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December 9, 2014
Tamara S. Syrek Jensen, J.D.
Acting Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mail
Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
By Online Submission
Re: National Coverage Analysis for Lung Cancer Screening with Low Dose Computed
Tomography (CAG-00439N)
Dear Ms. Syrek Jensen:
I-ELCAP greatly appreciates the opportunity to provide comments on the Proposed Decision
Memorandum and to voice our overall support in expanding this lifesaving benefit to the Medicare
population. We express our continued desire to work constructively with you and your staff on any
other potential issues related to other regulatory requirements that may be under consideration to
ensure CMS does not inadvertently restrict equitable access especially for populations at highest
risk. We are committed to helping to provide CMS with the evidence to rapidly mature lung cancer
screening so it can be the most economical and effective cancer screening service.
We are fully in agreement with the overarching public health priority to insure equitable access to
high quality screening programs built on existing frameworks of evidence based protocols and
multi-disciplinary care according to best practices and have dedicated our efforts toward these
goals.
The International Early Lung Cancer Action Program (I-ELCAP) has been performing CT
screening for lung cancer for more than 20 years. Since our inception we recognized the need for
continued process improvement and developed a large international collaboration that stores its
data on a web-based infrastructure using structured reporting with the data and images being
collected in a secure HIPAA-compliant registry. In addition, I-ELCAP holds semi-annual meetings
(31 to date) where we continuously update the screening protocols based on analysis of collected
data and consensus review. Our database is the largest in the world and the protocols we have
developed based on analysis of it have been the basis for the management protocols used by the
large clinical screening trials including Mayo Clinic, NLST and NELSON trials as well as the basis
for updates to protocols developed by various guideline organizations such as NCCN. Our
research led to the implementation of the NLST and resulted in more publications than any other
lung cancer screening group in the world. We have shared our research and processes and donated
our imaging to many image registries for free public use.
We strongly support the position of the Lung Cancer Alliance (LCA), The Society of Thoracic
Surgeons (STS), and the American College of Radiology (ACR), a coalition representing lung
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cancer patients, diagnostic radiologists, radiation oncologists, nuclear medicine physicians, medical
physicists, and thoracic surgeons in their request to CMS to make targeted modifications to the
proposed decision regarding the age bracket for individuals eligible to receive low-dose CT
(LDCT) lung cancer screens, the definition of asymptomatic patients, the requirement of
provider visits to obtain an order for annual follow-up screening, and the 15-year smoking
cessation threshold which are detailed in their letter submitted on December 8, 2014. In particular
we believe that there is a pervasive misunderstanding of the available evidence regarding the
benefits of screening. It is our view that the NLST results, which has been used as the primary
source of evidence, was not designed to demonstrate the magnitude of that benefit, nor was it
designed to provide information on whether lung cancers are different in those outside of the NLST
enrollment criteria. There is nothing to suggest that cancers are different in those over 75 or those
who have quit more than 15 years ago and therefore the same life-saving benefit should apply to
them as well. This rationale also applies to those younger than 55 such as the group recommended
in the NCCN guidelines. All that differs in these groups is frequency of cancer and competing
risks which is even lower for those younger than 55 years of age. Prior studies have shown that
screening is cost effective in these groups.
We are hopeful that no provisions will be placed on continued enrollment in the I-ELCAP registry
as might occur if there was only a single national registry that was accepted by CMS. That could
have the impact of discouraging broad-based participation in further studies or trials which would
occur if a center has to participate in two registries, for example in the I-ELCAP registry and a
single CMS-approved registry to get reimbursed as this would become overly burdensome.
Likewise, we also believe that our current management protocols are comprehensive and evidencebased and are the most widely tested of any screening program. They continue to be endorsed by
the Lung Cancer Alliance Framework. We believe that sites interested in screening and especially
those sites already following our current protocols be allowed to continue using them. Ultimately,
we believe that by allowing more than one management protocol to be acceptable to CMS will
allow data driven comparisons, including with the LungRads protocol suggested by the ACR.
Limiting the continued accrual to our registry would have the paradoxical effect of restricting
further evidence development.
I-ELCAP respectfully requests that CMS recognize the processes we have developed to be
considered acceptable for certification and meeting the “with training and experience in LDCT lung
cancer screening” imaging center criteria. I-ELCAP has the historical knowledge, experience and
existing framework in facilitating imaging center criteria and has extensive publications to
document these efforts. I-ELCAP has worked with academic and community medical centers and
developed criteria for their participation. In addition, I-ELCAP already has an enormous database
on those risk categories outside of the NLST enrollment criteria which we can continue to collect
as part of a CED and provide to CMS. The level of detail in the data collection in the I-ELCAP
registry is more extensive than that suggested in the draft CMS recommendation and will allow for
more comprehensive analysis leading to continued protocol updates.
As noted in the opening of this letter, we consider equitable access to high quality screening the
overarching public health priority and we look forward to continued dialogue and collaboration
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with CMS in developing and implementing a safe and effective national coverage policy that will
save thousands of lives.
Sincerely,
Claudia I. Henschke, PhD, MD
Principal Investigator of I-ELCAP
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