Medicare Compliance for Clinical Laboratories

Author: Christopher Young
Reviewer: Barbara Cebulski, MS, MLS(ASCP) and Joshua J. Cannon, MS, MLS(ASCP)CMSHCM

Continuing Education Credits

Florida Board of Clinical Laboratory Science CE - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)

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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.

Objectives

  • 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: Laws and RegulationsA laboratory located within an urban hospital provides testing for the hospital and its outreach testing program.A medical laboratory professional in the microbiology department receives a call from a friend who works in a laboratory in a physician's office. The physician is not a regular laboratory client, but the microbiologist knows that the sales department wa
    • Compliance Issues
      • Confidentiality
        • Confidentiality
        • Case Study 2: Confidentiality and Compliance IssuesTwo hospital employees, a billing clerk and a clinical laboratory professional (from a different department), are having lunch together in the hospital cafeteria. The billing clerk mentioned seeing a bill go through the system for one of her coworker's biopsies. She asks the laboratory professional to please look up the biopsy report and let her k
      • Billing
        • Billing
      • Inducements
        • Marketing and Record Retention
        • Kick-Backs and Inducements
        • Phlebotomists and Equipment in Client Offices
        • Utilization and Other Regulations
        • Couriers and Referral Tests
        • Case Study 3: InducementsA laboratory-contracted courier is making a routine stop in a client's office and is approached by the office manager, with whom he is very friendly because he has been going to this office for years. The office manager asked the courier if Dr. John Smith was a regular stop on his route, and the courier answered yes. The manager then asks if he would do her a little favor
        • Case Study 4: UtilizationA client service representative receives a call from a major laboratory client. The client requests that the laboratory write off the charges for a test the office administrator ordered by mistake, even though the laboratory has already done the test and reported the results to the office. Since this service representative works with this office frequently, she believes th
      • Documentation
        • Documentation
      • Whistleblowers
        • Whistleblowers
      • Processes and Issues Related to Medicare Reimbursement
        • Medical Necessity
          • Medical Necessity
        • ABNs
          • Advance Beneficiary Notice
          • ABN Form CMS-R-131
          • Case Study 5: ABNsA phlebotomist from the laboratory draws blood samples in a nursing home every day. The phlebotomist picks up the requisitions for blood tests at the nursing station and then goes to the various rooms to draw blood from the patients. She notices that every requisition has an Advanced Beneficiary Notice (ABN) attached to it that the patient signs, even when the ordered tests don't
        • 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: Unclear Test OrdersIt is 11:00 PM, and the specimen collection and processing department is finishing the night's accessioning and test order entry. A specimen processor is working on a requisition with an order for a hepatic profile, but there are two tubes of blood with the order, one of which is a lavender-top tube. This is the fourth requisition from this same doctor's office, an
          • 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: Management ResponsibilitiesThe setting is an extensive reference laboratory that processes a high volume of tests with turnaround time deadlines to meet. Meeting the deadlines depends on the specimen collection and processing department completing its work on time. The specimen collection and processing department manager receives a memorandum from the compliance officer (CO) that se
            • Case Study 8: Employee ResponsibilityTwo clerks are working in close proximity in a billing office. One billing clerk notices that one of their fellow employees is changing or adding codes to requisitions they are processing.The billing clerk asks the employee about it and is explained that the computer requires something to be entered in the ICD code field, and since they only do this with non-Me
          • Billing Department
            • Laboratory Billing Department Communication With Physicians and Patients
            • Advance Beneficiary Notices (ABNs) and the Billing Department
            • Documentation
            • Case Study 9: Test RequisitionsA billing clerk is processing requisitions as a part of the typical day's work. The department is pressured to reduce accounts receivable, meaning the more clean claims are filed, the better. A particular requisition is for a Medicare patient with an "LMRP" test. Unfortunately, there is no diagnosis code associated with the ordered test. The billing clerk remembers a
          • Sales and Marketing
            • Equipment, Contracts, and Pricing
              • Excused Charges and Other Inducements
              • Client Contracts
              • Test Pricing and Antitrust Laws
              • Sales Proposals and Discounts
            • References
              • References

Additional Information

Level of Instruction: Basic
Intended Audience: Medical laboratory scientists, medical laboratory technicians, laboratory supervisors, and laboratory managers. This course is also appropriate for MLS and MLT students and pathology residents.
Author information: Christopher Young, of Laboratory Management Support Services, Phoenix, AZ, is an independent consultant, nationally recognized speaker, and expert currently specializing in compliance, sales and marketing, and customer service in clinical laboratories. He has extensive first-hand laboratory experience in positions ranging from phlebotomist to decision support coordinator and in his consulting practice.
The author has no conflict of interest to disclose.  
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.
Joshua J. Cannon, MS, MLS(ASCP)CMSHCM received his Bachelor of Science and Master of Science in Medical Laboratory Science from Thomas Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist and Specialist in Hematology certifications through the ASCP Board of Certification. He was a professor at Thomas Jefferson University for seven years before transitioning into his current role as Education Developer at MediaLab by Vastian. His areas of expertise and professional passions include clinical hematology and interprofessional education.  
Course Description: 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. It 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.