CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
Tag: laboratory tests
CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additional work ups for a second opinion, some 80%
CEO SUMMARY: In a letter to the Texas Legislature, 20 Texas medical societies say UnitedHealthcare’s BeaconLBS program would be detrimental to patient care. The Texas Medical Association and the Texas Society of Pathologists said they were concerned that the program increases the administrative burden on referring physicians, takes away a physicians’ right to choose a
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number of labs that reported and the volume
CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in revenue during the first two to three years of the Medicare
THROUGHOUT THE WORLD, THE UNITED STATES IS ENVIED for the quality and ready access to medical laboratory tests that it delivers to physicians and their patients. Yes, there are criticisms that healthcare costs too much in this country compared with costs in other nations. But few countries offer both convenient access to testing services and
This is an excerpt from a 3,200-word article in the December 19 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: THE DARK REPORT’S annual list of the Lab Industry’s Top 10 stories for
CEO SUMMARY: In launching BeaconLBS in Texas, UnitedHealthcare included a new, more onerous twist than it used for BeaconLBS in Florida. To be a BeaconLBS in-network ‘lab of choice,’ a lab must be in the lowest quartile for lab test prices. Any lab above the 25th percentile would have to renegotiate its contract with UHC
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab industry that finds itself struggling just
ON THE SUBJECT OF LAB TEST MARKET PRICE REPORTING as required under PAMA, many clinical laboratory executives, pathologists, and industry experts see deep flaws in the process the federal Centers for Medicare & Medicaid Services has established. Yet, CMS itself seems blind to these flaws.
Fortunately, the clinical lab executives are not alone. The Office of