SPECIAL ALERT: CMS Public Comment Period for VNS Therapy in TRD Now Open
The Centers for Medicare and Medicaid Services (CMS) has now published a Request for Public Comment on a Draft National Coverage Policy for VNS Therapy for patients with treatment-resistant depression (TRD). The Draft National Coverage Policy proposes non coverage of VNS Therapy for TRD. While this position is not expected to impact the coverage currently available for the treatment of pharmacoresistant epilepsy, this position will deny access to the only FDA-approved treatment for TRD for Medicare beneficiaries, and potentially some Medicaid beneficiaries.
The public comment period provides an opportunity for those individuals with experience with VNS Therapy to express their opinion regarding the proposed VNS Therapy National Coverage Policy.
During the thirty days from February 5, 2007 to March 7, 2007, you may submit your comments on the proposed National Coverage Policy for VNS Therapy for TRD electronically at http://www.cms.hhs.gov/mcd/viewnca.asp?from=ncd&nca_id=195. Once on this website, click on the orange comment button to submit your comment electronically.
You may also send your comments to the following address:
Centers for Medicare and Medicaid Services
Att: Beverly A. Lofton, MHA
Ref: NCA for Vagus Nerve Stimulation for Treatment of Resistant Depression (TRD) (CAG-00313R) C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
The more voices that are heard during this period, the greater the probability that Medicare will provide important coverage for VNS Therapy in patients with TRD.
Your overall experience with VNS Therapy, particularly your experience related to the implant procedure, will be very valuable to CMS as they design their final National Coverage Policy. Comments including any of the following aspects of your experience and perspective are most meaningful to CMS:
- Your knowledge of and experience with VNS Therapy;
- Your opinion regarding the proposed CMS non coverage position for patients with TRD; and
- Comments on patient outcomes you have observed in your patients treated with VNS Therapy (including any patients covered by Medicare) with a particular emphasis on the unique, accumulating, and durable long-term safety and effectiveness benefits and the safety of the implant procedure.
The impact of your comments will be amplified if they are supported with peer reviewed data, and please include any applicable financial disclosure with your letter. Please note that the Comment Period will end on March 7, 2007.
We appreciate your interest regarding access to treatment with VNS Therapy for patients with TRD and thank you for your time and participation in this public comment period. If you have any questions regarding this process, please contact your therapeutic consultant, nurse case manager, or call 1-877-NOW-4VNS.
UNITED STATES INDICATION FOR USE:
VNS Therapy is indicated for the 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.
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