Reimbursement and Coverage

Clinical laboratories are reimbursed for providing services to Medicare beneficiaries using either the Physician Fee Schedule (PFS) or the Clinical Laboratory Fee Schedule (CLFS), depending on the nature of the service.  In addition, clinical laboratories provide services to beneficiaries of other government programs such as Medicaid, TRICARE and the Federal Employee Health Benefit Plan (FEHBP),…

Clinical laboratories are reimbursed for providing services to Medicare beneficiaries using either the Physician Fee Schedule (PFS) or the Clinical Laboratory Fee Schedule (CLFS), depending on the nature of the service.  In addition, clinical laboratories provide services to beneficiaries of other government programs such as Medicaid, TRICARE and the Federal Employee Health Benefit Plan (FEHBP), as well as commercial plans.

Lab reimbursement in many of these programs has been reduced in recent years, and in the case of the Medicare program, annual cuts are scheduled in current law not only as a result of sequestration, but also through annual cuts built into the Affordable Care Act.

While payments for lab services are being slashed, the costs associated with providing critical laboratory services - including labor, supplies, and transportation - continue to climb.

Although many labs have managed to navigate changes in markets and reimbursement and while still continually improving quality, continued arbitrary and severe payment reductions will result in reduced access to essential tests for critically ill patients, less innovation, more closures or consolidation of businesses, and more people out of jobs.

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  • A Statement from the American Clinical Laboratory Association (ACLA) on the HHS-CMS Final Rule Allowing Patients Direct Access to Personal Laboratory Results

    February 04, 2014
    On behalf of ACLA — a not-for-profit association representing the nation’s leading national and regional clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies – ACLA President Alan Mertz issued the following statement: The ACLA today expressed its support for a new regulation issued by the Department of Health and Human Services (HHS), to be released inContinue Reading »...
  • ACLA Comments on Gapfill Reconsideration Period for BRCA 1 & 2

    January 24, 2014
    January 24, 2014 Mr. Marc Hartstein, Director Hospital and Ambulatory Policy Group Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 31344 MoPathGapfillInquiries@cms.hhs.gov RE: Notification of Reconsideration Period – 2013 Gapfill Payment Amounts Dear Marc, Please accept the comments of the American Clinical Laboratory Association (“ACLA”) on the Notification of Reconsideration Period – 2013 Gapfill Payment Amounts for molecularContinue Reading »...
  • ACLA Letter to CMS Regarding Gapfill Payment Rates for BRCA1 and BRCA2 Sequencing

    December 31, 2013
    Jonathan Blum Principal Deputy Administrator Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 Dear Mr. Blum: On behalf of the American Clinical Laboratory Association (“ACLA”), we are writing to express our strong objection to CMS’s recent action establishing a new reduced price for CPT code 81211 (BRCA1 and BRCA2 sequencing) as part of the gapfill price-setting process. As discussed below,Continue Reading »...
  • New Independent Study Shows Medicare Receives Lower Rates for Clinical Laboratory Services

    December 04, 2013
    Washington, D.C. — Today Avalere Health, a private data analysis firm, released a study that refutes past claims that commercial plans pay lower rates for lab services than Medicare. Instead, the study found that Medicare rates are almost always lower than average rates paid by private plans. Commissioned by the American Clinical Laboratory Association (ACLA), Avalere’s study is the most comprehensive comparison of privateContinue Reading »...
  • Statement from the American Clinical Laboratory Association on Medicare Physician Fee Schedule Final Rule

    November 27, 2013
    Today the American Clinical Laboratory Association (ACLA) commends the Centers for Medicare & Medicaid Services (CMS) for not finalizing a proposal to slash Medicare payments for anatomic pathology services which diagnose breast, colon, prostate, skin, ovarian, leukemia and other cancers. The proposal, included in the CY2014 Physician Fee Schedule Proposed Rule published in July, would have capped Medicare payments to independent laboratories to HospitalContinue Reading »...
  • Comments on Proficiency Testing Referral Sanctions Proposed Rule

    November 15, 2013
    Ms. Marilyn Tavenner, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G, Hubert H. Humphrey Building 200 Independence Avenue SW Washington, DC 20201 RE: CMS-1443-P: Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral;Continue Reading »...
  • Comments Regarding 2013 Final Gapfill Prices

    October 30, 2013
    Mr. Marc Hartstein, Director Hospital and Ambulatory Policy Group Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244 RE: Final 2013 Gapfill Payment Amounts for Molecular Pathology Tests Dear Marc, Please accept the comments of the American Clinical Laboratory Association (“ACLA”) on the final 2013 Gapfill Payment Amounts for Molecular Pathology Tests.1 ACLA is an association representing clinicalContinue Reading »...
  • Comments on CY 2014 CMS Preliminary Payment Determinations

    October 25, 2013
    Mr. Glenn McGuirk Acting Director, Hospital and Ambulatory Policy Group Centers for Medicare & Medicaid Services Center for Medicare 7500 Security Boulevard Mail Stop C4-01-26 Baltimore, Maryland 21244 Re: Centers for Medicare and Medicaid Services Calendar Year 2014 New and Reconsidered Clinical Laboratory Fee Schedule Test Codes and Preliminary Payment Determinations Dear Mr. McGuirk: On behalf of the American Clinical Laboratory Association (“ACLA”), weContinue Reading »...
  • Bipartisan Group of Senators Urge Medicare Officials to Drop Proposal to Cut Payments for Anatomic Pathology Services

    October 18, 2013
    Washington, D.C. — The American Clinical Laboratory Association (ACLA) praises U.S. Senators Amy Klobuchar (D-MN) and Johnny Isakson (R-GA), and 38 of their colleagues for sending a letter this week urging Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner to reconsider cuts to Medicare payments for anatomic pathology services that diagnose breast, prostate, leukemia, and other cancers. Specifically, the letter argues thatContinue Reading »...
  • 115 Members of Congress Urge Medicare Officials to Drop Proposal to Cut Medicare Payments for Pathology Services

    October 10, 2013
    Washington, D.C. — The American Clinical Laboratory Association (ACLA) applauds efforts by U.S. Congressmen Jim Gerlach (R-PA), Bill Pascrell Jr. (D-NJ) and 113 of their colleagues in the House who sent a letter yesterday to Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner requesting a withdrawal of a recommendation in the CY 2014 Medicare Physician Fee Schedule Proposed Rule to cut MedicareContinue Reading »...
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