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2015’s Top 10 Lab Stories Show Significant Changes

CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…

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Price Cuts, Long Delays in Payment Are Expected – December 31, 2012

CEO SUMMARY:  In addition to a steep cut in the 88305 CPT code, anatomic pathology laboratories can expect cuts in the payment from Medicare for molecular and prostate biopsy testing. Two national experts in lab billing and reimbursement warn labs to expect confusion in how both pub…

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State of Clinical Lab Industry Likely to Be Mixed in 2016

CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…

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Toxicology Lab Millennium Pays $256M to DOJ, Files For Bankruptcy

IN ANOTHER MAJOR LAB FRAUD CASE, toxicology lab company Millennium Health will pay $256 million to settle allegations in a whistleblower lawsuit that it overbilled federal healthcare programs for unnecessary lab testing. Just 22 days after this agreement, Millennium Health filed a pe…

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Will 2016 Bring Opportunity or Tribulations for Labs?

WE ARE JUST ABOUT EIGHT WEEKS FROM THE ADVENT OF 2016. Given the rapid transformation of healthcare that continues to unfold, it is timely to assess how clinical labs and pathology groups are likely to fare during the coming year. On the plus side, the ongoing evolution toward integration of clinica…

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Protecting Access to Medicare Act of 2014: Will price reporting rule drive small labs out of business?

This first assessment of the PAMA (Protecting Access to Medicare Act of 2014) proposed rule on market reporting of lab prices gives pathologists and lab executives insights about the good, the bad, and the…

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Labs Have Questions for CMS on Proposed Rule

CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…

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CMS Releases Draft of PAMA Market Price Rule

CEO SUMMARY: CMS’ proposed rule details how it will collect private market data, then use that data to establish prices for the Medicare Part B Clinical Laboratory Fee Schedule beginning in 2017. The proposed rule will limit data reporting to les…

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New Developments in $1 Billion Lab Fraud Case

CEO SUMMARY: Court documents filed last month in the federal qui tam case against Health Diagnostic Laboratory, Singulex, Berkeley Heart Lab, BlueWave Healthcare Consultants, and several lab executives allege that the defendants used illegal inducements and kickbacks to file false c…

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Lab Briefs

QUEST SETTLES TEST-PRICING CASE WITH FOUR CALIFORNIA LABS LAST WEEK, A CALIFORNIA JUDGE APPROVED the settlement of a lawsuit that claimed Quest Diagnostics Incorporated had violated a state law that forbids selling services (in this case, lab testing) below cost. In a deci…

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