Psychiatr News March 2, 2007
Volume 42, Number 5, page 2
© 2007 American Psychiatric Association
VNS Hits Government Snags
Cyberonics Inc.'s vagus nerve stimulation (VNS) device was dealt two
significant regulatory blows over the past two months from the Centers for
Medicare and Medicaid Services and the Food and Drug Administration.
In a "Proposed Decision Memorandum" released February 5, the
Medicare Coverage and Analysis Group at the Centers for Medicare and Medicaid
Services (CMS) proposed that the federal health insurance program adopt a
"national noncoverage determination" for VNS.
CMS said the decision to not cover the average $15,000 cost of the device,
plus an additional $10,000 in surgical and hospitalization costs associated
with its implantation, was based upon the Medicare board's finding that VNS is
"not reasonable and necessary for treatment of resistant
depression."
Two weeks earlier, the Food and Drug Administration (FDA), during a public
meeting of the agency's Neurological Devices Panel, reviewed the status of
postapproval studies the agency had required Cyberonics to conduct as a
condition of the device's initial approval in 2004. FDA officials noted that
Cyberonics' efforts to complete the requested studies appeared to be on track
but expressed concern over several barriers that could hamper Cyberonics'
ability to complete the studies. These include the high cost of the device and
its implantation and the lack of coverage by major third-party
payers—perhaps including Medicare.
In February 2005 the FDA issued an approvable letter for VNS for
treatment-resistant depression and conditioned final approval on the
completion of a one-year, randomized, dose-ranging study and a five-year
observational registry study. The FDA granted final approval on July 15, 2005,
for the use of VNS as an "adjunctive long-term treatment of chronic or
recurrent depression for patients 18 years of age or older who are
experiencing a major depressive episode and have not had an adequate response
to four or more anti-depressant treatments" (Psychiatric News,
August 19).
According to Cyberonics, since the device's approval for
treatment-resistant depression, approximately 2,200 patients have been treated
with VNS, and about 280 insurers have provided coverage on a case-by-case
basis.
Richard Rudolph, M.D., Cyberonics' chief medical officer, told members of
the FDA's Neurological Devices Panel that the randomized dose-ranging study
was under way, with 89 patients enrolled at 26 study sites as of the end of
2006. Because of the insurance-coverage problems that threaten completing the
study on schedule, however, Cyberonics has decided to donate the devices and
pay for all related implantation costs, he said.
Medicare does not have a "national coverage determination" on
VNS for treatment of resistant depression. In its absence, coverage is
determined by local Medicare contractors.
The adverse CMS decision was prompted by a formal request from Cyberonics
in July 2006 asking regulators to approve coverage of VNS for a subset of
patients with treatment-resistant depression—those who had or refused
electroconvulsive therapy or who have been hospitalized for depression.
Currently Medicare covers VNS only for "patients with medically
refractory partial onset seizures, for whom surgery is not recommended or for
whom surgery has failed."
"We are extremely disappointed by the CMS proposal to decline our
request for expanded coverage of VNS therapy to include that small subset of
patients," said George Parker, Cyberonics' interim chief operating
officer. "These patients are experiencing a devastating illness
associated with extremely high health care utilization, costs, and
disability....A recent study has shown that annual medical costs associated
with [this subset of patients] average approximately $47,000."
More information on the request for Medicare coverage of VNS is
posted at
<www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=195>.
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