Illinois General Assembly - Full Text of SB2952
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Full Text of SB2952  100th General Assembly


Sen. Melinda Bush

Filed: 4/20/2018





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2    AMENDMENT NO. ______. Amend Senate Bill 2952 by replacing
3everything after the enacting clause with the following:
4    "Section 5. The Illinois Controlled Substances Act is
5amended by changing Sections 316, 318, and 320 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 Schedule II, III, IV, and V controlled
10substances that includes the following components and
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.



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



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1    the next business day after the date on which a controlled
2    substance is dispensed, or at such other time as may be
3    required by the Department by administrative rule.
4        (3) A dispenser must transmit the information required
5    under this Section by:
6            (A) an electronic device compatible with the
7        receiving device of the central repository;
8            (B) a computer diskette;
9            (C) a magnetic tape; or
10            (D) a pharmacy universal claim form or Pharmacy
11        Inventory Control form;
12        (4) The Department may impose a civil fine of up to
13    $100 per day for willful failure to report controlled
14    substance dispensing to the Prescription Monitoring
15    Program. The fine shall be calculated on no more than the
16    number of days from the time the report was required to be
17    made until the time the problem was resolved, and shall be
18    payable to the Prescription Monitoring Program.
19    (b) The Department, by rule, may include in the
20Prescription Monitoring Program certain other select drugs
21that are not included in Schedule II, III, IV, or V. The
22Prescription Monitoring Program does not apply to controlled
23substance prescriptions as exempted under Section 313.
24    (c) The collection of data on select drugs and scheduled
25substances by the Prescription Monitoring Program may be used
26as a tool for addressing oversight requirements of long-term



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1care institutions as set forth by Public Act 96-1372. Long-term
2care pharmacies shall transmit patient medication profiles to
3the Prescription Monitoring Program monthly or more frequently
4as established by administrative rule.
5    (d) The Department of Human Services shall appoint a
6full-time Clinical Director of the Prescription Monitoring
8    (e) (Blank).
9    (f) Within one year of the effective date of this
10amendatory Act of the 100th General Assembly, the Department
11shall adopt rules requiring all Electronic Health Records
12Systems to interface with the Prescription Monitoring Program
13application program on or before January 1, 2021 to ensure that
14all providers have access to specific patient records during
15the treatment of their patients. These rules shall also address
16the electronic integration of pharmacy records with the
17Prescription Monitoring Program to allow for faster
18transmission of the information required under this Section.
19The Department shall establish actions to be taken if a
20prescriber's Electronic Health Records System does not
21effectively interface with the Prescription Monitoring Program
22within the required timeline.
23    (g) The Department, in consultation with the Advisory
24Committee, shall adopt rules allowing licensed prescribers or
25pharmacists who have registered to access the Prescription
26Monitoring Program to authorize a licensed or non-licensed



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1designee employed in that licensed prescriber's office or a
2licensed designee in a licensed pharmacist's pharmacy, and who
3has received training in the federal Health Insurance
4Portability and Accountability Act to consult the Prescription
5Monitoring Program on their behalf. The rules shall include
6reasonable parameters concerning a practitioner's authority to
7authorize a designee, and the eligibility of a person to be
8selected as a designee.
9(Source: P.A. 99-480, eff. 9-9-15; 100-564, eff. 1-1-18.)
10    (720 ILCS 570/318)
11    Sec. 318. Confidentiality of information.
12    (a) Information received by the central repository under
13Section 316 and former Section 321 is confidential.
14    (a-1) To ensure the federal Health Insurance Portability
15and Accountability Act privacy of an individual's prescription
16data reported to the Prescription Monitoring Program received
17from a retail dispenser under this Act, the data shall be
18stored and isolated from any other database and remain under
19the full and complete control of the Prescription Monitoring
21    (a-2) As an active step to address the current opioid
22crisis in this State and to prevent and reduce addiction
23resulting from a sports injury or an accident, the Prescription
24Monitoring Program and the Department of Public Health shall
25coordinate a continuous review of the Prescription Monitoring



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



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



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



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1        (4) prescription monitoring entities in other states
2    per the provisions outlined in subsection (g) and (h)
3    below;
4confidential prescription record information collected under
5Sections 316 and 321 (now repealed) that identifies vendors or
6practitioners, or both, who are prescribing or dispensing large
7quantities of Schedule II, III, IV, or V controlled substances
8outside the scope of their practice, pharmacy, or business, as
9determined by the Advisory Committee created by Section 320.
10    (g) The information described in subsection (f) may not be
11released until it has been reviewed by an employee of the
12Department who is licensed as a prescriber or a dispenser and
13until that employee has certified that further investigation is
14warranted. However, failure to comply with this subsection (g)
15does not invalidate the use of any evidence that is otherwise
16admissible in a proceeding described in subsection (h).
17    (h) An investigator or a law enforcement officer receiving
18confidential information under subsection (c), (d), or (f) may
19disclose the information to a law enforcement officer or an
20attorney for the office of the Attorney General for use as
21evidence in the following:
22        (1) A proceeding under any State or federal law that
23    involves a controlled substance.
24        (2) A criminal proceeding or a proceeding in juvenile
25    court that involves a controlled substance.
26    (i) The Department may compile statistical reports from the



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1information described in subsection (a). The reports must not
2include information that identifies, by name, license or
3address, any practitioner, dispenser, ultimate user, or other
4person administering a controlled substance.
5    (j) Based upon federal, initial and maintenance funding, a
6prescriber and dispenser inquiry system shall be developed to
7assist the health care community in its goal of effective
8clinical practice and to prevent patients from diverting or
9abusing medications.
10        (1) An inquirer shall have read-only access to a
11    stand-alone database which shall contain records for the
12    previous 12 months.
13        (2) Dispensers may, upon positive and secure
14    identification, make an inquiry on a patient or customer
15    solely for a medical purpose as delineated within the
16    federal HIPAA law.
17        (3) The Department shall provide a one-to-one secure
18    link and encrypted software necessary to establish the link
19    between an inquirer and the Department. Technical
20    assistance shall also be provided.
21        (4) Written inquiries are acceptable but must include
22    the fee and the requestor's Drug Enforcement
23    Administration license number and submitted upon the
24    requestor's business stationery.
25        (5) As directed by the Prescription Monitoring Program
26    Advisory Committee and the Clinical Director for the



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1    Prescription Monitoring Program, aggregate data that does
2    not indicate any prescriber, practitioner, dispenser, or
3    patient may be used for clinical studies.
4        (6) Tracking analysis shall be established and used per
5    administrative rule.
6        (7) Nothing in this Act or Illinois law shall be
7    construed to require a prescriber or dispenser to make use
8    of this inquiry system.
9        (8) If there is an adverse outcome because of a
10    prescriber or dispenser making an inquiry, which is
11    initiated in good faith, the prescriber or dispenser shall
12    be held harmless from any civil liability.
13    (k) The Department shall establish, by rule, the process by
14which to evaluate possible erroneous association of
15prescriptions to any licensed prescriber or end user of the
16Illinois Prescription Information Library (PIL).
17    (l) The Prescription Monitoring Program Advisory Committee
18is authorized to evaluate the need for and method of
19establishing a patient specific identifier.
20    (m) Patients who identify prescriptions attributed to them
21that were not obtained by them shall be given access to their
22personal prescription history pursuant to the validation
23process as set forth by administrative rule.
24    (n) The Prescription Monitoring Program is authorized to
25develop operational push reports to entities with compatible
26electronic medical records. The process shall be covered within



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1administrative rule established by the Department.
2    (o) Hospital emergency departments and freestanding
3healthcare facilities providing healthcare to walk-in patients
4may obtain, for the purpose of improving patient care, a unique
5identifier for each shift to utilize the PIL system.
6    (p) The Prescription Monitoring Program shall
7automatically create a log-in to the inquiry system when a
8prescriber or dispenser obtains or renews his or her controlled
9substance license. The Department of Financial and
10Professional Regulation must provide the Prescription
11Monitoring Program with electronic access to the license
12information of a prescriber or dispenser to facilitate the
13creation of this profile. The Prescription Monitoring Program
14shall send the prescriber or dispenser information regarding
15the inquiry system, including instructions on how to log into
16the system, instructions on how to use the system to promote
17effective clinical practice, and opportunities for continuing
18education for the prescribing of controlled substances. The
19Prescription Monitoring Program shall also send to all enrolled
20prescribers, dispensers, and designees information regarding
21the unsolicited reports produced pursuant to Section 314.5 of
22this Act.
23    (q) A prescriber or dispenser may authorize a designee to
24consult the inquiry system established by the Department under
25this subsection on his or her behalf, provided that all the
26following conditions are met:



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1        (1) the designee so authorized is employed by the same
2    hospital or health care system; is employed by the same
3    professional practice; or is under contract with such
4    practice, hospital, or health care system;
5        (2) the prescriber or dispenser takes reasonable steps
6    to ensure that such designee is sufficiently competent in
7    the use of the inquiry system;
8        (3) the prescriber or dispenser remains responsible
9    for ensuring that access to the inquiry system by the
10    designee is limited to authorized purposes and occurs in a
11    manner that protects the confidentiality of the
12    information obtained from the inquiry system, and remains
13    responsible for any breach of confidentiality; and
14        (4) the ultimate decision as to whether or not to
15    prescribe or dispense a controlled substance remains with
16    the prescriber or dispenser.
17    The Prescription Monitoring Program shall send to
18registered designees information regarding the inquiry system,
19including instructions on how to log onto the system.
20    (r) The Prescription Monitoring Program shall maintain an
21Internet website in conjunction with its prescriber and
22dispenser inquiry system. This website shall include, at a
23minimum, the following information:
24        (1) current clinical guidelines developed by health
25    care professional organizations on the prescribing of
26    opioids or other controlled substances as determined by the



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1    Advisory Committee;
2        (2) accredited continuing education programs related
3    to prescribing of controlled substances;
4        (3) programs or information developed by health care
5    professionals that may be used to assess patients or help
6    ensure compliance with prescriptions;
7        (4) updates from the Food and Drug Administration, the
8    Centers for Disease Control and Prevention, and other
9    public and private organizations which are relevant to
10    prescribing;
11        (5) relevant medical studies related to prescribing;
12        (6) other information regarding the prescription of
13    controlled substances; and
14        (7) information regarding prescription drug disposal
15    events, including take-back programs or other disposal
16    options or events.
17    The content of the Internet website shall be periodically
18reviewed by the Prescription Monitoring Program Advisory
19Committee as set forth in Section 320 and updated in accordance
20with the recommendation of the advisory committee.
21    (s) The Prescription Monitoring Program shall regularly
22send electronic updates to the registered users of the Program.
23The Prescription Monitoring Program Advisory Committee shall
24review any communications sent to registered users and also
25make recommendations for communications as set forth in Section
26320. These updates shall include the following information:



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1        (1) opportunities for accredited continuing education
2    programs related to prescribing of controlled substances;
3        (2) current clinical guidelines developed by health
4    care professional organizations on the prescribing of
5    opioids or other drugs as determined by the Advisory
6    Committee;
7        (3) programs or information developed by health care
8    professionals that may be used to assess patients or help
9    ensure compliance with prescriptions;
10        (4) updates from the Food and Drug Administration, the
11    Centers for Disease Control and Prevention, and other
12    public and private organizations which are relevant to
13    prescribing;
14        (5) relevant medical studies related to prescribing;
15        (6) other information regarding prescribing of
16    controlled substances;
17        (7) information regarding prescription drug disposal
18    events, including take-back programs or other disposal
19    options or events; and
20        (8) reminders that the Prescription Monitoring Program
21    is a useful clinical tool.
22(Source: P.A. 99-480, eff. 9-9-15; 100-125, eff. 1-1-18.)
23    (720 ILCS 570/320)
24    Sec. 320. Advisory committee.
25    (a) There is created a Prescription Monitoring Program



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1Advisory Committee to assist the Department of Human Services
2in implementing the Prescription Monitoring Program created by
3this Article and to advise the Department on the professional
4performance of prescribers and dispensers and other matters
5germane to the advisory committee's field of competence.
6    (b) The Prescription Monitoring Program Advisory Committee
7shall consist of 12 members appointed by the Clinical Director
8of the Prescription Monitoring Program The Clinical Director of
9the Prescription Monitoring Program shall appoint members to
10serve on the advisory committee. The advisory committee shall
11be composed of prescribers and dispensers licensed to practice
12medicine in his or her respective profession as follows: 4
13physicians licensed to practice medicine in all its branches;
14one advanced practice registered nurse; one physician
15assistant; one optometrist or ophthalmologist; one dentist;
16one podiatric physician; and 3 pharmacists. The Advisory
17Committee members serving on the effective date of this
18amendatory Act of the 100th General Assembly shall continue to
19serve until January 1, 2019. Prescriber and dispenser
20nominations for membership on the Committee shall be submitted
21by their respective professional associations. If there are
22more nominees than membership positions for a prescriber or
23dispenser category, as provided in this subsection (b), the
24Clinical Director of the Prescription Monitoring Program shall
25appoint a member or members for each profession as provided in
26this subsection (b), from the nominations to serve on the



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1advisory committee. At the first meeting of the Committee in
22019 members shall draw lots for initial terms and 4 members
3shall serve 3 years, 4 members shall serve 2 years, and 4
4members shall serve one year. Thereafter, members shall serve 3
5year terms. Members may serve more than one term but no more
6than 3 terms. The Clinical Director of the Prescription
7Monitoring Program may appoint a representative of an
8organization representing a profession required to be
9appointed. The Clinical Director of the Prescription
10Monitoring Program shall serve as the Secretary chair of the
12    (c) The advisory committee may appoint a chairperson and
13its other officers as it deems appropriate.
14    (d) The members of the advisory committee shall receive no
15compensation for their services as members of the advisory
16committee, unless appropriated by the General Assembly, but may
17be reimbursed for their actual expenses incurred in serving on
18the advisory committee.
19    (e) The advisory committee shall:
20        (1) provide a uniform approach to reviewing this Act in
21    order to determine whether changes should be recommended to
22    the General Assembly;
23        (2) review current drug schedules in order to manage
24    changes to the administrative rules pertaining to the
25    utilization of this Act;
26        (3) review the following: current clinical guidelines



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1    developed by health care professional organizations on the
2    prescribing of opioids or other controlled substances;
3    accredited continuing education programs related to
4    prescribing and dispensing; programs or information
5    developed by health care professional organizations that
6    may be used to assess patients or help ensure compliance
7    with prescriptions; updates from the Food and Drug
8    Administration, the Centers for Disease Control and
9    Prevention, and other public and private organizations
10    which are relevant to prescribing and dispensing; relevant
11    medical studies; and other publications which involve the
12    prescription of controlled substances;
13        (4) make recommendations for inclusion of these
14    materials or other studies which may be effective resources
15    for prescribers and dispensers on the Internet website of
16    the inquiry system established under Section 318;
17        (5) semi-annually on at least a quarterly basis, review
18    the content of the Internet website of the inquiry system
19    established pursuant to Section 318 to ensure this Internet
20    website has the most current available information;
21        (6) semi-annually on at least a quarterly basis, review
22    opportunities for federal grants and other forms of funding
23    to support projects which will increase the number of pilot
24    programs which integrate the inquiry system with
25    electronic health records; and
26        (7) semi-annually on at least a quarterly basis, review



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1    communication to be sent to all registered users of the
2    inquiry system established pursuant to Section 318,
3    including recommendations for relevant accredited
4    continuing education and information regarding prescribing
5    and dispensing.
6    (f) The Advisory Committee shall select from its members 7
7members of the Peer Review Committee composed of: The Clinical
8Director of the Prescription Monitoring Program shall select 5
9members, 3 physicians and 2 pharmacists, of the Prescription
10Monitoring Program Advisory Committee to serve as members of
11the peer review subcommittee.
12        (1) 2 physicians;
13        (2) one pharmacist;
14        (3) one dentist;
15        (4) one advanced practice registered nurse;
16        (5) one physician assistant; and
17        (6) one optometrist or ophthalmologist.
18    The purpose of the Peer Review Committee peer review
19subcommittee is to advise the Program on matters germane to the
20advisory committee's field of competence, establish a formal
21peer review of professional performance of prescribers and
22dispensers, and develop communications to transmit to
23prescribers and dispensers. The deliberations, information,
24and communications of the Peer Review Committee peer review
25subcommittee are privileged and confidential and shall not be
26disclosed in any manner except in accordance with current law.



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1        (1) The Peer Review Committee peer review subcommittee
2    shall periodically review the data contained within the
3    prescription monitoring program to identify those
4    prescribers or dispensers who may be prescribing or
5    dispensing outside the currently accepted standard and
6    practice standards in the course of their profession
7    professional practice. The Peer Review Committee member,
8    whose profession is the same as the prescriber or dispenser
9    being reviewed, shall prepare a preliminary report and
10    recommendation for any non-action or action. The
11    Prescription Monitoring Program Clinical Director and
12    staff shall provide the necessary assistance and data as
13    required.
14        (2) The Peer Review Committee peer review subcommittee
15    may identify prescribers or dispensers who may be
16    prescribing outside the currently accepted medical
17    standards in the course of their professional practice and
18    send the identified prescriber or dispenser a request for
19    information regarding their prescribing or dispensing
20    practices. This request for information shall be sent via
21    certified mail, return receipt requested. A prescriber or
22    dispenser shall have 30 days to respond to the request for
23    information.
24        (3) The Peer Review Committee peer review subcommittee
25    shall refer a prescriber or a dispenser to the Department
26    of Financial and Professional Regulation in the following



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1    situations:
2            (i) if a prescriber or dispenser does not respond
3        to three successive requests for information;
4            (ii) in the opinion of a majority of members of the
5        Peer Review Committee peer review subcommittee, the
6        prescriber or dispenser does not have a satisfactory
7        explanation for the practices identified by the Peer
8        Review Committee peer review subcommittee in its
9        request for information; or
10            (iii) following communications with the Peer
11        Review Committee peer review subcommittee, the
12        prescriber or dispenser does not sufficiently rectify
13        the practices identified in the request for
14        information in the opinion of a majority of the members
15        of the Peer Review Committee peer review subcommittee.
16        (4) The Department of Financial and Professional
17    Regulation may initiate an investigation and discipline in
18    accordance with current laws and rules for any prescriber
19    or dispenser referred by the peer review subcommittee.
20        (5) The Peer Review Committee peer review subcommittee
21    shall prepare an annual report starting on July 1, 2017.
22    This report shall contain the following information: the
23    number of times the Peer Review Committee peer review
24    subcommittee was convened; the number of prescribers or
25    dispensers who were reviewed by the Peer Review Committee
26    peer review committee; the number of requests for



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1    information sent out by the Peer Review Committee peer
2    review subcommittee; and the number of prescribers or
3    dispensers referred to the Department of Financial and
4    Professional Regulation. The annual report shall be
5    delivered electronically to the Department and to the
6    General Assembly. The report to the General Assembly shall
7    be filed with the Clerk of the House of Representatives and
8    the Secretary of the Senate in electronic form only, in the
9    manner that the Clerk and the Secretary shall direct. The
10    report prepared by the Peer Review Committee peer review
11    subcommittee shall not identify any prescriber, dispenser,
12    or patient.
13(Source: P.A. 99-480, eff. 9-9-15; 100-513, eff. 1-1-18.)
14    Section 99. Effective date. This Act takes effect upon
15becoming law.".