TAG:
HHS
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 …
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…
CURRENT ISSUE
Volume XXXIII, No. 8 – June, 2026
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
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