Regulatory Issues

  • Comments on EHR Certification 2014 Edition

    May 04, 2012
      May 4, 2012 Dr. Farzad Mostashari, National Coordinator for Health Information Technology Office of the National Coordinator for Health Information Technology Department of Health and Human Services Attn: 2014 Edition EHR Standards and Certification Criteria Proposed Rule Hubert H. Humphrey Building, Ste. 729D 200 Independence Avenue SW Washington, DC 20201 RE: RIN 0991-AB82: Health Information Technology: Standards, Implementation Specifications, and Certification Criteria forContinue Reading »...
  • Letter to Reps Kind and Price Regarding Health Information Technology Reform Act

    March 14, 2012
      March 14, 2012 The Honorable Ron Kind 1406 Longworth House Office Building Washington, DC 20515 The Honorable Tom Price 403 Cannon House Office Building Washington, DC 20515 Dear Congressmen Kind and Price: On behalf of the American Clinical Laboratory Association (ACLA), I am writing in support of the Health Information Technology Reform Act, HR 4066, which seeks to exclude pathologists from incentive paymentsContinue Reading »...
  • Comments Regarding Sunshine Rule

    February 17, 2012
      February 17, 2012 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS—5060—-P Mail Stop C4—26—05 7500 Security Boulevard Baltimore, MD 21244-1850 RE: CMS-5060-P Transparency Reports and Reporting of Physician Ownership or Investment Interests Dear Acting Administrator Tavenner: The American Clinical Laboratory Association (ACLA) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS)Continue Reading »...
  • 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 »...
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