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American Clinical Laboratory Association The Voice for Laboratories Presentation to the Genetic Alliance Strategies for

Executive Summary: ACLA. Mission and PurposeMembers and Board of DirectorsAccomplishments and AgendaBenefits of MembershipResourcesResults for Life" Value Campaign. ACLA's Mission and Purpose. Not-for-profit organization created in 1971 which offers the benefits of representation, education,

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American Clinical Laboratory Association The Voice for Laboratories Presentation to the Genetic Alliance Strategies for

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    1. American Clinical Laboratory Association The Voice for Laboratories Presentation to the Genetic Alliance Strategies for Success Teleconference May 30, 2007 Alan Mertz President, ACLA

    2. Executive Summary: ACLA Mission and Purpose Members and Board of Directors Accomplishments and Agenda Benefits of Membership Resources “Results for Life” Value Campaign

    3. ACLA’s Mission and Purpose Not-for-profit organization created in 1971 which offers the benefits of representation, education, information and research Advocate laws and regulations that benefit the laboratory industry and patients Promote public awareness about the value of laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment

    4. ACLA Members ACLA Membership More than Doubled In Three Years, Represents Diversity of Laboratory Industry Independent Laboratories Esoteric/Biotech/Genetic-Molecular Regional Full Service ESRD National Full Service Pathology Hospital Laboratories All Types of Members Represented on Board

    5. ACLA Member Companies ? Acadiana Medical Laboratories, Ltd. ? AmeriPath, Inc. / Specialty Labs ? ARUP Laboratories ? Aureon Laboratories, Inc. ? Bio-Reference Laboratories, Inc. ? CBLPath, Inc. ? Clarient ? Combimatrix Molecular Diagnostics, Inc. ? DaVita ? DCI Laboratory ? Genomic Health, Inc. ? Genzyme Corporation ? Laboratory Corporation of America ? LipoScience, Inc. ? Monogram Biosciences, Inc.

    6. ACLA Member Companies (cont’d.) ? Oncotech, Inc. ? PathNet Esoteric Laboratory Institute ? Pathology Associates Medical Laboratories ? Pediatrix Screening, a division of Pediatrix Medical Group ? Precision Therapeutics, Inc. ? Quest Diagnostics Incorporated ? RenaLab ? RedPath Integrated Pathology, Inc. ? Satellite Laboratory Services ? Spectra Laboratories, Inc., a division of Fresenius Medical Care ? Spectrum Laboratory Network ? Stanford University Medical Center Laboratory ? Virco Labs, Inc. ? Woodbury Clinical Laboratory, Inc. ? XDx, Inc.

    7. ACLA Board of Directors Mara Aspinall - Genzyme Genetics Nicholas Brownlee - Fresenius Medical Care Marc Grodman, MD - Bio-Reference Laboratories Gary Hilburn - Acadiana Medical Laboratories Dave King – Laboratory Corporation of America Keith Laughman - AmeriPath/Specialty Laboratories Alan Mertz - ACLA Surya Mohapatra, PhD - Quest Diagnostics Incorporated Randy Scott, PhD - Genomic Health Ronald Weiss - ARUP Laboratories

    8. ACLA Major Accomplishments Defeat Lab Co-Pay in Medicare Fighting Laboratory “Competitive Bidding” Demo S. 736 on LDT/FDA Not Added to Drug User Bills Lead on FDA IVDMIA Guidance/Legislation CMS Narrows and Delays “Medically Unlikely Edits” CMS Limits “POD” Labs in PFS Rule Health IT Issues HHS “Safe Harbor” Rule Includes Labs Health IT Legislation Includes Labs Labs Gain Voice in Standards Development

    9. Accomplishments (cont’d.) Florida Withdraws Competitive Bidding Medicare “Claims Processing Fee” Withdrawn ACLA Influences CPT Coding Development/Revision 11 new CPT lab test codes added to the clinical lab fee schedule CMS Adopts Flow Cytometry Recommendations ACLA Data on Lab Utilization Presented to MedPAC HHS OIG “Excess Charges” Proposed Rule Opposed ACLA Launches “Results for Life” Value of Labs Campaign

    10. ACLA’s 2006-2007 Agenda Leading Fight for Repeal of Competitive Bidding in Medicare Leading Efforts on FDA Regulation/Legislation on LDTs Adequate Reimbursement for Labs under Medicare No Cuts, No Co-Pay, No CPI Freeze Coding, Coverage, Reimbursement for New Tests Stopping Unreasonable MUEs Representing Labs on Health IT Raising Visibility of Labs/Promoting Value of Labs

    11. FDA and Lab Developed Tests ACLA FDA Committee Met with FDA (October 2006) ACLA Audioconference (November 2006) Live Statement at FDA Public Hearing (February 2007) Comments on IVDMIA Guidance Dialogue with CMS on CLIA Working with Legislative Sponsors Senators Kennedy, Obama

    12. Benefits of Membership Information Sharing Impact Reimbursement/Regulation Networking Meetings/Publications Represent Labs With Broader Lab and Health Community

    13. Meetings, Publications, Communication Annual Membership Meeting Friday Weekly Update Conference Call Committees Ad Hoc Meetings with CMS, FDA, Congress AudioConferences Monthly “Results” Newsletter Web Page Regular Email Updates

    14. ACLA Committees Billing and Reimbursement CPT CLIA ESRD FDA Federal Affairs Flow Cytometry Competitive Bidding Demo Workgroup HIPAA Implementation Information Technology Legal (Stark, OIG, etc.) Public Affairs Science State Issues Transportation/Occupational Health Workforce Supply

    15. LabLine AudioConferences

    16. Results Newsletter

    17. Resources: ACLA Staff and Outside Counsel Alan Mertz, President JoAnne Glisson, Senior Vice President, Regulatory/State Affairs David Mongillo, Vice President for Policy and Medical Affairs Jason DuBois, Vice President, Government Relations Cheryl Hawkins, Membership Coordinator Kathryn Froelich, Project Manager/Executive Assistant ________ Peter Kazon, Esq., Outside Counsel, Alston & Bird Stacy Rampy and Dean Rosen, Outside Lobbying, Mehlman, Vogel, Castagnetti

    18. “Results for Life” Value Campaign - Taking the Offensive on Value

    19. - Campaign Purpose Purpose: Raise the image of the clinical laboratory with policymakers, physicians, payers, public Promote: Patient centric value of lab testing Value of lab tests linked to improved outcomes Appreciation for technological sophistication of test Build upon: Key industry attributes and position laboratory tests as today’s best value in health care.

    20. - Roll out event

    21. A Cutting-Edge Website www.labresultsforlife.org

    22. - Managing Chronic Disease

    23. - Preventing Disease

    24. - Changing the Course of Disease

    25. - Sponsors Contributors – this is NOT just ACLA!! All ACLA Members Participating Sponsors Outside Participating Sponsors Abbott Molecular College of American Pathologists Roche Diagnostics Siemens Medical Solution Diagnostics Sysmex America Outside Sponsors American Association of Bioanalysts American Association for Clinical Chemistry American Medical Technologists American Society for Microbiology Association for Molecular Pathology

    26. Thank You!

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