‘A major regulatory win’: Imaging advocates praise new rule enhancing coverage for breakthrough devices
The Medical Imaging & Technology Alliance on Thursday praised a recently issued final rule that will eliminate regulatory red tape slowing coverage of innovative imaging devices and other medical technologies.
Finalized Monday by the Centers for Medicare & Medicaid Services, this rule creates a new pathway to expedite patient access to “breakthrough” devices, as deemed by the U.S. Food & Drug Administration. Typically, there is lag time between when the FDA approves such technologies and Medicare coverage.
“The Medicare Coverage Innovative Technology final rule is a major regulatory win—not only for MITA, which has actively advocated for swifter market access policies, but also for countless American patients who will now have expanded access to innovative, FDA-authorized medical solutions that would otherwise be left in limbo,” Executive Director Patrick Hope said in a statement.
As part of this final rule, once the FDA approves a device as “breakthrough” it will immediately receive national coverage for up to four years. During that period, CMS will specify if additional data is needed to maintain coverage beyond four years. Federal regulators will also reassess devices after the immediate coverage period is finished, using clinical information to approve or deny further reimbursement.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, or AdvaMed, on Tuesday, praised the announcement.
“On behalf of our industry and the potentially millions of seniors who stand to benefit from these lifechanging innovations, we applaud the administrator’s leadership and thank her and her team for taking this important step forward,” he said in a statement.
Both AdvaMed and MITA encouraged the incoming Biden administration to keep this change in place and pledged to work with the President-elect on implementing the new pathway.
“As CMS works to implement this important policy update in the final days of the current administration, we strongly urge President-elect Biden and his health team to uphold this change and continue on the path towards greater patient access to these innovative medical solutions,” Hope concluded.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.