Regulatory Issues

  • ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests

    October 14, 2011
    For Immediate Release, October 14, 2011 Contact: Alan Mertz, 202-637-9466 ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests Washington DC – The American Clinical Laboratory Association (ACLA) today announced its “full and strong” support for legislation introduced by Rep. Michael Burgess (R-TX) that would modernize the current regulatory pathway for all laboratory developed tests. The legislation, H.R. 3207, the Modernizing LaboratoryContinue Reading »...
  • Letter to Rep. Burgess Regarding the Modernizing Laboratory Test Standards for Patients Act

    October 14, 2011
        October 14, 2011   The Honorable Michael Burgess, MD United States House of Representatives 2241 Rayburn House Office Building Washington, D.C. 20515   Dear Congressman Burgess:   The American Clinical Laboratory Association (ACLA) is extremely pleased to offer our full and strong support for H.R. 3207 the Modernizing Laboratory Test Standards for Patients Act. This Bill is in lock‐step with the needContinue Reading »...
  • Comments to NIH Regarding Practical Utility of the Proposed Collection of Information for the Genetic Testing Registry

    September 26, 2011
        September 26, 2011  Genetic Testing Registry Staff National Institutes of Health Re:      Comments on the practical utility of the proposed collection of information for the Genetic Testing Registry The American Clinical Laboratory Association (ACLA) appreciates the opportunity to provide additional comments on the practical utility of the proposed collection of information for the Genetic Testing Registry (GTR). ACLA represents national, regional, andContinue Reading »...
  • Letter to HHS Regarding Nationwide Electronic Health Information Exchange

    September 23, 2011
      September 23, 2011 Department of Health & Human Services Office of the National Coordinator for Health Information Technology Attention: Stephen Posnack Hubert H. Humphrey Building 200 Independence Avenue, SW Suite 729D Washington, DC  20201 Re: Metadata Standards to Support Nationwide Electronic Health Information Exchange Dear Mr. Posnack: On behalf of the American Clinical Laboratory Association (“ACLA”), I am pleased to provide these comments onContinue Reading »...
  • Comment to Centers for Medicare & Medicaid Services on New Genetic Codes

    July 18, 2011
      The American Clinical Laboratory Association (ACLA) is pleased to provide comments to the Centers for Medicare and Medicaid Services (CMS) on new genetic CPT codes being developed by the American Medical Association. ACLA is an association representing clinical and anatomic pathology laboratories throughout the country, including local, regional, and national laboratories. As providers of diagnostic testing services to Medicare beneficiaries, including genetic andContinue Reading »...
  • ACLA Applauds CMS for Proposed Rule Repealing Physician Signature Requirement Avoiding Disruption of Patient Access to Laboratory Services

    June 30, 2011
    FOR IMMEDIATE RELEASE: JUNE 30, 2011 Contact: Alan Mertz American Clinical Laboratory Association (202) 637-9466 amertz@clinical-labs.org ACLA APPLAUDS CMS FOR PROPOSED RULE REPEALING PHYSICIAN SIGNATURE REQUIREMENT AVOIDING DISRUPTION OF PATIENT ACCESS TO LABORATORY SERVICES Washington DC – The American Clinical Laboratory Association (ACLA) applauds the Centers for Medicare and Medicaid Services (CMS) for issuing a proposed rule rescinding the physician signature requirement for laboratoryContinue Reading »...
  • ACLA and HL7 Announce Approval of First-Ever Electronic Directory of Services (eDOS) Implementation Guide

    June 27, 2011
    Ann Arbor, MI, USA and Washington, DC, USA – The American Clinical Laboratory Association (ACLA) and Health Level Seven® International (HL7®) announce the approval of the first-ever implementation guide in the laboratory industry for a reliable process to deliver a laboratory’s electronic Directory of Service to those providers ordering laboratory services in a meaningful and constructive process. The Version 2 Implementation Guide establishes aContinue Reading »...
  • Letter to the Tennessee Medical Laboratory Licensing Board

    June 06, 2011
    Ms. Lynda England, Director Tennessee Medical Laboratory Licensing Board Division of Health Related Boards 227 French Landing, Ste. 300 Heritage Place Metro Center Nashville, Tennessee 37243   Ms. England: On behalf of the American Clinical Laboratory Association, I am writing to seek clarification of the April 15, 2011 policy statement from the Tennessee Medical Laboratory Licensing Board regarding “Patient Test Management/Laboratory Reports” (hereinafter “PolicyContinue Reading »...
  • Letter to CMS Regarding Physician Signature Rule

    May 02, 2011
    Jonathan D. Blum Centers for Medicare & Medicaid Services Director, Center for Medicare Management Mail Stop 314G 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Mr. Blum: On behalf of the American Clinical Laboratory Association (“ACLA”), I am writing to express our appreciation for your assistance with the “physician signature” rule that was included in the 2011 Physician Fee Schedule (PFS) Rule. In thatContinue Reading »...
  • Memorandum in Opposition to 2011-2012 Proposed Health Budget

    February 24, 2011
    In effect, DOH has turned the clinical laboratory reference system special revenue account into an unauthorized and unsupervised revenue stream that is limited only by the bounds of the defendant’s [DOH’s] creativity in characterizing the Wadsworth Center’s expenses as attributable to the oversight of the plaintiffs [laboratories]. Decision and Order of Edward A. Sheridan, J.H.O., Albany County Supreme Court, American Association of Bioanalysts v.Continue Reading »...
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