Medicare should pay for device to fight depression, researcher says

ST. LOUIS -- The federal agency that oversees the government health insurance programs Medicare and Medicaid will announce next month whether to pay for an implantable device designed to treat severe depression.

So far, it has indicated it will not, citing lack of evidence it works.

But a Saint Louis University researcher who says he has seen severely depressed patients improve dramatically with the device strongly disagrees. He says it can save lives.

"It's not a perfect science yet, but while we're working on that, let's help these people out," said Dr. Charles Conway, assistant professor of psychiatry at the university's School of Medicine.

He said as many as 15 percent of people who suffer from a particularly severe form of depression known as treatment-resistant depression die by suicide, and that the government is setting the bar impossibly high for a population with a high mortality rate.

"These are not people who are a little sad," Conway said. "They're debilitated. They're on Social Security disability for their condition. Their lives are completely disrupted. They can't carry on ordinary lives. Suicide attempts and completions are relatively common."

About 4 million Americans suffer from treatment-resistant depression and don't respond to antidepressants or other forms of therapy.

From 2000 to 2003, Conway was the principal investigator at Saint Louis University as part of a 20-site clinical trial on the effectiveness of vagus nerve stimulation for such patients. And he recently received funding to expand his study.

The small stimulation device, like a cardiac pacemaker, is surgically implanted in the chest. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain.

The Food and Drug Administration has approved it to treat seizure disorders, and more recently, severe depression.

Of the 10 subjects enrolled in the St. Louis trial, all of whom had suffered depression more than 15 years, four recovered from all their depression symptoms. Five years later, they remain depression-free, Conway said.

The Centers for Medicare and Medicaid Services cited the multisite national study when it announced in February that there was too little evidence of the device's benefit to warrant Medicare paying for it. The agency is reviewing 800 public comments, and will issue a final decision in May.

"The trial was supposed to demonstrate a certain degree of benefit, and didn't," Dr. Steve Phurrough, director of coverage for CMS, said Monday. "I have to assume it's not doing what it's supposed to do."

He said Medicare doesn't have the legal option to pay for the device for compassionate use.

"We need good trials by good quality organizations ... that demonstrate who benefits if anyone," Phurrough said.

Even if CMS decides in May not to pay for coverage, it will reconsider if new evidence is presented, Phurrough said.

Starting in July, Conway and a colleague at Washington University, mood disorders researcher, Yvette Sheline, will study 20 severely depressed people for five years. They'll use imaging technology at different intervals to see what area of the brain is being activated by the device, and who is likely to respond. The images will be compared to people's moods.

Just how the device works isn't known for sure. It's believed the device electrically stimulates brain neurons which produces mood-altering chemical changes in the brain.