"We don't anticipate that these changes will impact the coding," says Barbara Veath, senior reimbursement manager for heart failure products with Medtronic Inc. CMS has yet to announce when the coverage goes into effect. In a June 6 release, CMS announced these two indications for ICDs:
Medicare's cost per patient for each ICD implantation is about $40,000, which includes the cost of the device. Physician groups and ICD manufacturers say the coverage won't be enough to help all the patients who need these life-saving devices.
ICD manufacturers Guidant Corp. and Medtronic Inc. asked CMS for expanded coverage, citing positive results from Multicenter Automatic Defibrillator Implantation Trial II (MADIT II).
But the coverage doesn't include all of the participants in the clinical trial. "We are happy to see that an expanded patient population can receive this life-saving therapy; however, we are disappointed that the entire MADIT II population was not included," a Medtronic spokesman says.
CMS will publish coverage details in the Federal Register and will issue instructions to local contractors before the new coverage goes into effect. This normally takes about six months, CMS states.