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I attended the Medicare Coverage Advisory Committee (MCAC) Executive Committee today. The committee recommended that CMS grant national coverage for DBS. CMS will issue a decision within 60 days, and after that there will be a period of about 6 months to implement national procedures. Medicare contractors in about half of states already cover DBS and most other states are allowing coverage on a case-by case basis, so the decision may be more a ratification of what is in process already, with the added value of uniform implementation of the coverage nationwide. DBS coverage by state is on Medtronic's web site www.medtronic.com/neuro/parkinsons/coverage.html From the PD community Barry Green, the requester for National coverage, wrote a statement which was read and I offered my general comments as a representative of the Parkinson Foundation. While they stopped short of the term "breakthrough treatment" for fear that this would put pressure on DBS as 1st line treatment, MCAC instituted a new category "substantially better than current treatment" to rate this technology based on the evidence for levodopa responsive patients for whom medical treatments were no longer effective. The procedure costs $90K -120K for bilateral implantation according to a Medtronic's representative. I raised the issue of "quality" of care which generated some discussion so I am glad I went. The patient perspective on quality is the need for some standards and regulation about the facilities and the training and experience of the treatment team as well as consumer information on how to select providers. Experience to date with DBS is that most adverse events are a result of surgery and placement of the electrode so selection of the right team to install the device is essential. FDA doesn't set standards for practice, but working with the manufacturer, FDA can carry out studies to monitor adverse events in practice. Medicare can set broad quality standards on things like the use of appropriate facilities and staffing to perform the surgery, but does not have pre authorization mechanisms to enforce best practice knowledge. Add patient groups to communicate to their constituencies, and professional groups to define the standards. If all these groups work together, they have sufficient authority to achieve improvements in the general application of DBS that have been achieved in research protocols (80-90% of patients improve 25% on average up to as much as 50%). Perry Cohen Washington DC ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn