Featured News

  • ACLA Written Statement for 21st Century Cures Hearing on LDT Regulation

    September 08, 2014
      Statement Of Alan Mertz, President, The American Clinical Laboratory Association For U.S. House of Representatives Energy and Commerce Committee Subcommittee on Health Hearing on 21st Century Cures: Examining the Regulation of Laboratory-Developed Tests September 9, 2014 9:30 a.m. 2322 Rayburn House Office Building   Introduction Chairman Pitts, Ranking Member Pallone, and members of the Subcommittee, the American Clinical Laboratory Association (ACLA) is pleasedContinue Reading »...
  • ACLA Comments on PFS Proposed Rule for CY 2015

    August 28, 2014
      See the original PDF here.     August 27, 2014 Administrator Marilyn Tavenner Centers for Medicare and Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue SW Washington, DC 20201 RE: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for MedicareContinue Reading »...
  • ACLA Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs)

    July 31, 2014
    WASHINGTON, DC – In response to today’s announcement that the Food and Drug Administration (FDA) will release a draft guidance in 60 days to regulate laboratory developed tests (LDTs), the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments. Historically,Continue Reading »...
  • ACLA Praises Letter to OMB From Nation’s Leading Academic Medical Center Labs Opposing FDA Regulation of Laboratory Developed Tests

    July 17, 2014
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) today lauded a letter sent from twenty three laboratory directors of the nation’s most prestigious academic medical centers to Brian Deese, Acting Director of the Office of Management and Budget (OMB), urging him to refrain from releasing draft guidance from the Food and Drug and Administration (FDA) that would impose an additional cumbersome regulatory approvalContinue Reading »...
  • ACLA Comments to CMS: Major Overhaul of Medicare Rates for Lab Services Should Be a Collaborative and Transparent Process

    July 14, 2014
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) in public comments presented to the Centers for Medicare & Medicaid Services (“CMS”) today, provided input on various aspects of implementation of relevant provisions of the Protecting Access to Medicare Act of 2014 (“PAMA”) which modifies the Medicare reimbursement rate methodology for lab services. “ACLA supports a measured and thoughtful analysis as well as robustContinue Reading »...
  • A Statement by the American Clinical Laboratory Association (ACLA) on CMS’ Proposed Rule on Payment Rates and Policies for Clinical Laboratories

    July 11, 2014
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) – a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies – released a statement today commenting on the Centers for Medicare & Medicaid Services’ (CMS) 2014 rule announced July 3, that proposes to change payment ratesContinue Reading »...
  • ACLA Responds to OIG Report on Clinical Labs Billing Practices: Lab Industry Committed to Appropriate Use, Cautions Report’s Methodologies Are Questionable

    July 09, 2014
    WASHINGTON, DC – In response to the Department of Health and Human Services Office of Inspector General report released today on Questionable Billing for Medicare Part B Clinical Laboratory Services, the American Clinical Laboratory Association (ACLA) reiterated its commitment to appropriate utilization of laboratory services, which includes preventing fraudulent or abusive billing practices, but cautioned the report’s methodology does not present a clear pictureContinue Reading »...
  • ACLA Response to LDT Demo Notice

    July 02, 2014
    July 1, 2014 Major General Richard W. Thomas, MD Chief Medical Officer and Director Defense Health Agency, Healthcare Operations Directorate 7700 Arlington Boulevard Falls Church, VA 22042 Dear General Thomas: On behalf of the American Clinical Laboratory Association (“ACLA”) and our members, I am writing to express our appreciation for the recent action by the Defense Health Agency (“DHA”) to establish a demonstration projectContinue Reading »...
  • Senators Ask CMS to Put Changes To Doc Fee Codes in Proposed Rule

    June 24, 2014
    Bloomberg BNA June 23 — Twelve senators have asked the Centers for Medicare & Medicaid Services to place information on modifications of physician codes in the upcoming proposed Medicare Part B fee schedule, rather than just in the final rule. Placing “the results of CMS’s analysis and the rationale for any payment modifications” just in the final rule “limits the ability of providers to review the rationale and variousContinue Reading »...
  • ACLA, AdvaMedDx, and The Coalition for 21st Century Medicine Joint PAMA Implementation Letter to CMS

    June 23, 2014
    June 23, 2014 Ms. Anne E. Tayloe Hauswald, Director Division of Ambulatory Services Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244 Dear Ms. Hauswald, Thank you for meeting with us on May 19, 2014 to discuss implementation of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which adds Section 1834A to the SocialContinue Reading »...
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