The current administration’s proposed budget for 2020 includes allowing Medicare patients to benefit from more and longer access to “breakthrough” medical devices, and the industry could not be happier.
“Currently, the latest innovations that FDA designates as ‘breakthrough’ devices — those that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions — have an expedited path to market. But there is no equivalent path at CMS (Centers for Medicare and Medicaid Services) so these important technologies can efficiently obtain coverage and get to the patients who need them,” Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed) said in a statement released March 11.
The president’s proposed budget would change that, allowing Medicare to pay for up to four years of a covered patient’s use of a breakthrough device.
Breakthrough devices are those designated by the U.S. Food and Drug Administration to be somewhat fast-tracked through the approval process (this does not mean they are guaranteed approval) because of their medical importance and potential to relieve diseases or debilitating conditions. Companies that develop breakthrough devices are matched with FDA staffers that help expedite the regulatory process.
While final approval can take longer because of the possibility of unforeseen complications, the FDA says, individuals who cannot avail themselves of currently available treatments receive the benefit of new and innovative technologies.
“The Administration’s FY 2020 budget plan to provide Medicare coverage for up to four years to beneficiaries participating in clinical trials of FDA-designated breakthrough devices is an important step toward providing patients expedited access to these life-saving devices. In addition, the plan will incentivize companies to continue to develop these breakthrough devices,” Whitaker’s statement continued.
