SB3920 102ND GENERAL ASSEMBLY

  
  

 


 
102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
SB3920

 

Introduced 1/21/2022, by Sen. Melinda Bush

 

SYNOPSIS AS INTRODUCED:
 
720 ILCS 570/316
720 ILCS 570/318

    Amends the Illinois Controlled Substances Act. Provides that the Department of Human Services must provide for a Prescription Monitoring Program for all prescription medications (rather than Schedule II, III, IV, and V controlled substances). Provides that the dispenser must transmit to the central repository the diagnosis code (ICD-10). Deletes provision that the dispenser must transmit to the central repository the date the controlled substance is dispensed. Provides that the Department may release prescription record information to a person who medically coordinates, directs, supervises, or establishes standard operating procedures for a prescriber or dispenser; if the person is evaluating the job performance of the prescriber or dispenser; or is performing quality assessment and improvement activities, including outcomes evaluation or development of clinical guidelines, and if the disclosure does not contain personally identifiable information of a patient and is limited to only those records about the prescriber or dispenser the person medically coordinates, directs, or supervises, or for whom the person establishes standard operating procedures.


LRB102 23875 RLC 33068 b

 

 

A BILL FOR

 

SB3920LRB102 23875 RLC 33068 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 Sections 316 and 318 as follows:
 
6    (720 ILCS 570/316)
7    Sec. 316. Prescription Monitoring Program.
8    (a) The Department must provide for a Prescription
9Monitoring Program for all prescription medications Schedule
10II, III, IV, and V controlled substances that includes the
11following components and requirements:
12        (1) The dispenser must transmit to the central
13    repository, in a form and manner specified by the
14    Department, the following information:
15            (A) The recipient's name and address.
16            (B) The recipient's date of birth and gender.
17            (C) The national drug code number of the
18        controlled substance dispensed.
19            (C-5) The diagnosis code (ICD-10).
20            (D) (Blank). The date the controlled substance is
21        dispensed.
22            (E) The quantity of the controlled substance
23        dispensed and the minimum days supply.

 

 

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1            (F) The dispenser's United States Drug Enforcement
2        Administration registration number.
3            (G) The prescriber's United States Drug
4        Enforcement Administration registration number.
5            (H) The dates the controlled substance
6        prescription is filled.
7            (I) The payment type used to purchase the
8        controlled substance (i.e. Medicaid, cash, third party
9        insurance).
10            (J) The patient location code (i.e. home, nursing
11        home, outpatient, etc.) for the controlled substances
12        other than those filled at a retail pharmacy.
13            (K) Any additional information that may be
14        required by the department by administrative rule,
15        including but not limited to information required for
16        compliance with the criteria for electronic reporting
17        of the American Society for Automation and Pharmacy or
18        its successor.
19        (2) The information required to be transmitted under
20    this Section must be transmitted not later than the end of
21    the business day on which a controlled substance is
22    dispensed, or at such other time as may be required by the
23    Department by administrative rule.
24        (3) A dispenser must transmit the information required
25    under this Section by:
26        (3.5) The requirements of paragraphs (1), (2), and (3)

 

 

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1    of this subsection also apply to opioid treatment programs
2    that are licensed or certified by the Department of Human
3    Services' Division of Substance Use Prevention and
4    Recovery and are authorized by the federal Drug
5    Enforcement Administration to prescribe Schedule II, III,
6    IV, or V controlled substances for the treatment of opioid
7    use disorders. Opioid treatment programs shall attempt to
8    obtain written patient consent, shall document attempts to
9    obtain the written consent, and shall not transmit
10    information without patient consent. Documentation
11    obtained under this paragraph shall not be utilized for
12    law enforcement purposes, as proscribed under 42 CFR 2, as
13    amended by 42 U.S.C. 290dd-2. Treatment of a patient shall
14    not be conditioned upon his or her written consent.
15            (A) an electronic device compatible with the
16        receiving device of the central repository;
17            (B) (blank); a computer diskette;
18            (C) (blank); or a magnetic tape; or
19            (D) (blank). a pharmacy universal claim form or
20        Pharmacy Inventory Control form.
21        (3.5) The requirements of paragraphs (1), (2), and (3)
22    of this subsection also apply to opioid treatment programs
23    that are licensed or certified by the Department of Human
24    Services' Division of Substance Use Prevention and
25    Recovery and are authorized by the federal Drug
26    Enforcement Administration to prescribe Schedule II, III,

 

 

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1    IV, or V controlled substances for the treatment of opioid
2    use disorders. Opioid treatment programs shall attempt to
3    obtain written patient consent, shall document attempts to
4    obtain the written consent, and shall not transmit
5    information without patient consent. Documentation
6    obtained under this paragraph shall not be utilized for
7    law enforcement purposes, as proscribed under 42 CFR 2, as
8    amended by 42 U.S.C. 290dd-2. Treatment of a patient shall
9    not be conditioned upon his or her written consent.
10        (4) The Department may impose a civil fine of up to
11    $100 per day for willful failure to report controlled
12    substance dispensing to the Prescription Monitoring
13    Program. The fine shall be calculated on no more than the
14    number of days from the time the report was required to be
15    made until the time the problem was resolved, and shall be
16    payable to the Prescription Monitoring Program.
17    (a-5) Notwithstanding subsection (a), a licensed
18veterinarian is exempt from the reporting requirements of this
19Section. If a person who is presenting an animal for treatment
20is suspected of fraudulently obtaining any controlled
21substance or prescription for a controlled substance, the
22licensed veterinarian shall report that information to the
23local law enforcement agency.
24    (b) The Department, by rule, may include in the
25Prescription Monitoring Program certain other select drugs
26that are not included in Schedule II, III, IV, or V. The

 

 

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1Prescription Monitoring Program does not apply to controlled
2substance prescriptions as exempted under Section 313.
3    (c) The collection of data on select drugs and scheduled
4substances by the Prescription Monitoring Program may be used
5as a tool for addressing oversight requirements of long-term
6care institutions as set forth by Public Act 96-1372.
7Long-term care pharmacies shall transmit patient medication
8profiles to the Prescription Monitoring Program monthly or
9more frequently as established by administrative rule.
10    (d) The Department of Human Services shall appoint a
11full-time Clinical Director of the Prescription Monitoring
12Program.
13    (e) (Blank).
14    (f) Within one year of January 1, 2018 (the effective date
15of Public Act 100-564), the Department shall adopt rules
16requiring all Electronic Health Records Systems to interface
17with the Prescription Monitoring Program application program
18on or before January 1, 2021 to ensure that all providers have
19access to specific patient records during the treatment of
20their patients. These rules shall also address the electronic
21integration of pharmacy records with the Prescription
22Monitoring Program to allow for faster transmission of the
23information required under this Section. The Department shall
24establish actions to be taken if a prescriber's Electronic
25Health Records System does not effectively interface with the
26Prescription Monitoring Program within the required timeline.

 

 

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1    (g) The Department, in consultation with the Prescription
2Monitoring Program Advisory Committee, shall adopt rules
3allowing licensed prescribers or pharmacists who have
4registered to access the Prescription Monitoring Program to
5authorize a licensed or non-licensed designee employed in that
6licensed prescriber's office or a licensed designee in a
7licensed pharmacist's pharmacy who has received training in
8the federal Health Insurance Portability and Accountability
9Act and 42 CFR 2 to consult the Prescription Monitoring
10Program on their behalf. The rules shall include reasonable
11parameters concerning a practitioner's authority to authorize
12a designee, and the eligibility of a person to be selected as a
13designee. In this subsection (g), "pharmacist" shall include a
14clinical pharmacist employed by and designated by a Medicaid
15Managed Care Organization providing services under Article V
16of the Illinois Public Aid Code under a contract with the
17Department of Healthcare and Family Services for the sole
18purpose of clinical review of services provided to persons
19covered by the entity under the contract to determine
20compliance with subsections (a) and (b) of Section 314.5 of
21this Act. A managed care entity pharmacist shall notify
22prescribers of review activities.
23(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19;
24102-527, eff. 8-20-21; revised 11-24-21.)
 
25    (720 ILCS 570/318)

 

 

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1    Sec. 318. Confidentiality of information.
2    (a) Information received by the central repository under
3Section 316 and former Section 321 is confidential.
4    (a-1) To ensure the federal Health Insurance Portability
5and Accountability Act privacy of an individual's prescription
6data reported to the Prescription Monitoring Program received
7from a retail dispenser under this Act, and in order to execute
8the duties and responsibilities under Section 316 of this Act
9and rules for disclosure under this Section, the Clinical
10Director of the Prescription Monitoring Program or his or her
11designee shall maintain direct access to all Prescription
12Monitoring Program data. Any request for Prescription
13Monitoring Program data from any other department or agency
14must be approved in writing by the Clinical Director of the
15Prescription Monitoring Program or his or her designee unless
16otherwise permitted by law. Prescription Monitoring Program
17data shall only be disclosed as permitted by law.
18    (a-2) As an active step to address the current opioid
19crisis in this State and to prevent and reduce addiction
20resulting from a sports injury or an accident, the
21Prescription Monitoring Program and the Department of Public
22Health shall coordinate a continuous review of the
23Prescription Monitoring Program and the Department of Public
24Health data to determine if a patient may be at risk of opioid
25addiction. Each patient discharged from any medical facility
26with an International Classification of Disease, 10th edition

 

 

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

 

 

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

 

 

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

 

 

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1confidential prescription record information collected under
2Sections 316 and 321 (now repealed) that identifies vendors or
3practitioners, or both, who are prescribing or dispensing
4large quantities of Schedule II, III, IV, or V controlled
5substances outside the scope of their practice, pharmacy, or
6business, as determined by the Advisory Committee created by
7Section 320; and .
8        (5) a person who medically coordinates, directs,
9    supervises, or establishes standard operating procedures
10    for a prescriber or dispenser; if the person is evaluating
11    the job performance of the prescriber or dispenser; or is
12    performing quality assessment and improvement activities,
13    including outcomes evaluation or development of clinical
14    guidelines, and if the disclosure does not contain
15    personally identifiable information of a patient and is
16    limited to only those records about the prescriber or
17    dispenser the person medically coordinates, directs, or
18    supervises, or for whom the person establishes standard
19    operating procedures.
20    (g) The information described in subsection (f) may not be
21released until it has been reviewed by an employee of the
22Department who is licensed as a prescriber or a dispenser and
23until that employee has certified that further investigation
24is warranted. However, failure to comply with this subsection
25(g) does not invalidate the use of any evidence that is
26otherwise admissible in a proceeding described in subsection

 

 

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1(h).
2    (h) An investigator or a law enforcement officer receiving
3confidential information under subsection (c), (d), or (f) may
4disclose the information to a law enforcement officer or an
5attorney for the office of the Attorney General for use as
6evidence in the following:
7        (1) A proceeding under any State or federal law that
8    involves a controlled substance.
9        (2) A criminal proceeding or a proceeding in juvenile
10    court that involves a controlled substance.
11    (i) The Department may compile statistical reports from
12the information described in subsection (a). The reports must
13not include information that identifies, by name, license or
14address, any practitioner, dispenser, ultimate user, or other
15person administering a controlled substance.
16    (j) Based upon federal, initial and maintenance funding, a
17prescriber and dispenser inquiry system shall be developed to
18assist the health care community in its goal of effective
19clinical practice and to prevent patients from diverting or
20abusing medications.
21        (1) An inquirer shall have read-only access to a
22    stand-alone database which shall contain records for the
23    previous 12 months.
24        (2) Dispensers may, upon positive and secure
25    identification, make an inquiry on a patient or customer
26    solely for a medical purpose as delineated within the

 

 

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1    federal HIPAA law.
2        (3) The Department shall provide a one-to-one secure
3    link and encrypted software necessary to establish the
4    link between an inquirer and the Department. Technical
5    assistance shall also be provided.
6        (4) Written inquiries are acceptable but must include
7    the fee and the requestor's Drug Enforcement
8    Administration license number and submitted upon the
9    requestor's business stationery.
10        (5) As directed by the Prescription Monitoring Program
11    Advisory Committee and the Clinical Director for the
12    Prescription Monitoring Program, aggregate data that does
13    not indicate any prescriber, practitioner, dispenser, or
14    patient may be used for clinical studies.
15        (6) Tracking analysis shall be established and used
16    per administrative rule.
17        (7) Nothing in this Act or Illinois law shall be
18    construed to require a prescriber or dispenser to make use
19    of this inquiry system.
20        (8) If there is an adverse outcome because of a
21    prescriber or dispenser making an inquiry, which is
22    initiated in good faith, the prescriber or dispenser shall
23    be held harmless from any civil liability.
24    (k) The Department shall establish, by rule, the process
25by which to evaluate possible erroneous association of
26prescriptions to any licensed prescriber or end user of the

 

 

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1Illinois Prescription Information Library (PIL).
2    (l) The Prescription Monitoring Program Advisory Committee
3is authorized to evaluate the need for and method of
4establishing a patient specific identifier.
5    (m) Patients who identify prescriptions attributed to them
6that were not obtained by them shall be given access to their
7personal prescription history pursuant to the validation
8process as set forth by administrative rule.
9    (n) The Prescription Monitoring Program is authorized to
10develop operational push reports to entities with compatible
11electronic medical records. The process shall be covered
12within administrative rule established by the Department.
13    (o) Hospital emergency departments and freestanding
14healthcare facilities providing healthcare to walk-in patients
15may obtain, for the purpose of improving patient care, a
16unique identifier for each shift to utilize the PIL system.
17    (p) The Prescription Monitoring Program shall
18automatically create a log-in to the inquiry system when a
19prescriber or dispenser obtains or renews his or her
20controlled substance license. The Department of Financial and
21Professional Regulation must provide the Prescription
22Monitoring Program with electronic access to the license
23information of a prescriber or dispenser to facilitate the
24creation of this profile. The Prescription Monitoring Program
25shall send the prescriber or dispenser information regarding
26the inquiry system, including instructions on how to log into

 

 

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1the system, instructions on how to use the system to promote
2effective clinical practice, and opportunities for continuing
3education for the prescribing of controlled substances. The
4Prescription Monitoring Program shall also send to all
5enrolled prescribers, dispensers, and designees information
6regarding the unsolicited reports produced pursuant to Section
7314.5 of this Act.
8    (q) A prescriber or dispenser may authorize a designee to
9consult the inquiry system established by the Department under
10this subsection on his or her behalf, provided that all the
11following conditions are met:
12        (1) the designee so authorized is employed by the same
13    hospital or health care system; is employed by the same
14    professional practice; or is under contract with such
15    practice, hospital, or health care system;
16        (2) the prescriber or dispenser takes reasonable steps
17    to ensure that such designee is sufficiently competent in
18    the use of the inquiry system;
19        (3) the prescriber or dispenser remains responsible
20    for ensuring that access to the inquiry system by the
21    designee is limited to authorized purposes and occurs in a
22    manner that protects the confidentiality of the
23    information obtained from the inquiry system, and remains
24    responsible for any breach of confidentiality; and
25        (4) the ultimate decision as to whether or not to
26    prescribe or dispense a controlled substance remains with

 

 

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1    the prescriber or dispenser.
2    The Prescription Monitoring Program shall send to
3registered designees information regarding the inquiry system,
4including instructions on how to log onto the system.
5    (r) The Prescription Monitoring Program shall maintain an
6Internet website in conjunction with its prescriber and
7dispenser inquiry system. This website shall include, at a
8minimum, the following information:
9        (1) current clinical guidelines developed by health
10    care professional organizations on the prescribing of
11    opioids or other controlled substances as determined by
12    the Advisory Committee;
13        (2) accredited continuing education programs related
14    to prescribing of controlled substances;
15        (3) programs or information developed by health care
16    professionals that may be used to assess patients or help
17    ensure compliance with prescriptions;
18        (4) updates from the Food and Drug Administration, the
19    Centers for Disease Control and Prevention, and other
20    public and private organizations which are relevant to
21    prescribing;
22        (5) relevant medical studies related to prescribing;
23        (6) other information regarding the prescription of
24    controlled substances; and
25        (7) information regarding prescription drug disposal
26    events, including take-back programs or other disposal

 

 

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

 

 

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1        (6) other information regarding prescribing of
2    controlled substances;
3        (7) information regarding prescription drug disposal
4    events, including take-back programs or other disposal
5    options or events; and
6        (8) reminders that the Prescription Monitoring Program
7    is a useful clinical tool.
8(Source: P.A. 99-480, eff. 9-9-15; 100-125, eff. 1-1-18;
9100-1093, eff. 8-26-18.)