TAG:
laboratory tests
SEC Charges Theranos with ‘Massive Fraud’
CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could co…
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…
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 …
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…
Hospital Board Expressed Doubts about Lab Billing
CEO SUMMARY: Pass-through billing arrangements, particularly those involving clinical laboratory tests, have long been recognized by healthcare attorneys as having great potential to violate certain federal and state laws. Despite this fact, board members of a financially-struggling commu…
NEWSMAKER INTERVIEW: Ralph Taylor, CEO of Sysmex America
“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. Core laboratories have something unique and irreplacea…
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.” …
Use of ‘1099 Marketers’ and Lab Compliance Risk
CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements….
Allegations in UHC health insurance fraud case involve multiple defendants
This is an excerpt from a 5,000-word article in the January 22, 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. …
Alberta Health to Build New Lab to Serve Edmonton, Province
FOLLOWING YEARS OF CONTROVERSY associated with different plans to build a large new laboratory facility to serve Edmonton and the surrounding region, Alberta Health Services (AHS) will finance and build the new lab with its own resources. Last month, the Alberta government announced…
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.
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