TAG:

compliance requirements

Several Big Surprises in 2018’s Top 10 Lab Stories

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…

Read More



2019 Outlook: Lab Industry Future Looks Dire, From Reactions to Recent Medicare Fraud Cases to PAMA Reporting and Other Stress Factors

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…

Read More



Peeking at Whistleblower Claims: How Labs Induce Physicians

IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have f…

Read More



Cigna Audits Tox Test Labs For Proof that Patients Paid

CEO SUMMARY: In an unusually strong move, health insurer Cigna is auditing laboratories, including some labs that do toxicology testing. In these audits, the health insurer seeks documentation that the testing is medically necessary and that the laboratories are collecting copaym…

Read More



Theranos: Many Questions, but Very Few Answers

CEO SUMMARY: Winston Churchill famously said that “Russia is a riddle wrapped in a mystery inside an enigma.” That description could apply to Theranos, the company that claims it is poised to disrupt the entire clinical laboratory testing industry. In Phoenix, where Theranos is r…

Read More



Theranos: Many Questions, but Very Few Answers

WHEN A COMPANY THAT GOES PUBLIC WITH ITS GOALS, regularly and repeatedly declaring its lofty ambitions to do good for mankind by disrupting the status quo and replacing it with something new and wonderful, it invites itself to be judged by its actions and what it actually delivers. Since Thera…

Read More



Attorneys Outline Issues in FDA’s LDT Guidance

CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…

Read More



Aetna Files Suit against NJ Lab, Plans to Sue Two More Labs

FINALLY, A MAJOR HEALTH INSURER IS taking a hard line against clinical laboratories it suspects of committing fraud. Aetna Health, Inc., and Aetna Life Insurance Company, of Hartford, Connecticut, have sued one lab company and included physicians as defendants in tha…

Read More



Pathologists Benefit from Hospital Lab Consulting

CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …

Read More



Are Prosecutors Afraid of Big and Little Lab Firms?

CEO SUMMARY: Settlements in the big whistleblower suits involving major lab companies typically generate national headlines. But seldom do the views of the “quiet majority” of lab owners and lab executives get much attention. These are the majority of lab professionals workin…

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.