Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
FDA Releases Report Listing 20 Potentially Dangerous Lab Tests
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
By Kelly A. Briganti, Editorial Director, G2 Intelligence Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug Administration...
USPSTF Recommendations Cut PSA Testing; More Personalized Screening Called For
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Prostate-specific antigen (PSA) screening rates, along with the incidence of early-stage prostate cancer, have declined since the 2012 U.S. Preventive Services Task Force (USPSTF) recommendation to...
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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