Devices

Add Device Identifier to Medicare Forms: Senators

Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have written to FDA commissioner Robert Califf urging that the device identifier (DI) portion of a medical device’s unique device identifier be included on Medicare claim forms. “Given the decades-long effort to include DI information on Medicare claims forms,” the senators’ 10/24 letter says, “we urge your agency to fairly and expeditiously review the stakeholder comments and testimony [from a 6/14 National Committee on Vital and Health Statistics letter] and to give full consideration to the interests of patients and taxpayers in your evaluation.”

Grassley and Warren say the inclusion of DIs on claims transactions “would greatly improve our healthcare system’s ability to identify risks and reach patients who may be affected by device failures, which contribute to serious health problems and impose significant financial costs.”

They further state that including DI in the Medicare claims form remains a top unimplemented recommendation by the HHS Inspector General to reduce fraud, waste, and abuse in HHS programs.

“It is therefore critical for FDA to promptly clarify its strong support for the inclusion of DI information in the Medicare claims, a policy that FDA endorsed as recently as last year,” the letter concludes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome