TAG:
clinical laboratories
ACLA Files Appeal in Federal PAMA Lawsuit
There is an important new development in the lawsuit in federal court that challenges how the Department of Health and Human Services (HHS) is implementing the Protecting Access to Medicare Act of 2014 (PAMA). An appeal was filed by attorneys representing the American Cli…
No relief in sight for 2018 Clinical Laboratory Fee Schedule, but critical issues remain
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…
Judge Rules ‘Pull-Through’ Is Illegal Inducement
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…
ACLA Lawyer Says Judge’s PAMA Ruling Is Narrow
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…
Court Dismisses ACLA Claims in PAMA Case
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…
Two Federal Court Decisions Are Bad News for Labs
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….
Will Hospital Labs Anchor Integrated Care?
STEP BY STEP, HEALTHCARE IN THE UNITED STATES is moving toward a system in which clinical care is fully integrated and providers are reimbursed for the value they provide. This trend presents clinical laboratories and anatomic pathology groups with a challenge and an opportunity. The challenge comes…
September 10, 2018 Intelligence: Late Breaking Lab News
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
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 …
Pathologists Have Their ‘Carpe Diem’ Opportunity!
FOR MORE THAN TWO DECADES, leaders and forward-thinkers in the pathology profession bemoaned the fact that lab tests and anatomic pathology services were priced as commodities. From the podiums of various lab and healthcare conferences, they urged their peers to identify, document, and educate health…
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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