SB0285 EnrolledLRB103 25015 RLC 51349 b

1    AN ACT concerning criminal law.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Controlled Substances Act is
5amended by changing Sections 316 and 317 and by adding Section
6316.1 as follows:
 
7    (720 ILCS 570/316)
8    Sec. 316. Prescription Monitoring Program.
9    (a) The Department must provide for a Prescription
10Monitoring Program for Schedule II, III, IV, and V controlled
11substances that includes the following components and
12requirements:
13        (1) The dispenser must transmit to the central
14    repository, in a form and manner specified by the
15    Department, the following information:
16            (A) The recipient's name and address.
17            (B) The recipient's date of birth and gender.
18            (C) The national drug code number of the
19        controlled substance dispensed.
20            (D) (Blank). The date the controlled substance is
21        dispensed.
22            (E) The quantity of the controlled substance
23        dispensed and days supply.

 

 

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1            (F) The dispenser's United States Drug Enforcement
2        Administration registration number.
3            (G) The prescriber's United States Drug
4        Enforcement Administration registration number.
5            (H) The dates the controlled substance
6        prescription is filled.
7            (I) The payment type used to purchase the
8        controlled substance (i.e. Medicaid, cash, third party
9        insurance).
10            (J) The patient location code (i.e. home, nursing
11        home, outpatient, etc.) for the controlled substances
12        other than those filled at a retail pharmacy.
13            (K) Any additional information that may be
14        required by the department by administrative rule,
15        including but not limited to information required for
16        compliance with the criteria for electronic reporting
17        of the American Society for Automation and Pharmacy or
18        its successor.
19        (2) The information required to be transmitted under
20    this Section must be transmitted not later than the end of
21    the business day on which a controlled substance is
22    dispensed, or at such other time as may be required by the
23    Department by administrative rule.
24        (3) A dispenser must transmit electronically, as
25    provided by Department rule, the information required to
26    be transmitted under this Section. by:

 

 

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1            (A) an electronic device compatible with the
2        receiving device of the central repository;
3            (B) a computer diskette;
4            (C) a magnetic tape; or
5            (D) a pharmacy universal claim form or Pharmacy
6        Inventory Control form.
7        (3.5) The requirements of paragraphs (1), (2), and (3)
8    of this subsection also apply to opioid treatment programs
9    that are licensed or certified by the Department of Human
10    Services' Division of Substance Use Prevention and
11    Recovery and are authorized by the federal Drug
12    Enforcement Administration to prescribe Schedule II, III,
13    IV, or V controlled substances for the treatment of opioid
14    use disorders. Opioid treatment programs shall attempt to
15    obtain written patient consent, shall document attempts to
16    obtain the written consent, and shall not transmit
17    information without patient consent. Documentation
18    obtained under this paragraph shall not be utilized for
19    law enforcement purposes, as proscribed under 42 CFR 2, as
20    amended by 42 U.S.C. 290dd-2. Treatment of a patient shall
21    not be conditioned upon his or her written consent.
22        (4) The Department may impose a civil fine of up to
23    $100 per day for willful failure to report controlled
24    substance dispensing to the Prescription Monitoring
25    Program. The fine shall be calculated on no more than the
26    number of days from the time the report was required to be

 

 

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1    made until the time the problem was resolved, and shall be
2    payable to the Prescription Monitoring Program.
3    (a-5) Notwithstanding subsection (a), a licensed
4veterinarian is exempt from the reporting requirements of this
5Section. If a person who is presenting an animal for treatment
6is suspected of fraudulently obtaining any controlled
7substance or prescription for a controlled substance, the
8licensed veterinarian shall report that information to the
9local law enforcement agency.
10    (b) The Department, by rule, may include in the
11Prescription Monitoring Program certain other select drugs
12that are not included in Schedule II, III, IV, or V. The
13Prescription Monitoring Program does not apply to controlled
14substance prescriptions as exempted under Section 313.
15    (c) The collection of data on select drugs and scheduled
16substances by the Prescription Monitoring Program may be used
17as a tool for addressing oversight requirements of long-term
18care institutions as set forth by Public Act 96-1372.
19Long-term care pharmacies shall transmit patient medication
20profiles to the Prescription Monitoring Program monthly or
21more frequently as established by administrative rule.
22    (d) The Department of Human Services shall appoint a
23full-time Clinical Director of the Prescription Monitoring
24Program.
25    (e) (Blank).
26    (f) It is the responsibility of any new, ceased, or

 

 

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1unconnected healthcare facility and its selected Electronic
2Health Records System or Pharmacy Management System to make
3contact with and ensure integration with the Prescription
4Monitoring Program. As soon as practicable after the effective
5date of this amendatory Act of the 103rd General Assembly, the
6Department shall adopt rules requiring Electronic Health
7Records Systems and Pharmacy Management Systems to interface,
8by January 1, 2024, with the Prescription Monitoring Program
9to ensure that providers have access to specific patient
10records during the treatment of their patients. The Department
11shall identify actions to be taken if a prescriber's
12Electronic Health Records System and Pharmacy Management
13Systems does not effectively interface with the Prescription
14Monitoring Program once the Prescription Monitoring Program is
15aware of the non-integrated connection. Within one year of
16January 1, 2018 (the effective date of Public Act 100-564),
17the Department shall adopt rules requiring all Electronic
18Health Records Systems to interface with the Prescription
19Monitoring Program application program on or before January 1,
202021 to ensure that all providers have access to specific
21patient records during the treatment of their patients. These
22rules shall also address the electronic integration of
23pharmacy records with the Prescription Monitoring Program to
24allow for faster transmission of the information required
25under this Section. The Department shall establish actions to
26be taken if a prescriber's Electronic Health Records System

 

 

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1does not effectively interface with the Prescription
2Monitoring Program within the required timeline.
3    (g) The Department, in consultation with the Prescription
4Monitoring Program Advisory Committee, shall adopt rules
5allowing licensed prescribers or pharmacists who have
6registered to access the Prescription Monitoring Program to
7authorize a licensed or non-licensed designee employed in that
8licensed prescriber's office or a licensed designee in a
9licensed pharmacist's pharmacy who has received training in
10the federal Health Insurance Portability and Accountability
11Act and 42 CFR 2 to consult the Prescription Monitoring
12Program on their behalf. The rules shall include reasonable
13parameters concerning a practitioner's authority to authorize
14a designee, and the eligibility of a person to be selected as a
15designee. In this subsection (g), "pharmacist" shall include a
16clinical pharmacist employed by and designated by a Medicaid
17Managed Care Organization providing services under Article V
18of the Illinois Public Aid Code under a contract with the
19Department of Healthcare and Family Services for the sole
20purpose of clinical review of services provided to persons
21covered by the entity under the contract to determine
22compliance with subsections (a) and (b) of Section 314.5 of
23this Act. A managed care entity pharmacist shall notify
24prescribers of review activities.
25(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19;
26102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)
 

 

 

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1    (720 ILCS 570/316.1 new)
2    Sec. 316.1. Access to the integration of pharmacy records
3with the Prescription Monitoring Program.
4    (a) Subject to the requirements and limitations set out in
5this Section and in administrative rule, the Department shall
6not require, either expressly or effectively, Electronic
7Health Records Systems, pharmacies, or other providers to
8utilize a particular entity or system for access to the
9integration of pharmacy records with the Prescription
10Monitoring Program.
11        (1) Any entity or system for integration (transmitting
12    the data maintained by the Prescription Monitoring
13    Program) into an Electronic Health Records System,
14    Certified Health IT Module, Pharmacy Dispensing System, or
15    Pharmacy Management System must meet applicable
16    requirements outlined in administrative rule, including,
17    but not limited to, the following:
18            (A) enter into a data sharing agreement with the
19        Department of Human Services, Prescription Monitoring
20        Program;
21            (B) all security requirements noted within this
22        Section, administrative rule, and all other applicable
23        State and federal security and privacy requirements;
24            (C) the Prescription Monitoring Program shall have
25        administrative control over the approval of each site

 

 

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1        and individual integration point and the Prescription
2        Monitoring Program shall have the ability to disable
3        individual integration points, at no additional cost
4        to the State;
5            (D) interstate data sharing shall be completed
6        with written authorization from the Prescription
7        Monitoring Program;
8            (E) data available from the Prescription
9        Monitoring Program shall not be stored, cached, or
10        sold and the State may inspect and review an entity or
11        system for integration to assure and confirm the same,
12        subject to a reasonable non-disclosure agreement, as
13        permitted by State law, to protect the entity's or
14        system's trade secrets or other proprietary
15        information;
16            (F) analysis of data shall only be allowed with
17        express written permission from the Prescription
18        Monitoring Program; and
19            (G) access to audit data, shall be available in
20        hourly to real-time increments at no cost to the
21        State.
22        (2) Electronic Health Record Systems, Certified Health
23    IT Modules, Pharmacy Management Systems, and Pharmacy
24    Dispensing Systems integrated with the Prescription
25    Monitoring Program must meet applicable requirements
26    outlined in rule, including, but not limited to, the

 

 

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1    following:
2            (A) provide their customers (healthcare entity,
3        pharmacy, provider, prescriber, dispenser, etc.) the
4        choice of approved integration vendor, meeting the
5        requirements of this Section and administrative rule,
6        or direct connect to the Illinois Prescription
7        Monitoring Program;
8            (B) provide their customers with access to the
9        data provided by the customer's chosen integration
10        vendor as allowed under State and federal statute; and
11            (C) follow all State and federal security and
12        privacy standards.
13        (3) Customers required to integrate under State or
14    federal law must meet the requirements outlined in
15    administrative rule, including, but not limited to, the
16    following:
17            (A) the customer retains the choice of which
18        integration vendor or direct connect is utilized to
19        connect to the Illinois Prescription Monitoring
20        Program; and
21            (B) customers seeking to contract with a new
22        integration vendor, shall enter into a memorandum of
23        understanding with the Prescription Monitoring
24        Program.
25    (b) The Illinois Prescription Monitoring Program may
26exercise the power, by rule, to require Memoranda of

 

 

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1Understanding with all customers. The general contents of the
2memorandum of understanding shall be set out in rule and shall
3include, but not be limited to:
4        (1) the acknowledgment and choice of the customer of
5    the method of integration with the Prescription Monitoring
6    Program and
7        (2) the data use and other requirements on the
8    customer in accessing and using the Prescription
9    Monitoring Program.
10    A fee cannot be levied as part of a memorandum of
11understanding required by the Department under this Section.
12    (c) Non-compliance by the Integration Vendor, Electronic
13Health Record System, Certified Health IT Module, Pharmacy
14Management System or Pharmacy Dispensing System, customer, or
15any parties required to comply with this Section may result in
16the party being prohibited from serving as entity or system
17for integration with the Prescription Monitoring Program,
18termination of contracts, agreements, or other business
19relationships. The Department shall institute appropriate cure
20notices, as necessary to remedy non-compliance.
 
21    (720 ILCS 570/317)
22    Sec. 317. Central repository for collection of
23information.
24    (a) The Department must designate a central repository for
25the collection of information transmitted under Section 316

 

 

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1and former Section 321.
2    (b) The central repository must do the following:
3        (1) Create a database for information required to be
4    transmitted under Section 316 in the form required under
5    rules adopted by the Department, including search
6    capability for the following:
7            (A) A recipient's name and address.
8            (B) A recipient's date of birth and gender.
9            (C) The national drug code number of a controlled
10        substance dispensed.
11            (D) (Blank). The dates a controlled substance is
12        dispensed.
13            (E) The quantities and days supply of a controlled
14        substance dispensed.
15            (F) A dispenser's Administration registration
16        number.
17            (G) A prescriber's Administration registration
18        number.
19            (H) The dates the controlled substance
20        prescription is filled.
21            (I) The payment type used to purchase the
22        controlled substance (i.e. Medicaid, cash, third party
23        insurance).
24            (J) The patient location code (i.e. home, nursing
25        home, outpatient, etc.) for controlled substance
26        prescriptions other than those filled at a retail

 

 

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1        pharmacy.
2        (2) Provide the Department with a database maintained
3    by the central repository. The Department of Financial and
4    Professional Regulation must provide the Department with
5    electronic access to the license information of a
6    prescriber or dispenser.
7        (3) Secure the information collected by the central
8    repository and the database maintained by the central
9    repository against access by unauthorized persons.
10    All prescribers shall designate one or more medical
11specialties or fields of medical care and treatment for which
12the prescriber prescribes controlled substances when
13registering with the Prescription Monitoring Program.
14    No fee shall be charged for access by a prescriber or
15dispenser.
16(Source: P.A. 99-480, eff. 9-9-15.)
 
17    Section 99. Effective date. This Act takes effect upon
18becoming law, except that Section 316.1 takes effect July 1,
192024.