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…
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…
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…
How Private Payers Audit Labs for Possible Claims Fraud
EDITOR’S NOT…
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 …
Private Health Insurers Are Aware of Problems with CPT Code 81408
EDITOR’S NO…
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…
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…
Smaller Labs Must Verify Z-code Arrangement with Lab Companies
EDITOR’S NO…
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…
CURRENT ISSUE
Volume XXXII, No. 8 – June 2, 2025
The leveraging of data is very important for creating laboratory and healthcare efficiencies. In an exclusive interview with The Dark Report, Bradley Bostic, founder, chair, and CEO of healthcare and laboratory data intelligence Company HC1, discusses trends in healthcare, how to position clinical laboratories as a strategic asset, and ways to analyze diagnostic data to improve efficiency and increase the bottom line.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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