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Medicare Should Deny Payment for Unproven Anti-Depression Device

Pre-Market Testing Was Flawed, Public Citizen says

WASHINGTON - 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.


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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

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