103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 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 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 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 LRB103 38877 RTM 69014 b A BILL FOR
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 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.
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 LRB103 38877 RTM 69014 b
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A BILL FOR
HB5462LRB103 38877 RTM 69014 b HB5462 LRB103 38877 RTM 69014 b
HB5462 LRB103 38877 RTM 69014 b
1 AN ACT concerning regulation.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Illinois Insurance Code is amended by
5 changing Section 356z.63 as follows:
6 (215 ILCS 5/356z.63)
7 Sec. 356z.63 356z.61. Coverage of pharmacy testing,
8 screening, vaccinations, and treatment.
9 (a) A group or individual policy of accident and health
10 insurance or a managed care plan that is amended, delivered,
11 issued, or renewed on or after January 1, 2025 shall provide
12 coverage for health care or patient care services provided by
13 a 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.
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 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.
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.
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LRB103 38877 RTM 69014 b
A BILL FOR
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.
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1 (b) Vaccines ordered and administered by a pharmacist as
2 described in subsection (d) of Section 3 of the Pharmacy
3 Practice Act shall be covered and reimbursed at no less than
4 the rate that the vaccine is reimbursed at when ordered and
5 administered by a physician licensed to practice medicine in
6 all 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
9 changing 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
13 where otherwise limited therein:
14 (a) "Pharmacy" or "drugstore" means and includes every
15 store, shop, pharmacy department, or other place where
16 pharmacist care is provided by a pharmacist (1) where drugs,
17 medicines, or poisons are dispensed, sold or offered for sale
18 at retail, or displayed for sale at retail; or (2) where
19 prescriptions of physicians, dentists, advanced practice
20 registered nurses, physician assistants, veterinarians,
21 podiatric physicians, or optometrists, within the limits of
22 their licenses, are compounded, filled, or dispensed; or (3)
23 which has upon it or displayed within it, or affixed to or used
24 in 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
4 similar or like import, either in the English language or any
5 other language; or (4) where the characteristic prescription
6 sign (Rx) or similar design is exhibited; or (5) any store, or
7 shop, or other place with respect to which any of the above
8 words, objects, signs or designs are used in any
9 advertisement.
10 (b) "Drugs" means and includes (1) articles recognized in
11 the official United States Pharmacopoeia/National Formulary
12 (USP/NF), or any supplement thereto and being intended for and
13 having for their main use the diagnosis, cure, mitigation,
14 treatment or prevention of disease in man or other animals, as
15 approved by the United States Food and Drug Administration,
16 but does not include devices or their components, parts, or
17 accessories; and (2) all other articles intended for and
18 having for their main use the diagnosis, cure, mitigation,
19 treatment or prevention of disease in man or other animals, as
20 approved by the United States Food and Drug Administration,
21 but does not include devices or their components, parts, or
22 accessories; and (3) articles (other than food) having for
23 their main use and intended to affect the structure or any
24 function of the body of man or other animals; and (4) articles
25 having for their main use and intended for use as a component
26 or any articles specified in clause (1), (2) or (3); but does
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1 not include devices or their components, parts or accessories.
2 (c) "Medicines" means and includes all drugs intended for
3 human or veterinary use approved by the United States Food and
4 Drug 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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1 practice of pharmacy in this State must be actively licensed
2 as a pharmacist under this Act.
3 (e) "Prescription" means and includes any written, oral,
4 facsimile, or electronically transmitted order for drugs or
5 medical devices, issued by a physician licensed to practice
6 medicine in all its branches, dentist, veterinarian, podiatric
7 physician, or optometrist, within the limits of his or her
8 license, by a physician assistant in accordance with
9 subsection (f) of Section 4, or by an advanced practice
10 registered nurse in accordance with subsection (g) of Section
11 4, containing the following: (1) name of the patient; (2) date
12 when prescription was issued; (3) name and strength of drug or
13 description of the medical device prescribed; and (4)
14 quantity; (5) directions for use; (6) prescriber's name,
15 address, and signature; and (7) DEA registration number where
16 required, for controlled substances. The prescription may, but
17 is not required to, list the illness, disease, or condition
18 for which the drug or device is being prescribed. DEA
19 registration numbers shall not be required on inpatient drug
20 orders. A prescription for medication other than controlled
21 substances shall be valid for up to 15 months from the date
22 issued for the purpose of refills, unless the prescription
23 states otherwise.
24 (f) "Person" means and includes a natural person,
25 partnership, association, corporation, government entity, or
26 any other legal entity.
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1 (g) "Department" means the Department of Financial and
2 Professional Regulation.
3 (h) "Board of Pharmacy" or "Board" means the State Board
4 of Pharmacy of the Department of Financial and Professional
5 Regulation.
6 (i) "Secretary" means the Secretary of Financial and
7 Professional Regulation.
8 (j) "Drug product selection" means the interchange for a
9 prescribed pharmaceutical product in accordance with Section
10 25 of this Act and Section 3.14 of the Illinois Food, Drug and
11 Cosmetic Act.
12 (k) "Inpatient drug order" means an order issued by an
13 authorized prescriber for a resident or patient of a facility
14 licensed under the Nursing Home Care Act, the ID/DD Community
15 Care Act, the MC/DD Act, the Specialized Mental Health
16 Rehabilitation Act of 2013, the Hospital Licensing Act, or the
17 University of Illinois Hospital Act, or a facility which is
18 operated by the Department of Human Services (as successor to
19 the Department of Mental Health and Developmental
20 Disabilities) or the Department of Corrections.
21 (k-5) "Pharmacist" means an individual health care
22 professional and provider currently licensed by this State to
23 engage in the practice of pharmacy.
24 (l) "Pharmacist in charge" means the licensed pharmacist
25 whose name appears on a pharmacy license and who is
26 responsible for all aspects of the operation related to the
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1 practice of pharmacy.
2 (m) "Dispense" or "dispensing" means the interpretation,
3 evaluation, and implementation of a prescription drug order,
4 including the preparation and delivery of a drug or device to a
5 patient or patient's agent in a suitable container
6 appropriately labeled for subsequent administration to or use
7 by a patient in accordance with applicable State and federal
8 laws and regulations. "Dispense" or "dispensing" does not mean
9 the physical delivery to a patient or a patient's
10 representative in a home or institution by a designee of a
11 pharmacist or by common carrier. "Dispense" or "dispensing"
12 also does not mean the physical delivery of a drug or medical
13 device to a patient or patient's representative by a
14 pharmacist's designee within a pharmacy or drugstore while the
15 pharmacist is on duty and the pharmacy is open.
16 (n) "Nonresident pharmacy" means a pharmacy that is
17 located in a state, commonwealth, or territory of the United
18 States, other than Illinois, that delivers, dispenses, or
19 distributes, through the United States Postal Service,
20 commercially acceptable parcel delivery service, or other
21 common carrier, to Illinois residents, any substance which
22 requires a prescription.
23 (o) "Compounding" means the preparation and mixing of
24 components, excluding flavorings, (1) as the result of a
25 prescriber's prescription drug order or initiative based on
26 the prescriber-patient-pharmacist relationship in the course
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1 of professional practice or (2) for the purpose of, or
2 incident to, research, teaching, or chemical analysis and not
3 for sale or dispensing. "Compounding" includes the preparation
4 of drugs or devices in anticipation of receiving prescription
5 drug orders based on routine, regularly observed dispensing
6 patterns. Commercially available products may be compounded
7 for dispensing to individual patients only if all of the
8 following conditions are met: (i) the commercial product is
9 not reasonably available from normal distribution channels in
10 a timely manner to meet the patient's needs and (ii) the
11 prescribing practitioner has requested that the drug be
12 compounded.
13 (p) (Blank).
14 (q) (Blank).
15 (r) "Patient counseling" means the communication between a
16 pharmacist or a student pharmacist under the supervision of a
17 pharmacist and a patient or the patient's representative about
18 the patient's medication or device for the purpose of
19 optimizing proper use of prescription medications or devices.
20 "Patient counseling" may include without limitation (1)
21 obtaining a medication history; (2) acquiring a patient's
22 allergies and health conditions; (3) facilitation of the
23 patient's understanding of the intended use of the medication;
24 (4) proper directions for use; (5) significant potential
25 adverse events; (6) potential food-drug interactions; and (7)
26 the need to be compliant with the medication therapy. A
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1 pharmacy technician may only participate in the following
2 aspects of patient counseling under the supervision of a
3 pharmacist: (1) obtaining medication history; (2) providing
4 the offer for counseling by a pharmacist or student
5 pharmacist; and (3) acquiring a patient's allergies and health
6 conditions.
7 (s) "Patient profiles" or "patient drug therapy record"
8 means the obtaining, recording, and maintenance of patient
9 prescription information, including prescriptions for
10 controlled substances, and personal information.
11 (t) (Blank).
12 (u) "Medical device" or "device" means an instrument,
13 apparatus, implement, machine, contrivance, implant, in vitro
14 reagent, or other similar or related article, including any
15 component part or accessory, required under federal law to
16 bear the label "Caution: Federal law requires dispensing by or
17 on the order of a physician". A seller of goods and services
18 who, only for the purpose of retail sales, compounds, sells,
19 rents, or leases medical devices shall not, by reasons
20 thereof, be required to be a licensed pharmacy.
21 (v) "Unique identifier" means an electronic signature,
22 handwritten signature or initials, thumb print, or other
23 acceptable biometric or electronic identification process as
24 approved by the Department.
25 (w) "Current usual and customary retail price" means the
26 price that a pharmacy charges to a non-third-party payor.
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1 (x) "Automated pharmacy system" means a mechanical system
2 located within the confines of the pharmacy or remote location
3 that performs operations or activities, other than compounding
4 or administration, relative to storage, packaging, dispensing,
5 or distribution of medication, and which collects, controls,
6 and maintains all transaction information.
7 (y) "Drug regimen review" means and includes the
8 evaluation of prescription drug orders and patient records for
9 (1) known allergies; (2) drug or potential therapy
10 contraindications; (3) reasonable dose, duration of use, and
11 route of administration, taking into consideration factors
12 such as age, gender, and contraindications; (4) reasonable
13 directions for use; (5) potential or actual adverse drug
14 reactions; (6) drug-drug interactions; (7) drug-food
15 interactions; (8) drug-disease contraindications; (9)
16 therapeutic duplication; (10) patient laboratory values when
17 authorized and available; (11) proper utilization (including
18 over or under utilization) and optimum therapeutic outcomes;
19 and (12) abuse and misuse.
20 (z) "Electronically transmitted prescription" means a
21 prescription that is created, recorded, or stored by
22 electronic means; issued and validated with an electronic
23 signature; and transmitted by electronic means directly from
24 the prescriber to a pharmacy. An electronic prescription is
25 not an image of a physical prescription that is transferred by
26 electronic means from computer to computer, facsimile to
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1 facsimile, or facsimile to computer.
2 (aa) "Medication therapy management services" means a
3 distinct service or group of services offered by licensed
4 pharmacists, physicians licensed to practice medicine in all
5 its branches, advanced practice registered nurses authorized
6 in a written agreement with a physician licensed to practice
7 medicine in all its branches, or physician assistants
8 authorized in guidelines by a supervising physician that
9 optimize therapeutic outcomes for individual patients through
10 improved medication use. In a retail or other non-hospital
11 pharmacy, medication therapy management services shall consist
12 of the evaluation of prescription drug orders and patient
13 medication 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
5 following:
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
17 patient care functions authorized by a physician licensed to
18 practice medicine in all its branches for his or her
19 identified patient or groups of patients under specified
20 conditions or limitations in a standing order from the
21 physician.
22 "Medication therapy management services" in a licensed
23 hospital 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
4 of medication therapy management services, with or without the
5 dispensing of drugs or devices, intended to achieve outcomes
6 that improve patient health, quality of life, and comfort and
7 enhance patient safety.
8 (cc) "Protected health information" means individually
9 identifiable health information that, except as otherwise
10 provided, 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
18 individually 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
24 or group of patients issued by a physician licensed to
25 practice medicine in all its branches in Illinois.
26 (ee) "Address of record" means the designated address
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1 recorded by the Department in the applicant's application file
2 or licensee's license file maintained by the Department's
3 licensure maintenance unit.
4 (ff) "Home pharmacy" means the location of a pharmacy's
5 primary operations.
6 (gg) "Email address of record" means the designated email
7 address recorded by the Department in the applicant's
8 application file or the licensee's license file, as maintained
9 by the Department's licensure maintenance unit.
10 (Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
11 102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
12 1-1-23; 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
17 electronic file to maintain required dispensing information.
18 (b) Pharmacies using such a common electronic file are not
19 required to physically transfer prescriptions or information
20 for dispensing purposes between or among pharmacies
21 participating in the same common prescription file; provided,
22 however any such common file must contain complete and
23 adequate records of such prescription and refill dispensed as
24 stated in Section 18.
25 (c) The Department may formulate such rules, not
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1 inconsistent with law, as may be necessary to carry out the
2 purposes of and to enforce the provisions of this Section
3 within the following exception: The Department shall not
4 impose greater requirements on either common electronic files
5 or a hard copy record system.
6 (d) Drugs shall in no event be dispensed more frequently
7 or in larger amounts than the prescriber ordered without
8 direct prescriber authorization by way of a new prescription
9 order.
10 (e) The dispensing by a pharmacist licensed in this State
11 or another state of a prescription contained in a common
12 database shall not constitute a transfer, provided that (1)
13 all pharmacies involved in the transactions pursuant to which
14 the prescription is dispensed and all pharmacists engaging in
15 dispensing functions are properly licensed, permitted, or
16 registered in this State or another jurisdiction, (2) a policy
17 and procedures manual that governs all participating
18 pharmacies and pharmacists is available to the Department upon
19 request and includes the procedure for maintaining appropriate
20 records for regulatory oversight for tracking a prescription
21 during each stage of the filling and dispensing process, and
22 (3) the pharmacists involved in filling and dispensing the
23 prescription and counseling the patient are identified. A
24 pharmacist shall be accountable only for the specific tasks
25 performed.
26 (f) Nothing in this Section shall prohibit a pharmacist
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1 who is exercising his or her professional judgment from
2 dispensing additional quantities of medication up to the total
3 number of dosage units authorized by the prescriber on the
4 original prescription and any refills.
5 (g) A pharmacist who is exercising his or her professional
6 judgment 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
19 if it is in the best interest of patient care, so long as the
20 prescriber's directions are also modified to equate to an
21 equivalent amount of drug dispensed as prescribed.
22 A pharmacist may complete missing information on a
23 prescription 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
4 distributor of a prescription drug, or any person on behalf of
5 such manufacturer or distributor, to distribute a prescription
6 drug without charge or for less than its fair market value to
7 any person directly or indirectly.
8 Nothing in this Section shall be construed to prohibit the
9 distribution 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
2 to dispense a prescription drug below fair market value,
3 including the cost of dispensing. Any payor that reimburses a
4 pharmacy below fair market value, including the cost of
5 dispensing, shall not be able to include this pharmacy towards
6 any network adequacy requirements and shall not be in
7 compliance with any willing provider provisions.
8 (Source: P.A. 85-796.)
9 Section 15. The Illinois Public Aid Code is amended by
10 changing 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
14 reimbursement under this Article for prescription drugs
15 provided to a recipient of aid under this Article shall
16 include the name of the prescriber or an acceptable
17 identification number as established by the Department.
18 (b) Pharmacies providing prescription drugs under this
19 Article shall be reimbursed at a rate which shall include a
20 professional dispensing fee as determined by the Illinois
21 Department, plus the current acquisition cost of the
22 prescription drug dispensed. The Illinois Department shall
23 update its information on the acquisition costs of all
24 prescription drugs no less frequently than every 30 days.
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1 However, the Illinois Department may set the rate of
2 reimbursement for the acquisition cost, by rule, at a
3 percentage of the current average wholesale acquisition cost.
4 (c) (Blank).
5 (d) The Department shall review utilization of narcotic
6 medications in the medical assistance program and impose
7 utilization controls that protect against abuse.
8 (e) When making determinations as to which drugs shall be
9 on a prior approval list, the Department shall include as part
10 of the analysis for this determination, the degree to which a
11 drug may affect individuals in different ways based on factors
12 including the gender of the person taking the medication.
13 (f) The Department shall cooperate with the Department of
14 Public Health and the Department of Human Services Division of
15 Mental Health in identifying psychotropic medications that,
16 when given in a particular form, manner, duration, or
17 frequency (including "as needed") in a dosage, or in
18 conjunction with other psychotropic medications to a nursing
19 home resident or to a resident of a facility licensed under the
20 ID/DD Community Care Act or the MC/DD Act, may constitute a
21 chemical restraint or an "unnecessary drug" as defined by the
22 Nursing Home Care Act or Titles XVIII and XIX of the Social
23 Security Act and the implementing rules and regulations. The
24 Department shall require prior approval for any such
25 medication prescribed for a nursing home resident or to a
26 resident of a facility licensed under the ID/DD Community Care
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1 Act or the MC/DD Act, that appears to be a chemical restraint
2 or an unnecessary drug. The Department shall consult with the
3 Department of Human Services Division of Mental Health in
4 developing a protocol and criteria for deciding whether to
5 grant such prior approval.
6 (g) The Department may by rule provide for reimbursement
7 of the dispensing of a 90-day supply of a generic or brand
8 name, non-narcotic maintenance medication in circumstances
9 where it is cost effective.
10 (g-5) On and after July 1, 2012, the Department may
11 require the dispensing of drugs to nursing home residents be
12 in a 7-day supply or other amount less than a 31-day supply.
13 The Department shall pay only one dispensing fee per 31-day
14 supply.
15 (h) Effective July 1, 2011, the Department shall
16 discontinue coverage of select over-the-counter drugs,
17 including analgesics and cough and cold and allergy
18 medications.
19 (h-5) On and after July 1, 2012, the Department shall
20 impose utilization controls, including, but not limited to,
21 prior approval on specialty drugs, oncolytic drugs, drugs for
22 the treatment of HIV or AIDS, immunosuppressant drugs, and
23 biological products in order to maximize savings on these
24 drugs. The Department may adjust payment methodologies for
25 non-pharmacy billed drugs in order to incentivize the
26 selection of lower-cost drugs. For drugs for the treatment of
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1 AIDS, the Department shall take into consideration the
2 potential for non-adherence by certain populations, and shall
3 develop protocols with organizations or providers primarily
4 serving those with HIV/AIDS, as long as such measures intend
5 to maintain cost neutrality with other utilization management
6 controls such as prior approval. For hemophilia, the
7 Department shall develop a program of utilization review and
8 control which may include, in the discretion of the
9 Department, prior approvals. The Department may impose special
10 standards on providers that dispense blood factors which shall
11 include, in the discretion of the Department, staff training
12 and education; patient outreach and education; case
13 management; in-home patient assessments; assay management;
14 maintenance of stock; emergency dispensing timeframes; data
15 collection and reporting; dispensing of supplies related to
16 blood factor infusions; cold chain management and packaging
17 practices; care coordination; product recalls; and emergency
18 clinical consultation. The Department may require patients to
19 receive a comprehensive examination annually at an appropriate
20 provider in order to be eligible to continue to receive blood
21 factor.
22 (i) On and after July 1, 2012, the Department shall reduce
23 any rate of reimbursement for services or other payments or
24 alter any methodologies authorized by this Code to reduce any
25 rate of reimbursement for services or other payments in
26 accordance with Section 5-5e.
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1 (j) On and after July 1, 2012, the Department shall impose
2 limitations on prescription drugs such that the Department
3 shall not provide reimbursement for more than 4 prescriptions,
4 including 3 brand name prescriptions, for distinct drugs in a
5 30-day period, unless prior approval is received for all
6 prescriptions in excess of the 4-prescription limit. Drugs in
7 the following therapeutic classes shall not be subject to
8 prior approval as a result of the 4-prescription limit:
9 immunosuppressant drugs, oncolytic drugs, anti-retroviral
10 drugs, and, on or after July 1, 2014, antipsychotic drugs. On
11 or after July 1, 2014, the Department may exempt children with
12 complex medical needs enrolled in a care coordination entity
13 contracted with the Department to solely coordinate care for
14 such children, if the Department determines that the entity
15 has a comprehensive drug reconciliation program.
16 (k) No medication therapy management program implemented
17 by the Department shall be contrary to the provisions of the
18 Pharmacy Practice Act.
19 (l) Any provider enrolled with the Department that bills
20 the Department for outpatient drugs and is eligible to enroll
21 in the federal Drug Pricing Program under Section 340B of the
22 federal Public Health Service Act shall enroll in that
23 program. No entity participating in the federal Drug Pricing
24 Program under Section 340B of the federal Public Health
25 Service Act may exclude fee-for-service Medicaid from their
26 participation in that program, however, entities defined in
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1 Section 1905(l)(2)(B) of the Social Security Act are excluded
2 from this requirement. This subsection does not apply to
3 outpatient drugs billed to Medicaid managed care
4 organizations.
5 (m) Notwithstanding any other provision of this Code to
6 the contrary, vaccines ordered and administered by a
7 pharmacist as described in
subsection (d) of Section 3 of the
8 Pharmacy Practice Act shall be covered and reimbursed at no
9 less than the rate that the vaccine is reimbursed at when
10 ordered and administered by a physician licensed to practice
11 medicine in all its branches.
12 (Source: P.A. 102-558, eff. 8-20-21; 102-778, eff. 7-1-22.)
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