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HHS
Providers May Be Ordering Inappropriate Vitamin D Tests
Heightened consumer interest has been driving demand for vitamin D testing in recent years. However, clinical laboratories should be aware that some providers could be ordering the wrong test to measure levels of the vitamin, in part due to the way that online or…
In Earnings Calls, Execs at Quest and Labcorp Push for RESULTS Act
Chief executives at Labcorp and Quest Diagnostics made it clear during recent investor calls that they want Congress to pass the RESULTS Act. The Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act is seen b…
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…
Elizabeth Holmes Seeks Trump Clemency for Conviction
Elizabeth Holmes, the convicted former CEO of Theranos, is again drawing public attention as she seeks clemency from President Donald Trump, reviving interest in one of the most notorious fraud cases in Silicon Valley and clinical laboratory history. …
Office of Inspector General Briefs
Congress Wants Review of Test Fraud As part of a spending bill approved by Congress recently, there is a small provision that hints at future review of clinical laboratory tests by the US Department of Health and Human Services’ Office of Inspector General (OIG)….
Permanent PAMA Reform Must Happen in 2026
Previously, it would have been hard to imagine …
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 …
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
Labs Directly Attack Upcoming PAMA Cuts
CEO SUMMARY: The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA c…
CURRENT ISSUE
Volume XXXIII, No. 4 – March 23, 2026
A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.
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