TAG:
clinical laboratory tests
Rural Hospital Group Says Lab Billing Model Is Legal
CEO SUMMARY: In recent years, many rural hospitals have entered into agreements to expand their laboratory outreach businesses. In an interview, the president of the National Association of Rural Hospitals said rural hospitals often bill for lab outreach services under Medicare’s 70/30 …
Theranos News Gets Worse for the Former Silicon Valley Hero
CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ ci…
Holmes, Balwani Indicted by Department of Justice
CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts aga…
How Many Patients Were Harmed at Theranos?
CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the …
Did National Labs Sign Value-based Payer Contracts?
IT IS AN IMPORTANT SIGN OF THE TIMES when press releases about the two new national lab services agreements that UnitedHealthcare just announced with Laboratory Corporation of America and Quest Diagnostics emphasize how value-based programs will be a…
Cleveland Clinic Lab dramatically reduces doctors ordering unnecessary tests
This is an excerpt from a 2,920-word article in the May 7, 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. …
Cleveland Clinic Lab Has Multi-year Test Utilization Success
CEO SUMMARY: Over the 24 months of a first-generation round of laboratory test utilization management projects, the Cleveland Clinic laboratories prevented more than 30,000 duplicate or inappropriate test orders, saving almost $2.7 million. Now implementing a second-generation of labtest …
Response to FDA’s Gottlieb on Reducing Regulatory Burden
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
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…
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…
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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