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

Volume XXX, No. 6 - April 17, 2023

HHS Draft Rule Will Standardize Electronic Signatures

TDR Insider / By Robert Michel

Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in missed reimbursements. This situation might change once a proposed rule from the U.S. Department of Health and Human Services is implemented that defines and standardizes physician electronic signatures. …

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What’s Next in 2023 for Clinical Laboratories?

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

AS YOU OPEN THIS ISSUE OF THE DARK REPORT, in New Orleans, about 900 senior lab administrators, executives, and pathologists will be gathered at the 28th annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. One big question that will be asked is: What’s next for clinical labs during the balance of 2023? …

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Draft Rule Standardizes Electronic Signatures

Clinical Laboratory Trends, Lab Risk & Compliance, Laboratory Compliance / By Robert Michel

CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in missed reimbursements. This situation might change once a proposed rule from the U.S. Department of Health and Human Services is implemented that defines and standardizes physician …

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Pathologist Sues Hulu Over Depiction in Theranos TV Series

Clinical Laboratory, People / By Scott Wallask

THERE IS AN INTRUGUING NEW TWIST IN THE LONG-RUNNING SAGA of the now-defunct Theranos. Pathologist and former Theranos CLIA lab director Adam Rosendorff, MD, is taking Hulu to court. Rosendorff, the federal government’s star witness during the fraud trial of former Theranos CEO Elizabeth Holmes, recently issued a court summons to Hulu over the streaming …

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OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens

Lab Risk & Compliance, Laboratory Compliance / By Scott Wallask

CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage patients to return specimens collected at home. However, one healthcare attorney advises labs to read the details of the OIG review carefully. Using …

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Quest Acquires Lab Outreach from New York-Presbyterian

Clinical Laboratory Trends, Lab Marketplace / By Scott Wallask

IT’S THE LATEST DEAL THAT AFFIRMS STATEMENTS by executives of the two largest national labs that hospital CEOs have a growing interest in selling their laboratory outreach businesses. Recently, Quest Diagnostics announced that it will take over the laboratory outreach program at New York-Presbyterian. A joint news release issued on Feb. 14 stated that the …

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Pharmacogenetic Tests Deliver for Avera Health Lab

Clinical Laboratory, Genetic Testing, Lab Intelligence, Molecular Diagnostics / By Scott Wallask

CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians about what they want from genetic tests and master the nuances of getting provider buy-in when launching new genetic tests. INITIAL STRATEGIES USED BY AVERA …

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VA: 120,000 Cancelled Lab Tests Did Not Route to Physicians

IVD/Lab Informatics, Laboratory Information Systems / By Scott Wallask

OFFICIALS FROM THE DEPARTMENT OF VETERANS AFFAIRS (VA) AND ORACLE CERNER found themselves on the hot seat before Congress on March 15, answering questions about problems with deployment of the new electronic health records (EHR) system. One week earlier, the VA had issued a report identifying issues with its ongoing implementation of a new EHR throughout …

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IVD Firms Prepare for OTC, Home Test Market Expansion

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

CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the idea that consumers—at the first sign of symptoms—will want a self-administered respiratory illness test either at home or easily available at a local pharmacy. SOME …

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April 17, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Scott Wallask

There may soon be a new name for the well-known American Association for Clinical Chemistry (AACC). The proposed new name is Association for Diagnostics & Laboratory Medicine (ADLM). As of press time, AACC members were set to vote on the new name on April 21—either in person at AACC’s Annual Membership Business Meeting or online. …

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