Here's what we know of Medicare's thought process from the letter to Dr. Mehta's group last December:
Re: Venogram and Venoplasty for Multiple Sclerosis
Dear Dr. Roddy:
I have received your Octover 21, 2010 letter requesting coverage and billing for the performance of venograms and venoplasties in patients with multiple sclerosis (MS).
[…edited out trial information] All services (diagnostic and therapeutic) associated with such a trial are also non-covered and non-reimbursable, including testing that might be required to determine whether the beneficiary is eligible for entry into such a trial.
Your have also requested coverage and reimbursement for Medicare-coverage and reimbursement for these same services outside of a clinical trial. Included with your letter were the following articles from the medical literature:
* Zamboni, P, Consorti G, Galeotti R., Gianesini S, et al, "Venous Collateral Circulation of the Extracranial Cerebrospinal outflow Routes", Current Neurovascular Research 2009, 6:204-212
* Zamboni, P, Galeotti R, Menegatti E, Malagoni AM, et al, "A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency, " Journal of Vascular Surgery 2009, 50:1348-1358
* Zamboni P, Galeotti R,Menegatti E, Malagoni AM, et al, "Chronic cerbrospinal venous insufficiency in patients with multiple sclerosis," Journal of Neurology Neurosurgery and Psychiatry 2009, 80:392-399
The first article describes the venous circulation in detail. The second describes the prevalence of venous obstruction in patients with MS and the third article reports results of venoplasty in such patients. These last two articles report a small study population (65 beneficiaries) and it is unclear whether these are even a different study population. The group is subdivided into three sub-groups of relapsing-remitting, primary progressive and secondary progressiv forms of the disease, further reducing the statistical and clinical significance. The treatment reults reported varied with the type of MS identified. The authors state the importance of additional longitudinal studies before accepting venoplasty as standard treatment for MS.
You have provided one article reporting a single site study with treatment of 65 patients, stratified into even smaller groups, followed for onley 12-18 months. However the trial that you alternatively proposed is to enroll 600 patients. It appears that diagnostic venography and venoplasty is not yet standard of care and remains investigational.
Therefore these services remain Medicare non-covered and non-reimbursable, even when performed outside of a clinical trial. All diagnostic tests for the purpose of identifying MS patients with venous obstruction (eg ultrasound, contrast venography, etc) as well all services related to the treatment of such obstructions (eg venoplasty) and all related services are considered not reasonable or necessary, and will be denied.
I regret that my response could not have been more favorable.
Paul G. Deutsch