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

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