September 2023

IVD Consolidation Reduces Choices for Labs

Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Today, that consolidation has handed unprecedented economic power to the nation’s two multi-billion-dollar lab corporations and to the IVD manufacturers who sell them automation, analyzers, and tests. …

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Is Lab and IVD Consolidation Ready to Hit the Wall?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in clinical laboratory testing and IVD manufacturing may be close to ending. We present our …

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No Surprises Act Sparks a Slew of Court Decisions

Lab Risk & Compliance, Laboratory Billing, Laboratory Compliance / By Scott Wallask

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 resolution processes are key areas of disagreement between the opposing sides. Pathologists and clinical labs will be affected by the final outcomes of these court challenges. …

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IVD and Lab Consolidation Reduces Choices for Labs

Clinical Laboratory Trends, In Vitro Diagnostics, IVD/Lab Informatics, Lab Marketplace, Laboratory Equipment / By Robert Michel

CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Today, that consolidation has handed unprecedented economic power to the nation’s two multi-billion-dollar lab corporations and to the IVD manufacturers who sell them automation, analyzers, …

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Don’t Automate Bad Work Processes in Microbiology

Lab Intelligence, Laboratory Automation, Laboratory Equipment, People / By Scott Wallask

CEO SUMMARY: Automation is not always right for every lab’s microbiology department, according to consultants from bioMérieux. When evaluating automated instruments, it is necessary to review work flow and manual processes in microbiology to identify inefficiencies. Once those are addressed, automation may be a logical next step. IT’S OFTEN ASSUMED BY CLINICAL LABORATORY LEADERS in …

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Lab Data Crucial to Insurer Risk Adjustment Models

Clinical Laboratory Trends, Lab Intelligence, Laboratory Management / By Scott Wallask

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 patients. Clinical labs have lab test data that can identify undiagnosed disease and share in the higher risk-adjusted payments. IN TRANSITIONING FROM FEE-FOR-SERVICE MODELS TO …

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Private Health Insurers Are Aware of Problems with CPT Code 81408

Lab Intelligence, Lab Risk & Compliance, Laboratory Billing, Laboratory Compliance, Managed Care Contracts / By Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. RECENTLY, THE DARK REPORT …

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UHC Will Delay Enforcement of Z-codes for Genetic Test Claims

Genetic Testing, Laboratory Billing, Managed Care Contracts, Molecular Diagnostics / By Scott Wallask

IN THE LATEST BACKPEDAL ON ITS NEW POLICY, UNITEDHEALTHCARE (UHC) appears to have dropped its requirement for genetic testing laboratories to use Z-codes for claims under commercial health plans—for now. Earlier, we reported that the enforcement date had moved from Aug. 1 to Oct. 1. Since then, the payer has changed language in its guidance …

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

Clinical Laboratory, Lab Risk & Compliance, Laboratory Billing, Laboratory Management / By Scott Wallask

Joint Commission Looks at Cyberattacks The Joint Commission issued a Sentinel Event Alert for hospitals to address cyberattacks. The alert prominently mentions clinical labortory concerns. The alert notes that laboratory systems and other critical technology could be down for four weeks or longer following a cyberattack. “Ensuring access to medical history/results and making sure laboratory, …

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September 11, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Here’s another twist in the saga of Theranos, the defunct and discredited lab testing company. Consumers who received inaccurate results from Theranos’ blood tests may get some measure of justice. Walgreens Boots Alliance agreed to settle a class action lawsuit with these consumers for $44 million, Bloomberg reported on Sept. 7. The proposal, which needs …

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