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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. Currently, the proposed screening method is 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 10 to 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-aided detection or diagnosis (CAD) technologies that may have an impact on the use of CT scanning or chest radiographs for lung cancer screening. CAD points out possible findings to the radiologist who then decides if the finding is abnormal. CAD 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 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. Refer to the Preventive Health Services medical policy.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
03/18/2015: Policy reviewed; description updated. Policy statements unchanged. Added statement in policy section to refer to the Preventive Health Services medical policy. Policy guidelines updated to add medically necessary and investigational definitions.
08/14/2015: Medical policy revised to add ICD-10 codes.
12/31/2015: Added the following new 2016 HCPCS code to the Code Reference section: G0297.
06/06/2016: Policy number L.2.01.411 added.
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.