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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Avellino Expands Gene Testing for LASIK Prep Test
By Ron Shinkman, Editor, Laboratory Industry Report California-based Avellino Labs has expanded its molecular testing menu for patients who are considering lasik or other elective surgeries that will alter the structure of their eyes. Elective laser eye surgery,...
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...
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...