Compliance

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Compliance

• Thomas J. Dilts MT(ASCP),MBPA
• Vice Chair of Administraion and Operations
• VCUHS 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,bound
  aries,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 governments 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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