ACLA In The News

  • 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 »...
  • 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 »...
  • Personal genetic tests face sharper scrutiny after 23andMe

    December 11, 2013
    23andMe Inc.’s clash with U.S. regulators over the direct sale of its gene analysis service to consumers signals stiffer oversight of thousands of tests in an industry predicted to increase fivefold in size. The Personal Genome Test from Google-backed 23andMe gives individuals an analysis of their risk of hundreds of diseases based on DNA data. The Food and Drug Administration’s action last month toContinue Reading »...
  • Labs Relieved CMS Halted Plan to Slash Pay for Diagnostics

    December 05, 2013
    Clinical laboratories are relieved that CMS held off on its plan to cap Medicare pay to independent labs at the lower rates paid to hospital outpatient or ambulatory surgery centers for diagnostic tests, which would have cut pay an average of 25 percent for tests that physicians interpret. The lower pay rates would have applied to anatomic pathology services that are commonly used toContinue Reading »...
  • CMS Issues Medicare Physician Fee Schedule Without Finalizing Proposal Most Harmful to Independent Laboratories

    December 03, 2013
    On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the Medicare Physician Fee Schedule (“MPFS”) and other revisions to Medicare Part B for calendar year 2014. As we reported when CMS published the MPFS proposed rule, the changes proposed under the MPFS would have significantlyContinue Reading »...
  • Labs say CMS penalties still too severe on ‘proficiency testing’

    November 26, 2013
    Clinical laboratories and hospitals and systems that own them say the CMS has failed to add enough nuance to the enforcement framework that protects its process for making sure that labs are proficient. In response to lobbying from the industry, Congress acted last year to give the CMS more discretion to determine when labs were intentionally undermining a system in which the CMS sendsContinue Reading »...
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