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Full Text of SB3024  102nd General Assembly

SB3024sam001 102ND GENERAL ASSEMBLY

Sen. Melinda Bush

Filed: 2/15/2022

 

 


 

 


 
10200SB3024sam001LRB102 22161 RLC 36027 a

1
AMENDMENT TO SENATE BILL 3024

2    AMENDMENT NO. ______. Amend Senate Bill 3024 by replacing
3everything after the enacting clause with the following:
 
4    "Section 5. The Illinois Controlled Substances Act is
5amended by changing Section 318 as follows:
 
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

 

 

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1this Section, the Clinical Director of the Prescription
2Monitoring Program or his or her designee shall maintain
3direct access to all Prescription Monitoring Program data. Any
4request for Prescription Monitoring Program data from any
5other department or agency must be approved in writing by the
6Clinical Director of the Prescription Monitoring Program or
7his or her designee unless otherwise permitted by law.
8Prescription Monitoring Program data shall only be disclosed
9as permitted by law.
10    (a-2) As an active step to address the current opioid
11crisis in this State and to prevent and reduce addiction
12resulting from a sports injury or an accident, the
13Prescription Monitoring Program and the Department of Public
14Health shall coordinate a continuous review of the
15Prescription Monitoring Program and the Department of Public
16Health data to determine if a patient may be at risk of opioid
17addiction. Each patient discharged from any medical facility
18with an International Classification of Disease, 10th edition
19code related to a sport or accident injury shall be subject to
20the data review. If the discharged patient is dispensed a
21controlled substance, the Prescription Monitoring Program
22shall alert the patient's prescriber as to the addiction risk
23and urge each to follow the Centers for Disease Control and
24Prevention guidelines or his or her respective profession's
25treatment guidelines related to the patient's injury. This
26subsection (a-2), other than this sentence, is inoperative on

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1prescriber or dispenser obtains or renews his or her
2controlled substance license. The Department of Financial and
3Professional Regulation must provide the Prescription
4Monitoring Program with electronic access to the license
5information of a prescriber or dispenser to facilitate the
6creation of this profile. The Prescription Monitoring Program
7shall send the prescriber or dispenser information regarding
8the inquiry system, including instructions on how to log into
9the system, instructions on how to use the system to promote
10effective clinical practice, and opportunities for continuing
11education for the prescribing of controlled substances. The
12Prescription Monitoring Program shall also send to all
13enrolled prescribers, dispensers, and designees information
14regarding the unsolicited reports produced pursuant to Section
15314.5 of this Act.
16    (q) A prescriber or dispenser may authorize a designee to
17consult the inquiry system established by the Department under
18this subsection on his or her behalf, provided that all the
19following conditions are met:
20        (1) the designee so authorized is employed by the same
21    hospital or health care system; is employed by the same
22    professional practice; or is under contract with such
23    practice, hospital, or health care system;
24        (2) the prescriber or dispenser takes reasonable steps
25    to ensure that such designee is sufficiently competent in
26    the use of the inquiry system;

 

 

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

 

 

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

 

 

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1        (3) programs or information developed by health care
2    professionals that may be used to assess patients or help
3    ensure compliance with prescriptions;
4        (4) updates from the Food and Drug Administration, the
5    Centers for Disease Control and Prevention, and other
6    public and private organizations which are relevant to
7    prescribing;
8        (5) relevant medical studies related to prescribing;
9        (6) other information regarding prescribing of
10    controlled substances;
11        (7) information regarding prescription drug disposal
12    events, including take-back programs or other disposal
13    options or events; and
14        (8) reminders that the Prescription Monitoring Program
15    is a useful clinical tool.
16    (t) Notwithstanding any other provision of this Act,
17neither the Prescription Monitoring Program nor any other
18person shall disclose any information in violation of the
19restrictions and requirements of paragraph (3.5) of subsection
20(a) of Section 316 as implemented under Public Act 102-527.
21(Source: P.A. 99-480, eff. 9-9-15; 100-125, eff. 1-1-18;
22100-1093, eff. 8-26-18.)".