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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Labs In Court
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HIPAA Compliance: Quest Pays $195K to Settle Class Action for HIV Data Breach
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Compliance Corner: Must Employee Notify Lab of DUI?
QUESTION If one...
Quest Pays $88.7K to Settle Specimen Collection Fee Kickback Charges Against Its Subsidiary
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New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs
In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws to 21st century market conditions,
New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
CMS Delays Controversial Hospital Price Transparency Rules
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Reimbursement: CMS Increases 2020 AIC Medicare Appeal Thresholds
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Quest Shells Out $195K to Settle Massive HIV Data Breach Class Action
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