103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
SB3491

 

Introduced 2/9/2024, by Sen. Laura Fine

 

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

    Amends the Illinois Controlled Substances Act. Provides that decisions regarding the treatment of patients experiencing chronic pain shall be made by the prescriber with dispensing by the pharmacist in accordance with the corresponding responsibility as described in federal regulations and State administrative rules. Provides that ordering, prescribing, dispensing, administering, or paying for controlled substances, including opioids, shall not be predetermined by specific morphine milligram equivalent guidelines. Provides that confidential information received from opioid treatment programs or confidential information otherwise protected under federal confidentiality of substance use disorder patient records shall not be included in the information shared to the central repository under the Prescription Monitoring Program. Provides that an applicant for this information must have a valid court order or subpoena for the confidential information requested. Defines "chronic pain" and "opiates". Effective immediately.


LRB103 36910 RLC 67023 b

 

 

A BILL FOR

 

SB3491LRB103 36910 RLC 67023 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.
16    "Opioid" means a narcotic drug or substance that is a
17Schedule II controlled substance under paragraph (1), (2),
18(3), or (5) of subsection (b) or under subsection (c) of
19Section 206.
20    (b) Decisions regarding the treatment of patients
21experiencing chronic pain shall be made by the prescriber with
22dispensing by the pharmacist in accordance with the
23corresponding responsibility as described in 21 CFR 1306.04(a)

 

 

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1and 77 Ill. Adm. Code 3100.380(a).
2    (c) Ordering, prescribing, dispensing, administering, or
3paying for controlled substances, including opioids, shall not
4be predetermined by specific morphine milligram equivalent
5guidelines.
 
6    (720 ILCS 570/318)
7    Sec. 318. Confidentiality of information.
8    (a) Information received by the central repository under
9Section 316 and former Section 321 is confidential.
10    (a-1) To ensure the federal Health Insurance Portability
11and Accountability Act and confidentiality of substance use
12disorder patient records rules that mandate the privacy of an
13individual's prescription data reported to the Prescription
14Monitoring Program received from a retail dispenser under this
15Act, and in order to execute the duties and responsibilities
16under Section 316 of this Act and rules for disclosure under
17this Section, the Clinical Director of the Prescription
18Monitoring Program or his or her designee shall maintain
19direct access to all Prescription Monitoring Program data. Any
20request for Prescription Monitoring Program data from any
21other department or agency must be approved in writing by the
22Clinical Director of the Prescription Monitoring Program or
23his or her designee unless otherwise permitted by law.
24Prescription Monitoring Program data shall only be disclosed
25as permitted by law. Confidential information received from

 

 

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1opioid treatment programs or confidential information
2otherwise protected under federal confidentiality of substance
3use disorder patient records regulated under 42 CFR Part 2
4shall not be included in the information shared under
5subsection (c),(d), (e), or (f).
6    (a-2) As an active step to address the current opioid
7crisis in this State and to prevent and reduce addiction
8resulting from a sports injury or an accident, the
9Prescription Monitoring Program and the Department of Public
10Health shall coordinate a continuous review of the
11Prescription Monitoring Program and the Department of Public
12Health data to determine if a patient may be at risk of opioid
13addiction. Each patient discharged from any medical facility
14with an International Classification of Disease, 10th edition
15code related to a sport or accident injury shall be subject to
16the data review. If the discharged patient is dispensed a
17controlled substance, the Prescription Monitoring Program
18shall alert the patient's prescriber as to the addiction risk
19and urge each to follow the Centers for Disease Control and
20Prevention guidelines or his or her respective profession's
21treatment guidelines related to the patient's injury. This
22subsection (a-2), other than this sentence, is inoperative on
23or after January 1, 2024.
24    (b) The Department must carry out a program to protect the
25confidentiality of the information described in subsection
26(a). The Department may disclose the information to another

 

 

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1person only under subsection (c), (d), or (f) and may charge a
2fee not to exceed the actual cost of furnishing the
3information.
4    (c) The Department may disclose confidential information
5described in subsection (a) to any person who is engaged in
6receiving, processing, or storing the information.
7    (d) The Department may release confidential information
8described in subsection (a) to the following persons:
9        (1) A governing body that licenses practitioners and
10    is engaged in an investigation, an adjudication, or a
11    prosecution of a violation under any State or federal law
12    that involves a controlled substance.
13        (2) An investigator for the Consumer Protection
14    Division of the office of the Attorney General, a
15    prosecuting attorney, the Attorney General, a deputy
16    Attorney General, or an investigator from the office of
17    the Attorney General, who is engaged in any of the
18    following activities involving controlled substances:
19            (A) an investigation;
20            (B) an adjudication; or
21            (C) a prosecution of a violation under any State
22        or federal law that involves a controlled substance.
23        (3) A law enforcement officer who is:
24            (A) authorized by the Illinois State Police or the
25        office of a county sheriff or State's Attorney or
26        municipal police department of Illinois to receive

 

 

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1        information of the type requested for the purpose of
2        investigations involving controlled substances; or
3            (B) approved by the Department to receive
4        information of the type requested for the purpose of
5        investigations involving controlled substances; and
6            (C) engaged in the investigation or prosecution of
7        a violation under any State or federal law that
8        involves a controlled substance.
9        (4) Select representatives of the Department of
10    Children and Family Services through the indirect online
11    request process. Access shall be established by an
12    intergovernmental agreement between the Department of
13    Children and Family Services and the Department of Human
14    Services.
15    (e) Before the Department releases confidential
16information under subsection (d), the applicant must
17demonstrate in writing to the Department that:
18        (1) the applicant has reason to believe that a
19    violation under any State or federal law that involves a
20    controlled substance has occurred; and
21        (2) the requested information is reasonably related to
22    the investigation, adjudication, or prosecution of the
23    violation described in subdivision (1); and .
24        (3) the applicant has a valid court order or subpoena
25    for the confidential information requested.
26    (f) The Department may receive and release prescription

 

 

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1record information under Section 316 and former Section 321
2to:
3        (1) a governing body that licenses practitioners;
4        (2) an investigator for the Consumer Protection
5    Division of the office of the Attorney General, a
6    prosecuting attorney, the Attorney General, a deputy
7    Attorney General, or an investigator from the office of
8    the Attorney General;
9        (3) any Illinois law enforcement officer who is:
10            (A) authorized to receive the type of information
11        released; and
12            (B) approved by the Department to receive the type
13        of information released; or
14        (4) prescription monitoring entities in other states
15    per the provisions outlined in subsection (g) and (h)
16    below;
17confidential prescription record information collected under
18Sections 316 and 321 (now repealed) that identifies vendors or
19practitioners, or both, who are prescribing or dispensing
20large quantities of Schedule II, III, IV, or V controlled
21substances outside the scope of their practice, pharmacy, or
22business, as determined by the Advisory Committee created by
23Section 320.
24    (f-5) In accordance with a confidentiality agreement
25entered into with the Department, a medical director, or a
26public health administrator and their delegated analysts, of a

 

 

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1county or municipal health department or the Department of
2Public Health shall have access to data from the system for any
3of the following purposes:
4            (1) developing education programs or public health
5        interventions relating to prescribing trends and
6        controlled substance use; or
7            (2) conducting analyses and publish reports on
8        prescribing trends in their respective jurisdictions.
9    At a minimum, the confidentiality agreement entered into
10with the Department shall:
11        (i) prohibit analysis and reports produced under
12    subparagraph (2) from including information that
13    identifies, by name, license, or address, any
14    practitioner, dispenser, ultimate user, or other person
15    administering a controlled substance; and
16        (ii) specify the appropriate technical and physical
17    safeguards that the county or municipal health department
18    must implement to ensure the privacy and security of data
19    obtained from the system. The data from the system shall
20    not be admissible as evidence, nor discoverable in any
21    action of any kind in any court or before any tribunal,
22    board, agency, or person. The disclosure of any such
23    information or data, whether proper or improper, shall not
24    waive or have any effect upon its confidentiality,
25    non-discoverability, or non-admissibility.
26    (g) The information described in subsection (f) may not be

 

 

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1released until it has been reviewed by an employee of the
2Department who is licensed as a prescriber or a dispenser and
3until that employee has certified that further investigation
4is warranted. However, failure to comply with this subsection
5(g) does not invalidate the use of any evidence that is
6otherwise admissible in a proceeding described in subsection
7(h).
8    (h) An investigator or a law enforcement officer receiving
9confidential information under subsection (c), (d), or (f) may
10disclose the information to a law enforcement officer or an
11attorney for the office of the Attorney General for use as
12evidence in the following:
13        (1) A proceeding under any State or federal law that
14    involves a controlled substance.
15        (2) A criminal proceeding or a proceeding in juvenile
16    court that involves a controlled substance.
17    (i) The Department may compile statistical reports from
18the information described in subsection (a). The reports must
19not include information that identifies, by name, license or
20address, any practitioner, dispenser, ultimate user, or other
21person administering a controlled substance.
22    (j) Based upon federal, initial and maintenance funding, a
23prescriber and dispenser inquiry system shall be developed to
24assist the health care community in its goal of effective
25clinical practice and to prevent patients from diverting or
26abusing medications.

 

 

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1        (1) An inquirer shall have read-only access to a
2    stand-alone database which shall contain records for the
3    previous 12 months.
4        (2) Dispensers may, upon positive and secure
5    identification, make an inquiry on a patient or customer
6    solely for a medical purpose as delineated within the
7    federal HIPAA law.
8        (3) The Department shall provide a one-to-one secure
9    link and encrypted software necessary to establish the
10    link between an inquirer and the Department. Technical
11    assistance shall also be provided.
12        (4) Written inquiries are acceptable but must include
13    the fee and the requester's Drug Enforcement
14    Administration license number and submitted upon the
15    requester's business stationery.
16        (5) As directed by the Prescription Monitoring Program
17    Advisory Committee and the Clinical Director for the
18    Prescription Monitoring Program, aggregate data that does
19    not indicate any prescriber, practitioner, dispenser, or
20    patient may be used for clinical studies.
21        (6) Tracking analysis shall be established and used
22    per administrative rule.
23        (7) Nothing in this Act or Illinois law shall be
24    construed to require a prescriber or dispenser to make use
25    of this inquiry system.
26        (8) If there is an adverse outcome because of a

 

 

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1    prescriber or dispenser making an inquiry, which is
2    initiated in good faith, the prescriber or dispenser shall
3    be held harmless from any civil liability.
4    (k) The Department shall establish, by rule, the process
5by which to evaluate possible erroneous association of
6prescriptions to any licensed prescriber or end user of the
7Illinois Prescription Information Library (PIL).
8    (l) The Prescription Monitoring Program Advisory Committee
9is authorized to evaluate the need for and method of
10establishing a patient specific identifier.
11    (m) Patients who identify prescriptions attributed to them
12that were not obtained by them shall be given access to their
13personal prescription history pursuant to the validation
14process as set forth by administrative rule.
15    (n) The Prescription Monitoring Program is authorized to
16develop operational push reports to entities with compatible
17electronic medical records. The process shall be covered
18within administrative rule established by the Department.
19    (o) Hospital emergency departments and freestanding
20healthcare facilities providing healthcare to walk-in patients
21may obtain, for the purpose of improving patient care, a
22unique identifier for each shift to utilize the PIL system.
23    (p) The Prescription Monitoring Program shall
24automatically create a log-in to the inquiry system when a
25prescriber or dispenser obtains or renews his or her
26controlled substance license. The Department of Financial and

 

 

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1Professional Regulation must provide the Prescription
2Monitoring Program with electronic access to the license
3information of a prescriber or dispenser to facilitate the
4creation of this profile. The Prescription Monitoring Program
5shall send the prescriber or dispenser information regarding
6the inquiry system, including instructions on how to log into
7the system, instructions on how to use the system to promote
8effective clinical practice, and opportunities for continuing
9education for the prescribing of controlled substances. The
10Prescription Monitoring Program shall also send to all
11enrolled prescribers, dispensers, and designees information
12regarding the unsolicited reports produced pursuant to Section
13314.5 of this Act.
14    (q) A prescriber or dispenser may authorize a designee to
15consult the inquiry system established by the Department under
16this subsection on his or her behalf, provided that all the
17following conditions are met:
18        (1) the designee so authorized is employed by the same
19    hospital or health care system; is employed by the same
20    professional practice; or is under contract with such
21    practice, hospital, or health care system;
22        (2) the prescriber or dispenser takes reasonable steps
23    to ensure that such designee is sufficiently competent in
24    the use of the inquiry system;
25        (3) the prescriber or dispenser remains responsible
26    for ensuring that access to the inquiry system by the

 

 

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1    designee is limited to authorized purposes and occurs in a
2    manner that protects the confidentiality of the
3    information obtained from the inquiry system, and remains
4    responsible for any breach of confidentiality; and
5        (4) the ultimate decision as to whether or not to
6    prescribe or dispense a controlled substance remains with
7    the prescriber or dispenser.
8    The Prescription Monitoring Program shall send to
9registered designees information regarding the inquiry system,
10including instructions on how to log onto the system.
11    (r) The Prescription Monitoring Program shall maintain an
12Internet website in conjunction with its prescriber and
13dispenser inquiry system. This website shall include, at a
14minimum, the following information:
15        (1) current clinical guidelines developed by health
16    care professional organizations on the prescribing of
17    opioids or other controlled substances as determined by
18    the Advisory Committee;
19        (2) accredited continuing education programs related
20    to prescribing of controlled substances;
21        (3) programs or information developed by health care
22    professionals that may be used to assess patients or help
23    ensure compliance with prescriptions;
24        (4) updates from the Food and Drug Administration, the
25    Centers for Disease Control and Prevention, and other
26    public and private organizations which are relevant to

 

 

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

 

 

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1    ensure compliance with prescriptions;
2        (4) updates from the Food and Drug Administration, the
3    Centers for Disease Control and Prevention, and other
4    public and private organizations which are relevant to
5    prescribing;
6        (5) relevant medical studies related to prescribing;
7        (6) other information regarding prescribing of
8    controlled substances;
9        (7) information regarding prescription drug disposal
10    events, including take-back programs or other disposal
11    options or events; and
12        (8) reminders that the Prescription Monitoring Program
13    is a useful clinical tool.
14    (t) Notwithstanding any other provision of this Act,
15neither the Prescription Monitoring Program nor any other
16person shall disclose any information in violation of the
17restrictions and requirements of paragraph (3.5) of subsection
18(a) of Section 316 as implemented under Public Act 102-527.
19(Source: P.A. 102-751, eff. 1-1-23.)
 
20    Section 99. Effective date. This Act takes effect upon
21becoming law.