Sen. Laura Ellman

Filed: 3/29/2023

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 421

2    AMENDMENT NO. ______. Amend Senate Bill 421 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 as follows:
 
6    (720 ILCS 570/316)
7    Sec. 316. Prescription Monitoring Program.
8    (a) The Department must provide for a Prescription
9Monitoring Program for Schedule II, III, IV, and V controlled
10substances that includes the following components and
11requirements:
12        (1) The dispenser must transmit to the central
13    repository, in a form and manner specified by the
14    Department, the following information:
15            (A) The recipient's name and address.
16            (B) The recipient's date of birth and gender.

 

 

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

 

 

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1    the business day on which a controlled substance is
2    dispensed, or at such other time as may be required by the
3    Department by administrative rule.
4        (3) A dispenser must transmit electronically, as
5    provided by Department rule, the information required to
6    be transmitted under this Section. by:
7            (A) an electronic device compatible with the
8        receiving device of the central repository;
9            (B) a computer diskette;
10            (C) a magnetic tape; or
11            (D) a pharmacy universal claim form or Pharmacy
12        Inventory Control form.
13        (3.5) The requirements of paragraphs (1), (2), and (3)
14    of this subsection also apply to opioid treatment programs
15    that are licensed or certified by the Department of Human
16    Services' Division of Substance Use Prevention and
17    Recovery and are authorized by the federal Drug
18    Enforcement Administration to prescribe Schedule II, III,
19    IV, or V controlled substances for the treatment of opioid
20    use disorders. Opioid treatment programs shall attempt to
21    obtain written patient consent, shall document attempts to
22    obtain the written consent, and shall not transmit
23    information without patient consent. Documentation
24    obtained under this paragraph shall not be utilized for
25    law enforcement purposes, as proscribed under 42 CFR 2, as
26    amended by 42 U.S.C. 290dd-2. Treatment of a patient shall

 

 

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

 

 

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

 

 

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1Public Act 100-564), the Department shall adopt rules
2requiring all Electronic Health Records Systems to interface
3with the Prescription Monitoring Program application program
4on or before January 1, 2021 to ensure that all providers have
5access to specific patient records during the treatment of
6their patients. These rules shall also address the electronic
7integration of pharmacy records with the Prescription
8Monitoring Program to allow for faster transmission of the
9information required under this Section. The Department shall
10establish actions to be taken if a prescriber's Electronic
11Health Records System does not effectively interface with the
12Prescription Monitoring Program within the required timeline.
13    (g) The Department, in consultation with the Prescription
14Monitoring Program Advisory Committee, shall adopt rules
15allowing licensed prescribers or pharmacists who have
16registered to access the Prescription Monitoring Program to
17authorize a licensed or non-licensed designee employed in that
18licensed prescriber's office or a licensed designee in a
19licensed pharmacist's pharmacy who has received training in
20the federal Health Insurance Portability and Accountability
21Act and 42 CFR 2 to consult the Prescription Monitoring
22Program on their behalf. The rules shall include reasonable
23parameters concerning a practitioner's authority to authorize
24a designee, and the eligibility of a person to be selected as a
25designee. In this subsection (g), "pharmacist" shall include a
26clinical pharmacist employed by and designated by a Medicaid

 

 

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1Managed Care Organization providing services under Article V
2of the Illinois Public Aid Code under a contract with the
3Department of Healthcare and Family Services for the sole
4purpose of clinical review of services provided to persons
5covered by the entity under the contract to determine
6compliance with subsections (a) and (b) of Section 314.5 of
7this Act. A managed care entity pharmacist shall notify
8prescribers of review activities.
9(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19;
10102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)
 
11    (720 ILCS 570/317)
12    Sec. 317. Central repository for collection of
13information.
14    (a) The Department must designate a central repository for
15the collection of information transmitted under Section 316
16and former Section 321.
17    (b) The central repository must do the following:
18        (1) Create a database for information required to be
19    transmitted under Section 316 in the form required under
20    rules adopted by the Department, including search
21    capability for the following:
22            (A) A recipient's name and address.
23            (B) A recipient's date of birth and gender.
24            (C) The national drug code number of a controlled
25        substance dispensed.

 

 

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1            (D) (Blank). The dates a controlled substance is
2        dispensed.
3            (E) The quantities and days supply of a controlled
4        substance dispensed.
5            (F) A dispenser's Administration registration
6        number.
7            (G) A prescriber's Administration registration
8        number.
9            (H) The dates the controlled substance
10        prescription is filled.
11            (I) The payment type used to purchase the
12        controlled substance (i.e. Medicaid, cash, third party
13        insurance).
14            (J) The patient location code (i.e. home, nursing
15        home, outpatient, etc.) for controlled substance
16        prescriptions other than those filled at a retail
17        pharmacy.
18        (2) Provide the Department with a database maintained
19    by the central repository. The Department of Financial and
20    Professional Regulation must provide the Department with
21    electronic access to the license information of a
22    prescriber or dispenser.
23        (3) Secure the information collected by the central
24    repository and the database maintained by the central
25    repository against access by unauthorized persons.
26    All prescribers shall designate one or more medical

 

 

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1specialties or fields of medical care and treatment for which
2the prescriber prescribes controlled substances when
3registering with the Prescription Monitoring Program.
4    No fee shall be charged for access by a prescriber or
5dispenser.
6(Source: P.A. 99-480, eff. 9-9-15.)
 
7    Section 99. Effective date. This Act takes effect upon
8becoming law.".