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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…

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GE, UPMC Ending Omnyx, Their Digital Pathology Joint Venture

IN RECENT WEEKS, pathology laboratory clients of the Omnyx digital pathology system learned that the joint venture is ending. Company officials tell these customers that their digital pathology systems will continue to receive service. Omnyx was formed in 2008 as a joint venture bet…

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Score for Theranos after AACC: Fail.

This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …

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Medicare Poised to Hit Pathologists’ Income, Again!

IN JANUARY, THE MEDICARE PROGRAM WILL INTRODUCE a new reimbursement scheme for physicians that will alter the income for every pathologist who treats Medicare patients. Just the fact that th…

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What will the future hold for Theranos?

This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …

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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 …

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CMS CLIA Sanction Letter Sent To Theranos Raises Questions

CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…

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Theranos Now Scrambling To Save What It Can

CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…

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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…

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Cover-Up Charged After Alleged Surgical Pathology Error

CEO SUMMARY: In an explosive civil case, documents show a pathologist erroneously diagnosed a patient as having cancer of an essential body organ and that the organ was removed unnecessarily, stated an attorney for the whistleblower. The patient has not yet been told of the misdiagnosis o…

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