TAG:
stark act
Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs
This is an excerpt of a 1,385-word article in the March 22, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Dark Report explains how changes to the Stark Law and Anti-Kickback Statute will benefit labs,…
Revised Stark and AKS Rules Are Good News for Labs
CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickb…
Ruling Against UroPath Signals More Fed Action
CEO SUMMARY: It was a signal win for federal healthcare officials when a federal district court judge in Washington, DC, dismissed a case brought by UroPath, LLC. UroPath had sued HHS Secretary Michael Leavitt seeking to challenge the physician fee schedule final order and the anti-markup…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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