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Lab Industry Advisor Subscriptions Include
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
Cleveland HeartLab Acquires Proprietary Cardiac Risk Algorithm Technology
By Ron Shinkman, Editor, Laboratory Industry Report The Ohio-based Cleveland HeartLab (CHL) has acquired technology developed by Stanford University that can more accurately predict the likelihood of heart attacks. Known as MIRISK, its nucleus is an algorithm that...
Roche to Take Majority Stake in Foundation Medicine
By Stephanie Murg, Managing Director, G2 Intelligence Roche is betting big on cancer genomics. The Swiss pharmaceutical giant has agreed to acquire a majority stake in Foundation Medicine (Cambridge, Mass.), which uses genetic sequencing to optimize treatment...
Pharmaceutical Company Uses Speaker Fees To Provide Kickbacks
By Christopher P. Young, Editor, G2 Compliance Advisor Pharmaceutical company Daiichi Sankyo Inc. paid $39 million and agreed to enter into a five-year Corporate Integrity Agreement to settle government allegations of using speaker fees and lavish dinners as a...
FDA Workshop Continues the Debate About LDT Regulation
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence The debate regarding FDA regulation of laboratory developed tests (LDTs) continues to swirl as the FDA held a two-day workshop providing a forum for public comment from more than 80 presenters. The...
CDC Seeks Collaborator in Achieving Earlier HIV Detection
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence In keeping with Medicare's expanded coverage of HIV screenings aimed at achieving earlier detection of the virus (see National Intelligence Report, Feb. 12, 2015), the CDC is also focusing on earlier and...
LabCorp Completes $6.2 Billion Covance Acquisition
By Stephanie Murg, Managing Director of Conferences, G2 Intelligence LabCorp (Burlington, N.C.) has become the nation's largest provider of health care diagnostic services with its acquisition of contract research organization Covance (Princeton, N.J.). Announced...
Contractor Issues a Reminder on NPI Change
By Christopher P. Young, Editor, G2 Compliance Advisor Contractors sent all Medicare Part B providers a notice on Feb. 16 reminding them that effective April 1, laboratories submitting claims for reference laboratory or anti-markup tests will no longer include the...