Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXXI, No. 3 - February 26, 2024

Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’

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. This is …

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More Labs Recognize Big Changes Are Coming

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’

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

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

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?

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

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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February 26, 2024, Intelligence: Late-Breaking Lab News

Following an investment of $1.75 million, officials at University of Maine at Augusta (UMA) opened a new lab facility this month that allows it to double the number of medical laboratory technicians it can train, from eight to 10 to as many as 20. In its coverage of the new training lab’s grand opening, the …

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