Nov. 11, 2009
Medicare Should Deny Payment for Unproven Anti-Depression Device
Pre-Market Testing Was Flawed, Public Citizen says
WASHINGTON, D.C. – Medicare should deny reimbursement for a medical device for depression that the Food and Drug Administration (FDA) approved despite unconvincing test results, Public Citizen said today in a letter sent to Medicare officials.
“The scant evidence presented for approval of this device does not come close to matching the type of data typically required for approval of anti-depressant drugs” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Medicare should not approve coverage of this unproven device because it could divert patients from more effective therapies.”
The controlled trial submitted to the FDA for approval of Neuronetics’ NeuroStar Transcranial Magnetic Stimulation Therapy System showed that the costly device had no significant clinical or statistical impact in treating major depressive disorder in patients who had not benefited from prior antidepressant medication, Public Citizen said.
Public Citizen’s letter to the Centers for Medicare and Medicaid Services requests that the agency issue a negative “national coverage determination,” which would preclude the agency for reimbursing providers who use the device, saying the device has never met FDA’s effectiveness standard for approval, much less Medicare’s more stringent standard that the device be “reasonable and necessary.”
Neuronetics’ device directs short, alternating bursts of magnetic impulses to the nerve cells in the part of the brain associated with mood regulation. The device initially went through the FDA’s less rigorous 510(k) approval process because Neuronetics claimed that the NeuroStar device was similar to another device the FDA had already approved. Ultimately it was approved through a relatively obscure pathway called de novo.
But Public Citizen’s letter cites the exclusion of six patients from NeuroStar’s controlled trial and statistical manipulations after the trial was completed that skewed the results in the company’s favor.
READ Public Citizen’s letter.