Medicare Compliance for Clinical Laboratories

(based on 3496 customer ratings)

Author: Christopher Young
Reviewer: Barbara Cebulski, MS, MLS(ASCP)

Based on the OIG Compliance Program Guidance for Clinical Laboratories, this course covers all elements of a successful Medicare compliance program. LMRPs, ABNs, coding, and requisitions are given full treatment. Special sections for billing departments, managers, and sales / marketing departments emphasize requirements specific for these areas. Ten case studies allow employees to practice their knowledge and get feedback. This course is ideal for bench laboratory workers, sales and clerical staff, but is appropriate for all laboratorians.

Continuing Education Credits


  • Define "voluntary compliance program," discuss the elements that should be included, and explain why it is important for the laboratory to implement the program.
  • Identify the Medicare laws and regulations that are applicable to clinical laboratories.
  • Identify compliance problems and issues.
  • Explain each of these terms or processes that are related to Medicare reimbursements: Medical necessity; International Classification of Diseases(ICD)and Current Procedural Terminology (CPT) coding; Advance Beneficiary Notice.
  • State the responsibilities of laboratory administration, management, laboratory employees, and the billing department that are related to Medicare compliance.

Course Outline

  • Voluntary Compliance Program
    • Introduction
      • What is a voluntary compliance program?
    • Seven Elements of a Compliance Program
      • Seven Fundamental Elements of a Voluntary Compliance Program
      • Element 1
      • Element 2
      • Element 3
      • Element 4
      • Element 5
      • Element 6
      • Element 7
  • Laws and Regulations
      • Laws and Regulations Applicable to Medicare
      • Case Study 1
  • Compliance Issues
    • Confidentiality
      • Confidentiality
      • Case Study 2
    • Billing
      • Billing
    • Inducements
      • Marketing and Record Retention
      • Inducements
      • Phlebotomists and Equipment in Client Offices
      • Utilization and Other Regulations
      • Couriers and Referral Tests
      • Case Study 3
      • Case Study 4
    • Documentation
      • Documentation
    • Whistleblowers
      • Whistleblowers
  • Processes and issues related to Medicare Reimbursement
    • Medical Necessity
      • Medical Necessity
    • ABNs
      • Advance Beneficiary Notice (ABN)
      • ABN Form CMS-R-131
      • Case Study 5
    • Coding
      • International Classification of Disease (ICD) Coding
      • HCPCS and CPT-4 Coding
  • Test Ordering
    • Orders
      • Test Requisitions
      • Issues Related to Test Ordering, Performance, and Resulting
      • Written and Verbal Orders
      • Ambiguous or Unclear Test Orders
      • Case Study 6
    • Tests
      • Panels and Profiles
      • Physician Notices and Acknowledgements
  • Responsibilities for Medicare Compliance
      • Laboratory Administration's Responsibilities
      • Management Personnel Responsibilities
      • Employee's Responsibility
      • Case Study 7
      • Case Study 8
    • Billing Department
      • Laboratory Billing Department Communication With Physicians and Patients
      • Advance Beneficiary Notices (ABNs) and the Billing Department
      • Documentation
      • Case Study 9
  • Sales and Marketing
    • Equipment, contracts, and pricing
      • Excused Charges and Other Inducements
      • Client Contracts
      • Test Pricing and Antitrust
      • Sales Proposals and Discounts
  • References
      • References

Additional Information

General Course Information: This course is designed to train laboratory staff on the basic concepts of Medicare compliance. It is based on the OIG Compliance Program Guidance for Clinical Laboratories, and covers seven elements of a successful compliance program: risk areas, coding, ABNs, tests and panels, inducements, billing, and whistleblowers. It includes real-life case studies that highlight pertinent issues.
Intended Audience: All clinical laboratory personnel.
Level of Instruction: Basic
Author information: Christopher Young, of Laboratory Management Support Services, Phoenix, AZ, is an independent consultant, and nationally recognized speaker and expert currently specializing in compliance, sales and marketing, and customer service, as they pertain to clinical laboratories. He has extensive first-hand laboratory experience, in positions ranging from phlebotomist, to decision support coordinator, and in his consulting practice.
Reviewer information: Barbara Cebulski, MS, MLS(ASCP) has over 40 years of experience in the medical laboratory profession as a technologist, section supervisor, and laboratory manager. She was an Inspection and Technical Specialist for nine years with the College of American Pathologists in the Laboratory Accreditation Program and, until her retirement in 2015, was Program Director for MediaLab, Inc. Barbara holds a Masters in Instructional Technology from Georgia State University.

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