Assessing the Clinical Service & Revenue Issues of the LDT Rule

By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…

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Unpacking the Surprises in the FDA LDT Rule

By R. Lewis Dark | From the Volume XXXI, No. 12 – September 3, 2024 Issue

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

CEO SUMMARY: 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 ho…

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Congressional Subcommittee Hears Testimony on FDA LDT Rule

By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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2024: Year of Decision for FDA Regulation of LDTs

By R. Lewis Dark | From the Volume XXX, Number 18 – December 26, 2023 Issue

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…

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Year’s Top 10 Lab Stories Contain Surprises & Twists

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…

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Congress Averts PAMA Cuts to Lab Test Rates for 2023

By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue

CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….

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2022’s Top 10 Lab Stories Confirm Challenging Times

By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue

CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …

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