Clinical Laboratory Testing Volume 2: Business Strategies

Content

• 1. Overview
  • 1.1 Objectives of the Report
  • 1.2 Methodology
  • 1.3 Scope of the Report
  • 1.4 Executive Summary
• 2. IVD Clinical Laboratory Market
  • 2.1 Introduction
  • 2.2 Key Players for Independent Clinical Labs
  • 2.3 Reimbursement Pressure
  • 2.4 Medicare Part B Spending Trends
  • 2.5 Cost of Billing and Average Receipts for Commercial Labs
  • 2.6 Hospital Outreach Programs
  • 2.7 Criteria for Selection of Lab Services
• 3. The Clinical Laboratory Testing Market
  • 3.1 U.S. Market
    • 3.1.1 Hospital-based Clinical Laboratories
    • 3.1.2 Commercial Clinical Laboratory Testing
    • 3.1.3 Physician Office Laboratories (POLs)
  • 3.2 Clinical Lab Testing Key Players
    • 3.2.1 Commercial Clinical Labs
    • 3.2.2 Hospital Lab Collaborative Ventures
    • 3.2.3 Specialty Labs
  • 3.3 Revenue and Reimbursement
  • 3.4 Outlook for Clinical Laboratory Testing
    • 3.4.1 Long-Term Changes
    • 3.4.2 Market Drivers
    • 3.4.3 The Limits to Growth
    • 3.4.4 Key Technologies
    • 3.4.5 Conclusion
• 4. Hot Sectors in the Clinical Lab Testing Market
  • 4.1 Workplace Drugs-of-Abuse Testing
  • 4.2 Clinical Toxicology
  • 4.3 Clinical Testing for the Pharmaceutical Industry
  • 4.4 Heavy Metal, Trace Element, and Solvent Analyses
  • 4.5 Diabetes (Glucose) Testing
  • 4.6 Molecular Diagnostic Testing
  • 4.7 Cardiac Markers
  • 4.8 Blood Bank Screening
  • 4.9 Genetic Testing
  • 4.10 Predictive Medicine Testing
  • 4.11 Personalized Medicine
  • 4.12 Cancer Testing
  • 4.13 Cell Based Cancer Testing
  • 4.14 Monitoring Technologies
  • 4.15 Anatomic Pathology
• 5. Important Technology Trends
  • 5.1 Technology Platform Innovations in Point-of-Care Testing
  • 5.2 The New Paradigm
  • 5.3 Consolidated Workstations
  • 5.4 Automation in the Laboratory
  • 5.5 Laboratory Information Systems
  • 5.6 New User-friendly Interface
  • 5.7 Data-Management Issues
    • 5.7.1 Wireless LANs
    • 5.7.2 Data and Workflow Management Systems
    • 5.7.3 Beckman Central Command
    • 5.7.4 Clinical IT More Widely Available in Physician Practices
    • 5.7.5 Physician Electronic Health Records (EHRs)
• 6. Business Trends in the Clinical Laboratory Analyzer Sector
  • 6.1 Key Developments
  • 6.2 Sector Consolidation
  • 6.3 Acquisition Pricing
  • 6.4 A Closer Look at Six Big Lab Deals
  • 6.5 Acquisition, License Agreements, Internal Development and Partnerships
  • 6.6 Comparison of Quest and LabCorp
    • 6.6.1 Quest
    • 6.6.2 Acquisitions
    • 6.6.3 Quest's Growth, 2000-2006
    • 6.6.4 Laboratory Corporation of America
    • 6.6.5 LabCorp's Growth, 2000-2006
    • 6.6.6 Competitive Advantages at Quest and LabCorp
    • 6.6.7 National Managed Care Contracts
    • 6.6.8 Billing and Collection Management
    • 6.6.9 Lower Reagent and Supply Costs
    • 6.6.10 Esoteric Testing Capabilities
    • 6.6.11 Ability to Invest in Web-Based Connectivity Solutions
    • 6.6.12 Competitive Disadvantages of Quest and LabCorp
    • 6.6.13 Difficulties with Turnaround Times and Stat Services
    • 6.6.14 Physician-Laboratory Communication
    • 6.6.15 Specimen Pickup Scheduling Inflexibility
  • 6.7 Regulation of Clinical Laboratory Operations
    • 6.7.1 CLIA and State Regulations
    • 6.7.2 Drug Testing
    • 6.7.3 Controlled Substances
    • 6.7.4 Medical Waste, Hazardous Waste and Radioactive Materials
    • 6.7.5 FDA
    • 6.7.6 Occupational Safety
    • 6.7.7 Specimen Transportation
    • 6.7.8 Corporate Practice of Medicine
  • 6.8 Hospital Outreach Programs
  • 6.9 Supply Chain and GPO Contracting
  • 6.10 Specialty Labs
  • 6.11 Expansion of Hospital-Based Labs and Hospital Outreach Programs
  • 6.12 Managed Care
• 7. Company Profiles
  • 7.1 ACM Medical Laboratory
  • 7.2 American Esoteric Laboratories
  • 7.3 American Medical Laboratories
  • 7.4 AmeriPath
  • 7.5 ARUP Laboratories
  • 7.6 Athena Diagnostics
  • 7.7 Bio-Reference Laboratories, Inc
  • 7.8 BioTech Labs
  • 7.9 BioLabs, Inc
  • 7.10 CBLPath
  • 7.11 Centrex Clinical Laboratories
  • 7.12 Clarient, Inc
  • 7.13 Clinical Laboratories of Hawaii
  • 7.14 Clinical Reference Laboratory
  • 7.15 Clongen Laboratories
  • 7.16 CompuNet Clinical Laboratories
  • 7.17 Diagnostic Systems Laboratories
  • 7.18 Enzo Biochem, Inc
  • 7.19 Esoterix
  • 7.20 Focus Diagnostics
  • 7.21 Fresenius Medical Care AG & Co. KGaA
  • 7.22 Geneva Laboratories
  • 7.23 Genomic Health, Inc
  • 7.24 Genzyme
  • 7.25 IBT Laboratories
  • 7.26 Integrated Regional Laboratories
  • 7.27 LabCorp
  • 7.28 MDS Diagnostic Services
  • 7.29 MEDTOX Scientific, Inc
  • 7.30 Meriter Health Services
  • 7.31 Mid America Clinical Laboratories
  • 7.32 Monogram Biosciences, Inc
  • 7.33 Myriad Genetics, Inc
  • 7.34 National Jewish Medical and Research Center
  • 7.35 Parkway Clinical Laboratories
  • 7.36 Pathology Associates Medical Laboratories
  • 7.37 Psychemedics Corporation
  • 7.38 Quest Diagnostics Incorporated
  • 7.39 RDL Reference Laboratory
  • 7.40 Satellite Laboratory Services
  • 7.41 Spectrum Laboratory Network
• 8. Clinical Laboratory Testing Sector Trends and Forecasts
  • 8.1 Home Care Analysis
  • 8.2 Non-Traditional Collection for Laboratory Testing
  • 8.3 New Systems for Critical-Care and Near-Patient Testing
  • 8.4 Shift to Preventative Medicine
  • 8.5 Mergers of Diagnostic Companies
  • 8.6 Information Management Advances
  • 8.7 Test Ordering Patterns
  • 8.8 Patient Satisfaction
  • 8.9 Move Away from Central Laboratory
  • 8.10 Healthcare Cost Controls
  • 8.11 Competition for Services
  • 8.12 Drivers and Barriers of Clinical Laboratory Testing
  • 8.13 Confluence of New Technology
  • 8.14 New Trends in Clinical Laboratory Testing
    • 8.14.1 Trends in Reimbursement Practices
    • 8.14.2 Managed Care
    • 8.14.3 Point of Care Testing
    • 8.14.4 Satellite Facilities
• List of Figures
  • Figure 2.1: Total Medicare Expenditures, 1995-2005
  • Figure 2.2: Effect of Medicare Laboratory Fee Schedule Changes on a $10 Test, 1984-2006
  • Figure 2.3: Part B Spending on Clinical Laboratory Services, 1991-2005
  • Figure 2.4: Cost Per Billable Test
  • Figure 2.5: Annual Billable Tests Processed Per FTE
  • Figure 2.6: Outreach Business Operated at a Freestanding Lab Facility
  • Figure 2.7: Volume of Dedicated Sales and Marketing Staff for Outreach Business
  • Figure 2.8: Separately Managed Outreach Billing and Collection
  • Figure 3.1: Lab Revenue by Lab Type
  • Figure 3.2: Lab Revenue by Test Type
  • Figure 3.3: Physician Office Laboratory Revenue, 2000-2006
  • Figure 3.4: Unweighted Average Medicare Reimbursement for the 10 Most Common POL Tests
  • Figure 3.5: Total Number of Non-Waived POLs, 2000-2006
  • Figure 3.6: Number of New Tests Granted CLIA-Waived Status, 2000-2006
  • Figure 3.7: High-Volume Waived Tests
  • Figure 4.1: Laboratory Service Revenue from Pap Testing, 1998-2005
  • Figure 4.2: Percentage of Pap Tests Performed Using Mono-Layer Methods, 1998-2006
  • Figure 4.3: Market Share for Pap Test Vendors, 2006
  • Figure 5.1: Percentage of Physicians in Practices with IT for Specific Clinical Activities
  • Figure 5.2: Office-Based Physicians That Use EHRs, 2001-2005
  • Figure 6.1: Average Revenue Multiple Paid to Acquire Labs, 2000-2006
  • Figure 6.2: Hospital Market Share for Outreach Programs
• List of Tables
  • Table 2.1: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005
  • Table 2.2: Medicare Spending on Clinical Lab Services, 1991-2005
  • Table 2.3: Medicare Part B Spending Per Medicare Enrollee, 1998-2005
  • Table 2.4: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005
  • Table 2.5: Washington G-2 Hospital Lab Outreach Survey
  • Table 3.1: U.S. Clinical Laboratory Testing Market Revenue, 2005-2012
  • Table 3.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006
  • Table 3.3: Growth Rates of Test Types
  • Table 3.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012
  • Table 3.5: Twenty Most Common Laboratory Tests Offered at Family Physician Offices
  • Table 3.6: Important New Waived Tests
  • Table 3.7: Revenue Growth At 14 Publicly-Traded Lab Companies, 2005
  • Table 3.8: Payer Group wise Percentage of Total Volume of Requisitions and Net Revenues
  • Table 4.1: Pap Testing at the Largest U.S. Laboratory Companies, 2006
  • Table 5.1: Applications for Wireless LAN Technology
  • Table 6.1: Laboratory/Pathology Acquisitions
  • Table 6.2: Revenue Growth at Quest Diagnostics, 2000-2006
  • Table 6.3: Revenue Growth at LabCorp, 2000-2006
  • Table 6.4: LabCorp Revenue from Managed Care Contracts, 2004-2006
  • Table 6.5: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006
  • Table 8.1: Medicare Billing Guidelines for Multi-channel Laboratory Tests
  • Table 8.2: Targeted Lab Tests and Brief Educational Reminder Messages