CMS seeks comments on MRI for patients with ICDs, pacemakers

The Centers for Medicare & Medicaid Services (CMS) opened a national coverage analysis June 28 for MRI for patients with implanted cardioverter-defibrillators or pacemakers in clinical studies.

CMS received a request to reconsider the current National Coverage Determination for MRI and modify the contraindication to coverage for MRI for patients with cardiac devices if the following criteria are met:
  • A clinically-indicated MRI is performed as part of a prospective clinical trial determined to determine the risk of the procedure; and
  • The study is conducted after an Investigational Device Exemption has been approved by the FDA for the proposed research.

The 30-day public comment period is open from June 28 to July 28, and the proposed decision memo due date is Dec. 28.

Comments can be submitted through this website: http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup