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Congress
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…
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…
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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