The following comment is submitted on behalf of
the American Psychiatric Association. A hardcopy
of the comment is being sent as well.

September 6, 2006

Jyme H. Schafer, M.D., MPH
Coverage and Analysis Group
Office of Clinical Standards and Quality
The Centers for Medicare and Medicaid Services (CMS)
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Reconsideration request for National Coverage
Determination 160.18 (CAG-00313R)

Dear Doctor Schafer:

On behalf of the American Psychiatric Association
(APA), the medical specialty society representing
more than 36,000 of the nation’s psychiatrists, I
am writing in response to the CMS request (as
referenced above) for public comments on the
consideration for national coverage of the Vagus
Nerve Stimulation (VNS) system for the treatment
of Medicare beneficiaries with treatment resistant
depression (TRD).

As we understand it, CMS makes its National
Coverage Determinations based on requests from
individuals or entities that identify an item or
service as a potential benefit (or to prevent
potential harm) to Medicare beneficiaries.
Through its decision-making process, CMS
determines whether the item or service is
reasonable and necessary for the diagnosis or
treatment of illness. For the reasons discussed
below, it is our recommendation that national
coverage for the vagus nerve stimulation system be
granted within the parameters stipulated in the
request.

Our members are the frontline medical specialists
in the treatment of Medicare beneficiaries with
mental illness. They practice in all settings,
including private practices, group practices,
hospitals and hospital-based clinics, nursing
facilities, and community health centers. In
addition, psychiatrists serve as academic faculty,
practice in academic medical settings, and are at
the forefront of research into the sources of and
new treatments for mental illness. Since our
members are the physicians most likely to be
treating the group of patients requiring this
treatment, we think it is important that we
provide our input to your deliberations.

In undertaking this review of the NCD request for
VNS treatment for patients with treatment
resistant, or refractory, depression and
preparing our comments, we consulted with the
APA’s Council on Research, whose members comprise
many of the world’s leading psychiatrists and
psychiatric researchers. In our request for their
views, we specifically asked that any individuals
with conflicts of interest recuse themselves from
tendering comments. The recommendation herein is
derived from the review of only those experts with
no conflict of interest.

Patients With Treatment Resistant Depression (TRD)
Depression is a serious medical condition. While
there is no official definition of treatment
resistant depression, the term is used in clinical
psychiatry to describe cases of major depressive
disorder that do not respond to typical modes of
treatment, such as psychotherapy and common
antidepressants such as SSRIs. Until the FDA
approved VNS, the treatment of resistant
depression most commonly involved
electroconvulsive therapy (ECT) and/or the use of
non-standard medications.
Partial response and non-response to
antidepressant medications are common problems for
patients with depression. It is estimated that
between 10 and 30 percent of depressed patients
for whom antidepressants are prescribed are
partially or totally resistant to the treatment.
While we do not have accurate data on the
prevalence of this in the Medicare population, our
collective clinical experience would indicate that
the Medicare population, those over and under the
age of 65, would at a minimum reflect the
prevalence in the general population.
Patients with treatment resistant depression
clearly comprise a very problematic subgroup of
the overall population of those with depressive
disorder. Treatment resistant depression is a
debilitating, chronic disease which, by
definition, has a very poor prognosis for
recovery. These patients suffer from the most
severe form of major depressive disorder and have
relatively few, if any, appropriate medically
beneficial alternatives available for the
treatment of their illness. The psychotropic
medications that have been so successful in
treating much of the population with depression
have failed to bring relief for them, and they
often rightfully feel that they are without hope
for a positive medical intervention.

The VNS Reconsideration Request
The request for national coverage of VNS therapy
for this population includes a number of
stipulations for the coverage that stringently
define the group of patients who would generally
meet the definition of having treatment resistant
depression.

While the FDA approval states VNS is “indicated
for 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 adequate antidepressant treatments,”
the NCD request provides a number of other
stipulations that further restrict the patient
population that would be eligible to receive
coverage for VNS treatment. Included among these
are requirements that the patient must have either
previously been treated or have refused
electroconvulsive therapy (ECT) or have been
hospitalized due to depression. There are eight
more stipulations that further define the clinical
situation necessary for coverage, ranging from the
patient not being an imminent risk for suicide to
the prescribing physician having to be a
psychiatrist or other physician who has had
experience treating patients for TRD. We think
that these stipulations define the population of
Medicare beneficiaries for whom the treatment is
reasonable and necessary.

As you know, the VNS system received its FDA
approval in July 2005. We note the conclusion
drawn by the FDA in its Summary of Safety and
Effectiveness Data for the VNS Therapy System:
CDRH believes that the PMA applicant has provided
reasonable assurance of safety and effectiveness
based on valid scientific evidence as required by
statute and regulation for the approval of a Class
III medical device. CDRH has come to this
conclusion because the sponsor has provided data
that were systematically collected and analyzed
which showed significant improvement from baseline
over one and two years for a definable subset of
the target population, and comparative data
against a reasonably matched control which also
showed sustained improvement over time.

Recommendation for Coverage
Given the existence of this population of Medicare
patients with TRD, who have a clinical history
that clearly shows that there are no other
medically beneficial treatment alternatives
available to them, and given the FDA’s approval of
the safety and effectiveness of VNS for the
treatment of major depressive disorder, it is our
medical opinion that VNS is, as defined by
§1862(a)(1)(A) of the Social Security Act,
“reasonable and necessary” for the treatment of
those Medicare patients with treatment resistant
depression.

The criteria for coverage should be consistent
with those delineated in the request; including
that coverage be limited to those patients who
have tried and failed at least four antidepressant
treatments of adequate dosage and time; and who
have either previously been treated with or
refused treatment with ECT, or previously been
hospitalized for depression.


Sincerely,



Pedro Ruiz, M.D.
President