Issue: Volume XVII No. 14 - October 4, 2010

Early Warning on LDTs and Pre-Authorization

ANY PATHOLOGIST OR LABORATORY MANAGER who considers this to be a quiet time in the laboratory testing industry is setting themselves up for a rude awakening in the not too distant future. Several stories in this issue are written specifically to call attention to major developments in the profession of laboratory testing. First is the …

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Lab Industry Unprepared For FDA Action on LDTs

CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to …

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Many Questions About FDA Regulation of LDTs

CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover …

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Hospital-Owned Medical Groups Serving More Patients Per Doc

IT’S WIDELY KNOWN BY PATHOLOGISTS and laboratory administrators that hospitals and health systems are buying up private medical practices at an accelerating rate. This is a trend that favors hospital laboratory outreach programs, but may not be auspicious for the national laboratories. For this reason, certain findings in the Medical Group Management Association’s (MGMA) latest …

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Systems Approach For Pre-Authorization Of Genetic Tests

CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there is now an opportunity for clinical labs and pathology groups to deliver added …

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Dark Daily

October 4, 2010 “Intelligence: Late Breaking Lab News”

In Hawaii, two competing clinical laboratory companies have joined forces to save a medical technologist (MT) training program from closure. Together, Clinical Laboratories of Hawaii, LLP (CLH–owned by Sonic Healthcare), and Diagnostic Laboratory Services, Inc. (DLS), contributed more than $100,000 to the John A. Burns School of Medicine (JABSOM) at the University of Hawaii at …

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