Comments and Letters

  • Comments on RUO IUO

    August 24, 2011
      August 24, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville MD 20852 RE: Docket No, FDA-2011-D-0305 Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products labeled for Research Use Only or Investigational Use Only: Frequently Asked Ouestions Dear Sir or Madam: The American Clinical Laboratory Association (“ACLA”) is pleased to provide commentsContinue 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 »...
  • Letter to Senators Reid and McConnell, Representatives Boehner and Pelosi Regarding Coalition Letter Against Medicare Coinsurance for Lab Services

    July 11, 2011
      Dear Majority Leader Reid, Minority Leader McConnell, Speaker Boehner, and Minority Leader Pelosi: We, the undersigned organizations, represent the interests of a broad cross-section of our nation’s Medicare beneficiaries as well as the health care providers who care for them. While we believe it is critically important for our nation’s fiscal health to address the deficit, we are deeply concerned by a numberContinue Reading »...
  • Letter to Congress from Patient and Senior Groups on Lab Coinsurance

    July 11, 2011
      Dear Majority Leader Reid, Minority Leader McConnell, Speaker Boehner, and Minority Leader Pelosi: We, the undersigned organizations, represent the interests of a broad cross-section of our nation’s Medicare beneficiaries as well as the health care providers who care for them. While we believe it is critically important for our nation’s fiscal health to address the deficit, we are deeply concerned by a numberContinue Reading »...
  • Letter to Senators Reid and McConnell Regarding Coinsurance

    July 07, 2011
      The Honorable Harry Reid Majority Leader U.S. Senate 522 Hart Senate Office Building Washington, DC 20510 The Honorable Mitch McConnell Minority Leader U.S. Senate 317 Russell Senate Office Building Washington, DC 20510 Dear Majority Leader Reid and Minority Leader McConnell: The undersigned laboratory and health care organizations, representing America’s community, regional, and national laboratories, their employees, practitioners, and the Medicare patients we serveContinue Reading »...
  • Letter to Representative Don Young Regarding Coinsurance

    June 27, 2011
      June 27, 2011 The Honorable Don Young United States House of Representatives 2314 Rayburn House Office Building Washington, DC 20515 Dear Representative Young: The American Clinical Laboratory Association (ACLA) represents the leading providers of laboratory services in the United States. We are writing to convey our serious concerns about the possible imposition of coinsurance for clinical laboratory services provided under Medicare, as partContinue 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 »...
  • Comments on the Medicare Shared Savings Program: Accountable Care Organizations Proposed Rule

    June 06, 2011
    The American Clinical Laboratory Association (ACLA) is pleased to have this opportunity to submit our comments on the Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Proposed Rule (the “Proposed Rule”).1 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 member companies will be directlyContinue Reading »...
  • Comments on ACO proposed F-A Waivers

    June 06, 2011
    COMMENTS OF THE AMERICAN CLINICAL LABORATORY ASSOCIATION ON THE MEDICARE PROGRAM; WAIVER DESIGNS IN CONNECTION WITH THE MEDICARE SHARED SAVINGS PROGRAM AND THE INNOVATION CENTER; NOTICE WITH COMMENT PERIOD (CMS-1345-NC2) The American Clinical Laboratory Association (ACLA) is pleased to have this opportunity to submit our comments on the Medicare Program: Waiver Designs in Connection with the Medicare Shared Savings Program and the Innovation Center;Continue Reading »...
  • Memorandum in Opposition to New York AB 3551/SB 4660

    June 01, 2011
    MEMORANDUM IN OPPOSITION AB3551/SB4660 (In relation to referrals of patients for health or health related items or services) The American Clinical Laboratory Association (ACLA) opposes AB 3551/SB 4660. ACLA is an association representing clinical laboratories throughout the country, including local, regional and national laboratories, virtually all of which are licensed by New York to provide services to New York residents and several of whichContinue Reading »...
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