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The Dark Report

Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

Clinical Laboratory / By Robert Michel

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbers reported for test volume and pricing. Quest Diagnostics’ earnings call was first, on Feb. …

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March 18, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

In California last month, Quest Diagnostics entered into a settlement agreement with California Attorney General Rob Bonta and nine local district attorneys. KCRA News of Sacramento reported that the “settlement resolves allegations that the company unlawfully disposed of hazardous waste, medical waste, and protected health information. The illegal disposal was said to occur at all …

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Attorney Discusses Federal Cases Involving EKRA Violations by Labs

Laboratory Compliance / By Robert Michel

IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does not. The federal statutes’ conflicting language on this point created …

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Successful Ransomware Attack Misses Lab Claims

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

HAS ANYONE NOTICED THAT CYBERCRIMINALS ARE STEADILY INCREASING THE SCALE AND MAGNITUDE OF THEIR ATTACKS? The ongoing disruption from the Feb. 21 ransomware attack on Change Healthcare, owned by UnitedHealth Group, has triggered substantial financial losses and major interruptions to the cash flow of hospitals and providers throughout the United States. As you will read …

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More Labs Recognize Big Changes Are Coming

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

ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABORATORY INDUSTRY is to recognize what is different today, compared to the recent past. One source of these insights here at The Dark Report is the many conversations we have as we finalize selecting 140 speakers and panelists to take the podium at 88 sessions …

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Labs Should Prepare for Arrival of ‘Perfect Storm’

Clinical Laboratory Trends / By Robert Michel

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 reforms and updates to the 1992 CLIA rules. …

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HHS Publishes Final Rule for Health IT Interoperability

Laboratory Information Systems / By Robert Michel

THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released its finalized rules for …

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Genetic Testing Firm Invitae Files Chapter 11 Bankruptcy, Pursues Sale

Genetic Testing / By Robert Michel

INVITAE CORP., A MEDICAL GENETICS COMPANY, got the go ahead in mid-February from the U.S. Bankruptcy Court for the District of New Jersey “to find a buyer and exit from Chapter 11 by late July,” Reuters reported. Invitae said in a news release that it was filing for voluntary chapter 11 protection “to safeguard its …

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Is There Evidence That Some Doctors Wish to Use Local Labs?

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. CONVENTIONAL WISDOM HOLDS THAT …

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CMS Issues AI Guidance for Medicare Advantage

Clinical Laboratory / By Mary Van Doren

CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal government is to regulate AI’s role in patient care. Labs have a major …

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