Sen. Michael E. Hastings

Filed: 3/26/2019





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2    AMENDMENT NO. ______. Amend Senate Bill 1665 by replacing
3everything after the enacting clause with the following:
4    "Section 5. The Illinois Controlled Substances Act is
5amended by changing Sections 314.5, 316, and 320 as follows:
6    (720 ILCS 570/314.5)
7    Sec. 314.5. Medication shopping; pharmacy shopping.
8    (a) It shall be unlawful for any person knowingly or
9intentionally to fraudulently obtain or fraudulently seek to
10obtain any controlled substance or prescription for a
11controlled substance from a prescriber or dispenser while being
12supplied with any controlled substance or prescription for a
13controlled substance by another prescriber or dispenser,
14without disclosing the fact of the existing controlled
15substance or prescription for a controlled substance to the
16prescriber or dispenser from whom the subsequent controlled



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1substance or prescription for a controlled substance is sought.
2    (b) It shall be unlawful for a person knowingly or
3intentionally to fraudulently obtain or fraudulently seek to
4obtain any controlled substance from a pharmacy while being
5supplied with any controlled substance by another pharmacy,
6without disclosing the fact of the existing controlled
7substance to the pharmacy from which the subsequent controlled
8substance is sought.
9    (c) A person may be in violation of Section 3.23 of the
10Illinois Food, Drug and Cosmetic Act or Section 406 of this Act
11when medication shopping or pharmacy shopping, or both.
12    (c-5) Effective January 1, 2018, each prescriber
13possessing an Illinois controlled substances license shall
14register with the Prescription Monitoring Program.
15Notwithstanding any provision of this Act to the contrary,
16beginning on and after the effective date of this amendatory
17Act of the 101st General Assembly, a licensed veterinarian
18shall be exempt from registration and prohibited from accessing
19patient information in the Prescription Monitoring Program.
20Licensed veterinarians that are existing registrants shall be
21removed from the Prescription Monitoring Program. Each
22prescriber or his or her designee shall also document an
23attempt to access patient information in the Prescription
24Monitoring Program to assess patient access to controlled
25substances when providing an initial prescription for Schedule
26II narcotics such as opioids, except for prescriptions for



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1oncology treatment or palliative care, or a 7-day or less
2supply provided by a hospital emergency department when
3treating an acute, traumatic medical condition. This attempt to
4access shall be documented in the patient's medical record. The
5hospital shall facilitate the designation of a prescriber's
6designee for the purpose of accessing the Prescription
7Monitoring Program for services provided at the hospital.
8    (d) When a person has been identified as having 3 or more
9prescribers or 3 or more pharmacies, or both, that do not
10utilize a common electronic file as specified in Section 20 of
11the Pharmacy Practice Act for controlled substances within the
12course of a continuous 30-day period, the Prescription
13Monitoring Program may issue an unsolicited report to the
14prescribers, dispensers, and their designees informing them of
15the potential medication shopping. If an unsolicited report is
16issued to a prescriber or prescribers, then the report must
17also be sent to the applicable dispensing pharmacy.
18    (e) Nothing in this Section shall be construed to create a
19requirement that any prescriber, dispenser, or pharmacist
20request any patient medication disclosure, report any patient
21activity, or prescribe or refuse to prescribe or dispense any
23    (f) This Section shall not be construed to apply to
24inpatients or residents at hospitals or other institutions or
25to institutional pharmacies.
26    (g) Any patient feedback, including grades, ratings, or



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1written or verbal statements, in opposition to a clinical
2decision that the prescription of a controlled substance is not
3medically necessary shall not be the basis of any adverse
4action, evaluation, or any other type of negative
5credentialing, contracting, licensure, or employment action
6taken against a prescriber or dispenser.
7(Source: P.A. 99-480, eff. 9-9-15; 100-564, eff. 1-1-18.)
8    (720 ILCS 570/316)
9    Sec. 316. Prescription Monitoring Program.
10    (a) The Department must provide for a Prescription
11Monitoring Program for Schedule II, III, IV, and V controlled
12substances that includes the following components and
14        (1) The dispenser must transmit to the central
15    repository, in a form and manner specified by the
16    Department, the following information:
17            (A) The recipient's name and address.
18            (B) The recipient's date of birth and gender.
19            (C) The national drug code number of the controlled
20        substance dispensed.
21            (D) The date the controlled substance is
22        dispensed.
23            (E) The quantity of the controlled substance
24        dispensed and days supply.
25            (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    (a-5) Notwithstanding subsection (a), a licensed
13veterinarian is exempt from the reporting requirements of this
14Section. If a person who is presenting an animal for treatment
15is suspected of fraudulently obtaining any controlled
16substance or prescription for a controlled substance, the
17licensed veterinarian shall report that information to the
18local law enforcement agency.
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 January 1, 2018 (the effective date
10of Public Act 100-564) this amendatory Act of the 100th General
11Assembly, the Department shall adopt rules requiring all
12Electronic Health Records Systems to interface with the
13Prescription Monitoring Program application program on or
14before January 1, 2021 to ensure that all providers have access
15to specific patient records during the treatment of their
16patients. These rules shall also address the electronic
17integration of pharmacy records with the Prescription
18Monitoring Program to allow for faster transmission of the
19information required under this Section. The Department shall
20establish actions to be taken if a prescriber's Electronic
21Health Records System does not effectively interface with the
22Prescription Monitoring Program within 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. In this subsection (g), "pharmacist"
9shall include a clinical pharmacist employed by and designated
10by a Medicaid Managed Care Organization providing services
11under Article V of the Illinois Public Aid Code under a
12contract with the Department of Healthcare Health and Family
13Services for the sole purpose of clinical review of services
14provided to persons covered by the entity under the contract to
15determine compliance with subsections (a) and (b) of Section
16314.5 of this Act. A managed care entity pharmacist shall
17notify prescribers of review activities.
18(Source: P.A. 99-480, eff. 9-9-15; 100-564, eff. 1-1-18;
19100-861, eff. 8-14-18; 100-1005, eff. 8-21-18; 100-1093, eff.
208-26-18; revised 2-20-19.)
21    (720 ILCS 570/320)
22    Sec. 320. Advisory committee.
23    (a) There is created a Prescription Monitoring Program
24Advisory Committee to assist the Department of Human Services
25in implementing the Prescription Monitoring Program created by



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1this Article and to advise the Department on the professional
2performance of prescribers and dispensers and other matters
3germane to the advisory committee's field of competence.
4    (b) The Prescription Monitoring Program Advisory Committee
5shall consist of 15 16 members appointed by the Clinical
6Director of the Prescription Monitoring Program composed of
7prescribers and dispensers licensed to practice medicine in his
8or her respective profession as follows: one family or primary
9care physician; one pain specialist physician; 4 other
10physicians, one of whom may be an ophthalmologist; 2 advanced
11practice registered nurses; one physician assistant; one
12optometrist; one dentist; one veterinarian; one clinical
13representative from a statewide organization representing
14hospitals; and 3 pharmacists. The Advisory Committee members
15serving on August 26, 2018 (the effective date of Public Act
16100-1093) this amendatory Act of the 100th General Assembly
17shall continue to serve until January 1, 2019. Prescriber and
18dispenser nominations for membership on the Committee shall be
19submitted by their respective professional associations. If
20there are more nominees than membership positions for a
21prescriber or dispenser category, as provided in this
22subsection (b), the Clinical Director of the Prescription
23Monitoring Program shall appoint a member or members for each
24profession as provided in this subsection (b), from the
25nominations to serve on the advisory committee. At the first
26meeting of the Committee in 2019 members shall draw lots for



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1initial terms and 6 members shall serve 3 years, 5 members
2shall serve 2 years, and 5 members shall serve one year.
3Thereafter, members shall serve 3-year 3 year terms. Members
4may serve more than one term but no more than 3 terms. The
5Clinical Director of the Prescription Monitoring Program may
6appoint a representative of an organization representing a
7profession required to be appointed. The Clinical Director of
8the Prescription Monitoring Program shall serve as the
9Secretary of the committee.
10    (c) The advisory committee may appoint a chairperson and
11other officers as it deems appropriate.
12    (d) The members of the advisory committee shall receive no
13compensation for their services as members of the advisory
14committee, unless appropriated by the General Assembly, but may
15be reimbursed for their actual expenses incurred in serving on
16the advisory committee.
17    (e) The advisory committee shall:
18        (1) provide a uniform approach to reviewing this Act in
19    order to determine whether changes should be recommended to
20    the General Assembly;
21        (2) review current drug schedules in order to manage
22    changes to the administrative rules pertaining to the
23    utilization of this Act;
24        (3) review the following: current clinical guidelines
25    developed by health care professional organizations on the
26    prescribing of opioids or other controlled substances;



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



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1    regarding prescribing and dispensing.
2    (f) The Advisory Committee shall select from its members 10
311 members of the Peer Review Committee composed of: 6, and one
5        (1) 3 physicians;
6        (2) 3 pharmacists;
7        (3) one dentist;
8        (4) one advanced practice registered nurse;
9        (4.5) (blank) one veterinarian;
10        (5) one physician assistant; and
11        (6) one optometrist.
12    The purpose of the Peer Review Committee is to establish a
13formal peer review of professional performance of prescribers
14and dispensers. The deliberations, information, and
15communications of the Peer Review Committee are privileged and
16confidential and shall not be disclosed in any manner except in
17accordance with current law.
18        (1) The Peer Review Committee shall periodically
19    review the data contained within the prescription
20    monitoring program to identify those prescribers or
21    dispensers who may be prescribing or dispensing outside the
22    currently accepted standard and practice of their
23    profession. The Peer Review Committee member, whose
24    profession is the same as the prescriber or dispenser being
25    reviewed, shall prepare a preliminary report and
26    recommendation for any non-action or action. The



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1    Prescription Monitoring Program Clinical Director and
2    staff shall provide the necessary assistance and data as
3    required.
4        (2) The Peer Review Committee may identify prescribers
5    or dispensers who may be prescribing outside the currently
6    accepted medical standards in the course of their
7    professional practice and send the identified prescriber
8    or dispenser a request for information regarding their
9    prescribing or dispensing practices. This request for
10    information shall be sent via certified mail, return
11    receipt requested. A prescriber or dispenser shall have 30
12    days to respond to the request for information.
13        (3) The Peer Review Committee shall refer a prescriber
14    or a dispenser to the Department of Financial and
15    Professional Regulation in the following situations:
16            (i) if a prescriber or dispenser does not respond
17        to three successive requests for information;
18            (ii) in the opinion of a majority of members of the
19        Peer Review Committee, the prescriber or dispenser
20        does not have a satisfactory explanation for the
21        practices identified by the Peer Review Committee in
22        its request for information; or
23            (iii) following communications with the Peer
24        Review Committee, the prescriber or dispenser does not
25        sufficiently rectify the practices identified in the
26        request for information in the opinion of a majority of



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1        the members of the Peer Review Committee.
2        (4) The Department of Financial and Professional
3    Regulation may initiate an investigation and discipline in
4    accordance with current laws and rules for any prescriber
5    or dispenser referred by the Peer Review Committee peer
6    review subcommittee.
7        (5) The Peer Review Committee shall prepare an annual
8    report starting on July 1, 2017. This report shall contain
9    the following information: the number of times the Peer
10    Review Committee was convened; the number of prescribers or
11    dispensers who were reviewed by the Peer Review Committee;
12    the number of requests for information sent out by the Peer
13    Review Committee; and the number of prescribers or
14    dispensers referred to the Department of Financial and
15    Professional Regulation. The annual report shall be
16    delivered electronically to the Department and to the
17    General Assembly. The report to the General Assembly shall
18    be filed with the Clerk of the House of Representatives and
19    the Secretary of the Senate in electronic form only, in the
20    manner that the Clerk and the Secretary shall direct. The
21    report prepared by the Peer Review Committee shall not
22    identify any prescriber, dispenser, or patient.
23(Source: P.A. 99-480, eff. 9-9-15; 100-513, eff. 1-1-18;
24100-861, eff. 8-14-18; 100-1093, eff. 8-26-18; revised



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1    Section 99. Effective date. This Act takes effect upon
2becoming law.".