Illinois General Assembly - Full Text of HB5426
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Full Text of HB5426  102nd General Assembly

HB5426 102ND GENERAL ASSEMBLY

  
  

 


 
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

    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.


LRB102 25428 BMS 34713 b

 

 

A BILL FOR

 

HB5426LRB102 25428 BMS 34713 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. References to this Act. This Act may be
5referred to as the Fast Access to Safe Treatments for Early
6Response 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
10of procedures under this Act for patients who have tested
11positive for COVID-19 but lack a primary care physician, or
12who are not insured or who may have difficulty securing
13treatment through their insurance plans, and encourage
14pharmacy sales in the additional circumstance when a person
15can provide payment for the drug products sought from the
16pharmacy.
 
17    Section 10. The Illinois Administrative Procedure Act is
18amended 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.
21To provide for the expeditious and timely implementation of
22Section 45 of the Pharmacy Practice Act, emergency rules
23implementing Section 45 of the Pharmacy Practice Act may be
24adopted in accordance with Section 5-45 by the Department of

 

 

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1Financial and Professional Regulation. The adoption of
2emergency rules authorized by Section 5-45 and this Section is
3deemed to be necessary for the public interest, safety, and
4welfare.
5    This Section is repealed one year after the effective date
6of this amendatory Act of the 102nd General Assembly.
 
7    Section 15. The Pharmacy Practice Act is amended by
8changing Section 3 and by adding Section 45 as follows:
 
9    (225 ILCS 85/3)
10    (Section scheduled to be repealed on January 1, 2023)
11    Sec. 3. Definitions. For the purpose of this Act, except
12where otherwise limited therein:
13    (a) "Pharmacy" or "drugstore" means and includes every
14store, shop, pharmacy department, or other place where
15pharmacist care is provided by a pharmacist (1) where drugs,
16medicines, or poisons are dispensed, sold or offered for sale
17at retail, or displayed for sale at retail; or (2) where
18prescriptions of physicians, dentists, advanced practice
19registered nurses, physician assistants, veterinarians,
20podiatric physicians, or optometrists, within the limits of
21their licenses, are compounded, filled, or dispensed; or (3)
22which has upon it or displayed within it, or affixed to or used
23in 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
3similar or like import, either in the English language or any
4other language; or (4) where the characteristic prescription
5sign (Rx) or similar design is exhibited; or (5) any store, or
6shop, or other place with respect to which any of the above
7words, objects, signs or designs are used in any
8advertisement.
9    (b) "Drugs" means and includes (1) articles recognized in
10the official United States Pharmacopoeia/National Formulary
11(USP/NF), or any supplement thereto and being intended for and
12having for their main use the diagnosis, cure, mitigation,
13treatment or prevention of disease in man or other animals, as
14approved by the United States Food and Drug Administration,
15but does not include devices or their components, parts, or
16accessories; and (2) all other articles intended for and
17having for their main use the diagnosis, cure, mitigation,
18treatment or prevention of disease in man or other animals, as
19approved by the United States Food and Drug Administration,
20but does not include devices or their components, parts, or
21accessories; and (3) articles (other than food) having for
22their main use and intended to affect the structure or any
23function of the body of man or other animals; and (4) articles
24having for their main use and intended for use as a component
25or any articles specified in clause (1), (2) or (3); but does
26not include devices or their components, parts or accessories.

 

 

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1    (b-1) "Drugs associated with COVID-19" includes (1)
2articles recognized in the official United States
3Pharmacopoeia/National Formulary (USP/NF), or any supplement
4thereto and being intended for and having for their main use
5the diagnosis, cure, mitigation, treatment or prevention of
6disease in man or other animals, as approved by the United
7States Food and Drug Administration, but does not include
8devices or their components, parts, or accessories; (2) all
9other articles intended for and having for their main use the
10diagnosis, cure, mitigation, treatment or prevention of
11disease in man or other animals, as approved by the United
12States Food and Drug Administration, but does not include
13devices or their components, parts, or accessories; (3)
14articles (other than food) having for their main use and
15intended to affect the structure or any function of the body of
16man or other animals; (4) articles that have been (a) approved
17for commercial use or sale in the United States by the United
18States Food and Drug Administration under an Emergency Use
19Authorization associated with COVID-19, (b) which have
20otherwise satisfied the product identifier requirements of the
21United States Drug Supply Chain Security Act for the
22Interoperable Exchange of Information for Tracing of Human
23Finished Prescription Drugs, or (c) which have been approved
24by the regulatory authorities of another nation, where the
25United States Food and Drug Administration has permitted
26importation to address product shortages through such agency's

 

 

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1discretionary exercise of its enforcement authority; and (5)
2articles having for their main use and intended for use as a
3component or any articles specified in clause (1), (2), (3),
4or (4); but does not include devices or their components,
5parts, or accessories.
6    (c) "Medicines" means and includes all drugs intended for
7human or veterinary use approved by the United States Food and
8Drug Administration.
9    (c-1) "Medicines for COVID-19" means all drugs intended
10for human or veterinary use approved by the United States Food
11and Drug Administration, or that have received Emergency Use
12Authorization in connection with COVID-19, or that have
13otherwise satisfied the product identifier requirements of the
14United States Drug Supply Chain Security Act for the
15Interoperable Exchange of Information for Tracing of Human
16Finished Prescription Drugs, or any other drug approved for
17human use by the regulatory authorities of another nation that
18the United States Food and Drug Administration agrees may be
19imported to address product shortages through such agency's
20discretionary 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
12practice of pharmacy in this State must be actively licensed
13as a pharmacist under this Act.
14    (e) "Prescription" means and includes any written, oral,
15facsimile, or electronically transmitted order for drugs or
16medical devices, issued by a physician licensed to practice
17medicine in all its branches, dentist, veterinarian, podiatric
18physician, or optometrist, within the limits of his or her
19license, by a physician assistant in accordance with
20subsection (f) of Section 4, or by an advanced practice
21registered nurse in accordance with subsection (g) of Section
224, containing the following: (1) name of the patient; (2) date
23when prescription was issued; (3) name and strength of drug or
24description of the medical device prescribed; and (4)
25quantity; (5) directions for use; (6) prescriber's name,
26address, and signature; and (7) DEA registration number where

 

 

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1required, for controlled substances. The prescription may, but
2is not required to, list the illness, disease, or condition
3for which the drug or device is being prescribed. DEA
4registration numbers shall not be required on inpatient drug
5orders. A prescription for medication other than controlled
6substances shall be valid for up to 15 months from the date
7issued for the purpose of refills, unless the prescription
8states otherwise.
9    (f) "Person" means and includes a natural person,
10partnership, association, corporation, government entity, or
11any other legal entity.
12    (g) "Department" means the Department of Financial and
13Professional Regulation.
14    (h) "Board of Pharmacy" or "Board" means the State Board
15of Pharmacy of the Department of Financial and Professional
16Regulation.
17    (i) "Secretary" means the Secretary of Financial and
18Professional Regulation.
19    (j) "Drug product selection" means the interchange for a
20prescribed pharmaceutical product in accordance with Section
2125 of this Act and Section 3.14 of the Illinois Food, Drug and
22Cosmetic Act.
23    (k) "Inpatient drug order" means an order issued by an
24authorized prescriber for a resident or patient of a facility
25licensed under the Nursing Home Care Act, the ID/DD Community
26Care Act, the MC/DD Act, the Specialized Mental Health

 

 

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1Rehabilitation Act of 2013, the Hospital Licensing Act, or the
2University of Illinois Hospital Act, or a facility which is
3operated by the Department of Human Services (as successor to
4the Department of Mental Health and Developmental
5Disabilities) or the Department of Corrections.
6    (k-5) "Pharmacist" means an individual health care
7professional and provider currently licensed by this State to
8engage in the practice of pharmacy.
9    (l) "Pharmacist in charge" means the licensed pharmacist
10whose name appears on a pharmacy license and who is
11responsible for all aspects of the operation related to the
12practice of pharmacy.
13    (m) "Dispense" or "dispensing" means the interpretation,
14evaluation, and implementation of a prescription drug order,
15including the preparation and delivery of a drug or device to a
16patient or patient's agent in a suitable container
17appropriately labeled for subsequent administration to or use
18by a patient in accordance with applicable State and federal
19laws and regulations. "Dispense" or "dispensing" does not mean
20the physical delivery to a patient or a patient's
21representative in a home or institution by a designee of a
22pharmacist or by common carrier. "Dispense" or "dispensing"
23also does not mean the physical delivery of a drug or medical
24device to a patient or patient's representative by a
25pharmacist's designee within a pharmacy or drugstore while the
26pharmacist is on duty and the pharmacy is open.

 

 

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1    (n) "Nonresident pharmacy" means a pharmacy that is
2located in a state, commonwealth, or territory of the United
3States, other than Illinois, that delivers, dispenses, or
4distributes, through the United States Postal Service,
5commercially acceptable parcel delivery service, or other
6common carrier, to Illinois residents, any substance which
7requires a prescription.
8    (o) "Compounding" means the preparation and mixing of
9components, excluding flavorings, (1) as the result of a
10prescriber's prescription drug order or initiative based on
11the prescriber-patient-pharmacist relationship in the course
12of professional practice or (2) for the purpose of, or
13incident to, research, teaching, or chemical analysis and not
14for sale or dispensing. "Compounding" includes the preparation
15of drugs or devices in anticipation of receiving prescription
16drug orders based on routine, regularly observed dispensing
17patterns. Commercially available products may be compounded
18for dispensing to individual patients only if all of the
19following conditions are met: (i) the commercial product is
20not reasonably available from normal distribution channels in
21a timely manner to meet the patient's needs and (ii) the
22prescribing practitioner has requested that the drug be
23compounded.
24    (p) (Blank).
25    (q) (Blank).
26    (r) "Patient counseling" means the communication between a

 

 

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1pharmacist or a student pharmacist under the supervision of a
2pharmacist and a patient or the patient's representative about
3the patient's medication or device for the purpose of
4optimizing proper use of prescription medications or devices.
5"Patient counseling" may include without limitation (1)
6obtaining a medication history; (2) acquiring a patient's
7allergies and health conditions; (3) facilitation of the
8patient's understanding of the intended use of the medication;
9(4) proper directions for use; (5) significant potential
10adverse events; (6) potential food-drug interactions; and (7)
11the need to be compliant with the medication therapy. A
12pharmacy technician may only participate in the following
13aspects of patient counseling under the supervision of a
14pharmacist: (1) obtaining medication history; (2) providing
15the offer for counseling by a pharmacist or student
16pharmacist; and (3) acquiring a patient's allergies and health
17conditions.
18    (s) "Patient profiles" or "patient drug therapy record"
19means the obtaining, recording, and maintenance of patient
20prescription information, including prescriptions for
21controlled substances, and personal information.
22    (t) (Blank).
23    (u) "Medical device" or "device" means an instrument,
24apparatus, implement, machine, contrivance, implant, in vitro
25reagent, or other similar or related article, including any
26component part or accessory, required under federal law to

 

 

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1bear the label "Caution: Federal law requires dispensing by or
2on the order of a physician". A seller of goods and services
3who, only for the purpose of retail sales, compounds, sells,
4rents, or leases medical devices shall not, by reasons
5thereof, be required to be a licensed pharmacy.
6    (v) "Unique identifier" means an electronic signature,
7handwritten signature or initials, thumb print, or other
8acceptable biometric or electronic identification process as
9approved by the Department.
10    (w) "Current usual and customary retail price" means the
11price that a pharmacy charges to a non-third-party payor.
12    (x) "Automated pharmacy system" means a mechanical system
13located within the confines of the pharmacy or remote location
14that performs operations or activities, other than compounding
15or administration, relative to storage, packaging, dispensing,
16or distribution of medication, and which collects, controls,
17and maintains all transaction information.
18    (y) "Drug regimen review" means and includes the
19evaluation of prescription drug orders and patient records for
20(1) known allergies; (2) drug or potential therapy
21contraindications; (3) reasonable dose, duration of use, and
22route of administration, taking into consideration factors
23such as age, gender, and contraindications; (4) reasonable
24directions for use; (5) potential or actual adverse drug
25reactions; (6) drug-drug interactions; (7) drug-food
26interactions; (8) drug-disease contraindications; (9)

 

 

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1therapeutic duplication; (10) patient laboratory values when
2authorized and available; (11) proper utilization (including
3over or under utilization) and optimum therapeutic outcomes;
4and (12) abuse and misuse.
5    (z) "Electronically transmitted prescription" means a
6prescription that is created, recorded, or stored by
7electronic means; issued and validated with an electronic
8signature; and transmitted by electronic means directly from
9the prescriber to a pharmacy. An electronic prescription is
10not an image of a physical prescription that is transferred by
11electronic means from computer to computer, facsimile to
12facsimile, or facsimile to computer.
13    (aa) "Medication therapy management services" means a
14distinct service or group of services offered by licensed
15pharmacists, physicians licensed to practice medicine in all
16its branches, advanced practice registered nurses authorized
17in a written agreement with a physician licensed to practice
18medicine in all its branches, or physician assistants
19authorized in guidelines by a supervising physician that
20optimize therapeutic outcomes for individual patients through
21improved medication use. In a retail or other non-hospital
22pharmacy, medication therapy management services shall consist
23of the evaluation of prescription drug orders and patient
24medication 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
16following:
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
2patient care functions authorized by a physician licensed to
3practice medicine in all its branches for his or her
4identified patient or groups of patients under specified
5conditions or limitations in a standing order from the
6physician.
7    "Medication therapy management services" in a licensed
8hospital 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.
14    (bb) "Pharmacist care" means the provision by a pharmacist
15of medication therapy management services, with or without the
16dispensing of drugs or devices, intended to achieve outcomes
17that improve patient health, quality of life, and comfort and
18enhance patient safety.
19    (cc) "Protected health information" means individually
20identifiable health information that, except as otherwise
21provided, is:
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

 

 

HB5426- 20 -LRB102 25428 BMS 34713 b

1    medium.
2    "Protected health information" does not include
3individually 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
9or group of patients issued by a physician licensed to
10practice medicine in all its branches in Illinois.
11    (ee) "Address of record" means the designated address
12recorded by the Department in the applicant's application file
13or licensee's license file maintained by the Department's
14licensure maintenance unit.
15    (ff) "Home pharmacy" means the location of a pharmacy's
16primary operations.
17    (gg) "Email address of record" means the designated email
18address recorded by the Department in the applicant's
19application file or the licensee's license file, as maintained
20by the Department's licensure maintenance unit.
21(Source: P.A. 101-349, eff. 1-1-20; 102-16, eff. 6-17-21;
22102-103, eff. 1-1-22; 102-558, eff. 8-20-21; revised
2310-26-21.)
 
24    (225 ILCS 85/45 new)
25    Sec. 45. Dispensation of COVID-19 drugs or COVID-19

 

 

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1medicines.
2    (a) The dispensing of COVID-19 drugs or COVID-19 medicines
3to a patient shall be pursuant to a valid prescription or
4standing order by a physician licensed to practice medicine in
5the State of Illinois, a physician licensed to practice
6medicine in all its branches in Illinois, or the medical
7director of a local health department, pursuant to the
8following:
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
16this Section, so long as such rules do not interfere with or
17unduly burden patients seeking to secure medication to treat
18or prevent a COVID-19 infection, unless the dispensation of
19prescription drugs under this Section is the cause of a drug
20shortage in hospitals, urgent care facilities, or involving
21physicians that necessitates prioritizing patient access, and
22no less restrictive alternative is available. The Department
23may adopt rules to permit direct sales from manufacturers or
24drug compounders if drug or medication shortages exist. The
25Department's rulemaking authority under this Section shall
26expire one year after the effective date of this amendatory

 

 

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1Act of the 102nd General Assembly.
2    (c) Nothing in this Section shall be construed to obligate
3or otherwise require a pharmacist to dispense COVID-19 drugs
4or COVID-19 medicines to any particular patient under any
5standing order or prescription under this Section, or
6otherwise preempt the pharmacist from exercising his or her
7professional judgment.
 
8    Section 20. The Illinois Public Aid Code is amended by
9adding 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
12COVID-19 drugs and COVID-19 medications provided by a
13pharmacist.
14    (a) Subject to approval by the federal Centers for
15Medicare and Medicaid Services, the medical assistance
16program, including both the fee-for-service program and
17managed care medical assistance program established under this
18Article, shall cover patient care services provided by a
19pharmacist for COVID-19 drugs and COVID-19 medications.
20    (b) The Department shall establish a fee schedule for
21patient care services provided by a pharmacist for COVID-19
22drugs and COVID-19 medications assessment and consultation.
23    (c) The rate of reimbursement for patient care services
24provided by a pharmacist for COVID-19 drugs and COVID-19

 

 

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1medications assessment and consultation shall be at 85% of the
2fee schedule for physician services by the medical assistance
3program.
4    (d) A pharmacist must be enrolled in the medical
5assistance program as an ordering and referring provider
6before providing COVID-19 drugs and COVID-19 medications
7assessment and consultation that is submitted by a pharmacy or
8pharmacist provider for reimbursement pursuant to this
9Section.
10    (e) The Department shall apply for any necessary federal
11waivers or approvals to implement this Section within 30 days
12after this Section becomes law. The Governor shall inform the
13General Assembly of any federal funds that have been
14distributed to the State of Illinois by the federal government
15pursuant to any legislation pertaining to COVID-19 that may be
16used to fund these treatments until waiver or Centers for
17Medicare and Medicaid Services approval for payment is
18secured.
19    (f) This Section does not restrict or prohibit any
20services currently provided by pharmacists as authorized by
21law, including, but not limited to, pharmacist services
22provided under this Code or authorized under the Illinois
23Title XIX State Plan, or services that a patient can self-pay
24for the COVID-19 drugs, COVID-19 medicine, or related
25treatment.
26    (g) The Department shall submit to the Joint Committee on

 

 

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1Administrative Rules administrative rules for this Section as
2soon as practicable but no later than 3 months after federal
3approval is received.
 
4    Section 25. No portion of this Act may be suspended by the
5emergency powers of the Governor pursuant to Section 7 of the
6Illinois Emergency Management Agency Act.
 
7    Section 99. Effective date. This Act takes effect upon
8becoming law.