Bill Text: IL HB4430 | 2021-2022 | 102nd General Assembly | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Amends the Pharmacy Practice Act. Provides that in accordance with a standing order by a physician licensed to practice medicine in all its branches or the medical director of a county or local health department, a pharmacist may provide patients with prophylaxis drugs for human immunodeficiency virus pre-exposure prophylaxis or post-exposure prophylaxis. Provides that a pharmacist may provide initial assessment and dispensing of prophylaxis drugs for human immunodeficiency virus pre-exposure prophylaxis or post-exposure prophylaxis. Contains requirements for the standing order. Provides that a pharmacist must communicate the services provided under the provisions to the patient and the patient's primary health care provider or other health care professional or clinic, if known. Provides that if there is no primary health care provider provided by the patient, then the pharmacist must give a list of primary health care providers or clinics in the area. Provides that a pharmacist shall complete an educational training program accredited by the Accreditation Council for Pharmacy Education or Department of Financial and Professional Regulation related to human immunodeficiency virus pre-exposure prophylaxis and human immunodeficiency virus post-exposure prophylaxis. Makes conforming and other changes. Makes corresponding changes in the Illinois Clinical Laboratory and Blood Bank Act. Amends the Illinois Insurance Code. Provides that an insurance carrier or third-party payor shall reimburse a pharmacist or other health care professional for dispensing HIV prophylaxis medications and providing other services to a covered person in accordance with the current version of the guidelines of the Centers for Disease Control and Prevention and the United States Preventive Services Task Force. Provides that reimbursement shall provide an adequate consultation fee or, if medical billing is not available, an enhanced dispensing fee that is equivalent to 85% of the fees for services provided by an advanced practice registered nurse or physician. Amends the Illinois Public Aid Code. Provides that services provided by the pharmacist under the provisions concerning HIV prophylaxis in the Pharmacy Practice Act shall be covered and reimbursed at no less than 85% of the rate that the services are reimbursed when provided by a physician. Makes other changes. Effective January 1, 2023.

Spectrum: Partisan Bill (Democrat 57-1)

Status: (Passed) 2022-06-10 - Public Act . . . . . . . . . 102-1051 [HB4430 Detail]

Download: Illinois-2021-HB4430-Introduced.html

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102ND GENERAL ASSEMBLY State of Illinois 2021 and 2022 HB4430 Introduced , by Rep. Kelly M. Cassidy 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
HB4430 LRB102 22176 SPS 31305 b
AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Pharmacy Practice Act is amended by
changing Sections 3 and 43 as follows:
(225 ILCS 85/3)
(Section scheduled to be repealed on January 1, 2023)
Sec. 3. Definitions. For the purpose of this Act, except
where otherwise limited therein:
(a) "Pharmacy" or "drugstore" means and includes every
store, shop, pharmacy department, or other place where
pharmacist care is provided by a pharmacist (1) where drugs,
medicines, or poisons are dispensed, sold or offered for sale
at retail, or displayed for sale at retail; or (2) where
prescriptions of physicians, dentists, advanced practice
registered nurses, physician assistants, veterinarians,
podiatric physicians, or optometrists, within the limits of
their licenses, are compounded, filled, or dispensed; or (3)
which has upon it or displayed within it, or affixed to or used
in connection with it, a sign bearing the word or words
"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
"Drugs", "Dispensary", "Medicines", or any word or words of

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

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

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

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

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of drugs and devices (except labeling by a manufacturer,
repackager, or distributor of non-prescription drugs and
commercially packaged legend drugs and devices), proper
and safe storage of drugs and devices, and maintenance of
required records; and
(13) the assessment and consultation of patients and
dispensing of hormonal contraceptives; and .
(14) 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.
As applicable to the State's Medicaid program and other
payers, patient care services ordered and administered in
accordance with this subsection 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.
A pharmacist who performs any of the acts defined as the
practice of pharmacy in this State must be actively licensed
as a pharmacist under this Act.
(e) "Prescription" means and includes any written, oral,
facsimile, or electronically transmitted order for drugs or
medical devices, issued by a physician licensed to practice
medicine in all its branches, dentist, veterinarian, podiatric
physician, or optometrist, within the limits of his or her

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

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

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

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

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

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

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

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

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

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

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

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

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hormonal contraceptives assessment and consultation.
(b) The Department shall establish a fee schedule for
patient care services provided by a pharmacist for hormonal
contraceptives assessment and consultation.
(c) The rate of reimbursement for patient care services
provided by a pharmacist for hormonal contraceptives
assessment and consultation shall be at 85% of the fee
schedule for physician services by the medical assistance
program.
(d) A pharmacist must be enrolled in the medical
assistance program as an ordering and referring provider prior
to providing patient care service hormonal contraceptives
assessment and consultation that is submitted by a pharmacy or
pharmacist provider for reimbursement pursuant to this
Section.
(e) The Department shall apply for any necessary federal
waivers or approvals to implement this Section by January 1,
2022.
(f) This Section does not restrict or prohibit any
services currently provided by pharmacists as authorized by
law, including, but not limited to, pharmacist services
provided under this Code or authorized under the Illinois
Title XIX State Plan.
(g) The Department shall submit to the Joint Committee on
Administrative Rules administrative rules for this Section as
soon as practicable but no later than 6 months after federal

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