TAG:
the clinical laboratory
Cleveland Clinic Lab Has Multi-year Test Utilization Success
By Joseph Burns | From the Volume XXV No. 7 – May 7, 2018 Issue
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 …
Cleveland Clinic Lab dramatically reduces doctors ordering unnecessary tests
By R. Lewis Dark | From the Volume XXV No. 7 – May 7, 2018 Issue
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. …
Legal Briefs Explain Problems with PAMA Implementation
By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue
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…
Response to FDA’s Gottlieb on Reducing Regulatory Burden
By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue
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 …
D.C. Circuit Court Reverses Medical Necessity Ruling
By Joseph Burns | From the Volume XXV No. 5 – March 26, 2018 Issue
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 …
A coming transformation: Control over important diagnostic technologies is about to change hands
By Mary Van Doren | From the Volume XXV No. 5 – March 26, 2018 Issue
This is an excerpt from a 2,920-word article in the March 26, 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: He…
Why Pharma, Private Equity Want to Reshape Lab Industry
By Joseph Burns | From the Volume XXV No. 5 – March 26, 2018 Issue
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…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
By Joseph Burns | From the Volume XXV No. 4 – March 5, 2018 Issue
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…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue
“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.” …
Allegations in UHC health insurance fraud case involve multiple defendants
By Mary Van Doren | From the Volume XXV No. 2 – January 22, 2018 Issue
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. …
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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