Comments and Letters

  • Citizen Petition to FDA Regarding Laboratory Developed Tests (LDTs)

    June 04, 2013
      Division of Dockets Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD 20852 CITIZEN PETITION The American Clinical Laboratory Association (ACLA) submits this petition under the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) to request the Commissioner of Food and Drugs to take the actions described in Section A with respectContinue Reading »...
  • Letter to CMS Regarding Gap Fill

    April 30, 2013
      Marilyn B. Tavenner Administrator Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services 200 Independence Ave., SW Washington, DC 20201 Dear Administrator Tavenner: We are a coalition of patients, providers, clinical laboratories, diagnostic test manufacturers, pharmaceutical companies, and venture capital investors unified in our concern over interim 2013 Medicare Administrative Contractor (MAC) reimbursement rates for molecular diagnostic testing. ThisContinue Reading »...
  • Letter to Sens Baucus and Hatch Regarding Clinical Laboratory Fee Schedule

    April 16, 2013
      The Honorable Max Baucus Chairman, Committee on Finance United States Senate 219 Dirksen Senate Office Building Washington, DC 20510 The Honorable Orrin Hatch Ranking Member, Committee on Finance United States Senate 219 Dirksen Senate Office Building Washington, DC 20510 Dear Chairman Baucus and Ranking Member Hatch: On behalf of the undersigned organizations—representing America’s community, regional, hospital-based, and national clinical laboratories; the laboratory professionalsContinue Reading »...
  • Letter Regarding Gapfilling for Molecular Pathology Tests

    March 27, 2013
      Mr. Marc Hartstein Director, Hospital and Ambulatory Policy Group Centers for Medicare and Medicaid Services Mail Stop C4-01-26 7500 Security Boulevard Baltimore, MD 21244 RE: Gapfilling for Molecular Pathology Tests Dear Marc: I am writing on behalf of ACLA to follow-up on our prior conversations regarding the gapfilling process for new molecular pathology codes, which CMS has mandated. As you know, in theContinue Reading »...
  • Letter to Chairman Baucus and Ranking Member Hatch Regarding Coinsurance

    March 01, 2013
      March 1, 2013 The Honorable Max Baucus Chairman, Committee on Finance U.S. Senate 219 Dirksen Senate Office Building Washington, DC 20510 The Honorable Orrin Hatch Ranking Member, Committee on Finance U.S. Senate 219 Dirksen Senate Office Building Washington, DC 20510 Dear Chairman Baucus and Ranking Member Hatch: We, the undersigned, applaud your leadership in strengthening the Medicare program for current and future beneficiaries.Continue Reading »...
  • CLC Letter to Sen Baucus Regarding Clinical Lab Fee Schedule

    February 15, 2013
      February 15, 2012 The Honorable Max Baucus United States Senate 511 Hart Senate Office Building Washington, DC 20510 Dear Senator Baucus: The undersigned laboratory and health care organizations, representing America’s community, regional, and national laboratories and the Medicare patients we serve, ask that you oppose any cuts to the Medicare Part B Clinical Laboratory Fee Schedule as you work to address physician payContinue Reading »...
  • Comments on PFS Final Rule for CY 2013

    December 21, 2012
        December 21, 2012   Ms. Marilyn Tavenner, Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attn: CMS-1590-FC P.O. Box 8013 Baltimore, Maryland 21244-8013   Dear Ms. Tavenner:   The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to comment on the “Medicare Program; Revision of Payment Policies Under the Physician Fee Schedule for CY 2013, FinalContinue Reading »...
  • Letter to CMS Regarding Gapfilling

    November 30, 2012
    November 30, 2012   Marilyn Tavenner, Acting Administrator Centers for Medicare and Medicaid Service 7500 Security Boulevard Baltimore, Maryland 21244   Dear Ms. Tavenner: On behalf of the American Clinical Laboratory Association (“ACLA”), I am writing to express our serious concerns about the Centers for Medicare and Medicaid Services’ (“CMS’s” or “the agency’s”) intention to direct the Medicare Administrative Contractors (“MACs”) to use gapfillingContinue Reading »...
  • Letter to Daniel Levinson Regarding LDTs in Work Plan

    November 15, 2012
      November 15, 2012   Mr. Daniel Levinson Office of the Inspector General Department of Health and Human Services 300 Independence Avenue SW Washington, DC 20201   Dear Mr. Levinson:   We are writing with regard to an item in the Office of the Inspector General’s (“OIG’s”) Work Plan for 2013 on oversight of Laboratory-Developed Tests (“LDTs”). The American Clinical Laboratory Association (“ACLA”) isContinue Reading »...
  • Comments on Proposed UDI Rule

    November 07, 2012
        November 7, 2012 BY ELECTRONIC SUBMISSION Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2011-N-0090; RIN 0910-AG31; Unique Device Identification System: Proposed Rule Dear Sir/Madam: The American Clinical Laboratory Association (“ACLA”) is pleased to provide comments to the Food and Drug Administration (“FDA”) on issues related to the proposed rule,Continue Reading »...
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