Congress Archives

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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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

Volume XXXII, No. 6 – April 21, 2025

Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.

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