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CMS proposes to roll back add‑on payment pathway for breakthrough devices

A photo of the Department of Health and Human Services Seal at the Headquarters of the Centers for Medicare & Medicaid
Photo: Kayla Bartkowski/Getty Images

A proposed rule change would require breakthrough devices to meet the same evidence standards as all other new technologies, reshaping reimbursement incentives starting in 2028.

In a move that could reshape how emerging technologies reach Medicare beneficiaries, the Centers for Medicare and Medicaid Services (CMS) is proposing to eliminate a special reimbursement pathway that has helped fast‑tracked medical devices secure additional payments in hospitals.

The proposal, released as part of the agency’s 2027,

The

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