Total-Body CT Screening

Number: 0603

Policy

Aetna considers total body (i.e., full-body or whole-body) CT screening or full-body ultrafast (electron-beam) CT screening experimental and investigational because it has not been shown to be effective as a screening test.

Background

A number of for-profit medical clinics have been heavily advertising total-body ultrafast computed tomography (CT) scanning as a screening test.  However, no medical professional organization has recommended the use of ultrafast whole-body CT as a screening test.  In addition, there are no published clinical trials examining the safety and effectiveness of whole-body ultrafast CT scanning.

The American College of Radiology Board of Chancellors issued the following position statement on full-body CT screening:

“The American College of Radiology (ACR), at this time, does not believe there is sufficient scientific evidence to justify recommending total body computed tomographic (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 effective or is 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 increased patient anxiety, unnecessary follow-up examinations and treatments and wasted expense.  ACR will continue to monitor scientific studies concerning this procedure.  The benefits and risks of this method of screening have not been assessed in adequate clinical trials.  In addition, these screening tests may unnecessarily expose patients to harmful levels of radiation.”

A technology assessment conducted by the Institute for Clinical Systems Improvement (2003) reached the following conclusions:

  • Whole-body CT should not be considered as a screening tool at this time.  Whole-body CT screening is not specific enough or tailored appropriately to detect coronary artery calcification, lung cancer, or colon polyps or masses.
  • The CT screening procedure is safe except for the risk of radiation exposure and minor side effects that have been reported.  There are potentially hazardous risks associated with false positive and false negative findings and associated follow-up procedures.
  • No evidence exists to evaluate the effectiveness of whole-body CT as a screening test for patients with no symptoms or a family history suggesting disease (Conclusion Grade: Grade Not Assignable).  There is concern that this procedure may lead to the discovery of numerous findings that will not ultimately affect a patient’s health, but will result in increased patient anxiety, unnecessary follow-up examinations and treatments, and wasted expense.

Routine full-body CT screening may increase risk of cancer mortality.  Brenner and Elliston (2004) estimated that the lifetime risk of cancer death increases after just 1 CT scan and grows with each successive scan.  For example, a single full-body CT scan in a 45-year old results in a 1 in 1,250, or 0.08 %, increased chance of dying from cancer.  This risk jumps to 1 in 50, or 1.9 %, for an adult who begins having scans at 45 and has 1 each year for 30 years.  This study also found that radiation-induced lung cancer was the main form of cancer associated with CT scans.

Furtado et al (2005) retrospectively determined the frequency and spectrum of findings and recommendations reported with whole-body CT screening at a community screening center.  The radiological reports of 1,192 consecutive patients who underwent whole-body CT screening of the chest, abdomen, and pelvis at an outpatient imaging center from January to June 2000 were reviewed.  Scans were obtained with electron-beam CT without oral or intravenous contrast material.  Reported imaging findings and recommendations were retrospectively tabulated and assigned scores.  Descriptive statistics were used (means, standard deviations, and percentages); comparisons between subgroups were performed with univariate analysis of variance and chi(2) or Fisher exact tests.  Screening was performed in 1,192 patients (mean age of 54 years).  Sixty-five % (774/1,192) were men and 35 % (418/1,192) were women; 903 (76 %) of 1,192 patients were self-referred, and 1,030 (86 %) of 1,192 subjects had at least 1 abnormal finding described in the whole-body CT screening report.  There were a total of 3,361 findings, with a mean of 2.8 per patient.  Findings were described most frequently in the spine (1,065/3,361; 32 %), abdominal blood vessels (561/3,361; 17 %), lungs (461/3,361; 14 %), kidneys (353/3,361; 11 %), and liver (183/3,361); 5 %).  A total of 445 (37 %) patients received at least 1 recommendation for further evaluation.  The most common recommendations were for additional imaging of the lungs or the kidneys.  The authors concluded that with whole-body CT screening, findings were detected in a large number of subjects, and most findings were benign by description and required no further evaluation; 37 % of patients had findings that elicited recommendations for additional evaluation, but further research is needed to determine the clinical importance of these findings and the effect on patient care.

Sierink et al (2012) evaluated the value of immediate total-body CT during the primary survey of injured patients compared with conventional radiographic imaging supplemented with selective CT.  A systematic search of the literature was performed in MEDLINE, Embase, Web of Science and Cochrane Library databases.  Reports were eligible if they contained original data comparing immediate total-body CT with conventional imaging supplemented with selective CT in injured patients.  The main outcomes of interest were overall mortality and time in the emergency room (ER).  A total of 4 studies were included describing a total of 5,470 patients; 1 study provided 4,621 patients (84.5 %).  All 4 studies were non-randomized cohort studies with retrospective data collection.  Mortality was reported in 3 studies.  Absolute mortality rates differed substantially between studies, but within studies mortality rates were comparable between immediate total-body CT and conventional imaging strategies (pooled odds ratio 0.91, 95 % confidence interval: 0.79 to 1.05).  Time in the ER was described in 3 studies, and in 2 was significantly shorter in patients who underwent immediate total-body CT: 70 versus 104 mins (p = 0.025) and 47 versus 82 mins (p < 0.001) respectively.  The authors concluded that this review showed differences in time in the ER in favor of immediate total-body CT during the primary trauma survey compared with conventional radiographic imaging supplemented with selective CT.  There were no differences in mortality.  They stated that the substantial reduction in time in the ER is a promising feature of immediate total-body CT; but well-designed and larger randomized studies are needed to see how this will translate into clinical outcomes.

Gentile et al (2013) stated that total body computed tomography (TB-CT) scan is not mandatory in the diagnostic/staging algorithm of chronic lymphocytic leukemia (CLL).  These researchers determined the value and prognostic significance of TB-CT scan in early stage CLL patients.  Baseline TB-CT scan was performed in 240 Binet stage A CLL patients (179 Rai low- and 61 Rai intermediate-risk) included in a prospective multi-center observational study (clinicaltrial.gov ID:NCT00917549).  The cohort included 69 clinical monoclonal B lymphocytosis (cMBLs).  Patients were re-staged considering only radiological data.  Following TB-CT scans, 20 % of cases re-classified as radiologic Binet (r-Binet) stage B. r-Binet B patients showed a higher incidence of unfavorable cytogenetic abnormalities (p = 0.027), as well as a shorter PFS (p = 0.001).  At multi-variate analysis, r-Binet stage [HR = 2.48; p = 0.004] and IGHV mutational status [HR = 3.01; p = 0.002] retained an independent predictive value for PFS.  Among 179 Rai low-risk cases, 100 were redefined as r-Rai intermediate-risk based upon TB-CT scan data, showing a higher rate of cases with higher ZAP-70 (p = 0.033) and CD38 expression (p = 0.029) and β2-microglobulin levels (p < 0.0001), as well as a shorter PFS than those with r-Rai low-risk (p = 0.008).  r-Rai stage [HR = 2.78; p = 0.046] and IGHV mutational status [HR = 4.25; p = 0.009] retained a significant predictive value for PFS at multi-variate analysis.  Forty-two percent of cMBL patients were reclassified as r-small lymphocytic lymphomas (r-SLLs) by TB-CT scan.  The authors concluded that TB-CT scan appeared to provide relevant information in early stage CLL related to the potential and the timing of patients to progress towards the more advanced disease stages.

Healy et al (2014) stated that full-body CT scanning is increasingly being used in the initial evaluation of severely injured patients.  These researchers analyzed the literature to determine the benefits of full-body scanning in terms of mortality and length of time spent in the emergency department (ED).  A systematic search of the PubMed and Cochrane Library databases was performed.  Eligible studies compared trauma patients managed with selective CT scanning with patients who underwent immediate full-body scanning.  Using random effects modelling, the pooled odds ratio (OR) was used to calculate the effect of routine full-body CT on mortality while the pooled weighted mean difference (WMD) was used to analyze the difference in ED time.  A total of 5 studies (8,180 patients) provided mortality data while 4 studies (6,073 patients) provided data on ED time.  All were non-randomized cohort studies and were prone to several sources of bias.  There was no mortality difference between groups (pooled OR = 0.68; 95 % confidence interval [CI]: 0.43 to 1.09, p = 0.11).  There was a significant reduction in the time spent in the ED when patients underwent full-body CT (pooled effect size of WMD =-32.39 mins; 95 % CI: -51.78 to -13.00; p = 0.001).  The authors concluded that they eagerly await the results of randomized controlled trials (RCTs); firm clinical outcome data are expected to emerge in the near future, although data on cost and radiation exposure are needed before definitive conclusions can be made.

Surendran and colleagues (2014) reviewed the literature for all outcomes measured in comparing whole-body computed tomography (WBCT) with selective imaging in trauma patients and evaluated the comprehensiveness of relevant dimensions for this comparison.  These investigators performed a systematic review of studies comparing WBCT and selective imaging approaches during the initial assessment of multi-trauma patients.  Peer-reviewed studies including cohort studies, RCTs, meta-analyses, and systematic reviews were identified through large database searches and filtered through methodological inclusion criteria.  Data on study characteristics, hypotheses and conclusions made, outcomes assessed, and references to potential benefits and harms were extracted.  A total of 8 retrospective cohort studies and 2 systematic reviews were identified; 6 primary studies evaluated mortality as an outcome; and 4 studies found a significant difference in results favoring WBCT imaging over selective imaging.  All 5 articles assessing various time intervals in hospital following imaging after injury found significantly reduced times with WBCT.  Radiation exposure was found to be increased after WBCT imaging compared with selective imaging in the only study in which it was evaluated.  The 2 systematic reviews analyzed the same 3 articles with regard to mortality but concluded differently about overall benefits.  The authors concluded that WBCT imaging appeared to be associated with reduced times to events in hospital following traumatic injury and appeared to be associated with decreased mortality.  Whether this is a true effect mediated through an as yet unsubstantiated change in management or the result of hospital- or individual-level confounders is unclear.  Moreover, they stated that when evaluating these outcomes, it seemed that the authors of both primary studies and systematic reviews have often been selective in their choice of short-term outcomes, painting an incomplete picture of the issue.

UpToDate review on “Full body CT scan for screening

An UpToDate review on “Full body CT scan for screening” (Jackson et al, 2015) stated:

  • There are limited data on the accuracy and cost-effectiveness of screening asymptomatic individuals with total body imaging. 
  • Data from the use of CT for lung cancer screening and for detection of coronary calcium suggest that total body imaging can be expected to have a very high ratio of false-positive findings to true-positive findings.  There are no data that total body imaging improves outcomes.
  • Potential harms of total body imaging include: False-positive results leading to unnecessary tests and procedures as well as psychological distress, true-positive results leading to over-diagnosis of disease and futile therapies, and individual and societal costs.
  • In the absence of additional data from well-performed controlled trials of total body imaging, we recommend that low-risk asymptomatic individuals not undergo such screening (Grade 1C).

Total-Body CT in Trauma Patients

Treskes and colleagues (2017a) stated that total-body CT scanning (TBCT) could improve the initial in-hospital evaluation of severe trauma patients.  Indications for TBCT, however, differ between trauma centers, so more insight in how to select patients that could benefit from TBCT is required.  These investigators reviewed currently used indications for TB CT in trauma patients and described mortality and Injury Severity Scores of patient groups selected for TBCT.  They carried out a systematic review by searching Medline and Embase databases.  Studies evaluating or describing criteria for selection of patients with potentially severe injuries for TBCT during initial trauma care were included.  Also, studies comparing TB CT during the initial assessment of injured patients with conventional imaging and selective CT in specific patient groups were included.  A total of 30 eligible studies were identified; 3 studies evaluated indications for TBCT in trauma with divergent methods.  Combinations of compromised vital parameters, severe trauma mechanisms and clinical suspicion on severe injuries were often used indications; however, clinical judgement was used as well.  Studies describing TBCT indications selected patients in different ways and were difficult to compare regarding mortality and injury severity.  The authors concluded that indications for TBCT in trauma showed a wide variety in structure and cut-off values for vital parameters and trauma mechanism dimensions; consensus on indications for TBCT in trauma was lacking.  They stated that consensus on outcome measures for justification of TBCT should be obtained to guide further research on the appropriate indications for TBCT in trauma.  Moreover, these researchers noted that future research needs to prospectively determine the positive predictive value of separate TBCT indications for multiple and severely injured patients.  Positive predictive values for TBCT indications are useful for determining the proportion of patients that were appropriately selected for TBCT, and the concomitant radiation exposure could, therefore, be accepted.  To determine the proportion of the multiple and severely injured patients selected for TBCT, sensitivity of a set of indications has to be calculated.  Emphasis on specific diagnostic tests changes when another type of outcome measure is chosen such as reduction of missed injuries.

Treskes and colleagues (2017b) examined if there is a difference in frequency and clinical relevance of incidental findings detected by TBCT compared to those by the standard work-up (STWU) with selective CT scanning.  Trauma patients from five trauma centers were randomized between April 2011 and January 2014 to TBCT imaging or STWU consisting of conventional imaging with selective CT scanning.  Incidental findings were divided into 3 categories: major finding -- may cause mortality; moderate finding -- may cause morbidity; and minor finding -- hardly relevant.  Generalized estimating equations were applied to assess differences in incidental findings.  A total of 1,083 patients were enrolled, of which 541 patients (49.9 %) were randomized for TBCT and 542 patients (50.1 %) for STWU.  Major findings were detected in 23 patients (4.3 %) in the TBCT group compared to 9 patients (1.7 %) in the STWU group (adjusted rate ratio 2.851; 95 % CI: 1.337 to 6.077; p < 0.007).  Findings of moderate relevance were detected in 120 patients (22.2 %) in the TBCT group compared to 86 patients (15.9 %) in the STWU group (adjusted rate ratio 1.421; 95 % CI: 1.088 to 1.854; p < 0.010).  The authors concluded that when using TBCT instead of selective CT scanning in primary trauma care, a greater number of clinically relevant incidental findings could be expected.  Data did not show a significantly higher work-load through follow-up; however, documentation of follow-up was suboptimal.  They stated that when evaluating trauma patients with TBCT scanning, extra alertness towards detection, documentation and follow-up of relevant incidental findings is needed.

The authors stated that this study had several drawbacks.  First, the categorization of incidental findings into 3 relevance groups was subject to personal interpretation since there was no consensus guideline.  Discrepancies between previous studies showed that specific findings were not always classified in the same category of clinical relevance.  To minimize the effect of interpretation, the categorization of expected incidental findings was performed before data acquisition, in accordance with previous literature and under the supervision of an experienced radiologist.  The classification system used in this study closely resembled those of previous studies.  Second, the documentation of incidental findings in the radiology reports could be incomplete.  The number of incidental findings may have been influenced by the acute setting of trauma care, and therefore findings of minor or moderate interest may not have been reported at all, since they appeared irrelevant during primary trauma care.  However, the risk of under-estimation was reduced by the double-reading system.  On the other hand, the rate of unknown findings might be over-estimated, because previous imaging of the patient might not have been available during formulation of the radiology report.  Third, the follow-up was likely under-estimated due to reporting issues as well.  Follow-up was between 6 months and 2 years after the first trauma presentation, and only within the in-hospital documentation of the trauma centers where the patient was initially seen.  Subsequently, some patients (e.g., those with pulmonary nodules) would receive their first follow-up after 1 year or in a different hospital.  Furthermore, it was possible that the finding was discussed and that a watchful waiting approach was preferred but not reported in the patient’s file.

Furthermore, an UpToDate review on “Initial management of trauma in adults” (Raja and Zane, 2018) states that “While whole body CT scanning may improve outcomes following certain high-risk trauma, such as explosions, high speed motor vehicle collisions, and falls from great heights, we believe it should not be used indiscriminately given the short-term risk of contrast-related renal injury and the long-term risk of radiation-induced cancer, as well as the substantial cost … Some authors advocate whole body CT for severely injured patients with alterations in mental status.  In a retrospective database analysis of 5,208 patients in Japan with scores on the Glasgow Coma Scale (GCS) ranging from 3 to 12, decreased mortality was noted in patients who received whole body CT scans.  Although further study of the outcomes and cost effectiveness of whole body CT is needed, the approach may be beneficial in such patients, in whom examination findings are often limited or unclear”.  Whole body CT scanning is not mentioned in the Summary and Recommendations of this review.

Treskes and colleagues (2019) noted that immediate total-body CT (iTBCT) is often used for screening of potential severely injured patients.  Patients requiring emergency bleeding control interventions benefit from fast and optimal trauma screening.  These researchers examined if an initial trauma assessment with iTBCT is associated with lower mortality in patients requiring emergency bleeding control interventions.  In the REACT-2 trial, patients who sustained major trauma were randomized for iTBCT or for conventional imaging and selective CT scanning (standard work-up; STWU) in 5 trauma centers.  Patients who underwent emergency bleeding control interventions following their initial trauma assessment with iTBCT were compared for mortality and clinically relevant time intervals to patients that underwent the initial trauma assessment with the STWU.  In the REACT-2 trial, a total of 1,083 patients were enrolled of which 172 (15.9 %) underwent emergency bleeding control interventions following their initial trauma assessment.  Within these 172 patients, 85 (49.4 %) underwent iTBCT as primary diagnostic modality during the initial trauma assessment.  In trauma patients requiring emergency bleeding control interventions, in-hospital mortality was 12.9 % (95 % CI: 7.2 to 21.9 %) in the iTBCT group compared to 24.1 % (95 % CI: 16.3 to 34.2 %) in the STWU group (p = 0.059).  Time to bleeding control intervention was not reduced; 82 mins (inter-quartile range [IQR] 5 to 121) versus 98 mins (IQR 62 to 147), p = 0.108.  The authors concluded that the findings of this study could not demonstrate a beneficial effect on survival by the fast and detailed diagnostic work-up by immediate total-body CT for trauma patients requiring emergency bleeding control interventions.  There was probably a lack of statistical power for the detection of the potentially clinically relevant risk reduction in mortality by iTBCT.  These researchers stated that further research should be performed to confirm the suggested reduction in mortality by iTBCT in trauma patients requiring bleeding control interventions.  In addition, they noted that future research should focus on how to select patients who could benefit from iTBCT after trauma.

The authors stated that a drawback of this study was that this subgroup analysis was un-planned at the design stage, resulting in a lack of statistical power for the detection of the observed clinically relevant contrast between the mortality rates.  During the enrollment of this trial, associations between TBCT and emergency bleeding control interventions were reported and made this subgroup of specific interest and thus legitimize the additional analysis on these patients.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

HCPCS codes not covered for indications listed in the CPB::

S8092 Electron beam computed tomography (also known as ultrafast CT, cine CT)

The above policy is based on the following references:

  1. American College of Radiology (ACR). American College of Radiology Statement on Total Body CT Screening. Approved by ACR Board of Chancellors September 27, 2000. Reston, VA: ACR; 2000. 
  2. Black WC. Overdiagnosis: An under recognized cause of confusion and harm in cancer screening. J Natl Cancer Inst. 2000;92:1280-1282.
  3. Bazell R. Are full-body scans healthy? Experts raise questions about benefits, risks of new screening method [News]. NBC News, June 22, 2001. Available at: http://stacks.msnbc.com/news/591260.asp. Accessed January 15, 2002.
  4. U.S. doctors offer full body scan. BBC News, January 2, 2001. Available at: http://news.bbc.co.uk/hi/english/health/newsid_1097000/1097136.stm. Accessed January 15, 2002.
  5. Lewis C. Full-body CT scans. What you need to know. FDA Consum. 2001;35(6):10.
  6. Carson P. The battle over full-body scans. Manag Care. 2001;10(9):43-46.
  7. Lee TH, Brennan TA. Direct-to-consumer marketing of high-technology screening tests. N Engl J Med. 2002;346:529-531.
  8. Illes J, Fan E, Koenig BA, et al. Self-referred whole-body CT imaging: Current implications for health care consumers. Radiology. 2003; 228(2): 346-351.
  9. Pennachio DL. Full-body scans--or scams? Med Econ. 2002;79(15):62, 68, 71.
  10. Worrell B. Full body scans: Fad or new frontier for hospital radiology? Health Care Strateg Manage. 2002;20(9):1, 17-9.
  11. Institute for Clinical Systems Improvement (ICSI), Technology Assessment Committee. Whole-body computed tomography as a screening test. Technology Assessment No. 080. Bloomington, MN: ICSI; December 2003.
  12. Brenner DJ, Elliston CD. Estimated radiation risks potentially associated with full-body CT screening. Radiology. 2004;232:735-738.
  13. Beinfeld MT, Wittenberg E, Gazelle GS. Cost-effectiveness of whole-body CT screening. Radiology. 2005;234(2):415-422.
  14. Furtado CD, Aguirre DA, Sirlin CB, et al. Whole-body CT screening: Spectrum of findings and recommendations in 1192 patients. Radiology. 2005;237(2):385-394.
  15. Sierink JC, Saltzherr TP, Reitsma JB, et al. Systematic review and meta-analysis of immediate total-body computed tomography compared with selective radiological imaging of injured patients. Br J Surg. 2012;99 Suppl 1:52-58.
  16. Gentile M, Cutrona G, Fabris S, et al. Total body computed tomography scan in the initial work-up of Binet stage A chronic lymphocytic leukemia patients: Results of the prospective, multicenter O-CLL1-GISL study. Am J Hematol. 2013;88(7):539-544.
  17. Ha CS, Hodgson DC, Advani R, et al; Expert Panel on Radiation Oncology-Hodgkin Lymphoma. ACR Appropriateness Criteria follow-up of Hodgkin lymphoma [online publication]. Reston, VA: American College of Radiology (ACR); 2014.
  18. Leyendecker JR, Clingan MJ, Eberhardt SC, et al; Expert Panel on Urologic Imaging. ACR Appropriateness Criteria post-treatment surveillance of bladder cancer [online publication]. Reston, VA: American College of Radiology (ACR); 2014.
  19. Moy L, Newell MS, Bailey L, et al; Expert Panel on Breast Imaging. ACR Appropriateness Criteria stage I breast cancer: Initial workup and surveillance for local recurrence and distant metastases in asymptomatic women [online publication]. Reston, VA: American College of Radiology (ACR); 2014.
  20. Healy DA, Hegarty A, Feeley I, et al. Systematic review and meta-analysis of routine total body CT compared with selective CT in trauma patients. Emerg Med J. 2014;31(2):101-108.
  21. Surendran A, Mori A, Varma DK, Gruen RL. Systematic review of the benefits and harms of whole-body computed tomography in the early management of multitrauma patients: Are we getting the whole picture? J Trauma Acute Care Surg. 2014;76(4):1122-1130.
  22. Jackson JL, Berbano, E, O’Malley P. Full body CT scan for screening. UpToDate [online serial]. Waltham, MA; UpToDate; reviewed April 2015.
  23. Hajibandeh S, Hajibandeh S. Systematic review: Effect of whole-body computed tomography on mortality in trauma patients. J Inj Violence Res. 2015;7(2):64-74.
  24. Treskes K, Saltzherr TP, Luitse JS, et al. Indications for total-body computed tomography in blunt trauma patients: A systematic review. Eur J Trauma Emerg Surg. 2017a;43(1):35-42.
  25. Treskes K, Bos SA, Beenen LFM, et al; REACT-2 study group. High rates of clinically relevant incidental findings by total-body CT scanning in trauma patients; Results of the REACT-2 trial. Eur Radiol. 2017b;27(6):2451-2462.
  26. Raja A, Zane RD. Initial management of trauma in adults. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2018.
  27. Treskes K, Saltzherr TP, Edwards MJR, et al; REACT-2 study group. Emergency bleeding control interventions after immediate total-body CT scans in trauma patients. World J Surg. 2019;43(2):490-496.