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Latest From Sue Darcey
A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.
The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.
US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.
Proposed legislation to make local coverage determinations by Medicare contractors more transparent and inclusive of industry input has been advanced by the US House and now goes to the Senate.
The US Centers for Disease Control and Prevention (CDC) has issued a guidance on diagnosing and treating pediatric mild traumatic brain injury, that advises health care providers to avoid use of computed tomography, MRI, single photo-emission CTs, and skull radiographs in diagnosing kids 18 years and younger.
The House Ways and Means Committee advanced legislation backed by the device industry to improve the transparency and accountability of the process Medicare Administrative Contractors use to make local coverage determinations for new medical technology.