Illinois-2023-HB2046-Introduced

103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB2046

Introduced , 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.

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A BILL FOR

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1 AN ACT concerning criminal law.

2 Be it enacted by the People of the State of Illinois,

3 represented in the General Assembly:

4 Section 5. The Illinois Controlled Substances Act is

5 amended by changing Section 318 and by adding Section 315.7 as

6 follows:

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

10 substance that is a Schedule II controlled substance under

11 paragraph (1), (2), (3), or (5) of subsection (b) or under

12 subsection (c) of Section 206.

13 (b) All decisions regarding the treatment of patients

14 experiencing pain, including chronic pain, shall be made by

15 the prescriber.

16 (c) Ordering, prescribing, dispensing, administering, or

17 paying for controlled substances, including opioids, shall not

18 in any way be predetermined by specific morphine milligram

19 equivalent 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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1 Section 316 and former Section 321 is confidential.

2 (a-1) To ensure the federal Health Insurance Portability

3 and Accountability Act and confidentiality of substance use

4 disorder patient records rules that mandate the privacy of an

5 individual's prescription data reported to the Prescription

6 Monitoring Program received from a retail dispenser under this

7 Act, and in order to execute the duties and responsibilities

8 under Section 316 of this Act and rules for disclosure under

9 this Section, the Clinical Director of the Prescription

10 Monitoring Program or his or her designee shall maintain

11 direct access to all Prescription Monitoring Program data. Any

12 request for Prescription Monitoring Program data from any

13 other department or agency must be approved in writing by the

14 Clinical Director of the Prescription Monitoring Program or

15 his or her designee unless otherwise permitted by law.

16 Prescription Monitoring Program data shall only be disclosed

17 as permitted by law.

18 (a-2) As an active step to address the current opioid

19 crisis in this State and to prevent and reduce addiction

20 resulting from a sports injury or an accident, the

21 Prescription Monitoring Program and the Department of Public

22 Health shall coordinate a continuous review of the

23 Prescription Monitoring Program and the Department of Public

24 Health data to determine if a patient may be at risk of opioid

25 addiction. Each patient discharged from any medical facility

26 with an International Classification of Disease, 10th edition

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1 code related to a sport or accident injury shall be subject to

2 the data review. If the discharged patient is dispensed a

3 controlled substance, the Prescription Monitoring Program

4 shall alert the patient's prescriber as to the addiction risk

5 and urge each to follow the Centers for Disease Control and

6 Prevention guidelines or his or her respective profession's

7 treatment guidelines related to the patient's injury. This

8 subsection (a-2), other than this sentence, is inoperative on

9 or after January 1, 2024.

10 (b) The Department must carry out a program to protect the

11 confidentiality of the information described in subsection

12 (a). The Department may disclose the information to another

13 person only under subsection (c), (d), or (f) and may charge a

14 fee not to exceed the actual cost of furnishing the

15 information.

16 (c) The Department may disclose confidential information

17 described in subsection (a) to any person who is engaged in

18 receiving, processing, or storing the information.

19 (d) The Department may release confidential information

20 described 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

2 information under subsection (d), the applicant must

3 demonstrate 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

13 record information under Section 316 and former Section 321

14 to:

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;

3 confidential prescription record information collected under

4 Sections 316 and 321 (now repealed) that identifies vendors or

5 practitioners, or both, who are prescribing or dispensing

6 large quantities of Schedule II, III, IV, or V controlled

7 substances outside the scope of their practice, pharmacy, or

8 business, as determined by the Advisory Committee created by

9 Section 320.

10 (f-5) In accordance with a confidentiality agreement

11 entered into with the Department, a medical director, or a

12 public health administrator and their delegated analysts, of a

13 county or municipal health department or the Department of

14 Public Health shall have access to data from the system for any

15 of 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

22 with 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

13 released until it has been reviewed by an employee of the

14 Department who is licensed as a prescriber or a dispenser and

15 until that employee has certified that further investigation

16 is warranted. However, failure to comply with this subsection

17 (g) does not invalidate the use of any evidence that is

18 otherwise admissible in a proceeding described in subsection

19 (h).

20 (h) An investigator or a law enforcement officer receiving

21 confidential information under subsection (c), (d), or (f) may

22 disclose the information to a law enforcement officer or an

23 attorney for the office of the Attorney General for use as

24 evidence 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

4 the information described in subsection (a). The reports must

5 not include information that identifies, by name, license or

6 address, any practitioner, dispenser, ultimate user, or other

7 person administering a controlled substance.

8 (j) Based upon federal, initial and maintenance funding, a

9 prescriber and dispenser inquiry system shall be developed to

10 assist the health care community in its goal of effective

11 clinical practice and to prevent patients from diverting or

12 abusing 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

17 by which to evaluate possible erroneous association of

18 prescriptions to any licensed prescriber or end user of the

19 Illinois Prescription Information Library (PIL).

20 (l) The Prescription Monitoring Program Advisory Committee

21 is authorized to evaluate the need for and method of

22 establishing a patient specific identifier.

23 (m) Patients who identify prescriptions attributed to them

24 that were not obtained by them shall be given access to their

25 personal prescription history pursuant to the validation

26 process as set forth by administrative rule.

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1 (n) The Prescription Monitoring Program is authorized to

2 develop operational push reports to entities with compatible

3 electronic medical records. The process shall be covered

4 within administrative rule established by the Department.

5 (o) Hospital emergency departments and freestanding

6 healthcare facilities providing healthcare to walk-in patients

7 may obtain, for the purpose of improving patient care, a

8 unique identifier for each shift to utilize the PIL system.

9 (p) The Prescription Monitoring Program shall

10 automatically create a log-in to the inquiry system when a

11 prescriber or dispenser obtains or renews his or her

12 controlled substance license. The Department of Financial and

13 Professional Regulation must provide the Prescription

14 Monitoring Program with electronic access to the license

15 information of a prescriber or dispenser to facilitate the

16 creation of this profile. The Prescription Monitoring Program

17 shall send the prescriber or dispenser information regarding

18 the inquiry system, including instructions on how to log into

19 the system, instructions on how to use the system to promote

20 effective clinical practice, and opportunities for continuing

21 education for the prescribing of controlled substances. The

22 Prescription Monitoring Program shall also send to all

23 enrolled prescribers, dispensers, and designees information

24 regarding the unsolicited reports produced pursuant to Section

25 314.5 of this Act.

26 (q) A prescriber or dispenser may authorize a designee to

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1 consult the inquiry system established by the Department under

2 this subsection on his or her behalf, provided that all the

3 following 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

21 registered designees information regarding the inquiry system,

22 including instructions on how to log onto the system.

23 (r) The Prescription Monitoring Program shall maintain an

24 Internet website in conjunction with its prescriber and

25 dispenser inquiry system. This website shall include, at a

26 minimum, 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

21 reviewed by the Prescription Monitoring Program Advisory

22 Committee as set forth in Section 320 and updated in

23 accordance with the recommendation of the advisory committee.

24 (s) The Prescription Monitoring Program shall regularly

25 send electronic updates to the registered users of the

26 Program. The Prescription Monitoring Program Advisory

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1 Committee shall review any communications sent to registered

2 users and also make recommendations for communications as set

3 forth in Section 320. These updates shall include the

4 following 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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1 neither the Prescription Monitoring Program nor any other

2 person shall disclose any information in violation of the

3 restrictions 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.)