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Compliance

Compliance. Thomas J. Dilts MT(ASCP),MBPA Vice Chair of Administraion and Operations VCUHS Department of Pathology. Compliance. An enterprise wide attitude,culture,and commitment that supports honesty,integrity and diligence in the work place. HOW TO KEEP YOU OUT OF JAIL .

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Compliance

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  1. Compliance Thomas J. Dilts MT(ASCP),MBPA Vice Chair of Administraion and Operations VCUHS Department of Pathology

  2. Compliance An enterprise wide attitude,culture,and commitment that supports honesty,integrity and diligence in the work place

  3. HOW TO KEEP YOU OUT OF JAIL

  4. COMPLIANCE DIRECTION • Laboratories are creatures of Federal and State Laws • Three Major compliance directions: a) regulatory compliance b) financial compliance c) patient rights/privacy compliance

  5. History • EEOC-Equal Employment Opportunity Commission - 1965 • CLIA-Clinical Laboratory Improvement Act – 1967 • OSHA-Occupational Health and Safety Act – 1970 • ADA-American Disabilities Act – 1990 • HIPAA-Health Insurance Portability and Accountability Act – 1996 • OIG Guidance for Clinical Labs - 1998

  6. Who does this affect? • You • Laboratory • Facility • Health care workers • Patients

  7. Laboratory Compliance Plan – (1998) • Written standard of conduct e.g. CPT-4,ICD-9 • Chief Compliance Officer • Education and training programs • Hotline for complaints – whistleblowers • System to respond to allegations • Use of audits – monitor compliance • Investigation and correction of system problems

  8. COMPLIANCE DIRECTION • Laboratories are creatures of Federal and State Laws • Three Major compliance directions: a) regulatory compliance b) financial compliance c) patient rights/privacy compliance

  9. REGULATORY COMPLIANCE

  10. Regulatory/Accrediting Agencies • CMS – Centers for Medicare and Medicaid Services • CAP – College of American Pathologists • JCAHO – Joint Commission for Accreditation of Healthcare Organizations • FDA – Food and Drug Administration • COLA – Commission on Office Laboratory accreditation • AABB – American Association of Blood Banks

  11. Other Regulatory Agencies • OSHA – Occupational and Safety Administration • DOT – Department of Transportation • Department of Health and Human Services -----HIPAA – Health Insurance Portability and Accountability Act ---- (consumer control,accountability,public responsibility,boundaries,security)

  12. FINANCIAL COMPLIANCE

  13. Medicare Billing and Reimbursement • Fraud and Abuse/Kickbacks - 1970s • Stark laws - 1980s • False Claims Act – 1980s • Patient billing - 1990s • Billing code changes - 2000s

  14. Patient Billing • CPT-4 (Current Procedural Terminology Code – AMA) • ICD-9 (International Classification of Diseases, Ninth Revision – WHO) • ABN (Advance Beneficiary Notice) • Charge master • Claims Submission • Ordering Tests

  15. PATIENT RIGHTS/PRIVACY COMPLIANCE

  16. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--HIPAA

  17. Laboratory Policies • Communicating Quality and Safety Concerns • Request for Release of Pathology Record, Slides, and/or Blocks • Specimen Collection Boxes • Electronic Mail(E-Mail) and Internet Access/Usage • Release of Autopsy Reports • Request for Release of Pathology Records, Slides, and/or Blocks

  18. Penalties - 1999 • $490M paid in noncompliance • 390 defendants convicted • 2976 excluded from the Federal Health Care Program • Three times the government’s damages plus civil penalties of $5,000 to $10,000 each offense • Sentinel events • Protection of whistleblowers

  19. Penalties for Non-compliance-Today • $100 fine per day for each unmet standard (up to $25,000 per year, per person, per standard). • $50,000 fine and one year in prison for improper disclosure of health information. • $100,000 fine plus five years in prison for obtaining health information under false pretenses. • $250,000 fine and ten years in prison for using health information for personal gain.

  20. HIPAA • Big brother is watching • Job termination

  21. RECOVERY AUDIT CONTRACTORS RAC Auditors

  22. Summary • Laboratories are creatures of Federal and State Laws • Three Major compliance directions: a) regulatory compliance b) financial compliance c) patient right compliance

  23. References • Kurec AS, Schofield S and Watters MC (eds). The CLMA Guide to Managing a Clinical Laboratory. 3rd ed. Wayne, PA: CLMA; 2000 • Roseff, S.D., Harris, A,L., Rodgers, C.H., (submitted for publication 2004) Basic Concepts and the Current Health Care Environment. Section I,chapter 5. In Wilkinson,D.S.,(ed) Clinical Management in the 21st Century.ASM press Washington DC (to be in print 2004)

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