CMS fast tracks breakthrough devices
Medtech innovators and Medicare beneficiaries…it’s time for you to celebrate! CMS has just removed a key barrier that has hindered U.S. physicians and seniors from timely access to critical advancements in medical technology.
Announced earlier this month, the Medicare Coverage of Innovative Technology (MCIT) final rule will provide more than 60 million Medicare beneficiaries access to advanced medical technology faster than ever. Under the MCIT rule, Medicare can provide national coverage for FDA-designated breakthrough devices simultaneous to FDA approval, up to a period of four years. After this period, CMS can determine if it will continue covering the device based on patient outcomes.
“This is a great day for medtech innovators who take chances with bold ideas for the opportunity to address unmet needs in healthcare,” said Laura Nobles, Pazanga Health CEO. “While the details still need to be worked out, such as clarifying Medicare’s rule to only cover items deemed reasonable and necessary, we applaud CMS for recognizing the need to immediately cover these breakthrough technologies and look forward to the benefit it will provide for both physicians and patients.”
Once the final MCIT rule goes into effect, it will also include breakthrough devices that received FDA approval within two calendar years prior to the final rule’s effective date. This gives physicians and their Medicare patients more immediate access to innovative and potentially life-saving devices that might otherwise not be available for another two-to-three years.