February 15, 2005
WASHINGTON, D.C.---Sen. James M. Inhofe (R-Okla.) today announced that after continued discussions between his office and leaders at the Centers for Medicare and Medicaid Services (CMS), CMS will be expanding Medicare coverage of implantable cardiac defibrillators (ICDs) to include patients with a narrow QRS interval, a move expected to save thousands of lives per year.
“After speaking with doctors from Oklahoma, I learned of concerns with a CMS coverage decision based on a major research trial (MADIT II). The trial examined the benefits of Implantable Cardiac Defibrillators (ICDs), phenomenal devices that are close to a cure for the leading cause of death in this country, and yet still remain in the lower range of cost for medical interventions.
“Initially, CMS coverage excluded a significant portion of the trial’s patients-those with a narrow QRS duration. I was concerned that this type of decision-making would lead to the rationing of vital health care instead of allowing statistically valid research to govern coverage guidelines. We must ensure that patients receive the best care possible and that federal bureaucracy does not tie our doctor’s hands. I applaud CMS for their decision to include these patients.” Senator Inhofe’s office highlighted results from a major medical study, MADIT II, which established that patients with a narrow QRS interval also obtain a significant benefit from ICD therapy. Accordingly, Senator Inhofe requested that CMS revisit its prior decision that excluded coverage for ICD therapy for patients with a narrow QRS interval. After meeting with Senator Inhofe’s staff and Oklahoma doctors, CMS now believes that the evidence is sufficient to remove the QRS coverage limitation as part of a new guideline.
CMS stated in their report on ICDs that, “... careful analysis of the new data from this trial in combination with data from all previous ICD trials showed that patients with a certain finding on electrocardiograms of their heart, called a narrow QRS, may also derive a small but measurable, significant benefit from having an ICD.”
For more information on the CMS coverage guideline please visit: http://www.cms.hhs.gov