Medical Policy: 06.01.19
Original Effective Date: February 2003
Reviewed: February 2021
Revised: April 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
This policy does not apply to individuals with signs and/or symptoms. In symptomatic individuals, a diagnostic work up appropriate to the clinical presentation should be undertaken, rather than screening.
Lung cancer is the leading cause of cancer related mortality in the United States and worldwide. In 2019, it is estimated that 142,670 deaths (76,650 in men and 66,020 in women) from lung cancer will occur in the United States, which is about 24% of all the U.S. deaths from cancer. Five-year survival rates for lung cancer are only 19%, partly because most patients have advanced stage lung cancer at initial diagnosis. These facts combined with the success of screening in improving outcomes in patients with cervical, colon and breast cancers have been the impetus for studies to develop an effective lung cancer screening test. Ideally, effective screening will lead to earlier detection of lung cancer (before patients have symptoms and when treatment is more likely to be effective) and will decrease mortality. Currently, most lung cancer is diagnosed clinically when patients present with symptoms such as persistent cough, pain and weight loss; unfortunately, patients with these symptoms usually have advanced lung cancer. Early detection of lung cancer is an important opportunity for decreasing mortality. Data support using low dose CT (LDCT) of the chest to screen select patients who are at high risk for lung cancer. (NCCN Version 1.2021).
The American Cancer Society for 2021 estimates 235,760 new cases of lung cancer will be diagnosed and estimates there will be 131,880 deaths.
The goal of screening is to detect disease at a stage when it is not causing symptoms and when treatment will be most successful. Screening should benefit the individual by increasing life expectancy and increasing quality of life. The rate of false-positive results should be low to prevent unnecessary additional testing. The large fraction of the population without the disease should not be harmed (low risk), and the screening test should not be so expensive that it places an onerous burden on the health care system. Thus, the screening test should: 1) improve outcomes; 2) be scientifically validated (e.g. have acceptable levels of sensitivity and specificity; and 3) be low risk, reproducible, accessible and cost-effective (NCCN Version 1.2021).
Chest x-ray (CXR) and sputum cytology have been the most common methods used for screening lung cancer, but previous studies have failed to demonstrate that screening with these modalities resulted in improved health outcomes. A clinical strategy for lung cancer detection that has demonstrated promise is low-dose computed tomography (LDCT), also known as spiral or helical CT scanning. LDCT is a non-contrast radiographic technique that can provide high quality, three-dimensional images of the lungs during a single breath hold with less radiation.
Shared patient and physician decision making may be the best approach before deciding whether to do LDCT lung cancer screening, especially for patients with comorbid conditions. Individuals who choose to undergo lung cancer screening should enter an organized screening program at an institution with expertise in LDCT screening, with access to a multidisciplinary team skilled in the evaluation, diagnosis, and treatment of abnormal lung lesions.
While screening for lung cancer has the potential benefits of decreased morbidity and mortality from lung cancer it also has potential harms, which include:
Patients with several comorbid conditions may be at greater risk than those with few or none. Therefore, the initial risk assessment before screening needs to include an assessment of functional status to determine whether patients can tolerate curative intent treatment if they are found to have lung cancer. Patients with extensive comorbidity may not be candidates for lung cancer screening, because treatment for lung cancer might not prolong survival and could cause potential morbidity and mortality.
Lung cancer is the leading cause of cancer-related death in the United States, accounting for approximately 28% of all deaths from cancer. Death from lung cancer is often related to the initial stage of diagnosis. The average 5-year survival rate for lung cancer is among the lowest (17%) of all types of cancer but is higher when the disease is diagnosed at an early stage (52%). However, only 15% of lung cancer cases are diagnosed at such a stage.
The purpose of lung cancer screening using low-dose computed tomography (LDCT) is to detect disease at a stage when it is not causing symptoms and when treatment will be most successful. Screening should benefit the individual by increasing life expectancy and increasing quality of life.
LDCT is a non-contrast radiographic technique that can provide high quality, three-dimensional images of the lungs during a single breath hold with less radiation.
The relevant population of interest is asymptomatic adults with a smoking history and currently smoke or have quit smoking.
Risk assessment includes age, total cumulative exposure to tobacco smoke, and years since quitting smoking are the most important risk factors for lung cancer. Other risk factors include specific occupational exposures, radon exposure, family history, and history of pulmonary fibrosis or chronic obstructive lung disease.
In March 2021, the USPSTF updated and replaced the 2013 USPSTF recommendation statement on screening for lung cancer using low dose computed tomography. On March 9, 2021 the USPSTF released the following final recommendation:
The current NCCN guideline for Lung Cancer Screening Version 1.2021 recommends lung cancer screening in high risk individuals and there are 2 groups of individuals who qualify as high-risk:
Low-dose computed tomography (LDCT) has high sensitivity and acceptable specificity for detecting lung cancer in high-risk persons and is the only currently recommended screening test for lung cancer.
Most lung cancer cases are non-small cell lung cancer (NSCLC), and most screening programs focus on the detection and treatment of early-stage NSCLC. Although chest radiography and sputum cytologic evaluation have been used to screen for lung cancer, LDCT has greater sensitivity for detecting early-stage cancer.
Non–small cell lung cancer is treated with surgical resection when possible and also with radiation and chemotherapy. Annual LDCT screening may not be useful for patients with life-limiting comorbid conditions or poor functional status who may not be candidates for surgery.
Although lung cancer screening is not an alternative to smoking cessation, the USPSTF found adequate evidence that annual screening for lung cancer with LDCT in a defined population of high-risk persons can prevent a substantial number of lung cancer–related deaths.
Although chest radiography and sputum cytologic evaluation have been used to screen for lung cancer, LDCT has greater sensitivity for detecting early-stage cancer.
The magnitude of benefit to the person depends on that person's risk for lung cancer because those who are at highest risk are most likely to benefit. Screening cannot prevent most lung cancer–related deaths, and smoking cessation remains essential.
Annual screening for lung cancer with low-dose computed tomography is of moderate net benefit in asymptomatic persons who are at high risk for lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking.
The harms associated with LDCT screening include false-negative and false-positive results, incidental findings, overdiagnosis, and radiation exposure.
Of the nonrandomized screening studies, the I-ELCAP study is the largest. It included 31,567 individuals with high-risk factors from around the world, all of whom were screened with baseline and annual screening LDCT cans analyzed centrally in New York. In the I-ELCAP study is the largest, Henschke et. al. reported that a high percentage of stage I cancers (85%) were detected using LDCT, with an estimated 92% actuarial 10-year survival rate for stage I cancers resected within 1 month of diagnosis (62% of all cancers detected). Three participants with clinical stage 1 cancer who opted not to undergo treatment died within 5 years, similar to other data examining the natural history of stage I NSCLC. The authors concluded that annual screening LDCT can detect lung cancer that is curable. Limitations regarding the I-ELCAP study include that is was not randomized, the median follow-up time was only 40 months, and less than 20% of the subjects were observed for more than 5- years. Given the limited follow-up, the 10-year survival estimates may be overstated.
A study by Bach et. al. raised concern that LDCT screening may lead to overdiagnosis of indolent cases without substantially decreasing the number of advanced cases or the overall attributable deaths from lung cancer. Although overdiagnosis did occur with LDCT in the NLST (National Lung Screening Trial), the magnitude was not large when compared with radiographic screening (83 versus 17 stage 1A bronchioloalveolar carcinoma). An analysis of the NLST data stated that 18% of lung cancers detected by LDCT seemed to be indolent. Data suggest that baseline CT scans find more indolent cancers, and subsequent annual scan find more rapidly growing cancers.
The National Lung Screening Trial (NLST) was a prospective, randomized lung cancer screening trial, sponsored by the National Institute of Health (NHI) comparing the annual screening by low dose computed tomography (LDCT) scanning with annual chest x-ray for two years in 53, 454 high risk individuals at 33 United States medical centers. Participants were men and women 55 to 74 years of age with a history of at least 30 pack years of smoking, current smokers and those who had discontinued smoking within 15 years of enrollment. This trial was designed to have 90% power to detect a 21% decrease in the primary endpoint of lung cancer-specific mortality in the screened group. In 2013, the NLST researchers released their findings showed that annual screening LDCT decreased the RR of death from lung cancer by 20%. Overall, 24% of the LDCT scans and 7% of the chest radiographs performed more positive screens, an imbalance that was expected based on prior data. In each of the 3 rounds of screening, positive LDCT scan screens were determined to be actual lung cancer cases (i.e. true positive) 4%, 2% and 5% of the time, compared with 6%, 4%, and 7% of the time for positive chest radiographs.
Based on the published NLST results, 356 participants died of lung cancer in the LDCT arm and 443 participants died of lung cancer in the chest radiograph arm. Thus, annual screening LDCT decreased the RR of lung cancer death by 20% in the NLST. The NSLT represents the first randomized study showing an improvement in disease-specific mortality when using a lung cancer screening program. The NLST results indicate that to prevent one death from lung cancer, 320 individuals with high-risk factors must be screening with LDCT.
In 2019, Huang et. al. conducted a systematic review and meta-analysis to update the evidence of low dose computed tomography (LDCT) in lung cancer screening. The NELSON mortality results were presented in September 2018. Four other randomized control trials (RCTs) also reported the latest mortality outcomes in 2018 and 2019. Studies included met all of the following criteria: (1) only randomized controlled trials; (2) comparing LDCT to any other type of lung cancer screening; (3) adults, aged > 18 years, asymptomatic with risk factor for lung cancer (current or former smokers, family history of lung cancer, underlying lung disease, or environmental exposure to toxins); (4) benefits of interest included: lung cancer mortality, all-cause mortality, early detection (stage I) rates; (5) harms of interest included: death and major complications after invasive procedures (30–60 days post invasive procedures). Major complications were listed below: death, anaphylaxis, cardiac arrest, cerebral vascular accident/stroke, congestive heart failure, myocardial infarction, intervention-required thromboembolic complications, acute respiratory failure, respiratory arrest, bronchial stump leak requiring tube thoracostomy or other drainage for > 4 days, bronchopulmonary fistula, empyema, prolonged mechanical ventilation > 48 h postoperatively, tube placement-required hemothorax, brachial plexopathy, lung collapse, chylous fistula, injury to vital organ or vessel, wound dehiscence, and infarcted sigmoid colon. Invasive procedures included: surgery, biopsy, bronchoscopy or fine needle aspiration cytology.
Nine randomized controlled trials (RCTs) (with multiple publications) met the inclusion criteria. These RCTs contributed to lung cancer mortality outcomes. When compared with controls (no screening or CXR), LDCT screening was associated with a statistically significant reduction in lung cancer mortality (RR 0.83, 95% CI 0.76–0.90) with no heterogeneity observed (p = 0.43, I2 = 1%). Trial sequential analysis (TSA) confirmed that the conclusion for lung cancer mortality was sufficient and no more trials were needed. Seven included trials contributed information on all-cause mortality. On the contrary, LDCT screening demonstrated no statistically significant difference in all-cause mortality (RR 0.95, 95% CI 0.90–1.00). There was no heterogeneity with this outcome (I2 = 0%). Pooled analysis of seven RCTs showed significantly greater proportions (RR 2.08, 95% CI 1.43–3.03) of early- stage cancers in LDCT groups compared to controls.
As to the harm of screening, two studies reported number of deaths after invasive procedures for diagnosis purpose. Nineteen deaths were reported after 2129 invasive procedures in persons screened by LDCT and 11 deaths were reported after 792 invasive procedures in the control group. No significant difference (RR 0.64, 95% CI 0.30–1.33¸ I2 = 0) was shown. Only one study (NLST) reported major complication rates following invasive procedures for LDCT and CXR group. The risk was higher among persons who underwent LDCT compared with CXR screening (4.1 vs 3.2 per 10,000 screened).
In the subgroup analysis according to study quality, compared with controls, LDCT screening demonstrated a statistically significant reduction in lung cancer mortality among high quality studies (RR 0.82, 95% CI 0.73–0.91). However, the same situation has not been observed in low quality studies (RR 0.87, 95% CI 0.64–1.20, I2 = 23%). This suggests that trial quality might be a potential source of heterogeneity. They furthered explored the heterogeneity on the basis of sample size and conducted a subgroup analysis based on the different sample size. A sample size that is too small reduces the power of the trial and increases the margin of error, which can render the trial meaningless. Pooled analysis of findings from seven fairly small trials (total n = 27,968) comparing LDCT with controls showed no significant difference in lung cancer mortality. While findings from two large trials (NELSON, NLST; total n = 69,276), the results of the pooled data displayed a RR of 0.80 (95% CI 0.71–0.91). In addition, regardless male or female, LDCT showed a reduction of lung cancer mortality. Sensitivity analyses were robust. The positive association was consistent with any of these analyses. Reliability and stability of our conclusions were further confirmed.
This is the first meta-analysis of LDCT for lung cancer screening based on sufficient evidence demonstrated by trial sequential analysis (TSA) with the latest NELSON, MILD and LUSI mortality results included. NELSON trial is the only European fully powered RCT which presented its 10-year mortality findings in September 2018 at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC). In total, nine RCTs are included. Most RCTs (DANTE, DLCST, ITALUNG, LUSI, MILD, NELSON) are conducted in European countries, some trials are conducted in the USA (LSS, NLST) and China (Yang 2018). The majority of included studies are judged to be of moderate to high quality (some concerns and low risk of bias for mortality outcomes), but two studies (DANTE, MILD) are judged to be of low quality (high risk of bias for mortality outcomes). Pooled results comparing LDCT to no screening or CXR establish a survival benefit and show an increase in detection of stage I cancers. As for harms of lung cancer screening, LDCT leads to an increase in the frequency of invasive procedures but does not lead to more deaths soon after an invasive procedure compared with the control arms. The results are similar to previous meta-analyses but identified more studies, more participants and more events which enhanced the precision of the results. They also conducted trial sequential analyses which provide estimates about the reliability of current evidence and prevent premature conclusions from meta-analyses.
The authors concluded the present meta-analysis based on sufficient evidence demonstrated by trial sequential analysis (TSA) indicates that there is significant reduction in lung cancer mortality between LDCT and other control groups. Moreover, the results of the subgroup analyses indicate that, LDCT screening has shown statistically significant mortality benefits in high quality trials, whereas low-quality trials found no significant difference. It is mandatory to identify lung cancer risk factors among the Asian population and to establish appropriate eligible criteria in the screening program for different races. The benefit of LDCT is expected to be heavily influenced by the risk of lung cancer in the different target group (smoking status, female and Asian) being screened. Due to tenuous balance of benefits and harms, medical decision making is recommended for individuals who are considering LDCT screening. More studies are warranted to optimize the approach to LDCT screening.
Age, total exposure to tobacco smoke, and years since quitting smoking are important risk factors for lung cancer. Other risk factors include specific occupational exposures, radon exposure, family history, and history of pulmonary fibrosis or chronic obstructive lung disease. The incidence of lung cancer is relatively low in persons younger than 50 years but increases with age, especially after age 60 years. In current and former smokers, age-specific incidence rates increase with age and cumulative exposure to tobacco smoke.
Smoking cessation substantially reduces a person’s risk for developing and dying of lung cancer. Among persons enrolled in the National Lung Screening Trial (NLST), those who were at highest risk because of additional risk factors or a greater cumulative exposure to tobacco smoke experienced most of the benefit.
In 2021, the USPSTF updated and replaced the 2013 USPSTF recommendation statement on screening for lung cancer using low dose computed tomography. On March 9, 2021 the USPSTF released its final recommendation:
Based on review of the peer reviewed medical literature which included nonrandomized, randomized controlled trials (RCTs) and systematic reviews and meta-analyses regarding low dose computed tomography (LDCT) screening for lung cancer, the findings from two of the larger trials (NELSON, NLST [National Lung Screening Trial]); total n = 69,276), resulted in pooled data displaying a risk ratio (RR) of 0.80 (95% CI 0.71–0.91) regardless male or female, LDCT showed a reduction of lung cancer mortality. The NELSON trial is the only fully powered RCT which presented its 10-year mortality findings in 2018 at the International Association for the Study of Lung Cancer (IASCL) 19th World Conference on Lung Cancer (WCLC). Based on the meta-analysis completed in 2019 by Huang et. al., sufficient evidence has been demonstrated by these two trials as there was a significant reduction in lung cancer mortality between LDCT and other control groups. The U.S. Preventative Services Task Force (USPSTF) in 2013 found adequate evidence that annual screening for lung cancer with LDCT in a defined population of high-risk individuals can prevent a substantial number of lung cancer related deaths and the magnitude of benefit to the individual depends on that individual's risk for lung cancer because those who are at highest risk are most likely to benefit. The USPSTF concluded with moderate certainty that annual screening for lung cancer with LDCT is of moderate net benefit in asymptomatic individuals who are at high risk for lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking. In March of 2021 the USPSTF replaced the 2013 USPSTF recommendation statement on screening for lung cancer. The updated recommendation lowers the recommended age to include adults 50-54 years of age and reduces the triggering level of cigarette use to 20 pack-year usage (previously 30 pack-year usage). The current NCCN guideline Lung Cancer Screening Version 1.2021 states there are two groups of individuals that qualify as high- risk and lung cancer screening is recommended: Group 1: Individuals age 55 to 77 years with a 30 or more pack year history of smoking tobacco who currently smoke, or if a former smoker have quit within 15 years; Group 2: Individuals age 50 years and older with a 20 or more pack-year history of smoking tobacco who are either current or former smokers with at least one additional risk factor. The NCCN Lung Cancer Screening Panel members feel that individuals in group 2 are also at high risk for lung cancer based on data from the NLST and other studies. The NCCN Lung Cancer Screening Panel feels that limiting the use to the NLST criteria is arbitrary and naïve, because the NLST only used age and smoking history for exclusion criteria and did not consider other well-known risk factors for lung cancer. Others share this opinion. The NCCN Lung Cancer Screening Panel feels that it is important to expand screening beyond the NLST criteria to a larger group of individuals at risk for lung cancer. Using just the narrow NLST criteria shown in group 1 of the NCCN high-risk categories (e.g., individuals aged 55-77 years with a 30 or more pack-year smoking history) only 27% of patients currently being diagnosed with lung cancer would be candidates for LDCT screening. Data suggest that the lung cancer risk for individuals with a 20 to 29 pack year smoking history is similar to that of individuals with a 30 or more pack-year history. Expanding the groups at high- risk who are candidates for screening, for example, including individuals aged 50 or more years with a 20 or more pack-year smoking history and at least one additional risk factor (other than second-hand smoke) may save thousands of additional lives. Based on the literature low dose computed tomography (LDCT) has shown high sensitivity and acceptable specificity for the detection of lung cancer in high-risk individuals, Chest radiography and sputum cytology evaluation has not shown adequate sensitivity or specificity as screening tests. Pooled results comparing LDCT to no screening or chest x-ray (CXR) establish a survival benefit and show an increase in detection of stage I cancers. Therefore, LDCT is currently the only recommended screening test for lung cancer in high-risk individuals. The evidence is sufficient to determine this technology results in meaningful improvement in the net health outcomes for those individuals at high-risk for lung cancer. Therefore, screening for lung cancer with low dose computed tomography (LDCT) annually may be considered medically necessary for high-risk patients who meet criteria.
Clinicians may encounter asymptomatic individuals who are interested in lung cancer screening but do not meet the criteria of being a high-risk individual for lung cancer, and these individuals would be considered low risk and per the current NCCN guideline for Lung Cancer Screening Version 1.2021 these individuals are <50 years of age or > 81 years of age and/or with a smoking history of less than 20 pack years. The NCCN Lung Cancer Screening Panel and the ACR (American College of Radiology) do not recommend lung cancer screening for these individuals at low-risk for lung cancer based on nonrandomized studies and observational data. The evidence is insufficient to show that screening for lung cancer in low-risk individuals would be beneficial or would outweigh the harms associated with screening for asymptomatic individuals considered at any risk other than high- risk.
In 2021, the USPSTF updated and replaced the 2013 USPSTF recommendation statement on screening for lung cancer using low dose computed tomography. On March 9, 2021 the USPSTF released its final recommendation:
The NCCN Lung Cancer Screening Panel recommends lung cancer screening using LDCT for individuals with high risk factors. There are 2 groups of individuals who qualify as high risk:
In 2019, the American Cancer Society (ACS) updated their guideline on lung cancer screening. The guideline recommends yearly lung cancer screening with a low-dose CT scan (LDCT) for certain people at higher risk for lung cancer who meet the following conditions:
In 2018, the American College of Chest Physicians (ACCP) updated their guidelines for screening for lung cancer, which includes the following recommendations:
Not applicable.
This policy does not apply to individuals with signs and/or symptoms. In symptomatic individuals, a diagnostic work up appropriate to the clinical presentation should be undertaken, rather than screening.
Wellmark Grandfathered Plans: For grandfathered plans refer to the member’s specific benefit plan document for details on how benefits are covered under a grandfathered plan.
Wellmark ACA, QHP, Non-grandfathered and Grand-mothered Plans:
Patient selection criteria below are based on the current U.S. Preventative Services Task Force (USPSTF) Grade B recommendation:
Lung cancer screening utilizing low-dose computed tomography (LDCT), no more frequently than annually may be considered medically necessary in an asymptomatic high-risk individual who meets ALL of the following criteria:
Lung cancer screening utilizing low dose computed tomography (LDCT) would be considered not medically necessary in an asymptomatic high-risk individual for the following indications:
*This is based on a range of chest or other organ signs, symptoms or conditions which would question the member’s ability to undergo non-surgical treatment if a lung cancer was discovered. For example, congestive heart failure, advanced cancer from another site or a patient with COPD who uses oxygen when ambulating, would be examples of conditions that would “substantially limit life expectancy.”
Lung cancer screening utilizing low-dose computed tomography (LDCT) is considered not medically necessary for asymptomatic individuals for any indications not listed above to include individuals at low-risk for lung cancer. Based on the peer reviewed medical literature and society guidelines such as the National Comprehensive Cancer Network (NCCN) the evidence is insufficient to show that screening would be beneficial or would outweigh the harms associated with screening for asymptomatic individuals considered at any risk other than high-risk meeting the above criteria.
A pack-year is a way to calculate the amount a person has smoked in their lifetime. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack year is equivalent of smoking an average of 20 cigarettes, 1 pack per day for 1 year, and so on.
The decision to undertake screening should involve a discussion of its potential benefits, limitations, and harms.
If a person decides to be screened, referral for lung cancer screening with low-dose CT should be to a center with experience and expertise in lung cancer screening.
If the person currently smokes, they should receive smoking cessation interventions.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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