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Lab Risk & Compliance

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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FDA’s Road to Regulation of Lab Developed Tests

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…

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SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…

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How Private Payers Audit Labs for Possible Claims Fraud

EDITOR’S NOT…

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No Surprises Act Sparks a Slew of Court Decisions

CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …

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Private Health Insurers Are Aware of Problems with CPT Code 81408

EDITOR’S NO…

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Lab News Briefs: Joint Commission, Bon Secours, Anthem, Walmart

Joint Commission Looks at Cyberattacks The Joint Commission issued a Sentinel Event Alert for hospitals to address cyberattacks. The alert pr…

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Big Employers Sue Payers over Price Transparency

CEO SUMMARY: Feeling they’ve been denied access by insurance companies to price data about medical claim payments, self-funded employer plans and unions are taking their health insurance companies…

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Smaller Labs Must Verify Z-code Arrangement with Lab Companies

EDITOR’S NO…

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OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’

CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…

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