TAG:
lab industry
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
Cigna Sues HDL, Alleges Unlawful Fee Scheme
CEO SUMMARY: In court papers, Cigna alleged that HDL misrepresented patients’ responsibilities by promising not to collect co-payments, co-insurance, or deductibles. Also, HDL promised not to seek reimbursement from patients for any portion of its bills that the health insurer did not c…
Protecting a Lab’s Access to Patients
TODAY I WANT TO CALL YOUR ATTENTION to a major issue in the lab testing industry that doesn’t get the full attention it deserves at most clinical labs and pathology groups. It is the fact that labs of all types and sizes are losing access to patients. Without access to adequate numbers of patients…
Theranos Pursues Different Business Plan in Arizona
CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…
Did Labs Rip Off Medicare? Feds Are Investigating
CEO SUMMARY: One reason why there is not a level playing field in lab industry compliance with laws governing kickbacks and anti-business behavior is that government officials do not act quickly against the lab industry’s worst offenders—if they take any action at all. News of a feder…
Defining a Path to Clinical Laboratory Best-in-Class via Benchmarks
CEO SUMMARY: With the American healthcare system undergoing a major transformation, it is essential that all clinical laboratories and pathology groups recognize this transformation and effect the right strategies to meet the needs of physicians, patients, and payers. A g…
Labs Wary of BeaconLBS, Express Major Concerns
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a p…
Dealing with Realities of Changing Market
CEO SUMMARY: Swift transformation of the American healthcare system is causing financial challenges for those clinical labs and pathology groups that have been slow to react to these developments. At NorDx Laboratories in Scarborough, Maine, the team is following the classic five rules fo…
Excluding Lab Competitors Helps Big Labs Grab Greater Market Share
CEO SUMMARY: Changes in healthcare are motivating health insurers and the nation’s largest lab testing companies to enter into contracts in which the large lab company lowers its lab test prices to the payer in return for having the payer exclude that lab company’s toughest competitor…
Could Health Insurers Be at War with Clinical Labs?
CEO SUMMARY: It may sound ridiculous to assert that the nation’s largest health insurers are now “waging war” against clinical labs. However, some very smart people in the profession of laboratory medicine are expressing this opinion. To support such a conclusion, they point to paye…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
See the full table of contentsHow 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.