Description:
This policy addresses whole-body computed tomography (CT) scanning or whole-body CT screening as a potential preventive measure for individuals who have no signs or symptoms of disease.

Background:
Whole-body computed tomography (CT) scans, which encompass the body from the neck to the pelvis, have been proposed as a general screening test for diseases of the thyroid (i.e., cancer), lungs (i.e., lung cancer), heart (i.e., cardiovascular disease [CVD]) and abdominal and pelvic organs (cancer, CVD). Often the test is marketed directly to the patient and is offered through mobile CT scanners that travel from community to community.

Related Policy 
60103 Computed Tomography to Detect Coronary Artery Calcification
60130 Screening for Lung Cancer Using CT Scanning or Chest Radiographs 
60132 Virtual Colonoscopy/CT Colonography 

Policy:
Whole-body computed tomography scans as a screening test are considered INVESTIGATIONAL.

Policy Guidelines:
There is no specific CPT code for whole body CT scanning. A series of CPT coding defining different aspects of whole body scanning might be submitted.

Benefit Application:
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (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.

Contractual or benefit limits or exclusions for preventive services may apply.

Rationale:
Literature searches using the MEDLINE database through March 11, 2013, have identified a single controlled trial on whole-body computed tomography (CT) scans. In 2007, Obuchowski et al. reported a small (50 subjects) randomized trial of whole-body screening (vs. no screening for three years) to determine the feasibility of a larger scale study.¹ Ninety percent of the subjects were reported to be compliant with follow-up at two years. Images were interpreted independently by six radiologists from two institutions. Based on one interpretation, 16 (64 percent) subjects in the screening group had abnormal findings, but no cancers were detected. A second interpretation showed a similar rate of abnormal findings, although abnormalities were not in the exact same group of 16 subjects. On average, medical costs were twice as high for screened subjects. The authors concluded that a full-scale randomized controlled trial (RCT) of whole-body screening will need to account for the large variability in interpretation of the images, the high rate of incidental findings and the low prevalence of cancers.

Also identified were two retrospective reviews of findings/recommendations from 982 and 1,192 whole-body CT screenings.^2,3 Both studies observed a strong association between age of the patient and the number of findings and recommendations. Actionable findings ranged from 22.5 percent of subjects younger than 40 years of age to 80 percent of patients older than or equal to 80 years of age (2). Follow-up imaging was the most common recommendation.³

Summary:
Evidence has not changed substantially since a 2003 review that concluded "no published studies demonstrate that these procedures reduce morbidity or mortality when used to screen healthy, asymptomatic patients."⁴ Moreover, the radiation dose of the computed tomography (CT) scan itself could lead to an excess lifetime risk of fatal cancer and that radiation dose and associate risk should be included as fundamental parameters for investigating the outcomes of a CT-based screening program.⁵ Evidence reviewed in a 2010 report from the Canadian Health Services Research Foundation indicates that whole-body CT screening uses 500 to 1,000 times the radiation levels of a routine chest X-ray, without any demonstrated positive effects on life expectancy.⁶ The current literature does not support an improvement in health outcomes with whole-body CT screening. Therefore, this procedure is considered investigational.

Practice Guidelines and Position Statements:
The American College of Radiology has posted the following statement regarding whole-body computed tomography (CT) scanning:⁷

"The American College of Radiology (ACR) recognizes that an increasing number of computed tomography (CT) screening examinations are being performed in the United States. Much CT screening is targeted at specific diseases, such as lung scanning for cancer in current and former smokers, coronary artery calcium scoring as a predictor of cardiac events and CT colonography (virtual colonoscopy) for colon cancer. Early data suggest that these targeted examinations may be clinically valid. Large, prospective, multicenter trials are currently underway or in the planning phase to evaluate whether these screening exams reduce the rate of mortality. The ACR, at this time, does not believe there is sufficient evidence to justify recommending total body CT screening for patients with no symptoms or a family history suggesting disease. To date, there is no evidence that total body CT screening is cost efficient or effective in prolonging life. In addition, the ACR is concerned that this procedure will lead to the discovery of numerous findings that will not ultimately affect patients' health but will result in unnecessary follow-up examinations and treatments and significant wasted expense. The ACR will continue to monitor scientific studies concerning these procedures."

Information from the U.S. Food and Drug Administration (FDA)⁸ indicates that recommendations from the U.S. Preventive Services Task Force and the American Medical Association have been added to those of the American College of Radiology, the American College of Cardiology/American Heart Association, the American Association of Physicists in Medicine and the Health Physics Society, all of whom do not recommend CT screening. The FDA has published the following information on whole-body CT scanning:

"At this time, the Food and Drug Administration (FDA) knows of no scientific evidence demonstrating that whole-body scanning of individuals without symptoms provides more benefit than harm to people being screened."

• "Whole-body CT screening has not been demonstrated to meet generally accepted criteria for an effective screening procedure.

• Medical professional societies have not endorsed whole-body CT scanning for individuals without symptoms.

• CT screening of high-risk individuals for specific diseases, such as lung cancer or colon cancer, is currently being studied.

• The radiation from a CT scan may be associated with a very small increase in the possibility of developing cancer later in a person's life."

References 

1. Obuchowski NA, Holden D, Modic MT et al. Total-body screening: preliminary results of a pilot randomized controlled trial. J Am Coll Radiol 2007; 4(9-Jan):604-11.

2. Obuchowski N, Modic MT. Total body screening: predicting actionable findings. Acad Radio 2006; 13(4):480-5.

3. Furtado CD, Aguirre DA, Sirlin CB et al. Whole-body CT screening: spectrum of findings and recommendations in 1192 patients. Radiology 2005; 237(2):385-94.

4. Dixon GD. Computed tomography for screening purposes: a review of the literature--2003. Mo Med 2003; 100(2):140-4.

5. Buls N, de Mey J, Covens P et al. Health screening with CT: prospective assessment of radiation dose and associated detriment. JBR-BTR 2005; 88(1):12-16.

6. Canadian Health Services Research Foundation. Myth: whole-body screening is an effective way to detect hidden cancers. J Health Serv Res Policy 2010; 15(2-Jan):118-9.

7. American College of Radiology. ACR Statement on Whole Body CT Screening. 2002. 

8. U.S. Food and Drug Administration. Whole body scanning using computed tomography. Last update 04/06/2010. 

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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