News

  • 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 »...
  • 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 »...
  • 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 »...
  • 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 »...
  • 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 »...
  • 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 »...
  • Breast Cancer Patients Deserve Better: Policy Must Support Innovation

    October 31, 2013
    October is National Breast Cancer Awareness Month. During this time, those of us in the advocacy community take stock of the millions of lives that have been affected forever by this dreadful disease. Breast cancer ranks second as a cause of death in women. Each year, about 230,000 women, and more than 2,000 men, receive a diagnosis of invasive breast cancer. Cancer survivors, caregiversContinue Reading »...