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McDonald Hopkins
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…
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 …
How Medicaid Cuts May Affect Clinical Labs
CEO Summary: As lawmakers debate the merits of President Donald Trump’s budget bill, it appears that Medicaid changes are on the horizon. For medical laboratories, three immediate areas to monitor include potentially decreased Medicaid recipients, federal cuts to Medicai…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Assessing the Clinical Service & Revenue Issues of the LDT Rule
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
CURRENT ISSUE
Volume XXXIII, No. 9 – July, 2026
Newsmaker Interview with Revvity’s Yves Dubaquie > How Specialty Diagnostic Tests Connect with Lab Customers: In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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