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 force concerning oversight of laboratory developed tests (LDTs). Responding to criticism that FDA regulation of LDTs is unnecessary due to CMS oversight under the Clinical Laboratory Improvement Amendments (CLIA), the announcement emphasized that…
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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 regulations. Gevorg "George" Kupelian was sentenced to 30 months in custody and ordered to repay Medicare $964,011 after admitting that he set up the southern California clinic for the purpose of defrauding Medicare. Kupelian admitted to…
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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 predict that ELR might reach 80 percent of total laboratory report volume by 2016.
As part of the Affordable Care Act, the U.S. Centers for Disease Control and Prevention (CDC) has provided funds to 57 state, local, and territorial health departments to assist with…
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By Ron Shinkman, Editor, Laboratory Industry Report
New Jersey-based Rosetta Genomics has closed a deal to acquire CynoGen, Inc., which does business as PersonalizeDx, for $3.9 million in cash and stock.
Rosetta acquired PersonalizeDx from California-based Prelude Corp., which had acquired PersonalizeDx from a third party a short time ago.
As part of the deal, Rosetta will gain rights to PersonalizeDx's assay for in situ ductal carcinoma. Rosetta specializes in molecular cancer tests, particularly for…
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