Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Search

Lab Risk & Compliance

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…

Read More



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 …

Read More



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…

Read More



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…

Read More



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…

Read More



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…

Read More



SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

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…

Read More



How Private Payers Audit Labs for Possible Claims Fraud

EDITOR’S NOT…

Read More



No Surprises Act Sparks a Slew of Court Decisions

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 …

Read More



Private Health Insurers Are Aware of Problems with CPT Code 81408

EDITOR’S NO…

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

;