103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB5462

 

Introduced 2/9/2024, by Rep. Anna Moeller

 

SYNOPSIS AS INTRODUCED:
 
215 ILCS 5/356z.63
225 ILCS 85/3
225 ILCS 85/20  from Ch. 111, par. 4140
225 ILCS 85/24  from Ch. 111, par. 4144
305 ILCS 5/5-5.12  from Ch. 23, par. 5-5.12
225 ILCS 85/9.6 rep.

    Amends the Pharmacy Practice Act. Provides that it is the practice of pharmacy to order and administer vaccines to patients 7 years of age and older for COVID-19 or influenza subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the United States Food and Drug Administration or in accordance with the United States Centers for Disease Control and Prevention's Recommended Immunization Schedule or the United States Centers for Disease Control and Prevention's Health Information for International Travel (rather than as authorized, approved, or licensed by the United States Food and Drug Administration). Provides that a pharmacist who is exercising his or her professional judgment may change the quantity of medication prescribed if specified conditions are satisfied. Provides that a pharmacist may change the dosage form of a prescription if it is in the best interest of patient care, so long as the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed. Provides that a pharmacist may complete missing information on a prescription if there is evidence to support the change. Repeals provisions concerning the administration of vaccines, tests, and therapeutics by registered pharmacy technicians and student pharmacists. Makes other changes. Amends the Illinois Insurance Code and the Medical Assistance Article of the Illinois Public Aid Code. Provides that the ordering and administration of vaccines by a pharmacist as part of the practice of pharmacy shall be covered and reimbursed under the medical assistance program and by other insurers at no less than the rate that the vaccine is reimbursed at when ordered and administered by a licensed physician.


LRB103 38877 RTM 69014 b

 

 

A BILL FOR

 

HB5462LRB103 38877 RTM 69014 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.
9    (a) A group or individual policy of accident and health
10insurance or a managed care plan that is amended, delivered,
11issued, or renewed on or after January 1, 2025 shall provide
12coverage for health care or patient care services provided by
13a pharmacist if:
14        (1) the pharmacist meets the requirements and scope of
15    practice described in paragraph (15), (16), or (17) of
16    subsection (d) of Section 3 of the Pharmacy 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    (b) Vaccines ordered and administered by a pharmacist as
2described in subsection (d) of Section 3 of the Pharmacy
3Practice Act shall be covered and reimbursed at no less than
4the rate that the vaccine is reimbursed at when ordered and
5administered by a physician licensed to practice medicine in
6all its branches.
7(Source: P.A. 103-1, eff. 4-27-23; revised 8-29-23.)
 
8    Section 10. The Pharmacy Practice Act is amended by
9changing Sections 3, 20, and 24 as follows:
 
10    (225 ILCS 85/3)
11    (Section scheduled to be repealed on January 1, 2028)
12    Sec. 3. Definitions. For the purpose of this Act, except
13where otherwise limited therein:
14    (a) "Pharmacy" or "drugstore" means and includes every
15store, shop, pharmacy department, or other place where
16pharmacist care is provided by a pharmacist (1) where drugs,
17medicines, or poisons are dispensed, sold or offered for sale
18at retail, or displayed for sale at retail; or (2) where
19prescriptions of physicians, dentists, advanced practice
20registered nurses, physician assistants, veterinarians,
21podiatric physicians, or optometrists, within the limits of
22their licenses, are compounded, filled, or dispensed; or (3)
23which has upon it or displayed within it, or affixed to or used
24in connection with it, a sign bearing the word or words

 

 

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

 

 

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1not include devices or their components, parts or accessories.
2    (c) "Medicines" means and includes all drugs intended for
3human or veterinary use approved by the United States Food and
4Drug Administration.
5    (d) "Practice of pharmacy" means:
6        (1) the interpretation and the provision of assistance
7    in the monitoring, evaluation, and implementation of
8    prescription drug orders;
9        (2) the dispensing of prescription drug orders;
10        (3) participation in drug and device selection;
11        (4) drug administration limited to the administration
12    of oral, topical, injectable, and inhalation as follows:
13            (A) in the context of patient education on the
14        proper use or delivery of medications;
15            (B) vaccination of patients 7 years of age and
16        older pursuant to a valid prescription or standing
17        order, by a physician licensed to practice medicine in
18        all its branches, except for vaccinations covered by
19        paragraph (15), upon completion of appropriate
20        training, including how to address contraindications
21        and adverse reactions set forth by rule, with
22        notification to the patient's physician and
23        appropriate record retention, or pursuant to hospital
24        pharmacy and therapeutics committee policies and
25        procedures. Eligible vaccines are those listed on the
26        U.S. Centers for Disease Control and Prevention (CDC)

 

 

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

 

 

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

 

 

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1        (10) the provision of those acts or services necessary
2    to provide pharmacist care;
3        (11) medication therapy management;
4        (12) the responsibility for compounding and labeling
5    of drugs and devices (except labeling by a manufacturer,
6    repackager, or distributor of non-prescription drugs and
7    commercially packaged legend drugs and devices), proper
8    and safe storage of drugs and devices, and maintenance of
9    required records;
10        (13) the assessment and consultation of patients and
11    dispensing of hormonal contraceptives;
12        (14) the initiation, dispensing, or administration of
13    drugs, laboratory tests, assessments, referrals, and
14    consultations for human immunodeficiency virus
15    pre-exposure prophylaxis and human immunodeficiency virus
16    post-exposure prophylaxis under Section 43.5;
17        (15) the ordering and administration of vaccines to
18    vaccination of patients 7 years of age and older for
19    COVID-19 or influenza subcutaneously, intramuscularly, or
20    orally as authorized, approved, or licensed by the United
21    States Food and Drug Administration or in accordance with
22    the United States Centers for Disease Control and
23    Prevention's Recommended Immunization Schedule or the
24    United States Centers for Disease Control and Prevention's
25    Health Information for International Travel. , pursuant to
26    the following conditions:

 

 

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1            (A) the vaccine must be authorized or licensed by
2        the United States Food and Drug Administration;
3            (B) the vaccine must be ordered and administered
4        according to the Advisory Committee on Immunization
5        Practices standard immunization schedule;
6            (C) the pharmacist must complete a course of
7        training accredited by the Accreditation Council on
8        Pharmacy Education or a similar health authority or
9        professional body approved by the Division of
10        Professional Regulation;
11            (D) the pharmacist must have a current certificate
12        in basic cardiopulmonary resuscitation;
13            (E) the pharmacist must complete, during each
14        State licensing period, a minimum of 2 hours of
15        immunization-related continuing pharmacy education
16        approved by the Accreditation Council on Pharmacy
17        Education;
18            (F) the pharmacist must comply with recordkeeping
19        and reporting requirements of the jurisdiction in
20        which the pharmacist administers vaccines, including
21        informing the patient's primary-care provider, when
22        available, and complying with requirements whereby the
23        person administering a vaccine must review the vaccine
24        registry or other vaccination records prior to
25        administering the vaccine; and
26            (G) the pharmacist must inform the pharmacist's

 

 

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1        patients who are less than 18 years old, as well as the
2        adult caregiver accompanying the child, of the
3        importance of a well-child visit with a pediatrician
4        or other licensed primary-care provider and must refer
5        patients as appropriate;
6        (16) the ordering and administration of COVID-19
7    therapeutics subcutaneously, intramuscularly, or orally
8    with notification to the patient's physician and
9    appropriate record retention or pursuant to hospital
10    pharmacy and therapeutics committee policies and
11    procedures for: (i) COVID-19 (SARS-CoV 2) or other
12    respiratory illnesses, conditions, or diseases; (ii)
13    influenza; (iii) group A Streptococcus Pharyngitis; (iv)
14    lice; (v) skin conditions, including ringworm and
15    athlete's foot; (vi) respiratory syncytial virus or RSV;
16    and (vii) other health conditions identified by a
17    statewide public health emergency, as defined in the
18    Illinois Emergency Management Agency Act. Eligible
19    therapeutics are those approved, authorized, or licensed
20    by the United States Food and Drug Administration and must
21    be administered subcutaneously, intramuscularly, or orally
22    in accordance with that approval, authorization, or
23    licensing; and
24        (17) the ordering and administration of tests and
25    screenings for (i) influenza, (ii) SARS-CoV 2 SARS-COV 2,
26    and (iii) group A Streptococcus Pharyngitis, (iv) lice,

 

 

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1    (v) skin conditions, including ringworm and athlete's
2    foot, (vi) RSV, and (vii) other health conditions
3    identified by a statewide public health emergency, as
4    defined in the Illinois Emergency Management Agency Act,
5    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. Eligible tests and screenings are those
9    approved, authorized, or licensed by the United States
10    Food and Drug Administration and must be administered in
11    accordance with that approval, authorization, or
12    licensing.
13        A pharmacist who orders or administers tests or
14    screenings for health conditions described in this
15    paragraph may use a test that may guide clinical
16    decision-making for the health condition that is waived
17    under the federal Clinical Laboratory Improvement
18    Amendments of 1988 and regulations promulgated thereunder
19    or any established screening procedure that is established
20    under a statewide protocol.
21        A pharmacist may delegate the administrative and
22    technical tasks of performing a test for the health
23    conditions described in this paragraph to a registered
24    pharmacy technician or student pharmacist acting under the
25    supervision of the pharmacist.
26    A pharmacist who performs any of the acts defined as the

 

 

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1practice of pharmacy in this State must be actively licensed
2as a pharmacist under this Act.
3    (e) "Prescription" means and includes any written, oral,
4facsimile, or electronically transmitted order for drugs or
5medical devices, issued by a physician licensed to practice
6medicine in all its branches, dentist, veterinarian, podiatric
7physician, or optometrist, within the limits of his or her
8license, by a physician assistant in accordance with
9subsection (f) of Section 4, or by an advanced practice
10registered nurse in accordance with subsection (g) of Section
114, containing the following: (1) name of the patient; (2) date
12when prescription was issued; (3) name and strength of drug or
13description of the medical device prescribed; and (4)
14quantity; (5) directions for use; (6) prescriber's name,
15address, and signature; and (7) DEA registration number where
16required, for controlled substances. The prescription may, but
17is not required to, list the illness, disease, or condition
18for which the drug or device is being prescribed. DEA
19registration numbers shall not be required on inpatient drug
20orders. A prescription for medication other than controlled
21substances shall be valid for up to 15 months from the date
22issued for the purpose of refills, unless the prescription
23states otherwise.
24    (f) "Person" means and includes a natural person,
25partnership, association, corporation, government entity, or
26any other legal entity.

 

 

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1    (g) "Department" means the Department of Financial and
2Professional Regulation.
3    (h) "Board of Pharmacy" or "Board" means the State Board
4of Pharmacy of the Department of Financial and Professional
5Regulation.
6    (i) "Secretary" means the Secretary of Financial and
7Professional Regulation.
8    (j) "Drug product selection" means the interchange for a
9prescribed pharmaceutical product in accordance with Section
1025 of this Act and Section 3.14 of the Illinois Food, Drug and
11Cosmetic Act.
12    (k) "Inpatient drug order" means an order issued by an
13authorized prescriber for a resident or patient of a facility
14licensed under the Nursing Home Care Act, the ID/DD Community
15Care Act, the MC/DD Act, the Specialized Mental Health
16Rehabilitation Act of 2013, the Hospital Licensing Act, or the
17University of Illinois Hospital Act, or a facility which is
18operated by the Department of Human Services (as successor to
19the Department of Mental Health and Developmental
20Disabilities) or the Department of Corrections.
21    (k-5) "Pharmacist" means an individual health care
22professional and provider currently licensed by this State to
23engage in the practice of pharmacy.
24    (l) "Pharmacist in charge" means the licensed pharmacist
25whose name appears on a pharmacy license and who is
26responsible for all aspects of the operation related to the

 

 

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1practice of pharmacy.
2    (m) "Dispense" or "dispensing" means the interpretation,
3evaluation, and implementation of a prescription drug order,
4including the preparation and delivery of a drug or device to a
5patient or patient's agent in a suitable container
6appropriately labeled for subsequent administration to or use
7by a patient in accordance with applicable State and federal
8laws and regulations. "Dispense" or "dispensing" does not mean
9the physical delivery to a patient or a patient's
10representative in a home or institution by a designee of a
11pharmacist or by common carrier. "Dispense" or "dispensing"
12also does not mean the physical delivery of a drug or medical
13device to a patient or patient's representative by a
14pharmacist's designee within a pharmacy or drugstore while the
15pharmacist is on duty and the pharmacy is open.
16    (n) "Nonresident pharmacy" means a pharmacy that is
17located in a state, commonwealth, or territory of the United
18States, other than Illinois, that delivers, dispenses, or
19distributes, through the United States Postal Service,
20commercially acceptable parcel delivery service, or other
21common carrier, to Illinois residents, any substance which
22requires a prescription.
23    (o) "Compounding" means the preparation and mixing of
24components, excluding flavorings, (1) as the result of a
25prescriber's prescription drug order or initiative based on
26the prescriber-patient-pharmacist relationship in the course

 

 

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1of professional practice or (2) for the purpose of, or
2incident to, research, teaching, or chemical analysis and not
3for sale or dispensing. "Compounding" includes the preparation
4of drugs or devices in anticipation of receiving prescription
5drug orders based on routine, regularly observed dispensing
6patterns. Commercially available products may be compounded
7for dispensing to individual patients only if all of the
8following conditions are met: (i) the commercial product is
9not reasonably available from normal distribution channels in
10a timely manner to meet the patient's needs and (ii) the
11prescribing practitioner has requested that the drug be
12compounded.
13    (p) (Blank).
14    (q) (Blank).
15    (r) "Patient counseling" means the communication between a
16pharmacist or a student pharmacist under the supervision of a
17pharmacist and a patient or the patient's representative about
18the patient's medication or device for the purpose of
19optimizing proper use of prescription medications or devices.
20"Patient counseling" may include without limitation (1)
21obtaining a medication history; (2) acquiring a patient's
22allergies and health conditions; (3) facilitation of the
23patient's understanding of the intended use of the medication;
24(4) proper directions for use; (5) significant potential
25adverse events; (6) potential food-drug interactions; and (7)
26the need to be compliant with the medication therapy. A

 

 

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1pharmacy technician may only participate in the following
2aspects of patient counseling under the supervision of a
3pharmacist: (1) obtaining medication history; (2) providing
4the offer for counseling by a pharmacist or student
5pharmacist; and (3) acquiring a patient's allergies and health
6conditions.
7    (s) "Patient profiles" or "patient drug therapy record"
8means the obtaining, recording, and maintenance of patient
9prescription information, including prescriptions for
10controlled substances, and personal information.
11    (t) (Blank).
12    (u) "Medical device" or "device" means an instrument,
13apparatus, implement, machine, contrivance, implant, in vitro
14reagent, or other similar or related article, including any
15component part or accessory, required under federal law to
16bear the label "Caution: Federal law requires dispensing by or
17on the order of a physician". A seller of goods and services
18who, only for the purpose of retail sales, compounds, sells,
19rents, or leases medical devices shall not, by reasons
20thereof, be required to be a licensed pharmacy.
21    (v) "Unique identifier" means an electronic signature,
22handwritten signature or initials, thumb print, or other
23acceptable biometric or electronic identification process as
24approved by the Department.
25    (w) "Current usual and customary retail price" means the
26price that a pharmacy charges to a non-third-party payor.

 

 

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1    (x) "Automated pharmacy system" means a mechanical system
2located within the confines of the pharmacy or remote location
3that performs operations or activities, other than compounding
4or administration, relative to storage, packaging, dispensing,
5or distribution of medication, and which collects, controls,
6and maintains all transaction information.
7    (y) "Drug regimen review" means and includes the
8evaluation of prescription drug orders and patient records for
9(1) known allergies; (2) drug or potential therapy
10contraindications; (3) reasonable dose, duration of use, and
11route of administration, taking into consideration factors
12such as age, gender, and contraindications; (4) reasonable
13directions for use; (5) potential or actual adverse drug
14reactions; (6) drug-drug interactions; (7) drug-food
15interactions; (8) drug-disease contraindications; (9)
16therapeutic duplication; (10) patient laboratory values when
17authorized and available; (11) proper utilization (including
18over or under utilization) and optimum therapeutic outcomes;
19and (12) abuse and misuse.
20    (z) "Electronically transmitted prescription" means a
21prescription that is created, recorded, or stored by
22electronic means; issued and validated with an electronic
23signature; and transmitted by electronic means directly from
24the prescriber to a pharmacy. An electronic prescription is
25not an image of a physical prescription that is transferred by
26electronic means from computer to computer, facsimile to

 

 

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1facsimile, or facsimile to computer.
2    (aa) "Medication therapy management services" means a
3distinct service or group of services offered by licensed
4pharmacists, physicians licensed to practice medicine in all
5its branches, advanced practice registered nurses authorized
6in a written agreement with a physician licensed to practice
7medicine in all its branches, or physician assistants
8authorized in guidelines by a supervising physician that
9optimize therapeutic outcomes for individual patients through
10improved medication use. In a retail or other non-hospital
11pharmacy, medication therapy management services shall consist
12of the evaluation of prescription drug orders and patient
13medication records to resolve conflicts with the following:
14        (1) known allergies;
15        (2) drug or potential therapy contraindications;
16        (3) reasonable dose, duration of use, and route of
17    administration, taking into consideration factors such as
18    age, gender, and contraindications;
19        (4) reasonable directions for use;
20        (5) potential or actual adverse drug reactions;
21        (6) drug-drug interactions;
22        (7) drug-food interactions;
23        (8) drug-disease contraindications;
24        (9) identification of therapeutic duplication;
25        (10) patient laboratory values when authorized and
26    available;

 

 

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

 

 

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1    therapeutics committee with respect to the fulfillment of
2    medication orders.
3    (bb) "Pharmacist care" means the provision by a pharmacist
4of medication therapy management services, with or without the
5dispensing of drugs or devices, intended to achieve outcomes
6that improve patient health, quality of life, and comfort and
7enhance patient safety.
8    (cc) "Protected health information" means individually
9identifiable health information that, except as otherwise
10provided, is:
11        (1) transmitted by electronic media;
12        (2) maintained in any medium set forth in the
13    definition of "electronic media" in the federal Health
14    Insurance Portability and Accountability Act; or
15        (3) transmitted or maintained in any other form or
16    medium.
17    "Protected health information" does not include
18individually identifiable health information found in:
19        (1) education records covered by the federal Family
20    Educational Right and Privacy Act; or
21        (2) employment records held by a licensee in its role
22    as an employer.
23    (dd) "Standing order" means a specific order for a patient
24or group of patients issued by a physician licensed to
25practice medicine in all its branches in Illinois.
26    (ee) "Address of record" means the designated address

 

 

HB5462- 20 -LRB103 38877 RTM 69014 b

1recorded by the Department in the applicant's application file
2or licensee's license file maintained by the Department's
3licensure maintenance unit.
4    (ff) "Home pharmacy" means the location of a pharmacy's
5primary operations.
6    (gg) "Email address of record" means the designated email
7address recorded by the Department in the applicant's
8application file or the licensee's license file, as maintained
9by the Department's licensure maintenance unit.
10(Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
11102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
121-1-23; 103-1, eff. 4-27-23.)
 
13    (225 ILCS 85/20)  (from Ch. 111, par. 4140)
14    (Section scheduled to be repealed on January 1, 2028)
15    Sec. 20. Dispensing systems.
16    (a) Two or more pharmacies may establish and use a common
17electronic file to maintain required dispensing information.
18    (b) Pharmacies using such a common electronic file are not
19required to physically transfer prescriptions or information
20for dispensing purposes between or among pharmacies
21participating in the same common prescription file; provided,
22however any such common file must contain complete and
23adequate records of such prescription and refill dispensed as
24stated in Section 18.
25    (c) The Department may formulate such rules, not

 

 

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1inconsistent with law, as may be necessary to carry out the
2purposes of and to enforce the provisions of this Section
3within the following exception: The Department shall not
4impose greater requirements on either common electronic files
5or a hard copy record system.
6    (d) Drugs shall in no event be dispensed more frequently
7or in larger amounts than the prescriber ordered without
8direct prescriber authorization by way of a new prescription
9order.
10    (e) The dispensing by a pharmacist licensed in this State
11or another state of a prescription contained in a common
12database shall not constitute a transfer, provided that (1)
13all pharmacies involved in the transactions pursuant to which
14the prescription is dispensed and all pharmacists engaging in
15dispensing functions are properly licensed, permitted, or
16registered in this State or another jurisdiction, (2) a policy
17and procedures manual that governs all participating
18pharmacies and pharmacists is available to the Department upon
19request and includes the procedure for maintaining appropriate
20records for regulatory oversight for tracking a prescription
21during each stage of the filling and dispensing process, and
22(3) the pharmacists involved in filling and dispensing the
23prescription and counseling the patient are identified. A
24pharmacist shall be accountable only for the specific tasks
25performed.
26    (f) Nothing in this Section shall prohibit a pharmacist

 

 

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1who is exercising his or her professional judgment from
2dispensing additional quantities of medication up to the total
3number of dosage units authorized by the prescriber on the
4original prescription and any refills.
5    (g) A pharmacist who is exercising his or her professional
6judgment may change the quantity of medication prescribed if:
7        (1) the prescribed quantity or package size is not
8    commercially available;
9        (2) the change in quantity is related to a change in
10    dosage form, strength, or therapeutic interchange;
11        (3) the change extends a maintenance drug for the
12    limited quantity necessary to coordinate a patient's
13    refills in a medication synchronization program; and
14        (4) the change to add missing non-pharmaceutical
15    devices or durable medical equipment that aid in the
16    appropriate clinical usage of a medication or achieving a
17    positive therapeutic outcome.
18    A pharmacist may change the dosage form of a prescription
19if it is in the best interest of patient care, so long as the
20prescriber's directions are also modified to equate to an
21equivalent amount of drug dispensed as prescribed.
22    A pharmacist may complete missing information on a
23prescription if evidence supports the change.
24    The change must be documented in the patient's record.
25(Source: P.A. 100-497, eff. 9-8-17.)
 

 

 

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1    (225 ILCS 85/24)  (from Ch. 111, par. 4144)
2    (Section scheduled to be repealed on January 1, 2028)
3    Sec. 24. It shall be unlawful for any manufacturer or
4distributor of a prescription drug, or any person on behalf of
5such manufacturer or distributor, to distribute a prescription
6drug without charge or for less than its fair market value to
7any person directly or indirectly.
8    Nothing in this Section shall be construed to prohibit the
9distribution of a prescription drug:
10        (a) at a discount in accordance with the laws of the
11    United States or the State of Illinois;
12        (b) to a person for use in an investigation conducted
13    under Federal Food and Drug Administration regulations;
14        (c) to a patient by a pharmacist in response to a
15    request written and signed by a medical practitioner which
16    designates the quantity to be distributed;
17        (d) to a licensed medical practitioner in response to
18    a request signed by the practitioner which designates the
19    quantity to be distributed;
20        (e) to an agency of the federal government or to a
21    state government or political subdivision for regulatory
22    or enforcement purposes;
23        (f) in an emergency as determined by the laws of the
24    United States or the State of Illinois; or
25        (g) to a bona fide charity authorized to possess and
26    dispense prescription drugs.

 

 

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1    It shall be unlawful to require a pharmacist or pharmacy
2to dispense a prescription drug below fair market value,
3including the cost of dispensing. Any payor that reimburses a
4pharmacy below fair market value, including the cost of
5dispensing, shall not be able to include this pharmacy towards
6any network adequacy requirements and shall not be in
7compliance with any willing provider provisions.
8(Source: P.A. 85-796.)
 
9    Section 15. The Illinois Public Aid Code is amended by
10changing Section 5-5.12 as follows:
 
11    (305 ILCS 5/5-5.12)  (from Ch. 23, par. 5-5.12)
12    Sec. 5-5.12. Pharmacy payments.
13    (a) Every request submitted by a pharmacy for
14reimbursement under this Article for prescription drugs
15provided to a recipient of aid under this Article shall
16include the name of the prescriber or an acceptable
17identification number as established by the Department.
18    (b) Pharmacies providing prescription drugs under this
19Article shall be reimbursed at a rate which shall include a
20professional dispensing fee as determined by the Illinois
21Department, plus the current acquisition cost of the
22prescription drug dispensed. The Illinois Department shall
23update its information on the acquisition costs of all
24prescription drugs no less frequently than every 30 days.

 

 

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1However, the Illinois Department may set the rate of
2reimbursement for the acquisition cost, by rule, at a
3percentage of the current average wholesale acquisition cost.
4    (c) (Blank).
5    (d) The Department shall review utilization of narcotic
6medications in the medical assistance program and impose
7utilization controls that protect against abuse.
8    (e) When making determinations as to which drugs shall be
9on a prior approval list, the Department shall include as part
10of the analysis for this determination, the degree to which a
11drug may affect individuals in different ways based on factors
12including the gender of the person taking the medication.
13    (f) The Department shall cooperate with the Department of
14Public Health and the Department of Human Services Division of
15Mental Health in identifying psychotropic medications that,
16when given in a particular form, manner, duration, or
17frequency (including "as needed") in a dosage, or in
18conjunction with other psychotropic medications to a nursing
19home resident or to a resident of a facility licensed under the
20ID/DD Community Care Act or the MC/DD Act, may constitute a
21chemical restraint or an "unnecessary drug" as defined by the
22Nursing Home Care Act or Titles XVIII and XIX of the Social
23Security Act and the implementing rules and regulations. The
24Department shall require prior approval for any such
25medication prescribed for a nursing home resident or to a
26resident of a facility licensed under the ID/DD Community Care

 

 

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1Act or the MC/DD Act, that appears to be a chemical restraint
2or an unnecessary drug. The Department shall consult with the
3Department of Human Services Division of Mental Health in
4developing a protocol and criteria for deciding whether to
5grant such prior approval.
6    (g) The Department may by rule provide for reimbursement
7of the dispensing of a 90-day supply of a generic or brand
8name, non-narcotic maintenance medication in circumstances
9where it is cost effective.
10    (g-5) On and after July 1, 2012, the Department may
11require the dispensing of drugs to nursing home residents be
12in a 7-day supply or other amount less than a 31-day supply.
13The Department shall pay only one dispensing fee per 31-day
14supply.
15    (h) Effective July 1, 2011, the Department shall
16discontinue coverage of select over-the-counter drugs,
17including analgesics and cough and cold and allergy
18medications.
19    (h-5) On and after July 1, 2012, the Department shall
20impose utilization controls, including, but not limited to,
21prior approval on specialty drugs, oncolytic drugs, drugs for
22the treatment of HIV or AIDS, immunosuppressant drugs, and
23biological products in order to maximize savings on these
24drugs. The Department may adjust payment methodologies for
25non-pharmacy billed drugs in order to incentivize the
26selection of lower-cost drugs. For drugs for the treatment of

 

 

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1AIDS, the Department shall take into consideration the
2potential for non-adherence by certain populations, and shall
3develop protocols with organizations or providers primarily
4serving those with HIV/AIDS, as long as such measures intend
5to maintain cost neutrality with other utilization management
6controls such as prior approval. For hemophilia, the
7Department shall develop a program of utilization review and
8control which may include, in the discretion of the
9Department, prior approvals. The Department may impose special
10standards on providers that dispense blood factors which shall
11include, in the discretion of the Department, staff training
12and education; patient outreach and education; case
13management; in-home patient assessments; assay management;
14maintenance of stock; emergency dispensing timeframes; data
15collection and reporting; dispensing of supplies related to
16blood factor infusions; cold chain management and packaging
17practices; care coordination; product recalls; and emergency
18clinical consultation. The Department may require patients to
19receive a comprehensive examination annually at an appropriate
20provider in order to be eligible to continue to receive blood
21factor.
22    (i) On and after July 1, 2012, the Department shall reduce
23any rate of reimbursement for services or other payments or
24alter any methodologies authorized by this Code to reduce any
25rate of reimbursement for services or other payments in
26accordance with Section 5-5e.

 

 

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1    (j) On and after July 1, 2012, the Department shall impose
2limitations on prescription drugs such that the Department
3shall not provide reimbursement for more than 4 prescriptions,
4including 3 brand name prescriptions, for distinct drugs in a
530-day period, unless prior approval is received for all
6prescriptions in excess of the 4-prescription limit. Drugs in
7the following therapeutic classes shall not be subject to
8prior approval as a result of the 4-prescription limit:
9immunosuppressant drugs, oncolytic drugs, anti-retroviral
10drugs, and, on or after July 1, 2014, antipsychotic drugs. On
11or after July 1, 2014, the Department may exempt children with
12complex medical needs enrolled in a care coordination entity
13contracted with the Department to solely coordinate care for
14such children, if the Department determines that the entity
15has a comprehensive drug reconciliation program.
16    (k) No medication therapy management program implemented
17by the Department shall be contrary to the provisions of the
18Pharmacy Practice Act.
19    (l) Any provider enrolled with the Department that bills
20the Department for outpatient drugs and is eligible to enroll
21in the federal Drug Pricing Program under Section 340B of the
22federal Public Health Service Act shall enroll in that
23program. No entity participating in the federal Drug Pricing
24Program under Section 340B of the federal Public Health
25Service Act may exclude fee-for-service Medicaid from their
26participation in that program, however, entities defined in

 

 

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1Section 1905(l)(2)(B) of the Social Security Act are excluded
2from this requirement. This subsection does not apply to
3outpatient drugs billed to Medicaid managed care
4organizations.
5    (m) Notwithstanding any other provision of this Code to
6the contrary, vaccines ordered and administered by a
7pharmacist as described in
subsection (d) of Section 3 of the
8Pharmacy Practice Act shall be covered and reimbursed at no
9less than the rate that the vaccine is reimbursed at when
10ordered and administered by a physician licensed to practice
11medicine in all its branches.
12(Source: P.A. 102-558, eff. 8-20-21; 102-778, eff. 7-1-22.)
 
13    (225 ILCS 85/9.6 rep.)
14    Section 20. The Pharmacy Practice Act is amended by
15repealing Section 9.6.