Sen. Laura Fine
Filed: 11/7/2024
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1 | AMENDMENT TO HOUSE BILL 5373 | ||||||
2 | AMENDMENT NO. ______. Amend House Bill 5373 by replacing | ||||||
3 | everything after the enacting clause with the following: | ||||||
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: | ||||||
10 | "Chronic pain" means a state in which pain persists beyond | ||||||
11 | the usual course of an acute disease or healing of an injury, | ||||||
12 | or which may or may not be associated with an acute or chronic | ||||||
13 | pathologic process that causes continuous or intermittent pain | ||||||
14 | over months or years. "Chronic pain" is considered to be pain | ||||||
15 | that persists for more than 12 weeks and is adversely | ||||||
16 | affecting the function or well-being of the individual. |
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1 | "Opioid" means a narcotic drug or substance that is a | ||||||
2 | Schedule II controlled substance under paragraph (1), (2), | ||||||
3 | (3), or (5) of subsection (b) or under subsection (c) of | ||||||
4 | Section 206. | ||||||
5 | (b) Decisions regarding the treatment of patients | ||||||
6 | experiencing chronic pain shall be made by the prescriber with | ||||||
7 | dispensing by the pharmacist in accordance with the | ||||||
8 | corresponding responsibility as described in 21 CFR 1306.04(a) | ||||||
9 | and 77 Ill. Adm. Code 3100.380(a). | ||||||
10 | (c) Ordering, prescribing, dispensing, administering, or | ||||||
11 | paying for controlled substances, including opioids, shall not | ||||||
12 | in any way be predetermined by specific morphine milligram | ||||||
13 | equivalent guidelines except as provided under federal law. | ||||||
14 | (d) Nothing in this Section shall interfere with the | ||||||
15 | review of prescriptions by the Prescription Monitoring | ||||||
16 | Program's Peer Review Committee. In reviewing prescriptions | ||||||
17 | for chronic pain, the peer review committee members shall | ||||||
18 | review the most updated clinical guidelines on treating | ||||||
19 | chronic pain for the period the prescriptions were written. | ||||||
20 | (720 ILCS 570/318) | ||||||
21 | (Text of Section before amendment by P.A. 103-881 ) | ||||||
22 | Sec. 318. Confidentiality of information. | ||||||
23 | (a) Information received by the central repository under | ||||||
24 | Section 316 and former Section 321 is confidential. | ||||||
25 | (a-1) To ensure the federal Health Insurance Portability |
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1 | and Accountability Act and confidentiality of substance use | ||||||
2 | disorder patient records rules that mandate the privacy of an | ||||||
3 | individual's prescription data reported to the Prescription | ||||||
4 | Monitoring Program received from a retail dispenser under this | ||||||
5 | Act, and in order to execute the duties and responsibilities | ||||||
6 | under Section 316 of this Act and rules for disclosure under | ||||||
7 | this Section, the Clinical Director of the Prescription | ||||||
8 | Monitoring Program or his or her designee shall maintain | ||||||
9 | direct access to all Prescription Monitoring Program data. Any | ||||||
10 | request for Prescription Monitoring Program data from any | ||||||
11 | other department or agency must be approved in writing by the | ||||||
12 | Clinical Director of the Prescription Monitoring Program or | ||||||
13 | his or her designee unless otherwise permitted by law. | ||||||
14 | Prescription Monitoring Program data shall only be disclosed | ||||||
15 | as permitted by law. Confidential information received from | ||||||
16 | opioid treatment programs or confidential information | ||||||
17 | otherwise protected under federal confidentiality of substance | ||||||
18 | use disorder patient records regulations under 42 CFR Part 2 | ||||||
19 | shall not be included in the information shared. | ||||||
20 | (a-2) As an active step to address the current opioid | ||||||
21 | crisis in this State and to prevent and reduce addiction | ||||||
22 | resulting from a sports injury or an accident, the | ||||||
23 | Prescription Monitoring Program and the Department of Public | ||||||
24 | Health shall coordinate a continuous review of the | ||||||
25 | Prescription Monitoring Program and the Department of Public | ||||||
26 | Health data to determine if a patient may be at risk of opioid |
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1 | addiction. Each patient discharged from any medical facility | ||||||
2 | with an International Classification of Disease, 10th edition | ||||||
3 | code related to a sport or accident injury shall be subject to | ||||||
4 | the data review. If the discharged patient is dispensed a | ||||||
5 | controlled substance, the Prescription Monitoring Program | ||||||
6 | shall alert the patient's prescriber as to the addiction risk | ||||||
7 | and urge each to follow the Centers for Disease Control and | ||||||
8 | Prevention guidelines or his or her respective profession's | ||||||
9 | treatment guidelines related to the patient's injury. This | ||||||
10 | subsection (a-2), other than this sentence, is inoperative on | ||||||
11 | or after January 1, 2024. | ||||||
12 | (b) The Department must carry out a program to protect the | ||||||
13 | confidentiality of the information described in subsection | ||||||
14 | (a). The Department may disclose the information to another | ||||||
15 | person only under subsection (c), (d), or (f) and may charge a | ||||||
16 | fee not to exceed the actual cost of furnishing the | ||||||
17 | information. | ||||||
18 | (c) The Department may disclose confidential information | ||||||
19 | described in subsection (a) to any person who is engaged in | ||||||
20 | receiving, processing, or storing the information. | ||||||
21 | (d) The Department may release confidential information | ||||||
22 | described in subsection (a) to the following persons: | ||||||
23 | (1) A governing body that licenses practitioners and | ||||||
24 | is engaged in an investigation, an adjudication, or a | ||||||
25 | prosecution of a violation under any State or federal law | ||||||
26 | that involves a controlled substance. |
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1 | (2) An investigator for the Consumer Protection | ||||||
2 | Division of the office of the Attorney General, a | ||||||
3 | prosecuting attorney, the Attorney General, a deputy | ||||||
4 | Attorney General, or an investigator from the office of | ||||||
5 | the Attorney General, who is engaged in any of the | ||||||
6 | following activities involving controlled substances: | ||||||
7 | (A) an investigation; | ||||||
8 | (B) an adjudication; or | ||||||
9 | (C) a prosecution of a violation under any State | ||||||
10 | or federal law that involves a controlled substance. | ||||||
11 | (3) A law enforcement officer who is: | ||||||
12 | (A) authorized by the Illinois State Police or the | ||||||
13 | office of a county sheriff or State's Attorney or | ||||||
14 | municipal police department of Illinois to receive | ||||||
15 | information of the type requested for the purpose of | ||||||
16 | investigations involving controlled substances; or | ||||||
17 | (B) approved by the Department to receive | ||||||
18 | information of the type requested for the purpose of | ||||||
19 | investigations involving controlled substances; and | ||||||
20 | (C) engaged in the investigation or prosecution of | ||||||
21 | a violation under any State or federal law that | ||||||
22 | involves a controlled substance. | ||||||
23 | (4) Select representatives of the Department of | ||||||
24 | Children and Family Services through the indirect online | ||||||
25 | request process. Access shall be established by an | ||||||
26 | intergovernmental agreement between the Department of |
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1 | Children and Family Services and the Department of Human | ||||||
2 | Services. | ||||||
3 | (e) Before the Department releases confidential | ||||||
4 | information under subsection (d), all of the following must be | ||||||
5 | demonstrated the applicant must demonstrate in writing to the | ||||||
6 | Department by the applicant that : | ||||||
7 | (1) the applicant has reason to believe that a | ||||||
8 | violation under any State or federal law that involves a | ||||||
9 | controlled substance has occurred; and | ||||||
10 | (2) the requested information is reasonably related to | ||||||
11 | the investigation, adjudication, or prosecution of the | ||||||
12 | violation described in subdivision (1) ; and . | ||||||
13 | (3) the applicant has a valid court order or subpoena, | ||||||
14 | or an administrative subpoena issued by the Department of | ||||||
15 | Financial and Professional Regulation, for the | ||||||
16 | confidential information requested. | ||||||
17 | (f) The Department may receive and release confidential | ||||||
18 | prescription record information collected under Sections 316 | ||||||
19 | and 321 (now repealed) that identifies vendors or | ||||||
20 | practitioners, or both, who are prescribing or dispensing | ||||||
21 | large quantities of Schedule II, III, IV, or V controlled | ||||||
22 | substances outside the scope of their practice, pharmacy, or | ||||||
23 | business, as determined by the Advisory Committee created by | ||||||
24 | Section 320, prescription record information under Section 316 | ||||||
25 | and former Section 321 to: | ||||||
26 | (1) a governing body that licenses practitioners; |
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1 | (2) an investigator for the Consumer Protection | ||||||
2 | Division of the office of the Attorney General, a | ||||||
3 | prosecuting attorney, the Attorney General, a deputy | ||||||
4 | Attorney General, or an investigator from the office of | ||||||
5 | the Attorney General; | ||||||
6 | (3) any Illinois law enforcement officer who is: | ||||||
7 | (A) authorized to receive the type of information | ||||||
8 | released; and | ||||||
9 | (B) approved by the Department to receive the type | ||||||
10 | of information released; or | ||||||
11 | (4) prescription monitoring entities in other states | ||||||
12 | per the provisions outlined in subsection (g) and (h) | ||||||
13 | below . ; | ||||||
14 | confidential prescription record information collected under | ||||||
15 | Sections 316 and 321 (now repealed) that identifies vendors or | ||||||
16 | practitioners, or both, who are prescribing or dispensing | ||||||
17 | large quantities of Schedule II, III, IV, or V controlled | ||||||
18 | substances outside the scope of their practice, pharmacy, or | ||||||
19 | business, as determined by the Advisory Committee created by | ||||||
20 | Section 320. | ||||||
21 | (f-5) In accordance with a confidentiality agreement | ||||||
22 | entered into with the Department, a medical director, or a | ||||||
23 | public health administrator and their delegated analysts, of a | ||||||
24 | county or municipal health department or the Department of | ||||||
25 | Public Health shall have access to data from the system for any | ||||||
26 | of the following purposes: |
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1 | (1) developing education programs or public health | ||||||
2 | interventions relating to prescribing trends and | ||||||
3 | controlled substance use; or | ||||||
4 | (2) conducting analyses and publish reports on | ||||||
5 | prescribing trends in their respective jurisdictions. | ||||||
6 | At a minimum, the confidentiality agreement entered into | ||||||
7 | with the Department shall: | ||||||
8 | (i) prohibit analysis and reports produced under | ||||||
9 | subparagraph (2) from including information that | ||||||
10 | identifies, by name, license, or address, any | ||||||
11 | practitioner, dispenser, ultimate user, or other person | ||||||
12 | administering a controlled substance; and | ||||||
13 | (ii) specify the appropriate technical and physical | ||||||
14 | safeguards that the county or municipal health department | ||||||
15 | must implement to ensure the privacy and security of data | ||||||
16 | obtained from the system. The data from the system shall | ||||||
17 | not be admissible as evidence, nor discoverable in any | ||||||
18 | action of any kind in any court or before any tribunal, | ||||||
19 | board, agency, or person. The disclosure of any such | ||||||
20 | information or data, whether proper or improper, shall not | ||||||
21 | waive or have any effect upon its confidentiality, | ||||||
22 | non-discoverability, or non-admissibility. | ||||||
23 | (g) The information described in subsection (f) may not be | ||||||
24 | released until it has been reviewed by an employee of the | ||||||
25 | Department who is licensed as a prescriber or a dispenser and | ||||||
26 | until that employee has certified that further investigation |
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1 | is warranted. Upon review and approval by a licensed | ||||||
2 | prescriber or dispenser, or trained designee, the Prescription | ||||||
3 | Monitoring Program may release information described in | ||||||
4 | subsection (f). However, failure to comply with this | ||||||
5 | subsection (g) does not invalidate the use of any evidence | ||||||
6 | that is otherwise admissible in a proceeding described in | ||||||
7 | subsection (h). | ||||||
8 | (h) An investigator or a law enforcement officer receiving | ||||||
9 | confidential information under subsection (c), (d), or (f) may | ||||||
10 | disclose the information to a law enforcement officer or an | ||||||
11 | attorney for the office of the Attorney General for use as | ||||||
12 | evidence 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 | ||||||
18 | the information described in subsection (a). The reports must | ||||||
19 | not include information that identifies, by name, license or | ||||||
20 | address, any practitioner, dispenser, ultimate user, or other | ||||||
21 | person administering a controlled substance. | ||||||
22 | (j) Based upon federal, initial and maintenance funding, a | ||||||
23 | prescriber and dispenser inquiry system shall be developed to | ||||||
24 | assist the health care community in its goal of effective | ||||||
25 | clinical practice and to prevent patients from diverting or | ||||||
26 | abusing 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 | ||||||
5 | by which to evaluate possible erroneous association of | ||||||
6 | prescriptions to any licensed prescriber or end user of the | ||||||
7 | Illinois Prescription Information Library (PIL). | ||||||
8 | (l) The Prescription Monitoring Program Advisory Committee | ||||||
9 | is authorized to evaluate the need for and method of | ||||||
10 | establishing a patient specific identifier. | ||||||
11 | (m) Patients who identify prescriptions attributed to them | ||||||
12 | that were not obtained by them shall be given access to their | ||||||
13 | personal prescription history pursuant to the validation | ||||||
14 | process as set forth by administrative rule. | ||||||
15 | (n) The Prescription Monitoring Program is authorized to | ||||||
16 | develop operational push reports to entities with compatible | ||||||
17 | electronic medical records. The process shall be covered | ||||||
18 | within administrative rule established by the Department. | ||||||
19 | (o) Hospital emergency departments and freestanding | ||||||
20 | healthcare facilities providing healthcare to walk-in patients | ||||||
21 | may obtain, for the purpose of improving patient care, a | ||||||
22 | unique identifier for each shift to utilize the PIL system. | ||||||
23 | (p) The Prescription Monitoring Program shall | ||||||
24 | automatically create a log-in to the inquiry system when a | ||||||
25 | prescriber or dispenser obtains or renews his or her | ||||||
26 | controlled substance license. The Department of Financial and |
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1 | Professional Regulation must provide the Prescription | ||||||
2 | Monitoring Program with electronic access to the license | ||||||
3 | information of a prescriber or dispenser to facilitate the | ||||||
4 | creation of this profile. The Prescription Monitoring Program | ||||||
5 | shall send the prescriber or dispenser information regarding | ||||||
6 | the inquiry system, including instructions on how to log into | ||||||
7 | the system, instructions on how to use the system to promote | ||||||
8 | effective clinical practice, and opportunities for continuing | ||||||
9 | education for the prescribing of controlled substances. The | ||||||
10 | Prescription Monitoring Program shall also send to all | ||||||
11 | enrolled prescribers, dispensers, and designees information | ||||||
12 | regarding the unsolicited reports produced pursuant to Section | ||||||
13 | 314.5 of this Act. | ||||||
14 | (q) A prescriber or dispenser may authorize a designee to | ||||||
15 | consult the inquiry system established by the Department under | ||||||
16 | this subsection on his or her behalf, provided that all the | ||||||
17 | following 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 | ||||||
9 | registered designees information regarding the inquiry system, | ||||||
10 | including instructions on how to log onto the system. | ||||||
11 | (r) The Prescription Monitoring Program shall maintain an | ||||||
12 | Internet website in conjunction with its prescriber and | ||||||
13 | dispenser inquiry system. This website shall include, at a | ||||||
14 | minimum, 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 | ||||||
9 | reviewed by the Prescription Monitoring Program Advisory | ||||||
10 | Committee as set forth in Section 320 and updated in | ||||||
11 | accordance with the recommendation of the advisory committee. | ||||||
12 | (s) The Prescription Monitoring Program shall regularly | ||||||
13 | send electronic updates to the registered users of the | ||||||
14 | Program. The Prescription Monitoring Program Advisory | ||||||
15 | Committee shall review any communications sent to registered | ||||||
16 | users and also make recommendations for communications as set | ||||||
17 | forth in Section 320. These updates shall include the | ||||||
18 | following 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, | ||||||
15 | neither the Prescription Monitoring Program nor any other | ||||||
16 | person shall disclose any information in violation of the | ||||||
17 | restrictions 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 | (Text of Section after amendment by P.A. 103-881 ) | ||||||
21 | Sec. 318. Confidentiality of information. | ||||||
22 | (a) Information received by the central repository under | ||||||
23 | Section 316 and former Section 321 is confidential. | ||||||
24 | (a-1) To ensure the federal Health Insurance Portability | ||||||
25 | and Accountability Act and confidentiality of substance use |
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| |||||||
1 | disorder patient records rules that mandate the privacy of an | ||||||
2 | individual's prescription data reported to the Prescription | ||||||
3 | Monitoring Program received from a retail dispenser under this | ||||||
4 | Act, and in order to execute the duties and responsibilities | ||||||
5 | under Section 316 of this Act and rules for disclosure under | ||||||
6 | this Section, the Clinical Director of the Prescription | ||||||
7 | Monitoring Program or his or her designee shall maintain | ||||||
8 | direct access to all Prescription Monitoring Program data. Any | ||||||
9 | request for Prescription Monitoring Program data from any | ||||||
10 | other department or agency must be approved in writing by the | ||||||
11 | Clinical Director of the Prescription Monitoring Program or | ||||||
12 | his or her designee unless otherwise permitted by law. | ||||||
13 | Prescription Monitoring Program data shall only be disclosed | ||||||
14 | as permitted by law. Confidential information received from | ||||||
15 | opioid treatment programs or confidential information | ||||||
16 | otherwise protected under federal confidentiality of substance | ||||||
17 | use disorder patient records regulations under 42 CFR Part 2 | ||||||
18 | shall not be included in the information shared. | ||||||
19 | (a-2) As an active step to address the current opioid | ||||||
20 | crisis in this State and to prevent and reduce substance use | ||||||
21 | disorders resulting from a sports injury or an accident, the | ||||||
22 | Prescription Monitoring Program and the Department of Public | ||||||
23 | Health shall coordinate a continuous review of the | ||||||
24 | Prescription Monitoring Program and the Department of Public | ||||||
25 | Health data to determine if a patient may be at risk of opioid | ||||||
26 | use disorder. Each patient discharged from any medical |
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1 | facility with an International Classification of Disease, 10th | ||||||
2 | edition code related to a sport or accident injury shall be | ||||||
3 | subject to the data review. If the discharged patient is | ||||||
4 | dispensed a controlled substance, the Prescription Monitoring | ||||||
5 | Program shall alert the patient's prescriber as to the risk of | ||||||
6 | developing a substance use disorder and urge each to follow | ||||||
7 | the Centers for Disease Control and Prevention guidelines or | ||||||
8 | his or her respective profession's treatment guidelines | ||||||
9 | related to the patient's injury. This subsection (a-2), other | ||||||
10 | than this sentence, is inoperative on or after January 1, | ||||||
11 | 2024. | ||||||
12 | (b) The Department must carry out a program to protect the | ||||||
13 | confidentiality of the information described in subsection | ||||||
14 | (a). The Department may disclose the information to another | ||||||
15 | person only under subsection (c), (d), or (f) and may charge a | ||||||
16 | fee not to exceed the actual cost of furnishing the | ||||||
17 | information. | ||||||
18 | (c) The Department may disclose confidential information | ||||||
19 | described in subsection (a) to any person who is engaged in | ||||||
20 | receiving, processing, or storing the information. | ||||||
21 | (d) The Department may release confidential information | ||||||
22 | described in subsection (a) to the following persons: | ||||||
23 | (1) A governing body that licenses practitioners and | ||||||
24 | is engaged in an investigation, an adjudication, or a | ||||||
25 | prosecution of a violation under any State or federal law | ||||||
26 | that involves a controlled substance. |
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1 | (2) An investigator for the Consumer Protection | ||||||
2 | Division of the office of the Attorney General, a | ||||||
3 | prosecuting attorney, the Attorney General, a deputy | ||||||
4 | Attorney General, or an investigator from the office of | ||||||
5 | the Attorney General, who is engaged in any of the | ||||||
6 | following activities involving controlled substances: | ||||||
7 | (A) an investigation; | ||||||
8 | (B) an adjudication; or | ||||||
9 | (C) a prosecution of a violation under any State | ||||||
10 | or federal law that involves a controlled substance. | ||||||
11 | (3) A law enforcement officer who is: | ||||||
12 | (A) authorized by the Illinois State Police or the | ||||||
13 | office of a county sheriff or State's Attorney or | ||||||
14 | municipal police department of Illinois to receive | ||||||
15 | information of the type requested for the purpose of | ||||||
16 | investigations involving controlled substances; or | ||||||
17 | (B) approved by the Department to receive | ||||||
18 | information of the type requested for the purpose of | ||||||
19 | investigations involving controlled substances; and | ||||||
20 | (C) engaged in the investigation or prosecution of | ||||||
21 | a violation under any State or federal law that | ||||||
22 | involves a controlled substance. | ||||||
23 | (4) Select representatives of the Department of | ||||||
24 | Children and Family Services through the indirect online | ||||||
25 | request process. Access shall be established by an | ||||||
26 | intergovernmental agreement between the Department of |
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1 | Children and Family Services and the Department of Human | ||||||
2 | Services. | ||||||
3 | (e) Before the Department releases confidential | ||||||
4 | information under subsection (d), all of the following must be | ||||||
5 | demonstrated the applicant must demonstrate in writing to the | ||||||
6 | Department by the applicant that : | ||||||
7 | (1) the applicant has reason to believe that a | ||||||
8 | violation under any State or federal law that involves a | ||||||
9 | controlled substance has occurred; and | ||||||
10 | (2) the requested information is reasonably related to | ||||||
11 | the investigation, adjudication, or prosecution of the | ||||||
12 | violation described in subdivision (1) ; and . | ||||||
13 | (3) the applicant has a valid court order or subpoena, | ||||||
14 | or an administrative subpoena issued by the Department of | ||||||
15 | Financial and Professional Regulation, for the | ||||||
16 | confidential information requested. | ||||||
17 | (f) The Department may receive and release confidential | ||||||
18 | prescription record information collected under Sections 316 | ||||||
19 | and 321 (now repealed) that identifies vendors or | ||||||
20 | practitioners, or both, who are prescribing or dispensing | ||||||
21 | large quantities of Schedule II, III, IV, or V controlled | ||||||
22 | substances outside the scope of their practice, pharmacy, or | ||||||
23 | business, as determined by the Advisory Committee created by | ||||||
24 | Section 320, prescription record information under Section 316 | ||||||
25 | and former Section 321 to: | ||||||
26 | (1) a governing body that licenses practitioners; |
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1 | (2) an investigator for the Consumer Protection | ||||||
2 | Division of the office of the Attorney General, a | ||||||
3 | prosecuting attorney, the Attorney General, a deputy | ||||||
4 | Attorney General, or an investigator from the office of | ||||||
5 | the Attorney General; | ||||||
6 | (3) any Illinois law enforcement officer who is: | ||||||
7 | (A) authorized to receive the type of information | ||||||
8 | released; and | ||||||
9 | (B) approved by the Department to receive the type | ||||||
10 | of information released; or | ||||||
11 | (4) prescription monitoring entities in other states | ||||||
12 | per the provisions outlined in subsection (g) and (h) | ||||||
13 | below . ; | ||||||
14 | confidential prescription record information collected under | ||||||
15 | Sections 316 and 321 (now repealed) that identifies vendors or | ||||||
16 | practitioners, or both, who are prescribing or dispensing | ||||||
17 | large quantities of Schedule II, III, IV, or V controlled | ||||||
18 | substances outside the scope of their practice, pharmacy, or | ||||||
19 | business, as determined by the Advisory Committee created by | ||||||
20 | Section 320. | ||||||
21 | (f-5) In accordance with a confidentiality agreement | ||||||
22 | entered into with the Department, a medical director, or a | ||||||
23 | public health administrator and their delegated analysts, of a | ||||||
24 | county or municipal health department or the Department of | ||||||
25 | Public Health shall have access to data from the system for any | ||||||
26 | of the following purposes: |
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1 | (1) developing education programs or public health | ||||||
2 | interventions relating to prescribing trends and | ||||||
3 | controlled substance use; or | ||||||
4 | (2) conducting analyses and publish reports on | ||||||
5 | prescribing trends in their respective jurisdictions. | ||||||
6 | At a minimum, the confidentiality agreement entered into | ||||||
7 | with the Department shall: | ||||||
8 | (i) prohibit analysis and reports produced under | ||||||
9 | subparagraph (2) from including information that | ||||||
10 | identifies, by name, license, or address, any | ||||||
11 | practitioner, dispenser, ultimate user, or other person | ||||||
12 | administering a controlled substance; and | ||||||
13 | (ii) specify the appropriate technical and physical | ||||||
14 | safeguards that the county or municipal health department | ||||||
15 | must implement to ensure the privacy and security of data | ||||||
16 | obtained from the system. The data from the system shall | ||||||
17 | not be admissible as evidence, nor discoverable in any | ||||||
18 | action of any kind in any court or before any tribunal, | ||||||
19 | board, agency, or person. The disclosure of any such | ||||||
20 | information or data, whether proper or improper, shall not | ||||||
21 | waive or have any effect upon its confidentiality, | ||||||
22 | non-discoverability, or non-admissibility. | ||||||
23 | (g) The information described in subsection (f) may not be | ||||||
24 | released until it has been reviewed by an employee of the | ||||||
25 | Department who is licensed as a prescriber or a dispenser and | ||||||
26 | until that employee has certified that further investigation |
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1 | is warranted. Upon review and approval by a licensed | ||||||
2 | prescriber or dispenser, or trained designee, the Prescription | ||||||
3 | Monitoring Program may release information described in | ||||||
4 | subsection (f). However, failure to comply with this | ||||||
5 | subsection (g) does not invalidate the use of any evidence | ||||||
6 | that is otherwise admissible in a proceeding described in | ||||||
7 | subsection (h). | ||||||
8 | (h) An investigator or a law enforcement officer receiving | ||||||
9 | confidential information under subsection (c), (d), or (f) may | ||||||
10 | disclose the information to a law enforcement officer or an | ||||||
11 | attorney for the office of the Attorney General for use as | ||||||
12 | evidence 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 | ||||||
18 | the information described in subsection (a). The reports must | ||||||
19 | not include information that identifies, by name, license or | ||||||
20 | address, any practitioner, dispenser, ultimate user, or other | ||||||
21 | person administering a controlled substance. | ||||||
22 | (j) Based upon federal, initial and maintenance funding, a | ||||||
23 | prescriber and dispenser inquiry system shall be developed to | ||||||
24 | assist the health care community in its goal of effective | ||||||
25 | clinical practice and to prevent patients from diverting or | ||||||
26 | abusing 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 | ||||||
5 | by which to evaluate possible erroneous association of | ||||||
6 | prescriptions to any licensed prescriber or end user of the | ||||||
7 | Illinois Prescription Information Library (PIL). | ||||||
8 | (l) The Prescription Monitoring Program Advisory Committee | ||||||
9 | is authorized to evaluate the need for and method of | ||||||
10 | establishing a patient specific identifier. | ||||||
11 | (m) Patients who identify prescriptions attributed to them | ||||||
12 | that were not obtained by them shall be given access to their | ||||||
13 | personal prescription history pursuant to the validation | ||||||
14 | process as set forth by administrative rule. | ||||||
15 | (n) The Prescription Monitoring Program is authorized to | ||||||
16 | develop operational push reports to entities with compatible | ||||||
17 | electronic medical records. The process shall be covered | ||||||
18 | within administrative rule established by the Department. | ||||||
19 | (o) Hospital emergency departments and freestanding | ||||||
20 | healthcare facilities providing healthcare to walk-in patients | ||||||
21 | may obtain, for the purpose of improving patient care, a | ||||||
22 | unique identifier for each shift to utilize the PIL system. | ||||||
23 | (p) The Prescription Monitoring Program shall | ||||||
24 | automatically create a log-in to the inquiry system when a | ||||||
25 | prescriber or dispenser obtains or renews his or her | ||||||
26 | controlled substance license. The Department of Financial and |
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1 | Professional Regulation must provide the Prescription | ||||||
2 | Monitoring Program with electronic access to the license | ||||||
3 | information of a prescriber or dispenser to facilitate the | ||||||
4 | creation of this profile. The Prescription Monitoring Program | ||||||
5 | shall send the prescriber or dispenser information regarding | ||||||
6 | the inquiry system, including instructions on how to log into | ||||||
7 | the system, instructions on how to use the system to promote | ||||||
8 | effective clinical practice, and opportunities for continuing | ||||||
9 | education for the prescribing of controlled substances. The | ||||||
10 | Prescription Monitoring Program shall also send to all | ||||||
11 | enrolled prescribers, dispensers, and designees information | ||||||
12 | regarding the unsolicited reports produced pursuant to Section | ||||||
13 | 314.5 of this Act. | ||||||
14 | (q) A prescriber or dispenser may authorize a designee to | ||||||
15 | consult the inquiry system established by the Department under | ||||||
16 | this subsection on his or her behalf, provided that all the | ||||||
17 | following 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 | ||||||
9 | registered designees information regarding the inquiry system, | ||||||
10 | including instructions on how to log onto the system. | ||||||
11 | (r) The Prescription Monitoring Program shall maintain an | ||||||
12 | Internet website in conjunction with its prescriber and | ||||||
13 | dispenser inquiry system. This website shall include, at a | ||||||
14 | minimum, 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 | ||||||
9 | reviewed by the Prescription Monitoring Program Advisory | ||||||
10 | Committee as set forth in Section 320 and updated in | ||||||
11 | accordance with the recommendation of the advisory committee. | ||||||
12 | (s) The Prescription Monitoring Program shall regularly | ||||||
13 | send electronic updates to the registered users of the | ||||||
14 | Program. The Prescription Monitoring Program Advisory | ||||||
15 | Committee shall review any communications sent to registered | ||||||
16 | users and also make recommendations for communications as set | ||||||
17 | forth in Section 320. These updates shall include the | ||||||
18 | following 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, | ||||||
15 | neither the Prescription Monitoring Program nor any other | ||||||
16 | person shall disclose any information in violation of the | ||||||
17 | restrictions 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; 103-881, eff. 1-1-25.) | ||||||
20 | Section 95. No acceleration or delay. Where this Act makes | ||||||
21 | changes in a statute that is represented in this Act by text | ||||||
22 | that is not yet or no longer in effect (for example, a Section | ||||||
23 | represented by multiple versions), the use of that text does | ||||||
24 | not accelerate or delay the taking effect of (i) the changes | ||||||
25 | made by this Act or (ii) provisions derived from any other |
| |||||||
| |||||||
1 | Public Act. | ||||||
2 | Section 99. Effective date. This Act takes effect upon | ||||||
3 | becoming law.". |