103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB4822

 

Introduced 2/6/2024, by Rep. Natalie A. Manley

 

SYNOPSIS AS INTRODUCED:
 
215 ILCS 5/356z.63
225 ILCS 85/3

    Amends the Pharmacy Practice Act and the Illinois Insurance Code. In the definition of "practice of pharmacy", includes the ordering of testing, screening, and treatment (rather than the ordering and administration of tests and screenings) for influenza. Makes conforming changes. Effective January 1, 2025.


LRB103 37464 RTM 67587 b

 

 

A BILL FOR

 

HB4822LRB103 37464 RTM 67587 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 5. The Illinois Insurance Code is amended by
5changing Section 356z.63 as follows:
 
6    (215 ILCS 5/356z.63)
7    Sec. 356z.63 356z.61. Coverage of pharmacy testing,
8screening, vaccinations, and treatment. A group or individual
9policy of accident and health insurance or a managed care plan
10that is amended, delivered, issued, or renewed on or after
11January 1, 2025 shall provide coverage for health care or
12patient care services provided by a pharmacist if:
13        (1) the pharmacist meets the requirements and scope of
14    practice described in paragraph (15), (16), or (17), or
15    (18) of subsection (d) of Section 3 of the Pharmacy
16    Practice Act;
17        (2) the health plan provides coverage for the same
18    service provided by a licensed physician, an advanced
19    practice registered nurse, or a physician assistant;
20        (3) the pharmacist is included in the health benefit
21    plan's network of participating providers; and
22        (4) reimbursement has been successfully negotiated in
23    good faith between the pharmacist and the health plan.

 

 

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1(Source: P.A. 103-1, eff. 4-27-23; revised 8-29-23.)
 
2    Section 10. The Pharmacy Practice Act is amended by
3changing Section 3 as follows:
 
4    (225 ILCS 85/3)
5    (Section scheduled to be repealed on January 1, 2028)
6    Sec. 3. Definitions. For the purpose of this Act, except
7where otherwise limited therein:
8    (a) "Pharmacy" or "drugstore" means and includes every
9store, shop, pharmacy department, or other place where
10pharmacist care is provided by a pharmacist (1) where drugs,
11medicines, or poisons are dispensed, sold or offered for sale
12at retail, or displayed for sale at retail; or (2) where
13prescriptions of physicians, dentists, advanced practice
14registered nurses, physician assistants, veterinarians,
15podiatric physicians, or optometrists, within the limits of
16their licenses, are compounded, filled, or dispensed; or (3)
17which has upon it or displayed within it, or affixed to or used
18in connection with it, a sign bearing the word or words
19"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
20"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
21"Drugs", "Dispensary", "Medicines", or any word or words of
22similar or like import, either in the English language or any
23other language; or (4) where the characteristic prescription
24sign (Rx) or similar design is exhibited; or (5) any store, or

 

 

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1shop, or other place with respect to which any of the above
2words, objects, signs or designs are used in any
3advertisement.
4    (b) "Drugs" means and includes (1) articles recognized in
5the official United States Pharmacopoeia/National Formulary
6(USP/NF), or any supplement thereto and being intended for and
7having for their main use the diagnosis, cure, mitigation,
8treatment or prevention of disease in man or other animals, as
9approved by the United States Food and Drug Administration,
10but does not include devices or their components, parts, or
11accessories; and (2) all other articles 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 (3) articles (other than food) having for
17their main use and intended to affect the structure or any
18function of the body of man or other animals; and (4) articles
19having for their main use and intended for use as a component
20or any articles specified in clause (1), (2) or (3); but does
21not include devices or their components, parts or accessories.
22    (c) "Medicines" means and includes all drugs intended for
23human or veterinary use approved by the United States Food and
24Drug Administration.
25    (d) "Practice of pharmacy" means:
26        (1) the interpretation and the provision of assistance

 

 

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1    in the monitoring, evaluation, and implementation of
2    prescription drug orders;
3        (2) the dispensing of prescription drug orders;
4        (3) participation in drug and device selection;
5        (4) drug administration limited to the administration
6    of oral, topical, injectable, and inhalation as follows:
7            (A) in the context of patient education on the
8        proper use or delivery of medications;
9            (B) vaccination of patients 7 years of age and
10        older pursuant to a valid prescription or standing
11        order, by a physician licensed to practice medicine in
12        all its branches, except for vaccinations covered by
13        paragraph (15), upon completion of appropriate
14        training, including how to address contraindications
15        and adverse reactions set forth by rule, with
16        notification to the patient's physician and
17        appropriate record retention, or pursuant to hospital
18        pharmacy and therapeutics committee policies and
19        procedures. Eligible vaccines are those listed on the
20        U.S. Centers for Disease Control and Prevention (CDC)
21        Recommended Immunization Schedule, the CDC's Health
22        Information for International Travel, or the U.S. Food
23        and Drug Administration's Vaccines Licensed and
24        Authorized for Use in the United States. As applicable
25        to the State's Medicaid program and other payers,
26        vaccines ordered and administered in accordance with

 

 

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1        this subsection shall be covered and reimbursed at no
2        less than the rate that the vaccine is reimbursed when
3        ordered and administered by a physician;
4            (B-5) following the initial administration of
5        long-acting or extended-release form opioid
6        antagonists by a physician licensed to practice
7        medicine in all its branches, administration of
8        injections of long-acting or extended-release form
9        opioid antagonists for the treatment of substance use
10        disorder, pursuant to a valid prescription by a
11        physician licensed to practice medicine in all its
12        branches, upon completion of appropriate training,
13        including how to address contraindications and adverse
14        reactions, including, but not limited to, respiratory
15        depression and the performance of cardiopulmonary
16        resuscitation, set forth by rule, with notification to
17        the patient's physician and appropriate record
18        retention, or pursuant to hospital pharmacy and
19        therapeutics committee policies and procedures;
20            (C) administration of injections of
21        alpha-hydroxyprogesterone caproate, pursuant to a
22        valid prescription, by a physician licensed to
23        practice medicine in all its branches, upon completion
24        of appropriate training, including how to address
25        contraindications and adverse reactions set forth by
26        rule, with notification to the patient's physician and

 

 

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1        appropriate record retention, or pursuant to hospital
2        pharmacy and therapeutics committee policies and
3        procedures; and
4            (D) administration of injections of long-term
5        antipsychotic medications pursuant to a valid
6        prescription by a physician licensed to practice
7        medicine in all its branches, upon completion of
8        appropriate training conducted by an Accreditation
9        Council of Pharmaceutical Education accredited
10        provider, including how to address contraindications
11        and adverse reactions set forth by rule, with
12        notification to the patient's physician and
13        appropriate record retention, or pursuant to hospital
14        pharmacy and therapeutics committee policies and
15        procedures.
16        (5) (blank);
17        (6) drug regimen review;
18        (7) drug or drug-related research;
19        (8) the provision of patient counseling;
20        (9) the practice of telepharmacy;
21        (10) the provision of those acts or services necessary
22    to provide pharmacist care;
23        (11) medication therapy management;
24        (12) the responsibility for compounding and labeling
25    of drugs and devices (except labeling by a manufacturer,
26    repackager, or distributor of non-prescription drugs and

 

 

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1    commercially packaged legend drugs and devices), proper
2    and safe storage of drugs and devices, and maintenance of
3    required records;
4        (13) the assessment and consultation of patients and
5    dispensing of hormonal contraceptives;
6        (14) the initiation, dispensing, or administration of
7    drugs, laboratory tests, assessments, referrals, and
8    consultations for human immunodeficiency virus
9    pre-exposure prophylaxis and human immunodeficiency virus
10    post-exposure prophylaxis under Section 43.5;
11        (15) vaccination of patients 7 years of age and older
12    for COVID-19 or influenza subcutaneously, intramuscularly,
13    or orally as authorized, approved, or licensed by the
14    United States Food and Drug Administration, pursuant to
15    the following conditions:
16            (A) the vaccine must be authorized or licensed by
17        the United States Food and Drug Administration;
18            (B) the vaccine must be ordered and administered
19        according to the Advisory Committee on Immunization
20        Practices standard immunization schedule;
21            (C) the pharmacist must complete a course of
22        training accredited by the Accreditation Council on
23        Pharmacy Education or a similar health authority or
24        professional body approved by the Division of
25        Professional Regulation;
26            (D) the pharmacist must have a current certificate

 

 

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1        in basic cardiopulmonary resuscitation;
2            (E) the pharmacist must complete, during each
3        State licensing period, a minimum of 2 hours of
4        immunization-related continuing pharmacy education
5        approved by the Accreditation Council on Pharmacy
6        Education;
7            (F) the pharmacist must comply with recordkeeping
8        and reporting requirements of the jurisdiction in
9        which the pharmacist administers vaccines, including
10        informing the patient's primary-care provider, when
11        available, and complying with requirements whereby the
12        person administering a vaccine must review the vaccine
13        registry or other vaccination records prior to
14        administering the vaccine; and
15            (G) the pharmacist must inform the pharmacist's
16        patients who are less than 18 years old, as well as the
17        adult caregiver accompanying the child, of the
18        importance of a well-child visit with a pediatrician
19        or other licensed primary-care provider and must refer
20        patients as appropriate;
21        (16) the ordering and administration of COVID-19
22    therapeutics subcutaneously, intramuscularly, or orally
23    with notification to the patient's physician and
24    appropriate record retention or pursuant to hospital
25    pharmacy and therapeutics committee policies and
26    procedures. Eligible therapeutics are those approved,

 

 

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1    authorized, or licensed by the United States Food and Drug
2    Administration and must be administered subcutaneously,
3    intramuscularly, or orally in accordance with that
4    approval, authorization, or licensing; and
5        (17) the ordering and administration of tests and
6    screenings for SARS-CoV-2
(i) influenza, (ii) SARS-COV 2,
7    and (iii) health conditions identified by a statewide
8    public health emergency, as defined in the Illinois
9    Emergency Management Agency Act, with notification to the
10    patient's physician and appropriate record retention or
11    pursuant to hospital pharmacy and therapeutics committee
12    policies and procedures. Eligible tests and screenings are
13    those approved, authorized, or licensed by the United
14    States Food and Drug Administration and must be
15    administered in accordance with that approval,
16    authorization, or licensing; and .
17        (18) the ordering of testing, screening, and treatment
18    for influenza.
19    A pharmacist who orders testing, screening, or treatments
20or administers tests or screenings for health conditions
21described in paragraphs (17) and (18) this paragraph may use a
22test that may guide clinical decision-making for the health
23condition that is waived under the federal Clinical Laboratory
24Improvement Amendments of 1988 and regulations promulgated
25thereunder or any established screening procedure that is
26established under a statewide protocol.

 

 

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1    A pharmacist may delegate the administrative and technical
2tasks of performing a test for the health conditions described
3in paragraphs (17) and (18) this paragraph to a registered
4pharmacy technician or student pharmacist acting under the
5supervision of the pharmacist.
6    A pharmacist who performs any of the acts defined as the
7practice of pharmacy in this State must be actively licensed
8as a pharmacist under this Act.
9    (e) "Prescription" means and includes any written, oral,
10facsimile, or electronically transmitted order for drugs or
11medical devices, issued by a physician licensed to practice
12medicine in all its branches, dentist, veterinarian, podiatric
13physician, or optometrist, within the limits of his or her
14license, by a physician assistant in accordance with
15subsection (f) of Section 4, or by an advanced practice
16registered nurse in accordance with subsection (g) of Section
174, containing the following: (1) name of the patient; (2) date
18when prescription was issued; (3) name and strength of drug or
19description of the medical device prescribed; and (4)
20quantity; (5) directions for use; (6) prescriber's name,
21address, and signature; and (7) DEA registration number where
22required, for controlled substances. The prescription may, but
23is not required to, list the illness, disease, or condition
24for which the drug or device is being prescribed. DEA
25registration numbers shall not be required on inpatient drug
26orders. A prescription for medication other than controlled

 

 

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1substances shall be valid for up to 15 months from the date
2issued for the purpose of refills, unless the prescription
3states otherwise.
4    (f) "Person" means and includes a natural person,
5partnership, association, corporation, government entity, or
6any other legal entity.
7    (g) "Department" means the Department of Financial and
8Professional Regulation.
9    (h) "Board of Pharmacy" or "Board" means the State Board
10of Pharmacy of the Department of Financial and Professional
11Regulation.
12    (i) "Secretary" means the Secretary of Financial and
13Professional Regulation.
14    (j) "Drug product selection" means the interchange for a
15prescribed pharmaceutical product in accordance with Section
1625 of this Act and Section 3.14 of the Illinois Food, Drug and
17Cosmetic Act.
18    (k) "Inpatient drug order" means an order issued by an
19authorized prescriber for a resident or patient of a facility
20licensed under the Nursing Home Care Act, the ID/DD Community
21Care Act, the MC/DD Act, the Specialized Mental Health
22Rehabilitation Act of 2013, the Hospital Licensing Act, or the
23University of Illinois Hospital Act, or a facility which is
24operated by the Department of Human Services (as successor to
25the Department of Mental Health and Developmental
26Disabilities) or the Department of Corrections.

 

 

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1    (k-5) "Pharmacist" means an individual health care
2professional and provider currently licensed by this State to
3engage in the practice of pharmacy.
4    (l) "Pharmacist in charge" means the licensed pharmacist
5whose name appears on a pharmacy license and who is
6responsible for all aspects of the operation related to the
7practice of pharmacy.
8    (m) "Dispense" or "dispensing" means the interpretation,
9evaluation, and implementation of a prescription drug order,
10including the preparation and delivery of a drug or device to a
11patient or patient's agent in a suitable container
12appropriately labeled for subsequent administration to or use
13by a patient in accordance with applicable State and federal
14laws and regulations. "Dispense" or "dispensing" does not mean
15the physical delivery to a patient or a patient's
16representative in a home or institution by a designee of a
17pharmacist or by common carrier. "Dispense" or "dispensing"
18also does not mean the physical delivery of a drug or medical
19device to a patient or patient's representative by a
20pharmacist's designee within a pharmacy or drugstore while the
21pharmacist is on duty and the pharmacy is open.
22    (n) "Nonresident pharmacy" means a pharmacy that is
23located in a state, commonwealth, or territory of the United
24States, other than Illinois, that delivers, dispenses, or
25distributes, through the United States Postal Service,
26commercially acceptable parcel delivery service, or other

 

 

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1common carrier, to Illinois residents, any substance which
2requires a prescription.
3    (o) "Compounding" means the preparation and mixing of
4components, excluding flavorings, (1) as the result of a
5prescriber's prescription drug order or initiative based on
6the prescriber-patient-pharmacist relationship in the course
7of professional practice or (2) for the purpose of, or
8incident to, research, teaching, or chemical analysis and not
9for sale or dispensing. "Compounding" includes the preparation
10of drugs or devices in anticipation of receiving prescription
11drug orders based on routine, regularly observed dispensing
12patterns. Commercially available products may be compounded
13for dispensing to individual patients only if all of the
14following conditions are met: (i) the commercial product is
15not reasonably available from normal distribution channels in
16a timely manner to meet the patient's needs and (ii) the
17prescribing practitioner has requested that the drug be
18compounded.
19    (p) (Blank).
20    (q) (Blank).
21    (r) "Patient counseling" means the communication between a
22pharmacist or a student pharmacist under the supervision of a
23pharmacist and a patient or the patient's representative about
24the patient's medication or device for the purpose of
25optimizing proper use of prescription medications or devices.
26"Patient counseling" may include without limitation (1)

 

 

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1obtaining a medication history; (2) acquiring a patient's
2allergies and health conditions; (3) facilitation of the
3patient's understanding of the intended use of the medication;
4(4) proper directions for use; (5) significant potential
5adverse events; (6) potential food-drug interactions; and (7)
6the need to be compliant with the medication therapy. A
7pharmacy technician may only participate in the following
8aspects of patient counseling under the supervision of a
9pharmacist: (1) obtaining medication history; (2) providing
10the offer for counseling by a pharmacist or student
11pharmacist; and (3) acquiring a patient's allergies and health
12conditions.
13    (s) "Patient profiles" or "patient drug therapy record"
14means the obtaining, recording, and maintenance of patient
15prescription information, including prescriptions for
16controlled substances, and personal information.
17    (t) (Blank).
18    (u) "Medical device" or "device" means an instrument,
19apparatus, implement, machine, contrivance, implant, in vitro
20reagent, or other similar or related article, including any
21component part or accessory, required under federal law to
22bear the label "Caution: Federal law requires dispensing by or
23on the order of a physician". A seller of goods and services
24who, only for the purpose of retail sales, compounds, sells,
25rents, or leases medical devices shall not, by reasons
26thereof, be required to be a licensed pharmacy.

 

 

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1    (v) "Unique identifier" means an electronic signature,
2handwritten signature or initials, thumb print, or other
3acceptable biometric or electronic identification process as
4approved by the Department.
5    (w) "Current usual and customary retail price" means the
6price that a pharmacy charges to a non-third-party payor.
7    (x) "Automated pharmacy system" means a mechanical system
8located within the confines of the pharmacy or remote location
9that performs operations or activities, other than compounding
10or administration, relative to storage, packaging, dispensing,
11or distribution of medication, and which collects, controls,
12and maintains all transaction information.
13    (y) "Drug regimen review" means and includes the
14evaluation of prescription drug orders and patient records for
15(1) known allergies; (2) drug or potential therapy
16contraindications; (3) reasonable dose, duration of use, and
17route of administration, taking into consideration factors
18such as age, gender, and contraindications; (4) reasonable
19directions for use; (5) potential or actual adverse drug
20reactions; (6) drug-drug interactions; (7) drug-food
21interactions; (8) drug-disease contraindications; (9)
22therapeutic duplication; (10) patient laboratory values when
23authorized and available; (11) proper utilization (including
24over or under utilization) and optimum therapeutic outcomes;
25and (12) abuse and misuse.
26    (z) "Electronically transmitted prescription" means a

 

 

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1prescription that is created, recorded, or stored by
2electronic means; issued and validated with an electronic
3signature; and transmitted by electronic means directly from
4the prescriber to a pharmacy. An electronic prescription is
5not an image of a physical prescription that is transferred by
6electronic means from computer to computer, facsimile to
7facsimile, or facsimile to computer.
8    (aa) "Medication therapy management services" means a
9distinct service or group of services offered by licensed
10pharmacists, physicians licensed to practice medicine in all
11its branches, advanced practice registered nurses authorized
12in a written agreement with a physician licensed to practice
13medicine in all its branches, or physician assistants
14authorized in guidelines by a supervising physician that
15optimize therapeutic outcomes for individual patients through
16improved medication use. In a retail or other non-hospital
17pharmacy, medication therapy management services shall consist
18of the evaluation of prescription drug orders and patient
19medication records to resolve conflicts with the following:
20        (1) known allergies;
21        (2) drug or potential therapy contraindications;
22        (3) reasonable dose, duration of use, and route of
23    administration, taking into consideration factors such as
24    age, gender, and contraindications;
25        (4) reasonable directions for use;
26        (5) potential or actual adverse drug reactions;

 

 

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1        (6) drug-drug interactions;
2        (7) drug-food interactions;
3        (8) drug-disease contraindications;
4        (9) identification of therapeutic duplication;
5        (10) patient laboratory values when authorized and
6    available;
7        (11) proper utilization (including over or under
8    utilization) and optimum therapeutic outcomes; and
9        (12) drug abuse and misuse.
10    "Medication therapy management services" includes the
11following:
12        (1) documenting the services delivered and
13    communicating the information provided to patients'
14    prescribers within an appropriate time frame, not to
15    exceed 48 hours;
16        (2) providing patient counseling designed to enhance a
17    patient's understanding and the appropriate use of his or
18    her medications; and
19        (3) providing information, support services, and
20    resources designed to enhance a patient's adherence with
21    his or her prescribed therapeutic regimens.
22    "Medication therapy management services" may also include
23patient care functions authorized by a physician licensed to
24practice medicine in all its branches for his or her
25identified patient or groups of patients under specified
26conditions or limitations in a standing order from the

 

 

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1physician.
2    "Medication therapy management services" in a licensed
3hospital may also include the following:
4        (1) reviewing assessments of the patient's health
5    status; and
6        (2) following protocols of a hospital pharmacy and
7    therapeutics committee with respect to the fulfillment of
8    medication orders.
9    (bb) "Pharmacist care" means the provision by a pharmacist
10of medication therapy management services, with or without the
11dispensing of drugs or devices, intended to achieve outcomes
12that improve patient health, quality of life, and comfort and
13enhance patient safety.
14    (cc) "Protected health information" means individually
15identifiable health information that, except as otherwise
16provided, is:
17        (1) transmitted by electronic media;
18        (2) maintained in any medium set forth in the
19    definition of "electronic media" in the federal Health
20    Insurance Portability and Accountability Act; or
21        (3) transmitted or maintained in any other form or
22    medium.
23    "Protected health information" does not include
24individually identifiable health information found in:
25        (1) education records covered by the federal Family
26    Educational Right and Privacy Act; or

 

 

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1        (2) employment records held by a licensee in its role
2    as an employer.
3    (dd) "Standing order" means a specific order for a patient
4or group of patients issued by a physician licensed to
5practice medicine in all its branches in Illinois.
6    (ee) "Address of record" means the designated address
7recorded by the Department in the applicant's application file
8or licensee's license file maintained by the Department's
9licensure maintenance unit.
10    (ff) "Home pharmacy" means the location of a pharmacy's
11primary operations.
12    (gg) "Email address of record" means the designated email
13address recorded by the Department in the applicant's
14application file or the licensee's license file, as maintained
15by the Department's licensure maintenance unit.
16(Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
17102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
181-1-23; 103-1, eff. 4-27-23.)
 
19    Section 99. Effective date. This Act takes effect January
201, 2025.