Sen. David Koehler

Filed: 4/27/2023

 

 


 

 


 
10300SB0285sam001LRB103 25015 RLC 61084 a

1
AMENDMENT TO SENATE BILL 285

2    AMENDMENT NO. ______. Amend Senate Bill 285 by replacing
3everything after the enacting clause with the following:
 
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.

 

 

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1            (B) The recipient's date of birth and gender.
2            (C) The national drug code number of the
3        controlled substance dispensed.
4            (D) (Blank). The date the controlled substance is
5        dispensed.
6            (E) The quantity of the controlled substance
7        dispensed and days supply.
8            (F) The dispenser's United States Drug Enforcement
9        Administration registration number.
10            (G) The prescriber's United States Drug
11        Enforcement Administration registration number.
12            (H) The dates the controlled substance
13        prescription is filled.
14            (I) The payment type used to purchase the
15        controlled substance (i.e. Medicaid, cash, third party
16        insurance).
17            (J) The patient location code (i.e. home, nursing
18        home, outpatient, etc.) for the controlled substances
19        other than those filled at a retail pharmacy.
20            (K) Any additional information that may be
21        required by the department by administrative rule,
22        including but not limited to information required for
23        compliance with the criteria for electronic reporting
24        of the American Society for Automation and Pharmacy or
25        its successor.
26        (2) The information required to be transmitted under

 

 

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1    this Section must be transmitted not later than the end of
2    the business day on which a controlled substance is
3    dispensed, or at such other time as may be required by the
4    Department by administrative rule.
5        (3) A dispenser must transmit electronically, as
6    provided by Department rule, the information required to
7    be transmitted under this Section. by:
8            (A) an electronic device compatible with the
9        receiving device of the central repository;
10            (B) a computer diskette;
11            (C) a magnetic tape; or
12            (D) a pharmacy universal claim form or Pharmacy
13        Inventory Control form.
14        (3.5) The requirements of paragraphs (1), (2), and (3)
15    of this subsection also apply to opioid treatment programs
16    that are licensed or certified by the Department of Human
17    Services' Division of Substance Use Prevention and
18    Recovery and are authorized by the federal Drug
19    Enforcement Administration to prescribe Schedule II, III,
20    IV, or V controlled substances for the treatment of opioid
21    use disorders. Opioid treatment programs shall attempt to
22    obtain written patient consent, shall document attempts to
23    obtain the written consent, and shall not transmit
24    information without patient consent. Documentation
25    obtained under this paragraph shall not be utilized for
26    law enforcement purposes, as proscribed under 42 CFR 2, as

 

 

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1    amended by 42 U.S.C. 290dd-2. Treatment of a patient shall
2    not be conditioned upon his or her written consent.
3        (4) The Department may impose a civil fine of up to
4    $100 per day for willful failure to report controlled
5    substance dispensing to the Prescription Monitoring
6    Program. The fine shall be calculated on no more than the
7    number of days from the time the report was required to be
8    made until the time the problem was resolved, and shall be
9    payable to the Prescription Monitoring Program.
10    (a-5) Notwithstanding subsection (a), a licensed
11veterinarian is exempt from the reporting requirements of this
12Section. If a person who is presenting an animal for treatment
13is suspected of fraudulently obtaining any controlled
14substance or prescription for a controlled substance, the
15licensed veterinarian shall report that information to the
16local law enforcement agency.
17    (b) The Department, by rule, may include in the
18Prescription Monitoring Program certain other select drugs
19that are not included in Schedule II, III, IV, or V. The
20Prescription Monitoring Program does not apply to controlled
21substance prescriptions as exempted under Section 313.
22    (c) The collection of data on select drugs and scheduled
23substances by the Prescription Monitoring Program may be used
24as a tool for addressing oversight requirements of long-term
25care institutions as set forth by Public Act 96-1372.
26Long-term care pharmacies shall transmit patient medication

 

 

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1profiles to the Prescription Monitoring Program monthly or
2more frequently as established by administrative rule.
3    (d) The Department of Human Services shall appoint a
4full-time Clinical Director of the Prescription Monitoring
5Program.
6    (e) (Blank).
7    (f) It is the responsibility of any new, ceased, or
8unconnected healthcare facility and its selected Electronic
9Health Records System or Pharmacy Management System to make
10contact with and ensure integration with the Prescription
11Monitoring Program. As soon as practicable after the effective
12date of this amendatory Act of the 103rd General Assembly, the
13Department shall adopt rules requiring Electronic Health
14Records Systems and Pharmacy Management Systems to interface,
15by January 1, 2024, with the Prescription Monitoring Program
16to ensure that providers have access to specific patient
17records during the treatment of their patients. The Department
18shall identify actions to be taken if a prescriber's
19Electronic Health Records System and Pharmacy Management
20Systems does not effectively interface with the Prescription
21Monitoring Program once the Prescription Monitoring Program is
22aware of the non-integrated connection. Within one year of
23January 1, 2018 (the effective date of Public Act 100-564),
24the Department shall adopt rules requiring all Electronic
25Health Records Systems to interface with the Prescription
26Monitoring Program application program on or before January 1,

 

 

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12021 to ensure that all providers have access to specific
2patient records during the treatment of their patients. These
3rules shall also address the electronic integration of
4pharmacy records with the Prescription Monitoring Program to
5allow for faster transmission of the information required
6under this Section. The Department shall establish actions to
7be taken if a prescriber's Electronic Health Records System
8does not effectively interface with the Prescription
9Monitoring Program within the required timeline.
10    (g) The Department, in consultation with the Prescription
11Monitoring Program Advisory Committee, shall adopt rules
12allowing licensed prescribers or pharmacists who have
13registered to access the Prescription Monitoring Program to
14authorize a licensed or non-licensed designee employed in that
15licensed prescriber's office or a licensed designee in a
16licensed pharmacist's pharmacy who has received training in
17the federal Health Insurance Portability and Accountability
18Act and 42 CFR 2 to consult the Prescription Monitoring
19Program on their behalf. The rules shall include reasonable
20parameters concerning a practitioner's authority to authorize
21a designee, and the eligibility of a person to be selected as a
22designee. In this subsection (g), "pharmacist" shall include a
23clinical pharmacist employed by and designated by a Medicaid
24Managed Care Organization providing services under Article V
25of the Illinois Public Aid Code under a contract with the
26Department of Healthcare and Family Services for the sole

 

 

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1purpose of clinical review of services provided to persons
2covered by the entity under the contract to determine
3compliance with subsections (a) and (b) of Section 314.5 of
4this Act. A managed care entity pharmacist shall notify
5prescribers of review activities.
6(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19;
7102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)
 
8    (720 ILCS 570/316.1 new)
9    Sec. 316.1. Access to the integration of pharmacy records
10with the Prescription Monitoring Program.
11    (a) Subject to the requirements and limitations set out in
12this Section and in administrative rule, the Department shall
13not require, either expressly or effectively, Electronic
14Health Records Systems, pharmacies, or other providers to
15utilize a particular entity or system for access to the
16integration of pharmacy records with the Prescription
17Monitoring Program.
18        (1) Any entity or system for integration (transmitting
19    the data maintained by the Prescription Monitoring
20    Program) into an Electronic Health Records System,
21    Certified Health IT Module, Pharmacy Dispensing System, or
22    Pharmacy Management System must meet applicable
23    requirements outlined in administrative rule, including,
24    but not limited to, the following:
25            (A) enter into a data sharing agreement with the

 

 

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1        Department of Human Services, Prescription Monitoring
2        Program;
3            (B) all security requirements noted within this
4        Section, administrative rule, and all other applicable
5        State and federal security and privacy requirements;
6            (C) the Prescription Monitoring Program shall have
7        administrative control over the approval of each site
8        and individual integration point and the Prescription
9        Monitoring Program shall have the ability to disable
10        individual integration points, at no additional cost
11        to the State;
12            (D) interstate data sharing shall be completed
13        with written authorization from the Prescription
14        Monitoring Program;
15            (E) data available from the Prescription
16        Monitoring Program shall not be stored, cached, or
17        sold and the State may inspect and review an entity or
18        system for integration to assure and confirm the same,
19        subject to a reasonable non-disclosure agreement, as
20        permitted by State law, to protect the entity's or
21        system's trade secrets or other proprietary
22        information;
23            (F) analysis of data shall only be allowed with
24        express written permission from the Prescription
25        Monitoring Program; and
26            (G) access to audit data, shall be available in

 

 

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1        hourly to real-time increments at no cost to the
2        State.
3        (2) Electronic Health Record Systems, Certified Health
4    IT Modules, Pharmacy Management Systems, and Pharmacy
5    Dispensing Systems integrated with the Prescription
6    Monitoring Program must meet applicable requirements
7    outlined in rule, including, but not limited to, the
8    following:
9            (A) provide their customers (healthcare entity,
10        pharmacy, provider, prescriber, dispenser, etc.) the
11        choice of approved integration vendor, meeting the
12        requirements of this Section and administrative rule,
13        or direct connect to the Illinois Prescription
14        Monitoring Program;
15            (B) provide their customers with access to the
16        data provided by the customer's chosen integration
17        vendor as allowed under State and federal statute; and
18            (C) follow all State and federal security and
19        privacy standards.
20        (3) Customers required to integrate under State or
21    federal law must meet the requirements outlined in
22    administrative rule, including, but not limited to, the
23    following:
24            (A) the customer retains the choice of which
25        integration vendor or direct connect is utilized to
26        connect to the Illinois Prescription Monitoring

 

 

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1        Program; and
2            (B) customers seeking to contract with a new
3        integration vendor, shall enter into a memorandum of
4        understanding with the Prescription Monitoring
5        Program.
6    (b) The Illinois Prescription Monitoring Program may
7exercise the power, by rule, to require Memoranda of
8Understanding with all customers. The general contents of the
9memorandum of understanding shall be set out in rule and shall
10include, but not be limited to:
11        (1) the acknowledgment and choice of the customer of
12    the method of integration with the Prescription Monitoring
13    Program and
14        (2) the data use and other requirements on the
15    customer in accessing and using the Prescription
16    Monitoring Program.
17    A fee cannot be levied as part of a memorandum of
18understanding required by the Department under this Section.
19    (c) Non-compliance by the Integration Vendor, Electronic
20Health Record System, Certified Health IT Module, Pharmacy
21Management System or Pharmacy Dispensing System, customer, or
22any parties required to comply with this Section may result in
23the party being prohibited from serving as entity or system
24for integration with the Prescription Monitoring Program,
25termination of contracts, agreements, or other business
26relationships. The Department shall institute appropriate cure

 

 

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1notices, as necessary to remedy non-compliance.
 
2    (720 ILCS 570/317)
3    Sec. 317. Central repository for collection of
4information.
5    (a) The Department must designate a central repository for
6the collection of information transmitted under Section 316
7and former Section 321.
8    (b) The central repository must do the following:
9        (1) Create a database for information required to be
10    transmitted under Section 316 in the form required under
11    rules adopted by the Department, including search
12    capability for the following:
13            (A) A recipient's name and address.
14            (B) A recipient's date of birth and gender.
15            (C) The national drug code number of a controlled
16        substance dispensed.
17            (D) (Blank). The dates a controlled substance is
18        dispensed.
19            (E) The quantities and days supply of a controlled
20        substance dispensed.
21            (F) A dispenser's Administration registration
22        number.
23            (G) A prescriber's Administration registration
24        number.
25            (H) The dates the controlled substance

 

 

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1        prescription is filled.
2            (I) The payment type used to purchase the
3        controlled substance (i.e. Medicaid, cash, third party
4        insurance).
5            (J) The patient location code (i.e. home, nursing
6        home, outpatient, etc.) for controlled substance
7        prescriptions other than those filled at a retail
8        pharmacy.
9        (2) Provide the Department with a database maintained
10    by the central repository. The Department of Financial and
11    Professional Regulation must provide the Department with
12    electronic access to the license information of a
13    prescriber or dispenser.
14        (3) Secure the information collected by the central
15    repository and the database maintained by the central
16    repository against access by unauthorized persons.
17    All prescribers shall designate one or more medical
18specialties or fields of medical care and treatment for which
19the prescriber prescribes controlled substances when
20registering with the Prescription Monitoring Program.
21    No fee shall be charged for access by a prescriber or
22dispenser.
23(Source: P.A. 99-480, eff. 9-9-15.)
 
24    Section 99. Effective date. This Act takes effect upon
25becoming law, except that Section 316.1 takes effect July 1,

 

 

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12024.".