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
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...
CMS Seeking Advice Regarding Molecular Pathology Tests Estimating Cancer Prognosis
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FDA Holds LDT Workshop Amid Flurry of Debate as Comment Period Nears End
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OIG Highlights Sampling Methodology Used in Audits
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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...
Research By Ambry Genetics Expands Links To Breast, Ovarian Cancer Risk
By Ron Shinkman, Editor, Laboratory Industry Report Ambry Genetics, the California-based clinical laboratory, has published data concluding that the genetic risk to breast and ovarian cancer is not confined solely the BRCA gene. BRCA testing has been the gold...
Angels Looking to Fill Funding Gap in Early-Stage Medtech
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Early-stage investment capital is difficult to come by. But, with some notable acquisitions and initial public offerings making headlines in 2014, angel investors are looking with renewed...