FDA OK’s, Insurers Pay

When the (registration required) FDA approves new medical devices for specific conditions, insurers are almost always required to cover them. Even if the approval makes no sense, the device fails in clinical trials, and there is no conclusive evidence of its efficacy.
The cost per case for the device and surgery is about $25,000; over 500 implants have been performed to date (the majority during the so-called clinical study).
Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health, approved an electrical stimulator for the treatment of depression, despite the unanimous opinion of the Center’s clinical staff that the device had no discernable impact. A Senate committee investigating the FDA could find
“no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him. “(NYTimes)
In fact, in a study conducted by the device’s manufacturer, the device utterly failed to produce any measurable impact on depression in the study group.
Now that the device is approved for treatment of depression, expect manufacturer Cyberonics to put on a full-court press to get doctors to prescribe it. This over the concerns expressed on the floor of the Senate:
“I am greatly concerned the FDA standard for approval may not have been met here, and if that’s the case it raises further difficult questions about whether Medicare or Medicaid dollars should be used to pay for this device now,” Grassley, an Iowa Republican, said during a speech on the Senate floor.” (Reuters)
What does this mean for you?
More of your dollars spent on highly questionable and really expensive technology.