MITA comments on '21st Century Cures 2.0' discussion

The Medical Imaging and Technology Alliance (MITA) recently published comments regarding the "21st Century Cures 2.0" discussion draft.

The alliance said it supports improved communication between the U.S. Food and Drug Administration and the U.S. Centers for Medicare and Medicaid Services (CMS) regarding breakthrough therapies. It also said such communication needs to establish expectations for how coverage of a product can be achieved.

MITA is urging a "complementary" priority review process for all other devices and procedures within the CMS for its coverage and reimbursement decisions.

MITA was also encouraged to see continued interest in digital health technologies. However, the alliance said more must be done to encourage CMS to implement policies for patient access to digital health technologies, including artificial intelligence (AI). Comment authors wrote that realizing AI's potential will involve an alignment of policy incentives that reward early adoption and ongoing innovation.