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DESCRIPTIONThere is interest in screening and early identification of lung cancer because the disease, when identified clinically, tends to have a poor prognosis. Two proposed screening methods are chest radiographs and low-dose computed tomography (CT) scans. Due to biases inherent in screening studies, randomized trials evaluating reduction in lung cancer morbidity and mortality are required to demonstrate the efficacy of screening.
Given the poor prognosis of lung cancer, there has been longstanding research interest in developing screening techniques for those at high risk. Previous studies of serial sputum samples or chest x-rays failed to demonstrate that screening improved health outcomes. More recently, there has been interest in low-dose computed tomography (CT) scanning as a screening technique, using either spiral (helical) or electron beam (ultrafast) CT scanning. Compared to conventional CT scans, these scans allow for the continuous acquisition of images, thus shortening the scan time and radiation exposure. A complete CT scan can be obtained within 20 seconds, or during one breath hold, in the majority of patients. The radiation exposure for this examination is greater than for that of a chest x-ray, but less than for a conventional CT scan.
There are also growing applications of computer-assisted detection or diagnosis (CAD) technologies that may have an impact on the use of CT scanning or chest radiographs for lung cancer screening. Computer-assisted detection points out possible findings to the radiologist who then decides if the finding is abnormal. Computer-assisted diagnosis uses a computer algorithm to analyze features of a lesion to determine the level of suspicion and is intended to enhance the reader's diagnostic performance. Both of these technologies may be expected to offer more benefit when used by relatively inexperienced readers and may help to standardize diagnostic performance.
In March 2001, the U.S. Food and Drug Administration (FDA) approved the RapidScreen RS-2000 system as a computer-aided detection (CAD) system intended to identify and mark regions of interest on digitized chest radiographs. In February 2004, the U.S. Food and Drug Administration (FDA) approved the R2 Technology ImageChecker CT system as a technique to assist in the detection of lung nodules on multi-detector CT scans of the chest. The R2 Technology ImageChecker also received FDA clearance for the Temporal Comparison software module in June 2004 and for the CT-LN 1000 in July 2004. The Temporal Comparison software module provides the ability to automatically track lung nodule progression or regression over time. The ImageChecker CT-LN 1000 is used for the detection of solid nodules in the lungs. Other systems that have been developed include iCAD's Second Look CT lung and Siemens' Syngo LungCARE CT.
Also, see the related medical policy, Whole Body Computed Tomography Scan as a Screening Test.
POLICYLow-dose computed tomography (CT) scanning, no more frequently than annually, may be considered medically necessary as a screening technique for lung cancer in individuals who meet ALL of the following criteria*:
* Patient selection criteria are based on the National Lung Screening Trial (NLST) and the U.S. Preventive Services Task Force (USPSTF) 2013 recommendation.
Low-dose CT scanning is considered investigational as a screening technique for lung cancer in all other situations.
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.
POLICY GUIDELINESThis policy does not apply to individuals with signs and/or symptoms of lung disease. In symptomatic individuals, a diagnostic work-up appropriate to the clinical presentation should be undertaken, rather than screening.
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 HISTORY11/2000: Approved by Medical Policy Advisory Committee (MPAC)
7/3/2001: ICD-9 diagnosis code V76.49 deleted
2/14/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
9/8/2003: Code Reference section updated, CPT 76499 deleted, ICD-9 diagnosis code V76.0 deleted
9/24/2004: Sources updated
3/28/2006: Coding updated. CPT4 2006 revisions added to policy
3/30/2006: Policy reviewed, no changes
5/18/2006: Policy revised. Revisions approved per Medical Policy Advisory Committee (MPAC)
6/21/2006: Coding reference section updated, CPT codes 0152T, 71250 added to policy, ICD-9 procedure code 87.41 code added to policy. ICD-9 diagnosis code range 162.2-162.9, 197.0, 231.2 deleted from policy.
12/19/2007: Coding updated per the 2008 CPT/HCPCS revisions.
1/6/2009: Policy reviewed, no changes
04/13/2010: Policy title changed from "Helical Computed Tomography (Spiral CT) for Lung Cancer Screening" to "Screening for Lung Cancer Using Computed Tomography (CT) Scanning or Chest Radiographs." Policy description updated. Added link to related medical policy. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
12/29/2010: Policy reviewed; no changes.
05/16/2012: Deleted "Chest Radiographs" from the policy title. Policy statement revised to state that low-dose computed tomography (CT) scanning, no more frequently than annually for 3 consecutive years, may be considered medically necessary as a screening technique for lung cancer in individuals who meet certain criteria. Added the following statement to the policy guidelines: This policy does not apply to individuals with signs and/or symptoms of lung disease. In symptomatic individuals, a diagnostic work-up appropriate to the clinical presentation should be undertaken, rather than screening. Deleted 0152T, 76376, 76377, and 76497 from the Code Reference section. Changed codes from non-covered to covered. Added 0174T, 0175T, and V76.0 to the Code Reference section as covered.
04/04/2013: Policy reviewed; no changes.
10/07/2014: Policy reviewed; description updated. Policy statement revised to remove "for 3 consecutive years" from the medically necessary statement. It previously stated: Low-dose computed tomography (CT) scanning, no more frequently than annually for 3 consecutive years, may be considered medically necessary as a screening technique for lung cancer in individuals who meet ALL of the following criteria." Medically necessary policy statement revised to change the screening age limit from "74" to "80." Added "the U.S. Preventive Services Task Force (USPSTF) 2013 recommendation" to the statement regarding patient selection criteria. Code Reference section updated to add HCPCS code S8032 and to remove CPT Codes 71250, 0174T, 0175T and ICD-9 procedure codes 87.41 and 87.42.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.30
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.