Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Please consider the following issues:

1. The CMS age range for coverage should align with the USPSTF recommendation of 55-80.
2. Shared decision making must be fair and balanced and must not create an unnecessary barrier to access
3. People with ashthma, emphysema, COPD, smokers cough or other lung disease should still have access to screening so long as they are not symptomatic for lung cancer.
4. Registries are important but the data elements should not be so expansive as to make data reporting overly burdensome and discourage centers from offering care.
5. Former smokers who have quit more than 15 years ago should still have access to screening. Risk is based on the intensity, duration and amount of smoking, not the amount of time since smokers quit.

Sincerely,
hildy Grossman, President
Upstage Lung Cancer

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Johnson & Johnson (J&J) is the world’s most comprehensive and broadly-based manufacturer of health care products for the consumer, pharmaceutical and medical devices and diagnostics markets. For more than 125 years, have supplied the health system with a broad range of products and have led the way in innovation, beginning with the first antiseptic bandages and sutures. We are continuing this heritage of innovation today, bringing important new pharmaceutical products to market in a range of therapeutic areas, as well as developing important advancements in medical devices and new consumer products.

These comments reflect the opinions of Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson and ETHICON, Inc., a medical device company of Johnson & Johnson that provide products and instruments used in thoracic surgery. Janssen conducts research & development in five therapeutic areas, including: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, and oncology. Lung cancer is one of three focus areas for Janssen Oncology based on its high unmet need.

J&J has been a long-time supporter of policies that diagnose and treat people at high risk for lung cancer. In August 2014, we submitted a support comment letter to CMS on USPSTF recommendations that support annual screening with LDCT for people deemed to be at high risk for lung cancer because of age and smoking history. We also worked closely with medical societies (e.g. American College of Radiology) and other stakeholders to understand the benefits of CT lung cancer screening as a cost-effective test to significantly reduce lung cancer deaths.

Therefore, we applaud CMS’ proposed decision to cover annual lung cancer screenings using Low Dose Computed Tomography (LDCT). This coverage policy will provide annual screenings for patients at the highest risk for lung cancer and potentially reducing their lung cancer mortality by nearly 20 percent. Furthermore, in a 2012 Health Affairs article, Pyenson cited an actuarial analysis of similar data suggesting that annual LDCT screening of 50–64-year-old current and former heavy smokers’ results in a cost per life saved comparable to colon cancer screening.¹

We support CMS’s proposal to include lung cancer screening counseling and shared decision making visit in the lung cancer screening process, which helps Medicare beneficiaries be well educated and informed of the possible clinical treatment paths that lie ahead. These shared decision making tools will help the doctor and patient to identify the best diagnostic approach together, resulting in a better informed Medicare patient. All clinicians who utilize these shared decision making tools should be knowledgeable and able to answer any question raised by the patient. We encourage CMS to provide appropriate incentives that encourage the use of shared decision making tools for the treatment selection. These tools should also be created in collaboration with outside experts who understand this clinical area and treatment path options. By creating a collaborative environment with clinicians and patients, all parties will benefit in the end.

We also applaud CMS’ proposal to create the first-ever national registry related to a preventive service. Providers are required to collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed. By collecting information on screening exam results, diagnostic follow-up of abnormal findings, lung cancer incidence and health outcomes, the registry can play a critical role in ensuring continuity of care and quality care for Medicare population.

In summary, we encourage CMS to finalize the national coverage decision on lung cancer screening and remove any reimbursement barrier for high risk Medicare beneficiaries to access lung cancer screening. Experience shows that by reducing costs more high-risk patients will likely be able to access lung cancer screenings.²

We appreciate the opportunity to comment on lung cancer screening and respectfully urge you to finalize the proposal.

Sincerely,

Steve Phillips

Senior Director, Health Policy & Reimbursement
Johnson & Johnson
Worldwide Government Affairs & Policy

1. Pyenson BS, Sander MS, Jiang Y, et al. An Actuarial Analysis Shows That Offering Lung Cancer Screening as an Insurance Benefit Would Save Lives at Relatively Low Cost. Health Affairs 2012; 4:770–779.
2. McKee, B. J., McKee, A. B., Flacke, S., Lamb, C. R., Hesketh, P. J., & Wald, C. (2013). Initial Experience With a Free, High-Volume, Low-Dose CT Lung Cancer Screening Program. Journal of the American College of Radiology.

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We are among the leading voices on minority health and health disparities. We have been actively engaged on issues related to fair and equitable deployment of lung cancer screening for several years. We are extremely pleased that on November 10, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a favorable Draft Coverage Decision Memorandum.

To the extent we have concerns, they center primarily around barriers to access and obstacles to adherence. Along these lines, we would ask:

1. The Draft Coverage Decision should be amended so that the upper age limit is 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation

As a threshold matter, there is no scientific justification for ignoring the USPSTF recommendations. USPSTF carefully and thoroughly considered the NLST findings for nearly three years. It weighed all the pros and cons and outlined them when it issued its recommendation to extend coverage to age 80. This recommendation was not made arbitrarily but was based on solid mathematical modeling. It including careful consideration of the impact of potentially invasive follow up care and surgery on all age groups and concluded that appropriately healthy patients between 75-80 year old could both endure and benefit from such care. For this reason alone, the age range for the CMS' coverage decision should be revised to align with the USPSTF recommendation.

It is important to note that the upper age limit used by NLST was a clinical trial criteria and was never intended to establish medical or public health policy. If CMS were to leave the upper at age at 74, it would exclude tens of thousands of seniors known to be at very high risk for lung cancer. The median age for lung cancer diagnosis is 70 years. While the majority of cases are diagnosed in people ages 65-74 (31.4%), according to SEER data, another 28% of lung cancers are diagnosed in people between 75 and 84. Ending coverage at age 74 is too soon and will mean that a very high-risk population, with years of life expectancy before it, will be denied access to this life saving screening.

Achieving widespread adherence to any screening protocol is challenging in the best of circumstances. For our communities, the obstacles to adherence are magnified by historic mistrust of the health system, cultural and linguistic differences, gaps in health literacy and day to day life challenges that make getting to screening difficult. Adding any unnecessary incongruence or confusion to this already complicated mix will make achieving adherence that much more difficult. When sister agencies from within the same federal department disagree, the impact is to confuse the public and generate even more mistrust. Stated more plainly: people will not know who to believe.

Finally, serious health equity issues could arise if Medicare coverage is not extended to age 80. We know that some seniors (or their loved ones) will be able to cover the cost of lung cancer screening out of pocket, while others will not. Leaving this discrepancy in place could lead to striking racial and class disparities in access care and life expectancy at the upper end of the coverage bracket.

2. "Shared decision making" must be fair and balanced, respectful of cultural and linguistic differences and must not pose a barrier to care

"Shared decision making" should be viewed as an opportunity to empower the patient to make the right health care decision. Information must be shared with our community that is fair and balanced, without over or under emphasizing risks or benefits. We must also be cognizant of cultural and linguistic differences.

We also must ensure that "shared decision making" does not inadvertently result in limiting access to care. As currently drafted, it appears that the "shared decision making" requirement requires a special doctors visit each time a patient needs to be screened. While such a visit is crucial at the initiation of screening, we worry that patients will not undertake follow up screens if it requires an extensive doctor appointment. Any extra or unnecessary hurdle will result in lower adherence rates. We therefore recommended that CMS retain the requirement for a doctor's visit for the initial screen and but remove it for the subsequent screens.

3. Patients with asthma, emphysema, COPD or other pulmonary symptoms should still be eligible for screening

As currently written, the draft decision memo would block access to screening to anyone with "pulmonary symptoms." Because of the high smoking rates and environmental exposures experienced by many members of our community, many minority patients who would benefit from lung cancer screening also have asthma, emphysema, COPD, smokers cough and other pulmonary symptoms. These patients should not be excluded from LDCT lung cancer screening exams. Indeed, many of them would benefit most from such screening because they are of increased risk for lung cancer.

4. Registry reporting must capture data that demonstrates lung cancer screening is equitably deployed and available minority communities.

We recognize the importance of data registries both as a mechanism to ensure quality care is delivered and as a way to continuously improve this care. Data registries should also collect demographic information - including race, ethnicity and gender - as this data will also help us understand whether lifesaving screening is being fairly and equitably deployed.

Lessons learned from other screenings show that adherence rates in poor and minority communities lag affluent and white communities. While some of this gap in adherence can be linked to cultural reluctance, other factors including lack of health insurance and fewer facilities either in the community or readily accessible by public transit can also contribute to this gap.

Today, lung cancer is - for the most part - an equal opportunity killer. It is the leading cancer killer of whites, African Americans, American Indians and Native Alaskans, Asian and Pacific Islander Americans and Hispanic Americans. However, if lung cancer screening is not deployed fairly and equitably, we will begin to see staggering disparities as our communities continue to be disproportionately targeted by tobacco industry predatory marketing practices. For this reason, it is crucial that demographic data be part of the minimum data set required for any CMS approved lung cancer registry.

Thank you for taking our concerns into consideration.

Sincerely,

Ho Luong Tran, MD, MPH
President and CEO
National Council of Asian Pacific Islander Physicians

Elena Rios, MD, MSPH
President and CEO
National Hispanic Medical Association

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We are among the leading voices on minority health and health disparities. We have been actively engaged on issues related to fair and equitable deployment of lung cancer screening for several years. We are extremely pleased that on November 10, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a favorable Draft Coverage Decision Memorandum.

To the extent we have concerns, they center primarily around barriers to access and obstacles to adherence. Along these lines, we would ask:

1. The Draft Coverage Decision should be amended so that the upper age limit is 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation

As a threshold matter, there is no scientific justification for ignoring the USPSTF recommendations. USPSTF carefully and thoroughly considered the NLST findings for nearly three years. It weighed all the pros and cons and outlined them when it issued its recommendation to extend coverage to age 80. This recommendation was not made arbitrarily but was based on solid mathematical modeling. It including careful consideration of the impact of potentially invasive follow up care and surgery on all age groups and concluded that appropriately healthy patients between 75-80 year old could both endure and benefit from such care. For this reason alone, the age range for the CMS' coverage decision should be revised to align with the USPSTF recommendation.

It is important to note that the upper age limit used by NLST was a clinical trial criteria and was never intended to establish medical or public health policy. If CMS were to leave the upper at age at 74, it would exclude tens of thousands of seniors known to be at very high risk for lung cancer. The median age for lung cancer diagnosis is 70 years. While the majority of cases are diagnosed in people ages 65-74 (31.4%), according to SEER data, another 28% of lung cancers are diagnosed in people between 75 and 84. Ending coverage at age 74 is too soon and will mean that a very high-risk population, with years of life expectancy before it, will be denied access to this life saving screening.

Achieving widespread adherence to any screening protocol is challenging in the best of circumstances. For our communities, the obstacles to adherence are magnified by historic mistrust of the health system, cultural and linguistic differences, gaps in health literacy and day to day life challenges that make getting to screening difficult. Adding any unnecessary incongruence or confusion to this already complicated mix will make achieving adherence that much more difficult. When sister agencies from within the same federal department disagree, the impact is to confuse the public and generate even more mistrust. Stated more plainly: people will not know who to believe.

Finally, serious health equity issues could arise if Medicare coverage is not extended to age 80. We know that some seniors (or their loved ones) will be able to cover the cost of lung cancer screening out of pocket, while others will not. Leaving this discrepancy in place could lead to striking racial and class disparities in access care and life expectancy at the upper end of the coverage bracket.

2. "Shared decision making" must be fair and balanced, respectful of cultural and linguistic differences and must not pose a barrier to care

"Shared decision making" should be viewed as an opportunity to empower the patient to make the right health care decision. Information must be shared with our community that is fair and balanced, without over or under emphasizing risks or benefits. We must also be cognizant of cultural and linguistic differences.

We also must ensure that "shared decision making" does not inadvertently result in limiting access to care. As currently drafted, it appears that the "shared decision making" requirement requires a special doctors visit each time a patient needs to be screened. While such a visit is crucial at the initiation of screening, we worry that patients will not undertake follow up screens if it requires an extensive doctor appointment. Any extra or unnecessary hurdle will result in lower adherence rates. We therefore recommended that CMS retain the requirement for a doctor's visit for the initial screen and but remove it for the subsequent screens.

3. Patients with asthma, emphysema, COPD or other pulmonary symptoms should still be eligible for screening

As currently written, the draft decision memo would block access to screening to anyone with "pulmonary symptoms." Because of the high smoking rates and environmental exposures experienced by many members of our community, many minority patients who would benefit from lung cancer screening also have asthma, emphysema, COPD, smokers cough and other pulmonary symptoms. These patients should not be excluded from LDCT lung cancer screening exams. Indeed, many of them would benefit most from such screening because they are of increased risk for lung cancer.

4. Registry reporting must capture data that demonstrates lung cancer screening is equitably deployed and available minority communities.

We recognize the importance of data registries both as a mechanism to ensure quality care is delivered and as a way to continuously improve this care. Data registries should also collect demographic information - including race, ethnicity and gender - as this data will also help us understand whether lifesaving screening is being fairly and equitably deployed.

Lessons learned from other screenings show that adherence rates in poor and minority communities lag affluent and white communities. While some of this gap in adherence can be linked to cultural reluctance, other factors including lack of health insurance and fewer facilities either in the community or readily accessible by public transit can also contribute to this gap.

Today, lung cancer is - for the most part - an equal opportunity killer. It is the leading cancer killer of whites, African Americans, American Indians and Native Alaskans, Asian and Pacific Islander Americans and Hispanic Americans. However, if lung cancer screening is not deployed fairly and equitably, we will begin to see staggering disparities as our communities continue to be disproportionately targeted by tobacco industry predatory marketing practices. For this reason, it is crucial that demographic data be part of the minimum data set required for any CMS approved lung cancer registry.

Thank you for taking our concerns into consideration.

Sincerely,

Ho Luong Tran, MD, MPH
President and CEO
National Council of Asian Pacific Islander Physicians

Elena Rios, MD, MSPH
President and CEO
National Hispanic Medical Association

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To Whom It May Concern,

The Kaiser Permanente Medical Care Program is the largest private integrated healthcare delivery system in the United States, delivering health care to approximately 9.1 million members in eight states and the District of Columbia and comprising Kaiser Foundation Health Plan, Inc., the nation’s largest nonprofit health plan; the nonprofit Kaiser Foundation Hospitals, which operates 38 hospitals and over 600 other clinical facilities; and the Permanente Medical Groups, independent physician groups that practice evidence-based care to meet the health needs of our members. Kaiser Permanente is committed to delivering high quality health care through cooperation and collaboration among providers, hospitals, our health plans, and our purchasers. We believe that greater clinical integration and shared accountability for quality and value will benefit consumers, the Medicare program, and will improve the U.S. health care system.

To that end, we are pleased to submit the following comments on the Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) for your consideration:

Beneficiary Eligibility Criteria:

- The “Asymptomatic (no signs or symptoms of lung disease)” criteria for screening is not clear. LDCT screening should NOT be ordered for the purpose of evaluating new or specific symptoms, as this is not consistent with screening. The eligible population will be expected to have symptoms associated with long-term smoking.

- Both initial and subsequent orders for LDCT screening should not be limited to specific visit types. In an integrated delivery system there will be other instances where an order may be appropriate. An electronic order should be the usual standard for documenting.

Shared Decision Making Visit Documentation Criteria:

- Kaiser Permanente believes that shared decision making can be carried out by a variety of tools appropriate to our population and that in person visits are not the sole mechanism. For example, Kaiser Permanente members have access to an online patient portal where shared decision making aids are provided. Furthermore, we believe shared decision making is an ongoing process that is continually tailored to members and their families as clinical circumstances change over time.

- Kaiser Permanente recommends that the required documentation for the written order for LDCT screening be retrievable from the electronic medical record and not necessarily captured in the order.

Radiology Imaging Center Eligibility Criteria:

- Kaiser Permanente recommends that all imaging centers currently accredited by a national body (e.g. TJC, ACR) for the provision of chest CT be grandfathered in for the provision of LDCT screening.

- Kaiser Permanente recommends that CMS revise the wording regarding dose to reflect the use of LDCT acquisition parameters that produce volumetric CT Dose Index (CTDI vol) of less than or equal to 3.0 milligray for ‘standard size patients’—defined to be 5’7” and 155 lbs—with expected adjustments for patients of varying body habitus. We believe this will ensure that an effective dose of less than 1.5mSv will be achieved across the population of screened members.

CMS-Approved National Registry

- Kaiser Permanente seeks clarification regarding the planned process for approval of internally developed registries. We recommend that databases that sufficiently capture all required registry submission criteria, as well as provide for aggregate reporting, be considered for CMS approval.

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December 10, 2014

Marilyn Tavenner
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Re: Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Administrator Tavenner:

The American Cancer Society Cancer Action Network (ACS CAN) appreciates the opportunity to comment on the proposed decision for screening for lung cancer with low dose computed tomography (LDCT) in the Medicare program. ACS CAN is the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, and supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. As the nation’s leading advocate for public policies that are helping to defeat cancer, ACS CAN ensures that cancer patients, survivors, and their families have a voice in public policy matters at all levels of government. ACS CAN commends the Centers for Medicare & Medicaid Services (CMS) for the proposed decision to cover lung cancer screening with LDCT. We support the proposed coverage determination and offer suggestions to further strengthen the proposal.

Overview

Lung cancer accounts for more cancer deaths (27 percent of all cancer deaths) than any other cancer and represents 13 percent of all cancer diagnoses.¹ While the 5-year survival rate for lung cancers diagnosed at the localized state is 54 percent, and is much better for the smallest localized tumors, only 15 percent of lung cancers are diagnosed at this stage. Reducing the incidence, suffering and death from lung cancer is a priority for ACS CAN and the American Cancer Society (the Society).

The Society updated its guidelines for lung cancer screening, with interim recommendations in 2011, and full guidelines approved and released in 2013. Likewise, on December 30, 2013 the U.S. Preventive Services Task Force (USPSTF) issued an updated final lung cancer screening recommendation, with a “B” grade for lung screening using LDCT for high risk populations. The USPSTF recommendation and the Society’s guidelines are somewhat similar with respect to eligibility for screening, and outline important clinical considerations during the administration of lung cancer screening. These include informed decision-making between doctors and at-risk patients, use of high quality LDCT screening facilities, and the delivery of tobacco cessation services for current smokers.

ACS CAN Comments

We are pleased that CMS, having weighed the evidence and opinions expressed during the previous comment period, has chosen to propose coverage of lung cancer screening with LDCT for high risk Medicare beneficiaries. We have carefully reviewed the proposed coverage decision and have the following comments.

Beneficiary Eligibility Criteria

CMS is proposing the following eligibility for lung cancer screening with LDCT: age 55-74 years; asymptomatic (no signs or symptoms of lung disease); tobacco smoking history of at least 30 pack-years; and a current smoker or one who has quit smoking within the last 15 years.

We strongly recommend that CMS extend the eligibility to age 80 to be consistent with the “B” recommendations of the USPSTF. While early recommendations from organizations that have issued lung cancer screening guidelines, including the American Cancer Society, have been conservative and adhered to the protocol eligibility of the National Lung Screening Trial (NLST), there are a number of compelling reasons to extend the eligibility to age 80.

First, the USPSTF “B” recommendation includes screening to age 80 based on favorable results from a mathematical model developed by a group of experienced modelers.¹ Given that the median age of incidence is age 70, adults ages 75-80 in good health are likely to benefit from lung cancer screening. Second, CMS must realize that modeling and observational data are the only data that will be available going forward for making coverage decisions in older adults, and the evidence from the model persuaded the USPSTF that extending screening to age 80 was beneficial and cost-effective. Another modeling analysis by Tammemägi, et al.², published this week in PLOS Med also supports the value of extending the screening eligibility to age 80. Since the possibility of additional data from randomized controlled trials is extremely remote, we believe these data should be regarded as informative. Third, we believe it is hard to justify having different coverage for Medicare beneficiaries compared with the coverage that will be required under the Affordable Care Act for adults covered by private insurance based on the USPSTF B rating.

Guideline developers relied on the NLST protocol as an early basis for screening eligibility pending new evidence in the published literature. CMS must realize that over time new data will become available that likely warrant modification of the risk profiles for screening eligibility, and indeed CMS received extensive comments in the prior comment period expressing interest in coverage with evidence development for adults who meet the absolute risk levels of NLST eligible adults, but with a different risk profile. Insofar as the modeling evidence was persuasive to AHRQ and the USPSTF, we believe CMS eligibility criteria for age should be the same as that recommendation by the USPSTF.

CMS states that eligible adults should be asymptomatic with no signs of symptoms of “lung disease.” We recommend that this be changed to no signs or symptoms of “lung cancer,” since there are number of conditions (asthma, emphysema, COPD, and other pulmonary symptoms) that are markers of elevated risk for lung cancer. It also should be emphasized that adults with symptoms of lung cancer should be referred for immediate diagnostic evaluation.

We disagree with ending eligibility for screening with LDCT 15 years following quit time for former smokers who have qualified to begin screening. Halpern, et al.³ provided convincing data that risk of lung cancer death for former smokers quitting between ages 50 and 64 leveled off near the risk attained at the time of quitting until around age 75, when it rose sharply. This means that an adult with a 30+ pack year history who quits at age 50 still would have significant risk of lung cancer death at age 65, when under the proposed coverage decision they would no longer be eligible for coverage for lung cancer screening. If they quit at age 60, they would cease to be eligible under the proposed rule due to the cut off at age 75 and the cutoff for duration at cessation. This would occur at a time when their risk would be rising sharply, according to Halpern and colleagues. The recent analysis Tammemägi, et al., mentioned above, also demonstrated that some former smokers with quit times greater than 15 years remained at elevated absolute risk. At this time, the less than 15 years since cessation requirement does not reliably identify a group that is no longer at risk for lung cancer. While we agree at this time that the 15 year threshold since cessation may be used for initial eligibility, we strongly urge CMS to not withdraw eligibility for former smokers after initiation of screening if time since cessation reaches 15 years.

A Written Order for LDCT lung Cancer Screening

We particularly applaud the proposed decision to formalize a lung cancer screening counseling and shared decision making visits. We assume that the intent of this requirement is to ensure that there is accountability for assessing eligibility, and that informed and shared decision making takes place. We agree that this is a reasonable requirement for the first screening examination, and can be achieved without costs to beneficiaries if done during the annual wellness examination.

We encourage CMS to provide guidance on best practices to clinicians who will conduct this visit, and to work with relevant organizations to develop standards for the information and materials that will be provided to adults at risk of lung cancer to assist in their decision making. The Society and ACS CAN stand ready to work with CMS and other professional groups in the development and dissemination of such guidance. It is preferable that the process of shared decision making, and the description of benefits, limitations, and harms be standardized for the same reasons that standards for the examination, personnel, and imaging facilities are being established. Further, this information can be regularly updated as new data become available. Given the often contentious debates over screening, and the wide range of measurements of benefits and harms in the medical literature related to other screening tests, it is preferable for this information to be standardized and meet with approval by CMS.

With respect to repeat screening, we are concerned that requiring a visit to obtain a “prescription” for annual screening will be burdensome to providers and patients, and will likely reduce uptake of repeat screening. It could also reduce adherence to annual screening due to delays in appointments and scheduling, and the absence of well-established routines in primary care for notifying patients that they are due for routine screening. Most adults of screening age are not reminded by their primary care physician when they are due for screening, and it also is clear that the annual Medicare wellness exam is severely underutilized by both clinicians and beneficiaries. There is little evidence that Medicare beneficiaries are being notified to make an appointment for this exam on a yearly basis. If CMS wishes to retain the requirement for a written order for each occasion of screening, then it must also require referring physicians to remind eligible adults when they are due for repeat screening and provide the written order without requiring a wellness visit, or any other type of face-to-face encounter. If the referring clinician has concerns that the patient’s health status has declined to the point where they are no longer a candidate for lung cancer screening, then this may be determined during continuing care since the previous exam, or during a wellness visit.

We strongly believe that post-screening counseling and shared decision making for those patients who are recalled is important. The post-screening counseling will provide an opportunity for beneficiaries and their providers to not only discuss the results of the screening and follow-up care, but will also provide an additional opportunity for tobacco cessation advice for current smokers. As with the pre-screening visit, we urge CMS to provide specific guidance to clinicians regarding best practices on how to conduct this counseling. As with the development of best practices for the pre-screening visit, these could be developed in collaboration with other relevant organizations.

Radiology Imaging Center Eligibility Criteria

As CMS works to finalize its coverage process, we urge the agency to establish criteria for visible validation and recognition for imaging centers that will be providing lung cancer screening with LDCT to Medicare beneficiaries, and surveillance to those with positive findings.

The ACS disagrees with providing deemed accreditation/designation status based on having participated in the NLST or other trial. First, the institution may have not continued LDCT lung imaging since the trial concluded, and original personnel may no longer be affiliated with that institution. Further, an accreditation/designation program can be regularly updated and apply new standards to re-approval. The ACS believes all approved imaging sites must meet the same criteria, and preferably this would be the current criteria established by the American College of Radiology (ACR) for a designated lung cancer screening center.

We also are concerned that the language “or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening,” is vague and not specific to any specific accreditation standards. As stated above, the ACS recommends that ACR CT Accreditation can serve as the basis for an approved accrediting body, and the imaging facility also should have ACR’s Lung Cancer Screening Center Designation, which would meet the criteria for training and experience.

Minimum Required Data Elements

We are pleased with the inclusion of minimum required data elements, but urge CMS to also include a measure for smoking cessation counseling and outcomes. We recommend the inclusion of a data element identifying when smoking cessation is addressed at the individual patient level. Smoking is the most important avoidable risk factor for lung cancer, accounting for approximately 85 percent of all cases. The best way to prevent lung cancer incidence and death is still to never smoke or quit smoking and to avoid exposure to secondhand smoke. Any patient being considered for lung cancer screening who still smokes should be offered cessation treatment. Tobacco cessation is the primary way to prevent lung cancer and lung cancer screening offers an ideal opportunity to provide vigorous education and cessation services to those at highest risk for lung cancer.

Conclusion

We thank you for the opportunity to comment on the proposed rule. ACS CAN remains committed to ensuring our constituents have access to life saving screenings, while raising awareness of cancer prevention and making strides in finding the cure for cancer. We look forward to continuing to work with you to improve access to evidence-based prevention tools and reduce the cancer burden. If there are any questions regarding these comments or additional information is needed, please contact Katie McMahon, Principal, Policy Development - Prevention at Katie.McMahon@cancer.org or 202-585-3245.

Sincerely,

Dick Woodruff
Vice President, Federal Relations and Strategic Alliances
American Cancer Society Cancer Action Network

References

1. de Koning HJ, Meza R, Plevritis SK, et al. Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the U.S. Preventive Services Task Force. Ann Intern Med 2014;160:311-20.
2. Tammemägi MC, Church TR, Hocking WG, Silvestri GA, Kvale PA, et al. (2014) Evaluation of the Lung Cancer Risks at Which to Screen Ever- and Never-Smokers: Screening Rules Applied to the PLCO and NLST Cohorts. PLoS Med 11(12): e1001764. doi:10.1371/journal.pmed.1001764
3. Halpern MT, Gillespie BW, Warner KE. Patterns of absolute risk of lung cancer mortality in former smokers. Journal of the National Cancer Institute 1993;85:457-64.

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Our facilities represent a network of over 250 lung cancer screening facilities across the United States that have earned the designation "Screening Center of Excellence" from Lung Cancer Alliance (LCA). As Screening Centers of Excellence, we endorse a set of guiding principles for high quality care set forth in LCA's National Framework for Excellence in Lung Cancer Screening and Continuum of Care, which was launched in 2011. These principles are:

• Empower patients by providing them clear information on the benefits and risks of lung cancer screening and prompt information about their results
• Require smoking cessation counseling to current smokers
• Adhere to best practices in radiation dosage and nodule management
• Work with multidisciplinary medical teams of experts and provide clear pathways to follow up care
• Commit to quality improvement and data collection to support advances in lung cancer screening and the continuum of care

As Screening Centers of Excellence, we have already demonstrated our profound commitment to ensuring that lung cancer screening is performed well and right in the community. We are driven by our knowledge that the greatest hope for surviving lung cancer is its early detection. When lung cancer screening is made fully and equitably available to those at high risk, we know that it will transform lung cancer from the nation's deadliest cancer to a survivable diagnosis.

We write collectively today to express our views on the Draft Coverage Decision Memorandum ("Draft Decision Memo") issued by the Centers for Medicare and Medicaid Services (CMS) on November 10, 2014. We are pleased that elements of the National Framework are included in the Draft Decision Memo. However, we have several concerns that are outlined below.

1. UPPER AGE LIMIT

Coverage of LDCT must be extended to age 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation.

We are deeply concerned by the decision to limit the age of Medicare coverage to the 55-74 year old population that participated in the National Lung Screening Trial (NLST) rather than the USPSTF upper age limit of 80. Extending the age of Medicare coverage to 80 is crucial for several reasons.

First, there will be confusion among patients and providers. In the best of circumstances, it is difficult to achieve adequate adherence with any screening protocol. Inconsistencies in eligibility criteria will create confusion and substantially contribute to challenges with adherence. For providers, the incongruence in age range for coverage will create practical burdens where there is a different set of criteria for those with private insurance, which MUST comply with full USPSTF recommendation, versus those with Medicare coverage - including potential disparities between coverage for those with Medicare Advantage plans (which typically mirror private market place benefits) versus traditional Medicare Part B. There must be a uniform and consistent public health message for patients and health care providers.

There is also no scientific justification for limiting access for the Medicare population to age 74. This age was used by NLST as part of their clinical trial criteria and was not intended to establish medical or public health policy. On the other hand, there is scientific justification for extending coverage beyond age 74. The median age for lung cancer diagnosis is 70 years. According to SEER data, 31.4% of lung and bronchus cancers are diagnosed in patients 65-74. The next highest incidence age group is 74-84, with 28.1% of lung and bronchus cancers diagnosed here. Ending coverage at age 74 is too soon and will mean that a very high-risk population, with years of life expectancy before it, will be denied access to this life saving screening.

There are also important health equity issues that could come into play if Medicare coverage is not extended to age 80. The fact is, some seniors (or their loved ones) will be able to cover the cost of lung cancer screening out of pocket, while others will not. CMS will have created a situation that could lead to striking racial and class disparities in access care and life expectancy at the upper end of the coverage bracket.

USPSTF carefully and thoroughly considered the NLST findings, weighing all the pros and cons in issuing its recommendation to extend coverage to age 80. This recommendation was not made arbitrarily but was based on solid mathematical modeling and confidence that follow up curative care could be delivered safely and effectively to the 75-80 year old age bracket. The age range for the CMS' coverage decision should be revised to align with the USPSTF recommendation.

2. SHARED DECISION MAKING

Lung Cancer Screening Centers of Excellence believe "shared decision making" based on fair and unbiased information is a crucial element to initiate a regiment of responsible lung cancer screening.

We support the "shared decision making" requirement set forth by CMS, noting that the information provided to patients must be fair and unbiased, without an over emphasis of risks or an under emphasis of the benefits of lung cancer screening. However, we believe it is important to clarify that the shared decision making discussion is only required to initiate the lung cancer screening regiment. However, we do not believe such an intensive requirement is reasonable or necessary for subsequent annual screenings. We therefore recommended that CMS retain the requirement for the initial screen and remove it for the subsequent screens.

3. NO SIGNS OR SYMPTOMS OF LUNG DISEASE

Requirement should be revised to “no symptoms suggestive of lung cancer."

As currently drafted, this definition is too expansive and inappropriate. Denying screening to patients with any symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer. Many of the highest risk patients who would benefit from lung cancer screening are patients with COPD, a smoking cough, asthma, emphysema, and other pulmonary symptoms. These patients should not be excluded from LDCT lung cancer screening exams.

We agree that patients with symptoms of possible lung cancer (hemoptysis, chest pain, cough), or patients with acute pulmonary symptoms (pneumonia, productive cough, fever, chills) should not receive lung cancer screening but instead should be evaluated for their symptoms using more appropriate methods.

4. [A]CCREDITED ADVANCED DIAGNOSTIC IMAGING CENTERS

Additional clarification is needed to ensure that the training and experience of Screening Centers of Excellence are appropriately recognized

We believe it is important that lung cancer screening take place in facilities with appropriate training and experience. Facilities should be able to demonstrate adequate training and experience through participation in major clinical trials such as NLST, medical studies that follow best published practices such as I-ELCAP or earned accreditation from appropriate professional societies such as ACR.

5. REGISTRIES

Screening Centers of Excellence support the registry requirement; however, we seek clarification regarding the elements of a "qualified registry" and want to ensure that the burdens of this reporting requirement are balanced against the important public health goal of fair and equitable access to quality care.

Many Screening Centers of Excellence are familiar with registry reporting requirements and recognize the importance of registries both as a mechanism to ensure that only high quality responsible care is being delivered and as a way to continuously improve the delivery of this care through the lessons learned from the data collected in the registries.

We also recognize, however, that data registry reporting requires the time of a suitably qualified professional team member which requires money. Screening centers affiliated with larger medical centers and typically found in larger urban may be able to readily comply with this requirement. But smaller practices in towns or rural areas may not have the staffing or funding capacity to comply with extensive data reporting requirements. Thus, it is important that an appropriate balance be struck between the burdensomeness of data collection and access to care.

Many screening centers are already participating in registry reporting as part of research protocols. We believe continuing to report to these registries should be adequate, provided the registry collects an agreed upon minimum set of data elements that can be reported in a standardized way.

6. NCCN HIGH RISK CATEGORY 2

CMS should open a CED for this high risk category

In the September 26, 2014 letter to CMS, which was signed by dozens of Screening Centers of Excellence, we specifically requested that CMS permit "coverage with evidence development" for lung cancer screening in patients between 50 and 54, with a twenty pack year smoking history and an additional risk factor including family history or exposure to certain environmental toxins. This group was identified by the National Comprehensive Cancer Network (NCCN) as an additional high-risk category (NCCN 2). A significant percentage of Screening Centers of Excellence screen individuals who fall within this high-risk category. For this reason, we reiterate the request to CMS that is open a CED for this the NCCN 2 high-risk category. There will never be another NLST. By opening a CED, CMS will not only help save lives today but it will also close a perceived evidence gap and save many more lives in the future.

7. SMOKER WHO HAS QUIT WITHIN THE PAST 15 YEARS

This requirement is paradoxical, arbitrary, and lacking in medical evidence.

Like the age 74 cut off, the decision to restrict participation in the NLST to former smokers who had quit in the past 15 years was a merely a clinical trial inclusion criteria and was not intended as a bright line standard for medical or public health policy.

We recognize that even the USPSTF accepted this "15 year" limit. However, we believe this limit is arbitrary and is not based in scientific evidence. Although not included in the NLST, others studies show that the risk of smoking-related cancers is predominantly related to the length of time someone has smoked. This risk gradually decreases over time, but former heavy smokers may remain at significant risk of lung cancer development many years after quitting.

Practically speaking, the arbitrary cutoff at 15 years would result in an implementation dilemma where patients are seemingly penalized for quitting smoking while those who continue to smoke continue to receive the benefits of screening. The 15-year smoking cessation criteria thus creates a paradox that could encourage patients to restart their smoking habit to become eligible or retain eligibility for the screening benefit.

CONCLUSION

The Screening Centers of Excellence appreciate the opportunity to share our concerns with you. We are grateful that CMS has issued a Draft Decision that proposes to offer significant coverage of lung cancer screening. Our hope is that CMS will be able to refine this decision and give appropriate weight to our experiences on the frontline delivering lung cancer screening safely and responsibly, each and every day.

Respectfully submitted,

Addison Gilbert Hospital
Brigham and Women’s Health Care
Center for Chest Care
Central DuPage Hospital, Northwestern Medicine
Clark Memorial Hospital
Conemaugh Health System
Deaconess Health System
Delnor Hospital, Northwestern Medicine
Edward Hospital
Eisenhower Medical Center
Fairfield Medical Center
Fox Chase Cancer Center
Franciscan St. Francis Health
Frederick Regional Health System
Hartford HealthCare
Helen G. Nassif Community Cancer Center - UnityPoint St. Lukes
Huntsman Cancer Institute
Inova Lung Cancer Screening Program
Inspira Health Network
John Muir Medical Center
John T. Mather Memorial Hospital
Keck Medical Center of University of Southern CA
Lahey Outpatient Center
Lancaster General Health
Lima Memorial Health System
Lung Cancer Screening Program, MD Anderson Cancer Center
Lutheran Hospital of Indiana
Maimonides Medical Center, Lung Cancer Screening Program
MedStar Georgetown University Hospital
Memorial Health System
Middlesex Hospital Total Lung Care Center
Mount Sinai Comprehensive Cancer Center
Nebraska Methodist Hospital
PIH Health Hospital-Whittier
Pinnacle Health
Pocono Medical Center
Premier Radiology
Providence Regional Medical Center, Everett
Roper St Francis Healthcare
Saint Agnes Hospital
Saint Alphonsus Health System
Saint Francis Hospital, Lung Cancer Screening Program
Seattle Radiologists – IELCAP Study Site
St Elizabeth's Medical Center
St Thomas Health
St. Joseph Mercy Hospital
St. Joseph Mercy Oakland Hospital
Stony Brook Cancer Center
Sylvester Comprehensive Cancer Center
The Center for Cancer Prevention and Treatment at St Joseph Hospital
The Lung Cancer Institute at Saint Barnabas Medical Center
Tuality Healthcare
UC Health University of Cincinnati Cancer Institute Comprehensive Lung Cancer Center
University Hospitals Seidman Cancer Center
University of California Davis Health System
University of Kansas Hospital
University of Maryland Baltimore Washington Medical Center
University of Maryland Upper Chesapeake Health
Upstate Medical University
Wellstar Health System

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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

Dear Ms. Syrek Jensen:

We applaud the Centers for Medicare & Medicaid Services draft decision to extend the life saving benefit of CT lung screening to the Medicare age population. Our comments and recommendations are as follows.

1. We agree patients and providers must engage in informed and shared decision making (SDM) when considering CT lung screening enrollment and strongly support a provider order be required for each exam. We respectfully request clarification that the, “lung cancer screening counseling and shared decision making visit” not mandate a face-to-face interaction to avoid raising barriers to enrollment among high-risk individuals of lower income levels who may have limited access to transportation to a provider’s office and among high-risk individuals in rural settings where travel to a provider’s office may require significant time commitment and cost. In addition to a face-to-face encounter, we respectfully request the final decision memo specify that a qualifying “visit” may occur via a variety of communication methods including teleconference and videoconference.

2. We respectfully request the, “lung cancer screening counseling and shared decision making visit” be a reimbursed event for the provider as the visit may or may not lead to enrollment in a CT lung screening program but will require dedicated time to conduct and an upfront investment of time to ensure familiarity with the relevant points of discussion. In addition we respectfully request that no co-pay be required of participating beneficiaries to avoid creating barriers to access for high-risk individuals of lower income levels.

3. We respectfully request that registry coverage with evidence be available for current and former smokers aged 50 years or older with at least a 20 pack-year smoking with one additional smoking related risk factor as defined in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Lung Cancer Screening Version 1.2015. (1,2) In our CT lung screening program this high-risk patient group has had positive rates and cancer detection rates similar to the NLST population. (3,4) Providing a mechanism for this additional group at high high-risk for lung cancer to access CT lung screening will allow us to learn more about screening in this population and could lead to thousands of additional American lives saved every year.

4. We respectfully request that centers engaged in institutional review board approved research initiatives to investigate the efficacy of CT lung screening outside the high-risk group(s) defined as eligible in the final decision memo not be penalized for engaging in such research including loss of the ability to submit claims for reimbursement for high-risk individuals meeting the final decision memo eligibility requirements.

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1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Lung Cancer Screening Version 1.2015. http://www.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf Accessed 12/10/2014.
2. LDCT LCS Stakeholder letter to CMS. http://www.acr.org/~/media/ACR/Documents/PDF/Advocacy/Fed%20Relations/LCS%20Stakeholder%20Letter%2009%2026%2014_FINAL.PDF. Accessed 10/7/2014.
3. McKee BJ, Hashim JA, French RJ, et al. Experience With a CT Screening Program for Individuals at High Risk for Developing Lung Cancer. Journal of the American College of Radiology : JACR. 2014. [Epub ahead of print].
4. Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. The New England journal of medicine. 2011;365(5):395-409.

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As the founder of a lung cancer advocate nonprofit organization, I respectfully ask CMS to revise its guidelines for covering lung cancer screening as follows:

1. Increase the age limit to match the USPSTF guidelines to include seniors up to age 80, rather than 74.
2. Lift restrictions preventing those most at-risk for developing lung cancer, specifically, people with COPD, emphysema, asthma or persistent cough.
3. Adapt a successful registry model from breast or colon cancer screening, rather than place unrealistic requirements on those serving the at-risk lung cancer community.
4. Expand the number of years after someone quit smoking to at least 20 years.

Thank you,

Dusty Joy Donaldson
Dusty Joy Foundation
www.dustyjoy.org
www.LiveLung.org

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I would like to recommend a few changes in the proposed CMS decision for lung cancer screening with LDCT.

1. Extended coverage to age 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation. As a public health professor and practitioner, I recognize the importance of consistent and clear evidence-based guidelines when working with the public, providers and policy makers. Since the USPSTF did mathematical modeling and provided rational for their decision, I believe that CMS should use the same age category. Also, I work with the state of Kentucky, which has the highest lung cancer incidence and mortality in the nation. According to the Kentucky Cancer Registry data from 2007-2011, the age-adjusted lung cancer incidence rate is highest in the age group 75-79 years at 599.8 per 100,000 population as compared to all other age group.

2. I propose revising the language from "asymptomatic" which could be interpreted too expansively to “no symptoms suggestive of lung cancer." Those who are eligible for lung cancer screening are also smokers who may have a smoker's cough, COPD or other pulmonary issues and should qualify for screening. I agree that those patients who have symptoms of lung cancer, such as hemoptysis, chest pain, or acute pulmonary symptoms, such as pneumonia or a fever, should not receive lung cancer screening. They should be evaluated for their symptoms with more appropriate methods.

3. I support the registry requirement; however, I would like seek clarification regarding the elements of a "qualified registry." I believe there should be an agreed upon minimum set of data elements that can be reported in a standardized way, but I do not think we should require participation in an existing registry or extensive data reporting elements. In Kentucky, we are working very closely with our Kentucky Cancer Registry to develop a high-quality lung cancer screening registry that will connect with our Kentucky Cancer Registry. Our Cancer Registry is internationally known for quality, case ascertainment, completeness and accuracy. The lung cancer screening will be developed in a high quality way that will allow for participation from both rural, community hospitals as well as academic medical centers.

Thank you for the opportunity to comment!

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HCA is a major hospital provider throughout the United States. We maintain a focus on patients and are engaged in many quality initiatives including the delivery of high quality patient care. We support Medicare coverage of Low Dose Computed Tomography (LDCT) screening for lung cancer in high risk patients as recommended by the United States Preventative Services Task Force (USPSTF). However we do have comments regarding the radiologist and the radiology imaging center eligibility criteria.

1. The following is listed in the decision memo under “Radiology imaging center eligibility criteria”:
For purposes of Medicare coverage of lung cancer LDCT screening, an eligible LDCT screening facility is one that:

"Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;"

We request CMS clarify that “radiology imaging center” refers to inpatient and outpatient centers including hospital outpatient imaging departments as LDCT lung cancer screenings will likely be performed in these settings.

We also request CMS clarify “accredited advanced diagnostic imaging center” and that American College of Radiology (ACR) CT Accreditation meets the requirement.

Additionally, we ask CMS to provide other mechanisms for providing covered services when an imaging center or hospital outpatient imaging department has not participated in prior lung cancer screening trials, such as designation by ACR as a Lung Cancer Screening Center will meet the LDCT lung cancer training and experience requirement.

2. The following is listed under “Radiologist eligibility criteria”:

Current certification with the American Board of Radiology or equivalent organization;

Documented training in diagnostic radiology and radiation safety;

Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past three years; and

Documented participation in continuing medical education in accordance with current American College of Radiology standards.

We question why another set of standards is needed outside the ACR CT Accreditation Program Requirements. Current certification with the ABR or equivalent organization meets the initial radiologist qualification for ACR CT Accreditation. Bullets two and four above are encompassed in the quality control and ongoing continuing education requirements of the ACR CT Accreditation Program. The supervision and interpretation requirements for continuing experience required in the ACR CT Accreditation Program already includes volumes for reading CTs for multiple and single organ systems.

We are concerned that the proposed Decision Memo requirements will unnecessarily limit access to screening in imaging centers and hospital outpatient imaging departments that are competent and qualified to perform the testing. We request that ABR or equivalent organization certification for the radiologist or ACR CT Accreditation for the imaging center or hospital imaging department be sufficient to perform and be reimbursed for LDCT lung cancer screening for Medicare patients.

Thank you for considering our comments.
Gayle Troccoli, RN, CPC/ Sr. Consultant HCA Regulatory Compliance Support/ 615-344-5104
gayle.troccoli@hcahealthcare.com

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December 8, 2014

Tamara S. Syrek Jensen, JD
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:

Thank you Ms. Jensen for the considerable effort you and your colleague have invested in the reimbursement decision for CT screening. This is one of the most important new cancer services that has ever been introduced. I have been working on lung cancer screening research for over thirty years and had the privilege of working with Dr. von Eschenbach around the process of initiating the National Lung Screening Trial during my twenty five years working as a researcher at the National Cancer Institute. I fully support the comments conveyed to CMS recently in the Joint Society letter and I have appreciated your gracious handling of this dialogue during the MEDCAC review in Baltimore and the in-person meeting I attended at your Washington office.

Now, I am writing to underscore two critical points in considering the final CMS decision on screening coverage. 1) The first is that progress with improving the screening process has occurred rapidly, but is not broadly understood. As recently as this week there was a New York Times article by Jane Brody relating that lung cancer screening had a high false positivity rate. That position is not consistent with the existing evidence. The important information from the ACR provided to your office which builds on International-Early Lung Cancer Action Project diagnostic work-up approach results in a much lower frequency of false positive diagnosis. I am attaching a recent publication from Lancet Oncology that I was invited to submit that summarizes the recent data from the NELSON group in Europe and their results with nodule size-based screening management that confirms the emerging data that a low rate of false positivity is readily achievable (Attachment 1). I also am attaching a recent review article published on this topic for the American Cancer Society (Attachment 2). The American public deserves policy decisions based on the most relevant evidence.

The efficiency of this currently widely accepted diagnostic approach results in a more cost efficient screening process as reported to your agency in the recent publication by Pyenson and co-workers. This finding is again different and more reliable information than the cost information that was recently cited in the recent Times piece. The National Lung Screening Trial was implemented over a dozen years ago and was designed to answer the mortality reduction question. It did not include a defined diagnostic work-up approach and the retrospective cost analysis recently published from that study is not relevant to the current screening implementation discussion where a more refined clinical management will be universally used. Please base your reimbursement decision upon accurate current data.

2) The goal of lung cancer screening is to routinely detect early curable lung cancer, but the challenge of late diagnosis is particularly experienced by medically underserved populations. Further, tobacco use leads to a great fraction of this disease, especially in African American tobacco users and predatory marketing practices for tobacco have been demonstrated with minority populations in the decision of United States v. Philip Morris (D.O.J. Lawsuit), resulting in a special obligation in the coverage decision for this service. Consistent with the intention of the Affordable Care Act, the lifesaving screening services must be made broadly available to all indicated high risk individuals entitled to federal health reimbursement through Medicare. Any administrative barriers that erode the access of underserved populations to this cancer screening service will be contrary to the will of Congress and the stated intention of the President. A remarkable consortium of institutions is working together to ensure the delivery of high quality screening services, but the issue of ease of access is the particular responsibility of CMS and how it mandated the provisions for reimbursement.

I greatly appreciate your thoughtful consideration of these two crucial issues in issuing your final decision regard national coverage of lung cancer screening services.

Sincerely,

James L. Mulshine, MD

Attachments (2)

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My hospital will be implementing a LDCT screening program. We have not participated in prior trials but are ACR accredited with CT scanners fully capable of performing LDCT and board-certified radiologists with the requisite training. We intend to apply for ACR accreditation as a LDCT screening provider. Will this meet the critera to be an eligible imaging center under the CMS guidelines? We would recommend this be the case as we are a high quality, low cost provider serving a patient population close to 600,000 with a high percentage of Medicare beneficiaries.

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The Society of Thoracic Radiology (STR) is greatly appreciative of the opportunity to comment on the recently proposed Decision Memorandum for National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). We applaud the Centers for Medicare and Medicaid’s (CMS) proposed decision to extend this life saving benefit to the Medicare age population. STR joins and supports all of the submitted comments of the joint societies, The Lung Cancer Alliance (LCA), The Society of Thoracic Surgeons (STS), and the American College of Radiology (ACR). In this regard, we respectfully request CMS to make targeted modifications to the proposed decision regarding the age bracket for individuals eligible to receive low-dose CT (LDCT) lung cancer screening, 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. Additionally, we agree on the importance of clarifying and strengthening aspects of eligibility criteria for qualifying radiologists and radiology imaging centers, as well as CMS-approved national lung screening data registries. We share the very significant concerns about the proposal to limit this screening benefit to high risk individuals ages 55-74. We strongly believe that a coverage decision excluding those patients who are ages 75-80 years old would neglect a significant patient population at high risk of lung cancer, as well as create a confusing and socially disparate policy that increases rather than decreases health care disparities in the elderly by creating a barrier to lung cancer screening access for lower income, elderly Americans. We consider equitable access to high quality screening the overarching public health priority as CMS develops and implements a safe and effective national coverage policy that will save thousands of lives.

Lynn S. Broderick, MD, FACR
Chair, Advocacy Committee
Society of Thoracic Radiology

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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 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 evidence-based 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 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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December 10, 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:

On behalf of the Prevent Cancer Foundation, the only national nonprofit organization solely dedicated to cancer prevention and early detection, we appreciate the opportunity to comment on the proposed National Coverage Determination for Lung Cancer Screening with Low Dose Computed Tomography (LDCT) (CAG-00439N). We were pleased to see the proposed decision of the Centers for Medicare & Medicaid Services (CMS) to ensure that Medicare beneficiaries will have access to this critical service.

CT lung scans are proven, effective screening measures that save lives. We have long advocated for these services to be available to individuals at high risk for lung cancer. At an average cost of $300 to $400, this test is too expensive for many older Americans in need and once finalized, this decision will help to eliminate that disparity.

However, there are some additional recommendations that the Prevent Cancer Foundation also supports. These include changes related to: (1) the age range for individuals eligible to receive LDCT screens; (2) the definition of asymptomatic patients; (3) the requirement of provider visits to obtain an order for annual follow-up screening; and (4) the 15-year smoking cessation threshold.

Age Range
The Prevent Cancer Foundation encourage CMS to consider a broader age range for coverage of LDCT scans. As written now, the proposal would provide coverage for individuals aged 55 to 74 years old. As the median age of diagnosis for lung cancer is 70 years, this age range is too restrictive. We encourage CMS to adopt the United States Preventive Services Task Force (USPSTF) recommendation of an age range from 55 to 80 years.

Definition of Asymptomatic Patients
The proposal defines “asymptomatic” as “no signs or symptoms of lung disease.” The Prevent Cancer Foundation recommends that this language be deleted and replaced with “symptoms suggestive of lung cancer.” This change will ensure that patients would not be inadvertently excluded from LDCT screening. It will also protect against potential retrospective denial of payment.

Requirement to Obtain an Order for Annual Follow-Up Screening
The proposal states that a written order for LDCT screening must meet the following criteria: For subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit (for example: during the Medicare annual wellness visit, tobacco cessation counseling services, or evaluation and management visit) with a physician (as defined in Section 1861 (r)(1) of the Act) or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Act).

While an initial screen is appropriate, it is unnecessary to require future orders for LDCT screens. The Prevent Cancer Foundation encourages CMS to implement the written order requirement and provider shared decision-making visit only for the initial screen. This will eliminate avoidable and excessive cost and burden.

15 Year Smoking Cessation Threshold
The Prevent Cancer Foundation recommends the elimination of language within the current proposal which requires a 15 year smoking cessation eligibility criteria. This arbitrary time period might unintentionally incentivize patients to restart their smoking habit to either become eligible or retain eligibility for the screening benefit. There is no evidence that lung cancer risk drops substantially after 15 years smoking cessation. This component does not contribute to successful prevention policy.

Thank you for your consideration of these comments. If we can provide further information, please feel free to call upon us as a resource. I can be reached at Carolyn.Aldige@PreventCancer.org or 703-519-2114.

Sincerely,

Carolyn Aldigé
President and Founder
Prevent Cancer Foundation

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Thank you for the opportunity to be a part of the public comments regarding CMS covering CT screening for lung cancer. This is a collective response of the Mayo Lung Screening Program and represents our philosophy for how screening is to be implemented in the population at high risk.

We applaud the decision to proceed with coverage for Medicare and Medicaid recipients age 55-74 with 30 pack-years of smoking. We are particularly pleased with the emphasis on smoking cessation counselling as we mandate this occur prior to receiving screening for current smokers. We also agree that shared decision making (recommended in the USPSTF guideline) should be a mandated event prior to initial screening, though note that this can be easily accomplished with a nurse in a protocol fashion. We agree that screening is not appropriate for most clinic setting and requires careful implementation in centers of proven expertise in chest radiology, pulmonary, thoracic surgery and medical and radiation oncology in a multidisciplinary and coordinated effort with registry management of findings and follow-up. We recognize that there may be opportunities to enhance the current proposal. We would suggest:

• Increasing the screening age from 74 to 80 for those at high risk who remain in good health and are candidates for curative intent therapy if lung cancer is identified. This age increase reflects the continued increasing risk for lung cancer between 75 and 80. This would also match the USPSTF recommendation so as to be less confusing for patients.
• Eliminating the stopping of screening after 15 years of smoking cessation. We realize that the NLST criteria included this as enrollment criteria which made sense from a study standpoint but risk for lung cancer continues to rise with age despite smoking cessation –though at a much slower rate than if smoking had continued. The stopping of screening after cessation is a disincentive for smoking cessation; smoking cessation it the most important step to do reduce ones risk of death from lung cancer and we do not want to add a disincentive.
• Including a threshold of risk above which enrollment would be appropriate even if the age and smoking criterion were not met. In other words, the message to a 25 pack-year smoker should not be to smoke 5 more years to be eligible for screening, it should be to stop smoking or stay stopped and start screening when old enough to meet the threshold of risk. The literature is clear that other factors including race, BMI, education level, presence of COPD or emphysema, and personal or family history of lung cancer are independent risk factors and were not part of the NLST criteria. For this reason we favor an individual risk calculation for lung cancer as the determinate of if and when screening should occur and have employed the PLCO2012 and require a threshold of 1.3% over the next 6 years if USPSTF criteria are not met.
• There is great opportunity to do a bad job of screening. Assessment of quality measures may help to duplicate or exceed the benefit demonstrated in the NLST and minimize the harm. We favor outcome measurements to assure the quality of nodule evaluation such as: the percentage of benign nodules among nodules surgically removed, number of biopsies performed per screened population, number of non-diagnostic biopsies, and percentage of stage I cancers among all cancers.

Additional program measures to assess might include percentage of patients scanned meeting eligibility criteria, percentage of current smokers who underwent tobacco cessation consultation prior to screening, timing of notification of results to patient, timing of abnormal result follow up notification, percent of patients with benign surgical biopsy, percent of VAT surgeries vs. thoracotomies, percent of early state cancer identified, five year survival rates in patients with cancer identified during screening, and percent of program drop outs.

We applaud the decision of CMS to reimburse lung cancer screening in appropriately implemented settings.

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The American Association for Thoracic Surgery (AATS) agrees with the Centers for Medicare and Medicaid Services (CMS) that there is sufficient evidence to support an annual low dose computed tomography (LDCT) as a preventive service benefit for Americans with a 30 pack year smoking history between the ages of 55 and 74. The AATS, however, is critical of the CMS draft proposal because it denies an equal or greater number of equally vulnerable Americans who would benefit from this method of screening for early stage lung cancer. Specifically, the AATS requests the following changes to the draft proposal: 1) Coverage that is not limited by an upper limit of age, but by the functional status of the beneficiary, 2) elimination of the “quit rule,” and 3) prospective accumulation of data that would assist future refinement of the screening guidelines.

The AATS Task Force for Lung Cancer Screening and Surveillance developed Guidelines that endorsed annual LDCT for 30 pack year smokers between the ages of 55 and 79. These recommendations acknowledged that the prospective randomized National Lung Screening Trial (NLST) had specifically excluded Americans over the age of 74 from participation, irrespective of their functional status or risk of developing lung cancer. Such exclusion is a form of age discrimination, and was likely unnecessary to complete the trial. Nevertheless, there is substantial data to show the anticipated benefit of including older Americans in LDCT screening, including: the aging of Americans, the preserved function of many older Americans, the increasing risk of developing lung cancer as a function of age up to 80years, the fact that half of all Americans with lung cancer are over the age of 71, the safety of interventions within this age group documented over the past decade, and the fact that lung cancer incidence exponentially rises over the age of 74 in smokers with greater than 20 pack years. The United States Preventive Services Task Force (USPSTF) independently concluded that the beneficial LDCT screen strategy was annual scans for smokers of 30 pack years between the ages of 55 and 80. The AATS concludes that there are currently no plans to repeat a randomized control trial of LDCT screening within the elderly population. Therefore, it is inadequate public policy to ignore the expected benefit of LDCT screening between the ages of 74 and 80 due to lack of prospective trial data, when this age group was specifically excluded from participation in the largest prospective trial of lung cancer screening.

The AATS stands in opposition to the “quit rule,” the specification that a 30 pack year smoker is no longer eligible for this preventive benefit if they have quit smoking for greater than 15 years. The “quit rule” is unnecessarily discriminatory to Medicare beneficiaries. The 55 year old smoker who enrolls in a lung cancer screening program and through the required smoking cessation counseling succeeds in quitting, will no longer receive LDCT once reaching 70 years of age and consequently will not be screened at the most likely time for the person to actually develop lung cancer. There is data that risk reduction for lung cancer among 30 pack year smokers is less than smokers with less tobacco exposure. 30 pack year smokers have an elevated risk of lung cancer for at least 25 years after smoking cessation. Furthermore, the AATS believes the demographics of the lung cancer have changed in the past 25 years, with a rise in adenocarcinoma, decrease in squamous cell carcinoma, and increase in frequency of part-solid nodules, resulting in a tripling of case number over the past 30 years. There is no compelling basic science evidence that the removal of the initial trigger leads to a reduction in risk with time. Rather, there is compelling evidence that carcinogen exposure leads to a trigger of events that continue toward neoplasia even after the initial trigger has been removed.

The AATS believes that LDCT screening guidelines will be refined as new data is accumulated. Specifically, the AATS believes that large database models can be used to calculate individual risk to refine the appropriate screening populations. Risk models developed in the US and Europe have already begun addressing a variety of non-cigarette smoking risk factors. In an effort to support the future refinement of those eligible for screening, the AATS requests CMS to consider adding additional datafields to those requested in their draft proposal to include family history of first degree relatives developing lung cancer prior to age 60, previous personal history of malignancy, personal history of pneumonia and environmental exposures to cigarette smoke, asbestos, and radon. Furthermore, screening result datafields should be added, such as the size of the nodule, lobe of location, degree of solidness, and cell type of cancers diagnosed. With more than 20% of lung cancer now diagnosed in lifetime non-smokers, it is imperative that data collected for a national registry include data beyond smoking.

Francine Jacobson, MD Co-Chair, AATS Task Force for Lung Cancer Screening and Surveillance
Michael Jaklitsch, MD Co-Chair, AATS Task force for Lung Cancer Screening and Surveillance

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December 10, 2014

Tamara Syrek Jensen, Esq.
Director, Coverage and Analysis Group
Centers For Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Syrek Jensen:

Lung cancer affects approximately 1 in 6 current- and former smokers and is the leading cause of cancer-related death among men and women in the US. The majority of people who are diagnosed with lung cancer will die from their disease due to the late stage at diagnosis. Fortunately, early-stage lung cancer is curable, and early detection by low-dose computed tomography (LDCT) has proven to save lives among high-risk individuals.

To this end, Moffitt Cancer Center would like commend the Centers for Medicare & Medicaid Services (CMS) on the initiation of a draft decision memo in support of LDCT coverage. This decision could significantly benefit approximately four million Medicare beneficiaries that fit the eligibility criteria for screening.

With regard to the proposed decision memo (CAG-00439N), we would like to express our opinion and provide additional information which may be useful in the decision making process.

1-Limiting the beneficiary eligibility age to 74

We are concerned with the decision to limit the beneficiary coverage to the 55-74 years of age population and we recommend that the age criteria be consistent with the United States Preventive Services Task Force (USPSTF) recommendation of 55-80 years of age. The USPSTF recommendation was based upon extensive review of past clinical trial data, current literature and mathematical modeling showing that follow-up could be delivered effectively and safely to high-risk subjects between the ages of 75-80. In addition, an average life expectancy among Americans has increased from about 75 years in the 1990’s at the time of NLST planning to about 78.7 years in 2010 (Arias E., Natl Vital Stat Rep. 2014 63;7). In 2014, it is expected that this number is already about 79.5 years. When a lung cancer is missed, it has a potential to drastically and immediately lower the expected longevity. We therefore recommend extending the eligibility to 80 years of age. This will also ensure that there is uniformity among screening protocols. Private insurers are mandated to comply with the USPSTF recommendation. The varying eligibility criteria between the private insurers and Medicare beneficiaries will complicate and create a barrier to protocol adherence for screening centers.

2-“For the initial LDCT lung cancer screening service: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit furnished by a physician or qualified non-physician practitioner.”

In our opinion, a dedicated visit before allowing a potential lung cancer screening participant to have LDCT is unnecessary. Such visit is unnecessary because, in practice, any general practitioner who refers their patients for cancer screening routinely counsels them on the risks and benefits and ensures they are a candidate. Breast or colorectal cancer screening tests do not warrant an extra visit just for pre-test counseling. In addition, such visit may act as an extra barrier for smokers or ex-smokers who typically are already afraid to even think about the possibility of having lung cancer to go for LDCT. Finally, the visit will unnecessarily increase the burden of healthcare utilization and cost. At our lung cancer screening program, our facility confirms that the subject meets all eligibility criteria prior to scheduling the subject for the imaging. A standing order is in place for the eligible patients.

3-“For purposes of Medicare coverage of lung cancer LDCT screening, an eligible LDCT screening facility is one that: (1) Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or (2) an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;”

In our opinion, the coverage should be granted only to those institutions who have participated in lung cancer screening trials. First, sufficient evidence exists for the efficacy of lung cancer screening only when this is performed within such institutions. Second, recent cost-effectiveness analysis (Black WC et al, NEJM 2014. 371; 19) indicated that the value of lung cancer screening varies markedly depending on how it is implemented. Screening conducted outside of a truly experienced institution may be vulnerable to misuse, creating harm to the subjects and increasing healthcare cost. For example, the excessive follow-up scans due to unwarranted medico-legal fear, historically observed in breast cancer screening, and the poor quality of life caused by anxiety among screening participants will markedly reduce the cost-effectiveness of lung cancer screening. In our opinion, at this time, only through the participation of past lung cancer screening trials can a definition of “accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening” be satisfied.

Respectfully submitted,
Moffitt Cancer Center
Tampa, FL

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Date: December 10, 2014

TO: CMS
RE: Response to “Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)”

I commend CMS for the thoughtful decision memo regarding LDCT for lung cancer screening. I know a lot of work went into preparing this document, and I think it contains a great deal of the critical components we need to ensure that we implement LDCT in a responsible way for our patients and our healthcare system.

As a major author on several systematic reviews and guidelines on LDCT screening and a collaborator on many others, I have been thinking about lung cancer screening a great deal for quite some time. Perhaps more importantly, as a co-director of the Yale Lung Screening And Nodule (SCAN) Program, I have experienced first-hand and been humbled by the challenges in developing a responsible program that seeks to maximize benefits while minimizing harms and unnecessary costs. Finally, I have learned a great deal for having visited other developing screening programs. These experiences lead me to comment on a few points regarding the Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).

I am aware of (and have contributed to) several responses that are being submitted to CMS by several societies. I am sending a further individual response to underscore two points that I think are important enough to highlight in particular.

Screening should be performed in healthy individuals

Screening for lung cancer should be done in individuals who are otherwise healthy. This is not stated or implied anywhere in the CMS proposal. The issue here is one of competing causes of death. If the likelihood of a lung cancer death is overshadowed by a high risk of other causes of death, screening for lung cancer is not likely to be effective. This is particularly important in the Medicare population. The NLST and all other lung cancer screening trials excluded patients with significant co-morbidities.

I recognize that CMS has addressed other issues that would stand in the way of realizing a benefit from screening, such as the ability or willingness to undergo treatment. However, this is a different matter than co-morbidities that would affect the relative risk of death from lung cancer. Furthermore, the statement that screened individuals be asymptomatic is meant to address the fact that these individuals should have no symptoms of lung cancer – but this does not address the issue of significant co-morbidities.

I think this is a critical issue, because many previous documents related to lung cancer screening have already contributed to confusion. Some major documents imply that the issue related to comorbidities is whether the patient is able to undergo lung cancer surgery, or any lung cancer treatment (e.g. SBRT), or is at increased risk for complications with diagnostic or treatment interventions. While these issues exist, the presence of a comorbidity that affects the likelihood of death from lung cancer as opposed to another cause is a different matter.

I would therefore suggest that CMS add a further bullet point to the “Beneficiary eligibility criteria”, namely:

Absence of any comorbidity that would affect life expectancy

I recognize that tools to define this are currently lacking, and that it must depend on the clinicians’ judgment. I also recognize that therefore, this is a metric that must rely on clinicians self-reporting and cannot (at present) be corroborated. However, I think it is important to draw attention to this matter, and require clinicians to stop and think about it with each patient that is screened.

Quality Metrics

Because the outcomes of lung cancer screening depend on a particularly complex interplay of many factors, the establishment of quality metrics to which screening programs must adhere to is crucial. This lesson has been learned from other screening efforts such as for breast cancer.

I recognize that establishment of such metrics and oversight is beyond the scope of the current CMS proposal. Nevertheless, the expectation of meeting appropriate metrics must be set. Currently, the CMS statement does not include any mention of quality metrics. For example, according to the CMS document, a program could ask for Medicare payment for those individuals meeting the CMS eligibility requirements, but at the same time screen anyone they choose to that falls outside this under whatever business model they choose. Although a program must report interventions and outcomes of screened individuals, there is no requirement that any metrics be met; a program is free to screen and intervene as often and in any way it chooses.

Therefore, where the characteristics of a screening program are described I suggest inclusion of text similar to the following:
The outcome of lung cancer screening depends on a complex interplay of many factors. The experience in screening for other cancers has shown that development of a structure and quality metrics is important to ensure a good balance of benefits and harms. Therefore, an appropriate body should develop quality metrics and targets for an acceptable screening program. A program appropriate for Medicare coverage must meet the standards set by this body.

I hope that these points and suggestions are of help to the CMS committee in finalizing the Decision on LDCT for Lung Cancer Screening.

Sincerely,

Frank Detterbeck
Professor & Section Chief
Yale Thoracic Surgery

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I give kudos to CMS for your recommendation to cover lung cancer screening for Medicare and Medicaid populations. This is a crucial first step in reducing lung cancer deaths.

I lost [PHI Redacted], to lung cancer in April 2013. [PHI Redacted] had all the risk factors for lung cancer. He was [PHI Redacted] at the time of his Stage IV diagnosis in October 2011, had an 80 pack year smoking history, quit smoking 11 years prior, had COPD and [PHI Redacted] died of lung cancer at the age of 62.

As a former care giver, a lung cancer advocate, and an MPH student, I respectfully ask CMS to consider the following comments for your final recommendation:

1. The 74 years of age upper age limit - The difference in the upper age limit of 80 years old for the USPSTF recommendation and the CMS limit of 74 years of age will serve to create a disparity in access to care for older Americans based on social economic status (SES). Those with the means to pay the several hundred dollars for an annual screen will have the option of continued screening to age 80. Although the highest percentage of lung cancer cases, 31.7%, are diagnosed in ages 65 to 74, those diagnosed in the 75-84 year old age group are a close second with 27.9% of diagnosed cases (1). In addition, it will create confusion in the physician and patient community on who can get screened based on insurance coverage. I recommend CMS change the upper age limit to 80 years old. The screening criteria already preclude participation in screening if the patient is unable to undergo diagnosis and treatment.

2. Clarification on the requirement to be asymptomatic – Many, if not most, smokers have some type of a chronic cough. In addition, many of the subtler symptoms of lung cancer such as tiredness, a cough and dyspnea are associated with numerous other conditions such as COPD or as side effects to blood pressure and Type 2 diabetes medications. These are some of the patients at highest risk of lung cancer. I would recommend the clarification specify being asymptomatic of new symptoms suspicious of lung cancer.

3. The 15 year quit date – Although quitting stops the accumulation of damage due to smoking, the accumulated damage is not reversed (2,3). The risk for lung cancer increases with age, so although a person quit smoking, if they have a heavy smoking history, it may be too late, even 15 years after quitting. I would ask CMS to reconsider, allowing patients who enter screening within the 15 year quit window to continue to be eligible for screening until they age out.

4. The requirement for a separate counseling and shared decision making visit with a physician or qualified non-physician practitioner for the initial screen. – Many physicians provide counseling and discussions on cancer screenings as part of a regular visit, such as an annual wellness check. Having a requirement for a lengthy separate visit makes it difficult to do in the time constrained primary care setting. Having the discussion during a regular visit when the physician and patient are already discussing smoking history, patient comorbidities and health status, patient risks, and smoking cessation if appropriate, is efficient and effective. I am concerned that many patients may decide it’s too much trouble to have a separate physician visit so would not get screening. I am also concerned the counseling session may be taken over by dedicated screening centers taking the discussion away from the primary care physician who knows the patient best, including the patient’s history, risk and smoking cessation quit attempts.

5. Coverage for NCCN Group 2 – The experience at Lahey Hospital & Medical Center (4) is that NCCN Group 2 has the same prevalence for lung cancer as those in NCCN Group 1. I ask that CMS consider covering NCCN Group 2 under coverage with evidence development. It would be difficult to not cover this group knowing they are at equivalent risk to those in NCCN Group 1 who will be covered based on the CMS draft recommendation.

Thank you for your consideration of my comments. Please do not hesitate to contact me if you need any more information or need me to clarify something.

Sincerely,
Andrea Borondy Kitts
Lung Cancer Advocate & MPH Student
860-682-3606
borondy@msn.com
References:
1. http://seer.cancer.gov/statfacts/html/lungb.html
2. Peto, J. (2011) That lung cancer incidence falls in ex-smokers: misconceptions 2. British Journal of Cancer, 104,389. doi:10.1038/sj.bjc.6606080.
3. Vineis, P., Alavanja, M.,Buffler, P.,Fontham, E., Franceschi, S,Gao, Y. T.,Gupta, P. C.,Hackshaw, A., Matos, E.,Samet, J.,Sitas, F.,Smith, J.,Stayner, L.,Straif, K.,Thun, M. J.,Wichmann, H. E.,Wu, A. H., Zaridze, D.,Peto, R.,Doll, R. (2004). Tobacco and Cancer: Recent Epidemiological Evidence. Journal of the National Cancer Institute, 96(2), 99- 106. Doi:10.1093/jnci/djh014 http://jnci.oxfordjournals.org/content/96/2/99.short
4. McKee BJ, Hashim JA, French RJ, et al. Experience with a CT Screening Program for Individuals at High Risk for Developing Lung Cancer. Journal of the American College of Radiology : JACR. 2014

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The comment below was sent to CMS with 2500 comments from the public. These comments contained Protected Health Information and therefore will not be posted.

December 10, 2014

Tamara Syrek Jensen, JD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mail Stop: S3-02-01 7500 Security Blvd. Baltimore, MD 21244

Re: Screening for Lung Cancer with Low Dose Computed Tomogr aphy (LDCT) (CAG-00439N)

Dear Ms. Jensen:

In addition to the American Lung Association's formal comments, which were also officially submitted to CMS today as well, the Lung Association is pleased to submit the 2,502 comments filed by our volunteers and e-advocates in support of Medicare coverage for low-dose CT screening for individuals at high-risk for developing lung cancer.

While most of these comments are identical as they were in response to the American Lung Association's call to action, we note many advocates took the time to personalize their comments and to share their personal stories as to why coverage for screening for individuals at high risk for developing lung cancer is so important.

One woman shared that she lost her husband to lung cancer and wonders if his life would have been saved had this screening had been in place before;

Another person shared that a loved one is fighting a battle against stage IV lung cancer.

On behalf of the Americans who are battling lung cancer, the American Lung Association thanks CMS for its thoughtful consideration of all of these comments and urges that a final decision be made by the original deadline so that individuals who meet the guidelines for annual lung cancer screenings can begin to receive this preventive treatment in February, 2015 with no cost-sharing.

Sincerely,

Paul G. Billings
Senior Vice President, Advocacy and Education

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December 10, 2014

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Syrek Jensen:

On behalf of AstraZeneca, I am pleased to submit these comments on the Centers for Medicare & Medicaid Services' (CMS's) proposed decision memorandum on screening for lung cancer with low dose computed tomography (LDCT) (the Proposed Decision).¹ AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, rheumatologic, autoimmune, oncology, infectious, and neurological diseases.

AstraZeneca is committed to developing new therapies for lung cancer, and we support initiatives aimed at improving the diagnosis, management, and treatment for individuals affected by this condition, including CMS's efforts to expand access to screening. We commend CMS for proposing to cover a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with LDCT, once per year. CMS proposes to cover these services for beneficiaries who satisfy the following criteria:

• Are 55-74 years in age;
• Are asymptomatic (no signs or symptoms of lung disease);
• Have a tobacco smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
• Are a current smoker or have quit smoking within the last 15 years; and
• Have a written order for LDCT lung cancer screening that meets specific criteria.²

CMS also proposes requirements for the screening and shared decision making visit, including "the use of one or more decision aids, to include benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure" and "counseling on the importance of adherence to annual LDCT lung cancer screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment." Finally, CMS proposes eligibility criteria for radiologists and radiology imaging centers that perform LDCT, which include a requirement that screening facilities submit specific data elements to a CMS-approved national registry.

In order to ensure that this service is available to all beneficiaries for whom screening would improve their health outcomes, we recommend that CMS expand the beneficiary age limit to 80 years old, carefully review the radiology imaging center criteria, design the registry to make it as easy as possible for imaging centers to participate, and take steps to ensure that a registry is approved upon issuance of the final decision.

I. CMS should expand the eligible patient population to include beneficiaries up to age 80 and consider allowing screening for patients with signs and symptoms of lung disease.

Although the United States Preventive Services Task Force (USPSTF) recommended that patients be screened up to age 80,³ CMS proposes to cover a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with LDCT, once per year for beneficiaries age 55 to 74 years only. We urge CMS to reconsider its decision and to cover screening for beneficiaries up to age 80, as supported by the USPSTF, the American Association for Thoracic Surgery (AATS), and the National Comprehensive Cancer Network (NCCN) Guidelines. The AATS recommendation, summarized in the Proposed Decision, supports screening with LDCT for high-risk patients aged 55 to 79 years. The current NCCN Guidelines recognize that screening "may benefit older patients who are 75 to 84 years old."⁴ These Guidelines conclude, "annual LDCT seems reasonable for select high risk patients older than age 74 years who are eligible for definitive treatment, generally defined as curative intent therapy (e.g., surgery, chemoradiation, stereotactic body radiation therapy [SBRT])."⁵ AstraZeneca supports this approach because we are hopeful that new therapies will become available for older patients, and as they do, these patients should be able to receive screening to identify their treatable cancers. Through use of up-to-date decision aids during the counseling and shared decision making visit, physicians and patients will be able to determine whether screening and potential treatments would be appropriate for each patient, taking into account age, comorbidities, and other factors.

We also are concerned that the requirement for patients to have "no signs or symptoms of lung disease" has the potential to render many beneficiaries ineligible for screening with no assurance that they will receive necessary diagnostic services for lung cancer diagnosis. The signs and symptoms of many lung diseases, including persistent cough, chest pain, and weight loss, can also be signs and symptoms of lung cancer. Patients who are known to have another lung disease might not receive appropriate testing for lung cancer because their physicians attribute their symptoms to the other disease. We recommend that CMS cover LDCT for beneficiaries with these signs and symptoms if they have not already received a chest CT that year.

II. CMS should review the proposed eligibility criteria for imaging centers carefully to ensure that they do not limit access to LDCT screening.

CMS proposes to require that each imaging center that performs LDCT screening meet certain criteria, including participation in past lung cancer screening trials, such as the National Lung Screening Trial (NLST), or being an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. This requirement would limit access to centers that currently provide LDCT lung cancer screening or that participated in the trial, and would not allow new centers to qualify. This could result in LDCT screening being offered by only a small number of facilities, and could deny access to this service for beneficiaries in rural and underserved areas. We urge CMS to review the criteria carefully and consider alternative approaches that would allow additional centers to qualify to provide LDCT screening.

III. CMS should take steps to ensure that the data reporting requirements impose minimal burdens on providers and that a registry is approved at the time the final decision is issued.

Finally, CMS proposes that imaging centers "must collect and submit data to a CMSapproved national registry for each LDCT lung cancer screening performed." The proposed data elements include not only information available at the time of the scan, such as the patient's date of birth, gender, race/ethnicity, and smoking status; the machine used, the radiation dose, and exam results, but also information that would only be available over time and from other providers, such as lung cancer incidence within one year and health outcomes. By requiring data from other practitioners and providers, CMS increases the burden imposed by the registry and makes it more complicated for imaging centers to comply with its requirements. We urge CMS to make the data collection requirements as simple as possible for providers to ensure that it does not discourage access to LDCT screening and that stakeholders are able to establish a registry in time for beneficiaries to receive the service upon issuance of the final decision. We also urge CMS to work with stakeholders to identify suitable registries and approve at least one registry at the time the final decision is released.

AstraZeneca thanks you for the opportunity to comment as CMS further develops its strategies for chronic care management, quality improvement, and transparency. If you have any further questions or would like any additional information on these or any other related topics, please contact me at 202-350-5542 or via email at Christine.Bloomquist@astrazeneca.com.

Sincerely,

Christine Bloomquist
Head of Policy & Executive Branch Advocacy
AstraZeneca Pharmaceuticals LP

1 Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N), Nov. 10, 2014, http://www.cms.gov/medicarecoverage- database/details/nca-proposed-decisionmemo.aspx?NCAId=274&bc=ACAAAAAAAgAAAA%3d%3d& ("Proposed Decision").
2 Proposed Decision.
3 USPSTF, Final Recommendation Statement: Lung Cancer Screening, http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatement Final/lung-cancer-screening.
4 NCCN Clinical Practice Guidelines in Oncology (NCCN GuidelinesR): Lung Cancer Screening, v. 1.2015, http://www.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf ("NCCN Guidelines"). 5 NCCN Guidelines at MS-10.

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8 December 2014

Tamara S. Syrek Jensen, J.D.
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C 1-0-06
7500 Security Boulevard
Baltimore, MD 21224

By Online Submission

Re: National Coverage Analysis for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N)

Dear Ms. Syrek Jensen:

On behalf of the DeCesaris Cancer Institute, Anne Arundel Medical Center (DCI), we are grateful for the opportunity to comment on the recently proposed National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). We strongly believe that the Centers for Medicare and Medicaid's (CMS) proposed decision to provide coverage for lung cancer screening will provide a significant benefit to our high risk population and in our battle against lung cancer overall. We also believe that all screening programs should adhere to evidencebased protocols and guidelines to ensure the provision of high quality care.

While we agree overall with CMS' proposed decision, we would like to respectfully make a few comments as follows:

We are in agreement with the statements written by the Lung Cancer Alliance, The Society of Thoracic Surgeons and The American College of Radiology that

• The median age of diagnosis of lung cancer is 70 years and a cutoff of 74 would exclude a large portion of the population who would benefit from this screening
• The USPSTF used a complex mathematical modeling system to justify this age range for patients otherwise eligible for LDCT screening
• Additionally, this would ensure uniformity across governmental agencies and decrease confusion amongst health care providers and patients

There is no evidence that the risk for lung cancer drops off significantly after 15 years of abstinence. While this 15 year period was part of the NLST inclusion criteria, we believe that not screening patients who have been abstinent for longer than 15 years would miss the opportunity to diagnose early lung cancers in these high risk patients. Limiting screening to the 15-year cut off may also incentivize smoking behavior for patients to remain eligible for lung cancer screening.

As put forth by the NLST authors, USPSTF recommendations, and others, screening is only a portion of the dedicated effort necessary to achieve positive results with lung cancer screening.

The DeCesaris Cancer Institute, Anne Arundel Medical Center is grateful to CMS for their comprehensive review of the evidence related to lung cancer screening and for the opportunity to voice our opinion prior to the final decision. We are confident that high quality lung cancer screening programs will positively impact our high risk patient population and we look forward to an ongoing partnership with CMS to provide fair and equitable coverage.

Sincerely,

Catherine Brady-Copertino, BSN, MS, OCN
Executive Director
DeCesaris Cancer Institute

Stephen Cattaneo, MD
Medical Director, Thoracic Oncology

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December 10, 2014

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Syrek Jensen:

The Association of Community Cancer Centers (ACCC) appreciates this opportunity to comment on the proposed decision memorandum on screening for lung cancer with low dose computed tomography (LDCT) (the Proposed Decision) issued by the Centers for Medicare & Medicaid Services' (CMS).¹ As a membership organization, ACCC's members include hospitals, physicians, nurses, social workers, and oncology team members who care for millions of patients and families fighting cancer. ACCC represents more than 18,000 cancer care professionals from approximately 900 hospitals and more than 1,200 private practices nationwide. These include Cancer Program Members, Individual Members, and members from 28 state oncology societies. Approximately sixty percent of cancer patients nationwide are treated by a member of ACCC. ACCC works on behalf of its members to preserve and protect the entire continuum of quality cancer care for our patients and our communities.

According to the Centers for Disease Control and Prevention, lung cancer is the leading cause of cancer death as well as the second most common cancer in the United States.² Further, according to Surveillance, Epidemiology, and End Results Program data from 2007-2011 available on the National Cancer Institute (NCI) website, nearly 60% of new cases are diagnosed between the ages of 65 and 84, with a median age of diagnosis of 70 years.³ As such, the Medicare population is particularly afflicted by this disease, and thus we strongly support CMS's efforts to expand access to the lifesaving benefit of lung cancer screening.

We applaud CMS for its proposal to cover a lung cancer screening counseling and shared decision making visit, and for appropriate Medicare beneficiaries, screening for lung cancer with LDCT, once per year, as an additional preventative service benefit under Medicare. In order to qualify for this benefit, Medicare beneficiaries must meet specific criteria, which include the following:

• Age 55-74 years;
• Asymptomatic (no signs or symptoms of lung disease);
• Tobacco smoking history of at least 30 pack years (one pack-year is equivalent to one pack per day for one year, and one pack is equivalent to 20 cigarettes);
• Current smoker or one who has quit smoking within the last 15 years; and
• Having a written order for LDCT lung cancer screening that meets certain specified criteria.⁴

In the Proposed Decision, CMS proposes requirements for the screening counseling and shared decision making visit. The visit requirements include assessing the beneficiary's risk factors; using decision aids that address benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure; and counseling beneficiaries on the importance of not smoking, the importance of adherence to annual LDCT lung cancer screening, the impact of comorbidities, and ability or willingness to undergo diagnosis and treatment. When appropriate, a written order for lung cancer screening with LDCT should be furnished during the visit. CMS also sets forth proposed eligibility criteria for radiologists and radiology imaging center offering these services.

While we applaud CMS's efforts to make this benefit accessible to Medicare beneficiaries, we encourage CMS to make certain modifications to its proposal before finalizing it. In particular, CMS should:

1. Expand the beneficiary age limit to 80 years old;
2. Revise eligibility criteria for radiologists to ensure Medicare beneficiary access to LDCT lung cancer screenings;
3. Revise the radiology imaging center criteria to allow screening at centers designated by the American College of Radiology (ACR) as Lung Cancer Screening Centers;
4. Ensure that the registry is minimally burdensome on providers and that a registry is operational in a timely manner upon issuance of the final decision; and
5. Clarify how proposed data collection requirements relate to CMS's recently issued final guidance on Coverage with Evidence Development (CED) to help ensure that CED is used in a predictable and transparent manner.

We address each of these items in additional detail below.

CMS proposes to cover a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with LDCT once per year for beneficiaries age 55 to 74 years only. We urge CMS to expand its proposed coverage of this benefit to beneficiaries up to age 80 to align with the recommendations of other important stakeholders. In particular, we note that the United States Preventative Services Task Force (USPSTF) recommends that patients be screened up to age 80.⁵ The American Association for Thoracic Surgery (AATS) similarly supports screening with LDCT for high-risk patients aged 55 to 79 years,⁶ and the current National Comprehensive Cancer Network (NCCN) guidelines, which support screening for patients age 50 or older with a smoking history of at least 20 pack-years and one additional risk factor other than second-hand smoke, provide that "screening may benefit older patients who are 75 to 84 years old" and note that "annual LDCT seems reasonable for select high risk patients older than age 74 years who are eligible for definitive treatment, generally defined as curative intent therapy."⁷

Thus, USPSTF, AATS, and NCCN are all in agreement that these screenings may benefit patients up to age 80. We urge CMS to expand the patient population eligible for these visits to include patients up to age 80, both to align with the recommendations of UPSTF, AATS, and NCCN and also to ensure that, as Medicare beneficiaries age, they can still benefit from the opportunity to receive screening and identify treatable cancers.

II. CMS should revise eligibility criteria for radiologists to ensure Medicare beneficiaries have appropriate access to LDCT screening.

CMS's Proposed Decision specifies certain eligibility criteria that radiologists must satisfy for purposes of Medicare coverage of lung cancer LDCT screening. These include a requirement that a radiologist must have "involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years."⁸ We believe that this requirement may unduly restrict access to these screening services, and we believe that the requirement for ACR Lung Cancer Screening Center designation for interpreting physicians to have performed 200 chest CT scans within the prior 36 months would be more appropriate. ACR's requirement would strike a better balance between ensuring that a sufficient number of radiologists are available to safeguard beneficiary access to this service, particularly in underserved and rural communities, and ensuring that physicians providing this service have adequate experience.

III. To ensure Medicare beneficiary access to LDCT screening, CMS should revise the radiology imaging center criteria to allow screening at centers designated by the ACR as Lung Cancer Screening Centers.

CMS's Proposed Decision also sets forth certain eligibility criteria that radiology imaging centers must satisfy for purposes of Medicare coverage of lung cancer LDCT screening. ACCC is concerned that the proposed criteria will make it difficult for new centers to qualify for providing these services.

The proposed criteria include a requirement that a center must have participated in past lung cancer screening trials, such as the National Lung Screening Trial, or must be an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. This requirement will render eligible only the small number of centers that either participated in the trial or currently provide LDCT lung cancer screening, and beneficiaries in rural and underserved areas may be denied access to this important service. We therefore urge CMS to re-evaluate the radiology imaging center criteria to help safeguard access to LDCT screenings for a broad range of Medicare beneficiaries. We suggest that CMS require centers to obtain ACR Lung Cancer Screening Center designation instead of fulfilling the proposed criterion. The ACR Lung Cancer Screening Center designation identifies accredited centers that satisfy specific criteria, including technical specifications and review of the center's protocol, that help to ensure the quality of LDCT services provided.⁹

IV. CMS should ensure that the registry's data reporting requirements are minimally burdensome on providers and that a registry is operational in a timely manner upon issuance of the final decision.

CMS's proposed eligibility criteria for radiology imaging centers includes that the imaging centers "must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed." The data collected must include, at minimum, certain elements. Some of these elements, such as patient's date of birth and gender and information about the machine used, are available at the time of the screening. However, certain other required data elements, such as diagnostic follow-up of abnormal findings within one year, lung cancer incidence within one year and health outcomes, will not be available at the time of the initial screening but rather must be collected over time and will require participation of other practitioners and providers, including radiologists surgeons, oncologists, and hospitals. Requirements that necessitate collecting data from other providers render the data reporting requirements more burdensome for reporting providers and may hinder efforts to establish a suitable registry.

We encourage CMS to narrow the registry's data reporting requirements to only those data elements addressing the scan provided and the findings from the scan. This will help to ensure that data collection requirements are minimally burdensome on providers and that beneficiaries have access to these screenings. In addition, simplifying the data reporting requirements will help stakeholders to establish a registry more quickly, which, in turn, increases the likelihood that beneficiaries will be able to receive the service upon issuance of the final decision. We encourage CMS to collaborate with stakeholders both to identify suitable registries and, prior to release of the final decision, to approve at least one registry.

V. CMS should clarify how proposed data collection requirements relate to CMS's recently issued final guidance on CED to ensure that CED is used in a predictable and transparent manner.

In the Proposed Decision, CMS does not refer to CED or any of the statutory authorities or principles and standards that CMS has established for use of CED. However, the Proposed Decision requires collection of extensive data elements through the use of a registry, which is similar to requirements established under CMS's recent guidance document and other national coverage determinations (NCDs) that use CED.¹⁰ If finalized, we believe that the Proposed Decision would effectively constitute CED as described in recently issued CMS guidance, although CMS identifies a different statutory authority for this Proposed Decision than for CED.

CMS's recently issued CED guidance describes how two distinct forms of CED have historically been employed by CMS. Specifically, CMS uses CED under Social Security Act 1862(a)(1)(A) for the collection of evidence to confirm that appropriate beneficiaries receive an item or service that has been determined to be reasonable and necessary. CMS uses CED under §1862(a)(1)(E) for the collection of data to support a future determination that an item or service is reasonable and necessary.

The Proposed Decision concludes that the evidence is sufficient to determine that lung cancer screening is reasonable and necessary, yet, in contrast to the approach to CED described in the guidance document for items and services that CMS has found to be reasonable and necessary, the Proposed Decision also includes a requirement to collect a variety of data elements, including diagnostic follow-up and outcomes data, for "post coverage analysis." These data will be used to "best establish duration and the cumulative limit in the number of LDCT screens, as well as inform, if appropriate, modifications to Medicare coverage."

The Proposed Decision's data collection requirements thus include components that are generally only collected for the form of CED used for items and services lacking data to support a conclusion that they are reasonable necessary. The collection of these data elements is inconsistent with the agency's determination that current evidence is sufficient to establish that lung cancer screening is reasonable and necessary. We note in Section IV, above, that these additional data elements will be burdensome for providers, and, in light of the conclusion that clinical evidence is sufficient to warrant coverage, collection of these additional data elements is also unnecessary.

It is critical that CED be used in a predictable and transparent manner. To help ensure that the same principles apply to all coverage determinations that require collection of data, regardless of whether CMS labels that requirement "CED," CMS should clarify how data collection requirements in the Proposed Decision relate to similar requirements in the guidance document CED and other NCDs. In addition, to minimize confusion among stakeholders, CMS should explicitly refer to CED and related guidance and principles when proposing coverage along with data collection.

Thank you again for the opportunity to share our comments on this Proposed Decision. If you have any questions or we can be of assistance as CMS works to finalize this decision, please contact Leah Ralph, Manager, Provider Economics and Public Policy, at 301-984-5071.

Respectfully submitted,

Becky L. DeKay
President
Association of Community Cancer Centers (ACCC)

1 Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N), Nov. 10, 2014, http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274&bc=ACAAAAAAAgAAAA%3d%3d& ("Proposed Decision").
2 Centers for Disease Control and Prevention, Lung Cancer, available at http://www.cdc.gov/cancer/lung/.
3 National Cancer Institute: SEER State Fact Sheets: Lung and Bronchus Cancer, available at http://seer.cancer.gov/statfacts/html/lungb.html.
4 Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) (Nov. 10, 2014), available at http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274 (“Proposed Decision”).
5 USPSTF, Final Recommendation Statement: Lung Cancer Screening, http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening
6 Jaklitsch 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, 144(1) Journal of Thoracic and Cardiovascular Surgery 33-8 (July 2012), available at http://aats.org/multimedia/files/Guidelines/Lung-Cancer-Screening-Using-low-dose-computed-tomography-scans.pdf.
7 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines R): Lung Cancer Screening, v. 1.2015, http://www.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf ("NCCN Guidelines").
8 ACR Designated Lung Cancer Screening Center Attestation Form, http://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Lung%20Screening/Lung%20Cancer%20Screening%20Center%20Attestation%20Form.pdf
9 ACR Lung Cancer Screening Center, http://www.acr.org/Quality-Safety/Lung-Cancer-Screening-Center.
10 CMS, Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development (Nov. 20, 2014), http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27.

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December 10, 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

Comments to CMS Proposed Coverage Decision for Lung Cancer Chest CT screening (CAG-00439N)

Ms. Syrek Jensen:

The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) are the largest societies representing pulmonary physicians, scientists, thoracic surgeons and radiologists, with approximately 34,000 members combined. Both organizations have developed evidence-based guidelines related to the prevention, diagnosis and treatment of lung cancer and these guidelines have been implemented globally.

We would like to commend CMS for a thoughtful and rational coverage decision regarding lung cancer chest CT screening. We are pleased that CMS not only recognizes the potential benefits of lung cancer screening and also shares our concerns with the substantial potential risks of widespread implementation of this technology. The proposed coverage decision will help to ensure that screening will be implemented in ways that maximize the benefits while minimizing the risks.

Our detailed review of the coverage decision has identified a few discrete areas that merit consideration in the drafting of a final coverage decision.

1. Multidisciplinary Management of Lung Cancer Screening Patients:

Lung cancer screening is not solely an imaging test; it is a process that should take place within an organized program. We suggest that the final coverage decision provide additional guidance with regards to the essential components of lung cancer screening programs that can effectively provide excellence in all aspects of screening: imaging, reporting, follow-up, prevention, and treatment.

In a recently published joint society policy statement (Mazzone et al, (1)) we outline the components of lung cancer screening programs that can influence the balance of benefit and harms. We provide policy statements that focus on multidisciplinary management of patients with high risk nodules detected on screening examinations. We think more focus is needed on 1. the requirement for defined management algorithms that can help to minimize excessive diagnostic testing, and 2. the development of quality metrics that can monitor and maintain appropriate standards for the true amount of radiation screened individuals are subjected to, as mentioned above.

Specifically, we list below the policy statement on lung nodule management algorithms:

A lung cancer screening 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, non-surgical 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 data related to the use of, and outcomes from, surveillance and diagnostic imaging, surgical and non-surgical biopsies for the management of screen detected lung nodules.

The proposed coverage decision's requirement for registry reporting addresses Policy Statements #5 and 6, but we strongly suggest that the final decision emphasize the requirement for all listed components to ensure that the screening process is optimized for patients with high risk nodules.

2. Compliance with Eligibility Criteria

The objective of lung cancer screening programs is to identify a group at high enough risk of developing lung cancer to benefit more than they are harmed. The balance with this choice is that more lives can be saved by screening at lower thresholds of risk, but the relative harms of screening increase as the threshold is lowered. We are in general agreement with the eligibility criteria suggested in the proposed coverage decision. We acknowledge the inherent challenges in determining the ideal balance of benefit and harm as the value of the benefit and harms is not equal, and varies with patient preferences.

To optimize outcomes in screened patients regardless of the final eligibility criteria, it is critical for participating programs to adhere to the specified eligibility criteria. Our policy statement suggests that for qualification as a lung cancer screening facility at least 90% of all screened subjects must match the lung cancer screening program's policy, excluding those enrolled in clinical trials.gov registered NIH, CDC, AHRQ, CMS, DOD, VA, and PCORI funded screening research protocols.

3. Shared Decision Making

Our societies have previously endorsed the importance of shared decision making for lung cancer screening (1, 2) and we applaud the CMS for also emphasizing its importance. We would like to make two changes to the current decision.

First, we suggest that this shared decision making visit could be performed by either the clinician ordering the screening CT or trained staff at the screening center, as currently endorsed in our recent statement with the American College of Chest Physicians (1). Trained staffs do not need to be physicians or qualified non-physician practitioners. A recent systematic review of shared decision making interventions did not find substantial differences in the efficacy of the intervention when delivered by non-physician staff (3). Furthermore, the VA has found that a nurse-driven, shared-decision making discussion is beneficial for veterans considering lung cancer screening (4) and we would expect similar benefits in non-veteran populations.

Thus, we suggest editing the text of the coverage decision as follows:

• A lung cancer screening counseling and shared decision making visit (conducted by a physician, qualified non-physician practitioner, or trained clinical staff) includes the following elements (and is appropriately documented in the beneficiary's medical records):

Secondly, as also reported in the systematic review of shared decision making interventions, there are no data regarding the efficacy of decision aids for people considering lung cancer screening (3). Even when studied in other cancer screening settings, there is a low strength of evidence that interventions improve decision quality. Indeed, the authors of this review state, "While shared decision making is widely viewed as an important patient-centered approach to preference-sensitive decisions, current evidence does not clearly demonstrate that studied approaches have consistent effects beyond increasing patient knowledge".

We have previously recommended that performance measures be based on at least moderate quality evidence (5). Given the lack of evidence for a specific approach to shared decision making among people considering lung cancer screening, we suggest the use of a decision aid be voluntary rather than a requirement.

We think that the term "overdiagnosis" is not useful in a clinical setting (6). Overdiagnosis is an epidemiological term that can only be assessed in retrospect for a population. We fully agree that it is important for clinicians and patients to recognize the fact that there is a spectrum of aggressiveness and that screening identifies a greater proportion of cancers with low aggressiveness. We suggest that the conversation between clinicians and screened individuals is better served with terms such as lung cancers that are "non-aggressive" or "indolent", and cancers that have "low-aggressiveness".

We therefore suggest that for the bullet point on shared decision-making, the term "over-diagnosis" be replaced by "detection of an increased proportion of non-aggressive lung cancers." We think this is important to provide greater understanding and allow judicious management, and prevent potentially increased harms in the management of detected nodules.

We suggest editing the text of the coverage decision as follows:

• Shared decision making, to include discussion of benefits, harms, follow-up diagnostic testing, detection of an increased proportion of non-aggressive lung cancers, false positive rate, and total radiation exposure;

4. Screening of Healthy Individuals

We agree in principle with the proposed coverage decision stipulation that screened individuals be "asymptomatic" as screening is (by its definition) for individuals without symptoms of the screened disease. However, as written, the term "asymptomatic' is not sufficiently specific and can be interpreted in a manner that will exclude subjects who can and will benefit from screening. For example, exertional dyspnea and stable cough are common among smokers without cancer but varies greatly from mild limitations in exercise capacity to inability to carry out activities of daily living. Between these two extremes lies a large population at high risk for lung cancer but very capable of undergoing appropriate lung cancer diagnosis, staging and treatment. We recommend that CMS consider revising the text to restrict screening to those without symptoms of lung cancer using more specific terms.

For example: Beneficiary eligibility criteria:

"Individuals offered screening should be without signs and symptoms of lung cancer such as hemoptysis, unexplained weight loss, significant dyspnea that limits activities of daily living, or other symptoms suggestive of the presence of malignancy. Individuals with co-morbid illness should be assessed for the ability to undergo diagnosis, staging and treatment interventions prior to offering screening.

Screening for lung cancer should be done in individuals who are otherwise healthy. An issue here is one of competing causes of death. If the likelihood of a lung cancer death is overshadowed by a high risk of other causes of death, screening for lung cancer is not likely to be effective. This is particularly important in the Medicare population. The NLST and all other lung cancer screening trials excluded patients with significant co-morbidities.

We recognize that CMS has addressed other issues that would stand in the way of realizing a benefit from screening, such as the ability or willingness to undergo treatment. However, this is a different matter than co-morbidities that would affect the relative risk of death from lung cancer.

We recognize that tools to define this are currently lacking, and that it must depend on the clinicians' judgment. We also recognize that therefore, this is a metric that must rely on clinicians self-reporting and cannot (at present) be corroborated.

However, we think it is important to draw attention to this matter, and require clinicians to stop and think about it with each patient that is screened.

5. Radiation dose requirement

We think the requirement suggested that every LDCT be < 1.5 mSv may be overly restrictive. There are situations (e.g. large body habitus) that may render this target impossible to achieve. We suggest that the statement be modified to allow for a radiation dose requirement to "average of 1.5 mSv" or "≤ 1.5 mSv in the large majority of patients".

6. Multi-Society, Multi-Disciplinary Governance

The components of lung cancer screening programs outlined above demonstrate the multi-disciplinary nature of the expertise required to develop and maintain a high quality screening program. In addition, many of the components of a successful screening program will be optimized over time by incorporating knowledge gained through research. We propose the following policy statements regarding governance be considered for the implementation of coverage for lung cancer screening.

1. A multi-society, multi-disciplinary governance structure should be developed and supported in order to advance quality standards based on evolving evidence, administer an expanded credentialing system, and suggest research priorities.
2. At a minimum, the multi-society governance should oversee the evolution of structured reporting; nodule management algorithms; the structure, maintenance, and integrity of a lung cancer screening registry; the research conducted on the registry; and research that would help to define the criteria for screening eligibility.

We hope these joint comments submitted by the ATS and CHEST are insightful. We look forward to working with CMS to implement the final lung cancer screening benefit.

Sincerely,

Thomas Ferkol, MD
President
American Thoracic Society

Curtis N. Sessler, MD FCCP
President
CHEST

References

1. Mazzone P, Powell CA, Arenberg D, Bach P, Detterbeck F, Gould M, Jaklitsch MT, Jett J, Naidich D, Vachani A, Wiener RS, Silvestri G. Components Necessary for High Quality Lung Cancer Screening: American College of Chest Physicians and American Thoracic Society Policy Statement. Chest 2014.
2. Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. Jama 2012; 307: 2418-2429.
3. Lillie SE, Partin MR, Rice K, Fabbrini AE, Greer NL, Patel S, MacDonald R, Rutks I, Wilt TJ. The Effects of Shared Decision Making on Cancer Screening - A Systematic Review. VA ESP Project #09-009 2014.
4. Kinsinger LS, Atkins D, Provenzale D, Anderson C, Petzel R. Implementation of a New Screening Recommendation in Health Care: The Veterans Health Administration's Approach to Lung Cancer ScreeningImplementation of a New Screening Recommendation in Health Care. Annals of Internal Medicine 2014; 161: 597-598.
5. Kahn JM, Gould MK, Krishnan JA, Wilson KC, Au DH, Cooke CR, Douglas IS, Feemster LC, Mularski RA, Slatore CG, Renda Soylemez W. An official american thoracic society workshop report: developing performance measures from clinical practice guidelines. Ann Am Thorac Soc 2014; 11: S186-195.
6. Detterbeck FC. Cancer, concepts, cohorts and complexity: avoiding oversimplification of overdiagnosis. Thorax 2012; 67: 842-845.

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Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality
Director, Coverage and Analysis Group
ATTN: Lung Cancer LDCT Screening
Mail Stop: S3-02-01
7500 Security Blvd.
Baltimore, MD21244
Sent via email to caginquiries@cms.hhs.gov

Re: CMS Decision Memo on Medicare Lung Cancer Screening Coverage

We are writing as Principal Investigators of the occupational medical screening programs funded under the US Department of Energy’s Former Worker Program (FWP; http://energy.gov/ehss/services/worker-health-and-safety/former-worker-medical-screening-program).  

The FWP infrastructure consists of four designated regional projects located near major DOE sites, as well as two nationwide projects.

• The regional projects include:
  • Pantex Former Worker Program, conducted by Drexel University in conjunction with The University of Texas Health Sciences Center at Tyler and West Texas A & M Partners Clinic
  • Medical Exam Program for Former Workers from Los Alamos and Sandia (NM) National Laboratories conducted by Johns Hopkins Bloomberg School of Public Health in conjunction with the University of New Mexico
  • Worker Health Protection Program conducted jointly by Queens College of the City University of New York, United Steelworkers, the Atomic Trades and Labor Council in Oak Ridge, and the former Fernald Atomic Trades and Labor Council
  • Former Worker Medical Screening Program for Line 1/Division B Iowa Army Ammunition Plant and Ames Laboratory conducted by The University of Iowa College of Public Health
• The two nationwide projects include:
  • The National Supplemental Screening Program, conducted by Oak Ridge Associated Universities in conjunction with National Jewish Health, Comprehensive Health Services, Axion Health, and the University of Colorado Denver
  • The Building Trades National Medical Screening Program, conducted by CPWR - The Center for Construction Research and Training in conjunction with the University of Cincinnati Medical Center, Duke University Medical Center, and Zenith American Solutions, Inc.

These medical screening programs have delivered over 100,000 occupational screening exams and more than 15,000 early lung cancer screenings using low dose CT (LDCT).   Based on our experience we would like to offer some suggestions for how the proposed Medicare rules can be improved.

Eligibility Criteria
The eligibility criteria are too restrictive. The current draft relies on the NLST design to define eligibility and fails to recognize that the ELCD field has gone through significant development and improvement since NLST was completed in 2010, including new, sophisticated clinical guidelines (such as NCCN), and review by USPSTF.

 We suggest the following changes to eligibility:

• For smokers with no other risk factors: age 55-79; 30 pack-years; less than 15 years since last smoked.  The increase in the upper age limit to 79 is consistent with USPSTF
• For individuals with a history of smoking and at least one of the following additional lung cancer risk factors:  radon exposure; occupational exposure(as defined by NCCN); cancer history (as defined by NCCN); family history of lung cancer; COPD or pulmonary fibrosis: age 50-79, 20 pack years; no restriction on time since last smoked
• For individuals with exposures to any of the additional risk factors referred above and CXR parenchymal/fibrosis finding (≥1/0): age 50-79; no requirement to have smoked.

Definition of Asymptomatic
The definition of asymptomatic is not adequate.  The rule simply says “no lung disease” but does not specify what is meant by “lung disease.”  The definition as proposed could exclude individuals with COPD, a high risk group both because of the underlying disease itself and the likely heavy smoking that led to COPD.  We suggest the following change

Individuals must have sufficient lung function to tolerate surgical intervention. This is consistent with NCCN.

Clarify the Screening Process
To make the proposal more easily understood, CMS should describe the screening process in three distinct stages: (1) counseling and shared decision-making; (2) LDCT screening; (3) multi-disciplinary evaluation of screening findings and follow-up planning; and (4) data entry into a registry.

Counseling and Shared Decision-making
The proposed requirements for counseling and shared decision-making are insufficiently developed. 

We think the procedures recommended by the NCCN provide a useful guide.  See

http://www.nccn.org/patients/guidelines/lung_screening/

Annual Order
The current draft requires a doctor’s order following a counseling and shared decision-making visit for each annual LDCT screening.  We think it is sufficient to require this for the first (baseline exam); having to do this again for each subsequent annual exam is redundant as long as the beneficiary goes to the same LDCT screening provider. 

Multi-disciplinary Evaluation and Follow-up Planning
We think the second stage LDCT screening is insufficiently developed.  The proposed definition focuses on the CT technique and the radiologist’s qualification, which is sufficient to interpret the scan but not necessarily to plan follow-up care.  Assuring continuity from radiological revaluation through treatment is important to assure optimal outcomes.   Therefore, CMS should consider adding a requirement that screening be tied to a lung cancer center of excellence, such as those recommended by the Lung Cancer Alliance:

• Multidisciplinary review of suspicious radiology findings (radiology, pulmonology, thoracic surgery, oncology)
• Plan for systematic and coordinated referral for treatment
• Smoking cessation plan.

Registry Requirements
Registry requirements are not sufficiently developed to meaningfully comment on.  The draft seems to expect that the CT radiologist will have to report data to which he or she has no access, such as pathology and death reports.   We ask that CMS consider the following questions:

• What are the objectives and planned uses of the registry?  Is CMS planning to use the data for auditing or other administrative purposes?
• What are the requirements for administering a registry?
• How does CMS plan to solicit for and approve registries?

Thank you for your consideration of these suggestions.

Sincerely,

Knut Ringen, DrPH, MHA, MPH
Laura Welch, MD
Building Trades National Medical Screening Program, conducted by CPWR - The Center for Construction Research and Training in conjunction with the University of Cincinnati Medical Center, Duke University Medical Center, and Zenith American Solutions, Inc.
http://www.btmed.org/default.cfm
1-800-866-9663

Laurence Fuortes, MD, MS
Former Worker Medical Screening Program for Line 1/Division B Iowa Army Ammunition Plant and Ames Laboratory conducted by The University of Iowa College of Public Health
http://www.iowafwp.org
1-866-282-5818

Brian S. Schwartz, MD, MS 
Patrick N. Breysse, PhD, CIH 
Maureen A. Cadorette, RN, PhD 
Medical Exam Program for Former Workers from Los Alamos and Sandia (NM) National Laboratories conducted by Johns Hopkins Bloomberg School of Public Health in conjunction with the University of New Mexico
http://www.jhsph.edu/LANLFW/index.html
1-877-500-8615

Donna Cragle, PhD
John McInerney, MD
Lee Newman, MD, MA
National Supplemental Screening Program, conducted by Oak Ridge Associated Universities in conjunction with National Jewish Health, Comprehensive Health Services, Axion Health, and the Colorado School of Public Health, University of Colorado Denver
http://www.orau.org/nssp/
1-866-812-6703

Arthur Frank, MD, PhD
Pantex Former Worker Program, conducted by Drexel University in conjunction with The University of Texas Health Science Center at Tyler and West Texas A & M University Health Partners Clinic.
1-888-378-8939

Steven Markowitz, MD, DrPH
Lewis Pepper, MD
Worker Health Protection Program conducted jointly by Queens College of the City University of New York, United Steelworkers, the Atomic Trades and Labor Council in Oak Ridge, and the former Fernald Atomic Trades and Labor Council
http://www.worker-health.org/
1-888-241-1199; 1-877-771-7977

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12/9/2014

Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality
Director, Coverage and Analysis Group
ATIN: Lung Cancer LDCT Screening
Mail Stop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

To whom it may concern:
Re: lung cancer screening comments

Kudos to CMS for your recommendation to cover lung cancer screening for Medicare and Medicaid populations. This is a crucial first step in reducing lung cancer deaths.

I am the Cancer Center Director at Hartford Hospital and wanted to share our experience as PI of our lung cancer screening research program at the 5 Hartford HealthCare System Hospitals and to provide our group comments on the draft recommendation.

The 5 hospitals have offered lung cancer screening at no charge since October 2013. Although part of the same health network, these 5 hospitals all have different demographics, different data management systems, and different populations served. Hartford Hospital (HH) located in the city of Hartford is the largest, a regional teaching hospital with 867 beds and a large underserved population. MidState Medical Center, located in Meriden, has 156 beds and is a smaller community hospital. The Hospital of Central Connecticut (HOCC) is a teaching hospital with 229 beds and is also a community hospital. Backus is a not for profit "full service" community hospital with 233 beds in Norwich. Windham Hospital, located in Willimantic is a not-for-profit community hospital and the smallest of this group with 130- beds. Combined the hospitals have performed over 800 LDCT scans with results matching those of the NLST. The purpose of our research is to determine the feasibility of a primary care based model in our community and to assure we are reaching the underserved population through this effort.

We have a physician referral model meaning we require a physician order for a screening. If a patient self refers and does not have a primary care physician, we provide a list to them. We screen both NCCN Group 1 and NCCN Group 2 eligible patients. Our program is based on the Lahey Hospital & Medical Center protocol except we are running it as a study and require informed consent from our participants. We use the Lahey developed LungRADS Lung Imaging Reporting and Data System based on NCCN guidelines for lung cancer screening V.l.2012 criteria and have multi-disciplinary follow-up for all positive findings and for all incidental findings.

Areas we respectfully ask CMS to reconsider for their final recommendation are:

Thank you for your consideration of the Hartford HealthCare Group comments. Please do not hesitate to contact me if you need any more information or need me to clarify something.

Sincerely,

Andrew Salner, MD
Director, Helen & Harry Gray Cancer Center
Pl. HHC lung cancer screening study
Hartford Hospital
Phone number: 860-972-2852
E-Mail: Andrew.Salner@hhchealth.org

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December 10, 2014

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Jensen:

The American Lung Association appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision to cover lung cancer screening with low dose computed tomography (LDCT) as a preventive service benefit under the Medicare program for appropriate beneficiaries.

Lung cancer is the leading cancer killer in the United States and has one of the lowest five-year survival rates of any cancer at 17.8 percent.¹ Lung cancer screening with LDCT is the only procedure proven to reduce lung cancer mortality in individuals at high-risk for lung cancer and does so cost effectively.^2,3 The American Lung Association is confident that secondary prevention in the form of screening to find the disease in an early and curable stage will significantly improve survivability.

For decades, the American Lung Association has led efforts to help smokers quit with our smoking cessation programs and advocacy work in an attempt to prevent lung cancer. We thank CMS for its recognition of the Lung Association work in this area. The American Lung Association supports the requirement of smoking cessation counseling or counseling about the importance of quitting and staying quit prior to obtaining approval for a LDCT scan. Furthermore, the Lung Association concurs with the need for radiologists to be certified by an appropriate professional society and have documented training and experience in interpreting lung cancer CT scans as well as the establishment of a prospective registry to collect standardized data on the entire patient experience.

As such, the Lung Association applauds CMS’ proposed decision to provide LDCT screening to eligible Medicare beneficiaries as a crucial first step in reducing lung cancer deaths. However, the Lung Association respectfully submits the following comments to CMS for consideration in establishing final recommendations. We believe that these modifications will not only improve the implementation of such screening but will remove potential barriers for underserved populations, maximizing the total number of lives saved.

Proposed Modifications
     The most important component of any screening program is the identification of those individuals who would most benefit from the service. Unfortunately, CMS and USPSTF have based their coverage recommendations on the stringent and limited age and smoking history inclusion criteria used in the NLST trial. While appropriate for a clinical trial determining the efficacy of a screening test, the use of such narrow criteria in the real world may not be effective, and as an example, would not include a 65 year-old smoker with a 60-pack-year smoking history and signs of early COPD. Most experts agree that coverage recommendations should be based on risk prediction models that incorporate not only age and smoking history but also health status and the potential risks of diagnostic work-up and treatment.

Age
     It is unclear as to why the decision was made to cover a narrower age range (55-74 years of age) than that recommended by the USPSTF recommendation (55-80 years of age). Studies published since the NLST have shown that LDCT screening in those 75-80 years of age is still cost-effective⁴ and that curative surgical and non-surgical techniques for this age group have demonstrated excellent outcomes with morbidity and mortality comparable with the younger population.⁵ Due to the confusing and complicated nature of screening for both providers and patients, the Lung Association urges CMS to reconsider the age criteria to match that of the USPSTF recommendation (55-80 years of age) as consistency will be important for reducing confusion for providers and patients.

Smoking History
     The Lung Association also believes that excluding patients from coverage once they have quit more than 15 years ago could create a “reverse incentive” encouraging patients to smoke in order to retain eligibility screening benefits. Although not studied in the NLST, the risk of smoking related malignancy is related to total exposure and gradually decreases over time indicating that former smokers remain at significant risk for lung cancer development,⁶ even after quitting. Therefore, the Lung Association urges CMS to support the NLST’s recommendation that once a patient has qualified into a screening program, they are not forced to exit when they reach the 15 year mark of cessation.

No Signs of Lung Disease
     Most concerning is the requirement that Medicare beneficiaries must be "asymptomatic" to currently qualify for screening. This contradicts the benchmarked NLST trial from which lung cancer screening with LDCT was deemed effective in reducing mortality and the current US Preventive Service Task Force (USPSTF) recommendations are based. In all likelihood, this criteria could exclude a significant number of high-risk subjects as a number of studies have clearly associated the degree of airflow obstruction with the risk of developing lung cancer, even when controlling for pack-years of smoking.^7–12 The Lung Association believes that patients with early but mild symptomatic chronic lung diseases, are the ones most in need of intensive counseling to quit tobacco and would benefit from the early detection of lung cancer, curable by surgery or other definitive therapies being tested or developed. We urge CMS to consider at least revising their recommendation to state that patients counselled for tobacco cessation or managed for existing chronic lung diseases such as COPD and pulmonary fibrosis should only be referred for annual LDCT screening if they have sufficient cardio-pulmonary reserve to realize benefit from potential early lung cancer curative procedures and who in the opinion of their physicians, after counseling and discussion, can make an informed-decision that they would benefit from screening for early lung cancer. Such an approach would eliminate those with other progressive systemic illnesses or severe cognitive decline and leave only those who would most benefit from lung cancer screening with LDCT.

Potential Barriers to Access      Lastly, the Lung Association is deeply concerned by two proposed criteria that we feel may lead to unintentional barriers to screening. The first is the requirement that each screen must be preceded by “shared decision making” provider visits. While in agreement that a shared decision-making consultation visit is essential for a first screen, we believe it is inappropriate to continue these requirements for future/subsequent screens. Having a requirement for additional shared decision making visits will most likely add costs, reduce compliance and unnecessarily burdening CMS, patient, provider and health care system. The exception to this is smoking cessation counseling which is extremely important to continue. As such, the Lung Association recommends that a physician order and documentation of shared decision making visit be required upon referral/enrollment in a CT lung screening program and that smoking cessation counseling be conducted in subsequent annual wellness visits as applicable.

     The Lung Association is also very concerned about the stringent criteria being asked of radiology imaging centers interested in accreditation for screening coverage. These criteria, such as being an accredited advanced diagnostic imaging center with significant experience with lung cancer screening with LDCT, may discourage smaller and/or less geographically-centered medical/health systems from “signing up” to offer these preventative services to the Medicare population, especially to those in underserved areas and populations. These marginalized populations (low income, often minority smokers) already lack the ability to access “low-cost, LDCT screening services” (i.e. loss leader) being offered by some regional hospitals/imaging centers and these strict standards would only further preclude this group’s ability to obtain lung cancer screening coverage. Furthermore, these stringent criteria may alienate the “loss leaders” and enable them to continue without concern for standardized screening procedures and reporting which will only contribute to confusion and heterogeneity of the quality of care. Therefore, the Lung Association recommends modifying the first criteria to state “…or an accredited provider of chest CT with training in LDCT lung cancer screening…” This would ensure that smaller and less-geographically centered providers could become accredited and would follow the necessary reporting protocols required by CMS. In addition, we recommend that CMS officials create and maintain a comprehensive list of approved centers and identify gaps and areas that are underserved.

Coverage for Evidence Development and Future Research
Smoking is a major risk factor for lung cancer causing roughly 85-90 percent of cases, but it is not the only risk factor for the disease.¹³ Family history of the disease, occupational exposures, personal history of tobacco related cancer, work in some occupations and industries, prior exposure to high dose ionizing chest radiation, radon exposure, COPD and pulmonary fibrosis have been all shown to increase the risk of lung cancer development. The failure to acknowledge these other risk factors is a clear deficiency in CMS’ proposed coverage determination.

     In October 2011, the National Comprehensive Cancer Network (NCCN) recommended that this group, commonly known as Group 2, be eligible for lung cancer screening.¹⁴ Unfortunately, the NLST was not designed or powered to find significant differences in this group and as such, both the USPSTF and CMS have not included this additional at-risk population in coverage recommendations. The Lung Association recognizes that the findings from the NLST of the efficacy of LDCT screening in reducing lung cancer mortality in one group of high risk patients represents a beginning and by no means defines the only or best selection criteria and technologies that will one day be useful for the early detection of this most deadly of cancers. Yet, as it is highly unlikely that another study like the NLST will be conducted on other at risk populations and the use of LDCT screening, this would be the optimal time for CMS to recommend data collection and coverage with evidence development to better understand other populations that would most benefit from screening with LDCT.

     The Lung Association recommends adding these potential risk factors to the data elements collected in the “to be determined” registry, so that after a certain period of time and subject enrollment, there may be “real-world” data on whether there is the expected higher prevalence and incidence of lung cancer in Group 2, and if so, whether they should be included in a broader community-implemented lung cancer screening population. If coverage with evidence is not recommended in the final coverage determination, there must be some acknowledgement that this group merits additional data collection and no penalties will be applied for those who are responsibly contributing to the field of future knowledge on this secondary high risk patient population.

The Lung Association will continue to advocate for governmental involvement and support for research (translational and clinical) in the field of cancer carcinogenesis, diagnosis and treatment, and specifically urge governmental agencies to be involved in studying best-practices in the implementation of primary and secondary prevention of lung cancers and other tobacco related illnesses.

In summary
     A strategic imperative of the American Lung Association is to “defeat lung cancer” and the organization has great interest in reducing the morbidity and mortality associated with this disease. Provider and patient education is essential to successful LDCT lung screening. Consistent with this goal, and under the auspices of our Scientific Advisory Committee, a Lung Cancer Subcommittee Screening Committee, chaired by Jonathan Samet, MD, MS, was convened to review the current scientific evidence on cancer screening in order to assist the Lung Association in offering the best possible guidance to the public and to those at high risk for lung cancer.

     The Lung Association urges CMS to revise its eligibility criteria to be analogous with those of the USPSTF final recommendations to alleviate confusion among providers and their patients as well as to ensure those most at need for screening get the services. This includes increasing the age range to 80; removing/revising the “asymptomatic” exclusion criteria; allowing individuals who have quit more than 15 years ago but who have been a part of the screening process to continue; and modifying the requirements for shared decision making visits and center accreditation to reduce barriers to patient access. The Lung Association also encourages that whatever inclusion criteria are finally adopted by the CMS, payment for screening with LDCT should allow parallel testing of ancillary technologies (blood, serum, sputum, nasal or buccal scrapings, breath analytics and other yet to be defined technologies) without prejudice.

     Lastly, the Lung Association implores CMS to allow for evidence development for those at-risk groups not included in the NLST, but for which biological plausibility exists for an increased risk of lung cancer. There should also be provision for open (HIPAA compliant) sharing of the demographics and outcome data that may or may not be mandated for payment, as part of a larger clinical research database for lung cancer and lung disease research.

     The American Lung Association is hopeful that CMS will incorporate these suggested recommendations and that a final decision is made by the original deadline so that individuals who meet the guidelines for annual lung cancer screenings can begin to receive this preventive treatment in February, 2015 with no cost-sharing.

These comments are respectfully submitted and intended to support and improve upon the proposed recommendations and help reduce mortality for those at risk for lung cancer.

Sincerely,

Harold Wimmer
National President and CEO

References:

1. U.S. National Institutes of Health, Institute NC. SEER Cancer Statistics Review, 1973–2011.
2. Aberle DR, Adams AM, Berg CD, et al. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N. Engl. J. Med. 2011;365(5):395-409. doi:10.1056/NEJMoa1102873.
3. Black WC, Gareen IF, Soneji SS, et al. Cost-Effectiveness of CT Screening in the National Lung Screening Trial. N. Engl. J. Med. 2014;371(19):1793-1802. doi:10.1056/NEJMoa1312547.
4. Pyenson BS, Henschke CI, Yankelevitz DF, Yip R, Dec E. Offering lung cancer screening to high-risk medicare beneficiaries saves lives and is cost-effective: an actuarial analysis. Am. Heal. drug benefits 2014;7(5):272-82. Available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4163779&tool=pmcentrez&rendertype=abstract. Accessed December 5, 2014.
5. Pinsky PF, Gierada DS, Hocking W, Patz EF, Kramer BS. National Lung Screening Trial Findings by Age: Medicare-Eligible Versus Under-65 Population. Ann. Intern. Med. 2014;161(9):627-633. doi:10.7326/M14-1484.
6. US Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress: A Report of the Surgeon General. Atlanta, GA; 2014.
7. Houghton AM, Mouded M, Shapiro SD. Common origins of lung cancer and COPD. Nat. Med. 2008;14(10):1023-4. doi:10.1038/nm1008-1023.
8. De Torres JP, Marín JM, Casanova C, et al. Lung Cancer in patients with COPD: Incidence and predicting factors. Am. J. Respir. Crit. Care Med. 2011;184(8):913-9. doi:10.1164/rccm.201103-0430OC.
9. Zulueta JJ, Wisnivesky JP, Henschke CI, et al. Emphysema Scores Predict Death from Chronic Obstructive Pulmonary Disease and Lung Cancer. Chest 2011. doi:10.1378/chest.11-0101.
10. Brenner DR, McLaughlin JR, Hung RJ. Previous lung diseases and lung cancer risk: a systematic review and meta-analysis. PLoS One 2011;6(3):e17479. doi:10.1371/journal.pone.0017479.
11. Denholm R, Schüz J, Straif K, et al. Is previous respiratory disease a risk factor for lung cancer? Am. J. Respir. Crit. Care Med. 2014;190(5):549-59. doi:10.1164/rccm.201402-0338OC.
12. Tammemägi MC, Katki HA, Hocking WG, et al. Selection criteria for lung-cancer screening. N. Engl. J. Med. 2013;368(8):728-36. doi:10.1056/NEJMoa1211776.
13. Alberg AJ, Brock M V, Ford JG, Samet JM, Spivack SD. Epidemiology of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013;143(5 Suppl):e1S-29S. doi:10.1378/chest.12-2345.
14. National Comprehensive Cancer Centers. Lung Screening Guideline.; 2014.

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12/9/2014
Tamara S. Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 212444

Dear Ms. Syrek Jensen,

As a Board Certified Registered Nurse and Certified Tobacco Treatment Specialist, I fully support CMS coverage for LDCT for the evaluation of high risk patients with a history of high tobacco use/dependence. Preventative care initiatives, such as LDCT, are crucial for detecting lung cancer in its early stages and providing treatment to this high-risk population, thereby lessening the staggering mortality rates associated. In addition, efforts to prevent obstacles for patients obtaining a LDCT must also be considered. Expanding age limits from 55-74 to 55-80, as per the USPSTF, will ensure that an octogenarian receive optimal treatment and the same standard of care, if a lung cancer is indeed detected. Furthermore, comprehensive, evidence-based, tobacco treatment and counseling must coincide with screening, and be supported by both the healthcare organization and CMS. Additionally, a re-visit or elimination to the criteria: “Smoker who has quit within the past 15 years.” I have had many patients who were heavy tobacco users and have been abstinent for a greater time-frame, and would still consider them to be among this high-risk population.

Respectfully Submitted,
Maria Feo, BSN, RN-BC, CTTS
Heart & Vascular Care Coordinator
Hunterdon Medical Center
Flemington, NJ 08822

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To the CMS Center for Clinical Standards and Quality Coverage Analysis Group:

We are writing on behalf of the multi-disciplinary Lung Cancer Screening Steering Committee at Boston Medical Center. Boston Medical Center (BMC) is the largest safety-net hospital in New England, and serves a racially, ethnically, and socioeconomically diverse patient population with a high prevalence of tobacco use disorders. We commend the CMS decision to cover low-dose computerized tomography (LDCT) for lung cancer screening in high-risk patients meeting specific eligibility criteria.

Based on established evidence and published studies, we suggest the following modifications:

1) We encourage expansion of eligibility to include individuals aged 55-80 as recommended by the United States Preventive Services Task Force (1), based on modeling that extended the findings of the National Lung Screening Trial (NLST) (1;2). We also support limiting lung cancer screening to individuals willing and able to undergo diagnostic evaluation and therapy for lung cancer.

2) We suggest clarifying the definition of "asymptomatic" in the eligibility criteria. In the draft decision, asymptomatic is defined as a patient without signs or symptoms of lung disease. However, in the NLST, only patients with hemoptysis and/or 15lbs of weight loss over the last year were excluded (2). Furthermore, patients with other lung diseases such as COPD, emphysema, and asbestos exposure, are at higher risk for developing lung cancer (3), and should not be excluded from screening.

Sincerely,

David Center MD, Hasmeena Kathuria MD, Christine Reardon MD, Karin Sloan MD, Katrina Steiling MD MSc, Renda S. Wiener MD MS (Pulmonary Medicine); Carl Jaffe MD, Alexander Norbash MD, Anuradha Rebello MD (Radiology); Hiran C. Fernando MD, Virginia Litle MD (Thoracic Surgery); on behalf of the BMC Lung Cancer Screening Steering Committee

References:
1. Moyer VA, et al. Annals of Internal Medicine, 2014; 160(5):330-338.
2. The National Lung Screening Trial Research Team. New England Journal of Medicine, 2011; 365:395-409.
3. Bach PB, et al. Journal of the National Cancer Institute, 2003; 95(6):470-478.

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December 10, 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,

The Washington State Radiology Society (WSRS) is greatly appreciative of the opportunity to comment on the recently proposed Decision Memorandum for National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). We applaud the Centers for Medicare and Medicaid’s (CMS) proposed decision to extend this life saving benefit on to the Medicare age population.

WSRS joins and supports all of the submitted comments of the joint societies, The Lung Cancer Alliance (LCA), The Society of Thoracic Surgeons (STS), and the American College of Radiology (ACR). In this regard, we respectfully request 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. Additionally, we agree on the importance of clarifying and strengthening aspects of eligibility criteria for qualifying radiologists and radiology imaging centers, as well as CMS-approved national lung screening data registries.

We share very significant concerns about the proposal to limit this screening benefit to high risk individuals ages 55-74. We strongly believe that a coverage decision excluding those patients’ ages 75-80 years old would neglect a significant patient population at high risk of lung cancer, as well create a confusing and socially disparate policy that increases rather than decreases health care disparities in the elderly by creating a barrier to lung cancer screening access for lower income, elderly Americans.

We consider equitable access to high quality screening the overarching public health priority as CMS develops and implements a safe and effective national coverage policy that will save thousands of lives.

Sincerely,

Eric J. Stern MD
President, Washington State Radiology Society

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We serve a high risk lung cancer population. Smoking history of these individuals along with occupational exposures due to manufacturing and mining make a large percentage of our service area population eligible for LDCT lung screenings.

The proposed requirement for radiology imaging center eligibility requiring that the patient has participated in the past in lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening” will place a hardship on our patients.

Our high risk lung cancer screening patients who desperately need this life saving screening will not have their LDCT paid for. Not only will it potentially be a hardship for rural facilities, but also for patients in those rural areas where the facilities do not have the resources to meet the required certification, and where the risk of lung cancer is the highest.

We respectfully request that this requirement for imaging center eligibility be removed from the proposed rule.

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It is already proven that LDCT will help save lives by early detection of lung cancers especially in the high risk population. But the restriction of: "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;" will inhibit facilities, mostly rural hospitals, who are currently not required to hold ACR accrediation status on their CT units ineligible. This restriction will result in undue hardship to rural populations like our who have a much higher percentage of smokers and people with occupational exposures due to manufacturing and mining which make a large percentage of our service area population eligible for LDCT lung screening. Hospital facilities should be allowed to provide the service as well as evidenced by quality studies. Many hospitals to date have not participated in the national lung screening trials. By allowing hospitals to provide the service, more patients will benefit.

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I write these comments on behalf of someone working in a Lung Cancer Screening Center (since 2012) and a Tobacco Treatment Program (since 2002) at a community hospital where I am on the Medical and Dental Staff. I support CMS covering LDCT for those high risk patients with an extensive tobacco use history. It is important to achieve maximum benefit to this population that there are minimal unnecessary barriers so early detection can become implemented widely and effectively:

1. For maximum benefit, high intensity tobacco treatment (for those current tobacco users and recent quitters) needs to be offered at the time of screening (before, concurrently, or immediately after the LDCT). The ideal situation is for the specialty trained clinician or tobacco treatment specialist to offer the evidence based counseling and medications (per PHS Clinical Guidelines, 2008 and real world studies) at the clinical setting where the LDCT is taken. If there is no specialist yet on the staff, then the clinician should refer the patient to evidence based local tobacco treatment programs or the national Quitline, 1866-Quit-Now.

2. Also, since tobacco causes abgout 90% of the lung cancer cases and there is a strong dose response relationship between tobacco use and lung cancer, the criteria "Smoker who has quit within the past 15 years" should be deleted. For example, there are many smokers who were very heavy smokers (i.e., two packs/day) but may have quit 16, 18, 19 years ago and some should be screened, if meeting the other clinical criteria, since they remain at "moderate-high risk." The strict research criteria used in some studies are too narrow for the entier US Medicare population and should be eliminated.

3. Criteria should change from screeening between ages 55-74, up to 80. For exampe, there remain many 75, 77, 80 year olds, with good performance status that could benefit from early detection, and possibly curative treatment of lung cancer.

4. I support the shared decision making visit to review risks/benefits with the patient of the LDCT. However, the proposed rulse are too narrow; they state the shared decision visit occurs with a "physician or qualified non-physician practitioner physician assistant, nurse practitioner, or clcinical nurse specialist..." I'm recommending this be expanded to include qualified non-physiican Meidcare approved practitioners such as licensed psychologists, licensed clinical social workers, and others who are tobacco treatment specialists/Medicare approved clinicians. For example, there are many patients who ahve no PCP or are between PCPs and would not get the LDCT because of having to jump through the hurdles of finding a new PCP. Some of these high risk patients are in treatment with a tobacco treatment specialist, whose specialty training and scope of practice allows them to review the risks and benefit of screening, in addition to offering expertise in managing any potential anxiety that could occur surrounding the decision to undergo a LDCT. Extra unneeded patient barriers (a separate visit with a new clinician), could lead to avoidance of screening for many months/years, and ultimately unintentionally to late detection (stage III-IV cancer), where treatment options are limited.

5. Related to number four is that a written order for LDCT is needed. While I agree with this, the written order needs to be expanded to include again a licensed psychologist, and/or LCSW or other approved Medicare clinician. The simple fact is that in some settings/geographical locations, many of these clinicians have advanced training to render high intensity tobacco treatment visits and/or have a solid relationship witht he patient already established. These clinicians, at times, are in a much better position to assess tobacco use history risk (ie.g., 30 pack years) and help this population comply with health behavior changes including navigating the health care systems. Expanded permission for these clinicians to also "order" the LDCT will have the benefit of, at times, assisting the patient in removing unneeded barriers that lead to early detection, instead of the typical scenarios that freuqnetly occur - procrastinations/delays of evidence based screeenings/treatments which unfortunately happen with this smoking population typically.

6. It was unclear if this benefit is fully covered at 100%, with no co-insurance/deductibles or if it is a 80%/20% benefit. It is therefore recommended that this benefit be 100% fully covered, with no co-insurance/copay responsiblity to the patient. This is consistent with private insurance LDCT coverage per USPSTF guidelines beginning January 2015. Additionally, reserach (Curry et al., 1998) and real world clinical experience has unfortunately shown that high co-pays/deductibles, lead to avoidance of early detections/screeenings/early intervention treatments.

Sincerly,
Chris Kotsen, PsyD, CTTS
Program Manager, Tobacco Quitcenter
Lung Cancer Institute
Steeplechase Cancer Center
Robert Wood Johnson University Hospital Somerset
Somerville, NJ

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December 9, 2014

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Syrek Jensen:

The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the proposed decision memorandum on screening for lung cancer with low dose computed tomography (LDCT) (the Proposed Decision). As the leading trade association representing medical imaging, radiation therapy, and radiopharmaceutical manufacturers, we have in-depth knowledge of the significant benefits to the health of Medicare beneficiaries that medical imaging and radiation therapy provide. MITA appreciates the opportunity to work with CMS on coverage of innovative imaging technologies, such as LDCT, that can identify deadly cancers at an early and more treatable stage and save Medicare beneficiaries’ lives. MITA supports the Proposed Decision and we urge the Centers for Medicare & Medicaid Services (CMS) to finalize it with the revisions and clarifications discussed below.

MITA’s members develop and manufacture medical imaging technology, including X-ray imaging, computed tomography (CT) scans, radiation therapy, related imaging acquisitions, diagnostic ultrasound, and nuclear imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI). Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures. In addition, medical imaging equipment often is used to select, guide, and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions. MITA’s members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

MITA agrees that the “evidence is sufficient to conclude that lung cancer screening is reasonable and necessary for prevention or early detection of illness or disability.” In the Proposed Decision, CMS discusses the ample evidence on the benefits of LDCT screening for lung cancer. We applaud CMS for its thoughtful review of the evidence and for issuing a Proposed Decision to cover this service for Medicare beneficiaries, allowing cancers to be treated at an earlier stage and saving lives.

As we discuss below, we recommend several revisions to the Proposed Decision:
- Expand the eligible patient population to include a) beneficiaries up to age 80, as recommended by the United States Preventive Services Task Force (USPSTF) and supported by the National Comprehensive Cancer Network (NCCN) Guidelines , and b) patients age 50 or older, with a smoking history of at least 20 pack-years and one additional risk factor other than second-hand smoke, as recommended by NCCN 6;
- Revise the radiologist eligibility criteria to ensure appropriate access to LDCT screening;
- Revise the facility eligibility criteria to allow screening at centers designated by the American College of Radiology (ACR) as Lung Cancer Screening Centers, to use NEMA XR-29 “Standard Attributes on CT Equipment Related to Dose Optimization and Management” standard , along with a required site-specific dose management program, instead of an upper limit “effective dose” of 1.5 mSv; and limit the registry to relevant data without imposing significant burdens on participating providers and take steps to ensure that at least one registry is operational in a timely manner following issuance of the final coverage decision.

We also note with interest that the Proposed Decision would require collection of data in a registry such that it would be, de facto, Coverage with Evidence Development (CED) not dissimilar from the recently issued guidance document on CED. That guidance document recognizes two approaches to CED: (1) collection of evidence to confirm that appropriate beneficiaries receive an item or service that has been determined to be reasonable and necessary, and (2) collection of data to support a future determination that an item or service is reasonable and necessary. Although the Proposed Decision concludes that the evidence is sufficient to determine that lung cancer screening is reasonable and necessary, the proposed requirement for the registry appears to combine elements of both approaches to CED. In particular, the requirement to collect extensive data elements, including diagnostic follow-up of abnormal findings within one year, lung cancer incidence within one year, and health outcomes, to be collected in a registry in order to “better establish duration and the cumulative limit in the number of LDCT screens, as well as inform, if appropriate, modifications to Medicare coverage,” is not consistent with the approach to CED described in the guidance document for items and services that have been found to be reasonable and necessary. This collection of data beyond what is necessary to determine that each beneficiary who receives LDCT screening meets the Proposed Decision’s requirements would be inconsistent with the conclusion that the clinical evidence is sufficient to warrant coverage. For the reasons we explain on pages 7 and 8, this data collection is both impractical and burdensome in addition to being unnecessary.

I. MITA recommends that CMS expand the eligible patient population to include beneficiaries up to age 80.

CMS proposes to cover a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with LDCT, once per year for beneficiaries age 55 to 74 years, who are asymptomatic (no signs or symptoms of lung disease), have a tobacco smoking history of at least 30 pack-years, and are current smokers or have quit smoking within the last 15 years. The USPSTF recommended screening for patients up to age 80 (recommendation grade B), however, and the most recent NCCN Guidelines recommend, with a category 2A rating, screening for patients age 50 or older, with a smoking history of at least 20 pack-years and one additional risk factor, other than second-hand smoke. The most recent NCCN Guidelines state:

Screening may benefit older patients who are 75 to 84 years old. Recent recommendations from USPSTF recommend LDCT for high-risk patients aged 55 to 80 years. Similarly, recommendations from the American Association for Thoracic Surgery [AATS] recommend LDCT for high-risk patients aged 55 to 79 years. In addition, data from modeling studies suggest that the most advantageous age range for screening is 55 to 80 years old. Thus, annual LDCT seems reasonable for select high risk patients older than age 74 years who are eligible for definitive treatment, generally defined as curative intent therapy (e.g., surgery, chemoradiation, stereotactic body radiation therapy [SBRT]).

MITA acknowledges that screening is intended to inform patient management decisions including, ultimately, appropriate treatment decisions, and therefore recommends that CMS cover the counseling and shared decision making visit and LDCT screening for beneficiaries up to age 80, consistent with the USPSTF recommendation, the NCCN Guidelines, and the recommendation of the AATS. The counseling and shared decision making visit, along with use of suitable decision aids, will help to ensure that LDCT is used appropriately in this population and that patients are informed about the risks and benefits of screening and follow-up diagnosis and treatment as they age.

II. MITA recommends that CMS revise the eligibility criteria for radiologists to ensure appropriate access to LDCT screening.

CMS proposes to require radiologists to meet the following criteria in order to perform LDCT screening and interpret results:

• Current certification with the American Board of Radiology or equivalent organization;
• Documented training in diagnostic radiology and radiation safety;
• Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years; and
• Documented participation in continuing medical education in accordance with current American College of Radiology standards.

MITA is concerned that the requirement for radiologists to have “involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years” will limit access to the service. We believe the requirement for ACR Lung Cancer Screening Center designation for interpreting physicians to have performed 200 chest CT scans within the prior 36 months is sufficient to ensure that physicians have adequate experience with this service. We ask CMS to implement this standard to ensure that a sufficient number of radiologists is available to fulfill Medicare beneficiaries’ need for LDCT screening , particularly in underserved and rural communities.

III. MITA recommends that CMS revise the eligibility criteria for imaging centers to ensure appropriate access to LDCT screening.

CMS proposes to require that each imaging center that performs LDCT screening:

• Has participated in past lung cancer screening trials, such as the National Lung Screening Trial (NLST), or [is] an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;
• Must use LDCTs with an effective radiation dose less than 1.5 mSv; and
• Must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed.

MITA has concerns about each of these criteria, and we recommend that CMS revise them in the final decision.

First, we are concerned that the requirement for the center to have participated in past lung cancer screening trials, such as the NLST, or be an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening will limit access to LDCT. Screening centers that did not participate in the NLST or that are not currently providing LDCT lung cancer screening will not qualify under the proposed criterion, and it is not apparent how additional centers will be able to gain the experience necessary to qualify. MITA recommends that CMS require centers to obtain ACR Lung Cancer Screening Center designation instead of fulfilling this proposed criterion. The ACR Lung Cancer Screening Center designation identifies accredited centers that meet specific criteria, including technical specifications and review of the center’s protocol. These criteria are sufficient to ensure the quality of LDCT services provided.

Second, we believe that instead of the proposed static limit for radiation exposure, which might be burdensome, unnecessary, and potentially clinically ineffective for imaging of some patients CMS should adopt the industry standard NEMA XR-29 along with a required site-specific dose management program, and employ the ACR Dose Index Registry or other suitable registries as means to ensure ongoing reduction in exposure. MITA believes that the Food and Drug Administration (FDA) has the sole responsibility for determining the safety and efficacy of medical devices and that if CMS establishes additional requirements, such as the specification of an upper limit for radiation exposure, CMS would unnecessarily duplicate those efforts.

The inflexible and non- CT specific value of 1.5 mSv is expressed in less relevant units of measure than have been, and will continue to be, internationally defined and used on all CT systems (Computed Tomography Dose Index - Volume (CTDIvol) expressed in mGy, and Dose Length product (DLP) expressed in mGy-cm). Additionally, in order to obtain the “effective dose” in units of mSv’s requires additional calculations to be performed using CTDIvol and DLP and other defined metrics and, most importantly, there are multiple methods used to perform these calculations that result in different values of effective dose in mSv for the same scan.

CTDIvol and DLP are used in the ACR Dose Index Registry and by the American Association of Physicists in Medicine (AAPM))

The 1.5mSv upper limit is based on an average dose in a trial which began more than a decade ago. Variations in body size – both girth and length – affect the dose required to achieve an image of adequate diagnostic quality. The 1.5 mSv reported in NLST is an average across all patients, hence a large proportion of them, approximately half, received more than 1.5 mSv in the course of obtaining their images of diagnostic quality. The unintended consequences of enforcing such a limit might be discriminatory, at least for the first few years, by denying access of larger patients. All studies and guides to date (e.g. NLST, ACR, AAPM, NCCN) recognize the need to adjust the dose based on the patient’s body size and habitus to ensure clinical efficacy.

The use of “effective dose” expressed in mSv is also problematic in part because it is neither displayed nor recorded by the scanner. As discussed, a more appropriate dose metrics is CTDIvol which is the internationally defined and accepted as the primary metric for CT radiation output. The CTDIvol value along with DLP (also internationally defined and accepted as a CT dose metric) are required by the international standard IEC 60601-2-44 “Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography” to be displayed before and after the patient scan and also recorded electronically in the patient record via a DICOM Radiation Dose Structured Report (RDSR). The RDSR, because of its standardization, is able to be read and transferred across all dose management tools. Using these metrics also would be consistent with hospitals’ accreditation standards. Recent revisions to the Joint Commission standards for diagnostic testing also require the CTDIvol and DLP to be recorded in the patient’s medical record and on the interpretive report for a diagnostic CT.

If CMS must include equipment standards, MITA strongly recommends the already established NEMA XR-29 standard which already has been recognized by Congress in the Protecting Access to Medicare Act.

NEMA XR-29 includes the requirement for the CT System to produce a RDSR. Because this is an electronically searchable and transportable report, it is used as part of any CT dose management program. MITA recommends that a site-specific dose management program be required. It enables sites to track and optimize their dose internally as well as report it, for example to the ACR Dose Registry, as a means of benchmarking. Reporting and tracking dose via the ACR Dose Index Registry has been shown to reduce unnecessary variability and drive ongoing reductions in dose. Independently of the NEMA XR-29 standard, voluntary participation by accredited CT imaging centers in the ACR Dose Index Registry has led to reduction in unnecessary variability in dosing within a site, as well as a reduction in the individual, and therefore also average, doses administered at that site. The accrediting body should periodically review the site’s dose management program for effectiveness.

NEMA XR-29 requires a system to have the “Dose Check” feature which is compliant to NEMA XR-25 “Computed Tomography Dose Check”. Dose check enables the site to set “notification values” for dose (CTDIvol and/or DLP) on a per protocol basis. Hence, for a lung screening protocol an appropriate notification value may be specifically set as a safety mechanism.

NEMA XR-29 also requires Automatic Exposure Control (AEC). AEC modulates a device’s output radiation appropriate to the specific patient’s body habitus so that the dose delivered is the lowest needed to produce the image quality defined by the operator. AEC thus optimizes dose for each exam. Whatever CMS does in this regard should neither usurp nor duplicate the exclusive responsibility of the FDA for the safety and efficacy of medical devices.

Third, we are concerned that CMS’s proposed data elements to be collected by a national registry will be burdensome for providers and will complicate the efforts to establish suitable registries. In particular, CMS proposes to require collection of data on diagnostic follow-up of abnormal findings within one year, lung cancer incidence within one year, and health outcomes, including all cause mortality and death within 60 days after most invasive procedure. These elements require collection of information that would not be known to the imaging center and therefore would require participation of other practitioners and providers, including radiologists, surgeons, oncologists, and hospitals over an extended period of time beyond the image acquisition. This expansive list of potential participants would increase the registry’s total burden on providers and represents burdensome efforts in the establishment and use of a registry that satisfies CMS’s requirements.

We recommend that CMS narrow the registry’s data elements to those addressing the scan provided and the findings from the scan. Many imaging centers already report most of these elements to the ACR Dose Index Registry, a registry that might be suitable for CMS’s purposes. If a new registry is needed, we urge CMS to work with stakeholders to ensure that at least one registry will be operational in a timely manner following issuance of the final coverage decision so that beneficiaries can begin receiving LDCT screening services soon after the final coverage determination is released.

Alternatively, in lieu of requiring reporting of doses to a registry, CMS could require facilities to record and store data on dose levels on site, as required by the Joint Commission’s recently revised standards. In addition to requiring that dose be recorded in the patient’s medical record and on the interpretive report, as discussed above, these standards require hospitals to “compile and analyze data on patient CT radiation doses and compare it with external benchmarks, when such benchmarks are available.” Using this information, CMS could review facilities’ records as appropriate to verify that appropriate doses are used.

IV. MITA recommends that CMS clarify how the proposed data collection requirement relates to the agency’s guidance on CED.

Finally, MITA asks CMS to clarify how the proposed requirement for data to be reported to a registry, along with CMS’s intent to use the data for “post coverage analysis” relates to the agency’s new final guidance on CED. In this guidance document, CMS describes CED as an approach to coverage, based on Social Security Act sections 1862(a)(1)(A) and 1862(a)(1)(E). When CMS uses CED under section 1862(a)(1)(A), the agency requires as a condition of coverage the “collection of additional clinical data, which allows CED to ensure that items and services are provided appropriately to patients meeting specific characteristics as described in an NCD.” Under section 1862(a)(1)(E), CED is used to support clinical research for items and services that are not considered to be “reasonable and necessary” under section 1862(a)(1)(A). In the CED guidance document, CMS identifies principles and standards that ensure that CED is applied in a transparent, predictable manner and results in studies that are well-designed and are not duplicative of existing research.

The Proposed Decision's requirements for collection of extensive data elements through a registry and CMS's plan to evaluate that information “to better establish duration and the cumulative limit in the number of LDCT screens, as well as inform, if appropriate, modifications to Medicare coverage,” are not dissimilar from requirements established under CMS’s recent guidance document and other national coverage determinations (NCDs) that use CED. In the Proposed Decision, CMS does not refer to CED, the statutory authorities for CED, or the principles and standards CMS has established for use of CED, however. In addition, the Proposed Decision’s data collection requirements also include diagnostic follow-up and outcomes data and plans for post-coverage analysis – components of the form of CED used for items and services lacking data to support a conclusion that they are reasonable and necessary – although CMS concludes that the evidence is sufficient now to determine that lung cancer screening is reasonable and necessary. As discussed above, MITA believes these additional data requirements and unnecessary and burdensome. They also are inconsistent with the conclusion that the clinical evidence is sufficient to warrant coverage. For these reasons, these additional data requirements should not be included in the final decision.

CMS’s lack of clarity about how the data collection requirements in Proposed Decision relate to similar requirements in the guidance document on CED and other NCDs is confusing and inconsistent. We recognize that the proposed coverage decision for LDCT is based on a different statutory authority than CMS cites for CED, but we believe that the same principles should apply to any coverage determination that requires collection of data, regardless of whether CMS labels that requirement as “CED.” We ask CMS to clarify its approach to requiring evidence development in coverage determinations so that CMS's policies will be clear to manufacturers and other stakeholders.

In conclusion, MITA appreciates the opportunity to submit these comments on the Proposed Decision. If we can be of assistance to CMS as it finalizes this decision, please contact Terri Wilson at twilson@medicalimaging.org.

Sincerely,

Gail Rodriguez, Ph.D.
Executive Director, MITA

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The proposed rule has LDCT must be less than 1.5 mSv. I am not against a standard that asks for a low dose, but effective dose is not to be used for an individual. In addition doing so does not take into account patient habitus as the factor typically used to determine effective dose from DLP assumes a medium size male. Although not perfect, a maximum CTDI may be more useful. That is something that appears on a CT scanner.

If wish to stick with the 1.5 mSv. then need to specify how that is to be calculated.

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Clarifications/comments

1. For persons who have already received a LDCT screen before age 65 and wish to continue with LDCT screening from age 65 on covered by Medicare – will a counseling and shared decision-making session be required? Do they need such a visit a.) always, b.) if they have not had such a counseling and/or shared decision making visit before, or c.) never? If the answer to the above is b or c., what (if any) documentation is needed that they had a prior LDCT screen or (for b.) that they had prior counseling? With the current wording, this is not clear.

2. For the eligibility criterion of “asymptomatic (no signs or symptoms of lung disease)”, this is not clear. What about subjects with COPD who have a chronic cough? Would they be eligible? About 17% of NLST participants reported a history of COPD at baseline. It might be better to word this as “asymptomatic (no signs or symptoms suspicious for lung cancer)”.

3. For subjects with a positive screen who have a nodule that is being followed, will subsequent LDCT scans be considered screening (with no co-pays) or diagnostic? For example, a positive baseline LDCT screen finds a nodule with 6 month follow-up LDCT recommended. At the 6 month exam, the nodule still needs follow-up in another 6 months, at 12 months from baseline. The existence of this nodule could be considered a “sign” of lung disease or a “sign” that is suspicious for lung cancer. Would the 12 month LDCT exam still be covered as a LDCT screen with no co-pay?

4. Several items concerning minimum required elements of screen exam results are not clear. For nodule size, is this longest diameter as in NLST or average size (mean of longest and perpendicular) as in Lung-RADS? It is unclear what the value is in reporting calcified nodules. It states solid or semi-solid, but what about non-solid (ground glass)? The current reporting requirements would not allow one to derive the Lung-RADS category for repeat screens, or even whether it was a positive screen under Lung-RADS, since for repeat screens knowledge of nodule pre-existence and/or growth is required to derive the Lung-RADS category.

5. The guidelines state "A LDCT lung cancer screening registry must be consistent with the recommendations of the USPSTF and must collect and submit at least the minimum data elements as developed by the National Cancer Institute.”
Suggest re-wording as follows: “A LDCT lung cancer screening registry must be consistent with the recommendations of the USPSTF and must collect and submit at least the minimum set of data elements as described below. This set was adapted from a list of data elements developed by the National Cancer Institute for evaluating LDCT screening in population settings.”

6. How will diagnostic follow-up, cancer incidence and lung-cancer and all-cause mortality be ascertained in order to submit these items to the registry? Diagnostic follow-up will not necessarily be carried out at the center performing the LDCT screening. Outside of a HMO setting where screening and diagnostic follow-up would be performed in the same health care entity, tracking diagnostic procedures and outcomes may be logistically difficult.
Another option would be to restrict the registry data elements to those items that could be ascertained at the time of the screen or shortly thereafter (screening results). For downstream events (e.g., diagnostic follow-up), these could be ascertained on a sampling basis, not a nationwide all-inclusive registry. In HMO settings, these elements could be captured without too much difficulty. In the more prevalent non-managed care settings, a linkage approach on a sample of screened subjects could be employed, linking with Medicare claims data, state cancer registries, and the National Death Index (NDI).

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National Cancer Institute
Division of Cancer Treatment and Diagnosis
Cancer Imaging Program

Tamara S. Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N)

Dear Ms. Syrek Jensen:

The Cancer Imaging Program in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (NCI) appreciates the opportunity to comment on the recently proposed National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). As you know, the NCI designed and carried out the National Lung Cancer Screening Trial (NLST) that established the efficacy of low dose lung cancer screening in a high risk population. We have carefully reviewed the proposed national coverage decision and have some suggestions and points for clarification.

Suggestions

1. The radiation dosing definition and measurement units should be modified to be in accordance with industry standard NEMA-XR-29, the American College of Radiology (ACR) Dose Index Registry, and current recommendations from the American Association of Physicists in Medicine (AAPM) which specify using mGy units, and should be customized for patient habitus, as discussed below.

   The effective dose in mSv (which the scanner does not report and requires making assumptions) is obsolete. Instead the dose in mGy (which the scanner does report) should be used with the LDCT value being ≤ 3.0 mGy for a standardized subject. The outdated value of 1.5 mSv is not only defined in less relevant units of measure than are currently used, but also is based on an average dose in a trial which began more than a decade ago. The 1.5 mSv reported in NLST was an average across all subjects; hence a large proportion of them received larger radiation doses. Variations in body size . both girth and length . affect the dose required to gain an image of adequate quality and an unintended consequence of mandating a 1.5mSv value would be to discriminate against larger subjects. The Computed Tomography Dose Index Volume (CTDIvol), expressed in mGy, is recommended by the American Association of Physicists in Medicine (AAPM).

   Effective dose is defined in ICRP 103 as a population dose metric and should not be used to estimate dose or risk to an individual. From a screening population point of view, one method to estimate the effective dose is to calculate the Dose Length Product (DLP) and then apply a conversion factor described in AAPM TG Report 96 to estimate the effective dose. For an idealized standard sized patient and a 25 cm scan length, and using the k factor of 0.014 mSv/mGy*cm; these protocols should result in an effective dose below 1 mSv for a standard subject (see table below). It is our understanding that this methodology is embodied in the industry standard NEMA-XR-29 and used in the current ACR Dose Index Registry and will be familiar to certified radiology centers.

   Dose values for an idealized standard sized patient (NOT for any individual)

   Dose Descriptor	Value	Reported at Scanner (Y/N)
   CTDIvol*	≤ 3.0 mGy	Y
   DLP*	≤ 75 mGy*cm	Y
   Effective Dose (DLP x .014)**	≤ 1.0 mSv	N**

   * The CTDIvol and DLP values in this table are for an idealized patient only; individual patients may have higher or lower values to reflect adjustment for patient size.
   ** Effective Dose is calculated for a population and should NOT be reported for an individual

   Additionally, we note that extensive on-going research and development, much of it supported by the NIH, is directed at reducing CT radiation dose without compromising image quality, so any limit set here is likely to be obsolete in a few years.

2. The eligibility criterion of "asymptomatic (no signs or symptoms of lung disease)" should be modified, as many potentially eligible subjects might have symptoms of lung disease that are not symptomatic of lung cancer, such as asthma or chronic cough in COPD. For example, about 17% of NLST participants reported a history of COPD at baseline. It would be better to word this more specifically as "asymptomatic (no signs or symptoms suspicious for lung cancer)".


3. An additional data field that should be considered to include is confounding risks such as asbestos exposure or other cancers.
4. The criteria used for defining a nodule that is eligible for follow-up would be better specified to follow one of the current consensus guidelines . such as LungRADs, NCCN, Fleischer or other well defined consensus criteria instead of recording nodule numbers and individual nodule sizes.

   Those consensus criteria have been well thought out by the medical community and will be modified with time as more data become available. This approach is also consistent with the new general requirement added in the last SGR that practitioners consult an Appropriate Use Criteria (AUC) policy to ensure proper use of medical imaging.

5. The guidelines state "A LDCT lung cancer screening registry must be consistent with the recommendations of the USPSTF and must collect and submit at least the minimum data elements as developed by the National Cancer Institute."

   Since the NCI data elements were not published or subjected to peer review, this is a suggested rewording:

   "A LDCT lung cancer screening registry must be consistent with the recommendations of the USPSTF and must collect and submit at least the minimum set of data elements as described below. This set was adapted from a list of data elements developed by the National Cancer Institute for evaluating LDCT screening in population settings."

6. Excluding subjects between 75 and 80, counter to the USPTF recommendation, where the incidence of lung cancer is relatively high, is difficult to justify. If CMMS does not have the needed authority to frame appropriate qualifiers, such as health status sufficient to undergo definitive therapies, CMMS should consider covering under a separate CED the remaining cohort of the USPTF recommended population, those from 75-80 years old.


7. The requirement for subjects to be < 15 years from quitting if they are currently tobacco free could have the perverse effect of discouraging quitting tobacco use or actually restating it in order to qualify for covered screens. We suggest that this requirement be eliminated, and if it cannot be, CMMS should consider covering the excluded subjects under a separate CED.


8. Requiring an additional prescription order for each and every subsequent screen after the first one will increase costs to both Medicare and the beneficiaries, complicate scheduling, and decrease adherence to screening guidelines. We suggest that this be reconsidered and eliminated unless other covered screening tests have the same requirement.

Clarifications needed

1. The requirement for the screening center to have participated in past lung cancer screening trials, such as the NLST, or be an accredited (by whom?) advanced diagnostic imaging center with training and experience in LDCT lung cancer screening is ambiguously worded. It could be interpreted as screening centers that did not participate in the NLST or that are not currently providing LDCT lung cancer screening cannot qualify, essentially providing no mechanism for any new centers to be qualified. A mechanism should be identified that allows new centers to be qualified, for example by obtaining ACR Lung Cancer Screening Center designation or an equivalent program that accredits centers meeting specific criteria, including technical specifications and review of the center's protocol.


2. For persons who have already received a LDCT screen before age 65 and wish to continue with LDCT screening from age 65 under coverage by Medicare, will a counseling and shared decision-making session be required? Is this counseling visit needed a) always, b) if they have not had a counseling and/or shared decision making visit before, or c) not at all? If the answer to the above is b or c, what (if any) documentation is needed that they had a prior LDCT screen or (for b) that they had prior counseling? With the current wording, this is not clear. Also, will CMMS cover the cost of the counseling and shared decision-making visit?


3. Is there a standardized instrument that defines the elements that constitute "counseling and shared decision making"? Should the proposed instruments be approved by CMMS? Must that instrument be signed by the individual who is offered screening?


4. For subjects with a positive screen who have a nodule that is being followed conservatively with more frequent LDCT scans (not with diagnostic CT scans), will the subsequent LDCT scans be considered screening (with no co-pays) or diagnostic? For example, a positive baseline LDCT screen finds a nodule and a 6 month follow-up LDCT is recommended. At the 6 month exam, the nodule still needs follow-up in another 6 months, at 12 months from baseline. The existence of this nodule could be considered a sign that is suspicious for lung cancer. Would the 6 month or 12 month LDCT exam still be covered as a LDCT screen with no co-pay?


5. For the registry element of nodule size, if CMMS chooses to not recommend use of one or more of the consensus guidelines, is this longest diameter as in NLST or average size (mean of longest and perpendicular) as in Lung-RADS? Also, it is unclear what the value is in reporting calcified nodules as they are not normally indicative of cancer. Finally, the data description states solid or semi-solid, but what about non-solid (ground glass)? Is the nodule described as well marginated or spiculated? (Note that, on the whole, we recommend using one or more of the professional consensus guidelines in place of enumerating and reporting details of nodules.)



6. How will diagnostic follow-up, cancer incidence, and lung-cancer and all-cause mortality be ascertained in order to submit these items to the registry? CMMS proposed to require collection of data on diagnostic follow-up of abnormal findings within one year, lung cancer incidence within one year, and health outcomes, including all-cause mortality and death within 60 days after the most invasive procedure. Outside of a HMO setting where screening and diagnostic follow-up would be performed in the same health care entity, tracking diagnostic procedures and outcomes may be logistically difficult as diagnostic follow-up will not necessarily be carried out at the center performing the LDCT screening.

   An alternative would be to restrict the registry data elements to those items that could be ascertained at the time of the screen or shortly thereafter (screening results). Many imaging centers already report most of these elements to the ACR Dose Index Registry, a registry that might be suitable for CMMS's purposes.

   For downstream events (e.g., diagnostic follow-up), these could be ascertained on a sampling basis, rather than a nationwide all-inclusive registry. In HMO settings, these elements could be captured without too much difficulty. In the more prevalent non-managed care settings, a linkage approach on a sample of screened subjects could be employed, linking with Medicare claims data, state cancer registries, and the National Death Index (NDI).

Thank you for consideration of these comments. We are available for any discussions or questions regarding them.

Sincerely yours,

Paula M. Jacobs, Ph.D.
Associate Director, Division of Cancer Treatment and Diagnosis
Cancer Imaging Program
National Cancer Institute, National Institutes of Health
9609 Medical Center Drive,
4W230, MSC 9729
Bethesda, MD 20892-9729
Phone: 240-276-6510, jacobsp@mail.nih.gov

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The requirement that the patient be "Asymptomatic (no signs or symptoms of lung disease)" is a bald face effort to appear to cover lung cancer screening and all the while refusing to pay for it. I do not believe this is a mere oversight by government bureaucrats who understand little of the practice of medicine, but rather a cleverly calculated political effort to claim coverage and yet make everyone ineligible.

Anyone who fulfills the smoking requirement is going to have a cough. Yes, cough is a pulmonary symptom and yet the regulations as proposed squarely places the doctor in the cross hairs of over zealous CMS officials or their surrogates for charges of fraud and abuse. CMS has become an adversary of the physician and this is just another example of it.

I could well accept the screening argument, if those with symptoms suggestive of cancer such as weight loss or hemoptysis were excluded, but those with cough and shortness of breath are likewise excluded. Almost all 30 pack year smokers are going to have some form of COPD and exhibit pulmonary symptoms that do not, per se, suggest undetected cancer. The entire reason to undertake screening exams is to detect early stage cancer before it presents with weight loss, hemoptysis or gnawing chest pain; when it is already far advanced.

There can be only two reasons this requirement is being promulgated: you are either inept or duplicitous. I’d put dollars to donuts it’s the latter.

Robert J. Johnson, MD

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Healthwise is a nonprofit organization founded in 1975 with the mission of helping people make better health decisions. Healthwise develops and distributes accurate and unbiased health information and decision support tools, including patient decision aids. Healthwise materials are not developed with funding from drug or device companies. Distribution is primarily electronic through web portals, health plans, and health systems; including prescriptions by clinicians through their electronic medical records. Since its founding, Healthwise materials have been accessed 1.5 billion times, and about 15% of U.S. physicians have access to Healthwise materials through their electronic medical records. Healthwise patient decision aids alone are accessed about 5 million times annually.

As a longtime proponent of ensuring people are informed and involved with their health care decisions, Healthwise supports CMS’ proposed decision to cover a lung cancer screening counseling and shared decision making visit for carefully selected beneficiaries, and to cover low dose computed tomography (LDCT) if they make an informed decision to proceed with screening. We agree that the balance of benefits and harms for this screening test is close enough that informed people who are clinically eligible for screening may or may not want this screening test. The absolute benefit of screening in terms of lung cancer mortality reduction was just 0.3% after about 6.5 years of follow-up in the largest trial, the NLST, while the cumulative false positive rate, ~35%, and the positive predictive value, ~4%, for LDCT are much worse than for other commonly used screening tests. The false positive rate in particular leads to additional procedures and procedural complications. We see shared decision making as absolutely essential given these tradeoffs.

In terms of the shared decision making process, we recommend that the beneficiary’s preference regarding screening after viewing the decision aid be recorded in the medical record along with the documentation of clinical eligibility. After all, whether a beneficiary, after being fully informed, prefers screening or not is in fact as important as his or her clinical eligibility. Ideally, the beneficiary’s response to the shared decision making process including the decision aid would be captured in the electronic medical record, consistent with current standards efforts within the meaningful use measures.

Decision aids for lung cancer screening should be permitted to be viewed either in preparation for the counseling and shared decision making visit, at the visit itself, or at both times. To ensure the shared decision making and counseling visit is practical in primary care settings, this visit should be able to be combined with a visit to address other medical issues, just as a Medicare Annual Wellness Visit can be combined with the delivery of a separately identifiable, medically necessary Evaluation and Management service. Conducting the SDM visit in primary care when the question of screening is first raised is preferable, before the beneficiary may have developed uninformed preferences about LDCT screening.

In terms of the shared decision making content including the associated decision aids, we recommend that alternatives to LDCT screening be explicitly included, such as no screening, with smoking cessation efforts if the person is a current smoker. Provision of alternatives is a key part of the doctrine of informed consent. Given that chest x-rays were included in the control arm of the NLST, people need to know about the lack of evidence supporting any other lung cancer screening test, including chest x-rays. We also recommend that the possibility of incidental findings other than pulmonary nodules be included as a potential harm of screening.

Healthwise also applauds the proposal to create a registry to study the outcomes of this coverage policy among Medicare beneficiaries who only comprised about one-fourth of the participants in the NLST. Regarding the registry, Healthwise recommends that a reduced data set (excluding the data types related to the screening procedure) be sent to the registry for patients who undergo a counseling and shared decision making visit but elect not to be screened. Reimbursement for the visit should take into consideration the reporting requirement. Data on beneficiaries who are eligible but decline screening will serve as a valuable comparator to the data from beneficiaries who accept screening, and can help define the “real world” outcomes of this decision in the Medicare population. This symmetrical reporting would also define the distribution of beneficiary preferences regarding LDCT screening, and the predictors of those preferences.

We agree that specific decision aids for lung cancer screening are being developed, including by our own nonprofit organization, Healthwise. However, we believe that just as quality criteria are necessary for the LDCT test itself and radiologist training, criteria are also needed to ensure decision aids are high quality. The International Patient Decision Aids Standards (IPDAS) committee has developed evidence-based criteria for high-quality decision aids (http://ipdas.ohri.ca/IPDAS_checklist.pdf), and these criteria are being used to inform a patient decision aid certification process under the auspices of the Health Care Authority of the State of Washington (Rev. Code Wash. 2012; Wash. Admin. Code 2012). We recommend that in light of the importance of high quality decision aids for this screening test as well as for other similar “close call” decisions among Medicare beneficiaries, that CMS support a national patient decision aid certification program, modeling on the Washington State process. We note that such a national certification program for patient decision aids is called for in section 646 of the Affordable Care Act. Furthermore, as inherently recognized in both the state and federal certification schema for patient decision aids, there is an important public policy and attestation requirement necessary for broad adoption and use of decision aids within clinical practice. The attestation of certification has three important constituents. Patients will want to be assured that decision aids are free of conflict of interest and that risks, benefits and alternatives are presented in a balanced fashion; providers will want to be assured that the content is evidence based; and payors will need to be confident that the decision aids provide accurate unbiased information that will allow the patient to make fully informed treatment decisions that accord with the patient’s preferences and values.

Thank you for considering our comments as CMS moves toward a final coverage decision.

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December 8, 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:

The Lung Cancer Alliance (LCA), The Society of Thoracic Surgeons (STS), and the American College of Radiology (ACR), a coalition representing lung cancer patients, diagnostic radiologists, radiation oncologists, nuclear medicine physicians, medical physicists, and thoracic surgeons, appreciate the opportunity to comment on the recently proposed National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). LCA, STS, and ACR, hereafter referred to as the “Joint Societies,” applaud the Centers for Medicare and Medicaid’s (CMS) proposed decision to extend this life saving benefit on to the Medicare age population.

The Joint Societies are in agreement that the overarching public health priority is to ensure equitable access to high quality screening programs built on existing frameworks of evidence based protocols and multi-disciplinary care according to best practices.

In this regard, the Joint Societies respectfully request 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 as outlined in our letter. Additionally, the Joint Societies are hopeful that this document will help clarify and strengthen aspects of eligibility criteria outlined for qualifying radiologists and radiology imaging centers, as well as CMS-approved national lung screening data registries.

Finally, the Joint Societies wish to 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.

Our comments and recommendations are as follows.

Comments

Beneficiary eligibility criteria: Age 55-74 years
Recommendation: CMS adopt the USPSTF recommendation (55-80 years)

The Joint Societies strongly oppose the decision to restrict access to this life saving screening test to high risk patients 74 years old and younger. The median age of diagnosis for this particular disease is 70 years and a cap of 74 would exclude a large patient group where this exam is medically necessary and appropriate.

In lieu of the provisions outlined in the proposed NCD, our organizations urge CMS to adopt the United States Preventive Services Task Force’s (USPSTF) recommendation of offering annual LDCT lung cancer scans to high risk patients between the ages of 55 and 80. The USPSTF provided robust mathematical modeling to justify this broader age range for patients eligible for LDCT screens and concluded the evidence, as a whole, deserved a “B” rating. It is important to note that the findings of the National Lung Screening Trial (NLST), which was funded by CMS’s sister agency, the National Cancer Institute, served as the foundation of the USPSTF’s recommendations. In addition, the USPSTF’s work was supported by the Agency for Healthcare Research and Quality and ultimately published in a well-respected peer-reviewed journal, specifically the Annals of Internal Medicine (Appendix #1). Furthermore, the National Comprehensive Cancer Network (NCCN) Lung Cancer Screening Guidelines, developed by a broad multi-disciplinary team of lung cancer specialists and epidemiologists recommend screening “until a patient is no longer eligible for definitive treatment,” and the American Association for Thoracic Surgery (AATS) guideline (Appendix #2) recommends annual screening through 79 years of age. The AATS guideline expands to upwards of 79 years as the risk of developing lung cancer is higher each year than the year before due to aging. For this reason, combined with the peak incidence of lung cancer at 70 years and the average life expectancy remaining greater than 9 additional years for all Americans up to age 79 years, AATS developed a recommendation for annual screening applicable to this upper age bracket. In addition, a recent article published in PLOS Medicine concludes that smokers aged 65-80 years are a high risk group who would benefit from screening (Appendix #3). Evidence shows advances in surgical techniques are very safe and an effective curative treatment in the upper age bracket (80).

Along with concerns surrounding limited patient access, our organizations are concerned that excluding patients between the ages of 75-80 from this benefit creates a lack of uniformity among governmental recommendations, as well as an unintentional exacerbation of health care disparities. Given the USPSTF explicit recommendation, many may view stopping at age 74 to be a case of age discrimination and an arbitrary decision to tailor recommendations based solely on the NLST clinical trial inclusion criteria, rather than on a preponderance of evidence gained from the NLST, other trials, mathematical modeling, and pre-existing data. Since a lack of Medicare coverage for 75-80 year-olds disproportionately impacts lower income elderly Americans, such a decision by CMS may be perceived as unfairly limiting access to lung cancer screening in those at highest need and with the least resources and advocacy.

The Joint Societies believe that the USPSTF recognized that NLST was a very long and massive randomized clinical trial (RCT) that required considerable financial resources and human capital to complete. In light of these realities, our organizations are confident that the Task Force fully understood that a similar type of RCT for high risk patients between the ages of 75 and 80 was highly unlikely. As a result, the USPSTF relied upon sophisticated mathematical modeling when determining an accepted age bracket for high risk patients capable of receiving annual LDCT lung cancer screens. In short, the Joint Societies strongly urge CMS to recognize the same realities and adopt the USPSTF recommendation of high risk patients between the ages of 55 and 80 being eligible to receive annual LDCT lung cancer screens.

Beneficiary eligibility criteria: Asymptomatic (no signs or symptoms of lung disease)
Recommendation: CMS revise NCD language to “Asymptomatic (symptoms suggestive of lung cancer)” and delete “(no signs or symptoms of lung disease)”

The Joint Societies recommend that CMS revise the definition of “Asymptomatic” patients as currently outlined in the NCD so that it reads “Asymptomatic (no symptoms suggestive of lung cancer).” Our organizations urge the deletion of the phrase, “... no signs or symptoms of lung disease,” outlined in the parenthesis.

This revised language will help clarify the medically appropriate indications and intent surrounding “asymptomatic” and eliminate any concerns about the current language inadvertently excluding patients who should be eligible to receive this important screening procedure. While we agree that symptoms or signs of an acute process, such as pneumonia, or active symptoms or signs of lung cancer should trigger a diagnostic exam in lieu of a screening LDCT, patients with chronic obstructive pulmonary disease (COPD), a smoking cough, asthma, emphysema, and other pulmonary symptoms are at particularly high risk of lung cancer and should not be excluded from LDCT lung cancer screening exams. By holding to a strict standard of “no signs or symptoms of lung disease,” we believe CMS unintentionally creates a barrier to a majority of patients who are at high risk of cancer and should be eligible for screening, as well as potentially creates a system that results in retrospective denial of payment if a patient is deemed to have had “symptoms.” Refining the current definition of asymptomatic patients to those without signs or symptoms of lung cancer allows appropriate high risk patients to retain access to this important procedure.

Beneficiary eligibility criteria: A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary’s medical records): A written order for LDCT lung cancer screening that meets the following criteria: For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit (for example: during the Medicare annual wellness visit, tobacco cessation counseling services, or evaluation and management visit) with a physician (as defined in Section 1861 (r)(1) of the Act) or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Act).

Recommendation: CMS retain and implement the provider shared decision-making visit and written order requirement only for the initial screen. These beneficiary eligibility criteria should be deleted for the subsequent screens.

The Joint Societies agree it is important to require a written order and shared decision-making consultative visit for the first screen, however, we believe it is inappropriate to continue these requirements for future/subsequent screens. Instead, our organizations recommend CMS implement the written order requirement and provider shared decision-making visit only for the initial screen.

Once a decision to screen an individual is implemented, a major component of a successful screening program is the patient adhering to a regimen of annual follow-up screens. To mandate additional provider visits in order for patients to obtain orders for subsequent lung cancer screenings will create added costs to both patients and Medicare, as well as threaten to decrease adherence and delay care by creating a barrier to annual follow-up LDCT.

Beneficiary eligibility criteria: Current smoker or one who has quit smoking within the last 15 years.
Recommendation: CMS delete the 15 year smoking cessation requirement.

The Joint Societies recommend CMS delete the 15 year smoking cessation eligibility criteria. It is important that CMS weigh the unintended consequences of this smoking cessation threshold. More specifically, as outlined in previous comment letters, our organizations are concerned that this arbitrary time period by which patients must have ceased tobacco use will actually incentivize patients to restart their smoking habit to either become eligible or retain eligibility for the screening benefit. While we recognize the 15 year smoking cessation threshold was part of the NLST inclusionary trial criteria, there is no evidence that lung cancer risk falls off substantially after 15 years smoking cessation. We ask that CMS implement their final decision based on the broader impact of a public policy decision. The final lung cancer screening NCD must utilize language and standards that ultimately prevent, rather than encourage smoking.

Radiology imaging center eligibility criteria: Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;
Recommendation: CMS recognize the ACR CT Accreditation as an approved Advanced Diagnostic Imaging Accrediting body and the ACR’s Lung Cancer Screening Center (LCS) Designation program as an accepted center certification.
Recommendation: CMS grandfather those sites that were previously accredited and designated as an accredited provider of chest CT and LCS designation, such as the ACR’s CT Accreditation and ACR’s LCS Center Designation and allow grandfathered sites a three year grace period to meet the newer thresholds defined by the NCD.
Recommendation: CMS delete “advanced diagnostic imaging center” AND delete “experience” and replace with “provider of chest CT”. The new language would state “… or an accredited provider of chest CT with training in LDCT lung cancer screening;”

The Joint Societies request that CMS recognize the ACR CT Accreditation as an approved accrediting body and the ACR’s Lung Cancer Screening Center Designation as an accepted certification program meeting the “with training and experience in LDCT lung cancer screening” imaging center criteria. The ACR’s accreditation program has approved status from CMS under the Medicare Improvements for Patients and Providers Act (MIPPA) and the College has the historical knowledge, experience and existing framework in facilitating the NCD imaging center criteria. In addition, obtaining CT accreditation from the ACR is a prerequisite for the College’s lung cancer screening designation. The ACR’s CT Accreditation and LCS Designation are available to all centers, including community-based facilities, and the College is prepared to process applications rapidly. In only several months since the ACR LCS Designation program was launched, it already has over 300 sites processed and that number is increasing daily.

In responding to the imaging center eligibility criteria, our joint organizations would like to offer comments on the language stating “with training and experience in LDCT lung cancer screening”. The Joint Societies request that CMS delete the word “experience” and, as a point of clarification, refer to a center certification/designation that includes training elements, such as the ACR’s LDCT LCS Designation. This revision would help clarify CMS’ intent and works parallel to the ACR’s existing framework that includes “training” criteria under the personnel qualifications section (i.e., 200 chest CT cases in the prior 36 months). The word “experience” is unclear, as this typically is associated with physician specific criteria.

In addition, the Joint Societies recommend CMS grandfather those sites that were previously accredited and designated as an accredited provider of chest CT with LCS designation, such as the ACR’s CT Accreditation and ACR’s LCS Center Designation; AND allow any grandfathered sites a three year grace period to meet the newer thresholds defined by the NCD. While the CMS NCD designation/certification criteria are similar to the ACR LDCT LCS Designation, there are some differences in thresholds (e.g., supervision and interpretation of 200 vs. 300 chest CTs) that would create administrative and financial burdens to those existing centers that have already met the benchmarks defined for a quality screening program. CMS can streamline their process and head off these types of barriers by grandfathering existing accredited and certified/designated facilities and offer a three year transition period for those centers to meet the new thresholds.

The joint organizations recommend CMS delete “advanced diagnostic imaging center” and replace with “provider of chest CT.” The new language would state “… or an accredited provider of chest CT with training and experience in LDCT lung cancer screening.” This revision is necessary, as some centers with Advanced Diagnostic Imaging (ADI) accreditation may not be accredited in chest CT. The broader scope of ADI encompassing other imaging modalities creates a potential loophole and can easily be addressed with revised language specifying “an accredited provider of chest CT.”

CMS-approved National Registries

The Joint Societies fully support CMS-approved national clinical practice lung cancer screening registries and will be reaching out to CMS CAG separately on this topic. As mentioned in our prior correspondence, the ACR National Radiology Data Registry (NRDR), for example, is CMS recognized for Physician Quality Reporting System (PQRS). As part of NRDR, the ACR clinical practice lung cancer screening registry is well on its way to being programmed and available in early 2015 using the elements provided in the September 26, 2014 stakeholder letter. We are available to explore further in facilitating the imaging center eligibility NCD criteria.

Radiology imaging center eligibility criteria: Must use LDCTs with an effective radiation dose less than 1.5 mSv;
Recommendation: CMS revise the wording to reflect “Must use LDCT with volumetric CT Dose Index (CTDIvol) of = 3.0mGy (milligray) for standard size patients (defined to be 5’7 and approximately 155lb) with appropriate reductions in CTDIvol for smaller patients and appropriate increases in CTDIvol for larger patients”

The Joint Societies recommend that CMS utilize dose to phantoms captured in mGy and revise the radiology imaging center eligibility criteria language to reflect “Must use LDCT with volumetric CT Dose Index (CTDIvol) of = 3.0mGy (milligray) for standard size patients (defined to be 5’7 and approximately 155lb) with appropriate reductions in CTDIvol for smaller patients, and appropriate increases in CTDIvol for larger patients”. While we agree with CMS’ intent in placing specific dose parameters as part of the imaging center criteria, the use of an effective radiation dose with mSv (millisieverts) may be confusing. More commonly, volumetric dose (CTDIvol) and use of dose to phantoms in mGy is accepted as the metric for radiation output. In addition, a one size fits all radiation dose limit does not address varying patient sizes and adjustments in dose that are medically needed. The recommended revised language above captures both the volumetric dose limit for a standard size patient as well as including appropriate dose reductions and increases based on patient size.

Provided below is text taken from the American Association of Physicists in Medicine (AAPM) Lung Cancer Screening Protocols that addresses the dose measurement. In addition, text is provided from the ACR LDCT LCS Designation regarding dose. Both of these resources support the recommended change.

AAPM Protocols

Effective Dose
Effective dose is defined in ICRP 103 as a population dose metric and should not be used to estimate dose or risk to an individual. From a screening population point of view, one method to estimate the effective dose is to calculate the Dose Length Product (DLP) and then apply a conversion factor described in AAPM TG Report 96 to estimate the effective dose. For an idealized standard sized patient (defined above) and a 25 cm scan length, and using the k factor of 0.014 mSv/mGy*cm; these protocols should result in an effective dose below 1 mSv (see table below).

Dose values for an idealized standard sized patient (NOT for any individual)
Dose Descriptor Value Reported at Scanner (Y/N)
CTDIvol* = 3.0 mGy Y
DLP* = 75 mGy*cm Y
Effective Dose (DLP x .014)** = 1.0 mSv N**
* The CTDIvol and DLP values in this table are for an idealized patient only; individual patients may have higher or lower values to reflect adjustment for patient size.
** Effective Dose is calculated for a population and should NOT be reported for an individual ACR Designated Lung Cancer Screening Center requirements

Radiation exposure levels consistent with lung screening protocols and not routine chest scans; the protocol shall have a CT Dose Index volume (CTDIvol) of ≤ 3 mGy, for a standard size patient (5’7, 154lb) (using 32-cm diameter CTDI phantom)
Exposure values be reduced for smaller-sized patients and increased for larger-sized patients using either manual methods (operator adjustment of technique via a technique chart) or automated methods (such as automatic tube current modulation and/or kV selection)

Radiologist eligibility criteria: Current certification with the American Board of Radiology or equivalent organization
Recommendation: CMS replace Board Certification requirement with “Board Certification or Eligibility”.

The Joint Societies recommend CMS allow “Board Eligibility” in addition to board certification under the radiologist eligibility criteria. Please note a recent revision and official definition of “board eligible" is now time limited. Residents are eligible to take their Certifying Exam 15 months after completion of training. (see http://www.theabr.org/ic-gen-board-eligibility). Provided below is the American Board of Radiology (ABR) respective language.

After you have completed your residency training at a program accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada (RCPSC), you are board eligible. You then will have six full calendar years to attain certification by passing both the Core and Certifying exams.

Generally, you will be eligible to take the Certifying Exam 15 months after completion of training, provided you have passed the Core Exam. You must pass both the Core and the Certifying examinations within the six-year board-eligible period.

If your board eligibility expires, you must take one additional year of training in a department with an ACGME- or RCPSC-accredited diagnostic radiology residency program in order to return to board-eligible status. The ABR must approve the additional year before it begins, and the training must occur after expiration of board eligibility status. During this period, your status would be “not certified, not board eligible.” At the end of that year, the department chair or program director must attest to satisfactory completion of the experience. After that documentation has been provided to the ABR, you would be able to re-enter the certification process and again would be required to pass both the Core and Certifying examinations within a new six-year period of board eligibility.

Summary

Our Joint Societies – LCA, STS, and ACR– greatly appreciate 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. However, we continue to have very significant concerns about the proposal to limit this screening benefit to high risk individuals ages 55-74. We strongly believe that a coverage decision excluding those patients’ ages 75-80 years old would neglect a significant patient population at high risk of lung cancer, as well create a confusing and socially disparate policy that increases rather than decreases health care disparities in the elderly by creating a barrier to lung cancer screening access for lower income, elderly Americans.

In addition, our joint recommendations also address the definition of asymptomatic patients, order writing requirements for annual follow-up LDCT, the 15-year smoking cessation threshold, and accreditation and designation.

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 with CMS in developing and implementing a safe and effective national coverage policy that will save thousands of lives.

Sincerely,

Laurie Fenton Ambrose
President & CEO
Lung Cancer Alliance

David A. Fullerton, MD
President
The Society of Thoracic Surgeons

William T. Thorwarth, Jr, MD, FACR
Chief Executive Officer
American College of Radiology

Cc: Patrick Conway, MD, CMS
Ella Kazerooni, MD, MS, FACR
Geraldine McGinty, MD, MBA, FACR
Debra Monticciolo, MD, FACR
Cindy Moran, ACR
Chris Sherin, ACR
Pam Wilcox, ACR
Angela Kim, ACR
Anita McGlothlin, ACR

Appendices/Attachments

#1 Screening for Lung Cancer: U.S. Preventative Services Task Force Recommendation Statement. Annals of Internal Medicine 2014; doi: 4 March, Vol 160, No. 5 Moyer VA, MD, MPH on behalf of the U.S. Preventive Services Task Force http://annals.org/article.aspx?articleid=1809422&resultClick=3

#2 The American Association for Thoracic Surgery (AATS) Guidelines for Lung Cancer Screening Using Low-dose Computed Tomography Scans for Lung Cancer Survivors and Other High-risk Groups. Journal of Thoracic and Cardiovascular Surgery 2012; July, Vol 144, No. 1 Jaklitsch MT, MD, Jacobson FL, MD, MPH, Austin JHM, MD et al. http://aats.org/multimedia/files/Guidelines/Lung-Cancer-Screening-Using-low-dose-computed-tomography-scans.pdf

#3 Evaluation of the Lung Cancer Risks at Which to Screen Ever- and Never-Smokers: Screening Rules Applied to the PLCO and NLST Cohorts. PLOS Medicine 2014; doi: December, Vol 11: Issue 12 Tammema MC, Church TR, Hocking WG, et al.

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Dear Sirs
I would ask that you review several aspects of the proposed lung cancer screening program
First lung cancer incidence increases with age reflecting dose response and cumulative risk hence it does not make sense to exclude otherwise eligible persons who are surgical candidates older than 75 years go age
Second the issue of occupational and other risks such as pneumoconiosis and or pulmonary fibrosis as recognized lung cancer risks independent of tobacco smoking need to be added to the eligibility based on statistical risk for lung cancer
Another issue is that the exclusion if symptomatic patients does not make any sense given the additional risk of COPD

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American Association of Physicists in Medicine
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Office of the President
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University of Wisconsin
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Phone: 608-263-9962       Fax: 608-890-3148
Email: bayouth@humonc.wisc.edu

December 8, 2014

BY ELECTRONIC DELIVERY

Tamara S. Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Comments on Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Syrek Jensen:

The American Association of Physicists in Medicine (AAPM)¹ is pleased to submit comments on the proposed decision memorandum on screening for lung cancer with low dose computed tomography (LDCT) (the Proposed Decision)². As the leading professional association representing medical physicists, we have in-depth knowledge of the significant benefits to the health of Medicare beneficiaries that medical imaging and radiation therapy provide. AAPM is very supportive of the Centers for Medicare & Medicaid Services’ (CMS) proposed decision to enable Lung Cancer Screening with computed tomography (CT) to the Medicare age population.

Members of the AAPM were involved with the National Lung Screening Trial (NLST), including several who served on the physics subcommittee of the NLST. These AAPM members were intimately involved in designing the CT scanning protocols for the NLST trial and published results on estimating the radiation dose to the subjects participating in the NLST. Based on this and other extensive experience with CT dosimetry and CT dose reporting, the AAPM also recently published Lung Cancer Screening CT protocols for 27 different CT scanners from six different manufacturers (including all of the major manufacturers).

Based on our technical experience and expertise, we respectfully request CMS to make targeted modifications to the proposed decision as described below. We also want to express our willingness to work constructively with you and your staff on any other issues related to technical aspects of Lung Cancer Screening with Low Dose CT.

1. For the “Radiology imaging center eligibility criteria” section, the specific criteria: “Must use LDCTs with an effective radiation dose less than 1.5 mSv”;

   AAPM recommends that:

   CMS revise the wording to “Must use LDCTs with a volumetric CTDI (CTDI_vol) of less than or equal to 3.0 mGy for a standard sized patient (defined to be 5’7” and approximately 155 pounds), with appropriate reductions in CTDI_vol for smaller patients and appropriate increases in CTDI_vol for larger patients.”

   Rationale for this recommended change:

   • Effective dose is dose to a population and not dose to an individual (as defined by the International Commission on Radiation Protection (ICRP)³ and therefore is not an appropriate criteria for this application.
   • Effective dose is not reported on the CT scanner display and would require additional calculations by a Qualified Medical Physicist.
   • The calculation of effective dose in this setting would be non-standardized, not fully automated and would have a substantial amount of variation between centers. Additionally, most methods do not take into account the size of the patient, resulting in substantial overestimation of the effective dose to patients larger than “standard size”, which for the current national population would be a high proportion of those scanned.⁴
   • If this value were to be interpreted as the limit for an individual patient, then centers would be forced to limit the scanner output for larger patients, which would result in degraded image quality and may prevent the CT exam from being interpretable by the radiologist.
   • By international standard, CT scanners report the radiation output metric of volumetric CTDI (CTDI_vol); this is the radiation dose absorbed by a standard test object (CTDI phantom). These values are displayed on the scanner prior to the scan as well as reported after the scan in the patient dose report.
   • Use of CTDI_vol does not require any additional calculations.
   • Limiting the CTDI_vol ensures that the CT exams will be performed with low dose.
   • For the NLST, the CTDI_vol was limited to less than 3.0 mGy for a standard sized patient and was allowed to increase for larger patients to obtain sufficient image quality so that a radiologist could interpret the scan.⁵
   • While allowing the scanner radiation output (and CTDI_vol value) to increase for a larger patient might appear to result in an increase in radiation dose, the actual absorbed dose is similar to or less than for smaller patients scanned with a smaller CTDI_vol. It has been shown that for the same scanner output (CTDI_vol), the larger patients absorb less radiation dose than the smaller patients (due to both the effective shielding of fat and muscle, as well as having a larger mass to absorb the radiation).⁶
   • Specifying the CTDI_vol limit for a standard sized patient will limit the radiation exposure of the patients undergoing screening CT exams and is a more direct method of ensuring that the CT exams are performed with low radiation dose; this will in turn ensure that the average effective dose will be less than 1.5 mSv to the population of patients being scanned.
   • Using the published AAPM Lung Cancer Screening Protocols⁷, the following estimate (see Table below) was calculated, showing that: 1) if the CTDI_vol was limited to 3.0 mGy for a standard sized patient, and 2) the scan region was limited to just the lungs (which on a standard sized patient only requires a 25 cm long scan), then the effective dose to the population would be below 1.5 mSv.
   • It should also be noted that only CTDI_vol and the dose length product (DLP) are reported on the scanner, while effective dose is not.
   Dose values for an idealized standard sized patient (NOT for any individual)

   Dose Descriptor	Value	Reported at Scanner Y/N
   CTDIvol*	≤ 3.0 mGy	Y
   DLP*	≤ 75 mGy*cm	Y
   Effective Dose (DLP x .014)**	≤ 1.0 mSv	N**

   * The CTDI_vol and DLP values in this table are for an idealized standard sized patient only; individual patients may have higher or lower values to reflect appropriate adjustment for patient size.
   ** Effective Dose is calculated for a population and should NOT be reported for an individual.
2. For the “Radiology imaging center eligibility criteria” section, the specific criteria: “Must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed. The data collected and submitted to a CMS-approved national registry must include, at minimum, all of the following elements: . . .” AAPM recommends:
   1. That CMS revise the wording in the row of data elements titled "Effective radiation dose".
   2. Changing the Data Type to “CT Scan Acquisition and Radiation Dose related parameters.”
   3. Changing specific data elements in that list to the following data elements, which are generally available for the vast majority of CT scanners and especially those used in Low Dose Lung Cancer Screening:
      1. volumetric CT Dose Index (CTDI_vol);
      2. Dose Length Product (DLP);
      3. kV;
      4. Pitch;
      5. Gantry rotation time, and
      6. Reconstructed image thickness
   4. Adding the following if they available (or when they become available in the near future):
      1. Size Specific Dose Estimate (SSDE)⁸,
      2. Water Equivalent Diameter (WED)⁹,
      3. Tube current (mA) or tube current-time product (mAs) or effective tube current time product (effective mAs), whichever one of these is available, and
      4. Scan time (time to complete the exam).

   Rationale for these recommended changes:

   In the table there is a column labeled "Data Type" and "effective radiation dose" is not a data type; in fact this is a non-standard term and may lead to some confusion. Effective dose refers to an estimated quantity that refers to the radiation dose to a population and thus is not appropriate to label or report for individual subjects. Therefore, we recommend "CT Scan Acquisition and Radiation Dose related parameters" because this set of data elements describe how the scan was acquired and elements that relate to the radiation dose used.

   We recommend the collection of data for CTDI_vol, DLP, kV, pitch, gantry rotation time and reconstructed image thickness as these parameters are both: (a) currently available and reported by all CT scanners and (b) describe elements of how the scan was acquired, including an indication of the radiation dose used.

   We recommend the other parameters if they are available (or as they become available) because: (a) not all of these parameters are currently available, but we expect that they will be available in the near future and (b) will provide more information about how the scan was acquired including description of the radiation dose that accounts for patient size.

   Specifically, the SSDE and WED provide a more complete estimate of patient size and the radiation dose to the patient, and takes into account the patient size, which is important because on most modern scanners the radiation dose is scaled to patient size. While not widely available yet, the AAPM has made a formal request to the CT scanner manufacturers (through the Medical Imaging and Technical Alliance) to begin reporting these parameters.

   The reporting of tube current, tube current-time product and effective tube current-time product is suggested because these parameters also provide important information with respect to the CT scan acquisition. There is inconsistent use of these parameters across manufacturers and therefore a standard data element is difficult to define, and will result in reporting ambiguity. The CTDI_vol value described above does take into account the effects of these settings and therefore it is a better descriptor of the scanner output; however this information, when available, would be of value to those individuals involved in radiation dose calculations.

   Finally, reporting the scan time (time to complete the exam) would be an important parameter to determine if centers were scanning in such a way that the CT scan could be completed in a single breath-hold (an important aspect of performing the screening CT exam).

AAPM appreciates the opportunity to comment on Proposed Decision Memorandum on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) and looks forward to continued interaction with CMS on this issue.

Please contact Lynne Fairobent, AAPM’s Senior Manager for Government Relations at (301) 209-3364 or via email: lynne@aapm.org or myself if you have additional questions.

Sincerely,

//signed//

John E. Bayouth, Ph.D., FAAPM

 1 The American Association of Physicists in Medicine (AAPM) is the premier organization in medical physics, a broadly based scientific and professional discipline encompassing physics principles and applications in biology and medicine whose mission is to advance the science, education and professional practice of medical physics. Medical physicists contribute to the effectiveness of radiological imaging procedures by assuring radiation safety and helping to develop improved imaging techniques (e.g., mammography, computed tomography, magnetic resonance, and ultrasound). They contribute to development of therapeutic techniques (e.g., prostate implants, stereotactic radiosurgery), collaborate with radiation oncologists to design treatment plans, and monitor equipment and procedures to insure that cancer patients receive the prescribed dose of radiation to the correct location. Medical physicists are responsible for ensuring that imaging and therapy facilities meet the rules and regulations of the U.S. Nuclear Regulatory Commission (NRC) and various State regulatory agencies. AAPM represents over 8,000 medical physicists.

2 Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N), Nov. 10, 2014, http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo.aspx?NCAId=274&bc=ACAAAAAAAgAAAA%3d%3d& (“Proposed Decision”).

3  International Commission on Radiological Protection, “The 2007 Recommendations of the International Commission on Radiological Protection,” ICRP Publication 103 International Commission on Radiological Protection, Essen, 2007.

4  AAPM Report 204:”Size-Specific Dose Estimates (SSDE) in Pediatric and Adult Body CT Examinations”, http://www.aapm.org/pubs/reports/RPT_204.pdf.

5  Cagnon CH, Cody DD, McNitt-Gray MF, Seibert JA, Judy PF, Aberle DR. Description and implementation of a quality control program in an imaging-based clinical trial. Acad Radiol. 2006 Nov; 13(11):1431-41.PMID: 17111584.

6  AAPM Report 204:”Size-Specific Dose Estimates (SSDE) in Pediatric and Adult Body CT Examinations”, http://www.aapm.org/pubs/reports/RPT_204.pdf.

7  AAPM Lung Cancer Screening CT Protocols Version 2.0 Sept. 9 2014 http://www.aapm.org/pubs/CTProtocols/documents/LungCancerScreeningCT.pdf.

8  AAPM Report 204:”Size-Specific Dose Estimates (SSDE) in Pediatric and Adult Body CT Examinations”, http://www.aapm.org/pubs/reports/RPT_204.pdf.

9  AAPM Report 220:” Use of Water Equivalent Diameter for Calculating Patient Size and Size-Specific Dose Estimates (SSDE) in CT: Report of AAPM Task Group 220”, http://www.aapm.org/pubs/reports/RPT_220.pdf.

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December 8th, 2014

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N)

Dear Ms. Syrek Jensen:

GE Healthcare, a Division of General Electric Company, appreciates this opportunity to comment on the proposed decision memo by the Centers for Medicare and Medicaid Services (CMS) concerning coverage for screening for lung cancer with low dose computed tomography (LDCT).¹

GE Healthcare provides transformational medical technologies and services that meet the demand for increased access, enhanced quality and more affordable healthcare around the world. With innovative medical imaging technologies, software & IT, patient monitoring, in vitro diagnostics, biopharmaceutical manufacturing equipment and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

GE Healthcare applauds and commends CMS for their proposed decision to provide coverage for life-saving LDCT lung cancer screening for Medicare beneficiaries. The proposed coverage policy, however, includes a requirement that LDCT facilities "Must use LDCTs with an effective radiation dose less than 1.5 mSv". For the reasons discussed below, GE Healthcare strongly believes that this requirement should be revisited by CMS before coverage is finalized.

First, establishing a radiation dose ceiling threatens patient care. As noted in the proposed decision memo, The National Lung Cancer Screening Trial (NLST) "estimated that each NLST low-dose CT resulted in an average effective dose of 1.5 mSv" (emphasis added).² The proposed coverage policy, however, would seemingly set the maximum LDCT dose at 1.5 mSv. Setting an arbitrary maximum dose would negatively impact larger patients (BMI, girth, height) because diagnostic-quality images may require higher effective radiation doses for these patients. The proposed maximum would require exclusion of a segment of the eligible, at-risk patients. Medical professional organizations, including the American College of Radiology (ACR), the American Association of Physicists in Medicine (AAPM) and the National Comprehensive Cancer Network (NCCN), recognize that dose must be individualized to the body characteristics of the patient to optimize the diagnostic quality of CT scanning.

Second, the proposed radiation dose measure is not precisely defined, inappropriate as a dose metric for a single patient, and impractical to implement. The use of effective dose has never been intended to be applied to a single patient; rather it is used to estimate risks to large patient populations. NLST used this metric in its report because they were reporting on a large population.

All CT systems must conform to the international standard IEC60601-2-44 "Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography". This enforced standard requires reporting of both the Computed Tomography Dose Index Volume (CTDIvol), expressed in mGy, and Dose Length Product (DLP), expressed in mGy-cm. Both of these dose metrics are globally well defined, and must be be displayed before and after the patient scan. They are also recorded electronically in the patient record via a globally standardized Radiation Dose Structured Report (RDSR). The use of both of these dose metrics would be appropriate and the best choice to use for recording dose. The international committee of CT experts that author this standard intentionally did not include effective dose because it is an incorrect metric to use on an individual patient.

Obtaining effective dose also requires a calculation to be performed, and there are several methods to do so, none of which are standardized. However, one simplistic method uses DLP as its primary input, and hence could be used after the patient exams as part of a dose management program's retrospective look at its scanning techniques using the RDSR.

AAPM recommends that dose be measured using CTDIvol, and is included in all their published LDCT lung cancer (LC) screening protocols. CTDvol is used in the ACR Dose Index Registry, other dose registries, and California's dose reporting law.³ Furthermore, expressing effective dose in milliseverts is impractical because it is not recorded or displayed by CT scanners.

GE Healthcare supports mandatory compliance to the NEMA XR-29 "Standard Attributes on CT Equipment Related to Dose Optimization and Management" standard because it requires the CT system to have the RDSR function as well as to meet NEMA XR-25 "Computed Tomography Dose Check" standard. The Dose Check feature enables the site to set "notification values" for dose (CTDIvol and/or DLP) on a per protocol basis. Hence, for a lung cancer screening protocol an appropriate notification value may be specifically set as a safety mechanism. This could then be reviewed by the accrediting body.

GE Healthcare urges CMS to revise the proposed decision memo by replacing the requirement that facilities must "use LDCTs with an effective radiation dose less than 1.5 mSv" with these new requirements:

• Facilities must use CT scanners that are compliant with the NEMA XR-29 standard.
• Facilities must report dose information (CTDIvol and DLP) to the ACR's Dose Index Registry, or other appropriate registries, to enable monitoring of radiation exposure.
• Facilities must have a bona fide onsite dose management program which includes their input and use of Dose Check notification values for their LC screening protocols.
• The certifying/accrediting body should perform a review of the facilities' dose management program and evaluate the doses being used for CT LC screening, as well as verify that appropriate Dose Check notification values are in place.

GE Healthcare is grateful for the opportunity to submit comments on the proposed coverage policy for LDCT lung cancer screening, and urges CMS to take our remarks into consideration when finalizing this policy.

Sincerely,

David W. Lee
GM and Head of Market Access
GE Healthcare

1 http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274
2 National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID: 21714641
3 SB 1237

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To whom it may concern,

With regard to CMS lung screening and the Beneficiary Eligibility Criteria

1) I request use of the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.

The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation).

Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.

2) I recommend to Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.

This definition is too rigid and inappropriate, as a significant amount of patients will have COPD and some pulmonary symptoms. Excluding patients with “no signs or symptoms of lung disease” excludes a major portion of the patients at risk of lung cancer. It is appropriate to exclude patients with symptoms of possible lung cancer or patients with acute pulmonary symptoms, since these patients should be evaluated for their symptoms independent of consideration for lung cancer screening, but denying screening to patients with symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer.

There is also a strong concern that CMS could retrospectively deny payment for screens given to patients that are ultimately determined to not be “asymptomatic.”

3) I request removal of the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years

This requirement is not evidence-based and it will have unintended consequences: the requirement actually incentivizes patients to continue to smoke, or resume smoking beyond 15 years in order to be eligible for the screening benefit.

4) I request that you Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.
CMS has proposed to require that patients receive a written order for LDCT lung cancer screening that meets the following criteria:
a) Initial LDCT requirements: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit.
b) For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit.

While STS supports shared-decision making between patients and physicians especially prior to the initial LDCT, to require an order for subsequent lung cancer screenings will create added costs (for Medicare and for beneficiaries), decreased compliance, and create a barrier to care for patients who are eligible for screening.

In order for a screening program to be effective, patients must comply. The requirement of an unnecessary clinician visit is a paradoxical and unjustified barrier to screening access and compliance.

5) I request that you Ensure appropriateness, accuracy of materials and references that are utilized for smoking cessation counseling. These materials, especially the formal decision aids, need to provide non-biased information based on actual science.

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As a general thoracic surgeon who cares for lung cancer patients as the majority of my practice, I applaud the decision by CMS to reimburse for CT screening for lung cancer. I do have a few concerns/comments about the proposed guidelines.

1. Although the NLST cut off the study population at 74, the USPTF recommends a cutoff of 80 and I support at least that if not higher. I see patients every week in their late 70s, 80s who are physically and mentally robust, have been found to have lung cancer, are totally curable with resection or SBRT if not robust enough. Denying these patients, who are clearly at risk if they meet the smoking criteria, makes no clinical sense and amounts to age discrimination.

2. Not sure what is specified in the proposal but the screen should occur at first eligibility and then should be annual as with mammography. Should not have to have a doctor visit to be screened just as don't for mammography or colonoscopy. Will serve as a barrier to screening.

3. Again, NLST used quit smoking within 15 yrs as the upper limit of the former smoker criteria for screening. Peter Jennings is the face of the person that quit 20 years prior and I see that week after week. Should not have a time limit on when they quit as long as they meet the pack year requirement.

4. The results of the screening, the handling of all the pulmonary nodules that will ensue, should be managed by providers/programs that meet some yet to be established criteria such that many unnecessary tests aren't done, etc... This needs to be an active area of discussion and research to ensure patient safety and good outcomes.

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As a practicing thoracic surgeon, I respectfully request the following:
Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.
Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.
Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years.
Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.
Ensure appropriateness, accuracy of materials and references that are utilized for smoking cessation counseling. These materials, especially the formal decision aids, need to provide non-biased information based on actual science.

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Major Issues with CMS’ Beneficiary Eligibility Criteria

1) REQUEST TO CMS: Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.

The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation).

Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.

2) REQUEST TO CMS: Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.

This definition is too rigid and inappropriate, as a significant amount of patients will have COPD and some pulmonary symptoms. Excluding patients with “no signs or symptoms of lung disease” excludes a major portion of the patients at risk of lung cancer. It is appropriate to exclude patients with symptoms of possible lung cancer or patients with acute pulmonary symptoms, since these patients should be evaluated for their symptoms independent of consideration for lung cancer screening, but denying screening to patients with symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer.

There is also a strong concern that CMS could retrospectively deny payment for screens given to patients that are ultimately determined to not be “asymptomatic.”

3) REQUEST TO CMS: Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years

This requirement is not evidence-based and it will have unintended consequences: the requirement actually incentivizes patients to continue to smoke, or resume smoking beyond 15 years in order to be eligible for the screening benefit.

4) REQUEST TO CMS: Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.

CMS has proposed to require that patients receive a written order for LDCT lung cancer screening that meets the following criteria:

a) Initial LDCT requirements: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit.

b) For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit.

While STS supports shared-decision making between patients and physicians especially prior to the initial LDCT, to require an order for subsequent lung cancer screenings will create added costs (for Medicare and for beneficiaries), decreased compliance, and create a barrier to care for patients who are eligible for screening.

In order for a screening program to be effective, patients must comply. The requirement of an unnecessary clinician visit is a paradoxical and unjustified barrier to screening access and compliance.

The following proposed requirement: Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening; Will limit the number of healthcare entities that will qualify to provide these screening exams. Consideration should be given to the demand and ability to provide. Limiting the number of locations will not ensure equal opportunity for participation. There will be many hospitals who have not participated in National Lung Screening Trials who would qualify to provide the screenings based on quality of CT exams and low dose parameters for these studies. Expanding the number of sites that can provide this service ensures that persons who qualify and require an LDCT study will have access to one.

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The language in this comment: "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;" will inhibit facilities, mostly hospitals, who are currently not required to hold ACR accrediation status on their CT units. The above mentioned "advanced diagnostic imaging center" verbiage resembles that in the MIPPA act which pertains to IDTFs. The opportunity to provide this service should not be solely limted to only the entities that are IDTFs. Hospital facilities should be allowed to provide the service as well as evidenced by quality studies. Many hospitals to date have not participated in the national lung screening trials. By allowing hospitals to provide the service, more patients will benefit.

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We at Group Health Cooperative appreciate the opportunity to comment on this proposed National Coverage Determination. We fully support the clinical direction of the determination, but have some operational concerns.

One concern is the beneficiary eligibility criteria of “asymptomatic” meaning “no signs or symptoms of lung disease.” Smokers are likely to have signs of lung disease that may or may not be related to cancer. We recommend that CMS clarify patients are eligible if they show “no signs or symptoms suggestive of active lung cancer.”

Additionally, we believe that face-to-face requirements in the NCD are unnecessarily burdensome, adding cost and inconvenience that ultimately impacts the beneficiary. This holds true for both subsequent annual surveillance and for the shared decision making requirement. Furthermore, we believe shared decision making visits are in scope for midlevel providers and shouldn’t be limited to physicians.

Finally, we greatly support the requirement to submit data to a national registry, and believe this will ultimately improve our ability to target appropriate treatments. However we are concerned that the breadth of information required will be difficult to produce in a short timeframe, and that overly-onerous requirements could have the unintended consequence of restricting access to these services to a small group of providers in any given market. We recommend that CMS convene a multi stakeholder group to determine a list of variables that is sufficiently robust, but also cost-effective and feasible to produce.

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The CMS requirement that screening be ordered during dedicated visits would require PCPs to open the lung cancer screening conversation during one visit but postpone a full discussion until a later scheduled “shared decision making” visit. This is contrary to usual primary care practice in which PCPs habitually provide preventive care on-the-fly, incorporating prevention with other patient care needs.

The requirement that PCPs use a decision aid during the dedicated visit is problematic. A PubMed search reveals only one published evaluation of a video-based lung cancer screening decision aid; this aid is unavailable and impractical for most primary care practices. CMS can’t reasonably expect PCPs (or integrated care groups) to develop and to disseminate their own, high-quality decision aids. Even if developed, decision aids are hard to get to the point-of-care, so PCPs rarely if ever use them. This is one reason that PCORI has stopped funding research to develop and test new decision aids.

CMS should consider alternatives to the shared decision-making/decision aid paradigm. One possibility would be to require ordering physicians to complete brief, on-line training (developed by CMS) regarding crucial information about lung cancer screening before they are allowed to order initial screening. CMS could allow integrated health systems to coordinate this training. After training, physicians could attest that they will only order lung cancer screening after assessing and counseling patients appropriately, but not necessarily during dedicated visits.

Another possibility would be for CMS to develop and disseminate a one-page decision aid that would be available to providers in PDF format in several languages. This would greatly facilitate CMS’ goal of promoting shared-decision making for this service. I would still argue that the aid need not be used in the context of dedicated screening visits, as PCPs might have patients review the aid independently while the PCPs steps out of the room to see other patients. The PCP could then return to the patient, confirm eligibility, address questions, and proceed as the patient wishes.

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Dear Secretary Burwell,

I am writing on behalf of The Ohio State University Comprehensive Cancer Center and the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) to heartily endorse your proposal to provide coverage for low-dose computed tomography (LDCT) as outlined in your recent proposed decision memo (CAG-00439N). We agree that a comprehensive screening program should include measures that ensure adequate shared decision making and the necessary radiology expertise in appropriate imaging techniques for screening.

We have already taken these important steps and others in our own screening program to ensure that our patients receive the highest quality of screening care. Our peer-reviewed data and our personal clinical experience with implementing CT screening have shown that when used in a high risk smoking population, this tool can save lives through early detection. We have screened nearly 300 high risk individuals and diagnosed both lung cancer at an early, more treatable stage as well as individuals with previously undiagnosed diseases of the lung –– through LDCT screening. Our program has implemented strict protocols to ensure proper screening criteria, risk stratification and a process of shared decision making. We also provide one on one education regarding screening and tobacco cessation and support a multidisciplinary approach to lung cancer diagnosis and management.

Low dose CT scans represent the first technology to have been found at all effective in diagnosing lung cancer at an early, treatable stage and impacting lung cancer-associated mortality. This is particularly important given the common late stage presentation of disease. By screening for lung cancer among high-risk individuals, we have the opportunity to shift the stage of lung cancer at which patients are diagnosed thus offering them hope for improved outcomes and quality of life. This is particularly important for the Medicare population since so many people are now able to live long and productive lives.

Sincerely,

Michael A. Caligiuri, M.D.

Director, Comprehensive Cancer Center
CEO, James Cancer Hospital & Solove Research Institute
JL Marakas Nationwide Insurance Enterprise Foundation Chair of Cancer Research
The Ohio State University

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The American Psychological Association Practice Organization (APAPO) supports the decision by the Centers for Medicare and Medicaid Services (CMS) to add screening for lung cancer with low dose computed tomography (LDCT) to Medicare. It is critical that Medicare beneficiaries be diagnosed and given treatment as early as possible for this deadly disease.

APAPO strongly recommends that psychologists participate in the shared decision making visit to help individuals understand the risks and benefits of screening. As noted in the proposed decision memo there are risks associated with screening, especially in regards to the incidence of false positives which in turn trigger additional testing. Individuals’ anxiety levels are raised when they are faced with the prospect of having a potentially fatal illness. Psychologists are trained to help individuals deal with anxiety and to articulate their thoughts and fears.

Psychologists have expertise in helping individuals quit or reduce smoking. Many individuals will need to undergo additional screening and begin or continue smoking cessation programs. A psychologist can assist individuals with both their efforts to quit smoking and the need to adhere to additional screenings and/or a treatment regimen. Having psychologists participate in the shared decision making visits will benefit providers and beneficiaries alike as incorporating behavioral health has been shown to increase patient compliance with treatment regimens.

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1) REQUEST TO CMS: Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.

The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation).Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.

2) REQUEST TO CMS: Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.

This definition is too rigid and inappropriate, as a significant amount of patients will have COPD and some pulmonary symptoms. Excluding patients with “no signs or symptoms of lung disease” excludes a major portion of the patients at risk of lung cancer. It is appropriate to exclude patients with symptoms of possible lung cancer or patients with acute pulmonary symptoms, since these patients should be evaluated for their symptoms independent of consideration for lung cancer screening, but denying screening to patients with symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer.There is also a strong concern that CMS could retrospectively deny payment for screens given to patients that are ultimately determined to not be “asymptomatic.”

3) REQUEST TO CMS: Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years

This requirement is not evidence-based and it will have unintended consequences: the requirement actually incentivizes patients to continue to smoke, or resume smoking beyond 15 years in order to be eligible for the screening benefit.

4) REQUEST TO CMS: Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.

CMS has proposed to require that patients receive a written order for LDCT lung cancer screening that meets the following criteria:

a) Initial LDCT requirements: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit.

b) For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit.

While I support shared-decision making between patients and physicians especially prior to the initial LDCT, to require an order for subsequent lung cancer screenings will create added costs (for Medicare and for beneficiaries), decreased compliance, and create a barrier to care for patients who are eligible for screening. In order for a screening program to be effective, patients must comply. The requirement of an unnecessary clinician visit is a paradoxical and unjustified barrier to screening access and compliance.

5) REQUEST TO CMS: Ensure appropriateness, accuracy of materials and references that are utilized for smoking cessation counseling. These materials, especially the formal decision aids, need to provide non-biased information based on actual science.

Thank you for considering thes points.

Sincerely,

Laki J. Rousou, MD

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The Society of Thoracic Surgeons (STS) has submitted suggested changes to the recommended lung cancer screening process with Low Dose Computed Tomography (LDCT).

As a practicing Cardiothoracic Surgeon participating in the largest multidisciplinary lung Cancer program in the Rocky Mountain Region, I fully support each and every change suggested by the STS.

Specifically:
1) REQUEST TO CMS: Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.

The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation). Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.

2) REQUEST TO CMS: Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.

This definition is too rigid and inappropriate, as a significant amount of patients will have COPD and some pulmonary symptoms. Excluding patients with “no signs or symptoms of lung disease” excludes a major portion of the patients at risk of lung cancer. It is appropriate to exclude patients with symptoms of possible lung cancer or patients with acute pulmonary symptoms, since these patients should be evaluated for their symptoms independent of consideration for lung cancer screening, but denying screening to patients with symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer. There is also a strong concern that CMS could retrospectively deny payment for screens given to patients that are ultimately determined to not be “asymptomatic.”

3) REQUEST TO CMS: Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years

This requirement is not evidence-based and it will have unintended consequences: the requirement actually incentivizes patients to continue to smoke, or resume smoking beyond 15 years in order to be eligible for the screening benefit.

4) REQUEST TO CMS: Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.

CMS has proposed to require that patients receive a written order for LDCT lung cancer screening that meets the following criteria:

a) Initial LDCT requirements: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit.

b) For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit.

While STS supports shared-decision making between patients and physicians especially prior to the initial LDCT, to require an order for subsequent lung cancer screenings will create added costs (for Medicare and for beneficiaries), decreased compliance, and create a barrier to care for patients who are eligible for screening.

In order for a screening program to be effective, patients must comply. The requirement of an unnecessary clinician visit is a paradoxical and unjustified barrier to screening access and compliance.

5) REQUEST TO CMS: Ensure appropriateness, accuracy of materials and references that are utilized for smoking cessation counseling. These materials, especially the formal decision aids, need to provide non-biased information based on actual science.

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Lung cancer Is the leading cause of cancer death for men and women in the US. Discovered early, there is a high rate of cure. However, most patients are not diagnosed until the late stages of the disease. Low dose CT screening has been extensively studied and found to reduce lung cancer mortality by the same amount as mammography. This screening technique also compares favorably to number of patients screened to cancers found for other screening tests such as colonoscopy. It is essential that CMS support this screening test by funding it for its beneficiaries.

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As a thoracic surgeon involved with clinical trials for lung cancer since 1999, I applaud CMS decision to approve lung cancer screening by low-dose CT for eligible high-risk persons. I request that the definition of eligibility be changed from "no signs or syptoms suggestivbe of lung disease" to "no signs or symptoms suggestive of lung cancer." Many of these participants have lung disease of various kinds due to decades of smoking, and they should be included, not excluded. Emphysema increases the risk of lung cancer. Secondly, the requirement for a physician visit and order for subsequent scans is burdensome and may be a barrier for continued compliance and access to screening. Please remove this requirement.
Thank you for considering these requests.

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The purpose of this message is to recommend that CMS change its Proposed Decision Memo outlining its coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). CMS should (1) use the USPSTF age recommendation (55-80 years) rather than ages 55-74; (2)remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years. (3)retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening; (4) cover LDCT for patients who have signs or symptoms of lung disease, as well as patients who have no signs or symptoms of lung disease.

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Major Issues with CMS’ Beneficiary Eligibility Criteria

1. REQUEST TO CMS: Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.
   The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation). Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.
2. REQUEST TO CMS: Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.
   This definition is too rigid and inappropriate, as a significant amount of patients will have COPD and some pulmonary symptoms. Excluding patients with “no signs or symptoms of lung disease” excludes a major portion of the patients at risk of lung cancer. It is appropriate to exclude patients with symptoms of possible lung cancer or patients with acute pulmonary symptoms, since these patients should be evaluated for their symptoms independent of consideration for lung cancer screening, but denying screening to patients with symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer.
   There is also a strong concern that CMS could retrospectively deny payment for screens given to patients that are ultimately determined to not be “asymptomatic.”
3. REQUEST TO CMS: Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years
   This requirement is not evidence-based and it will have unintended consequences: the requirement actually incentivizes patients to continue to smoke, or resume smoking beyond 15 years in order to be eligible for the screening benefit.
4. REQUEST TO CMS: Retain the requirement that a patient receive a written order for the initial screen and remove the requirement of a provider visit for subsequent screening.
   

   CMS has proposed to require that patients receive a written order for LDCT lung cancer screening that meets the following criteria:

   1. Initial LDCT requirements: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit.
   2. For Subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit.
   While STS supports shared-decision making between patients and physicians especially prior to the initial LDCT, to require an order for subsequent lung cancer screenings will create added costs (for Medicare and for beneficiaries), decreased compliance, and create a barrier to care for patients who are eligible for screening. In order for a screening program to be effective, patients must comply. The requirement of an unnecessary clinician visit is a paradoxical and unjustified barrier to screening access and compliance.
5. REQUEST TO CMS: Ensure appropriateness, accuracy of materials and references that are utilized for smoking cessation counseling. These materials, especially the formal decision aids, need to provide non-biased information based on actual science.

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I would recommend a seperate CPT code for LDCT's as a better method of tracking how many have been performed and following of results. With the same CPT code as a routine non contrast CT this can increase the chance's of the wrong test being completed.

In your final recommendations can you please be more specific in the criteria of asymptomatic (no signs and symptoms of lung disease) Do you mean patient's with COPD, Emphysema, ILD, Bronchiectasis, Sarcoidosis, Histoplasmosis, or do you mean signs of cancer such as unintentional weight loss.

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The proposed CMS regulations pertaining to low dose CT lung screening violate equal protection clause of the 14th Amendment of the United States Constitution. The US Preventive Task Force recommendations for CT lung screening which become law under the Patient Protection and Affordable Care Act include those 55 to 80 years with private insurance. The CMS proposed regulations for Medicare patients will only cover those 55 to 74 years. The Medicare patients 75 to 80 will not have CT lung screening coverage whereas others will resulting in unequal coverage and results.

Furthermore, the US Preventive Tack Force has no requirements for the procedures to perform CT lung screening whereas the proposed CMS regulations has many restrictions as who and how it is to be performed including:

The proposed radiologist eligibility criteria as stated is:

• Current certification with the American Board of Radiology or equivalent organization;
• Documented training in diagnostic radiology and radiation safety;
• Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years; and
• Documented participation in continuing medical education in accordance with current American College of Radiology standards.

To the best of my knowledge CMS has no legal authority to designate a radiologist eligibility criteria. The US Preventive Tack Force has no such requirements for those interpreting low dose CT lung scans for private insurers. Medical licensure is handled by state government. CMS has no legal authority to designate who can interpret CT images. CMS has legal authority to designate who can interpret mammograms but that is based on federal law concerning mammography. There has been no federal legislation that establishes CMS authority who can interpret CT studies.

Radiologists have been interpreting standard CT lung studies since the role out of CT machines in the 1970's. Radiologists have been interpreting high resolution CT lung studies as well since the 1970's although there has never been CPT codes which distinguishes standard CT lung studies and high resolution CT lung studies.

Interpreting low resolution CT lung studies requires less intellectual effort to perform because there is less to see do to the low radiation dose. Why then are there proposed regulations to require more training to interpret less resolution studies where only lung nodules are looked for?

The proposed regulations only state that the minimum required date elements in the report are to include effective radiation dose including CT dose index, tube current-time, tube voltage, scanning time, scanning volume, pitch, slice thickness (collimation). This shows lack of understanding of CT. In today's world there is the slice thickness during the raw data acquisition and there is the slice thickness in the reconstructions used for interpretation. Which slice thickness (collimation) are you requesting; the raw data of acquisition or the post processing for interpretation? If CMS understood the difference between the old single slice axial acquisition, the single slice helical acquisition, and the multi slice helical acquisition, the above may make more sense. (The FDA image used on page 11 of your proposed regulations appears to be an old single slice scanner.) Discussing these issues with the American College of Radiology would also provide better knowledge of the process.

Furthermore it should be known that to assist in the identification of lung nodules for further evaluation, thick slice 8mm maximum intensity projection reconstructions will add to the ease of identifying nodules when used with other slice thickness reconstructions.

Without this recognition of maximum intensity projection reconstructions, some interpreters may use this process for the benefit of the patient and other interpreters may not. This will result in some facilities providing better evaluation than others.

[PHI Redacted], not realizing until after the fact that the interpreter did not have special reconstruction software for volumetric through the colon reconstructions or flattening out of the colon reconstruction that would assist in the detection of polyps nor did he think it was necessary or helpful.

Hopefully all of the above is understood and will be considered. If you would like to discuss this further you may contact me or the American College of Radiology

Drafts of proposed petitions have be sent by e-mail to caginquiries@cms.hhs.gov.

Attachment

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I applaud the fact that CMS is considering coverage for lung cancer screening.

I have one issue regarding the inclusion criteria. Although any screening test is designed for "asymptomatic" patients, I believe in the case of lung cancer screening the requirement for "no evidence of lung disease" will exclude many potential patients that may benefit from Lung Cancer Screening. In the case of lung cancer, many patients have associated COPD/Emphysema and will likely exhibit respitatory symptoms. I do not believe that such symptoms should exclude them from potenially beneficial screening. I would hope you would reconsider this inclusion criteria. Thank you.

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According to the information, A LDCT screening facility is one that has participated in lung cancer screening trials in the past or is an accredited Imaging Center:

• Does this mean if you have not participated in LDCT prior you cannot start the program?
• Does this mean either ACR accredited or Joint Commission accredited will work to qualify us to be a center?

Must collect and submit data to a CMS approved National Registry:

• What are the options for this registry? Are there multiple registries that we would just need to pick and ask for approval to submit our information?
• Are the registries set up for us to designate someone access?
• Are the required elements set up in the registry to be easy to identify and log?

The low dose screening is an opportunity to identify cancers early, but just want to make sure we are not being asked to duplicate processes, especially with the implementation of the Radiation Dose Tracking mandate in the future.

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To whom it may concern,
I would like to voice my support for coverage of spiral CT for lung cancer screening. I am an Oncologist and understand the importance for screening in this high risk population. Studies have shown definitively that there is a clinical benefit and patients deserve to have this covered to improve the curative benefits we have from surgery, chemotherapy, and radiation. If coverage is not met, I would have to question the motives of CMS as to better the proven health benefits shown by clinical trials, or whether CMS is really trying to snuff out screening for cost measures.

Thank you for your consideration.

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I applaud your proposed decision to cover low-dose CT (LDCT) lung cancer screening in high risk patients for lung cancer who meet the additional eligibility criteria!

I am a radiologist and a nuclear medicine physician at an academic medical center. I have been the imaging director for an NCI-funded lung cancer screening trial for 4+ years, and can directly attest to the effectiveness of the latest data that show reduction in unnecessary biopsies and false-positives, as shown in the peer-reviewed literature, and also in the proposed Lung-RADS screening criteria from the American College of Radiology. Indeed, I suggest that in your final approved decision, that you require ACR Lung Cancer Screening accreditation, or its equivalent. Without such quality requirements, the results could duplicate the early days of screening mammography, where patients were being over-radiated and having poor quality exams that resulted in missed cancers. The patients deserve a high quality study, and CMS's requirement of ACR accreditation, or equivalent, would establish this for CMS recipients, with private carriers likely following suit.

In summary, thank you for thoughtfully supporting lung cancer screening by LDCT in the appropriate high-risk patients who meet additional eligibility criteria. I do suggest that you address LDCT quailty in your final version.

Regards,

Ronald C Walker, MD, FACNM, FACR
Vanderbilt University Medical Center

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I think this is a great step in catching lung cancer early. Too often, lung cancer is diagnosed in its later stages. The treatment is hard for the patient and their family. The cost for treatment is very expensive. I believe the lung cancer screening will allow providers to catch lung cancer earlier. Ensuring better quality of life. Better treatment and less cost for the insurance and patient. This is preventative care. This is a way to keep cost down and care for people.

Respectfully,

Jamie Kuri

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NCA:  Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

CAG-00439N

Summary:  I support your proposal to require that facilities must demonstrate training/experience in performing LDCT scans (Ssection: LDCT Lung Cancer Screening Imaging Centers, page 46) by either having participated in a previous national trial or through professional certification. 

I encourage you to:

1. Retain this requirement, particularly your proposal requiring facility certification;
2. Require that each facility performing LDCT:
   1. Use Board certified or eligible radiologists who have interpreted at least 300 CT Thorax studies in the past year;
   2. Be accredited to perform advanced diagnostic imaging; and, as proposed on page 46;
   3. Be certified by a professional association in the specific performance of LDCT ; or
      1. have participated in a national trial; and,
3. Consider using the ACR’s Lung Cancer Screening Center certification as the template for facility certification.

Discussion: 

Having been involved in developing a lung cancer screening program within our facility, I can attest that performing LDCT is not as simple as many believe.  CT is a complex modality and has complex workflows.  Implementing a safe and effective LDCT program is more than simply performing a low-dose initial Thorax CT exam.  While the initial screening exam is relatively straight-forward, the workflows and processes required to recognize and properly perform follow-up studies are not.  It is important to ensure that facilities and their staff have the requisite knowledge and understanding of the entire LDCT program.  Facilities who are not very attuned to the unique requirements of running a complex LDCT program may struggle to implement a safe and effective LDCT program.  

In addition to minimum requirements for the interpreting physician, similar requirements should be in place for each imaging center/facility.  In my opinion, bullet points #2.c and 3 above, are important to ensuring facilities are capable of implementing a safe and effective programs:  Each facility (hospital, physician-based, or IDTF) should be specifically certified to perform LDCT (or have formally participated in a National Trial).  Certification would ensure facilities meet minimum standards and staff training.  I believe this was your intent by this language, and I encourage you to maintain and expand upon it. 

I suggest you consider using the ACR’s Lung Cancer Screening Center designation as the facility certification template.  The combination of having appropriately experienced radiologists and qualified facilities will ensure Medicare beneficiaries receive the highest quality and safest exam possible.  If you have any questions or would like to discuss this further please contact me. 

Sincerely,

Michael Bohl, CEO
Radiology Group, PC, SC
1970 E 53rd St.
Davenport, Iowa 52807
563.421.5656
mbohl@rgimaging.com

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After 13 years in practice as a board certified Thoracic surgeon I commend CMS for endorsing lung cancer screening with LDCT. Despite advances in treatment, mortality rates are essentially unchanged since 1975. It has become clear that the only way to impact lung cancer mortality is to shift the stage at diagnosis. LDCT will accomplish this with appropriate multidisciplinary review of findings. Coupled with smoking cessation, we can dramatically decrease lung cancer mortality rate in the U.S. I urge you to make this coverage decision final.
Sincerely,
Oliver A.R. Binns, M.D.

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First of all, I am so glad Medicare has decided to potentially cover the CT Lung Screening for their patient population. However, I do have a couple of comments.
1) I would like to propose that the age cap of 74 years be reconsidered and that the "cap" be based on health status instead of age, like the NCCN Guidelines recommend. They word it as patients should "consider annual LDCT until patient is no longer eligible for definitive treatment". In other words until their health is such that they could not undergo treatment (surgery or chemo/XRT) if they were to be diagnosed with lung cancer.
2) Medicare also proposes that patients should be asymptomatic,defined as "no signs or symptoms of lung disease. I would like to propose that "lung disease" be changed to "lung cancer". NCCN Guidlines consider lung disease (COPD, emphysema, pulmonary fibrosis) as additional risk factors for the development of lung cancer. Medicare could even define which symptoms makes one not eligible such as couging up blood, new cough, chest pain, unexplained weight loss, etc.

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November 20, 2014

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Syrek Jensen:

On behalf of Covidien, I am pleased to submit comments to the Centers of Medicare and Medicaid Services (CMS) on the Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).

Covidien is a global healthcare products company. Our extensive product line, spanning medical devices and medical supplies, enables us to serve healthcare needs in hospitals, long-term care and alternate care facilities, doctors’ offices and in the home. As the manufacturer of the superDimension™ navigation system, a minimally invasive electromagnetic navigation platform that aids in the diagnosis of distal lung disease as well as a comprehensive suite of superDimension™ endoscopic tools for lung biopsy, and tools for video-assisted thoracoscopic surgery (VATS) lobectomy, we appreciate the opportunity to comment on CMS’s actions related to establishing a national coverage decision on lung cancer screening. We have seen the benefits of screening through empirical evidence generated from our customers and the extensive body of published evidence.

We are very supportive of the proposed decision for Medicare coverage of Screening for Lung Cancer with LDCT. We believe that the proposed coverage decision appropriately balances clinical risks, harms and benefits will further our mutual objective of ensuring appropriate access to innovative approaches and technologies for patients who are part of an at risk population susceptible to lung cancer.

In particular, we believe that coverage of LDCT lung cancer screening as outlined in the Proposed Decision Memo will provide the ability for Medicare patients to access screening that may lead to earlier stage diagnosis and treatment options, positively impacting life expectancy while lowering the costs of care in a population with limited treatment options (Pyenson BS, Sander MS, Jiang Y, Kahn H and Mulshine JL. An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost, Health Affairs, 31, no.4 (2012):770-779). Advances in technologies that may decrease the time and stage of patients accurately diagnosed with lung cancer are available and making a difference in treatment algorithms and tumor boards across the U.S. Investment in research to develop breakthroughs and enhance current technologies in lung cancer diagnostics will be paramount to the management of the disease. These technologies, paired with access to LCDT screening, have the ability to extend life years and reduce the costs of treatment for Medicare patients who currently have limited treatment options.

In conclusion, we encourage CMS to finalize its draft coverage decision without modification. LDCT lung cancer screening has been demonstrated through the existing body of evidence to increase life expectancy, allow physicians to diagnose patients at earlier stages and ultimately reduce the cost of care in a patient population with limited treatment options. Clinical risks are inherent within screening programs such as the harms associated with over treating, and the proposed parameters for coverage appropriate balance the risks and benefits of LDCT lung cancer screening. It will take innovation and a concerted effort in approach, diagnostics, treatment algorithms and technology to reduce the impact of lung cancer, and Medicare coverage of LDCT lung cancer screening is a critical step towards achieving this goal.

We appreciate the opportunity to provide comments on this final rule with comment. We look forward to working with CMS to ensure appropriate Medicare beneficiary access to life saving lung cancer screening. Please contact Jenifer Levinson, Vice President, Health Policy and Reimbursement, at 202.310.5130 or jenifer.levinson@covidien.com if we can be of further assistance.

Respectfully Submitted,

Michael Tarnoff, MD, FACS
Corporate Chief Medical Officer

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I believe this is definitely a step in the right direction in order to address the overwhelming evidence that supports lung screening and I applaud CMS for recognizing that data. Our facility is acreditited by ACR for chest CT but I would like to see CMS clarify the specifications for an "accredited advanced diagnostic imaging center." Also, I agree with others who have stated that measurement of "effective" dose should be made clear, whether that be as stated in "mSv" or the more common CT dose measure of mGy. In addition, I hope that the clarification of "no signs or symptoms of lung disease" does not exclude someone who currently has emphysema or COPD. Respectfully. pi

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Though the mean CTDI in the NLCST was @ 1.5 mSV, the current ACR recommendations are for < 3 mSv. There is a major degradation in image quality as you go from 3mSv to 1.5 mSv. I believe the value should be at the ACR recommendation. Also, the registry requirement is typical when there is a CMS coverage with evidence development, but lung cancer screening is not CED. This must be explained, or dropped. This requirement may limit some seniors access to screening, as smaller or non-academic facilities may not have the infrastructure to support the registry requirements.

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I am so discouraged that pressure from interest groups and non-medical personnel is being considered in relation to covering lung cancer screening. The MEDICAL board responsible for looking at the science and studies related to effectiveness and harm done by lung cancer screening has judged that more harm than good is done by these screenings. Why can't Congress listen to them? Just about everyone else who is weighing in has something to gain from approving the screenings- radiography companies, technicians, all want screenings covered so they can make more money. Don't approve this unnecessary and sometimes harmful test! Let's be led by science and evidence not passions and money.

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To whom it may concern,
Thank you for the proposed coverage determination, it is truly a huge step that will have a tremendous impact of the overall health of the American public.
As an oncology coordinator for a 281 bed acute care facility, I am concerned about the length of time involved in implementing a registry to meet the requirement. Our hospital already has an active program screening about 25 patients per year, but would need to stop offering this service until both the CMS eligible registries are identified and we are able to establish an account with the registry and implement a process for inputing our data. I would like to propose that the registry requirement have a delayed onset of 1 year (February 2016) to allow for this period of implementation.
Thank you for your consideration.
Sincerely,
Kathy Kronmal
Manager of Oncology and Research
UW Medicine Northwest Hospital and Medical Center

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I congratulate CMS for making the right decision to cover lung screens. I oversee a busy lung screening program in Miami, which started in July and has screened several hundreds patients. We have already caught several cancers. I strongly urge CMS to cover beneficiaries at least up to age 80 (to match the USPSTF criteria of age 55-80) and to consider the NCCN 2nd group criteria as an expansion of the current USPSTF criteria.

In the current decision memo, it is required that the referring clinician elicit smoking history and perform counseling, and I would ask that those criteria be fulfillable by the imaging department using individuals with the same training criteria (e.g., physician or non-physician practitioner). We are often in the best position to explain these risks and benefits. Thank you!

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Look at the data... 67% of people diagnosed with lung cancer die of lung cancer which could have been prevented with earlier detection. Lung cancer is the #1 Cancer of Women and causes the most deaths of cancers per year. Most people who get diagnosed with lung cancer are diagnosed too late because there is NO preventive screening. This NEEDS to change. And No, these people are not just smokers and lung cancer is not just caused by smoking. The death numbers keep escalating each year. This needs to stop.

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With regard to low-dose lung cancer screening CT:

• With respect to the discussed pre-CT clinic visit, eligible for coverage by CMS, who is responsible to perform/arrange/conduct the visit? One would expect not the radiologist; but, is this understood/agreed? If not, why not?
• Regarding radiologist qualifications, what is a “chest CT?” Would chest CT angiograms count? Would cardiac CTs count?
• Also regarding radiologist qualifications, what is “involvement?” Do attending chest conferences in the hospital in which chest CTs are shown count? Would using chest CTs from our teaching collections to teach radiology residents count?
• Regarding calculation of “effective dose,” can a site use the DLP method?

Thank you!

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My colleagues and I have completed an investigation into long-term survival of post-lobectomy persons which demonstrated a 7-year reduction in disease-free survival. This unfortunate penalty is acceptable for persons who would otherwise die of lung cancer. However, it will prove harmful for screen-identified persons who are overdiagnosed, offsetting, to an undetermined extent, the benefit of screening. Notably, this deficit in survival took place largely after 6-years. I would be more than happy to furnish details--abstract,covering letter, text and graphics.

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We are currently seeking clarification re: the LDCT eligibility criteria. Can you please clarify what criteria is needed to meet the “accredited advanced diagnostic Imaging Center with training and experience in LDCT lung cancer screening”?

Our Medical Center did not participate LDCT trials, but does however appear to meet all other criteria needed pending this clarification.

Radiology imaging center eligibility criteria:
For purposes of Medicare coverage of lung cancer LDCT screening, an eligible LDCT screening facility is one that:
- Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;

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I urge you NOT to extend FREE coverage for CT lung scans to smokers. Smokers have been overconsumers of policy holders' and tax payers' dollars for decades. I am a critical care nurse (for 40 years), advanced practice nurse, and supporter of most tenants of the Affordable Care Act but NOT this. Obviously, smokers can afford to pay for the CT scan; at least the cost of a carton of cigarettes. This is a waste of tax payer dollars that can be channeled into other good health care causes.
Janet Foster, PhD, APRN, CNS

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Medicare should only reimburse higher risk patients who meet NLST criteria. At least 20% of persons who meet NLST criteria have an unfavorable benefit-risk profile; CT screening would represent low value care. Medicare is right to endorse and reimburse this new screening method, but should take a proactive, discriminating, safety-conscious approach and deny reimbursement for lower risk patients. Specifically, the analysis by Kovalchik, et al (NEJM, 2013) reveals that > 5000 patients in the lowest 20th percentile of risk among those meeting NLST criteria need to be screened in order to prevent one lung cancer death. This extreme number needing to be screened in order to prevent one cancer death exceeds any conventional standard. Add the fact that the morbidity associated with invasive tests required to truly document CT-detected lung cancer far exceeds the morbidity associated with other screening-driven diagnostic efforts. This underemphasized risk amplifies the need to apply low dose CT only to higher risk groups. Therefore, Medicare reimbursement practice could favorably affect decision-making and reduce CT screening among individuals more likely to be harmed than helped, probably 20-40% of patients who otherwise would be eligible for screening. As examples: Patients 65-74 with only 30-35 pack years of smoking or ex-smokers with < 40 pack-years and > 10 years of abstinence from tobacco are probably not going to be well served by CT screening. Unfortunately, the available practical instruments to help clinicians identify low risk groups have not been disseminated, but will soon be available. This selective reimbursement makes sense. If Medicare reimbursement decisions customarily steer clear of risk-stratification issues, please recognize that eligibility for NLST represents tobacco-driven risk-stratification. Why not take the process another helpful step by denying reimbursement for the lower risk 'NLST eligible' groups? If the analyses cited above seem contrived or secondary, please recognize that this is the best data available, the closest thing to the truth about the value of low dose CT screening for lung cancer. Also recognize that the initial expert endorsements about lung canceer screening will likely be the most influential. Experience indicates that if expert groups and insurers don't promote a selective approach at the outset, we'll likely never see the discriminating safety-conscious approach that the public deserves.

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[PHI Redacted] Tragically, millions of people with Medicare have a similar condition (early development of lung cancer) but are not aware of it until they become symptomatic.

I am writing to you to urge the Centers for Medicare and Medicaid Services Coverage and Analysis Group to mandate for Medicare recipients annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Currently, the Affordable Care Act for private insurers mandates LDCT as a screening benefit for individuals up to age 64, but not for Medicare recipients.

Lung cancer is the leading cause of cancer for both men and women, with more than 156,000 patients dying from lung cancer each year in the United States, a figure that is greater than the mortality rates of breast, prostate, and colon cancer combined.

Furthermore, lung cancer is the leading cause of cancer death in every racial and ethnic subgroup, and is the leading cancer killer of women, taking more lives than breast and every gynecological cancer combined.

Lung cancer screening (LCS) with LDCT is the only procedure proven to reduce lung cancer mortality in individuals at high-risk for lung cancer, and does so cost effectively. It a denial of equal protection not to treat Medicare patients with same level of care that is required of private insurers under the ACA. Please, help others to extend their lives, the quality of their lives, and saving money in the future by approving this proven screening tool for Medicare patients today.

Thank you for your consideration,

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The first requirement for facilities to be eligible to perfrom LDCT is ambiguous and unreasonable. The requirement states that the facility is one that "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening". The requirement does not specify what constitutes "accredited" or "advanced". A straightforward list of unambigous requirements that are achievable for most imaging centers and hospital radiology departments should be presented. th

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I am in support of CMS' approval of screening for Lung Cancer with LDCT. CT Exposures are As Low As Reasonable Acceptable using the ALARA Principle with the application of the ASIR (adaptive statistical iterative reconstruction). This ASIR algorithm enhances patient safety with by using the lowest radiation dose feasible for this CT application. Coupling patient safety and historically effective findings with the use of LDCT, patients are well served by engaging with this type of service for detecting lung cancer at its earliest stages.

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I believe the age limit should be 55-80. Giving an arbitrary cut off age of 74 because "we" would not treat these patients with chemotherapy is incorrect. A patient's performance status and overall health status is more telling of being able to handle chemotherapy treatment than age. Plus the fact that early stage lung cancers are going to be easier to treat than more advanced cancer. I believe the age question needs to be looked at from an ethical view as to are we going to deny coverage because you are "too old" to care about treating now.

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One recommendation on what this guidance should include in its advisory to health care providers:
In addition to counseling patients to continue to refrain from smoking, health care providers should also provide counseling advising patients to test their homes for radon gas and to mitigate radon problems where they are confirmed to exist. Radon is the second leading cause of lung cancer and the great majority of radon-induced lung cancer deaths occur among those who have a history of significant cigarette smoking. For more information, consult appropriate officials at US EPA, DHHS CDC, and the American Lung Association.

References:
www.epa.gov/radon/
http://www.cdc.gov/nceh/radiation/brochure/profile_radon.htm
http://www.lung.org/healthy-air/home/resources/radon.html
Respectfully,
Kevin M. Stewart
Director of Environmental Health
American Lung Association of the Mid-Atlantic
3001 Old Gettysburg Road
Camp Hill, PA 17011
717.541.5864 ext. 136
kstewart@lunginfo.org

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If each of the medical criteria is indeed met and documented, and if the order is placed formally, then why would the "lung cancer screening counseling and shared decision making visit" also be necessary? In that setting, the main effects it would have would be a) to delay the screening lung CT, b) to entail an additional visit for busy patients and busy doctors, really just for documentation of elements that could have been documented already or without a clinic visit, and c) the additional fee for the patient (and/or his/her insurance) to cover that unnecessary clinic visit. Shouldn't the goals be to remove hurdles, not add them, and to decrease costs, not raise them?

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Under patient eligibility criteria for screening, the proposed memo indicates an age range of 55-74 years of age. However, the document published earlier this year by the USPSTF expanded that age range to 55-80 years old. The increased age limit at the upper end was determined from population modelling data from lung cancer screening trials.

Can the CMS age range be brought into line with the USPSTF guidelines? Insurers will need to cover A and B grade recommendations of the USPSTF under the ACA. It would be best to have CMS be consistent with USPSTF in defining age eligibility.

Thank you,
Christopher Wu, MD
Mclean, VA

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I interpret the recommendation for LDCT to be limited to only heavy smokers. This appears to disregard the much smaller groups who suffer from occupational exposure to carcinogens. Patients with documented asbestosis and other pneumoconiosis that are at high risk, even without smoking, should be included. These individuals who through no fault of their own can have serious risk factors.

The National Cancer Institute says: " Many studies have shown that the combination of smoking and asbestos exposure is particularly hazardous. Smokers who are also exposed to asbestos have a risk of developing lung cancer that is greater than the individual risks from asbestos and smoking added together (3, 6).

3. National Toxicology Program. Asbestos. In: Report on Carcinogens. Eleventh Edition. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 2005.

6.Agency for Toxic Substances and Disease Registry. Asbestos: Health Effects. Retrieved April 10, 2009, from: http://www.atsdr.cdc.gov/asbestos/asbestos/health_effects/index.html.

I request you add these high risk patients to the eligible group. Our government or someone should have helped them before their occupation put them at high risk. It seems unconscionable that they would be unprotected again.

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