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Alliance to Medicare: Medical Device Program Represents Step Backward from Previously Finalized Proposal

Published August 29, 2023

On August 28, the Alliance submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the Transitional Coverage of Emerging Technology (TCET) notice. The Alliance supports CMS’ general efforts to bring transparency and expedite coverage for breakthrough devices that represent a therapeutic advance for beneficiaries with a life-threatening or irreversibly debilitating disease. However, the Alliance is opposed to the current TCET proposal, as the end result may restrict rather than facilitate beneficiaries’ long-term access to innovative technologies.

The comments share objections to the agency’s proposed expanded use of coverage with evidence development coverage restrictions, without clear goals for the lifting of these limitations. Our feedback also flags concern with the expanded workload for CMS to provide timely and meaningful coverage determinations under the proposed program, given agency staffing and the exclusion of beneficiaries from the TCET progress.

The Alliance urged CMS to instead restore the prior Medicare Coverage of Innovative Technology (“MCIT”) final rule and presumptively cover eligible Breakthrough Devices for a period of four years (subject to the limitations of the prior final rule). In the absence of this action, the Alliance asked the agency to provide additional information on expectations and standards for the TCET program.

Read the full comment letter.

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