Comments and Letters

  • 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 »...
  • Comments on NPI Interim Final Rule

    June 07, 2010
    Acting Administrator Marilyn Tavenner Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   RE: Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (CMS-6010-IFC) Dear Acting Administrator Tavenner: On behalf of the American Clinical LaboratoryContinue Reading »...
  • Letter to Health Level Seven on Electronic Delivery of a Laboratory Directory of Services (eDOS)

    May 06, 2010
    Dr. Charles Jaffe, M.D., Ph.D. Health Level Seven, International 3300 Washtenaw Avenue, Suite 227 Ann Arbor, MI 48104 RE: American Clinical Laboratory Association Laboratory Test Compendium Framework Dear Dr. Jaffe: The American Clinical Laboratory Association (ACLA) represents national, regional, and local laboratories that collectively have an extensive history of providing the nation’s hospitals and physicians with leading-edge health information technology (IT) to streamline theContinue Reading »...
  • Comments on Device Tax and LDTs

    February 28, 2010
    See Original PDF here. February 28, 2010 Internal Revenue Service 1111 Constitution Avenue, NW Washington, DC 20224 Re: Notice 2010-89 Dear Ladies and Gentlemen: The American Clinical Laboratory Association (ACLA), is pleased to provide these comments regarding implementation of the excise tax on medical devices in new Section 4191 of the Internal Revenue Code (the ―Code‖), as added by Section 1405 of the HealthContinue Reading »...
  • Comments on the President’s Council of Advisors on Science and Technology (PCAST) Report

    January 19, 2010
    Department of Health and Human Services Office of the National Coordinator for Health Information Technology Attention: Steven Posnack Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, SW Washington, DC 20201 Re: Request for Information Regarding the President’s Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward”Continue Reading »...
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