PE R S PE C T IV E

Screening for Lung Cancer with Low-Dose CT

Screening for Lung Cancer with Low-Dose CT Translating

Science into Medicare Coverage Policy
Joseph Chin, M.D., Tamara Syrek Jensen, J.D., Lori Ashby, M.A., Jamie Hermansen, M.P.P., Joseph D. Hutter, M.D.,
and Patrick H. Conway, M.D.

ung cancer is the third most

common cancer and the leading cause of cancer-related deaths
in the United States. Attention
to lung cancer is especially relevant for the Medicare population, because the median age at
diagnosis is 70 years. A suitable
screening test has long been
sought to accurately detect lung
cancer at earlier stages, when
treatments are more effective and
survival is more likely. Currently, more than half of cases are
diagnosed after the cancer has
metastasized.1
Although low-dose computed
tomography (CT) has been studied in several screening trials,
the National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is the
only trial to date that has shown
that screening with low-dose CT
reduces lung-cancer mortality.2
That study provided the primary
evidence to support a Grade B
recommendation (indicating high
certainty that the net benefit is
moderate or...moderate certainty that the net benefit is
moderate to substantial) by the
U.S. Preventive Services Task
Force (USPSTF) one of three
requirements for adding coverage
of a preventive service to the
Medicare program. For such a
service to be covered by Medicare,
the Centers for Medicare and
Medicaid Services (CMS) must
also determine that it is reasonable and necessary for the prevention or early detection of an

illness or disability and that it is

appropriate for Medicare beneficiaries under conditions established in a national coverage
determination.
The NLST enrolled a well-
defined population (smokers or
former smokers 55 to 74 years of
age with a cigarette-smoking history of at least 30 pack-years),
used specific imaging protocols,
and employed a multidisciplinary
team of investigators. Such strict
parameters, although standard in

recommendation to include persons up to 80 years of age not on

the basis of empirical data but
on the basis of results of simulation models that assumed 100%
adherence to long-term, annual
screening a potentially unrealistic level that even the NLST
could not achieve (it reported 95%
adherence to three annual screening tests). Under our national coverage determination, at-risk patients 55 to 77 years of age are
eligible for a Medicare benefit.

CMS has established a mechanism to

provide responsible access to high-quality
lung-cancer screening with low-dose CT
in the Medicare population while data
continue to be collected.
studies, create challenges for
translating research into policy
and ultimately into practice. In
this instance, there were three key
implementation challenges that
CMS had to address in its coverage policy.
First, eligible patients must be
accurately identified for screening to be successful. Although
age is typically straightforward
to measure, incongruity between
the NLST which provided data
for patients up to 77 years of age
and screening recommendations may potentially compound
implementation problems. The
USPSTF extended its screening

In addition, a patients smoking history which is usually

self-reported and subject to recall
bias is particularly challenging yet critical to determine, since
screening trials in patients with
a less extensive smoking history
have not shown that health outcomes were improved.3,4 Screening persons at lower risk for lung
cancer, a practice known as downward eligibility creep, may very
well degrade the overall benefits
of screening.
To facilitate a focused discussion of patient-specific issues such
as age, smoking history, and
willingness to adhere to a long-

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PERS PE C T IV E

Screening for Lung Cancer with Low-Dose CT

term screening program and undergo additional diagnostic tests

and treatment if necessary, CMS
covers a distinct visit for formal
shared decision making using
dedicated evidence-based decision
aids. Shared decision making
involves engaging the patient in
dialogue and permits a careful
determination of the appropriateness of screening. As targeted
decision aids are developed and
tested, the effect of these visits
on appropriate screening and longterm population outcomes can be
measured to inform refinement of
their structure and delivery.
The second challenge was that
lung-cancer screening must be
performed as part of a cohesive
screening program to enhance
its likelihood of success. Radiologists should not only properly
furnish and interpret the lowdose CT but also reinforce the
importance of adherence to evidence-based screening, smoking
cessation, and follow-up evaluations. NLST investigators reported that participants with positive screening results always
received follow-up recommendations from NLST radiologists.5
Low-dose CT, though a key component of screening, may provide
no benefit if nodule identification
and reporting are not standardized and evidence-based algorithms are not used to determine
the subsequent course of action
and follow-up.
Accordingly, in its national coverage determination, CMS set specific criteria for radiologists and
imaging centers and required use
of a standardized nodule-identification-and-reporting system and
data collection. Although CMS
only requires collection of data
that will allow physicians to de-

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termine the appropriateness of

screening, it also emphasizes the
need to collect sufficient data on
health outcomes and adverse
events and to establish a broader
screening registry with this information to stimulate continuous
quality improvement.
These requirements are among
many important checks, since the
new Medicare coverage represents
the first wide implementation of
lung-cancer screening with lowdose CT. The Medicare Evidence
Development and Coverage Advisory Committee (MEDCAC) was
concerned about implementing
broad screening in the Medicare
population on the basis of results from one positive trial;
MEDCAC emphasized the need
for additional evidence on harms
from evaluation of false positive
results and extrapulmonic findings in older adults. The data to
be collected will facilitate monitoring of subsequent diagnostic
workup, treatments, and outcomes by allowing linkage of
clinical data to administrative
claims data. The American College of Radiology has recognized
the need for enhanced radiologist involvement and data collection in the cases of other imaging tests as seen in the Breast
Imaging Center of Excellence
program and the National Mammography Database and has
developed a similar approach for
lung-cancer screening as well.
Finally, during the course of
screening, a patient may encounter physicians from a number of
different specialties, including primary care, radiology, pulmonology, surgery, and oncology. Each
physician has a unique role and
responsibility, but communication
and coordination will be needed.

Since screening begins with shared

decision making, active participation of primary care clinicians
will help address issues that may
arise in appropriate patient selection and to maintain continuity
of screening-related care.
Recognizing the importance
of multidisciplinary involvement,
CMS directly engaged stakeholders from multiple professional
societies and health advocacy
organizations and asked them
to provide input into the elements of a scientifically sound,
sustainable screening program.
The knowledge and commitment of these experts, who included NLST investigators, were
invaluable in our development
of the basic structure and components of Medicares lung-cancer screening benefit, including
the establishment of an independent, multidisciplinary governance body. The success of this
type of approach has been demonstrated by the National Colorectal Cancer Roundtable, a collaborative partnership with more
than 60 member organizations
established by the American Cancer Society and the Centers for
Disease Control and Prevention.
A multisociety governance body
or national coalition will increase
multidisciplinary involvement and
help ensure that screening protocols continue to evolve and that
progress is made in reducing
lung-cancer mortality in the United States.
The NLST provided the initial
evidence to support lung-cancer
screening with low-dose CT. The
next step is to address the challenges ahead to ensure that population screening confers similar
benefits over time and minimizes risk. By creating a new pre-

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PE R S PE C T IV E

ventive benefit with specific evidence-based coverage criteria,

CMS has established a mechanism to provide responsible access to high-quality lung-cancer
screening with low-dose CT in
the Medicare population while
trials continue in Europe and
data on long-term screening outcomes in the United States are
collected to inform decisions
about screening frequency and
duration. However, the primary responsibility for ensuring appropriate integrated screening in which
benefits outweigh harms ultimately rests with practicing phy-

Screening for Lung Cancer with Low-Dose CT

sicians, informed patients, and

the multidisciplinary stakeholders
involved in screening efforts.
The views expressed in this article are
those of the authors and do not necessarily
represent the views or policies of the Centers for Medicare and Medicaid Services.
Disclosure forms provided by the authors
are available with the full text of this article
at NEJM.org.
From the Center for Clinical Standards and
Quality, Centers for Medicare and Medicaid
Services, Woodlawn, MD.
1. Surveillance, Epidemiology, and End Re
sults (SEER) Program. SEER stat fact sheets:
lung and bronchus cancer (http://www.seer
.cancer.gov/statfacts/html/lungb.html).
2. The National Lung Screening Trial Re

search Team. Reduced lung-cancer mortality

with low-dose computed tomographic
screening. N Engl J Med 2011;365:395-409.
3. Infante M, Cavuto S, Lutman FR, et al.
A randomized study of lung cancer screen
ing with spiral computed tomography:
three-year results from the DANTE trial.
Am J Respir Crit Care Med 2009;180:44553.
4. Saghir Z, Dirksen A, Ashraf H, et al. CT
screening for lung cancer brings forward
early disease the randomised Danish
Lung Cancer Screening Trial: status after five
annual screening rounds with low-dose CT.
Thorax 2012;67:296-301.
5. National Lung Screening Trial Research
Team. The National Lung Screening Trial:
overview and study design. Radiology 2011;
258:243-53.
DOI: 10.1056/NEJMp1502598
Copyright 2015 Massachusetts Medical Society.

n engl j med 372;22nejm.orgmay 28, 2015

The New England Journal of Medicine

Downloaded from nejm.org on August 3, 2015. For personal use only. No other uses without permission.
Copyright 2015 Massachusetts Medical Society. All rights reserved.

2085