In the realm of digital therapeutics, the health care landscape is poised for potential transformation as the Centers for Medicare and Medicaid Services (CMS) could reshape the regulatory environment with its new coverage pathway. CMS’s new pathway Transitional Coverage for Emerging Technologies (TCET) aims to expedite Medicare coverage for FDA-approved breakthrough devices. The voluntary TCET pathway fosters innovation by establishing an efficient and transparent coverage review process, while simultaneously ensuring robust safeguards for the Medicare population. Under this new pathway, manufacturers will have an opportunity to initiate discussions with CMS regarding evidence gaps that may impair Medicare coverage decisions before receiving FDA marketing approval. This early review will allow manufacturers to begin conducting studies that can address the evidence gaps to help improve coverage once the product is available. Learn more here.
Last Updated on January 23, 2024 by Aimed Alliance
