ORIGINAL ARTICLE

Lung Cancer Screening With Low-Dose CT

in the United States
Jan M. Eberth, PhD, MSPH

Abstract
The ndings of the landmark National Lung Screening Trial (NLST)showing a 20% reduction in lung cancer mortality when
screening with low-dose CT (LDCT), compared with chest radiographymarked a turning point in the eld of lung cancer screening,
inuencing organizational recommendations and leading to increasing acceptance of LDCT for screening of individuals at high risk for
lung cancer. However, many practices and institutions have experienced barriers in their attempts to implement successful screening
programs; these include challenges in maintaining the same high caliber of screening programs as those in the NLST, confusion
regarding insurance reimbursement protocols, and a lack of resources to help physicians discuss the specics of LDCT screening with
their patients.
To address these challenges, standards are being established to ensure consistent quality of screening programs, including certication
standards and protocols maintained by the ACR. In addition, the US Preventive Services Task Forces B rating, given to LDCT
screening in late 2013, resulted in mandated private insurance coverage beginning in 2015 and the 2015 CMS coverage determination
has spurred previously reluctant organizations to prepare for population-based screening. Despite these successes, protocols for billing
and claims processing are still evolving and organizations are considering how best to implement the shared decision-making process
required by CMS. Despite some procedural setbacks that have yet to be resolved, LDCT screening for individuals at high risk of lung
cancer has grown substantially since its effectiveness was shown by the NLST in 2011.
Key Words: Lung cancer, spiral CT, low-dose CT, early detection of cancer, health insurance reimbursement
J Am Coll Radiol 2015;12:1395-1402. Copyright
2015 American College of Radiology

BACKGROUND 1.22]), and similar stage and histology patterns in both

Randomized controlled trials and research studies have
been under way since the 1990s, to assess the benet of
various screening modalities on lung cancer staging and
mortality. The Prostate, Lung, Colorectal, and Ovarian
(PLCO) Cancer Screening Trial focused on comparing
annual chest radiographs to usual care (no screening), in
patients aged 55 to 74 years, from 1993 to 2001. They
found no reduction in lung cancer mortality associated
with annual screening, compared with usual care (risk
ratio 0.99 [95% condence interval {CI} 0.87-
Department of Epidemiology and Biostatistics; and Cancer Prevention and
Control Program, Arnold School of Public Health, University of South
Carolina, Columbia, South Carolina.
Corresponding author: Jan M. Eberth, PhD, Department of Epidemiology
and Biostatistics, Arnold School of Public Health, University of South
Carolina, Columbia, SC 29208; e-mail: jmeberth@mailbox.sc.edu.
Dr. Eberth received an implementation grant from the South Carolina
Cancer Alliance in 2014 to examine knowledge, attitudes and barriers to
LDCT screening among family practice physicians in South Carolina. The
subject matter of this paper will not have any direct bearing on that work,
and that activity has not exerted any inuence on this project.
groups [1].
The International Early Lung Cancer Action Project
(I-ELCAP) study team found that low-dose CT (LDCT)
screening was able to detect malignant disease 4 times
more frequently than were chest radiographs, in a sample
of asymptomatic high-risk patients aged 40 or more years.
Specically, identication of stage 1 cancers was higher
with LDCT screening, compared with chest radiographs
(85% versus 15%, respectively) [2]. Years later, the
National Cancer Institutes National Lung Screening
Trial (NLST) [3] found that asymptomatic patients aged
55 to 74 years, with a smoking history of at least 30
pack-years, and a current or former smoking history
(quit less than 15 years before), had a 20% reduction in
risk of death from lung cancer, if they were screened with
annual LDCT, as opposed to chest radiography, for three
consecutive years. The breakthrough ndings of that trial,
rst released to the public in 2011, paved the way for
organizations such as the US Preventive Services Task
Force (USPSTF) [4] and the American Cancer Society [5]

2015 American College of Radiology

1546-1440/15/$36.00 n http://dx.doi.org/10.1016/j.jacr.2015.09.016 1395
to reconsider their screening recommendations for lung
cancer (a detailed list of the most-current recommenda-
tions is provided elsewhere: See Tanoue et al [6]). Today,
many professional organizations agree that annual LDCT
screening for lung cancer is effective if it is conducted in
high-quality screening settings.
IMPROVING SCREENING EFFECTIVENESS
Although many organizations have endorsed LDCT
screening for lung cancer, researchers have continued to
grapple with how risk estimation could be improved, how
to lower the false-positive rate among those screened, and
how to implement screening in clinical practice, to ensure
results similar to those of the NLST. In a review of risk-
prediction studies for lung cancer, Tammemgi [7]
described several studies that compared lung cancer
outcomes (incidence or mortality) using risk models
versus NLST/USPSTF criteria. A risk-prediction model
based on PLCO data, such as personal history of cancer
and chronic obstructive pulmonary disorder (known as
the PLCOm2012 model) detected signicantly more lung
cancers, without loss of specicity, and with a lower false-
positive rate than did the model using NLST criteria with
six years of follow-up [8]. The PLCOm2012 model has
been applied to lung cancer mortality as well [9]. Using
PLCOm2012, the number needed to screen to prevent 1
lung cancer death was 255, with a 65th percentile
threshold, compared with the 320 reported in the
NLST [3].
Similarly, Kovalchik et al [10] found that among the
NLST cohort, risk stratication into quintiles based on
demographic and clinical risk factors seemed to alter
the risk-benet prole. Specically, the highest-risk
quintile had fewer false positives (97% in quintile 1
versus 88% in quintile 5), a greater proportion of lung
cancer deaths were prevented by LDCT, and fewer had to
be screened to save 1 life [10]. Studies such as these
indicate that risk estimation could be further improved,
to determine who would benet most (and be harmed
least) from LDCT screening for lung cancer.
Another approach that was recently tested, designed
to improve risk classication, is use of the ACR Lung-
RADS (Lung Imaging Reporting and Data System)
standardized nodule-classication system [11]. Dening a
positive screen as a nding of a solid/part-solid nodule,
sized 6 mm, rather than the 4 mm originally used as a
minimum by the NLST, McKee et al [12] observed a
reduced false-positive rate (ie, an increased positive pre-
dictive value from 6.9% to 17.3%) without an increase in
false negatives.
1396
Moreover, even with a larger nodule size required
for a positive classication, the same number of lung
cancers were ultimately diagnosed. McKee et al [13]
additionally tested whether screening individuals in
the National Comprehensive Cancer Network high-
risk group 2 (ie, lower age and smoking history
threshold; Table 1) would result in ndings similar to
those in the NLST population. The overall cancer
positivity and cancer detection rate was nearly
identical in the two groups, indicating that screening
people who have additional risk factors may be
valuablean argument made by Tammemgi [7].
EARLY CALLS FOR REIMBURSEMENT OF
LUNG CANCER SCREENING COSTS
Although the scientic questions just discussed, as well
as others, remain unanswered, implementation of lung
cancer screening in hospitals and clinics nationwide is
moving forward rapidly, particularly as a result of insurance
reimbursement requirements set forth by the Patient Pro-
tection and Affordable Care Act (PPACA) [14] and CMS
[15]. The PPACA mandates that USPSTF-recommended
screening tests that have an A or B rating (high certainty
that the net benet is substantial or moderate) are covered
without any patient cost-sharing by private health plans.
Grandfathered in health plans (ie, existing before March
23, 2010) that have not made substantial changes to their
coverage policies are exempt from this policy [14,16].
For LDCT screening, this mandate took effect at the
start of the 2015 plan year, a date that varies across health
plans. Insurance coverage for LDCT screening for lung
cancer among Medicare and Medicaid beneciaries, who
comprise 38% of the population [17,18], is not subject to
PPACA terms. A separate coverage determination process
is required by CMS [19] and was initiated in 2014 for
LDCT screening for lung cancer.
After CMS received formal requests for a national
coverage determination, a Medicare Evidence Develop-
ment & Coverage Advisory Committee (MEDCAC)
meeting was announced in February 2014 and held in
April 2014 [20]. After testimony and discussion among a
distinguished panel of scientists and advocates,
MEDCAC nally recommended that CMS not cover
LDCT screening for lung cancer, a decision that
echoed the recommendation by the American Academy
of Family Physicians that the evidence is insufcient to
recommend for or against screening for lung cancer
with LDCT in persons at high risk for lung cancer
based on age and smoking history [21]. In fact,
the overall average scores given by the MEDCAC panel
Journal of the American College of Radiology
Volume 12 n Number 12PB n December 2015
Table 1. Principles for designation through the ACR and the Lung Cancer Alliance as a lung cancer screening center, 2015
Domain ACR Designated Lung Cancer Screening Center
Shared decision
making
Screening protocols n Comply with the quality control program, as
detailed in the ACR CT Quality Control Manual
n Radiation exposure levels should be consistent
with lung cancer screening protocols and not
routine chest scans; a CT dose index volume of
3 mGy for a standard-sized patient
n Exposure values must be reduced for smaller-
sized patients and increased for larger-sized
patients, using manual or automated methods
Personnel n Interpreting physicians must have read 200
chest CTs in preceding 36 months
n Medical physicists and radiologic technologists
continue to meet the requirements of the CT
accreditation program
Equipment n CT equipment specications and performance
must meet state and federal requirements and
applicable ACR Practice Parameters and Tech-
nical Standards [26,27].
n CT scanners used for the purpose of lung
cancer screening are multidetector helical CT
scanners.
Smoking cessation n A mechanism must be in place to refer patients
for smoking cessation counseling or to provide
smoking cessation materials.
Follow-up and n Must use structured reporting system that in-
reporting cludes management recommendations
n Facilities that accept self-referrals must have
procedures for referring them to a qualied
health care provider if abnormal ndings are
present.
n Follow the ACR Practice Parameter for
Communication of Diagnostic Imaging
Findings.
Data collection and n Recommend participation in the ACR Dose In-
research dex Registry [28].
Other n Must maintain ACR CT accreditation in the
chest module (fees required for CT accredita-
tion and lung cancer screening center
designation)
Journal of the American College of Radiology
Eberth n Lung Cancer Screening With CT
Lung Cancer Alliance Screening Center of
Excellence
n Provides clear information on who is
candidate for screening and the risks and
benets of the screening process in lan-
guage appropriate to the candidate
n Must comply with comprehensive stan-
dards based on best practices for con-
trolling screening quality, radiation dose,
and diagnostic procedures, such as those
developed by the National Comprehensive
Cancer Network and International Early
Lung Cancer Action Project
n Works with a multidisciplinary clinical
team to carry out a coordinated
continuum of care for screening,
diagnosis, and disease management,
based on best practices
n Includes a comprehensive smoking
cessation program in its screening and
continuum of care program, based on best
practices evidence
n Will report results expeditiously to those
screened and the referring physician, and
will transmit copies of all reports and
scans in a timely manner if requested for a
second opinion or transfer of care
n Will provide those screened with infor-
mation on how they can donate images
and biospecimens to advance research in
the prevention, diagnosis, and treatment
of all types of lung cancer
n Will participate in outcome data collection
to further rene risk evaluation, screening,
and diagnosis protocols
n Has received or intends to receive desig-
nation as an ACR Designated Lung Cancer
Screening Center
1397
Table 2. The American College of Chest Physicians and American Thoracic Society Joint Policy Statement on Lung Cancer
Screening, 2015
Component
1. Who is offered lung
cancer screening
2. How often, and for
how long, to screen
3. How the CT scan is
performed
4. Lung-nodule
identication n The program should collect and report data about the number, size, and characteristics of lung
5. Structured reporting
6. Lung-nodule
management
algorithms
7. Smoking cessation
8. Patient and provider
education
9. Data collection
Note: The joint policy statement can be found in Reference 39.
Description of Policy Statements and/or Recommendations
n Lung cancer screening programs should collect data on all enrolled subjects, related to the risk of
developing lung cancer.
n The program should have a policy about who is offered screening that is in line with the US
Preventive Services Task Force guidelines.
n At least 90% of all screened subjects, excluding those in trials, must match the programs policy.
n People should be screened annually, up to age 80 years
n Screening should be discontinued once a person has not smoked for 15 consecutive years, or de-
velops a health problem that substantially limits life expectancy or the ability or willingness to have
curative lung surgery.
n Screening should be performed based on ACReSociety of Thoracic Radiology technical
specications.
n The program should collect data to ensure that the mean radiation dose is in compliance with
ACReSociety of Thoracic Radiology recommendations.
n The program should have a policy about the size and characteristics of a nodule to label as positive.
nodules from positive tests.
n The program should use a structured reporting system, such as Lung-RADS (Lung Imaging
Reporting and Data System).
n The program should collect data about compliance using such a system.
n The structured reporting system is used on 90% of all screens.
n The program must: 1. include clinicians with expertise in the management of lung nodules and the
treatment of lung cancer; 2. have developed lung-nodule care pathways; 3. have the ability to
characterize concerning nodules through PET imaging, nonsurgical, and minimally invasive surgical
approaches; 4. have an approach to communication with the ordering provider and/or patient; 5.
have a means to track nodule management; and 6. collect and report data related to the use of, and
outcomes from, surveillance and diagnostic imaging and surgical and nonsurgical biopsies for the
management of screen-detected lung nodules.
n The program must be integrated with a smoking cessation program.
n The program should collect and report data related to the smoking cessation interventions that are
offered to active smokers enrolled in the screening program.
n The program should educate providers so that they can adequately discuss the benets and harms
of screening with their patients.
n The program should develop or use standardized education materials to assist with education of
providers and patients.
n The program is responsible for oversight and supplementation of provider-based patient education.
n The program must collect data on all enrolled patients related to the quality of the program,
including those enrolled in registered clinical trials.
n A review of the data and subsequent quality improvement plan should be performed at least
annually.
n An annual summary of the data collected should be reported to an oversight body with the au-
thority to credential screening programs.

(1-5 scale; 1 low condence; 5 high condence) in
answer to three questions, were as follows [20]:
1. Do the benets outweigh the harms of screening in the
Medicare population (score: 2.36)?
2. Would the harms of screening be minimized if imple-
mented in the Medicare population (score: 2.29)?
3. Will clinically signicant gaps remain regarding use of
screening in the Medicare population (score: 4.57)?
Despite these setbacks, CMS stated, in a decision
memo issued on November 10, 2014: the evidence is
sufcient to add a lung cancer screening counseling
and shared decision making visit, and for appropriate
beneciaries, screening for lung cancer with low dose
computed tomography, once per year, as an additional
preventive benet. [22]. Very specic individual
eligibility criteria were proposed (age 55-74 years;

1398 Journal of the American College of Radiology

Volume 12 n Number 12PB n December 2015
asymptomatic for lung disease; tobacco smoking
history of 30 pack-years; and is a current smoker
or has quit smoking within past 15 years), as well as
details on the required components of the counseling
and shared decision-making visit that should precede
screening.
The elements to be discussed at this visit with a
health care provider include eligibility criteria for
screening, benets and harms of screening, diagnostic
testing, overdiagnosis, false-positive rate, total radiation
exposure, importance of adherence to annual screening,
impact of comorbidities, ability and willingness to un-
dergo diagnosis and/or treatment, and need for smoking
cessation or abstinence counseling among former
smokers. In addition, criteria for eligibility of
the reading radiologist and imaging center were
codied [22].
Final CMS Coverage Decision and Requirements
A nal coverage memo [15] was issued on February 5,
2015. Major changes in the nal coverage memo
(versus the proposal) include the following:
1. Eligible individuals may be screened from ages 55 to
77 years (versus 74 years).
2. Eligible individuals need to be asymptomatic for lung
cancer (versus asymptomatic for lung disease).
3. The reading radiologist needs to furnish the screening
in an eligible imaging facility.
4. The imaging facility must utilize a standardized lung-
nodule identication, classication, and reporting
system (such as Lung-RADS).
5. The imaging facility must make smoking cessation
interventions available for current smokers. The pro-
posed criteria that the imaging facility had partici-
pated in a past lung cancer screening trial, or was an
accredited advanced diagnostic imaging center with
training and experience in LDCT lung cancer
screening was removed from the nal coverage memo
[15]. Organizations that wanted to gain distinction for
their lung cancer screening program are encouraged,
but not required, to apply to become an ACR
Designated Lung Cancer Screening Center [23,24]
or a Lung Cancer Alliance Screening Center of
Excellence [25]both of which require that the
organization attest to set principles for quality
assurance and monitoring (Table 1).
In addition to requiring a shared decision-making
visit and furnishing a written order for LDCT
screening, reimbursement for screening is tied to the
Journal of the American College of Radiology
Eberth n Lung Cancer Screening With CT
screening centers participation in a CMS-approved
registry. Enrollment in a clinical data registry is
important for quality monitoring and surveillance. At
the time of this writing, the only CMS-approved registry
available for lung cancer screening was the ACR Lung
Cancer Screening Registry (LCSR) [18,29]. Required
and optional data elements set forth by the ACR LCSR
[30] can now be submitted via web-based forms by
registered sites. Facilities already participating in the
National Radiology Data Registry (NRDR) can add
the LCSR to their facilitys registration at no
additional cost, while there is a one-time registration
fee for new sites and an annual fee based on the
facilitys size. To participate in the LCSR, facilities are
not required to have a certied lung cancer screening
program, have current ACR accreditation, and
participating radiologists do not need to be ACR
members [29].
Coding for LDCT screening is evolving and varies
by insurance type. In late 2014, CMS released a S
code (S8032), within the Healthcare Common Proce-
dure Coding System (HCPCS), for LDCT screening
among private payers. Most recently, CMS released its
coding scheme for reimbursement of LDCT screening
among Medicare beneciaries. For the required shared
decision-making visit, providers should use HCPCS
code G0296 in conjunction with V15.82 (ICD-9) or
Z87.891 (ICD-10), which indicate a personal history of
tobacco use/nicotine dependence. The actual LCDT scan
should be billed using HCPCS code G0297 (also with
code V15.82 or Z87.891). Medicare will accept claims
for LDCT screening starting January 4, 2016 retroactive
to the date of its nal coverage determination - February
5, 2015. Claims should be led prior to the one-year
deadline from the date of service. No coinsurance or
deductibles shall be charged to the patient for either
the shared decision-making visit or the actual LDCT
scan [31,32].
For patients with Medicare Advantage plans, the
ACR has advised practices to contact patients individual
plans to determine their suggested billing process and
codes [33]. For private payers, on the other hand, most
plans require LDCT screening claims to carry the
procedure codes 71250 or S8032 (preferred after
October 2014) with diagnosis codes for cancer
screening (International Classication of Diseases
[ICD]-9: V76.0; ICD-10: Z12.2) and history of to-
bacco use (ie, ICD-9: V15.82 and/or 305.1; ICD-10:
F17.2, Z72.0, and/or Z87.891). Some payers addition-
ally require a prior authorization or medical-necessity
1399
determination for patients who receive LDCT screening. screening among beneciaries must be examined. For
At some sites, patients are permitted to pay for the test example, in stand-alone radiology ofces (versus hospi-
out of pocket, regardless of insurance coverage or tals) where diagnostic and treatment data are not regularly
whether they meet the USPSTF or CMS screening available for screened patients, administrators need to
eligibility criteria [34]. The out-of-pocket price typi- ensure that patients have consented to have their medical
cally ranges from being free (somewhat rare) to up to record data from other institutions extracted for follow-
$200-$500 (most common) [35]. up purposes, and/or partner with their state cancer reg-
istry for rapid case ascertainment. Additionally, having
Quality Assurance and Implementation of contracts in place with local hospitals and/or cancer
Screening treatment facilities may facilitate both patient referrals
Many have argued that the successes seen in the NLST and outcome tracking.
population, with reduction in lung cancer deaths as a
result of LDCT screening, may not translate to the
DECISION AIDS
broader community if similar quality standards are not
As noted by CMS, decision aids [15] may assist in the
upheld in clinics where screening is performed
shared decision-making process required for lung cancer
[20,36,37]. In late 2013, a multidisciplinary panel of
screening. In shared decision making, health care providers
experts met to discuss these challenges and offer
give patients information about options, risks, and benets
practical guidance on how to achieve efciency and
of potential treatments, and patients express their values
effectiveness in lung cancer screening programs. As
and preferences, possibly with the help of their family [40].
reported by Ramsey et al [38], the panel identied ve
This concept is tied to that of patient-centered care, dened
areas that are critical to the successful implementation
as care that is respectful of and responsive to individual
of LDCT screening: (1) correctly identifying
patient preferences, needs, and values [41].
individuals for screening (to avoid eligibility creep);
Evidence-based decision aids, in addition to physician
(2) providing access to screening at qualied facilities
counseling, can help patients clarify their values and per-
for eligible individuals; (3) ensuring appropriate
spectives regarding known risks and benets, better un-
follow-up of positive and negative screening results;
derstand gaps in scientic knowledge, and guide patients to
(4) promoting continuous quality improvement of
make a more informed choice among test options. In the
screening programs and downstream care; and 5. offer-
context of LDCT screening, research is under way to
ing smoking cessation support for all current smokers.
develop and test various decision aids, with most available
The panel stressed priorities for stakeholders as well,
materials [42-46] focusing on risks and benets of
such as adding screening-specic elds to electronic
screening, and little attention on directly eliciting patient
health record systems (eg, pack-years of smoking his-
preferences and values. Thus, more work is needed to
tory) and developing insurance- and employer-based
incorporate into existing decision aids, and those under
outreach campaigns to encourage high-risk individuals
development, questions about patient preferences, fears
to consider LDCT screening.
and worries, and willingness to adhere to annual screening.
After a similar expert-committee approach, the
Shared decision making is not the responsibility of any
American College of Chest Physicians and American
one health care provider. In fact, CMS recognizes that both
Thoracic Society issued a joint policy statement in early
physicians and qualied nonphysician providers, such as
2015 [39] to provide guidance to screening centers on the
nurse practitioners and physician assistants, may play a key
components of high-quality LDCT screening, and iden-
role in the shared decision-making process [15]. Many
tify areas for research. Nine components were outlined by
screening programs have come to rely heavily on a
the panel (Table 2)many of which echo the areas
provider team, rather than one individual, to ensure that
described by Ramsey et al [38].
patients are receiving appropriate prescreening education,
Research continues to be needed to not only rene
smoking cessation assistance (if needed), and referrals.
screening eligibility criteria and protocols for the scientic
community, but also assess the feasibility, both admin-
istratively and nancially, of collecting patient data to CONCLUSIONS
ensure quality of screening at an institutional level. In Although most clinicians, researchers, and public health
addition, the cost of submitting at least the minimum set advocates celebrate recent advances in LDCT screening,
of data elements required by CMS for reimbursement of many uncertainties remain about how to implement

1400 Journal of the American College of Radiology

Volume 12 n Number 12PB n December 2015
screening programs efciently and effectively. Addi-
tionally, studies have yet to answer key questions about
LDCT screening utilization, adequacy of the existing
infrastructure and resources to handle potential demand
for services, and compliance with screening standards
in community-based settings. Funding agencies and
advocacy organizations should continue to pursue this
line of inquiry and outreach activities aimed to promote
high-quality, accessible, and patient-centered LDCT
screening.
TAKE-HOME POINTS
- Research is under way to improve current screening
efcacy through risk-prediction models and studies
in varied patient populations.
- Many professional organizations and experts have
embraced population-based screening guidelines for
LDCT screening in high-risk populations, although
some remain cautious owing to concerns about the
risk and/or benet ratio, effectiveness of screening
conducted outside randomized controlled trial set-
tings, and eligibility creep.
- Reimbursement for LDCT screening in CMS ben-
eciaries is tied to a comprehensive set of patient,
radiologist, and facility eligibility criteria, including
submission of patient data to a CMS-approved reg-
istry, a counseling and shared decisionemaking visit
with a provider before screening, and board certi-
cation or eligibility.
- Despite recent LDCT screening coverage decisions,
uncertainties remain about logistics for submitting
claims for reimbursement and conrming imaging
facility and/or radiologist eligibility.
- Few values-based decision aids have been developed
for LDCT screening to date.
ACKNOWLEDGMENTS
The author thanks Erica Sercy, MSPH for her excellent
editorial support.
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Journal of the American College of Radiology
Volume 12 n Number 12PB n December 2015