News

  • ACLA Applauds Introduction of Bill Increasing Flexibility of Regulations that Currently Limit Access to Clinical Laboratory Tests

    July 13, 2012
    Washington, DC—The American Clinical Laboratory Association (ACLA) today announced its “full and strong support” for H.R. 6118, the Taking Essential Steps for Testing Act or TEST Act introduced by Rep. Michael Grimm (R-NY) in the House of Representatives. The proposed legislation would address a lack of regulatory flexibility in the Clinical Laboratory Improvement Amendments (CLIA). The bill would grant the Centers for Medicare andContinue Reading »...
  • Letter to Rep. Grimm Regarding TEST Act

    July 13, 2012
        July 13, 2012   The Honorable Michael Grimm United States House of Representatives 512 Cannon House Office Building Washington, DC 20515   Dear Representative Grimm:   The American Clinical Laboratory Association (ACLA) is pleased to offer our full and strong support for H.R. 6118, the Taking Essential Steps for Testing Act or TEST Act. This Bill would make a needed change toContinue Reading »...
  • Comments Regarding ONC RFI – Conditions for Trusted Exchange

    June 27, 2012
      June 27, 2012 Dr. Farzad Mostashari Office of the National Coordinator for Health Information Technology Attn: Governance RFI Department of Health and Human Services Hubert H. Humphrey Building, Ste. 729D 200 Independence Avenue, SW Washington, DC 20201 RE: Nationwide Health Information Network: Conditions for Trusted Exchange, Request for Information Dr. Mostashari, The American Clinical Laboratory Association (“ACLA”) is pleased to submit this responseContinue Reading »...
  • Comments on PRN 2012

    June 13, 2012
      June 13, 2012 Robert Melillo, Chief Legislation and Regulation New Jersey Department of Banking and Insurance 20 West State Street P.O. Box 325 Trenton, New Jersey 08625-0325   Sent via e-mail to: LegsRegs@dobi.state.nj.us RE: PRN 2012-066, Proposed Amendments: N.J.A.C. 11:22-1.1, 1.2, and 1.4   Dear Mr. Melillo,   The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to comment on the above-referenced ruleContinue Reading »...
  • Letter to FACA Program Lead Regarding McCaslin Nomination HITSC 2012

    June 08, 2012
      June 8, 2012   MacKenzie Robertson FACA Program Lead Office of the National Coordinator 355 E Street, SW, Suite 310 Washington, D.C. 20024   Dear Mr. Robertson: American Clinical Laboratory Association June 8, 2012 As President of the American Clinical Laboratory Association (ACLA), I am writing to urge that you appoint a representative of the laboratory industry as a Member to the HealthContinue Reading »...
  • Letter to Jon Blum Regarding Mitchell Study

    June 01, 2012
      June 1,2012   Jonathan D. Blum Centers for Medicare & Medicaid Services Director, Center for Medicare Management Mail Stop 314G 200 Independence Avenue, S.W. Washington, D.C. 20201   Dear Jon: Thank you very much for meeting with representatives of the College of American Pathologists and ACLA last week. We thought it was a very useful meeting and appreciated the opportunity to discuss pathologyContinue Reading »...
  • Comments to HHS on HPID and ICD-10 Extension Proposed Rule

    May 17, 2012
      May 17, 2012 Centers for Medicare and Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: File Code CMS-0040-P RIN 0938-AQ13 Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD-10-CM andContinue Reading »...
  • Comments Regarding Taxable Medical Devices

    May 07, 2012
      May 7, 2012 Steven T. Miller Deputy Commissioner for Services and Enforcement Internal Revenue Service 1111 Constitution Avenue, NW Washington, DC Submitted electronically via www.regulations.gov (IRS REQ-i 13770-JO) Re:       Taxable Medical  Devices;  CC:PA:I2PD:PR  (REC—113770-10). Dear Deputy Commissioner Miller: On behalf of the American Clinical Laboratory Association (“ACLA”), I am pleased to provide these comments in connection with the Internal Revenue Service’s (“IRS”) Notice of ProposedContinue Reading »...
  • ACLA Urges Health Subcommittee to Adopt Provisions on User-Fees and Laboratory- Developed Tests

    May 07, 2012
    Washington DC – The American Clinical Laboratory Association today urged the House Energy and Commerce Health Subcommittee to approve provisions in its device user-fee legislation that would allow HHS to waive user fees for clinical laboratories and lab-developed tests (LDTs), and that would further require FDA to notify Congress 60 days prior to issuing a guidance on the regulation of LDTs. ACLA conveyed itsContinue Reading »...
  • Letter to Chairman Pitts and Ranking Member Pallone Regarding MDUFA

    May 07, 2012
      May 7, 2012   The Honorable Joe Pitts Chairman Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2125, Rayburn House Office Building Washington, DC 20515 The Honorable Frank Pallone, Jr. Ranking Member Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2322-A, Rayburn House Office Building Washington, DC 20515   Dear Chairman Pitts and Ranking MemberContinue Reading »...