TAG:
the laboratory
Market Price Report Rules Must Address All Issues
CEO SUMMARY: Under the Protecting Access to Medicare Act, CMS must collect market price and volume data from certain labs beginning January 1, 2016. CMS will use this data to establish Part B clinical laboratory fees beginning in 2017. One lab association representing community a…
Florida Lab Story Has National Implications
PLEASE ALLOW ME TO THANK ALL OF YOU READERS who have contacted us with information, rumors, and useful intelligence about UnitedHealthcare’s laboratory benefit management program in Florida that is administered by BeaconLBS, a division of Laboratory Corporation of America. Your input, along with tha…
Gearing Up the Laboratory to Exceed Expectations of External Customers
CEO SUMMARY: This is the third installment of THE DARK REPORT’S description of the Laboratory Value Pyramid. It describes “Level Three: Deliver Value that Exceeds Expectations.” This is the level where the laboratory organization now shifts its emphasis from internal operation of…
Rheumatologists Oppose UnitedHealth’s BeaconLBS
CEO SUMMARY: Yet another specialty society is opposing the laboratory benefit management program UnitedHealthcare introduced in Florida last fall. Rheumatologists have joined four other specialty physicians in saying UHC’s BeaconLBS system could be detrimental to patient care. In…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
December 15, 2014 Intelligence: Late-Breaking Lab News
In certain respects, the noted physician and healthcare strategist Eric Topol, M.D., of Scripps Healthcare in La Jolla, California, can be considered a gadfly to pathology and the laboratory medicine profession. In his latest pronouncements on patient-centered healthcare, he warned c…
LipoScience Could Find No Other Interested Buyer than LabCorp
ONE EXAMPLE OF HOW TOUGH TIMES ARE for companies offering proprietary or patent-protected tests is the acquisition of LipoScience by Laboratory Corporation of America in a deal that was disclosed last September. It was announced that LabCorp would pay $85 million, o…
Labs Share Successes in Delivering More Value
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
Level Two of Value Pyramid Defines Internal Benchmarks
CEO SUMMARY: In this second installment of our series on the laboratory value pyramid, we introduce “Level Two: Establish and Meet Standards of Value.” This second level continues the lab’s focus on its internal operations and activities. The goal is for the lab to develop the working cultu…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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