4 | reactions; (6) drug-drug interactions; (7) drug-food | ||||||
5 | interactions; (8) drug-disease contraindications; (9) | ||||||
6 | therapeutic duplication; (10) patient laboratory values when | ||||||
7 | authorized and available; (11) proper utilization (including | ||||||
8 | over or under utilization) and optimum therapeutic outcomes; | ||||||
9 | and (12) abuse and misuse.
| ||||||
10 | (z) "Electronically transmitted prescription" means a | ||||||
11 | prescription that is created, recorded, or stored by | ||||||
12 | electronic means; issued and validated with an electronic | ||||||
13 | signature; and transmitted by electronic means directly from | ||||||
14 | the prescriber to a pharmacy. An electronic prescription is | ||||||
15 | not an image of a physical prescription that is transferred by | ||||||
16 | electronic means from computer to computer, facsimile to | ||||||
17 | facsimile, or facsimile to computer.
| ||||||
18 | (aa) "Medication therapy management services" means a | ||||||
19 | distinct service or group of services offered by licensed | ||||||
20 | pharmacists, physicians licensed to practice medicine in all | ||||||
21 | its branches, advanced practice registered nurses authorized | ||||||
22 | in a written agreement with a physician licensed to practice | ||||||
23 | medicine in all its branches, or physician assistants | ||||||
24 | authorized in guidelines by a supervising physician that | ||||||
25 | optimize therapeutic outcomes for individual patients through | ||||||
26 | improved medication use. In a retail or other non-hospital |
| |||||||
| |||||||
1 | pharmacy, medication therapy management services shall consist | ||||||
2 | of the evaluation of prescription drug orders and patient | ||||||
3 | medication records to resolve conflicts with the following: | ||||||
4 | (1) known allergies; | ||||||
5 | (2) drug or potential therapy contraindications; | ||||||
6 | (3) reasonable dose, duration of use, and route of | ||||||
7 | administration, taking into consideration factors such as | ||||||
8 | age, gender, and contraindications; | ||||||
9 | (4) reasonable directions for use; | ||||||
10 | (5) potential or actual adverse drug reactions; | ||||||
11 | (6) drug-drug interactions; | ||||||
12 | (7) drug-food interactions; | ||||||
13 | (8) drug-disease contraindications; | ||||||
14 | (9) identification of therapeutic duplication; | ||||||
15 | (10) patient laboratory values when authorized and | ||||||
16 | available; | ||||||
17 | (11) proper utilization (including over or under | ||||||
18 | utilization) and optimum therapeutic outcomes; and | ||||||
19 | (12) drug abuse and misuse. | ||||||
20 | "Medication therapy management services" includes the | ||||||
21 | following: | ||||||
22 | (1) documenting the services delivered and | ||||||
23 | communicating the information provided to patients' | ||||||
24 | prescribers within an appropriate time frame, not to | ||||||
25 | exceed 48 hours; | ||||||
26 | (2) providing patient counseling designed to enhance a |
| |||||||
| |||||||
1 | patient's understanding and the appropriate use of his or | ||||||
2 | her medications; and | ||||||
3 | (3) providing information, support services, and | ||||||
4 | resources designed to enhance a patient's adherence with | ||||||
5 | his or her prescribed therapeutic regimens. | ||||||
6 | "Medication therapy management services" may also include | ||||||
7 | patient care functions authorized by a physician licensed to | ||||||
8 | practice medicine in all its branches for his or her | ||||||
9 | identified patient or groups of patients under specified | ||||||
10 | conditions or limitations in a standing order from the | ||||||
11 | physician. | ||||||
12 | "Medication therapy management services" in a licensed | ||||||
13 | hospital may also include the following: | ||||||
14 | (1) reviewing assessments of the patient's health | ||||||
15 | status; and | ||||||
16 | (2) following protocols of a hospital pharmacy and | ||||||
17 | therapeutics committee with respect to the fulfillment of | ||||||
18 | medication orders.
| ||||||
19 | (bb) "Pharmacist care" means the provision by a pharmacist | ||||||
20 | of medication therapy management services, with or without the | ||||||
21 | dispensing of drugs or devices, intended to achieve outcomes | ||||||
22 | that improve patient health, quality of life, and comfort and | ||||||
23 | enhance patient safety.
| ||||||
24 | (cc) "Protected health information" means individually | ||||||
25 | identifiable health information that, except as otherwise | ||||||
26 | provided, is:
|
| |||||||
| |||||||
1 | (1) transmitted by electronic media; | ||||||
2 | (2) maintained in any medium set forth in the | ||||||
3 | definition of "electronic media" in the federal Health | ||||||
4 | Insurance Portability and Accountability Act; or | ||||||
5 | (3) transmitted or maintained in any other form or | ||||||
6 | medium. | ||||||
7 | "Protected health information" does not include | ||||||
8 | individually identifiable health information found in: | ||||||
9 | (1) education records covered by the federal Family | ||||||
10 | Educational Right and Privacy Act; or | ||||||
11 | (2) employment records held by a licensee in its role | ||||||
12 | as an employer. | ||||||
13 | (dd) "Standing order" means a specific order for a patient | ||||||
14 | or group of patients issued by a physician licensed to | ||||||
15 | practice medicine in all its branches in Illinois. | ||||||
16 | (ee) "Address of record" means the designated address | ||||||
17 | recorded by the Department in the applicant's application file | ||||||
18 | or licensee's license file maintained by the Department's | ||||||
19 | licensure maintenance unit. | ||||||
20 | (ff) "Home pharmacy" means the location of a pharmacy's | ||||||
21 | primary operations.
| ||||||
22 | (gg) "Email address of record" means the designated email | ||||||
23 | address recorded by the Department in the applicant's | ||||||
24 | application file or the licensee's license file, as maintained | ||||||
25 | by the Department's licensure maintenance unit. | ||||||
26 | (Source: P.A. 100-208, eff. 1-1-18; 100-497, eff. 9-8-17; |
| |||||||
| |||||||
1 | 100-513, eff. 1-1-18; 100-804, eff. 1-1-19; 100-863, eff. | ||||||
2 | 8-14-18; 101-349, eff. 1-1-20; revised 8-21-20.) | ||||||
3 | Section 40. The Illinois Public Aid Code is amended by | ||||||
4 | adding Section 5-5.12d as follows: | ||||||
5 | (305 ILCS 5/5-5.12d new) | ||||||
6 | Sec. 5-5.12d. Coverage for patient care services for | ||||||
7 | hormonal contraceptives provided by a pharmacist. | ||||||
8 | (a) Subject to approval by the federal Centers for | ||||||
9 | Medicare and Medicaid Services, the medical assistance | ||||||
10 | program, including both the fee-for-service and managed care | ||||||
11 | medical assistance programs established under this Article, | ||||||
12 | shall cover patient care services provided by a pharmacist for | ||||||
13 | hormonal contraceptives assessment and consultation. | ||||||
14 | (b) The Department shall establish a fee schedule for | ||||||
15 | patient care services provided by a pharmacist for hormonal | ||||||
16 | contraceptives assessment and consultation. | ||||||
17 | (c) The rate of reimbursement for patient care services | ||||||
18 | provided by a pharmacist for hormonal contraceptives | ||||||
19 | assessment and consultation shall be at 85% of the fee | ||||||
20 | schedule for physician services by the medical assistance | ||||||
21 | program. | ||||||
22 | (d) A pharmacist must be enrolled in the medical | ||||||
23 | assistance program as an ordering and referring provider prior | ||||||
24 | to providing hormonal contraceptives assessment and |
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1 | consultation that is submitted by a pharmacy or pharmacist | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2 | provider for reimbursement pursuant to this Section. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3 | (e) The Director shall seek any necessary federal waivers | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
4 | or approvals to implement this Section. This Section shall not | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
5 | be implemented until the receipt of all necessary federal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6 | waivers or approvals or until January 1, 2024, whichever comes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
7 | first. If federal approval is not obtained by January 1, 2024, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
8 | the provisions of this Section shall be implemented using | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
9 | State funds. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
10 | (f) This Section does not restrict or prohibit any | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
11 | services currently provided by pharmacists as authorized by | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
12 | law, including, but not limited to, pharmacist services | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
13 | provided under this Code or authorized under the Illinois | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
14 | Title XIX State Plan. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
15 | (g) The Department shall adopt administrative rules for | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
16 | this Section as soon as practicable but no later than May 1, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
17 | 2022.
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
18 | Section 99. Effective date. This Act takes effect January | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
19 | 1, 2022. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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