February 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

Commentary and Opinion by R. Lewis Dark / 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 / 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 / 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 / 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 / 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 / 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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Lab News Briefs

Clinical Laboratory / Robert Michel

New York Times Reviews DNA Testing Kits for Its Readers It’s a sign of the times when The New York Times considers it useful to conduct and publish a review of DNA ancestry testing kits to guide readers. AncestryDNA of Lehi, Utah, was picked as “the most effective service” for an at-home DNA testing purchase.

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

Late Breaking Lab News / Robert Michel

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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Read the Tea Leaves… FDA Will Require LDT Review

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

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTTON ISSUE within the clinical laboratory industry. Following the close of public comments on Dec. 4, it is the quiet period while the federal Food and Drug Administration (FDA) reviews the comments and considers changes to the draft rule it issued on Sept. 29,

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