Public Act 0477 103RD GENERAL ASSEMBLY

  
  
  
 

 
Public Act 103-0477
 
SB0285 EnrolledLRB103 25015 RLC 51349 b


  
    AN ACT concerning criminal law.
  
 
    Be it enacted by the People of the State of Illinois,
 
represented in the General Assembly:
  



 
 
    Section 5. The Illinois Controlled Substances Act is 
amended  by changing Sections 316 and 317 and by adding Section 
316.1 as follows:
 



    (720 ILCS 570/316)


    Sec. 316. Prescription Monitoring Program. 
    (a) The Department must provide for a
Prescription 
Monitoring Program for Schedule II, III, IV, and V controlled 
substances that includes the following components and 
requirements:

        (1) The

dispenser must transmit to the
central 
    repository, in a form and manner specified by the 
    Department, the following information:

            (A) The recipient's name and address.

            (B) The recipient's date of birth and gender.

            (C) The national drug code number of the 
        controlled
substance
dispensed.

            (D) (Blank). The date the controlled substance is 
        dispensed.

            (E) The quantity of the controlled substance 
        dispensed and days supply.

            (F) The dispenser's United States Drug Enforcement 
        Administration

registration number.

            (G) The prescriber's United States Drug 
        Enforcement Administration

registration number.

            (H) The dates the controlled substance 
        prescription is filled.
            (I) The payment type used to purchase the 
        controlled substance (i.e. Medicaid, cash, third party 
        insurance).
            (J) The patient location code (i.e. home, nursing    
        home, outpatient, etc.) for the controlled substances       
        other than those filled at a retail pharmacy.
            (K) Any additional information that may be 
        required by the department by administrative rule, 
        including but not limited to  information required for 
        compliance with the criteria for electronic reporting 
        of the American Society for Automation and Pharmacy or 
        its successor. 
        (2) The information required to be transmitted under 
    this Section must be
transmitted not later than the end of 
    the business day on which a
 controlled substance is 
    dispensed, or at such other time as may be required by the 
    Department by administrative rule.

        (3) A dispenser must transmit electronically, as 
    provided by Department rule, the information required to 
    be transmitted under this Section.
by:

            (A) an electronic device compatible with the 
        receiving device of the
central repository;

            (B) a computer diskette;

            (C) a magnetic tape; or

            (D) a pharmacy universal claim form or Pharmacy 
        Inventory Control form.

        (3.5) The requirements of paragraphs (1), (2), and (3)
 
    of this subsection  also apply to opioid treatment programs 
    that are
 licensed or certified by the Department of Human 
    Services'
Division of Substance Use Prevention and 
    Recovery and are
authorized by the federal Drug 
    Enforcement Administration to
prescribe Schedule II, III, 
    IV, or V controlled substances for
 the treatment of opioid 
    use disorders. Opioid treatment
 programs shall attempt to 
    obtain written patient consent, shall document attempts to 
    obtain the written consent, and shall not transmit 
    information without patient
 consent. Documentation 
    obtained under this paragraph shall not be utilized for 
    law
 enforcement purposes, as proscribed under  42 CFR 2,
 as 
    amended by 42 U.S.C. 290dd-2. Treatment of a patient
shall 
    not be conditioned upon his or her written consent. 
        (4)  The Department may impose a civil fine of up to 
    $100 per day for willful failure to report controlled 
    substance dispensing to the Prescription Monitoring 
    Program. The fine shall be calculated on no more than the 
    number of days from the time the report was required to be 
    made until the time the problem was resolved, and shall be 
    payable to the Prescription Monitoring Program. 

    (a-5) Notwithstanding subsection (a), a licensed 
veterinarian is exempt from the reporting requirements of this 
Section. If a person who is presenting an animal for treatment 
is suspected of fraudulently obtaining any controlled 
substance or prescription for a controlled substance, the 
licensed veterinarian shall report that information to the 
local law enforcement agency. 
    (b) The Department, by rule, may include in the 
Prescription Monitoring Program certain other select drugs 
that are not included in Schedule II, III, IV, or V. The 
Prescription Monitoring Program does not apply to
 controlled 
substance prescriptions as exempted under Section
313.

    (c) The collection of data on select drugs and scheduled 
substances by the Prescription Monitoring Program may be used 
as a tool for addressing oversight requirements of long-term 
care institutions as set forth by Public Act 96-1372.  
Long-term care pharmacies shall transmit patient medication 
profiles to the Prescription Monitoring Program monthly or 
more frequently as established by administrative rule. 
    (d) The Department of Human Services shall appoint a 
full-time Clinical Director of the Prescription Monitoring 
Program.
    (e) (Blank). 
    (f) It is the responsibility of any new, ceased, or 
unconnected healthcare facility and its selected Electronic 
Health Records System  or Pharmacy Management System to make 
contact with and ensure integration with the Prescription 
Monitoring Program.

As soon as practicable after the effective 
date of this amendatory Act of the 103rd General Assembly, the 
Department shall adopt rules requiring Electronic Health 
Records Systems and Pharmacy Management Systems to interface, 
by January 1, 2024, with the Prescription Monitoring Program 
to ensure that providers have access to specific patient 
records during the treatment of their patients.  The Department 
shall identify actions to be taken if a prescriber's 
Electronic Health Records System and Pharmacy Management 
Systems does not effectively interface with the Prescription 
Monitoring Program once the Prescription Monitoring Program is 
aware of the non-integrated connection. Within one year of 
January 1, 2018 (the effective date of Public Act 100-564), 
the Department shall adopt rules requiring all Electronic 
Health Records Systems to interface with the Prescription 
Monitoring Program application program on or before January 1, 
2021 to ensure that all providers have access to specific 
patient records during the treatment of their patients. These 
rules shall also address the electronic integration of 
pharmacy records with the Prescription Monitoring Program to 
allow for faster transmission of the information required 
under this Section. The Department shall establish actions to 
be taken if a prescriber's Electronic Health Records System 
does not effectively interface with the Prescription 
Monitoring Program within the required timeline.
    (g) The Department, in consultation with the Prescription 
Monitoring Program Advisory Committee, shall adopt rules 
allowing licensed prescribers or pharmacists who have 
registered to access the Prescription Monitoring Program to 
authorize a licensed or non-licensed designee employed in that 
licensed prescriber's office or a licensed designee in a 
licensed pharmacist's pharmacy who has received training in 
the federal Health Insurance Portability and Accountability 
Act and 42 CFR 2 to consult the Prescription Monitoring 
Program on their behalf.  The rules shall include reasonable 
parameters concerning a practitioner's authority to authorize 
a designee, and the eligibility of a person to be selected as a 
designee. In this subsection (g), "pharmacist" shall include a 
clinical pharmacist employed by and designated by a Medicaid 
Managed Care Organization providing services under Article V 
of the Illinois Public Aid Code under a contract with the 
Department of Healthcare and Family Services for the sole 
purpose of clinical review of services provided to persons 
covered by the entity under the contract to determine 
compliance with subsections (a) and (b) of Section 314.5 of 
this Act.  A managed care entity pharmacist shall notify 
prescribers of review activities.
(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19; 
102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)

 
    (720 ILCS 570/316.1 new)
    Sec. 316.1. Access to the integration of pharmacy records 
with the Prescription Monitoring Program.
    (a)  Subject to the requirements and limitations set out in 
this Section and in administrative rule, the Department shall 
not require, either expressly or effectively, Electronic 
Health Records Systems, pharmacies, or other providers to 
utilize a particular entity or system for access to the 
integration of pharmacy records with the Prescription 
Monitoring Program.
        (1)   Any entity or system for integration (transmitting 
    the data maintained by the Prescription Monitoring 
    Program) into an Electronic Health Records System, 
    Certified Health IT Module, Pharmacy Dispensing System, or 
    Pharmacy Management System must meet applicable 
    requirements outlined in administrative rule, including, 
    but not limited to, the following:
            (A)   enter into a data sharing agreement with the 
        Department of Human Services, Prescription Monitoring 
        Program;
            (B)   all security requirements noted within this 
        Section, administrative rule, and all other applicable 
        State and federal security and privacy requirements;
            (C)   the Prescription Monitoring Program shall have 
        administrative control over the approval of each site 
        and individual integration point and the Prescription 
        Monitoring Program shall have the ability to disable 
        individual integration points, at no additional cost 
        to the State;
            (D)   interstate data sharing shall be completed 
        with written authorization from the Prescription 
        Monitoring Program;
            (E)   data available from the Prescription 
        Monitoring Program shall not be stored, cached, or 
        sold and the State may inspect and review an entity or 
        system for integration to assure and confirm the same, 
        subject to a reasonable non-disclosure agreement, as 
        permitted by State law, to protect the entity's or 
        system's trade secrets or other proprietary 
        information;
            (F)   analysis of data shall only be allowed with 
        express written permission from the Prescription 
        Monitoring Program; and
            (G)   access to audit data, shall be available in 
        hourly to real-time increments at no cost to the 
        State.
        (2)   Electronic Health Record Systems, Certified Health 
    IT Modules, Pharmacy Management Systems, and Pharmacy 
    Dispensing Systems integrated with the Prescription 
    Monitoring Program must meet applicable requirements 
    outlined in rule, including, but not limited to, the 
    following:
            (A) provide their customers (healthcare entity, 
        pharmacy, provider, prescriber, dispenser, etc.) the 
        choice of approved integration vendor, meeting the 
        requirements of this Section and administrative rule, 
        or direct connect to the Illinois Prescription 
        Monitoring Program;
            (B) provide their customers with access to the 
        data provided by the customer's chosen integration 
        vendor as allowed under State and federal statute; and
            (C) follow all State and federal security and 
        privacy standards.
        (3) Customers required to integrate under State or 
    federal law must meet the requirements outlined in 
    administrative rule, including, but not limited to, the 
    following:
            (A) the customer retains the choice of which 
        integration vendor or direct connect is utilized to 
        connect to the Illinois Prescription Monitoring 
        Program; and
            (B) customers seeking to contract with a new 
        integration vendor, shall enter into a memorandum of 
        understanding with the Prescription Monitoring 
        Program.
    (b)  The Illinois Prescription Monitoring Program may 
exercise the power, by rule, to require Memoranda of 
Understanding with all customers. The general contents of the 
memorandum of understanding shall be set out in rule and shall 
include, but not be limited to:
        (1) the acknowledgment and choice of the customer of 
    the method of integration with the Prescription Monitoring 
    Program and
        (2) the data use and other requirements on the 
    customer in accessing and using the Prescription 
    Monitoring Program.
    A fee cannot be levied as part of a memorandum of 
understanding required by the Department under this Section.
    (c)  Non-compliance by the Integration Vendor, Electronic 
Health Record System, Certified Health IT Module, Pharmacy 
Management System or Pharmacy Dispensing System, customer, or 
any parties required to comply with this Section may result in 
the party being prohibited from serving as entity or system 
for integration with the Prescription Monitoring Program, 
termination of contracts, agreements, or other business 
relationships. The Department shall institute appropriate cure 
notices, as necessary to remedy non-compliance.
 



    (720 ILCS 570/317)



    Sec. 317. Central repository for collection of 
information. 

    (a) The Department must designate a central repository for

the collection of information transmitted under Section 316 
and former Section 321.

    (b) The central repository must do the following:

        (1) Create a database for information required to be 
    transmitted under
Section 316 in the form required under 
    rules adopted by the
Department, including search 
    capability for the following:

            (A) A recipient's name and address.

            (B) A recipient's date of birth and gender.

            (C) The national drug code number of a controlled 
        substance
dispensed.

            (D) (Blank). The dates a controlled substance is 
        dispensed.

            (E) The quantities and days supply of a controlled 
        substance dispensed.

            (F) A dispenser's Administration

registration 
        number.

            (G) A prescriber's Administration

registration 
        number.

            (H) The dates the controlled substance 
        prescription is filled.
            (I) The payment type used to purchase the    
        controlled substance (i.e. Medicaid, cash, third party 
        insurance).
            (J) The patient location code (i.e. home, nursing       
        home, outpatient, etc.) for controlled substance 
        prescriptions other than those filled at a retail 
        pharmacy. 
        (2) Provide the Department with a database maintained 
    by the central
repository.  The Department of Financial and

    Professional
Regulation must provide the
Department with 
    electronic access to the license information of a 
    prescriber or
dispenser.

        (3) Secure the information collected by the central 
    repository and the
database maintained by the central 
    repository against access by unauthorized
persons.
    All prescribers shall designate one or more medical 
specialties or fields of medical care and treatment for which 
the prescriber prescribes controlled substances when 
registering with the Prescription Monitoring Program. 
    No fee shall be charged for access by a prescriber or 
dispenser.


(Source: P.A. 99-480, eff. 9-9-15.)

  
 
    Section 99. Effective date. This Act takes effect upon 
becoming law, except that Section 316.1 takes effect July 1, 
2024.