TAG:
compliance requirements
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…
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…
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…
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…
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…
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…
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…
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…
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 …
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…
CURRENT ISSUE
Volume XXXI, No. 12 – September 3, 2024
This special intelligence briefing—presented in three parts—identifies the factors retarding a faster adoption of digital pathology. Also, how to protect your lab’s proprietary LDTs and assess the financial impact of compliance.
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