Lab Risk & Compliance
Hospice Fraud Crackdown Serves as Warning
CEO SUMMARY: Hospice providers were swept into a broad Medicare fraud enforcement effort, and some compliant centers got suspended from Medicare, according to The Washington Post. It’s…
Polling Data Shows Cracks in Medical Necessity Compliance
CEO SUMMARY: Data gathered from three separate events consistently points to a common problem in clinical laboratories: Nearly one-third of respondents indicated their organizations do not review medical nece…
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…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
Immigration Enforcement Considerations for Labs
CEO SUMMARY: ICE audits and immigration sweeps are on the rise and garnering plenty of public attention. There has also been a significant increase in the US government’s budget for immigration and border enforcement. With that in mind, compliance with Form I-9 regul…
Using Sophisticated Schemes, Fraudsters Hit the Next Level
Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…
FDA Issues Proposed Rule to Further Regulate LDTs
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
FDA’s Road to Regulation of Lab Developed Tests
CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…
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.
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