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Type: Press Release
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06/01/2009 ACLA Welcomes Five New Members -- Membership at All Time High [PDF, 104KB] view Press Release
04/21/2011 ACLA Press Release - CMS Delays Enforcement of Medicare Physician Signature Requirement Three Months

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04/21/2011 ACLA urges Immediate Action by Congress to Extend the Technical Component "Grandfather" view Press Release
04/21/2011 Letter to the Editor (USA Today) - ACLA Response to article on Diabetes view Press Release
05/04/2011 Letter to the Editor (New York Times) - The Genome Project: A Balance Sheet [PDF, #73KB] view Press Release
05/04/2011 ACLA IOAS Press Release - ACLA Urges Congress to Act on MedPAC Option Regarding Physician Self-referral [PDF, #158KB] view Press Release
05/04/2011 ACLA Press Release - ACLA Supports Physician Guidance in Patient-Centered Genetic Testing [PDF, 180KB] view Press Release
05/04/2011 ACLA Press Release - ACLA Membership, Associate Membership and Staff Expand [PDF, #339KB] view Press Release
05/04/2011 RFL Press Release: New Recommendation on Diabetes Lab Test Will Aid in Battling the Disease, Says Lab Group [PDF, 62KB] view Press Release
05/04/2011 ACLA Releases Draft IT Framework to Facilitate Lab Interface, Reduce Costs and Decrease Error Rates [PDF, 21KB] view Press Release
05/04/2011 Clinical Labs Report Additional Data to Aid in Detecting Kidney Disease [PDF, 73KB] view Press Release
05/04/2011 Laboratory Services Coalition Opposes Efforts to Include Medicare Laboratory Co-Pay in Senate Health Care Reform Package [PDF, 55KB] view Press Release
05/04/2011 Senate HELP Committee Accepts Amendment to Enhance Prevention and Wellness [PDF, 92KB] view Press Release
05/04/2011 ACLA Supports "Patient Access to Critical Lab Tests Act" [PDF, 92KB] view Press Release
05/04/2011 ACLA Responds to Article in Washington Post on Utilization [PDF, 18 KB] view Press Release
05/04/2011 Letter to Secretary Sebelius Unites Laboratory Community in Communicating the Need for Regulatory Balance in Genetic and Molecular Testing [PDF, 177KB] view Press Release
05/04/2011 ACLA Supports "Patient Access to Critical Lab Tests Act" [PDF, 154 KB] view Press Release
05/04/2011 Upcoming World Kidney Day Underscores Role of Low-Cost Lab Tests in Combating High-Cost Kidney Disease [PDF, 17 KB] view Press Release
05/04/2011 Editorial From Nature-Biotechnology on Genentech's Citizen Petition [PDF, 32 KB] view Press Release
05/04/2011 ACLA Responds to Genentech Citizen Petitiion [PDF, 404KB] view Press Release
05/04/2011 ACLA Responds to Washington Post Article by Patrick Swayze "I'm Battling Cancer, How About Some Help Congress?" [PDF, 10KB] view Press Release
05/04/2011 ACLA Submits Letter to the Editor of New York Times in response to front page article - Patients DNA May be Signal to Tailor Medication [PDF, #KB] view Press Release
05/04/2011 ACLA Announces New Associate Membership [PDF, 144KB] view Press Release
05/04/2011 Senate Passes Medicare Package, Lab Competitive Bidding Repeal [PDF, 85KB] view Press Release
05/04/2011 Congress Overrides President's Veto of Medicare Package - Repeal of Competitive Bidding, Extension of TC Grandfather Clause Become Law [PDF, 86KB] view Press Release
05/04/2011 Senate Puts off Vote on Medicare Package -- Vows to Address Issue in July [PDF, 213KB] view Press Release
05/04/2011 ACLA Lauds House Passage of "Medicare Improvements for Patients and Providers Act"- Repeal of Lab Competitive Bidding Included in Bill [PDF, 74KB] view Press Release
05/04/2011 ACLA Calls Baucus 'Medicare Improvement Act' a Triple PLay for Lab services, Grand Slam for Beneficiaries [PDF, 49KB] view Press Release
05/04/2011 ACLA Responds to SACGHS Report Release [PDF, 147KB] view Press Release
05/04/2011 ACLA Applauds Court for Preliminary Injunction on Lab Competitive Bidding Demo- Court Findings Bolster Case for Congressional Repeal [PDF] view Press Release
05/04/2011 ACLA Applauds Senate Passage of "Genetic Information Nondiscrimination Act" (April 25, 2008) [PDF, 144KB] view Press Release
05/04/2011 CMS Responds to ACLA Letter on Competitive Bidding; [PDF, 89KB] view Press Release
05/04/2011 ACLA Membership Continues to Grow and Diversify [PDF, 51.2KB] view Press Release
05/04/2011 Court Denies Temporary Restraining Order in San Diego Clinical Laboratory Bidding Case [PDF, 145.5KB] view Press Release
05/04/2011 Clinical Laboratory Coalition Stands United in Support of Lawsuit Against Federal Government [PDF, 52KB] view Press Release
05/04/2011 ACLA Applauds Lawmakers for Letter Urging Repeal of Competitive Bidding Demo [PDF, 55KB] view Press Release
05/04/2011 ACLA Press Release on Competitive Bidding Site Announcement [PDF, 165KB] view Press Release
05/04/2011 ACLA Press Release on Competitive Bidding Site Announcement [PDF, 165KB] view Press Release
05/04/2011 ACLA Applauds Introduction of Bipartisan Legislation to Repeal Competitive Bidding Demonstration Project [PDF, 144KB] view Press Release
05/04/2011 ACLA Supports CMS Response on Genetic Specialty [PDF, 144KB] view Press Release
05/04/2011 House Energy & Commerce Chairman John Dingell asks HHS Secretary Leavitt Tough Questions on Competitive Bidding (August 7, 2007) view Press Release
05/04/2011 ACLA Applauds Rep. Velazquez on Introduction of Legislation to Repeal Comp Bidding Demo (August 5, 2007) [PDF, 154KB] view Press Release
05/05/2011 ACLA Comments to FDA on IVDMIA Guidance (August 27, 2007) [PDF, 147KB] view Press Release
05/18/2011 ACLA Board Chairman to Testify to Congress on Competitive Bidding for Clinical Lab Services (July 23, 2007) [PDF, 50KB] view Press Release
05/18/2011 CMS Open Door Forum on Medicare Clinical Lab Services Competitive Bidding Demo Project (July 16, 2007) [PDF, 31KB] view Press Release
05/18/2011 ACLA Applauds House Passage of Genetic Information Nondiscrimination Act (April 26, 2007) [PDF, 144KB] view Press Release
05/18/2011 ACLA Supports Genomics and Personalized Medicine Act (March 23, 2007) [PDF, 143KB] view Press Release
05/18/2011 President's 2008 Budget - Competitive Bidding Proposal (February 5, 2007) [PDF, 147KB] view Press Release
05/18/2011 ACLA Asks CMS for a One Year Extension for Full Compliance with NPI [PDF, 147 KB] view Press Release
05/18/2011 ACLA Lauds House for Passing "Tax Relief and Health Care" Legislation - Urges Senate Passage [PDF, 203KB] view Press Release
05/18/2011 CMS Releases More Reasonable MUEs (November 7) [PDF, 144KB] view Press Release
05/18/2011 CMS Accepts ACLA Recommendations for Flow Cytometry (November 2) [PDF, 143 KB] view Press Release
05/18/2011 ACLA Adds Three New Laboratories to Membership (November 1) [PDF, 146 KB] view Press Release
05/18/2011 ACLA Decries Lack of Adequate Time to Prepare Bids (August 28) [PDF, 224 KB] view Press Release
05/18/2011 ACLA Applauds New Laboratory Safe Harbor for Health IT (August 8) [PDF, 59.0KB] view Press Release
05/18/2011 ACLA Questions January 1 2007 Selection Date for Competitive Bidding Winners (August 8) [PDF, 196KB] view Press Release
05/18/2011 ACLA Calls CMS Request for Competitive Bidding Comments "Putting Cart Before the Horse" (June 23) view Press Release
05/18/2011 Medical Group Coalition Urges CMS to Rethink Medically Unbelievable Edits Approach (April 17) view Press Release
05/18/2011 ACLA Report on Medicare Lab Spending Featured in National Intelligence Report (April 10) view Press Release
05/18/2011 ACLA Testifies in Favor of Health IT Legislation (House Energy & Commerce Health Subcommittee) (March 16) view Press Release
05/18/2011 ACLA Lauds Deadline Delay for Medically Unbelievable Edits (March 14) view Press Release
05/18/2011 ACLA Lauds Deadline Delay for Medically Unbelievable Edits (March 14) view Press Release
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05/07/2010 ACLA Letter Officially Transferring Ownership of eDOS to HL7 view Page What's New Article
05/11/2010 ACLA Response to Washington Post Story on DTC Testing view Page What's New Article
05/12/2010 Media Release

ACLA Supports Physician Guidance in Patient-Centered Genetic Testing

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05/24/2010 ACLA response

HHS' RFI - HIPAA Accounting of Disclosures Requirements

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05/24/2010 ACLA Joins Coalition

Urges Extension of TC Grandfather, Other Issues

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06/07/2010 ACLA Files Comments on CMS Interim Final Rule Denying Coverage For Lab Claims When Ordering Provider Not Enrolled in PECOs view Page What's New Article
06/21/2010 Original Article - A Decade Later, Genetic Map Yields Few New Curves

http://www.nytimes.com/2010/06/13/health/research/13genome.html?adxnnl=1&adxnnlx=1277139608-RnaHfdhtH0EM/leZuFtDwA

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06/22/2010 ACLA's Letter to the Editor (New York Times)

The Genome Project:  A Balance Sheet

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06/24/2010 Media Release

ACLA Urges Congress to Act on MedPAC Option Regarding Physician Self-referral 

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07/07/2010 ACLA writes CMS

 Urging solutions to regulatory gaps related to diagnosis data submission for indirect providers. 

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07/16/2010 ACLA's Statement to FDA

Regarding their Meeting on the Oversight of Laboratory Developed Tests 

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07/16/2010 ACLA's Press Release to FDA

Regarding their Meeting on the Oversight of Laboratory Developed Tests 

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07/29/2010 ACLA Comment to NIH

Regarding the proposed Genetic Test Registry.

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08/20/2010 ACLA Comments

Regarding the Medicare Physician Fee Schedule Proposed Rule for Calendar Year 2011 

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09/01/2010 Oppose CMS Proposal

 To Require Physician Signatures on Laboratory Orders

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09/14/2010 ACLA Comments

 Regarding Proposed Modifications to the HIPAA Privacy Rule

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09/15/2010 Clinical and Public Health Community Letter

Regarding oversight of laboratory developed tests 

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09/20/2010 ACLA Supplemental Comments to FDA

Regarding the Oversight of LDTs

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09/20/2010 Listen to live webcast

Of the 9.21 National Journal Summit, starting 8:30 a.m. Tuesday 

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09/20/2010 Sen. Tom Harkin to Keynote

Senator Tom Harkin to Keynote 9.21 National Journal Summit on Prevention

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09/28/2010 ACLA writes to Virginia Board of Health Professions

 To explain why mandating lab personnel standards and registration is not necessary

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10/27/2010 ACLA Responds to USA Today article

Regarding Diabetes

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11/04/2010 ACLA joins 13 other health care provider groups

 Urging extension of TC Grandfather & other expiring provisions

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11/04/2010 Recent CMS changes

 Will reduce patient access to laboratory tests and impose unnecessary burdens on laboratories 

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11/20/2010 Open Meeting on the FDA Oversight of Laboratory Developed Tests

November 22, 2010

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12/01/2010 Lab, rural and hospital groups

Urge Congress to extend TC Grandfather before year's end 

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12/15/2010 CLC Sign on Letter

 Re:  Physician Signature 

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01/11/2011 Medicare Changes

Medicare Should Change its Requirement for Physician Signatures on Lab Requisition Forms for Patients 

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01/20/2011 ACLA Comments

Regarding PCAST Health IT Report

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01/28/2011 Questions from the CLC

Questions from the Clinical Laboratory Coalition for CMS Regarding Physician Signature Issue

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02/11/2011 Burgess-Pascrell Letter to CMS

Regarding the Physician Signature Rule 

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02/11/2011 Menendez-Roberts Letter to CMS

Regarding the Physician signature Rule 

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02/28/2011 FAQs

Frequently Asked Questions About Genetic Testing 

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03/01/2011 ACLA Comments to FDA Panel

 Regarding DTC Genetic Tests 

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03/01/2011 ACLA Comments

Regarding Device Tax and LDTs

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03/17/2011 ACLA, Results for Life and The Hill Newspaper

 March 17th briefing "The Innovation Revolution".




Video and

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03/21/2011 ACLA Provides Comment to NIH

Regarding the Design Documents for the Genetic Test Registry 

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03/22/2011 CMS Sends Interim Final Rule to OMB

Regarding Physician Signature

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03/31/2011 CMS memorandum to contractors

Notifying them that they are not to enforce the physician signature requirement on requisitions for clinical lab tests

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04/13/2011 The Hill Briefing Section

Genetic Testing = Better Health, Lower Costs

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04/18/2011 Associate Members

Talking about members and stuff

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04/18/2011 Members Only

Our members only area is a repository for Membership Committees. Please contact us if you need access or would like to join a committee.

 

 

 

 

 

 

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04/18/2011 Issues and Advocacy

The American Clinical Laboratory Association (ACLA) is a not-for-profit organization which offers members the benefits of representation, education, information and research. 

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04/18/2011 What's New

Below are ACLA's recent news and events. Please contact us if you have any questions or would like more information about any of our latest happenings.

 

 

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04/19/2011 ACLA's 16th Annual Meeting Agenda

On April 19th and 20th

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04/19/2011 Sample Page Promoted to Front

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04/19/2011 Sample President Message1

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04/19/2011 President's Message

Thank you for visiting the ACLA website.  We strive to keep this website updated with the latest information on ACLA advocacy activities, position papers, and meetings.

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04/19/2011 Health Affairs Pathology Self - Referral Study

Heath Affairs Pathology Self Referral Study - Click Here

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04/19/2011 Annual Meeting 2011

NEW FRONTIERS Navigating Rapid Change in Politics, Regulation and Science The Grand Hyatt Hotel 1000 H Street, NW Washington, D.C. 20005

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04/19/2011 Results for Life

Results for Life, a campaign sponsored by the American Clinical Laboratory Association (ACLA) and its partners, strives to raise awareness of the vital role clinical lab testing plays in health care by highlighting the real-life stories of those whose lives were saved or improved by laboratory testing. The Results for Life campaign is not only supported by ACLA members but a broad group of clinical laboratory interests that include clinical diagnostic companies, physician and laboratory professional groups, and companies that provide services to the clinical laboratories.

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04/20/2011 Partners in Promoting Health

The American Clinical Laboratory Association (ACLA) is the clinical laboratory industry's leading advocate providing effective communication with Congress, regulatory bodies, other health care organizations and the public.

A not-for-profit association, ACLA represents the nation's leading national and regional clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies. We have established relationships with key entities and individuals throughout government with responsibility for regulation of the clinical laboratory industry and payment for laboratory services. Find out more...

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04/20/2011 About ACLA

Mission Statement

The American Clinical Laboratory Association (ACLA) is a not-for-profit organization created in 1971 which offers members the benefits of representation, education, information and research. Its primary purpose is to:

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04/20/2011 Typography

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Replicant 2 allows you to have the option of simply switching the font of all the text in the theme configuration. (select the font name to preview):-

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04/20/2011 ACLA Achievements

The American Clinical Laboratory Association (ACLA) is THE voice for clinical laboratories, and an effective advocate before federal and state government. Following are highlights of ACLA’s record of achievement on behalf of the laboratory industry.


Achievement_List

  1. ACLA is in the forefront of efforts to raise concerns about abusive pathology arrangements known as “PODs” or “Condo Labs.” These are contractual agreements allowing non-pathology clinicians and physician groups to bill for pathology services, for their own patients, in which they do not have active involvement in the pathology services. The Centers for Medicare and Medicaid Services has incorporated concerns expressed by ACLA in proposed changes to the rules on reassignment. CMS proposed...

  2. A proposed rule by the Health and Human Services (HHS) Office of Inspector General (OIG) was withdrawn in June 2007 which would have potentially exclude Medicare providers, including labs, from the Medicare program for submitting claims containing “excessive charges.” Excessive charges could include a single CPT code for which Medicare pays more than 120 percent of customary and usual charges. ACLA led opposition to this rule on behalf of the laboratory industry and submitted comments on...

  3. On September 7, 2006, the Food and Drug Administration (FDA) published draft guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), requesting comments within 90 days. The guidance creates a new approach to “medical device” regulation for IVDMIAs, and FDA has said it will require premarket review for certain laboratory-developed tests that combine assays and algorithms to produce results tailored to a specific patient. ACLA successfully requested FDA to extend the...

  4. The final 2007 Physician Fee Schedule, published by the Centers for Medicare and Medicaid Services (CMS) on November 1, 2006, included a number of provisions affecting clinical laboratories and pathology services. Of particular note, CMS accepted all of ACLA’s recommendations for revisions to the technical component of flow cytometry services. This action partially restores payment for these critically important patient services (increases between 14 and 25 percent despite the imposition...

  5. The Medically Unbelievable Edits [now renamed Medically Unlikely Edits (MUEs)] program is intended to identify obvious billing errors and to prevent erroneous Medicare billing claims by placing a unit of service limitation on each CPT code. The Centers for Medicare and Medicaid Services (CMS) is implementing MUEs in multiple quarterly phases. When the MUE program was first announced in late 2005, ACLA was one of the first to meet with CMS to raise concerns, among them that the proposed...

  6. ACLA and a coalition of other health care providers were successful in including in the "Medicare Improvement for Patients and Providers Act of 2008" a provision extending the so-called “technical component grandfather clause” through the end of calendar year 2009 . Using the grandfather clause, Medicare has permitted independent laboratories to bill and receive direct payments from Medicare for both specimen preparation (also known as the technical component of the service) and the...

  7. ACLA was the leader in the successful battle to eliminate a 2003 legislative provision that would have cut the Medicare lab fee schedule by 20 percent and require labs to try to make up the loss by billing and collecting a 20 percent co-pay from Medicare beneficiaries. The provision passed the Senate and was on its way to passage in the House until ACLA mounted a major advocacy campaign to stop it. Congress dropped the provision in November 2003, and ACLA has successfully kept the...

  8. Florida

    - A proposal by the Florida Agency for Health Care Administration (AHCA) to pick a single laboratory winner for Florida from the 100 laboratories providing services to Medicaid was withdrawn twice in the face of a May 2005 campaign by ACLA. ACLA led the opposition to the Invitation to Negotiate, filing administrative challenges to the proposal and coordinating a legislative advocacy campaign. ACLA led the challenges to the Florida proposal, and was the leader in the...

  9. ACLA Takes Lead Role for Lab Community

    ACLA is a leader for the lab industry in promoting lab interests as the government and outside groups develop health care IT interoperability standards. ACLA is positioned on important health care IT boards and coalitions, as well as having a working relationship with key government officials.

    Standards for Electronic Transmission of Health Data

    In a public statement before the American Health Information...

  10. ACLA is an active participant in the development, revision and payment of CPT codes for laboratory tests. ACLA’s CPT Committee works with the Pathology Coding Caucus, which develops consensus recommendations for the AMA’s CPT Editorial Panel for new code applications. ACLA provides recommendations to CMS for payment for new CPT codes at a public meeting each summer and then comments on the payment recommendations from CMS.

    ACLA is an active participant in all...

  11. In January 2005, the Medicare Payment Advisory Commission (MedPAC) passed a recommendation to Congress that would require labs to submit all laboratory values on claims submitted to Medicare. ACLA met with MedPAC Executive Director Dr. Mark Miller to express concerns, as well as sharing those concerns with key members of Congress. No further action of this nature has occurred.

  12. ACLA met in March 2006 with the Executive Director of the Medicare Payment Advisory Commission (MedPAC) to present the findings from an independent report on Trends in Medicare Laboratory Testing Services, which showed that any increase in laboratory utilization was consistent with medical practice guidelines. The report sponsored by ACLA and the American Association of Bioanalysts, the American Society for Clinical Laboratory Scientists, AdvaMed, and the Clinical Laboratory Management...

  13. ACLA successfully urged the removal of a costly “claims processing fee” from a September 2004 bill moving through the U.S. House that would have created a $5 fee for each Medicare claim returned for “completion or correction.”

  14. ACLA contacted CMS in January 2005 regarding a Change Request for “Independent Laboratory Billing for the Technical Component of Physician Pathology Services Furnished to Hospital Patients.” The notice appeared to change the application of the covered entity to the laboratory so that the individual laboratory would have needed to have the arrangement with the hospital. CMS advised ACLA that this was not their intention and rescinded the change request.

  15. Legislative History:

    Senators Ted Kennedy (D-MA), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Senator Barack Obama (D-IL), member of the Senate HELP Committee, have introduced in the first session of the 110th Congress legislation that would strengthen oversight of laboratory developed tests (LDTs). ACLA opposed Senator Kennedy’s legislation (S.736) because of concerns that it would stifle innovation for patient care and supported...

  16. On July 15th, the House and Senate voted overwhelmingly to override the President’s veto of “The Medicare Improvement for Patients and Providers Act of 2008”. The law includes three key provisions sought by the laboratory community: Total repeal of the laboratory competitive bidding demonstration project, extension of the so called “TC grandfather clause” for 18 months and reversal of a 10.6% reduction in the physician fee schedule. ACLA led efforts in...

  17. Rescind Physician Signature Requirement

    In November 2010, shortly after publication of the 2011 Medicare Physician Fee Schedule Final Rule, ACLA began building a coalition of supporters who also opposed CMS’ new physician signature requirement.  Following pressure from these groups, CMS issued a three-month enforcement delay avoiding implementation of the policy January 1, 2011.  ACLA worked tirelessly on a congressional sign-on letter to CMS to...

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04/20/2011 President's Message

Welcome to the ACLA Website!

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04/20/2011 ACLA Board of Directors

Edward Ashwood, MD (ACLA Vice Chair), President and CEO, ARUP Laboratories

Nicholas Brownlee, President, Spectra Renal Management, Fresenius Medical Care

Mark Capone, President, Myriad Genetics, Inc.

Franklin R. Cockerill, MD, Chair, Laboratory Medicine and Pathology, Mayo Clinic

Richard Daly (ACLA Treasurer), CEO, Laboratory Partners, Inc.

Carrie Eglinton Manner, CEO, Clarient/GE

Marc Grodman, MD, President, CEO, Chairman of the Board, Bio-Reference Laboratories, Inc.

Peter G. Gudaitis, President, Aculabs, Inc.

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04/20/2011 ACLA Staff
President

Since becoming President of ACLA in 2003,  ACLA’s membership has grown.  ACLA has greater visibility in Congress and with the Administration and ACLA has had a series of key advocacy successes.

During Mr. Mertz’s tenure, ACLA has become a leader on advocacy issues dealing with laboratory reimbursement, regulation and coding.    On reimbursement, ACLA was instrumental in stopping legislation that would have instituted coinsurance for laboratory services in Medicare, in repealing the Medicare Competitive Bidding Demonstration program, and heading off a proposal for imposing a new federal tax on all laboratory revenue.   ACLA also led the successful campaign to modify the “physician signature” requirement that was proposed by Medicare.

On the regulatory front, ACLA is recognized as being in the forefront of advocacy efforts to ensure that regulatory changes do not stifle innovation in genetic and molecular testing.     ACLA has also been a leader on molecular coding and reimbursement issues.

In 2007, ACLA launched the “Results for Life” educational campaign aimed at promoting the value of laboratory services.   In 2009, ACLA started its Associate Member program for non-laboratory health care companies and organizations as a means of broadening education and communication with the laboratory industry’s health partners.   

From 1998-2003, Mertz was Executive Vice President and Acting President of the Healthcare Leadership Council (HLC), and from 1980 to 1998 served in three senior staff positions in the House and Senate.  He was selected as a John C. Stennis Congressional Fellow in 1996, taught as an adjunct professor at George Washington University from 1997-1999, and is a frequent lecturer at American University in Washington, DC.  He holds a Masters Degree in American Politics from American University and a BA in Government from Monmouth College.

Senior Vice President

was named Director of Government Relations at ACLA in April 1996, and was promoted to Vice President of Government Relations in November 1996. As of February 2004, she has been named Senior Vice President. Ms. Glisson attended Vassar College and the University of Florida. From 1980 to 1983, she was a Professional Staff Member of the Senate Committee on Labor and Human Resources, under the supervision of Senator Edward M. Kennedy. She then served as Assistant Director for Government Relations at Stanford University from 1983 to 1985. Ms. Glisson returned to Washington, D.C. in 1985 as Legislative Representative of the Kaiser Permanente Medical Care Program. She joined Monsanto Company's Washington office as Health and Science Affairs Director in August 1990, and was promoted to Director, Health and Science Affairs in January 1993.

Vice President of Government Relations

Named Vice President for Government Relations at ACLA in February 2004, he comes to ACLA from his position as Manager of Congressional and Regulatory Affairs at the American Society for Clinical Pathology (ASCP) where he worked from 2001 through 2004.   During his tenure with ASCP, he developed a knowledge base in pathology and laboratory medicine among other issues.   Prior to that position he was Government Affairs Coordinator at the American Society of Hematology.   Mr. DuBois has an MBA from George Mason University, a Master's of Arts degree from Miami University of Ohio, and a Bachelor's degree from Gettysburg College.

Vice President Government Affairs

Francesca Fierro O'Reilly was named Vice President for Government Relations at ACLA in May 2011.

Ms. O’Reilly holds a master's in public administration from the University of North Carolina at Chapel Hill and a bachelor of arts in political science from Davidson College. 

She came to ACLA from the American Health Care Association (AHCA) where she served as Senior Director, Government Relations.  Before joining AHCA in 2006, Ms. O’Reilly advocated for a number of national membership and patient advocacy organizations, including the American Association of Colleges of Nursing, the National Association of Social Workers, and the Parkinson’s Action Network.  She began her career on Capitol Hill, serving for several years on the staffs of U.S. Senator Terry Sanford (NC) and U.S. Representative Eva Clayton (NC-01).

Vice President for Policy and Regulator Affairs

Jen Bowman is ACLA’s Vice President for Policy and Regulatory Affairs.  She counsels the nation’s leading clinical laboratories on issues that bridge health policy and business strategy.  She develops and advocates for the association’s regulatory and policy agenda. 

Jen has deep substantive expertise and over a decade of experience in health policy.  Prior to joining ACLA, she advised pharmaceutical clients on product positioning in the US and global markets with UK-based PRMA Consulting.  As a principal with the Podesta Group, she counseled health care clients on influencing strategies for health care reform and Medicare payment changes, advocating to the legislative and executive branches on their behalf.  

During seven years at Avalere Health LLC, Jen led many consulting engagements on the Medicare drug benefit, led the firm’s series of public conferences and audio conferences, and served on the leadership team.  Previously she worked for three years as a health analyst at the Congressional Budget Office, analyzing the economic impact of legislation on the federal budget and the private sector.

Jen earned a Master of Public Health degree from Yale University and a B.A. in Biochemistry from Rice University.

Administrator

Cheryl Hawkins, Administrator, has been employed with ACLA since June 1996. She is responsible for the day-to-day operations of ACLA's Washington office, and is the primary contact  for all membership and office issues. Before joining ACLA, Ms. Hawkins was a Legislative Assistant for the government affairs office of Meridian Oil, Inc.

Cheryl attended Prince Georges' Community College and the University of Maryland. She has been an active member of Executive Women International (EWI) of Washington DC since 1992, and currently serves on the Board of Directors.   EWI is a global women's organization with an equal focus on Connections, Careers, and Community.

Legal Counsel

Peter M. Kazon is a senior counsel in Alston & Bird's Washington, D.C. office concentrating on health care law and policy. Peter counsels health care providers on regulatory issues, especially matters involving Medicare reimbursement, Stark self-referral, fraud and abuse, food and drug law and antitrust. He also specializes in advising clinical laboratories and companies furnishing diagnostic services and products on regulatory issues. He advises companies on compliance with the Food, Drug and Cosmetic Act and its recent amendments, including premarket approval and clearance requirements, and related coverage, coding and reimbursement issues. He has extensive experience in hospital staff privilege matters and in third-party payor and Medicare and Medicaid reimbursement issues. A frequent speaker on health care issues, Peter's recent presentations include: "Genetic Tests, Pharmacogenomics and Drug Development,"BIO 2004 (June 2004); "Protecting Electronic Health Data: The New HHS Security Requirements,"Beckman Coulter Symposia 2004 (May 2004); "Medical Necessity Denials, Policy Determinations and Appeals," Institute on Medicare and Medicaid Payment Issues Program, presented by the American Health Lawyers Association (March 2004); "Congress Approves Medicare Reform: What's The Bottom-Line For Labs, Pathologists & Hospitals in 2004?"Washington G-2 Reports (December 2003). He is the author of "Doing Business with the New Medicare — A Policy Guide for Clinical Laboratory Testing,"published by Washington G-2 Reports (2004). After receiving a B.A., magna cum laude, from Tufts University in 1975, Peter earned his J.D. from Temple University in 1978, where he served on the staff of the Temple Law Quarterly. Peter is admitted to practice in the District of Columbia, Massachusetts and Maine and is a member of the bar associations in each of those jurisdictions. He is also a member of the American Health Lawyers Association.

Director of Regulatory and Reimbursement Affairs

Scott was named Director of Regulatory and Reimbursement Affairs in March 2012.

He holds a J.D. from the University of Wisconsin Law School and a B.S. in Biology from Boston College.

Prior to joining ACLA, Scott worked as a contract lobbyist and scientific advisor with Broydrick & Associates and represented various pharmaceutical and device companies and their interests on Capitol Hill. He has an extensive scientific background as a molecular biologist, and previously worked as a lab manager and research scientist at Harvard Medical School, where he studied renal fibrosis and epigenetics in the Division of Matrix Biology.

Executive Assistant

Sue Geibel joined the ACLA Staff as Executive Assistant to Alan Mertz, President ACLA, in September 2009. She provides general administrative support for the office as well as scheduling for Mr. Mertz.   Sue comes to ACLA from Capitol Hill where she served as Office Manager and Scheduler for three members of the U.S House of Representatives from 1995 to 2009.

She has a bachelor’s degree from American University, Washington, DC.

 

view Page ACLA Content
04/21/2011 ACLA in the News

June, 2011

August, 2011

September, 2011

October, 2011

January, 2012

February, 2012

March, 2012

April, 2012

May, 2012

view Page ACLA Content
04/21/2011 ACLA Associate Membership

We are pleased to announce that the American Clinical Laboratory Association (ACLA) has an Associate Membership category that will, for the first time, allow health care related companies and organizations including diagnostic manufacturers, non-profits, consultants, investment firms, law firms, information technology, billing firms, and others who work with the laboratory industry to benefit from many of ACLA’s advocacy, education, and collaborative programs as well as meet with the leaders of ACLA member companies.

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04/21/2011 2012 Annual Meeting
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04/22/2011 ACLA Help & Information System

W

elcome to the ACLA Help & Information System. The purpose of this help system is to instruct you on the various features of your website and how to add, edit or delete pieces of content.

The word "content" will be used throughout this entire tutorial. This website is a Content Management System. This means that every time you create a web page, news article, calendar event, member link or other options, each time you are creating new content for this website.

Use the outline below to go through the different help articles.

view Page Help Article
04/28/2011 Associate Members view Page Showcase3
05/01/2011 ACLA urges CMS

To replace physician signature requirement with "rule of reason".

view Page What's New Article
05/02/2011 Physician Signature Rule

CMS TO RESCIND PHYSICIAN SIGNATURE REQUIREMENT In a conversation with Jonathan Blum, Director of the Centers for Medicare, CMS, on February 11, 2011, ACLA was told that CMS will rescind the physician signature requirement for laboratory requisitions prior to the April 1, 2011 deadline.

view Page What's New Article
05/13/2011 AIM Coalition letter

To the Ways and Means Committee for its hearing on SGR

view Page What's New Article
Type: Header Image
Post datesort icon Title Preview Link Type Cat
04/19/2011 Sample Header Image view Header Image
04/20/2011 Sample Header Image4 view Header Image
05/17/2011 About ACLA view Header Image
05/17/2011 ACLA News Header view Header Image
05/17/2011 President's Message Header Image view Header Image
05/17/2011 ACLA Achievements Header Image view Header Image
05/18/2011 Board of Directors Header Image view Header Image
05/18/2011 ACLA Staff Header Image view Header Image
05/18/2011 Results Newsletter Header Image view Header Image
05/18/2011 Upcoming Events Header Image view Header Image
05/18/2011 ACLA Membership Header Image view Header Image
Type: Featured Link
Post datesort icon Title Preview Link Type Cat
04/20/2011 Sample Featured Link2 view Featured Link
04/20/2011 Sample Featured Link view Featured Link
04/20/2011 Sample Link1 view Featured Link
Type: Gallery Image Custom
Post datesort icon Title Preview Link Type Cat
04/20/2011 AM05 view Gallery Image Custom
04/20/2011 001 view Gallery Image Custom
04/20/2011 002 view Gallery Image Custom
04/20/2011 003 view Gallery Image Custom
04/20/2011 004 view Gallery Image Custom
04/20/2011 Photo1 view Gallery Image Custom
04/20/2011 Sample Photo2 view Gallery Image Custom
04/20/2011 Sample Photo3 view Gallery Image Custom
04/20/2011 Sample Photo4 view Gallery Image Custom
Type: ACLA Achievement
Post datesort icon Title Preview Link Type Cat
04/20/2011 "POD" Labs

ACLA is in the forefront of efforts to raise concerns about abusive pathology arrangements known as “PODs” or “Condo Labs.” These are contractual agreements allowing non-pathology clinicians and physician groups to bill for pathology services, for their own patients, in which they do not have active involvement in the pathology services. The Centers for Medicare and Medicaid Services has incorporated concerns expressed by ACLA in proposed changes to the rules on reassignment.

view ACLA Achievement
04/20/2011 HHS OIG “Excess Charge” Proposed Rule Withdrawn

A proposed rule by the Health and Human Services (HHS) Office of Inspector General (OIG) was withdrawn in June 2007 which would have potentially exclude Medicare providers, including labs, from the Medicare program for submitting claims containing “excessive charges.” Excessive charges could include a single CPT code for which Medicare pays more than 120 percent of customary and usual charges. ACLA led opposition to this rule on behalf of the laboratory industry and submitted comments on the proposal.

view ACLA Achievement
04/20/2011 FDA Withdraws Guidance on In Vitro Diagnostic Multivariate Index Assays

view ACLA Achievement
04/20/2011 Flow Cytometry Services Restored

The final 2007 Physician Fee Schedule, published by the Centers for Medicare and Medicaid Services (CMS) on November 1, 2006, included a number of provisions affecting clinical laboratories and pathology services. Of particular note, CMS accepted all of ACLA’s recommendations for revisions to the technical component of flow cytometry services.

view ACLA Achievement
04/20/2011 CMS Allows Stakeholder Input on "Medically Unlikely Edits” (MUEs)

view ACLA Achievement
04/20/2011 TC "Grandfather" Provision Extended

ACLA and a coalition of other health care providers were successful in including in the "Medicare Improvement for Patients and Providers Act of 2008" a provision extending the so-called “technical component grandfather clause” through the end of calendar year 2009 . Using the grandfather clause, Medicare has permitted independent laboratories to bill and receive direct payments from Medicare for both specimen preparation (also known as the technical component of the service) and the diagnosis (known as the professional component) of hospital patient specimens.

view ACLA Achievement
04/20/2011 Medicare Lab Co-Pay Dropped

ACLA was the leader in the successful battle to eliminate a 2003 legislative provision that would have cut the Medicare lab fee schedule by 20 percent and require labs to try to make up the loss by billing and collecting a 20 percent co-pay from Medicare beneficiaries. The provision passed the Senate and was on its way to passage in the House until ACLA mounted a major advocacy campaign to stop it. Congress dropped the provision in November 2003, and ACLA has successfully kept the provision from being reintroduced.

view ACLA Achievement
04/20/2011 Success on State Issues: Florida, New Jersey, New York, Pennsylvania

Florida

view ACLA Achievement
04/20/2011 Health Information Technology (IT)

ACLA Takes Lead Role for Lab Community

ACLA is a leader for the lab industry in promoting lab interests as the government and outside groups develop health care IT interoperability standards. ACLA is positioned on important health care IT boards and coalitions, as well as having a working relationship with key government officials.

Standards for Electronic Transmission of Health Data

view ACLA Achievement
04/20/2011 ACLA Active in CPT Coding Development/Revisions

ACLA is an active participant in the development, revision and payment of CPT codes for laboratory tests. ACLA’s CPT Committee works with the Pathology Coding Caucus, which develops consensus recommendations for the AMA’s CPT Editorial Panel for new code applications. ACLA provides recommendations to CMS for payment for new CPT codes at a public meeting each summer and then comments on the payment recommendations from CMS.

view ACLA Achievement
04/20/2011 ACLA Raises Concerns on MedPAC Lab Value Requirement

In January 2005, the Medicare Payment Advisory Commission (MedPAC) passed a recommendation to Congress that would require labs to submit all laboratory values on claims submitted to Medicare. ACLA met with MedPAC Executive Director Dr. Mark Miller to express concerns, as well as sharing those concerns with key members of Congress. No further action of this nature has occurred.

view ACLA Achievement
04/20/2011 MedPAC Delays Recommendations on Lab Services

ACLA met in March 2006 with the Executive Director of the Medicare Payment Advisory Commission (MedPAC) to present the findings from an independent report on Trends in Medicare Laboratory Testing Services, which showed that any increase in laboratory utilization was consistent with medical practice guidelines. The report sponsored by ACLA and the American Association of Bioanalysts, the American Society for Clinical Laboratory Scientists, AdvaMed, and the Clinical Laboratory Management Association was prepared by Dr. Chris Hogan, Ph.D. At the meeting Dr.

view ACLA Achievement
04/20/2011 Medicare “Claims Processing Fee” Withdrawn

ACLA successfully urged the removal of a costly “claims processing fee” from a September 2004 bill moving through the U.S. House that would have created a $5 fee for each Medicare claim returned for “completion or correction.”

view ACLA Achievement
04/20/2011 Path Change Request Rescinded

ACLA contacted CMS in January 2005 regarding a Change Request for “Independent Laboratory Billing for the Technical Component of Physician Pathology Services Furnished to Hospital Patients.” The notice appeared to change the application of the covered entity to the laboratory so that the individual laboratory would have needed to have the arrangement with the hospital. CMS advised ACLA that this was not their intention and rescinded the change request.

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Type: ACLA Staff
Post datesort icon Title Preview Link Type Cat
04/20/2011 Alan Mertz

Since becoming President of ACLA in 2003,  ACLA’s membership has grown.  ACLA has greater visibility in Congress and with the Administration and ACLA has had a series of key advocacy successes.

view ACLA Staff
04/20/2011 JoAnne Glisson

view ACLA Staff
04/20/2011 Jason DuBois

view ACLA Staff
04/20/2011 Francesca Fierro O'Reilly

Francesca Fierro O'Reilly was named Vice President for Government Relations at ACLA in May 2011.

Ms. O’Reilly holds a master's in public administration from the University of North Carolina at Chapel Hill and a bachelor of arts in political science from Davidson College. 

view ACLA Staff
04/20/2011 Cheryl Hawkins

Cheryl Hawkins, Administrator, has been employed with ACLA since June 1996. She is responsible for the day-to-day operations of ACLA's Washington office, and is the primary contact  for all membership and office issues. Before joining ACLA, Ms. Hawkins was a Legislative Assistant for the government affairs office of Meridian Oil, Inc.

view ACLA Staff
04/20/2011 Peter M. Kazon

view ACLA Staff
04/20/2011 Sue Geibel

Sue Geibel joined the ACLA Staff as Executive Assistant to Alan Mertz, President ACLA, in September 2009. She provides general administrative support for the office as well as scheduling for Mr. Mertz.   Sue comes to ACLA from Capitol Hill where she served as Office Manager and Scheduler for three members of the U.S House of Representatives from 1995 to 2009.

She has a bachelor’s degree from American University, Washington, DC.

 

view ACLA Staff
Type: News Letter
Post datesort icon Title Preview Link Type Cat
04/21/2011 Spring 2010 - Vol. 15, No. 2 view News Letter
04/21/2011 Winter 2009 - Vol. 15, No. 1 view News Letter
05/18/2011 November 2008 - Vol. 14, No. 8 view News Letter
05/20/2011 September 2008 - Vol. 14, No. 7 view News Letter
05/20/2011 August 2008 - Special Edition view News Letter
05/20/2011 June 2008- Vol. 14 No. 5 view News Letter
05/20/2011 April 2008 - Vol. 14, No. 4 view News Letter
05/20/2011 March 2008 - Vol. 14, No. 3 view News Letter
05/20/2011 February 2008 - Vol. 14, No. 2 view News Letter
05/20/2011 January 2008 - Vol. 14, No. 1 view News Letter
Type: Member Company
Post datesort icon Title Preview Link Type Cat
04/21/2011 Aculabs, Inc. view Member Company
04/21/2011 Agendia, Inc. view Member Company
04/27/2011 Mayo Medical Laboratories view Member Company
Type: Associate Member
Post datesort icon Title Preview Link Type Cat
04/21/2011 Abbott Molecular view Associate Member
04/21/2011 American Medical Technologists view Associate Member
Type: Calendar Event
Post datesort icon Title Preview Link Type Cat
04/21/2011 Website Release

This is the fun day when we will get a new website

view Calendar Event
04/21/2011 Website Lunch

On this day we will have an extended lunch because the new website does not require so much time to add content.

view Calendar Event
04/21/2011 Sample old dated event

This event should go away after expire

view Calendar Event
04/21/2011 Lorem ipsum

Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Vivamus lacinia accumsan ipsum quis commodo. Donec vehicula nunc et nibh consequat id egestas leo gravida. Integer consectetur, purus in varius pulvinar, leo libero dignissim erat, sed euismod eros nibh imperdiet sem. Nunc accumsan egestas consectetur. Sed consectetur, arcu ac porttitor molestie, mi tortor laoreet neque, fringilla convallis purus ante quis erat. In quis mauris sapien, a feugiat felis. Vestibulum ac lorem magna. Aliquam id tincidunt justo.

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04/21/2011 Class aptent taciti sociosqu

Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Vivamus lacinia accumsan ipsum quis commodo. Donec vehicula nunc et nibh consequat id egestas leo gravida. Integer consectetur, purus in varius pulvinar, leo libero dignissim erat, sed euismod eros nibh imperdiet sem. Nunc accumsan egestas consectetur. Sed consectetur, arcu ac porttitor molestie, mi tortor laoreet neque, fringilla convallis purus ante quis erat. In quis mauris sapien, a feugiat felis. Vestibulum ac lorem magna. Aliquam id tincidunt justo.

view Calendar Event
04/27/2011 2011 Annual Meeting view Calendar Event
04/28/2011 Sample event posted to both Upcoming and Calendar

sample event for upcoming

view Calendar Event Posted to Upcoming Events
04/28/2011 Sample Event ONLY on Calendar

Not posted to Upcoming Events

view Calendar Event Do not Post to Upcoming Events
Type: Book page
Post datesort icon Title Preview Link Type Cat
04/22/2011 Login

This tutorial will explain how a user should log into the ACLA website. A User without an account can freely roam and access your content which you have made available to anonymous users. Content that is available on to Member users will be revealed or available after the user logs into the website.



view Book page
04/22/2011 My Account view Book page
04/22/2011 Sitemap view Book page
04/22/2011 Content Categories

The layout of your website is fully automated and is implemented through a categorization feature. When creating new content for your website, you must tell the system what kind of content it is that you are creating. For example, if you want to create a news article that would show on the front page, you must tell the system that you are creating a news article. This tutorial will explain how.





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04/22/2011 Regions




Your website is divided into regions. A region is an area the may contain pieces of content. Pieces of content can be divided into blocks. A region may contain many blocks. For example, you will see that the front page has many regions. You would also see that the right side bar region appears to be divided into two blocks, a President's message and a featured content block.

Adding new content such as pages, news articles images or others, will be sorted into these regions automatically.



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04/22/2011 Showcase Regions 1-4



The showcase region contains four blocks. Blocks 1 - 4. These blocks are derived from selecting the category corresponding to the desired block in the create content form.

For example, to change the picture or create a new article for Showcase 1, you would select the "Add Content" menu item under "Home." There on the top of the form above the "Title" text field, you will see a block that has a list of categories. Select Showcase1 and then upload a new image and this will replace the current showcase1 block.

view Book page
04/22/2011 Menu Items view Book page
04/22/2011 Adding New Menu items view Book page
04/22/2011 Deleting Menu Items view Book page
04/22/2011 Editing Menu Items view Book page
04/22/2011 Front Page Content view Book page
04/22/2011 Editing the Front Page Block view Book page
04/22/2011 Featured News view Book page
04/22/2011 President's Message view Book page
04/22/2011 Sidebar Conent view Book page
04/22/2011 Events Calendar view Book page
04/22/2011 Extras Links view Book page
04/22/2011 Typography

W

hen adding new content to your website, you may want to "spice" up the appearance of it. There are already pre programmed option that you can use in html format for your content. These options are provided to you on page TYPOGRAPHY. Here you will find all of the available fancy toys that you can add to your pages. Don't be afraid to try them. You can not hurt anything. It is designed for even the most novice of website managers and programmers.

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04/22/2011 User Management

This tutorial is about how to conduct User Management. User Management can not be done until you are logged in as a Moderator or an Admin. Once logged in, you may use the admin menu on the top or you may append "/user" at the end of the url while at your home page.







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04/22/2011 User Roles view Book page
04/22/2011 Blocking a User view Book page
04/22/2011 Editing a User view Book page
04/22/2011 Creating a New User







view Book page
04/22/2011 Front Page Regions



Your front page and all other pages are sorted into regions of content. Each region can contain many blocks of content. The blocks are a filtered location for certain types of content. To add more blocks to a region, either the functionality is already present or you should contact the webmaster to add more for you.

view Book page
04/22/2011 Creating New Content




This tutorial series is about how to create content or pages for your website using the "Add Content" form. Using this form, any user with or without programming abilities can easily add new pages to the website, easily in seconds.






view Book page
04/22/2011 Content Page Regions



A standard content page is any other page than the front page. This is uniques because the moderator has the option to customized each piece of this content.

view Book page
04/22/2011 Create a new Page

This tutorial is about how to create a new page in your website.


view Book page
04/22/2011 Create a Showase Item

This tutorial is about how to create a new showcase item for the front page.



view Book page
04/22/2011 Create a President's Message

THis is a tutorial on how to create a new message from the President.



view Book page
04/22/2011 Create a News Article

This tutorial is about how to create a News article to be displayed in the website. THis news article will also be displayed on the front page of the site under the Featured News Block.






view Book page
04/22/2011 Deleting Site Content

This tutorial will explain the different methods for deleting site content. WARNING: Using either of these methods is permanent. Deleting content can not be undone or recovered without restoring a database backup. This option should only be used for content that you do not wish to be archived in the system. If you want to only make content "Unavailable" to a user, then you must select the "Unpublish" option instead.







view Book page
04/22/2011 Editing Site Content

This tutorial will be all about how to get to and edit site content that is already published.







view Book page
Type: Header Link
Post datesort icon Title Preview Link Type Cat
05/17/2011 Overview view Header Link
05/17/2011 President's Message view Header Link
05/17/2011 ACLA Achievements view Header Link
05/17/2011 Board of Directors view Header Link
05/17/2011 ACLA Staff view Header Link
05/17/2011 Press Releases view Header Link
05/17/2011 Overview view Header Link
05/17/2011 President's Message Header Image view Header Link
05/17/2011 ACLA Achievements view Header Link
05/17/2011 Board of Directors view Header Link
05/17/2011 ACLA Staff view Header Link
05/17/2011 Overview view Header Link
05/17/2011 President's Message view Header Link
05/17/2011 ACLA Achievements view Header Link
05/17/2011 Board of Directors view Header Link
05/17/2011 ACLA Staff view Header Link
05/18/2011 Overview view Header Link
05/18/2011 President's Message view Header Link
05/18/2011 ACLA Achievements view Header Link
05/18/2011 Board of Directors view Header Link
05/18/2011 ACLA Staff view Header Link
05/18/2011 Overview view Header Link
05/18/2011 President's Message view Header Link
05/18/2011 ACLA Achievements view Header Link
05/18/2011 Board of Directors view Header Link
05/18/2011 ACLA Staff view Header Link
05/18/2011 Press Releases view Header Link
05/18/2011 Events view Header Link
05/18/2011 Membership view Header Link
05/18/2011 Associate Membership view Header Link
05/18/2011 Membership view Header Link
05/18/2011 Associate Membership view Header Link
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