TAG:
lab risk & compliance
OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’
CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…
FDA Expected to Publish Proposed LDT Rule in August
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
Proposed Electronic Signature Rule Has Compliance Risks
CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …
CLIA Lab Accreditors Reveal Most Frequent Deficiencies
CEO SUMMARY: CAP, The Joint Commission, COLA, and A2LA took the stage at the recent Executive War College to detail their respective lists of the 10 most often-cited standards during…
Payers Request More Claims Documentation
CEO SUMMARY: Both anecdotal evidence from lab professionals and numbers-based data from XiFin point to a problem: More payers require clinical labs to produce more documentation that a test claim i…
Draft Rule Standardizes Electronic Signatures
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director
TANTALIZING DETAILS ABOUT FORMER THERANOS CEO ELIZABETH HOLMES’ purchase of a one-way plane ticket to Mexico prior to her conviction grabbed headlines following the filing of a motion to appeal her conviction. However, for clinical labo…
Labcorp to Pay $19m to Settle Whistleblower Allegations
LABCORP AGREED TO SETTLE WHISTLEBLOWER ALLEGATIONS that it violated the False Claims Act by allowing its phlebotomists to draw blood from patients when the company allegedly knew kickbacks were behind the test orders for other lab firms. As part of the settlement, Labcorp in Burli…
CLIA on Path to Recognize Lab Data As a Specimen
CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …
CURRENT ISSUE
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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