BlueCross and BlueShield of Montana Medical Policy/Codes
Lung Cancer Screening Using Computed Tomography (CT), Chest Radiographs, or Serial Sputum Cytology
Chapter: Radiology
Current Effective Date: September 24, 2013
Original Effective Date: June 16, 2011
Publish Date: September 24, 2013
Revised Dates: March 22, 2012; August 28, 2013
Description

Lung cancer, which is most frequently caused by cigarette smoking, is the second leading cancer in the U.S. and the leading cause of cancer-related deaths among men and women.  Lung cancer kills more people than cancers of the breast, prostate, colon, and pancreas combined.  Incidence of lung cancer increases with age.  Although cigarette smoking is the major risk factor for lung cancer, other risk factors include family history, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, environmental radon exposure, passive smoking, asbestos exposure, and certain occupational exposures.  Lung cancer has a poor prognosis, with average five year survival rates for all lung cancers of less than 15%, despite advances in therapy. 

Given the poor prognosis of lung cancer, there has been a growing interest in the development of screening techniques for those at high risk, who may be cured if the disease is diagnosed at an earlier stage.  Previous studies of serial sputum cytology (three to five consecutive daily deep cough secretions) and/or chest radiograph(s) (chest X-ray[s], CXR[s]) failed to demonstrate an improvement in health outcomes and reduced mortality from lung cancer with screening techniques.

More recently, there has been interest in low-dose CT as a screening technique, particularly using electron beam (also referred to as ultrafast), helical (spiral) computed tomography (CT) scanners.  Methodologic issues related to low dose chest CT scans include consideration of the tube current, slice thickness and pitch.  Compared to conventional CT scans, these scans allow for the continuous acquisition of images, thus shortening the scan time and radiation exposure.  A low tube current below 100 mAs is utilized, typically between 30-100mAs.  This compares with the usual chest CT tube current of around 100-200mAs.  A complete high-speed CT scan can be obtained within 10-25 seconds, or during one large breath hold, in the majority of patients.  The computer software constructs axial images from raw data, which can be rendered in three-dimensional data sets when necessary.  The radiation exposure is greater than a CXR, but much less than a conventional CT.

There are also growing applications of computer aided detection or diagnosis (CAD) technologies that may have an impact on the use of CXRs or CT scanning for lung cancer screening.  With computer assisted detection, a computer program is applied to identify abnormal findings, which might otherwise be overlooked.  Computer assisted diagnosis uses a computer algorithm to analyze features of a lesion, for the purpose of distinguishing benign and malignant disease, thereby enhancing the reader’s diagnostic interpretation.  Both of these technologies may be expected to offer more benefit when used by relatively inexperienced readers and may help standardize diagnostic performance. 

In March 2001, the U.S. Food and Drug Administration (FDA) approved the RapidScreen RS-2000TM system as a CAD system intended to identify and mark regions of interest on digitized chest X-rays.  In February 2004, the FDA approved the R2 Technology ImageChecker® CT system as a technique to assist in the detection of lung nodules on MDCT scans of the chest.  The R2 Technology ImageChecker also received FDA clearance for the Temporal Comparison software module in June 2004 and for the ImageChecker 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 newer systems that have been developed include, but are not limited to, the following iCAD’s Second Look CT Lung and Siemen’s Syngo LungCARE CT.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

Blue Cross and Blue Shield of Montana (BCBSMT) may consider low-dose computed tomography (CT) scanning, used no more frequently than annually for three consecutive years, medically necessary as a screening technique for lung cancer in individuals who meet ALL of the following criteria:

  • Between 55 and 74 years of age, AND
  • History of cigarette smoking of at least 30 pack years, AND
  • If former smoker, quit within the previous 15 years.

* patient selection criteria are based on the National Lung Screening Trial (NLST)

Investigational

BCBSMT considers low-dose CT scanning experimental, investigational and unproven as a screening technique for lung cancer in all other situations.

The following techniques, as a screening method for lung cancer, are considered experimental, investigational and unproven:

  • Chest radiography (chest X-rays, CXRs), with or without CAD; or
  • Serial sputum cytology.

The use of computer-aided detection or diagnosis (CAD) for interpretation of low-dose computed tomography or chest radiographs is considered experimental, investigational and unproven.

Policy Guidelines

CXR – Effective January 1, 2007, there are two Category III CPT codes to specifically denote when CAD is performed, either at the time of the reading of the CXR or at some other time. 

Code 0174T is performed with the primary procedure, and should be listed separately in addition to the code for the primary procedure (i.e., 0174T could be reported in conjunction with 71010, 71020, 71021, 71022, and 71030).

Code 0175T is performed remotely from primary interpretation (i.e., 0175T should not be reported in conjunction with 71010, 71020, 71021, 71022, and 71030).

CT Scan of Lung – Although there is a HCPCS code for electron beam CT (S8092), the only CPT code available is 71250, describing CT of thorax, which might be used.  Therefore, the distinction between medical necessity CT scans of thorax and high-speed CT scans for screening tests cannot be based on the CPT code alone.  Careful review of the diagnosis should be done when CPT code 71250 is used for a diagnostic test, rather than a screening test for lung cancer.

Rationale

This policy was originally created in 2007; this section of the current policy has been substantially revised, and has been updated with peer reviewed literature searches of the MedLine database through August 2011.  The following is a summary of the key literature to date. 

High-quality, randomized trials that examine the effect of screening on lung cancer morbidity and mortality are necessary to determine the true impact of this technology on health outcomes.  While survival from time of screening is commonly reported in screening trials, the apparent increase in survival may be confounded by one or more biases associated with screening:

  • Lead-time bias: Lead time refers to the length of time between when a cancer is detected by screening and when the first signs or symptoms would have appeared.  If screening identifies lung cancer earlier, survival could be longer due to the lead time rather than because of effective early treatment.
  • Length-time bias: This bias refers to the greater likelihood that screening will detect slow-growing indolent cancers (which take longer to become symptomatic) than faster-growing, more aggressive cancer.  Patients with screen-detected cancer may appear to live longer because the cancers are more indolent.
  • Overdiagnosis: This bias occurs when screening identifies non-lethal cancer (sometimes called pseudodisease).  When this type of cancer is identified and removed, the patient appears to have benefited from screening, although the cancer would not have been fatal if left undetected.

Low-Dose Spiral Computed Tomography

Findings from a large randomized controlled trial (RCT) in the United States that evaluated the impact of screening with low-dose CT on lung cancer morbidity and mortality, the National Lung Screening Trial (NLST), were published in 2011.  In addition, several smaller European RCTs are ongoing.  Following are descriptions of the major randomized trials.

National Lung Screening Trial: The NLST sponsored by the National Institutes of Health (NIH) was launched in 2002 (NEJM, 2011).  By April 2004, a total of 53,454 current or former smokers from 33 sites in the U.S. had been randomly assigned to screening in three consecutive years with either a chest radiograph (CXR) or low-dose spiral CT.  Study eligibility included age between 55 and 74 years, a history of cigarette smoking of at least 30 pack years and, for former smokers, quitting within the past 15 years.  Individuals with a previous diagnosis of lung cancer or who had signs and/or symptoms suggestive of lung cancer were excluded.  There was no study-wide diagnostic follow-up algorithm; individuals who had positive test findings were managed according to protocols at their local center.  A total of 95% of participants in the low-dose CT group and 93% in the CXT group adhered to the screening protocol.

In October 2010, the independent safety and monitoring board determined that sufficient data were available to conclude that there was a statistically significant reduction in the primary outcome, lung cancer mortality.  Consequently, the trial was terminated, and study results that occurred through December 31, 2009 were analyzed and reported.  During a median 6.5 year follow-up, a total of 356 of 26,722 (1.33%) participants in the low-dose CT group and 443 of 26,732 (1.66%) participants in the CXR group died of lung cancer, representing a relative risk reduction of 20% (95% CI [confidence interval]: 6.8% to 26.7%, p=0.004).  Using intention-to-treat analysis (ITT), the absolute risk reduction was 0.33% and the number needed to screen (NNS) for three years with a low-dose CT to prevent one death from lung cancer was 303.  Aberle et al. reported an NNS of 320 based on per-protocol data from participants who underwent at least one screen.  Overall mortality, a secondary outcome, was also significantly reduced in the low-dose CT screening group.  There were a total of 1,877 deaths (7.0%) in the low-dose CT group and 2,000 deaths (7.5%) in the CXR group—relative risk reduction 6.7% (95% CI: 1.2% to 13.6%, p=0.02); absolute risk reduction of 0.46% and the NNS of 219 (95% CI: 111 to 5,556).

Over all three screenings, the frequency of positive tests was 24.2% in the low-dose CT group and 6.9% in the CXR group.  Of these, 17,497 of 18,146 (96.4%) in the low-dose CT group and 4,764 of 5,043 (94.5%) in the radiography group were false positives.  The remaining 649 tests (3.6% of total positive tests) in the low-dose CT scan group and 279 (5.5% of total positive tests) in the CXR group were confirmed lung cancers.  During the screening phase, a total of 39.1% of participants in the low-dose CT group and 16.0% of those in the CXR group had at least one positive screening test.

During follow-up, 1,060 lung cancers were identified in the low-dose CT group and 941 lung cancers were identified in the CXR group.  The difference in the cancer rates between groups was statistically significant, with a rate ratio of 1.13 (95% CI: 6.8 to 26.7, p=0.004).  In addition to the screen-detected cancers, 44 cancers in the low-dose CT group and 137 in the radiography group were diagnosed after a negative screen.  Three hundred sixty-seven cancers in the low-dose CT group and 525 cancers in the CXR group were diagnosed among participants who either missed screening or who had completed their three screenings.

Selected data from Table 3 of the August 2011 publication from Aberle (2011), on rates of follow-up diagnostic procedures after a positive screening result are shown below.  Data represent all three screening rounds and include only cases for which diagnostic information is complete (over 97% of cases).          

Low-dose CT

(N=17,702)

n (% of total sample)

CXR

(N=4,953)

n (% of total sample)

Imaging exam

10,246 (57.9)  

3,884 (78.4)

  • Chest radiography

2,547 (14.4)    

1,613 (32.6)

  • Chest CT

8,807 (49.8)    

3,003 (60.6)

  • FDG PET*/PET-CT 

1,471 (8.3)      

397 (8.0)

Percutaneous cytologic exam or biopsy

322 (1.8)         

172 (3.5) 

Bronchoscopy

671 (3.8)         

225 (4.5)

Surgical procedure

713 (4.0)         

239 (4.8)

  • Mediastinoscopy or mediastinotomy

117 (0.7)         

55 (1.1)

 

  • Thoracoscopy

234 (1.3)         

53 (1.1)

  • Thoracotomy

509 (2.9)         

184 (3.7)

* (FDG) fluorodeoxyglucose (PET) Positron emission tomography

Selected data from Table 4 of the August 2011 publication from Aberle et al., on complication rates after the most invasive screening-related diagnostic procedures are shown below. The data are from all three screening rounds and include only cases for which diagnostic information is complete (over 97% of cases).  The frequencies of each major complication were not reported; rather the article included the total number of patients with any major complication.  (Percent of total sample was calculated). 

Low-dose CT

n (% of total sample)

Chest Radiography

n (% of total sample)

Lung cancer confirmed

649 (3.7)

279 (5.2)

  • At least one complication

184 (1.0) 

65 (1.3)

  • At least one major complication

75 (0.4)

24 (0.5)

  • Death within 60 days after invasive diagnostic procedure

10 (0.1) 

10 (0.2)

 

Lung cancer not confirmed

17,053 (96.3)

4,674 (94.4)

  • At least one complication

61 (0.3)

16 (0.3) 

  • At least one major complication

12 (0.1)

4 (0.1)

  • Death within 60 days after invasive diagnostic procedure*

6 (<0.1) 

0 (0)

*This does not include deaths among individuals who had follow-up diagnostic procedures but no invasive procedures: a total of n=5 in the low-dose CT group and n=4 in the radiography group.

NOTE: Major complications were defined as the following: acute respiratory failure, anaphylaxis, bronchopulmonary fistula, cardiac arrest, cerebral vascular accident or stroke, congestive heart failure, death, hemothorax requiring tube placement, myocardial infarction, respiratory arrest, wound dehiscence, bronchial stump leak requiring tube thoracostomy or other drainage for more than four days, empyema, injury to vital organ or vessel, prolonged mechanical ventilation over 48 hours postoperatively, thromboembolic complications requiring intervention, chylous fistula, brachial plexopathy, lung collapse, and infarcted sigmoid colon.

Cancer stage was reported for cancers with a known stage; 1,040 in the low-dose CT group and 929 in the CXR group.  Of the 1,040 confirmed lung cancers in the low-dose CT group, 416 (40%) were stage 1A and 104 (10%) were stage 1B.  Over half of the confirmed lung cancers identified by a positive screen (329 of 635, 52%) were stage 1A.  In the CXR group, 90 of 275 confirmed cancers identified by a positive screen (32.7%) were stage 1A.

In summary, the NLST was a large well-conducted trial.  It found a statistically significantly lower rate of lung cancer mortality with three annual CT screens compared to CXRs; the number needed to screen (NNS) to prevent one lung cancer death was 320 (95% CI: 193 to 934).  The study also found a statistically significant but modestly lower overall mortality in low-dose CT group.  There was a high rate of follow-up imaging tests but relatively low rates of invasive tests. There were few major complications reported after invasive testing, although major complications that did occur were not well-characterized.  The rates of other potential complications, in particular radiation-induced cancers, are not yet known.  Findings of the trial cannot be generalized to other populations, e.g., younger individuals or lighter smokers.  The NLST evaluated the utility of a series of three annual CT screens; the efficacy of other screening regimens is not known.

Potential risks also are associated with use of CT scanning for screening.  In 2004, Brenner assessed the radiation risks associated with low-dose CT screening (Brenner, 2004).  The estimated doses from low-dose CT screening were 5.2 mGy + 0.9 to the lung, based on the protocol used in the NLST.  (This would be equivalent to at least 250 standard chest x-rays.) Brenner concluded that the radiation-related lung cancer risks for a single examination at age 55 ranges from approximately 1 per 10,000 to approximately 5 per 10,000, depending on gender and whether the person is a current or former smoker.  The study estimated that there would be a 1.8% increase (95% CI: 0.5% to 5.5%) in the number of lung cancers associated with radiation from screening if 50% of all current and former smokers in the U.S. aged 50–75 years received annual CT screening.  The risks of screening could be reduced by scanning less frequently or beginning screening at a later age.

Several smaller European trials that evaluate spiral CT screening are ongoing.  Findings may ultimately be pooled with those from other RCTs in Europe and the U.S.  Each study includes a somewhat different screening population and screening regimen:

  • Danish Lung Cancer Screening Trial: Between 2004 and 2006, a total of 4,104 current or former smokers were randomized to screening with annual low dose CT for five years or no screening; lung cancer mortality is the primary outcome measure (Pedersen, 2009).  Among the 2,052 individuals who received baseline CT scans, 179 (8.7%) had positive findings; a large proportion of these findings (162 of 179, 91%) were false positive.  Seventeen individuals (0.8%) were found to have lung cancer; ten cases were stage I disease.
  • Detection and Screening of Early Lung Cancer by Novel Imaging Technology and Molecular Essays (DANTE) Trial: This trial, conducted in Italy, randomly assigned 2,811 male current or former smokers to receive five yearly spiral CT screening exams or physical examination alone.  All participants had baseline CXRs (Infante, Lung Cancer, 2009).  The study was initiated in 2001, and recruitment was completed in 2006.  Three year findings were published in 2009 (Infante, American Journal of Respiratory Critical Care and Medicine, 2009).  After a median of 33 months’ follow-up, significantly more lung cancer was detected in the CT screening group compared to control (4.7% vs. 2.8%, respectively, p=0.016).  More stage I disease was detected by CT screening; the rate of advanced lung cancer detection was similar in the two groups.
  • Italian Lung (ITALUNG) Trial: Another Italian study randomly assigned 3,206 current or former smokers to receive four yearly low dose CT scans or no screening (Lopes Pegna, 2009).  Participants will be followed up by cancer registry for lung cancer incidence and mortality and contacted by telephone four years after randomization.  At baseline, 1,406 underwent CT screening and 426 (30%) tested positive (nodule at or greater than 5 mm).  Twenty individuals were found to have lung cancer; 406 of 426 (95%) of positive screens were false-positive.
  • Netherlands-Leuvens Longkanger Screenings Onderzoek (NELSON) Trial: This study, conducted in the Netherlands and Belgium, randomly assigned current or former smokers to CT screening or no screening (van Iersel, 2007; van Klaveren, 2007).  The screening intervention consisted of a CT scan at baseline and one and three years after baseline.  Recruitment occurred between 2004 and 2006.  Of the 7,557 participants who underwent the first round of screening, 196 (2.6%) had positive scans and 177 (2.3%) were referred for work-up.  Seventy of the 177 were diagnosed with lung cancer; this represents 39.5% of participants worked up after a positive scan and 0.9% of screened individuals.  The 70 individuals had 72 lung cancers; 46 (64%) of these were classified as stage I.  The primary outcome of the trial is lung cancer mortality reduction after ten years.

A total of 1.466 participants in the NELSON trial participated in a related quality-life-study; 733 were randomized to the screening arm and 733 to the control arm reported by van den Bergh (2011).  They were given questionnaires before randomization, two months after the first screening round, and two years after baseline (six months after the second screening round).  The questionnaire response rate was 1,288 (88%) at baseline and 931 (79%) two years later. No statistically significant differences between the screened and control groups were found in scores on any quality-of-life measures at two years.  The authors interpreted this finding as suggesting that lung cancer screening did not negatively impact quality of life.

Baseline findings from the intervention group of randomized trials suggest a high false-positive rate with spiral CT scanning.  In addition, the Mayo CT Screening Study, published in 2002 by Swenson (2002), performed spiral CT scanning on 1,520 smokers and found lung nodules in 66% of patients.  The authors estimated that 98% of these nodules were benign, and if patients continued to be screened on a yearly basis, almost all patients would have at least one false-positive examination finding after a few years of screening.  All of these patients may require further follow-up examinations, creating concern that surgery for benign nodules could dramatically increase if spiral CT scanning becomes widespread as a screening technique.  More recently, false-positive findings from the Lung Screening Study, a feasibility study for the National Lung Screening Trial, were published in 2010.  A total of 3,318 current or former smokers were randomly assigned to screening with either low dose CT scans or CXRs.  Participants received baseline screening, and if they were not initially diagnosed with lung cancer, also received a second screen after one year.  False-positive findings were defined as a positive screen with a subsequent negative workup or at least 12 months of follow-up with no lung cancer diagnosis.  A total of 506 (31%) participants who received CT scans and 216 (14%) who received CXRs received at least one false-positive result.  Using Kaplan-Meier analysis, the investigators calculated that the probability of a false-positive CT examination was 21% after one screening and 33% after two screenings.  Estimated rates for chest radiography were 9% and 15%, respectively.

In addition to the RCTs described above, a large observational study that has received attention is the Early Lung Cancer Action Project (ELCAP) (Henschke, 2006).  A 2006 publication from Henschke et al. reported results from 31,657 patients who underwent a baseline and then annual CT scan for detection of lung cancer.  The study included smokers and former smokers; approximately 10% of the population included individuals with occupational or secondhand exposure to smoke.  Of the 31,567 participants who had a baseline examination, 4,186 (13%) had a positive result that required further workup.  A diagnosis of lung cancer was found in 484 patients (1.53%); 412 of 2,834 (85%) were stage-1 cancer.  The majority of lung cancers (405 of 484) were found during the baseline evaluation.  A total of 535 patients underwent biopsies during the study.  Of the biopsies from patients with clinical stage I cancer, 14% were squamous cell and 71% were adenocarcinoma.  The ten year survival rates were estimated, although approximately 20% of participants had follow-up completed beyond five years.  The estimated ten year survival rate of individuals diagnosed with lung cancer was 88% (95% CI: 84% to 91%).  While these results are encouraging for the number of cases identified with stage I disease, they do not indicate that CT screening improves health outcomes due to lack of a comparison group and potential biases such as lead time, length time, and overdiagnosis.  Moreover, there was a high rate of false positives, approximately 11.5% of the screened population.

There is insufficient evidence to determine whether CAD technology, which is discussed below, may improve the accuracy of CT scanning interpretation (Goo, 2003).

Chest Radiographs or X-rays (CXRs)

Several randomized trials of CXRs as a screening technique were published in the 1980s reported by Patz et al.  The studies found that, although patients undergoing screening with CXRs had a higher incidence of earlier stage lung cancers, more resectable lung cancer, and improved five year survival rate compared with the control group, there were no statistically significant differences in mortality attributable to lung cancer between the two groups (Patz, 2000). 

Findings from an additional RCT that evaluated the effectiveness of screening with CXRs, the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial, have been recently published.  This trial was initiated by the National Cancer Institute (NCI) in 1992 and enrollment was completed in 2001 (NCI, 2011).  Approximately 155,000 individuals were randomly assigned to receive selected screening interventions, including CXRs, or usual care.  Smokers received CXRs at baseline and annually for three years; never-smokers were screened at entry and annually for two years.  Results of subsequent screenings were published in 2010 (Hocking, 2010).  Positivity rates were 7.1%, 6.6%, and 7.0%, respectively, for the first, second, and third yearly follow-up CXRs.  Over the entire screening period, 18.5% of screened individuals had at least one positive screen.  In 2011, the investigators published the main outcome data related to lung cancer screening (Oken, 2011).  The rate of lung cancer mortality did not differ significantly in the two groups.  Over 13 years of follow-up, there were a total of 1,213 lung cancer deaths in the intervention group and 1,230 lung cancer deaths in the usual care group.  Cumulative lung cancer mortality rates (per 10,000 person-years of observation) were 14.0 in the intervention group and 14.2 in the control group (rate ratio [RR]: 0.99, 95% confidence interval [CI]: 0.87-1.22).  There was also no benefit of screening with CXRs when the analysis was limited to individuals who met criteria for the NLST, discussed earlier.  In this subset of study participants (n=30,321), there were 316 lung cancer deaths in the intervention group and 334 lung cancer deaths in the usual care group (RR: 0.94, 95% CI: 0.81 to 1.10).  The authors concluded that annual screening with chest radiographs did not reduce lung cancer mortality compared with usual care.

Computer-aided detection (CAD) or technology may increase the sensitivity of CXRs.  Early published literature regarding CAD for CXRs consists primarily of technical capabilities of CAD systems as reported by Freedman (2002 and 2004) and Kadeda (2004).  More recently, a retrospective study identified x-rays with missed cancerous nodules and evaluated them with a CAD system (OnGuard 3.0, Riverain Medical).  CAD correctly marked overlooked nodules in 46 of 89 (52%) patients, and there was a mean of 3.9 false-positive results per image (White, 2009).  The study only included radiographs of lung cancer patients; CAD was not evaluated for screening.  Another retrospective study, conducted in Europe by de Hoop (2010), evaluated CXRs from 46 individuals who had histologically proven lung cancer and 65 control patients who had no nodules larger than five mm in diameter identified at a CT screening that occurred within six weeks of the x-ray.  Each radiograph was evaluated without and then with CAD findings; the OnGuard CAD system was used.  CAD was not found to improve observer performance.  The average sensitivity of the reviewers (two radiologists and four residents) was similar without (49%) and with (51%) use of the CAD system.  Observers correctly identified 27 lesions without CAD, and with CAD assistance, three additional malignancies were identified.

Serial Sputum Cytology

Many studies have combined the use of CXRs and sputum cytology, done serially or not, to screen asymptomatic patients.  When serial sputum cytology is done alone, the data was suggestive of a modest benefit in early detection of lung cancer.  Two RCTs of lung cancer was initiated in the 1970’s, the Johns Hopkins Lung Project and Memorial Sloan-Kettering Lung Study.  The results were revisited in 2009 by Doria-Rose et al.  The original studies compared one arm receiving an annual CXR and four monthly sputum cytology studies (a dual-screen) to a second arm of CXRs alone.  Prior outcome studies revealed incomplete follow-up data, yet the published literature reported similar lung cancer mortality between the two groups.  The recent review authors estimated the efficacy of lung cancer screening with sputum cytology in an intention-to-screen analysis of lung cancer mortality, using combined data from those trials (n=20,426).  After nine years of follow-up, lung cancer mortality was slightly lower in the dual screen than in the CXR only arm.  Reductions were seen for squamous cell cancer deaths and in the heaviest smokers.  There were also fewer deaths from large cell carcinoma in the dual screen group; although, the reason for this result was unclear.  However, there is no evidence of utility as a general screening modality.

During an 18 month recruitment period, 181 individuals at high-risk for lung cancer were followed-up at a Chinese Chest Clinic and were invited to submit sputum sample for cytology (Lam, 2009).  Those with sputum atypia underwent a bronchoscopy and CT of thorax.  After a mean follow-up of 39 months, 13 were diagnosed with primary lung cancer.  Of those 13, 46.2% were diagnosed with early stages.  Bronchoscopy was performed in 85, and seven were confirmed to have lung cancer (six were in early stages).  Eighty-one had CT done and 92.6% had abnormal findings, though three lung cancers (all stage 0) were missed by CT.  Five more primary lung cancers were diagnosed during the follow-up period – one in sputum atypia group and the other four in the normal sputum group.  The overall sensitivity of sputum cytology in detecting lung cancer was 71.4% for all histology and 100% for squamous cell lung cancer.  While the study focused on a follow-up bronchoscopy after the sputum collection to screen for early stage lung cancer in the central airway, the outcome revealed the potential of sputum cytology as a diagnostic modality for smokers smoking more than 20 packs per year, greater than 40 years. 

Technology Assessments, Guidelines, or Position Statements Addressing CT, CXRs, or Serial Sputum Cytology

  • In October 2011, the National Comprehensive Cancer Network (NCCN) published a Lung Cancer Screening Guideline.  The guideline recommends screening with low-dose CT for individuals who meet the key eligibility criteria of the National Lung Screening Trial, i.e., age 55-74 years old, at least a 30 pack year history of smoking, and smoking cessation no more than 15 years ago.  In addition, the guideline recommends low-dose CT screening for individuals aged 50 years and older with at least a 20 pack year history of smoking and one additional risk factor for lung cancer (other than second-hand smoke).  The latter recommendation is based on non-randomized studies and observational data.  Screening is recommended annually for three years and until age 74.  The guideline does not mention screening with CXRs (NCCN, Lung Cancer Screening, 2012).
  • A statement by the American Cancer Society (ACS), updated in July 2011, stated that no major professional organization, including the ACS, recommends routine lung cancer screening.  However, the statement also acknowledges that as results of the NLST are further analyzed, some organizations may update their recommendations (ACS, 2012).
  • The 2007 American College of Chest Physicians (ACCP) guidelines on screening for lung cancer does not recommend low-dose CT and specifically recommends against the use of serial CXRs for lung cancer screening (Smith, 2009).
  • In May 2004, the U.S. Preventive Services Task Force (USPSTF) concluded that there was insufficient evidence to recommend for or against screening asymptomatic persons for lung cancer with low-dose CT, CXR, sputum cytology, or a combination of these tests due to poor evidence that screening would reduce lung cancer mortality rates (USPSTF, 2004).

Summary

The evidence on CT screening for lung cancer includes numerous RCTs that report on yield and stage of screening and one RCT that reports on clinical outcomes.  The largest RCT, the NLST was a multicenter trial published in 2011.  This was a high-quality trial that reported a decrease in both lung cancer mortality and overall mortality in a high-risk population screened with three annual low-dose CT scans compared to CXRs.  Thus, screening for lung cancer with low-dose CT may be considered medically necessary for high-risk patients who meet the major eligibility criteria of the NLST and experimental, investigational and unproven otherwise.

Although findings from RCTs conducted in the 1970s and 1980s suggest that CXRs are ineffective as a method of lung cancer screening, an additional large RCT, the PLCO, was published in 2011.  The study found that three annual screens with CXRs did not reduce lung cancer mortality compared to usual care.  Therefore, screening for lung cancer with CXRs, with or without CAD, is considered experimental, investigational and unproven.

In a search of peer reviewed literature through February 2012, no new peer reviewed literature for serial sputum cytology was identified that would change the coverage position of this medical policy.  Therefore screening for lung cancer with serial sputum cytology is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies          

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.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

V15.82, V76.0, 87.41, 87.44, 87.49, 90.41, 90.42, 90.43, 90.44, 90.45, 90.46, 90.49

ICD-10 Codes

F17.200-F17.299, Z12.2, Z87.891, BB09YZZ, BB0DZZZ, BB24ZZZ

Procedural Codes: 71010, 71015, 71020, 71021, 71022, 71030, 71250, 71260, 71270, 88104, 88108, 89220, 0174T, 0175T, S8092
References
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  22. Van Iersel, C.A., de Koning, H.J., et al.  Risk-based selection from the general population in a screening trial: selection criteria, recruitment and power for the Dutch-Belgian randomized lung cancer multi-slice CT screening trial (NELSON).  International Journal of Cancer (2007 February 15) 120(4):868-74.
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History
March 2012  Policy updated with literature review through December 15, 2011. Clinical input added. Reference 4 added; other references renumbered. Policy statement on chest radiographs removed and title changed accordingly. Statement added to Policy Guidelines that evidence does not support use of chest radiographs as a screening technique. A statement was also added to the Policy Guidelines that the policy does not apply to symptomatic individuals. 
September 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Screening for Lung Cancer Using CT Scanning or Chest Radiographs" to "Lung Cancer Screening Using Computed Tomography (CT), Chest Radiographs, or Serial Sputum Cytology".  Added codes 71010, 71015, 71020, 71021, 71022, 71030, 71260, 71270, 88104, 88108, 89220, and S8092.
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Lung Cancer Screening Using Computed Tomography (CT), Chest Radiographs, or Serial Sputum Cytology