TAG:
the clinical laboratory
Labs Caught Between Employer Hammer, Payer Anvil
STARTING ON JANUARY 1, 2017, THE CLINICAL LABORATORY INDUSTRY will undergo a new experiment in price-setting (and price-cutting) by the federal Centers for Medicare & Medicaid Services. On that date, certain labs must begin reporting market price data for each test and each payer…
Anatomic Pathology Profession Faces Challenges, Opportunities
CEO SUMMARY: For 10 years, three primary trends have reshaped the anatomic pathology profession. They are declining reimbursement, competition from physicians establishing in-office pathology labs, and a host of new government laws and regulations. More changes are coming, predicts one bu…
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…
What Is CAP’s Role When Lab Has a Serious Medical Error?
IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed. And the story doesn’t end there. It is …
ADLT Final Rule Creates Tough Questions for Labs
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
PAMA Final Rule a Threat To Community Lab Survival
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
Lab, Emergency Department at Cleveland Clinic Collaborate to Reduce Hemolysis Rates
CEO SUMMARY: Two years ago, the rate of hemolysis in blood drawn in the Cleveland Clinic’s Emergency Department was about nine times higher than the ASCP recommended rate of 2%. With a two-year cooperative agreement and funding from the federal Centers for Disease Control and Prevention…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
Theranos Saga Just Keeps Getting More Intriguing
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
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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