News

  • Comments Regarding CMS Proposed Requirements for the Medicare Incentive Reward Program and Provider Enrollment

    June 27, 2013
      Marilyn Tavenner, Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attn: CMS-1454-P P.O. Box 8013 Baltimore, Maryland 21244-8013 Re: Proposed Rule: Requirements for the Medicare Incentive Reward Program and Provider Enrollment, CMS-6045-P Dear Ms. Tavenner: The American Clinical Laboratory Association (“ACLA”) is pleased to have the opportunity to submit comments on the Centers for Medicare and Medicaid Services’Continue Reading »...
  • Clinical Lab Industry Files Petition Challenging FDA’s Authority to Regulate LDTs

    June 12, 2013
    The American Clinical Laboratory Association (ACLA) June 4 filed a citizenpetition challenging the Food and Drug Administration’s authority to regulate laboratory developed tests (LDTs) as medical devices. ACLA is attempting to head off any effort by FDA to regulate such tests, which currently are regulated under the Clinical Laboratory Improvement Amendments (CLIA) by a different agency, the Centers for Medicare & Medicaid Services. The petitionContinue Reading »...
  • Statement Regarding OIG Report on Medicare Spending on Clinical Lab Services

    June 12, 2013
    Washington, D.C. (June 12, 2013) – The Department of Health and Human Services (HHS) Office of Inspector General (OIG) yesterday released a report, “Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings.” The report examined 20 of the 1100 laboratory test codes (HCPCS) and concluded that Medicare paid “more than other insurers” for these codes. The American Clinical Laboratory Association (ACLA) saw theContinue Reading »...
  • Clinical Labs Industry Files Petition Against Potential FDA Regulation of Laboratory Developed Tests

    June 04, 2013
    Washington, D.C. — The American Clinical Laboratory Association (ACLA) filed today a citizen petition under the Federal Food, Drug, and Cosmetic Act (FDCA) challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) in response to statements that the agency intends to regulate LDTs as “devices” under the FDCA. As detailed in ACLA’s petition, LDTs are in vitro assays that clinicalContinue Reading »...
  • 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 »...
  • ACLA Opposes Further Cuts To Clinical Laboratories In President’s 2014 Budget – Proposal Would Cut Lab Reimbursement By An Additional 14% Over Ten Years

    April 10, 2013
    (Washington, DC) – The American Clinical Laboratory Association (ACLA) strongly opposes a proposal in the President’s 2014 budget that would reduce reimbursement for clinical laboratory services in Medicare by an additional $9.460 billion over ten years, a cut of at least 14% over ten years. This proposal, on top of the cuts already scheduled under current law, would bring total cuts to the ClinicalContinue 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 »...