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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
Circulogene Releases Dipstick Test For Tumor Analysis
By Ron Shinkman, Editor, Laboratory Industry Report Circulogene Theranostics has released a finger-stick test that allows clinicians to monitor the progression of cancer with just a drop or so of blood. The assay will analyze 10 kinds of cancer: Breast, colorectal,...
HCA Agrees to Pay $2 Million to Settle Claims of Unnecessary Lab Tests
By Kelly A. Briganti, Editorial Director, G2 Intelligence HCA Holdings, Inc. (formerly called Hospital Corporation of America) has settled health care fraud allegations relating to diagnostic testing for $2 million—including payment of damages and penalties. The...
Outlook for Medium-Size Labs Continues to Show Promise
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OIG Releases 2016 Work Plan, Again Targeting Laboratory Billing
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CMS Estimates 2016 PFS to Have Positive Impact on Pathology, Independent Labs
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Latest Major False Claims Act Settlement Involves 457 Hospitals in 43 States
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Final Rule Addresses MSSP Self-Referral and AKS Waivers
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23andMe’s Return Signals Expected Growth in DTC Market
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FDA Issues Report Citing Case Studies It Argues Supports Need for More Oversight of LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and...
DNA4Life Is Latest DTC Genetic Test Company to Receive FDA Letter
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Direct-to-consumer startup DNA4Life (Mandeville, La.) is the latest recipient of a letter from the U.S. Food and Drug Administration (FDA) questioning the company's marketing of an unapproved...