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Healthcare Practice Group
January 19, 2026, Intelligence: Late-Breaking Lab News
Entrepreneur Mark Cuban is calling for financial penalties to curb what he describes as systemic overbilling across the US healthcare system, a proposal that could significantly raise the stakes for insurers, hospitals, and clinical laboratories. In a provocative Dec. 24 post on X, Cuba…
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…
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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