Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
CMS Estimates 2016 PFS to Have Positive Impact on Pathology, Independent Labs
By Kelly A. Briganti, Editorial Director, G2 Intelligence This past year brought many unwelcome reimbursement developments—most notably, the initial steps to implement PAMA; but it also included the repeal of the dreaded Sustainable Growth Rate. The Centers for...
OIG Semiannual Report to Congress Highlights Fraud Recoveries
By Kelly A. Briganti, Editorial Director, G2 Intelligence The OIG released its Semiannual Report to Congress detailing its program integrity and oversight activities for the second half of the 2015 fiscal year (April to September) and highlighting its...
Use of “Contingent” Workers Under Scrutiny: Carefully Classify Your Workers
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Healthcare Sector Fares Well in GAO Review of Cybersecurity Progress
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T2 Biosystems Has Strong Diagnostic Tool in Fight Against Sepsis
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Quest Acquires Hartford HealthCare Outreach Business
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UCSF Launches Center to Focus on Genomic Medicine
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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...