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dark report

CAP Loses Accreditation Clients to Joint Commission

CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hun…

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THE DARK REPORT’s Ranking of 2019’s Top 10 IVD Companies

One trend continues to reshape the in vitro diagnostics (IVD) industry year after year: acquisitions.  Since the 1990s, the biggest IVD companies have frequently used acquisitions to boost their revenue and keep shareholders happy. But acquisition…

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January 27, 2020 Intelligence: Late-Breaking Lab News

In recent weeks, the Supreme Court declined to consider an appeal in a case which challenged a lab company’s patent on a clinical laboratory test. On Jan. 13, the justices rejected the appeal made by Athena Diagnostics, a division of Quest Diagnostics. In an earlie…

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33 Groups Cooperated to Get PAMA-Related LAB Act Passed

>CEO SUMMARY: At the end of 2019, the Laboratory Access for Beneficiaries (LAB) Act became law and addressed two of the three most onerous requirements in the Protecting Access to Medicare Act (PAMA) of 2014. It delays the data-reporting requirements under PAMA, an…

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Details Emerge in KU Hospital Misdiagnosis by Pathology Chair

AFTER A PATIENT FILED A LAWSUIT against a pathologist at the University of Kansas Hospital for fraud and negligence in a case stemming from a misdiagnosis of cancer in 2015, details about a settlement in the case were sealed. Now, some details have come out. Last month, NPR statio…

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Anti-Trust Regulators Opposed Illumina, Pacific Bioscience Deal

IN TWO COUNTRIES, regulators concerned about a possible monopoly of technologies and instruments used in human gene sequencing apparently were a major reason why the $1.2 billion acquisition of Pacific Biosciences by Illumina Corporation will not happen. The two c…

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How Northwell’s Lab Team Demonstrated Value Over 10 Years

CEO SUMMARY: Among hospital administrators, the popular wisdom is that their clinical lab is a cost center. This thinking leads them to consider drastic cost-management strategies that include partnering with commercial labs to manage in-hospital lab testing and the outright sale of lab o…

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Labs May Be Excluded from Revised Stark Law, AKS Rules

This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…

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In LabCorp Case, Judge Upholds Some Claim

CEO SUMMARY: In a federal lawsuit against Laboratory Corporation of America, plaintiffs who were uninsured or underinsured charged the lab company with engaging in “business practices that trick and harass customers into paying excessive prices.” Plaintiffs made this and other claims …

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Lawsuits Allege LabCorp, Quest Overcharged Uninsured Patients

CEO SUMMARY: Court documents filed in U.S. District courts in New Jersey and North Carolina provide details about how each of the two lab companies set lab test prices differently—as much as 10 times higher—for cash-paying patients than for patients who have Medicare, Medicaid, or com…

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