Lab Risk & Compliance
For AI Regulation, Look to Data Laws, FDA Action
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Stephen Beale | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Mark Terry | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Jillia Schlingman | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Robert Michel | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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…
SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…
How Private Payers Audit Labs for Possible Claims Fraud
By Virchow | From the Volume XXXII, No. 10 – July 14, 2025 Issue
EDITOR’S NOT…
No Surprises Act Sparks a Slew of Court Decisions
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …
Private Health Insurers Are Aware of Problems with CPT Code 81408
By Virchow | From the Volume XXXII, No. 10 – July 14, 2025 Issue
EDITOR’S NO…
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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