CMS to reimburse for pacemaker MR trials
The Centers for Medicare & Medicaid Services (CMS) has concluded that the evidence supporting the use of MRI in patients with pacemakers is promising though not convincing; deciding to retain its contraindication to the procedure while agreeing to reimbursement for clinical studies investigating the effects of MRI on patients with pacemakers.
The CMS published the decision in response to a letter submitted by Robert J. Russo, MD, PhD, a cardiologist and director of MRI at Scripps Clinic in San Diego, who requested that the CMS both retract its contraindication to MRI for patients with pacemakers and that the CMS provide Medicare coverage for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) that are enrolled in prospective clinical studies evaluating the use of MRI in these patients.
While refusing to rescind its contraindication, the CMS did agree to provide coverage for MRI trials in patients with pacemakers and ICDs, so long as the trial examines MRI’s effect on clinical management, treatment planning or the prevention of diagnostic or therapeutic interventions. Clinical studies evaluating whether MRI effects survival, quality of life or adverse events related to MR will also receive coverage, the CMS said.
Covered trials are subject to 22 conditions and clinical safeguards, including immediate and long-term post-MR follow-up to ensure pacemakers are unaffected as well as availaibility of crash carts in case patients experience significant arrhythmia.
The CMS published the decision in response to a letter submitted by Robert J. Russo, MD, PhD, a cardiologist and director of MRI at Scripps Clinic in San Diego, who requested that the CMS both retract its contraindication to MRI for patients with pacemakers and that the CMS provide Medicare coverage for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) that are enrolled in prospective clinical studies evaluating the use of MRI in these patients.
While refusing to rescind its contraindication, the CMS did agree to provide coverage for MRI trials in patients with pacemakers and ICDs, so long as the trial examines MRI’s effect on clinical management, treatment planning or the prevention of diagnostic or therapeutic interventions. Clinical studies evaluating whether MRI effects survival, quality of life or adverse events related to MR will also receive coverage, the CMS said.
Covered trials are subject to 22 conditions and clinical safeguards, including immediate and long-term post-MR follow-up to ensure pacemakers are unaffected as well as availaibility of crash carts in case patients experience significant arrhythmia.