Devices

Grassley, Warren Want UDI in Claims Form

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are asking FDA and HHS officials for information on the progress they have made in adding the unique device identifier (UDI) of medical devices to health insurance claims forms to improve post-market surveillance and curb Medicare waste. Their 3/8 letter reminds officials that in 2007 Congress required FDA to create the UDI system and in 2012 required that the Sentinel Initiative be expanded to medical devices. “Active post-market surveillance of medical devices can help to track product safety and performance, which is critical to public health and safety,” the senators write.

The letter notes that the HHS Center for Medicare and Medicaid Services (CMS) has opposed adding the UDI to claims forms “solely because of the technological challenges associated with the change.” Included with the letter is a preliminary report on an HHS Inspector General study finding that recalls of defective products have likely resulted in millions of claims for monitoring, replacement, and follow-up care at significant costs. “Inclusion of UDI in claims would allow for faster identification of poorly performing and recalled devices,” Grassley and Warren say, “and ensure that hospitals, device manufacturers, and CMS are all receiving proper reimbursement.”

They say that continued CMS opposition is contrary to statements made by HHS secretary Sylvia Burwell before the Senate HELP Committee and note that the opportunity to make changes to the claims form revision due to be implemented in 2021 will soon be gone. “Given the importance of this issue, we hope you will ensure that CMS works collaboratively with FDA and other stakeholders to ensure that the next update of the claims form will incorporate UDIs,” 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

Read more

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