PERSPECTIVE ARTICLE

Lung Cancer Screening With Low-dose Computed Tomography An Analysis of the MEDCAC Decision Mark S. Parker, MD,* Robert C. Groves, MD,* Alpha A. Fowler, III, MD,w Ray W. Shepherd, MD,w Anthony D. Cassano, MD,z Patricia L. Cafaro, DNP, CRNP, FNP-BC,y and Geoffrey T. Chestnut, MBA, MSHA8

Abstract: Lung cancer is the leading cause of cancer death in the United States and worldwide. However, among the top 4 deadliest cancers, lung cancer is the only one not subject to routine screening. Optimism for an effective lung cancer–screening examination soared after the release of the National Lung Screening Trial results in November 2011. Since then, nearly 40 major medical societies and organizations have endorsed low-dose computed tomography (LDCT) screening. In December 2013, the United States Preventive Services Task Force also endorsed LDCT. However, the momentum for LDCT screening slowed in April 2014 when the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel concluded that there was not enough evidence to justify the annual use of LDCT scans for the detection of early lung cancer. This article briefly reviews the epidemiology of lung cancer, the National Lung Screening Trial study results, and the growing national endorsement of LDCT from a variety of key stakeholder organizations. We subsequently analyze and offer our evidence-based counterpoints to the major assumptions underlying the MEDCAC decision. Key Words: lung cancer, lung cancer screening, low-dose computed tomography, United States Preventive Services Task Force, Medicare Evidence Development and Coverage Advisory Committee, American College of Radiology Lung Cancer Screening Program, Lung-RADS

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L

ung cancer is the leading cause of cancer death for both men and women, not only in the United States, but also worldwide. Of the top 4 deadliest cancers in the United

From the *Department of Diagnostic Radiology, Cardiothoracic Imaging; wDepartment of Internal Medicine, Division of Pulmonary Disease and Critical Care Medicine; zDepartment of Surgery, Division of Cardiothoracic Surgery; 8Department of Radiology; and yDepartment of Internal Medicine, VCU Medical Center, Richmond, VA. Mark S. Parker: receives royalties for the coauthorship of the thoracic imaging textbook, Chest Imaging Case Atlas, 2nd edition from Thieme, New York; Alpha A. Fowler: receives an NIH grant for human trials with Vitamin C-UM1 from the National Institutes of Health; Ray W. Shepherd: receives authorship royalties for Up-toDate; serves as a Consultant for Boston Scientific; and receives Industry Grants from Allegro Diagnostics, Veracyte-Bronschoscopy Trial, and EMPROVE for COPD Therapy as part of a Multi-Center Trial. The remaining authors declare no conflicts of interest. Correspondence to: Mark S. Parker, MD, Department of Diagnostic Radiology, Cardiothoracic Imaging, VCU Medical Center, Main Hospital, 3rd Floor, 1250 East Marshall Street, P.O. Box 980615, Richmond, VA, 23298-0615 (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins

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States (lung, prostate, breast, and colorectal), lung cancer is the only one not subject to routine screening.1,2 Historically, this reflected the fact that no screening test had been shown to reduce lung cancer–specific mortality. This scenario changed dramatically with the release of the National Lung Screening Trial (NLST) results in November 2011.3 This randomized control trial showed that highrisk persons who received a baseline and 2 subsequent annual low-dose helical computed tomography (LDCT) scans had a 20% lower risk of death from lung cancer compared with those screened with chest radiographs.3 For the first time, it seemed physicians had an examination capable of positively impacting the lives of patients at high risk for lung cancer. Since the release of the NLST data, nearly 40 major medical organization and societies have endorsed LDCT screening for the early detection of lung cancer.4–12 This culminated with the endorsement by the United States Preventive Services Task Force (USPSTF) in December 2013 (http://www.uspreventiveservicestaskforce.org/uspstf13/ lungcan/lungcanfact.pdf).13 There was growing consensus that a national lung cancer–screening program was about to become a reality. However, the momentum for screening slowed in April 2014 when the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel made a decision that surprised many in the medical community.14,15 The panel concluded that there was not enough evidence to justify annual LDCT scans for the detection of early lung cancer and voted against CMS payment for this screening tool.14,15 This article briefly reviews the epidemiology of lung cancer, the NLST study results, and the growing national endorsement of LDCT from a variety of key stakeholder organizations. We subsequently analyze and offer our evidence-based counterpoints to the major assumptions underlying the MEDCAC decision.

LUNG CANCER EPIDEMIOLOGY The American Cancer Society (ACS) estimates that 224,210 new diagnoses of lung cancer will be made in 2014 in the United States.1 This includes approximately 116,000 new diagnoses in men and about 108,210 in women. Further, the ACS estimates that 159,260 persons will die of lung cancer this year (86,930 in men and 72,330 in women).1 Although the incidence of lung cancer has declined in the United States by about 1.9% per year in men over the past 2 decades and more recently by approximately 0.3% per www.thoracicimaging.com |

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year in women, lung cancer still accounts for 27% of all cancer-related deaths.2 Cigarette smoking remains the single most important risk factor, and the risk increases with both the quantity and duration of tobacco abuse.2 It is estimated that 10% of heavy smokers will develop lung cancer.2 Unfortunately, the presentation of lung cancer is often insidious, producing minimal or no clinical symptoms until the disease is far advanced and no longer curable by surgical resection. In fact, most lung cancer patients already have locally advanced or metastatic disease at their first clinical presentation.16 Indeed, only 15% to 25% of patients have potentially resectable, early-stage disease confined to the chest at clinical presentation.2 If a lung cancer is not resectable when first discovered, most affected patients will die within the next 9 months.2 Despite advances in surgical therapy and chemo-radiation therapy, the 5-year survival rate for all newly diagnosed lung cancers of all stages remains a dismal 16% (1 in 7).2



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Lung Cancer Alliance, and the American Association of Thoracic Surgery.4–10 The American Academy of Family Physicians (AAFP) is one of the few medical societies that have not endorsed LDCT screening for lung cancer. The AAFP contends that the USPSTF made far-reaching and potentially costly recommendations based on the NLST study results alone.18 The AAFP further postulates that the favorable NLST results may be skewed because screening and patient management were conducted at major medical centers. Specifically, they contend that the NLST was performed exclusively at centers well known for their expertise in diagnostic imaging and in the diagnosis and treatment of lung cancer and that these results have not yet been replicated in community practices. The AAFP also argues that the long-term harms of radiation exposure from follow-up full-dose computed tomography (CT) scans are unknown, and they are likewise concerned about the number of patients who may undergo potentially unnecessary invasive bronchoscopy and surgical interventions.18

EARLY CANCER DETECTION The early detection of lung cancer when it is still small and localized is of paramount importance in mortality reduction. The merits of early detection screening programs for other malignancies such as breast and colon cancer are well established. For example, early detection of breast cancer using mammography has resulted in a 5-year survival rate of 90%.2 Likewise, screening for colorectal cancer has contributed to increased 5-year survival rates of almost 64%.2 Chest x-ray screening programs for the early detection of lung cancer have been previously used, but they failed to decrease lung cancer mortality. This is likely because conventional radiography could not detect cancers small enough or at an early enough stage to improve survival, even in high-risk heavy smokers.2

NLST The prospects of lung cancer screening changed dramatically when the National Cancer Institute (NCI) announced the initial results of the NLST. The NLST is the largest randomized control trial of lung cancer screening in high-risk persons to date. It was conducted at 33 medical centers across the United States and included >53,000 high-risk asymptomatic current or former smokers between the ages of 55 and 74 years with at least a 30-pack-year history of smoking.3,17 This $240 million trial, sponsored by the NCI and conducted by the American College of Radiology Imaging Network (ACRIN), showed that high-risk persons who received a baseline and 2 subsequent annual LDCT scans had a 20% lower risk of death from lung cancer than participants who received standard chest x-ray screening.3,17 LDCT detected more lung cancers at earlier and potentially more treatable stages, and it also reduced the number of lung cancer deaths in high-risk patients.

MEDICAL ORGANIZATIONS ENDORSING NLST GUIDELINES Since the release of the NLST results, at least 38 key stakeholder major medical societies and organizations have endorsed LDCT for the early detection of lung cancer. Notable societies and organizations include the American Lung Association, American College of Chest Physicians, American Society of Clinical Oncology, National Comprehensive Cancer Network, American Cancer Society,

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USPSTF RECOMMENDATIONS The USPSTF is an independent panel of non-Federal experts in preventive and evidence-based medicine.19 The task force comprises primary care providers (ie, internists, pediatricians, family physicians, gynecologists/obstetricians, nurses, and health behavior specialists).19 On July 30, 2013, the USPSTF released a draft recommendation statement on LDCT screening for lung cancer.20 The task force’s initial draft was posted for public comment on the USPSTF site at http://www.uspreventiveservicestaskforce.org and accepted comments from July 30 to August 26, 2013 at http://www.uspreventiveservicestaskforce.org/tfcomment. htm.19,20 The USPSTF conducted a comprehensive review of the medical evidence for LDCT in the early detection of lung cancer. This included not only the NLST results but also evidence from smaller randomized European trials, the latter of which had different eligibility criteria and study designs than the NLST. The USPSTF also commissioned modeling studies to optimize information regarding the best patient ages to begin and end lung cancer screening, appropriate screening intervals, and the relative benefits and harms of different screening protocols (http://www.uspreventive servicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf).13 On December 31, 2013, the USPSTF issued its final recommendation statement and also released a fact sheet to aid in the implementation of lung cancer–screening programs for high-risk individuals. The task force gave LDCT a “B” grade (the equivalent grade for screening mammography). The “B” grade indicates that there is high certainty the net benefit is moderate or there is moderate certainty the net benefit is moderate to substantial and that this particular service should be offered or provided (http://www. uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact. pdf).13 Importantly, the Affordable Health Care Act (ACA) requires private insurers to cover without copay all medical examinations or procedures receiving a grade “B” or higher from the USPSTF. More specifically, USPSTF recommended annual screening with LDCT in persons 55 to 80 years of age with the equivalent of a 30 pack-year of cigarette smoking who currently smoke or had quit within the past 15 years. They further recommended that screening should be discontinued once the r

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individual had not smoked for 15 years or developed health problems significantly limiting their life expectancy, ability, or willingness to undergo curative lung resection surgery (http://www.uspreventiveservicestaskforce.org/uspstf13/ lungcan/lungcanfact.pdf). 13 The USPSTF evidence suggested that implementing a screening program with these specific eligibility criteria would detect approximately one half of all lung cancers at an earlier, potentially resectable stage and could save as many as 20,000 lives each year in the United States (http://www.uspreventive servicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf).13 The USPSTF further emphasized that the benefits of screening would be maximized when qualified health professionals: (1) limit screening to high-risk persons; (2) accurately interpret the LDCT images; (3) strive to reduce false-positive studies in lieu of invasive procedures by additional imaging or short-term interval low-dose studies; and (4) enroll current smokers into smoking cessation programs (http://www.uspreventiveservicestaskforce.org/ uspstf13/lungcan/lungcanfact.pdf).13 The American College of Radiology (ACR) and the Radiological Society of North America (RSNA) immediately supported these recommendations and began developing standards to support lung cancer–screening programs across the country.21,22 More recently, the ACR in cosponsorship with the Society of Thoracic Radiology (STR) released specific practice parameters for the performance and reporting of LDCT for the early detection of lung cancer in high-risk persons.11,12

ASSESSING POTENTIAL MEDICARE COVERAGE: PRELUDE TO MEDCAC Medicare limits coverage to those items and services it deems reasonable and necessary for the diagnosis and treatment of an illness or injury.23 National coverage determinations are made through an evidence-based process, with various opportunities for public participation. In some instances, the US Centers for Medicare and Medicaid Services (CMS) supplements its own research by using outside technologies and/or consulting with the MEDCAC.23 CMS may also seek input from MEDCAC for independent expert advice in making decisions on the basis of the reasonable application of available scientific evidence. It may also enlist MEDCAC to address broader issues regarding policy coverage development and to identify evolving technologies appropriate for Medicare beneficiaries. It should be stressed that MEDCAC is only an advisory panel. Final decisions on all issues rest with CMS.24 In February 2014, CMS opened a 30-day public comment period on a proposal to make LDCT screening for highrisk individuals a covered preventive service under Medicare (http://www.auntminnie.com/index.aspx?sec = sup&sub = imc &pag = dis&ItemID = 106475). In March 2014, the ACR, Lung Cancer Alliance, American Association of Thoracic Surgery, and 38 other medical organizations and health care providers sent a joint letter to the acting director of CMS urging CMS to act upon the USPSTF recommendations and to provide full coverage for LDCT lung cancer screening in high-risk Medicare-Medicaid beneficiaries.25 As mentioned earlier in this article, under the ACA, the USPSTF grade “B” recommendation requires all private insurers to cover, without copay, LDCT. However, the ACA does not specify that Medicare provide full national coverage for its beneficiaries. This ACA “loophole” could enable CMS to deny reimbursement for LDCT while at the r

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same time requiring that private insurers pay for these same screening LDCT studies.25 In essence, this could create a 2-tier system leaving high-risk Medicare beneficiaries at greater risk of dying from lung cancer than individuals with private insurance.25 Within this context, CMS convened a MEDCAC meeting in April 2014 to review the evidence on lung cancer screening with LDCT and ascertain its merits as a covered preventive service (http://www.auntminnie. com/index.aspx?sec = sup&sub = imc&pag = dis&ItemID = 106475).25,26

MEDCAC AGENDA In April 2014, CMS published the agenda for its MEDCAC lung cancer–screening meeting.27 CMS requested that 3 primary issues be addressed related to patient screening criteria, frequency/duration of screening, and provider/ facility characteristics (Table 1).27 CMS also sought information on the influence of screening factors on patient education, informed consent, and the integration of smoking cessation into lung cancer–screening programs.27 The MEDCAC panel members were also asked to vote on 3 main questions that hinged on whether there was sufficient evidence to show that the benefits of screening would outweigh the harms (Table 2).27

MEDCAC PANEL COMPOSITION MEDCAC consists of 100 appointed members, including experts in clinical and administrative medicine, biological and physical sciences, public health administration, patient advocacy, health care data and information management and analysis, health care economics, medical ethics, and other related professions. Eighty-eight members are at-large standing members; 6 members represent consumer interests, 6 represent industry interests, and 6 serve as patient advocates. Only at-large members have voting rights. Voting members include clinical and methodology experts and patient advocates. Consumer industry representatives are nonvoting members, but bring the perspectives of beneficiaries and product development to the MEDCAC deliberations.24 The April 2014 lung cancer screening deliberating MEDCAC panel consisted of 14 members, including 9 physician-MDs, 3 PhDs, 1 clinical nurse practitioner, and 1 medical physicist.14 Nine of these panelists (5 physicians, 2 PhDs, 1 clinical nurse practitioner, and 1 medical physicist) were the only voting members. To the best of our knowledge, no voting members on the MEDCAC panel had specific research or clinical experience with the diagnosis, management, treatment, or imaging of lung cancer. Sixteen expert speakers from across the United States were invited to address the MEDCAC panel in support of LDCT lung cancer screening. These latter speakers represented relevant medical disciplines including: pulmonary and critical care medicine; lung cancer screening and staging; biomedical physics; cardiothoracic radiology; interventional

TABLE 1. CMS Issues to be Addressed by the MEDCAC Panel27 Identification of individuals eligible for screening Appropriate frequency and duration of screening Facility and provider characteristics predicting benefit or harm of screening

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TABLE 2. Main CMS Questions Voted on by the MEDCAC Panel27 How confident are you that there is adequate evidence that the benefits outweigh the harms of lung cancer screening with LDCT? How confident are you that the harms of lung cancer screening with LDCT if implemented in the Medicare population will be minimized? How confident are you that clinically significant evidence gaps remain regarding the use of LDCT for lung cancer screening in the Medicare population outside a clinical trial?

pulmonology; lung cancer research; cardiothoracic surgery; thoracic oncology; medical imaging and technology. The Director of the American Lung Association and the Chief Cancer Control Officer of the ACS were also invited. None of these 16 expert speakers were members of the MEDCAC panel.14

MEDCAC PANEL VOTING RESULTS On April 30, 2014, the MEDCAC panel was asked to rank their level of confidence, on a scale of 1 (low or no confidence) to 5 (high confidence), regarding the 3 CMS questions posed above. Their voting results are summarized in Table 3.14,15 The MEDCAC expert physicians and scientists concluded that there was not enough clinical evidence to justify annual LDCT screens to detect early lung cancer in heavy smokers and voted against payment.14 The panelists further concluded that they had little confidence that the benefits of subjecting high-risk Medicare beneficiaries to annual LDCT scans outweighed the potential risks of psychological trauma or unnecessary surgeries resulting from false-positive screening results. Some panelists suggested that the USPSTF may have erred in their “B” recommendation and that an “I” (incomplete) or perhaps a “C” (ie, providing this service to individual patients on the basis of professional judgment and patient preferences because there is at least moderate certainty that the net benefit is small) would have been more appropriate.28 The minutes and full transcript from the April 30th MEDCAC meeting are publically available online.15

ANALYSIS OF MEDCAC CONCLUSIONS AND DECISION We will now analyze key points of the MEDCAC panel’s major conclusions, followed by our evidence-based counterpoints to their supporting assumptions.

Assumptions Regarding Radiation Exposure Point. The chair of the MEDCAC panel cited concerns regarding the major stochastic risks of radiation-induced

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carcinogenesis from diagnostic CT scans and further provided a specific estimate on the quantitative cancer risk per number of CT scans performed.29 Counterpoint. In our opinion, the MEDCAC panel would have benefited from having an American Board of Radiology–certified radiologist to serve on their voting panel. Diagnostic radiologists are trained in radiation safety and dose-saving techniques in accordance with the “as low as reasonably achievable” (ALARA) principle— that is, performing diagnostic imaging tests using ionizing radiation with those doses that are ALARA to provide a diagnostic quality examination and answer the clinical concern. LDCT lung cancer screening and the imaging guidelines developed by the ACR epitomize this principle.28 We emphasize that, to date, there has been no peerreviewed published report that CT scans have directly caused cancer in any particular patient. No meta-analysis, randomized, controlled cohort trial, case-control or observational study, or even a case report demonstrating such has been published to our knowledge.29 The stochastic evidence cited by the MEDCAC chair stems from modeling studies based upon the radiation exposure incurred by the 1945 atomic bomb survivors in Hiroshima and Nagasaki and/or nuclear power plant accidents applying the linear nonthreshold (LNT) theory. This theory postulates that any and all radiation exposure is considered harmful and carcinogenic.30,31 The validity of the LNT model has been called into question, but it remains debated by radiation physicists and other experts. Equally important, the LNT model was originally developed as a protection guideline for “occupationally” exposed individuals. The LNT was not developed as an attempt to predict potential increased cancer deaths in persons exposed to “medical doses of ionizing radiation.”31,32 The MEDCAC panel chair also indicated that follow-up CT scans had a wide variation in radiation dose, delivering as much as 15 mSv and that the radiation exposure from screening and follow-up studies could not be predicted.28 To circumvent this concern, specific LDCT technique guidelines for a CTDIvol of r3 mGy (3 mSv) for a standardized lung cancer screening patient have been developed and recently published by the ACR and cosponsored by the STR.

Interpretation of NLST Data Mortality Reduction Point. The MEDCAC panel contended that older patients were underrepresented in the NLST and that there was no statistically significant reduction in mortality in the subset of Medicare-aged patients over the age of 65.29 In particular, they cited that approximately 25% of the NLST

TABLE 3. MEDCAC Panel Voting Results14,15

CMS Question Posed How confident are you that there is adequate evidence the benefits outweigh the harms of lung cancer screening with LDCT? How confident are you that the harms of lung cancer screening with LDCT if implemented in the Medicare population will be minimized? How confident are you that clinically significant evidence gaps remain regarding the use of LDCT for lung cancer screening in the Medicare population outside a clinical trial?

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Score Overall Ranges Average Score

Voting Member Average Score

1-4

2.36

2.22

2-3

2.29

2.33

4-5

4.57

4.67

r

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Lung Cancer Screening With LDCT/MEDCAC Decision

participants were older than 65 years, and none were older than 74.26,29,33 Counterpoint. Even though only 25% of the NLST participants were older than 65 years, this represented 14,219 Medicare-aged individuals and represents one of the largest high-risk populations studied to date.26,29,33 As explained by Michael T. Jaklitsch, MD, Associate Professor of Surgery at Harvard Medical School and a practicing thoracic surgeon, this number of participants “y provides plenty of power to assess the value of low-dose CT screening in the 65- to 74-year age group.”33 The 20% reduction in lung cancer–specific mortality might have been even greater if patients older than 74 years had participated in NLST because of the increased incidence of lung cancer in this age group.33 Further, the USPSTF based its recommendations not only on the NLST results, but also included other US and European trials, as well as sophisticated mathematical modeling exercises conducted by the NCI’s Cancer Intervention and Surveillance Modeling Network (CISNET). CISNET is a consortium of 5 groups, each with its own evidence on the natural history of lung cancer (http://surveillance.cancer.gov/ publications/; http://surveillance.cancer.gov/publications/fact sheets/).13,34–37 Combining these 5 models and input in hundreds of various screening scenarios, the CISNET analysis revealed an average mortality reduction of 14% and estimated that 50% of lung cancers would be detected at an early stage with LDCT screening. This analysis suggests that nearly 500 lung cancer deaths could be prevented per 100,000 screened individuals (http://surveillance.cancer.gov/publications/fact sheets/CISNET_Fact_Sheet.pdf; http://www.uspreventive servicestaskforce.org/uspstf13/lungcan/lungcanmodeling.pdf Accessed).34–38 This mathematical modeling also convincingly revealed benefit for screening even older patients from 74 to 80 years of age, further supporting Dr Jaklitsch’s hypothesis.33 Unfortunately, this mathematical model was not considered by MEDCAC.33 Moreover, data from the Surveillance, Epidemiology, and End Results (SEER) program showed that raising the upper age limit for screening to 80 years, as recommended by the USPSTF, would increase the number of detected lung cancers from about 40% among 55- to 74-yearolds to about 60% among 55- to 80-year-olds.38,39 These data combined with data from the Japanese prefectural cohort, case-control studies, and the prospective lung cancer–screening study results of >60,000 persons by the International Early Lung Cancer Action Program (I-ELCAP) were also not considered by MEDCAC.29,40 On September 9, 2014, a new analysis of data from the NLST was published concluding that LDCT lung cancer screening is even more effective in older Medicare-aged individuals than in younger persons.41 Pinsky and colleagues divided the NLST participants into 2 groups: (1) older current and former heavy smokers 65 to 74 years of

age; and (2) younger individuals 55 to 64 years old with similar smoking histories. The researchers not only found a higher prevalence of lung cancer in the older Medicare-aged group (1.5% vs. 0.7%) but that CT screening also had a higher positive predictive value in these Medicare-eligible persons (4.9% vs. 3.0%; P < 0.001) and necessitated a fewer number of screens to prevent 1 lung cancer death (245 screens vs. 364 screens).41

False-positive Studies Point. The MEDCAC panel contended that the 96% false-positive rate for LDCT was unacceptably high. The panel also voiced concerns over how a particular individual clinician might formulate a better management plan for handling a positive screen result.28 Counterpoint. Lung cancer screening, like other potential screening tests, may be associated with potential harm, including the detection of incidental findings and false-positive screening results. However, the USPSTF report acknowledged that “insufficient evidence” was found on the harms associated with incidental findings (http://www.uspreventiveservicestask force.org/uspstf13/lungcan/lungcanfact.pdf).13 In NLST, a “positive” screening result was defined as one in which a noncalcified nodule measuring at least 4 mm in diameter was detected.3 Across the baseline and 2 annual rounds of screens, 96% of the positive LDCT screens and 95% of the chest x-ray screens were falsely positive. That is, the suspicious imaging finding(s) did not represent a true lung cancer.3 It should be emphasized that the detection of a nodule does not necessarily convey the need for an invasive procedure. In fact, as explained by Dr Jaklitsch, “The value of low-dose CT screening is that the entire program is built on repeat lowdose CT scans, not invasive procedures.” Ninety-six percent of false-positive findings are sorted out with repeat LDCT imaging—not biopsy or surgery, but imaging.33 The STR and the ACR have also addressed the MEDCAC panel’s concern of what a particular clinician should do with a positive screen result.28 In particular, the ACR has developed a “Lung-RADS” system for specific reporting, follow-up, and management of both negative and positive LDCT screens.42 The ACR increased the size threshold for an actionable nodule from 4 to 6 mm on the basis of a large amount of supporting data. This change is anticipated to substantially reduce the number of falsepositive studies compared with NLST.42 The ACR LungRADS classification scheme for lung cancer screening, similar to applying the “Bi-Rads” system for screening mammography, would markedly reduce the need to work up positive studies and stratify the pertinent imaging findings. By applying the Lung-RADS system, it is estimated that only 1 in 10 individuals with a positive LDCT screen would require a biopsy.28,42 Comparing false-positive rates and guidelines used for the management of positive study results, and the number of lives saved per screening

TABLE 4. False-positive Rates of Other Accepted Screening Tests Versus LDCT43–47

Screening Test

False (+) Results Over 10 Annual Screens (%)

Cancer Deaths Prevented

Mammography

50-60

1 per 1905 screens over 11-20 y (40-49 y) 1 per 871 screens

Flexible sigmoidoscopy LDCT lung cancer

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30.3 (men) 19.3 (women) 96

1 per 320 screens

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examination, LDCT actually proves to be a more efficacious screening examination than the already widely utilized, accepted, and approved screening tests of mammography and flexible sigmoidoscopy (Table 4).43–47

False-negative Studies Although the false-negative rate of LDCT was reportedly not a major deciding factor in the final MEDCAC decision, for completeness, it should be mentioned that no gold standard exists for determining the true negative results on screening LDCT. The sensitivity is most often determined by the detection of a lung cancer within 1 year of the initial screening study on a follow-up screen. To date, 6 studies have reported the sensitivity of LDCT for detecting lung cancer, which ranges from 80% to 100% (most often >90%), with a resultant false-negative rate of 0% to 20%.48–54 These values are contrasted with the falsenegative rates of both screening mammography and flexible sigmoidoscopy in Table 5.43–46,48,54,55 These numbers would likewise suggest that LDCT for lung cancer screening is a potentially more efficacious test.

Overdiagnosis and Overtreatment Point. The estimated overdiagnosis rate of 18% in the NLST, if extrapolated to the community at large, may subject screened patients to unnecessary lung cancer diagnoses, additional diagnostic tests, and/or invasive procedures for indolent cancers that may never cause harm.3,15,28 Counterpoint. Overdiagnosis is not unique to LDCT screening but is intrinsic to cancer screening in general. For example, screening mammograms can detect cancer and cases of ductal carcinoma in situ (DCIS).56,57 This noninvasive tumor does indeed warrant appropriate treatment. However, screening mammography may also find cancers and other cases of DCIS that will never cause symptoms or threaten the individual’s life, thereby resulting in an “overdiagnosis” of breast cancer.56,57 Most often, one cannot distinguish those cancers and cases of DCIS that do and do not require treatment and thus all detected lesions are similarly treated.56,57 Overdiagnosis results in the phenomena of “overtreatment.” Overtreatment exposes these women to unnecessary additional imaging, biopsy, surgery, and potentially chemotherapy and radiation therapy.56,57 Analogously, in the NLST, investigators found that about 18% (approximately 1 in 5) cancers detected at LDCT were likely indolent.3,58 Such lung cancers are so slow growing that they are unlikely to ever cause symptoms or harm the patient. But, like some cases of DCIS, there are no easy means at this time to determine which of these lesions may require aggressive management and which ones will not.58 The number of cases of overdiagnosis found among the 320 NLST participants who would need to be screened to prevent 1 death from lung cancer was 1.38.3 The NLST authors stressed that the overdiagnosis rate is likely to diminish as further experience is gained and that this TABLE 5. False-negative Rates of Other Accepted Screening Tests Versus LDCT43–46,48,54,55

Screening Test

False () Screening Results (%)

Mammography Flexible sigmoidoscopy LDCT lung cancer

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estimate may therefore represent an upper limit of the potential overdiagnosis rate for LDCT.3 Supporting this hypothesis, the USPSTF modeling studies estimates that only 10% to 12% of screen-detected lung cancer cases would not otherwise be detected in a patient’s lifetime.46 NLST investigators have stated that the concept of overdiagnosis should be included when describing the risks of LDCT screening to patients and their referring physicians.3 The ACR-STR practice parameters for LDCT screening for lung cancer have also emphasized the importance of this factor.11,59

Potential Harm and Patient Anxiety Point. The MEDCAC panel commented that “ythousands of iatrogenic deaths” could be expected with nationwide screening. This conclusion was based on “16 iatrogenic deaths in the NLST study.”28,29 The MEDCAC panel also contended that “more patients suffered complications from screening than had their lives saved”.28,29 The panel further raised concerns that potential harms may be accentuated in the community, wherein the interpretation of screening CT results, use of invasive procedures, and complications from such procedures can widely vary.28,29 Counterpoint. To our knowledge, there is no evidence that even a single death in NLST was a direct complication of LDCT screening. Sixteen deaths did occur within 60 days of a screening examination, but no published report has attributed any one of these deaths to a specific procedure following a CT false-positive screen.14 Virtually all of the major complications at workup from screening occurred only in those persons who actually had lung cancer. The vast majority of those persons being screened, that is those without lung cancer, experienced no excessive harm.28 On the basis of analysis of the NLST data, most lung cancer deaths occurred after the screening program ceased. More specifically, 52% (1 in 2) of the NLST screen-detected lung cancer patients lived for >5 years.3,29 There is a misconception that all NLST participants were imaged and managed at major academic medical centers and thus these positive results are unlikely to be reexperienced or reproduced in community-based practices. This was not the case. About 25% of participating NLST medical centers were not tertiary care academic medical centers.3,17 Further, to our knowledge, no definitive clinical evidence has been published to support the concern that potential risks will be magnified in the community.33 Numerous community databases have shown no statistical significant difference between academic and communitybased programs in this regard. Some of these communitybased programs provided testimony to the MEDCAC panel.15,33 Although one would expect that false-positive results from LDCT screening would generate significant anxiety, this was not the case in the NLST. Indeed, in a substudy comprising nearly 3000 NLST participants, Gareen et al60 found no increased anxiety or decreased quality of life at 1 or 6 months after screening for participants having a falsepositive result. These authors emphasized that the detailed informed consent process for NLST participants likely contributed substantially to these findings. Indeed, the most important step to reducing patient anxiety before screening LDCT for lung cancer or any other cancer screening test is patient education.57,61–68 Toward this end, the ACR has been proactive in providing guidelines for this purpose as r

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well as frequently asked question sheets for both physicians and patients.11,69

Cost to Medicare System Many concerns have been raised as to whether the health care system can afford the projected costs of a national lung cancer–screening program. Joshua A. Roth, PhD, MHA, a postdoctoral research fellow at the Fred Hutchinson Cancer Research Center in Seattle, Washington, recently showed that adding LDCT screening to the Medicare Program could result in the diagnosis of about 54,900 earlier-stage and more treatable lung cancers over a 5-year period.70,71 Dr Roth, speaking at a presscast before the 2014 Annual Meeting of the American Society of Clinical Oncology, postulated that about $5.6 billion would be spent on an estimated 11.2 million additional LDCT scans alone during the next 5 years. Dr Roth went on to say that $1.1 billion would be spent on diagnostic workups, and $2.6 billion would be spent on cancer care, for a total cost of $9.3 billion to Medicare. Dr Roth further emphasized that if lung cancer screening is to be covered, it is imperative for Medicare and other contractual health care system providers to prepare not only for the increased demand for LDCT imaging but also for the treatment of early-stage lung cancers.70,71 However, to put this total 5-year expenditure into perspective, the costs would amount to only a $3.00/mo increase in premiums per Medicare member.70,71 Supporting Dr Roth’s conclusions, a recent study conducted by the actuarial firm Milliman found that implementing the screening recommendations proposed by the US Task Force would be highly cost-effective.72 More specifically, Pyenson and colleagues found that LDCT screening in high-risk Medicare-aged persons was more cost-effective than screening for cervical and breast cancer and was comparable to that of colorectal cancer screening. Applying the USPSTF guidelines, these researchers determined that 4.9 million Medicare beneficiaries would be eligible for screening in 2014. If all 4.9 million beneficiaries were screened and treated consistently beginning at age 55, approximately 358,000 additional people with current or prior lung cancer would still be alive. Pyenson et al72 estimated that the total cost of a life-year saved with LDCT is $18,452 with an estimated average annual cost of $241 per person screened.

LDCT ENDORSEMENTS FOLLOWING THE MEDCAC DECISION In June 2014, 178 members of Congress signed letters urging CMS to prioritize lung cancer screening as a covered examination. Members of the Senate called on Marilyn Tavenner, administrator for the CMS, for an expedited Medicare National Coverage Decision. They emphasized lung cancer’s high death toll and cited LDCT’s proven effectiveness. They further stressed the unequal access to preventive health care the absence of Medicare reimbursement would create.73,74 Also in June 2014, the American Medical Association House of Delegates came forward and urged Medicare, Medicaid, and private insurers to make LDCT a “required covered benefit.”75

CMS RELEASES LUNG CANCER SCREENING HCPCS CODE In July 2014, CMS released a new “S” code for LDCT lung cancer screening.76 This code is now included in the r

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quarterly update of the Healthcare Common Procedure Coding System (HCPCS) codes released by the Centers for CMS. The codes will be effective October 1, 2014.76

SUMMARY AND CONCLUSIONS In this perspective article, we have attempted to both recognize and address the various concerns that led to the MEDCAC panel’s decision. Because CMS is not bound to the MEDCAC panel’s decision, this issue is still open for debate. CMS is statutorily required to publish its draft decision coverage by November 10, 2014. There will then be a brief second public comment period with a final decision posted in early 2015. It is our hope that CMS will vote in favor of LDCT coverage so that its life-saving benefits will be available to all high-risk patients who meet eligibility requirements. REFERENCES 1. What is non-small cell lung cancer? Available at: http:// www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/ non-small-cell-lung-cancer-key-statistics. Accessed May 21, 2014. 2. American Cancer Society. Cancer Facts and Figures 2013. Available at: http://www.cancer.org/acs/groups/content/@ epidemiologysurveilance/documents/document/acspc-036845.pdf. Accessed May 21, 2014. 3. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, et al. Reduced lung cancer mortality rate with low-dose computed tomography. N Engl J Med. 2011;365:395–409. 4. American Lung Association. American Lung Association provides guidance on lung cancer screening. Available at: http:// www.lung.org/lung-disease/lung-cancer/lung-cancer-screeningguidelines/. Accessed May 21, 2014. 5. New lung cancer guidelines recommends offering screening to high-risk individuals. Available at: http://www.chestnet.org/ News/Press-Releases/2013/05/New-Lung-Cancer-GuidelinesRecommends-Establishment-of-Screening-Programs. Accessed May 21, 2014. 6. Lung cancer guidelines. Available at: http://www.asco.org/ guidelines/lung-cancer. Accessed May 21, 2014. 7. National Comprehensive Cancer Network. Available at: https:// www.nccn.org/store/login/login.aspx?ReturnURL = http://www. nccn.org /professionals / physician_gls/pdf/lung _screening.pdf. Accessed May 21, 2014. 8. American Cancer Society new lung cancer screening guidelines for heavy smokers. Available at: http://www.cancer.org/ cancer/news/new-lung-cancer-screening-guidelines-for-heavysmokers. Accessed May 21, 2014. 9. Lung Cancer Alliance. National Framework for Excellence in Lung Cancer Screening and Continuum of Care: uniting the at-risk public with responsible medical care now. Available at: http://www.lungcanceralliance.org/get-information/am-i-at-risk/ national-framework-for-lung-screening-excellence.html. Accessed May 21, 2014. 10. Jaklitsch MT, Jacobson FL, Austin JH, et al. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012;144:33–38. 11. American College of Radiology. Guidance for ACR members on lung cancer screening with CT. Available at: http:// www.acr.org/News-Publications/News/News-Articles/2013/ Quality-Care/20130624-Guidance-for-ACR-Members-on-LungCancer-Screening-with-CT. Accessed May 21, 2014. 12. Society of Thoracic Radiology. USPSTF draft recommendations: opportunity for public comment. Available at: http://thoracicrad. org/assets/downloads/membership/STR%20Public%20Statement %20on%20USPSTF%20Draft%20Recommendation%20for%

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