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Chronic cerebrospinal venous insufficiency (CCSVI) may be associated with multiple sclerosis (MS), although this is controversial and an active area of research. Correction of CCSVI has been attempted via percutaneous venoplasty. The intent of this procedure is to relieve MS symptoms by improving venous drainage of the central nervous system. Correction of CCSVI by this method may be referred to as the “Liberation Procedure.”
Multiple sclerosis (MS) is generally considered a chronic inflammatory demyelinating disease of the central nervous system (brain, spinal cord, optic nerve) felt to be triggered by an autoimmune response to myelin. However, in part due to the periventricular predilection of the lesions of multiple sclerosis, vascular etiologies (chronic cerebrospinal venous insufficiency) have also been considered. The core foundation of this vascular theory is that venous drainage from the brain is abnormal due to outflow obstruction in the draining jugular vein and/or azygos veins. This abnormal venous drainage, which is characterized by special ultrasound criteria, is said to cause intracerebral flow disturbance or outflow problems that lead to periventricular deposits. In the CCSVI theory, these deposits have a similarity to the iron deposits seen around the veins in the legs of patients with chronic deep vein thrombosis. Balloon dilatation, with or without stenting, has been proposed as a means to treat the outflow problems, thereby alleviating CCSVI and MS complaints.
The following 5 criteria were defined as features of CCSVI. To make the diagnosis of CCSVI, at least 2 of the 5 criteria need to be present:
Endovascular correction of CCSVI is a surgical procedure and as such is not subject to FDA approval. However, in 2012, FDA issued an alert concerning the potential for serious adverse events with the treatment for CCSVI.
POLICYThe identification and subsequent treatment of chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis is considered not medically necessary.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/21/2011: Approved by Medical Policy Advisory Committee.
07/17/2012: Policy reviewed; no changes.
05/14/2013: Added CPT code 75978 to the Code Reference section.
08/14/2013: Policy reviewed; no changes.
06/16/2014: Policy reviewed; description updated to add features of CCSVI. Policy statement unchanged.
07/13/2015: Code Reference section updated for ICD-10.
11/12/2015: Policy description updated regarding endovascular correction of CCSVI. Policy statement changed from investigational to not medically necessary. Investigative definition updated in policy guidelines section. Code Reference section updated to change "Investigational Codes" to "Not Medically Necessary Codes."
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.56
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
Not Medically Necessary Codes