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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Medicare and Medicaid Turn 50 Years Old This Week
By Kelly A. Briganti, Editorial Director, G2 Intelligence This week, on July 30, Medicare and Medicaid celebrate a 50th birthday. On that date in 1965, President Lyndon B. Johnson signed legislation establishing those federal health insurance programs. The Centers...
Incorporating HIE Data into Care Cuts Use of Lab Tests
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Leveraging clinical data from a health information exchange (HIE) can significantly reduce the number of duplicate laboratory tests and radiology assessments performed in the emergency room,...
Magellan Obtains FDA Approval for Point-Of-Care Lead Test
By Ron Shinkman, Editor, Laboratory Industry Report Magellan Diagnostics has received 510(k) regulatory approval from the U.S. Food and Drug Administration to market a new point-of-care test that would be used to test lead levels in blood. The test, known as...