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Labs Should Prepare for Arrival of ‘Perfect Storm’

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

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Who’s For and Against FDA Draft LDT Rule?

CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…

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Google, Epic to Help Hospitals Migrate EHR Data to Cloud

GOOGLE CLOUD OF MOUNTAIN VIEW, CALIF., inked a new deal with Epic Systems designed to encourage healthcare providers to move electronic health record (EHR) data to the cloud. This relationship will include efforts to step up the use of artificial intelligence (AI) an…

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2024: Year of Decision for FDA Regulation of LDTs

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…

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Artificial Intelligence: Now a Priority for Labs

CEO SUMMARY: It’s time to recognize the field of artificial Intelligence as the next major source of disruption. Not only will clinical laboratories, anatomic pathology groups, and diagnostics companies be disrupted by AI-powered technologies, but experts predict that almost eve…

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How Certain Labs Can Crack into Health Plans’ Closed Networks

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed…

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Hospitals, Pharmacies Struggle to Be Profitable

CEO SUMMARY: Pharmaceutical companies may be posting strong growth in revenue and profits. But that’s not true for the nation’s largest retail pharmacy chains. Rite Aid’s Chapter 11 bankruptcy filing earlier this month put a spotlight on financial stress at all the retail pharmacy c…

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FDA Issues Proposed Rule to Further Regulate LDTs

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…

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Lab Data Crucial to Insurer Risk Adjustment Models

CEO SUMMARY: Payers who use risk adjustment models as part of Medicare Advantage need diagnostic data that helps them document ICD-10 diagnoses that earn them higher premium payments for sicker pat…

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Guerrilla Kaizen Events Bring Rapid Change and Cost Savings

CEO SUMMARY: Lean Six Sigma principles are familiar to clinical laboratory and pathology leaders. But a lesser-known offshoot called “guerrilla Kaizen” aims to rapidly identify inefficiencies an…

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