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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
Labs Quickly Move Toward Electronic Reporting of Public Health Information
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Quest, Quintiles Will Create Clinical Trials Joint Venture
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OIG Advisory Opinion Includes Convenience and Efficiency as Potentially Improper Benefits
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OIG Sets Enforcement Sights on Reform Efforts
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Last Minute Efforts to Repeal the SGR are Now with the Senate
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Physicians Sentenced to Prison for Accepting Bribes for Test Referrals
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CMS Withdraws Memorandum, Seeks Public Comment on Blood Glucose Monitoring
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FDA and CMS Announce Joint Task Force Focusing on LDT Regulation
By Kelly A. Briganti, Editorial Director, G2 Intelligence Asserting that the agencies' regulatory roles are not duplicative, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced formation of a joint task...
Investigators Use Cell Phone Records to Help Prosecute Fraud
By Christopher P. Young, Editor, G2 Compliance Advisor Investigators used cell phone location data in over 800 instances to prove that a physician was not present at El Centro Clinic at the time certain tests were administered, as is required by Medicare...
CDC Says 'Steady' Progress Made in Electronic Reporting of Lab Results
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies National implementation of electronic laboratory reporting (ELR) continues to increase, according to a progress report published April 3 in Morbidity and Mortality Weekly Report. The authors...