Top Articles
Lab Stakeholders Discuss PAMA Reform
Washington insiders contend that 2025 may be a pivotal year for clinical laboratories to speak up
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
Form I-9 submissions are under a microscope, so laboratories should carefully verify compliance
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...
For AI Regulation, Look to Data Laws, FDA Action
The legal and regulatory landscape for AI use in clinical labs evolves with the technology
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...
Using Sophisticated Schemes, Fraudsters Hit the Next Level
However, federal investigators have proven worthy adversaries, fighting back with bulked-up coordination
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...
Effective Ways to Diminish Staff Recruiting Challenges
Needed are innovative thinking, positive community presence, and early recruiting of the young
Gone are the days when simply relying on basic retention efforts can keep a clinical laboratory operating. Instead, contemporary laboratory managers must take recruiting efforts more seriously, focus on community out-reach and involvement, deve...
National Enforcement Trends Will Test Labs
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Perhaps you saw news coverage recently when the US military dropped a dozen or so “bunker buster” bombs into underground Iranian nuclear facilities. I hawkishly contend that diagnostic lab directors...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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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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