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Over 750,000 strokes occur annually in the United States. Some strokes are caused by emboli and these frequently present as acute neurologic emergencies. Tissue plasminogen activator (tPA) given intravenously within 3 hours of symptom onset is approved by the U.S. Food and Drug Administration (FDA) for treatment of acute ischemic strokes. Mechanical embolectomy is being studied as a method of stroke treatment.
The Merci® Retriever was cleared by the FDA in August 2004 through the 510(k) process. This device was judged equivalent to a predicate device, the Concentric Retriever. The FDA clearance indicated that the MERCI Clinical Study established that no new issues of safety and effectiveness exist when the Merci® Retriever is used for thrombus removal versus foreign body removal from the neurovasculature. A modified Merci® Retriever, also manufactured by Concentric Medical., Inc, received 510(k) clearance from the FDA in May 2006. The clearance notes that the Modified Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for intravenous tPA or who fail intravenous tPA therapy are candidates for treatment. The device also has clearance for retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral, and coronary vasculature.
In September 2007, the FDA granted 510(k) marketing clearance to the Penumbra System™ which is another mechanical device designed to reduce clot burden in acute stroke due to large-vessel occlusive disease. This system removes clot through the use of a small suction device.
POLICYMechanical embolectomy is considered investigational in the treatment of acute stroke.
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.
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.
POLICY HISTORY12/13/2006: Policy added.
3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
1/11/2008: Policy reviewed, no changes
8/27/2009: Description section updated. Policy statement unchanged.
12/08/2009: Exclusions Section updated with FEP verbiage.
10/21/2010: Policy reviewed; no changes.
09/28/2011: Policy reviewed; no changes.
11/28/2012: Policy reviewed; no changes.
12/13/2013: Policy reviewed; no changes.
08/24/2015: Code Reference section updated for ICD-10.
06/09/2016: Policy number L.2.01.430 added.
09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 03CG3Z6 and 03CG4Z6.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.76
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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