Regulatory Issues

  • Comments to CMS Regarding Lab Issues ESRD PPS

    August 30, 2013
    Laurence Wilson Director, Chronic Care Policy Group Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 Dear Mr. Wilson: On behalf of the members of the American Clinical Laboratory Association (“ACLA”), many of whom provide services to end stage renal disease (“ESRD”) beneficiaries on renal dialysis, I am writing to express our concerns about post-regulatory issuances by theContinue Reading »...
  • Comments Regarding CMS Proposed Requirements for the Medicare Incentive Reward Program and Provider Enrollment

    June 27, 2013
      Marilyn Tavenner, Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attn: CMS-1454-P P.O. Box 8013 Baltimore, Maryland 21244-8013 Re: Proposed Rule: Requirements for the Medicare Incentive Reward Program and Provider Enrollment, CMS-6045-P Dear Ms. Tavenner: The American Clinical Laboratory Association (“ACLA”) is pleased to have the opportunity to submit comments on the Centers for Medicare and Medicaid Services’Continue Reading »...
  • Clinical Labs Industry Files Petition Against Potential FDA Regulation of Laboratory Developed Tests

    June 04, 2013
    Washington, D.C. — The American Clinical Laboratory Association (ACLA) filed today a citizen petition under the Federal Food, Drug, and Cosmetic Act (FDCA) challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) in response to statements that the agency intends to regulate LDTs as “devices” under the FDCA. As detailed in ACLA’s petition, LDTs are in vitro assays that clinicalContinue Reading »...
  • ACLA Applauds Enactment of Bill Increasing Flexibility of Regulations that Threaten Access to Clinical Lab Tests

    December 04, 2012
    For Release: December 4, 2012 Contact: Jason DuBois, 202-637-9466 ACLA Applauds Enactment of Bill Increasing Flexibility of Regulations that Threaten Access to Clinical Lab Tests WASHINGTON, DC — The American Clinical Laboratory Association (ACLA) today applauded President Barack Obama for signing into law the Taking Essential Steps for Testing Act (TEST Act), introduced in the House by Rep. Michael Grimm (R-NY) and in theContinue Reading »...
  • ACLA Lauds Senate Approval of Bill Increasing Flexibility of Regulations that Threaten Access to Clinical Lab Tests

    November 15, 2012
    For Release: November 15, 2012 Contact: Jason Dubois, 202-637-9466 ACLA Lauds Senate Approval of Bill Increasing Flexibility of Regulations that Threaten Access to Clinical Lab Tests WASHINGTON, DC — The American Clinical Laboratory Association (ACLA) today applauded the U.S. Senate for yesterday’s passage of the Taking Essential Steps for Testing Act (TEST Act), introduced in the House by Rep. Michael Grimm (R-NY). The HouseContinue Reading »...
  • ACLA Applauds House Passage of Bill that Increases Flexibility of Regulations which Threaten Access to Clinical Lab Tests

    September 20, 2012
    For Release: Sept. 20, 2012 Contact: Jason DuBois, 202-637-9466 ACLA Applauds House Passage of Bill that Increases Flexibility of Regulations which Threaten Access to Clinical Lab Tests WASHINGTON, DC—The American Clinical Laboratory Association (ACLA) today applauded the U.S. House of Representatives for yesterday’s passage of H.R. 6118, the Taking Essential Steps for Testing Act (TEST Act), introduced by Rep. Michael Grimm (R-NY). A SenateContinue Reading »...
  • Comments Regarding ONC Lab Health IT Survey

    August 17, 2012
        August 17, 2012   COMMENTS OF THE AMERICAN CLINICAL LABORATORY ASSOCIATION ON OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY PROPOSED INFORMATION COLLECTION REQUEST REGARDING HEALTH INFORMATION EXCHANGE IN CLINICAL LABORATORIES   The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to offer its comments on the Office of the National Coordinator for Health Information Technology (“ONC”) proposed project, “National Survey on Health InformationContinue Reading »...
  • Letter to CMS Regarding POS Policy

    July 24, 2012
      July 24, 2012   Mr. Marc Hartstein Acting Director, Hospital and Ambulatory Policy Group Centers for Medicare & Medicaid Services Center for Medicare 7500 Security Boulevard Mail Stop C4-01-26 Baltimore, Maryland 21244   Dear Mr. Hartstein, The American Clinical Laboratory Association (ACLA) is writing to thank you and your colleagues for the time you took in March to discuss ACLA’s concerns about TransmittalContinue Reading »...
  • Letter to Sen. Klobuchar Regarding TEST Act

    July 18, 2012
      July 18, 2012   The Honorable Amy Klobuchar United States Senate 302 Senate Hart Office Building Washington, DC 20510   Dear Senators Klobuchar:   The American Clinical Laboratory Association (ACLA) is pleased to offer our full and strong support for S. 3391, the Taking Essential Steps for Testing Act or TEST Act. This Bill would make a needed change to existing regulation benefittingContinue Reading »...
  • ACLA Applauds Introduction of Bill Increasing Flexibility of Regulations that Currently Limit Access to Clinical Laboratory Tests

    July 13, 2012
    Washington, DC—The American Clinical Laboratory Association (ACLA) today announced its “full and strong support” for H.R. 6118, the Taking Essential Steps for Testing Act or TEST Act introduced by Rep. Michael Grimm (R-NY) in the House of Representatives. The proposed legislation would address a lack of regulatory flexibility in the Clinical Laboratory Improvement Amendments (CLIA). The bill would grant the Centers for Medicare andContinue Reading »...
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