CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

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The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Get the full story on our sister site, Medical Design & Outsourcing.

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The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Nominees need to be FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October th…

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