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Legal Briefs Explain Problems with PAMA Implementation

CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own reque…

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FDA’s Gottlieb Favors Flexibility with LDTs, NGS

CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…

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ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates

CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…

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January 22, 2018 Intelligence: Late Breaking Lab News

In a first for Australia, a pathology lab was given authorization to use patient-collected cervical specimens from eligible women for cervical cancer screening purposes. VCS Pathology of Melbourne, Victoria, was given this authorization by Australia’s National Association o…

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Lab Executives Declare Concerns about Fee Cuts

CEO SUMMARY: Members of Joint Venture Hospital Laboratories in Michigan anticipate that the 2018 Clinical Laboratory Fee Schedule rates being implemented under PAMA will lower payment from Medicare to less than the cost of running tests, especially for rural and critical access hospitals….

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Medicare Fees Less Than Lab Costs to Serve SNFs?

CEO SUMMARY: Anticipating the negative financial impact of the Medicare 2018 Clinical Laboratory Fee Schedule, a community lab company serving 24 nursing homes on the Jersey Shore stopped offering such services at the end of last year, a lab director told THE DARK REPORT. “The same forc…

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What’s in the cards for ACLA’s PAMA-CMS lawsuit?

This is an excerpt from a 2,580-word article in the January 2, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …

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Helping You Plan Your Lab’s Financial Future

WE ARE NOW IN THE NEW YEAR and the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS) is a reality. The dramatic price cuts that the federal Centers for Medicare and Medicaid Services has enacted is the single most disruptive financial event the clinical laboratory industry has fa…

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ACLA Suit Challenges HHS’ Data-Collection Efforts

CEO SUMMARY: In a lawsuit filed last month, the American Clinical Laboratory Association charged that HHS failed to comply with the statutory requirements of the Protecting Access to Medicare Act of 2014 when setting the 2018 Clinical Laboratory Fee Schedule. In the lawsuit, ACLA said HHS…

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ACLA Sues HHS over Market Price Study, Fee Cuts

IT’S A LONG-AWAITED DEVELOPMENT! Today, a federal lawsuit was filed against the Department of Health and Human Services (HHS) by the American Clinical Laboratory Association (ACLA). The lab association is asking a federal judge to review specific actions taken by …

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