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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
Joint Statement Calls for Education Regarding Expanded Carrier Screening
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies A new joint statement has been issued by five medical societies regarding use of expanded carrier screening in reproductive medicine. The paper, published in Obstetrics & Gynecology, does...
Genomic Profiling Shows Promise for Personalized Approach to Cancer of Unknown Primary Site
By Stephanie Murg, Managing Director of Conferences, G2 Intelligence Last Thursday marked the debut of JAMA Oncology, which will be published online each week before premiering as a monthly formal print/online issue beginning in April, and among the first published...
Laboratory Fees Reduced in 2015
By Christopher P. Young, Editor, G2 Compliance Advisor While a quarter of a percent reduction in laboratory fees in 2015 doesn’t sound like much, when spread over thousands of tests it can have a meaningful impact on a laboratory’s bottom line. Centers for Medicare...
Biotech Industry 'Shatters' Records in 2014
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The biotechnology industry closed 2014 breaking records in many key financing categories, including private venture capital investment and initial public offerings (IPOs). While exact...
California Pathology Practice Admits To Balance-Billing Patients
By Ron Shinkman, Editor, Laboratory Industry Report A San Diego-area pathology practice was recently cited by California regulators for years of billing hospital emergency room patients for sums they were not legally obligated to pay. North Coast Pathology Medical...
Quest CEO Outlines Growth Strategies for a Changing Market
By Stephanie Murg, Managing Director, G2 Intelligence The nation’s largest provider of laboratory services is not waiting to react to the changing dynamics of healthcare but is balancing aggressive cost-cutting with a decisive focus on diagnostic information...
FDA to Hold Public Workshop on Next Generation Sequencing
By Kelly A. Briganti, Editorial Director, G2 Intelligence Next Generation Sequencing (NGS) diagnostic tests bring incredible opportunities for patient care, yet at the same time present significant challenges for oversight. Recognizing these challenges and...
CMS Says More Data On the Way
By Christopher P. Young, Editor, G2 Compliance Advisor In spite of objections from the American Medical Association (AMA), a Centers for Medicare and Medicaid Services (CMS) spokesperson told a Wall Street Journal (WSJ) reporter that it intends to publish annual...
Laboratory Medicine Shifting Away from Academic Orientation
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Increasingly, the practice of laboratory medicine is burdened by administrative responsibilities leaving less time for research among academic clinical chemists (laboratory physicians and...
Guilty Pleas In Biodiagnostic Case Reach 35
By Ron Shinkman, Editor, Laboratory Industry Report A Jersey City, NJ physician has become the latest person to plead guilty for his part in a kickback scheme involving Parsippany, NJ-based Biodiagnostic Laboratory Services. Anthony DelPiano, M.D., admitted in...