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Compliance
Thomas J. Dilts MT(ASCP),MBPAVice Chair of Administraion and
OperationsVCUHS Department of Pathology
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Compliance
An enterprise wide attitude,culture,and commitment that
supports honesty,integrity and diligence in the work place
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HOW TO KEEP YOU OUT OF JAIL
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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
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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
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Who does this affect?
• You• Laboratory• Facility• Health care workers• Patients
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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
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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
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REGULATORY COMPLIANCE
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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
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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)
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FINANCIAL COMPLIANCE
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Medicare Billing and Reimbursement
• Fraud and Abuse/Kickbacks - 1970s• Stark laws - 1980s• False Claims Act – 1980s• Patient billing - 1990s• Billing code changes - 2000s
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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
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PATIENT RIGHTS/PRIVACY COMPLIANCE
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HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT--HIPAA
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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
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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
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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.
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HIPAA
• Big brother is watching• Job termination
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RECOVERY AUDIT CONTRACTORS
RAC Auditors
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Summary
• Laboratories are creatures of Federal and State Laws
• Three Major compliance directions: a) regulatory compliance b) financial compliance c) patient right compliance
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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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