Office of Inspector General

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1 Office of Inspector General Mary Reinle Begley Inspector General

2 Division of Health Care Division of Regulated Child Care Division of Audits & Investigations

3 Division of Health Care Health Care facility responsibilities: Inspecting Monitoring Licensing and certifying Investigating complaints Facility plans review Regulation development

4 Certification Accreditation Licensure Certification = Federal Requirements Accreditation = Substitute for Federal Requirements Licensure = State Requirements

5 Division of Health Care Responsibilities Licensure: Office of Inspector General s (OIG) Division of Health Care is responsible for licensing all health care facilities as defined by KRS (1). OIG regulates approximately 35 licensure categories. Certification: The Centers for Medicare & Medicaid Services (CMS) contracts with OIG to conduct Medicare/Medicaid certification enforcement activities.

6 Role of Accreditation Accreditation: Is voluntary Can substitute for on-going State Agency review. Must be approved by CMS as meeting or exceeding Medicare requirements.

7 Regulations STATE FEDERAL nfo/01_overview.asp

8 Division of Health Care Responsibilities The enforcement branches of the Division of Health Care are responsible for conducting on-site visits of all health care facilities in the state to determine compliance with applicable licensing regulations and Medicare/Medicaid certification requirements.

9 Enforcement Branch County Coverage Northern Eastern Western Southern

10 Types of Surveys State Monitoring Initial Recertification Revisit Complaint Validation Federal Monitoring Comparative Regional Office (RO) surveyors replicate a State Agency (SA) survey ( look behind ) Federal Oversight Support Survey (FOSS) RO observes and evaluates a SA survey team s conduct of the actual survey

11 Licensed/Certified Facilities Facility Type Intermediate Care Facilities for the Mentally Retarded Total 12 Long Term Care Facilities 289 Accredited Hospitals 105 Non-accredited Hospitals 23 Psychiatric Hospitals 12 Critical Access Hospitals 31 Home Health Agencies 104

12 Licensed/Certified Facilities Facility Type Total Hospice 26 Outpatient PT/OT/Speech 90 Comprehensive Outpatient Rehabilitation 6 Facility Portable X-ray 15 Ambulatory Surgical Center 34 End Stage Renal Disease 96 CLIA 3,512

13 Number of Licensed Facilities Facility Type Total Physician Office Labs 456 Licensed Labs 93 Drug Prevention Facilities 18 Alcohol and Other Drug Entities 192 Free Standing Personal Care Homes 83 Family Care Homes 93

14 Position Type Health Care Staff Total Health Surveyors 75 LSC Surveyor 6 CLIA Surveyors 3 Administrative Staff 24 Support Staff 23 Total Staff 131

15 FREQUENCY OF SURVEYS ACCREDITED HOSPITALS Type CERTIFICATION: Frequency Hospital validation 1% from CMS listing CAH validation 5% LICENSURE COMPLAINT INVESTIGATIONS 5-10% validation surveys Based on nature of complaint

16 FREQUENCY OF SURVEYS NON-ACCREDITED HOSPITALS Type CERTIFICATION LICENSURE Frequency 5 year maximum interval 3 yr. intervals for poor performers 5% from CMS listing Annual COMPLAINT INVESTIGATIONS Based on nature of complaint

17 Hospital Complaints 7/1/2009 6/30/2010 # Hospital Complaints: 277 intakes 337 allegations # EMTALA Complaints 14 total

18 Condition of Participation Cited 7/1/2009 6/30/2010 ACUTE CARE HOSPITALS Tag Description Total A-0015 Patients Rights 3 A-0385 Nursing Services 2 A-0528 Radiologic Services 1 A-0700 Physical Environment 2

19 Condition of Participation Cited 7/1/2009 6/30/2010 CRITICAL ACCESS HOSPITAL Tag Description Total C Organizational Structure 1 C Provision of Services 1 C Clinical Records 1 C 030 Periodic Evaluation & QA Review 1

20 Condition of Participation Cited 7/1/2009 6/30/2010 HOSPITAL LONG TERM Tag Description Total A-0700 Physical Environment 1 A-0747 Infection Control 1 A-0940 Surgical Services 1

21 When Not in Compliance with Conditions of Participation (COP) If immediate jeopardy is determined 23 day termination track begins for both accredited and non-accredited. For non-accredited hospital/cah, if COP is out (not jeopardy) 90 day termination track begins.

22 When Not in Compliance with Conditions of Participation (COP) For accredited hospital/cah, if COP is out (not jeopardy), CMS will put facility under state jurisdiction Full survey will be conducted to determine compliance with all COPs. If full survey determines that COPs are out, 90 day termination track then begins.

23 Enforcement and Termination Survey process determines compliance with applicable health and safety standards Non-compliance with Medicare conditions of participation = threat of termination State completes Statement of Deficiencies (Form CMS 2567) Recommends certification or not Provider has 10 days to respond to deficiencies

24 Immediate Jeopardy (IJ) Three components of IJ must be present in order for the IJ to exist: Harm - Actual or potential for harm Immediacy Now or soon without action Responsibility Did the entity know/should the entity have known about the situation? Were the circumstances investigated and corrective measures initiated and re-evaluated?

25 CMS Initiatives Five Star Rating system The rating is based on three separate categories: Health inspections Quality measures Staffing levels

26 OIG Audits & Investigations 26

27 Investigations Two main types of investigations: Provider Recipient 27

28 Medicaid Welfare Fraud Hotline Majority of both provider and recipient complaints are received through OIG Medicaid Welfare Fraud Hotline ,074 Hotline Calls in SFY ,267 Hotline Calls in SFY ,308 Hotline Calls in SFY

29 Medicaid Welfare Fraud Hotline Hotline callers include: Recipients Other providers Patients Border state program integrity units General public 29

30 Other Source Referrals Department for Medicaid Services (DMS) OAG, Medicaid Fraud Control Unit (MFCU) Other state agencies such as Department of Revenue OIG Cabinet contractors Licensure boards 30

31 Fraud Knowingly and willfully executing or attempting to execute, a scheme or artifice to defraud any health care benefit program. To obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody of, or control of, any health care benefit program. 31

32 Common Provider Fraud Allegations Billing for services not rendered Soliciting, offering, or receiving kickbacks, bribes or rebates Unbundling Kickbacks and bribes 32

33 Abuse Receiving payment for items and service when there is no legal entitlement for that payment and the provider has not knowingly or intentionally misrepresented the facts to obtain payment. It results in unnecessary costs to the Medicare or Medicaid programs.

34 Abuse Duplicate claims Upcoding Billing in excess of what was necessary for the patient

35 Substantiated Provider Investigations Finding of potential criminal conduct is immediately referred to the Office of Attorney General Medicaid Fraud Control Unit (MFCU) Finding of inappropriately paid claims is referred to Medicaid for recoupment Recommendations to Medicaid for automated processes which would disallow future inappropriate payments Policy change recommendations to the Medicaid program 35

36 Unsubstantiated Provider Investigations Investigative report is sent to Medicaid May refer to other investigative agencies such as the Revenue Cabinet or licensure boards 36

37 Provider Complaint Flow Chart Hotline Complaint Reviewed OIG makes complaint determination Complaints are referred, investigated, or closed Referred to designated agency Preliminary Investigation is conducted Closed sent to designated agency 37

38 What is KASPER? KASPER is Kentucky s Prescription Drug Monitoring Program (PDMP) Tracks Schedule II V controlled substance prescriptions dispensed within the state as reported by pharmacies and other dispensers. Real-time Web accessed database that provides a tool to help address one of the largest threats to patient safety in the Commonwealth of Kentucky; the misuse, abuse and diversion of controlled pharmaceutical substances.

39 The Need for KASPER Abuse of controlled prescription medications is at epidemic levels Diversion of controlled substances is reaching epidemic proportions. Diverters cover large geographic areas to obtain drugs.

40 Fraud Detected by KASPER Can reveal a provider who is overprescribing for a Medicaid recipient Can reveal a Medicaid recipient who is doctor shopping and/or diverting prescription drugs 40

41 Controlled Substance Schedules Schedule I Illegal Drugs e.g. heroin, marijuana, etc. Schedule II Most addictive legal drugs; high abuse potential e.g. oxycodone (Oxycontin, Percocet, Tylox). Schedule III Less abuse potential than I or II e.g. hydrocodone combinations (Vicodin, Lortab). Schedule IV Less abuse potential than III e.g. benzodiazepines (Xanax, Valium). Schedule V least abuse potential e.g. codeine containing cough mixtures.

42 The Florida Connection Jim Moran, The Miami Herald April 8, 2009

43 The Florida Connection Chan Lowe, South Florida Sun-Sentinel August 29, 2009

44 KASPER is..used by health care providers to help identify patients who may be at risk for prescription drug abuse and to verify compliance with a treatment regimen established by the patient s health care team.also used as a tool for law enforcement and regulatory officials during bona fide investigations and other appropriate reviews

45 KASPER is not..designed to prevent patients from obtaining prescription drugs or to decrease the number of doses dispensed.

46 The KASPER Program KASPER is considered one of the most comprehensive Prescription Drug Monitoring Programs in the nation. Members of the Congressional Prescription Drug Abuse Caucus have cited KASPER as a model program in reducing prescription drug abuse and diversion.

47 34 States Have PDMPs States with Monitoring Programs WA OR NV CA AK MT ID WY UT CO AZ NM HI ND MN SD WI NY MI NE IA PA OH IL IN W V VA KS MO KY OK TN NC AR SC MS TX LA AL GA FL C-II only C-II, III C-II, III, IV C-II, III, IV,V VV V T N H N J PR ME RI DE MD DC

48 KASPER Operation KASPER tracks most Schedule II V substances dispensed in KY. Approximately 11 million controlled substance prescriptions reported to the system annually. KASPER data is 1 to 7 days old. Dispensers have 7 days to report. RelayHealth processes & provides data once per day. Reports available to authorized individuals. Available via fax in 2-8 hours. Available via Web within 15 seconds (90% of requests). Available 24/7 from any PC with Web access.

49 KASPER Report Contents A KASPER report shows: All controlled substance prescriptions an individual has had for a specified period of time, The prescribing practitioner, and The dispenser The KASPER report provides a tool to allow the practitioner to make a more informed controlled substance prescribing decision for their patient.

50 KASPER Stakeholders Licensing Boards to investigate potential inappropriate prescribing by a licensee only. Practitioners and Pharmacists to review a current patient s controlled substance prescription history for medical and/or pharmaceutical treatment. Law Enforcement Officers to review an individual s controlled substance prescription history as part of a bona fide drug investigation. 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.

51 2009 KASPER Usage Law Enforcement = 2.3% (13% of LE have accounts) Pharmacists = 3.8% (22% of pharmacists have accounts) Judges, Medicaid, Other <.1% Prescribers = 93.8% (30% of prescribers have accounts)

52 KASPER Records Total/Per Person 11M Number of Records 8.4M 8.4M 8.5M 8.8M 9.3M 10M 10.2M Number of Controlled Substance Prescriptions Per Person

53 KASPER Reports Requested 533K Number of Reports 109K 122K 186K 274K 362K 418K

54 Ultram Ativan Tramadol 5% C-IV Top Prescribed Controlled Substances by Therapeutic Category by Doses Lorazepam 4% C-IV Darvocet Propoxyphene 4% C-IV Zolpidem 3% C-IV Ambien Pregabalin 3% C-V Lyrica Hydrocodone/APAP 43% C-III Valium Diazepam 5% C-IV Clonazepam 7% C-IV Oxycodone 12% C-II Alprazolam 14% C-IV Lortab Lorcet Vicodin Klonopin OxyContin Percocet Xanax

55 Controlled Substance Prescribing 2009

56 Controlled Substance Usage 2009

57 Rx s Dispensed in KY by State of Origin 1,179 73

58 Prescription Monitoring Information Exchange (PMIX) PMIX Goals: Implement a standardized, secure approach for exchange of PDMP data among the states. Utilize a PMIX hub server to facilitate data exchange rather than point-to-point links between each pair of states. Implement a national-level PDMP data sharing solution with state-level control. Plan to implement live data exchange between pilot users in KY and OH in December 2010.

59 Wrap Up My door is always open to you! Let me know how we can be of assistance! My best to you! Inspector General

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