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September 2015
In this Issue

  • ISMS Analysis of House Bill 1 (Lang/Kotowski)

    Dispensing and Administration of Opioid Antagonists

    Pharmacists Dispensing Antagonists

    • Amends the Pharmacy Practice Act to create "Lali’s Law," to authorize pharmacists to dispense opioid antagonists. This dispensing must be done in accordance with written procedures and protocols developed by the Department of Financial and Professional Regulation (IDFPR), with the Department of Public Health (IDPH) and Department of Human Services (DHS).
    • Pharmacists dispensing opioid antagonists pursuant to this new Section must complete a training program developed by IDPH.
    • Amends the Good Samaritan Act to provide that a pharmacist who dispenses or administers an opioid antagonist without fee or compensation shall not, as a result of their acts of omissions, except for willful and wanton misconduct, be liable for civil damages. 

    DHS Drug Overdose Prevention Program

    • Requires the Director of the Division of Alcoholism and Substance Abuse (DASA) to publish a report annually regarding statewide overdose trends. The report must now include an analysis of drug overdose information reported by hospitals and coroners. 
    • Updates existing law authorizing DHS to create a program for the dispensing, prescribing, or distribution of Naloxone to use the term "opioid antagonist" and also improves definition to account for potential advances in opioid antagonists.
    • Clarifies that health care professionals can prescribe opioid antagonists to persons who may not be personally at risk of experiencing an opioid overdose, but rather may be able to assist another individual during an opioid overdose. 
    • Ensures civil immunity, except for willful and wanton misconduct, for lay people administering opioid antagonists to those experiencing an opioid overdose.
    • Allows for criminal immunity for healthcare professional administering or dispensing opioid antagonists to patients or others who may administer the opioid antagonist.
    • Updates the definition of "health care professional" to include pharmacists and also accurately reflecting the terminology referencing advanced practice nurses and physician assistants.
    • Requires every state and local government agency employing law enforcement officers and firemen to have opioid antagonists and provide training for the administration of opioid antagonists. This requirement also applies to publicly and privately owned ambulances and other transport vehicles. 
    • These entities may apply to DHS for a grant to acquire opioid antagonists and to fund training programs.
    • Requires DHS to create a public education program about opioid and heroin overdose, including information regarding the immunity for those who administer opioid antagonists.
    • Amends existing law that currently authorizes select school personnel to administer asthma medication and epi-pens to include the administration of opioid antagonists. 

    Emergency Medical Services Directors Committee

    • Requires the EMS Medical Directors Committee to address regional standing medical orders for the administration of opioid antagonists.

    Disposal of Unused Medication

    Medication Take-Back Program

    • Requires the Illinois Environmental Protection Agency (IEPA) to establish by rule a medication take-back program to allow for the collection and disposal of unused controlled substances.
    • This program must be established by June 1, 2016 and IEPA must issue a report to the General Assembly detailing the amount of controlled substances collected under the program. 
    • IEPA must also create a sign detailing information on approved collection sites for controlled substances and mail-back programs. This sign must be posted by pharmacies in the area where medications are dispensed. 
    • Finally, the amendment authorizes IEPA to include collection of controlled substances in its existing household waste collections. 

    Prescription Pill and Drug Disposal Fund

    • Expands eligibility for grants by the Illinois Criminal Justice Information Authority from the Prescription Pill and Drug Disposal Fund. Municipalities or organizations that establish containers designated for the collection and disposal of unused controlled substances may receive grants from the Fund. In addition, publication or advertising of collection events or mail-back programs conducted by municipalities or organizations is also eligible for grant funding.
    • Doubles the existing fee ($20 to $40) assessed against certain criminal offenses that supports the Prescription Pill and Drug Disposal Fund. 

    Prescribing Requirements

    Schedule II Drugs

    • In addition to the current restrictions on the three, 30-day sequential prescriptions for Schedule II drugs, a physician must document in a patient’s medical record the medical necessity for the amount and duration of the three, 30-day sequential prescriptions for Schedule II narcotics.

    Medication Shopping

    Unsolicited Reports

    • Authorizes the Prescription Monitoring Program (PMP) to issue an unsolicited report to a prescriber when a person has been identified as having three or more prescribers or three or more pharmacies, or both, that do not utilize a common electronic file within the course of a 30-day period.
    • Current law allows the PMP the discretion to issue such reports when a person has six or more prescribers or six or more pharmacies or both that do not utilize a common electronic file within the course of a 30-day period.
    • The amendment provides that these reports will be sent to dispensers and the designees of prescribers and dispensers. 

    Protections from Negative Feedback

    • Provides that any patient feedback, including grades, ratings, or written or verbal statements, in opposition to a clinical decision that the prescription of a controlled substance is not medically necessary shall not be the basis of any adverse action, evaluation, or any other type of negative credentialing, contracting, licensure, or employment action taken against a prescriber or dispenser. 

    Violations of the Controlled Substances Act

    • Makes the attempt to acquire a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge a violation of the Controlled Substances Act. 
    • Creates a new offense to knowingly withhold information requested from a practitioner with the intent to obtain a controlled substance that has not been prescribed by misrepresentation, fraud, forgery, deception, subterfuge, or concealment of a material fact.

    Prescription Monitoring Program

    Automatic Enrollment in the Prescription Monitoring Program

    • Requires the automatic enrollment in the PMP for all dispensers and prescribers when they obtain or renew their controlled substance license. 
    • IDFPR is required to request an email address in its application for a new or renewed controlled substance license. 
    • All prescribers shall designate one or more medical specialties or fields of medical care and treatment when the prescriber registers with the PMP.

    Authorization of Designee to view PMP

    • Allows for prescribers and dispensers to authorize a designee to consult the PMP on their behalf. 
    • The following conditions must be met in order to allow for the designee to view the PMP: (1) the designee 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 PMP; (3) the prescriber or dispenser remains responsible for ensuring that access to the PMP by the designee is limited to authorized purposes and occurs in a manner that protects the confidentiality of the information obtained from the PMP 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.
    • Designees will receive information on how to use the PMP. 

    PMP Website

    • The PMP is required to maintain a website with specific information, including current clinical guidelines on the prescribing of opioids and other controlled substances; accredited continuing education programs related to prescribing and dispensing; programs or information developed by health care professionals that may be used to assess patients or help ensure compliance with prescriptions, and updates from federal agencies and other public and private organizations that are relevant to prescribing.
    • The website must be periodically reviewed by the PMP Advisory Committee. 

    Updates from the PMP

    • The PMP is required to send periodic updates to all enrolled prescribers and dispensers on a variety of different topics, including opportunities for accredited continuing education related to prescribing and dispensing.
    • These communications must also be reviewed by the PMP Advisory Committee.

    PMP Information

    • Requires dispensers to transmit additional information to the PMP, including the date of birth and gender of the person receiving the prescription, and the day’s supply indicated by the prescription. 
    • Information to be reported to the PMP must now be transmitted no later than the end of the next business day after the date the controlled substance is dispensed. Current law requires the information to be transmitted within 7 days after the prescription is dispensed.

    Electronic Health Record (EHR) Pilot Project

    • Within one year of the effective date of the bill (immediate), DHS must adopt rules establishing pilot initiatives involving a cross-section of hospitals in Illinois to increase the integration of PMP information with EHR’s.
    • The PMP Advisory Committee shall consult with DHS to identify funding sources to support pilot projects promoting the integration of the PMP with EHR’s. 

    PMP Advisory Committee

    • Reconstitutes the make-up of the PMP Advisory Committee to be appointed by the clinical director of the PMP, instead of by the Secretary of DHS or their designee. 
    • The composition of the PMP Advisory Committee is as follows: four physicians, one advanced practice nurse, one physician assistant, one optometrist, one dentist, one podiatric physician, and three pharmacists. The clinical director has the ability to appoint a representative of an organization representing a profession required to be appointed to the Committee.
    • The clinical director of the PMP shall serve as the Chair of the Committee.
    • The PMP Advisory Committee must complete reviews of grant opportunities and the content of the PMP website on a quarterly basis.

    Peer Review Subcommittee

    • The Peer Review Subcommittee shall be composed of five members selected by the clinical director, three physicians and two pharmacists from the PMP Advisory Committee. 
    • The purpose of the Peer Review Subcommittee is to establish a formal peer review of the professional performance of prescribers and dispensers. The deliberations, information, and communications of the Peer Review Subcommittee are privileged and confidential and shall not be disclosed in any manner except in accordance with current law.
    • The Peer Review Subcommittee may identify prescribers and dispensers who may be prescribing outside currently accepted medical standards and send those prescribers and dispensers a "request for information." This communication shall be sent via certified mail, return receipt requested. A prescriber or dispenser has 30 days to respond to the request for information.
    • A prescriber or dispenser will be referred to IDFPR by the Peer Review Subcommittee in the following circumstances: (1) if a prescriber or dispenser does not respond to three successive requests for information; (2) in the opinion of the majority of members of the Peer Review Committee, the prescriber or dispenser does not have a satisfactory explanation for the practices identified by the Peer Review Subcommittee in its request for information; or (3) following communications with the Peer Review Subcommittee, the prescriber or dispenser does not sufficiently rectify the practices identified in the request for information in the opinion of the majority of the members of the Peer Review Subcommittee.
    • IDFPR may initiate an investigation and discipline in accordance with current laws and rules for any prescriber or dispensers referred by the Peer Review Subcommittee.
    • The Peer Review Subcommittee is required to submit an annual report detailing its activities for the prior year starting on July 1, 2017. This report is to be submitted to DHS and the General Assembly.

    Confidentiality Protections

    • Amends the Open Meetings Act to allow for the meetings of the Advisory Committee and the Peer Review Subcommittee to be closed to the public when discussing specific prescribers, dispensers, or patients. 

    Pharmacy Information

    • Pharmacies are required to maintain a policy regarding the type of identification necessary, if any, to receive a prescription in accordance with state and federal law. The pharmacy is required to post this information in the place where prescriptions are filled. 

    Overdose Reporting Requirements

    Coroners

    • Requires coroners to report to IDPH when a drug overdose is determined to be a cause or contributing factor in a death.
    • IDPH is required to use this information to create a semi-annual report to the General Assembly and a monthly report on its website.

    Emergency Departments

    • When treatment is provided in a hospital emergency room, a health care professional, hospital administrator, or their designee is required to report a drug overdose to IDPH within 48 hours of providing treatment or at such time the overdose is confirmed. 
    • IDPH shall by rule create a form for this report with specific fields and with the input of a statewide organization representing a majority of hospitals in Illinois.
    • The identity of the person and entity reporting shall not be disclosed to the subject of the report. The healthcare professional, hospital administrator, or designee and his or her employer shall not be held criminally, civilly, or professionally liable for the required reporting, except for willful or wanton misconduct. 
    • IDPH is also required to use this information for a report to the General Assembly.

    Insurance Coverage Provisions

    Opioid Antagonist Mandate

    • Creates a new mandate in the insurance code to require coverage for at least one opioid antagonist, including refills.

    Application of Current Mandates

    • Applies the mandate of Section 370c (Mental and Emotional Disorders) and 370c.1 (Mental Health Parity) of the Insurance Code to the State Employees Group insurance plan. 
    • Applies the mandate of Section 370c to the Counties code and the Municipal Code. 

    Mental and Emotional Disorders

    • In an existing mandate for Mental and Emotional Disorders, provides that no additional criteria may be used to make medical necessity determinations for substance use disorders besides the criteria established by the American Society of Addiction Medicine. 
    • Also in this existing mandate for Mental and Emotional Disorders, requires the offer of coverage for medically necessary acute treatment services and medically necessary clinical stabilization services.
    • "Acute treatment services" means 24-hour medically supervised addiction treatment that provides evaluation and withdrawal management. "Clinical stabilization services" means 24-hour treatment following acute treatment services, which may include intensive education and counseling.

    Mental Health Parity

    • Requires the Department of Insurance (DOI) to enforce the requirements of state and federal mental health parity laws. 
    • Expands the existing mental health parity mandate to include addiction parity and to apply to qualified health plans offered through the Health Insurance Marketplace.
    • Also in the Mental Health and Addiction Parity mandate, requires insurers to use policies and procedures for the election and placement of substance abuse treatment drugs on their formulary that are no less favorable to the insured as those policies and procedures the insurer uses for the selection and placement of other drugs. 
    • Insurers must follow the expedited coverage determination for substance abuse treatment drugs in the Managed Care Reform and Patient Rights Act. 
    • Requires the DOI to implement several education initiatives regarding parity. 
    • By January 1, 2016, the DOI must develop a plan for a Consumer Education Campaign on mental health and addiction parity, which must include live training events and the establishment of a consumer hotline to assist consumers in navigating the parity process.
    • The DOI shall convene a working group of health care insurance carriers, mental health advocacy groups, substance abuse patient advocacy groups, and mental health physician groups for the purpose of discussing issues related to the treatment and coverage of substance abuse disorders and mental illness. 
    • Creates the Parity Education Fund as a special fund in the state treasury to be used by the DOI to provide financial assistance for the consumer education campaign related to mental health and addiction parity. 

    External Review

    • Amends the Health Carrier External Review Act to require the written notice of the right to review, to also include a copy of the DOI’s Request for External Review form. 

    Medicaid

    • On or after July 1, 2015, requires coverage by Medicaid for all Food and Drug Administration approved forms of medication assisted treatment prescribed for the treatment of alcohol dependence or the treatment of opioid dependence. The bill also prohibits medication assisted treatment for opioid and alcohol dependency from being subject to any utilization control, limitations on prior authorization, or lifetime treatment limits. 
    • Also on or after July 1, 2015, requires coverage for opioid antagonists for Medicaid beneficiaries.
    • Applies existing insurance mandates for Section 370c (Mental and Emotional Disorders) and 370c.1 (Mental Health and Addiction Parity) to Medicaid beneficiaries.

    Drug Awareness Campaign

    • Requires the State Board of Education and DHS to develop a three year heroin and opioid prevention program for elementary and secondary schools. 
    • Participation in the program by school districts is voluntary. Subject to appropriation, DHS shall reimburse a school district for the costs associated with participation in the program.

    Civil and Criminal Forfeiture

    • Allows for the distribution of criminal forfeiture funds to be used to purchase opioid antagonists. 

    Drug Courts

    • Expands eligibility for drug court programs for those sentenced to probation for certain offenses under the Cannabis Control Act, the Controlled Substances Act, and the Methamphetamine Control and Community Protection Act. 
    • Subject to appropriation, requires mandatory education seminars on substance abuse and addiction for all drug court prosecutors and public defenders throughout the state. 



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