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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…

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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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Of Theranos, ADLTs, and Surgical Pathology Errors

THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry. Thera…

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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…

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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…

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Genetic Testing Lab Finds Payers Respond To Education on Test Utility

CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…

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Payers Using Two Approaches To Price Molecular and Genetic Tests

EXECUTIVE SUMMARY: This analysis, unique to THE DARK REPORT, contrasts the decision of Palmetto GBA to distinguish between “hotspot” tumor panels (meaning those targeting 5 to 50 genes and 51 or more genes) versus “sequencing” tumor panels in coding and pricing NGS test panels, wi…

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Palmetto GBA Issues Guidance On Billing NGS Test Panels

CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…

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Payers Using Two Approaches To Price Molecular, Genetic Tests

PRIVATE PAYERS AND MEDICARE contractors are taking divergent approaches to establishing coverage policies and setting prices for molecular and genetic tests. That’s what Kuo Bianchini Tong, MS, CEO of Quorum Consulting Inc., sees happening. “One approach seeks to recognize the c…

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New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests

CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…

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