Don’t Pass Up Chance to Steer LDTs, PAMA Reform

By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue

CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…

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LDT Oversight May Fall to Congress, CLIA

By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue

CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…

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Enjoy the LDT Court Victory, Yet Remain Vigilant

By R. Lewis Dark | From the Volume XXXII, No. 6 – April 21, 2025 Issue

  VICTORY IN COURT! FOR AN INDU…

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With LDT Rule Vacated, Labs Await FDA Retort

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

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OIG Issues New Report on Medicare 2023 Lab Spend

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…

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Using AI to Predict Outcomes in FDA LDT Lawsuits

By R. Lewis Dark | From the Volume XXXII, No. 1 – January 6, 2025 Issue

Given the popular sentiment that artificial intelligence (A…

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Once Again, Congress Acts to Defer Medicare Lab Fee Cuts

By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue

LAST MONTH, CONGRESS ONCE AGAIN DEFERRED MEDICARE REIMBURSEMENT CUTS OF UP TO 15% f…

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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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