DEPARTMENT OF HUMAN SERVICES

NOTICE OF PROPOSED AMENDMENTS

1) Heading of the Part: Electronic Prescription Monitoring Program

2) Code Citation: 77 Ill. Adm. Code 2080

4) Statutory Authority: Implementing and authorized by Sections 316, 317, 318, 319, 320 and 321 of Article III of the Illinois Controlled Substances Act [720 ILCS 570/316, 317, 318, 319, 320 and 321].

5) A Complete Description of the Subjects and Issues Involved: The Prescription Monitoring Program (PMP) monitors all retail prescriptions for Schedule II, III, IV and V drugs that are dispensed except for hospital inpatients within the State of Illinois. This rulemaking includes updated definitions and amendments addressing mandated registration, utilization, unsolicited letters to pharmacies, access to the PMP, changes to both PMP Advisory Committee and Peer Review Committee, and new requirements for the PMP pursuant to Public Acts 100-0564, 100-0125, 100-1093, and 101-0414.

6) Published studies or reports, and sources of underlying data, used to compose this rulemaking? None

7) Will this proposed rulemaking replace an emergency rule currently in effect? No

8) Does this rulemaking contain an automatic repeal date? No

9) Does this proposed rulemaking contain incorporations by reference? No

10) Are there any other rulemakings pending on this Part? No

11) Statement of Statewide Policy Objectives: This rulemaking does not create or expand a State mandate.

12) Time, Place, and Manner in which interested persons may comment on this proposed rulemaking: Interested persons may present their comments concerning these rules within 45 days after the date of this issue of the Illinois Register. All requests and comments should be submitted in writing to:

Tracie Drew, Chief
Bureau of Administrative Rules and Procedures
Department of Human Services
100 South Grand Avenue East
Harris Building, 3rd Floor
Springfield, Illinois 62762

(217) 785-9772

13) Initial Regulatory Flexibility Analysis:

A) Types of small businesses, small municipalities and not for profit corporations affected: Pharmacies that report controlled substance prescriptions.

B) Reporting, bookkeeping or other procedures required for compliance: None

C) Types of professional skills necessary for compliance: None

14) Small Business Impact Analysis:

A) Types of businesses subject to the proposed rule:

B) Categories that the agency reasonably believes the rulemaking will impact, including:

15) Regulatory Agenda on which this rulemaking was summarized: July 2022

The full text of the Proposed Amendments begins on the next page:

TITLE 77: PUBLIC HEALTH

CHAPTER X: DEPARTMENT OF HUMAN SERVICES

SUBCHAPTER e: CONTROLLED SUBSTANCES ACTIVITIES

PART 2080

ELECTRONIC PRESCRIPTION MONITORING PROGRAM

AUTHORITY: Implementing and authorized by Sections 316, 317, 318, 319, 320, and 321 of Article III of the Illinois Controlled Substances Act [720 ILCS 570/316, 317, 318, 319, 320, and 321].

SOURCE: Adopted at 10 Ill. Reg. 4497, effective March 3, 1986; amended at 17 Ill. Reg. 11424, effective July 6, 1993; amended at 20 Ill. Reg. 3107, effective February 2, 1996; recodified from the Department of Alcoholism and Substance Abuse to the Department of Human Services at 21 Ill. Reg. 9319; amended at 26 Ill. Reg. 3975, effective March 4, 2002; amended at 33 Ill. Reg. 17333, effective December 9, 2009; amended at 39 Ill. Reg. 6421, effective April 22, 2015; amended at 40 Ill. Reg. 3737, effective February 29, 2016; amended at 41 Ill. Reg. 11909, effective September 13, 2017; amended at 45 Ill. Reg. 8351, effective June 24, 2021; amended at 46 Ill. Reg. _____, effective _____.

Section 2080.10 Authority

This Part is promulgated pursuant to the Illinois Controlled Substances Act (the Act) [720 ILCS 570] which that empowers the Department of Human Services to codify the efforts of this State to conform with the regulatory systems of the federal government and other states to establish national coordination of efforts to control the abuse of Schedule II-, III, IV and V retail dispensed drugs. It relates to the collection of prescription information listed in Schedule II-, III, IV and V within Sections 206, 208, 210, and 212 of the Act, or in the federal Schedule II-, III, IV and V and "Amendment of Schedules" list of drugs at 21 USC 812(b)(2), (b)(3), (b)(4), (b)(5) and (c).

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.20 Incorporation by Reference and Definitions

No incorporations by reference in this Part include any later amendments or editions. The definitions that apply to this Part are those found in the Act.

"Act" means the Illinois Controlled Substances Act [720 ILCS 570].

"Account" refers to the clinical entity that is providing direct patient care and is registered with the ILPMP to have access to patient-specific data through the ILPMP Prescription Information Library (PIL).

"Account Custodian" means the licensed healthcare professional whose registration may be used by other members of the healthcare group for access to the PIL.

"Birth Date" means the medication recipient's birth date.

"Central Repository" means a place designated by the Department where Schedule II-, III, IV and V drug data and other healthcare data are is stored or housed.

"Certified Health IT Module" means any service, component, or a combination thereof that can meet the requirements of at least one certification criterion adopted under the Office of the National Coordinator for Health Information Technology (ONC).

"Clinical Director" or "PMP Administrator" means a Department of Human Services administrative employee licensed to either prescribe or dispense controlled substances who shall run the clinical aspects of the Department of Human Services Prescription Monitoring Program and its Prescription Information Library [720 ILCS 570/102 (d-5)]. The Clinical Director may be assisted by a PMP Assistant Administrator.

"Connecting Entity" or "Entity" means the health system, hospital, medical office, clinic, or practice that maintains the Electronic Health Record system or employs the professional making the ILPMP query.

"Controlled Substance" means a drug, substance, or immediate precursor in the Schedules of Article II of the Illinois Controlled Substances Act or a drug or other substance, or immediate precursor, designated as a controlled substance by DHS [720 ILCS 570/102(f)].

"DEA Number" means the United States Drug Enforcement Administration Agency prescriber or dispenser registration number.

"Department" or "DHS" means the Illinois Department of Human Services, or its successor agency.

"DFPR" means the Illinois Department of Financial and Professional Regulation.

"Dispenser" means any practitioner or pharmacy that dispenses a controlled substance to an alternative user or research subject by or pursuant to the lawful order of a prescriber [720 ILCS 570/102(p) and (q)].

"DoIT" means the Illinois Department of Innovation and Technology.

"DPH" means the Illinois Department of Public Health.

"Drugs of Interest" means drugs contributing to clinical reviews of controlled substances; determined to need additional monitoring or to assist in facilitating medication optimization and utilization; and drugs used in overdose prevention. Drugs of interest include, but are not limited to, muscle relaxants, butalbital, acetaminophen and caffeine, gabapentin, naltrexone, and naloxone.

"EHR" means electronic health record for a Licensed Healthcare Entity.

"Electronic Device" means using a computer system to transmit prescriptions from a prescriber directly to a dispenser.

"Electronic Integration" means the process by which ILPMP data is directly accessible within the EHR system.

"Exempt Prescribers in Hospitals and Institutions" means prescribers in hospitals or institutions licensed under the Hospital Licensing Act [210 ILCS 85] who authorize the administration or dispensing of Schedule II drugs within the hospital or institution, for consumption within the hospital or institution (e.g., controlled substance prescriptions when a prescriber does not maintain a DEA and State controlled substance license, but prescribes based upon the institution's (hospital's) controlled substance license).

"Facsimile Equipment" means any device capable of sending or receiving facsimiles of documents through a connection with a telecommunications network.

"Freestanding Clinic" means urgent care operations or outpatient surgery centers and similar operations that do not provide overnight in-house stays.

"Health IT Module" means any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted under the Office of the National Coordinator for Health Information Technology (ONC).

"ILPMP" means the Illinois Prescription Management Program.

"Illinois Controlled Substances License Number" means the State license number issued by DFPR permitting prescribers to possess, prescribe or dispense, and permitting dispensers to possess and dispense, controlled substances in Illinois pursuant to the Controlled Substances Act (see 77 Ill. Adm. Code 3100).

"Illinois Healthcare License Number" means the license assigned by DPH to facilities designated to provide specific types or levels of healthcare.

"Initial CII Opioid Prescription" means every prescription for a Schedule II narcotic (opioid).

"Licensed Healthcare Entity" means those operations that are licensed to provide health services by either DPH or DFPR.

"Licensed Healthcare Provider" means any individual who meets the professional licensing requirements and follows the standards set forth by DFPR and is authorized to prescribe or dispense controlled substances within Illinois.

"Licensed Professional Administrator" means the clinical director of the Prescription Monitoring Program, who must be licensed to either prescribe or dispense controlled substances.

"Medication Shopping" means the conduct prohibited under Section 314.5(a) of the Act.

"Mid-level Practitioner" means:

a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95];

an advanced practice registered nurse who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatrist, in accordance with Section 65-40 of the Nurse Practice Act [225 ILCS 65]; or

an advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist who has been granted authority to prescribe by a hospital affiliate in accordance with Section 65-45 of the Nurse Practice Act [225 ILCS 65]; or

an animal euthanasia agency.

"National Drug Code Identification Number" or "NDC Identification Number" means the number used to provide uniform product identification for all substances recognized as drugs in the United States Pharmacopoeia National Formulary, USP31-NF26 (US Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 (2013)).

"NCPDP Protocol" means the computing standards implemented by the National Council for Prescription Drug Programs.

"One-to-One Secure Link" or "One-to-One Connection" means connecting a provider and the ILPMP through an EHR or a pharmacy management system.

"Patient ID" means the identification of the individual receiving the medication or the responsible individual obtaining the medication on behalf of the recipient or the owner of the animal. The standards for establishing patient ID for the purpose of proper filling of a prescription are established by Section 2080.70(d).

"Patient Location Code" means the location of the patient when receiving pharmacy services.

"Pharmacist-In-Charge" means the licensed pharmacist whose name appears on the pharmacy license and who is responsible for all aspects of the operation related to the practice of pharmacy.

"Pharmacy Shopping" means the conduct prohibited under Section 314.5(b) of the Act.

"PMIX -Based Protocol" means industry and government standards used to facilitate and reduce the cost of participating and sharing the ILPMP information by requiring end-to-end security, standards-based exchange services, common exchange data and metadata, and hub-to-hub capability.

"PMP Administrator" See definition of "Clinical Director".

"ILPMP Assistant Administrator" means an employee of the Department with a background in computer and business processes who operates under the designated, specific authority of the Clinical Director.

"PMPnow" means the automated, one-to-one connection service that allows an a ILPMP patient profile request to be generated directly within a Requester's EHR or pharmacy/dental management system.

"Prescribed" means ordered by a prescriber verbally, electronically, or in writing.

"Prescriber" means the healthcare professional that is authorized to prescribe medications as set forth in the various professional practices of the State of Illinois.

"Prescription Monitoring Program Information Library" or "PMP PIL" means an electronic database that collects, tracks, and stores controlled substance and select drug an electronic library containing 12 months of controlled substance, retail, prescription information information that is accessible only by prescribers and dispensers for patient treatment usage [720 ILCS 570/102(nn-5)].

"Prescription Monitoring Program" or "PMP" means the entity that collects, tracks, and stores reported data on controlled substances and select drugs [720 ILCS 570/102(nn-10)].

"Prescription Monitoring Program Advisory Committee" or "PMPAC" means a committee consisting of licensed healthcare providers representing all professions that are licensed to prescribe or dispense controlled substances. The committee serves in a consultant context regarding longitudinal evaluations of compliance with evidence-based clinical practice and controlled substances. The committee makes recommendations regarding the scheduling of controlled substances and recommendations concerning continuing education designed to improve the health and safety of the citizens of Illinois regarding pharmacotherapies of controlled substances.

"Provider" means the prescriber or dispenser acting in the direct care of the patient.

"Push Reports" means the electronic exchange of patient specific health care information contained in electronic medical records from the PMP, without the requirement of the individual clinician having to "sign" into the PMP and request the patient information.

"Quantities of a Controlled Substance Dispensed" means the total of an NDC product dispensed whether it is in a solid unit such as a tablet or capsule, in a liquid unit such as milliliters, or in another unit as specified within the product identification.

"Recipient's Name" means the given or common name of a person who is the intended user of a dispensed medication. It may also mean the species or common name or common given name of an animal that is the intended user of a dispensed medication. If an animal's name is entered, the owner's name is required also.

"Requester" means the prescriber, dispenser, or registered designee that is initiating a patient query of ILPMP data. A Requester must be authorized to access ILPMP data via a valid ILPMP registered website (www.ilpmp.org) user account.

"RESTful -Based Web Service" means a computing architectural style, consisting of a coordinated set of components, connectors, and data elements within a distributed hypermedia system, in which the focus is on component roles and a specific set of interactions between data elements rather than implementation details. Its purpose is to induce performance, scalability, simplicity, modifiability, visibility, portability, and reliability.

"Sample Trend Analysis" means the summary reports that look at utilization rates for specific classes of medications over time.

"Schedule Drug" means any substances listed in the federal Controlled Substances Act (21 U.S.C. 812) or the Illinois Controlled Substances Act [720 ILCS 570] or by the Department pursuant to its authority under Section 202 of the Illinois Controlled Substances Act [720 ILCS 570/202]. Schedule I-, II, III, IV and V substances are listed in section 812 of the federal Controlled Substances Act (21 U.S.C. 812(b)(2), (b)(3), (b)(4), (b)(5) and (c)) and Sections 204, 206, 208, 210 and 212 of the Illinois Controlled Substances Act [720 ILCS 570/204, 206, 208, 210 and 212].

"Sex" means the medication recipient's gender.

"SOAP -Based Web Service" means a messaging protocol that allows programs that run on disparate operating systems (e.g., Windows or Linux) to communicate using Hypertext Transfer Protocol (HTTP) and its Extensible Markup Language (XML).

"Vendor" means the company providing EHR, Certified or Health IT Module, or pharmacy management software services to its connecting entity customers.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.30 General Description

The ILPMP Prescription Monitoring Program (PMP) monitors all retail prescriptions for Schedule II-, III, IV and V drugs and drugs of interest that are dispensed (, except for hospital inpatients unless required by 720 ILCS 570/313) and drug abuse treatment programs licensed by the Department, within the State of Illinois. Each time a Schedule II-, III, IV or V drug or drug of interest is dispensed, the dispenser must transmit specific information to a central repository within the ILPMP designated by the Department.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.50 Authorized Prescribers

A prescription for a Schedule II-, III, IV or V drug shall be issued only by a prescriber who:

a)Possesses a valid professional license issued by DFPR as a physician licensed to practice medicine in all of its branches, dentist, optometrist, podiatrist, veterinarian, advanced practice registered nurse granted full practice practitioner with delegated prescriptive authority, advanced practice registered nurse with delegated prescriptive authority, a physician assistant with delegated prescriptive authority, or other licensed prescriber of another state or jurisdiction;

b) Is licensed to prescribe Schedule II-, III, IV or V drugs by the State of Illinois or any state;

c) Must be registered by the United States Drug Enforcement Administration (DEA) to prescribe Schedule II-, III, IV or V drugs; and d) Complies with all requirements under 21 CFR 1306.08 and 21 CFR 1311. (Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.70 Schedule II-, III, IV and V Drug Prescription Requirements

a)A dispenser may fill a prescription for a Schedule II-, III, IV or V drug upon receipt of a written, electronic, facsimile, or verbal order of a prescriber physician unless otherwise specifically exempted or allowed by federal or State law.

b) A prescription for a Schedule II-, III, IV or V drug shall:

1) Be dated as of and signed on the day when issued;

2) Bear the full name and address of the patient, or in the case of veterinary treatment, the full name and address of the animal owner, as well as the species or common name of the animal being treated;

3) Bear the full name and address of the prescriber;

4) Bear the DEA Registration number of the prescriber;

5) Have affixed to the face of the prescription the prescriber's electronic or handwritten signature, initials, thumbprint, or other biometric or electronic identification process approved by DFPR pursuant to Section 3 of the Pharmacy Practice Act [225 ILCS 85];

6) If written, be written in ink with a pen, typewriter, or computer printer or with an indelible pencil;

7) Specify the drug name, strength, dosage, and form;

8) Specify the quantity of drug to be dispensed, both written and numeric;

9) Not allow a Schedule II prescription to be filled more than 90 days after the date of issue;

10) Not allow more than a 30-day supply of a Schedule II drug on any one prescription;

11) Not allow for any refills of Schedule II drugs;

12) Contain only one Schedule II drug prescription order per prescription blank;

13) Limit the maximum time allowed for a Schedule III, IV or V prescription to be filled at six months with a maximum of five refills;

14) Allow more than one prescription order per prescription blank for a Schedule III-, IV or V drug;

15) Allow electronic prescriptions in accordance with federal rules set forth in 21 CFR 1300, 1304, 1306, 1311 (2010) [720 ILCS 570/311.5]; and

16) Allow an individual physician the authority to prescribe multiple prescriptions (3 sequential 30-day supplies) for the same Schedule II controlled substance, authorizing up to a 90-day supply [720 ILCS 570/312(a-5)].

c) In the case of an emergency, a prescriber may issue a lawful oral prescription, when failure to issue might result in loss of life or intense suffering. The oral prescription shall include a statement concerning the circumstances constituting the emergency for which the oral prescription was used. Within 7 days after issuing an emergency prescription, the prescriber shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The prescription shall comply with all requirements of Section 309 of the Act.

d) Patient ID for Proper Filling:

1) The sex field is a verifying element of a patient ID. The patient's gender shall be entered in the sex field.

2) The birth date is a verifying element of a patient ID and needs to be entered in the birth date field (yyyymmdd).

3) The final verifying element of a patient ID for an animal or individual is not a set standard. Each pharmacy or chain may adopt its own standard. The concern is that if a standard is too rigid, the enterprise's business activity will suffer. Any of the following may be used. If the primary choice is not available (e.g., if the patient is an undocumented alien), another choice may be used:

A) Driver's license or equivalent, state-issued ID;

B) Telephone number of the patient's residence (include area code);

C) An internal pharmacy ID system;

D) Employer ID;

E) Student ID;

F) Insurance ID.

4) If a child's or other person's prescription is delivered to or accepted by a person other than the intended user, an ID should verify the name of the individual accepting the prescription.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.100 Dispenser Responsibility

a) Each time a Schedule II-, III, IV or V drug or other selected drugs, as described in Section 2080.230, is dispensed, the dispenser must transmit, by the end of the same no later than the next business day after dispensing, to the central repository the following data, and or any other data deemed necessary by the ILPMPAC:

1) Dispenser DEA number.

2) Dispenser's Dispenser full name and address.

3) Recipient's (or animal and owner's) name and address.

4) NDC identification number of the Schedule II-, III, IV or V drug dispensed.

5) Quantity of the Schedule II-, III, IV or V drug dispensed.

6) Date prescription filled.

7) Date prescription written.

8) Prescriber DEA number.

9) Prescriber full name.

10) Patient ID.

11) Patient sex (M for male, F for female or U for unknown).

12) Patient birth date (yyyymmdd - year, month, day).

13) Date dispensed.

14) Payment type (i.e., Medicaid, cash, third-party insurance).

15) Patient location code (i.e., home, nursing home, outpatient, etc.).

16) Days' supply (based on dispensed quantity).

b) If no Schedule II-, III, IV or V drug or other selected drugs, as described in Section 2080.230, is dispensed, the dispenser must transmit a zero report, as outlined set forth in the American Society of Automation in Pharmacy (ASAP) Prescription Monitoring Program Standard Version 4.2 (2011), to the central repository, no later than the end of the same next business day. The incorporation by reference includes no later amendments or editions.

c) For hospitals licensed under the Hospital Licensing Act [210 ILCS 85], any discharge or outpatient prescription exceeding a 72-hour quantity must be reported to the ILPMP central repository no later than the end of the same next business day after dispensing. The report shall contain the following data, or any other data deemed necessary by the ILPMPAC:

1) Dispenser DEA number.

2) Dispenser's full Dispenser name and address.

3) Recipient's (or animal and owner's) name and address.

4) NDC identification number of the Schedule II-, III, IV or V drug dispensed.

5) Quantity of the Schedule II-, III, IV or V drug dispensed.

6) Date prescription filled.

7) Date prescription written.

8) Prescriber DEA number.

9) Prescriber name and address.

10) Patient ID.

11) Patient sex (M for male, F for female, or U for unknown).

12) Patient birth (yyyymmdd - year, month, day).

13) Date dispensed.

14) Payment type (i.e., Medicaid, cash, third-party insurance).

15) Patient location code (i.e., home, nursing home, outpatient, etc.).

16) Days' supply (based on dispensed quantity).

d) The Department may shall impose a civil fine of $100 per day for willful failure to comply with statutory reporting requirements. Assessment of the fines will be processed monthly and begins fine begins on the day after the report was required to be submitted and ends on the day the failure to report is remedied. Fines shall be payable to the Prescription Monitoring Program.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.190 Reports

a) For the purpose of intervention to prevent misuse, a prescriber or dispenser may request that reports about his or her patients be sent to them via a secure method if a patient meets the current PMP indications of potential misuse criteria set forth by the PMPAC.

ab) A personal information report of a patient's prescription profile may be obtained if:

1) The patient, parent, or guardian completes a notarized request; and

2) The patient, parent, or guardian submits the notarized request by mail to the ILPMP at:

Illinois Prescription Monitoring Program
401 North 4^th Street, First Floor
Springfield, Illinois 62702

bc) When a person has been identified as having 53 or more prescribers or 53 or more pharmacies, or both, that do not utilize a common electronic file as specified in Section 20 of the Pharmacy Practice Act [225 ILCS 85] for controlled substances within the course of a 6-month continuous 30-day period, the ILPMP may issue an unsolicited report to the prescribers informing them of the potential medication shopping [720 ILCS 570/314.5(d)]. If an unsolicited report is issued to a prescriber or prescribers, then the report must also be sent to the applicable dispensing pharmacy. The individual prescriber's judgment determines what actions, if any, they he or she should take upon receipt of the unsolicited 5-5-63-3-1 reports.

cd) The ILPMP is authorized to develop operational push reports to entities with compatible electronic medical records [720 ILCS 570/318(n)]. The push report will only include information for patients that are in the ILPMP organization's electronic health medical record (EHR EMR). It is the responsibility of the entity to keep the access to this confidential patient information secure. These entities must:

1) Meet and maintain the ILPMP's current security standards prior to the electronic transfer of information from the ILPMP to its respective EHR EMR;

2) Be a licensed healthcare entity; and

3) Only use this confidential patient information for the treatment of the relevant patient.

de) Technical error and administrative function reports needed to determine that the records are received and maintained in good order may be used.

ef) Sample trend analysis reports may be prepared extemporaneously by ILPMP staff. The disposition of all extemporaneous reports shall be at the discretion of the Clinical Director licensed, professional administrator of the ILPMP.

fg) Authorized persons listed in this subsection may request information from the ILPMP.

1) Official inquiries must be from any one of the following:

A) DFPR;

B)An investigator from the Illinois Consumer Protection Division of the Office of the Attorney General; or

C) A law enforcement officer; or.

D) Select representatives of the Department of Children and Family Services.

2) Inquiries must be submitted in writing and demonstrate that:

A) The applicant has reason to believe that a violation under State or federal law that involves a controlled substance by an individual has occurred; and [720 ILCS 570/318(e)(1)]

B) The requested information is reasonably related to the investigation of the individual, adjudication, or prosecution of the violation. [720 ILCS 570/318(e)(2)]

3) The Department may impose a fee for the cost of generating and furnishing the requested information.

gh) Any other reports concerning the information received from dispensers shall only be prepared at the direction of the Clinical Director or successor administrator who meets the statutory requirements. The information described in subsection (g) may not be released until it has been reviewed by an employee of the Department who is licensed as a prescriber or a dispenser and until that employee has certified that further investigation is warranted [720 ILCS 570/318(g)].

hi) As directed by the PMPAC and the Clinical Director for the ILPMP, aggregate data that does not indicate any prescriber, practitioner, dispenser, or patient may be used for clinical studies under Article VIII, Part 21 of the Code of Civil Procedure [735 ILCS 5/Art. VIII, Part 21] (Medical Studies).

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.200 Prescriber and Dispenser Inquiry System

The Department's Bureau of Pharmacy and Clinical Support Systems or successor shall establish, operate, maintain, and enhance a stand-alone, one-to-one secure link with the necessary encrypted software that shall function as a prescriber and dispenser inquiry system to be known as the Illinois Prescription Monitoring Program (ILPMP) Information Library (PIL). The Bureau must install a system to track each use of the ILPMP PIL. The tracking system will only be utilized for the following purposes:

a) Determining if a prescriber or dispenser is properly using the ILPMP PIL. If it is considered by the ILPMP PIL staff that any registered user is not using the ILPMP PIL responsibly, an investigator from DFPR's the Illinois Department of Financial and Professional Regulation's Bureau of Drug Compliance will be contacted in order to investigate the issue. If the ILPMP PIL supervisor considers the issue serious and of immediate concern, the registered user's ILPMP PIL access may be suspended.

b) Determining if a non-registered person or entity is attempting to access the system. The ILPMP PIL staff shall report the situation to the Department and to one or more of the following entities:

1) Illinois law enforcement agency;

2) Illinois regulatory entity;

3) federal agency; or

4) an agency in another state.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.203 Registering with the ILPMP

Each prescriber possessing an Illinois Controlled Substance License shall register with the ILPMP.

(Source: Added at 46 Ill. Reg. _____, effective _____)

Section 2080.205 Accessing the ILPMP

a) Medical prescribers or dispensers or their authorized designee may utilize the ILPMP for patient care after obtaining authorization from the ILPMP staff.

b) Each prescriber or their designee shall also document in the patient's medical record an attempt to access patient information in the ILPMP to assess patient access to controlled substances when providing an initial CII opioid prescription except for oncology treatment, palliative care, or for a 7-day or less supply to treat an acute, traumatic medical condition.

c) Only the following licensed or certified healthcare professionals shall serve as an authorized designee for a prescriber or dispenser for office or pharmacy practice sites:

1) registered nurse;

2) licensed practical nurse;

3) pharmacy technician;

4) certified medical assistant; or

5) dental hygienist.

d) The prescriber or dispenser shall only have up to three designees, with the exception of a hospital or other authorized location such as a long-term care facility/opioid treatment facility

e) The hospital or authorized location shall facilitate the designation of a prescriber's designee for the purpose of accessing the ILPMP for services provided at that location. The EHR system shall send the user's name or other individual identifier to document the person accessing the ILPMP data.

f) The prescriber and dispenser shall register the designees and must also agree to the terms and conditions for designees.

g) Each designee shall have an individual account that must be linked to the prescriber or dispenser.

h) ILPMP staff shall verify the following information about each designee:

1) license/certification number;

2) employer's phone number and address; and

3) work email address. If no work email address is available, ILPMP staff shall contact the prescriber or dispenser to verify the designee.

i) ILPMP shall send out a notice for the prescriber or dispenser to ensure continued employment of their designees. If the designee is no longer employed with the prescriber or dispenser, the prescriber or dispenser shall terminate the designee's access to the ILPMP by locking the designee's account or by notifying the ILPMP that the designee's account should be locked.

j) A user may only access the ILPMP for a patient's medical treatment.

k) Department staff shall develop, modify, and maintain data files of the ILPMP.

l) ILPMP users are ultimately responsible for any usage of their authorization credentials.

m) In order to expedite the approval and oversight of ILPMP applicants and users, the ILPMP must be managed by a licensed dispenser.

n) ILPMP staff determine if a PMP user applicant may become a ILPMP user by using the following criteria:

1) Applicant's first and last name;

2) Pharmacy, clinic, or office street address, city, state, and zip code;

3) DEA number;

4) For a pharmacist's application, the pharmacy DEA number;

5) Illinois prescriber or dispenser license number; and

6) Business telephone number.

o) PMP staff shall determine if a ILPMP user applicant may become a ILPMP group user by applying the following criteria:

1) The prescriber or dispenser who will be the account's custodian shall provide the following information:

A) First and last name;

B) DEA number;

C) National Provider Identifier (NPI) number;

D) Illinois prescriber or dispenser license number; and

E) Business telephone number;

2) Hospital emergency department's or other authorized location's street address, city, state, and zip code;

3) The pharmacist-in-charge (PIC) as the central user of the hospital pharmacy; and

4) A listing of all users with the following information:

A) First and last name;

B) Individual NPI;

C) DEA number; and

D) Illinois healthcare license number.

p) For ILPMP user applications for which ILPMP staff is unable to make a determination, the Clinical Director or designee shall review those user applications and render a professional decision as to whether access shall be granted.

q) The ILPMP Administrator shall review the user access log for any unusual or improper activity by a user.

r) The Clinical Director or their designee shall directly monitor the development, modification, and/or expansion of the ILPMP.

(Source: Added at 46 Ill. Reg. _____, effective _____)

Section 2080.207 EHR Integration with the ILPMP

a) EHR systems are required to be integrated via PMPnow through a one-to-one secure link from the EHR to the ILPMP servers to allow information to return from the ILPMP servers to the Requester directly.

1) The connecting entity must maintain both an electronic and physical safeguard of the information.

2) Security failures or misuse will be handled as any other violation of the Health Insurance Portability and Accountability Act (HIPAA) (42 USC 1320 et seq.).

3) A list of providers and locations served by the EHR system must be provided to the ILPMP on a semi-annual basis and:

A) Shall contain the following information:

i) Location name;

ii) Address;

iii) City;

iv) State;

v) Zip code;

vi) Contact at facility;

vii) Facility contact email address;

viii) Health care provider name (first and last);

ix) Health care provider DEA;

x) Health care provider NPI (National Provider Identifier); and

xi) Health care provider license number.

B) Shall be sent to the ILPMP in one of the following electronic formats:

i) Excel (.xlsx or .xls); or

ii) Comma separated values (.csv).

4) When requested, the entity must provide an audit of the user that performed the search, the patient information that was searched on, and the date and time of the search.

b) Electronic integration shall be done using the following process:

1) The entity shall either email dhs.pmp@illinois.gov to request the PMPnow integration or request that the EHR vendor provides provide PMPnow integration to the vendor's Requesters as a function of its general software configuration.

2) The entity shall determine its feasibility for connectivity to the PMPnow service. PMPnow supports the following connectivity options, one of which must be used by the connecting entity:

A) A SOAP-based web service that uses a PMIX-based protocol;

B) A RESTful-based web service that uses the NCPDP protocol;

C) A RESTful-based web service that uses a PMIX-based protocol;

D) Fast Healthcare Interoperability Resources (FHIR);

E) Access to PMP through a verified RxCheck connection; or

F) The use of a PMP authorized/funded integration application.

3) The technology used for connecting/integration with the ILPMP must meet the one-to-one secure link connection requirement (see subsection (a)).

43) Following successful testing, the connection is ready to be activated. ILPMP will activate the production environment for the entity's use in exchanging transactions.

c) Data Uses and Retention

1) Data passed directly from the PMP to the EHR authenticated Requester shall not be:

A) Unencrypted in transit;

B) Analyzed;

C) Data mined or scrapped;

D) Deconstructed; or

E) Used for other collection of individual data points.

2) An EHR authenticated Requester is an individual granted a username and password by the facility/location for which the EHR is utilized for patient care.

3) With permission from the ILPMP, electronic messaging to authenticate that the Requester performed a qualified search of the ILPMP may be returned to the EHR for documentation of the query.

4) Data sets displayed through the ILPMP extend beyond controlled substances and shall not be distributed or accessed without authorized permission.

d) The Department may impose a civil fine of $100$50 per day user per month on any facility and/or EHR vendor that willfully fails to comply with statutory integration requirements as reflected in this Section. Assessment of the fine may begin on January 1, 2022, one year after the statutory requirement took effect on January 1, 2021, and shall remain in effect until the facility and/or vendor completes the EHR integration process. Fines will be assessed on a monthly basis. Fines shall be payable to the Illinois Prescription Monitoring Program. Fines will not be assessed if the delay in integration is due to Department resources/limitations.

e) The Department may develop a fee structure to cover the cost of the technology implementation of connecting and maintaining the secure one-to-one connection. This fee structure will be posted on the ILPMP website (www.ilpmp.org). Fees shall be payable to the Illinois Prescription Monitoring Program.

fe) Injury and Accident Notifications. Medical facilities that are connecting entities shall send the ILPMP real-time, patient information related to injuries and accidents based upon diagnosis codes set forth by the ILPMP. Data received from medical facilities will be posted displayed on the ILPMP website (www.ilpmp.org) and the PMPnow integration tool. Medical facilities must follow ILPMP technical standards.

gf) A one-to-one secure link (see subsection (a)) connects the provider and the ILPMP through an EHR. An EHR system may provide this connection. An EHR may, alternatively, designate a Certified Health IT Module that is an integrated component of that EHR to provide that connection when the following requirements are met:

1) The Certified Health IT Module connection shall ensure that the Requester has access to the ILPMP data at any point in the Requester's workflow.

2) The MME calculations shall remain consistent with the presentation of this information when provided by the ILPMP directly through an EHR vendor.

3) Attestation to the existence of a legal agreement between the EHR vendor and the Certified Health IT Module vendor and attestation that the Certified Health IT Module serves as an integrated component of the EHR when using a Certified Health IT Module access method.

4) The Certified Health IT Module connection must meet the security requirements for electronic health record systems set forth by the Office of the National Coordinator for Health Information Technology (ONC).

5) The Certified Health IT Module must be certified by the ONC or an ONC-Authorized Certification Body (ONC-ACB). Certification must be published on the ONC's Certified Health IT Product List. The ILPMP reserves the right to terminate the connection points if the vendor/product is decertified by an ONC-ACB.

h) Exemptions to connection/integration requirements.

1) Providers who do not have/use an electronic health record system or electronic prescription system may certify that they do not have/use an electronic health record system or electronic prescription system within their practice/facility/location.

2) Prescribers who certify with DFPR that they will not issue more than 25 prescriptions during a 12-month period shall provide a copy of the certification to DHS as documentation of exemption from the connection/integration requirement. [720 ILCS 570/311.6 Opioid Prescriptions]

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.208 Pharmacy Management Systems Integration with the ILPMP

a) Pharmacy management systems are required to be integrated via PMPnow through a one-to-one secure link connection from the pharmacy management system to the ILPMP servers to allow information to return from the ILPMP servers to the Requester directly.

1) The connecting entity shall maintain both an electronic and physical safeguard of the information.

2) Security failures or misuse will be handled as any other violation case of the Health Insurance Portability and Accountability Act (HIPAA) violation under (42 USC 1320 et seq.).

3) A list of pharmacists and pharmacy locations using the pharmacy management system shall be provided to the ILPMP on a semiannual basis and:

A) Shall contain the following information:

i) Location name;

ii) Address;

iii) City;

iv) State;

v) Zip code;

vi) Contact at pharmacy;

vii) Pharmacy contact email address;

viii) Pharmacists' Pharmacists names (first and last);

ix) Pharmacy DEA number;

x) Pharmacy NPI; and

xi) Pharmacists' Pharmacists license numbers.

B) Shall be sent to the ILPMP in one of the following electronic formats:

i) Excel (.xlsx or .xls); or

ii) Comma separated values (.csv).

4) When requested, the entity must provide an audit of the user that performed the search, the patient information that was searched on, and the date and time of the search.

b) Electronic integration shall be performed using the following process:

1) The entity shall either email dhs.pmp@illinois.gov to request the PMPnow integration or request that the pharmacy management system vendor provide PMPnow integration to the vendor's Requesters as a function of the vendor's general software configuration.

2) The entity shall determine its feasibility for connectivity to the PMPnow service. PMPnow supports the following connectivity options, one of which must be used by the connecting entity:

A) A SOAP-based web service that uses a PMIX-based protocol;

B) A RESTful-based web service that uses the NCPDP protocol;

C) A RESTful-based web service that uses a PMIX-based protocol;

D) Fast Healthcare Interoperability Resources (FHIR);

E) Access to the ILPMP through a verified RxCheck connection; or

F) The use of a ILPMP authorized/funded integration application.

3) The technology used for connecting/integration with the ILPMP must meet the requirement of a one-to-one secure link connection requirement (see subsection (a)).

43) Following successful testing, the connection is ready to be activated. The ILPMP will activate the production environment for the entity's use in exchanging transactions.

c) Data Uses and Retention

1) Data passed directly from the ILPMP to the pharmacy management system authenticated Requester shall not be:

A) Unencrypted in transit;

B) Analyzed;

C) Data mined or scrapped;

D) Deconstructed; or

E) Used for other collection of individual data points.

2) A pharmacy management system authenticated Requester is an individual granted a username and password by the facility/location in which the pharmacy management system is utilized for patient care.

3) With permission from the ILPMP, electronic messaging to authenticate that the Requester performed a qualified search of the ILPMP may be returned to the pharmacy management system for documentation of the query.

4) Data sets displayed through the ILPMP extend beyond controlled substances and shall not be distributed or accessed without authorized permission.

d) The Department may impose a civil fine of $100$50 per day user per month on any pharmacy and/or pharmacy management software system vendor that willfully fails to comply with statutory integration requirements as reflected in this Section. Assessment of the fine may begin on January 1, 2022, one year after the statutory requirement took effect on January 1, 2021, and shall remain in effect until the facility and/or vendor pharmacy completes the EHR integration process. Fines will be assessed on a monthly basis. Fines shall be payable to the Illinois Prescription Monitoring Program. Fines will not be assessed if the delay in integration is due to Department resources/limitations.

e) The Department may develop a fee structure to cover the cost of the technology implementation of connecting and maintaining the secure one-to-one connection. This fee structure will be posted on the ILPMP website (www.ilpmp.org). Fees shall be payable to the Illinois Prescription Monitoring Program.

fe) A one-to-one secure link (see subsection (a)) connects the provider and the ILPMP through a pharmacy management system. A pharmacy management system may provide this connection. A pharmacy management system Pharmacy Management System may, alternatively, designate a Certified Health IT Module that is an integrated component of that pharmacy management system Pharmacy Management System to provide that connection when the following requirements are met:

1) The Certified Health IT Module connection must ensure that the Requester has access to the ILPMP data at any point in the Requester's workflow.

2) MME calculations shall remain consistent with the presentation of this information when provided by the ILPMP directly through an EHR vendor.

3) Attestation to the existence of a legal agreement between the pharmacy management system Pharmacy Management System and the Certified Health IT Module vendor and attestation that the Certified Health IT Module serves as an integrated component of the pharmacy management system Pharmacy Management System when using a Certified Health IT Module access method.

4) The Certified Health IT Module connection must meet the security requirements for electronic health record systems set forth by the Office of the National Coordinator for Health Information Technology (ONC).

5) The Certified Health IT Module must be certified by the ONC or an ONC-Authorized Certification Body (ONC-ACB). Certification must be published on the ONC's Certified Health IT Product List. The ILPMP reserves the right to terminate the connection points if the vendor/product is decertified by the ONC-ACB.

g) Exemptions to connection/integration requirements

1) Pharmacies that do not have/use an electronic health record system, electronic prescription system, or pharmacy management system may certify they do not have/use an electronic health record system or electronic prescription system within their practice/facility/location.

2) Pharmacies that do not dispense controlled substances and have completed an exemption from reporting request, can also request an exemption from integration.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.210 Access to the Prescription Information Library (PIL) (Repealed)

a) Any entity choosing to undergo electronic integration should do so using the process in this subsection (a).

1) The entity shall email dhs.pmp@illinois.gov to request the Automated Connection Guide (ACG) and shall review its contents once the ACG is received.

A) The ACG describes the electronic message exchange processing flow and provides all the technical specifications for the transaction.

B) The entity shall share the ACG with its EHR vendor and its information technology support team to begin work to prepare for the electronic integration.

2) The entity shall determine its connectivity to the PMP for electronic integration.

A) The PMP Automated Connection supports two connectivity options. The entity must use one of the following connectivity options:

i) a SOAP based web service that uses a PMIX based protocol; or

ii) a RESTful based web service that uses the NCPDP protocol.

B) The entity shall complete the Meaningful Use Registration of Intent with the Illinois Department of Public Health (https://murs.illinois.gov). Once the Meaningful Use Registration of Intent is completed, the PMP will arrange a connectivity consultation with the entity.

3) The PMP will set up a secure, HIPAA compliant electronic integration testing environment during the connectivity determination process for use to test transactions. This testing environment shall be used by the entity to test transactions before moving to production.

4) Following successful testing, the connection is ready to be activated. The PMP will activate the production environment for the entity's use in exchanging transactions and the electronic integration process is complete.

A) The participating entities must maintain both electronic and physical security of the information.

B) Security failures or misuse of the account will be handled as any other case of HIPAA violation pursuant to 42 USC 1320 et seq.

b) Medical prescribers or dispensers or their authorized designee may utilize the PIL for patient care after obtaining authorization from the PMP.

c) Only the following licensed healthcare professionals shall serve as an authorized designee for a prescriber or dispenser for office or pharmacy practice sites:

1) registered nurse;

2) licensed practical nurse;

3) pharmacy technician;

4) student pharmacist; or

5) certified medical assistant.

d) The prescriber or dispenser shall only have up to three designees.

e) The prescriber and dispenser shall register the designees and must also agree to the terms and conditions for designees.

f) Each designee shall have an individual account that must be linked to the prescriber or dispenser.

g) PMP staff shall verify the following information about each designee:

1) license/certification number;

2) employer's phone number and address; and

3) work email address. If no work email is available, PMP staff shall contact the prescriber or dispenser to verify the designee.

h) PMP shall send out a notice for the prescriber or dispenser to ensure continued employment of their designees. If the designee is no longer employed with the prescriber or dispenser, the prescriber or dispenser shall terminate the designee's access to the PMP by locking the designee's account or by notifying the PMP that the designee's account should be locked.

i) A user may only access the PIL for a patient's medical treatment.

j) Department staff shall develop, modify and maintain data files of the PIL.

k) PIL users are ultimately responsible for any usage of their authorization credentials.

l) In order to expedite the approval and oversight of PIL applicants and users, the PIL must be managed by a licensed dispenser.

m) PIL staff determine if a PIL user applicant may become a PIL user by using the following criteria:

1) Applicant's first and last name;

2) Pharmacy, clinic or office street address, city, state and zip code;

3) DEA number;

4) For a pharmacist's application, the pharmacy DEA number;

5) Illinois prescriber or dispenser license number; and

6) Business telephone number.

n) PIL staff determine if a PIL user applicant may become a PIL group user by applying the following criteria:

1) The prescriber or dispenser who will be the account's custodian shall provide the following information:

A) First and last name;

B) DEA number;

C) National Provider Identifier (NPI) number;

D) Illinois prescriber or dispenser license number; and

E) Business telephone number;

2) Hospital emergency department's or freestanding clinic's street address, city, state and zip code;

3) The pharmacist-in-charge (PIC) as the central user of the hospital pharmacy; and

4) A listing of all users with the following information:

A) First and last name; and

B) Illinois healthcare license number.

o) The Clinical Director or designee shall review user applications that are unusual and render a professional decision as to whether access shall be granted.

p) The PMP Assistant Administrator shall review the user access log for any unusual or improper activity by a user.

q) The Clinical Director or his or her designee shall directly monitor the development, modification and/or expansion of the PIL.

(Source: Repealed at 46 Ill. Reg. _____, effective _____)

Section 2080.212 Injury and Accident Notification System

a) Medical facilities shall send the ILPMP real-time, patient information related to injuries and accidents based upon diagnosis codes set forth by the ILPMP.

1) Patient information and diagnosis codes shall be transmitted via HL7 messaging or other secure, approved transmission following ILPMP technical standards.

2) Data received from medical facilities will be displayed on the ILPMP website and PMPnow integration tool.

3) Patient diagnosis identifying injury or accident shall be verified against prescription of controlled substance medications. Prescribers participating in the care of patients who have a diagnosis of injury or accident and receive a retail dispensed controlled substance shall be notified via message within the ILPMP website (www.ilpmp.org) and PMPnow of the risk of addiction.

b) Medical facilities who dispense/administer, directly to a patient, controlled substance medications and other medications of interest as determined by the ILPMP Clinical Director or their designee, may participate in additional data sharing to identify patients who may be at risk of addiction or other substance use disorder.

1) Data will be transmitted via HL7 messaging or other secure, approved transmission following ILPMP technical standards.

2) Data will be displayed to allow providers to utilize their professional/clinical judgement when providing care and services to patients.

(Source: Added at 46 Ill. Reg. _____, effective _____)

Section 2080.220 Error Reporting

a) If a prescriber notices an error in their his or her prescription information, they he or she shall report it to the dispensing pharmacy Department by using the built in PMP error reporting system within 3 business 7 days after discovery of the error.

b) A dispenser who notices an error in a prescription they have he or she has dispensed and transmitted shall retract the incorrect prescription and retransmit the prescription correctly within 3 business 7 days after discovery of the error.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.230 Designated Controlled Substances and Other Selected Drugs

For tracking purposes, the Department, upon recommendation of the PMPAC, may designate and list drugs, other substances, and immediate precursors as:

a) A Schedule I if the Department finds that:

1) the substance has high potential for abuse; and

2) the substance has no currently accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision [720 ILCS 570/203].

b) A Schedule II if the Department finds that:

1) the substance has high potential for abuse;

2) the substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and

3) the abuse of the substance may lead to severe psychological or physiological dependence [720 ILCS 570/205].

c) A Schedule III if the Department finds that:

1) the substance has a potential for abuse less than the substances listed in Schedules I and II;

2) the substance has currently accepted medical use in treatment in the United States; and

3) abuse of the substance may lead to moderate or low physiological dependence or high psychological dependence [720 ILCS 570/207].

d) A Schedule IV if the Department finds that:

1) the substance has a low potential for abuse relative to substances in Schedule III;

2) the substance has currently accepted medical use in treatment in the United States; and

3) abuse of the substance may lead to limited physiological dependence or psychological dependence relative to the substances in Schedule III [720 ILCS 570/209].

e) A Schedule V if the Department finds that:

1) the substance has low potential for abuse relative to the controlled substances listed in Schedule IV;

2) the substance has currently accepted medical use in treatment in the United States; and

3) abuse of the substance may lead to limited physiological dependence or psychological dependence relative to the substances in Schedule IV, or the substance is a targeted methamphetamine precursor as defined in the Methamphetamine Precursor Control Act [720 ILCS 648]. [720 ILCS 570/211]

f) Other Selected Drugs, including:

1) those medications that may contribute to clinical reviews of scheduled medications;

2) those medications determined to need additional monitoring or to assist in facilitating medication optimization and utilization; and

3) the dispensing of Naloxone for opioid overdose prevention; and.

4) drugs that may interact with controlled substances.

(Source: Amended at 46 Ill. Reg. _____, effective _____)

Section 2080.245 Advanced Practice Registered Nurse with Full Practice Authority

a) An Advanced Practice Registered Nurse granted Full Practice Authority under 225 ILCS 65/65-43 who prescribes benzodiazepines or Schedule II narcotic drugs, such as opioids, shall establish a consulting relationship with a physician and shall record that relationship in the ILPMP website (www.ilpmp.org). The consulting relationship does not require any type of written agreement between the two professionals, nor is it required to be reported to DFPR under these rules. The Advanced Practice Registered Nurse is responsible for entering in the ILPMP the name, DEA number, and license number of the consulting physician.

b) Information necessary for the ILPMP form:

1) Name (First, MI, Last);

2) DEA number;

3) Profession; and

4) Professional license numbers.

c) For benzodiazepines or Schedule II Narcotics (opioids) only, the consulting physician:

1) Name (first, MI, last);

2) DEA number;

3) Profession; and

4) Practitioner's professional license numbers

d) List of specific Schedule II narcotic drugs by generic name.

(Source: Added at 46 Ill. Reg. _____, effective _____)

Section 2080.320 Illinois Prescription Monitoring Program Advisory Committee (ILPMPAC)

The Illinois A Prescription Monitoring Program Advisory Committee (ILPMPAC) is established to aid in the implementation of the ILPMP and to advise the Clinical Director on the professional performance of prescribers and dispensers and other matters relevant to the ILPMPAC's field of competence.

a) The Clinical Director shall serve as a non-voting secretary of the committee and appoint the members of the ILPMPAC based on nominations from their respective professional associations. The ILPMPAC may appoint a chairperson and other officers as it deems appropriate with the approval of the Secretary of the Department of Human Services.

b) The ILPMPAC shall consist of the following:

1) one family or primary care physician the Clinical Director who shall serve as the chairperson of the PMPAC;

2) one pain specialist physician;

32) four other physicians licensed to practice medicine who are not primarily pain specialists or family or primary care physicians, one of whom may be an ophthalmologist in all of its branches;

43) three pharmacists;

5) two advanced practice registered nurses;

64) one dentist;

5) one podiatric physician;

76) one optometrist;

8) one clinical representative from a statewide organization representing hospitals; and

7) one advanced practice nurse; and

98) one physician assistant.

c) The ILPMPAC shall:

1) evaluate and recommend changes to the Illinois Controlled Substances Act [720 ILCS 570];

2) evaluate and recommend changes to the Administrative Rules regarding the ILPMP;

3) recommend inclusion inclusions of training materials for prescribers and dispensers regarding Continuing Medical Education and Continuing Education programs;

4) at least on a semi-annual quarterly basis, review the contents of the ILPMP Illinois Prescription Monitoring Program website (ilpmp.org) to ensure that the contents are current;

5) at least on a semi-annual quarterly basis, review opportunities for federal grants and other forms of funding to support projects to increase the number of EHRs integrating seamlessly to the ILPMP; and

6) at least on a semi-annual quarterly basis, review and prepare any communication to be sent to all registered users of the system relevant to prescribing and dispensing of controlled substances.

(Source: Amended at 46 Ill. Reg. _____, effective _____)Section 2080.325 Peer Review Committee Subcommittee

The ILPMPAC is authorized to have a standing subcommittee. This subcommittee shall be a ten-five member Peer Review Committee peer review subcommittee. The Peer Review Committee peer review subcommittee shall advise the ILPMP on matters relating to the advisory committee's field of competence, establish a formal peer review of the professional performance of prescribers and dispensers, and develop communications to transmit to prescribers and dispensers. The deliberations, information, and communications of the Peer Review Committee peer review subcommittee are privileged and confidential and shall not be disclosed in any manner except in accordance with the Act.

a) The ILPMPAC Clinical Director shall appoint the five members shall select 10 of its members to be part of the Peer Review Committee peer review subcommittee.

b) The Peer Review Committee peer review subcommittee shall consist of the following:

1) three physicians of the PMPAC; and

2) three two pharmacists; of the PMPAC.

3) one dentist;

4) one advanced practice registered nurse;

5) one physician assistant; and

6) one optometrist.

c) Technical advisors from State medical and pharmacy schools with no voting authority may be appointed to the peer review subcommittee to aid the voting members on an as needed basis.

cd) The Peer Review Committee peer review subcommittee shall meet, at a minimum, semi-annually. quarterly. The scheduling of these meetings should be set to allow the meetings to occur the month prior to the publicly scheduled meeting of the PMPAC.

de) The Peer Review Committee peer review subcommittee shall periodically review the data contained within the ILPMP database prescription monitoring program to identify those prescribers or dispensers who may be prescribing or dispensing outside the currently established professional standards for the prescriber's or dispenser's field of practice and for the type of medication (e.g., opioids) or type of care (e.g., hospice) applicable to the prescription under review. The Peer Review Committee member(s), whose profession is the same as the prescriber or dispenser being reviewed, shall make recommendations for any non-action or action. The ILPMP Clinical Director and staff shall provide necessary assistance and data as required.

ef) The Peer Review Committee may request peer review subcommittee shall identify prescribers or dispensers who may be prescribing outside of the currently accepted medical standards in the course of their professional practice and send the identified prescriber or dispenser a request for information regarding the his or her prescribing or dispensing practices of identified providers. Requests for information shall be sent via certified mail. A prescriber or dispenser shall have 30 days to respond to the request for information.

fg) The Peer Review Committee peer review subcommittee shall refer a prescriber or dispenser to DFPR the Department of Financial and Professional Regulation:

1) if a prescriber or dispenser does not respond to three successive requests for information;

2) if, in the opinion of a majority of the members present of the Peer Review Committee peer review subcommittee, the prescriber or dispenser does not have a satisfactory explanation for the practices identified by the Peer Review Committee peer review subcommittee or the prescriber or dispenser does not have a satisfactory explanation for the practices identified by the Peer Review Committee peer review subcommittee in its request for information; or

3) if, following communications with the Peer Review Committee peer review subcommittee, the prescriber or dispenser does not sufficiently rectify the practices identified in the request for information in the opinion of a the majority of the members present of the Peer Review Committee peer review subcommittee.

gh) The Peer Review Committee peer review subcommittee shall prepare an annual report to the General Assembly starting on July 1, 2017. The report to the General Assembly shall be filed with the Clerk of the House of Representatives and the Secretary of the Senate in electronic form only, in the manner that the Clerk and the Secretary shall direct. The report shall contain the following information:

1) the number of times the Peer Review Committee peer review subcommittee was convened;

2) the number of prescribers or dispensers who were reviewed by the Peer Review Committee peer review subcommittee;

3) the number of requests for information sent out by the Peer Review Committee subcommittee; and

4) the number of prescribers or dispensers referred to DFPR the Department of Financial and Professional Regulation.

i) The following process shall be followed to allow PMP data to be publicly disseminated:

1) all data formats considered for dissemination shall be presented to the peer review subcommittee by its chairperson;

2) all deliberations shall be recorded to ensure accuracy of the minutes for each meeting;

3) Based upon the deliberations of the peer review subcommittee regarding the data to be disseminated, a summary report shall be written by the chairperson and forwarded to the General Counsel for review and approval of dissemination by the General Counsel, Chief of Staff and Secretary.

4) Official direction for the final processing and/or dissemination of the data will be sent via the General Counsel, Chief of Staff or Secretary's office to the chairperson of the PMPAC peer review subcommittee who will then disseminate the data accordingly.

(Source: Amended at 46 Ill. Reg. _____, effective _____)