Bill Amendment: IL SB0285 | 2023-2024 | 103rd General Assembly

NOTE: For additional amemendments please see the Bill Drafting List

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Bill Title: CONTROLLED SUB-ELECTRON RECORD

Status: 2023-08-04 - Public Act . . . . . . . . . 103-0477 [SB0285 Detail]

Download: Illinois-2023-SB0285-Senate_Amendment_001.html

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Sen. David Koehler

Filed: 4/27/2023

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AMENDMENT TO SENATE BILL 285
AMENDMENT NO. ______. Amend Senate Bill 285 by replacing
everything after the enacting clause with the following:
"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.

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(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

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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

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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

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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,

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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

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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

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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

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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

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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

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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

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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,

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2024.".