SUBJECT: Proposed LCD DL37729 for MRgFUS for Essential Tremor
Dear Dr. Lurvey:
The American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS)
and American Society for Stereotactic and Functional Neurosurgery (ASSFN) appreciate the opportunity
to comment on the proposed local coverage determination (LCD) titled “Magnetic Resonance Image
Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor: DL37729.” We strongly
support Noridian’s proposal to cover the procedure and would like to see the conditions under which
Noridian will allow coverage expanded.
We understand that Noridian developed the “Coverage Indications and Limitations” for MRgFUS based
on the patient selection criteria used in the pivotal trial. The continued application of these criteria should
be reconsidered, as the criteria for the clinical trial do not all necessarily reflect the real-world application
of this procedure. In addition, propagating these criteria does not account for the knowledge gained
through the pivotal trial about patient selection and treatment techniques.
Below are our comments on the proposed criteria for coverage indications, limitations and/or medical
necessity
The LCD addresses use of Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for the
treatment of idiopathic essential tremor (ET) patients with medication-refractory tremor.
…
Read full letter here
