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
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
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
Who does this affect?
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You
Laboratory
Facility
Health care workers
Patients
Laboratory Compliance Plan –
(1998)
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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
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
REGULATORY COMPLIANCE
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
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)
FINANCIAL COMPLIANCE
Medicare Billing and
Reimbursement
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Fraud and Abuse/Kickbacks - 1970s
Stark laws - 1980s
False Claims Act – 1980s
Patient billing - 1990s
Billing code changes - 2000s
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
PATIENT RIGHTS/PRIVACY
COMPLIANCE
HEALTH INSURANCE
PORTABILITY AND
ACCOUNTABILITY ACT-HIPAA
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
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
Penalties for Non-complianceToday
• $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.
HIPAA
• Big brother is watching
• Job termination
RECOVERY AUDIT
CONTRACTORS
RAC Auditors
Summary
• Laboratories are creatures of Federal and
State Laws
• Three Major compliance directions:
a) regulatory compliance
b) financial compliance
c) patient right compliance
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)