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DESCRIPTIONPerfusion imaging using CT (computed tomography) provides an assessment of cerebral blood flow that may assist in the identification of ischemic regions of the brain. This technology is proposed as a method to aid treatment decisions in patients being evaluated for acute ischemic stroke, subarachnoid hemorrhage and head trauma.
The goal of acute stroke thrombolytic treatment is to rescue the ischemic penumbra, an area of brain that surrounds the infarct core and is hypoperfused but does not die quickly. Multimodal CT (computed tomography) and magnetic resonance imaging (MRI) can be used to assess the cerebral parenchyma, vasculature, and tissue viability in the acute ischemic stroke setting, and are used to detect ischemic tissue, and exclude hemorrhage and other conditions that mimic acute cerebral ischemia.
The approved therapy, intravenous tissue plasminogen activator (tPA), requires only a non-contrast CT scan to exclude the presence of hemorrhage (a contraindication to the use of the drug). Current guidelines are to administer (tPA) within the first 3 hours after an ischemic event, preceded by a CT scan. Many patients, however, do not present within the 3-hour window, and thrombolysis carries a risk of intracranial hemorrhage. Thus, more sophisticated imaging may be needed to select the proper use of intra-arterial thrombolysis or mechanical thrombectomy in patients who present more than 3 hours after an ischemic stroke. Perfusion imaging is also being evaluated in the management of other neurological conditions such as subarachnoid hemorrhage and head trauma.
The potential utility of perfusion imaging of acute stroke is described as the following:
Similar information can be provided by CT and MRI in terms of infarct core and penumbra. However, multimodal CT has a short protocol time (5-6 min), and since it can be performed with any modern CT equipment is more widely available in the emergency setting. CT perfusion is performed by capturing images as an iodinated contrast agent bolus passes through the cerebral circulation and accumulates in the cerebral tissues. (Older perfusion methodologies such as single-photon emission CT [SPECT] and xenon-enhanced CT [XeCT] scanning use a diffusible tracer.) The quantitative perfusion parameters are calculated from density changes for each pixel over time with commercially available deconvolution-based software, where cerebral blood flow (CBF) is equal to regional cerebral blood volume (CBV) divided by mean transit time (MTT). CT angiography/CT perfusion requires ionizing radiation and iodinated contrast. It is estimated that a typical perfusion CT deposits a slightly greater radiation dose than a routine unenhanced head CT (approximately 3.3 mSv).
On October 8, 2009, the U.S. Food and Drug Administration (FDA) issued an Initial Communication about excess radiation during perfusion CT imaging to aid in the diagnosis and treatment of stroke from one facility. Together with state and local health authorities, the FDA has identified at least 250 patients who were exposed to excess radiation during CT perfusion scans. The FDA has received reports of possible excess exposures at facilities in other states, involving more than one manufacturer of CT scanners. The FDA has provided recommendations for facilities and practitioners, and is continuing to work with manufacturers, professional organizations, and state and local public health authorities to investigate the scope and causes of these excess exposures and their potential public health impact.
Several post-processing software packages (e.g., Siemens’ syngo Perfusion-CT, GE Healthcare’s CT Perfusion 4, Philips Medical System’s Brain Perfusion Option) have received 510(k) marketing clearance from the FDA for use with a CT system to perform perfusion imaging. The software is being distributed with new CT scanners.
POLICYCT based perfusion imaging is considered investigational for all indications including the diagnosis and management of acute cerebral ischemia (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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY4/25/2007: Policy Added
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
7/22/2008: Policy reviewed, no changes
06/09/2010: Policy description extensively re-written regarding use of CT perfusion imaging and FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
07/29/2011: Policy reviewed; no changes.
01/09/2013: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes to policy statement. Added "of the Brain" to the policy title for clarification purposes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 6.01.49
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.