103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB2046

 

Introduced 2/7/2023, by Rep. Kelly M. Cassidy

 

SYNOPSIS AS INTRODUCED:
 
720 ILCS 570/315.7 new
720 ILCS 570/318

    Amends the Illinois Controlled Substances Act. Provides that all decisions regarding the treatment of patients experiencing pain, including chronic pain, shall be made by the prescriber. Provides that ordering, prescribing, dispensing, administering, or paying for controlled substances, including opioids, shall not in any way be predetermined by specific morphine milligram equivalent guidelines. Provides that, before the Department of Human Services releases confidential information from the central repository, the applicant, in addition to other requirements of the Act, must demonstrate in writing to the Department that the applicant has a valid court order or subpoena for the release of the confidential information requested.


LRB103 05014 RLC 51034 b

 

 

A BILL FOR

 

HB2046LRB103 05014 RLC 51034 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, "opioid" means a narcotic drug or
10substance that is a Schedule II controlled substance under
11paragraph (1), (2), (3), or (5) of subsection (b) or under
12subsection (c) of Section 206.
13    (b) All decisions regarding the treatment of patients
14experiencing pain, including chronic pain, shall be made by
15the prescriber.
16    (c) Ordering, prescribing, dispensing, administering, or
17paying for controlled substances, including opioids, shall not
18in any way be predetermined by specific morphine milligram
19equivalent guidelines.
 
20    (720 ILCS 570/318)
21    Sec. 318. Confidentiality of information.
22    (a) Information received by the central repository under

 

 

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1Section 316 and former Section 321 is confidential.
2    (a-1) To ensure the federal Health Insurance Portability
3and Accountability Act and confidentiality of substance use
4disorder patient records rules that mandate the privacy of an
5individual's prescription data reported to the Prescription
6Monitoring Program received from a retail dispenser under this
7Act, and in order to execute the duties and responsibilities
8under Section 316 of this Act and rules for disclosure under
9this Section, the Clinical Director of the Prescription
10Monitoring Program or his or her designee shall maintain
11direct access to all Prescription Monitoring Program data. Any
12request for Prescription Monitoring Program data from any
13other department or agency must be approved in writing by the
14Clinical Director of the Prescription Monitoring Program or
15his or her designee unless otherwise permitted by law.
16Prescription Monitoring Program data shall only be disclosed
17as permitted by law.
18    (a-2) As an active step to address the current opioid
19crisis in this State and to prevent and reduce addiction
20resulting from a sports injury or an accident, the
21Prescription Monitoring Program and the Department of Public
22Health shall coordinate a continuous review of the
23Prescription Monitoring Program and the Department of Public
24Health data to determine if a patient may be at risk of opioid
25addiction. Each patient discharged from any medical facility
26with an International Classification of Disease, 10th edition

 

 

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1code related to a sport or accident injury shall be subject to
2the data review. If the discharged patient is dispensed a
3controlled substance, the Prescription Monitoring Program
4shall alert the patient's prescriber as to the addiction risk
5and urge each to follow the Centers for Disease Control and
6Prevention guidelines or his or her respective profession's
7treatment guidelines related to the patient's injury. This
8subsection (a-2), other than this sentence, is inoperative on
9or after January 1, 2024.
10    (b) The Department must carry out a program to protect the
11confidentiality of the information described in subsection
12(a). The Department may disclose the information to another
13person only under subsection (c), (d), or (f) and may charge a
14fee not to exceed the actual cost of furnishing the
15information.
16    (c) The Department may disclose confidential information
17described in subsection (a) to any person who is engaged in
18receiving, processing, or storing the information.
19    (d) The Department may release confidential information
20described in subsection (a) to the following persons:
21        (1) A governing body that licenses practitioners and
22    is engaged in an investigation, an adjudication, or a
23    prosecution of a violation under any State or federal law
24    that involves a controlled substance.
25        (2) An investigator for the Consumer Protection
26    Division of the office of the Attorney General, a

 

 

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

 

 

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1    (e) Before the Department releases confidential
2information under subsection (d), the applicant must
3demonstrate in writing to the Department that:
4        (1) the applicant has reason to believe that a
5    violation under any State or federal law that involves a
6    controlled substance has occurred; and
7        (2) the requested information is reasonably related to
8    the investigation, adjudication, or prosecution of the
9    violation described in subdivision (1); and
10        (3) the applicant has a valid court order or subpoena
11    for the release of the confidential information requested.
12    (f) The Department may receive and release prescription
13record information under Section 316 and former Section 321
14to:
15        (1) a governing body that licenses practitioners;
16        (2) an investigator for the Consumer Protection
17    Division of the office of the Attorney General, a
18    prosecuting attorney, the Attorney General, a deputy
19    Attorney General, or an investigator from the office of
20    the Attorney General;
21        (3) any Illinois law enforcement officer who is:
22            (A) authorized to receive the type of information
23        released; and
24            (B) approved by the Department to receive the type
25        of information released; or
26        (4) prescription monitoring entities in other states

 

 

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1    per the provisions outlined in subsection (g) and (h)
2    below;
3confidential prescription record information collected under
4Sections 316 and 321 (now repealed) that identifies vendors or
5practitioners, or both, who are prescribing or dispensing
6large quantities of Schedule II, III, IV, or V controlled
7substances outside the scope of their practice, pharmacy, or
8business, as determined by the Advisory Committee created by
9Section 320.
10    (f-5) In accordance with a confidentiality agreement
11entered into with the Department, a medical director, or a
12public health administrator and their delegated analysts, of a
13county or municipal health department or the Department of
14Public Health shall have access to data from the system for any
15of the following purposes:
16            (1) developing education programs or public health
17        interventions relating to prescribing trends and
18        controlled substance use; or
19            (2) conducting analyses and publish reports on
20        prescribing trends in their respective jurisdictions.
21    At a minimum, the confidentiality agreement entered into
22with the Department shall:
23        (i) prohibit analysis and reports produced under
24    subparagraph (2) from including information that
25    identifies, by name, license, or address, any
26    practitioner, dispenser, ultimate user, or other person

 

 

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1    administering a controlled substance; and
2        (ii) specify the appropriate technical and physical
3    safeguards that the county or municipal health department
4    must implement to ensure the privacy and security of data
5    obtained from the system. The data from the system shall
6    not be admissible as evidence, nor discoverable in any
7    action of any kind in any court or before any tribunal,
8    board, agency, or person. The disclosure of any such
9    information or data, whether proper or improper, shall not
10    waive or have any effect upon its confidentiality,
11    non-discoverability, or non-admissibility.
12    (g) The information described in subsection (f) may not be
13released until it has been reviewed by an employee of the
14Department who is licensed as a prescriber or a dispenser and
15until that employee has certified that further investigation
16is warranted. However, failure to comply with this subsection
17(g) does not invalidate the use of any evidence that is
18otherwise admissible in a proceeding described in subsection
19(h).
20    (h) An investigator or a law enforcement officer receiving
21confidential information under subsection (c), (d), or (f) may
22disclose the information to a law enforcement officer or an
23attorney for the office of the Attorney General for use as
24evidence in the following:
25        (1) A proceeding under any State or federal law that
26    involves a controlled substance.

 

 

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

 

 

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

 

 

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1    (n) The Prescription Monitoring Program is authorized to
2develop operational push reports to entities with compatible
3electronic medical records. The process shall be covered
4within administrative rule established by the Department.
5    (o) Hospital emergency departments and freestanding
6healthcare facilities providing healthcare to walk-in patients
7may obtain, for the purpose of improving patient care, a
8unique identifier for each shift to utilize the PIL system.
9    (p) The Prescription Monitoring Program shall
10automatically create a log-in to the inquiry system when a
11prescriber or dispenser obtains or renews his or her
12controlled substance license. The Department of Financial and
13Professional Regulation must provide the Prescription
14Monitoring Program with electronic access to the license
15information of a prescriber or dispenser to facilitate the
16creation of this profile. The Prescription Monitoring Program
17shall send the prescriber or dispenser information regarding
18the inquiry system, including instructions on how to log into
19the system, instructions on how to use the system to promote
20effective clinical practice, and opportunities for continuing
21education for the prescribing of controlled substances. The
22Prescription Monitoring Program shall also send to all
23enrolled prescribers, dispensers, and designees information
24regarding the unsolicited reports produced pursuant to Section
25314.5 of this Act.
26    (q) A prescriber or dispenser may authorize a designee to

 

 

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

 

 

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

 

 

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1Committee shall review any communications sent to registered
2users and also make recommendations for communications as set
3forth in Section 320. These updates shall include the
4following information:
5        (1) opportunities for accredited continuing education
6    programs related to prescribing of controlled substances;
7        (2) current clinical guidelines developed by health
8    care professional organizations on the prescribing of
9    opioids or other drugs as determined by the Advisory
10    Committee;
11        (3) programs or information developed by health care
12    professionals that may be used to assess patients or help
13    ensure compliance with prescriptions;
14        (4) updates from the Food and Drug Administration, the
15    Centers for Disease Control and Prevention, and other
16    public and private organizations which are relevant to
17    prescribing;
18        (5) relevant medical studies related to prescribing;
19        (6) other information regarding prescribing of
20    controlled substances;
21        (7) information regarding prescription drug disposal
22    events, including take-back programs or other disposal
23    options or events; and
24        (8) reminders that the Prescription Monitoring Program
25    is a useful clinical tool.
26    (t) Notwithstanding any other provision of this Act,

 

 

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1neither the Prescription Monitoring Program nor any other
2person shall disclose any information in violation of the
3restrictions and requirements of paragraph (3.5) of subsection
4(a) of Section 316 as implemented under Public Act 102-527.
5(Source: P.A. 102-751, eff. 1-1-23.)