IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
Tag: american clinical laboratory
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 request for summary judgment; and most recently ACLA filed its rebuttal to the
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 do so, the agency would work with third parties, such as the
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 used that flawed data to set payment rates
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 of Testing Authorities (NATA). Other pathology labs in Australia are expected to be granted similar authorization in coming
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 forces driving this laboratory to close its nursing home
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. CMS established the 2018 CLFS under the Patient Access to Medicare Act
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.
CEO SUMMARY: This expert analysis shows that laboratories may face an uphill fight
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 disregarded the law’s requirement that all applicable laboratories would
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 faced in the past two decades.
As we have reported,