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L.8.01.409
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 brainis 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:
Reflux constantly present (for a duration >0.8 s) in the supine and upright positions at the level of an internal jugular or vertebral vein. This parameter was evaluated during a short breath-hold following normal breathing and not under Valsalva maneuver.
Reflux at the level of veins of the deep cerebral system (for a duration >0.5 s). This was evaluated with the patient in the sitting and supine positions, and venous flow was enhanced by inviting the patient to breath in.
Stenosis (<0.3 cm), valve abnormalities and septa on B-mode imaging.
Absence of flow at the level of the internal jugular or vertebral vein, despite numerous deep inspirations.
No increase in the diameter of the internal jugular vein when changing from an upright to a supine position (lack of change in pressure).
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.
The identification and subsequent treatment of chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis is considered not medically necessary.
Federal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative 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.
07/21/2011: 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."
05/26/2016: Policy number A.8.01.56 added.
12/30/2016: Code Reference section updated to add new 2017 CPT code 37248.
05/22/2020: Code Reference section updated to remove deleted CPT codes 35460, 35476, and 75978.
12/12/2022: Policy number changed from "A.8.01.56" to "L.8.01.409." Policy reviewed. Policy statement unchanged.
02/15/2024: Policy reviewed; no changes.
03/27/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 8.01.56
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
37248 | Transluminal balloon angioplasty (except dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; initial vein |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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