An Update on Kentucky All Schedule Prescription Electronic Reporting (KASPER) Mary Reinle Begley Inspector General Kentucky David R. Hopkins KASPER Program Manager Office of Inspector General Health Care Compliance Association November 9, 2012 Contents Pill Mills KASPER Program Update Controlled Substance Prescribing in Kentucky (House Bill 1) Pain Management Facilities 1
Pill Mills Jeff and Chris George Photos from Palm Beach Post 2
Dr. Paul H. Volkman Story: Bill Estep, Lexington Herald-Leader, February 14, 2012. AP Photo released by U.S. Marshals Service (undated) Care More Pain Management Clinic Photo: Scott Utterback, Louisville Courier-Journal, January 25, 2012 3
Care More Pain Management Clinic Photo: Scott Utterback, Louisville Courier-Journal, January 25, 2012 KASPER Program Update 4
KASPER KASPER is Kentucky s Prescription Monitoring Program (PMP). KASPER tracks Schedule II V controlled substance prescriptions dispensed within the state as reported by pharmacies and other dispensers. Enhanced KASPER (ekasper) is the real-time web accessed database that provides a tool to help address the misuse, abuse and diversion of controlled pharmaceutical substances. KASPER Operation KASPER tracks most Schedule II V substances dispensed in KY. Over 11 million controlled substance prescriptions reported to the system each year. KASPER data is 1 to 7 days old. Dispensers have 7 days to report. Health Information Designs processes & provides data once per day. Reports available to authorized individuals. Available via web typically within 15 seconds (92% of requests). Available 24/7 from any PC with Web access. 5
Status of Prescription Drug Monitoring Programs (PDMPs) VT WA OR NV CA MT ID WY UT CO AZ NM ND MN NY SD WI MI PA IA NE OH IL IN WV VA KS MO KY NC TN OK AR SC GA MS AL ME NH MA RI CT NJ DE MD DC AK TX LA FL Operational PDMPs HI Enacted PDMP legislation, but program not yet operational Legislation pending GU Research is current as of February 1, 2012 2011 KASPER Reports Requested 6
2011 KASPER Reports Requested 811 708 Number of Reports in Thousands 122 186 274 362 418 533 2004 2005 2006 2007 2008 2009 2010 2011 Top Prescribed Controlled Substances by Therapeutic Category by Doses - 2011 Zolpidem 3.8% Ambien Lorazepam 4.2% Ativan Tramadol 3.1% Ultram Pregabalin 2.8% Lyrica Amphetamine 2.7% Adderall Hydrocodone 42.8% Lortab Lorcet Vicodin Diazepam 4.9% Valium Clonazepam 6.9% Klonopin Alprazolam 13.3% Xanax Oxycodone 15.5% OxyContin Percodan Percocet 7
KASPER Stakeholders Licensing Boards to investigate potential inappropriate prescribing by a licensee. Practitioners and Pharmacists to review a current patient s controlled substance prescription history for medical and/or pharmaceutical treatment. Law Enforcement Officers, OIG employees, Commonwealth s attorneys, county attorneys - to review an individual s controlled substance prescription history as part of a bona fide drug investigation, or drug prosecution. Medicaid to screen members for potential abuse of pharmacy benefits and to determine lock-in ; to screen providers for adherence to prescribing guidelines for Medicaid patients. A judge or probation or parole officer to help ensure adherence to drug diversion or probation program guidelines. KASPER Usage December 31, 2011 Pharmacists = 3.5% (26% of KY pharmacists have accounts) Law Enforcement = 1.5% (13% of KY LE have accounts) Judges, Other =.1% Prescribers = 94.9% (32% of KY prescribers have accounts) 8
Goals of KASPER KASPER was designed as a tool to help address prescription drug abuse and diversion by providing: A source of information for health care professionals An investigative tool for law enforcement and regulatory agencies KASPER was not designed to: Prevent people from obtaining prescription drugs Decrease the number of doses dispensed Controlled Substance Prescribing in Kentucky House Bill 1 9
ekasper Reporting Schedule II controlled substances and Schedule III controlled substances that contain hydrocodone administered to a patient Beginning July 1, 2013 Controlled substance administration or dispensing must be reported within seven days through June 30, 2013 Must be reported within one day of administration or dispensing on or after July 1, 2013 ekasper Accounts ekasper registration is mandatory for Kentucky practitioners or pharmacists authorized to prescribe or dispense controlled substances to humans. 10
ekasper Master Accounts 12/31/2011 04/24/2012 07/20/2012 10/24/2012 Doctor* 5,470 5,680 11,923 15,988 APRN 690 781 1,523 1,771 Pharmacist 1,385 1,450 3,602 4,683 Total 7,545 7,911 17,048 22,442 *Includes physicians, dentists, optometrists and podiatrists ekasper Provider Usage KRS 218A.172 (HB1) ekasper must be queried: Prior to initial prescribing or dispensing of a Schedule II controlled substance, or a Schedule III controlled substance containing hydrocodone No less than every three months Before issuing a new prescription or refills for a Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone 11
ekasper Provider Usage - Regulations Expanded by Licensure Boards to include all Schedule III controlled substances and the following Schedule IV controlled substances: Ambien Anorexics Ativan Klonopin Librium Nubain Oxazepam Phentermine Soma Stadol Stadol NS Tramadol Valium Versed Xanax CS Prescribing Regulations Licensure Boards 201 KAR 5:130 Kentucky Board of Optometric Examiners KASPER requirements 201 KAR 8:532 Kentucky Board of Dentistry KASPER requirements 201 KAR 9:230, 201 KAR 9:260 Kentucky Board of Medical Licensure KASPER requirements 201 KAR 20:057 Kentucky Board of Nursing KASPER requirements 201 KAR 25:090 Kentucky Board of Podiatry KASPER requirements. 12
KASPER Reports 2011 weekday average: 2,888 Current weekday average: 18,722 ekasper Delegate Accounts ekasper delegate accounts allowed for: An employee of the practitioner s or pharmacist s practice acting under the specific direction of the practitioner or pharmacist 13
ekasper Prescriber Reports CS prescribers can obtain an ekasper report on themselves: To review and assess the individual prescribing patterns To determine the accuracy and completeness of information contained in ekasper To identify fraudulent prescriptions ekasper Patient Reports ekasper reports can be shared with the patient or person authorized to act on the patient s behalf ekasper reports can be placed in the patient s medical record, with the report then being deemed a medical record subject to disclosure on the same terms and conditions as an ordinary medical record 14
ekasper Error Correction Patient or provider should contact the dispenser to correct records in error Inaccurate KASPER reports due to system errors should be reported to the Drug Enforcement and Professional Practices Branch 502-564-7985 ekasper Planned Enhancements Hospital or facility accounts Improved KASPER data quality Improved prescription record data matching Improved report processing speeds 15
Pain Management Facilities HB 1 Ownership Requirements Physician ownership requirement on all pain management facilities (PMF) Exception for those health facilities operating as a PMF on April 24, 2012 No sanctions or convictions imposed on facility or employees 16
Oversight KBML responsible for licensure standards for physician-owned pain management facilities. OIG, Division of Health Care is responsible for licensure standards for existing pain management facilities that qualify for the physician-ownership exemption of HB 1. Inspections/Complaint Investigations The OIG began inspecting PMFs for compliance with 902 KAR 20:420E on July 23, 2012. PMFs will be subject to an unannounced initial inspection and at least one unannounced inspection annually. The OIG will investigate credible, relevant complaints or allegations against the facility. Complaint investigations will be unannounced. 17
Determining Whether a Facility is a PMF The majority of patients of practitioners are provided treatment for pain that includes the use of controlled substances. To determine majority, the OIG will calculate the majority of patients based upon the number of unduplicated patients treated in a one month time period and may use data from KASPER. Professional Standards for Prescribing and Dispensing Controlled Substances All licensed prescribers in a PMF must comply with the professional standards relating to the prescribing and dispensing of controlled substances established by their professional licensing boards. 18
Referral to Licensing Boards and Law Enforcement The Cabinet will refer a physician or practitioner to the appropriate professional licensure board and law enforcement agency if a surveyor has probable cause to believe that the facility s prescriber is engaged in the improper, inappropriate, or illegal prescribing or dispensing of controlled substances. Adverse Action and Appeals The Cabinet will deny, revoke, or issue an emergency suspension for violations identified in 902 KAR 20:420E. Facilities may file a written request for a hearing with the Cabinet upon receipt of notice to deny, revoke, or suspense the facility s license on an emergency basis. 19
Mary Reinle Begley Kentucky 275 East Main Street, 5ED Frankfort, KY 40621 502-564-2888 Mary.Begley@ky.gov David R. Hopkins 502-564-2815 extension 3333 Dave.Hopkins@ky.gov 20