TAG:
lab test
Discovery of Pathology Errors Shows Quality Flaws
MOST PATHOLOGISTS WOULD AGREE THAT PATIENTS AND THEIR PHYSICIANS have every right to expect a timely, accurate lab test result. Stated differently, patients and physicians implicitly trust that a pa…
Legal Briefs Explain Problems with PAMA Implementation
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own reque…
D.C. Circuit Court Reverses Medical Necessity Ruling
MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary. The court also ruled that ordering physicians do not need to determine medical …
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
Anthem Seeks $13.5M from California Hospital
CEO SUMMARY: Anthem charged 37-bed Sonoma West Medical Center in Sebastopol, Calif., of engaging in an improper billing scheme to defraud Anthem and its affiliated Blue Cross and Blue Shield plans. In effect, the charge is a notification to SWMC that Anthem intends to sue SWMC and its…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…
Anthem accuses tiny hospital of pass-through billing scheme
This is an excerpt from a 1,300-word article in the March 5, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: THE…
Two Major, Disruptive Changes Coming to Labs
TWO MAJOR, DISRUPTIVE CHANGES lie ahead for both clinical laboratories and anatomic pathology group practices. Each disruptive factor has nothing to do with how payers select in-network labs or reimburse for lab testing services. Rather, one of these two major changes involves fundamental advances i…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
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Volume XXXII, No. 12 – August 25, 2025
In an exclusive interview, a laboratory industry M&A specialist discusses what’s driving lab outreach sales to national lab companies. Also, The Dark Report analyzes ways in which pathology and clinical labs can profitably partner with pharmaceutical companies.
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