TAG:
clinical lab
Lab Professions ‘Haves,’ ‘Have Nots,’ and Thieves
ONCE AGAIN, THE LATEST NEWS OF IMPORTANCE in the clinical laboratory industry includes disparate topics that include legal/regulatory, new technology in anatomic pathology, fraud involving lab testing, and more consolidation in the in vitro diagnostics (IVD) industry….
Restitution and Guilty Plea in Two Lab Fraud Cases
CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…
Despite COVID-19, Regular Lab Testing Expands
TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are sh…
Understanding Key Parts of New AKS, Stark Law Rules
CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…
COVID-19 Variant Sequencing Offers Clinical Opportunities
This is an excerpt of a 2,987-word article in the March 1, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and fou…
SARS-CoV-2 Variant Sequencing Offers Clinical Opportunities
CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and found multiple uses for such test results to help hospitals, health systems, schools, and municipalities identify infection sources and track the virus’ spread. In one case,…
Pathologist’s Prison Term Is a Warning for AP Groups
CEO SUMMARY: In January, a former VA pathologist was sentenced to 20 years in federal prison following his conviction on charges of involuntary manslaughter and mail fraud. The facts in this case show why leaders of clinical labs and pathology groups need to be aware of individuals …
Hospitals Say New UHC Policy on Lab Network Is Anticompetitive
IT’S NOT OFTEN THAT HOSPITAL ASSOCIATIONS WILL DIRECTLY OPPOSE the changes that health insurers want to make in how they pay for clinical laboratory tests. But that is now happening with UnitedHealthcare’s new lab test payment policy that directly reduces what many hospital labs are paid fo…
CAP Loses Accreditation Clients to Joint Commission
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hun…
Academic, Commercial Collaboration for Testing
CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, t…
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.