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New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks

There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 hours, any cyberattack and the payment of any ransom payments associated with a cyberattack. The …

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Wisconsin Diagnostic Lab’s Alternative Staff Solutions

Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the community to educate recent college graduates and high school students about the …

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Lab Market Is Fragmenting, Creating New Opportunities

Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want specialized expertise and choice. Today’s market for clinical laboratory testing services is fragmenting at a pace that …

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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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Machine Learning Is Ready to Give Clinical Labs New Capabilities

In the second part of an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson explains how new developments in digital technologies will expand the value and role of lab test data. He predicts that labs will use artificial Intelligence (AI)—rooted in machine learning, natural language processing, and neural networks—to create operational efficiencies while …

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Clinisys CEO Discusses Strategic Changes That Labs Need to Make

In an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the main forces transforming healthcare here in the United States and abroad. He connects these trends with advances in cloud-based technology, artificial intelligence, and machine learning. Simpson became CEO and President at lab informatics provider Clinisys in 2017. Since then, he has …

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FDA Releases Proposed Rule to Further Regulate LDTs

The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point. Last week, the agency made the draft rule public, prior to its official publication this week. This move by the FDA—which picked up significant momentum over …

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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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Actions Pathologists Can Take to Protect Their Income

Given that pathology reimbursements are always on the chopping block and labor costs are at all-time highs, it’s understandable that anatomic pathologists today feel a threat to their livelihoods. The Panel of National Pathology Leaders is pointing out steps to protect pathologists’ income that include carefully determining fair market value under Medicare Part A contracts …

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OIG Says Billing Code 81408 Is at Risk of ‘Improper’ Payment

Clinical laboratories may have heard billing code 81408 referred to as “fraudomatic,” and now the Office of Inspector General (OIG) has attached a remarkable number to this problem: $888 million over four years. Payers now have an even greater reason to inspect 81408 claims from genetic testing labs. Reaffirming past reporting here and elsewhere, a …

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