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Public Act 100-1093


 

Public Act 1093 100TH GENERAL ASSEMBLY

  
  
  

 


 
Public Act 100-1093
 
SB2952 EnrolledLRB100 16820 RLC 31961 b

    AN ACT concerning criminal law.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    Section 5. The Illinois Controlled Substances Act is
amended by changing Sections 316, 318, and 320 as follows:
 
    (720 ILCS 570/316)
    Sec. 316. Prescription Monitoring Program.
    (a) The Department must provide for a Prescription
Monitoring Program for Schedule II, III, IV, and V controlled
substances that includes the following components and
requirements:
        (1) The dispenser must transmit to the central
    repository, in a form and manner specified by the
    Department, the following information:
            (A) The recipient's name and address.
            (B) The recipient's date of birth and gender.
            (C) The national drug code number of the controlled
        substance dispensed.
            (D) The date the controlled substance is
        dispensed.
            (E) The quantity of the controlled substance
        dispensed and days supply.
            (F) The dispenser's United States Drug Enforcement
        Administration registration number.
            (G) The prescriber's United States Drug
        Enforcement Administration registration number.
            (H) The dates the controlled substance
        prescription is filled.
            (I) The payment type used to purchase the
        controlled substance (i.e. Medicaid, cash, third party
        insurance).
            (J) The patient location code (i.e. home, nursing
        home, outpatient, etc.) for the controlled substances
        other than those filled at a retail pharmacy.
            (K) Any additional information that may be
        required by the department by administrative rule,
        including but not limited to information required for
        compliance with the criteria for electronic reporting
        of the American Society for Automation and Pharmacy or
        its successor.
        (2) The information required to be transmitted under
    this Section must be transmitted not later than the end of
    the next business day after the date on which a controlled
    substance is dispensed, or at such other time as may be
    required by the Department by administrative rule.
        (3) A dispenser must transmit the information required
    under this Section by:
            (A) an electronic device compatible with the
        receiving device of the central repository;
            (B) a computer diskette;
            (C) a magnetic tape; or
            (D) a pharmacy universal claim form or Pharmacy
        Inventory Control form;
        (4) The Department may impose a civil fine of up to
    $100 per day for willful failure to report controlled
    substance dispensing to the Prescription Monitoring
    Program. The fine shall be calculated on no more than the
    number of days from the time the report was required to be
    made until the time the problem was resolved, and shall be
    payable to the Prescription Monitoring Program.
    (b) The Department, by rule, may include in the
Prescription Monitoring Program certain other select drugs
that are not included in Schedule II, III, IV, or V. The
Prescription Monitoring Program does not apply to controlled
substance prescriptions as exempted under Section 313.
    (c) The collection of data on select drugs and scheduled
substances by the Prescription Monitoring Program may be used
as a tool for addressing oversight requirements of long-term
care institutions as set forth by Public Act 96-1372. Long-term
care pharmacies shall transmit patient medication profiles to
the Prescription Monitoring Program monthly or more frequently
as established by administrative rule.
    (d) The Department of Human Services shall appoint a
full-time Clinical Director of the Prescription Monitoring
Program.
    (e) (Blank).
    (f) Within one year of the effective date of this
amendatory Act of the 100th General Assembly, the Department
shall adopt rules requiring all Electronic Health Records
Systems to interface with the Prescription Monitoring Program
application program on or before January 1, 2021 to ensure that
all providers have access to specific patient records during
the treatment of their patients. These rules shall also address
the electronic integration of pharmacy records with the
Prescription Monitoring Program to allow for faster
transmission of the information required under this Section.
The Department shall establish actions to be taken if a
prescriber's Electronic Health Records System does not
effectively interface with the Prescription Monitoring Program
within the required timeline.
    (g) The Department, in consultation with the Advisory
Committee, shall adopt rules allowing licensed prescribers or
pharmacists who have registered to access the Prescription
Monitoring Program to authorize a licensed or non-licensed
designee employed in that licensed prescriber's office or a
licensed designee in a licensed pharmacist's pharmacy, and who
has received training in the federal Health Insurance
Portability and Accountability Act to consult the Prescription
Monitoring Program on their behalf. The rules shall include
reasonable parameters concerning a practitioner's authority to
authorize a designee, and the eligibility of a person to be
selected as a designee.
(Source: P.A. 99-480, eff. 9-9-15; 100-564, eff. 1-1-18.)
 
    (720 ILCS 570/318)
    Sec. 318. Confidentiality of information.
    (a) Information received by the central repository under
Section 316 and former Section 321 is confidential.
    (a-1) To ensure the federal Health Insurance Portability
and Accountability Act privacy of an individual's prescription
data reported to the Prescription Monitoring Program received
from a retail dispenser under this Act, and in order to execute
the duties and responsibilities under Section 316 of this Act
and rules for disclosure under this Section, the Clinical
Director of the Prescription Monitoring Program or his or her
designee shall maintain direct access to all Prescription
Monitoring Program data. Any request for Prescription
Monitoring Program data from any other department or agency
must be approved in writing by the Clinical Director of the
Prescription Monitoring Program or his or her designee unless
otherwise permitted by law. Prescription Monitoring Program
data shall only be disclosed as permitted by law.
    (a-2) As an active step to address the current opioid
crisis in this State and to prevent and reduce addiction
resulting from a sports injury or an accident, the Prescription
Monitoring Program and the Department of Public Health shall
coordinate a continuous review of the Prescription Monitoring
Program and the Department of Public Health data to determine
if a patient may be at risk of opioid addiction. Each patient
discharged from any medical facility with an International
Classification of Disease, 10th edition code related to a sport
or accident injury shall be subject to the data review. If the
discharged patient is dispensed a controlled substance, the
Prescription Monitoring Program shall alert the patient's
prescriber as to the addiction risk and urge each to follow the
Centers for Disease Control and Prevention guidelines or his or
her respective profession's treatment guidelines related to
the patient's injury. This subsection (a-2), other than this
sentence, is inoperative on or after January 1, 2024.
    (b) The Department must carry out a program to protect the
confidentiality of the information described in subsection
(a). The Department may disclose the information to another
person only under subsection (c), (d), or (f) and may charge a
fee not to exceed the actual cost of furnishing the
information.
    (c) The Department may disclose confidential information
described in subsection (a) to any person who is engaged in
receiving, processing, or storing the information.
    (d) The Department may release confidential information
described in subsection (a) to the following persons:
        (1) A governing body that licenses practitioners and is
    engaged in an investigation, an adjudication, or a
    prosecution of a violation under any State or federal law
    that involves a controlled substance.
        (2) An investigator for the Consumer Protection
    Division of the office of the Attorney General, a
    prosecuting attorney, the Attorney General, a deputy
    Attorney General, or an investigator from the office of the
    Attorney General, who is engaged in any of the following
    activities involving controlled substances:
            (A) an investigation;
            (B) an adjudication; or
            (C) a prosecution of a violation under any State or
        federal law that involves a controlled substance.
        (3) A law enforcement officer who is:
            (A) authorized by the Illinois State Police or the
        office of a county sheriff or State's Attorney or
        municipal police department of Illinois to receive
        information of the type requested for the purpose of
        investigations involving controlled substances; or
            (B) approved by the Department to receive
        information of the type requested for the purpose of
        investigations involving controlled substances; and
            (C) engaged in the investigation or prosecution of
        a violation under any State or federal law that
        involves a controlled substance.
        (4) Select representatives of the Department of
    Children and Family Services through the indirect online
    request process. Access shall be established by an
    intergovernmental agreement between the Department of
    Children and Family Services and the Department of Human
    Services.
    (e) Before the Department releases confidential
information under subsection (d), the applicant must
demonstrate in writing to the Department that:
        (1) the applicant has reason to believe that a
    violation under any State or federal law that involves a
    controlled substance has occurred; and
        (2) the requested information is reasonably related to
    the investigation, adjudication, or prosecution of the
    violation described in subdivision (1).
    (f) The Department may receive and release prescription
record information under Section 316 and former Section 321 to:
        (1) a governing body that licenses practitioners;
        (2) an investigator for the Consumer Protection
    Division of the office of the Attorney General, a
    prosecuting attorney, the Attorney General, a deputy
    Attorney General, or an investigator from the office of the
    Attorney General;
        (3) any Illinois law enforcement officer who is:
            (A) authorized to receive the type of information
        released; and
            (B) approved by the Department to receive the type
        of information released; or
        (4) prescription monitoring entities in other states
    per the provisions outlined in subsection (g) and (h)
    below;
confidential prescription record information collected under
Sections 316 and 321 (now repealed) that identifies vendors or
practitioners, or both, who are prescribing or dispensing large
quantities of Schedule II, III, IV, or V controlled substances
outside the scope of their practice, pharmacy, or business, as
determined by the Advisory Committee created by Section 320.
    (g) The information described in subsection (f) may not be
released until it has been reviewed by an employee of the
Department who is licensed as a prescriber or a dispenser and
until that employee has certified that further investigation is
warranted. However, failure to comply with this subsection (g)
does not invalidate the use of any evidence that is otherwise
admissible in a proceeding described in subsection (h).
    (h) An investigator or a law enforcement officer receiving
confidential information under subsection (c), (d), or (f) may
disclose the information to a law enforcement officer or an
attorney for the office of the Attorney General for use as
evidence in the following:
        (1) A proceeding under any State or federal law that
    involves a controlled substance.
        (2) A criminal proceeding or a proceeding in juvenile
    court that involves a controlled substance.
    (i) The Department may compile statistical reports from the
information described in subsection (a). The reports must not
include information that identifies, by name, license or
address, any practitioner, dispenser, ultimate user, or other
person administering a controlled substance.
    (j) Based upon federal, initial and maintenance funding, a
prescriber and dispenser inquiry system shall be developed to
assist the health care community in its goal of effective
clinical practice and to prevent patients from diverting or
abusing medications.
        (1) An inquirer shall have read-only access to a
    stand-alone database which shall contain records for the
    previous 12 months.
        (2) Dispensers may, upon positive and secure
    identification, make an inquiry on a patient or customer
    solely for a medical purpose as delineated within the
    federal HIPAA law.
        (3) The Department shall provide a one-to-one secure
    link and encrypted software necessary to establish the link
    between an inquirer and the Department. Technical
    assistance shall also be provided.
        (4) Written inquiries are acceptable but must include
    the fee and the requestor's Drug Enforcement
    Administration license number and submitted upon the
    requestor's business stationery.
        (5) As directed by the Prescription Monitoring Program
    Advisory Committee and the Clinical Director for the
    Prescription Monitoring Program, aggregate data that does
    not indicate any prescriber, practitioner, dispenser, or
    patient may be used for clinical studies.
        (6) Tracking analysis shall be established and used per
    administrative rule.
        (7) Nothing in this Act or Illinois law shall be
    construed to require a prescriber or dispenser to make use
    of this inquiry system.
        (8) If there is an adverse outcome because of a
    prescriber or dispenser making an inquiry, which is
    initiated in good faith, the prescriber or dispenser shall
    be held harmless from any civil liability.
    (k) The Department shall establish, by rule, the process by
which to evaluate possible erroneous association of
prescriptions to any licensed prescriber or end user of the
Illinois Prescription Information Library (PIL).
    (l) The Prescription Monitoring Program Advisory Committee
is authorized to evaluate the need for and method of
establishing a patient specific identifier.
    (m) Patients who identify prescriptions attributed to them
that were not obtained by them shall be given access to their
personal prescription history pursuant to the validation
process as set forth by administrative rule.
    (n) The Prescription Monitoring Program is authorized to
develop operational push reports to entities with compatible
electronic medical records. The process shall be covered within
administrative rule established by the Department.
    (o) Hospital emergency departments and freestanding
healthcare facilities providing healthcare to walk-in patients
may obtain, for the purpose of improving patient care, a unique
identifier for each shift to utilize the PIL system.
    (p) The Prescription Monitoring Program shall
automatically create a log-in to the inquiry system when a
prescriber or dispenser obtains or renews his or her controlled
substance license. The Department of Financial and
Professional Regulation must provide the Prescription
Monitoring Program with electronic access to the license
information of a prescriber or dispenser to facilitate the
creation of this profile. The Prescription Monitoring Program
shall send the prescriber or dispenser information regarding
the inquiry system, including instructions on how to log into
the system, instructions on how to use the system to promote
effective clinical practice, and opportunities for continuing
education for the prescribing of controlled substances. The
Prescription Monitoring Program shall also send to all enrolled
prescribers, dispensers, and designees information regarding
the unsolicited reports produced pursuant to Section 314.5 of
this Act.
    (q) A prescriber or dispenser may authorize a designee to
consult the inquiry system established by the Department under
this subsection on his or her behalf, provided that all the
following conditions are met:
        (1) the designee so authorized is employed by the same
    hospital or health care system; is employed by the same
    professional practice; or is under contract with such
    practice, hospital, or health care system;
        (2) the prescriber or dispenser takes reasonable steps
    to ensure that such designee is sufficiently competent in
    the use of the inquiry system;
        (3) the prescriber or dispenser remains responsible
    for ensuring that access to the inquiry system by the
    designee is limited to authorized purposes and occurs in a
    manner that protects the confidentiality of the
    information obtained from the inquiry system, and remains
    responsible for any breach of confidentiality; and
        (4) the ultimate decision as to whether or not to
    prescribe or dispense a controlled substance remains with
    the prescriber or dispenser.
    The Prescription Monitoring Program shall send to
registered designees information regarding the inquiry system,
including instructions on how to log onto the system.
    (r) The Prescription Monitoring Program shall maintain an
Internet website in conjunction with its prescriber and
dispenser inquiry system. This website shall include, at a
minimum, the following information:
        (1) current clinical guidelines developed by health
    care professional organizations on the prescribing of
    opioids or other controlled substances as determined by the
    Advisory Committee;
        (2) accredited continuing education programs related
    to prescribing of controlled substances;
        (3) programs or information developed by health care
    professionals that may be used to assess patients or help
    ensure compliance with prescriptions;
        (4) updates from the Food and Drug Administration, the
    Centers for Disease Control and Prevention, and other
    public and private organizations which are relevant to
    prescribing;
        (5) relevant medical studies related to prescribing;
        (6) other information regarding the prescription of
    controlled substances; and
        (7) information regarding prescription drug disposal
    events, including take-back programs or other disposal
    options or events.
    The content of the Internet website shall be periodically
reviewed by the Prescription Monitoring Program Advisory
Committee as set forth in Section 320 and updated in accordance
with the recommendation of the advisory committee.
    (s) The Prescription Monitoring Program shall regularly
send electronic updates to the registered users of the Program.
The Prescription Monitoring Program Advisory Committee shall
review any communications sent to registered users and also
make recommendations for communications as set forth in Section
320. These updates shall include the following information:
        (1) opportunities for accredited continuing education
    programs related to prescribing of controlled substances;
        (2) current clinical guidelines developed by health
    care professional organizations on the prescribing of
    opioids or other drugs as determined by the Advisory
    Committee;
        (3) programs or information developed by health care
    professionals that may be used to assess patients or help
    ensure compliance with prescriptions;
        (4) updates from the Food and Drug Administration, the
    Centers for Disease Control and Prevention, and other
    public and private organizations which are relevant to
    prescribing;
        (5) relevant medical studies related to prescribing;
        (6) other information regarding prescribing of
    controlled substances;
        (7) information regarding prescription drug disposal
    events, including take-back programs or other disposal
    options or events; and
        (8) reminders that the Prescription Monitoring Program
    is a useful clinical tool.
(Source: P.A. 99-480, eff. 9-9-15; 100-125, eff. 1-1-18.)
 
    (720 ILCS 570/320)
    Sec. 320. Advisory committee.
    (a) There is created a Prescription Monitoring Program
Advisory Committee to assist the Department of Human Services
in implementing the Prescription Monitoring Program created by
this Article and to advise the Department on the professional
performance of prescribers and dispensers and other matters
germane to the advisory committee's field of competence.
    (b) The Prescription Monitoring Program Advisory Committee
shall consist of 16 members appointed by the Clinical Director
of the Prescription Monitoring Program The Clinical Director of
the Prescription Monitoring Program shall appoint members to
serve on the advisory committee. The advisory committee shall
be composed of prescribers and dispensers licensed to practice
medicine in his or her respective profession as follows: one
family or primary care physician; one pain specialist
physician; 4 other physicians, one of whom may be an
ophthalmologist licensed to practice medicine in all its
branches; 2 one advanced practice registered nurses nurse; one
physician assistant; one optometrist; one dentist; one
podiatric physician; one veterinarian; one clinical
representative from a statewide organization representing
hospitals; and 3 pharmacists. The Advisory Committee members
serving on the effective date of this amendatory Act of the
100th General Assembly shall continue to serve until January 1,
2019. Prescriber and dispenser nominations for membership on
the Committee shall be submitted by their respective
professional associations. If there are more nominees than
membership positions for a prescriber or dispenser category, as
provided in this subsection (b), the Clinical Director of the
Prescription Monitoring Program shall appoint a member or
members for each profession as provided in this subsection (b),
from the nominations to serve on the advisory committee. At the
first meeting of the Committee in 2019 members shall draw lots
for initial terms and 6 members shall serve 3 years, 5 members
shall serve 2 years, and 5 members shall serve one year.
Thereafter, members shall serve 3 year terms. Members may serve
more than one term but no more than 3 terms. The Clinical
Director of the Prescription Monitoring Program may appoint a
representative of an organization representing a profession
required to be appointed. The Clinical Director of the
Prescription Monitoring Program shall serve as the Secretary
chair of the committee.
    (c) The advisory committee may appoint a chairperson and
its other officers as it deems appropriate.
    (d) The members of the advisory committee shall receive no
compensation for their services as members of the advisory
committee, unless appropriated by the General Assembly, but may
be reimbursed for their actual expenses incurred in serving on
the advisory committee.
    (e) The advisory committee shall:
        (1) provide a uniform approach to reviewing this Act in
    order to determine whether changes should be recommended to
    the General Assembly;
        (2) review current drug schedules in order to manage
    changes to the administrative rules pertaining to the
    utilization of this Act;
        (3) review the following: current clinical guidelines
    developed by health care professional organizations on the
    prescribing of opioids or other controlled substances;
    accredited continuing education programs related to
    prescribing and dispensing; programs or information
    developed by health care professional organizations that
    may be used to assess patients or help ensure compliance
    with prescriptions; updates from the Food and Drug
    Administration, the Centers for Disease Control and
    Prevention, and other public and private organizations
    which are relevant to prescribing and dispensing; relevant
    medical studies; and other publications which involve the
    prescription of controlled substances;
        (4) make recommendations for inclusion of these
    materials or other studies which may be effective resources
    for prescribers and dispensers on the Internet website of
    the inquiry system established under Section 318;
        (5) semi-annually on at least a quarterly basis, review
    the content of the Internet website of the inquiry system
    established pursuant to Section 318 to ensure this Internet
    website has the most current available information;
        (6) semi-annually on at least a quarterly basis, review
    opportunities for federal grants and other forms of funding
    to support projects which will increase the number of pilot
    programs which integrate the inquiry system with
    electronic health records; and
        (7) semi-annually on at least a quarterly basis, review
    communication to be sent to all registered users of the
    inquiry system established pursuant to Section 318,
    including recommendations for relevant accredited
    continuing education and information regarding prescribing
    and dispensing.
    (f) The Advisory Committee shall select from its members 11
members of the Peer Review Committee composed of: The Clinical
Director of the Prescription Monitoring Program shall select 5
members, 3 physicians and 2 pharmacists, of the Prescription
Monitoring Program Advisory Committee to serve as members of
the peer review subcommittee.
        (1) 3 physicians;
        (2) 3 pharmacists;
        (3) one dentist;
        (4) one advanced practice registered nurse;
        (4.5) one veterinarian;
        (5) one physician assistant; and
        (6) one optometrist.
    The purpose of the Peer Review Committee peer review
subcommittee is to advise the Program on matters germane to the
advisory committee's field of competence, establish a formal
peer review of professional performance of prescribers and
dispensers, and develop communications to transmit to
prescribers and dispensers. The deliberations, information,
and communications of the Peer Review Committee peer review
subcommittee are privileged and confidential and shall not be
disclosed in any manner except in accordance with current law.
        (1) The Peer Review Committee peer review subcommittee
    shall periodically review the data contained within the
    prescription monitoring program to identify those
    prescribers or dispensers who may be prescribing or
    dispensing outside the currently accepted standard and
    practice standards in the course of their profession
    professional practice. The Peer Review Committee member,
    whose profession is the same as the prescriber or dispenser
    being reviewed, shall prepare a preliminary report and
    recommendation for any non-action or action. The
    Prescription Monitoring Program Clinical Director and
    staff shall provide the necessary assistance and data as
    required.
        (2) The Peer Review Committee peer review subcommittee
    may identify prescribers or dispensers who may be
    prescribing outside the currently accepted medical
    standards in the course of their professional practice and
    send the identified prescriber or dispenser a request for
    information regarding their prescribing or dispensing
    practices. This request for information shall be sent via
    certified mail, return receipt requested. A prescriber or
    dispenser shall have 30 days to respond to the request for
    information.
        (3) The Peer Review Committee peer review subcommittee
    shall refer a prescriber or a dispenser to the Department
    of Financial and Professional Regulation in the following
    situations:
            (i) if a prescriber or dispenser does not respond
        to three successive requests for information;
            (ii) in the opinion of a majority of members of the
        Peer Review Committee peer review subcommittee, the
        prescriber or dispenser does not have a satisfactory
        explanation for the practices identified by the Peer
        Review Committee peer review subcommittee in its
        request for information; or
            (iii) following communications with the Peer
        Review Committee peer review subcommittee, the
        prescriber or dispenser does not sufficiently rectify
        the practices identified in the request for
        information in the opinion of a majority of the members
        of the Peer Review Committee peer review subcommittee.
        (4) The Department of Financial and Professional
    Regulation may initiate an investigation and discipline in
    accordance with current laws and rules for any prescriber
    or dispenser referred by the peer review subcommittee.
        (5) The Peer Review Committee peer review subcommittee
    shall prepare an annual report starting on July 1, 2017.
    This report shall contain the following information: the
    number of times the Peer Review Committee peer review
    subcommittee was convened; the number of prescribers or
    dispensers who were reviewed by the Peer Review Committee
    peer review committee; the number of requests for
    information sent out by the Peer Review Committee peer
    review subcommittee; and the number of prescribers or
    dispensers referred to the Department of Financial and
    Professional Regulation. The annual report shall be
    delivered electronically to the Department and to the
    General Assembly. The report to the General Assembly shall
    be filed with the Clerk of the House of Representatives and
    the Secretary of the Senate in electronic form only, in the
    manner that the Clerk and the Secretary shall direct. The
    report prepared by the Peer Review Committee peer review
    subcommittee shall not identify any prescriber, dispenser,
    or patient.
(Source: P.A. 99-480, eff. 9-9-15; 100-513, eff. 1-1-18.)
 
    Section 99. Effective date. This Act takes effect upon
becoming law.

Effective Date: 8/26/2018