On October 28, 2025, CMS issued an NCD that covers FDA approved cardiac contractility modulation (CCM) for heart failure under Coverage with Evidence Development (CED) when furnished in accordance with the coverage criteria specified in the NCD. The complete NCD decision memorandum is available on our website (see link below).
https://www.cms.gov/medicare-coverage-database/view/ncacal- decision-memo.aspx?proposed=N&ncaid=317
Below is a list of studies that have been determined to meet the requirements for coverage under CED.
Study Title: BRIGHTEN-HF Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Sponsor: Impulse Dynamics
Clinicaltrials.gov number: NCT07209098
CMS Approval Date: 11/06/2025
Page Last Modified:
11/10/2025 11:22 AM