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| | 102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022 HB5426 Introduced 1/31/2022, by Rep. Deanne M. Mazzochi SYNOPSIS AS INTRODUCED: |
| 5 ILCS 100/5-45.21 new | | 225 ILCS 85/3 | | 225 ILCS 85/45 new | | 305 ILCS 5/5-5.12f new | |
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Provides that the Act may be referred to as the Fast Access to Safe Treatments for Early Response to COVID-19 Act or the "FASTER" Act. Amends the Pharmacy Practice Act. Sets forth provisions concerning dispensation of COVID-19 drugs or COVID-19 medicines. Provides that the Department of Financial and Professional Responsibility may adopt emergency rules to implement the provisions. Provides that the Department may adopt rules to permit direct sales from manufacturers or drug compounders if drug or medication shortages exist. Provides that the Department's rulemaking authority shall expire one year after the effective date of the amendatory Act. Provides that nothing in the provisions shall be construed to obligate or otherwise require a pharmacist to dispense COVID-19 drugs or COVID-19 medicines to any particular patient under any standing order or prescription, or otherwise preempt the pharmacist from exercising his or her professional judgment. Defines terms. Amends the Illinois Public Aid Code. Sets forth provisions concerning coverage for patient care services for COVID-19 drugs and COVID-19 medications provided by a pharmacist. Makes a conforming change in the Illinois Administrative Procedure Act. Effective immediately.
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| | A BILL FOR |
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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 1. References to this Act. This Act may be |
5 | | referred to as the Fast Access to Safe Treatments for Early |
6 | | Response to COVID-19 Act, or the "FASTER" Act. |
7 | | Section 5. Findings. The General Assembly finds that: |
8 | | (1) the effectiveness of current therapies identified |
9 | | to treat COVID-19 patients oftentimes necessitates that |
10 | | patients receive treatment within hours or mere days of |
11 | | diagnosis; |
12 | | (2) best practices in response to a diagnosis of |
13 | | COVID-19 is to immediately contact a primary care |
14 | | provider; |
15 | | (3) there are many individuals in the State of |
16 | | Illinois who lack a primary care provider, or, if |
17 | | providers are overwhelmed or overworked, or where staffing |
18 | | or bed shortages exist, patients may not be able to secure |
19 | | a primary care provider visit or contact within the time |
20 | | period needed when drug therapies may be most effective, |
21 | | which is not in the best interests of the patients; and |
22 | | (4) to protect public safety, by reducing the number |
23 | | of patients who progress to more serious disease that |
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1 | | requires hospitalization, and to ensure improved outcomes |
2 | | and patient welfare, it is necessary to provide more |
3 | | flexibility and options for patients to secure remedial |
4 | | treatments, particularly oral dosing treatments or |
5 | | treatments that can be sold at a pharmacy, which unlike |
6 | | intravenous or infusion treatments, may not need to be |
7 | | administered with the assistance of a skilled medical |
8 | | practitioner. |
9 | | The General Assembly further finds and encourages the use |
10 | | of procedures under this Act for patients who have tested |
11 | | positive for COVID-19 but lack a primary care physician, or |
12 | | who are not insured or who may have difficulty securing |
13 | | treatment through their insurance plans, and encourage |
14 | | pharmacy sales in the additional circumstance when a person |
15 | | can provide payment for the drug products sought from the |
16 | | pharmacy. |
17 | | Section 10. The Illinois Administrative Procedure Act is |
18 | | amended by adding Section 5-45.21 as follows: |
19 | | (5 ILCS 100/5-45.21 new) |
20 | | Sec. 5-45.21. Emergency rulemaking; Pharmacy Practice Act. |
21 | | To provide for the expeditious and timely implementation of |
22 | | Section 45 of the Pharmacy Practice Act, emergency rules |
23 | | implementing Section 45 of the Pharmacy Practice Act may be |
24 | | adopted in accordance with Section 5-45 by the Department of |
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1 | | Financial and Professional Regulation. The adoption of |
2 | | emergency rules authorized by Section 5-45 and this Section is |
3 | | deemed to be necessary for the public interest, safety, and |
4 | | welfare. |
5 | | This Section is repealed one year after the effective date |
6 | | of this amendatory Act of the 102nd General Assembly. |
7 | | Section 15. The Pharmacy Practice Act is amended by |
8 | | changing Section 3 and by adding Section 45 as follows:
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9 | | (225 ILCS 85/3)
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10 | | (Section scheduled to be repealed on January 1, 2023)
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11 | | Sec. 3. Definitions. For the purpose of this Act, except |
12 | | where otherwise
limited therein:
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13 | | (a) "Pharmacy" or "drugstore" means and includes every |
14 | | store, shop,
pharmacy department, or other place where |
15 | | pharmacist
care is
provided
by a pharmacist (1) where drugs, |
16 | | medicines, or poisons are
dispensed, sold or
offered for sale |
17 | | at retail, or displayed for sale at retail; or
(2)
where
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18 | | prescriptions of physicians, dentists, advanced practice |
19 | | registered nurses, physician assistants, veterinarians, |
20 | | podiatric physicians, or
optometrists, within the limits of |
21 | | their
licenses, are
compounded, filled, or dispensed; or (3) |
22 | | which has upon it or
displayed within
it, or affixed to or used |
23 | | in connection with it, a sign bearing the word or
words |
24 | | "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical
Care", |
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1 | | "Apothecary", "Drugstore",
"Medicine Store", "Prescriptions", |
2 | | "Drugs", "Dispensary", "Medicines", or any word
or words of |
3 | | similar or like import, either in the English language
or any |
4 | | other language; or (4) where the characteristic prescription
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5 | | sign (Rx) or similar design is exhibited; or (5) any store, or
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6 | | shop,
or other place with respect to which any of the above |
7 | | words, objects,
signs or designs are used in any |
8 | | advertisement.
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9 | | (b) "Drugs" means and includes (1) articles recognized
in |
10 | | the official United States Pharmacopoeia/National Formulary |
11 | | (USP/NF),
or any supplement thereto and being intended for and |
12 | | having for their
main use the diagnosis, cure, mitigation, |
13 | | treatment or prevention of
disease in man or other animals, as |
14 | | approved by the United States Food and
Drug Administration, |
15 | | but does not include devices or their components, parts,
or |
16 | | accessories; and (2) all other articles intended
for and |
17 | | having for their main use the diagnosis, cure, mitigation,
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18 | | treatment or prevention of disease in man or other animals, as |
19 | | approved
by the United States Food and Drug Administration, |
20 | | but does not include
devices or their components, parts, or |
21 | | accessories; and (3) articles
(other than food) having for |
22 | | their main use and intended
to affect the structure or any |
23 | | function of the body of man or other
animals; and (4) articles |
24 | | having for their main use and intended
for use as a component |
25 | | or any articles specified in clause (1), (2)
or (3); but does |
26 | | not include devices or their components, parts or
accessories.
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1 | | (b-1) "Drugs associated with COVID-19" includes (1) |
2 | | articles recognized in the official United States |
3 | | Pharmacopoeia/National Formulary (USP/NF), or any supplement |
4 | | thereto and being intended for and having for their main use |
5 | | the diagnosis, cure, mitigation, treatment or prevention of |
6 | | disease in man or other animals, as approved by the United |
7 | | States Food and Drug Administration, but does not include |
8 | | devices or their components, parts, or accessories; (2) all |
9 | | other articles intended for and having for their main use the |
10 | | diagnosis, cure, mitigation, treatment or prevention of |
11 | | disease in man or other animals, as approved by the United |
12 | | States Food and Drug Administration, but does not include |
13 | | devices or their components, parts, or accessories; (3) |
14 | | articles (other than food) having for their main use and |
15 | | intended to affect the structure or any function of the body of |
16 | | man or other animals; (4) articles that have been (a) approved |
17 | | for commercial use or sale in the United States by the United |
18 | | States Food and Drug Administration under an Emergency Use |
19 | | Authorization associated with COVID-19, (b) which have |
20 | | otherwise satisfied the product identifier requirements of the |
21 | | United States Drug Supply Chain Security Act for the |
22 | | Interoperable Exchange of Information for Tracing of Human |
23 | | Finished Prescription Drugs, or (c) which have been approved |
24 | | by the regulatory authorities of another nation, where the |
25 | | United States Food and Drug Administration has permitted |
26 | | importation to address product shortages through such agency's |
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1 | | discretionary exercise of its enforcement authority; and (5) |
2 | | articles having for their main use and intended for use as a |
3 | | component or any articles specified in clause (1), (2), (3), |
4 | | or (4); but does not include devices or their components, |
5 | | parts, or accessories. |
6 | | (c) "Medicines" means and includes all drugs intended for
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7 | | human or veterinary use approved by the United States Food and |
8 | | Drug
Administration.
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9 | | (c-1) "Medicines for COVID-19" means all drugs intended |
10 | | for human or veterinary use approved by the United States Food |
11 | | and Drug Administration, or that have received Emergency Use |
12 | | Authorization in connection with COVID-19, or that have |
13 | | otherwise satisfied the product identifier requirements of the |
14 | | United States Drug Supply Chain Security Act for the |
15 | | Interoperable Exchange of Information for Tracing of Human |
16 | | Finished Prescription Drugs, or any other drug approved for |
17 | | human use by the regulatory authorities of another nation that |
18 | | the United States Food and Drug Administration agrees may be |
19 | | imported to address product shortages through such agency's |
20 | | discretionary exercise of its enforcement authority. |
21 | | (d) "Practice of pharmacy" means: |
22 | | (1) the interpretation and the provision of assistance |
23 | | in the monitoring, evaluation, and implementation of |
24 | | prescription drug orders; |
25 | | (2) the dispensing of prescription drug orders; |
26 | | (3) participation in drug and device selection; |
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1 | | (4) drug administration limited to the administration |
2 | | of oral, topical, injectable, and inhalation as follows: |
3 | | (A) in the context of patient education on the |
4 | | proper use or delivery of medications; |
5 | | (B) except as set forth in subparagraph (B-10), |
6 | | vaccination of patients 7 years of age and older |
7 | | pursuant to a valid prescription or standing order, by |
8 | | a physician licensed to practice medicine in all its |
9 | | branches, upon completion of appropriate training, |
10 | | including how to address contraindications and adverse |
11 | | reactions set forth by rule, with notification to the |
12 | | patient's physician and appropriate record retention, |
13 | | or pursuant to hospital pharmacy and therapeutics |
14 | | committee policies and procedures. Eligible vaccines |
15 | | are those listed on the U.S. Centers for Disease |
16 | | Control and Prevention (CDC) Recommended Immunization |
17 | | Schedule, the CDC's Health Information for |
18 | | International Travel, or the U.S. Food and Drug |
19 | | Administration's Vaccines Licensed and Authorized for |
20 | | Use in the United States. As applicable to the State's |
21 | | Medicaid program and other payers, vaccines ordered |
22 | | and administered in accordance with this subsection |
23 | | shall be covered and reimbursed at no less than the |
24 | | rate that the vaccine is reimbursed when ordered and |
25 | | administered by a physician; |
26 | | (B-5) following the initial administration of |
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1 | | long-acting or extended-release form opioid |
2 | | 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 | | (B-10) vaccination for COVID-19 with a drug |
17 | | product that has been finally approved for use by the |
18 | | Food and Drug Administration for patients 18 years of |
19 | | age and older, or patients from the age of 12 or older |
20 | | with the written informed consent of a parent or legal |
21 | | guardian, pursuant to a valid prescription or standing |
22 | | order, by a physician licensed to practice medicine in |
23 | | all its branches, upon completion of appropriate |
24 | | training, including how to address contraindications |
25 | | and adverse reactions, and including training |
26 | | associated with the latest medical guidance relating |
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1 | | to location of injections and aspiration technique, |
2 | | set forth by rule, with notification to the patient's |
3 | | physician and appropriate record retention, or |
4 | | pursuant to hospital pharmacy and therapeutics |
5 | | committee policies. No vaccination with a drug product |
6 | | that has been made, used, sold, or distributed |
7 | | pursuant to only an Emergency Use Licensure approval |
8 | | from the United States Food and Drug Administration |
9 | | may be dosed or administered under this Section; nor |
10 | | may any vaccination with a COVID-19 vaccine under this |
11 | | Section occur for any population under the age of 18 |
12 | | where the Food and Drug Administration's issuance of |
13 | | final approval was contingent on the conduct of |
14 | | additional safety or efficacy studies; where the |
15 | | person falls within the scope of a patient population |
16 | | for which clinical trials for are ongoing; or which |
17 | | are only authorized by the United States Food and Drug |
18 | | Administration under an Emergency Licensure |
19 | | Authorization; for a patient where administration is |
20 | | contraindicated; where a physician has determined |
21 | | there is no medical necessity for the vaccination; or |
22 | | where the person otherwise has medical conditions or a |
23 | | patient history that necessitates consultation with a |
24 | | physician to provide meaningful informed consent. |
25 | | (C) administration of injections of |
26 | | alpha-hydroxyprogesterone caproate, pursuant to a |
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1 | | valid prescription, by a physician licensed to |
2 | | practice medicine in all its branches, upon completion |
3 | | of appropriate training, including how to address |
4 | | contraindications and adverse reactions set forth by |
5 | | rule, with notification to the patient's physician and |
6 | | appropriate record retention, or pursuant to hospital |
7 | | pharmacy and therapeutics committee policies and |
8 | | procedures; and |
9 | | (D) administration of injections of long-term |
10 | | antipsychotic medications pursuant to a valid |
11 | | prescription by a physician licensed to practice |
12 | | medicine in all its branches, upon completion of |
13 | | appropriate training conducted by an Accreditation |
14 | | Council of Pharmaceutical Education accredited |
15 | | provider, including how to address contraindications |
16 | | and adverse reactions set forth by rule, with |
17 | | notification to the patient's physician and |
18 | | appropriate record retention, or pursuant to hospital |
19 | | pharmacy and therapeutics committee policies and |
20 | | procedures. |
21 | | (5) (blank); |
22 | | (6) drug regimen review; |
23 | | (7) drug or drug-related research; |
24 | | (8) the provision of patient counseling; |
25 | | (9) the practice of telepharmacy; |
26 | | (10) the provision of those acts or services necessary |
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1 | | to provide pharmacist care; |
2 | | (11) medication therapy management; |
3 | | (12) the responsibility for compounding and labeling |
4 | | of drugs and devices (except labeling by a manufacturer, |
5 | | repackager, or distributor of non-prescription drugs and |
6 | | commercially packaged legend drugs and devices), proper |
7 | | and safe storage of drugs and devices, and maintenance of |
8 | | required records; and |
9 | | (13) the assessment and consultation of patients and |
10 | | dispensing of hormonal contraceptives. |
11 | | A pharmacist who performs any of the acts defined as the |
12 | | practice of pharmacy in this State must be actively licensed |
13 | | as a pharmacist under this Act.
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14 | | (e) "Prescription" means and includes any written, oral, |
15 | | facsimile, or
electronically transmitted order for drugs
or |
16 | | medical devices, issued by a physician licensed to practice |
17 | | medicine in
all its branches, dentist, veterinarian, podiatric |
18 | | physician, or
optometrist, within the
limits of his or her |
19 | | license, by a physician assistant in accordance with
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20 | | subsection (f) of Section 4, or by an advanced practice |
21 | | registered nurse in
accordance with subsection (g) of Section |
22 | | 4, containing the
following: (1) name
of the patient; (2) date |
23 | | when prescription was issued; (3) name
and strength of drug or |
24 | | description of the medical device prescribed;
and (4) |
25 | | quantity; (5) directions for use; (6) prescriber's name,
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26 | | address,
and signature; and (7) DEA registration number where |
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1 | | required, for controlled
substances.
The prescription may, but |
2 | | is not required to, list the illness, disease, or condition |
3 | | for which the drug or device is being prescribed. DEA |
4 | | registration numbers shall not be required on inpatient drug |
5 | | orders. A prescription for medication other than controlled |
6 | | substances shall be valid for up to 15 months from the date |
7 | | issued for the purpose of refills, unless the prescription |
8 | | states otherwise.
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9 | | (f) "Person" means and includes a natural person, |
10 | | partnership,
association, corporation, government entity, or |
11 | | any other legal
entity.
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12 | | (g) "Department" means the Department of Financial and
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13 | | Professional Regulation.
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14 | | (h) "Board of Pharmacy" or "Board" means the State Board
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15 | | of Pharmacy of the Department of Financial and Professional |
16 | | Regulation.
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17 | | (i) "Secretary"
means the Secretary
of Financial and |
18 | | Professional Regulation.
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19 | | (j) "Drug product selection" means the interchange for a
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20 | | prescribed pharmaceutical product in accordance with Section |
21 | | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and |
22 | | Cosmetic Act.
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23 | | (k) "Inpatient drug order" means an order issued by an |
24 | | authorized
prescriber for a resident or patient of a facility |
25 | | licensed under the
Nursing Home Care Act, the ID/DD Community |
26 | | Care Act, the MC/DD Act, the Specialized Mental Health |
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1 | | Rehabilitation Act of 2013, the Hospital Licensing Act, or the |
2 | | University of Illinois Hospital Act, or a facility which is |
3 | | operated by the Department of Human
Services (as successor to |
4 | | the Department of Mental Health
and Developmental |
5 | | Disabilities) or the Department of Corrections.
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6 | | (k-5) "Pharmacist" means an individual health care |
7 | | professional and
provider currently licensed by this State to |
8 | | engage in the practice of
pharmacy.
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9 | | (l) "Pharmacist in charge" means the licensed pharmacist |
10 | | whose name appears
on a pharmacy license and who is |
11 | | responsible for all aspects of the
operation related to the |
12 | | practice of pharmacy.
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13 | | (m) "Dispense" or "dispensing" means the interpretation, |
14 | | evaluation, and implementation of a prescription drug order, |
15 | | including the preparation and delivery of a drug or device to a |
16 | | patient or patient's agent in a suitable container |
17 | | appropriately labeled for subsequent administration to or use |
18 | | by a patient in accordance with applicable State and federal |
19 | | laws and regulations.
"Dispense" or "dispensing" does not mean |
20 | | the physical delivery to a patient or a
patient's |
21 | | representative in a home or institution by a designee of a |
22 | | pharmacist
or by common carrier. "Dispense" or "dispensing" |
23 | | also does not mean the physical delivery
of a drug or medical |
24 | | device to a patient or patient's representative by a
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25 | | pharmacist's designee within a pharmacy or drugstore while the |
26 | | pharmacist is
on duty and the pharmacy is open.
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1 | | (n) "Nonresident pharmacy"
means a pharmacy that is |
2 | | located in a state, commonwealth, or territory
of the United |
3 | | States, other than Illinois, that delivers, dispenses, or
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4 | | distributes, through the United States Postal Service, |
5 | | commercially acceptable parcel delivery service, or other |
6 | | common
carrier, to Illinois residents, any substance which |
7 | | requires a prescription.
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8 | | (o) "Compounding" means the preparation and mixing of |
9 | | components, excluding flavorings, (1) as the result of a |
10 | | prescriber's prescription drug order or initiative based on |
11 | | the prescriber-patient-pharmacist relationship in the course |
12 | | of professional practice or (2) for the purpose of, or |
13 | | incident to, research, teaching, or chemical analysis and not |
14 | | for sale or dispensing. "Compounding" includes the preparation |
15 | | of drugs or devices in anticipation of receiving prescription |
16 | | drug orders based on routine, regularly observed dispensing |
17 | | patterns. Commercially available products may be compounded |
18 | | for dispensing to individual patients only if all of the |
19 | | following conditions are met: (i) the commercial product is |
20 | | not reasonably available from normal distribution channels in |
21 | | a timely manner to meet the patient's needs and (ii) the |
22 | | prescribing practitioner has requested that the drug be |
23 | | compounded.
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24 | | (p) (Blank).
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25 | | (q) (Blank).
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26 | | (r) "Patient counseling" means the communication between a |
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1 | | pharmacist or a student pharmacist under the supervision of a |
2 | | pharmacist and a patient or the patient's representative about |
3 | | the patient's medication or device for the purpose of |
4 | | optimizing proper use of prescription medications or devices. |
5 | | "Patient counseling" may include without limitation (1) |
6 | | obtaining a medication history; (2) acquiring a patient's |
7 | | allergies and health conditions; (3) facilitation of the |
8 | | patient's understanding of the intended use of the medication; |
9 | | (4) proper directions for use; (5) significant potential |
10 | | adverse events; (6) potential food-drug interactions; and (7) |
11 | | the need to be compliant with the medication therapy. A |
12 | | pharmacy technician may only participate in the following |
13 | | aspects of patient counseling under the supervision of a |
14 | | pharmacist: (1) obtaining medication history; (2) providing |
15 | | the offer for counseling by a pharmacist or student |
16 | | pharmacist; and (3) acquiring a patient's allergies and health |
17 | | conditions.
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18 | | (s) "Patient profiles" or "patient drug therapy record" |
19 | | means the
obtaining, recording, and maintenance of patient |
20 | | prescription
information, including prescriptions for |
21 | | controlled substances, and
personal information.
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22 | | (t) (Blank).
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23 | | (u) "Medical device" or "device" means an instrument, |
24 | | apparatus, implement, machine,
contrivance, implant, in vitro |
25 | | reagent, or other similar or related article,
including any |
26 | | component part or accessory, required under federal law to
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1 | | bear the label "Caution: Federal law requires dispensing by or |
2 | | on the order
of a physician". A seller of goods and services |
3 | | who, only for the purpose of
retail sales, compounds, sells, |
4 | | rents, or leases medical devices shall not,
by reasons |
5 | | thereof, be required to be a licensed pharmacy.
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6 | | (v) "Unique identifier" means an electronic signature, |
7 | | handwritten
signature or initials, thumb print, or other |
8 | | acceptable biometric
or electronic identification process as |
9 | | approved by the Department.
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10 | | (w) "Current usual and customary retail price" means the |
11 | | price that a pharmacy charges to a non-third-party payor.
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12 | | (x) "Automated pharmacy system" means a mechanical system |
13 | | located within the confines of the pharmacy or remote location |
14 | | that performs operations or activities, other than compounding |
15 | | or administration, relative to storage, packaging, dispensing, |
16 | | or distribution of medication, and which collects, controls, |
17 | | and maintains all transaction information. |
18 | | (y) "Drug regimen review" means and includes the |
19 | | evaluation of prescription drug orders and patient records for |
20 | | (1)
known allergies; (2) drug or potential therapy |
21 | | contraindications;
(3) reasonable dose, duration of use, and |
22 | | route of administration, taking into consideration factors |
23 | | such as age, gender, and contraindications; (4) reasonable |
24 | | directions for use; (5) potential or actual adverse drug |
25 | | reactions; (6) drug-drug interactions; (7) drug-food |
26 | | interactions; (8) drug-disease contraindications; (9) |
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1 | | therapeutic duplication; (10) patient laboratory values when |
2 | | authorized and available; (11) proper utilization (including |
3 | | over or under utilization) and optimum therapeutic outcomes; |
4 | | and (12) abuse and misuse.
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5 | | (z) "Electronically transmitted prescription" means a |
6 | | prescription that is created, recorded, or stored by |
7 | | electronic means; issued and validated with an electronic |
8 | | signature; and transmitted by electronic means directly from |
9 | | the prescriber to a pharmacy. An electronic prescription is |
10 | | not an image of a physical prescription that is transferred by |
11 | | electronic means from computer to computer, facsimile to |
12 | | facsimile, or facsimile to computer.
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13 | | (aa) "Medication therapy management services" means a |
14 | | distinct service or group of services offered by licensed |
15 | | pharmacists, physicians licensed to practice medicine in all |
16 | | its branches, advanced practice registered nurses authorized |
17 | | in a written agreement with a physician licensed to practice |
18 | | medicine in all its branches, or physician assistants |
19 | | authorized in guidelines by a supervising physician that |
20 | | optimize therapeutic outcomes for individual patients through |
21 | | improved medication use. In a retail or other non-hospital |
22 | | pharmacy, medication therapy management services shall consist |
23 | | of the evaluation of prescription drug orders and patient |
24 | | medication records to resolve conflicts with the following: |
25 | | (1) known allergies; |
26 | | (2) drug or potential therapy contraindications; |
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1 | | (3) reasonable dose, duration of use, and route of |
2 | | administration, taking into consideration factors such as |
3 | | age, gender, and contraindications; |
4 | | (4) reasonable directions for use; |
5 | | (5) potential or actual adverse drug reactions; |
6 | | (6) drug-drug interactions; |
7 | | (7) drug-food interactions; |
8 | | (8) drug-disease contraindications; |
9 | | (9) identification of therapeutic duplication; |
10 | | (10) patient laboratory values when authorized and |
11 | | available; |
12 | | (11) proper utilization (including over or under |
13 | | utilization) and optimum therapeutic outcomes; and |
14 | | (12) drug abuse and misuse. |
15 | | "Medication therapy management services" includes the |
16 | | following: |
17 | | (1) documenting the services delivered and |
18 | | communicating the information provided to patients' |
19 | | prescribers within an appropriate time frame, not to |
20 | | exceed 48 hours; |
21 | | (2) providing patient counseling designed to enhance a |
22 | | patient's understanding and the appropriate use of his or |
23 | | her medications; and |
24 | | (3) providing information, support services, and |
25 | | resources designed to enhance a patient's adherence with |
26 | | his or her prescribed therapeutic regimens. |
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1 | | "Medication therapy management services" may also include |
2 | | patient care functions authorized by a physician licensed to |
3 | | practice medicine in all its branches for his or her |
4 | | identified patient or groups of patients under specified |
5 | | conditions or limitations in a standing order from the |
6 | | physician. |
7 | | "Medication therapy management services" in a licensed |
8 | | hospital may also include the following: |
9 | | (1) reviewing assessments of the patient's health |
10 | | status; and |
11 | | (2) following protocols of a hospital pharmacy and |
12 | | therapeutics committee with respect to the fulfillment of |
13 | | medication orders.
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14 | | (bb) "Pharmacist care" means the provision by a pharmacist |
15 | | of medication therapy management services, with or without the |
16 | | dispensing of drugs or devices, intended to achieve outcomes |
17 | | that improve patient health, quality of life, and comfort and |
18 | | enhance patient safety.
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19 | | (cc) "Protected health information" means individually |
20 | | identifiable health information that, except as otherwise |
21 | | provided, is:
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22 | | (1) transmitted by electronic media; |
23 | | (2) maintained in any medium set forth in the |
24 | | definition of "electronic media" in the federal Health |
25 | | Insurance Portability and Accountability Act; or |
26 | | (3) transmitted or maintained in any other form or |
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1 | | medium. |
2 | | "Protected health information" does not include |
3 | | individually identifiable health information found in: |
4 | | (1) education records covered by the federal Family |
5 | | Educational Right and Privacy Act; or |
6 | | (2) employment records held by a licensee in its role |
7 | | as an employer. |
8 | | (dd) "Standing order" means a specific order for a patient |
9 | | or group of patients issued by a physician licensed to |
10 | | practice medicine in all its branches in Illinois. |
11 | | (ee) "Address of record" means the designated address |
12 | | recorded by the Department in the applicant's application file |
13 | | or licensee's license file maintained by the Department's |
14 | | licensure maintenance unit. |
15 | | (ff) "Home pharmacy" means the location of a pharmacy's |
16 | | primary operations.
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17 | | (gg) "Email address of record" means the designated email |
18 | | address recorded by the Department in the applicant's |
19 | | application file or the licensee's license file, as maintained |
20 | | by the Department's licensure maintenance unit. |
21 | | (Source: P.A. 101-349, eff. 1-1-20; 102-16, eff. 6-17-21; |
22 | | 102-103, eff. 1-1-22; 102-558, eff. 8-20-21; revised |
23 | | 10-26-21.) |
24 | | (225 ILCS 85/45 new) |
25 | | Sec. 45. Dispensation of COVID-19 drugs or COVID-19 |
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1 | | medicines. |
2 | | (a) The dispensing of COVID-19 drugs or COVID-19 medicines |
3 | | to a patient shall be pursuant to a valid prescription or |
4 | | standing order by a physician licensed to practice medicine in |
5 | | the State of Illinois, a physician licensed to practice |
6 | | medicine in all its branches in Illinois, or the medical |
7 | | director of a local health department, pursuant to the |
8 | | following: |
9 | | (1) For a drug sought for an active infection, a |
10 | | pharmacist may dispense a drug supply sufficient for one |
11 | | patient for a period not to exceed one week, unless |
12 | | continued active infection has been demonstrated. |
13 | | (2) For a drug sought for prophylactic or maintenance |
14 | | therapy, a pharmacist may dispense no more than a 30-day |
15 | | supply or one month supply. |
16 | | (3) If the standing order places restriction on the |
17 | | age, duration, dosing range, or other patient risk |
18 | | criteria, a pharmacist shall have the patient complete a |
19 | | self-screening risk assessment. The self-screening tool |
20 | | may incorporate a screening tool prepared by any federal, |
21 | | State, or local agency, or medical association of licensed |
22 | | physicians based in the State of Illinois if one is |
23 | | available. A screening assessment may be performed through |
24 | | telephonic or electronic means. |
25 | | (4) Based upon the results of the self-screening and |
26 | | patient assessments, the pharmacist shall use his or her |
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1 | | professional and clinical judgment as to when a patient |
2 | | should be referred to the patient's physician or another |
3 | | health care provider. Pharmacists shall direct patients |
4 | | who lack a primary health care provider to find a |
5 | | provider. |
6 | | (5) A pharmacist shall provide, during the patient |
7 | | assessment and consultation, education regarding the |
8 | | COVID-19 drugs or COVID-19 medicines to be dispensed, if a |
9 | | pharmacist is aware of additional risk factors outside the |
10 | | standing order. |
11 | | (6) The patient consultation shall take place in a |
12 | | private manner. |
13 | | (7) A pharmacist and pharmacy shall maintain |
14 | | appropriate records. |
15 | | (b) The Department may adopt emergency rules to implement |
16 | | this Section, so long as such rules do not interfere with or |
17 | | unduly burden patients seeking to secure medication to treat |
18 | | or prevent a COVID-19 infection, unless the dispensation of |
19 | | prescription drugs under this Section is the cause of a drug |
20 | | shortage in hospitals, urgent care facilities, or involving |
21 | | physicians that necessitates prioritizing patient access, and |
22 | | no less restrictive alternative is available. The Department |
23 | | may adopt rules to permit direct sales from manufacturers or |
24 | | drug compounders if drug or medication shortages exist. The |
25 | | Department's rulemaking authority under this Section shall |
26 | | expire one year after the effective date of this amendatory |
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1 | | Act of the 102nd General Assembly. |
2 | | (c) Nothing in this Section shall be construed to obligate |
3 | | or otherwise require a pharmacist to dispense COVID-19 drugs |
4 | | or COVID-19 medicines to any particular patient under any |
5 | | standing order or prescription under this Section, or |
6 | | otherwise preempt the pharmacist from exercising his or her |
7 | | professional judgment. |
8 | | Section 20. The Illinois Public Aid Code is amended by |
9 | | adding Section 5-5.12f as follows: |
10 | | (305 ILCS 5/5-5.12f new) |
11 | | Sec. 5-5.12f. Coverage for patient care services for |
12 | | COVID-19 drugs and COVID-19 medications provided by a |
13 | | pharmacist. |
14 | | (a) Subject to approval by the federal Centers for |
15 | | Medicare and Medicaid Services, the medical assistance |
16 | | program, including both the fee-for-service program and |
17 | | managed care medical assistance program established under this |
18 | | Article, shall cover patient care services provided by a |
19 | | pharmacist for COVID-19 drugs and COVID-19 medications. |
20 | | (b) The Department shall establish a fee schedule for |
21 | | patient care services provided by a pharmacist for COVID-19 |
22 | | drugs and COVID-19 medications assessment and consultation. |
23 | | (c) The rate of reimbursement for patient care services |
24 | | provided by a pharmacist for COVID-19 drugs and COVID-19 |
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1 | | medications assessment and consultation shall be at 85% of the |
2 | | fee schedule for physician services by the medical assistance |
3 | | program. |
4 | | (d) A pharmacist must be enrolled in the medical |
5 | | assistance program as an ordering and referring provider |
6 | | before providing COVID-19 drugs and COVID-19 medications |
7 | | assessment and consultation that is submitted by a pharmacy or |
8 | | pharmacist provider for reimbursement pursuant to this |
9 | | Section. |
10 | | (e) The Department shall apply for any necessary federal |
11 | | waivers or approvals to implement this Section within 30 days |
12 | | after this Section becomes law. The Governor shall inform the |
13 | | General Assembly of any federal funds that have been |
14 | | distributed to the State of Illinois by the federal government |
15 | | pursuant to any legislation pertaining to COVID-19 that may be |
16 | | used to fund these treatments until waiver or Centers for |
17 | | Medicare and Medicaid Services approval for payment is |
18 | | secured. |
19 | | (f) This Section does not restrict or prohibit any |
20 | | services currently provided by pharmacists as authorized by |
21 | | law, including, but not limited to, pharmacist services |
22 | | provided under this Code or authorized under the Illinois |
23 | | Title XIX State Plan, or services that a patient can self-pay |
24 | | for the COVID-19 drugs, COVID-19 medicine, or related |
25 | | treatment. |
26 | | (g) The Department shall submit to the Joint Committee on |