Regulatory Issues

  • Comments on J11 Draft LCD for Molecular Diagnostic Tests

    January 16, 2012
      January 16, 2012 Dr. Elaine Jeter Medical Director Palmetto GBA (J11 MAC) P.O. Box 100190 Columbia, South Carolina 29202 RE: Palmetto GBA Draft Local Coverage Determination (LCD) for Molecular Diagnostic Tests (MDT) (DL 32394) Dear Dr. Jeter: The American Clinical Laboratory Association (“ACLA”) hereby submits comments on Palmetto GBA’s (“Palmetto’s”) Draft Local Coverage Determination (“LCD”) for Molecular Diagnostic Tests.1 ACLA is an associationContinue Reading »...
  • Letter to CMS Regarding Saturation Biopsy

    December 10, 2011
        December 10, 2011   Mr. Marc Hartstein, Acting Director Hospital and Ambulatory Policy Group Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244   Dear Mr. Hartstein:   On behalf of the American Clinical Laboratory Association (“ACLA”), I am writing to express our concerns about CMS’s recent actions with respect to HCPCS code G0416, which isContinue Reading »...
  • Letter to Chairman Camp and Ranking Member Levin Regarding TC “Grandfather” Provision

    December 07, 2011
      December 7, 2011 The Honorable Dave Camp Chairman House Committee on Ways and Means Washington, DC 20515 The Honorable Sandy Levin Ranking Member House Committee on Ways and Means Washington, DC 20515 Dear Chairman Camp and Ranking Member Levin: The undersigned organizations, representing laboratories, hospitals, laboratory professionals, physicians, and the patients we serve, urge you to extend an expiring provision that would ensureContinue Reading »...
  • Comment Letter on Palmetto LCD for Molecular Diagnostic Tests

    December 02, 2011
        December 2, 2011   Dr. Elaine Jeter, Medical Director Mr. Michael Barlow, Vice President Palmetto GBA (J1 MAC) P.O. Box 100190, AG 300 Columbia, South Carolina 29202-3190   RE: Palmetto GBA Draft Local Coverage Determination (LCD) for Molecular Diagnostic Tests (MDT) (DL 32288)   Dear Dr. Jeter and Mr. Barlow:   The American Clinical Laboratory Association (“ACLA”) hereby submits comments on PalmettoContinue Reading »...
  • Comments on HHS Proposed Rule on Patient Access to Test Results

    November 14, 2011
      November 14, 2011   Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue S.W. Washington, DC 20201   RE:      BIN 0938-AQ38; CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports; Proposed Rule Dear Sir or Madam,   The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to comment onContinue Reading »...
  • Letter On Implementation of Meaningful Use 2 and re-implementation of Meaningful Use 3

    October 31, 2011
    October 31, 2011   Farzad Mostashari, MD, ScM Office of the National Coordinator for Health Information Technology U.S. Department of Health and Human Services 200 Independence Avenue S.W. Suite 729-D Washington, D.C. 20201   RE: Implementation of Meaningful Use 2 and re-implementation of Meaningful Use 3   Dear Dr. Mostashari,   The American Clinical Laboratory Association (ACLA) is an association representing clinical laboratories throughout theContinue Reading »...
  • 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 »...
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