HB5373 EngrossedLRB103 36911 RLC 67024 b

1    AN ACT concerning criminal law.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Controlled Substances Act is
5amended by changing Section 318 and by adding Section 315.7 as
6follows:
 
7    (720 ILCS 570/315.7 new)
8    Sec. 315.7. Chronic pain treatment.
9    (a) In this Section:
10    "Chronic pain" means a state in which pain persists beyond
11the usual course of an acute disease or healing of an injury,
12or which may or may not be associated with an acute or chronic
13pathologic process that causes continuous or intermittent pain
14over months or years. "Chronic pain" is considered to be pain
15that persists for more than 12 weeks and is adversely
16affecting the function or well-being of the individual.
17    "Opioid" means a narcotic drug or substance that is a
18Schedule II controlled substance under paragraph (1), (2),
19(3), or (5) of subsection (b) or under subsection (c) of
20Section 206.
21    (b) Decisions regarding the treatment of patients
22experiencing chronic pain shall be made by the prescriber with
23dispensing by the pharmacist in accordance with the

 

 

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1corresponding responsibility as described in 21 CFR 1306.04(a)
2and 77 Ill. Adm. Code 3100.380(a).
3    (c) Ordering, prescribing, dispensing, administering, or
4paying for controlled substances, including opioids, shall not
5be predetermined by specific morphine milligram equivalent
6guidelines.
7    (d) Nothing in this Section shall interfere with the
8review of prescriptions by the Prescription Monitoring
9Program's Advisory Committee. In reviewing prescriptions for
10chronic pain, the advisory committee members shall review the
11most updated clinical guidelines on treating chronic pain for
12the period the prescriptions were written.
 
13    (720 ILCS 570/318)
14    Sec. 318. Confidentiality of information.
15    (a) Information received by the central repository under
16Section 316 and former Section 321 is confidential.
17    (a-1) To ensure the federal Health Insurance Portability
18and Accountability Act and confidentiality of substance use
19disorder patient records rules that mandate the privacy of an
20individual's prescription data reported to the Prescription
21Monitoring Program received from a retail dispenser under this
22Act, and in order to execute the duties and responsibilities
23under Section 316 of this Act and rules for disclosure under
24this Section, the Clinical Director of the Prescription
25Monitoring Program or his or her designee shall maintain

 

 

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1direct access to all Prescription Monitoring Program data. Any
2request for Prescription Monitoring Program data from any
3other department or agency must be approved in writing by the
4Clinical Director of the Prescription Monitoring Program or
5his or her designee unless otherwise permitted by law.
6Prescription Monitoring Program data shall only be disclosed
7as permitted by law. Confidential information received from
8opioid treatment programs or confidential information
9otherwise protected under federal confidentiality of substance
10use disorder patient records regulated under 42 CFR Part 2
11shall not be included in the information shared.
12    (a-2) As an active step to address the current opioid
13crisis in this State and to prevent and reduce addiction
14resulting from a sports injury or an accident, the
15Prescription Monitoring Program and the Department of Public
16Health shall coordinate a continuous review of the
17Prescription Monitoring Program and the Department of Public
18Health data to determine if a patient may be at risk of opioid
19addiction. Each patient discharged from any medical facility
20with an International Classification of Disease, 10th edition
21code related to a sport or accident injury shall be subject to
22the data review. If the discharged patient is dispensed a
23controlled substance, the Prescription Monitoring Program
24shall alert the patient's prescriber as to the addiction risk
25and urge each to follow the Centers for Disease Control and
26Prevention guidelines or his or her respective profession's

 

 

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1treatment guidelines related to the patient's injury. This
2subsection (a-2), other than this sentence, is inoperative on
3or after January 1, 2024.
4    (b) The Department must carry out a program to protect the
5confidentiality of the information described in subsection
6(a). The Department may disclose the information to another
7person only under subsection (c), (d), or (f) and may charge a
8fee not to exceed the actual cost of furnishing the
9information.
10    (c) The Department may disclose confidential information
11described in subsection (a) to any person who is engaged in
12receiving, processing, or storing the information.
13    (d) The Department may release confidential information
14described in subsection (a) to the following persons:
15        (1) A governing body that licenses practitioners and
16    is engaged in an investigation, an adjudication, or a
17    prosecution of a violation under any State or federal law
18    that involves a controlled substance.
19        (2) An investigator for the Consumer Protection
20    Division of the office of the Attorney General, a
21    prosecuting attorney, the Attorney General, a deputy
22    Attorney General, or an investigator from the office of
23    the Attorney General, who is engaged in any of the
24    following activities involving controlled substances:
25            (A) an investigation;
26            (B) an adjudication; or

 

 

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1            (C) a prosecution of a violation under any State
2        or federal law that involves a controlled substance.
3        (3) A law enforcement officer who is:
4            (A) authorized by the Illinois State Police or the
5        office of a county sheriff or State's Attorney or
6        municipal police department of Illinois to receive
7        information of the type requested for the purpose of
8        investigations involving controlled substances; or
9            (B) approved by the Department to receive
10        information of the type requested for the purpose of
11        investigations involving controlled substances; and
12            (C) engaged in the investigation or prosecution of
13        a violation under any State or federal law that
14        involves a controlled substance.
15        (4) Select representatives of the Department of
16    Children and Family Services through the indirect online
17    request process. Access shall be established by an
18    intergovernmental agreement between the Department of
19    Children and Family Services and the Department of Human
20    Services.
21    (e) Before the Department releases confidential
22information under subsection (d), the applicant must
23demonstrate in writing to the Department that:
24        (1) the applicant has reason to believe that a
25    violation under any State or federal law that involves a
26    controlled substance has occurred; and

 

 

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1        (2) the requested information is reasonably related to
2    the investigation, adjudication, or prosecution of the
3    violation described in subdivision (1); and .
4        (3) the applicant has a valid court order or subpoena
5    for the confidential information requested.
6    (f) The Department may receive and release prescription
7record information under Section 316 and former Section 321
8to:
9        (1) a governing body that licenses practitioners;
10        (2) an investigator for the Consumer Protection
11    Division of the office of the Attorney General, a
12    prosecuting attorney, the Attorney General, a deputy
13    Attorney General, or an investigator from the office of
14    the Attorney General;
15        (3) any Illinois law enforcement officer who is:
16            (A) authorized to receive the type of information
17        released; and
18            (B) approved by the Department to receive the type
19        of information released; or
20        (4) prescription monitoring entities in other states
21    per the provisions outlined in subsection (g) and (h)
22    below;
23confidential prescription record information collected under
24Sections 316 and 321 (now repealed) that identifies vendors or
25practitioners, or both, who are prescribing or dispensing
26large quantities of Schedule II, III, IV, or V controlled

 

 

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1substances outside the scope of their practice, pharmacy, or
2business, as determined by the Advisory Committee created by
3Section 320.
4    (f-5) In accordance with a confidentiality agreement
5entered into with the Department, a medical director, or a
6public health administrator and their delegated analysts, of a
7county or municipal health department or the Department of
8Public Health shall have access to data from the system for any
9of the following purposes:
10            (1) developing education programs or public health
11        interventions relating to prescribing trends and
12        controlled substance use; or
13            (2) conducting analyses and publish reports on
14        prescribing trends in their respective jurisdictions.
15    At a minimum, the confidentiality agreement entered into
16with the Department shall:
17        (i) prohibit analysis and reports produced under
18    subparagraph (2) from including information that
19    identifies, by name, license, or address, any
20    practitioner, dispenser, ultimate user, or other person
21    administering a controlled substance; and
22        (ii) specify the appropriate technical and physical
23    safeguards that the county or municipal health department
24    must implement to ensure the privacy and security of data
25    obtained from the system. The data from the system shall
26    not be admissible as evidence, nor discoverable in any

 

 

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1    action of any kind in any court or before any tribunal,
2    board, agency, or person. The disclosure of any such
3    information or data, whether proper or improper, shall not
4    waive or have any effect upon its confidentiality,
5    non-discoverability, or non-admissibility.
6    (g) The information described in subsection (f) may not be
7released until it has been reviewed by an employee of the
8Department who is licensed as a prescriber or a dispenser and
9until that employee has certified that further investigation
10is warranted. Upon review and approval by a licensed
11prescriber or dispenser, the Prescription Monitoring Program
12administrator or the Department's general legal counsel may
13release information. However, failure to comply with this
14subsection (g) does not invalidate the use of any evidence
15that is otherwise admissible in a proceeding described in
16subsection (h).
17    (h) An investigator or a law enforcement officer receiving
18confidential information under subsection (c), (d), or (f) may
19disclose the information to a law enforcement officer or an
20attorney for the office of the Attorney General for use as
21evidence in the following:
22        (1) A proceeding under any State or federal law that
23    involves a controlled substance.
24        (2) A criminal proceeding or a proceeding in juvenile
25    court that involves a controlled substance.
26    (i) The Department may compile statistical reports from

 

 

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1the information described in subsection (a). The reports must
2not include information that identifies, by name, license or
3address, any practitioner, dispenser, ultimate user, or other
4person administering a controlled substance.
5    (j) Based upon federal, initial and maintenance funding, a
6prescriber and dispenser inquiry system shall be developed to
7assist the health care community in its goal of effective
8clinical practice and to prevent patients from diverting or
9abusing medications.
10        (1) An inquirer shall have read-only access to a
11    stand-alone database which shall contain records for the
12    previous 12 months.
13        (2) Dispensers may, upon positive and secure
14    identification, make an inquiry on a patient or customer
15    solely for a medical purpose as delineated within the
16    federal HIPAA law.
17        (3) The Department shall provide a one-to-one secure
18    link and encrypted software necessary to establish the
19    link between an inquirer and the Department. Technical
20    assistance shall also be provided.
21        (4) Written inquiries are acceptable but must include
22    the fee and the requester's Drug Enforcement
23    Administration license number and submitted upon the
24    requester's business stationery.
25        (5) As directed by the Prescription Monitoring Program
26    Advisory Committee and the Clinical Director for the

 

 

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1    Prescription Monitoring Program, aggregate data that does
2    not indicate any prescriber, practitioner, dispenser, or
3    patient may be used for clinical studies.
4        (6) Tracking analysis shall be established and used
5    per administrative rule.
6        (7) Nothing in this Act or Illinois law shall be
7    construed to require a prescriber or dispenser to make use
8    of this inquiry system.
9        (8) If there is an adverse outcome because of a
10    prescriber or dispenser making an inquiry, which is
11    initiated in good faith, the prescriber or dispenser shall
12    be held harmless from any civil liability.
13    (k) The Department shall establish, by rule, the process
14by which to evaluate possible erroneous association of
15prescriptions to any licensed prescriber or end user of the
16Illinois Prescription Information Library (PIL).
17    (l) The Prescription Monitoring Program Advisory Committee
18is authorized to evaluate the need for and method of
19establishing a patient specific identifier.
20    (m) Patients who identify prescriptions attributed to them
21that were not obtained by them shall be given access to their
22personal prescription history pursuant to the validation
23process as set forth by administrative rule.
24    (n) The Prescription Monitoring Program is authorized to
25develop operational push reports to entities with compatible
26electronic medical records. The process shall be covered

 

 

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1within administrative rule established by the Department.
2    (o) Hospital emergency departments and freestanding
3healthcare facilities providing healthcare to walk-in patients
4may obtain, for the purpose of improving patient care, a
5unique identifier for each shift to utilize the PIL system.
6    (p) The Prescription Monitoring Program shall
7automatically create a log-in to the inquiry system when a
8prescriber or dispenser obtains or renews his or her
9controlled substance license. The Department of Financial and
10Professional Regulation must provide the Prescription
11Monitoring Program with electronic access to the license
12information of a prescriber or dispenser to facilitate the
13creation of this profile. The Prescription Monitoring Program
14shall send the prescriber or dispenser information regarding
15the inquiry system, including instructions on how to log into
16the system, instructions on how to use the system to promote
17effective clinical practice, and opportunities for continuing
18education for the prescribing of controlled substances. The
19Prescription Monitoring Program shall also send to all
20enrolled prescribers, dispensers, and designees information
21regarding the unsolicited reports produced pursuant to Section
22314.5 of this Act.
23    (q) A prescriber or dispenser may authorize a designee to
24consult the inquiry system established by the Department under
25this subsection on his or her behalf, provided that all the
26following conditions are met:

 

 

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1        (1) the designee so authorized is employed by the same
2    hospital or health care system; is employed by the same
3    professional practice; or is under contract with such
4    practice, hospital, or health care system;
5        (2) the prescriber or dispenser takes reasonable steps
6    to ensure that such designee is sufficiently competent in
7    the use of the inquiry system;
8        (3) the prescriber or dispenser remains responsible
9    for ensuring that access to the inquiry system by the
10    designee is limited to authorized purposes and occurs in a
11    manner that protects the confidentiality of the
12    information obtained from the inquiry system, and remains
13    responsible for any breach of confidentiality; and
14        (4) the ultimate decision as to whether or not to
15    prescribe or dispense a controlled substance remains with
16    the prescriber or dispenser.
17    The Prescription Monitoring Program shall send to
18registered designees information regarding the inquiry system,
19including instructions on how to log onto the system.
20    (r) The Prescription Monitoring Program shall maintain an
21Internet website in conjunction with its prescriber and
22dispenser inquiry system. This website shall include, at a
23minimum, the following information:
24        (1) current clinical guidelines developed by health
25    care professional organizations on the prescribing of
26    opioids or other controlled substances as determined by

 

 

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1    the Advisory Committee;
2        (2) accredited continuing education programs related
3    to prescribing of controlled substances;
4        (3) programs or information developed by health care
5    professionals that may be used to assess patients or help
6    ensure compliance with prescriptions;
7        (4) updates from the Food and Drug Administration, the
8    Centers for Disease Control and Prevention, and other
9    public and private organizations which are relevant to
10    prescribing;
11        (5) relevant medical studies related to prescribing;
12        (6) other information regarding the prescription of
13    controlled substances; and
14        (7) information regarding prescription drug disposal
15    events, including take-back programs or other disposal
16    options or events.
17    The content of the Internet website shall be periodically
18reviewed by the Prescription Monitoring Program Advisory
19Committee as set forth in Section 320 and updated in
20accordance with the recommendation of the advisory committee.
21    (s) The Prescription Monitoring Program shall regularly
22send electronic updates to the registered users of the
23Program. The Prescription Monitoring Program Advisory
24Committee shall review any communications sent to registered
25users and also make recommendations for communications as set
26forth in Section 320. These updates shall include the

 

 

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1following information:
2        (1) opportunities for accredited continuing education
3    programs related to prescribing of controlled substances;
4        (2) current clinical guidelines developed by health
5    care professional organizations on the prescribing of
6    opioids or other drugs as determined by the Advisory
7    Committee;
8        (3) programs or information developed by health care
9    professionals that may be used to assess patients or help
10    ensure compliance with prescriptions;
11        (4) updates from the Food and Drug Administration, the
12    Centers for Disease Control and Prevention, and other
13    public and private organizations which are relevant to
14    prescribing;
15        (5) relevant medical studies related to prescribing;
16        (6) other information regarding prescribing of
17    controlled substances;
18        (7) information regarding prescription drug disposal
19    events, including take-back programs or other disposal
20    options or events; and
21        (8) reminders that the Prescription Monitoring Program
22    is a useful clinical tool.
23    (t) Notwithstanding any other provision of this Act,
24neither the Prescription Monitoring Program nor any other
25person shall disclose any information in violation of the
26restrictions and requirements of paragraph (3.5) of subsection

 

 

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1(a) of Section 316 as implemented under Public Act 102-527.
2(Source: P.A. 102-751, eff. 1-1-23.)
 
3    Section 99. Effective date. This Act takes effect upon
4becoming law.