News

  • Clinical Labs Voice ‘Deep’ Concern with Proposed Medicare Fee Schedule

    July 12, 2013
    The American Clinical Laboratory Association said this week it is “deeply concerned” about two types of cuts in a proposed Medicare payment regulation to be published next week in the Federal Register. “First, absent any discussion with clinical laboratories, patients, and other stakeholders, CMS proposes to identify codes and propose revised payments in the Clinical Laboratory Fee Schedule due to ‘technological changes,’” the lobby said in aContinue Reading »...
  • Letter from CLC to HHS OIG Meeting Request

    July 11, 2013
      Daniel R. Levinson Inspector General Department of Health and Human Services Office of Inspector General 330 Independence Avenue, SW Washington, DC 20201 Dear Mr. Levinson: On behalf of the undersigned organizations—representing America’s community, regional, hospital-based, and national clinical laboratories; the laboratory professionals who provide care for the Medicare patients we serve; and diagnostic manufacturers—we write to request a meeting with your office toContinue Reading »...
  • Statement on CMS Proposed Physician Fee Schedule Rule

    July 09, 2013
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) issued the following statement on the proposed rule published today in the Federal Register by the Centers for Medicare and Medicaid Services (CMS), “Medicare Program: Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions for Part B for CY 2014” (the “Proposed Rule”): ACLA is deeply concerned withContinue Reading »...
  • Statement on CMS Proposed Physician Fee Schedule Rule

    July 09, 2013
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) issued the following statement on the proposed rule published today in the Federal Register by the Centers for Medicare and Medicaid Services (CMS), “Medicare Program: Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions for Part B for CY 2014” (the “Proposed Rule”): ACLA is deeply concerned withContinue Reading »...
  • ACLA Submits Comments on Gapfill Pricing for Molecular Pathology Services

    July 02, 2013
    (WASHINGTON, D.C.) The American Clinical Laboratory Association (ACLA) submitted comments today to the Centers for Medicare & Medicaid Services’ (CMS) regarding the agency’s 2013 gapfill pricing under the Clinical Laboratory Fee Schedule (CLFS) for molecular pathology services. For 2013, CMS decided to use the gapfilling methodology to establish payment rates for more than 100 new Tier I and Tier II molecular pathology test codesContinue Reading »...
  • 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 »...