102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
HB4430

 

Introduced 1/21/2022, by Rep. Kelly M. Cassidy - Margaret Croke - Greg Harris, Ann M. Williams, Anne Stava-Murray, et al.

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3
225 ILCS 85/43
305 ILCS 5/5-5.12d

    Amends the Pharmacy Practice Act. Provides that the definition of "practice of pharmacy" includes the initiation, dispensing, or administration of drugs, laboratory tests, assessments, referrals, and consultations for human immunodeficiency virus pre-exposure prophylaxis and human immunodeficiency virus post-exposure prophylaxis. Provides that as applicable to the State's Medicaid program and other payers, patient care services ordered and administered by a pharmacist shall be covered and reimbursed at no less than 85% of the rate that the services are covered and reimbursed when ordered or administered by physicians. Provides that a pharmacist shall provide patient care services for human immunodeficiency virus pre-exposure prophylaxis and human immunodeficiency virus post-exposure prophylaxis to a patient after satisfying specified requirements. Amends the Illinois Public Aid Code. Provides that specified provisions concerning coverage of patient care services provided by a pharmacist shall apply to all patient care services provided by a pharmacist (rather than patient care services for hormonal contraceptives assessment and consultation only). Effective immediately.


LRB102 22176 SPS 31305 b

 

 

A BILL FOR

 

HB4430LRB102 22176 SPS 31305 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 Pharmacy Practice Act is amended by
5changing Sections 3 and 43 as follows:
 
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2023)
8    Sec. 3. Definitions. For the purpose of this Act, except
9where otherwise limited therein:
10    (a) "Pharmacy" or "drugstore" means and includes every
11store, shop, pharmacy department, or other place where
12pharmacist care is provided by a pharmacist (1) where drugs,
13medicines, or poisons are dispensed, sold or offered for sale
14at retail, or displayed for sale at retail; or (2) where
15prescriptions of physicians, dentists, advanced practice
16registered nurses, physician assistants, veterinarians,
17podiatric physicians, or optometrists, within the limits of
18their licenses, are compounded, filled, or dispensed; or (3)
19which has upon it or displayed within it, or affixed to or used
20in connection with it, a sign bearing the word or words
21"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
22"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
23"Drugs", "Dispensary", "Medicines", or any word or words of

 

 

HB4430- 2 -LRB102 22176 SPS 31305 b

1similar or like import, either in the English language or any
2other language; or (4) where the characteristic prescription
3sign (Rx) or similar design is exhibited; or (5) any store, or
4shop, or other place with respect to which any of the above
5words, objects, signs or designs are used in any
6advertisement.
7    (b) "Drugs" means and includes (1) articles recognized in
8the official United States Pharmacopoeia/National Formulary
9(USP/NF), or any supplement thereto and being intended for and
10having for their main use the diagnosis, cure, mitigation,
11treatment or prevention of disease in man or other animals, as
12approved by the United States Food and Drug Administration,
13but does not include devices or their components, parts, or
14accessories; and (2) all other articles intended for and
15having for their main use the diagnosis, cure, mitigation,
16treatment or prevention of disease in man or other animals, as
17approved by the United States Food and Drug Administration,
18but does not include devices or their components, parts, or
19accessories; and (3) articles (other than food) having for
20their main use and intended to affect the structure or any
21function of the body of man or other animals; and (4) articles
22having for their main use and intended for use as a component
23or any articles specified in clause (1), (2) or (3); but does
24not include devices or their components, parts or accessories.
25    (c) "Medicines" means and includes all drugs intended for
26human or veterinary use approved by the United States Food and

 

 

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

 

 

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

 

 

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

 

 

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1    of drugs and devices (except labeling by a manufacturer,
2    repackager, or distributor of non-prescription drugs and
3    commercially packaged legend drugs and devices), proper
4    and safe storage of drugs and devices, and maintenance of
5    required records; and
6        (13) the assessment and consultation of patients and
7    dispensing of hormonal contraceptives; and .
8        (14) the initiation, dispensing, or administration of
9    drugs, laboratory tests, assessments, referrals, and
10    consultations for human immunodeficiency virus
11    pre-exposure prophylaxis and human immunodeficiency virus
12    post-exposure prophylaxis.
13    As applicable to the State's Medicaid program and other
14payers, patient care services ordered and administered in
15accordance with this subsection shall be covered and
16reimbursed at no less than 85% of the rate that the services
17are covered and reimbursed when ordered or administered by
18physicians.
19    A pharmacist who performs any of the acts defined as the
20practice of pharmacy in this State must be actively licensed
21as a pharmacist under this Act.
22    (e) "Prescription" means and includes any written, oral,
23facsimile, or electronically transmitted order for drugs or
24medical devices, issued by a physician licensed to practice
25medicine in all its branches, dentist, veterinarian, podiatric
26physician, or optometrist, within the limits of his or her

 

 

HB4430- 7 -LRB102 22176 SPS 31305 b

1license, by a physician assistant in accordance with
2subsection (f) of Section 4, or by an advanced practice
3registered nurse in accordance with subsection (g) of Section
44, containing the following: (1) name of the patient; (2) date
5when prescription was issued; (3) name and strength of drug or
6description of the medical device prescribed; and (4)
7quantity; (5) directions for use; (6) prescriber's name,
8address, and signature; and (7) DEA registration number where
9required, for controlled substances. The prescription may, but
10is not required to, list the illness, disease, or condition
11for which the drug or device is being prescribed. DEA
12registration numbers shall not be required on inpatient drug
13orders. A prescription for medication other than controlled
14substances shall be valid for up to 15 months from the date
15issued for the purpose of refills, unless the prescription
16states otherwise.
17    (f) "Person" means and includes a natural person,
18partnership, association, corporation, government entity, or
19any other legal entity.
20    (g) "Department" means the Department of Financial and
21Professional Regulation.
22    (h) "Board of Pharmacy" or "Board" means the State Board
23of Pharmacy of the Department of Financial and Professional
24Regulation.
25    (i) "Secretary" means the Secretary of Financial and
26Professional Regulation.

 

 

HB4430- 8 -LRB102 22176 SPS 31305 b

1    (j) "Drug product selection" means the interchange for a
2prescribed pharmaceutical product in accordance with Section
325 of this Act and Section 3.14 of the Illinois Food, Drug and
4Cosmetic Act.
5    (k) "Inpatient drug order" means an order issued by an
6authorized prescriber for a resident or patient of a facility
7licensed under the Nursing Home Care Act, the ID/DD Community
8Care Act, the MC/DD Act, the Specialized Mental Health
9Rehabilitation Act of 2013, the Hospital Licensing Act, or the
10University of Illinois Hospital Act, or a facility which is
11operated by the Department of Human Services (as successor to
12the Department of Mental Health and Developmental
13Disabilities) or the Department of Corrections.
14    (k-5) "Pharmacist" means an individual health care
15professional and provider currently licensed by this State to
16engage in the practice of pharmacy.
17    (l) "Pharmacist in charge" means the licensed pharmacist
18whose name appears on a pharmacy license and who is
19responsible for all aspects of the operation related to the
20practice of pharmacy.
21    (m) "Dispense" or "dispensing" means the interpretation,
22evaluation, and implementation of a prescription drug order,
23including the preparation and delivery of a drug or device to a
24patient or patient's agent in a suitable container
25appropriately labeled for subsequent administration to or use
26by a patient in accordance with applicable State and federal

 

 

HB4430- 9 -LRB102 22176 SPS 31305 b

1laws and regulations. "Dispense" or "dispensing" does not mean
2the physical delivery to a patient or a patient's
3representative in a home or institution by a designee of a
4pharmacist or by common carrier. "Dispense" or "dispensing"
5also does not mean the physical delivery of a drug or medical
6device to a patient or patient's representative by a
7pharmacist's designee within a pharmacy or drugstore while the
8pharmacist is on duty and the pharmacy is open.
9    (n) "Nonresident pharmacy" means a pharmacy that is
10located in a state, commonwealth, or territory of the United
11States, other than Illinois, that delivers, dispenses, or
12distributes, through the United States Postal Service,
13commercially acceptable parcel delivery service, or other
14common carrier, to Illinois residents, any substance which
15requires a prescription.
16    (o) "Compounding" means the preparation and mixing of
17components, excluding flavorings, (1) as the result of a
18prescriber's prescription drug order or initiative based on
19the prescriber-patient-pharmacist relationship in the course
20of professional practice or (2) for the purpose of, or
21incident to, research, teaching, or chemical analysis and not
22for sale or dispensing. "Compounding" includes the preparation
23of drugs or devices in anticipation of receiving prescription
24drug orders based on routine, regularly observed dispensing
25patterns. Commercially available products may be compounded
26for dispensing to individual patients only if all of the

 

 

HB4430- 10 -LRB102 22176 SPS 31305 b

1following conditions are met: (i) the commercial product is
2not reasonably available from normal distribution channels in
3a timely manner to meet the patient's needs and (ii) the
4prescribing practitioner has requested that the drug be
5compounded.
6    (p) (Blank).
7    (q) (Blank).
8    (r) "Patient counseling" means the communication between a
9pharmacist or a student pharmacist under the supervision of a
10pharmacist and a patient or the patient's representative about
11the patient's medication or device for the purpose of
12optimizing proper use of prescription medications or devices.
13"Patient counseling" may include without limitation (1)
14obtaining a medication history; (2) acquiring a patient's
15allergies and health conditions; (3) facilitation of the
16patient's understanding of the intended use of the medication;
17(4) proper directions for use; (5) significant potential
18adverse events; (6) potential food-drug interactions; and (7)
19the need to be compliant with the medication therapy. A
20pharmacy technician may only participate in the following
21aspects of patient counseling under the supervision of a
22pharmacist: (1) obtaining medication history; (2) providing
23the offer for counseling by a pharmacist or student
24pharmacist; and (3) acquiring a patient's allergies and health
25conditions.
26    (s) "Patient profiles" or "patient drug therapy record"

 

 

HB4430- 11 -LRB102 22176 SPS 31305 b

1means the obtaining, recording, and maintenance of patient
2prescription information, including prescriptions for
3controlled substances, and personal information.
4    (t) (Blank).
5    (u) "Medical device" or "device" means an instrument,
6apparatus, implement, machine, contrivance, implant, in vitro
7reagent, or other similar or related article, including any
8component part or accessory, required under federal law to
9bear the label "Caution: Federal law requires dispensing by or
10on the order of a physician". A seller of goods and services
11who, only for the purpose of retail sales, compounds, sells,
12rents, or leases medical devices shall not, by reasons
13thereof, be required to be a licensed pharmacy.
14    (v) "Unique identifier" means an electronic signature,
15handwritten signature or initials, thumb print, or other
16acceptable biometric or electronic identification process as
17approved by the Department.
18    (w) "Current usual and customary retail price" means the
19price that a pharmacy charges to a non-third-party payor.
20    (x) "Automated pharmacy system" means a mechanical system
21located within the confines of the pharmacy or remote location
22that performs operations or activities, other than compounding
23or administration, relative to storage, packaging, dispensing,
24or distribution of medication, and which collects, controls,
25and maintains all transaction information.
26    (y) "Drug regimen review" means and includes the

 

 

HB4430- 12 -LRB102 22176 SPS 31305 b

1evaluation of prescription drug orders and patient records for
2(1) known allergies; (2) drug or potential therapy
3contraindications; (3) reasonable dose, duration of use, and
4route of administration, taking into consideration factors
5such as age, gender, and contraindications; (4) reasonable
6directions for use; (5) potential or actual adverse drug
7reactions; (6) drug-drug interactions; (7) drug-food
8interactions; (8) drug-disease contraindications; (9)
9therapeutic duplication; (10) patient laboratory values when
10authorized and available; (11) proper utilization (including
11over or under utilization) and optimum therapeutic outcomes;
12and (12) abuse and misuse.
13    (z) "Electronically transmitted prescription" means a
14prescription that is created, recorded, or stored by
15electronic means; issued and validated with an electronic
16signature; and transmitted by electronic means directly from
17the prescriber to a pharmacy. An electronic prescription is
18not an image of a physical prescription that is transferred by
19electronic means from computer to computer, facsimile to
20facsimile, or facsimile to computer.
21    (aa) "Medication therapy management services" means a
22distinct service or group of services offered by licensed
23pharmacists, physicians licensed to practice medicine in all
24its branches, advanced practice registered nurses authorized
25in a written agreement with a physician licensed to practice
26medicine in all its branches, or physician assistants

 

 

HB4430- 13 -LRB102 22176 SPS 31305 b

1authorized in guidelines by a supervising physician that
2optimize therapeutic outcomes for individual patients through
3improved medication use. In a retail or other non-hospital
4pharmacy, medication therapy management services shall consist
5of the evaluation of prescription drug orders and patient
6medication records to resolve conflicts with the following:
7        (1) known allergies;
8        (2) drug or potential therapy contraindications;
9        (3) reasonable dose, duration of use, and route of
10    administration, taking into consideration factors such as
11    age, gender, and contraindications;
12        (4) reasonable directions for use;
13        (5) potential or actual adverse drug reactions;
14        (6) drug-drug interactions;
15        (7) drug-food interactions;
16        (8) drug-disease contraindications;
17        (9) identification of therapeutic duplication;
18        (10) patient laboratory values when authorized and
19    available;
20        (11) proper utilization (including over or under
21    utilization) and optimum therapeutic outcomes; and
22        (12) drug abuse and misuse.
23    "Medication therapy management services" includes the
24following:
25        (1) documenting the services delivered and
26    communicating the information provided to patients'

 

 

HB4430- 14 -LRB102 22176 SPS 31305 b

1    prescribers within an appropriate time frame, not to
2    exceed 48 hours;
3        (2) providing patient counseling designed to enhance a
4    patient's understanding and the appropriate use of his or
5    her medications; and
6        (3) providing information, support services, and
7    resources designed to enhance a patient's adherence with
8    his or her prescribed therapeutic regimens.
9    "Medication therapy management services" may also include
10patient care functions authorized by a physician licensed to
11practice medicine in all its branches for his or her
12identified patient or groups of patients under specified
13conditions or limitations in a standing order from the
14physician.
15    "Medication therapy management services" in a licensed
16hospital may also include the following:
17        (1) reviewing assessments of the patient's health
18    status; and
19        (2) following protocols of a hospital pharmacy and
20    therapeutics committee with respect to the fulfillment of
21    medication orders.
22    (bb) "Pharmacist care" means the provision by a pharmacist
23of medication therapy management services, with or without the
24dispensing of drugs or devices, intended to achieve outcomes
25that improve patient health, quality of life, and comfort and
26enhance patient safety.

 

 

HB4430- 15 -LRB102 22176 SPS 31305 b

1    (cc) "Protected health information" means individually
2identifiable health information that, except as otherwise
3provided, is:
4        (1) transmitted by electronic media;
5        (2) maintained in any medium set forth in the
6    definition of "electronic media" in the federal Health
7    Insurance Portability and Accountability Act; or
8        (3) transmitted or maintained in any other form or
9    medium.
10    "Protected health information" does not include
11individually identifiable health information found in:
12        (1) education records covered by the federal Family
13    Educational Right and Privacy Act; or
14        (2) employment records held by a licensee in its role
15    as an employer.
16    (dd) "Standing order" means a specific order for a patient
17or group of patients issued by a physician licensed to
18practice medicine in all its branches in Illinois.
19    (ee) "Address of record" means the designated address
20recorded by the Department in the applicant's application file
21or licensee's license file maintained by the Department's
22licensure maintenance unit.
23    (ff) "Home pharmacy" means the location of a pharmacy's
24primary operations.
25    (gg) "Email address of record" means the designated email
26address recorded by the Department in the applicant's

 

 

HB4430- 16 -LRB102 22176 SPS 31305 b

1application file or the licensee's license file, as maintained
2by the Department's licensure maintenance unit.
3(Source: P.A. 101-349, eff. 1-1-20; 102-16, eff. 6-17-21;
4102-103, eff. 1-1-22; 102-558, eff. 8-20-21; revised
510-26-21.)
 
6    (225 ILCS 85/43)
7    (Section scheduled to be repealed on January 1, 2023)
8    Sec. 43. Patient care services provided by a pharmacist
9Dispensation of hormonal contraceptives.
10    (a) The dispensing of hormonal contraceptives to a patient
11shall be pursuant to a valid prescription or standing order by
12a physician licensed to practice medicine in all its branches
13or the medical director of a local health department, pursuant
14to the following:
15        (1) a pharmacist may dispense no more than a 12-month
16    supply of hormonal contraceptives to a patient;
17        (2) a pharmacist must complete an educational training
18    program accredited by the Accreditation Council for
19    Pharmacy Education and approved by the Department that is
20    related to the patient self-screening risk assessment,
21    patient assessment contraceptive counseling and education,
22    and dispensation of hormonal contraceptives;
23        (3) a pharmacist shall have the patient complete the
24    self-screening risk assessment tool; the self-screening
25    risk assessment tool is to be based on the most current

 

 

HB4430- 17 -LRB102 22176 SPS 31305 b

1    version of the United States Medical Eligibility Criteria
2    for Contraceptive Use published by the federal Centers for
3    Disease Control and Prevention;
4        (4) based upon the results of the self-screening risk
5    assessment and the patient assessment, the pharmacist
6    shall use his or her professional and clinical judgment as
7    to when a patient should be referred to the patient's
8    physician or another health care provider;
9        (5) a pharmacist shall provide, during the patient
10    assessment and consultation, counseling and education
11    about all methods of contraception, including methods not
12    covered under the standing order, and their proper use and
13    effectiveness;
14        (6) the patient consultation shall take place in a
15    private manner; and
16        (7) a pharmacist and pharmacy must maintain
17    appropriate records.
18    (a-5) A pharmacist shall provide patient care services for
19human immunodeficiency virus pre-exposure prophylaxis and
20human immunodeficiency virus post-exposure prophylaxis to a
21patient, pursuant to the following:
22        (1) a pharmacist shall initiate, dispense, and
23    administer any medication or laboratory tests and perform
24    a patient assessment, provide consultation, or any
25    referral in accordance with the most current version of
26    the Centers for Disease Control and Prevention, United

 

 

HB4430- 18 -LRB102 22176 SPS 31305 b

1    States Preventive Services Task Force, or generally
2    recognized evidence-based clinical guidelines; and
3        (2) a pharmacist must provide notification to the
4    patient's health care provider pursuant to the patient's
5    authorization and contact information provided by the
6    patient and ensure appropriate record retention.
7    (b) The Department may adopt rules to implement this
8Section.
9    (c) Nothing in this Section shall be interpreted to
10require a pharmacist to dispense hormonal contraception under
11a standing order issued by a physician licensed to practice
12medicine in all its branches or the medical director of a local
13health department.
14(Source: P.A. 102-103, eff. 1-1-22.)
 
15    Section 10. The Illinois Public Aid Code is amended by
16changing Section 5-5.12d as follows:
 
17    (305 ILCS 5/5-5.12d)
18    Sec. 5-5.12d. Coverage for patient care services for
19hormonal contraceptives provided by a pharmacist.
20    (a) Subject to approval by the federal Centers for
21Medicare and Medicaid Services, the medical assistance
22program, including both the fee-for-service and managed care
23medical assistance programs established under this Article,
24shall cover patient care services provided by a pharmacist for

 

 

HB4430- 19 -LRB102 22176 SPS 31305 b

1hormonal contraceptives assessment and consultation.
2    (b) The Department shall establish a fee schedule for
3patient care services provided by a pharmacist for hormonal
4contraceptives assessment and consultation.
5    (c) The rate of reimbursement for patient care services
6provided by a pharmacist for hormonal contraceptives
7assessment and consultation shall be at 85% of the fee
8schedule for physician services by the medical assistance
9program.
10    (d) A pharmacist must be enrolled in the medical
11assistance program as an ordering and referring provider prior
12to providing patient care service hormonal contraceptives
13assessment and consultation that is submitted by a pharmacy or
14pharmacist provider for reimbursement pursuant to this
15Section.
16    (e) The Department shall apply for any necessary federal
17waivers or approvals to implement this Section by January 1,
182022.
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.
24    (g) The Department shall submit to the Joint Committee on
25Administrative Rules administrative rules for this Section as
26soon as practicable but no later than 6 months after federal

 

 

HB4430- 20 -LRB102 22176 SPS 31305 b

1approval is received.
2(Source: P.A. 102-103, eff. 1-1-22.)
 
3    Section 99. Effective date. This Act takes effect upon
4becoming law.