101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
SB3147

 

Introduced 2/6/2020, by Sen. Sara Feigenholtz

 

SYNOPSIS AS INTRODUCED:
 
20 ILCS 2310/2310-701 new
215 ILCS 5/356z.33 new
225 ILCS 85/3
305 ILCS 5/5-5.12c new

    Amends the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois. Provides that the Director of Public Health shall establish a standing order complete with the issuance of a prescription for a smoking cessation product. Prescribes minimum requirements for the standing order. Amends the Illinois Insurance Code. Provides that a group or individual policy of accident and health insurance or a managed care plan that is amended, delivered, issued, or renewed after the effective date of the amendatory Act shall provide coverage for patient care services provided by a pharmacist for smoking cessation assessments and consultations. Amends the Pharmacy Practice Act. Provides that the "practice of pharmacy" includes the assessment and consultation of patients and dispensing of tobacco and nicotine cessation drugs and products. Amends the Illinois Public Aid Code. Provides that, subject to approval by the federal Centers for Medicare and Medicaid Services, the medical assistance program shall cover patient care services provided by a pharmacist for smoking cessation assessments and consultations. Defines terms. Effective January 1, 2020.


LRB101 09463 JRG 54561 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

SB3147LRB101 09463 JRG 54561 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 Department of Public Health Powers and
5Duties Law of the Civil Administrative Code of Illinois is
6amended by adding Section 2310-701 as follows:
 
7    (20 ILCS 2310/2310-701 new)
8    Sec. 2310-701. Tobacco and nicotine cessation drugs and
9products; standing order.
10    (a) If the Director of Public Health is a physician
11licensed to practice medicine in all its branches in the State,
12the Director shall establish a standing order complete with the
13issuance of a prescription for a smoking cessation product in
14accordance with this Section. If the Director is not a
15physician licensed to practice medicine in all its branches in
16the State, then the Medical Director of the Department of
17Public Health shall establish a standing order in accordance
18with this Section.
19    (b) The standing order, at a minimum, shall require
20compliance with the following before a smoking cessation
21product may be dispensed:
22        (1) A pharmacist shall have the patient complete the
23    self-screening risk assessment tool. The self-screening

 

 

SB3147- 2 -LRB101 09463 JRG 54561 b

1    risk assessment tool is to be based on the Modified
2    Fagerstrom Test for Nicotine Dependence, or United States
3    Food and Drug Administration-approved functional
4    equivalent for nicotine dependence.
5        (2) Based upon the results of the self-screening risk
6    assessment and the patient assessment the pharmacist shall
7    use his or her professional and clinical judgment as to
8    when a patient should be referred to the patient's
9    physician or another health care provider.
10        (3) The pharmacist shall provide counseling and
11    education about all available smoking cessation products
12    during the patient assessment and consultation, including
13    the indications, contraindications, proper use,
14    effectiveness of smoking cessation products, and any other
15    information that is required to be given to a patient
16    during the counseling process.
17        (4) The patient consultation shall take place in a
18    private manner consistent with rules adopted by the
19    Department of Financial and Professional Regulation.
20    (c) The Department shall adopt rules that require a
21pharmacist to:
22        (1) complete an educational training program
23    accredited by the Accreditation Council for Pharmacy
24    Education and approved by the Department that is related to
25    the patient self-screening risk assessment, patient
26    assessment, smoking cessation counseling and education,

 

 

SB3147- 3 -LRB101 09463 JRG 54561 b

1    and dispensation of smoking cessation products; and
2        (2) dispense smoking cessation products to patients as
3    soon as practicable after meeting the requirements of
4    paragraph (1) of subsection (b).
5    (d) All State and federal laws governing insurance coverage
6of smoking cessation products shall apply to smoking cessation
7products dispensed by a pharmacist under this Section.
8    (e) Nothing in this Section prohibits a licensed pharmacist
9from participating in the initiation, management,
10modification, and discontinuation of therapy through a
11standing order as allowed in this Section.
12    (f) In this Section, "smoking cessation product" means a
13prescribed medically acceptable oral drug, transdermal patch,
14chewing gum, or lozenge that is approved by the United States
15Food and Drug Administration to quit smoking.
 
16    Section 10. The Illinois Insurance Code is amended by
17adding Section 356z.33 as follows:
 
18    (215 ILCS 5/356z.33 new)
19    Sec. 356z.33. Coverage for smoking cessation services and
20products. A group or individual policy of accident and health
21insurance or a managed care plan that is amended, delivered,
22issued, or renewed after the effective date of this amendatory
23Act of the 101st General Assembly shall provide coverage for
24patient care services and smoking cessation products provided

 

 

SB3147- 4 -LRB101 09463 JRG 54561 b

1by a pharmacist for smoking cessation assessments and
2consultation.
 
3    Section 15. The Pharmacy Practice Act is amended by
4changing Section 3 as follows:
 
5    (225 ILCS 85/3)
6    (Section scheduled to be repealed on January 1, 2020)
7    Sec. 3. Definitions. For the purpose of this Act, except
8where otherwise limited therein:
9    (a) "Pharmacy" or "drugstore" means and includes every
10store, shop, pharmacy department, or other place where
11pharmacist care is provided by a pharmacist (1) where drugs,
12medicines, or poisons are dispensed, sold or offered for sale
13at retail, or displayed for sale at retail; or (2) where
14prescriptions of physicians, dentists, advanced practice
15registered nurses, physician assistants, veterinarians,
16podiatric physicians, or optometrists, within the limits of
17their licenses, are compounded, filled, or dispensed; or (3)
18which has upon it or displayed within it, or affixed to or used
19in connection with it, a sign bearing the word or words
20"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
21"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
22"Drugs", "Dispensary", "Medicines", or any word or words of
23similar or like import, either in the English language or any
24other language; or (4) where the characteristic prescription

 

 

SB3147- 5 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 6 -LRB101 09463 JRG 54561 b

1    in the monitoring, evaluation, and implementation of
2    prescription drug orders;
3        (2) the dispensing of prescription drug orders;
4        (3) participation in drug and device selection;
5        (4) drug administration limited to the administration
6    of oral, topical, injectable, and inhalation as follows:
7            (A) in the context of patient education on the
8        proper use or delivery of medications;
9            (B) vaccination of patients 14 years of age and
10        older pursuant to a valid prescription or standing
11        order, by a physician licensed to practice medicine in
12        all its branches, upon completion of appropriate
13        training, including how to address contraindications
14        and adverse reactions set forth by rule, with
15        notification to the patient's physician and
16        appropriate record retention, or pursuant to hospital
17        pharmacy and therapeutics committee policies and
18        procedures; and
19            (C) administration of injections of
20        alpha-hydroxyprogesterone caproate, pursuant to a
21        valid prescription, by a physician licensed to
22        practice medicine in all its branches, upon completion
23        of appropriate training, including how to address
24        contraindications and adverse reactions set forth by
25        rule, with notification to the patient's physician and
26        appropriate record retention, or pursuant to hospital

 

 

SB3147- 7 -LRB101 09463 JRG 54561 b

1        pharmacy and therapeutics committee policies and
2        procedures;
3        (5) vaccination of patients ages 10 through 13 limited
4    to the Influenza (inactivated influenza vaccine and live
5    attenuated influenza intranasal vaccine) and Tdap (defined
6    as tetanus, diphtheria, acellular pertussis) vaccines,
7    pursuant to a valid prescription or standing order, by a
8    physician licensed to practice medicine in all its
9    branches, upon completion of appropriate training,
10    including how to address contraindications and adverse
11    reactions set forth by rule, with notification to the
12    patient's physician and appropriate record retention, or
13    pursuant to hospital pharmacy and therapeutics committee
14    policies and procedures;
15        (6) drug regimen review;
16        (7) drug or drug-related research;
17        (8) the provision of patient counseling;
18        (9) the practice of telepharmacy;
19        (10) the provision of those acts or services necessary
20    to provide pharmacist care;
21        (11) medication therapy management; and
22        (12) the responsibility for compounding and labeling
23    of drugs and devices (except labeling by a manufacturer,
24    repackager, or distributor of non-prescription drugs and
25    commercially packaged legend drugs and devices), proper
26    and safe storage of drugs and devices, and maintenance of

 

 

SB3147- 8 -LRB101 09463 JRG 54561 b

1    required records; and .
2        (13) the assessment and consultation of patients and
3    dispensing of tobacco and nicotine cessation drugs and
4    products pursuant to the standing order under Section
5    2310-701 of the Department of Public Health Powers and
6    Duties Law of the Civil Administrative Code of Illinois.
7    A pharmacist who performs any of the acts defined as the
8practice of pharmacy in this State must be actively licensed as
9a pharmacist under this Act.
10    (e) "Prescription" means and includes any written, oral,
11facsimile, or electronically transmitted order for drugs or
12medical devices, issued by a physician licensed to practice
13medicine in all its branches, dentist, veterinarian, podiatric
14physician, or optometrist, within the limits of his or her
15license, by a physician assistant in accordance with subsection
16(f) of Section 4, or by an advanced practice registered nurse
17in accordance with subsection (g) of Section 4, containing the
18following: (1) name of the patient; (2) date when prescription
19was issued; (3) name and strength of drug or description of the
20medical device prescribed; and (4) quantity; (5) directions for
21use; (6) prescriber's name, address, and signature; and (7) DEA
22registration number where required, for controlled substances.
23The prescription may, but is not required to, list the illness,
24disease, or condition for which the drug or device is being
25prescribed. DEA registration numbers shall not be required on
26inpatient drug orders. A prescription for medication other than

 

 

SB3147- 9 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 10 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 11 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 12 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 13 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 14 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 15 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 16 -LRB101 09463 JRG 54561 b

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

 

 

SB3147- 17 -LRB101 09463 JRG 54561 b

1or group of patients issued by a physician licensed to practice
2medicine in all its branches in Illinois.
3    (ee) "Address of record" means the designated address
4recorded by the Department in the applicant's application file
5or licensee's license file maintained by the Department's
6licensure maintenance unit.
7    (ff) "Home pharmacy" means the location of a pharmacy's
8primary operations.
9    (gg) "Email address of record" means the designated email
10address recorded by the Department in the applicant's
11application file or the licensee's license file, as maintained
12by the Department's licensure maintenance unit.
13(Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18;
14100-497, eff. 9-8-17; 100-513, eff. 1-1-18; 100-804, eff.
151-1-19; 100-863, eff. 8-14-18.)
 
16    Section 20. The Illinois Public Aid Code is amended by
17adding Section 5-5.12c as follows:
 
18    (305 ILCS 5/5-5.12c new)
19    Sec. 5-5.12c. Coverage for patient care services for
20tobacco and nicotine cessation drugs and products provided by a
21pharmacist.
22    (a) Subject to approval by the federal Centers for Medicare
23and Medicaid Services, the medical assistance program,
24including both the fee-for-service and managed care medical

 

 

SB3147- 18 -LRB101 09463 JRG 54561 b

1assistance programs established under this Article, shall
2cover patient care services provided by a pharmacist for
3smoking cessation assessments and consultations.
4    (b) The Department shall establish a fee schedule for
5patient care services provided by a pharmacist for smoking
6cessation assessments and consultations.
7    (c) The rate of reimbursement for patient care services
8provided by a pharmacist for smoking cessation assessments and
9consultations shall be at 85% of the fee schedule for physician
10services by the medical assistance program.
11    (d) A pharmacist must be enrolled in the medical assistance
12program as an ordering and referring provider prior to
13providing smoking cessation assessments and consultations that
14are submitted by a pharmacy or pharmacist provider for
15reimbursement pursuant to this Section.
16    (e) The Director shall seek any necessary federal waivers
17or approvals to implement this Section. This Section shall not
18be implemented until the receipt of all necessary federal
19waivers or approvals or until January 1, 2022, whichever comes
20first. If federal approval is not obtained by January 1, 2022,
21the provisions of this Section shall be implemented using State
22funds.
23    (f) This Section does not restrict or prohibit any services
24currently provided by pharmacists as authorized by law,
25including, but not limited to, pharmacist services provided
26under this Code.

 

 

SB3147- 19 -LRB101 09463 JRG 54561 b

1    (g) The Department shall adopt administrative rules for
2this Section as soon as practicable but no later than May 1,
32020.
 
4    Section 99. Effective date. This Act takes effect January
51, 2020.