Devices

Senators Ask Standards Group for UDI Use

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have asked the Accredited Standards Committee X12 about steps it is taking to include medical device unique device identifiers on health insurance forms. “Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked and evaluated at the model level, enable the collection and analysis of detailed device and patient data, facilitate outcome comparisons across device models, and protect the integrity of the Medicare program by allowing for faster identification of poorly performing and recalled devices and ensuring that proper reimbursements take place with regard to these devices,” the senators wrote in an 8/29 letter.

The senators ask the standards organization to brief their staffs by 9/9 on:

the process for developing recommended changes to claims forms;
the timeline associated with each stage of the process;
the process for incorporating feedback from members, including on an HHS request that the organization revisit current requirements to support capturing device identifier information on the claims form;
the status of discussions about inclusion of device identifier information in claims for implantable devices; and
the status of discussions about inclusion of device identifier information into claims for reimbursable supplies, such as pre-filled syringes.

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