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Medicare
ACLA Lawyer Says Judge’s PAMA Ruling Is Narrow
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: Many lab professionals were disappointed at the news that a federal judge dismissed the American Clinical Laboratory Association’s arguments in its lawsuit against the federal Department of Health and Human Services (HHS). In an interview, the ACLA’s lead lawyer on the ca…
Two Federal Court Decisions Are Bad News for Labs
By R. Lewis Dark | From the Volume XXV No. 14 – October 1, 2018 Issue
Every pathologist and clinical lab administrator should pay attention to two federal court decisions made recently in two different legal cases. One decision is bad news for the entire clinical lab industry. The other is bad news for lab companies that push compliance with federal anti-kickback laws….
Court Dismisses ACLA Claims in PAMA Case
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
Judge Rules ‘Pull-Through’ Is Illegal Inducement
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: In a ruling issued Sept. 12, a U.S. District Court judge decided that two common clinical laboratory business practices are illegal inducements that can lead to charges of ling false claims. The practices occur when labs pay physicians to package and mail patients’ specimen…
Defunct, Oft-Troubled Calloway Labs Hit with $1.4M Federal Judgement
By Robert Michel | From the Volume XXV No. 14 – October 1, 2018 Issue
HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for busine…
No relief in sight for 2018 Clinical Laboratory Fee Schedule, but critical issues remain
By Mary Van Doren | From the Volume XXV No. 14 – October 1, 2018 Issue
This is an excerpt from a 2,400-word article in the October 1, 2018 issue of THE DARK REPORT. The complete article is available at all times to paid members of the Dark Intelligence Group, and non-members may access one premium article per month. CEO SUMMARY: Many lab professionals a…
Pathology Errors a Factor in 3 Deaths at VA Hospital
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: Outside pathologists are reviewing the pathology reports of almost 20,000 patients of an Arkansas Veterans Administration hospital following termination of a Chief of Pathology who was believed to have handled cases while impaired. Currently, the review identified 256 cases w…
Peeking at Whistleblower Claims: How Labs Induce Physicians
By Robert Michel | From the Volume XXV No. 14 – October 1, 2018 Issue
IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have f…
September 10, 2018 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXV No. 13 – September 10, 2018 Issue
News that a laboratory’s courier truck was high-jacked in broad daylight with patient specimens aboard puts the spotlight on whether the security practices labs use to protect drivers, vehicles, and the patient specimens they may be carrying are adequate. On Aug. 3 in Durham, N.C., a driver of a c…
Biggest Lab Firms Diverge on Hospital Lab Strategies
By Joseph Burns | From the Volume XXV No. 13 – September 10, 2018 Issue
CEO SUMMARY: Almost half of the nation’s hospitals and health systems are rethinking how to use their clinical labs to support clinical and financial strategies. Options range from outright sale of their lab outreach businesses to lab management agreements or joint ventures with one of …
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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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