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




SB2952 EnrolledLRB100 16820 RLC 31961 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, 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.
17            (C) The national drug code number of the controlled
18        substance dispensed.
19            (D) The date the controlled substance is
20        dispensed.
21            (E) The quantity of the controlled substance
22        dispensed and days supply.
23            (F) The dispenser's United States Drug Enforcement



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



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1            (B) a computer diskette;
2            (C) a magnetic tape; or
3            (D) a pharmacy universal claim form or Pharmacy
4        Inventory Control form;
5        (4) The Department may impose a civil fine of up to
6    $100 per day for willful failure to report controlled
7    substance dispensing to the Prescription Monitoring
8    Program. The fine shall be calculated on no more than the
9    number of days from the time the report was required to be
10    made until the time the problem was resolved, and shall be
11    payable to the Prescription Monitoring Program.
12    (b) The Department, by rule, may include in the
13Prescription Monitoring Program certain other select drugs
14that are not included in Schedule II, III, IV, or V. The
15Prescription Monitoring Program does not apply to controlled
16substance prescriptions as exempted under Section 313.
17    (c) The collection of data on select drugs and scheduled
18substances by the Prescription Monitoring Program may be used
19as a tool for addressing oversight requirements of long-term
20care institutions as set forth by Public Act 96-1372. Long-term
21care pharmacies shall transmit patient medication profiles to
22the Prescription Monitoring Program monthly or more frequently
23as established by administrative rule.
24    (d) The Department of Human Services shall appoint a
25full-time Clinical Director of the Prescription Monitoring



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1    (e) (Blank).
2    (f) Within one year of the effective date of this
3amendatory Act of the 100th General Assembly, the Department
4shall adopt rules requiring all Electronic Health Records
5Systems to interface with the Prescription Monitoring Program
6application program on or before January 1, 2021 to ensure that
7all providers have access to specific patient records during
8the treatment of their patients. These rules shall also address
9the electronic integration of pharmacy records with the
10Prescription Monitoring Program to allow for faster
11transmission of the information required under this Section.
12The Department shall establish actions to be taken if a
13prescriber's Electronic Health Records System does not
14effectively interface with the Prescription Monitoring Program
15within the required timeline.
16    (g) The Department, in consultation with the Advisory
17Committee, shall adopt rules allowing licensed prescribers or
18pharmacists who have registered to access the Prescription
19Monitoring Program to authorize a licensed or non-licensed
20designee employed in that licensed prescriber's office or a
21licensed designee in a licensed pharmacist's pharmacy, and who
22has received training in the federal Health Insurance
23Portability and Accountability Act to consult the Prescription
24Monitoring Program on their behalf. The rules shall include
25reasonable parameters concerning a practitioner's authority to
26authorize a designee, and the eligibility of a person to be



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1selected as a designee.
2(Source: P.A. 99-480, eff. 9-9-15; 100-564, eff. 1-1-18.)
3    (720 ILCS 570/318)
4    Sec. 318. Confidentiality of information.
5    (a) Information received by the central repository under
6Section 316 and former Section 321 is confidential.
7    (a-1) To ensure the federal Health Insurance Portability
8and Accountability Act privacy of an individual's prescription
9data reported to the Prescription Monitoring Program received
10from a retail dispenser under this Act, and in order to execute
11the duties and responsibilities under Section 316 of this Act
12and rules for disclosure under this Section, the Clinical
13Director of the Prescription Monitoring Program or his or her
14designee shall maintain direct access to all Prescription
15Monitoring Program data. Any request for Prescription
16Monitoring Program data from any other department or agency
17must be approved in writing by the Clinical Director of the
18Prescription Monitoring Program or his or her designee unless
19otherwise permitted by law. Prescription Monitoring Program
20data shall only be disclosed as permitted by law.
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 as to the addiction risk and urge each to follow the
9Centers for Disease Control and Prevention guidelines or his or
10her respective profession's treatment guidelines related to
11the patient's injury. This subsection (a-2), other than this
12sentence, is inoperative on or after January 1, 2024.
13    (b) The Department must carry out a program to protect the
14confidentiality of the information described in subsection
15(a). The Department may disclose the information to another
16person only under subsection (c), (d), or (f) and may charge a
17fee not to exceed the actual cost of furnishing the
19    (c) The Department may disclose confidential information
20described in subsection (a) to any person who is engaged in
21receiving, processing, or storing the information.
22    (d) The Department may release confidential information
23described in subsection (a) to the following persons:
24        (1) A governing body that licenses practitioners and is
25    engaged in an investigation, an adjudication, or a
26    prosecution of a violation under any State or federal law



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



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1    intergovernmental agreement between the Department of
2    Children and Family Services and the Department of Human
3    Services.
4    (e) Before the Department releases confidential
5information under subsection (d), the applicant must
6demonstrate in writing to the Department 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).
13    (f) The Department may receive and release prescription
14record information under Section 316 and former Section 321 to:
15        (1) a governing body that licenses practitioners;
16        (2) an investigator for the Consumer Protection
17    Division of the office of the Attorney General, a
18    prosecuting attorney, the Attorney General, a deputy
19    Attorney General, or an investigator from the office of the
20    Attorney General;
21        (3) any Illinois law enforcement officer who is:
22            (A) authorized to receive the type of information
23        released; and
24            (B) approved by the Department to receive the type
25        of information released; or
26        (4) prescription monitoring entities in other states



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



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1include information that identifies, by name, license or
2address, any practitioner, dispenser, ultimate user, or other
3person administering a controlled substance.
4    (j) Based upon federal, initial and maintenance funding, a
5prescriber and dispenser inquiry system shall be developed to
6assist the health care community in its goal of effective
7clinical practice and to prevent patients from diverting or
8abusing medications.
9        (1) An inquirer shall have read-only access to a
10    stand-alone database which shall contain records for the
11    previous 12 months.
12        (2) Dispensers may, upon positive and secure
13    identification, make an inquiry on a patient or customer
14    solely for a medical purpose as delineated within the
15    federal HIPAA law.
16        (3) The Department shall provide a one-to-one secure
17    link and encrypted software necessary to establish the link
18    between an inquirer and the Department. Technical
19    assistance shall also be provided.
20        (4) Written inquiries are acceptable but must include
21    the fee and the requestor's Drug Enforcement
22    Administration license number and submitted upon the
23    requestor's business stationery.
24        (5) As directed by the Prescription Monitoring Program
25    Advisory Committee and the Clinical Director for the
26    Prescription Monitoring Program, aggregate data that does



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



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



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



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1        (2) accredited continuing education programs related
2    to prescribing of controlled substances;
3        (3) programs or information developed by health care
4    professionals that may be used to assess patients or help
5    ensure compliance with prescriptions;
6        (4) updates from the Food and Drug Administration, the
7    Centers for Disease Control and Prevention, and other
8    public and private organizations which are relevant to
9    prescribing;
10        (5) relevant medical studies related to prescribing;
11        (6) other information regarding the prescription of
12    controlled substances; and
13        (7) information regarding prescription drug disposal
14    events, including take-back programs or other disposal
15    options or events.
16    The content of the Internet website shall be periodically
17reviewed by the Prescription Monitoring Program Advisory
18Committee as set forth in Section 320 and updated in accordance
19with the recommendation of the advisory committee.
20    (s) The Prescription Monitoring Program shall regularly
21send electronic updates to the registered users of the Program.
22The Prescription Monitoring Program Advisory Committee shall
23review any communications sent to registered users and also
24make recommendations for communications as set forth in Section
25320. These updates shall include the following information:
26        (1) opportunities for accredited continuing education



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



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1in implementing the Prescription Monitoring Program created by
2this Article and to advise the Department on the professional
3performance of prescribers and dispensers and other matters
4germane to the advisory committee's field of competence.
5    (b) The Prescription Monitoring Program Advisory Committee
6shall consist of 16 members appointed by the Clinical Director
7of the Prescription Monitoring Program The Clinical Director of
8the Prescription Monitoring Program shall appoint members to
9serve on the advisory committee. The advisory committee shall
10be composed of prescribers and dispensers licensed to practice
11medicine in his or her respective profession as follows: one
12family or primary care physician; one pain specialist
13physician; 4 other physicians, one of whom may be an
14ophthalmologist licensed to practice medicine in all its
15branches; 2 one advanced practice registered nurses nurse; one
16physician assistant; one optometrist; one dentist; one
17podiatric physician; one veterinarian; one clinical
18representative from a statewide organization representing
19hospitals; and 3 pharmacists. The Advisory Committee members
20serving on the effective date of this amendatory Act of the
21100th General Assembly shall continue to serve until January 1,
222019. Prescriber and dispenser nominations for membership on
23the Committee shall be submitted by their respective
24professional associations. If there are more nominees than
25membership positions for a prescriber or dispenser category, as
26provided in this subsection (b), the Clinical Director of the



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1Prescription Monitoring Program shall appoint a member or
2members for each profession as provided in this subsection (b),
3from the nominations to serve on the advisory committee. At the
4first meeting of the Committee in 2019 members shall draw lots
5for initial terms and 6 members shall serve 3 years, 5 members
6shall serve 2 years, and 5 members shall serve one year.
7Thereafter, members shall serve 3 year terms. Members may serve
8more than one term but no more than 3 terms. The Clinical
9Director of the Prescription Monitoring Program may appoint a
10representative of an organization representing a profession
11required to be appointed. The Clinical Director of the
12Prescription Monitoring Program shall serve as the Secretary
13chair of the committee.
14    (c) The advisory committee may appoint a chairperson and
15its other officers as it deems appropriate.
16    (d) The members of the advisory committee shall receive no
17compensation for their services as members of the advisory
18committee, unless appropriated by the General Assembly, but may
19be reimbursed for their actual expenses incurred in serving on
20the advisory committee.
21    (e) The advisory committee shall:
22        (1) provide a uniform approach to reviewing this Act in
23    order to determine whether changes should be recommended to
24    the General Assembly;
25        (2) review current drug schedules in order to manage
26    changes to the administrative rules pertaining to the



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



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1    electronic health records; and
2        (7) semi-annually on at least a quarterly basis, review
3    communication to be sent to all registered users of the
4    inquiry system established pursuant to Section 318,
5    including recommendations for relevant accredited
6    continuing education and information regarding prescribing
7    and dispensing.
8    (f) The Advisory Committee shall select from its members 11
9members of the Peer Review Committee composed of: The Clinical
10Director of the Prescription Monitoring Program shall select 5
11members, 3 physicians and 2 pharmacists, of the Prescription
12Monitoring Program Advisory Committee to serve as members of
13the peer review subcommittee.
14        (1) 3 physicians;
15        (2) 3 pharmacists;
16        (3) one dentist;
17        (4) one advanced practice registered nurse;
18        (4.5) one veterinarian;
19        (5) one physician assistant; and
20        (6) one optometrist.
21    The purpose of the Peer Review Committee peer review
22subcommittee is to advise the Program on matters germane to the
23advisory committee's field of competence, establish a formal
24peer review of professional performance of prescribers and
25dispensers, and develop communications to transmit to
26prescribers and dispensers. The deliberations, information,



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1and communications of the Peer Review Committee peer review
2subcommittee are privileged and confidential and shall not be
3disclosed in any manner except in accordance with current law.
4        (1) The Peer Review Committee peer review subcommittee
5    shall periodically review the data contained within the
6    prescription monitoring program to identify those
7    prescribers or dispensers who may be prescribing or
8    dispensing outside the currently accepted standard and
9    practice standards in the course of their profession
10    professional practice. The Peer Review Committee member,
11    whose profession is the same as the prescriber or dispenser
12    being reviewed, shall prepare a preliminary report and
13    recommendation for any non-action or action. The
14    Prescription Monitoring Program Clinical Director and
15    staff shall provide the necessary assistance and data as
16    required.
17        (2) The Peer Review Committee peer review subcommittee
18    may identify prescribers or dispensers who may be
19    prescribing outside the currently accepted medical
20    standards in the course of their professional practice and
21    send the identified prescriber or dispenser a request for
22    information regarding their prescribing or dispensing
23    practices. This request for information shall be sent via
24    certified mail, return receipt requested. A prescriber or
25    dispenser shall have 30 days to respond to the request for
26    information.



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



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