CMS has proposed a voluntary Transitional Coverage for Emerging Devices pathway to speed up Medicare coverage for breakthrough medical devices. The program allows coverage while evidence of their effectiveness is gathered. CMS aims to address concerns raised about the previous expedited coverage process, ensuring a balance between timely access to innovative technologies and rigorous evaluation. The proposal reflects CMS’s commitment to evolving policies and streamlining the pathway to Medicare coverage for breakthrough devices.
CMS (Centers for Medicare and Medicaid Services) has put forth a proposal to establish a novel pathway for Medicare coverage of groundbreaking medical treatments labeled as breakthrough devices. This initiative, known as the Transitional Coverage for Emerging Devices pathway, was outlined in a fact sheet released on June 22. While participation in the program is voluntary for manufacturers of these devices, it aims to enable Medicare coverage for new devices during the collection of evidence regarding their effectiveness.
The primary objective of this rule is to expedite the typically sluggish approval process for Medicare coverage. A survey conducted in 2022 among professionals in the medical device industry revealed that it took an average of 4.7 years for newly approved devices to receive national Medicare coverage after obtaining FDA approval. Recognizing the need for a more efficient approach, CMS intends to implement this pathway to hasten access to Medicare coverage for breakthrough devices.
It is noteworthy that in 2021, CMS rescinded a previous rule that aimed to expedite coverage for breakthrough devices. The decision was made due to concerns that the process did not adequately evaluate the effectiveness of these devices. The Transitional Coverage for Emerging Devices pathway is a new attempt to address these concerns and provide an improved framework for assessing the value and impact of breakthrough devices.
By introducing this voluntary program, CMS aims to strike a balance between timely access to innovative medical technologies for Medicare beneficiaries and ensuring rigorous evaluation of their clinical effectiveness. This proposal reflects the agency’s commitment to evolving its policies to keep pace with advancements in medical technology and streamline the pathway to Medicare coverage for breakthrough devices.