Compliance

Thomas J. Dilts MT(ASCP),MBPAVice Chair of Administraion and

OperationsVCUHS 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?

• You• Laboratory• Facility• Health care workers• Patients

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

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

• 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-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.

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)