News

  • Extenders Coalition Letter to Senators Reid and McConnell, Representatives Pelosi and Boehner

    November 01, 2010
    November 1, 2010 The Honorable Harry Reid Majority Leader, United States Senate S-221, United States Capitol Washington, DC 20510 The Honorable Nancy Pelosi Speaker, United States House of Representatives H-232, United States Capitol Washington, DC 20510 The Honorable Mitch McConnell Minority Leader, United States Senate S-231, United States Capitol Washington DC 20510 The Honorable John Boehner Minority Leader, United States House of Representatives H-204Continue Reading »...
  • Letter to Dr. Carter Regarding Draft “Study of the Need to Regulate Medical Laboratory Scientists and Medical Laboratory Technicians”

    September 28, 2010
      September 28, 2010 Elizabeth A. Carter, Ph.D. Executive Director for the Virginia Board of Health Professions Perimeter Center 9960 Mayland Drive, Suite 300 Richmond, Virginia 23233 Dear Dr. Carter: On behalf of the members of the American Clinical Laboratory Association (ACLA), I am writing to provide our comments on the draft “Study of the Need to Regulate Medical Laboratory Scientists and Medical LaboratoryContinue Reading »...
  • Letter Regarding Meeting with Palmetto GBA J-1 Contractor Medical Directors

    September 17, 2010
      September 17, 2010 Mr. Michael Barlow Vice President, Medicare Operations Palmetto GBA 4249 Easter Way Columbus, OH 43219 Dear Mr. Barlow: On behalf of the members of the American Clinical Laboratory Association (ACLA), I am writing to seek a meeting with you and the Palmetto GBA J-1 contractor medical directors to discuss our concerns about Palmetto’s recently announced plans to launch the CMSContinue Reading »...
  • Letter to FDA Regarding Oversight of Laboratory Developed Tests

    September 15, 2010
      September 15, 2010 Jeffery E. Shuren, M.D., J.D. Director, Center for Devices and Radiological Health U.S. Food and Drug Administration Building WO66, Room 5442 10903 New Hampshire Ave. Silver Spring MD 20993 RE: Docket No. FDA-2010-N-0274 – Oversight of Laboratory Developed Tests Dear Dr. Shuren: The undersigned groups, which represent the full spectrum of laboratory medicine operations and the providers of clinical andContinue Reading »...
  • Comments on Supplemental LDTs

    September 15, 2010
      September 15, 2010 RE:       Docket No. FDA-2010-N-0274   —  Oversight of Laboratory Developed Tests; Public  Meeting;  Request  for  Comments   EXECUTIVE  SUMMARY Clinical laboratories are providers of testing services; not medical device manufacturers, a fact that necessitates flexibility and innovative thinking on FDA’s part in regulating LDTs. (See page  3 -4) Regulation of clinical laboratory developed tests (LDTs) should not vary based on the settingContinue Reading »...
  • Comments on Modifications to HIPAA Privacy Comments

    September 13, 2010
      September 13, 2010 The American Clinical Laboratory Association (ACLA) is pleased to have this opportunity to submit our comments on the Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act; Proposed Rule (the “Proposed Rule”) issued by the Office for Civil Rights (OCR). ACLA is an association representing clinical laboratories throughout the country, inclucgContinue Reading »...
  • Comments on Physician Fee Schedule CY 2011

    August 20, 2010
      August 20, 2010 The American Clinical Laboratory Association (ACLA) is pleased to have this opportunity to submit our comments on the Medicare Physician Fee Schedule Proposed Rule for Calendar Year (CY) 2011 (“the Proposed Rule”).’ ACLA is an association representing clinical laboratories throughout the country, including local, regional, and national laboratories. As providers of clinical diagnostic laboratory services to Medicare beneficiaries, ACLA memberContinue Reading »...
  • Comments Regarding Proposed NIH Genetic Test Registry

    July 29, 2010
    Re: Request for Information on the National Institutes of Health Plan to Develop a Genetic Testing Registry Dear Dr. Collins: On behalf of the American Clinical Laboratory Association (ACLA), I am pleased to submit these comments on the proposed National Institutes of Health (NIH) Genetic Test Registry (GTR). ACLA represents national, regional, and local laboratories across the country, many of which offer extensive menusContinue Reading »...
  • Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests

    July 16, 2010
    July 16, 2010 For Immediate Release Contacts: Alan Mertz, 202-637-9466; amertz@clinical-labs.org David Mongillo, 202-637-9466; dmongillo@clinical-labs.org Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests “21st Century tests require 21st Century Solutions” Washington, DC — The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced wayContinue Reading »...
  • The Genome Project: A Balance Sheet

    June 15, 2010
    To the Editor: Mapping the human genome was not just about finding cures. It was also about understanding disease so we could provide better care. That is now happening in spades throughout the health system. Genetic tests can identify the exact molecular nature of a patient or disease, allowing for better prevention and targeted treatment. The cure rate for childhood leukemia now exceeds 80Continue Reading »...