TAG:
lab risk & compliance
CMS and CDC Consider Major Updates to CLIA Regulations
CEO Summary: CMS and CDC are weighing updates to CLIA that could reshape oversight of laboratory developed tests, AI tools, molecular testing, and clinical laboratory compliance. A healthcare attorney notes that CLIA modernization i…
Polling Data Shows Cracks in Medical Necessity Compliance
CEO SUMMARY: Data gathered from three separate events consistently points to a common problem in clinical laboratories: Nearly one-third of respondents indicated their organizations do not review medical nece…
Federal Shift on Medicaid Fraud Offers Warning to Labs
CEO SUMMARY: While the announcement of the largest autism fraud case in DOJ history doesn’t directly pertain to clinical labs, it still indicates heightened scrutiny of Medicaid-funded healthcare services n…
Federal Shift on Medicaid Fraud Offers Warning to Labs
CEO SUMMARY:While the announcement of the largest autism fraud case in DOJ history doesn’t directly pertain to clinical labs, it still indicates heightened scrutiny of Medicaid-funded healthcare services na…
Expect RESULTS Act Vote by End of the Year
CEO SUMMARY: Evidence at the 2026 Executive War College suggests a coming push in clinical lab advocacy, focusing on the RESULTS Act to establish a permanent, database-driven reimbursement model. Simultaneously, federal regulators have floated the idea of heightened scruti…
Recent OIG Opinion Explores Lab-Urgent Care Arrangement
For decades, the US Department of Health and Human Services’ Office of Inspector General (OIG) has analyzed clinical laboratory business arrangements by asking how much compliance risk they pose. With the release of Advisory Opinion 26-02 on …
Why Labs Must Rethink Audit Readiness in 2026
CEO SUMMARY: Doing everything right is no longer enough to ensure claims are paid. With AI-driven audits on the rise, lab leaders must ensure their organizations can prove compliance—quickly, clearly, and consistently. Based on commentary from RCM experts Ann Lambrix and…
Ruling Limits Lab Onus on Medical Necessity
CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision pr…
Clinical Labs Must Prep for Heightened Audits
CEO SUMMARY: A new report from the Office of Inspector General sheds interesting light on just how much genetic testing has increased among Medicare Part B beneficiaries. With billions of dollars in reimbursement at stake for clinical laboratories, expect federal officials…
PAMA Cuts Averted Until ‘27; Labs Plan Next Move
CEO SUMMARY: Clinical laboratories have again avoided a potential financial disaster, at least for now, after Congress shifted PAMA cuts to test reimbursement rates until January 2027. However, the victory is temporary absent permanent PAMA reform. To that end, laboratory …
CURRENT ISSUE
Volume XXXIII, No. 10 – August 2026
In the August 2026 briefing, The Dark Report explains the relevance behind CMS potentially changing how it pays for “software as a medical service”. Other topics include a look into how health system executives view clinical labs, possible CLIA updates, and a 30/60/90-day approach to reducing reliance on traveling medical lab techs.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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