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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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153.0 Malignant neoplasm of hepatic flexure 153.1 Malignant neoplasm of transverse colon 153.2 Malignant neoplasm of descending colon 153.3 Malignant neoplasm of sigmoid colon 153.6 Malignant neoplasm of ascending colon 153.7 Malignant neoplasm of splenic flexure 153.8 Malignant neoplasm of other specified sites of large intestine 153.9 Malignant neoplasm of colon, unspecified site 230.3 Carcinoma in situ of colon V76.51 Special screening for malignant neoplasms, colon

Unproven Diagnosis Codes:

555.0 Regional enteritis of small intestine

Computed Tomographic Colonography - Commercial Medical Management Guideline

555.1 Regional enteritis of large intestine 555.2 Regional enteritis of small intestine with large intestine 555.9 Regional enteritis of unspecified site 562.00 Diverticulosis of small intestine (without mention of hemorrhage) 562.01 Diverticulitis of small intestine (without mention of hemorrhage) 562.02 Diverticulosis of small intestine with hemorrhage 562.03 Divertulitis of small intestine with hemorrhage 562.10 Diverticulosis of colon (without mention of hemorrhage) 562.11 Diverticulitis of colon (without mention of hemorrhage) 562.12 Diverticulosis of colon with hemorrhage 562.13 Diverticulitis of colon with hemorrhage This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Computed Tomographic Colonography - Commercial Medical Management Guideline TITLE: Computed Tomography (CT) Angiography of the Head Authorized By: Medical Management Guideline Committee

Adoption Date: 10/14/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Computed Tomography (CT) Angiography of the Head - Commercial Medical Management Guideline This policy describes the use of computed tomography angiography (CTA) of the head for neurological applications, primarily for the investigation of cerebrovascular disease such as stroke. Although patients presenting with an acute stroke are generally initially evaluated with unenhanced CT scanning to distinguish ischemic from hemorrhagic causes, CTA may be used to visualize the cerebral vessels and provide more information about the vessels involved.

Medical Multi-slice computerized tomography scanners are manufactured by a number of vendors, including Products General Electric Healthcare (Fairfield, CT); Philips Medical Systems (Andover, MA); Siemens Medical Solutions (Malvern, PA); Shimadzu Medical Systems North America (Columbia, MD); and Toshiba American Medical Systems (New York, NY).

Search Acute hemorrhagic stroke, acute ischemic stroke, berry aneurysm, blood vessel, cerebral aneurysm, cerebral Terms artery, Circle of Willis, contrast medium, Doppler ultrasound, helical CT, intracerebral hemorrhage, multislice CT, nonionic, spiral CT, streptokinase, sub-second scanning, thrombolic stroke, TIA, tissue plasminogen activator, t-PA, tPA Background A stroke is either ischemic or hemorrhagic. An ischemic stroke results from acute arterial occlusion due to an embolus, thrombosis, or vessel stenosis. A hemorrhagic stroke can be caused by disruption of a fragile vessel wall, or a ruptured cerebral aneurysm or arteriovenous malformation (AVM). With the introduction of thrombolytic therapies, it has become essential to determine the nature of a stroke prior to initiating treatment, as administration of a thrombolytic agent to a patient with ischemic stroke may avoid significant post-stroke morbidity, but administration of a thrombolytic agent to a person with a hemorrhagic stroke can be lethal. The treatment has to be initiated within a few hours and delays can significantly affect outcomes.





Upon presentation with an acute stroke, patients generally receive an urgent unenhanced computed tomography (CT) scan to distinguish ischemic from hemorrhagic causes. However, arterial occlusion and presence of collateral circulation cannot be visualized with an unenhanced CT scan, so other imaging technologies must be used to evaluate the site and extent of vascular occlusion. There are several possibilities that differ in terms of availability, invasiveness, time requirement, and applicability The reference standard for visualization of cerebral vessels is intra-arterial digital subtraction angiography (DSA). However, DSA is invasive, time-consuming, and accompanied by neurological complications as well as major stroke or death in a small percentage of patients. (Solenski, 2004) Other alternatives are magnetic resonance imaging (MRI), magnetic resonance angiography (MRA), transcranial Doppler sonography (TDS), positron emission tomography (PET), and CT angiography (CTA).

CTA is performed with multi-slice helical CT scanners, capable of imaging blood vessels using intravenous contrast media. Images are taken during the arterial phase of blood flow, and then processed by a computer to produce a threedimensional (3D) image of the arterial tree. Imaging can be carried out immediately after an unenhanced CT scan. Uptake of CTA has perhaps been slowed by the need for advanced CT technology, its dependence on use of contrast media, and the existing presence of two significant competitive technologies, MRA and TDS. However, MRA and TDS have relative limitations: they take longer and require significant patient cooperation. (Brandt et al., 1999) CTA has applications both before and after acute events. For ischemic stroke, investigative work generally involves locating the affected vessels after an event. However, it can also be used for assessment of patients presenting with transient ischemic attacks (TIAs). Asymptomatic people at risk for intracranial aneurysms (ICAs) or AVMs may be investigated, as well as patients presenting with subarachnoid hemorrhages (SAHs).

Computed Tomography (CT) Angiography of the Head - Commercial Medical Management Guideline Audience Targeted Business This document was developed primarily for use by clinical staff and Medical Directors in Health Plans, Clinical Coverage Review, Care Coordination Units and Medical Claim Review. Other Area business units may find this document helpful.

Targeted Enrollees, in all benefits plans, who have known or suspected cerebrovascular disease.

Population Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Computed tomography angiography (CTA) of the head is unproven for use in the evaluation of patients with one or more

of the following conditions:

- acute ischemic stroke,

- subarachnoid hemorrhage (SAH),

- intracranial aneurysm (ICA),

- arteriovenous malformation (AVM),

- asymptomatic persons with a personal or family history of cerebrovascular disease,

- parenchymal hemorrhage or cerebral hematoma, or

- vertebro-basilar insufficiency or transient ischemic attack (TIA), or other neurological conditions, due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature.

Clinical Information Clinical Recommendations Note: This section provides detailed information about the clinical intended use for the treatment that is the topic of this Technology Assessment. The detailed information provided in this section is NOT used to decide whether or not a service is paid for. Rather, it provides background information and rationale about the scientifically appropriate use of the treatment, for discussion purposes with providers. See "Coverage" section to determine what procedure(s) are covered/non-covered (i.e., paid for where such benefits are available).

Clinical evidence does not support the use of computed tomography angiography (CTA) of the head for the evaluation of

patients with one or more of the following conditions:

- acute ischemic stroke,

- subarachnoid hemorrhage (SAH),

- intracranial aneurysm (ICA),

- arteriovenous malformation (AVM),

- asymptomatic persons with a personal or family history of cerebrovascular disease,

- parenchymal hemorrhage or cerebral hematoma, or

- vertebro-basilar insufficiency or transient ischemic attack (TIA), or other neurological conditions.

There are few randomized comparisons between CTA and other imaging techniques or sufficient follow-up to evaluate the overall impact of CTA on patient outcomes for these conditions. Due to the lack of studies comparing CTA with other noninvasive imaging modalities, the most appropriate role for CTA cannot be defined.

Clinical Precautions Computed Tomography (CT) Angiography of the Head - Commercial Medical Management Guideline Computed tomography angiography (CTA) requires the use of a contrast agent, which can cause mild to severe allergic reactions that, in rare cases, may lead to death. Therefore, caution is to be exercised in patients with known sensitivity to contrast agents. CTA is contraindicated in patients with known significant contraindications to contrast media.

Setting(s) Computed tomography (CT) scans are carried out on both inpatients and outpatients. A Outpatient / specialized technologist performs the procedure. Images are interpreted by neuroradiologists, Inpatient neurologists, and/or neurosurgeons.

Regulatory Requirements U.S. Food and Drug Administration (FDA): Two FDA statutes regulate computed tomography (CT) imaging systems.

They are regulated as radiation-emitting electronic products under the Radiation Control for Health and Safety Act and as Class II medical devices under the Medical Device Amendments to the Food, Drug, and Cosmetic Act. A number of CT

imaging systems have been approved by the FDA. See the following Web sites for more information:

http://www.fda.gov/cdrh/ct/regulatory.html. Accessed August 2007.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Use product code JAK) Accessed August 2007.

Research Evidence Studies evaluating computed tomography angiography (CTA) were selected for review if they had abstracts and provided a prospective comparison of CTA to the reference standard investigation, digital subtraction angiography (DSA), and/or to other imaging modalities and included at least 20 patients.

Acute Ischemic Stroke: The study that provided the largest comparison of CTA with DSA and with magnetic resonance angiography (MRA) included 145 patients and found good agreement overall: CTA versus MRA, 98% (236/242 vessels);

and CTA versus DSA, 99% (225/227 vessels). Using MRA as a reference standard for detection of vessel stenosis or occlusion, CTA sensitivity was calculated as 83% and specificity as 99%. Using DSA as a reference standard, CTA sensitivity was 89% and specificity was 100%. (Shrier et al., 1997) In a smaller study (n=21), all occlusions detected by DSA were also seen on CTA, and there was significant agreement about sites of occlusions and collateral circulation.

(Knauth et al, 1997) CTA was compared with DSA in a small study by Wildermuth et al. (1998). The study included 40 patients. All pts underwent CTA, 6 underwent DSA, and 22 underwent transcranial Doppler sonography (TDS). In this study, results for 6 of 7 patients (86%) with CTA and DSA and for 22 of 22 patients (100%) with CTA and TDS were consistent. Brandt et al. (1999) compared CTA with DSA and found consistent results in 6 of 6 patients (100%). The goal of the study was primarily to compare CTA with TDS in acute basilar artery ischemia; CTA was deemed to be superior. Another study of 70 patients also found that CTA was superior to TDS in the diagnosis of middle cerebral artery disease. (Suwanwela et al., 2002) A study comparing CTA with DSA evaluated 54 patients presenting with cerebral ischemia. All patients had CTA, which was followed by DSA in 9 patients primarily to determine whether they were candidates for thrombolysis therapy.



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