News

  • 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 »...
  • Tricare users will soon pay more for some medical tests, maintenance medications only available through mail

    January 13, 2014
    Tricare beneficiaries will soon pay more for some diagnostic genetic tests ordered by their civilian physicians – including procedures used to detect cystic fibrosis or determine cancer treatments – if the Defense Health Agency deems them to be medically unnecessary. Stars and Stripes is reporting Tricare stopped reimbursing clinical laboratories in January 2013 for more than 100 different genetic or molecular pathology tests. The laboratoriesContinue Reading »...
  • MILITARY UPDATE: Some lab fees soon will be billed to Tricare patients

    January 11, 2014
    TRICARE beneficiaries soon will have to pay out of pocket for certain diagnostic genetic tests their civilian physicians order but the Defense Health Agency doesn’t view as appropriate or medically necessary. In January 2013, without notice to beneficiaries or to health care providers, TRICARE stopped reimbursing clinical laboratories for more than 100 different genetic or “molecular pathology” tests. Beneficiaries haven’t complained yet because theContinue Reading »...
  • Some lab fees soon will be billed to Tricare patients

    January 09, 2014
    Tricare beneficiaries soon will have to pay out of pocket for certain diagnostic genetic tests that their civilian physicians order, but that the Defense Health Agency doesn’t view as appropriate or medically necessary. In January 2013, without notice to beneficiaries or to health care providers, Tricare stopped reimbursing clinical laboratories for more than 100 different genetic or “molecular pathology” tests. Beneficiaries haven’t complained yetContinue 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 »...
  • OIG And CMS Permit EHR Donations Through 2021, Except For Labs

    December 27, 2013
    At long last, the Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized regulations amending the Anti-Kickback Statute safe harbor and the Stark Law exception, respectively, for donation of electronic health records (EHR) items and services. As I explained in a previous post, CMS and OIG had proposed to extend theContinue Reading »...
  • Center Medicare and Medicaid Services (CMS), Office of Inspector General (OIG) Extend Electronic Health Records (EHR) Stark Law Exception, Anti-Kickback Safe Harbor Through 2021

    December 26, 2013
    December 27, 2013, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) will publish final rules that extend through December 31, 2021 the existing Stark Law Exception (42 CFR 411.357(w)) and Anti-Kickback Statute Safe Harbor (42 CFR 1001.952(y)) applicable to the donation of electronic health records (EHR) items and services.   December 31, 2021 is theContinue Reading »...
  • A new sunset for EHR safe harbor

    December 26, 2013
    The federal government extended the life of the hospital-physician EHR “safe harbor” by almost a decade, while giving labs a much-sought exclusion. The eight-year-old EHR exemption to the federal physician self-referral and kickback laws have been extended to 2021 by the Centers for Medicare & Medicaid Services (CMS) and the HHS Inspector General. In a year-end set of new regulations, CMS finalized the StarkContinue Reading »...
  • AMP proposes new, service-oriented terminology for high quality laboratory testing

    December 20, 2013
    The Association for Molecular Pathology (AMP) released a special article in the January 2014 issue of the Journal of Molecular Diagnostics titled “Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests”(LDTs). The article was authored by the Laboratory Developed Tests Working Group of the AMP Professional Relations Committee. “The article serves as a re-affirmation of AMP’s continued assertion that the CLIA program, in combination with laboratory accreditation programs andContinue Reading »...
  • BILLINGS, ANDREWS and ADDARIO: Penny-wise, pound-foolish medicine

    December 17, 2013
    Detecting cancer and other serious diseases just got harder, thanks to a shortsighted decision from federal officials. At issue are government payment rates for molecular diagnostic tests — essentially, analyses of changes in a person’s genetic code and how those changes affect the individual’s disease. Earlier this year, the Centers for Medicare and Medicaid Services proposed severely reducing the amount that the government would pay for such tests.Continue Reading »...