Full Text of SB0421 103rd General Assembly
SB0421sam001 103RD GENERAL ASSEMBLY | 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 | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 5. The Illinois Controlled Substances Act is | 5 | | amended 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 | 9 | | Monitoring Program for Schedule II, III, IV, and V controlled | 10 | | substances that includes the following components and | 11 | | requirements:
| 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 | 10 | | veterinarian is exempt from the reporting requirements of this | 11 | | Section. If a person who is presenting an animal for treatment | 12 | | is suspected of fraudulently obtaining any controlled | 13 | | substance or prescription for a controlled substance, the | 14 | | licensed veterinarian shall report that information to the | 15 | | local law enforcement agency. | 16 | | (b) The Department, by rule, may include in the | 17 | | Prescription Monitoring Program certain other select drugs | 18 | | that are not included in Schedule II, III, IV, or V. The | 19 | | Prescription Monitoring Program does not apply to
controlled | 20 | | substance prescriptions as exempted under Section
313.
| 21 | | (c) The collection of data on select drugs and scheduled | 22 | | substances by the Prescription Monitoring Program may be used | 23 | | as a tool for addressing oversight requirements of long-term | 24 | | care institutions as set forth by Public Act 96-1372. | 25 | | Long-term care pharmacies shall transmit patient medication | 26 | | profiles to the Prescription Monitoring Program monthly or |
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| 1 | | more frequently as established by administrative rule. | 2 | | (d) The Department of Human Services shall appoint a | 3 | | full-time Clinical Director of the Prescription Monitoring | 4 | | Program. | 5 | | (e) (Blank). | 6 | | (f) It is the responsibility of any new, ceased, or | 7 | | unconnected healthcare facility and its selected Electronic | 8 | | Health Records System or Pharmacy Management System to make | 9 | | contact with and ensure integration with the Prescription | 10 | | Monitoring Program.
As soon as practicable after the effective | 11 | | date of this amendatory Act of the 103rd General Assembly, the | 12 | | Department shall adopt rules requiring Electronic Health | 13 | | Records Systems and Pharmacy Management Systems to interface, | 14 | | by January 1, 2024, with the Prescription Monitoring Program | 15 | | to ensure that providers have access to specific patient | 16 | | records during the treatment of their patients. These rules | 17 | | may define integration requirements and exceptions, and, in | 18 | | order to allow for faster transmission of information under | 19 | | this Section, may address the electronic integration of | 20 | | pharmacy records with the Prescription Monitoring Program. The | 21 | | Department shall identify actions to be taken if a | 22 | | prescriber's Electronic Health Records System and Pharmacy | 23 | | Management Systems does not effectively interface with the | 24 | | Prescription Monitoring Program once the Prescription | 25 | | Monitoring Program is aware of the non-integrated connection. | 26 | | Within one year of January 1, 2018 (the effective date of |
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| 1 | | Public Act 100-564), the Department shall adopt rules | 2 | | requiring all Electronic Health Records Systems to interface | 3 | | with the Prescription Monitoring Program application program | 4 | | on or before January 1, 2021 to ensure that all providers have | 5 | | access to specific patient records during the treatment of | 6 | | their patients. These rules shall also address the electronic | 7 | | integration of pharmacy records with the Prescription | 8 | | Monitoring Program to allow for faster transmission of the | 9 | | information required under this Section. The Department shall | 10 | | establish actions to be taken if a prescriber's Electronic | 11 | | Health Records System does not effectively interface with the | 12 | | Prescription Monitoring Program within the required timeline. | 13 | | (g) The Department, in consultation with the Prescription | 14 | | Monitoring Program Advisory Committee, shall adopt rules | 15 | | allowing licensed prescribers or pharmacists who have | 16 | | registered to access the Prescription Monitoring Program to | 17 | | authorize a licensed or non-licensed designee employed in that | 18 | | licensed prescriber's office or a licensed designee in a | 19 | | licensed pharmacist's pharmacy who has received training in | 20 | | the federal Health Insurance Portability and Accountability | 21 | | Act and 42 CFR 2 to consult the Prescription Monitoring | 22 | | Program on their behalf. The rules shall include reasonable | 23 | | parameters concerning a practitioner's authority to authorize | 24 | | a designee, and the eligibility of a person to be selected as a | 25 | | designee. In this subsection (g), "pharmacist" shall include a | 26 | | clinical pharmacist employed by and designated by a Medicaid |
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| 1 | | Managed Care Organization providing services under Article V | 2 | | of the Illinois Public Aid Code under a contract with the | 3 | | Department of Healthcare and Family Services for the sole | 4 | | purpose of clinical review of services provided to persons | 5 | | covered by the entity under the contract to determine | 6 | | compliance with subsections (a) and (b) of Section 314.5 of | 7 | | this Act. A managed care entity pharmacist shall notify | 8 | | prescribers of review activities. | 9 | | (Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19; | 10 | | 102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)
| 11 | | (720 ILCS 570/317)
| 12 | | Sec. 317. Central repository for collection of | 13 | | information.
| 14 | | (a) The Department must designate a central repository for
| 15 | | the collection of information transmitted under Section 316 | 16 | | and 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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| 1 | | specialties or fields of medical care and treatment for which | 2 | | the prescriber prescribes controlled substances when | 3 | | registering with the Prescription Monitoring Program. | 4 | | No fee shall be charged for access by a prescriber or | 5 | | dispenser.
| 6 | | (Source: P.A. 99-480, eff. 9-9-15.)
| 7 | | Section 99. Effective date. This Act takes effect upon | 8 | | becoming law.".
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